chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nose bleed; This is a spontaneous report from a contactable consumer. This 66-year-old male consumer (patient) reported that he received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration on 09Feb2021 at 12:15 (at the age of 66 years) as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6203, Expiry Date: not reported), via an unspecified route of administration in left arm on 02Mar2021 at 12:30 (at the age of 66 years) as dose 2, single for covid-19 immunisation. Medical history included pain and was a cancer patient. Regarding medical conditions, caller stated that he had something to do with his thyroid but that it was not relevant. Family medical history relevant to AE(s): Stated that he had a brother about 40 years ago who had nose bleeds. Stated that was how he knew how to stop his when it started bleeding. That brother currently lived in another location. Concomitant medication(s) included paracetamol (TYLENOL), took one, sometimes as needed taken for an unspecified indication, start and stop date were not reported; gabapentin, 300mg capsule, takes at night as needed taken for pain from an unspecified start date and ongoing (Started about a year ago. He mentioned that he did not take a lot of it, he did not take it every day). No investigation assessment done. Vaccination facility type was pharmacy and not military facility. Prior vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was none. About two weeks into the first vaccination he noticed something but didn't take it for much of anything. He got a nose bleed. On 03Mar2021 (the day after his second vaccination), he got another nose bleed. Never had that happened before. States he washes out his nose in the morning and cleans it out by blowing it and washing it. Stated that since his most recent nose bleed he hasn't been blowing as hard. Nose bleed had not happened again. It only happened those 2 times. Stated that he did not know to call to report until he went to his doctor appointment and mentioned it and they said he should call. His weight as 230, 235, 236. Caller added that his weight was less 3 years ago, that was only after he had an operation. Stated that he had labs done a day before; but they were just routine blood work. Caller did verify that his doctor appointment and blood work from 15Mar2021 were not for this particular event. It was a routine visit and he waited to mention that his nose bleeds until his appointment. No emergency room or physician office visit required. The outcome of event was recovered.  No Follow-up attempts are possible. Information about lot/batch cannot be obtained.
TOOK 3 UNREFRIGERATED DOSES OF VIVOTIF; A spontaneous case report was received from a caregiver on 29-May-2019 for two consumers.  Based on the information obtained from a caregiver, two individual case safety reports PVX201905-000436 (PVX2019-1366; first daughter) and PVX201905-000437 (PVX2019-1367, second daughter) were created and cross-linked in the database.  This case describes a female consumer who "took 3 unrefrigerated doses of Vivotif". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer stored Vivotif at 73 degree Fahrenheit and then, took three unrefrigerated doses. She took the first dose of Vivotif on 25-May-2019.   Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took 3 unrefrigerated doses of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took 3 unrefrigerated doses of Vivotif" was considered as not applicable. US-PaxVax Berna GmbH-PVX201905-000437:
10/12/2020 34 yr female reported to clinic for vaccinations (MMR, Hep B & Flu). After administration of 3rd vaccine employee reported feeling hot and stated "I'm going down". Employee head moved forward, upper body slumped over, RN was at employee side, called out her name, no response, RN called for Syncope assistance at 0908 am. Employee was called by her name and she responded, AAO x 3 (awake, alert-recalled her name, location she was at, and todays date). Employee legs were elevated, wet cloth placed to forehead, sugary drink given, vitals 0908 am BP 96/60, HR 59, RR 17. Employee denies Hx of fainting during injection/vaccinations, Denies any chest pain, no wheezing, no tongue swelling, no neurological deficits noted, and no respiratory deficit. The reason for fainting is unclear-employee assessed by Dr stated possible vagal syncope.  Vitals: Sitting- 0908 am BP 96/60, 59 HR 0912 am BP 98/67 , HR 58 0914 am BP 95/65 , HR 73 0916 am BP 98/67 , HR 58  0920 am 108/69, HR 67 0936 am standing- BP 114/71, HR 74, MD Assessment in progress 0951 D/C sitting vitals BP 113/82, HR 64; standing BP 113/86, HR 77, cleared for discharge by Dr/ RN
first dose 35 days ago; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose 35 days ago) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose 35 days ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose 35 days ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not reported. Nurse has called that the patient who is trying to get the second dose outside of the recommended time frame.
pt recv vax 23SEP96 & 30SEP96 or 1OCT96 pt devel 6 or 7 vesicular lesions in mouth, upper trunk & back accompanied by a low grade fever of 100.5;lesions progressed over the next several days & by 4OCT96 90 lesions;test revealed wild-t
felt tiredness after each of his Moderna Covid-19 vaccinations; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt tiredness after each of his Moderna Covid-19 vaccinations) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (felt tiredness after each of his Moderna Covid-19 vaccinations). At the time of the report, FATIGUE (felt tiredness after each of his Moderna Covid-19 vaccinations) outcome was unknown.            No concomitant medications were reported.   No treatment drugs were reported.   This case was linked to MOD-2022-554801, MOD-2022-554825 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2022: Follow up document contains no new information.
