chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had c/o feeling lightheaded approximately 5-10 minutes post vaccine.; This is a spontaneous report from a contactable other healthcare professional. A 77-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via intramuscular route of administration on 18Feb2021 at 11:00 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and known allergies to penicillin and shellfish (unknown reaction). Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and unspecified medications (the patient unable to remember other medications at that time); for an unknown indication from an unknown date and unknown if ongoing. On 18Feb2021 at 11:00, approximately 5-10 minutes post vaccine, the patient had complained of feeling lightheaded. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event feeling lightheaded approximately 5-10 minutes post vaccine was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Diffuse red papular rash on arms, legs followed by swollen lips, feet and hands and more widespread rash.  Administered Benadryl and steroids.
Since the second I have had no energy, and cannot walk far, and also my legs have been sore when I walk.  Before I had it i used to walk 3-5 miles a day, quickly now when I walk I am slow and have to stop frequently because of the lack of energy.  We  have an upstairs condo unit and walking up my breathing is very heavy and loud.  I am clearly lacking energy and the ability to do any muscular activiites with any reliability.  Many people have commented on my lack of energy.  My wife,  had all the same shots the same time and batch and has all the same symptons
Ringing in ears (Tinnitus) Ongoing since I got the shot and wont go away.
Nerve pain in head and teeth day of vaccination.  Since that day, long painful lines like scratches on back; these keep recurring
He did have a double ear infection at the time of the vaccine. He was taking amoxicillin-pot-clavulanate. On 7/13/2022, a rash developed. He discontinued the antibiotic on 7/13/2022 as well. It was red and puffy. It spread throughout the day. We took him to urgent care and was prescribed a steroid DECADRON dexamethasone. His rash continued to spread then on 7/14/2022, he tested positive for COVID-19. The rash spread over his whole body and he started to swell. I was told to give him liquid BENADRYL. The rash continued and moved to his face, eyes, hands, and feet. I took him to the ER at a hospital. While at ER he was prescribed ZYRTEC and full body hydrocortisone and BENADRYL at night before bed. The rash started itching and legs were so swollen that he could not walk and could not grab anything due to his hands swollen. Then I was recommended TYLENOL and ibuprofen. This continued for 1 week. The rash was completely gone by 7/20/2022. We took him off the meds, then on 7/24/2022 his rash came back. The rash is still active at the moment but we are able to contain it. He never showed many symptoms of COVID-19 other than coughing and congestion. His swelling and rash was the worse.
8/11/2008-14:00 Given MOTRIN (100/5) 1 1/2 tsp. prior to VARIVAX. Parents report "high" fever 1 1/2 hour after vaccine and whimpers and hysterical laugh. 11 PM parents gave MOTRIN (100/5) one tsp. 12 AM 21/2-3 min febrile seizure and again 03:30.
he is experiencing too much sweating; runny nose; hurting of the left hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 15Apr2021 (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: HYPERHIDROSIS (non-serious), outcome "unknown", described as "he is experiencing too much sweating"; RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "hurting of the left hand".  Additional Information: Patient called to report that he was experiencing too much sweating, runny nose and hurting of the left hand after getting the 1st dose of covid-19 vaccine last 15Apr2021. He was scheduled to receive the 2nd dose on 06May2021. He asked if these were normal to experience.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case is linked to cases 2018SA298667, 2018SA298673, 2018SA298674, 2018SA298679, 2018SA298676, 2018SA298677, 2018SA298678, 2018SA298675, 2018SA298672, 2018SA300037, 2018SA300038 (same reporter). This case involves a patient (demographics unknown, ages ranging from 32-50 years) who received vaccine FLUZONE HIGH DOSE inadvertently. The patient's past medical history was not provided. No other vaccines were administered on that day. On 25-Oct-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ039AA via unknown route in the unknown site. It was a case of actual medication error due to inappropriate age at vaccine administration, Overdose accidental, and wrong vaccine administered because of Flu vaccine. It was reported that they had two different kinds of flu vaccine which caused the confusion. The patient did not experience any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
TOOK ONLY 2 DOSES AND NEVER FINISHED THE ENTIRE COURSE; This spontaneous case (PVX2019-839) was received from a pharmacist on 09-Apr-2019. It describes a male consumer who "took only 2 doses and never finished the entire course". The consumer was receiving Vivotif capsule for travel.  Case report: The consumer took only 2 doses of Vivotif in Jun 2018, after that he never finished the course.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took only 2 doses and never finished the entire course" was unknown.  Company's Comment: The causality of the event "took only 2 doses and never finished the entire course" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took only 2 doses and never finished the entire course" was considered as not applicable.
