chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV1
Symptoms: Product preparation issue
Clinical narrative: no diluent but 1 extra vial of vaccine, so concluded that one the last 9 kids probably just got the diluent; no diluent but 1 extra vial of vaccine, so concluded that one the last 9 kids probably just got the diluent; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of inappropriate dose of vaccine administered in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation. On an unknown date, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate dose of vaccine administered (Verbatim: no diluent but 1 extra vial of vaccine, so concluded that one the last 9 kids probably just got the diluent) and inappropriate preparation of medication (Verbatim: no diluent but 1 extra vial of vaccine, so concluded that one the last 9 kids probably just got the diluent). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date 10 April 2024: The healthcare provider reported that getting down to the last vial of Rotarix and noticed there was no diluent but 1 extra vial of vaccine, so concluded that one the last 9 kids probably just got the diluent, which led to  inappropriate dose of vaccine administered and inappropriate preparation of medication.
Sex: U
Vaccine: RSV
Symptoms: Pruritus
Clinical narrative: itching; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a 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 pruritus (Verbatim: itching). The outcome of the pruritus was not reported.   It was unknown if the reporter considered the pruritus to be related to Arexvy.     It was unknown if the company considered the pruritus to be related to Arexvy.   Additional Information: GSK Receipt date 09-APR-2024: The case was received from the patient via interactive digital media.   The patient was reporter and asked if itching was a side effect.
Sex: U
Vaccine: RSV
Symptoms: Auditory disorder
Clinical narrative: my hearing to become; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of hearing disability in a 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 hearing disability (Verbatim: my hearing to become). The outcome of the hearing disability was not reported.   The reporter considered the hearing disability to be possibly related to Arexvy.     The company considered the hearing disability to be possibly related to Arexvy.   Additional Information: GSK Receipt date: 09-APR-2024 This case was reported by patient via (Open field AE monitoring) interactive digital media. The reporter reported that the Arexvy vaccine seems to had caused his or her hearing to become sounding. Reporter asked information on this.
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: administration of a expired dose of Kinrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa-IPV (Kinrix) (batch number 3KS4F, expiry date 22-MAR-2024) for prophylaxis.   On 09-APR-2024, the patient received Kinrix. On 09-APR-2024, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: administration of a expired dose of Kinrix). 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 10 April 2024: Pharmacist reported that the administration of a expired dose of Kinrix. HCP stated Kinrix expired on 22nd March 2024 and was administered to a patient on 9th April 2024, which led to expired vaccine used. The reporter consented to follow up.
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: patient did not recived 2nd dose 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 54-year-old male patient who received HBV (Engerix B adult) for prophylaxis.   Previously administered products included Engerix B (received 1st dose of Engerix B adult on 06-APR-2023).   On an unknown date, the patient did not receive the 2nd dose of Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced incomplete course of vaccination (Verbatim: patient did not recived 2nd dose 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: 10-APR-2024 The pharmacist reported that the patient did not return to complete the series. Till the time of reporting patient did not receive 2nd dose of Engerix B adult, which led to incomplete course of vaccination. The reporter consented to the follow up.
Sex: U
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Inappropriate dose administered; Gave a dose of the pediatric Havrix 720 to an adult; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a patient who received HAV (Havrix pediatric) for prophylaxis.   In APR-2024, the patient received Havrix pediatric. In APR-2024, an unknown time after receiving Havrix pediatric, the patient experienced underdose (Verbatim: Inappropriate dose administered) and adult use of a child product (Verbatim: Gave a dose of the pediatric Havrix 720 to an adult). The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-APR-2024 The registered nurse (RN) reported that an office she gives a dose of pediatric Havrix 720 to an adult, which led to underdose and adult use of a child product. The reporter didn't mention a specific date of administration, only that it had been on the previous day of that week. The vaccine administration facility was the same as primary reporter. Lot number of vaccine and patient information was not provided by reporter but agreed to provide such information if followed up. The reporter consent to follow up.
