chrisvoncsefalvay/vaers-outcomes huggingface dataset:
W/in 5min of immun pt started sneezing w/swelling of both eyes; Both eyes swelled almost completely shut; Given Epinephrine at ER;
Head pressure; pain where Botox injected; Extreme pain and pressure; Dizziness; Vertigo; Headache; Ear pain; This is a spontaneous report from a contactable consumer or other non-HCP. A 50-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8729), via an unspecified route of administration in left arm on 09Apr2021 as single dose for covid-19 immunization. Medical history included migraine, Graves' disease, hypothyroidism and blood pressure measurement. Historical vaccine included BNT162B2 for Covid-19 immunization. Concomitant medications included botox, propranolol, emgality galcanezumab levothyroxine and prednisone. On 10Apr2021, the patient experienced extreme pain and pressure, dizziness, vertigo, headache, ear pain patient had head pressure and pain where botox injected. Consumer stated, I was calling to report a reaction to a medication to the second COVID Vaccine. So, migraine suffer (Later clarified as medical history) and I take numerous medications to prevent migraine. One of the interactions that I experienced is Botox injection with and the second COVID vaccine, I had a reaction. Consumer stated, it was not immediate, it was the day after and it would have been, it was Saturday. So, 10Apr2021. Consumer stated, it doesn't have any expiration date. I dont see expiration. There was a date printed here April 2nd. Wherever I received my Botox injection, I received Botox injection in my shoulders, in my neck, left side of my (incomplete sentence), the temples in the face, the upper face. I have extreme pain and pressure. Consumer stated, "After it was getting worse it started getting better, the pressure and pain with causing me dizziness, vertigo and a headache and ear pain I went into my primary doctor and she gave a prescription of steroid, Prednisone 20 mg (treatment) and it started with 3 tablet by mouth for 3 days then it went to 2 tablet by mouth for 3 days then it went 1 tablet by mouth for 3 days and then it went to half a tablet for 3 days. Severe head pressure and upper head pressure. Caller would like to report the reaction she experienced after the 2nd dose. Caller has migraine and experienced pain where Botox injected and also experienced head pressure. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
Adverse Reactions; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced adverse reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse reactions was not reported. This report was non-serious.
Starting 2 hours after vaccination - patient was complaining of fever/chills, nausea, and vomiting. As of 10/30/18 at 8 AM when adverse reactions were brought to the pharmacy attention the patient was still experiencing the adverse reactions.
Information has been received from a consumer concerning a male patient who is a member of his wife's family, who on an unspecified date was vaccinated with a dose of MMR II. On an unknown date, the patient developed autism (Asperger's Syndrome). Consumer did not know the details but suspects MMR II was involved because the grandfather, who is a physician, and related to both families suggested the consumer space out the vaccines when vaccinating the consumer's son to prevent this from happening again in the family. Consumer also mentioned the brother to the child that had autism also was "a little developmentally slow". Consumer did not wish to provide any additional information as he was not close with that family and had no real details. The patient did not seek medical attention. At the time of reporting, the patient had not recovered. Upon internal review, autism (Asperger's Syndrome) was considered to be an other important medical event. No further information is available.
This spontaneous report was received from a registered nurse via company representative referring to a 14-year-old female patient. The patient's medical history included bad cold 2 months prior (September 2013) to the episode. On an unknown date in November 2012 the patient completed vaccination with the 3rd dose series of GARDASIL (lot # not reported( (dose not reported) to prevent HPV. No other concomitant therapies reported. On an unknown date in November 2013, approximately one year after completing a 3 dose series of GARDASIL the patient developed guillain-barre syndrome (hospitalization, medically significant and disability). The patient was then hospitalized for 2 months. The patient was reported to be still paralysed on her left side. The patient sought medical attention. It was reported that the patient was hospitalized in one hospital and was transferred to another hospital. The causality of the event was unspecified. The outcome of the event was reported as not recovered/not resolved. Additional information has been requested.
Pt recv vax on 4/20/99; 5 1/2 hr post vax pt exp back pain, unable to walk; tx=Motrin
had them; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details provided were as follows: This case was reported by patient's friend. Age at vaccination was not reported. The patient received Shingles vaccine and after 2 weeks experienced shingles for a month. Follow-up would not be possible as no contact details available.
