chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient got Bexsero's expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA81EZ, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th February 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 8th February 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by the Medical assistant. The age at vaccination was unknown. The reporter stated that an expired dose of Bexsero was administered to the patient, which led to expired vaccine used. The reporter consented to follow up. This case is linked with US2022023436, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022023436:Same reporter. Patient 2 of 2.
chest tightness; nauseated; vomiting; profuse sweating; Throat tightness; palpitation; Dizziness; headache; This is a spontaneous report from a contactable Nurse (patient self).  A 45-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in Arm Left on 05Aug2021 15:45 (Lot Number: EW0186) (at the age of 45-year-old, not pregnant) as dose 1, single for COVID-19 immunisation.  Medical history included Bells Palsy, partial thyroidectomy, hysterectomy, asthma, known allergies: shellfish and Bactrim. Concomitant medication included orlistat.  The most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient had not been tested for COVID-19.  On 05Aug2021 16:15, the patient was severely nauseated and vomiting, palpitation with chest tightness and throat tightness, dizziness and headache, profuse sweating. Rapid response called she was sent to ED.  The adverse event result in Emergency room/department or urgent care.  Treatment received including Benadryl, zofran, Tylenol.  Outcome of the events was not resolved.  The reporter assessed this report as non-serious.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events nauseated and vomiting, palpitation with chest tightness and throat tightness, dizziness and headache, profuse sweating and the suspect drug BNT162B2. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
itchy rash; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Apr-2021 and was forwarded to Moderna on 05-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced RASH PRURITIC (itchy rash). The patient was treated with PREDNISONE for Itchy rash, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itchy rash, at an unspecified dose and frequency. On 01-Apr-2021, RASH PRURITIC (itchy rash) had resolved. Took treatment with Prednisone and Benadryl.          Patient reported that no reported events with second dose and she is doing fine. No concomitant medications reported by reporter. Action taken with mRNA-1273 was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: Follow up was received Outcome of event after 1st dose changed to recovered/resolved. Dose 2 details were added.
Initial information received on 06-Jun-2018 regarding an unsolicited valid non-serious case received from a Nurse via other company (Merck). This case involves a patient (gender and age was not reported) who was administered a dose of PENTACEL (batch number, expiry date, route and site of administration were not reported) and a dose of PEDIARIX on an unspecified date. This is an actual medication error case due to extra dose administered to the patient. No medical history was reported. No details of concomitant therapy were reported. No adverse event reported. Lab data and corrective treatment: not applicable. 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. Documents held by sender: none.
The patient experienced no symptoms.; a shipment of PNEUMOV AX 23 was due to be delivered on 2/26/2020 but was not delivered until 2/27/2020.; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The report considers one patient and one combination product. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided.   The reporter informed that a shipment of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was due to be delivered on 26-FEB-2020, but was not deliver until 27-FEB-2020. On 09-MAR-2020, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection, lot # S029542, expiration date 10-JUN-2021 (exact dose, route of administration and anatomical location were not reported) for prophylaxis. The administered dose was from the late shipment. The patient experienced no symptoms. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. manufactureraddress:; manufacturercity:; manufacturerstate: ; manufacturercountry: ; devicelotnumber: S029542; expirationdate: 10-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Headache, diarrhea, and stomach ache 6 days after first COVID vaccine dose. Received second dose 3 weeks later in May 2021 as per recommendations at that time. Received monovalent purple cap booster dose in December 2021.  Symptoms progressed over the rest of 2021 to chronic daily headache while awake (by December 2021), orthostatic intolerance with dizziness (by June 2021), heat intolerance (by June 2021), and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). All symptoms have continued to present time.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse report of administration of expired FLUMIST was received from a nurse concerning a 22-year-old female.  Neither medical history nor concomitant medications were reported.  On 17-Feb-2009, the patient received expired FLUMIST vaccine.  The vaccine had an expiration date of 11-Jan-2009.  As of 18-Mar-2009, there were no adverse events associated with this medication;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired.  Additional information was received on 12-May-2009 and incorporated into the narrative:  Product complaint investigation results.