Age: 4.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered
Clinical narrative: administration of an adult dose of Havrix to a 4 y/o; administration of an adult dose of Havrix to a 4 y/o; Frist dose of Havrix administered in 2021, Booster dose on April 9, 2024.; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 4-year-old female patient who received HAV (Havrix 1440 adult) (batch number T9TL9, expiry date 05-DEC-2025) for prophylaxis.   Previously administered products included Havrix (Received 1st dose of Havrix in 2021).   On 09-APR-2024, the patient received Havrix 1440 adult. On 09-APR-2024, an unknown time after receiving Havrix 1440 adult, the patient experienced overdose (Verbatim: administration of an adult dose of Havrix to a 4 y/o), adult product administered to child (Verbatim: administration of an adult dose of Havrix to a 4 y/o) and drug dose administration interval too long (Verbatim: Frist dose of Havrix administered in 2021, Booster dose on April 9, 2024.). The outcome of the overdose, adult product administered to child and drug dose administration interval too long were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-APR-2024 The nurse reported administration of an adult dose of Havrix to a 4 year old patient which led to overdose and adult product administered to child . The 1st dose of Havrix administered in 2021 and the booster dose on April 9, 2024 which led to drug dose administration interval too long.  The reporter consented to follow up.
Age: 1.83
Sex: M
Vaccine: HEPAB
Symptoms: Extra dose administered
Clinical narrative: patient completed a Hep A series in the past (over 6 months ago) and they administered a Twinrix dose on 4/2/2024 to the patient.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 22-month-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Hepatitis A (patient completed a Hep A series in the past (over 6 months ago)).   On 02-APR-2024, the patient received Twinrix. On 02-APR-2024, an unknown time after receiving Twinrix, the patient experienced extra dose administered (Verbatim: patient completed a Hep A series in the past (over 6 months ago) and they administered a Twinrix dose on 4/2/2024 to the patient.). 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 11 April 2024: Pharmacist called to inquired how do we complete the series for Hep B? The pharmacist reported a patient completed a Hep A series in the past (over 6 months ago) and they administered a Twinrix dose to the patient. The reported wanted to knowhow should we complete the series for Hep B? The pharmacist unable to provide any patient details. The reporter did not consent to follow-up. The pharmacist reported a patient completed a Hep A series in the past (over 6 months ago) and they administered a Twinrix dose which led to extra dose administered of Hepatitis A.
Sex: F
Vaccine: MENB
Symptoms: Intercepted product prescribing error
Clinical narrative: prescription for Bexsero for a 8-month old child; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced intercepted drug prescribing error (Verbatim: prescription for Bexsero for a 8-month old child). The outcome of the intercepted drug prescribing error 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: 15-APR-2024 Pharmacist requested data on administration of Bexsero to 8 month old patient. The reporter stated that they have received a prescription for Bexsero for a 8-month old child, which led to intercepted drug prescribing error. The reporter consented to follow up. Vaccine had not been administered at the time of the call.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: For unknown reasons, the second dose was delayed; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 95-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the 1st dose in 2021).   In JAN-2024, the patient received the 2nd dose of Shingrix (intramuscular). In JAN-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: For unknown reasons, the second dose was delayed). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 15-APR-2024 The reporter was the patient's son. The reporter stated that for unknown reasons, the second dose was delayed. Nothing else was reported. The reporter did not consent to follow-up. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Seizure
Clinical narrative: at midnight the same day got a seizure, another patient receive Infanrix, same lot number yesterday (April 16th 2024) and then got a seizure; This serious case was reported by a other health professional via call center representative and described the occurrence of seizure in a 19-month-old male patient who received DTPa (Infanrix) (batch number TX77L, expiry date 21-FEB-2025) for prophylaxis.   Co-suspect products included HAV (Havrix) (batch number 2233, expiry date 14-NOV-2025) for prophylaxis, Measles vaccine, Mumps vaccine, Rubella vaccine (Mmr) for prophylaxis and Varicella zoster vaccine (Varicella vaccine) for prophylaxis.   On 15-APR-2024, the patient received Infanrix, Havrix, Mmr and Varicella vaccine. On 16-APR-2024, 1 days after receiving Infanrix and Havrix, the patient experienced seizure (Verbatim: at midnight the same day got a seizure, another patient receive Infanrix, same lot number yesterday (April 16th 2024) and then got a seizure) (serious criteria GSK medically significant). The outcome of the seizure was unknown.   