chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received first dose of covid vaccine and Tested positive; Received first dose of covid vaccine and Tested positive; This is a spontaneous report from a contactable consumer from the Pfizer-sponsored program.   A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter called in and wanted to know the time interval between Remdesivir and BNT162B2. It was reported that the patient received the first dose of BNT162B2 and tested positive and was treated with Remdesivir and wanted the second dose. The outcome of the event was unknown.   Information on the batch/lot number has been requested.
Patient experienced hives on stomach and back approx. 5 pm the next day. At 10 pm she spoke to pharmacist who advised to seek medical attn. and proceeded to ER. Placed on prednisone and sent home.
Pain in arm clarified that it was on the injection site; Her arm still has a round, red, knot. It's like a circle on arm and stuff clarified that it was on the injection site; could not lift the injected arm as good as she once was; Pfizer Booster shot; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient. A 58 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 30Dec2021 13:15 (Lot number: FJ8757) at the age of 58 years as dose 3, (booster) single for Covid-19 Immunization. Relevant medical history included: "Blood pressure abnormal" (ongoing). Concomitant medication included: LOSARTAN HCTZ taken for Blood pressure abnormal (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Lot- ER8734), administration date: 01Apr2021, when the patient was 58 years old, for Covid-19 Immunization; Bnt162b2 (Dose 2, Lot- EN0164), administration date: 23Apr2021, when the patient was 58 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Dec2021 13:15, outcome "not recovered", described as "Pfizer Booster shot"; VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "Pain in arm clarified that it was on the injection site"; VACCINATION SITE MASS (non-serious), outcome "not recovered", described as "Her arm still has a round, red, knot. It's like a circle on arm and stuff clarified that it was on the injection site"; INJECTED LIMB MOBILITY DECREASED (non-serious), outcome "not recovered", described as "could not lift the injected arm as good as she once was". Therapeutic measures were taken as a result of vaccination site pain, vaccination site mass, injected limb mobility decreased. Clinical course: Patient called to report that she had Pfizer Booster shot. After she took the shot, on unknown date, she felt pain in the arm and stuff. Her arm still has a round, red, knot. It's like a circle on arm and stuff. Patient later on clarified that these were on the injection site. Patient also could not lift the injected arm as good as she once was. She called her doctor and was told to apply a heating pad. In addition, she was taking Tylenol and Benadryl and started doing a soft massage to help it out.
Patient was given varicella vaccine 3 weeks after receiving MMR vaccine. No adverse signs/symptoms seen at appointment time or reported by patient/parent.
Patient experienced chills and muscle aches for 36 hours after receiving her 2nd COVID vaccine.
Sudden onset of pain in R upper arm, severe shaking, severe chills, rare incontinency, fainting (totally rare)  Began drinking fluids in excess. Weak and sleepy next day.
Patient did not receive complete dose of bivalent booster.  Patients' son declined second dose at this time
NO TREATMENT TAKEN, HEADACHE AND ARM REACTION, LASTED A FEW DAYS AND, BODY PAIN LASTED 24 HOURS
Chest pain - went away and came back in the same area of the chest. Patient went to an urgent care facility were they refereed them to a nearby hospital. 2 EKGs were preformed, one at the urgent care and the other at the hospital.
Fever; Body aches; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (Fever) and MYALGIA (Body aches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PYREXIA (Fever) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever) was resolving and MYALGIA (Body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Action taken with mRNA-1273 in response to the events was not applicable.
Sore arm at injection site; Got Flucelvax in the same left arm at the same time as Comirnaty; This spontaneous case was received on 26-Oct-2023 from Seqirus via Pfizer (reference number: 202300322326), reported by other non-healthcare professional (consumer) and concerned a patient of an unreported age and gender.   The patient's concurrent conditions included penicillin allergy. The patient's concomitant medications were not reported.    On 08-Oct-2023 at 10:30 am, the patient was vaccinated with the fifth dose of a non-company, co-suspect Comirnaty vaccine (tozinameran; anatomical location: left arm, dose, route of administration and indication: not reported). The batch number was not reported.  On the same date, at the same time as reported, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; anatomical location: left arm, dose, route of administration and indication: not reported) (explicitly coded as 'Product administration error'). The batch number was not reported.  On the same date, after receiving Flucelvax Quadrivalent and non-company, co-suspect Comirnaty, the patient experienced a sore arm at the injection site.   At the time of initial reporting, the patient was recovering from the event of 'vaccination site pain'.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.  Company comment: The event of vaccination site pain is assessed as possibly related to Flucelvax Quadrivalent due to a plausible temporal relationship. However, the causality is confounded by administration of non-company co-suspect COVID-19 vaccine.; Sender's Comments: The event of vaccination site pain is assessed as possibly related to Flucelvax Quadrivalent due to a plausible temporal relationship. However, the causality is confounded by administration of non-company co-suspect COVID-19 vaccine.