This spontaneous report as received from a nurse refers to an unspecified number patients of unknown age and gender. On an unknown date of 2014 (reported as since 08-AUG-2014), the patients were vaccinated with VARIVAX (Merck) which was improperly stored (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse who stated that it will take some time to get the VARIVAX (Merck) information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received on 13-NOV-2014 from the registered nurse concerning a patient (age range reported as 6-12, units not reported) of unknown gender. On 24-OCT-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported) which was improperly stored. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Pt experienced a fever of 102.2 within 72 hours of vaccination given on 3/9/00. Pt was hospitalized on 3/12/00 because of fever rising from 100 - 103 over a period of 48 hours with a decrease of appetite. Symptoms resolved.
Immediately after patient was given vaccine, the patient passed out for 1-2 minutes, then vomited, became light-headed, and broke out into sweats. After 2 minutes the patient regained consciousness, however, the other symptoms persisted for about 10 minutes.
LIGHTHEADED/ ACUTE HEADACHE  INITIAL BP 143/98mmHg - [30 MINUTES POST]  BP 139/88mmHg Treatment cold packs - laid supine with feet elevated - hydration 20 fl oz water.
01/23/2015 after returning from Childcare became fussy and developed fever. 01/25/2015 rash started on face and spread down to the remainder of the body. Developed eye drainage, rhinorrhea, cough, malaise, decreased appetite. Was taken to ER. Treated with antipyretics and testing for measles done. 02/03/2015 symptoms improved and able to return to childcare.
Flu vaccine was not administered correctly. the dose was not injected into the muscle of the arm as recommend.
The pt developed a generalized hives on 9/1/00. No fever and no other problems.
Patient got immediate pain when vaccine was administered too high on the arm. Pain continued to arm immobility including swelling and tenderness with shoulder and joint pain. She also had numbing in the thumb. Patient too 325 mg on tylenol thursday evening for the pain and it did not help.
Despite them checking and double checking with the provider to give him Moderna, they gave him Pfizer; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Despite them checking and double checking with the provider to give him Moderna, they gave him Pfizer) in a 21-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jul-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Despite them checking and double checking with the provider to give him Moderna, they gave him Pfizer). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Despite them checking and double checking with the provider to give him Moderna, they gave him Pfizer) outcome was unknown.            No concomitant medication were provided.  It was reported that 4 weeks ago 20 month old got the Moderna vaccine. Further it was reported that patient got second vaccine. Despite them checking and double checking with the provider to give patient Moderna, they gave Pfizer.   No treatment details were provided
Headache, Myalgia, Arthralgia, Fever LETHARGY/EXHAUSTION Narrative:
Tachycardia developed within minutes of receiving second dose of vaccine and continued for 2-3 hours. Monitored in the ER and when heart came down, was sent home. Experienced tachycardic episodes, lasting for about 5 minutes  off and on for 2-3 days afterwards.
Diagnosed with coronavirus; This spontaneous case was reported by a consumer and describes the occurrence of CORONAVIRUS INFECTION (Diagnosed with coronavirus) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced CORONAVIRUS INFECTION (Diagnosed with coronavirus). At the time of the report, CORONAVIRUS INFECTION (Diagnosed with coronavirus) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, SARS-CoV-2 test: positive (Positive) she got diagnosed with corona virus.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
itchy throat then gave benadryl 50mg and famotidine 20mg at 10:09 ,  Itchy throat persisted and sent patient to ER.  On arrival to ER throat and tongue started to swell.  ER administered EPIpen and steroids and monitored 2 hours post treatment.  Patient had to additional benadryl and pepcid the next evening due to coughing.  Patient started oral steroids on 01/02/2020 in the morning.
EYES ROLLED BACK IN HER HEAD. BODY STIFFENED. ADMITTED TO THE HOSPITAL ON 08/15/2010 EEG CONFIRMED SEIZURES.
