chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Cardiac imaging procedure, Cardiac monitoring, Cerebrovascular accident, Dysstasia, Magnetic resonance imaging head abnormal
Clinical narrative: 1st symptoms were weakness in left arm and barely could stand up.  Patient did not seek treatment right away,.  symptoms lasted 48-72 hours.
Age: 77.0
Sex: M
Vaccine: COVID19-2, FLU4
Symptoms: Muscular weakness, Scan with contrast, Ultrasound Doppler
Clinical narrative: 1st symptoms were weakness in left arm and barely could stand up.  Patient did not seek treatment right away,.  symptoms lasted 48-72 hours.
Age: 0.5
Sex: U
Vaccine: COVID19-2, DTAPIPVHIB, PNC15, RV5
Symptoms: Irritability postvaccinal, Vaccination site bruising
Clinical narrative: Irritability for a day and a half after vaccines; VACCINATION SITE BRUISING; This spontaneous report was received from a nurse via other company and referred to a 6-month-old patient. The patient's medical history included cough. The patient's concurrent conditions were not provided. Concomitant medications included vitamin D NOS. It was reported that the patient was never been diagnosed with/ tested positive for COVID-19.  On 09-JUN-2023, the patient was vaccinated with third dose of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 1 dosage form, lot #W039033, expiration date was not provided but upon internal validation established as 01-OCT-2024, administered intramuscularly for prophylaxis (strength and anatomical location was not provided) and third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 dosage form, lot #W036464, expiration date was not provided but upon internal validation established as 24-MAR-2024, administered orally for prophylaxis (strength was not provided); and third dose of diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), 1 dosage form, lot# UJ786AA, administered intramuscularly (strength, formulation, expiry date, and indication were not provided).  On 09-JUN-2023 at 15:22, the patient was also vaccinated with first dose of davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) injection, 0.25 milliliter, lot# AS7185B, administered for COVID-19 prophylaxis (strength, expiry date, and route of administration were not provided).  On an unknown date in June 2023, the patient experienced irritability for a day and a half after vaccines (Irritability postvaccinal), vaccination site bruising (some bruising on the right thigh where the patient received diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL) and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE)).   At the time of the report, the outcome of all events was reported as recovered. No treatment medication was provided.  The causal relationship between all events and all suspect vaccines was not provided.
Age: 31.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Pain, Pain in extremity, Product use in unapproved indication, Sleep disorder
Clinical narrative: indication:HPV; the area of injection being very hot; pain in her arm; injection site pain; wakes her up at night.; This spontaneous report was received from a 31-year-old female patient and referred to herself. The patient's medical history was not reported. The patient was allergy to egg and glutem. Concomitant therapies were not reported.  On 23-JAN-2024, the patient was vaccinated with pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) injection, administered for papilloma viral infection (hpv) (strength, dose, anatomical location, lot #, expiry date, and route of administration were not provided) (Product use in unapproved indication).  The patient called inquiring about the pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) and its ingredients.  During call patient started talking about how she had the injection on 23-JAN-2024 and still has pain in her arm as well as the area of injection being very hot (Pain in extremity; Vaccination site warmth). She said it feels like a 'bee sting'. She indicated that the injection site pain wakes her up at night (Vaccination site pain; Poor quality sleep).  She provided only her first name and no other demographics and no other information. No health care professional (HCP) information given. No letter to be sent.  The patient had sought medical attention but received no treatment.  At the time of reporting, the outcome of all events was unknown. The causal relationship between all events and pneumococcal 23v polysaccharide vaccine (PNEUMOVAX23) was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE, no PQC; Nurse reported VARIVAX was administered after a temperature excursion to one patient. Date of administration was 28-FEB-2024. Nurse stated the patient has no reported any adverse events. No further information provided. Cross reference AE case: 02561; This spontaneous report was received from licensed practical nurse concerning a patient of unknown age and gender.   The patient's medical history, concurrent conditions and concomitant medication were not reported.  On 28-FEB-2024, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, once, (lot #X023323, has been verified to be valid expiration date: 20-SEP-2025) administered for prophylaxis (strength, and route of administration were not provided). After a temperature excursion (product storage error).The operator of the device was health professional. The nurse stated the patient has no reported any adverse events. No further information provided.   It was reported that temperature was -14.5 degrees Celsius, with 20 minutes time frame with no previous temperature excursion.  This is one of the two cases reported from the same source.; Sender's Comments:  US-009507513-2403USA000908:
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration, No adverse event, Product dose omission issue
