chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain upper, Injection site erythema, Malaise, Pain in extremity
Clinical narrative: arm soreness; arm swelling; redness at the site of the injection; sick to her stomach; This case was reported by a consumer via call center representative and described the occurrence of stomach pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced stomach pain, pain in arm, swelling arm and injection site erythema. On an unknown date, the outcome of the stomach pain was recovered/resolved and the outcome of the pain in arm, swelling arm and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the stomach pain, pain in arm, swelling arm and injection site erythema to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-JUN-2022 Reporter's Comment: The reporter is patient. The patient stated received first dose of Shingrix a month ago. The patient stated that felt sick to her stomach for about 3 days but that resolved. The patient also stated that she had arm soreness, arm swelling and redness at the site of the injection (left arm) which had not resolved after one month.
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling
Clinical narrative: arm soreness; arm swelling; redness at the site of the injection; sick to her stomach; This case was reported by a consumer via call center representative and described the occurrence of stomach pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced stomach pain, pain in arm, swelling arm and injection site erythema. On an unknown date, the outcome of the stomach pain was recovered/resolved and the outcome of the pain in arm, swelling arm and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the stomach pain, pain in arm, swelling arm and injection site erythema to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-JUN-2022 Reporter's Comment: The reporter is patient. The patient stated received first dose of Shingrix a month ago. The patient stated that felt sick to her stomach for about 3 days but that resolved. The patient also stated that she had arm soreness, arm swelling and redness at the site of the injection (left arm) which had not resolved after one month.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only received the adjuvant component of the vaccine; only received the adjuvant component of the shingrix vaccine; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 75PE7, expiry date 3rd June 2023) for prophylaxis.   On 29th June 2022, the patient received the 1st dose of Shingrix. On 29th June 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 29-JUN-2022 Reporter's Comment: The reporter stated that patient only received the adjuvant component of the Shingrix vaccine on 29th June 2022 inadvertently. Additional supportive information: The patient only received adjuvant component which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Injection site pain, Memory impairment
Clinical narrative: Went to get out of the car and was extremely dizzy; Could not remember any words/had trouble remembering words; Pain at injection site; Had tiredness; This case was reported by a consumer via call center representative and described the occurrence of pain injection site in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number A725Y, expiry date 30th May 2023) for prophylaxis.   On 6th April 2022, the patient received the 1st dose of Shingrix (intramuscular). On 6th April 2022, less than a day after receiving Shingrix, the patient experienced pain injection site and tiredness. On 8th April 2022, the patient experienced dizziness and forgetfulness. On 8th April 2022, the outcome of the dizziness and forgetfulness were recovered/resolved. In April 2022, the outcome of the pain injection site and tiredness were recovered/resolved.   It was unknown if the reporter considered the pain injection site, tiredness, dizziness and forgetfulness to be related to Shingrix.     Linked case(s) involving the same patient:  US2022099905   Additional Information: GSK Receipt Date: 29-JUN-2022/ 29-JUN-2022 Reporter's comments: This case was reported by the patient herself. The patient stated that she received her Shingrix vaccine in the Left deltoid and later that day she had pain at the injection site and had tiredness both of which resolved a day or two later. After 2 days on 8th April 2022, she went to get out of the car and was extremely dizzy and could not remember any words. The pharmacist said, the patient had trouble remembering words. Both the symptoms resolved in less than 30 minutes. The pharmacist stated that patient had not yet received the second dose of Shingrix. The patient would like to talk to safety herself. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022099905:FU1 - Deleted
Age: 0.17
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: infant received Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old male patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 9th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th May 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 17th May 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 30-JUN-2022 Reporter's Comment: An infant patient received Kinrix. The reporter consented for follow up. Additional Supportive Information: An infant patient received Kinrix, which led to the inappropriate age at vaccine administration.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administered a pt an expired dose of Havrix; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 19-year-old male patient who received HAV (Havrix) (batch number K4Y4L, expiry date 17th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th June 2022, the patient received Havrix (intramuscular) 1 ml and Havrix Pre-Filled Syringe Device. On 30th June 2022, unknown after receiving Havrix and Havrix 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: 30-Jun-2022 Reporter's Comments: The reporter stated that the patient was administered an expired dose of Havrix (expiration date 17th June 2022) intramuscularly into his left arm on the day of reporting. The reporter consented to follow up with himself/herself and with HCP. Additional Supportive Information: The patient was administered an expired dose of Havrix, which led to expired vaccine used.