chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills Headache Dizzy Muscle tenderness Light sensitivity Nausea Confusion Fatigue Huge welt approx. 2 inches below injection site that measures 2inches x 3inches Fever of 102 that has since gone away Nagging cough
Impact to menstrual cycle Reduced regular cycle from 27-29 to 21 -26 days reduced bleeding from 4-5 days to 2-3 days
This spontaneous report was received from a medical assistant, concerning a child (>12 months) patient of unknown gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On an unknown date in January 2018, the patient was vaccinated with improperly stored VARIVAX injection, lot #N022986 and expiration date 23-AUG-2019 (strength, dose, frequency and route of administration were not reported) for prophylaxis. No adverse symptoms were reported. The temperature of excursion was reported as - 6.3 Celsius degrees during a time frame of 1 hour and 26 minutes on 02-JAN-2018. There was no previous temperature of excursion reported. There was a digital data logger involved. This is one among the several reports reported by the medical assistant. Sender's Comments: 1801USA002808: 1806USA010177: 1806USA010178: 1806USA010179: 1806USA010180: 1806USA010171: 1806USA010181: 1806USA010174: 1806USA010173: 1806USA010175.
injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix (intramuscular). In April 2019, less than a week after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: About 2 days before the date of reporting, the patient received Shingrix in the left arm. The patient did not consent to follow up. No further details were provided.
With in 10 min. after receiving the vaccination I started to wheeze, cough and itch my eyes.  I immediately had trouble breathing with the feeling that my throat was closing.  That's when the EMT's took me to the ambulance  and gave me an injection and other treatment  that I can not remember and then I was transferred to the hospital.   At the hospital I received more meds and within a short time other then being tired I felt  better.  I went home and went to bed a slept to the next morning.
CHIEF COMPLAINT:   Pt. arrives via EMS c/o SOB and cough onset yesterday as well as chest pain today. Pt. comes from home found out she is Covid possitive on past Thursday. Denies temperature, diahrrea, nausea, no vomiting either.   HISTORY OF PRESENT ILLNESS:     45 years old female with past medical history of morbid obesity, she has history of prediabetes pituitary microadenoma hyperprolactinemia presents to the ER complaining of shortness of breath, cough, symptoms have been present for 7 days, she scheduled herself for COVID-19 and was positive.  She denies chest pain abdominal pain no diarrhea, no lower extremity edema no orthopnea.,  She was found to be hypoxic in the ER, mildly tachycardic, but no significant respiratory distress.  She has history of morbid obesity and obstructive sleep apnea.
This is a 69y.o. female with a past medical history significant for ESRD, CAD, and diabetes. Limited history secondary to patient's mentation. Patient does admit that she has shortness of breath. On examination she is alert and oriented ×1, BiPAP in place difficulty hearing/understanding patient with mask was on. Discussion with family states that she has been altered for approximately 1 week now. States that she recently had an amputation of right lower extremity forefoot for which she has required multiple transfusions and revision. Limited history with regards to family members medical history. Patient's family member states that she has been in and out of rehabilitation facilities for amputation.     In the ED, Vitals on arrival of T 97.8°F, BP 165/68, HR 71, RR 24, SpO2 99% on 3L Labs remarkable for sodium 136, potassium 6.4 hemolyzed, chloride 101, bicarbonate 23, BUN 56, creatinine 6.87, calcium 9.5. Lipase 52. AST 94, ALT 45, alkaline phosphatase 99, total bili 0.8, direct bili 0.2. Magnesium 2.4. TSH 2.04. Troponin 0.18, 0.19. Alcohol less than 10. Salicylate and acetaminophen within normal limits. Lactic acid 1.3. Covid positive. VBG 7.26/68/30. D-dimer 2530. BNP 3911. ABG 7.37/50/303/28. Iron 28, transferrin sat 13.white Blood cell count 8.1, hemoglobin 7.5, platelets 210. Patient received Decadron 20 mg. Nephrology, cardiology, podiatry, and Neurology consulted.
