chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Malaise, Neuralgia, Pain
Clinical narrative: shingles shot was a little rough; it was worse than the other pain; nerve pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of malaise in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID VACCINE) for covid-19 prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of malaise (received 1st dose on an unknown date, refer case US2023AMR051224).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and COVID VACCINE. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced malaise (Verbatim: shingles shot was a little rough), pain (Verbatim: it was worse than the other pain) and nerve pain (Verbatim: nerve pain). Rechallenge with Shingles vaccine was positive. The outcome of the malaise and pain were unknown and the outcome of the nerve pain was not reported.   It was unknown if the reporter considered the malaise, pain and nerve pain to be related to Shingles vaccine.     It was unknown if the company considered the malaise, pain and nerve pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR051224   Additional Information: Receipt Date: 16-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that the second Shingles vaccine was a little rough. The patient had all the Covid shots.  The patient stated that still, from the people know who have had it, it was nothing compared to shingles.  The patient had 2 knee replacements and had a lot of nerve pain.  The patient stated that it was worse than the other pain.  The patient stated that oxy did not really touch it.  The patient stated that shingles was a nerve pain and it could go on for weeks and in some instances, be permanent.  The patient was not willing to roll that dice. The patient advised everyone to get vaccinated. As it was unclear from narrative, when patient received Covid shots, conservatively captured suspect.; Sender's Comments:  US-GSK-US2023AMR051224:Same reporter
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo mixed with an unapproved diluent; Vaccine administered mixed with other dilueent; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA768A, expiry date 31-DEC-2023) for prophylaxis.   On 03-APR-2023, the patient received the 1st dose of Menveo (left arm). On 03-APR-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo mixed with an unapproved diluent) and inappropriate dose of vaccine administered (Verbatim: Vaccine administered mixed with other dilueent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 03-APR-2023 The patient received the lyophilized portion of the menveo vaccine with an unapproved diluent. Menveo reconstituted with an unapproved diluent instead of the supplied CYW-135 liquid conjugate, which led to Wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Malaise
Clinical narrative: Bleeding at injection site; Feeling sick; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site hemorrhage in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (On 25th January 2023, received 1st dose and experienced feeling sick, refer case US2023AMR049488).   On 01-APR-2023, the patient received the 2nd dose of Shingrix (intramuscular). On 01-APR-2023, immediately after receiving Shingrix, the patient experienced injection site hemorrhage (Verbatim: Bleeding at injection site) and feeling unwell (Verbatim: Feeling sick). Rechallenge with Shingrix was positive. The outcome of the injection site hemorrhage and feeling unwell were resolved.   It was unknown if the reporter considered the injection site hemorrhage and feeling unwell to be related to Shingrix.     It was unknown if the company considered the injection site hemorrhage and feeling unwell to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR049488   Additional Information: GSK Receipt date: 03-APR-2023. Patient stated that he had his second dose of Shingrix and felt sick again and that there was bleeding at the injection site immediately after receiving the dose. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023AMR049488:Same reporter
Sex: M
Vaccine: HEPA
Symptoms: Accidental underdose, Underdose
Clinical narrative: about half the volume was leaked, not administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 4-year-old male patient who received HAV (Havrix) (batch number D7HA9, expiry date 27-OCT-2024) for prophylaxis.   On 03-APR-2023, the patient received Havrix. On 03-APR-2023, an unknown time after receiving Havrix, the patient experienced accidental underdose (Verbatim: about half the volume was leaked, not administered). The outcome of the accidental underdose 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:03-APR-2023. Reporter stated that patient moved while receiving Havrix vaccine and about half the volume was leaked and not administered to the patient which led to accidental underdose. The reporter consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Vaccine not properly reconstituted; Only diluent administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Vaccine not properly reconstituted) and inappropriate dose of vaccine administered (Verbatim: Only diluent administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 03-APR-2023 The patient received only the diluent component of Shingrix without being properly reconstituted with the powder. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 84.0
Sex: F
Vaccine: FLU4
Symptoms: Endotracheal intubation, Incorrect route of product administration
Clinical narrative: administered via intravenous (intubated emergently); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 84-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 2772C) for prophylaxis.   On 02-APR-2023, the patient received Fluarix Quadrivalent 2022-2023 season (intravenous). On 02-APR-2023, an unknown time after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced intramuscular formulation administered by other route (Verbatim: administered via intravenous (intubated emergently)). The outcome of the intramuscular formulation administered by other route 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:3-APR-2023 Fluarix was administered via intravenous to a patient by mistake. The Vaccine Administration Facility was the same as Primary Reporter. No expiration date was reported. The patient ended up being intubated emergently. No further details provided at the time of call. The reporter consent to follow up via email. Patient was administered Fluarix Quadrivalent via intravenous, which led to intramuscular formulation administered by other route.
