chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via sales rep and described the occurrence of light headedness in a patient who received BEXSERO. Co-suspect products included MENACTRA. On an unknown date, the patient received BEXSERO at an unknown dose and MENACTRA at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced light headedness. On an unknown date, the outcome of the light headedness was unknown. It was unknown if the reporter considered the light headedness to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. It was reported that the office manager could answer any further questions. The contact details for the same was also provided.
Light rash.Chest more, little bit on my face/serious rash on my arms/It itches.  It's reddish. It's a rash.; Light rash.Chest more, little bit on my face/serious rash on my arms/It itches.  It's reddish. It's a rash; This is a spontaneous report from a contactable consumer. A 74-Year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 10Apr2021 a single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 20Mar2021 a single dose for COVID-19 immunization. Clinical course reported as Caller received first dose 20Mar2021, second dose 10Apr2021. Caller reports light rash. Chest more, little bit on my face. "Don't you have a team? It's their vaccine.  Hospital. Escalate. I'm gonna live with it. I have a serious rash on my arms. I won't ask for legal. It itches. It's reddish. It's a rash. I hope to God. I'll take it out a month. I am going to give it a month. I am going to wait on legal." Caller states she is using cream perrigo. triamcinolone acetonide cream usp. She's concerned that it doesn't go away. "You guys are saving lives" Use it for two weeks the pharmacist said take a break. Caller repeated asked for a team for a treatment recommendation. Potential Duplicate AE. On an unspecified date, Patient experienced Rash erythematous and rash pruritic. Therapeutic measures were taken for the events. The outcome of the events were not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
High fever, chills, vomiting, headache, dizziness started at 9:30 pm and lasted for 24 hours
Right side of face developed numbness. Elevated heart rate and blood pressure.  Took Benadryl. Started after the required 15 minute waiting period on my way home. Next day had headache, day 3 had a 10 hour period of elevated heart rate, twice up to 145. Day 4 runny nose and sneezing started along with headache.  Numbness lessened but didn?t go away until day 5.  Day 9 nasal congestion and sneezing have caused a wet, post nasal drip cough.
High Blood pressure. Fever. Swollen lymph nodes. Swollen throat.  Sweating. Faint. Disoriented. Passing out. Dizziness. Light headed. Blurred vision. Headache nausea diarrhea runny nose sore throat hot and cold feel like I have a fever. Fatigue. Bed ridden. Couldn?t lift my head off the pillow.
Patient reported fever, aches and pains - specifically in back, and overall weakness for several days.
Anaphylactic reaction; light-headed; her throat started to get tight and close on her; This is a spontaneous report from a contactable consumer (patient). This non-pregnant 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 18Aug2021 10:15 (Lot Number: EW0217) at age of 62-years-old as dose 1, single for COVID-19 immunisation.  Medical history included Asymmetric and Cancer on face, known allergies: yes. No other vaccine in four weeks. There were other medications in two weeks.  The patient felt light-headed, and then her throat started to get tight and close on her, had an Anaphylactic reaction on 18Aug2021 10:45 AM. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the events included Epinephrine injection, Benadryl and Prednisone. The outcome of the events was recovered in Aug2021. There was no COVID prior vaccination. No COVID tested post vaccination.   Follow-up attempts are completed. No further information is expected.
.This literature marketed report has been received from the authors of the published literature article, describing a pediatric transplant recipient patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of hepatitis a vaccine, inactivated (manufacturer unknown) (dose, lot # and expiration date were not reported). On an unknown date, the patient had detectable Hepatitis A (HAV) ribonucleic acid (RNA) in specimen, which confirmed that the child was infected with HAV. Further investigation to ascertain how the patient acquired HAV was under way. The authors considered hepatitis A to be related to hepatitis a vaccine, inactivated (manufacturer unknown). Additional information has been requested.
