chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Muscular weakness, Nausea
Clinical narrative: Severe flu-like symptoms; Nausea; Weakness in legs; Headache, as if her head was in a vise; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included COVID Vaccination and Mono Clonal Antibodies. Concurrent medical conditions included liver transplant.   On 28th December 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced influenza-like symptoms, nausea, lower extremities weakness of and headache. On an unknown date, the outcome of the influenza-like symptoms, nausea, lower extremities weakness of and headache were unknown.   It was unknown if the reporter considered the influenza-like symptoms, nausea, lower extremities weakness of and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-Apr-2022 Reporter's Comments: The patient self-reported this case. The patients concomitant medications included Antirejection drugs (undefined). The patient received her fist dose of Shingrix and experienced severe flu like symptoms, nausea, weakness in legs, headache (described as if her head was in a vise). The patient could not recall when the symptoms started and how long they lasted. The reporter did not consent to follow-up. Reporter did not wish to consent for HCP follow-up. Reporter provided limited information. Additional Supportive Information: This case has been linked to US2022066912, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022066912:Same reporter.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Injection site erythema, Injection site rash
Clinical narrative: Red rash at the injection site; Red rash at the injection site; Chills; Flu like symptoms; Fatigue; Fever; Muscle aches; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number X2X35, expiry date unknown) for prophylaxis.   On 15th April 2022, the patient received the 2nd dose of Shingrix (intramuscular) 50 µg. On 15th April 2022, less than a day after receiving Shingrix, the patient experienced chills. On 16th April 2022, the patient experienced injection site rash, injection site erythema, influenza-like symptoms, fatigue, fever and muscle pain. On an unknown date, the outcome of the injection site rash, injection site erythema, chills, influenza-like symptoms, fatigue, fever and muscle pain were recovered/resolved.   It was unknown if the reporter considered the injection site rash, injection site erythema, chills, influenza-like symptoms, fatigue, fever and muscle pain to be related to Shingrix.     Additional Information: GSK receipt date: 19-Apr-2022 Reporter's comment: The case was reported patient's wife. She reported that her husband received his second Shingrix dose on Friday afternoon, into his left arm.  On same day of vaccination, in evening he began to had chills.  On Saturday morning (one day after receiving vaccination), he had developed flu-like symptoms including fatigue, fever, and muscle aches, as well as a red rash at the injection site that spread 6 to 8 inches in diameter.  The reporter reported that the patient's reactions were lasted about 3 days and were now resolved. Expiration date of the vaccine administered was unknown. The reporter declined to give consent to contact patient's health care professional. Did not consent to follow-up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Red rash at the injection site; Red rash at the injection site; Chills; Flu like symptoms; Fatigue; Fever; Muscle aches; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 69-year-old male patient who received Herpes zoster (Shingrix) (batch number X2X35, expiry date unknown) for prophylaxis.   On 15th April 2022, the patient received the 2nd dose of Shingrix (intramuscular) 50 µg. On 15th April 2022, less than a day after receiving Shingrix, the patient experienced chills. On 16th April 2022, the patient experienced injection site rash, injection site erythema, influenza-like symptoms, fatigue, fever and muscle pain. On an unknown date, the outcome of the injection site rash, injection site erythema, chills, influenza-like symptoms, fatigue, fever and muscle pain were recovered/resolved.   It was unknown if the reporter considered the injection site rash, injection site erythema, chills, influenza-like symptoms, fatigue, fever and muscle pain to be related to Shingrix.     Additional Information: GSK receipt date: 19-Apr-2022 Reporter's comment: The case was reported patient's wife. She reported that her husband received his second Shingrix dose on Friday afternoon, into his left arm.  On same day of vaccination, in evening he began to had chills.  