chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not getting her 2nd dose of SHINGRIX; This non-serious case was reported by a nurse via sales rep and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: not getting her 2nd dose of SHINGRIX). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 19-Jul-2023 The reporter was a field representative that was at a work related lunch gathering.   The reporter stated at lunch a nurse practitioner reported that she was not getting her 2nd dose of Shngrix due to an adverse event that another nurse practitioner, that works in her practice, experienced.   No further information available at this time. The reporter consented to follow up. The case was linked with case US2023099652, reported by the same reporter for different patient. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2023099652:same reporter, different patient
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema
Clinical narrative: raised area approximately 5 inches in diameter; Large red area at injection site 5 inches in diameter; This non-serious case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAR-2023, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb (Verbatim: raised area approximately 5 inches in diameter) and injection site erythema (Verbatim: Large red area at injection site 5 inches in diameter). The outcome of the extensive swelling of vaccinated limb and injection site erythema were resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to Shingrix.   It was unknown if the company considered the extensive swelling of vaccinated limb and injection site erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-JUL-2023 The reporter asked if she should get her 2nd Shingrix dose. She reported that following her first dose in March 2023 she had a red, raised area approximately 5 inches in diameter that lasted 2 to 3 weeks. The patient did not have the doctor's contact information.  The reporter tried a quick internet search but found nothing. The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Carpal tunnel syndrome, Pain in extremity
Clinical narrative: Carpal Tunnel Syndrome in both hands; lot of pain in both hands; This non-serious case was reported by a consumer via call center representative and described the occurrence of carpal tunnel syndrome in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-APR-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid) .5 ml. In MAY-2023, 6 weeks after receiving Shingrix, the patient experienced carpal tunnel syndrome (Verbatim: Carpal Tunnel Syndrome in both hands) and pain in hand (Verbatim: lot of pain in both hands). The outcome of the carpal tunnel syndrome and pain in hand were not resolved.   It was unknown if the reporter considered the carpal tunnel syndrome and pain in hand to be related to Shingrix.     It was unknown if the company considered the carpal tunnel syndrome and pain in hand to be related to Shingrix.   Additional Information: GSK Receipt date: 19-JUL-2023 The reporter reported that patient received her first Shingrix vaccine later patient developed Carpal Tunnel Syndrome in both hands and also reported patient was on a lot of pain in both hands.  The reporter reported that the patient left hand was going to be operated on 17th August 2023, the other hand would be operated on later.  The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Shingrix + Late 2nd dose; This non-serious case was reported by a physician 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 5 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Shingrix + Late 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date 19 Jul 2023: The physician was  wondering if a patient had started the 1 shot series and forgot to get the second and it had been 5 years. The reporter asked if the patient had to restart the entire series? Till the time of reporting the patient did not receive 2nd dose of shingrix which led to incomplete course of vaccination.
Sex: U
Vaccine: MENB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Early 2nd dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Men B NVS (Bexsero) for prophylaxis.   Concomitant products included MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO).   On 30-JUN-2023, the patient received the 2nd dose of Bexsero. On 30-JUN-2023, an unknown time after receiving Bexsero and an unknown time after receiving BEXSERO, the patient experienced drug dose administration interval too short (Verbatim: Early 2nd dose). The outcome of the drug dose administration interval too short 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: 20-JUL-2023 A nurse reported that a patient received the first dose of Bexsero back in 22 June 2023, received the second dose on 30 June 2023.  The reporter did not consent to follow-up. The patient received early the 2nd dose which led to Drug dose administration interval too short.