Patient is a 41-year-old who developed an abrupt onset headache in January after having a booster of COVID Pfizer vaccine.        She recalls the headache onset approximately 10 days after the vaccine. With a rapid head turning she felt there was a pain in the neck as well. She was seen by a chiropractor with a couple of manipulations complicated by echo in her ear but with significant resolution of the neck pain.        The headache now is described as right frontal pressure-like with stiffness of the neck improved with yoga exercises. There is no associated light or noise sensitivity.        She categorically denies any positional headache, headache worsened by coughing and sneezing and by bowel movement. Visual obscuration is also not reported
Hives & Rash Initially 10:30am until 11:00 PM, reported to doctor. Benadryl 125mg throughout the day. Multiple symptoms, problems, events, and still ill. 12/4/09 Medical records received for DOS11/2 - 11/7/09. Final DX: Apparent adverse medication reaction to H1N1 vaccine, polyarthralgia, viral syndrome  Rash s/p vaccine. Migrating and diffuse.  HA. Rhinorrhea. Palpitations. Anxiety.  Polyarthralgias, myalgia.  Abd pain,  polyuria and dysuria. Cough. Excessive diaphoresis. Continued after steroid therapy.
This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information regarding the patients' concurrent conditions and medical conditions was not provided. On unspecified dates starting on or after 31-MAR-2016, the patients were administered an unspecified number of improperly stored doses of RECOMBIVAX HB, intramuscular injection, (lot #L045117, its expiration date: 06-OCT-2018; lot # M001578, its expiration date: 21-NOV-2018) (route, dose and frequency were not reported). Information regarding the patient's concomitant medication was not provided. The temperature was 33 degree F and the time frame: 13 hours and 30 minutes. Therefore, there was not a previous temperature excursion and the call was not because of a data logger. Additionally, no adverse effects were reported. This is one of several reports from the same reporter (MARRS # 1605USA008485 and MARRS # 1605USA008486). Additional information has been requested.
FEVER AND SWELLING AT INJECTION SITE.   BODY ACHE,  FEVER 100.1, FATIGUE, SLEPT FOR MOST OF DAY ANF NITE BETTER  ON 3/3/21
I woke up to what seemed to be an ingrown hair. In the next 3 days grew to size of a mango. Ended up being an abscess that needed to be surgically removed. Once cultures returned it turned out to be MRSA.
8 x 7cm red, erythematous no pain or pruritis (L) deltoid.
Vaccine that administered beyond use date after the thaw process/expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Patient age was reported as 65 years 3 months.  It was unknown if the patient had ever been diagnosed with or tested positive for COVID-19. It was unknown if the patient had any acute illness at the time of vaccination and up to one month before. It was also unknown if the patient had any chronic or long-standing health conditions  On 10-Jun-2022 the vaccination facility was made aware of administration of vaccines beyond use date after the thaw process while audit was conducted. Patient got Moderna with vaccine Ndc code.  No patient involved with any adverse reaction.  No treatment medication was reported by reporter
pt recvd vax;devel large hives on chest,back & arms;arthritis associated w/ pain;inc local T,swelling,redness,limitation of movements of rt wrist,rt & lt knees;sx lasted 3-4 days;dph,pred & amoxicillin given;
I experience hearing issues 24-hours after receiving the vaccine and am suffering from extreme hearing loss. I went to the Urgent Care who then referred me to an ENT. My hearing aids have been adjusted  but it did not help. I have an appointment to go see an ENT who gave me three shots in my ears to find out if the symptoms are associated with the vaccine or my  Hypothyroidism.  I am still having the symptoms and will be going back to see the Audiologist 10/15/2021 and will be going to the ENT as well..
1 1/2hr p/vax pt came to office w/a rash which was dx as varicella;exposure hx @ sitter's;
Four days after receiving vaccinations, patient developed fluid accumulation near elbow.  Per patient, swelling is approximately size of lemon with no skin color or temperature changes.  Area is not tender but deltoid muscle still sore to use.
Roughly 10 hours after receiving the 2nd Moderna covid vaccine my hand turned red and swollen bilaterally and from the 2nd knuckle down to the end of the fingers they were completely pale and the nails began turning blue. The change in color was a very defined straight line border. It was not painful and there was no numbness or tingling. I had not been outside or done anything involving a change of temperature. Along with my second dose I also experienced severe chills/shivering , nausea, sweating, fatigue, and body aches. These also happened with the first dose. The change in color to my hands lasted about 2 hours. There does not seem to be any lingering issues since then.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-JUN-2018, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot number M038359, expiration date 13-MAY-2018; dose and route of administration were not reported) for prophylaxis. It was reported that the vaccine was properly stored. No adverse effects were reported.
