chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No other AE reported; Administration of an expired MMR Il dose; This spontaneous report has been received from a medical assistant referring to a patient of unreported age and gender. No information regarding the patient's concurrent conditions, pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 09-DEC-2021, the patient was vaccinated with expired measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II), 0.5 ml one time (expired product administered) (lot number S037501 has been verified to be a valid number, expiration date reported and established as 20-NOV-2021;, dose number, vaccination scheme, route of administration, and anatomical location of vaccination were not reported), for prophylaxis.  The measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II), had no prior temperature excursion.  No additional adverse events (AE) were reported.
Patient received Hep A vaccine in left arm. Chair was turned around to administer Influenza in Right Arm. Within 30 seconds of Influenza vaccination patient slumped in chair and had a temporary loss of consciousness. There appeared to be some arm twitching which may indicate some seizure activity. Her mother was outside of room in waiting area and came in and patient was moved to bench area to lie down. When consciousness was regained seconds later, patient reported feeling lightheaded and "queasy" but otherwise felt ok. Patient remained lying down with her mother and RPh for approx. 20mins in room, and then was walked to her car with her mother and a staff member. No additional action was taken. Mother was advised by RPH to notify healthcare provider of reaction, and to ensure that any future vaccinations, if recommended by provider, are administered in a more controlled healthcare setting.
ROTATEQ oral vaccine third dose on 3/4/14. Vomiting and diagnosis of intussusception 3/30/14 (26 days later). Treated with laparoscopic reduction.
dizziness; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on 29Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 07Feb2021, the patient had experienced dizziness. The outcome of event was unknown.  Information on the lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
1/20/21 at 5:00pm injection site (right arm) became swollen and tender. Pain moved down to elbow and into hand. Pain caused difficulty sleeping. Awoke 1/21/21 5:00am and noticed pain moved into right armpit. Through morning pain moved into right side of chest, around lymph node area of under-arm. Swelling and tenderness persisted. At 1:00pm on 1/21/21 pain had not subsided which prompted concern and evaluation at Emergency Room.  Ultrasound performed with no significant findings.   As of 1/22/21 at 8:11am swelling and some tenderness persist.
On June 15, I started feeling heated, tired, and numbness to my left arm. On the 16th, I noticed my left arm, left leg, and the left side of my face was numb, and I went to the ER. I was diagnosed as having a stroke and admitted for 2 days. Then I was transferred to a rehab facility. I still receive outpatient therapy from the rehab center.
Information has been received from a registered nurse concerning a multiple unspecified patients of unknown ages and gender. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. Concomitant therapies were not reported. On an unknown dates, the patients were administered improperly stored doses of RECOMBIVAX HB lot # L048849, expiration date 04-FEB-2018, (dosages and therapy routes were not provided), for prophylaxis. No adverse effects were reported. The doses of RECOMBIVAX HB were exposed to a temperature below of 32F and lowest of 31.74F and were out of range for 2 hours and 50 minutes. A data logger was used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. Additional information has been requested. This is one of several reports from the same source.; Sender's Comments: US-009507513-1701USA003089:
First 72 hours: Sore, red then bruised arm, unusual tiredness 9th day: "COVID arm" i.e. bright red around injection site, hot, itchy
Onset of menstrual cycle after no cycle for 2+ years Heaviest cycle in 7+ years Severe blood clotting Dark brown blood Severe menstrual cramps Increased oiliness in skin/scalp (estimated 5x normal production)
FEVER; TIRED; This spontaneous report received from a patient via a company representative 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced fever, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and tired was not reported. This report was non-serious.
Patient said that the arm starting to swell up bigger and bigger starting a couple hours after vaccination. She said she iced it to make it feel better. The shoulder started to develop a big bump, was warm to the touch, red, itchy, and hurt when pressed.