Sex: F
Vaccine: VARZOS
Symptoms: Genital herpes
Clinical narrative: Genital herpes; This non-serious case was reported by a consumer via call center representative and described the occurrence of genital herpes in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In NOV-2022, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced genital herpes (Verbatim: Genital herpes). The outcome of the genital herpes was not resolved.   It was unknown if the reporter considered the genital herpes to be related to Shingrix.     It was unknown if the company considered the genital herpes to be related to Shingrix.   Additional Information: GSK Receipt date: 3-APR-2023. Patient reported that she had recently experienced a case of genital herpes and might have to postpone Shingrix 2nd dose. Patient did not want to provide any additional information. Adverse event filed with limited information. The reporter did not consent to follow-up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose 3 years after the 1st; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On 5th March 2020, received 1st dose).   On 01-APR-2023, the patient received the 2nd dose of Shingrix. On 01-APR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose 3 years after the 1st). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt date: 03-Apr-2023. The pharmacy manager stated that a patient who was not immunocompromised received Shingrix second dose almost 3 years apart.  The reporter did not consent to follow-up. The patient received 2nd dose late than recommended schedule, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Vx mixed with different diluent; Vx with different diluent administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA764A, expiry date 31-DEC-2023) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Vx mixed with different diluent) and inappropriate dose of vaccine administered (Verbatim: Vx with different diluent administered). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 04-APR-2023 The reporter (medical assistant) called in to report the administration of Menveo that was reconstituted with a different diluent other than the supplied meningococcal CYW-135. The reporter asked how to proceed with the patient. The reporter consented to follow up. At the time of reporting, the patient was administered with Menveo that was reconstituted with a different diluent other than the supplied meningococcal CYW-135, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Engerix-B pediatric given to an adult; Engerix-B pediatric given to an adult; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 20-year-old female patient who received HBV (Engerix B pediatric) (batch number FB9RH, expiry date 21-JAN-2024) for prophylaxis.   On 04-APR-2023, the patient received the 1st dose of Engerix B pediatric. On 04-APR-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Engerix-B pediatric given to an adult) and adult use of a child product (Verbatim: Engerix-B pediatric given to an adult). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date: 04-APR-2023 The reporter reported that an Engerix-B pediatric dose was administered to 20 year-old patient. The reporter consented to follow up by email.  At the time of reporting, the adult patient was administered with an Engerix-B pediatric dose, which led to underdose and adult use of a child product.
Age: 4.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered at inappropriate site, Product administered to patient of inappropriate age
Clinical narrative: Boostrix given to a 4-year-old; Boostrix administered in the left thigh; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3JS9E, expiry date 18-MAR-2024) for prophylaxis.   On 04-APR-2023, the patient received Boostrix (intramuscular, left thigh) .5 ml. On 04-APR-2023, an unknown time after receiving Boostrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Boostrix given to a 4-year-old) and vaccine administered at inappropriate site (Verbatim: Boostrix administered in the left thigh). The outcome of the inappropriate age at vaccine administration and vaccine administered at inappropriate site were 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: 04-APR-2023 The physician reported that the patient received a dose of Boostrix vaccine.  Nothing further to report.  The healthcare professional was transferred to medical information for next steps. The reporter consented to follow up. The 4 year old patient received a dose of Boostrix into left thigh, which led to Inappropriate age at vaccine administration and vaccine administered at inappropriate site.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Menveo given instead of Men B vaccine; Third dose of Menveo administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA912A, expiry date 31-MAR-2024) for prophylaxis.   On 04-APR-2023, the patient received the 3rd dose of Menveo. On 04-APR-2023, an unknown time after receiving Menveo, the patient experienced wrong vaccine administered (Verbatim: Menveo given instead of Men B vaccine) and extra dose administered (Verbatim: Third dose of Menveo administered). The outcome of the wrong vaccine administered and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 04-APR-2023 and 05-APR-2023 The medical assistant reported that the patient received third dose of Menveo instead of Men B vaccine. The reporter consented to follow up. The patient received third dose of Menveo instead of Men B vaccine, which led to wrong vaccine administered and extra dose administered. The case US2023050262 was identified as duplicate of this case. The case US2023050262 was deleted and all future correspondence would be added in the present case, which stands as case of record for this patient.