Patient is a G2P1 with no past medical history.  LMP 12/21.  Patient was 7 weeks pregnant at the time of vaccination.   Patient has previously carried 1 healthy term pregnancy with no complications.  She received the vaccination on 2/6/2022 and had a miscarriage of current pregnancy 4 days later on 2/10/2022.  Miscarriage was confirmed by lab testing on 2/16 showing low beta hcg consistent with miscarriage.
pt recv vax 17OCT95 & 3APR96 pt devel atypical chickenpox rash w/100-200 lesions;MD felt this was a case breakthrough chickenpox;
Headache Narrative: Dose #2, Day #1 localized injection site soreness; Day#2 entire R arm was swollen and sore, swollen gland R side of neck, headache entire head, fatigue
Patient received their 3rd dose.  After 2 minutes of receiving the dose, patient felt dizzy and lightheaded.  She also felt like throwing up.  We asked Dad if they would like us to call EMS, and Dad wanted to wait few more minutes.  We check blood pressure at 3:00pm and it was 102/73 pulse 70-- After drinking some water and orange juice and waiting for 10-15 minutes the patient felt better and wanted to leave on their own will.  We measure blood pressure at 315pm and it was 105/78 pulse 73.  Patient left
Patient fainted after about 10 seconds of Covid-19 Moderna (2nd dose) administration. Patient reported to lose consciousness for about 10 seconds. Patient was then helped getting back to his chair staying that he was feeling fine. I sat with patient for about 2 minutes and noticed that he was a little pale and sweating. I asked patient if he wanted to lie down and he refused. I told patient to remain still while I was getting help and called 911. I again fainted and I put patient down on the floor and monitored his breathing, heart rate. I gained consciousness back after 10 to 15 seconds. Store manager arrived. Patient drank some water. Patient seems to be aware of surroundings. EMTs arrived soon after. During the time that EMTs were monitoring patient. Patient fainted again and was taken to hospital.
Two days after my first dose of the Moderna COVID 19 vaccine I developed ringing in both ears. I have never had this before. There is nothing that seems to make it better.
Received 18 mo. immunization on 11/20/06 including DTaP and IPV. 3 days later, pt. had fever and concurrent seizure. Since that time, pt. has had recurrent seizures and is now on medication. Pertussis for 1st reaction/seizure or decreased seizure threshold.
She got her vaccine, she had no side effects other than her mouth being really really dry.  She went to bed, and was awakened at 3:00 AM with ringing in her ears.  She is living on 3 hours of sleep a day due to the persistent ringing in the ears.   She went to the tinnitus center who gave her some medication for the swelling and to wait and see if it goes away or if this is permanent.  Right now she is very upset that the public is not being informed of this information.
Fever, chills, muscle aches, chest congestion, sweats, cough with chest pain
The pt experienced a hyporesponsive, and hypoactive reaction for 3 days.
This spontaneous report has been received from a pharmacist concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On 29-SEP-2017, the patient was mistakenly vaccinated with VARIVAX with lot number M015735 and expiration date on 30-MAR-2018 (dose, dose number, route of administration and anatomical location were not provided), administered for prophylaxis, reconstituted using the sterile diluent (MERCK). No adverse effects were reported.
I noticed about a week or less after getting the vaccine injection that my face started breaking out a lot on my jawline/chin. For awhile I thougth it was related to wearing a mask. But later recalled a family member breaking out on her face after getting the 1st moderna injection. I than made the connection to how shorterly after the injection that I noticed a strong break out of acne on my face and that it was not likely from a mask since it did not have this problem before the injection/ have been wearing masks for about a year with the pandemic.
Pt reports extreme itching approx 3 days after vaccine lasting 5 days - pt also has redness 3-4" around injection site and it's hot to touch. Marble sized lump present as well. No fever or pain.
