chrisvoncsefalvay/vaers-outcomes huggingface dataset:
When reconstituting the Pfizer COVID19, an error was made but not discovered until 3 doses (0.3ml ea) had been given.  There were only 3 + doses in the vial.  Upon review it appears that only 1 ml of NaCl had been used to dilute.
Sore swollen arm, ache all over, headache, fatigue, swollen neck/face.  3 days.
Patient received the second dose of Shingrix vaccination and experienced nausea, a headache that lasted multiple days, and body aches beginning 3 hours after the dose was given. Patient claims no issues following first dose
Pain in left arm between shoulder and elbow. Difficulty sleeping due to arm pain.   Severe pain in left arm.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 11Aug2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Lisinopril, reaction(s): "Allergy"; Rosuvastatin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included COVID 19 Treatment with Paxlovid from 28Jul2022 to 03Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association be-tween the event and the suspect drug cannot be excluded. The case will be reas-sessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 66-year-old female patient who received SHINGRIX. In May 2018, the patient received SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site warmth were not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: This case was received via click to chat. The patient received SHINGRIX vaccine 5 days before the date of reporting and at the time of reporting the patient still had a large area of red, swelling and heat at injection site. The reporter did not have the lot number or expiration date of the vaccine and declined to provide further contact details. Chat was transferred to Response Center.
This spontaneous report was received from a nurse concerning a patient of unknown gender and age. The patient's pertinent medical history and concurrent conditions were not provided. On 11-MAR-2016, the patient was inadvertently administered an expired dose of ROTATEQ (Lot # K005273, expiration date: 23-FEB-2016) (dose not provided) oral. Concomitant medications were not provided. No adverse effects were reported. Additional information has been requested.
Day after pfizer vcivid booster, developed R sided occipital head pain (not headache) with sharp intermittent components. Next day, R eve felt "strange" with gritty feeling and occasional tearing. Next day, developed R sided facial weakness (bell's palsy), Started 60 mg prednisone within 2 hours of developing bell's palsy after speaking with my PCP by phone as i was out of state for work.
From 10/7/2011 to 10/23/2011 I had tremors, unsteady gait, left sided weakness, and unable to form words properly. I was like this until I went through a "Detox" to get the high level of mercury out of my system.
only adjuvant suspension component was given; only adjuvant suspension component was given; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number Y37L9, expiry date 10th October 2022) for prophylaxis.   On 12th April 2021, the patient received the 1st dose of Shingrix (intramuscular). On 12th April 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication. On an unknown date, the patient experienced inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received only adjuvant suspension component of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The nurse reported that when attempting to administer vaccine she had not realize that it needed to be reconstituted. The reporter consented to follow up.
PT called 4/2/03 to report having chest pains at night for the past 2 wks. She had chest pains, cold hands and difficulty moving only in the evenings. PT was referred to private provider, who is considering Dx of pericarditis.
Janssen COVID-19 Vaccine EUA  Fever, severe chills, nausea, vomiting, lower back pain.  Went to Emergency Department because back pain was so severe and nausea/vomiting was ongoing.  Received and IM dose of Toradol. Received oral Zofran prescription at discharge.  Spent about 2 hours in ED.
Fever, dizziness, headache, body aches, joint pain, fatigue. Began Friday 2/12/21 Sxs lasted 2 days  Redness, swelling, bruising, pain at injection site. Started day of 2nd Covid vaccine 2/11/21. Still having pain and also have a bruising at injection site.
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. In approximately August 2015 (reported as 8 or 9 months ago), the patient was vaccinated with the first dose of unidentified Merck HPV vaccine (name and lot number not provided) (dose and route were not reported). On 19-MAY-2016, the patient received the second dose of GARDASIL (lot# L038135 with expiration date 27-MAY-2017, dose and route were not reported) (inappropriate schedule of drug administration). No adverse event was reported. Additional information has been requested.
Got sick from the flu shot; This case was reported by a consumer via call center representative and described the occurrence of sickness in a female patient who received Flu Seasonal QIV (FluLaval Quadrivalent) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced sickness. On an unknown date, the outcome of the sickness was not recovered/not resolved.   The reporter considered the sickness to be related to FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-SEP-2022 Reporter's comment: The reporter stated that the FluLaval Quadrivalent shots made kids sick. The reporter stated that GlaxoSmithKline need not to sold that product because it made kids sick. No additional details were provided. Additional Supportive Information: This case had been linked with case US2022AMR134801, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR134801:Same reporter.
I have shingles that started the day after the shot.  The shingles are on the left side of my neck, along the jawline, and behind the left ear.; This is a spontaneous report from a non-contactable consumer. A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 26Feb2021 17:30 (Batch/Lot Number: EN6198) as SINGLE DOSE for covid-19 immunisation.  Medical history included hypothyroidism. Concomitant medication(s) included rosuvastatin (ROSUVASTATIN); levothyroxine sodium (LEVOTHYROXIN); loratadine (LORATADINE).  The patient previously took clindamycin, and amoxicillin and experienced known allergies. On 27Feb2021, it was reported "I have shingles that started the day after the shot. The shingles are on the left side of my neck, along the jawline, and behind the left ear." Therapeutic measures were taken as a result of the event: given an antiviral medicine. The patient did not have COVID prior vaccination, the patient was not COVID tested post vaccination. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected.