Admission Date: 9/26/2022 Discharge Date: 9/29/2022 ? Pneumonia due to COVID-19 virus  HOSPITAL COURSE: Patient is a 69 y.o. male with past medical history significant for paroxysmal Afib on eliquis, CHF, PVD, T2DM, liver cirrhosis, Parkinson's disease who presented to the ED for concern of chest pain and shortness of breath. Associated cough, rhinorrhea, and nasal congestion. In the emergency department, vital signs were stable. Labs significant for WBC 15, Pro BNP 2600 (previous 2000), procal 0.04. COVID-19 PCR positive. CXR showed severe congestive changes and bronchial thickening concerning for CHF versus inflammatory infection process worse in the left lung than the right.  He was started on azithromycin and Rocephin. He was admitted for further evaluation and management.    With negative procal, antibiotics were discontinued. Decadron started for covid and possible CXR findings. He was continued on IV diuresis for acute on chronic diastolic heart failure. Repeat echo showed EF 57% (down from 67% previously) with findings consistent with RV pressure overload. He was transitioned back to home torsemide. Oxygen was weaned off. He was discharged home in stable condition with upcoming cardiology appointment scheduled.    Of note, leukocytosis increasing, suspect steroid induced as infectious symptoms improving, no fever. Patient did not want to stay to be monitored further, return precautions given.
administration site was too high to the arm; bruises on her shoulder; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2), administered in arm, administration date 19Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 19Apr2021, described as "administration site was too high to the arm"; CONTUSION (non-serious) with onset Apr2021, described as "bruises on her shoulder".  Additional information: The administration site was too high to the arm. That caused bruises on her shoulder. Wanted to know if she could continue on the 2nd dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A high risk employee received 1st vaccine dose of Moderna through the Health Center (HC) on 2/1/2021. This patient was seen as an employee only and was not established patient of the HC.  The patient reported "having symptoms of Bronchititis" on 2/5/2021 prior to being hospitalized for 7 days (2/5/21 to 2/12/21). On 2/12/2021, an ER visit at Medical Center & transported to General Hospital on 2/13/21. On 3/11/2021, we were notified that the patient died on 3/10/21.
Sharp pain in right breast/nipple; Sharp pain in right breast/nipple; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733) via an unspecified route of administration in the left arm on 09Apr2021 at 11:45 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included depression, hypothyroidism, fibromyalgia and COVID-19. The patient was allergic to penicillin. Concomitant medications included piroxicam (PAXIL), levothyroxine sodium (LEVOTHYROXIN), vitamin d nos (MANUFACTURER UNKNOWN) and cobamamide (VITAMIN B12); from an unknown date and for unknown indication. Prior to the vaccination, the patient was 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 09Apr2021 at 12:00, the patient experienced sharp pain in right breast/nipple entire day after receiving vaccine. This was the opposite side from where the patient received the shot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events sharp pain in right breast/nipple were recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Febrile seizure less than 24 hours after immunization. Immunization 5/6. Temp 102 that night. Early 5/7 AM, febrile seizure.
It's been a week since the 2d dose. Last week, I had site soreness, swelling, and light rash. I also had headache (similar to sinus infection pain) and 100F for about 24 hours. All symptoms subsided within 72 hours.
Greatly intensified persistent ringing in both ears, multiple sounds ( simultaneous high pitched tones and roaring) Much milder persistent ringing (right ear only) had been noted (starting almost exactly one year earlier than vaccine date) after recovering from a very mild case of shingles. Was successfully treated with antiviral oral medication within 72 hours. After Shingrix vaccine, there was sudden onset of notably louder constant tinnitus in both ears, multiple high pitched ringing and roaring. In early October 2021 ringing and roaring intensified again by a great deal, maybe from stress.
Patient received vaccines at Health Dept. Clinic on Wednesday AM(7-13-05).  On Thursday 7-14-05 complained of soreness in Rt upper arm.  Friday 7-15-05 Rt upper was "red, hot and swollen" (10X5cm) called family physician who recommended cold compresses.
pt recv vax 28MAY98 1030AM & 30MAY98 began vomiting 10PM;no diarrhea;fever 103 taken @ armpit;1JUN98 10AM to ER examined & sent home;pt vomited in parking lot of  hosp;3JUN98 had 3 diarrheas, 3 vomit projectile;
Red rash on left arm from shot site down to elbow area. Feels itchy and it hurts. Slightly swollen. Have had 99-100 degree temperature since 3/5/21. Body aches and headache.