still has redness in the right arm he was vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (still has redness in the right arm he was vaccinated) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (still has redness in the right arm he was vaccinated). At the time of the report, VACCINATION SITE ERYTHEMA (still has redness in the right arm he was vaccinated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication were provided  No treatment was reported   Reporter did not allow further contact
Patient received vaccine at 5 pm and began noticing reaction symptoms at 5:05 pm. Patient reported feeling tightness in her throat that went to the back of her tongue and her lips felt tingly. Patient reported that all symptoms quickly went away. Patient stayed for 30 minute observation and once complete, patient denied any further or new reaction symptoms. Patient left observation on her own. No medication were given.
The pt developed sparse but diffuse 3mm macules with surrounding erythema (sparing mucus membranes) on palms and soles. Otherwise, apparently without symptoms or findings.
I was 6 weeks pregnant and had a miscarriage. I started bleeding 3 days after receiving the flu shot. I had had one ultrasound and Beta HCG the week prior to the shot which both depicted a normal intrauterine pregnancy prior to the injection. I have no prior history of miscarriage, I have 2 living children from my 2 prior pregnancies.
pt recv vax; on 21mar94, exp fever, neck stiffness, joint pain & devel swelling;
For fifteen years I have had a small rash on my abdomen. In the early part of January 2021, I noticed that it had started to spread to other areas of my body and itch where it had never been symptomatic before. I called to make an appointment with my primary care physician. She referred me to a dermatologist, who at the time only advised me to moisturize the area. In November of 2022, I went to the local urgent care a couple of times as the itching was unbearable. They prescribed oral steroids, topical creams, lotions, a KENALOG cream was the only one that seemed to work. I went to a new dermatologist who did a biopsy and discovered it was Grover's disease. My primary care also did bloodwork to rule out an autoimmune disease, the bloodwork came back negative. I cannot remember the exact dates of the test they were ran in February of this year. I am still using KENALOG cream and phototherapy. I am still itchy and the issue had not resolved. I am not sure if they will be able to find a way to make this better.
pt had a recent hospitalization (admitted on 1/12/22) with dx CMML with severe leukocytosis, thrombocytopenia, anemia; while in the hosp, pt had a positive COVID test on 1/19/22; treated with dexamethasone and remdesivir; dc'd to home on 2/1/22 on 2L O2 via NC with home health; 2/3/22 readmitted to hosp with worsening SOB, nausea, vomited once; EMS found O2 sats to be 74% on 2L NC; CT scan of chest showed COVID pneumonia; O2 supplementation at 4L via NC; DNR/DNI; given ABX and dexamethasone; pt worsened, need for O2 increased; maxed out on Vapotherm and NRB; given transfusions; pt expired in the hospital
Patient noted mouth and throat itching about 5 minutes after vaccination. Patient took 2 25mg benadryl about 15 after vaccination. Patient left pharmacy and later noted chest pain and nausea. These symptoms were severe enough to cause patient to go to the ER where they ruled out a pulmonary embolism. Patient was prescribed and oral steroid per patient statement.
Mild nasal congestion that lasted for 3 days running. While overseas contracted COVID-19 and had to stay an extra 5 days until tested negative and cleared to get on the flight back home. Healthcare professional consulted was Pharmacist.
Arm soreness, muscle aches, fatigue, nausea, vomiting approximately 24 hrs after administration. Symptoms continue 18 hours after onset.
