chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, concurrent conditions and medical history reported. On an unknown date in May 2016, the patient was vaccinated with the first dose of ZOSTAVAX (dose, route of administration, lot#, expiry date and site of administration were not reported). On 04-DEC-2016, the patient was inadvertently administered a second dose of ZOSTAVAX. No adverse effects reported. Additional information has been requested.
Chicken pox like rash started 12-15-05 vaccinated on 12/6/05.
Pfizer COVID vaccine incorrectly diluted with 0.9% normal saline in multi-dose vial with preservative. Correct diluent should be 0.9% normal saline in single-dose vial without preservative. When Pfizer was called at store level, they were not able to give any information on anything other than the single-use vials that were studied. Called the morning of 8/3/21 and spoke to the medical team at Pfizer who gave the same information. She was able to say that the reason Pfizer wants medical providers to use the single-use vials is so that there is no cross contamination from puncturing the vial multiple times to dilute multiple vaccine vials. The multi-dose vials that were used were only punctured once so no risk of contamination. Considering this a valid dose still since the vaccine was still diluted and administered with normal saline.
Moderna vial was placed in fridge on 01/01/22. Moderna vial with the lot number of, 041J21A has not undergone a temperature excursion. Patient was administered Moderna booster(0.25ML) on 03/03/22 at 12:45PM. Patient was 17 weeks at the time of administration.  Patient has not reported to Clinic with symptoms at this time.  Patient is approx 145lbs. Patient's expected due date is July 31, 2022.
redness; Soreness in arm; hot to touch; extremely itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), PAIN IN EXTREMITY (Soreness in arm), FEELING HOT (hot to touch) and PRURITUS (extremely itchy) 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 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (redness), PAIN IN EXTREMITY (Soreness in arm), FEELING HOT (hot to touch) and PRURITUS (extremely itchy). At the time of the report, ERYTHEMA (redness), PAIN IN EXTREMITY (Soreness in arm), FEELING HOT (hot to touch) and PRURITUS (extremely itchy) outcome was unknown.
Coughing, Sneezing, fever of 103, general malasie. Treatment - Tynenol, orange juice & water.
Started Typhoid capules first thing in the a.m. Monday afternoon, dizzy, light-headed. Tues. diarrhea started x 5 times, Wed fever 103, severe GI pain, followed by vomiting- went to urgent care.
vaccines do not prevent getting covid; vaccines do not prevent getting covid; This is a spontaneous report received from a non-contactable reporter (Consumer), Program ID: The reporter is the patient.  An adult female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "vaccines do not prevent getting covid".  Additional information; I have been vaccinated and boosted even though these vaccines do not prevent getting covid I have had it 2 times both after being fully vaccinated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
MENACTRA given in (R) arm and GARDASIL # 1 given in (L) arm at 0930. 1000 - leaving our office - face very red. Noon - Mom calls - child at school - "dizzy" - went home to rest. Woke up with face burning and tightness in throat. Went to ER around 1900 see attached ER report.
This case was reported by a healthcare professional via a sales representative and described the occurrence of swelling of upper arm in a child subject of unspecified gender who was vaccinated with KINRIX. In February 2009 the subject received 1st dose of KINRIX in an unknown arm. At an unspecified time after vaccination with KINRIX, the subject experienced swelling of upper arm (the arm where KINRIX was given). At the time of reporting the outcome of the events was unspecified. The healthcare professional considered the event was probably related to vaccination with KINRIX. It was reported that  5 subjects in the age range of 4 to 6 years received KINRIX within the last week and developed swelling in the arm where the KINRIX was given. No specific details were known at the time of reporting. Linked cases include A0770472A, A0770474A, A0770475A and A0770476A.
Site: Itching at Injection Site-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch Generalized-Mild
This spontaneous report was received from a Licensed Vocational Nurse and refers to a patient of unspecified age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date, the patient received less than the recommended dose of the second dose in the series of GARDASIL 9 "due to leakage around the needle" of the vaccine. (dose, route and anatomical location were not reported) (lot number reported as M016193, expiration date 24-APR-2018). No adverse effects reported. No further information provided. Additional information has been requested.
This is a spontaneous report from a contactable pharmacist. A 65-year-old female patient received PREVNAR 13 (Lot # R12276, Expiry Date 01Feb2018, NDC # 0005197102) via an unspecified route of administration at single dose on 16Jun2017 for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arm was getting red, it was warm, it was itchy on 16Jun2017 evening. The pharmacist stated and there was an area that was continuing to move out past the injection site about 5-6 inches in diameter and 5 days later the pharmacist saw the border around the injection site was moving, there was an area that was continuing to move out past the injection site. The outcome was reported as worsened. The pharmacist assessed the events warm and area that was continuing to move out past the injection site as related.
A 70-year-old male patient, who had no concurrent illnesses or allergies, but whose medical history was questionable as he was taking Aspirin at the time, had received a dose of Fluzone SV 2009-2010 (lot number U3196AA) on 02 September 2009. Right after receiving the vaccination, the patient developed a "bump" or mass and bruise and bleeding at the injection site. It was not reported whether the patient required medical evaluation or if he received any treatment, but no diagnosis testing or laboratory data were performed. At the time of this report, the injection site was still bruised. The patient had not recovered. The reporter for this case is the same as for case 2009-03720. Documents held by sender: None
Vaccine/Guillain-Barre Syndrome timeline  Mid-June 2020 - contracted Covid-19 (mild symptoms such as body aches, fatigue. Lost taste/smell for 48 hours)  07/20/2021 - Pfizer (1st Dose)  8/06/2021 - notice light numbness in toes  08/11/2021 - Pfizer (2nd dose)  08/16/2021 - admit self to Hospital ER. Symptoms of numbness and tingling has spread through feet up to calves. Could walk but awkwardly. ER does lumbar MRI and sees nothing wrong. Suggests I follow up with neurologist and releases me  08/17/2021 to 08/25/2021 - symptoms progressively get worse. Spread to hands and forearms. Collapsing at top of stairs from knees buckling.   08/26/2021 - appt with PA of neurosurgeon at hospital. Explain spread of numbness/tingling. GBS becomes suspected diagnosis. PA sends me across street to Hospital ER to get another MRI for thoracic and cervical portions of spine to eliminate any pinched nerves as cause. No pinched nerve detected. Admitted to hospital for GBS treatment.   08/26/2021 to 09/01/2021 - complete 5 days of IVIG treatment. Back and stomach both numb and tingling now. Chest upwards is clear. No symptoms seem to be getting worse or spreading after first day of being admitted. Symptoms completely stabilized.   09/01/2021 - transferred to Medical Center for inpatient physical therapy.   09/01/2021 to 09/11/2021 - 1 hour of physical therapy and 2 hours of occupational therapy every day. Some symptoms improve mildly (such as wrists) but largely remain the same.   09/11/2021 - released from Hospital with Aunt.   09/16/2021 - Outpatient PT eval with therapist at Hospital. Therapist recommends hand specialist for fine motor skills and recommends 3x a week PT (45min sessions)  09/16/2021 to 10/06/2021 - physical therapy 3x a week for 45 mins each. occupational therapist evaluation lead to occupational (hand) therapy 2x a week. numbness/tingling has significantly decreased but is still present, mostly in legs. still unable to extend fingers properly. cannot flex or extend foot/toes. overall weakness apparent but improving.
Patient hospitalized and the EMR only listed one dose of vaccine given back in April. We offered for patient to receive second dose and patient accepted. After dose given her husband noted that she had already received two doses in April. The doses are not visible in MCIR, the one dose that is listed in the EMR is manually entered by a primary care provider. The patient has no adverse sequalae so far.
I received my Covid-19 vaccine on 12/26/2021. On 06/23/2022 I woke up with itchy throat and progressed to mild fever to high fever towards the end of the day. I went to get tested on 06-26-2022 and was tested positive for Covid-19. I then took TYLENOL. Mild symptoms still on going.
4-5 years ago patient got the initial SHINGRIX vaccine, but never got the second shot; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (4 to 5 years ago patient got the initial Shingrix vaccine).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 4-5 years ago patient got the initial SHINGRIX vaccine, but never got the second shot). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 12-JUL-2023 Email inquiry sent by sales rep on behalf of HCP. The patient got the initial Shingrix vaccine, but never got the second shot. The reporter wanted to know should the patient start all over or could the patient go and get a second shot. The vaccine administration facility was the same as primary reporter. No additional information available due to the way the question sent in. It was unknown if follow up was permissible.
5:30 Developing a scratchy throat. 8:00 felt weak and achy. 9:30 developed headache and dizziness. (took Tylenol) 2/10 - 2/12 symptoms continued with 103 degree fever. (took Tylenol, Advil, Benadryl, and Sudafed)
Information has been received from a consumer concerning her 16 year old daughter with no medical history and no drug allergies, who in November 2007, was vaccinated IM with a 0.5 mL first dose of Gardasil. Concomitant vaccination included Recombivax. Subsequently, the patient was pregnant. In November 2007, the patient had a miscarriage at approximately 16 weeks. The gestation period at the time of the first dose was unknown. The patient was hospitalized for approximately 2-3 days. No laboratory diagnostics were performed. The patient did not discontinue her dosing schedule. The patient was vaccinated with a second dose of Gardasil on 08-FEB-2008. At the time of the report, the outcome of the patient was unknown. No product quality complaint was involved. Upon internal review miscarriage was determined to be an other important medical event. Additional information has been requested.
ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN ACUTE DVT, UNSPECIFIED VEIN 2/22/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Red rash approx 3-4 in in diameter just below the injection point (on thigh)... raised and warm to the touch.
Cold sweat and blacked out at home next day after 1st shot. Husband witnessed. After 2nd shot both my husband and myself had ear issues like ringing in ears.
1 of 3 pts who recvd DTP/MMR; immunized from the same DTP vial pt devel fever 101 & 8 cm area of erythema below the inject site; pt also limping; seen by MD; treated w/APAP;
Erythema, induration, urticaria. Greater than 4 weeks after administration.
Body aches; Nausea; Chills; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 62-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: tp7533) via an unspecified route of administration in the left arm on 02Apr2021 at 12:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, hypercholesterolemia, asthma, heart arrhythmia and gastroesophageal reflux disease (GERD). Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), flecainide (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN) and al; all from unknown dates for unknown indications. The patient received the first dose of shingles vaccine (MANUFACTURER UNKNOWN) in the left arm on 09Mar2021 within four weeks prior to the COVID-19 vaccination. The patient previously took codeine (MANUFACTURER UNKNOWN) and experienced a drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 at 23:00, the patient experienced nausea, chills, body aches and headache. The adverse events did not result in doctor or other healthcare professional office/clinic visit/emergency visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events nausea, chills, body aches and headache were resolved on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Ringing in ears/Tinnitus; Nausea; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8727), via an unspecified route of administration, administered in Left Arm on 23Mar2021 (at age of 51 years old) at single dose for COVID-19 immunisation. Medical history included did had surgery a month before and did had a bunch of lab work to get to that. Concomitant medication(s) included rosuvastatin calcium (CRESTOR), zolpidem. The patient experienced Ringing in ears, Nausea, Tinnitus, all on 13Apr2021. First dose was 23Mar2021; second dose scheduled for 14Apr2021. May delay or not get second dose. Caller states he got his first shot on 23Mar2021 (three weeks before) and is scheduled for his second shot today (14Apr2021). Says that yesterday (13Apr2021) he began experiencing ringing in his ears and nausea. States he looked online and saw that other people were also experiencing tinnitus and that it got worse after the second shot. Says some of them had said it got so bad they could not sleep or hear. He is worried about getting his second shot today and is asking if he should possibly delay it, or not get it? Patient took first vaccine 3 weeks before today and patient was due for the second vaccine today and patient started developing some ringing in ear a couple days before and patient didn't really think about much of it and so patient heard of few other people mentioned the same thing so patient was reading about it and hear that it is you know a side effect that people are experiencing. Patient just want to know if patient should not take the second dose that is scheduled for today or not, people like online people are saying the second dose made it much worse and people had severe ringing to the point where it affected their hearing and they couldn't sleep and it got along after their second dose, and that's what patient was about to go get today so patient want to know if patient should not take the second dose?". The outcome of the events was unknown. No Treatment in response to events.