No adverse effects were reported; the first ofGARDASIL 9 the patient was 14 years and 3 months old, the second dose ofGARDASIL 9 when the patient was 15 years and 3 months old.; This spontaneous report was received from a medical assistant and refers to a 15 year old patient of an unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 21-JUL-2018 (when the patient was 14 years and 3 months old),  the patient was vaccinated with their first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, route, vaccination site, lot# and expiration date were not provided); for prophylaxis.  On 21-JUL-2019 (when the patient was 15 years and 3 months old), the patient was vaccinated with their second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, route, vaccination site, lot# and expiration date were not provided); for prophylaxis. No adverse effects were reported.
On 5-9-21 had a series of brain events - similar to focal epilepsy. Beginning Monday, 5-10-21 through Wednesday 5-12-21, complete memory loss. The days that followed were again the focal epilepsy type episodes, 4 to 5 a day. A 24 hour EEG proved that it was not epilepsy. In October in ER, and MRI verified that I had several stroke events. My right carotid artery is now compromised with fibromuscular dysplasia. In April 2021 had a scan of both carotid arteries and they were completely clear. Vaccine was given in right arm. My brain is now compromised and I have been deemed disabled as I am unable to do much for myself on a daily basis.
About 6 minutes after the shot was administered my daughter was standing with me checking out of the medical clinic and suddenly felt "very thirsty" and then said, "Mama, I'm not feeling well. I am so dizzy," I looked at her and she looked very pale and scared and then leaned on me and suddenly she went limp and fainted. I called the nurse over to help me and then our doctor came running over to help my daughter. They were able to lay her down on the exam table and she came to within about a minute. She was sweating and very scared and feeling very sick. The doctor and nurse gave her crackers and water and took her blood pressure. She stayed there for about 15 minutes eating crackers, drinking water, and had a lollipop. She was still very scared but I was able to get her up and walking around and within a few more minutes we were able to leave the medical clinic.
Resident previously received the Moderna series (2 vaccinations). She was given the Pfizer booster on 10/7/21 with no adverse reactions thus far. MD notified, family notified. Pharmacist administered the vaccine.
next day after the vaccine, i had sharp electrical shocks on the wrist of the right hand and some tingling in hand. my legs have been more shaky and my left hand and arm have been tingling with pain. i've been more tired and dizzy. my body has been achy.   hx of hyponatremia from trileptal (SIADH)
Discrete papular rash over torso with increased popules at groin area, spots on arms, legs also.  Very itchy spots. Vesicles also.  Febrile x 2 days.
No additional AEs/PQCs reported; VARIVAX was administered following temperature excursion; This spontaneous report was received from an other health professional referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-MAY-2023, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot# W031815, expiration date: 05-OCT-2024 (strength, route of administration and anatomical location were not reported) for prophylaxis.   Administered dose of vaccine was exposed for the temperature excursion of 9 degrees Fahrenheit for 2 hours and 6 minutes.  No previous temperature excursion had occurred. There were no additional adverse events reported.  This is one of the five cases reported by same reporter.; Sender's Comments:  US-009507513-2305USA001392: US-009507513-2305USA001570: US-009507513-2305USA001594: US-009507513-2305USA001746:
Patient started Friday (12/18/20 the day the vaccine was given) with itching, swelling, warm to touch, red, and enlarging in size. The symptoms continued to worsen over the weekend and was seen in office today 12/21/20.
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to clinic for follow-up after second vaccination reporting arm swelling. After first vaccination reported arm redness, swelling, and discomfort that resolved with home management. Fifteen days after initial vaccination patient reported fever, diarrhea, headache, and fever and tested positive for COVID-19. Patient's illness resolved with home management and received second vaccine. Arm swelling after second vaccine dose diagnosed as local reaction and home management advised.
Patient had tingling in the mouth and a scratchy feeling in her throat.   Evaluated by EMS.
