chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 21-JAN-2019, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R019391 with expiration date 05-JUL-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
This spontaneous report was received from a 39-year-old female consumer reporting on herself. No information regarding the patient's medical history or concurrent conditions was reported. The patient reported that on separate unspecified dates in 2009, she received the first 2 doses of GARDASIL (doses, routes of administration, anatomical location, lot# and expiration dates were not provided). On an unspecified date, in 2015 (reported as "recently, this past week"), the patient received a dose of GARDASIL (dose, route of administration, anatomical location, lot# and expiration date were not reported). No adverse events were reported. Additional information has been requested.
Vaccine expired on 04-Apr-2022 and stored in the refrigerator on same day of administration; Vaccine was expired on 04-Apr-2022 and administered on 13-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and stored in the refrigerator on same day of administration) and EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 04-Apr-2022 and administered on 13-Apr-2022) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 04-Apr-2022 and administered on 13-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and stored in the refrigerator on same day of administration). At the time of the report, PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and stored in the refrigerator on same day of administration) and EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 04-Apr-2022 and administered on 13-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's weight was reported as 136. No concomitant medication information was provided.  HCP stated they administered expired doses of the Moderna COVID-19 Vaccine to 27 patients. It was reported that the vials were thawed on the same day of administration. The vails had not undergone ay temperature excursion. It was also reported that patient had no known reactions in office. No treatment medication information was reported.
Tested positive again for COVID-19; Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report received from contactable consumer. The reporter is the patient.  An 80-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: EL3247), in left arm, on 01Mar2021 as dose 2, single (Lot number: ENG200), in right arm and on 30Sep2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR; ESTRADIOL. The following information was reported: VACCINATION FAILURE (medically significant) with onset 06Apr2022, outcome "recovered" (14Apr2022), COVID-19 (medically significant) with onset 06Apr2022, outcome "recovered" (10Apr2022) and all described as "Tested positive for COVID-19"; DISEASE RECURRENCE (medically significant) with onset 21Apr2022, outcome "recovered" (24Apr2022), described as "Tested positive again for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Apr2022) Positive; (14Apr2022) Negative; (21Apr2022) Positive; (24Apr2022) Negative; (27Apr2022) Negative; (19May2022) Negative; (02Jun2022) Negative; (08Jun2022) Negative. Therapeutic measures were taken as a result of vaccination failure, COVID-19. Per clinical course, the patient had no known allergies. The patient tested positive for COVID-19 on 06Apr2022. The patient then began taking nirmatrelvir/ ritonavir (PAXLOVID) from 06Apr2022 to 10Apr022. The patient had tested negative for COVID-19 on 14Apr2022 and then tested positive again on 21Apr2022. Further, the patient tested negative for COVID-19 on 24Apr2022, 27Apr2022, 19May2022, 02Jun2022, and 08Jun2022. The patient was administered with the fourth (booster) dose with Moderna COVID-19 vaccine (Lot Number: 038A22A) on 24May2022 in right arm.
Patient receives venom immunotherapy. She received her 1st Covid vaccine on 2/6/21. She was in on 2/23/21 for her  venom immunotherapy and had a  very large localized reaction to this immunotherapy which is not normal for this patient.
Scattered red papules. Few with scabs - scattered over trunk, extremities, scalp, face, pubic area approx 40
Sore arm, red injection site, itching, burning. Not as sore after about 48 hours but still red and hot injection site. Today is 02/04/2021 and arm is still red and a little itchy. and warm.  This is 2 weeks later. No other side effects.
migraine, head pressure, extreme jaw pain, nauseous, vomiting, violent chills, muscle pain in neck, back, spine; no appetite, rash on arm at injection site
mouth tingling; swelling; numbness; body tingling; blood pressure was checked and it was high; This is a spontaneous report from a contactable consumer (patient's mother) reported for a female patient.  A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection Lot/Batch number: unknown), via an unspecified route of administration on 17Jan2021 as single dose for COVID-19 immunization. Medical history included asthma. Concomitant medications were not reported. On 17Jan2021, the patient immediately developed mouth tingling, swelling and numbness and well as all over body tingling. The reporter stated that the patient's blood pressure was checked and it was high and took Benadryl as treatment. The next day, the patient visited her primary care provider, and was prescribed prednisone. The reporter stated that the patient was still experiencing tingling. The patient also visited to an allergist, and had a reaction to the Miralax, which was still very red and itchy. The caller stated that the allergist suggested the patient to double up on Claritin and Benadryl. The reporter stated that the patient also experienced difficulty breathing from allergist inoculations and was prescribed an EpiPen. The reporter wanted to know whether the patient can receive the second vaccine dose. The patient had a physician office visit for the events. The patient received treatment for the events. The outcome of the events was not resolved for tingling and unknown for all other events.  Information on lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
MY SON SICK AND IN THE HOSPITAL; A spontaneous report has been received from a consumer. The report concerns a male patient (age not provided) of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist (influenza virus vaccine live, intranasal) (batch number unknown), via nasal route, on an unknown date.     On an unknown date, the patient experienced my son sick and in the hospital (preferred term: Illness).     It is unknown if any action was taken with Flumist (influenza virus vaccine live, intranasal).     The outcome of the event was unknown.    The event was considered serious (hospitalised).     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST  Common Device Name: Nasal Spray   Product Role: Suspect
Patient stated a week later patient developed a rash on right forearm area near wrist with a small area on his hand. Patient stated it was very itchy and has gotten worse. You can see some blisters on the skin. Patient not sure if it is related to the vaccine or from pulling weeds. Patient advised to contact his doctor on Monday.