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Menveo administered to a 13 yo patient; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 13-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA687A, expiry date unknown) for prophylaxis.   Previously administered products included Menveo (received 1st dose on 4th November 2019 of batch number AMVA125A).   On 27th June 2022, the patient received the 2nd dose of Menveo. On 27th June 2022, unknown after receiving Menveo, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 30-JUN-2022 Reporter's Comments: The reporter consented to follow up by email. Additional supportive information: The 13 years old patient received a Menveo vaccine as a second dose, which led to extra dose administered.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Anosmia, Dyspnoea, Parosmia, Sleep disorder
Clinical narrative: sense of smell has diminished greatly/not gotten back her sense of smell; Smells smoke; This case was reported by a consumer via call center representative and described the occurrence of loss of smell in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 3G33K, expiry date 10th July 2023) for prophylaxis.   Previously administered products included CHICKEN POX VACCINE (received on an unknown date) and COVID 19 BOOSTER (received on an unknown date). Concurrent medical conditions included covid-19.   On 13th June 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In June 2022, less than 3 weeks after receiving Shingrix, the patient experienced loss of smell and smell alteration. On an unknown date, the outcome of the loss of smell and smell alteration were not recovered/not resolved.   It was unknown if the reporter considered the loss of smell and smell alteration to be related to Shingrix.     Additional Information: GSK Receipt Date: 30-Jun-2022. Reporters comment: The patient self-reported this case. The patient received Shingrix vaccine on right deltoid. The patient stated ever since she received her first dose of shingrix, she began smelling smoke, like someone was blowing cigarette smoke in her face.  The smell would wake her up at night because she could not breathe. The patient stated the smell of smoke has subsided, but not totally resolved. The patient also stated that since she received the shingrix vaccine, her sense of smell has diminished greatly. She stated that she used to have a great sense of smell, that she could pick up on odors well in advance of anyone else. At the time of the call, the patient has not gotten back her sense of smell. The reporter consented to follow up with HCP. Additional Supportive Information: This case has been linked with US2022100577, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022100577:Same reporter
Age: 54.0
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site warmth
Clinical narrative: flu-like symptoms; heat at the injection site; redness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of flu-like symptoms in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID VACCINE) for prophylaxis.   The patient's past medical history included cellulitis. Concurrent medical conditions included thyroid disorder and shingles.   On 28th June 2022, the patient received the 1st dose of Shingrix (intramuscular) and the 4th dose of COVID VACCINE. On 28th June 2022, less than a day after receiving Shingrix, the patient experienced flu-like symptoms, injection site warmth and injection site redness. On an unknown date, the outcome of the flu-like symptoms was recovered/resolved and the outcome of the injection site warmth and injection site redness were not recovered/not resolved.   It was unknown if the reporter considered the flu-like symptoms, injection site warmth and injection site redness to be related to Shingrix.     Additional Information: GSK Receipt Date: 30-JUN-2022 Reporter's Comments: The reporter was the patient. The patient had redness and heat at the injection site. The redness and heat increased the next day of vaccination but had not worsened on the day of reporting. The first evening she had flu-like symptoms.  On an unknown date in June 2022, the outcome of the flu-like symptoms was recovered/resolved. Patient also had her fourth COVID vaccine (unknown manufacturer) on the same day in the same arm, below the Shingrix injection site.  On 28th June 2022, less than a day after receiving Covid vaccine, the patient experienced flu-like symptoms, injection site warmth and injection site redness. It was unknown if the reporter considered the flu-like symptoms to be related to Covid vaccine. The reporter did not suspect the area of redness and heat were due to the COVID vaccine.  She had nothing else to report.  The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Anosmia, Appetite disorder, Condition aggravated, Hyperaesthesia, Middle insomnia