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Pain, Palpitations, Pyrexia
Clinical narrative: racing heart; fever; fatigue; body aches; dizziness; This non-serious case was reported by a physician via call center representative and described the occurrence of heart racing in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In JAN-2023, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 1 day after receiving Shingrix, the patient experienced heart racing (Verbatim: racing heart), fever (Verbatim: fever), fatigue (Verbatim: fatigue), general body pain (Verbatim: body aches) and dizziness (Verbatim: dizziness). The outcome of the heart racing, fever, fatigue, general body pain and dizziness were resolved.   It was unknown if the reporter considered the heart racing, fever, fatigue, general body pain and dizziness to be related to Shingrix.     It was unknown if the company considered the heart racing, fever, fatigue, general body pain and dizziness to be related to Shingrix.   Additional Information: GSK Receipt Date: 04-APR-2023 The reporter was asked about safety of giving a patient her 2nd dose of Shingrix.  The patient received her first dose in January of 2023 and experienced the adverse events racing heart, fever, fatigue, body aches, and dizziness. The reporter was consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Neck mass, Swelling
Clinical narrative: Adverse reaction, lump in neck; This non-serious case was reported by a consumer via call center representative and described the occurrence of local swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced local swelling (Verbatim: Adverse reaction, lump in neck). The outcome of the local swelling was resolved.   It was unknown if the reporter considered the local swelling to be related to Shingrix.     It was unknown if the company considered the local swelling to be related to Shingrix.   Additional Information: GSK receipt date: 04-APR-2023 The reporter reported an adverse reaction experienced by another female patient, after they received the first dose of Shingrix.  The reporter reported being told the other patient experienced a lump in their neck after the first dose and was advised not to receive the second dose of Shingrix.  The reporter reported the lump had resolved. The reporter did not consent to follow-up. This case was linked with US2023049708, reported by the same reporter.; Sender's Comments:  US-GSK-US2023049708:Same report, other patient
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: given an expired dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number AF799, expiry date 01-APR-2023) for prophylaxis.   On 05-APR-2023, the patient received the 1st dose of Shingrix. On 05-APR-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: given an expired dose). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 5-Apr-2023 The licensed practical nurse asked that the dose should be repeated. The reporter could not confirm Lot number in their system as valid. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. The patient received an expired dose of Shingrix, which led to expired vaccine used.
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 70-year-old male patient who received Men B NVS (Bexsero) (batch number ABX06AA, expiry date 30-MAR-2023) for prophylaxis.   On 05-APR-2023, the patient received Bexsero. On 05-APR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: received an expired dose). 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: 5-Apr-2023 The reporter consented to follow-up. The patient received an expired dose of Bexsero, which led to expired vaccine used.
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number ABXC06AA, expiry date 31-MAR-2023) for prophylaxis.   On 05-APR-2023, the patient received Bexsero. On 05-APR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: received an expired dose). 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: 5-Apr-2023 The reporter did not had patient details at the time of call, follow-up via email in health care professional details were preferred. The vaccine administration facility was the same as primary reporter. The patient received an expired dose of Bexsero, which led to expired vaccine used.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 01Oct2020, 2nd 28Nov2022; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received 1st dose on 1st October 2020).   On 28-NOV-2022, the patient received the 2nd dose of Shingrix. On 28-NOV-2022, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose 01Oct2020, 2nd 28Nov2022). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 7-Apr-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose in 2020, 2nd dose today; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received first dose in December 2020).   On 07-APR-2023, the patient received the 2nd dose of Shingrix. On 07-APR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose in 2020, 2nd dose today). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 7-Apr-2023 The pharmacist reported that the second dose was given on the day of reporting to another agent after transferring the health care professional to them to answer their medical information questions. Follow up email was sent by her to safety team. The vaccine administration facility was the same as primary reporter. The patient received second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient was inadvertently administered an expired vaccine/ Patient received an expired vaccine (two days after expiration); Patient received dose 1 on 26-Aug-2021 and dose 2 on 14-Mar-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was inadvertently administered an expired vaccine/ Patient received an expired vaccine (two days after expiration)), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 26-Aug-2021 and dose 2 on 14-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 28-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     It was reported that the acute illnesses at the time of vaccination and up to one month before or any chronic or long-standing health conditions were none.     On 14-Mar-2023 at 10:35 AM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 14-Mar-2023 at 10:35 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was inadvertently administered an expired vaccine/ Patient received an expired vaccine (two days after expiration)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 26-Aug-2021 and dose 2 on 14-Mar-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was inadvertently administered an expired vaccine/ Patient received an expired vaccine (two days after expiration)), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 26-Aug-2021 and dose 2 on 14-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was inadvertently administered an expired vaccine/ Patient received an expired vaccine (two days after expiration)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 26-Aug-2021 and dose 2 on 14-Mar-2023).    Prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination or at the time of the adverse event were none.   It was reported that patient received an expired vaccine (two days after expiration). After checked with the vaccine manufacturer, it was deemed acceptable and valid. The vaccine administered was Moderna 12 plus Monovalent (Red Cap).   Treatment medication was not provided by the reporter.   This case was linked to GU-MODERNATX, INC.-MOD-2023-715414 (Linked Report). This case was linked to MOD-2023-718113 (Patient Link).; Sender's Comments:  GU-MODERNATX, INC.-MOD-2023-715414:Patient
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient tested positive to COVID-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Patient tested positive to COVID-19) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026c21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced COVID-19 (Patient tested positive to COVID-19). At the time of the report, COVID-19 (Patient tested positive to COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  On 14-MAR-2023 10:35, patient had 2nd dose of 0.5 milliliter in left arm with batch number 071B22A.  No treatment information was provided.   This case was linked to MOD-2023-718111 (Patient Link).
