chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 02Mar2021 (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 "not recovered", described as "headache". Additional information: Patient received his first dose of the Pfizer-Biontech Covid19 vaccine 02Mar2021. The following weekend he developed a headache and he's "had it ever since".  No follow-up attempts are possible. information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a physician via company representative refers to a 9 year old female patient. The patient's concurrent conditions and drug allergies were unspecified. Approximately in September 2015 (reported as about three weeks ago), the patient was vaccinated with first dose of 0.5 ml GARDASIL 9. On an unknown date in September 2015, the patient lost her eyebrows. The patient's eyebrows are starting to come back in some places but have not fully returned. It was unclear if the patient will continue therapy with the remaining GARDASIL 9 series. The patient sought medical attention. The outcome of the event was reported as recovering/resolving. The relatedness of the event with GARDASIL 9 was not reported. Additional information has been requested.
Information has been received from an office manager concerning a 7 year old patient who on 16-OCT-2000 was vaccinated subcutaneously with a dose of varicella virus vaccine live (Oka/Merck) (lot# 631475/1003J). On 08 MAR 2007 a specimen, obtained from the patient's abdominal area, was sent for rapid viral culture test for chickenpox. Culture results noted no herpes simplex or varicella zoster isolated. Clinical observations, noted on 09 MAR 2007, including red spots, itching on trunk, legs and head, indicated the patient had a mild chickenpox breakthrough. The patient had been exposed to shingles two weeks prior. The patient sought unspecified medical attention. At the time of reporting the outcome was unknown. There was no product quality complaint involved. Additional information is not expected.
Client states that approximately one hour after receiving vaccine his left arm became numb and the numbness progressively descended to his left leg and his left foot. He also reports nausea, headache, and dizziness.
The day after she recieved the vaccination, she had to be rushed to the hospital, had a major seizure that lasted several minutes. Never had a seizure before or after.
Severe involuntary movements as if  I was on crack, mostly my legs, sever, sever agitation.  Sweating, vomiting, extreme pain all over.  Extremities are still not the same, nor am I.
Pt's arm became red and progressive swelling and tender with increased warmth, over 48 hours and then peaked at 7 inches by 8 cm wide. Threated with 60 mg of steroids, Prednisone 20mg qd x 4 days. In 12 hours much better.
Administered booster dose of Moderna (blue top).  Person should have received Moderna Bivalent booster (blue top). No adverse event occurred.
My entire body has itched since August; High fever for 5 days; rash appears makes my skin like leather; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number 1, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose number 2, Manufacturer unknown), for Covid-19 immunization. The following information was reported: PRURITUS (non-serious) with onset Aug2021, outcome "not recovered", described as "My entire body has itched since August"; PYREXIA (non-serious) with onset Aug2021, outcome "recovered", described as "High fever for 5 days"; RASH (non-serious) with onset Aug2021, outcome "not recovered", described as "rash appears makes my skin like leather". The events "my entire body has itched since august", "high fever for 5 days" and "rash appears makes my skin like leather" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that Since taking the Pfizer Booster in Aug2021. The patient had  been in and out of doctors offices, entire body has itched since August. The itching started less than 24 hours after the booster, as well as high fever for 5 days. The patient had another appointment this morning because as the patient can no longer tolerate the itching. Every spot on body where the rash appears makes skin like leather.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Narrative:  Patient was observed for 15 minutes post vaccine administration  without issue. Patient received COVID 19 booster after 9/22 PCP visit; began to feel lightheaded when he got home. Patient reported he passed out at home.  Friends found him, called emergency services and transported him to community ER. He was treated with IV Fluids, albuterol, & ondansetron. After discharge to home, he developed N/V, no diarrhea, no fever, no body pain except soreness at injection  site. He reported he did not overdose on any drugs as listed on the ER discharge paperwork. On September 27, 2021 the ER notes were faxed to the agency and  patients PCP. The notes indicate the ER visit was the result of the patient snorting some opioid-had overdosed with hypoxia to the high 80's. He had been in the ER for 6 hours on oxygen, given nebs and recovered. The ER visit had not been due to the COVID Vaccine. Patient denied taking any drugs.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "migraine with aura" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" (07Sep2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Sep2023) Negative, notes: Negative test 3 days after Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 31Aug2023 to 04Sep2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 28-OCT-2015 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) (lot # L010596, expiration date 06-APR-2017; dose and route were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion four times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 24, 9 and R; 24, 8.4 and R; 24, 8.1 and R; 24, 8.3 and R. Thee storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Shingrix reconstituted with a Merck diluent; Shingrix reconstituted with a Merck diluent; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th October 2021, the patient received Shingrix. On 4th October 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient was administrated Shingrix which was inadvertently reconstituted with a Merck diluent as supposed to the AS01B adjuvant, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
No adverse event; Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster).    Concomitant medications were not reported.  It was reported that 100 patients were administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults. No AEs were reported.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.   It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  Treatment medications were not reported.   This case was linked to MOD-2022-646512 (Patient Link).