Sex: U
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, raised area 3 inches in diameter around injection site; Red, raised area 3 inches in diameter around injection site; This non-serious case was reported by a physician via sales rep and described the occurrence of injection site swelling in a 11-year-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo (intramuscular, unknown arm). On an unknown date, an unknown time after receiving Menveo, the patient experienced injection site swelling (Verbatim: Red, raised area 3 inches in diameter around injection site) and injection site erythema (Verbatim: Red, raised area 3 inches in diameter around injection site). The outcome of the injection site swelling and injection site erythema were unknown.   It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to Menveo.     It was unknown if the company considered the injection site swelling and injection site erythema to be related to Menveo.   Additional Information: GSK Receipt Date: 20-JUL-2023 The reporter consented to follow up.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Inappropriate Reconstitution Technique/administered the vaccine diluent/adjuvant was without active component; Inappropriate Reconstitution Technique/administered the vaccine diluent/adjuvant was without active component; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number 432BC, expiry date 25-OCT-2024) for prophylaxis.   On 20-JUL-2023, the patient received the 2nd dose of Shingrix (intramuscular). On 20-JUL-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Inappropriate Reconstitution Technique/administered the vaccine diluent/adjuvant was without active component) and inappropriate dose of vaccine administered (Verbatim: Inappropriate Reconstitution Technique/administered the vaccine diluent/adjuvant was without active component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date 19 Jul 2023: The reporter was an HCP/pharmacist. The reporter stated that there was an error with a Shingrix vaccine administration. The vaccine was not premix before providing the second dose. The reporter stated that patient was administered the vaccine diluent/adjuvant was without active component. The reporter consented to follow up. The patient was administered the vaccine diluent/adjuvant was without active component which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only received the adjuvant only for the 2nd dose of Shingrix; only received the adjuvant only for the 2nd dose of Shingrix; 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 the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: only received the adjuvant only for the 2nd dose of Shingrix) and inappropriate dose of vaccine administered (Verbatim: only received the adjuvant only for the 2nd dose of Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-JUL-2023 The patient only received the adjuvant only for the 2nd dose of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No reactions were reported. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: Severe fatigue; Extreme body ache; This non-serious case was reported by a physician via sales rep and described the occurrence of fatigue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-JUL-2023, the patient received the 1st dose of Shingrix. On 18-JUL-2023, 1 days after receiving Shingrix, the patient experienced fatigue (Verbatim: Severe fatigue) and general body pain (Verbatim: Extreme body ache). The outcome of the fatigue and general body pain were resolving.   It was unknown if the reporter considered the fatigue and general body pain to be related to Shingrix.     It was unknown if the company considered the fatigue and general body pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-JUL-2023 The reporter reported that the patient received Shingrix vaccine and experienced adverse reaction. The patient had severe fatigue and extreme body ache 1 day after received vaccination. The reporter stated that on 20th July 2023 the patient was mentioned that she felt much better . The reporter did not provided patient information like initials and age nor the data about the Shingrix vaccine lot number and expiry date. The reporter did consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea
Clinical narrative: Shortness of Breath; This non-serious case was reported by a physician via sales rep and described the occurrence of shortness of breath in a male 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 shortness of breath (Verbatim: Shortness of Breath). The outcome of the shortness of breath was resolved.   It was unknown if the reporter considered the shortness of breath to be related to Shingrix.  It was unknown if the company considered the shortness of breath to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-JUL-2023 The reporter called to report an adverse event for her healthcare professional that she learned of at close of day yesterday.  The reporter reported that the healthcare professional stated that one of her patient received a Shingrix vaccine and after he left the office, he experienced a lot of shortness of breath. The reporter said that the patient drove himself to the ER where he was checked out and was fine (No other information was known). Minimal information was available. The reporter consented to follow up.
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Condition aggravated, Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Oral Suspension intramuscularly; left leg thigh area is red; Warm to the touch; lump that has grown since the injection; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number nl2rk, expiry date 18-FEB-2025) for prophylaxis.   Concurrent medical conditions included injection site lump.   On 19-JUL-2023, the patient received Rotarix lyophilized formulation (intramuscular, left thigh). In JUL-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced injection site erythema (Verbatim: left leg thigh area is red), injection site warmth (Verbatim: Warm to the touch) and condition aggravated (Verbatim: lump that has grown since the injection). On 19-JUL-2023, the patient experienced inappropriate route of vaccination (Verbatim: Oral Suspension intramuscularly). The outcome of the injection site erythema, injection site warmth, condition aggravated and inappropriate route of vaccination were unknown.   It was unknown if the reporter considered the injection site erythema, injection site warmth and condition aggravated to be related to Rotarix lyophilized formulation and Rotarix Pre-Filled Unspecified Oral Administration Device.     It was unknown if the company considered the injection site erythema, injection site warmth and condition aggravated to be related to Rotarix lyophilized formulation and Rotarix Pre-Filled Unspecified Oral Administration Device.   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: 21-JUL-2023 The reporter was the mother of the patient. The reporter reported that the patient received Rotarix oral suspension in her left thigh by intramuscular route which led to, inappropriate route of vaccination. The reporter stated that her left thigh area was red, warm to the touch and there was a lump that had grown since the injection was administered. The reporter did consent to follow up.