This spontaneous report was received from a certified medical assistant, referring to multiple unspecified patients of unknown age and gender.  Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored RECOMBIVAX HB (lot # M042322 expiration date: 21-FEB-2019; lot # M039642 expiration date: 03-JUL-2019) for prophylaxis. The vaccines were exposed to 32 degrees F to 35  degrees F (0 degrees C to 1 degrees C) and the cumulative time was 32 hours. A data logger was used. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA007407: US-009507513-1703USA007389: US-009507513-1703USA007408:
Woke up at 4:30 AM, felt feverish, got worse as the day progressed. Developed a headache, fast pulse, chills, muscle weakness, etc. took 1000mg Tylenol at 1 PM and 7 PM, symptoms got better each time.
ITCHING(CHIN/NECK), SORENESS OF UPPER RIGHT QUADRANT OF RIGHT BREAST. NO TREATMENT. ALL EVENTS RESOLVED.
I woke up Sunday morning (about 40 hours after the vaccine) with pain in my shoulders, clavicle, collarbone - also had pressure on collarbone, sensitive to touch, and some cough. Pressure and cough have subsided this morning , pain is still present.  It hurts once in a while when swallowing and neck area I checked the lymph nodes at hurt some (I examined my neck like a doctor would to feel for possible swollen lymph nodes but can't tell if they are swollen or not).  I put "no" under recovered because the pain is still there.
Initial report received from healthcare professional on 12 December 2013. A patient (age and gender unknown) whose medical history and concomitant medications were not reported received MENACTRA (lot number and expiration date unknown) (route, site and dose number not reported) on an unknown date. On an unknown date, stated staff member inadvertently stuck self with needle which had been used to withdraw MENACTRA from vial, stated no reaction noted at site was just calling to see if would have any possible reaction. No actual clinical data. Would monitor patient as would any vaccine, will need to follow own facility policy for needle stick, and please call us back if patient would have any reaction. No MIS AE filled since no reaction. Not a PC since was stuck with needle after withdrawing MENACTRA vaccine from vial into own plastic syringe without difficulty and incurred needle stick when "recapping" needle. Laboratory investigation and corrective treatment were not reported. Documents held by sender: none.
Pink, warm area surrounding injection site. Area spread to approx. 10 cm radius c/o pain to area also.
Pt became tachycardia and htn 15 minutes after vaccine. Pt complained of numbness all over. Pt was placed on oxygen, Benadryl 25mg po, and Pepcid 10mg po. Heart rate came down to 90-110 at 15 min after reaction and 30 min after back up to 130s. Pt was sent to Emergency room for further eval.
Cold symptoms starting on 11/7/22 and worsening over 2 days.  Symptoms included frequent dry cough, nasal congestion, fatigue, and chills.  I would describe it as the worse cold I have had.
No signs or symptoms reported; temperature excursion on PNEUMOVAX 23/ PNEUMOVAX 23 was given on 4/2/2021/ Temperature: 0.8C; This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 02-APR-2021, the patient was vaccinated with incorrectly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T035379 with expiration date on 31-MAY-2022, 0.5 milliliter (route of administration was unknown) for prophylaxis. The vaccine underwent temperature excursion of 0.8 degrees Celsius for 54 minutes. No adverse event was reported. Digital data logger was involved. No previous excursions occurred. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
RECEIVED AN UN-NEEDED VACCINE (HBV) DUE TO PARENT ANSWERING TO WRONG NAME - CHILDREN'S NAMES WERE PRONOUNCED THE SAME, BORN SAME MONTH AND YEAR AND NEEDED SIMILAR BUT NOT IDENTICAL VACCINES.  PARENT CHANGED CHILD'S NAME DURING REGISTRATION PROCESS, ALSO.
Eight days after vaccine patient experienced painful bumps on back and sides of his scalp. After five days, patient went to clinic where he was diagnosed with Shingles.  Was prescribed Valacyclovir. Patient is recovering.
2 hrs p/vax pt cried none stop for 2 hrs; lt leg appeared to hurt to mother;
At 10pm on August 5th, 2022, the patient started feeling hot and flush while working.  He received his Influenza vaccine 3.75 hours prior.  His arm became red and warm.  It swelled up a little bit.  It has been sore for 2 days and notified the pharmacy 2 days post injection.  He woke up on August 7, 2022 and it was still pink and had several small bumps at the injection.  The pharmacy did not use any Latex products while administering the vaccine.  He has not had any previous reactions to influenza or other vaccinations in the past per conversations with the patient.