Extreme weakness; Chills; Fever; This spontaneous case was reported by a health care professional and describes the occurrence of ASTHENIA (Extreme weakness), CHILLS (Chills) and PYREXIA (Fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced ASTHENIA (Extreme weakness), CHILLS (Chills) and PYREXIA (Fever). On 08-Apr-2021, ASTHENIA (Extreme weakness), CHILLS (Chills) and PYREXIA (Fever) had resolved.        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 concomitant medications were reported.  The patient did not take any medication to treat the symptoms.
LOWER PART OF LEFT LEG SWOLLEN; This spontaneous report received from a consumer concerned a 71 year old female. 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: 1805029, expiry: UNKNOWN) dose was not reported, one total, in right arm administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced lower part of left leg swollen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lower part of left leg swollen. This report was non-serious.
Multiple outbreaks of herpes zoster; This initial spontaneous report has been received from a lawyer regarding a case in litigation, concerning a patient (pt) of unknown age and gender. The pt's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions, or allergies were not reported. On 05-NOV-2014, the pt was vaccinated with ZOSTAVAX subcutaneous injection (dose, strength, vaccination scheme, route of administration, anatomical location lot number, and expiration date were not provided), administered for long-term prevention of shingles and zoster-related conditions, at physician's office. Subsequently, the pt was treated by providers for the following injuries resulting from the pt's ZOSTAVAX use: multiple outbreaks of herpes zoster. The outcome of the claimed event was not recovered. The causality of the claimed event was considered related.
Patient states that injection site began to swell with mild discomfort. He then noticed redness and itching from area. Patient states no pain, just discomfort.
Large injection site reaction, with rash, hardened red area of about 6 inches x 3 inches.  101-degree fever for 3 days, followed by chills and shivering.  Overall sickness.  Slept very little, ate very little.  Possible cellulitis from injection.   (As a side note:  Patient was given 3 doses of Prevnar before 6 months of age).
Large area of redness, soreness and itching at injection sight on 1/20/21, Nine days following injection. Continues with redness only as of 1/25/21
This spontaneous report has been received from the medical assistant refers to a 4 year old female patient. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. Concomitant therapies administered to them included sterile diluent (MRK) used to reconstitute the PROQUAD was properly stored. On 30-MAY-2018 (also reported as 25-MAY-2018), the patient was vaccinated with improperly stored doses of PROQUAD recombinant Human albumin (rHA) (lot number R001541, expiration date 15-JUL-2019), subcutaneously. The doses of PROQUAD were exposed to a temperature excursion of 6 degrees Fahrenheit (°F) to 14°F (also reported as "9F") for a time frame of 10 minutes; and of 15°F to 46°F (also reported as "25F") for 20 minutes. The temperature excursion was not detected by the Digital Data Logger. There was no previous temperature excursion either. No adverse effects or product quality complaints were reported. This is one of the multiple reports received from the same reporter. Sender's Comments: US-009507513-1806USA001756.
Pt receiving 1st HPV-GARDASIL imm. orange juice given prior to inj. Pt sitting in chair-imm. given. 2 min later, Pt was pale and saying he was light headed and throat was tightening up/hard to speak. Pt laid down, orange juice/water, sucker given and vitals taken. Vitals WNL. 5 min later, Pt says doing better. Monitored for 25 min. Vitals still WNL, Pt said no longer dizzy and throat ok.
3/5 Patient presented to ED after being  found on floor at home and complaining of neck pain. primary care giver noted that patient had had several recent falls, increasing weakness and decreased appetite for several days prior to presentation. Pt was found to have UE weakness in ED and cervical spine CT showed C2 fx and cord hematoma resulting in severe cervical stenosis. Screening nasal swab for admission was positive of SARS-CoV-2. Pt had no hypoxemia.   3/6 pt was intubated for acute hypoxic hypercapnia secondary to hypoventilation from medication. The was then found to have MRSA pneumonia. He was treated with both dexamethasone and IV vancomycin.  3/8 had C2-C6 laminectomy Progressed slowly and  was extubated and worked with PT/OT/ST. Found to have occult sacral  fx. Was eventually discharged to SNF on 3/17/21