Normal arm soreness following a vaccination throughout the day. Around 6 pm though I began to have minor body aches and shivers and I began to feel really cold (fever maybe). I bundled up and took some tylenol before I went to bed at around 10:30. When I woke up at 6:30 I didnt have any of those symptoms, just the arm soreness again, and even that was barely there
After the vaccination on approximately 530pm Oct 18 pt felt fine, no sickness symptoms. Woke up Oct 19 AM w/swollen eyes, red, plugged sinuses, general body aches & pains as if she had the flu. Pt remembers having this reaction about 7 years ago to flu vaccine but did not remember when filling out the pre-vaccination paper work. At 4pm Oct -> eye swelling down but has headache.
Patient had in household exposure to COVID (+), she herself was asymptomatic but did test positive on 4/29/21 with break through COVID as she was fully vaccinated.
Unspecified COVID manufacturer, unspecified route/site, unspecified dose # Reported in patient chart 6/20/21 with swelling, hypertension
Received first injection on 2/26/2021 Rash and welt at injection site tender to the touch still present even 2 weeks after injection
BILATERAL CEREBELLAR STROKES I received the second shot of Pfizer MRNA on Nov 7, 2021. On Nov 29th, ,at the age of 59, I suffered the first of two strokes. Early that morning I woke up at approximately 1 am dizzy, throwing up and having some difficulty when moving my legs. My wife took me to a local emergency hospital. They did a CT scan of my head and said it was clear, no sign of a stroke. I was diagnosed with vertigo, given anti-nausea prescriptions and sent home that morning feeling ok. The following morning it happened again so we went back to the same emergency hospital and they wanted to transport me by ambulance  (See continuation pg)
Hives and welts with itching  starting around the mouth, under the arms, around outside of both breasts and wrapping around the back for aprox 4 days with some shortness of breath at onset. After day 4 just areas of some hives under arms  a bit.
Bad headaches, CHILLS,  fever,  whole body aches, nausea and feeling tired/drained
Information has been received from a registered nurse concerning a 17 year old female with unknown past medical history and unknown allergies, who on 6/28/02 was vaccinated with what was believed to be the first dose of MMR II. Concomitant therapy was unknown. On 7/8/02 the pt developed headaches and a rash. The rash began on her chest and then spread to her back and face. Unspecified medical attention was sought and the pt was treated with naproxen sodium for her headaches, which was effective. Additional info has been requested.
Vestibular issues, vestibular neuritis, vestibular migraine, severe forehead pain, severe tinnitus. Tx included vestibular rehab and nortryptiline 40mg daily. Medication helped 10%.
Pt described loss in range of motion in right arm since 10/15/14 after vaccination.
Health department nurse received phone call from RN at patient's MD office.  Nurse reported client at home and had a seizure following the same morning receipt of a flu shot.  EMS called and arrived at home.  Patient not taken to ER or hospitalized.  Patient has history of epilepsy and has received flu vaccine in the past.
I had a sudden worsening of COPD symptoms that at first I put down to heart issues developing.  My doctor later added inhalers for asthma (anoro elipta daily and albuterol for emergencies)..  I had NEVER had to use inhalers for breathing before and quit smoking 6 years prior to this so it wasnt that!  I still have to use the inhalers to this day and this represented a SUDDEN worsening of my symptoms which had been stable for years prior to the shot and have stabilized since!
Hospitalized (11.18.21);  COVID-19 positive (11.18.21);  Fully Vaccinated  Admission Date: 11/18/2021 Discharge Date: Nov 23, 2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Pneumonia due to COVID-19 virus [U07.1, J12.82] HOSPITAL COURSE:PT is a 65 year old female with a past medical history of type 2 diabetes, hypertension, and hyperlipidemia who had received a COVID vaccine who presented with 2 weeks of symptoms including body aches, anorexia, nausea, and diarrhea.  She was found to be Covid-19 positive with hypoxia in the emergency department and was started on supplemental oxygen and dexamethasone.  At time of admission, she was found to have mildly elevated procalcitonin with findings of lobar consolidation on chest x-ray consistent with a community-acquired pneumonia.  After presenting with several days of diarrhea and poor appetite, she was noted to have an AKI with hypovolemic hyponatremia in the setting of dehydration and was treated with IV fluids.  Her blood sugars were noted to be very labile while on steroids, her home Lantus dose was increased and she received corrective insulin while inpatient.  She required up to 6L oxygen by NC and was weaned to room air prior to discharge. She was treated with ceftriaxone and azithromycin for a total course of 5 days.  She did not qualify for remdesivir, but was treated with steroids, started on dexamethasone in hospital and discharged with instructions continue dexamethasone course as outpatient. Patient was discharged in stable condition, in no acute distress, afebrile, with O2Sat >92% on room air.   Pulmrehab evaluated the patient with ambulating desat to 88% but patient declined home oxygen. Patient will continue dexamethasone at discharge to complete 10 total days. Patient seen by regulatory authortity with home insulin and DM medication reccs at discharge as noted.
