chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 15 year old female student with hyperhydrosis and acne who on 03-JUL-2007 was vaccinated in to right arm at 10:30 AM with a first dose of Gardasil lot #658094/0524U). On 03-JUL-2007, a second dose of concomitant suspect therapy included Varivax, lot # 657618/0602U, was given in to left arm at 10:30 AM. Other concomitant therapy included MENACTRA lot # 42323AA. The physician reported that "The patient fainted after receiving first dose of GARDASIL. It was reported that the patient did not eat anything that morning". In follow up it was reported that patient fainted about 10 minutes after the injection, she was caught by the nurse and layed down with legs up. On 03-JUL-2007 he patient recovered with no problem. Additional information has been requested.  Additional infromation is not expected.
A report was received from a consumer on 11/18/03, concerning a 6.5 month old male vaccinee who inadvertently received Fluvirin on 11/14/03. On 11/14/03, the vaccinee inadvertently received Fluvirin. The vaccinee did not exhibit any adverse symptoms at the time of reporting. Follow up pending.
Concurrent medical conditions included Diabetes mellitus. Concomitant products included PIOGLITAZONE, GLIMEPIRIDE and LISINOPRIL for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (A little bit sore for a couple of days). On 21-Feb-2021, the patient experienced PAIN (It was really painful), FEELING HOT (It was real warm), HYPERGLYCAEMIA (181 blood sugar), PERIPHERAL SWELLING (Arm got swollen up) and VACCINATION SITE ERYTHEMA (Redness below vaccination site). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 21-Feb-2021, PAIN (It was really painful), FEELING HOT (It was real warm), HYPERGLYCAEMIA (181 blood sugar) and PERIPHERAL SWELLING (Arm got swollen up) had resolved. At the time of the report, PAIN IN EXTREMITY (A little bit sore for a couple of days) had resolved and VACCINATION SITE ERYTHEMA (Redness below vaccination site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Blood glucose fluctuation: 181 Inconclusive. On 22-Feb-2021, Blood glucose fluctuation: 115.4 normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Case number PHEH2015US019572, is an initial spontaneous report received from a health care professional (HCP) on 30 Sep 2015. This report refers to a 43 year old female patient. Historical conditions and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX (batch number: 173539) intramuscularly at a dose of 0.5 ml on 23 Sep 2015. The HCP reported that the FLUCELVAX which was stored at room temperature for 24 hours was administered to employees. No adverse event was reported following the medication error (incorrect storage of drug).
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned. No adverse events were reported. Vial did not undergo any temperature excursion. Vial was placed in refrigerator on 18-Nov-2021.  No treatment medications were reported.
Patient presented with blisters in mouth. He visited oral surgeon who prescribed amoxicillin. Blisters continued to spread throughout the body. He visited our office and a biopsy was done which resulted in the diagnosis of Pemphigus Vulgaris. He was treated with high dose oral steroids, topical steroids and referred to Heme Onc for an infusion of Rituximab
Pt States the evening she got her flu shot she experienced shortness of breath, wheezing, itchy throat, coughing.  She took a benadryl and it was resolved shortly therafter with no issues.  Pt has gotten flu shot before with no current medical concerns.
01/28/22 presents to EC ED for "L arm paresthesias". PMHx of "COPD, small cell lung cancer w mediastinal adenopathy, chronic hypoxic RF/vocal cord paralysis s/p trach"
Patient received a third primary dose instead of bivalent booster.  Patient did not have any reported adverse events due to the third monovalent.  Was told to report to VAERS from the immunization program.
patient received Moderna Vaccine on 7/30/21. Spoke with Guardian on 8/13/21. No side effects reported
fever of 101, runny diarrhea x 4 days;  Annual follow-up received on 10/4/00 states that the pt has recovered. No other data provided.
Case number PHEH216US026715, is an initial spontaneous report received from a healthcare professional on 14 Oct 2016. This report refers to a patient of an unknown age and unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (unknown whether seasonal or pandemic, batch number: not reported) on an unknown date. On an unspecified date, the patient experienced rash for about 12 days so far. The outcome, seriousness and causality of the event were not reported.
Bruise on arm that is about 5 in long and 2 in wide sore to the touch and swollen. Low fever 99.7.
He started losing the use of his hands in October.  Went to see an Orthopedic Dr on November 3rd thinking it was a trigger finger but Dr said it wasn't.  He wanted some neurological tests run to determine if it was a stroke.  Test came back negative.  Neurologist could not determine the issue but advised it was muscle and not nerves. Was sent to a second neurologist for another opinion and they confirmed the results from the first dr.   By December, he had no use of his hands at all.  They consider them claw hands.
