chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna pediatric dose instead of the bivalent booster dose.).    This case contains information for the 8 of 16 patients described by the reporter.  No concomitant medications were reported.  It was reported no adverse event reported on any of the patients involved.  No treatment medications were reported.    This case was linked to US-MODERNATX, INC.-MOD-2023-697687 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697687:Master case
severe pain; Right arm swelling; redness; hand numbness and tingling; hand numbness and tingling; right axillary lymph node enlargement; insomnia due to pain; insomnia due to pain; severe fatigue; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 14Feb2022 04:30 (Lot number: FJ6369) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "tachycardia" (unspecified if ongoing); "GERD" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: PROTONIX [OMEPRAZOLE]; PROPRANOLOL; VITAMIN D [COLECALCIFEROL]. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: E43246, Location of injection: Arm Left), administration date: 13Jan2021, when the patient was 48 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EH9899, Location of injection: Arm Left), administration date: 23Dec2020, when the patient was 48 years old, for Covid-19 immunization. No other vaccine in four weeks. The following information was reported: PAIN (medically significant) with onset 15Feb2022 07:00, outcome "recovering", described as "severe pain"; PERIPHERAL SWELLING (non-serious) with onset 15Feb2022 07:00, outcome "recovering", described as "Right arm swelling"; ERYTHEMA (non-serious) with onset 15Feb2022 07:00, outcome "recovering", described as "redness"; HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 15Feb2022 07:00, outcome "recovering" and all described as "hand numbness and tingling"; LYMPHADENOPATHY (non-serious) with onset 15Feb2022 07:00, outcome "recovering", described as "right axillary lymph node enlargement"; INSOMNIA (non-serious), PAIN (non-serious) all with onset 15Feb2022 07:00, outcome "recovering" and all described as "insomnia due to pain"; FATIGUE (non-serious) with onset 15Feb2022 07:00, outcome "recovering", described as "severe fatigue". Due to the events the patient missed 2 days of work so far. No covid prior vaccination. No covid tested post vaccination. Therapeutic measures were taken as a result of pain, peripheral swelling, erythema, hypoaesthesia, paraesthesia, lymphadenopathy, insomnia, pain, fatigue included Tylenol , Ibuprofen, Benadryl ice packs.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on current available information, there is reasonable possibility of causal association between the event pain and the suspect drug BNT162B2
Patient was given 3rd dose in Baby Pfizer vaccine series 4 weeks prior to due date
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with (Merck) VARIVAX which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received 27-OCT-2104 from the registered nurse who stated that it will take some time to get the (Merck) VARIVAX information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received on 13-NOV-2014 from the registered nurse concerning a patient (age range reported as 18, units not reported) of unknown gender. On 13-NOV-2014, the patient was vaccinated with a dose of (Merck) VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment medication reported. It was stated that the date of refrigeration was 07-May-2021.   This case was linked to MOD-2021-365189 (Patient Link).
Large rash at injection site and developing "pox" spots on trunk, arms, legs, and neck.  Visited doctor who confirmed chicken pox.
3 days after Rotateq given developed significant diarrhea with stools and for many white cells, no blood, neg cultures, OVP-no other explanation-took 6 hrs to totally resolve
In the arm or the shoulder that I got the shot I had severe swelling and I have pain on the opposite side also, in the other shoulder too; severely swollen shoulder at the top; In the arm or the shoulder that I got the shot I had severe swelling and I have pain on the opposite side also, in the other shoulder too; severely swollen shoulder at the top; This morning my armpit underneath is swollen/swelling; I have pain on the opposite side also, in the other shoulder too."; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 09Mar2022 09:00 (Batch/Lot number: unknown) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PERIPHERAL SWELLING (non-serious), PAIN (non-serious) all with onset Mar2022, outcome "not recovered" and all described as "In the arm or the shoulder that I got the shot I had severe swelling and I have pain on the opposite side also, in the other shoulder too; severely swollen shoulder at the top"; SWELLING (non-serious) with onset Mar2022, outcome "not recovered", described as "This morning my armpit underneath is swollen/swelling"; ARTHRALGIA (non-serious) with onset Mar2022, outcome "not recovered", described as "I have pain on the opposite side also, in the other shoulder too."". Therapeutic measures were not taken as a result of peripheral swelling, pain, swelling, arthralgia.  Additional information: Patient reported vitamins as concomitant product. She had prior vaccination of first shot and the second shot. She received the booster vaccine on Wednesday.Consumer stated height was "5 feet" (When clarified reported as 5 feet 2 inches, consumer confirmed the same).  The lot number for bnt162b2 was not provided and will be requested during follow up.