arm itchy red at site of injection over next 2-3 days warm red swollen itchy; itching at the injection site; golf ball bump at the injection site; body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (body aches), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE SWELLING (golf ball bump at the injection site) and VACCINATION SITE ERYTHEMA (arm itchy red at site of injection over next 2-3 days warm red swollen itchy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus, Hypertension (controlled) since 2017, Macular degeneration since 2020 and Penicillin allergy. Concomitant products included METOPROLOL, METFORMIN and ACETYLSALICYLIC ACID (ASPIRINE) for an unknown indication.   On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 24-Mar-2021, the patient experienced MYALGIA (body aches). On 25-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE SWELLING (golf ball bump at the injection site). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (arm itchy red at site of injection over next 2-3 days warm red swollen itchy). On 26-Mar-2021, VACCINATION SITE PRURITUS (itching at the injection site) and VACCINATION SITE SWELLING (golf ball bump at the injection site) had resolved. At the time of the report, MYALGIA (body aches) and VACCINATION SITE ERYTHEMA (arm itchy red at site of injection over next 2-3 days warm red swollen itchy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Body temperature: 100.7 degree Celsius (High) high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient is allergy to IVP dye No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: No specific follow-up information recorded.
got the 2 vaccines/ Suspected vaccination failure; got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's wife. The age at vaccination was not reported. The reporter stated that, her husband got the 2 vaccines and then got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Patient received a Pfizer BioNTech Adolescent/Adult Vaccine (Lot# 301458A) that was stored in the regular freezer (-25 to  -15 oC) beyond 14 days. On 22JAN22 Pfizer responded to the agency that stability data does not support the use of the Pfizer Vaccine (Lot# 301458A). Pfizer further states decision to release or dispose of the product is the responsibility of agency. The website states that if the manufacturer does not have the information to support the stability of the vaccine, repeat the dose immediately with no minimum interval.
Raised, bruised area in left upper arm measuring 1.5 cm x 1 cm at sight of Hepatitis A vaccination 3 days ago
Patient was in a lot of pain from head to toe from 2nd dose of SHINGRIX, felt really sick, couldn't get out of bed for a few days; better now but still recovering.
Pt recvd 2nd dose of vax OCT92 & by the end of October had only 1/8 of an inch of hair all over head w/itching & flaking;
Patient at 32 weeks 6 days EGA received Tdap as part of her routine prenatal care. Over the following 7 days developed worsening shoulder pain and decreased ROM.
Fever; Chills; Joint pain; Headache; Body Aches; Swelling of the Throat; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient (not pregnant) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 18Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included Ulcerative colitis, no Known allergies. No concomitant medication. The patient previously took the first dose of bnt162b2 in right arm for COVID-19 immunization. Facility type vaccine was Hospital. No other vaccine in four weeks. No Other medications in two weeks. On 19Jan2021 08:00, the patient experienced Fever, Chills, Body Aches, Joint pain, Headache and Swelling of the throat. No treatment received for the events. No covid prior vaccination. No covid tested post vaccination. The outcome of the events was recovered on an unspecified date in Jan2021.  No follow-up attempts are possible. Information on lot/batch cannot be obtained.
Left armpit blew up; Fever; Swollen glands in my armpit; little nervous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Lot number: EN6207) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Chronic pain" (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN] taken for pain; ADDERALL; OMEPRAZOLE; DULOXETINE; OXAL; TURMERIC [CURCUMA LONGA RHIZOME]. Vaccination history included: Bnt162b2 (1st dose of covid vaccine, lot number:EN6203), administration date: 26Feb2021, when the patient was 66 years old, for COVID-19 Immunization. The following information was reported: SWELLING (non-serious) with onset 2021, outcome "unknown", described as "Left armpit blew up"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "unknown", described as "Swollen glands in my armpit"; NERVOUSNESS (non-serious) with onset 2021, outcome "unknown", described as "little nervous".  Additional information: Additional information: seriousness and onset dates of the events was unspecified. Patient was received other medications and start and stop dates of concomitants was unspecified. As the patient is the reporter states that she had reaction to the Pfizer treatment, after the second shot on her left armpit blew up so, she was little nervous about getting the booster in Pfizer and she did not know if, could recommend Moderna or Johnson and Johnson, but Johnson & Johnson just came out and said that there is this causing blood clots (general statement)." Age at the time of adverse event, Consumer stated, "her age was 67, and do not understand what else you said, At time it was 66, she guess and do not know that do not keep tracking and all think withheld (Further not clarified appropriately, hence not captured in tab)", patient took treatment for the chronic pain (History) so I take Advil and pain patches. There were no prior vaccinations, Consumer stated, she had the injection at withheld drive through location.  withheld at withheld, this is where it was" Consumer was informed about the role of Pfizer Drug Safety and Pfizer Medical Information department and provided with the number as withheld and requested to dial the option 3 and informed about timings as 8 AM to 8 PM from Monday to Friday. consumer was informed that Pfizer might contact the consumer in case further information is required.  No follow-up attempts are possible. No further information is expected.