It was unknown if the reporter considered the seizure to be related to Infanrix, Infanrix Pre-Filled Syringe Device and Havrix.     It was unknown if the company considered the seizure to be related to Infanrix, Infanrix Pre-Filled Syringe Device and Havrix.   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: 17-APR-2024 The reporter reported that a patient received Infanrix and at midnight the same day got a seizure. The same day received HepA (Havrix), MMR and Varicella vaccines (from Merck). It was unknown if the reporter considered the seizure to be related to MMR and Varicella vaccines. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. This case had been linked with US2024049461, reported by the same reporter.; Sender's Comments:  US-GSK-US2024049461:2ND PATIENT
Sex: U
Vaccine: COVID19
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: DEAFNESS IN ONE EAR; RINGING IN EAR; This solicited report received from a consumer via PPSCVM000196: Janssen Social Media Account (via J and J managed social media) concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced deafness in one ear, and ringing in ear (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ringing in ear, and the outcome of deafness in one ear was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and deafness in one ear was not related, and  with ringing in ear was related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0- Deafness unilateral. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Diabetes mellitus, Hyperlipidaemia
Clinical narrative: worsening of diabetes; worsening of hyperlipidemia; This report concerns a subject of unknown age and gender who was involved in study. The subject received COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) for COVID-19 prophylaxis. The report describes a case of DIABETES MELLITUS (worsening of diabetes). The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the subject received dose of COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) (unknown route) 1 dosage form at an unspecified frequency. On 10-Oct-2023, the subject experienced DIABETES MELLITUS (worsening of diabetes) (seriousness criterion medically significant) and HYPERLIPIDAEMIA (worsening of hyperlipidemia). At the time of the report, DIABETES MELLITUS (worsening of diabetes) and HYPERLIPIDAEMIA (worsening of hyperlipidemia) was resolving.        The action taken with COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) (Unknown) was unknown.   For COVID-19 VACCINE MRNA (SPIKEVAX COVID-19 VACCINE NOS) (Unknown), the reporter considered DIABETES MELLITUS (worsening of diabetes) and HYPERLIPIDAEMIA (worsening of hyperlipidemia) to be not related.    This was a Sponsored case with study name.  Other action taken was reported as Concomitant medication. subject had received unknown concomitant medication. The reporter's causality for the events were reported as not related. No treatment medications were reported.  Company comment: This is a case concerning a subject of unknown age and gender, with no reported medical history, who experienced unexpected, serious (medically significant) event of diabetes mellitus (described as worsening of diabetes) and non serious unexpected event of hyperlipidemia (described as worsening of hyperlipidemia). Temporal association with a dose of SPIKEVAX COVID-19 VACCINE NOS is unclear. At the time of report events were resolving. Reporter's causality was provided as not related for both events. No further information about the events was provided. The Company causality is assessed as not related for both events in agreement with reported assessment, considering unclear temporal association and lack of biological plausibility for causality. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Pemphigoid
Clinical narrative: skin disease called Bullous Phemgoid/I broke out in bullous phemgoid; This spontaneous case was reported by a patient and describes the occurrence of PEMPHIGOID (skin disease called Bullous Phemgoid/I broke out in bullous phemgoid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. ASKU and ASKU) for COVID-19 prophylaxis.     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, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PEMPHIGOID (skin disease called Bullous Phemgoid/I broke out in bullous phemgoid) (seriousness criterion medically significant). At the time of the report, PEMPHIGOID (skin disease called Bullous Phemgoid/I broke out in bullous phemgoid) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported.   The patient got 2 doses of the madrna, few months later she broke out in bullous phemgoid, she need to get a hold of whoever was in charge of the COVID madrna shots. She now had bullous phemgoid for the rest of her life, been trying to treat it with many different treatments and it still had not worked. It was really bad in the beginning she had pictures of my body all over the place of the rash or disease that the madrna COVID shot effected her body. She was still dealing with it today.  