Injection site is warm to the touch; Sore at the injection site; swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site is warm to the touch), VACCINATION SITE PAIN (Sore at the injection site) and VACCINATION SITE SWELLING (swelling at injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 207031A21A and 207030m20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Asthma since 1965, Hypothyroidism since 1969, Diabetic since 2000, Acid reflux (esophageal) since 2010, Egg allergy, Penicillin allergy, Sulfonamide allergy, Drug allergy and Hypophosphatasia since 1985.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Injection site is warm to the touch), VACCINATION SITE PAIN (Sore at the injection site) and VACCINATION SITE SWELLING (swelling at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) 19-Mar-2021 for Swelling, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 31-Mar-2021, VACCINATION SITE WARMTH (Injection site is warm to the touch), VACCINATION SITE PAIN (Sore at the injection site) and VACCINATION SITE SWELLING (swelling at injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Body temperature: 100.4 f (High) 100.4 F.         The concomitant medications were not reported.  The patient took Benadryl 30 minutes before vaccination and took Tylenol an hour post vaccination. Patient had a medical  history of Flu vaccine
He developed a rash 10 days post smallpox vaccination. He describes it as tiny, red, flat spots above the SPV site, up the shoulder and neck on that side and a few on his chest. The ones on my chest are raised. No discomfort, pruritus, malaise. Feeling well otherwise. No F, C, SOB, chest pain. The SPV site is the size of a nickel and unremarkable.
Chronic tinnitus. ENT diagnosed. No treatment available. Loud ringing in both ears. Left ear louder. Sometimes a constant ringing and other times pulsating. 10 months of constant noise. No ear issues prior to this event. Never went to and ENT before this.
This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. There was no information about pertinent medical history reported. The patient's concomitant therapies included sterile diluent. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD lot number N009773 with expiration date 20-SEP-2018 and lot number N012489 with expiration date 17-OCT-2018 or VARIVAX lot number N017701 with expiration date 09-JUN-2019 and lot number N12131 with expiration date N012131 (dose, route and anatomical location were not reported for the above vaccines described) all for prophylaxis. The vaccines were exposed to temperatures between 6 to 14 F (Fahrenheit) during 3 hours and 40 minutes. There was a previous temperature excursion at the range of 6 to 14 F (Fahrenheit) for 4 hours and 30 minutes. Data digital logger was filled. Lot number N017701 has been verified to be a valid lot number varicella virus vaccine live.
Patient reported a local reaction around the injection site consisting of redness and swelling. The skin is warm to the touch. She reports itching but no pain in the area
This is a spontaneous report from a contactable reporter who reported for a consumer. This 5-year-old, male consumer (race unknown) started to receive PREVNAR 13 since an unknown date at an unknown dose and frequency. The relevant medical history and concomitant medications were unknown. The consumer on an unknown date in Dec2012 experienced pneumonia for which he was hospitalized for a week in Dec2012 after taking fourth and final shot of PREVNAR 13. The relevant laboratory data was unknown. Last action taken with PREVNAR 13 in response to the reported event was unknown. Therapeutic measure taken for the reported event was unknown. The consumer had recovered from the reported event on an unknown date. Follow-up (18FEB2014): Follow-up attempts completed. No further information expected.
Upon focused PE finding 11/19/15 there is a 5cm circumferential light erythematous macule around the injection site of left deltoid which then leads to a 5cm circumferential hive-appearing lesion with very mild edema and mild tenderness on the left medial bicep. Mild pruritis. No warmth.  Afebrile.  Denies throat itching, dyspnea, SOB, wheezing, CP.  Able to tolerate food well.
was administered a Hepatitis B vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of wrong vaccine administered in a 63-year-old female patient who received Hepatitis B vaccine for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 13-JUL-2023, the patient received Hepatitis B vaccine. On 13-JUL-2023, an unknown time after receiving Hepatitis B vaccine and an unknown time after receiving TWINRIX, the patient experienced wrong vaccine administered (Verbatim: was administered a Hepatitis B vaccine).  The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK Receipt Date: 13-OCT-2023 The patient self-reported this case. The patient returned on 13th July 2023 and was administered a Hepatitis B vaccine (manufacturer not specified) instead of TWINRIX, which led to wrong vaccine administered. The reporter consented to follow up.
Client given dose of COVID 19 Vaccine that had been thawed 35 days prior to administration. No adverse effects noted. Contacted Pfizer manufacturer. Evaluation completed. Vaccine was determined to still be stable at date of administration
Reddened areas follow by red, bumpy rash at injection sites. Itchy.