On Saturday morning (one day after receiving vaccination), he had developed flu-like symptoms including fatigue, fever, and muscle aches, as well as a red rash at the injection site that spread 6 to 8 inches in diameter.  The reporter reported that the patient's reactions were lasted about 3 days and were now resolved. Expiration date of the vaccine administered was unknown. The reporter declined to give consent to contact patient's health care professional. Did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: feeling feverish; shivering uncontrollably; shaking uncontrollably; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th January 2022, the patient received the 1st dose of Shingrix (intramuscular). On 28th January 2022, 12 hrs after receiving Shingrix, the patient experienced fever, shivering and tremor. The patient was treated with paracetamol (Tylenol). On 28th January 2022, the outcome of the fever, shivering and tremor were recovered/resolved.   The reporter considered the fever, shivering and tremor to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine intramuscularly into unspecified arm and about 12 hours after the vaccination experienced felt feverish and shaking/shivering uncontrollably. The patient took her temperature and it was 102 degrees. She took Tylenol.  The patient took her temperature again 30 minutes later, and the fever had gone up to 104.2. All  above symptoms resolved that same day.  The patient felt fine on 29th January 2022. The patient did not want to provide her email address.  GlaxoSmithKline failed to ask for her date of birth or age. The patient did not have the paperwork which would have the lot number/expiration date of the Shingrix but she did provide the contact information for her doctor's office where she got the shot and the doctor's office should have that data on file. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Ear discomfort, Headache, Hypoacusis, Pyrexia
Clinical narrative: left ear being plugged; hearing muffled; Headache; Fever; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th March 2022, the patient received the 1st dose of Shingrix. On 28th March 2022, less than a day after receiving Shingrix, the patient experienced headache and fever. On 13th April 2022, the patient experienced ear feels clogged and muffled hearing in both ears. On 31st March 2022, the outcome of the headache and fever were recovered/resolved. On an unknown date, the outcome of the ear feels clogged and muffled hearing in both ears were not recovered/not resolved.   It was unknown if the reporter considered the headache, fever, ear feels clogged and muffled hearing in both ears to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and on the same day she noted she had a headache and fever post vaccination which lasted about 3 days and was now resolved.   A week ago the patient also noticed a sensation of her left ear being plugged or blocked.  The patient also noted her hearing was not decreased but muffled. Symptom had not resolved.  The patient called in to inquired on possible side effects of Shingrix. Provided information per PI (Package insert) on side effects with Shingrix.  Provided medical advise disclaimer and referred to HCP (Health Care Professional). The patient refused to provide full demographics or DOB. She stated her age was above 50. The reporter did not consent to follow-up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pustular, Rash vesicular
Clinical narrative: chickenpox like rash with pustules on her arms and legs; chickenpox like rash; This case was reported by a consumer via call center representative and described the occurrence of pustular rash in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th April 2022, the patient received the 2nd dose of Shingrix. On 19th April 2022, 4 days after receiving Shingrix, the patient experienced pustular rash and vesicular rash. On an unknown date, the outcome of the pustular rash and vesicular rash were not recovered/not resolved.   It was unknown if the reporter considered the pustular rash and vesicular rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-APR-2022 Reporter's Comments: This case was self reported by patient. The patient reported that she received dose of Shingrix and after 4 days she developed a chickenpox like rash with pustules on her arms and legs. AE (Adverse Event) filed. The reporter was given medical disclaimer. Referred to HCP (Heath Care Professional). Spoked per package insert and content. The reporter provided MI (medical information) phone number for HCP (Health care professional) reference. Offered after call survey. The reporter consent to follow up.