Clinical narrative: experiencing a "cigarette smell" sensation; Tenderness; Itch; Doesn't smell as well as she used to, Lack of smell; Lack of smell worsened; Affects apetite; waking up at night; Sensitivity; This case was reported by a nurse via call center representative and described the occurrence of smell alteration in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included tenderness. Concurrent medical conditions included smell alteration (The patient was experiencing a cigarette smell sensation before the first dose of Shingrix) and loss of smell. Concomitant products included COVID-19 VACCINE (COVID-19 BOOSTER).   On 13th June 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced smell alteration, tenderness, pruritus, loss of smell, condition aggravated, appetite disorder, nocturnal awakening and hyperesthesia. On an unknown date, the outcome of the smell alteration, loss of smell, condition aggravated, appetite disorder and nocturnal awakening were not recovered/not resolved and the outcome of the tenderness and pruritus were recovered/resolved and the outcome of the hyperesthesia was unknown.   It was unknown if the reporter considered the smell alteration, tenderness, pruritus, loss of smell, condition aggravated, appetite disorder, nocturnal awakening and hyperesthesia to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-JUN-2022 and 01-JUL-2022 Reporter's Comment: The reporter reported that, she received the Shingrix.  The reporter reported that, she was experiencing a cigarette smell sensation before the first dose.  However, cigarette smell sensation worsened after the first dose.  The reporter stated that, she had tenderness but it wasn't that bad and didn't last that long and an itch but it came and went, both events occurring after her first dose of Shingrix.  She stated that, she didn't smell as well as she used to.  She was experiencing this before Shingrix but her lack of smell worsened after receiving Shingrix.  She also stated that her issue with smelling smoke affects her appetite and she was wakening up at night because she was smelling smoke.  She also shared that, she received her booster shot for Covid two months before receiving Shingrix and that the sensitivity/tenderness with the Covid shot was 10 times worse than it was with Shingrix. The reporter declined to provide additional information. The reporter did not consent to follow-up. Additional Supportive Information: The case had been linked to US2022100573,reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022100573:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Parosmia, Pruritus, Tenderness
Clinical narrative: experiencing a "cigarette smell" sensation; Tenderness; Itch; Doesn't smell as well as she used to, Lack of smell; Lack of smell worsened; Affects apetite; waking up at night; Sensitivity; This case was reported by a nurse via call center representative and described the occurrence of smell alteration in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included tenderness. Concurrent medical conditions included smell alteration (The patient was experiencing a cigarette smell sensation before the first dose of Shingrix) and loss of smell. Concomitant products included COVID-19 VACCINE (COVID-19 BOOSTER).   On 13th June 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced smell alteration, tenderness, pruritus, loss of smell, condition aggravated, appetite disorder, nocturnal awakening and hyperesthesia. On an unknown date, the outcome of the smell alteration, loss of smell, condition aggravated, appetite disorder and nocturnal awakening were not recovered/not resolved and the outcome of the tenderness and pruritus were recovered/resolved and the outcome of the hyperesthesia was unknown.   It was unknown if the reporter considered the smell alteration, tenderness, pruritus, loss of smell, condition aggravated, appetite disorder, nocturnal awakening and hyperesthesia to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-JUN-2022 and 01-JUL-2022 Reporter's Comment: The reporter reported that, she received the Shingrix.  The reporter reported that, she was experiencing a cigarette smell sensation before the first dose.  However, cigarette smell sensation worsened after the first dose.  The reporter stated that, she had tenderness but it wasn't that bad and didn't last that long and an itch but it came and went, both events occurring after her first dose of Shingrix.  She stated that, she didn't smell as well as she used to.  She was experiencing this before Shingrix but her lack of smell worsened after receiving Shingrix.  She also stated that her issue with smelling smoke affects her appetite and she was wakening up at night because she was smelling smoke.  She also shared that, she received her booster shot for Covid two months before receiving Shingrix and that the sensitivity/tenderness with the Covid shot was 10 times worse than it was with Shingrix. The reporter declined to provide additional information. The reporter did not consent to follow-up. Additional Supportive Information: The case had been linked to US2022100573,reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022100573:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: late for the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on November 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 05-JUL-2022 Reporter's Comments: The pharmacist reported that a patient was late for the second dose of Shingrix.  No adverse event was reported.  Only 1st dose was administered, no patient's identifiers provided. No LOT number and expiration date were provided. No vaccination date was provided. The reporter consented to follow up. Additional supportive information: As the patient received only first dose and now late for second dose, which led to incomplete course of vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnic origin. Initial information was processed with additional information received from Regulatory Authority on 06-JUL-2022. The patient's height, and weight were not reported. The patient's past medical history included: cancer (3 time cancer survivor). Concurrent conditions included congestive heart failure and had some other issues. Patient was allergic to Polyethelene glycol 100 and possibly Polysorbate 80. The patient previously received two doses of covid-19 vaccine (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of administration not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, administered on an unspecified date for prophylactic vaccination. It was unspecified whether patient had experienced any adverse events following vaccination with covid-19 vaccine (dose number in series 1). The patient additionally