Patient tested positive for COVID-19 on 2/19/21. Patient due for second dose of COVID-19 vaccine on 02/26/21. Second dose administered on 2/26/21.  Second dose administered after 7 days of positive test instead of recommended 10 days after positive test.
Monitored x 15 min per guidelines. Began to experience SOB and throat swelling, after which pt presented to the ED for tx, dx acute hypertensive urgency with severe hypertension.
Patient waited 30 minutes after the shot was given then drove home. While driving, he experienced scratchy throat like mild food allergy reaction.  Upon arriving home, he took one Benadryl around 4:46 pm, drank water and rest.
Discharge Provider:  MD Primary Care Provider:  MD Admission Date: 6/26/2022 Discharge Date: Jul 1, 2022  PRESENTING PROBLEM: Difficulty breathing [R06.89] Acute respiratory failure with hypoxia (HCC) [J96.01] Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present (HCC) [A41.9] COVID-19 virus infection [U07.1]   HOSPITAL COURSE: Patient is a 95M  with Alzheimer's dementia, hearing loss, vertigo, previous stroke, sleep apnea, BPH, severe aortic stenosis status post TAVR, chronic systolic and diastolic heart failure and hypothyroidism who presented with a chief complaint of 1-2 days of fatigue/weakness and decreased appetite.   He was in his usual state of health until the day prior to presentation. He was out with family and when he returned, he had no appetite and did not eat dinner and this continued again in the morning. He also had an episode of diarrhea.   Upon arrival, he had a fever of 39° C and  mild leukocytosis of 11.19.  He had a mild nonproductive cough and his chest x-ray showed mild cardiomegaly and pulmonary vascular congestion, but no obvious infiltrate or pleural effusion.  Procalcitonin was negative (0.13). His SARS-CoV-2 PCR was negative. However, respiratory viral panel was sent and SARS-CoV-2 resulted positive there.   He was admitted for sepsis and acute respiratory failure due to COVID 19. He is fully vaccinated against COVID 19. CXR no infiltrate. CT angiogram thorax showing subsegmental right middle lobe pulmonary embolism no evidence of right heart strain. Echo with EF of 59% no WMA. He received remdesivir x5 days given acute hypoxemia. Levaquin started in ED but was not continued. He was weaned down to room air by discharge.   For his acute PE, he was transitioned from lovenox to eliquis with plan for 3 months of treatment. Home ASA 81 mg held while on eliquis to decrease bleeding risk.   He appeared to have a mild acute kidney injury compared to his previous baseline labs (0.89-- >1.06). UA negative for UTI. Renal function improved to baseline by discharge.   He did develop mild delirium/acute encephalopathy in the setting of known dementia. He has hearing loss which makes it harder to communicate. He is known to lip read which makes it harder for him to understand his care team with mask on. No treatment needed for his acute confusion. Frequent redirection, avoiding sedative/narcotics and encourage proper sleep wake cycle was re inforced.   PT/OT recommend SAR and he was discharged to facility in stable condition on 7/1/22
had been stored outside of recommended storage range; No additional AE details; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions or medical history provided. Concomitant therapies included sterile diluent(MERCK STERILE DILUENT).    On an unknown date, the patient was vaccinated with an improperly stored dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHA (recombinant Human albumin), lot # U029147, expiration date 16-MAR-2023) for prophylaxis (dose, route and site of administration were not reported).   The administered dose of the vaccine experienced a temperature excursion of -58 Degree Fahrenheit to 5 Degree Fahrenheit with average of -7 Degree Fahrenheit for 2 hours and below -59 Degree Fahrenheit with average of -65.2 Degree Fahrenheit for 46 hours. Pharmacist would like to know when the patient could be re-vaccinated. No additional adverse event detail.  This is one case of some cases from same reporter.; Sender's Comments:  US-009507513-2204USA006370: US-009507513-2204USA006442:
This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Could hardly walk), CHILLS (Chilling and shivering/She used 7 blankets and was still freezing) and MYALGIA (Body aches) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination. No Medical History information was reported. On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (Could hardly walk), CHILLS (Chilling and shivering/She used 7 blankets and was still freezing) and MYALGIA (Body aches). At the time of the report, GAIT DISTURBANCE (Could hardly walk), CHILLS (Chilling and shivering/She used 7 blankets and was still freezing) and MYALGIA (Body aches) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant product use was provided. It was reported that about 12 hours later, the patient experienced chilling and shivering. No treatment medication was provided. This case was linked to MOD-2022-456356, MOD-2022-456359 (Patient Link).