VACCINE THAT WAS GIVEN WAS IN THE REFRIDGERATOR PAST THE 10 WEEK VIABILITY PERIOD
Arm site pain; Muscle aches; Joint pain; Nausea; Headache; Tired; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 13Apr2021 at 09:00(at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy, migraine and COVID-19. Concomitant medications included vitamin d nos (VITAMIN D), fexofenadine hydrochloride, pseudoephedrine hydrochloride (ALLEGRA D), multi-vitamin (MANUFACTURER UNKNOWN) and aluminium hydroxide, magnesium hydroxide (MAGNESIUM) for unknown indication from an unknown date. The patient previously received Keflex (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Apr2021 at 12:00, the patient experienced arm site pain, muscle aches, joint pain, nausea, headache and tired. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events arm site pain, muscle aches, joint pain, nausea, headache and tired were not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
No adverse effects were reported in the patient; the physician reports that a patient received a dose of PROQUAD following a temperature excursion; This spontaneous report was received from a physician referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies.  On 09-SEP-2019, the patient received a dose of with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) with lot number S012535 and expiration date on 20-OCT-2020 (dose, dose number, route of administration, anatomical injection site were not reported) for prophylaxis; following a temperature excursion (product storage error).  It was reported that on an unknown date, the vaccines were exposed to a temperature excursion between 15 Fahrenheit (F) degrees to 16 F degrees (-9 Celsius (C) degrees to 8 C degrees) (30 F degrees) for 60 minutes. There were no previous temperature excursions and the Digital Data logger report. was not involved. No adverse effects were reported in the patient.
Initial report was received from a healthcare professional on 06 December 2012. A 30-year-old female patient had received a dose one intramuscular injection of ADACEL, lot number and site not reported, on 03 December 2012. Seventy-two hours later on 06 December 2012, the patient experienced facial swelling, lip swelling and the site was sore with some induration. The swelling was somewhat relieved by BENADRYL and a steroid. The patient had no illness at the time of vaccination and an unknown past medical history. Outcome was not recovered. Documents held by sender: None.
Vomit, fever, extreme dizziness, onset of severe muscle weakness, incontinent, slipped to floor and laid there for 9 hours unable to move not a inch found by family who said I was out of it.
Patient noticed a red, hot tender ring around the site of injection 5 days following vaccination. Ring has grown slowly, and it is believed the reaction began immediately following vaccination, but was not noticed right away. At 5 days post vaccination the area affected is approximately 7 inches in diameter.
said felt tingling and heat in legs. said they felt "like cotton" and was afraid to stand up
Reported at 6:29 sat on toilet with right arm pain of 7-8 out of 10. Reached for her cell phone on sink and had a syncopal episode 1 day post vaccine. reports history of vasovagal and hyperglycemia. A provider she works with was called and she was given juice, crackers, and two Advil. Pain resolved, no other symptoms reported. Is being followed up by her PCP for workup. No other syncopal episodes reported therafeter.
Within 2 nhours post vax, the pt developed hives. Her mother administered diphenhydramine and took the infant to the pediatrician's office, epinephrine was administered. The hives resolved by that evening. The generalized hives treated with epinephrine are considered medically important.
No additional adverse effect reported.; patient received VARN AX via intramuscular route; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history or concomitant medications was provided.  On 22-FEB-2020, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection via an intramuscular way (exact dose, frequency, lot# and expiration date were not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent (manufacturer unknown). No additional adverse effect was reported.
3" circular reaction @ vaccine site Red, swollen, itchy Patient is a 5 year old female. Rash on the leg. Had WCC on Tuesday, received her Quadracel and later that night had developed redness and swelling around the site of injection. It has been itching, so treated with Benadryl with some relief of symptoms. However, today rash seems to be getting worse. Skin is tense and warm, no pain. No drainage. No fevers. Allergy list reviewed Medication reconciliation performed
The first day of vaccination, He said he had a sore arm and was really tired. The following day he said he was tired and arm was sore still then that went away. On January 1st he wasn't complaining of anything, but I did notice that he peed his pants. He has been having accidents for the past couple of days. It had stopped for two days. Then he started peeing his pants again for 3 or 4 days. Now he has an accident about 1 to 3 times a day. That is unusual for him. I haven't taken him to a doctor yet, but we are going to see one today at 2PM because he is still peeing on his self.