clinic on 11-9-2021 for Pfizer Pediatrics. 13 year old was given peds dose. Discovered 11-10-21 & reported 11-10-21.  was administrator
Migraine After the First Shot; Tired After the First Shot; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine After the First Shot) and FATIGUE (Tired After the First Shot) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04A21A and 021B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced MIGRAINE (Migraine After the First Shot) and FATIGUE (Tired After the First Shot). On 07-Mar-2021, MIGRAINE (Migraine After the First Shot) and FATIGUE (Tired After the First Shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    This case was linked to , INC.-MOD-2021-076824 (E2B Linked Report).; Sender's Comments:  .-MOD-2021-076824:Same patient - second doose
Pneumococcal 23 was ordered. In error Prevnar 13 was given. No adverse reactions reported at this time.
Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. No medical history or drug reaction/allergies was reported.  On unknown dates since 13-AUG-2015, doses of PNEUMOVAX23 (pre-filled syringes, lot# L002310 with expired date 08-JUL-2016, dose and route were unknown), which were exposed to temperatures outside of the recommended range, had been administered to unspecified patients. No concomitant medication was reported. The reporter was not aware of any adverse effects. Additional information has been requested.
Patient received flu vaccine on 10/2/2019 during a school flu clinic event sponsored by Health Department with participation of Nursing. Client mention that when she received the vaccine she got discomfort right away but thinking it was just a regular effect from the shot but that discomfort extend the next day became moderate pain on 10/3/2019 till 10/8/2019 and from 10/9/2019 till 10/11/2019 pain decrease to low pain but became intensify from 10/12/19 till 10/14/2019 that opt her to seek medical help and see her PCP. As per patient PCP diagnosed that the shot was given to high and not in the muscle. Patient verbalized that during the course of events she did not experience any fever, no chills, no redness on the site, no discharges on the site but only tender to touch. Patient told Public health nurse that she will need to seek physical therapist help as per PCP advise because she had limited range of motion on that site. Public Health Nurse took this telephone report on 10/15/2019 through a call from the school nurse where client works as one of the staff.
This non-serious spontaneous case, was initially received on 18-Oct-2017, from other health professional (nurse), concerns a patient of unspecified age and gender. On 04-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). On 04-Oct-2017, employees were given vaccine from a vial that leaked. It was reported that, after piercing the vial, when it was turned upside down and upon injecting air, vial was dripping from the rubber seal. The nurse could withdraw only 7 doses from the vial. The patient was administered with full doses. There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided was 1025066. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch. However a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received on 21-Nov-2017: Added PTC number and the QA (quality assurance) report results. New event drug administration error was coded. Narrative amended accordingly. Non-significant case correction received with IRD 18-Oct-2017: The verbatim of the event 'product leakage' was corrected and narrative was amended.
Developed warmth and redness at site of injection of IPV.  Required doctor visit and starting of antibiotics for mild cellulitis.
