chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PT MENTIONED SHE WAS NERVOUS ABOUT GETTING THE SHOT.  AFTER SHE RECEIVED THE SHOT, SHE WENT INTO THE WAITING ROOM AND A FEW MINS LATER, FELT LIKE SHE WAS GOING TO PASS OUT. WE HAD HER LAY ON THE FLOOR AND ELEVATED HER FEET.  SHE PROCEEDED TO PASS OUT.  WE ADMINISTERED THE SMELLING SALTS, SHE WAS SLIGHTLY AWAKE BUT OUT OF IT AND SAID SHE DIDN'T SMELL ANYTHING.  WE LIFTED HER MASK AND DID ANOTHER SMELLING SALT AND SHE "WOKE UP" BUT STILL REMAINDED ON THE FLOOR. SHE FELT WEIRD, EYES REMAINDED CLOSED AND SHE WAS SLIGHTLY CRYING AN SCARED.  WE ASKED HER PARTNER IF THIS HAS EVERY HAPPENED BEFORE AND HE SAID SHE HAS ONLY PASSED OUT B/C OF PAIN NOT ANXIETY.  WE TOOK HER PRESSURE/HEART RATE EVERY 5 MIN FOR 15 MIN.  IT WAS ELEVATED 165/110 (HR 69) AND STAYED AROUND THAT EACH READING.  WE ASKED HER IF SHE WANTED US TO CALL EMT AFTER THE FIRST 5-10 MIN AND SHE WASN'T SURE.  15-20 MIN LATER WE CALLED EMT AND THEY CAME TO ASSIST.  THEY TOOK HER VITALS AND THEN EVENTUALLY HELPED HER SIT UP AND EVENTUALLY SHE WALKED OUT ON HER OWN.
First day 37,7 max of fever, pain at injection site, tiredless and little headache. Second day injection site swelling and redness (round more than 10 cm of rush) and pain near lymph nodes under the same arm of vaccine injection site.
Intractable Nausea/Vomiting, Slurred Speech, Loss of Balance, Difficulty Walking, need increase assistance with all Activities of Daily Living
expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered). On 19-Aug-2021, EXPIRED PRODUCT ADMINISTERED (expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   The caller stated that they administered this vaccine to patients after this 30-day mark. That vaccine vials were never punched until use and the doctor at the office wants to know if what else should be done. The office manager stated that they called ever patient the following day and no adverse events were noted, and they performed an antibody test on all of them and the patients antibody numbers were in the 800-900 range.
Severe flu like reactions for 2.5 days. Fever, extreme fatigue, body muscle aches, chills, headache, loss of appetite, slight nausea.
Patient presented to ED with chest pain on her right breast radiating to the back intermittently. No associated N/V, diaphoresis, or SOB. Pt was started on a heparin drip but was later discharged home after being cleared by cardiology. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.
Dizziness/vertigo. Feels like I?m falling for a split second or the earth shifted to the side. Also strange heart palpitations every so often, one or two hard beats then normal. Saw cardiologist in 2020 and there were no abnormalities. I did not have the covid virus.
After receiving Covid 19 vaccine the patient had Flushing, extreme  sweating and passing out while sitting. The pharmacist & I propped his feet up, gave him an ice pack and waited with him until he felt better.
This spontaneous report was received from a female patient over 26 years old, referring to herself. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On 05-JUN-2018, the patient was vaccinated with the first dose of GARDASIL 9 0.5 ml, for prophylaxis (strength, route, lot number and expiration date were not reported). On 31-JUL-2018, the patient received the second dose of GARDASIL 9. Since an unknown date, the patient's period became irregular, skipping a month and then had two within the same month (menstruation irregular). The outcome of menstruation irregular was unknown. Causality assessment was not provided.