Approximately 2 weeks subsequent to receiving one dose of varicella virus vaccine live the pt started breaking out in spots. Gradually the pt developed over two hundred generalized rashes. In was noted that none of the rashes were crusted but 2 or 3 were leaking a clear fluid.
she felt a little dizzy/a little dizziness; headache; This is a spontaneous report from a contactable consumer (patient herself). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 04Feb2021 (at the age of 77-year-old) at a single dose for COVID-19 immunisation. Medical history included cancer, heart problems and ongoing COVID. The patient's concomitant medications were not reported. The patient reported that she has had a light case of COVID and took the COVID vaccine this morning. She said that after receiving the vaccine, she is experiencing, not major, a little dizziness/dizzy and headache on an unknown date in Feb2021. She is not really worried about it. She did not want to take anything before she called and verified if it was ok; but she called to ask if she can take TYLENOL after having gotten the vaccine. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 33-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 036A21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (C- section, Live, full-term birth) on 14-Mar-2019, Pregnancy (C- section, Live, full-term birth) on 27-Jul-2020 and Asthma.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 28-Dec-2020 and the estimated date of delivery was 04-Oct-2021. On 06-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifth week of the pregnancy.  On 06-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, Pregnancy test: positive (Positive) Pregnancy test - positive.         Estimated date of conception was on 07-Jan-2021. Number of fetuses was one. Patient had missed miscarriage and fetus stopped growing at eight weeks.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Second dose details, pregnancy details were updated
Patient has advanced dementia. The patient has been on treatment and under the care of Neurology.  The patient has been exhibiting change of mentation with confusion and agitation.  Decreased p.o. intake.  The patient was tested positive for COVID-19 even though she is saturating in the mid 90s on room air.  The patient does not seems to be in a major respiratory distress, yet when I came to see the patient along with the nurse, the patient was very agitated, was pacing within the room, noncooperative at all due to her dementia.  The patient had low-grade fever with possibility of pneumonia on the right middle lobe.
Blood in urine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BLOOD URINE PRESENT (Blood in urine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD URINE PRESENT (Blood in urine). At the time of the report, BLOOD URINE PRESENT (Blood in urine) outcome was unknown. Not Provided          No concomitant product use was reported  No treatment information was provided
Difficulty in breathing.  Mild gasping for breath. 102.6 fever for 2 days, aches and weakness. My arm at the injection site swelled up, and was very red and hot and it was the whole upper arm.   The trouble breathing was very scary as I live alone.. Thank goodness I had oxygen at home that I sleep with, and a nebulizer.
Arm (topside and underarm side) was painful starting the 2nd day and lasted 3 days.  Starting the 2nd day I had severe body aches and chills for the entire day.
Patient received this vaccination 5 weeks after receiving Flu vaccine on 12/09/2021
I woke that next morning I could not write. I made an appointment to see doctor because it didn't improve. Went to see a sports medicine doctor and occupational therapy.
Patient fainted about 1 to 2 min after getting vaccine. Patient felt very hot and was given an ice pack and began to sweat. After about 10 min patient was helped to a sitting position.
Vaccine given to someone less than 18 years old; A spontaneous report was received from a physician concerning an adolescent patient of unspecified age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, vaccine given to someone less than 18 years old.  There were no medical history and concomitant medications provided.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection.   The physician reports the vaccine was given to someone less than 18 inadvertently. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, vaccine given to someone less than 18 years old, was considered resolved on an unknown date.; Reporter's Comments: This concerns an adolescent patient of unspecified age and gender, less than 18 years old who received their first of two planned doses of mRNA-1273 (lot#: unknown) intramuscularly in the arm for prophylaxis of COVID-19 infection. There were no reported adverse events associated with this event of product administered to patient of inappropriate age.
Presents today after hours clinic with redness at injection site, early cellulitis/non-septic vasculitis. Immunizations were given on 08/08/2011. Please ask MA for additional questions of PCP Dr.