Information has been received from a registered nurse concerning a 6 year old white male patient with an allergy to penicillin who was vaccinated in the left thigh on 3/22/99 with a first dose of varicella virus vaccine live (lot # 628522/1843H). On approximately 5/12/04, earlier this week, the patient developed a chicken pox like rash. There were no other symptoms. There was no treatment required. Unspecified medical attention was sought. There was no product quality complaint involved. Follow up information received from a registered nurse indicated that on 5/11/04 the patient developed red dots and white pustules. The mother had called the office and indicated that her other children had chicken pox prior, and it looks same. The patient was not seen by the physician, but was advised to keep home until lesions crusted over. No fever was noted. The outcome was reported as recovered. No additional information is expected.
localized soreness in arm; This is a spontaneous report from a non-contactable physician via Pfizer sales representative. A male (nephew) patient of unknown age received on an unknown date BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose in the arm for COVID-19 shot. Medical history and concomitant medications were not reported. The patient, who is an ER doc, had localized soreness in arm from vaccination. Outcome was unknown. No follow up attempts are possible, information about batch number cannot be obtained.
Fever started approximately 6 hours after injection.  Symptoms included high fever, sweating, chills, shaking, entire body aches and pains, headache and disorientation.  Fever peaked about 11pm and began for the most part subsided by morning with a persistent headache.
Back pain (across upper back) axillary swelling reddened area on breast ipsilateral to injection site.
Local reaction Lt arm, rash 4.5 x 3.0 cm length to MCV4.
pt had a positive COVID test on 9/2/21; lives in a nursing home; family declined ABX treatment for pt's COVID; requested comfort care; pt expired in the nursing home
p/vax pt devel blurred vision, facial flushing, nausea, felt as if throat was closing;pt also devel tenderness @ lt deltoid region which progressed to a sore lt arm where had limited ROM;pt recovered;
pt recv vax 19MAR98 & that same day pt exp h/a, nausea, general malaise as well as a large local rxn w/itching;
On 2/9/2023, I had flu-like symptoms, such as a fever of 101, aches, and chills. That night, I took a home antigen test and got a negative result. On 2/10/2023, my symptoms worsened. My temperature was the same, but the aches and chills were worse. I went to the doctor and underwent a nasal swab test, and the result was positive. They prescribed Paxlovid and prednisone, and I started taking both of those that afternoon, and I took both for five days. By 2/11/2023, my symptoms were gone. I then completed the course of medication and followed the CDC isolation protocols. On 2/18/2023 or 2/19/2023, I took a home antigen test and got a negative result. Everything was fine afterwards. I have a prior history of atrial fibrillation, which I had surgically corrected in 2019, so I do an EKG reading every morning and every evening as a precaution. I began noticing abnormalities in my EKG readings about 2/19/2023 or 2/20/2023. I had sinus rhythm with wide QRS. I also had episodes of sinus rhythm with premature ventricular contractions. On the morning of 2/24/2023, I did an EKG, which indicated an atrial fibrillation. I saw my cardiologist on 3/1/2023. It was confirmed that I was in atrial fibrillation, and I underwent a cardioversion on 3/10/2023. It was successful, and I am now taking 200mg of amiodarone once a day. I now feel fine, and my EKG readings and heartrate are normal again.
she did not reconstitute the SHINGRIX antigen with the adjuvant; she did not reconstitute the SHINGRIX antigen with the adjuvant; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11-JUL-2023, the patient received Shingrix (left deltoid). On 11-JUL-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: she did not reconstitute the SHINGRIX antigen with the adjuvant) and inappropriate dose of vaccine administered (Verbatim: she did not reconstitute the SHINGRIX antigen with the adjuvant). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 11-JUL-2023 Pharmacist reported that she did not reconstitute the Shingrix antigen with the adjuvant. Reporter stated that she injected only the adjuvant into the patient's left deltoid.  Pharmacist reported adverse event to GlaxoSmithKline 15 minutes after adverse event occurred. (AE filed).  The patient was asymptomatic without harm at present time. The reporter was transferred to medical information for further instructions. Consented to follow up.
His colleagues vaccine batch has more side effects for than other batches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (His colleagues vaccine batch has more side effects for than other batches) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (His colleagues vaccine batch has more side effects for than other batches). At the time of the report, VACCINATION COMPLICATION (His colleagues vaccine batch has more side effects for than other batches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter. The caller was curious about the consistency of Moderna vaccine sizes. He wanted to know how many vials are produced in each batch.   Reporter did not allow further contact
Sleepless, dizziness, delirium, nausea, fever, vomiting, light sensitivity, sick for 24 hrs.