Company comment-This is a spontaneous case concerning a female patient of unknown age with no medical history reported who experienced the serious unexpected (medically significant) event pemphigoid. Two doses of mRNA-1273 vaccine, were administered on unknown dates. Onset date of the event and vaccination dates were not provided hence latency cannot be assessed. The patient stated that she never had a problem until she had to get the 2 doses of vaccine to work when COVID was going around. Few months after vaccination she broke out in bullous pemphigoid. The side effects were horrible on her whole body as per the patient's words. She is still dealing with the disease till this day. She has had lots of treatments, and it still has not gone away. No further details were provided for medical review. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2024: Live Follow-up received with non-significant information. On 21-Apr-2024: Live Follow-up received with non-significant information. On 21-Apr-2024: Live Follow-up received with significant information included reporter details, patient full name and narrative updated.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Condition aggravated
Clinical narrative: Patient had autoimmune; condition aggravated; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Apr-2024 and was forwarded to Moderna on 22-Apr-2024.      This spontaneous case was reported by a patient and describes the occurrence of AUTOIMMUNE DISORDER (Patient had autoimmune) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Patient verbatim ""I have autoimmune. well, they think it's autoimmune and my symptoms have increased very, very much so in the last couple of years.".  Concurrent medical conditions included Autoimmune disease flare up.    In October 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (Patient had autoimmune) (seriousness criterion medically significant) and CONDITION AGGRAVATED (condition aggravated). At the time of the report, AUTOIMMUNE DISORDER (Patient had autoimmune) and CONDITION AGGRAVATED (condition aggravated) outcome was unknown.            It was unknown if the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown. It was reported that patient receives first moderna shot on unspecified date of March or April 2020 and after that she had it every 6 months having the last shot on October 2023 confirming that it was the 2023-2024 formula. Patient had autoimmune. Her symptoms had increased very, very much so in the last couple of years.  Treatment information was not provided.  Company comment:  This is a spontaneous case concerning a patient of unknown age and gender, with a current condition of an unspecified autoimmune disorder, who experienced the unexpected serious (medically significant) event of an autoimmune disorder and condition aggravation with an unknown latency reported in relation to the administration of an unreported dose of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine. No further information on the clinical course, investigations, or treatment received was available in the report. The benefit-risk relationship of the mRNA-1273.815 (SPIKEVAX 2023-2024) Vaccine is not affected by this report.   This case was linked to MOD-2024-765849 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: PNC20
Symptoms: Asthenia, Fatigue, Increased upper airway secretion, Muscular weakness, Myalgia
Clinical narrative: really weak; tired; Legs were hurting bad/My right arm hurt; muscle weakness; muscle soreness; Phlegm in my throat; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 16Apr2024 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCTIVE COUGH (non-serious) with onset 18Apr2024, outcome "unknown", described as "Phlegm in my throat"; ASTHENIA (non-serious), outcome "unknown", described as "really weak"; FATIGUE (non-serious), outcome "unknown", described as "tired"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Legs were hurting bad/My right arm hurt"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "muscle weakness"; MYALGIA (non-serious), outcome "unknown", described as "muscle soreness".  Additional information: The patient stated, "So, I got the shot on Tuesday, the Prevnar 20, and everything was fine. The person who gave me the shot was pharmacist and they said, I may rub it a lot that night and tomorrow, I will have less pain in my shoulder. I might just have some shoulder pain. So, I rubbed it really good. I never really got any shoulder pain the next day. So, I thought, I dodged the bullet. The next day after, all of a sudden, I am starting to get like all this phlegm in my throat. You know like so, I think I had a reaction and basically now I am really weak, and tired and I was walking the dog last night, I always the dog 2.2 miles, and basically my legs were hurting bad and they did say, I did see one of the side effects on (website withheld) was muscle soreness. So, I am just wondering, are any of these symptoms, is there anything you are looking at with the Prevnar 20 shot that I have covered like a reaction? But the next day, my right arm hurt and they shot me in the left arm. So, I was sitting here going, maybe that is the muscle weakness or muscle soreness."  The information on the batch/lot number for [PNEUMOCOCCAL 20-VAL CONJ VAC (DIPHT CRM197 PROTEIN)] will be requested and submitted if and when received.
Sex: U
Vaccine: PNC20
Symptoms: Pain in extremity
Clinical narrative: really weak; tired; Legs were hurting bad/My right arm hurt; muscle weakness; muscle soreness; Phlegm in my throat; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 16Apr2024 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCTIVE COUGH (non-serious) with onset 18Apr2024, outcome "unknown", described as "Phlegm in my throat"; ASTHENIA (non-serious), outcome "unknown", described as "really weak"; FATIGUE (non-serious), outcome "unknown", described as "tired"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Legs were hurting bad/My right arm hurt"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "muscle weakness"; MYALGIA (non-serious), outcome "unknown", described as "muscle soreness".  Additional information: The patient stated, "So, I got the shot on Tuesday, the Prevnar 20, and everything was fine. The person who gave me the shot was pharmacist and they said, I may rub it a lot that night and tomorrow, I will have less pain in my shoulder. I might just have some shoulder pain. So, I rubbed it really good. I never really got any shoulder pain the next day. So, I thought, I dodged the bullet. The next day after, all of a sudden, I am starting to get like all this phlegm in my throat. You know like so, I think I had a reaction and basically now I am really weak, and tired and I was walking the dog last night, I always the dog 2.2 miles, and basically my legs were hurting bad and they did say, I did see one of the side effects on (website withheld) was muscle soreness. So, I am just wondering, are any of these symptoms, is there anything you are looking at with the Prevnar 20 shot that I have covered like a reaction? But the next day, my right arm hurt and they shot me in the left arm. So, I was sitting here going, maybe that is the muscle weakness or muscle soreness."  The information on the batch/lot number for [PNEUMOCOCCAL 20-VAL CONJ VAC (DIPHT CRM197 PROTEIN)] will be requested and submitted if and when received.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Nov2022 as dose 4 (booster), single (Lot number: 062F22A) at the age of 70 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single (Lot number: FJ1620), in right arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single) and as dose 2, single) for covid-19 immunisation. The patient had no relevant medical history. Patient had no known allergies.The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Apr2024, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Apr2024, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 11Apr2024 to 15Apr2024.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: got covid a month after her updated vaccine; got covid a month after her updated vaccine; This is a spontaneous report received from a Consumer or other non HCP.  An adult female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Nov2023 as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "lung issues" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2023, outcome "recovered" and all described as "got covid a month after her updated vaccine". The event "got covid a month after her updated vaccine" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 as Paxlovid from 24Dec2023 to 28Dec2023. Clinical course: The reporter stated that she got covid a month after her updated vaccine and was entirely convinced that she was not actually given a vaccine at (withheld). She had no side effects, and didn't even felt the vaccination when it was administered.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient may have died after taking the Pfizer COVID-19 vaccine; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  An 18-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Lot number: FN2908) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death) with onset 2022, outcome "fatal", described as "Patient may have died after taking the Pfizer COVID-19 vaccine". The patient date of death was 2022. The reported cause of death was unknown.  No follow-up attempts are possible.; Reported Cause(s) of Death: Patient may have died after taking the Pfizer COVID-19 vaccine
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Haemoglobin, Haemoglobin decreased, Palpitations
Clinical narrative: Her hb was .1 points away from a transfusion; chest pain; next day felt a big thump in heart. 2nd day another big thump in heart; This is a spontaneous report received from an Other HCP.  A 47-year-old female patient (unknown if pregnant) received BNT162b2 (COMIRNATY), in Oct2022 as dose 1, single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history included: "SICKLE CELL TRAIT" (ongoing). The patient's concomitant medications were not reported. The following information was reported: HAEMOGLOBIN DECREASED (medically significant) with onset Oct2022, outcome "unknown", described as "Her hb was .1 points away from a transfusion"; CHEST PAIN (non-serious) with onset Oct2022, 2 hrs after the suspect product(s) administration, outcome "unknown"; PALPITATIONS (non-serious) with onset Oct2022, 1 day after the suspect product(s) administration, outcome "unknown", described as "next day felt a big thump in heart. 2nd day another big thump in heart". The events "her hb was .1 points away from a transfusion", "chest pain" and "next day felt a big thump in heart. 