Clinical narrative: The patient missed the second dose of Vivotif vaccine; The patient missed the second dose of Vivotif vaccine; Case reference number US-BN-2023-010630 is a spontaneous case report initially received from a nurse (reference number: EMG2023-2429) on 03-Dec-2023 and concerns a 25-year-old female patient.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient took the first dose of Vivotif (batch number: not reported) at an unknown dose and route of administration for an unknown indication. As reported, the patient missed the second dose of Vivotif vaccine (explicitly coded as 'inappropriate schedule of vaccine administered' and 'missed dose').   At the time of the initial report, it was unknown if the patient experienced any adverse event due to Vivotif vaccine.  No further information provided.; Reporter's Comments: A 25-year-old female patient missed the second dose of Vivotif vaccine which is considered as missed dose and inappropriate schedule of vaccine administered. Product dose omission issue and inappropriate schedule of product administration are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Product dose omission issue and inappropriate schedule of product administration are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 25-year-old female patient missed the second dose of Vivotif vaccine which is considered as missed dose and inappropriate schedule of vaccine administered. Product dose omission issue and inappropriate schedule of product administration are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Vivotif vaccine. The patient's medical history and concomitant medication details were not provided. Product dose omission issue and inappropriate schedule of product administration are both assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient took two capsules of Vivotif back to back on days; Case reference number US-BN-2023-010666 initially received from Communications (reference number USBAV23-2053) on 7-Dec-2023, is a spontaneous case received from consumer and concerns a female patient of unknown age.  The patient's relevant medical history details and concomitant medications were not provided.  On an unknown date, the patient took two capsules of Vivotif (batch number unknown) back-to-back on days (explicitly coded as 'Inappropriate schedule of vaccine administered'). Indication for vaccination was not provided.  At the time of initial report, it was unknown if the patient experienced any adverse event.  No further information provided.; Reporter's Comments: A female patient of unknown age took two capsules of Vivotif back-to-back on days, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event. Inappropriate schedule of product administration is considered as listed per company convention. The patient's relevant medical history details and concomitant medications were not provided. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A female patient of unknown age took two capsules of Vivotif back-to-back on days, which is considered as inappropriate schedule of vaccine administered. It was unknown if the patient experienced any adverse event. Inappropriate schedule of product administration is considered as listed per company convention. The patient's relevant medical history details and concomitant medications were not provided. Inappropriate schedule of product administration has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; The patient had shingles twice; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: The patient had shingles twice). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-FEB-2024 This case was reported by a patient via interactive digital media. The patient stated that he/she got shingles after getting the vaccine. The patient had shingles twice. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had them three times / Suspected vaccination failure; had them three times; that hurt that bad; off from work for 7 weeks; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles after he got the shot). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK received date: 27-Feb-2024 This case was reported by a consumer via interactive digital media. Reporter stated that, those vaccines do not help you from getting the shingles. A friend of reporter went and got the shot and he broke out in the shingles after he got the shot. Reporter also stated, they say that the shingles shot is only 50/50 where you get them or not. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2024AMR026168:same reporter,Different patient (reporter's case)
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Scar, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; painful; scarred patient's face; itchy; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles), pain (Verbatim: painful), scar (Verbatim: scarred patient's face) and pruritus (Verbatim: itchy). The outcome of the vaccination failure was unknown and the outcome of the shingles, pain, scar and pruritus were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pain, scar and pruritus to be related to Shingrix.     It was unknown if the company considered the vaccination failure, shingles, pain, scar and pruritus to be related to Shingrix.   Additional Information: GSK received date: 27-Feb-2024 This case was reported by a patient via interactive digital media. The patient had shingles again for the second, on opposite side of face then first time and also had received the vaccine.  The patient stated, they said only 5 percent get it most re the, once.  First time so painful that scarred patient's face. This time in patient's hair down forehead and it was so painful and itchy.  The patient also stated that get the vaccine and save yourself. Would not wish them on the worst enemy.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: Death; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced unknown cause of death (Verbatim: Death) (serious criteria death and GSK medically significant). The reported cause of death was unknown.   It was unknown if the reporter considered the unknown cause of death to be related to Shingrix.     It was unknown if the company considered the unknown cause of death to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-MAR-2024 The case was received from the patient's friend via interactive digital media. The patient died from this vaccine.; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: MENB