At 8:15pm on 12/05/2017 the arm became immobile and excruciatingly painful. If I needed to move the arm, I had to lift it with the opposite hand. I could not sleep on 12/05 at all due to pain and immobility. There was no redness or swelling. I was able to nap on the afternoon of that day. By the morning of 12/07/2017, the pain had lessened and I was able to move my arm, although painfully. Today is 12/08/2017, and the arm/shoulder pain persists upon motion or pressure, but it is bearable.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 18-OCT-2012 10:46, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
At 11:19 am the recipient stated she felt a warm sensation on her mouth and tingling of the lips. VS: BP=141/90, HR= 94, O2 Sat=96% RA, Temp= 37 Celsius.  VS at 11:28 am:  BP=141/90, HR= 94, O2 Sat=95% RA, Temp= 37 Celsius.  at 11:30 participant stated the tingling of the lips had gone away, but the warm sensation on her mouth continued.  At 12:20 the participant stated she still had the warm sensation on her mouth but the tingling was absent.  12:30 pm the participant felt comfortable leaving and left the facility.
Several minute after getting vaccine: -Temporary loss of vision, throat swelling, difficulty breathing,= duration 5-10 min. (Unsure) -drop in blood pressure and pulse.  Duration 30 min (unsure, doc was monitoring) -sporadic numbness throughout body including back of head. Duration: 1 hour and then tapered off, but total of several hours. Some sporadic vision issues occurred after the initial burst over the course of an hour as well.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 19Feb2021 at 09:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart disease" (unspecified if ongoing), notes: Other medical history: Heart disease - high blood pressure -high cholesterol; "high blood pressure" (unspecified if ongoing), notes: Other medical history: Heart disease - high blood pressure -high cholesterol; "high cholesterol" (unspecified if ongoing), notes: Other medical history: Heart disease - high blood pressure -high cholesterol. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: COVID-19: (unspecified date) Unknown results, notes: COVID 19 Treatment; (20Jul2022) Positive, notes: Tested positive 4 days after completing treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Product: COVID 19 Treatment, Brand: Paxlovid. Treatment start date: 11Jul2022; Treatment stop date: 16Jul2022. Indication: Treatment of COVID-19. The patient had no known allergies. Tested positive 4 days after completing treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
J96.00 ACUTE RESPIRATORY FAILURE 6/9/2021 ACUTE RESPIRATORY DISTRESS J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/30/2021 ACUTE RESPIRATORY DISTRESS
The vaccine was initially stored in the refrigerator on 11-Jan-2022 and administered on 11-May-2022; inadvertently administered expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administered expired dose of the Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 11-Jan-2022 and administered on 11-May-2022) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 035C21A, 038B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administered expired dose of the Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 11-Jan-2022 and administered on 11-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administered expired dose of the Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (The vaccine was initially stored in the refrigerator on 11-Jan-2022 and administered on 11-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   The reporter reported that the staff were not dating the boxes of vaccine when placing them in the fridge for storage. This lot number (084J21A) was received and placed in the fridge on 11-Jan-2022, which means that all doses administered more than 30 days after 11-Jan-2022 and were not in accordance The vaccine in question did not experience any temperature excursions.  The patient had not reported any adverse reaction.  No treatment information was provided by the reporter.
New onset Diabetes Mellitus - insulin dependent.60 day follow-up received on 10/12/00 states the pt has recovered.
Slight pain on left side under the ribs when I breath in deep; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (Slight pain on left side under the ribs when I breath in deep) 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 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL CHEST PAIN (Slight pain on left side under the ribs when I breath in deep). At the time of the report, MUSCULOSKELETAL CHEST PAIN (Slight pain on left side under the ribs when I breath in deep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No Treatment medications were reported.
second dose "put him down"; really sick for 2 days; couldn't get out of bed; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (second dose "put him down"), ILLNESS (really sick for 2 days), BEDRIDDEN (couldn't get out of bed), CHILLS (chills) and MYALGIA (body aches) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 845812A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jul-2021, 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 experienced DEPRESSED MOOD (second dose "put him down"), ILLNESS (really sick for 2 days), BEDRIDDEN (couldn't get out of bed), CHILLS (chills) and MYALGIA (body aches). At the time of the report, DEPRESSED MOOD (second dose "put him down"), ILLNESS (really sick for 2 days), BEDRIDDEN (couldn't get out of bed), CHILLS (chills) and MYALGIA (body aches) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided.