chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site reaction 2 days post vaccination after second dose. 3.5 cm x 5.5 cm injection site erythema; Injection site reaction 2 days post vaccination after second dose. 3.5 cm x 5.5 cm injection site erythema; This is a spontaneous report from a contactable other hcp. A 13-years-old female patient received second dose of BNT162B2 (Formulation; Solution for injection; Batch/Lot number: unknown), dose 2 via an unspecified route of administration on 02Jul2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Not known allergies. The patient previously received first dose of BNT162B2 on an unspecified date for covid-19 immunisation. On 03Jul2021 the patient experienced Injection site reaction 2 days post vaccination after second does. 3.5 cm x 5.5 cm injection site erythema. AE resulted in emergency room/department or urgent care. The patient received treatment with Diphenhydramine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.  Information related to batch/Lot no. was requested.
Blood pressure rose and stayed high, treated with Benazapril  (40mg) once a day and Amlodipine (5 mg) once a day. Now stable.
Patient was given TDap shop 10:45 am. Patient felt weak, sweating nearly lost consciousness but regained in like few minutes. Tried to call 911 while on phone pt recovered and said no paramedics required. Patient left in 15 min fine.
in general he didn't feel well; deep cough, not mucousy just really bad cough; he is rolling around, in a lot of pain, pain all over; This is a spontaneous report received from a non-contactable consumer (patient's fiance) via medical information team. A 39-year-old male patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: unknown) via an unspecified route of administration on 21Apr2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that he didn't have any side effects or anything, until last evening on 26Apr2021, started feeling, in general didn't feel well, as the night progressed and currently, he was rolling around, in a lot of pain, pain all over, and deep cough, not mucousy just really bad cough." Also explained that cough not included in list of reported side effects, referred to HCP. The outcome of the events was unknown.   No Follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Patient presented to ER with worsening chest pain. diagnosed with pericardial effusion, pleural effusion, pneumonia. Patient discharged home in stable condition will follow up with cardiology clinic.
Patient woke up around 1 am with extreme chills and shivering to the point where he could not control his shaking. He felt that the shaking was similar to convulsion like movements. He also had to urinate 8 times that night.
Severe apnea/bradycardia/desaturation events-12 hours after vaccines requiring intubation. Seizure-like activity began ~14 hours after vaccinations. Clinical sepsis with hypotension requiring pressors, hypothermia, and anemia ensued. in 20 hours after admission. Brother (twin) received same vaccines from same lot number and asymptomatic. Prognosis is unclear at this time.  06/17/2008 MR received for DOS 5/13-30/2008 with D/C DX; Respiratory Failure.  Prematurity.  Apnea of Prematurity. Sepsis-clinical. Infant presented after being found by mom to be unresponsive. Found to be bradycardic, with apnea and O2 desaturations in the ER. Pt was intubated and placed on a vent. Devceloped RUL atelectasis which resolved. Hypotension was initially unresponsive to fluid and required Dopamine.Pt tx with cortisone for absolute adrenal deficiency. Neurologically pt developed jerking, twitching, tongue thrusting felt to be seizures.  Pt somnolent with poor tone 2' to phenobarb. + dysphagia so NG tube placed for nutritional supplementation.  Given PRBC for low Hct. Tx with abx and antivirals for clinical sepsis.  ID consult with Impression adverse cardiorespiratory event following immunizations.
Erythema, swelling, itching within a 21cm perimeter from injection site, extending to shoulder to upper chest.
have flu like symptoms but no positive test results; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Type 1 Diabetes" (ongoing), notes: m also type 1 diabetic but yet never contracted the disease. The patient's concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "have flu like symptoms but no positive test results".   Additional information: Customer Verbatim "How do I sign up to be studied or compensated for covid-19 trial study. I work in a highly contagious environment yet I Tve never tested positive through both outbreaks. I Tm currently vaccinated and I Tm also type 1 diabetic but yet never contractedthe disease. I Tve have flu like symptoms but no positive test results".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Second day after vaccine had joint pain and chills third and 4 day stomachache. 1 week after started having neck pain on my left side until now and irradiate toarse my shoulder and arm p to my hand on left side also random days present dizziness when I lie down blurry vision. on January 19 had neck pain shoulder pain and headaches on left side too went to Dr. and his medical diagnosis was muscle spasm might be induce due to stress pre-scribe Diazepam 5 mg . start taking it on Wednesday January 20-2021 but Saturday January 23 my upper lip started getting swollen , IL STOP THE MEDICATION ON MONDAY JANUARY 27 LIPS got better but still filling burning sensation inside mucosa on left side of the lip. still mild swollen started taking Zyrtec my concern is second doses of Pfizer vaccine is this Friday 29 should I get it or wait ?? what I Have could be effects from first Dose??.