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: Patient was 5 weeks pregnant when vaccine was administered; This non-serious prospective pregnancy case was reported by a nurse via sales rep and described the occurrence of vaccine exposure during pregnancy in a 16-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero (unknown arm). On an unknown date, an unknown time after receiving Bexsero, the patient experienced vaccine exposure during pregnancy (Verbatim: Patient was 5 weeks pregnant when vaccine was administered). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Gestation time at first exposure (Bexsero): 5 Weeks Pregnancy Exposure (Bexsero): To mother in first trimester Pregnancy Outcome: Pregnancy was ongoing   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: 27-FEB-2024 This report was submitted via the online direct entry reporting system. The patient was 5 weeks pregnant when vaccine was administered, which led to vaccine exposure during pregnancy. This was possibly also reported by account manager.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: time interval too long/didn't get the recommended second dosage; This non-serious case was reported by a consumer and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (its almost 3 years received a single dosage of Shingrix).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: time interval too long/didn't get the recommended second dosage). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 25-FEB-2024 The reporter stated his wife had received the first dose of shingrix vaccine almost 3 years ago and did not the recommended second dosage. She had received the first dosage prior to Covid. The reporter asked about the data regarding the efficacy when the second dosage was greater than 12 months.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Severe hives; Rash; This non-serious case was reported by a nurse via interactive digital media and described the occurrence of hives in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced hives (Verbatim: Severe hives) and rash (Verbatim: Rash). The outcome of the hives and rash were not resolved.   The reporter considered the hives and rash to be related to Shingrix.     The company considered the hives and rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-FEB-2024 This case was reported by a patient via interactive digital media. The patient stated that he/she had severe hives and rash from the Shingrix vaccine for nearly five years.  The patient did not get the second shot. The patient stated that, GSK website claims only 4 percent of people had such an outbreak after receiving their vaccine. They call it shingles-like/varicella-like hives/rash. The reporter sent GSK an Email to report it period, not to seek compensation.  That was never the point. Now even a flu shot caused a flare up. The patient was tired of no one being able to do anything about it, the patient took pictures of the affected areas.  The reporter mentioned, company did not even offer a suggestion nor did they respond in anyway.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered
Clinical narrative: Patient administered Pediatriux then IPV [IPOL] with no adverse event; This non-serious case was reported by a nurse via other manufacturer and described the occurrence of extra dose administered in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On 18-JAN-2024, the patient received Pediarix. On 18-JAN-2024, an unknown time after receiving Pediarix, the patient experienced extra dose administered (Verbatim: Patient administered Pediatriux then IPV [IPOL] with no adverse event). The outcome of the extra dose administered 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: 27-FEB-2024 The reporter reported that the patient received the Pediatrix and then IPV vaccine on same day, which led to extra dose administered. The reporter consented to follow-up.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration, Intercepted product administration error
Clinical narrative: Appointment for possible Shingrix third dose; timeframe between the first two doses was 2 year apart; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number 75JT4, expiry date 30-SEP-2025) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 01-OCT-2021).   On 14-NOV-2023, the patient received the 2nd dose of Shingrix. On an unknown date, the patient did not receive the 3rd dose of Shingrix. On 14-NOV-2023, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: timeframe between the first two doses was 2 year apart). On an unknown date, the patient experienced intercepted drug administration error (Verbatim: Appointment for possible Shingrix third dose). The outcome of the drug dose administration interval too long and intercepted drug administration error were unknown.   Additional Information: GSK Receipt Date: 26-FEB-2024 The pharmacist had a patient with an appointment for a Shingrix third dose because the timeframe between the first two doses was 2 years apart, which led to lengthening of the vaccination schedule for 2nd dose of Shingrix and intercepted drug administration error for 3rd dose of Shingrix.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product use issue
Clinical narrative: a pregnant patient who received Arexvy.; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: a pregnant patient who received Arexvy.). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 26-FEB-2024 The pharmacist had a pregnant patient who received Arexvy, which led to vaccine exposure during pregnancy. The reporter did not consent to follow-up.
