chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse practitioner via company representative refers to a non pregnant female patient of unknown age. On 05-AUG-2014 the patient was vaccinated with first dose of GARDASIL (0.5 ml, intramuscularly). On 22-SEP-2014, the patient experienced unspecified vaginal rash located on her labia. The patient was seen in an unspecified emergency room on 22-SEP-2014 and had unspecified labs drawn which resulted negative (exact date was not provided). The patient was not admitted to the hospital and was told to follow-up with her unspecified gynecologist. It was also reported that the patient was seen on 23-OCT-2014 by nurse practitioner. The outcome of unspecified vaginal rash was unknown. The relatedness between unspecified vaginal rash and vaccination with GARDASIL was not reported. Additional information has been requested.
First documented seizure was witnessed by mother. Had suspected seizures after first shot on 4/17/08, Second shot was 10/16/08. First seizure was 12/09/08.
Admit for COVID pna. Fully vaccinated and with prior COVID infection earlier in the month. Steroids, merrem, O2, vit-c, zinc. Presumed to be post-COVID gram neg pna. Discharged to HCF.
Syncope several seconds after HPV shot, recovered after several minutes (out X approximately 30 sec) took approximately 10 min to feel better.
Patient returned to the pharmacy stating she had a rash at the injection site that appeared 11/18/21.  She states it is red, itchy and slightly warm to the touch.  The rash starts at the injection site, extends down the tricip almost to the elbow.
Pt recv vax 7/97; on 11/23/98 pt exp HAV IgM positive
I had under arm lymph node pain with the booster that made me see a doctor. I had some lymph node pain under my arm with the second dose as well. With the booster the lymph node pain traveled down into my lower chest area.
sx began 4AM 15OCT97 abd cramps, nausea, frontal h/a, extreme muscle aches, fever 102;
Vaccine administration was at 4:20 pm, 2nd dose with nurse, she got pale for a moment, sweaty, disoriented, dizziness, and urinary incontinence. Ambulance came at 5:00pm, Vital signs: BP 130/80, P 80, DX 218.
Pt. received FLUZONE HD on 10-13. Pt. came into pharmacy and stated she developed welts on her back and shoulders. Pt. following up with Dermatologist.
tenderness; pain at injection site; This spontaneous case was reported by a health care professional and describes the occurrence of INJECTION SITE PAIN (pain at injection site) and TENDERNESS (tenderness) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced INJECTION SITE PAIN (pain at injection site). On 18-Jan-2021, the patient experienced TENDERNESS (tenderness). On 12-Jan-2021, INJECTION SITE PAIN (pain at injection site) had resolved. At the time of the report, TENDERNESS (tenderness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
No adverse event; Bivalent doses were given 6 months apart. 1st Bivalent booster 16-Sep-2022 and 2nd Bivalent booster 07-Mar-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Bivalent doses were given 6 months apart. 1st Bivalent booster 16-Sep-2022 and 2nd Bivalent booster 07-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7170B and AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 16-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 07-Mar-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (Bivalent doses were given 6 months apart. 1st Bivalent booster 16-Sep-2022 and 2nd Bivalent booster 07-Mar-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Bivalent doses were given 6 months apart. 1st Bivalent booster 16-Sep-2022 and 2nd Bivalent booster 07-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (Bivalent doses were given 6 months apart. 1st Bivalent booster 16-Sep-2022 and 2nd Bivalent booster 07-Mar-2023).    Concomitant drugs were not reported. Dosage text was reported as additional booster. No adverse events were reported from patient. Treatment medications were not provided.   Reporter did not allow further contact
Patient is fully vaccinated.  COVID positive at ED visit on 12/30/2021.  32-year-old female presenting with concern for Covid and also a migraine. Patient is positive for cough, chills, fever (101) and headache.  No real shortness of breath. Denies chest pain. BP 132/83  | Pulse 89  | Temp 99.6 °F (37.6 °C)  | Resp 18  | Ht 172.7 cm (5' 8")  | Wt 118 kg (260 lb)  | LMP 11/30/2021  | SpO2 96%  | BMI 39.53 kg/m² IV established. Headache cocktail ordered. Patient was feeling much better. Headache significantly improved. Discharged from ED.