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 14-MAY-2015, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" which had a lot number of K007828 and expiration date on 02-MAR-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the GARDASIL vaccine had two temperature excursions; one for 32 hours with lowest recorded temperature of 32 F (0 celsius) and other one for 712 hours with lowest recorded temperature of 33 F (0.555555556 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Pt got Guillain-Barre Syndrome diagnosis 10 days after vaccination. Seen in ER and admitted to hospital to intensive care.
Patient came in with a rash on upper torso, neck, face and scalp.  Patient did not have any difficulty breathing.  Told patient to take Benadryl (which I showed where it was on the shelves) and visit an urgent care for immediate evaluation.
This spontaneous report as received from a health care worker refers to a patient of unknown age and gender. The reporter reported that the patient had received 3 doses of VARIVAX (Merck). On 20-AUG-2012, the patient had the first dose of VARIVAX (Merck) (lot number and expiry date was not reported) 0.5 milliliter (ml) subcutaneously. On 06-AUG-2012, the patient was vaccinated with a second dose of VARIVAX (Merck) (lot number and expiry date was not reported) 0.5 ml, subcutaneous and on 06-MAR-2013 was vaccinated with the third dose of VARIVAX (Merck) (lot number and expiry date was not reported) 0.5 ml, subcutaneously. No adverse effect reported. Additional information has been requested.
Within one hour of vaccine pt complained of itchy little red spots.  Approx. 3 1/2 hrs after vaccine, pt developed increase of itching, hives on face, neck, torso and arms.  Treated with Benadryl.
The patient received her FIRST dose of Moderna COVID vaccine on 1/26/21 and SECOND dose on 2/23/21. On 3/8, she first started to experience shortness of breath, which was attributable to cardiac etiology and diastolic heart failure at the time, but which in retrospect may have been her earliest symptom of new onset myasthenia gravis, which is the AE I am wanting to report. She was hospitalized from 3/8-3/13, and underwent extensive cardiac workup that was negative. She again developed shortness of breath on 3/17/21 and was re-admitted to the hospital on 3/18/21 for diuresis for presumed diastolic heart failure exacerbation, received diuresis from 3/18-3/22/21 but then developed new onset diplopia, at which pint I evaluated her in neurological consultation on 3/22. Her brain MRI disclosed an UNrelated incidental  small left cerebellar infract, but her neurological exam showed a new R lateral rectus palsy and new moderate to severe left eyelid ptosis, suspicious for myasthenia gravis. Anti-acetylcholineseterase antibodies--- binding, blocking, and modulating, were all sent off and came back all strongly positive on 3/26-27/21. The patient then called stating she had developed recurrent shortness of breath, new onset dysphagia, and worsening double vision. I urgently re-evaluated her in outpatient follow-up in my office on 4/2/21 and sent her immediately to the hospital to be readmitted, where she remains as of this reporting date and she has been receiving IVIG with improvement in her symptoms. She did NOT have any previous known history of eyelid ptosis, dysphagia, diplopia, or muscle weakness. In retrospect, the patient states that her current symptomatology began around 3/7/21 with the benefit of hindsight. I am reporting this event because it is very unusual for an 82 year old WOMAN to develop new onset of myasthenia gravis, and it is a known autoimmune disease, and a vaccine would be a plausible trigger for its development, or trigger for its first symptomatic manifestation. I was also especially concerned because my fellow neurologist, ALSO had a patient develop myasthenia gravis about 2 weeks or so following their second dose of the Pfizer COVID vaccine. It would be an EXTRAORDINARY coincidence for two instances of new onset myasthenia gravis to occur 2 weeks post- vaccination at essentially the same time in an institution of our size, so we both felt obliged to report both cases ASAP to the VAERS. I was not able to reach the patient in her hospital room today to get additional specifics about where she got the vaccine, its lot number etc., however she is a retired and has indicated her willingness to provide you with any and all additional information you need, and I am also personally very willing to provide any additional information about her eventual outcome.
Woke up to Uncontrollable shivering and full body shaking at 3 a.m.  very scary.  Lasted for about 30 minutes.  Then was able to go back to sleep.
4/20/16 - Upper respiratory infection. 4/27/16 - Urinary tract infection/urinary reflux. 5/6/16 - Ultrasound urinary reflux. 5/9/16 - Infantile spasms and epilepsy.
developed shingles, saw PCP on day 5 to diagnose, start antivirals. Symptoms (rash, pain) started on day 1.