At first I noticed weakness and fatigue. Next, when I woke up I was in pain. Everything hurt from my upper neck all the way down to my body except for my feet. My bones, joints, subcutaneous tissue, skin, and muscles hurt. I was just in a lot of pain. I had swelling, numbness, and stiffness in all of my fingers to the point to where I had difficulty using my hands. I am still having these symptoms currently and they are constant, but some days are better than others. I had went to my PCP first. She did bloodwork and said I possibly have Lupus. I have had appointments with neurologist, orthopedic hand surgeon, rheumatologist, and an oncologist. It came to the conclusion that I have an autoimmune disease. I have been having daily nosebleeds since getting the vaccine. October 1st, 2021 when I went to the doctor they said I have a perforated nasal septum which is causing the nose bleeds.
5 minutes post injection, anterior to the injection site became irritated and itchy. The area became red post irritation. There was soreness the next day but this is typical. Starting 1/22/21 at 10 am the site became itchy and inflamed, is now hard to the touch and throbbing.
This spontaneous report was received from an office manager concerning a 12 month old female patient. The patient had no any pre-existing allergies, birth defects, medical conditions or illness at time of vaccination. On 18-JUN-2018, the patient was vaccinated with her first dose of Oka-Merck PROQUAD, subcutaneously in the left thigh, lot # N035174, expiration date: 09-JUN-2019; and with her first dose of Oka/Merck VARIVAX subcutaneously in the left thigh, lot # N031003, expiration date: 03-NOV-2019, both for prophylaxis. Concomitant therapies included PREVNAR and sterile diluent. The reporter stated that "wrong medication was pulled" because the doctor ordered MMR virus vaccine (manufacturer unknown) and varicella vaccine, but the patient received Oka-Merck PROQUAD. During verification, the verifier seen MMR on label, but did not realize it said Oka-Merck PROQUAD "further down the label". No adverse effects reported. On 19-JUN-2018, the patient was asymptomatic, and in a follow up visit 10 days later the patient was still asymptomatic. No prescription drug treatment was required.
This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING ABNORMAL (feel like death/feel dead) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feel like death/feel dead). At the time of the report, FEELING ABNORMAL (feel like death/feel dead) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications details were not reported by the reporter.Treatment details was not reported by the reporter.Reporter did not allow further contact.
"There was a little round, red place" (injection site); "it hurt a little." (injection site); This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA ("There was a little round, red place" (injection site)) and INJECTION SITE PAIN ("it hurt a little." (injection site)) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA ("There was a little round, red place" (injection site)) and INJECTION SITE PAIN ("it hurt a little." (injection site)). On 28-Jan-2021, INJECTION SITE ERYTHEMA ("There was a little round, red place" (injection site)) and INJECTION SITE PAIN ("it hurt a little." (injection site)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include blood pressure and thyroid medication were reported.  No Treatment medication was provided.  patient reported that she was doing physical therapy and it's improving.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up information received on 21-JUN-2021; contains No Significant information
10/4/11 approx. started feeling tired, headache, neck and back pain, felt like muscles contracting, pain in injection side and to armpit, chills temps not taken, restless through the night.
Started feeling really worn out and exhausted, with shortness of breath, with a sore throat, and was coughing more than usual. Took a home test and tested positive. Felt severe aches, fever and fatigue. Called Dr. and was prescribed PAXLOVID. Has started taking it and waiting to feel better.
This spontaneous report as received from an office manager refers to a patient of unknown age and gender. On 10-OCT-2012, the patient was vaccinated with GARDASIL (dose, route and lot not provided). No concomitant medications were reported. The office manager that on 10-OCT-2012 the patient was being administered a dose of GARDASIL from a GARDASIL prefilled syringe but during injection some of the product came out of the syringe tip at the hub of the needle attachment and an incomplete dose was given to the patient. No adverse effect reported. PQC filed. Additional information is not expected.
Patient called 9/27/19 stating that later in the day on 9/24/19 she began experiencing achy joints, nausea, lack of appetite, and redness in her arm (not stated which arm). As of today, she is still experiencing nausea, lack of appetite, and redness in arm (not stated which arm). Patient was counseled to monitor symptoms this weekend. If symptoms are not better by Monday or get worse during the weekend, she should contact us again or her doctor.