2nd day another big thump in heart" required physician office visit and emergency room visit. Clinical Course: A 47, 48 year old patient with sickle cell trait had her first Covid vaccine and with in 2 hours had chest pain. The next day felt a big thump in heart. 2nd day another big thump in heart so went to hospital but was not admitted.  Her hb was .1 points away from a transfusion.; Sender's Comments: Based from patients relevant medical history of having sickle trait disease and vaccine safety profile , the causal association of reported event hemoglobin decreased is assessed as not related to suspected vaccine.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: passed away/died from the Pfizer Vaccine.; This is a spontaneous report received from a Consumer or other non HCP.  A 20-year-old female patient (pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: FN2908, Expiration Date: 31Oct2022) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "passed away/died from the Pfizer Vaccine.". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: Patient's family claims their daughter died from the Pfizer Vaccine. Clarified the Pfizer Vaccine to be, Covid-19 Monovalent Vaccine 12 and older. The reporter had reached out and provided a lot number to see if the vaccine is associated with the lot number. Reporter confirmed the cause of death was not provided. Product Details:  Caller was looking at the picture included in the email of the vaccine card that was from a TV screen and can barely read information. The picture included half of vaccine card is cut off. Probed for date received vaccine and provided 20Jul, but the year is completely cut off. Confirmed only one dose involved, the first dose. The lot number was listed on the vaccine card. Expiration date: Caller looked up the expiration date listed in their system and provided as 31Oct2022.; Reported Cause(s) of Death: passed away/died from the Pfizer Vaccine
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Pain in extremity, Pneumonia
Clinical narrative: chest pains; sore arm; pneumonia; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 08Mar2021 as dose 2, single (Lot number: EN6201) at the age of 54 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Anatomical Site of injection: Right Arm, Batch/Lot number: EL3302), administration date: 17Feb2021, when the patient was 54-year-old, for COVID-19 immunization, reaction(s): "pneumonia", "sore arm", "chest pains". The following information was reported: CHEST PAIN (medically significant) with onset 09Mar2021, outcome "unknown", described as "chest pains"; PNEUMONIA (medically significant) with onset 2021, outcome "unknown"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered", described as "sore arm". The events "chest pains", "pneumonia" and "sore arm" required emergency room visit. Therapeutic measures were taken as a result of chest pain. Therapeutic measures were not taken as a result of pain in extremity. Clinical course: No relevant tests reported.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400053594 Same patient/reporter/product/event, different dose;US-PFIZER INC-202400054453 Same patient/reporter/product/, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Vaccination site pain
Clinical narrative: all injection were intramuscular right arm just minor soreness; My wife also took paxloid but she did not exhibit a negative test and then a rebound positive test; My wife also took paxloid but she did not exhibit a negative test and then a rebound positive test; Interchange of vaccine products; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EN6200), on 23Mar2021 as dose 2, single (Lot number: EN6208), on 24Sep2021 as dose 3 (booster), single (Lot number: FC3184) and on 01Apr2022 as dose 4 (booster), single (Lot number: J87762), all intramuscular for covid-19 immunisation; davesomeran, elasomeran (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 08Sep2022 as dose 5 (booster), single (Lot number: A57143C) and on 17May2023 as dose 6 (booster), single (Lot number: 045H22A), all intramuscular for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Sep2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "My wife also took paxloid but she did not exhibit a negative test and then a rebound positive test"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "all injection were intramuscular right arm just minor soreness". Therapeutic measures were taken as a result of drug ineffective, covid-19 from an unspecified date in Feb2024 for five-day drug course. Clinical course: Patient also took Paxlovid but she did not exhibit a negative test. That is she remained positive for about two weeks after completing the five-day drug course. The treatment markedly reduced the severity of symptoms. All injection were intramuscular right arm just minor soreness.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400049118 Different  patient/same product, different dose/event;
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction
Clinical narrative: erectile dysfunction; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ERECTILE DYSFUNCTION (medically significant) with onset 2022, outcome "unknown".  Clinical course: The reporter stated that he has issues with erectile dysfunction when he got the vaccine. Diagnosed in 2022 but got the vaccine in 2021.