RUSH SENSATION; SWELLING IN RIGHT SIDE AND LEFT SIDE BUT RGHT SIDE HAD MORE SWELLING/ SWELLING IN LOWER ANKLES; INCREASED HEART RATE; REDNESS ALL OVER THE BODY; FATIGUE/TIRED/WIPED OUT; This spontaneous report received from a patient concerned a 56 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A,expiry: 01-JUN-2021) dose was not reported, administered on 01-MAY-2021 11:00 for prophylactic vaccination. No concomitant medications were reported.  On 01-MAY-2021, the subject experienced rush sensation. On 01-MAY-2021, the subject experienced swelling in right side and left side but rght side had more swelling/ swelling in lower ankles. On 01-MAY-2021, the subject experienced increased heart rate. On 01-MAY-2021, the subject experienced redness all over the body. On 01-MAY-2021, the subject experienced fatigue/tired/wiped out. Laboratory data included: Electrocardiogram (NR: not provided) normal, Heart rate (NR: not provided) 70-75 BPMS, 90's BPM, USUAL 60-65 BPM, 132 BPMS, and Laboratory test (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rush sensation, and redness all over the body, swelling in right side and left side but right side had more swelling/ swelling in lower ankles, and increased heart rate on 01-MAY-2021, and fatigue/tired/wiped out on 02-MAY-2021. This report was non-serious. This case, from the same reporter is linked to 20210504154 and 20210505260.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 03-MAY-2010, the patient was inoculated at a County Health Department with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated at physician office for persistent and severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
w/in 5min of vax pt exp nausea, shakey, diaphoretic, pale, c/o trouble breathing; BP 80, weak pulse; given EPi, 02, fluids w/improvement
felt like he had an ingrown hair or pimple under his arm; tender; lymph node was swollen; swollen on the crease of arm,  under the arm pit, back of his arm; soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), ACNE (felt like he had an ingrown hair or pimple under his arm), TENDERNESS (tender), SWELLING (lymph node was swollen) and PERIPHERAL SWELLING (swollen on the crease of arm,  under the arm pit, back of his arm) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No medical history reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN (soreness). On 18-Feb-2021, the patient experienced ACNE (felt like he had an ingrown hair or pimple under his arm), TENDERNESS (tender), SWELLING (lymph node was swollen) and PERIPHERAL SWELLING (swollen on the crease of arm,  under the arm pit, back of his arm). At the time of the report, PAIN (soreness), ACNE (felt like he had an ingrown hair or pimple under his arm), TENDERNESS (tender), SWELLING (lymph node was swollen) and PERIPHERAL SWELLING (swollen on the crease of arm,  under the arm pit, back of his arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On 3rd August 2018, less than a year after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were reported as follows: The pharmacist reported this case for a family member. The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. The pharmacist did not administer the SHINGRIX vaccine. The patient had 4 inch circle of redness around the injection site.
Has early signs of covid; tested positive on covid; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer. A female patient of an unspecified age received 2 doses of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient reported that she has early signs of covid. She tested positive for covid n unspecified date.  Information on the Batch/Lot number has been requested.
Case number PHEH2014US004300 is an initial spontaneous report from a pharmacist received on 27 Feb 2014. This report refers to a 52-year-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1310101) intramuscularly into right arm on an unknown date. On 08 Nov 2013, post vaccination, she experienced pain that radiates up her arm and into her shoulder. The pharmacist states that the patient had not seen a physician and the patient still had the symptoms. Seriousness and causality of the events was not reported.