received booster of company suspect covid-19 vaccine ad26.cov2.s (dose number in series 2) (form of admin not reported, route of admin not reported, batch number: 213A21A, expiry: unknown) dose, start therapy date were not reported, 1 total administered on an unspecified date for prophylactic vaccination. Concomitant medications included palbociclib for cancer. On an unspecified date, patient contracted Covid (suspected covid-19 infection and suspected clinical vaccination failure) two months after the first booster (dose number in series 2). It was a severe case but patient was able to get the monoclonal antibody infusion. Patient felt that the vaccine offered some protection from more severe illness and the earlier forms of the Covid. The action taken with covid-19 vaccine was not applicable. The outcome of suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed. This report was associated with product quality complaint: 90000239586.; Sender's Comments: V0:20220664235-Covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure . The event(s) has compatible/suggestive 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. V0:20220664235-Covid-19 vaccine ad26.cov2.s- Suspected covid-19 infection. The event(s) has a compatible/suggestive 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: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: FATIGUE; ARM SORENESS AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 73 year old female. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported and batch number: 1805018, expiry: 20-JAN-2022) dose was not reported, 1 total administered to left arm on 16-MAR-2021 for prophylactic vaccination. The patient had fatigue and arm soreness at the injection site following vaccination with first dose of covid-19 vaccine ad26. cov2. s (Dose number in series 1). The patient recovered from fatigue, and arm soreness at the injection site. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822811 expiry: 17-AUG-2022) dose was not reported, 1 total administered to left arm on 05-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, (dose number in series 2) the patient experienced fatigue and arm soreness at the injection site (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fatigue, and arm soreness at the injection site. This report was non-serious. This case, involving the same patient is linked to 20220702519.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: LITTLE BIT SORE; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient previously received with 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 was not reported, 1 total administered on an unspecified date in MAY-2021 for prophylactic vaccination. The patient had zero symptoms following vaccination with first dose of covid-19 vaccine ad26.cov2.s (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 was not reported, 1 total administered on NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced little bit sore after receiving his booster dose (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little bit sore was not reported. This report was non-serious.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test negative, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINE FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 26 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: Polycystic ovarian syndrome (PCOS), and allergy (Bo), and other pre-existing medical conditions included: The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, 1 total administered on 06-MAR-2021 for prophylactic vaccination. Age at time of vaccination 25 years old. No concomitant medications were reported.  The patient additional received non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (Dose number in series 2) (form of admin, and route of admin were not reported, batch number: 031H21A, expiry: UNKNOWN) dose was not reported, administered on 17-NOV-2021 to left arm for prophylactic vaccination. On an unspecified date, the patient experienced covid-19 infection for which patient received Paxlovid as a treatment (coded as confirmed covid-19 infection) (dose number in series 2) which led to confirmed clinical vaccination failure (dose number in series 1). The patient received non-company co-suspect drug Paxlovid (form of administration, route of administration, batch number, and expiry were not reported) dose was not reported, administered from 17-JUN-2022 to 21-JUN-2022 for treatment of COVID-19. The patient was not receiving any other medications/products within 2 weeks of starting COVID-19 treatment. It was reported that, the patient tested negative on the last day (21-JUN-2022) of Paxlovid treatment, 3 days later (as of 24-JUN-2022) the symptoms came back overnight and then tested positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable, elasomeran (Moderna Covid-19 Vaccine) was not applicable and with Paxlovid was drug discontinued. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint, and reference number requested.; Sender's Comments: V0:20220713757-covid-19 vaccine ad26.cov2.s- confirmed clinical vaccination failure. The event(s) has a compatible/suggestive 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.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 TEST POSITIVE; This spontaneous report received from a consumer concerned a female of unspecified age.  The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported 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 covid-19 test positive. Laboratory data (dates unspecified) included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious. This report was associated with product quality complaint: 90000241343.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: we vaccinated patient with expired medication; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (we vaccinated patient with expired medication) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 067H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (we vaccinated patient with expired medication). At the time of the report, EXPIRED PRODUCT ADMINISTERED (we vaccinated patient with expired medication) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-600773, US-MODERNATX, INC.-MOD-2022-600743, US-MODERNATX, INC.-MOD-2022-600769, US-MODERNATX, INC.-MOD-2022-600775 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2022: Follow up received included patient details added hence report type changed to spontaneous from invalid case.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-600773:Same reporter US-MODERNATX, INC.-MOD-2022-600769:Same reporter US-MODERNATX, INC.-MOD-2022-600743:Same reporter US-MODERNATX, INC.-MOD-2022-600775:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Confusional state, Fatigue, Illness