This spontaneous report as received from a licensed practitional nurse refers to an unspecified number of patients of unknown age and gender. The nurse reported that on unknown dates unspecified number of patients were vaccinated with improperly stored PROQUAD (route, dose, lot number and expiration date were not provided. No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Client reported to feel lightheaded 30 seconds after receiving vaccine. RN who administered vaccine reported that she noticed client was sweaty, client asked for water, was given Gatorade consumed 1/2 bottle. Pt. reported to feel lightheaded and was assisted to the floor by RN with legs raised onto chair.Pt. reported to have eaten about an hour before receiving vaccination. Reported to not have consumed alcohol, but stated to have smoked weed last night.  At 1410: VS#1 taken lying down HR 63 and O2-98%. VS#2  taken lying down BP 105/66, HR 67, O2 98%. VS#3 taken lying down BP 112/68, HR 72, O2 98%. VS#4 taken sitting on floor BP 111/56, HR 80, O2 99%.  At 14:18 VS#5 taken sitting in chair BP 103/67, HR 76, O2 98%.
Right arm very swollen on the side where shot was given. It got very red as well as my neck and rib cage and the side of my hip. I did run a low grade fever!
Pt recvd rubella vax 11APR91 & on 21APR91 pt devel fever, malaise, arthralgia, & rash; tx Atarax; sx lasted approx 3 days & resolved;
The same happened on 02Nov2021. I fell to the floor and couldn not get up for approx 10 minutes.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 29Apr2021 10:45 (Batch/Lot number: unknown) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "cancer" (unspecified if ongoing); "Known allergies: sulpha" (unspecified if ongoing). Concomitant medication(s) included: ALPRAZOLAM; SERTRALINE; HYDROCHLOROTHIAZIDE. Vaccination history included: Bnt162b2 (Prev dose product: COVID-19, Prev dose brand: Pfizer, Prev dose brand unknown: False, Prev dose Lot unknown reason: Not available/provided to reporter at the time of report completion, Pev dose lot unknown True, Prev dose administration date: 06Apr2021, Prev dose administration time: 12:00 PM, Prev dose vaccine location: Right arm, Prev dose dose number: 1), administration date: 06Apr2021, when the patient was 71 years old, for COVID-19 Immunization, reaction(s): "Thinking I was having a stroke", "I collapsed to the floor and could not get up for 10 minutes.", "I had no response from my legs or arms or hands". The following information was reported: FALL (non-serious) with onset 02Nov2021, outcome "recovering", described as "The same happened on 02Nov2021. I fell to the floor and couldn not get up for approx 10 minutes.". The event "the same happened on 02nov2021. i fell to the floor and couldn not get up for approx 10 minutes." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fall.  Additional info: Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was  not diagnosed with COVID-19. Since the vaccination, the patient had been not tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (17Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
high fever (100-102); severe fatigue; chills; sweats; joint pain; malaise; lassitude
Patient came to pharmacy window asking for flu shot. Ran prescription and a prompt for prevnar13 came up. I checked in All Transactions tab of patient profile and saw she's gotten the pneumovax23 on 10/02/2018. I asked the patient whether she has gotten the prevnar13 shot before to which she replied no. I've counseled on the vaccine in regards to what it is, how it works, potential side effects. She stated she wanted to receive the prevnar13 shot as well. It was covered under Medicare Part B. After patient received both vaccines of the HD flu and prevnar13, I was made aware by my technician afterwards that she actually has gotten the prevnar13 awhile back and had let me know that the All Transactions tab only shows up to 17 months previously from the current date. Her last prevnar13 shot was completed on 09/29/2017 .  Patient currently on 10/30/20 has received both the Prevnar13 and Fluad HD vaccine.  I've spoke with the patient and had let her know upon checking she did receive the prevnar13 vaccine previously. She mentioned she hadn't had any issues with the last pneumonia shot (pneumovax23) other than some muscle tenderness. She had emotional concern of 2/10 but explained most likely she wouldn't receive a large benefit from the same vaccine but wouldn't harm her as she's gotten the vaccine previously. Pt was contempt with the answer and was glad a follow up call was done. Currently, no known issues had arise and had let patient know to contact the pharmacy if there is any questions or concerns.