On Friday, May 14th, 2021 client received her first dose of Pfizer COVID vaccine to left deltoid (LOT # EW0182, EXP 5/15/21) at approximately 11:04 AM. Pt verbalized the only medication she is on is hormonal birth control, and has a history of a Penicillin allergy, no further allergies or conditions indicated. After receiving the vaccine, the client told RN that she has a history of anxiety and syncopy after blood draws. Pt sat at the vaccine station and stated she was feeling very weak and anxious. Co-lead RN  and Lead RN  noticed pt across the room and went to assess around 11:10. Upon observation, pt looked pale in color and had cool, clammy skin. While at vaccine station, pt had small emesis x2 at 11:12 am. At 11:10 am vitals were taken by EMT : BP: 126/89, HR: 99, O2: 100%. Client was escorted to the zero-gravity chair and was given a bottle of water and Gatorade. Upon assessment by EMTs  client's last meal was cereal at 09:00 am. At 11:35 am vitals were taken: BP: 88/74, Hr: 77, RR: 16, O2 sat: 99%, with a strong radial pulse.  Immediately after, Co-Lead RN  offered pt chips as pt had no further episodes of emesis. Pt sat in zero-gravity chair eating chips and vitals were taken again at 11:55 am, BP: 88/78, HR: 79, RR: 20, and O2: 98%. At that time pt stated that she was ?feeling much better?. At 12:05 pm, final vitals were taken, BP: 95/65, HR: 74, RR: 20, O2: 98%. Patient was alert and oriented x4 during entire interaction. No further interventions indicated. Pt was educated by Co-Lead RN  and Lead RN  on signs and symptoms of adverse reactions and when to go to the ED/call MD. Pt was able to ambulate with her brother-in-law to her car unassisted with a steady gait at approximately 12:07 pm.
This spontaneous report was received from a healthcare worker and refers to a unspecified number of patients of unknown age and gender. In approximately 2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, frequency and route were not reported, lot # M004116 with expiration date: 12-OCT-2017). No adverse effects were reported. Administered vaccine experienced the temperature excursion of 31.5 degrees Fahrenheit for 2 minutes on 10-MAY-2016. Data logger was involved. There was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Pt had a syncopal event within 24 hours of vaccination with tetnus, HPV, and Mennigococal vaccines. Pt blacked out, fell backwards, hit the back of her head fracturing the right occiput. She has an open skull fracture, repaired with staples, pt also has a prolonged qt interval. Pt admitted to the intensive care unit for close cardiac monitoring with ECG and every hour neuro checks.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: Patient reported extreme dizziness and light headedness; found on floor in waiting error. Remained conscious the entire time. Improved with water and cold compress. Called 911 but by the end of conversation patient was up and moving, no need for them to respond.
Injection site became very hot, itchy, red, hard, and inflamed. Large red circle about 1.5 inches in diameter. Lasted 2 days, until poultice of warm turmeric and then ice pack was applied. Took 500 mg tylenol. Went to sleep. Much better next day.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 95 and not receiving regular care in the facility. Last PCP appointment was 2 years prior. He passed away on 3/29/21 with no documented details regarding his possible cause of death. Potential contributing comorbidities include advanced age, CKD, HLD, HTN, CAD, myelodysplastic disease
pt presents with Covid-19 Patient states covid positive with vaccination. Tested positive on 25th, states o2 was low at home. O2 is good here.  Positive for cough.  Decreased breath sounds present. low O2 sat reading. Ambulatory O2 sat of 88% and placed on 2L nasal cannula. CXR shows Covid-19 PNA.  Initiated on steroids-Decadron, azithromycin and O2 supplementation to maintain sats in 90s
diarrhea; vomiting; body aches; fever; nausea; lethargy; sob (Shortness of breath); This is a spontaneous report from a contactable nurse. A 58-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EJ1686, from 04Jan2021 10:45 to 04Jan2021 10:45 at a single dose for COVID-19 immunization. Medical history included heart disorder and prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included prasugrel hydrochloride (EFFIENT), metoprolol, ASA, lisinopril and atorvastatin. The patient experienced diarrhea, vomiting, body aches, fever, nausea, lethargy and shortness of breath (SOB) on 04Jan2021. The patient did not receive any treatment for the adverse events. The outcome of the evet was not recovered.
Injection site reaction. Mild localized redness and swelling. Reaction occurred on 12/15, the day after receiving 1st dose of Pfizer covid vaccine. Day 4 12/18 injection site is circular redness, approx 2.5 inches in diameter. Mild discomfort, not painful not itchy. Have been applying over the counter 1% hydrocortisone cream with some relief.