Developed flu-like symptoms, including headache within 24 hours of receipt of vaccine. On day 2 post vaccination developed blurred vision and increasing cephalgia. On day 4 post vaccination developed diplopia and sixth cranial nerve palsy.  Nurse follow up on 06/28/04 states: "ADD: photophobia, eyes aching, bilateral perceptual decompensation, esotropia, Immune mediated response to vax, fatigue, insomnia, falling."
shoulder pain gone/shoulder injury and pain didn't have that anymore after; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (shoulder pain gone/shoulder injury and pain didn't have that anymore after) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Shoulder injury (didn't have that anymore after the Moderna vaccine.) and Pain (didn't have that anymore after the Moderna vaccine.).    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 THERAPEUTIC RESPONSE UNEXPECTED (shoulder pain gone/shoulder injury and pain didn't have that anymore after). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (shoulder pain gone/shoulder injury and pain didn't have that anymore after) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment medication was provided. Reporter states as the shoulder pain issue was NOT me, but an article I shared with her about another lady.   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2021: Significant follow up-Patient identifier gender female provided. i-narrative updated (as the shoulder pain issue was NOT me, but an article I shared with her about another lady).
patient presented to pharmacy complaining of painful arm radiating down to her hand from injection site along with swelling in left arm. Patient also reports blisters in mouth and throat as well as generalized itching
Systemic: Chills-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Additional Details: pt reports that he was very nervous coming in to get the shot and felt immediately lightheaded after administration. we gave him a sugary drink and 2 benadryl and called ems. Patient declined EMS offer to go to the er. They determined his blood pressure and heart rate were slightly elevated but within allowable range. He went home under the care of his partner. I instructed them to report to the er if any other symptoms occur and to follow up with us if there is anything else
Aug 11- Awoke with small rash at injection site and a sense of being off. At approximately 1pm, began to experience tunnel vision, shortness of breath, chest pressure, clamy skin, loss of color, headache, dizziness and nausea. Went to hospital.
Red, warm, itchy patch around injection site starting a week after injection.  This is the third day of reaction.
Vaccination was being entered into the computer and it kicked out the lot number for DTAP. I do not know if DTAP, for sure, was given or if TD R/T is on paper. Usual routine is to give infant DTAP not TD. Could have had an adult just before and was to that lot number and through DTAP bottle away. Called state for what to do. There was no incidence with child as come in her and was seen and no complaint by parent. No reaction. (Given TD instead of DTAP and state instructed pt to come in a get DTAP. He got that dose today. DTPA, IM, RL).
Diffuse pruritic rash all over body. Symptoms persisting despite home use of Benadryl x 5 days.
Information has been received from a physician concerning a 16-year-old male who was vaccinated (in infancy) with his first dose of varicella virus vaccine live (Oka/Merck) and not a second booster. On an unknown date (when he was 16-years-old) the patient developed a rash pleomorphic on torso and neck classic of chicken pox (previously reported as varicella), as well as a fever, headache, and sore throat. The patient was seen in the emergency room (previously reported as "hospitalized"). The patient was discharged from the ER on symptomatic treatment. The physician reports that "this is a case of a 2nd booster". On an unknown date the patient recovered. A product quality complaint was not involved. Additional information is not expected.
About 10 min after receiving the vaccination, patient felt faint and passed out while walking around in the store. EMS was called and assessed the patient. Patient was conscious and did not need to leave with EMS.
This spontaneous report refers to a 65-year-old female patient reporting on herself. Pertinent medical history included high blood pressure and reaction/allergy to KEFLEX. On 19-DEC-2014 the patient was vaccinated with ZOSTAVAX (strength, route, dose, lot, batch # and expiration date not reported) in the left arm. Concomitant therapies included medication for blood pressure. On 21-DEC-2014 she was extremely tired and slept for almost the whole day. On 22-DEC-2014, she felt faint and had a drop in blood pressure. She also reported that the vaccination site was hot to touch and she had a rash. (On an unknown date in December 20140. She saw a non-primary doctor who marked the rash with a marker to see if it spread. There was not treatment given for the events. The outcome of vaccination site was hot to touch and she had a rash was not recovered. The outcome of she felt faint, she was extremely tired, she slept for almost the whole day and had a drop in blood pressure was unknown. Additional information has been requested.
Syncopal episode 15 minutes after injection with HPV #1 and MENACTRA. Brief loss of consciousness (less than 1 minute).