Sex: M
Vaccine: MNQ
Symptoms: Headache, Pain
Clinical narrative: Body aches; Headache; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a adult male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 21st April 2022, the patient received Menveo. On 21st April 2022, less than a day after receiving Menveo, the patient experienced general body pain and headache. On an unknown date, the outcome of the general body pain and headache were recovered/resolved.   It was unknown if the reporter considered the general body pain and headache to be related to Menveo.     Additional Information: GSK receipt date: 21-Apr-2022 Reporter's comment: The patient self reported this case. The patient stated that he received Menveo vaccine on the date of reporting (today) and had body aches and headaches since receiving the vaccine.   The patient stated that he was okay and he was fine. The patient did not wish to provide further details. Did not consent to follow-up.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: received an expired dose of engerix-B; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 19-year-old female patient who received HBV (Engerix B) (batch number 722KC, expiry date 6th April 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   In April 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. In April 2022, unknown after receiving Engerix B and Engerix B 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 by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 22-Apr-2022 Reporter's comment: A health care professional reported that a patient received an expired dose of Engerix-B. Consented to follow up. Additional Supportive Information: The patient received an expired dose of Engerix-B, which led to expired vaccine used.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: patient was administered an expired dose of Engerix-b; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 19-year-old male patient who received HBV (Engerix B) (batch number 722KC, expiry date 6th April 2022) for prophylaxis.   On 22nd April 2022, the patient received Engerix B. On 22nd April 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 22-APR-2022 Reporter's comments: The manager reported that a dose of Engerix-B was given to the patient and it was already expired. The reporter consent to follow up. Additional Supportive Information: The use of Engerix-B dose which was already expired on 6th April 2022, which led to expired vaccine used. The Vaccine Administration Facility is the same as primary reporter.
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Boostrix instead of Infanrix; Patient receiving Boostrix, 3 years of age; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 3-year-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 22-APR-2022 Reporter's comments: The advisory service reported that a patient received dose of Boostrix vaccine instead of Infanrix. The HCP (health care professional) stated another advisory service reported the AE (adverse event), so did not provide any information about the situation, only wanted to know how to proceed.  Additional Supportive Information: The health care professional reported that a patient received Boostrix vaccine instead of Infanrix at inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration. This case is linked with case US2022068744 reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022068744:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Extreme fatigue/debilitating fatigue; This case was reported by a consumer via call center representative and described the occurrence of fatigue extreme in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th March 2022, the patient received the 2nd dose of Shingrix. On 24th March 2022, less than a day after receiving Shingrix, the patient experienced fatigue extreme. On 25th April 2022, the outcome of the fatigue extreme was recovered/resolved.   It was unknown if the reporter considered the fatigue extreme to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-APR-2022 Reporter's Comments: The patient received 2nd Shingrix shot and experienced extreme fatigue since then, debilitating fatigue almost everyday. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: given at an interval of greater than 6 months; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 5J27J, expiry date 6th May 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in 2020).   On 24th April 2022, the patient received the 2nd dose of Shingrix. On 24th April 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 25-APR-2022 Reporter's Comments: Pharmacist reporting second dose of Shingrix given at an interval of greater than 6 months.  Reported information within adverse event was all that the health care professional (HCP) provided at this time. HCP gave consent for safety team to follow up. The reporter consented to follow up. Additional Supportive Information: The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site nerve damage, SARS-CoV-2 antibody test, Wrong technique in product usage process
Clinical narrative: INCORRECT VACCINE ADMINISTRATION TECHNIQUE (WRONG SIZE NEEDLE USE); NERVE WAS HIT DURING INJECTION; HEADACHE, HEAD PAIN; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's weight was less than 90 pounds and height was 154.94 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced headache and head pain (Dose number in series 1). The patient felt that wrong size needle was used and the health care professional was standing while doing the injection and a nerve was hit during injection. The patient said that any side effect she had experienced was due to the administration technique (wrong size needle, incorrect vaccine administration technique). She also states that she felt like that the wrong technique might have led to less absorption of the vaccine. The patient had a SARS-C0V-2 IGG antibody (severe acute respiratory syndrome coronavirus 2 immunoglobulin G) test and the results were 0.93 and the range value should not be less than 1.00. She stated that this test was just to verify and also she did not have covid-19 infection within that time period (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, head pain, nerve was hit during injection and wrong size needle, incorrect vaccine administration technique was not reported (Dose number in series 1). The patient received additional covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of administration, batch number and expiry were not reported) dose was not reported, 1 total administered on unspecified date for prophylactic vaccination. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 2). This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use