Left upper arm from shoulder to elbow swollen and red. Hot and painful. Pt was given Tylenol by family.
FLARES; HEART PALPITATIONS; Stomach pain; DELTA VARIANT OF COVID; First dose on 18-Dec-2020 and second dose on 08-Jan-2021; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (FLARES), PALPITATIONS (HEART PALPITATIONS), ABDOMINAL PAIN UPPER (Stomach pain), COVID-19 (DELTA VARIANT OF COVID) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18-Dec-2020 and second dose on 08-Jan-2021) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products PANCREATIN (CREON) capsule for an unknown indication and ADALIMUMAB (HUMIRA) solution for injection for an unknown indication.    Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.   On 18-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started PANCREATIN (CREON) (Oral) UNK, Delayed Release Pellets and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose once a week. On 08-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18-Dec-2020 and second dose on 08-Jan-2021). On an unknown date, the patient experienced CONDITION AGGRAVATED (FLARES), PALPITATIONS (HEART PALPITATIONS), ABDOMINAL PAIN UPPER (Stomach pain) and COVID-19 (DELTA VARIANT OF COVID). At the time of the report, CONDITION AGGRAVATED (FLARES), PALPITATIONS (HEART PALPITATIONS), ABDOMINAL PAIN UPPER (Stomach pain), COVID-19 (DELTA VARIANT OF COVID) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18-Dec-2020 and second dose on 08-Jan-2021) outcome was unknown.            It was reported the patient was on Humira and had been switched to weekly due to flares. Patient was taking Creon and still not well. She had heart palpitation after second vaccine. She got delta variant of COVID of 2021. The reporter's causality for the event(s) of DELTA VARIANT OF COVID, FLARES, HEART PALPITATIONS and STOMACH PAIN with Humira was Not Provided. The reporter's causality for the event(s) of DELTA VARIANT OF COVID, FLARES, HEART PALPITATIONS and STOMACH PAIN with Pancrelipase Capsule, Delayed Release Pellets was No Reasonable Possibility It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  No treatment medications were reported.
flat, hive all over, TX Atarax 10mg 5cc's 4-5 times daily for itching.
PATIENT RECEIVED SECOND DOSE OF MODERNA COVID-19 VACCINE, AND 2 DAYS LATER HAD ADVERSE EFFECTS: FEVER OF 101.4, FACIAL PAIN, MUSCLE ACHES, AND TINNITIS. ALL SYMPTOMS RESOLVED EXCEPT FOR THE TINNITIS. PT TX SELF WITH OTC MEDS.
trouble sleeping/sleeplessness; trouble breathing; stabbing back pain; This case was reported by a consumer via call center representative and described the occurrence of difficulty sleeping in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st March 2022, the patient received the 1st dose of Shingrix. On 1st March 2022, less than a day after receiving Shingrix, the patient experienced difficulty sleeping, difficulty breathing and back pain. On 6th March 2022, the outcome of the difficulty sleeping, difficulty breathing and back pain were recovered/resolved.   It was unknown if the reporter considered the difficulty sleeping, difficulty breathing and back pain to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received dose of Shingrix vaccine and that evening she began to experience stabbing back pain that caused trouble breathing and sleeping. The patient was referred to HCP(health care professional). Spoke per PI(package insert) and content. The reporter consented to follow-up.
Patient was at the clinic for a well child check, her health maintenance record was saying that she was overdue for her Hep A, after discussing the pros and cons of receiving it and explaining that it was mandatory for early-child education/ daycares that she should probably get started on the series. Provider ordered it. Immunization was given in left arm. While entering information into the computer and updating health maintenance it shown that this was the 3rd dose of Hep A. Provider notified, Patients mom was updated and was going to watch for any symptoms, She had no reactions while in clinic.
Received 2 month imm; infant began having loose, frequent stools with blood streaks apparent. Seen by peds provider 6 days later, placed on nutragmen with resolution of blood in stool.
Initial and follow up information has been received from a RN concerning a 72 yr old female pt who on 07Dec04 was vaccinated in the arm (unspecified) with a dose of pneumococcal 23v polysaccharide vaccine (lot649732/0513P). It was reported that after vaccination, approx on 07Dec04, the pt subsequently developed bacterial cellulitis from pneumococcal 23v polysaccharide vaccine (lot 649732/0513P). In follow up, the nurse reported that after the vaccination, the pt developed redness and swelling of the arm, and experienced extreme arm pain. The pt was diagnosed with bacterial cellulitis. The nurse reported that the pt's physician believed the reaction was from the vaccine. The pt was treated with an unnamed medication. In follow up, the nurse reported that the pt was treated with antibiotics (unspecified).  It was also reported that the pt received pneumococcal 23v polysaccharide vaccine five years ago. The physician expressed concern regarding the lot. The nurse reported that three other pt's experienced adverse events after administration of pneumococcal 23v polysaccharide vaccine (lot 649732/0513P) (WAES 0412USA01335 and 0412USA01726).  The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.