Prior to administering dose 2, the patient mentioned that he felt dizzy for about 10 minutes after the first dose. He said it went away. I monitored him after the second dose, and he did not have any reported effects.
Pt got very diaphoretic and felt lightheaded. BP 173/84 with HR of 55 and O2sats 96%. Pt observed by RN until returned to baseline.
Baseball size red area on right arm.  Hot to the touch.  Itching all started the day after the vaccine.   Cold compresses to arm, antihistamines, if does not decrease to return for an appointment.
Deviation from the recommended interval between 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Deviation from the recommended interval between 2 doses) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Deviation from the recommended interval between 2 doses). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Deviation from the recommended interval between 2 doses) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication information was reported.
Within one hour of receiving the vaccine I began to have a headache, which has progressed into a migraine and continues to persist. This is day 6. Prescribed Maxalt, OTC Exedrin Migraine, and Ibuprofen have not been effective to relieve. I have taken more migraine medication in the past 6 days than I have in the past 6 months. I woke up on 9/27/18 having some difficulty breathing, feeling almost asthmatic, although I am not. That has since resolved. This is the first flu shot I recall getting.
PATIENT'S SISTER CALLED THIS AFTERNOON STATING HE HAD RECEIVED THE JANSSEN COVID VACCINE 4/05 AND THEY FOUND HIM DEAD THIS MORNING. THEY ARE NOT CERTAIN IF IT WAS FROM VACCINE. THEY CLAIM HE HAS NO OTHER HEALTH ISSUES AND IS NOT ON ANY OTHER MEDICATIONS. THEY HAVE NOT PERFORMED AUTOPSY. SHE WAS MORE RELAYING INFORMATION RATHER THAN BLAMING THE DEATH ON THE VACCINE. SHE REQUESTED WE SUBMIT REPORT TO VAERS; SHE HAS NO WAY TO AND DOES NOT KNOW HOW.
Swollen tongue; severe nausea; golf ball-size swelling at injection site; joints aching; severe headache; temperature of 97; difficulties swallowing; A-Fib.
This spontaneous report as received from a medical assistant refers to a unspecified number of patients of unkonwn age and gender. On an unknown date the patients were vaccinated with ROTATEQ. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The medical assistant reported that doses of ROTATEQ were improperly stored and were administered (on an unknown date). No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Patient reports that he was administered with the vaccine on october 2 and in the afternoon he felt a bulge in the left side of neck and shoulder area. Patient verbalizes that the next day he started to feel pain in the left side of neck area and shoulder.
Developed pulsatile tinnitus. Started out intermittently in occurrence and is now constant. It is a low pulsating roar that seems to occur with my pulse. Is especially noticeable at night. If I wake in the middle of the night it affects my ability to go back to sleep. Ive never had anything like this happen before and is definitely related to the vaccine as it developed after that. It is quite debilitating as it affects my quality of sleep. I face constant fatigue from how this tinnitus has affected my ability to get a good night's sleep. It is a low roar or a swishing sound that occurs in my head constantly, but is heard prominently when I am in a quiet room or at night.
This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A patient of unspecified age and gender received a single dose of PREVNAR 13, on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date patient experienced sore arm: the arm was still sore 11 days after vaccination. Final outcome of the event was unknown.
Injection site, left deltoid, warm to the touch, rosy pink, non raised, erythema measuring 55 mm by 60 mm in diameter.  Patient has full range of motion, but complains of discomfort, 48 hours post injection.
This spontaneous prospective pregnancy report refers to a 23 years old female patient and was received from the patient's husband. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On approximately 16-APR-2018 (reported as "about three weeks ago"), the patient was administered an unspecified varicella vaccine, which might have been VARIVAX injection (dose, route of administration, lot # and expiration date were not reported), as she needed to get vaccinated. Concomitant therapies included sterile diluent (manufacturer unknown). The patient might have been pregnant or gotten pregnant around the same time the vaccine was administered. She could have been about three weeks pregnant (last menstrual period (LMP) date in April 2018). The estimated due date was not provided. On 06-MAY-2018 (reported as "yesterday"), the patient found out she was pregnant by a urine pregnancy test, which was positive. The reporter stated, that the physician did not ask or check if she was pregnant or trying to become pregnant before the vaccine was administered. Trimesters of exposure included the first trimester. The pregnancy outcome was pending. No adverse effects were reported.
pt. c/o nose bleeding 20 mins after the vaccine;  BP 149/113; 145/101;  P-66
Pt recv vax on 11/10/98; on 11/11/98 pt exp ill feeling, pain in neck & back, dizzy, fever (102)x 4 days, unable to bend or turn neck
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On 28-JUL-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # M000996, expiry date 07-JAN-2018, dose, strength, vaccination site, route unspecified). The vaccine was exposed to a temperature of 6.5 Fahrenheit (F) for 80 hours. Digital data logger was not involved. There was no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Severe, excruciating headache , joint and muscle pain, chills w sweating, nausea, muscle weakness, sore throat. All symptoms were most pronounced for approx 20 hours and are slowly abating 48 hours later. W the first dose symptoms were similar but less pronounced.  On both occasions I have had to remain in bed.