19 yo female presents with swelling and pain in R arm after getting several vaccines 4 days ago. Also had severe GI sx very quickly after vaccinations, had to go to ED for IVF and treatment, released yesterday afternoon. 4 days ago had rabies vaccine, influenza, pneumococcal and meningococcal. Unsure which arm got which vaccine (Rabies and pneumococcal vaccine given in L deltoid, Influenza and MENVEO in R per records). 5 hours later started to note lightheadedness and nausea, and left arm pain. Started to have joint pain and sensitivity of skin on soles of feet. Tossing and turning all night due to discomfort in back and hips. Woke up with sweats. The next day felt day felt better when awoke, but then quickly started to feel myalgias/arthralgias and nausea again. Unable to eat due to nausea. Having shaking chills and fever which persisted throughout the night. The next day mother came down and brought her ibuprofen/acetaminophen and ginger ale. But nausea getting worse, started to vomit. Vomited multiple times. Went to ED due to vomiting and dehydration. At that time was noting some pain in left arm, and red bump left deltoid area. Had labs done (influenza negative, noted to have elevated WBC of 24). Got IVF, nausea medicine, and sent home; told likely reaction to vaccine. Nausea and vomiting now improved. Ate bagel yesterday and small bowl of cereal this am. Last ZOFRAN just prior to coming in. Arm has been sore since vaccinations, then over past 2 days left arm getting more swollen, with a few scattered areas of erythema. This morning arm more swollen, feeling a little "numb". Yesterday was more painful, today more swollen and "numb" over lateral arm in area of swelling. No more chills. Did have sweats last night. Generally feeling much better, other than left arm swelling and blotchy rash. No myalgias or arthralgias. Immunizations reviewed: no hx of prior rabies vaccines (this was first), no hx of prior pneumococcal vaccine.
Tingling is hands and feet, shooting pains in brain stem and head, feeling foggy, arms and legs fully feeling like they are ?falling asleep?
Got dropped foot within 10 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Lot number: Unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERONEAL NERVE PALSY (non-serious), outcome "unknown", described as "Got dropped foot within 10 days".  Additional information: When the reporter was asked if there is any other people who got the vaccine (Pfizer COVID-19 Vaccine) and experienced the same issues, reporter stated, "Yes, because I know 2 girls they got dropped foot within 10 days". The reporter also stated, "That is not my place to report about their medical information but I will give them this number for them to call because I don't know the total exact."  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300400555 same drug/event, different patients;
Information has been received from a female consumer of unknown age referring to herself. The patient's pertinent medical history and drug allergies were not reported. On an unknown date of 2014 (reported as last year) the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, strength and route unknown). On an unknown date of 2015 (reported as this year) the patient experienced a thumbnail sized flaky red spot with a pimple. The spot of the red pimple was dry and flaky. The outcome of the event was unknown. Causality was not provided. Additional information is not expected since there is no physician's contact information.
Headache, Myalgia, Arthralgia, Fever,  chills, fever to 103.6, body aches, H/A, back ache
Patient woke up at 3 AM feeling chills and chest pain, reported fever. She went to the emergency room and was admitted until the 24th. She had tachycardia and leukocytosis and was treated with broad spectrum antibiotics because of suspected sepsis. Blood and urine cultures returned negative.
Onset of fever 4 days after vaccination, fussy....102 rectally - ran temp in that range till 7/12/11 when temp increased to 103 degrees. Then began to subside now no longer fussy....fever free. 7/13/11.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The reporter stated that the patient experienced soreness for three days at the injection site after receiving the SHINGRIX vaccination. The reporter (patient's husband) gave permission for physician to be contacted. The reporter filed additional report for himself (for tolerance see case US2018158148).