eczema got worse than before the vaccine; TMJ was exacerbated; blistering on his fingers; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group, Program ID: (172086). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in Apr2021 as dose 2, single (Batch/Lot number: unknown) and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "chronic Lyme's disease", start date: 1999 (unspecified if ongoing), notes: he has had chronic Lyme's disease since 1999 but was only diagnosed on 2013. The patient's concomitant medications were not reported. The following information was reported: ECZEMA (non-serious), outcome "unknown", described as "eczema got worse than before the vaccine"; TEMPOROMANDIBULAR JOINT SYNDROME (non-serious), outcome "unknown", described as "TMJ was exacerbated"; BLISTER (non-serious), outcome "unknown", described as "blistering on his fingers".  Clinical course: Reporter was asking about Paxlovid and explains that he has had chronic Lyme's disease since 1999 but was only diagnosed in 2013 when he pulled a tick out of his leg which he actually got very sick with flu like symptoms for. He stated that his lyme disease presents itself as eczema on his fingers that are brutal have not gone away since 1999. He mentioned that his doctor put him on and off different antibiotics (such as Doxycycline) from 2013. Reporter shared that the eczema on his fingers worsens as the seasons transition and that typically there was only little eczema on the months of Jun, July, Aug, Sep and at the onset of October onwards it got worse. Now, reporter reported that after he got his Pfizer covid 19 shots on Mar2021 and Apr2021, and eventually the booster dose on Nov2021, reporters eczema and TMJ was exacerbated. He reported that his eczema got worse than before the vaccine and that he had blistering on his fingers. Then at around Jul this year, reporter was prescribed Paxlovid for 5 days by his doctor to try it out for his Lyme disease. Reporter then stated that when he used Paxlovid with another antibiotic Ceftin, his eczema healed but when he had to use Paxlovid with Amoxicillin his eczema came back, because of the success of his treatment his doctor had prescribed him again and again to take Paxlovid and is now on Day 39.   The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
CDC reports: 5 yo experienced marked alteration in LOC (probably fainted) following DTP/OPV/MMR immunization.
Feverish Friday evening, onset 7:30 PM High fever (102) Saturday, bedridden Low grade fever Sunday (99), but active Site is still red, swollen, and painful on Monday, October 5, three days following injection.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 70-year-old male patient who received SHINGRIX for prophylaxis. On 6th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced fever, influenza-like symptoms and chills. On an unknown date, the outcome of the fever, influenza-like symptoms and chills were recovered/resolved. It was unknown if the reporter considered the fever, influenza-like symptoms and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. But, it could be 69 or 70 years old. The patient experienced fever, chills and flu like symptoms. The date of onset was unknown but all the events are resolved by the time of reporting. The patient wondered if he should receive the 2nd shot based on his reaction to the 1st dose. The caller was transferred to Medical Information for additional assistance.
p/2 mos vax pt fussy inconsolably x 4 days, febrile despite APAP; fussiness started the same day of vax;
Headache, Myalgia, Arthralgia, Chills, fatigue Narrative:  Other Relevant History:
Narrative: PATIENT ADMITTED TO LOCAL HOSPITAL. CAME TO HOSPITAL REQUESTING REFILL OF APIXABAN 5/2021. THAT IS THE FIRST RECORD I SAW OF THE PE. REPORT NOT ENTTERED BY PROVIDER UNTIL 10/21. I DON'T THINK THE PATIENT INFORMED THE HOSPITAL WHAT WAS GOING ON AT THE TIME IT HAPPENED, NOR DID HE INDICATE OR KNOW IT MIGHT BE RELATED TO THE VACCINATION.
On the clinic day, the vaccine was transported out from the pharmacy to the facility without a digital data logger. The packing used for transport was refrigerated packaging tote to maintain a temperature of 36 F - 46 F.  However, that is not approved by vaccine transportation. The total time (from when vaccine left the pharmacy to the clinic completion) was less than 6 hours. There were no adverse events.