I broke out in a rash that traveled around my body for 2 weeks. It started on the back of my knees and moved to my hips and sides, butt and back of my legs. Then it went up to my neck and little on my face and feet. It was very uncomfortable and itchy. The rash resembled hives. My throat swelled up a bit and it made it difficult to swallow. I also had heartburn. I went to urgent care the following Monday after I received the vaccine and got a steroid shot that helped the symptoms. However, they returned after two days.
After 24 hours I felt sick for 8  hours.  Nausea, headache, fever, light headed.  Then I was fine.  The vaccination location never bothered me.  On Day 8 after the vaccination, my arm had a raised red, hot welt the size of a quarter.  On day 9 I became sick again and continue to feel sick today ( day 11) with fever, chills, nausea, headache, light headed, cough,
Swollen area under the skin on left hand that is causing  numbness in the palm, thumb and first finger. Some swelling to the hand as well
Less than 24 hrs, acute onset, on back & some on face her anterior & extremities "too many to count"  Recommended TYLENOL & topical BENADRYL every 6 hours & AVENO baths
I was vaccinated for Covid-19 (second shot) 12/27/2021. The afternoon of 12/28/2021 I started feeling tired. 12/28/2021 I got up at 0545 and was not feeling well. I had a head ache and a back ache and I felt exhausted, at 0630 I broke out in a sweat and continued not to feel good, I decided to stay home at this point. I set my alarm to call into work at 0730. I stayed in bed until 1215 and continued feeling bad and tired until 1645 when I felt better.
Client received a seasonal FluMist intranasally. Once the family had returned home and read the VIS, they discovered that asthma is a contraindication. Client had no bad reactions, but his parents wanted us to know he has asthma.
Around 9pm I got very short of breath and got very sick. I was very nauseous and the next day I fainted.
got the first dose of the Moderna vaccine on 22Jan2021 and has not received the second dose yet.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (got the first dose of the Moderna vaccine on 22Jan2021 and has not received the second dose yet.) in a 71-year-old male patient who received mRNA-1273 (batch no. 032L20B) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (got the first dose of the Moderna vaccine on 22Jan2021 and has not received the second dose yet.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (got the first dose of the Moderna vaccine on 22Jan2021 and has not received the second dose yet.) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Information has been received from a physician concerning a 5 year old male who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  The physician reported break through chickenpox around the patient's temple and arm with about 12 spots.  One of the sores looked puss-filled.  The patient may have rubbed against a child with shingles.  At the time of the report, the patient had not required a doctor's visit.  It was also noted that unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.
12.38 pm Very Sleepy  5 pm muscle pain on left arm  6 pm very tired  8 pm joint pain on left arm   Sunday 05/02/2021 8 am headache , muscle pain and joint pain on left arm  10 am feeling unwell  11 am chills  1 pm nausea (not vomit)  4 pm headache, muscle pain- joint pain on left arm  8 pm feeling unwell   Monday 05/03/2021 8 am headache, muscle pain and joint pain on left arm whole day the same symptoms   Tuesday 05/04/2021 8 am muscle pain on left arm  whole day the same symptoms   Wednesday 05/05/2021  feel better
Information has been received from a physician via a company representative on 05-FEB-2015 referring to a 7 year old female patient. Concurrent condition and medical history were not reported. On 13-MAR-2008, the patient was vaccinated with the first dose of ROTATEQ (lot# 59682/1733U, expiration date 04-AUG-2009, dose 2ml) orally. On 15-MAY-2008 and 15-JUL-2008, the patient were vaccinated with the second and the third dose of ROTATEQ (batch#/lot# 60379/0144X, expiration date 03-OCT-2009, dose 2ml) orally. On 28-JAN-2015, the patient experienced vomiting, diarrhea, a low grade fever and tested positive for rotavirus. On 30-JAN-2015, the patient sought for medical attention by office visit. Fluids and other unspecified treatments were given for the adverse events. The outcome of the events was reported as recovered/resolved on an unknown date in 2015. Additional information has been requested.
No additional AE reported.; a patient was inadvertently administered PROQUAD and VARIVAX.; This spontaneous report was received from a pharmacist regarding a patient of an unknown age and gender. The patient's medical, concurrent conditions, and concomitant therapies were not reported.  On 10-MAY-2023 (reported as "today"), the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 milliliter, lot #W016360 (expiration date not reported but upon internal validation established as 16-NOV-2023), administered as prophylaxis (strength, anatomical location, and route of administration were not provided); and varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, lot #W011624, (expiration date not reported but upon internal validation established as 06-APR-2024), administered as prophylaxis (strength, anatomical location, and route of administration were not provided) (Accidental overdose). No adverse events were reported.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On 05-JAN-2015, the patient was vaccinated with an improperly stored GARDASIL (lot # K004204, expiry date 12-JAN-2017) (dosing regimen, route and frequency unknown). No concomitant medications were reported. No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us by the agency. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and regulatory authority website for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call from the agency that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.