Patient received Moderna Vaccine at 6:44pm in left deltoid.  Patient c/o rash under chin and SOB while in monitoring area.  Patient given Diphenhydramine HCL  25 mg  1 tab orally.  Ambulance called and O2 applied at 7:09pm.  Patient alert and speaking with staff. Patient transported to Hospital.
I had an episode of atrial fibrillation. I went to the ER at Hospital on 10/25/2021. They administered Cardizem and heparin. That made my heart beat go back to a normal rhythm. I stayed there for 24 hours, and then they discharged me. Now I am on long acting Cardizem. I have an upcoming appointment with a cardiologist.
Severe Hives on day of injection that spread from the vaccinated arm and over to the other arm. Rash located on the trunk up to the collar bone onto the buttocks.    They turned into sores/ulcers that were EXTREMELY itchy. When the sores fell of they left deep holes that have become infected.    I also had heart issues, my pulse was at 165.
didn't feel good,felt crappy; laid around and fatigue; second dose: 02Nov2021 Lot#939905 ,1st booster: 08Mar22 Lot#030A21A; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (didn't feel good,felt crappy), FATIGUE (laid around and fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose: 02Nov2021 Lot#939905 ,1st booster: 08Mar22 Lot#030A21A) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 939905) for COVID-19 vaccination.     Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE] and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose: 02Nov2021 Lot#939905 ,1st booster: 08Mar22 Lot#030A21A). On an unknown date, the patient experienced FEELING ABNORMAL (didn't feel good,felt crappy) and FATIGUE (laid around and fatigue). At the time of the report, FEELING ABNORMAL (didn't feel good,felt crappy), FATIGUE (laid around and fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose: 02Nov2021 Lot#939905 ,1st booster: 08Mar22 Lot#030A21A) outcome was unknown.            No treatment drugs were reported   This case was linked to MOD-2022-577184, MOD-2022-577205, MOD-2022-577206 (Patient Link).
headache; tiredness; dizziness; nausea; body hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 13Mar2021 (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: HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "tiredness"; DIZZINESS (non-serious) with onset Mar2021, outcome "unknown", described as "dizziness"; NAUSEA (non-serious) with onset Mar2021, outcome "unknown", described as "nausea"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "body hurts".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Pt experienced redness and swelling to right thigh. Treated with warm compresses, Benadryl and Augmentin.
Pain in chest muscle on left side, left arm pain, back pain.  No treatment because patient does not have insurance and will not go see a doctor.
On 4/13/05 the child received MMR#2 (right thigh), IPV#4 (left thigh) and DTAP#5 (left thigh). The mother states that the child immediately started scratching his head and face. About 5 minutes later she noted red, raised bumps about the size of mosquito bites all over his body (she does not recall if the lesions were on the soles of feet or palms of the hands). The child was given BENADRYL and released after about 40 minutes. The mother states that the child never had SOB, wheezing, difficulty swallowing, abdominal pain or diarrhea. She does not recall if the child's lips were swollen, but she states that his eyelids were puffy. The pt did not receive any additional doses of BENADRYL or any other meds. The next morning (16 hrs after onset) the rash was gone, but mom noted thigh swelling, erythema and induration (left worse than right). The pt was seen on 4/15/05 for the thigh swelling, erythema and induration. The child was treated with TYLENOL with resolution of sx in about 7 days.
Pfizer-BioNTech COVID-19 Vaccine EUA: three days after vaccination patient reported to primary care provider experiencing nausea, vomiting, diarrhea, and poor oral intake for two days. Patient also reported palpitations, dyspnea on exertion, and chest pain and was sent to the emergency department (ED). On arrival to the ED vital signs within normal ranges except pulse 112 beats per minute. Intravenous fluids and acetaminophen administered with symptom improvement. Repeat vital signs within normal ranges and patient discharged home stable.  The next day patient returned to the ED with palpitations, dizziness, and shortness of breath. Vital signs all within normal ranges. Patient administered intravenous fluids and ondansetron with symptom improvement and discharged to home stable.
Bells palsy diagnosis. Given Prednisone. Started to recover then received second dose on 04/06/2021 and symptoms of bells palsy returned to level prior to medication.