Covid like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (Covid like symptoms) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced SUSPECTED COVID-19 (Covid like symptoms). The patient was treated with CHLORPHENAMINE MALEATE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (THERAFLU [CHLORPHENAMINE MALEATE;PARACETAMOL;PSEUDOEPHEDRINE HYDROCHLORIDE]) at an unspecified dose and frequency; ZINC at an unspecified dose and frequency; VITAMIN B COMPLEX at an unspecified dose and frequency and VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency. At the time of the report, SUSPECTED COVID-19 (Covid like symptoms) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     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.   Concomitant medications included Blood pressure medication.
She says she developed 102.0 fever, aches, headache and chills on Saturday 6/4. She says she was sick for a week.
Received GARDASIL immunization - 1st dose, passed out immediately. Laid down and went into seizure-like symptoms, eyes rolling, very stiff body, hands clenched, lasted about 30 sec. She didn't remember anything. Very tired rest of evening and weak. She said her fingers tingled. Her eyes had very dark circles and she was very pale.
When I first started noticing this exactly, I am unsure. Either shortly before the vaccination or shortly after. I always read before I fall asleep, quiet. I noticed there seemed to be an extra beat in my heart, only lasting one or two seconds and it would go away. I would ignore it, but it went on. I didn't know what to think of it. Not every night, very sporadic. My GP referred me to a cardiologist and there was a tremendous fluttering in my chest. Not painful, and that triggered me to call the doctor.
Day 1: tired and headache, ate lunch, but fell asleep at 6:00pm and didn't eat dinner, acetaminophen every 4-6 hours Day 2: Severe headache, nausea, slept most of day, couldn't get out of bed, could only eat crackers, acetaminophen every 4-6 hours Day 3: Severe headache, nausea, vomiting, slept most of day, couldn't get out of bed, could not eat any food, alternating acetaminophen and ibuprophen every 2-3 hours Day 4: Severe headache, nausea, vomiting, slept most of day, couldn't get out of bed, could not eat any food, alternating acetaminophen and ibuprophen every 2-3 hours Day 5:  Severe headache, nausea, slept most of day, couldn't get out of bed, at a little bit of soup, alternating acetaminophen and ibuprophen every 2-3 hours Day 6: lighter headache, could eat light meals.
Shooting pain down arm, burning, inability to move arm, swelling, redness, bruising, fever.
The patient received a flu shot instead of the new Covid-19 booster that he made an appointment for. No adverse reaction occurred on the day of vaccination.
The evening after vaccine, pt started with fatigue, chills, HA, and nausea.
Patient stated that her symptoms started the evening she received the vaccination and was in extreme pain all over her body. This lasted for a good 2 days and still does not feel right almost a week later.
This spontaneous report was received from a pharmacist and refers to a 61 year old male patient who was a physician. He did not have any pertinent medical history, drug reactions or allergies. On approximately 11-NOV-2015 (reported as "one month ago"), the patient was vaccinated with one dose of ZOSTAVAX lot # L017165 (dose, route of administration and expiration date were not reported). The patient did not take any concomitant medications. On 11-DEC-2015 (also reported as "approximately one month after ZOSTAVAX administration"), the patient experienced right sided abdominal pain. The patient sought medical attention. He was seen in the emergency room (ER) on 11-DEC-2015 and had an unspecified lab test performed (results not provided). The outcome of right sided abdominal pain was not reported. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
Patient developed a fever that lasted 3 days post vaccination. Is also experiencing swelling around his eyes, as well as upper respiratory symptoms not resolved if treated as seasonal allergies (has persisted since vaccination until present).