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Dose Administered/ expired dose of Bexsero was administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number ABXC08AA, expiry date 31-MAR-2023) for prophylaxis.   On 21-JUL-2023, the patient received Bexsero. On 21-JUL-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired Dose Administered/ expired dose of Bexsero was administered to a patient). 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: 21-Jul-2023 The nurse declined to provide patient details with permission and also became disconnected from the call before being able to provide any additional details (also wanted to remain anonymous).  The reporter consented to follow-up. The patient received an expired dose of Bexsero, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: she was administered the first dose of Shingrix back in 2020; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: she was administered the first dose of Shingrix back in 2020). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 21-JUL-2023 The reporter called on behalf of herself to inform that she had not received the 2nd dose of Shingrix yet. The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 52.0
Sex: F
Vaccine: HEPAB, VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: patient received an early 3rd dose of Twinrix when folowing the standard schedule; Extra dose administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 52-year-old female patient who received HAB (Twinrix) (batch number 2pg39, expiry date 19-SEP-2025) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 924E7, expiry date 18-AUG-2024) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX), HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX) and VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 21-JUL-2023, the patient received the 3rd dose of Twinrix and the 3rd dose of Shingrix. On 21-JUL-2023, an unknown time after receiving Twinrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: patient received an early 3rd dose of Twinrix when folowing the standard schedule) and extra dose administered (Verbatim: Extra dose administered). The outcome of the drug dose administration interval too short and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US-GSK-US2023100587   Additional Information: GSK Receipt Date: 21-JUL-2023 Registered nurse reported that patient received an early 3rd dose of Twinrix when following the standard schedule.  The patient received 1st dose on 19th May 2023 and 2nd dose 23rd June 2023. On 21 July 2023, the patient received the 3rd dose of Twinrix which led to shortening of vaccinations schedule. The patient that received the 2nd dose of Shingrix on 23rd June 2023 and received a third dose on 21st July 2023, which led to extra dose administered. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: expired dose administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 07-MAY-2023) for prophylaxis.   On 21-JUL-2023, the patient received Kinrix. On 21-JUL-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: expired dose administered). 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: 21-JUL-2023 Nurse stated that a patient today was administered an expired dose of Kinrix, which led to expired vaccine used. Permission for follow-up was not asked,
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: patient received an expired dose of boostrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 31-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number HF2YA, expiry date 15-JUL-2023) for prophylaxis.   On 24-JUL-2023, the patient received Boostrix (left deltoid). On 24-JUL-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: patient received an expired dose of boostrix). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt date: 24-JUL-2023 A pharmacist reported that a patient received an expired dose of boostrix which led to expired vaccine used.  The reporter consented to follow up.
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: Maternal exposure during pregnancy, No adverse event
Clinical narrative: Maternal exposure during pregnancy; No adverse event; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and NO ADVERSE EVENT (No adverse event) in a 31-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved 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 assessment was provided for MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy).    Concomitant and treatment medications were not reported.  Index number was reported as MONU2257.  Company comment: This is a spontaneous case concerning a 31-year-old female patient with no medical history reported, who experienced the unexpected non-serious events of maternal exposure during pregnancy and no adverse event. The events occurred after the fourth dose of mRNA-1273.222 vaccine. No information disclosed about diagnostic tests performed or treatments received. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report. Events seriousness assessed as reported.     Reporter did not allow further contact; Reporter's Comments: This is a spontaneous case concerning a 31-year-old female patient with no medical history reported, who experienced the unexpected non-serious events of maternal exposure during pregnancy and no adverse event. The events occurred after the fourth dose of mRNA-1273.222 vaccine. No information disclosed about diagnostic tests performed or treatments received. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report. Events seriousness assessed as reported.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Illness, Nasopharyngitis, Pain in extremity
Clinical narrative: Sore arm; Bad cold; Sickness; covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19), PAIN IN EXTREMITY (Sore arm), NASOPHARYNGITIS (Bad cold) and ILLNESS (Sickness) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A, 00787721, 011F21A and 006M21A) for COVID-19 prophylaxis.     The patient's past medical history included Heart disorder. Concurrent medical conditions included Thyroid disorder.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Aug-2022, received fourth 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 (covid 19). In December 2022, the patient experienced ILLNESS (Sickness). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and NASOPHARYNGITIS (Bad cold). At the time of the report, COVID-19 (covid 19), PAIN IN EXTREMITY (Sore arm), NASOPHARYNGITIS (Bad cold) and ILLNESS (Sickness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details not reported by the reporter. It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that the patient only had a sore arm each time he had received the shot. The reporter did not know which arm he received the vaccine in and how long his sore arm lasted for. However, he never tested himself for COVID so the reporter  was unsure if had COVID again at that time.  Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-733911 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2023: Live followup received contains updated batch no and administration date.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733911:Bivalent case