Pt recv vax on 3/8/99; on 3/9/99 pt exp lack of appetite, dec fluid intake, weight loss; pt imp 3/12/99
Admitted to the hospital; Second dose was supposed to be 15 Feb 2021/missed; A Spontaneous report was received from a pharmacist concerning a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was admitted to the hospital and missed his second dose which was supposed to be 15 Feb 2021.  The patient's medical history was not provided by the reporter. Concomitant product use was not provided by the reporter.  On 18 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) via an unknown route for prophylaxis of COVID-19 infection.   On an unknown date, two weeks after the first dose the patient was admitted to the hospital.  His second dose was supposed to be on 15 Feb 2021, but he missed that. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event admitted to the hospital was unknown and outcome of the event second dose was supposed to be 15 Feb 2021/missed was resolved on 15 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
non traumatic painless bruise on the right foot; Petechial rash and bruising; This spontaneous case was reported by a consumer and describes the occurrence of PETECHIAE (Petechial rash and bruising) and CONTUSION (non traumatic painless bruise on the right foot) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (allergy to sulfa), IgA deficiency since 2020, GERD and Hyperlipidemia. Concomitant products included ATORVASTATIN for High cholesterol.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced PETECHIAE (Petechial rash and bruising). On 03-May-2021, the patient experienced CONTUSION (non traumatic painless bruise on the right foot). At the time of the report, PETECHIAE (Petechial rash and bruising) and CONTUSION (non traumatic painless bruise on the right foot) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Pilosoc at a dose of 20 mg used for treatment of GRED and administered via oral route of administration.   This case was linked to MOD-2021-049489 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Follow up received and patient initial updated. On 17-Aug-2021: Significant follow-up received on 17-AUG-2021 including added new reporter HCP, updated patient's allergic condition , concomitant medication were added, both the events onset date and outcome were updated
Seen in our office on 7/22/08 for 4 year old well check up.  Woke up on 7/24/08 with red & swollen arm. Seen again in our office diagnosed with vaccine reaction/early cellulitis.  Treated with augmentin
DRY COUGH; SNEEZING; FEELING REALLY CRUDDY; PAIN IN MY ARM; LOW GRADE FEVER; HEADACHE; CHILLS; CONGESTED; CLEAR MUCOUS; BODY ACHE; This spontaneous report received from a patient concerned a 38 year old male. The patient's weight was 209 pounds, and height was 67 inches. The patient's past medical history included covid-19, got really sick, fever, body ache, dry cough, and mucus was really green, and concurrent conditions included alcohol user, and smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with hydrocodone bitartrate/paracetamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 13-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On 14-JUL-2021, the subject experienced body ache. On 14-JUL-2021, the subject experienced congested. On 14-JUL-2021, the subject experienced clear mucous. On 14-JUL-2021, the subject experienced chills. On 14-JUL-2021, the subject experienced pain in my arm. On 14-JUL-2021, the subject experienced low grade fever. On 14-JUL-2021, the subject experienced headache. On 15-JUL-2021, the subject experienced dry cough. On 15-JUL-2021, the subject experienced sneezing. On 15-JUL-2021, the subject experienced feeling really cruddy. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Not Provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low grade fever, body ache, headache, dry cough, congested, clear mucous, chills, feeling really cruddy, pain in my arm, and sneezing. This report was non-serious.
pt recvd vax 11JAN94 & 12JAN94 inject site became reddened, swollen & hot; area of redness was approx 2"; had fever of 101-102; inject site became multi-colored; Lab tests 13JAN94 showed WBC count 24,004; area of erythema & induragion 6x7cm
Had itchy eyes, loss of smell, loss of taste, fever for 15 hours started 5/24/21 at 1pm until 5/25/21 4am.
Pericarditis. mild constant chest pain. 2 OTC ibuprofen pills 3 times a day for 7 days
Upon data entry into system, it was noted that patient received the Janssen shot in March of 2021. The Pfizer dose was already given and patient noted they had not received a vaccine during screening. Upon requesting they stated they spoke with their primary care provider who advised him to get a Pfizer vaccine for maximum coverage. He intended to receive two different types of vaccines, and the health department advised patient not to come back for second dose.