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 74-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number HF2YA, expiry date 15-JUL-2023) for prophylaxis.   On 26-FEB-2024, the patient received Boostrix. On 26-FEB-2024, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Expired vaccine administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 26-FEB-2024 Pharmacist reported that an expired dose of Boostrix was administered to a patient which led to expired vaccine used.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: the second dose has not been administered yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (In October 2023, received first dose).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: the second dose has not been administered yet). The outcome of the incomplete course of vaccination 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: 27-FEB-2024 The reporter called to asked for information regarding a patient who received the first dose of Twinrix and the second dose had not been administered yet. The health care provider asked what was the recommended schedule to complete the series. The reporter did not consent to follow-up. Till the time of reporting patient did not received the second dose of Twinrix, which led to incomplete course of vaccination.
Age: 59.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: inadvertently administered Arexvy vaccine to patient under the age of 60; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 59-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number GX3T4, expiry date 20-AUG-2025) for prophylaxis.   On 26-FEB-2024, the patient received Arexvy. On 26-FEB-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: inadvertently administered Arexvy vaccine to patient under the age of 60). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 27-FEB-2024 The pharmacist informed that inadvertently administered four Arexvy vaccines to patients under the age of 60 which led to inappropriate age at vaccine administration. This was 1 of the 4 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024025758:Same reporter / different patient US-GSK-US2024025765:Same reporter / different patient US-GSK-US2024025764:Same reporter / different patient
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: She knew someone that had swollen lymphnodes after the moderna vaccine.; This spontaneous case was reported by a non-health professional and describes the occurrence of LYMPHADENOPATHY (She knew someone that had swollen lymphnodes after the moderna vaccine.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (She knew someone that had swollen lymphnodes after the moderna vaccine.). At the time of the report, LYMPHADENOPATHY (She knew someone that had swollen lymphnodes after the moderna vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-058637 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-058637:Master Case (Valid Case)
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    The patient's past medical history included Pneumonia (10 or more years ago). Previously administered products included for Pneumonia: Pneumonia vaccine. Past adverse reactions to the above products included No adverse effect with Pneumonia vaccine. Concurrent medical conditions included Distended bile duct (Common bile duct enlarged, been monitoring for six years.). Concomitant products included PRAVASTATIN for an unknown indication.   On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form On an unknown date, received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 19-Sep-2022 for COVID-19 treatment, at a dose of 1 dosage form twice a day and NIRMATRELVIR, RITONAVIR (PAXLOVID) on 09-Aug-2023 for COVID-19 treatment, at a dose of 1 dosage form twice a day. At the time of the report, COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: Positive. In 2023, SARS-CoV-2 test: Positive.         It was reported that patient took Paxlovid twice before, once in 2022, and once in 2023. Patient got fully vaccinated and has gotten all of the boosters. Patient clarified that all of initial vaccines were the Moderna Covid-19 vaccines, and last 2 booster doses were the Pfizer Covid-19 vaccines. Patient was exposed to a lot of kids and wears a mask sometimes. When patient got Covid for the first time it felt like it was going into lungs. The second time, patient took Paxlovid out of precaution. It was very effective and helped with all of the symptoms, but not the fogginess. Patient was not currently feeling sick. Patient stopped Pravastatin immediately when prescribed the Paxlovid.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Flushing, Headache, Lip swelling