So I received the 4th dose and then a few days later, I started having an itch where my neck meets the shoulder, I have had shingles before and I recognized what it was. On the 19th I went to the medical office building and was seen by NP, which confirmed that it was shingles and she prescribed 21 tablets of VALACYCLOVIR 1 gram each and for me to take them until they were complete. She also prescribed a cream and she also mentioned that it was a possible connection to the vaccine. I took the pills and it seemed to clear up.
A patient received a booster dose instead of the first dose of the Moderna Vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (A patient received a booster dose instead of the first dose of the Moderna Vaccine) in a 28-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (A patient received a booster dose instead of the first dose of the Moderna Vaccine). At the time of the report, ACCIDENTAL UNDERDOSE (A patient received a booster dose instead of the first dose of the Moderna Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were given. No treatment information were given.  A patient received a booster dose instead of the first dose of the Moderna Vaccine, the nurse gave the patient a .25 mL dose instead of a .5 mL dose. HCP just wants to confirm if patient had to be administered with.25 mL so the 2 doses can count as one.  No adverse events were reported as a result of this misadministration.
Headache Pain/Discomfort at injection site, fatigue or tiredness Narrative:
the patient felt dizzy and light headed ...vitals taken 3 times and was released by the nurse.  1. 4:59 temp98, bp 140/92 hr 78 oxy 97 2. 5:05 temp 98, bp 142/90, hr 72 oxy 99 3. 5:15  temp 97.8  bp 130/80, 0xy 98 hr 74  patient recovered and was released by the nurse
The patient came in after 2 months of receiving the vaccination (12/03/2014) to complain of the muscle pain she says got after receiving the flu shot. She says she does not have any pain during the day unless she tries to reach for something. At night she says the muscle is painful and freezes up. She also states that the pain is improving and going away. At the time of getting the flu shot the pharmacist went over all the signs and symptoms of common adverse effects (muscle weakness and pain included) and how to treat them if they should develop.
Patient had sore arm and swelling around the injection site within 24 hours of vaccination. Then bruising started to show up approximately 7 days later (Sept. 23, 2018). Bruise started in Upper Left Arm and then it moved down to his elbow area. He went to his Primary Care Physician on Tuesday Sept. 25, 2018 and Dr. examined his Left arm with bruises and the swelling at the injection site. Dr. told patient that he haven't seen something like this before. Dr. told patient to buy ice pack to apply it to his arm to decrease the swelling at the injection site. On October 1, 2018, the bruise is getting a bit lighter but the swelling at the injection site and sore arm still exist.
WE RECEIVED A TELEPHONE CALL AT 4:45 PM ON 1/27/21 THAT WAS NON RESPONSIVE AND A FOLLOWING CALL AT 5:00 PM THAT SHE HAD PASSED.
Angioedema to lips, tongue, torso, and upper extremities. Rish/hives to upper body. Burning sensation  and redness throughout body unable to wear clothes due to painful to tough on skin, appeared as a severe sunburn. Shortness of breath.
Tachycardia, fatigue, no energy, right leg began swelling, rash.
Carries/cavities in my teeth became inflamed requiring eventual extraction of 4 teeth. I had a strong reaction to this second dose of Pfizer resulting in flu type symptoms for 3 days. I just received a moderna booster 11 / 3  and have only had a mild 1 day reaction.
I had a sore throat for a few days that developed into a dry cough and sneezing. I had coughing with pain in my rib area as well. I had a post nasal drip, causing me to cough and I was feeling tired and fatigued. On July 22, 2021 (few days after symptoms began) I contacted the DR. The outcome of the DR visit was that I had a viral infection. The DR advised take over the counter medication, no prescriptions. I felt better around the 23rd of July anyway.
Information has been received from a RN concerning a 16 month old white female with no illness at the time of vaccination who on 14Nov03 was vaccinated with a first dose of varicella virus vaccine live (lot 644794/0334N), in the right thigh. On 06apr04 the pt developed herpes zoster on chest also reported as a mild case of shingles. Medical attention was sought. The pt was given acyclovir tablets. The pt recovered on 13Apr04. No product quality complaint involved. There were also three other cases reported (WAES0404USa01771, 0404USA01827, and 0404USA01829). No further information is expected.