Response to CDC vSafe phone callback. Symptoms:  Drop in Hemoglobin level after shot.  Hemoglobin OK day before shot in by unrelated Complete Blood Count Test.  After vaccination, level dropped to abnormal level in unrelated blood test 20 days after. No medical activity between vaccination and blood test. No symptoms other than blood test.  Hemoglobin returned to normal level 35 days later. No history of Hemoglobin issues before vaccination.
Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 09-May-2022/ Vaccine expiration date 05 May 2022; Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 09-May-2022/ Vaccine expiration date 05 May 2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 09-May-2022/ Vaccine expiration date 05 May 2022) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 09-May-2022/ Vaccine expiration date 05 May 2022) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 008C21A and 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 09-May-2022/ Vaccine expiration date 05 May 2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 09-May-2022/ Vaccine expiration date 05 May 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 09-May-2022/ Vaccine expiration date 05 May 2022) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 09-May-2022/ Vaccine expiration date 05 May 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  Vaccine expired on 05 May 2022. It was reported that the reporter had identified an additional issue that 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 are not in accordance with the EUA.  Date the vial was initially stored in the refrigerator was 11-Jan-2022. The vial did not undergo any temperature excursions. Patient received First booster dose on 09-May-2022. Did not reported any adverse reactions.  Treatment information was not provided by the reporter.
Pneumovax23 administered on 10-FEB-2012 and PREVNAR 13 on 29-MAY-2015; This spontaneous report was received from a 68year-old male patient, concerning to herself. The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.   On 10-FEB-2012, the patient was vaccinated with  Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided). Therefore, it was reported that on 29-MAY-2015 another dose of  pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) was administered to the patient (inappropriate schedule of product administration). No adverse event was reported.   This is one of two reports received from the same patient.; Sender's Comments:  US-009507513-1907USA012667:
potential allergic reaction to bivalent Pfizer booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team, Program ID.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "no reaction"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "no reaction"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: 33130BA.), administration date: Dec2021, for COVID-19 Immunization, reaction(s): "no reaction". The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "potential allergic reaction to bivalent Pfizer booster".  Additional information: It was reported that patient took three Pfizer shots before with no issue. Through some research, it was found that tromethamine replaced PBS as the buffer in the Pfizer formulation sometime around Oct2021. Tromethamine was approved in Oct2021 and she received her third shot in Dec2021.   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.
HBP reported a 2-month-old patient received VARIVAX. No additional AE/no PQC.; HBP reported a 2-month-old patient received VARIVAX. No additional AE/no PQC.; This spontaneous report was received from an office manager concerning a 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-JUN-2023, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX)  lot #W017551, expiration date: 01-JUN-2024, administered as prophylaxis (Drug use in unapproved age group) (strength, and route of administration were not provided). No additional adverse event was reported.
Fever 99.1 degree F, gave TYLENOL. Right leg still sore at site of injection, claims hurts to walk.
Patient presented to the emergency department on 8/19/2021 with fever and cough that started 6 days ago. While at home he has had mild shortness of breath, nausea, diarrhea, and fatigue.   Chest Xray shows interval development of a moderate size right pleural effusion and adjacent consolidation.  Patient had a thoracentesis with removal of 1.7 L.