Clinical narrative: feeling of burning up; swollen lip; flushes in her whole face; she experienced severe chills; splitting headache/ severe headache; body ache for almost 24 hours; This spontaneous case was reported by a patient and describes the occurrence of BURNING SENSATION (feeling of burning up), LIP SWELLING (swollen lip), FLUSHING (flushes in her whole face), CHILLS (she experienced severe chills) and HEADACHE (splitting headache/ severe headache) in a 70-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stomach ache, Back ache, Neck pain, Diverticulitis, Cardiac valve leak (leaky heart valve), GI upset and Blood pressure diastolic (diastolic artery). Concurrent medical conditions included Arthritis, Fibromyalgia, Allergy to NSAIDs and Drug allergy (steroids).    On 29-Feb-2024, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 29-Feb-2024, the patient experienced BURNING SENSATION (feeling of burning up), LIP SWELLING (swollen lip), FLUSHING (flushes in her whole face), CHILLS (she experienced severe chills), HEADACHE (splitting headache/ severe headache) and MYALGIA (body ache for almost 24 hours). At the time of the report, BURNING SENSATION (feeling of burning up), LIP SWELLING (swollen lip), FLUSHING (flushes in her whole face), CHILLS (she experienced severe chills) and HEADACHE (splitting headache/ severe headache) had not resolved and MYALGIA (body ache for almost 24 hours) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient had no information about the previous COVID-19 vaccination doses but this current shot has the worst reaction to her body. The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medication was reported. The patient that last night the patient had experienced severe chills, feeling of burning up, splitting headache and her whole body was like run over by a train. Patient also added having a swollen lip, flushes in her whole face, severe headache and body ache for almost 24 hours. Body ache was resolved on an unknown date on 2024. No treatment medication was reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: feeling of burning up; swollen lip; flushes in her whole face; she experienced severe chills; splitting headache/ severe headache; body ache for almost 24 hours; This spontaneous case was reported by a patient and describes the occurrence of BURNING SENSATION (feeling of burning up), LIP SWELLING (swollen lip), FLUSHING (flushes in her whole face), CHILLS (she experienced severe chills) and HEADACHE (splitting headache/ severe headache) in a 70-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stomach ache, Back ache, Neck pain, Diverticulitis, Cardiac valve leak (leaky heart valve), GI upset and Blood pressure diastolic (diastolic artery). Concurrent medical conditions included Arthritis, Fibromyalgia, Allergy to NSAIDs and Drug allergy (steroids).    On 29-Feb-2024, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 29-Feb-2024, the patient experienced BURNING SENSATION (feeling of burning up), LIP SWELLING (swollen lip), FLUSHING (flushes in her whole face), CHILLS (she experienced severe chills), HEADACHE (splitting headache/ severe headache) and MYALGIA (body ache for almost 24 hours). At the time of the report, BURNING SENSATION (feeling of burning up), LIP SWELLING (swollen lip), FLUSHING (flushes in her whole face), CHILLS (she experienced severe chills) and HEADACHE (splitting headache/ severe headache) had not resolved and MYALGIA (body ache for almost 24 hours) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient had no information about the previous COVID-19 vaccination doses but this current shot has the worst reaction to her body. The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medication was reported. The patient that last night the patient had experienced severe chills, feeling of burning up, splitting headache and her whole body was like run over by a train. Patient also added having a swollen lip, flushes in her whole face, severe headache and body ache for almost 24 hours. Body ache was resolved on an unknown date on 2024. No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Hallucination, Noninfective oophoritis
Clinical narrative: hallucinations; swollen ovaries; This spontaneous case was reported by a patient and describes the occurrence of HALLUCINATION (hallucinations) and NONINFECTIVE OOPHORITIS (swollen ovaries) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced HALLUCINATION (hallucinations) (seriousness criterion medically significant) and NONINFECTIVE OOPHORITIS (swollen ovaries) (seriousness criterion medically significant). At the time of the report, HALLUCINATION (hallucinations) and NONINFECTIVE OOPHORITIS (swollen ovaries) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       The concomitant medication was not reported by reporter.   Dosage text for suspect product was reported as unknown.  The treatment medication was not reported by reporter.  Company Comment: This is a Spontaneous case reported by a patient, concerning a patient of unknown age and gender, with no medical history reported, who experienced the unexpected and serious (due to medically significant) events of Hallucination and Noninfective oophoritis, which occurred on an unknown date related to an unspecified dose of SPIKEVAX NOS vaccine. Since no vaccination, nor events dates were provided, temporal association and latency cannot be properly assessed. No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of SPIKEVAX NOS vaccine is not affected by this report.
Age: 66.0
Sex: M
Vaccine: RSV
Symptoms: Chills, Headache, Joint stiffness
Clinical narrative: Chills, headache,  joint stiffness.  Treated with acetaminophen 1000 mg po with improvement.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Fainting and passing out after the vaccine
Age: 54.0
Sex: M
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received dose of RSV at age 54 when not indicated to receive until age 60.  No complaints from patient regarding any adverse effects post vaccination.