Approximately 20 min after injection pt began developing itching. Pt was asked to alert nurse if itching increased. Per pt increased in the next 5 min. Pt was brought back to room for evaluation. Pt denied any difficulty breathing, throat or tongue swelling. No visible rash. Pt was having severe itching and 50mg of Benadryl was given IM at 9:55am. At 1015 pt reported decrease in itching. Pt had no other symptoms. Pt continued to have relief from itching after 30 min. Pt was asked to stay an additional 30 min for observation. Pt developed no further symptoms and continued to have relief from itching. Pt was instructed to seek medical attention if itching returned, if she had any difficulty breathing, any swelling of her throat or tongue.  Pt was free to leave at 1120am.
11/8/2022 I woke up with a severe sore throat and could not swallow it was so painful. I also had significant lethargy, fatigue and headache. The next day, those symptoms intensified, and I felt even more fatigued. I went to the urgent care. I had a positive COVID test. Told me what precautions to take, did not prescribe any medications. About 2 days later, I started to feel significantly better. After a week, I was much better. I have long COVID symptoms of headaches, nausea, irregular blood pressure readings, brain fog, off and on fatigue and chilblains.
Patient received the 1st COVID Pfizer vaccine, lot #EW0182 and use by date is 05/13/21 at 0930am. Co-Lead Vaccinator, RN, EMT, and EMT observer,  responded to the patient who stated, " I have the sensation to clear my throat, almost as if there is this pressure in my throat,"  at 0925.  The patient was sitting in the gravity chair and airway was patent, respiratory rate was regular and even with no signs of labored breathing. The patients vitals were taken at 0926 and were as follows: 118/74 ( right arm, sitting upright), 80 bpm, and RR of 15, and alert and oriented to person, time, place, and situation. Lead vaccinator, gave the patient diphenhydramine (Benadryl) 50mg, liquid suspension, PO at 0930. The client was placed in the supine position in the gravity chair. The patient denied difficulty breathing, shortness of breath, itching, dizziness, headaches, or nausea. The patient was talking in full sentences and was in no apparent distress. The patient stated, " The pressure in my throat is getting better, I just want to swallow is all." Vital signs were all within normal limits at 0935: 126/80 (right arm, sitting upright), 80 beats per minute, respiratory rate of 14 breaths per minute, 100% oxygen saturation. At 0940, the patient continued to state, " I just have the sensation to swallow." The patient was placed in fowler's position. The patient continued speaking in full sentences, oxygen saturation levels remained at 100%.  The patient stated, " I prefer to be sitting upright," so the patient was then placed in a sitting upright position in the gravity chair. At 0951, the patient's vital signs were 126/80, 68 beats per minute, 100% oxygen saturation, and 14 respirations per minute.  Patient was able to swallow without difficulty and no distress was observed. Patient verbalized hx of being afraid of needles and has no pertinent medical history. Patient denied having any chronic medical conditions and was on progesterone and estradiol for hormone replacement therapy. At 1000, patient's vital signs were 118/80 (right arm, sitting upright), 70 beats per minute, O2 sat of 100%, and RR of 15 breaths per minute. Patient was instructed about ER precautions. Gave patient V-Safe information, and reported occurrence in VAERS. Instructed patient to inform nurse of previous reaction to the first dose of Pfizer. Patient left site at 1002 with family member who provided transportation.
Pt received Menveo (1st dose) and Bexsero (2nd dose as 1st dose was given at a different location) on 2/10/2020.   Pt stated developed approximately 4cm square like area of red/purple bruising and "hard" swelling to right arm below the injection site.   Reaction lasted about a week and resolved without further issues.   Care Health was unaware of reaction until 2/17/2020 when we called patient to schedule the next Menveo injection.   Per patient scheduler on 2/17/2020: spoke with patient she stated that she had an allergic reaction to the vaccine. Per patient she is waiting to see what her Doctors says and will hold off on making the 2nd appointment.   On 2/28/2020: Program Coordinator/Program: received a call from RN at the MD?s office and she informed me that the MD wishes to not proceed with the Menveo booster due to the patient?s allergic reaction. The patient?s Staff also reached out to me and confirmed this information as well.
10 min post vaccine administration child developed hives on abdomen, left lower and upper arm at injection site. Few on face. Urticaria.  Given Benadryl 25 mg po and observed for 1 hour.  No progression of skin lesions, no systemic symptoms.