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dysstasia, Hypoaesthesia
Clinical narrative: The second Covid booster completely knocked her out, she clarified as she could not feel her hands and could not stand up; The second Covid booster completely knocked her out, she clarified as she could not feel her hands and could not stand up; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (The second Covid booster completely knocked her out, she clarified as she could not feel her hands and could not stand up) and HYPOAESTHESIA (The second Covid booster completely knocked her out, she clarified as she could not feel her hands and could not stand up) in a 52-year-old female 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 Multiple sclerosis. Concomitant products included OCRELIZUMAB (OCREVUS), LORATADINE (CLARITIN [LORATADINE]), CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) and MAGNESIUM for an unknown indication.    In October 2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSSTASIA (The second Covid booster completely knocked her out, she clarified as she could not feel her hands and could not stand up) and HYPOAESTHESIA (The second Covid booster completely knocked her out, she clarified as she could not feel her hands and could not stand up). At the time of the report, DYSSTASIA (The second Covid booster completely knocked her out, she clarified as she could not feel her hands and could not stand up) and HYPOAESTHESIA (The second Covid booster completely knocked her out, she clarified as she could not feel her hands and could not stand up) outcome was unknown.            Patient received 2 Covid Vaccines and 2 boosters. Patient had the first vaccine on 17-Mar-2021, the second vaccine on 14-Apr-2021, the first booster on 04-Nov-2021 and the second booster on -Oct-2022.   The second Covid booster completely knocked her out, then it was clarified as she could not feel her hands and could not stand up, she stated it did its job, kept her out of the hospital but it was rough for 24 hours.   It was reported that all the vaccines were Moderna.  Treatment Medication use information was not provided by reporter.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Patient tested positive for Covid after more than 15 days of receiving second dose of Moderna COVID-19 vaccine; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION FAILURE (Patient tested positive for Covid after more than 15 days of receiving second dose of Moderna COVID-19 vaccine) and COVID-19 (COVID-19) in a 40-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 047B21A and 003821A) for COVID-19 prophylaxis.     Patent had no acute illnesses at the time of vaccination and upto one month before. It was unknown if patient had any chronic long-standing health conditions at the time of vaccination or not.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced VACCINATION FAILURE (Patient tested positive for Covid after more than 15 days of receiving second dose of Moderna COVID-19 vaccine) and COVID-19 (COVID-19). At the time of the report, VACCINATION FAILURE (Patient tested positive for Covid after more than 15 days of receiving second dose of Moderna COVID-19 vaccine) and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Nov-2021, SARS-CoV-2 test: (Positive) test done in hospital.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient's race was reported as North American Indian/Inuit/Meitis.  No treatment medications were reported. Company comment- This vaccination failure spontaneous case concerns a 40-year-old male patient with no medical history reported, who experienced the non-serious unexpected event COVID-19 approximately 6 months after receiving a second dose of mRNA-1273 vaccine. First and second doses of mRNA-1273 vaccine were administered in an appropriate schedule of vaccination. Patient tested positive for COVID-19 test. No further clinical information was provided for medical reviewing. The benefit risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2023-730391 (Patient Link).
Age: 71.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient given expired dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given expired dose) and NO ADVERSE EVENT (No adverse event) in a 71-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Jun-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 08-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given expired dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient given expired dose) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient given expired dose).    No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was provided.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine used; no adverse event; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (no adverse event) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    Concomitant medication was not provided. Patient was given expired dose, contacted Moderna lot analysis and determined  that vaccine maintained the activity necessary to protect. For bivalent, the date moved to refrigeration was on June 7, 2023 and published expiration date was May 23, 2023, the date of administration was June 8, 2023 for Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) Lot: 010H22A The date moved to refrigeration was June 7, 2023, published expiration date was May 30, 2023 and date of administration: June 8, 2023 for Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) Lot: 019H22A The below are Lot that were put in fridge to thaw and Administered 010H22Awas thaw on 07 Jun 2023 and administered on 08 Jun 2023  For 015B22A thaw on 08 Mar 2023 and administer on 09 Mar 2023 For 015B22A thaw and administer on 22 Mar 2023 For 015B22A thaw on 10 Apr 2023 For 015B22A thaw on 10 Apr 2023 and administer on 13 Apr 2023. For 015B22A thaw on 12 Apr 2023 and administer on 13 Apr 2023. For 019H22A thaw on 07 Jun 2023 and administer on 08 Jun 2023 Later mail was received, for lot 015B22A was put in fridge on 22 Mar 2023 and administered on 23 Mar 2023. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732753, US-MODERNATX, INC.-MOD-2023-732768 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-Jul-2023: Live follow-up received iNarrative updated On 11-Jul-2023: Live follow-up received iNarrative updated On 21-Jul-2023: Follow up received and added patient details, added suspect dosage information, updated narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732753:Bivalent (MOD-2023-732749 - Monovalent) US-MODERNATX, INC.-MOD-2023-732768:Bivalent case ( (MOD-2023-732749 - Monovalent))