Clinical narrative: OFF LABEL USE; GOT VACCINATED WITH JNJ VACCINE AFTER HAVING TAKEN A SINGLE SHOT OF PFIZER M-RNA VACCINE; This spontaneous report received from a patient concerned a 67 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported.  The patient's concurrent conditions included: asthma. The patient was not pregnant at the time of vaccination. The patient previously received 1 dose of Pfizer m-RNA vaccine (tozinameran) (dose number in series 1) (forms of admin, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, administered on an unspecified date for prophylactic vaccination. No adverse events were reported following vaccination Pfizer m-RNA vaccine (tozinameran) (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination which was an off label use as patient got vaccinated with JNJ vaccine after having taken a single shot of pfizer m-rna vaccine (inappropriate schedule of vaccine administered) (dose number in series 2).  The batch number was not reported and has been requested.  No concomitant medications were reported. The patient also received additional second covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, route of admin, batch number and expiry: were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with second covid-19 vaccine ad26.cov2.s (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and got vaccinated with JNJ vaccine after having taken a single shot of pfizer m-RNA vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Angiotensin converting enzyme, Antibody test, Vaccination failure, Vaccine breakthrough infection
Clinical narrative: BREAKTHROUGH INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report was received from literature: This report concerned a patient of unspecified age, sex, race and ethnicity. The objective of this was to analysis the SARS-CoV-2 specific antibody and cellular responses in healthy vaccine recipients who experienced breakthrough infections a median of 50 days after receiving a booster mRNA vaccine. The patient's height, and weight were not reported. The patient had no comorbidities. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin was not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. The patient received non-company suspect vaccine Elasomeran (Moderna) (Dose number in series: 2) (form of admin, route of admin were not reported, batch number: Unknown and expiry: Unknown), dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient had mild upper respiratory tract symptoms and experienced breakthrough infection (Dose number in series: 2) which was confirmed clinical vaccination failure (Dose number in series: 1). It was reported that, the days between booster shot and symptom onset was 50, days between symptom onset and blood drawn was 7, and days between booster shot and blood drawn was 54. Laboratory data (dates unspecified) included: Angiotensin converting enzyme (ACE inhibiting antibodies) (NR: not provided) slightly higher, and Antibody test (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s, and Elasomeran (Moderna) was not applicable. The outcome of the confirmed clinical vaccination failure and breakthrough infection was not reported. The author emphasized that breakthrough infections with the Omicron variant can occur despite robust immune responses to the vaccine strain spike protein. This report was serious (Other Medically Important Condition). This case is associated with a product quality complaint, and reference number requested. This case, from the same reporter is linked to 20220430845 and 20220452198.; Sender's Comments: V0: 20220452187- covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.  20220452187- covid-19 vaccine ad26.cov2.s - breakthrough  infection. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: GOT COVID 3 TIMES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced got covid 3 times.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid 3 times was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nasal congestion, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: COLD LIKE SYMPTOMS; STUFFY NOSE; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown ) dose was not reported, 1 total administered on an unspecified date in APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s. (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient additionally received booster Pfizer Biontech Covid-19 vaccine (Tozinameran) (Dose number in series 2) (form of admin not reported, route of admin not reported, batch number: unknown, expiry: unknown ) dose was not reported, administered on an unspecified date in NOV-2021 for prophylactic vaccination. On 25-APR-2022, the patient experienced stuffy nose (Dose number in series 2). Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 26-APR-2022, the patient experienced cold-like symptoms (Dose number in series 2). The outcome of the stuffy nose, suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was non serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Today I received a expired vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Today I received a expired vaccine.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 3005836) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Today I received a expired vaccine.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Today I received a expired vaccine.) outcome was unknown. Not Provided          No Concomitant medication reported. No Treatment medication reported.