2 inches below the vaccine injection site a red, hard, warm lesion has formed (about 2 inches in diameter).
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2010, the patient was inoculated with ZOSTAVAX for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided) at pharmacy for routine adult health maintenance and for the long-term prevention. It was mentioned that the vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2013, the patient was treated in a Clinic for a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. At the time of the report, outcome of the aforementioned events was unknown. The relatedness assessment between the aforementioned adverse events and ZOSTAVAX was related.
Fever up to 105 rectally x 48-72 hours. Irritability.
One hour after the vaccine I had headache, my feet were sweating, a little of wheezing and experienced fatigue.  On day two my symptoms continue  added nausea , cramping of my right toes and an upset stomach feeling started, also I started to feel dizzy.  6/11/21. The ER said to drink lots of fluids and sent me home.  Today is day 14 and I am still sick with nausea and dizziness and anxiety.  I went to my primary doctor on Thursday 6/17/21.   My period arrived 10 days earlier with heavy discharge and small clots.  My period ended  yesterday.   I am not able to drive, work or go out because I am dizzy.   My body feels strange.
An LVN received a bottle of undiluted Pfizer Pedi COVID Vaccination in the morning from the RN.  When there were no more doses left after four doses were given, this was report to the RN.  There were no adverse reactions observed or reported in the patient observation area today.  This medication error was reported to me and immediately escalated to our director at 9:15am.  The nursing director advised us to contact the Infectious Disease Physician for next step.  Dr. advised contacting Pedicatric Infectious Disease.  Dr. informed that four patients received 0.75mcg instead of 0.3mcg of Pedi Pfizer vaccination this morning.  Dr. kindly consulted:  1. No particular action to be done at this point except to contact the parents and make them aware to monitor for the same potential side effect (fever, headache, etc.).   2. Reassure parent/guardian that their child received a lower dose than a teen or adolescent would have received, even with this extra dose.   3. Patient is at higher risk for these reactions, but he is not particularly concerned from a vaccine standpoint.   4. If patient experiences any significant side effects, have physician evaluate.   5.  Continue with second dose as usual, unless strong reaction from this dose.
pain in the arm which he received the vaccine.; muscle aching; This spontaneous report has been received from a 72 year old male patient, who was also a medical doctor, reporting on himself. The patient had no pertinent medical history. His concurrent conditions included drug reaction/allergy to penicillin. His concomitant therapies included ibuprofen, unspecified daily vitamins and a daily unspecified prostate pill.  On 29-AUG-2020 (reported as "10 days ago"), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), one time intramuscular injection for prophylaxis (reported as recommended vaccine). Dose, dose number, anatomical location, lot number and expiration date were not provided.      The patient stated that on 01-SEP-2020, after receiving the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine, he experienced muscle aching (myalgia) and pain in the arm which he received the vaccine (pain in extremity). He was asked if he was experiencing any other side effects or generalized muscle aching and he denied any other side effects. He had been taking ibuprofen to help with the pain but stated that after the medication wore off, the pain flared back up. There was never any swelling or redness, just muscle ache/pain in the entire upper arm where it was administered. No lab diagnostics or studies were performed. The patient did not seek medical attention.  At the time of reporting, the patient had not recovered from pain in extremity and myalgia and the causal relationship between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events was unknown.
Diarrhea with bloody discharge; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer. A male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Feb2021 at SINGLE DOSE for Covid vaccine. The patient medical history and concomitant medications were not reported. The patient experienced diarrhea with bloody discharge. The outcome was unknown.   Information on the lot/batch number has been requested.
Red rash on left arm (arm of injection). Appeared 3 days after vaccine administration.  Was very red and itchy however not quite so bad today.  Specialist told patient over phone that she had an allergic reaction however patient has also had the shingles 3 times in the past (twice in the past 9 months) so we believe it may actually be a mild case. Suggested to the patient to try cortisone cream and benadryl/claritin.  Also suggested that she should follow-up with an ergent care facility tomorrow if gets worse.
Patient stat that he experienced a bruised area which "ooze" out a yellow fluid mixed with blood. He also states he experienced "flu" like symptoms.
Call from mom 12/7 am reporting child woke up at 4:30 fussy, crying, T 102.5/R , 1" size induration, hardness, slight bruise. By 4 hours later size of induration 2". Mom to monitor, use Motrin, compress MD appointment prn.