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Cough, Fatigue, Loss of personal independence in daily activities
Clinical narrative: dry cough; off colored phlegm; he cannot go through his usual activities; soreness; slight temperature; tiredness; covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19), COUGH (dry cough), SPUTUM DISCOLOURED (off colored phlegm), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (he cannot go through his usual activities) and PAIN (soreness) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013B22A, 030L20A, 011A21A and 012H21B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Pain: HYDROCODONE. Past adverse reactions to the above products included No adverse event with HYDROCODONE. Concurrent medical conditions included Blood pressure high and Intervertebral disc bulging.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jul-2023, the patient experienced COVID-19 (covid 19). On an unknown date, the patient experienced COUGH (dry cough), SPUTUM DISCOLOURED (off colored phlegm), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (he cannot go through his usual activities), PAIN (soreness), PYREXIA (slight temperature) and FATIGUE (tiredness). At the time of the report, COVID-19 (covid 19), COUGH (dry cough), PAIN (soreness), PYREXIA (slight temperature) and FATIGUE (tiredness) was resolving and SPUTUM DISCOLOURED (off colored phlegm) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (he cannot go through his usual activities) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jul-2023, SARS-CoV-2 test: Positive. On an unknown date, Body temperature: 100 degree Celsius hardly 100 degrees.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was taking blood pressure medication as concomitant medication. Treatment details was not reported by the reporter.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test, Sputum discoloured
Clinical narrative: dry cough; off colored phlegm; he cannot go through his usual activities; soreness; slight temperature; tiredness; covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19), COUGH (dry cough), SPUTUM DISCOLOURED (off colored phlegm), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (he cannot go through his usual activities) and PAIN (soreness) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013B22A, 030L20A, 011A21A and 012H21B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Pain: HYDROCODONE. Past adverse reactions to the above products included No adverse event with HYDROCODONE. Concurrent medical conditions included Blood pressure high and Intervertebral disc bulging.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jul-2023, the patient experienced COVID-19 (covid 19). On an unknown date, the patient experienced COUGH (dry cough), SPUTUM DISCOLOURED (off colored phlegm), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (he cannot go through his usual activities), PAIN (soreness), PYREXIA (slight temperature) and FATIGUE (tiredness). At the time of the report, COVID-19 (covid 19), COUGH (dry cough), PAIN (soreness), PYREXIA (slight temperature) and FATIGUE (tiredness) was resolving and SPUTUM DISCOLOURED (off colored phlegm) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (he cannot go through his usual activities) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jul-2023, SARS-CoV-2 test: Positive. On an unknown date, Body temperature: 100 degree Celsius hardly 100 degrees.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was taking blood pressure medication as concomitant medication. Treatment details was not reported by the reporter.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient given expired dose, contacted Moderna, lot analysis determined vaccine maintained the activity necessary to protect.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given expired dose, contacted Moderna, lot analysis determined vaccine maintained the activity necessary to protect.) and NO ADVERSE EVENT (No adverse event) in a 40-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 23-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given expired dose, contacted Moderna, lot analysis determined vaccine maintained the activity necessary to protect.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient given expired dose, contacted Moderna, lot analysis determined vaccine maintained the activity necessary to protect.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient given expired dose, contacted Moderna, lot analysis determined vaccine maintained the activity necessary to protect.).    Concomitant medications were not reported.  Patient was given expired dose.  It was unknown if the patient experienced any additional symptoms/events.   Treatment information was not reported.
Age: 21.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 21-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 23-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    Concomitant medication was not reported. Patient given expired dose, contacted Moderna, lot analysis determined vaccine maintained the activity necessary to protect. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.
Age: 30.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient given expired dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given expired dose) and NO ADVERSE EVENT (No adverse event) in a 30-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Mar-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 09-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given expired dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient given expired dose) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient given expired dose).    Concomitant medication was not reported. Patient given expired dose, contacted Moderna, lot analysis determined vaccine maintained the activity necessary to protect. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.
Age: 22.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Patient given expired dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given expired dose) and NO ADVERSE EVENT (no adverse event) in a 22-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.  In 2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. In 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given expired dose). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient given expired dose) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient given expired dose).    Concomitant product use was not provided by the reporter.  Patient given expired dose. It was unknown if the patient experienced any additional symptoms/events.  Treatment information was not provided.