VERIFIED WITH STAFF. KEPT 10-15 MIN REACTION NOTICED. INFORMED DR. AND ORDERED BENADRYL
blood pressure and pulse ran extremely high; 156/95; blood pressure and pulse ran extremely high; pulse of 123; nose bleeds; very bad headache; fever of 101; chills; muscle and body aches so bad; muscle and body aches so bad; nausea; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 17Apr2021 14:30 (Batch/Lot Number: ER8729), at the age of 50 years old, as dose 2, single for covid-19 immunisation in a doctor's office/urgent care. Medical history included hypertension, acid reflux, and allergies to adhesive, all from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. No covid prior to vaccination and was not tested for covid post vaccination. Concomitant medications included acetylsalicylic acid (ASPIRIN); acetylsalicylic acid (BABY ASPIRIN); sucralfate (CARAFATE); acetylsalicylic acid (CARTIA); omeprazole (PROTONIX); and an unspecified blood pressure medicine.  The patient previously took cefdinir (OMICEF) and experienced allergies; dose 1 of BNT162B2 on 27Mar2021 14:15 (Lot number: ER8730) at the age of 50 years old for covid-19 immunisation. No other vaccine received in four weeks. On 18Apr2021 01:00, the patient's blood pressure and pulse ran extremely high for the week of the 2nd dose of the vaccine and her doctor had to up her blood pressure medicine the following week because it was running 156/95 with a pulse of 123 when she was just sitting still. Also, her physician had to take her off 81 mg aspirin as she was also getting nose bleeds after the vaccine from the 2nd day (18Apr2021) on until he took her off the baby aspirin and increased her blood pressure medication. On 17Apr2021, she had all the side effects the night of and the day after the shot, she had fever of 101, chills, muscle and body aches so bad she couldn't get out of bed and nausea. Also, she had very bad headache for week following and a part of second week after 2nd dose. The patient received treatment for events. The patient was recovering from the events.   Follow-up attempts are completed. No further information is expected.
woke up on last day of a 7 night cruise with a sore throat.  Drove home for 2 days with running nose and coughing.  Treated with over the counter medicine and finally called the doctor on  6 after not getting any better.  He told me to continue what I was doing as it was too late to treat for COVID.  After another day or two went to a walk in clinic.  Received a shot, and perscription for a steroid and cough medicine.   Continued to take my medicine but  was still sick with horrible cough and  bad congestion.  Was in bed about 2 1/2 weeks not able to do anything.  After I was able to be up I continued to have no energy for about 2 months.  I now feel back to normal and able to do the things I enjoy.  I am NEVER sick and I think that is the reason it hit me so hard.
Vaccine administered on 11/29/22 after lot expiration date 11/25/22. : Pt tolerated injection well no adverse reaction noted after 10 minutes.
This spontaneous report was received from a pharmacist referring to a female patient of unknown age. The patient's concurrent conditions and medical history included Shingles over 1 years ago and she got cold sores frequently. On 09-SEP-2016, the patient was vaccinated with ZOSTAVAX (Lot # M024700, expiration 18-JUL-2017) dose and route were not provided for shingles prevention. There was no concomitant medication reported. On an unspecified date in September 2016, the patient called to report that she was beginning to experience a cold sore on her lip. At the time of the report, the outcome of oral herpes was reported as not recovered/not resolved. The reporting pharmacist did not assess the causal relationship between the adverse events and the vaccination with ZOSTAVAX. Additional information has been requested.
10/23 Itching chin and scalp. 10/24 Burning feet. 10/24 Rash. 10/25 Swollen hands, erythematous. Swelling tongue and feet. 10/25 Urgent care facility. 10/25 Epinephrine. 10/25 Vomit x 2.
w/in 4 days of vax pt exp inject site react which included redness & probable sterile abscess; seen in office 28JUN93; treatment: warm soaks, afebriel; no drainage reported to date;
Patient reports she vomited 1 time approximately 4 hours following injection of Gardasil. Patient's mother reports that the patient vomited following the first injection in series.
half dollar size itchy bump at injection site 7 days after injection.  Lasted for 2-3 days.
I just had my second shot yesterday morning. For the first dose, I didn't have any of the typical side effects other than sore arm. On June 4th, I started having vaginal bleeding. I called the on call triage and the bleeding was significant enough to go to ER. Was there and almost had a DNC at that point because the doctor felt the bleeding was so significant. But there was a wait in ER,  had an ultrasound, by that time bleeding slowed down and I went home with the caveat that if the bleeding returned to go to ER again. The doctor's were saying that a miscarriage was going to happen....so we were taking it day by day. 10 days later, I started bleeding again and then I miscarried on Tuesday of this week.  I started cramping at 1;:00 in the morning and felt the water break and then started bleeding heavily again at 03:00 in morning. Follow up with OB's on June 7th.  And I went to ER and once we got there and they checked the ultrasound and they couldn't see the baby any more and they had me go in to a D&E.    Pregnancy - 3rd pregnancy - one live birth (my son); the first pregnancy was an elective abortion; Estimated date of delivery was going  to be December 1 (I was 15 weeks)
This patient was given a tetanus shot on 11/21/00. The patient called 2 weeks later stating her right arm where the injection was given was swollen, red, and blisters around the swollen area. She consulted with a doctor and the doctor suggested ice to the arm. If not better within 24 hours to see private MD.  12/11/00, the patient states she is completely recovered.
Lightheaded / Dizzy 1:00 pm Nauseous 1:00 - 2:00 pm. Vomiting 2:00 p.m. Headache 2:00 p.m. - until next morning Called my physician - told to call back next day if not feeling better