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Dyspnoea, Gait disturbance
Clinical narrative: Shortness of breath; I can barely walk half a block; Progressively worse with each shot; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (Shortness of breath), GAIT DISTURBANCE (I can barely walk half a block) and CONDITION AGGRAVATED (Progressively worse with each shot) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath), GAIT DISTURBANCE (I can barely walk half a block) and CONDITION AGGRAVATED (Progressively worse with each shot). At the time of the report, DYSPNOEA (Shortness of breath) had not resolved and GAIT DISTURBANCE (I can barely walk half a block) and CONDITION AGGRAVATED (Progressively worse with each shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not reported. It was reported that patient received spikevax bivalent vaccine dose 5 on 18-oct-2022 intramuscular route. Batch number was unknown for all the doses. Patient had Shortness of Breath. Over time developed into severe shortness of breath. Now at point patient can barely walk half a block. People keep asking if in need of help. Progressively worse with each shot. Started shortly after first short and worse after each shot. It was unknown if the patient experienced any additional symptoms/events.  Treatment medications were not reported.   This case was linked to MOD-2023-718857 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 10-Feb-2023 and dose was administered on 23-MAR-2023; No adverse event; Dose administered after 30-day Use By Date (patient 1); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date (patient 1)), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Feb-2023 and dose was administered on 23-MAR-2023) and NO ADVERSE EVENT (No adverse event) in a 51-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Mar-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date (patient 1)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Feb-2023 and dose was administered on 23-MAR-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date (patient 1)), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Feb-2023 and dose was administered on 23-MAR-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date (patient 1)) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Feb-2023 and dose was administered on 23-MAR-2023).    No concomitant medications were reported. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Vial size was reported as 2.5 mL.Vial was initially stored in the refrigerator on 10-Feb-2023. Vial did not undergo any temperature excursions. No treatment information was provided.
Age: 49.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 10-Feb-2023 and dose was administered on 31-MAR-2023; no adverse event; 5 patients received expired doses/Dose administered after 30-day Use By Date (patient #4); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 patients received expired doses/Dose administered after 30-day Use By Date (patient #4)), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Feb-2023 and dose was administered on 31-MAR-2023) and NO ADVERSE EVENT (no adverse event) in a 49-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-Mar-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (5 patients received expired doses/Dose administered after 30-day Use By Date (patient #4)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Feb-2023 and dose was administered on 31-MAR-2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 patients received expired doses/Dose administered after 30-day Use By Date (patient #4)), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Feb-2023 and dose was administered on 31-MAR-2023) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (5 patients received expired doses/Dose administered after 30-day Use By Date (patient #4)) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 10-Feb-2023 and dose was administered on 31-MAR-2023).    No concomitant medications was reported. The size of vial was 2.5 ml. The vial was initially stored in the refrigerator on 10-feb-2023. The vial did not undergo any temperature excursions. No treatment drug details was reported.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted, Product availability issue
Clinical narrative: Her daughter received the 1st dose of the Moderna COVID-19 vaccine primary series about a month back. She is due for her 2nd dose today; her daughter received the 1st dose of the Moderna COVID-19 vaccine primary series about a month back. She is due for her 2nd dose today; No adverse event; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (her daughter received the 1st dose of the Moderna COVID-19 vaccine primary series about a month back. She is due for her 2nd dose today), PRODUCT AVAILABILITY ISSUE (her daughter received the 1st dose of the Moderna COVID-19 vaccine primary series about a month back. She is due for her 2nd dose today) and NO ADVERSE EVENT (No adverse event) in a 20-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (her daughter received the 1st dose of the Moderna COVID-19 vaccine primary series about a month back. She is due for her 2nd dose today), PRODUCT AVAILABILITY ISSUE (her daughter received the 1st dose of the Moderna COVID-19 vaccine primary series about a month back. She is due for her 2nd dose today) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (her daughter received the 1st dose of the Moderna COVID-19 vaccine primary series about a month back. She is due for her 2nd dose today), PRODUCT AVAILABILITY ISSUE (her daughter received the 1st dose of the Moderna COVID-19 vaccine primary series about a month back. She is due for her 2nd dose today) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT ADMINISTRATION INTERRUPTED (her daughter received the 1st dose of the Moderna COVID-19 vaccine primary series about a month back. She is due for her 2nd dose today) and PRODUCT AVAILABILITY ISSUE (her daughter received the 1st dose of the Moderna COVID-19 vaccine primary series about a month back. She is due for her 2nd dose today).    Concomitant medication was not provided.   Treatment information was not provided.   Reporter did not allow further contact