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine went into 28-degree Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022 15:27; Vaccine went into 28-degree Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022 15:27; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 28-degree Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022 15:27) and PRODUCT STORAGE ERROR (Vaccine went into 28-degree Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022 15:27) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2022 at 3:27 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Mar-2022 at 3:27 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 28-degree Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022 15:27). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 28-degree Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022 15:27). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 28-degree Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022 15:27) and PRODUCT STORAGE ERROR (Vaccine went into 28-degree Celsius thaw state on or about 24-Dec-2021 and administered on 11-MAR-2022 15:27) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reportedly patient ethnicity was given.  Concomitant medications details were not reported by the reporter.   Booster vaccine administration time reported as 15:27:29. Treatment details was not reported by the reporter.   This case was linked to MOD-2022-542869 (Patient Link).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 20-Feb-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 20-Feb-2022; This spontaneous case was reported by an emergency medical technician and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 20-Feb-2022) and EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 20-Feb-2022) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2022 at 9:34 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 10-Feb-2022 at 9:34 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 20-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 20-Feb-2022). At the time of the report, PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 20-Feb-2022) and EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 20-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The ethnicity was reported.  The patient had received the booster dose.  It was reported that a series of approximately 540 patients had received lot 066H21A past its 30 days of an expiry date. The vaccine was administered up until its manufactured expiry date of 04-Apr-2022 and lot number was no longer possessed.  No treatment medications were reported.   This case was linked to MOD-2022-542869 (Patient Link).
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 09-Feb-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 09-Feb-2022; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 09-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 09-Feb-2022) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2022 at 2:58 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Feb-2022 at 2:58 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 09-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 09-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 09-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 09-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.   Census Ethnicity of the patient was reported. The patient received booster dose.  Treatment details were not reported by the reporter.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Feb-2022 at 17:36:48; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Feb-2022 at 17:36:48; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Feb-2022 at 17:36:48) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Feb-2022 at 17:36:48) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2022 at 5:36 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Feb-2022 at 5:36 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Feb-2022 at 17:36:48). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Feb-2022 at 17:36:48). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Feb-2022 at 17:36:48) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Feb-2022 at 17:36:48) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. The patient's ethnicity was reported. It was unknown if the patient had acute illness at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long lasting health conditions. Concomitant product use was not provided by the reporter. It was unknown if the patient received any prescriptions, over the counter medications, dietary supplements or herbal remedies at the time of vaccination and or at the time of adverse event. It was unknown if the patient received other vaccines given on the same day and it was also unknown if the patient received other vaccines within one month prior to any dose of Moderna vaccine. It was unknown if the patient experienced any adverse events or not. The patient received Moderna vaccine past its 30 day of expiry date. It went into 2-to-8-degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022.  No treatment information was provided.   This case was linked to MOD-2022-542869 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine went into 2-8 Celsius thaw state on or about 20-Dec-2021 and administered on 12-Feb-2022; Covid-19 vaccine that were given beyond the 30 day use by date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 20-Dec-2021 and administered on 12-Feb-2022) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     It was reported Acute illness at the time of vaccination and up to one month before and Chronic or long-standing health conditions were unknown.     On 12-Feb-2022 at 12:50 PM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 12-Feb-2022 at 12:50 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 20-Dec-2021 and administered on 12-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 20-Dec-2021 and administered on 12-Feb-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at time of vaccination and/or at the time of adverse event were unknown. Other vaccine given on the same day as that of Moderna vaccine was unknown. Other vaccines received within one month prior to any dose of Moderna COVID-19 vaccine was unknown.  Patient was administered vaccine past its 30 days expiry date vaccine went into 2 to 8 Celsius thaw state on or about to 20-Dec-2021, this vaccine was administered until its manufacturing (Mfg) expiration date of 04-Apr-2022.   No treatment medication information provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Fatigue, Immunisation reaction, Nausea