Patient felt tingling in left hand. Patient's blood pressure taken. Patient monitored by RN and seen  by Resident. As per patient tingling went away
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 26 Feb 2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 26 Feb 2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 26 Feb 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 26 Feb 2022) in a 41-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 26-Feb-2022 at 9:19 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Feb-2022 at 9:19 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 26 Feb 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 26 Feb 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 26 Feb 2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 26 Feb 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Patient received vaccine past its 30 day expiry date.  Vaccines went into 2 to 8 C thaw state on or about 24 Dec 2021. Patient received booster dose of vaccine.  No treatment medication was reported by reporter.
Hospitalized for acute hypoxemic respiratory failure, COVID19 pneumonia  1/11/22-1/14/22. Treated with baricitinib, Remdesivir, dexamethasone, zinc 50 mg daily, vitamin D3 50 mcg daily and vitamin C 1,000 mg daily
Had finished giving client vaccines, mother walked out with daughter to have her sit in waiting room so she could bring her other child in for shots 2 approx 9:40 AM. At 9:50 AM, after giving the other child shots was called to the front because the first client I had done had fallen out of the chair. RNs were assisting to get her legs elevated and place a cold pack on back of neck. Client was alert and talking. B/P 120/78. Mom stated that she gets dizzy with shots, but had never fainted and she had not eaten this morning. 10:00 AM complains of being cold. Pt was covered with jacket. B/P now 118/75. Glucose given by RN. Pupils checked, normal reaction. Client complains of headache, redness noted around (L) eye at outer browbone and cheekbone. No bruising or swelling noted at this time. 10:10 AM B/P now 110/70. Client was helped to a sitting position on floor and then helped to feet and sat in chair. Client states she is feeling better and was answering questions about school. Verbalized her name and stated she was hungry. RN asked mother if she wanted EMS called and mother declined. She stated she would take her daughter to clinic and would call RN after the assessment. RN called the mother at 1PM on her cell phone as a courtesy to inquire about the daughter's condition. Mother stated the Dr looked her over and said that she was OK and did not need any further treatment and no meds were prescribed. Mother states the daughter has no more complaint.
No adverse reaction, pt received 2nd dose Moderna. 1st dose given was Pfizer.  Patient felt fine, was advised that since both are mRNA shots the vaccine series is considered complete and to report any unusual side effects other than what we counseled him on as normal Side effects of the vaccine administration. To date, no concerns have been brought to pharmacy attention
Patient requested booster, and should have received 3rd dose. Primary series was started as Pfizer, so he should have received a 3rd Pfizer.  Unknown adverse event. Patient did report  fever, cough, weakness, dizziness, and chills the following day-but was unknown at that time that patient received the incorrect vaccine.
On 15FEB93 pt recvd vax & mom stated today 1 year later pt wa awoke next AM w/fever almost 103, h/a & c/o difficulty walking (stiffness); appetite good; color pale;
This spontaneous report was received from a nurse and refers to multiple patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (strength, dose, route of administration, anatomical location, lot # and expiration date were not provided). The reporter stated that the vaccines reached a temperature of -11 Celsius degrees for an unspecified amount of time (dates were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Chest pain; This is a spontaneous report from a contactable consumer or other non-HCP.   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiry date were unknown), via an unspecified route of administration on 02Oct2021 as dose number unknown, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 02Oct2021, same day of vaccination, the patient experienced chest pain. The reporter had a question about the Comirnaty Vaccine, if it was an authorized. The reporter had a friend that took it and had a chest pain. It was Comirnaty the same as the BioNTech vaccine, patient was having Chest pain. So, reporter don't know if should take it. The reporter just wanted to know if the Comirnaty the same BioNTech (further clarification unknown), the two different name that reporter was guessing. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
anxiety; He feels ear pressure, pain; He feels ear pressure, pain and ear fullness/hurting his ears; ear fullness; sound sensitivity; ear ringing/tinnitus; hyperacusis; This is a spontaneous report from a contactable consumer (mother).   A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on 17May2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included the first dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On unknown date in 2021, patient experienced ear ringing/tinnitus and hyperacusis. He got second dose on 17May2021. After this experience he got anxiety. He got sound sensitivity, sounds (whispering, footsteps to airplane), hurting his ears. He felt ear pressure, pain and ear fullness. It was reported that the patient visited ENT, neurologist and stated that no one can figure out how to cure it. He was basically isolated in a room. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected. Information about batch number cannot be obtained.