Clinical narrative: Confusion; Very Sick; no energy; High Fever over 103; Fatigue; Vomiting; This spontaneous case was reported by a non-health professional and describes the occurrence of CONFUSIONAL STATE (Confusion), ILLNESS (Very Sick), ASTHENIA (no energy), PYREXIA (High Fever over 103) and FATIGUE (Fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Encephalopathy on 16-Sep-2019, Drug overdose on 16-Sep-2019, Drug overdose on 15-Sep-2019 and MRI brain abnormal on 21-Sep-2019. Concurrent medical conditions included Bipolar disorder since 21-Sep-2019. Concomitant products included QUETIAPINE FUMARATE (SEROQUEL), CLONIDINE HYDROCHLORIDE (CATAPRES [CLONIDINE HYDROCHLORIDE]), SALBUTAMOL SULFATE (VENTOLIN HFA) and NALOXONE HYDROCHLORIDE (NARCAN) for an unknown indication.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONFUSIONAL STATE (Confusion), ILLNESS (Very Sick), ASTHENIA (no energy), PYREXIA (High Fever over 103), FATIGUE (Fatigue) and VOMITING (Vomiting). At the time of the report, CONFUSIONAL STATE (Confusion), ILLNESS (Very Sick), ASTHENIA (no energy), PYREXIA (High Fever over 103), FATIGUE (Fatigue) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 High fever. On an unknown date, SARS-CoV-2 test: Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medication information was provided.   This case was linked to MOD-2022-599461 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: Confusion; Very Sick; no energy; High Fever over 103; Fatigue; Vomiting; This spontaneous case was reported by a non-health professional and describes the occurrence of CONFUSIONAL STATE (Confusion), ILLNESS (Very Sick), ASTHENIA (no energy), PYREXIA (High Fever over 103) and FATIGUE (Fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Encephalopathy on 16-Sep-2019, Drug overdose on 16-Sep-2019, Drug overdose on 15-Sep-2019 and MRI brain abnormal on 21-Sep-2019. Concurrent medical conditions included Bipolar disorder since 21-Sep-2019. Concomitant products included QUETIAPINE FUMARATE (SEROQUEL), CLONIDINE HYDROCHLORIDE (CATAPRES [CLONIDINE HYDROCHLORIDE]), SALBUTAMOL SULFATE (VENTOLIN HFA) and NALOXONE HYDROCHLORIDE (NARCAN) for an unknown indication.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONFUSIONAL STATE (Confusion), ILLNESS (Very Sick), ASTHENIA (no energy), PYREXIA (High Fever over 103), FATIGUE (Fatigue) and VOMITING (Vomiting). At the time of the report, CONFUSIONAL STATE (Confusion), ILLNESS (Very Sick), ASTHENIA (no energy), PYREXIA (High Fever over 103), FATIGUE (Fatigue) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 High fever. On an unknown date, SARS-CoV-2 test: Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medication information was provided.   This case was linked to MOD-2022-599461 (Patient Link).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of accidental underdose (given 0.25mL dose instead of the 0.5mL for the first full dose) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 017B22A) for COVID-19 immunization. No medical history reported. On Jul 1, 2022, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; .25 milliliter. On Jul 1, 2022, patient experienced accidental underdose (given 0.25mL dose instead of the 0.5mL for the first full dose). At the time of the report, accidental underdose (given 0.25mL dose instead of the 0.5mL for the first full dose) outcome unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reporter would like to know if he should restart the first dose, or start the second dose.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid-19) 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.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Jun-2022, the patient experienced COVID-19 (covid-19). At the time of the report, COVID-19 (covid-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jun-2022, SARS-CoV-2 test: (Positive) Positive. On 25-Jun-2022, SARS-CoV-2 test: (Negative) Negative.         No Concomitant medication reported.  It had been reported that Symptoms included fever, sore throat, a scratchy cough, body aches, hip pain, and back pain.  It was reported that They started feeling better around the 24th or 25th of June.  No Treatment medication reported.  Company comment: This is a spontaneous case concerning a male patient of unknown age with no reported medical history. Patient has vaccination history of receiving first and second dose of mRNA-1273 vaccine with unknown dosage interval. Patient experienced the unexpected non-serious AESI event of Covid-19. The event occurred approximately 6 to 7 months after the first booster dose of mRNA-1273 vaccine administration with positive Covid-19 test result. It was reported that after 6 to 7 days, patient felt better and tested negative for Covid-19 at the same time. No other information surrounding the event was reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-600557 (E2B Linked Report).; Sender's Comments: This is a spontaneous case concerning a male patient of unknown age with no reported medical history. Patient has vaccination history of receiving first and second dose of mRNA-1273 vaccine with unknown dosage interval. Patient experienced the unexpected non-serious AESI event of Covid-19. The event occurred approximately 6 to 7 months after the first booster dose of mRNA-1273 vaccine administration with positive Covid-19 test result. It was reported that after 6 to 7 days, patient felt better and tested negative for Covid-19 at the same time. No other information surrounding the event was reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-600557:MOD22-017743