1 day after immunization had flu like symptoms consistin of low grade fever, vomiting, all over muscle ache
Blister at site of injection which opened and started stinging; Wrist swelling; Slight temperature increase; Chills; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 11:00 (at the age of 79-years-old) as a single dose for COVID-19 immunisation. Medical history included colitis, heart stent and valve replacement. Concomitant medications included losartan (MANUFACTURER UNKNOWN), atorvastatin calcium (LIPITOR) and mesalazine (LIALDA), vitamin c (MANUFACTURER UNKNOWN) and vitamin d nos (MANUFACTURER UNKNOWN)  started on an unknown date for an unknown indication. The patient received augmentin (MANUFACTURER UNKNOWN) for an unknown indication and experienced allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 17Mar2021 at 11:00 (at the age of 79-years-old) as a single dose for COVID-19 immunisation. 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 07Apr2021 (day of injection), the patient experienced fatigue and chills, on 08Apr2021, the patient experienced blister at injection site, wrist swelling, slight temperature increase on second day after vaccine.  No therapeutic measures were taken as a result of these events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event blister at injection site, wrist swelling, slight temperature increase, chills and fatigue was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
the patient is approximately 5 weeks pregnant/ the patient was administered MMR II and VARlVAX; No additional AE information provided; This spontaneous prospective pregnancy report as received from a nurse refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-FEB-2021, the patient underwent routine testing that included a urine test for pregnancy which came back positive on the same day.  The patient was scheduled for routine vaccines and did not disclose to the nurse administrating the vaccines that she was pregnant so on 24-FEB-2021, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # T000889, expiration date: 08-JAN-2022, 0.5 ml (route of administration and anatomical location were not reported) for prophylaxis and a dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, lot # T027301, expiration date: 12-AUG-2022 (route of administration and anatomical location were not reported) for prophylaxis. The nurse administering the vaccines was not aware the patient's urine pregnancy test came back positive. The last menstrual period (LMP) was reported as 05-JAN-2021, estimated date of delivery (EDD) was calculated as 12-OCT-2021. It was also reported that the reporter estimated the patient was approximately 5 weeks pregnant. The pregnancy outcome was pending. The patient was being referred to an obstetrics and gynaecology (OBGYN) for further care and testing.
Tired/Fatigue; Headache; fever; shortness of breath; pain in the arms and shoulder; pain in the arms and shoulder; numbness; weakness; This is a spontaneous report from a contactable consumer (patient). A 42-years-old non pregnant female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EW0187, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 07May2021 11:15 as DOSE 1, SINGLE for covid-19 immunization at Pharmacy or Drug Store. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. On 18May2021, the patient experienced headache, fever, miserable condition because of shortness of breath, pain in the arms and shoulder, numbness, weakness, tired/fatigue. Since the vaccination, the patient had not been tested for COVID-19. The patient did not visit hospital due to the events. The case is considered to be non-serious. The patient was treated for fever and pain in the arms and shoulder with ibuprofen. The outcome of the events was not recovered.
No side effects reported; expired dose of ROTATEQ that was administered to a patient; This spontaneous report as received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 14-NOV-2023, the patient was vaccinated with expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral solution (lot #1879866, expiration date 30-OCT-2023, exact dose and route of administration were not provided) for prophylaxis (Expired vaccine used). No side effects reported. Vaccine never had any temperature excursions. No additional adverse event (AE)/product quality complaint (PQC) (No adverse event).
This spontaneous report was received from a registered nurse referring to a 19 years old male patient. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported. On 21-APR-2021 the patient was vaccinated with first dose of hepatitis A vaccine, inactivated (VAQTA) (once, lot # T023913, expiration date 31-MAR-2022; route was not reported) for prophylaxis. The patient was now back to receive his second dose of hepatitis A vaccine, inactivated (VAQTA), but the patient was now 19. The HCP was asking if a 19 years old patient can receive two pediatric doses of hepatitis a vaccine, inactivated (VAQTA) 0.5mL today (11-NOV-2022) and it counted as a valid adult dose. AE filed due to possibility that 19 years old patient may receive two hepatitis A vaccine, inactivated (VAQTA) 0.5mL pediatric doses on the same day to count as an adult second dose (circumstance or information capable of leading to medication error, product administered to patient of inappropriate age). Second dose/doses of hepatitis A vaccine, inactivated (VAQTA) had not been administered to patient. No additional AE reported.
Several small (1 mm) papules on 3rd/4th/5th fingers of right hand around the nailbed. Vaccine given in (L) arm.
Severe COVID-19 (14 Days Post-Dose 2); This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Severe COVID-19 (14 Days Post-Dose 2)) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Severe COVID-19 (14 Days Post-Dose 2)). At the time of the report, COVID-19 (Severe COVID-19 (14 Days Post-Dose 2)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.   Reporter did not allow further contact; Sender's Comments: This case concerns a patient, with medical history (not reported), who experienced the non-serious unexpected event(s) of Covid-19. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine). On an unknown date, the patient experienced COVID-19 . The rechallenge was considered NA. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.
A 45-year-old female patient reports that 60 minutes after leaving the vaccination center, she presented the following symptoms: Nausea; Vomiting; Fever; Headache; Rash when scratching; Itching; Swelling on the lips; Small bruise on your left upper limb. After taking your second dose of MODERNA.