Patient's granddaughter stated that the evening that the vaccine was received (4/3), the patient was having difficulty breathing with cough and sinus inflammation. The patient had no other symptoms the next morning (4/4), but she took a nap later in the morning and didn't wake up.
Information has been received from a physician concerning a 15 year old male with no medical history and no drug reactions/allergies who on 02-JUN-2011 was intramuscularly vaccinated with the first dose of 0.5 ml GARDASIL (lot # not reported) in his left arm. The reporter stated that the patient did not receive any other vaccines on 02-JUN-2011 and on 03-JUN-2011 ("today") the patient had stiffness in the right side of his neck that was hard to touch. The reporter did also note that the patient slept on the couch last night. No treatment was given for this adverse event. No lab diagnostics were performed. At the time of reporting, the patient had not recovered. The patient called the office to seek medical attention. Additional information has been requested.
Rhinorrhea/Runny Nose; Unevaluable event. Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (forzen)) was received from a father regarding his 7 year old son who developed a runny nose and "felt run down." The patient received the first dose on an unspecified date. The father reported that within 3 days of receiving Flumist (2003-4 Formula), his son developed a runny nose and "felt run down". The events lasted several days. The patient's nine year old brother experienced a similar reaction (see MCN: HQWYE812504FEB04). No additional information was available at the time of this report
This spontaneous prospective pregnancy report as received from a Registered Nurse refers to an 18 year old female patient. The patient had no pertinent medical history and no drug reactions/allergies. On 08-OCT-2014 the patient was vaccinated with GARDASIL (lot # K004205) 0.5 ml once, intramuscular. The patient had no concomitant medication. On 09-OCT-2014, the patient did a home pregnancy test and found out she was pregnant. The patient sought medical attention at the office of the nurse on 09-OCT-2014 for an ultrasound which confirmed patient was pregnant. Pregnant Gestation was reported as 17 weeks. Last menstrual period was estimated as 12-JUN-2014 and the estimated date of delivery was estimated as 19-MAR-2015. No adverse events were reported. No treatment was given for the event. The outcome of the pregnancy was unknown. Additional information has been requested.
Pt was administered IM menquadfi at 2:15 pm after completing physical. At that time patient was anxious about vaccination and I offered pt water. Pt declined and I administered vaccination and gave pt ice pack after administration. Pt jumped right off of table, I discussed with patient and stepmom and brother (who also received menquadfi) that they should move arms around and can use tylenol later for any remaining pain. Approximately 10 minutes later receptionist from front desk called to state pt was feeling faint. RNs went up to pt first to assess. Pt was pale and shaking but sitting in chair, complaining of dizziness. I brought the BP machine and water to pt, RN applied ice packs to patient's neck and forehead. V/s in waiting room were 122/73, pulse 88 and pulseox 98%. After water and ice packs patient did state he felt improvement in symptoms. Had patient sit in chair for 15 minutes. Able to stand up, pt stated he felt fine though he was still shaky. Able to walk off floor with assistance from stepmom and dad who came up from car.
Swelling and hardness at injection site the morning after injection. 1 day after injection experienced fever, chills, headache, extreme fatigue for 12 hours. 3 days after injection developed a red, itchy, hot rash about 4 inches in diameter near injection site.
Per mom, 10 mins after vaccine child complained of chest pain, elevated heart rate, nausea, hands shaky, child looked pale to face and lips were white. Ringing to ears and not able to hear with blurr vision. Child was very anxious and nervous before vaccine child was fasting.
Extreme Vertigo(dizziness) vomiting, nausea, passed out struck head on dresser and floor.