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: got covid in Apr2022 after getting their booster shot; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (got covid in Apr2022 after getting their booster shot) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A, 010M20A and 025L20A) for COVID-19 vaccination.     The patient did not had any allergies.  Concurrent medical conditions included Atrial fibrillation (several year).   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced COVID-19 (got covid in Apr2022 after getting their booster shot). At the time of the report, COVID-19 (got covid in Apr2022 after getting their booster shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2022, SARS-CoV-2 test: (Positive) Positive.         Concomitant medication included heart medication that was not specified.  No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  The event did not cause patient to seek medical care. The patient did not experienced a similar event in the past.  The patient received a monocluid antibody Bebteloviamab.  Company Comment: This spontaneous case concerns an 80-year-old, female patient with no reported relevant medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19. The event occurred approximately 5 months after completion of mRNA-1273 as primary series vaccination and as first booster dose. Circumstances leading to the event and presenting symptoms were not provided in the case, although the patient mentioned this did not require her to be hospitalized. She was treated with Bebtelovimab and recovered from the event after an unknown duration. The patient's advanced age remains a confounder for contracting the infection. The benefit-risk relationship of mRNA-1273 is not affected by this report; Sender's Comments: This spontaneous case concerns an 80-year-old, female patient with no reported relevant medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19. The event occurred approximately 5 months after completion of mRNA-1273 as primary series vaccination and as first booster dose. Circumstances leading to the event and presenting symptoms were not provided in the case, although the patient mentioned this did not require her to be hospitalized. She was treated with Bebtelovimab and recovered from the event after an unknown duration. The patient's advanced age remains a confounder for contracting the infection. The benefit-risk relationship of mRNA-1273 is not affected by this report
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills
Clinical narrative: chills for 6 hours; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills for 6 hours) in a 59-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 15-Jun-2022, the patient experienced CHILLS (chills for 6 hours). On 15-Jun-2022, CHILLS (chills for 6 hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2022, Body temperature: high.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication were reported.  Patient stated that one hour after the vaccination, got a temperature and chills for 6 hours. And that patient would be getting their second dose on the 6-Jul-2022 .    No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Product administration interrupted
Clinical narrative: First Moderna primary series dose three months ago and now would like to receive the second Moderna primary series dose; This spontaneous case was reported by a physician assistant and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (First Moderna primary series dose three months ago and now would like to receive the second Moderna primary series dose) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (First Moderna primary series dose three months ago and now would like to receive the second Moderna primary series dose). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (First Moderna primary series dose three months ago and now would like to receive the second Moderna primary series dose) outcome was unknown.        mRNA-1273 (Spikevax) (Intramuscular) dosing was interrupted on an unknown date.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient received their first Moderna primary series dose three months ago and now would like to receive the second Moderna primary series dose. No treatment medications were reported.   Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The Moderna covid19 vaccine was on the 2Feb2021 and second dose was on the 23Marc2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The Moderna covid19 vaccine was on the 2Feb2021 and second dose was on the 23Marc2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 006M20A) for COVID-19 vaccination.     No medical history and allergies were reported by the reporter.  Concomitant products included PROPRANOLOL, TICAGRELOR (BRILINTA), LOSARTAN, ASPIRIN [ACETYLSALICYLIC ACID], BUSPIRONE, VITAMIN D [VITAMIN D NOS], MONTELUKAST, CITALOPRAM, FISH OIL, LORAZEPAM, MULTIVITAMINS [VITAMINS NOS], ESTROGENS CONJUGATED (PREMARIN) and ROSUVASTATIN for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The Moderna covid19 vaccine was on the 2Feb2021 and second dose was on the 23Marc2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The Moderna covid19 vaccine was on the 2Feb2021 and second dose was on the 23Marc2021) outcome was unknown.            Patient didn't have COVID-19 test or diagnosis previously.  Patient went to the cardiologist on 06-Jun-2022 for treatment.     This case was linked to MOD-2022-600726 (Patient Link).