Sex: U
Vaccine: RSV
Symptoms: Device connection issue, Syringe issue
Clinical narrative: Container was cracked and flange was defective; Container was cracked and flange was defective; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 19Feb2024, this case now contains all required information to be considered valid.  This is a spontaneous report received from a Pharmacist from product quality group, Program ID. A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HM0172, Expiration Date: Feb2025), as dose number unknown, single (Lot number: HM0172, Expiration Date: Mar2025) and as dose number unknown, single (Lot number: GY5655, Expiration Date: Feb2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE DEFECTIVE (non-serious), DEVICE BREAKAGE (non-serious), outcome "unknown" and all described as "Container was cracked and flange was defective".  Additional information: Trying to reconstitute Abrysvo, but issue occurred when reconstituting. Container was cracked and flange was defective. Seems like holder, the one that goes to syringe, exploded and now liquid is in floor. A quality issue and needs a credit for it. Clarified it did not explode but when reconstituted it ended up on floor. Clarified there has been a total of 3 Abrysvo vaccines that have had this same issue. 3 Abrysvo vaccines had same issue when tried to mix it, guesses everything went on floor too for 2 prior occurrences also.  The reporter considered "container was cracked and flange was defective" not related to rsv vaccine prot.subunit pref 2v. Causality for "container was cracked and flange was defective" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Sex: F
Vaccine: RSV
Symptoms: Dyspnoea, Palpitations
Clinical narrative: Shortness of breath; Palpitations; This is a spontaneous report received from a Nurse.  A female patient in her 60's received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 27Feb2024 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PALPITATIONS (non-serious) with onset 27Feb2024, outcome "unknown"; DYSPNOEA (non-serious) with onset 27Feb2024, outcome "unknown", described as "Shortness of breath". Additional information: the patient had shortness of breath and palpitations after receiving Abrysvo vaccine; the event happened at the pharmacy.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: PNC20
Symptoms: Syringe issue
Clinical narrative: vaccine damaged/ Syringe neck, where it meets adapter, snapped right off; This is a spontaneous report received from an Other HCP from product quality group.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: HG7738, Expiration Date: Apr2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), outcome "unknown", described as "vaccine damaged/ Syringe neck, where it meets adapter, snapped right off".  Causality for "vaccine damaged/ syringe neck, where it meets adapter, snapped right off" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).  Additional information: This product had not been used for patient, there had been no patient involvement.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 diagnosed with antigen tests; COVID-19 diagnosed with antigen tests; This is a spontaneous report received from a Physician.  A 68-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "LUTS" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Azithromycin, reaction(s): "Drug Allergy: Azithromycin". Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 diagnosed with antigen tests". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included full course of Paxlovid taken from 15Feb2024 to 20Feb2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 omi xbb.1.5  in this patient cannot be completely excluded.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Still had COVID/ did not want to get COVID, but got it anyway; Still had COVID/ did not want to get COVID, but got it anyway; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 84-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Knee surgeries", start date: 2021 (unspecified if ongoing), notes: She had surgeries in 2021, but was vaccinated after her surgeries. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Still had COVID/ did not want to get COVID, but got it anyway".  Clinical course: Seriousness reported as no and suspect reported as Comirnaty and/or Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula). She mentioned she received the 1st dose and 2 boosters of the Pfizer vaccine and is complaining that she still had COVID. Because they were alerting the elderly and people to get the shot and did not want to get COVID. Injection believes it was in her right arm. Consumer calling about the Pfizer COVID-19 Vaccine and reported that she still had COVID after having the vaccines. The transferring agent stated that she wanted to know about a lawsuit case filed against Pfizer from 2-3 years ago that she heard about today. Does not remember the dates she had COVID. Thinks it was in late 2021 or sometime in 2022. caller does not have her vaccination card to provide NDC, Lot, or expiry dates for the Pfizer COVID-19 vaccines that she received. She did not want to get COVID, but got it anyway. Caller said that she had the first series of shots and a booster. She does not remember if the first doses were 1 or 2 shots. Patient received booster dose (other) as they were advising elderly people in particular to get the booster. COVID-19 was on a rampage and there was several cases around where she lived. It was a extra precaution. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No family medical history relevant to adverse events.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 will be requested and submitted if and when received.