Age: 88.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: Husband almost he died from covid; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Husband almost he died from covid) in an 88-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised and Cancer (Takes medicine for cancer).    On an unknown date, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In August 2022, the patient experienced COVID-19 (Husband almost he died from covid). At the time of the report, COVID-19 (Husband almost he died from covid) was resolving.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   It was reported that wife called in on behalf of her husband. Patient already had 5 shots. Her husband almost died from COVID so an AE needs to be done he had COVID last august he got it from his wife and he almost died it lasted for a long time but he was a lot better from what he was. No treatment medication was provided.
Age: 12.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted, Product availability issue
Clinical narrative: THEY ARE HAVING TROUBLE SOURCING VACCINE FOR THE SECOND DOSE; Product availability issue; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (THEY ARE HAVING TROUBLE SOURCING VACCINE FOR THE SECOND DOSE), PRODUCT AVAILABILITY ISSUE (Product availability issue) and NO ADVERSE EVENT (no adverse event) in a 12-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (THEY ARE HAVING TROUBLE SOURCING VACCINE FOR THE SECOND DOSE), PRODUCT AVAILABILITY ISSUE (Product availability issue) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (THEY ARE HAVING TROUBLE SOURCING VACCINE FOR THE SECOND DOSE), PRODUCT AVAILABILITY ISSUE (Product availability issue) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT ADMINISTRATION INTERRUPTED (THEY ARE HAVING TROUBLE SOURCING VACCINE FOR THE SECOND DOSE) and PRODUCT AVAILABILITY ISSUE (Product availability issue).    No concomitant medications were reported. The patient received first dose of moderna primary series at another health care facility. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 10-Apr-2023: Non-significant follow up received: Reference Id's were updated
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 10-FEB-2023 and vaccine was administered on 29-MAR-2023; No adverse event; The patient received expired dose after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received expired dose after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-FEB-2023 and vaccine was administered on 29-MAR-2023) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.   No Medical History information was reported.    On 29-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 29-Mar-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received expired dose after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-FEB-2023 and vaccine was administered on 29-MAR-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received expired dose after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-FEB-2023 and vaccine was administered on 29-MAR-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The patient received expired dose after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-FEB-2023 and vaccine was administered on 29-MAR-2023).    No concomitant medications were reported.  The pharmacist confirms that 5 patients received expired doses. The vial size was 2.5 mL. The vial did not undergo any temperature excursions.  No treatment information was provided.
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 10-FEB-2023 and vaccine was administered on 27-MAR-2023; no adverse event; The patient received expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received expired dose), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-FEB-2023 and vaccine was administered on 27-MAR-2023) and NO ADVERSE EVENT (no adverse event) in a 73-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 27-Mar-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received expired dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-FEB-2023 and vaccine was administered on 27-MAR-2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received expired dose), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-FEB-2023 and vaccine was administered on 27-MAR-2023) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The patient received expired dose) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-FEB-2023 and vaccine was administered on 27-MAR-2023).    No concomitant medications was reported.  The vial size was 2.5 mL. The vial was initially stored in the refrigerator on 10-Feb-2023. The vial did not undergone any temperature excursions. Moderna bivalent was set to expire on march 12 and 5 patients were administered the vaccine. The pharmacist confirms that 5 patients received expired doses. Dose administered after 30-day Use By Date.    No treatment medications was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-719094 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-719094:same reporter