The patient is calling it an allergic reaction; patient became very nauseous; had an elevated BP; decreased heart rate.; also vomited a few times; wasn't able to eat for several days; also developed a rash a few days later; vasovagal reaction; panic attack; anxiety; This is a spontaneous case from Pfizer sponsored program. A contactable pharmacist reported that a 57 years old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 13May2021 (Batch/Lot Number: ER8736; Expiration Date: 31Jul2021) as 0.3 mL, SINGLE for covid-19 immunisation. The patient medical history included has a lengthy list of allergies. There were no concomitant medications. The patient had her first Pfizer Covid vaccine dose on 13May2021 and was advised to wait 30 minutes for monitoring afterwards because she has a lengthy list of allergies. While waiting 30 minutes, the patient became very nauseous, had an elevated BP and decreased heart rate. She was taken to the ED and also vomited a few times. Her vomiting continued for a few days after she left the ED. She also developed a rash a few days later. The caller states that the ED diagnosed her with a vasovagal reaction. The caller states that she didn't feel comfortable giving the patient the second dose based off of the reaction and wants to know if we can help her determine if the patient had a severe allergic reaction. She is not sure. The patient is calling it an allergic reaction, but the caller is not so sure. The caller thinks it may have just been a panic attack. The patient ended up in the ER with high blood pressure, low heart rate, and nausea. She was nauseous for 3 days. The patient also said she developed a rash, but the rash was not documented with the ER visit. The caller doesn't know if this constitutes a severe allergic reaction or not. She just knows that the nausea lasted several days. The patient wasn't able to eat for several days because she vomited everything she ate. That was according to the patient. The caller believes that the vaccine caused the reaction, or it at least caused the anxiety. Treatment included steroids. Multiorgan involvement: yes. Cardiovascular, dermatologic, and gastrointestinal involvement. There was no respiratory involvement to the caller's knowledge. Outcome of events was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation and known safety profile of suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Went to donate blood today (07Oct) and it was too thick; Product=COVID 19; Administration date=27Sep2021; Dose number=3; This is a spontaneous report from a contactable consumer (Patient). A 68-year-old female (Non pregnant) patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: 3183), via an unspecified route of administration, administered in arm left on 27Sep2021, at 10:45 (Age at vaccination 68-years-old), as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient did not have covid prior to vaccination and also not have any known allergies. The patient medical history was not reported. Concomitant medications included influenza vaccine (FLU, Lot number: 70461012103), via unspecified route, administered in arm taken for an unspecified indication from 21Sep2021 to 21Sep2021. The patient previously received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EN6205), via an unspecified route of administration, administered in arm left on 08Mar2021 as DOSE 2, SINGLE and received first dose (Lot number: EM9809), via an unspecified route of administration, administered in arm left on 15Feb2021 as DOSE 1, SINGLE for covid-19 immunization. On 07Oct2021, the patient went to donate blood today and it was too thick, she donates it every two months, never had this reaction. On 21Sep2021, patient received dose number 3 as booster dose. The patient went to physician office. No therapeutic measures were taken as a result of event. The clinical outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Within 15-minutes of vaccination, the patient reported pruritus around injection site, as well as pruritus and edema in her face, around her mouth and eyes. Patient denied SOB, CP, Abdominal pain, N/V, or HA. EMS evaluated patient on-site. The patient was hypertensive (174/86). Due to patient's complaint and physical exam, EMS administered Benadryl 50mg IV. EMS transported patient to Largo Medical Center Emergency Department. In the ED, the patient had bilateral palpebral edema, pruritus surrounding injection site spreading down the extremity, and lips were erythematous. No SOB or tongue/throat swelling noted. Patient was hypertensive (164/72). ED Physician administered PO Pepcid and Prednisone by provider in triage.  The patient stated they felt improvement after the Benadryl treatment and requested to be discharged from ED. Patient was given information and strict return precautions about anaphylaxis.
Red raised area on left thigh. Advised cool compress, TYLENOL or MOTRIN.
She reported to the school nurse having a headache and dizziness after administration of the vaccine which is persisting today. The school nurse reports that she became so dizzy she lost balance and fell in the parking lot hitting her head. When discussing the previous 2 HPV vaccines she received with her she notes that she did feel on the verge of passing out for the remainder of the day with each.
This spontaneous report as received from a physician refers to the physician's nephew, a 20 year old male patient. No medical history was reported. The physician administered 3 doses of RECOMBIVAX HB to the patient when he was a child. However, recently, the physician found that the patient had negative antibody titers. Therefore, the physician administered one dose of RECOMBIVAX HB on an unspecified date and then a second dose of RECOMBIVAX HB 3 weeks later. At the time of the report, the current hepatitis B antibody titer was unknown. The patient did not take any concomitant medications. No further information provided. Additional information is not expected.
PT HAD A DEALYED REACTION. FEVER FOR 7 DAYS AND THEN NEUROLOGICAL SYMPTOMS. Seeing Specialist Physician for treatment.
immune response / very strong / muscle aches; immune response / very strong / fever; it knocked me out for a day; This case was reported by a physician and described the occurrence of muscle pain in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced muscle pain, fever and feeling unwell. On an unknown date, the outcome of the muscle pain, fever and feeling unwell were unknown.   The reporter considered the muscle pain, fever and feeling unwell to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced muscle aches and fever. The adverse event in the article and think that the closest side effects that seen it compared to be the shingles vaccine, which was a little bit of a rough vaccine to get in that the immune response was very strong.  The reporter had it the shingles vaccine personally and it knocked out for a day and then was fine.