Initial information has been received for the Pregnancy Registry for GARDASIL from a physician concerning a 20 year old female who was a smoker and allergic to peanuts who on 16-JUL-2007 was vaccinated with a first dose of GARDASIL. The physician reported that the patient was pregnant when she was given the first dose of GARDASIL vaccine. It was unknown if patient sought any medical attention. The outcome was unknown. Follow up information from the doctor's office received concerning a 21 year old (previous reported as 20 years old) female patient who was a smoker (one pack per day), had one Pregnancy and one elective termination (date and year not reported). The patient also had concurrent condition of peanut allergy, attention deficit disorder, questionable bipolar disorder (off therapy x 6 months), "asthma rare", thalassaemia trait ("B thal trait") and was rhesus antibodies negative. On 18-JUL-2007 (previous reported as 16-JUL-2007) she was vaccinated with a second dose of GARDASIL, lot # 653938/0954F. It was reported that on 22-AUG-2007 patient was treated with VITAFOL +DHA for prenatal care and on 18-JAN-2008 she was treated with REPLIVAA 21/7) for anemia. On 20-FEB-2008 she was treated with MONISTAT 7) for yeast infection. It was also reported that she was off of therapy CONCERTA, ABILIFY and KLONOPIN for six months. In follow up information from the physician's office it was reported that patient had an ultrasound on 14-SEP-2007 for validity and dating. The result showed intrauterine pregnancy and fetal heart was positive. On 01-NOV-2007 the maternal serum alpha-fetoprotein test was done and the result was within normal. On 15-NOV-2007 a diagnostic test level 11 was done which showed placenta previa anatomic evaluation was within normal limit. On 21-NOV-2007, 04-FEB-2008 and on 03-MAR-2008 patient received three doses of globulin, RHOGAM x1 for Rh negative bleeding. In follow up it was reported that patient had routine pregnancy laboratory tests and in November 2007 she had "MSQS" laboratory test and the result was within normal range. On 15-NOV-2007 she had a level 11 ultrasound which showed placenta previa and on 30-JAN-2008 she had another ultrasound which also showed placental previa. On 29-FEB-2008 the patient was treated with CELESTONE 12 milligram (for reason unknown). On 01-MAR-2008 patient delivered a normal female baby by cessesaren section delivery due to placenta previa, bleeding 33 weeks from her LMP. The baby weighed 3 lb 10 oz and her length was 16.25. Her apgar score was 8/9 and her head circumference was 30.25 centimeter. The baby was reported as premature and was transferred the neonatal intensive care unit (NICU) in the hospital. Upon internal review mother having placental previa, bleeding which required a cesesarean section delivery was determined to be an other medical event. No other information available at this time. Additional information has been requested.
Moderna 2/24/21, 3/24/21. Positive on 2/1/22
throwing up for the past day; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (throwing up for the past day) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A and 049E21A) for COVID-19 vaccination.     The patient's past medical history included Psoriasis.   On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Sep-2021, the patient experienced VOMITING (throwing up for the past day). At the time of the report, VOMITING (throwing up for the past day) outcome was unknown.            No concomitant medications reported.  No treatment medications reported.
Patient received meningococcal vaccine (MCV4 Menactra by Sanofi-Pasteur) on Wednesday, 4-09-014 around 5:15 in the afternoon.  Patient stated that the injection site was sore for about 2-3 days, and on Saturday, 4-12-14 around 8:00 pm, he noticed that his arm was getting red in the left arm area where the injection was given.  He said the next day the reddened area became larger and by Tuesday, 04/15/16 when he presented to the clinic for evaluation, the area had grown to extend to just below the mid arm but above the elbow.  Patient was advised to take Benadryl in which he did, and he reported today, 4/16/14 that after taking the Benadryl, the reddened area was almost gone.  He stated that he never had pain nor fever with the redness.  The area was slightly raised, but the redness was evenly distributed with no rash.
This spontaneous report as received from a medical assistant refers to an infant female patient of unknown age. On an unknown date between 13-MAY-2013 and 14-JUN-2013 the patient was vaccinated with RECOMBIVAX HB (2.5/0.5 units not provided), (0.5 ml intramuscularly, dose number unknown) (lot # H018691 exp date 07-FEB-2015). RECOMBIVAX HB that had a temperature excursion. NO adverse effects were reported. This case is related with the following cases on same reporter link: 13074USA007921, 1309USA012211, 1309USA012212, 1309USA012213, 1309USA012214, 1309USA012215, 1309USA012216, 1309USA012217, 1309USA012218, 1309USA012219, 1309USA012220, 1309USA012221, 1309USA012222, 1309USA012223, 1309USA012224, 1309USA012225, 1309USA012226, 1309USA012227, 1309USA012228, 1309USA012229, 1309USA012230, 1309USA012231, 1309USA012210. Additional information is not expected.
Right thigh with significant swelling, urticaria 8x6cm area.  Treated with BENADRYL 'X2 with improvement.
Entire body feels as if it is covered in a sunburn. Skin is painful to the touch, multiple joint swelling locations including knees,  feet, and hands. Face swelling,  eye swelling and drainage,  blurred vision. Fatigue and headache first symptoms at onset. Tingling in hands and feet.