WCB low; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WHITE BLOOD CELL COUNT DECREASED (non-serious), outcome "unknown", described as "WCB low". Relevant laboratory tests and procedures are available in the appropriate section.  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 physician via company representatives, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 29-SEP-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot No. J007946; expiration date 24-MAR-2016), (route of administration and anatomical location were not reported). On an unspecified dates, the RECOMBIVAX HB had four temperature excursions: 72 hours (Highest recorded temperature was 9 F (9 Celsius); 48 hours (Lowest recorded temperature was 0 F (0 Celsius); 24 hours (Lowest recorded temperature was -1 F (-1 Celsius) and 48 hours (Lowest recorded temperature was 1 F (1 Celsius). No adverse effects reported. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Information has been received from a physician's assistant for the pregnancy Registry for GARDASIL, concerning a female patient with no pertinent medical history or no known drug allergies, who on 10-APR-2009 was vaccinated with the first dose of GARDASIL (lot not reported). The patient was pregnant, her LMP was on 03-MAR-2009 (reported as 12 weeks and 6 days of gestation), her EDD: 08-DEC-2009. The patient underwent prenatal blood work (results not reported) and was taking prenatal medication. Follow up information has been received from a physician assistant who reported that the patient delivered a healthy female on 12-SEP-2009 at 37 +3 weeks EGA (estimated gestational age). The patient had had an unplanned primary cesarean section secondary to fetal breech position. The baby's Apgar scores were 8 and 9 at 1 and 5 min. respectively, and weighed 3089 grams. It was reported that the mother did fine postoperatively and fully recovered. Both she and the baby were discharged home together 2 days postpartum. The mother was seen in the office at 2 weeks postpartum for an incision-postpartum check and "everything was fine." Upon internal review primary cesarean section secondary to fetal breech position was considered to be as other important medical event. No further information is available.
pt @ home had spell w/shaking & was cold & also had episode where pt was pale & unresponsive lasted approx 5-10 minutes;
Using a 3 ml (23 g, 1 inch) dropSafe needle and towards the end of administration the needle twisted off allowing a small portion of the dose to run down the patients arm.
Right after face tighting 2.5 weeks of flu like strmptoms,severe stomach pains, horrific diarrhea,  vomiting,  nausea,  headache, could not think clearly. Malise, rheumatoid arthritis severe flare up  Been sick again for 9 days started 3/28/2021 Severe kidney pain, nausea, headache, lethargic, right calve feels like it is in a fire. Could not figure out what was going on  Diagnosis Shingles 5/5/2021
Woke up at 2:00 AM and every joint, every muscle, every tendon in my body was in excruciating pain. It was like it triggered an attack of Polymyalgia Rheumatica  (PMR). I could not get out of Bed for 2 days. I had the shot on a Thursday and today is Monday and I am still exhausted and not back to normal. My arm was swollen for 48 hours with a big lump.
pt was brought to local ER 31MAR96;fever 105.7 had sl cough;
Starting 1/29/2021 neck muscle soreness began and has gotten progressively worse 1/31/2021 to where it is difficult to move neck.
Patient received PREVNAR 13 on 2/09/2017 and again on 02/05/2018. Patient has not reported any side effects besides arm soreness after the vaccine.
High fever over 103 degrees for an infant for 1 week/7 days. Infection in urine and in blood. Pink eye/conjunctivitis. Hospitalization fluids administered and antibiotics administered. Note: Antibiotics started to be administered prior to blood tests and pink eye tests, etc.
Subsequent to receiving one dose of varicella virus vaccine live, on 7/1/98, the pt experienced a mild case of chickenpox with a slight rash on his face and stomach, on 4/27/99. The next day the pt sought medical attention and it was noted that his lesions were still progressing.
Abnormal Routine CBC 4/15/2021 -> atypical lymphocytes and nucleated RBC'c Referred and hematologist 05/10/2021 and 06/01/2021 Bone Marrow biopsy 5/24/2021 Diagnosed with Bcell Lymphoma officially 06/01/2021
ill; diagnosed w/pneumonia and placed on breathing tubes; erratic and racing HR, unable to get it in control; Severe pain; muscle aches; joint pain; shivers; fever; breathing issues; This case was reported by a consumer via other manufacturer and described the occurrence of illness in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On 19th October 2020, the patient received the 2nd dose of Shingrix. On 19th October 2020, less than a day after receiving Shingrix, the patient experienced illness (serious criteria hospitalization). On an unknown date, the patient experienced pneumonia (serious criteria GSK medically significant), heart racing, pain, muscle pain, joint pain, shivers, fever and difficulty breathing. On an unknown date, the outcome of the illness, pneumonia, heart racing, pain, muscle pain, joint pain, shivers, fever and difficulty breathing were unknown.   The reporter considered the illness, pneumonia, heart racing, pain, muscle pain, joint pain, shivers, fever and difficulty breathing to be possibly related to Shingrix.  Additional details were reported as follows: The patient became ill on the night of vaccination and was admitted to hospital for 12 to 13 days The patient also experienced severe pain, muscle aches, joint pain, shivers, fever, erratic and racing heart rate which were unable to get it in control, breathing issues. The patient stated that he was diagnosed with pneumonia and placed on breathing tubes. The patient's 5 tests for Covid came back negative. The reporter felt good possibiity related to the vaccine.
Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. The patient reported that, he or she got the Shingle shot and also got shingles later. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset for event and laboratory confirmation for shingles were not provided.
1:30 PM- PATIENT  STATED SHE FELT LIKE SHE HAD SOME ANXIETY RELATED TO GETTING VACCINATION AND THINKS SHE GOT TOO WARM IN CAR.  NOTED FACE IS WARM/FLUSHED. PATIENT IS ALERT AND TALKATIVE.  CUFF IS TOO SMALL FOR B/P. HR- 91, PULSE OX- 97%.  1:45 PM- 25 MG BENADRYL GIVEN ORALLY. 1:55 PM CLIENT CHOSE TO LEAVE, STATES SHE IS FEELING BETTER. LIVES NEARBY,  FLUSHING DECREASED.  DROVE SELF HOME.
2 small red knots where injection given in right arm. *ROI sent on 9/21/10 - 0 response.
Jerking his head down and to the right and arms coming up a bit. He has myloclonic is what the ped neurologist said after several EEGs.
there was 5 of us and none of us had reactions, only our shoulders was hurting a little but we had not fever; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 5 patients. This is 1st of 5 reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Enquired, the patient was told that, if she didn't get a reaction that means the shot was not effective and was not working, was that true. The patient stated that, there was 5 of them and none of them had reactions, only their shoulders was hurting a little, but we had not fever. The outcome of the event was unknown.  Information on lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021171051 same drug/AE, different patient.;US-PFIZER INC-2021171050 same drug/AE, different patient.;US-PFIZER INC-2021171048 same drug/AE, different patient.;US-PFIZER INC-2021171049 same drug/AE, different patient.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 33-year-old male. Neither medical history nor concomitant medications were reported. On 26-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. There was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 18-Mar-2009 that indicated no adverse events were reported through the medical clinic. Additional information was received on 12-May-2009 and incorporated into the narrative: Product complaint investigation results.
Feels miserable; Cannot function; Much pain; Ulcers in her mouth; Sores in her mouth on the left side; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH ULCERATION (Ulcers in her mouth), STOMATITIS (Sores in her mouth on the left side), FEELING ABNORMAL (Feels miserable), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Cannot function) and PAIN (Much pain) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A and 050E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, the patient experienced MOUTH ULCERATION (Ulcers in her mouth) and STOMATITIS (Sores in her mouth on the left side). On an unknown date, the patient experienced FEELING ABNORMAL (Feels miserable), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Cannot function) and PAIN (Much pain). The patient was treated with HYDROGEN PEROXIDE (PEROXIDE) for Adverse event, at an unspecified dose and frequency. At the time of the report, MOUTH ULCERATION (Ulcers in her mouth), STOMATITIS (Sores in her mouth on the left side), FEELING ABNORMAL (Feels miserable), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Cannot function) and PAIN (Much pain) outcome was unknown.            No Concomitant medications were reported. Treatment medication include pain pills that are not working.  Additional information reported include that the only thing patient did different than before was getting the vaccine.   This case was linked to MOD-2021-354275 (Patient Link).
a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (a sore arm) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced MYALGIA (a sore arm). At the time of the report, MYALGIA (a sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. No treatment medication provided.
Generalized Vaccinia, lesions on abdomen, back, bilateral arms, face, neck and head appeared 10 days after vaccination, also swollen left axilla lymph nodes, no pruritus. No history of skin conditions. Had chills and feeling sick a couple days after vaccination but has resolved. No treatment, usually self limiting. Placed on 72 hr quarters and provided infection control precautions. Patient to follow up if signs of infection.
Chills, muscle ache, new loss of taste, shortness of breath, fatigue and nausea. Abdominal pain and diarrhea Hospitalization
I cleaned the area of the patient's right deltoid with an alcohol wipe. I administered 0.5mL of the Jynneos vaccine into patient's right deltoid. Patient tolerated vaccine with no sudden reaction.