Clinical narrative: first booster had a stronger reaction than the other two; felt more tired; felt a little nauseated; 0.5 mL booster dose administered; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (first booster had a stronger reaction than the other two), FATIGUE (felt more tired), NAUSEA (felt a little nauseated) and ACCIDENTAL OVERDOSE (0.5 mL booster dose administered) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, the patient experienced ACCIDENTAL OVERDOSE (0.5 mL booster dose administered). On an unknown date, the patient experienced VACCINATION COMPLICATION (first booster had a stronger reaction than the other two), FATIGUE (felt more tired) and NAUSEA (felt a little nauseated). At the time of the report, VACCINATION COMPLICATION (first booster had a stronger reaction than the other two), FATIGUE (felt more tired) and NAUSEA (felt a little nauseated) had resolved and ACCIDENTAL OVERDOSE (0.5 mL booster dose administered) outcome was unknown.            No Concomitant Medications were provided by the Reporter Patient had no allergy to medications, food and other products. Patient never had COVID positive test or diagnosis. Patient had no acute and chronic illness at the time of vaccination and up to one month before. Patient had no vaccine within one month prior to Moderna vaccine. It had been stated that could not provided information about the other doses or the lot numbers. The events did not cause the patient to seek medical care. just rested for a day  No Treatment Medications were provided by the Reporter   This case was linked to MOD-2022-550463, MOD-2022-550488 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2022: Live Follow-up received contains Significant information Reporter address added, Patient demographics added, new events were added
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Influenza like illness
Clinical narrative: Flu-like symptoms; It affected my knee ,It started hurting last night/ worsening knee pain; I had chills; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), ARTHRALGIA (It affected my knee ,It started hurting last night/ worsening knee pain) and CHILLS (I had chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Allergies related to medications, food and other products were unknown.  It was unknown if patient ever have tested or diagnosed positive for COVID.  History related to o mentioned adverse event and both acute and chronic illnesses at the time of vaccination was unknown.  Information about other vaccines given within 1 month prior to Moderna COVID-19 vaccine was unknown.    On 25-Apr-2022 at 2:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2022, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), ARTHRALGIA (It affected my knee ,It started hurting last night/ worsening knee pain) and CHILLS (I had chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 26-Apr-2022 at an unspecified dose and frequency. In April 2022, INFLUENZA LIKE ILLNESS (Flu-like symptoms) and CHILLS (I had chills) had resolved. At the time of the report, ARTHRALGIA (It affected my knee ,It started hurting last night/ worsening knee pain) had not resolved.     No concomitant medication information was provided.  Patient mentioned that she was going to physical therapy and stated that they put patient on a new machine and it affected her knee. The patient stated that she had ice on her knee and also asked whether she can take Advil.  Patient had not seeked medical care.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2022: Follow-up document received and includes no new information.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine adminsitered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine adminsitered) 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 EXPIRED PRODUCT ADMINISTERED (expired vaccine adminsitered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired vaccine adminsitered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported.   Reporter mentioned that a patient told that he received an expired booster dose of the Moderna Covid-19 Vaccine. The vaccine was expired for 5 days.  No treatment medications reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Type IV hypersensitivity reaction
Clinical narrative: Very sore and painful for a few days; The last two doses she actually experienced a delay type of hypersensitive reaction; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Very sore and painful for a few days) and TYPE IV HYPERSENSITIVITY REACTION (The last two doses she actually experienced a delay type of hypersensitive reaction) in a female 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Very sore and painful for a few days) and TYPE IV HYPERSENSITIVITY REACTION (The last two doses she actually experienced a delay type of hypersensitive reaction). At the time of the report, PAIN (Very sore and painful for a few days) and TYPE IV HYPERSENSITIVITY REACTION (The last two doses she actually experienced a delay type of hypersensitive reaction) had resolved.            No concomitant medications were reported. The patient reported that the last two doses the patient actually experience a delay type of hypersensitive reaction and just wanted to make Moderna aware as an adverse event. No seriousness to it, it resolved on its own and it was very sore and painful for a few days.  No treatment medications were reported.   This case was linked to MOD-2022-550462 (Patient Link).