Sex: U
Vaccine: DTPPVHBHPB, PNC20
Symptoms: Mucous stools, Pyrexia
Clinical narrative: mucousy stools; fever of 104 degrees Fahrenheit; This is a spontaneous report received from a Nurse. Other Case identifier: 2024SA100201.  A 3-month-old patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (batch/lot number: unknown) for immunization; diphtheria vaccine toxoid, hepatitis B vaccine rhbsag (yeast), hib vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (VAXELIS) for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "fever of 104 degrees Fahrenheit"; MUCOUS STOOLS (non-serious), outcome "unknown", described as "mucousy stools". Relevant laboratory tests and procedures are available in the appropriate section. Clinical course: The RN reporting that VAXELIS was administered to a patient and the infant "developed a fever of 104 degrees Fahrenheit." The RN also stated that the mother of the infant was reporting "mucousy stools." The RN reported that "the infant recovered and that the fever lasted 24 hours that's why we think it was caused by the vaccine." The RN was wanting to report this potential AE and was wondering if further Vaxelis vaccine should be given to a patient that had this type of reaction and a very high fever.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: she had taken vaccine shots and still got Covid-19/diagnosed with Covid-19; she had taken vaccine shots and still got Covid-19/diagnosed with Covid-19; This is a spontaneous report received from a Consumer or other non HCP from product quality group.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she had taken vaccine shots and still got Covid-19/diagnosed with Covid-19".  Additional information: The patient was diagnosed with Covid-19 and also mentioned that she had taken vaccine shots and still got Covid-19. She was prescribed Paxlovid however it is too expensive for her.   Batch/lot number is not provided, and it cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Pain in extremity, Pneumonia
Clinical narrative: sore arm; pneumonia; chest pains; This is a spontaneous report received from a Consumer or other non HCP.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EL3302) at the age of 54 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: CHEST PAIN (medically significant) with onset Feb2021, outcome "unknown", described as "chest pains"; PNEUMONIA (medically significant) with onset Feb2021, outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm". The events "pneumonia", "chest pains" and "sore arm" required emergency room visit. Therapeutic measures were taken as a result of chest pain. Therapeutic measures were not taken as a result of pain in extremity. Clinical course: The patient did not wish to provide details regarding medical history, relevant tests. Past 2 vaccinations gave chest pains within 24 hrs of shots, ended up in ER within 2 week of each shot. Stated pneumonia.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400093090 Same patient/product, different dose;US-PFIZER INC-202400054453 Same patient/same product, different dose/event;
Age: 0.33
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: inadvertently administered an expired dose of ActHib with no reported adverse event; Initial information received on 19-Apr-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old male patient who was inadvertently administered with an expired dose of HIB (PRP/T) Vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine; Rotavirus Vaccine; Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (DTAP); and Polio Vaccine; all for Prophylactic vaccination.  On 18-Apr-2024, the patient had inadvertently received expired 0.5 ml (total) (dose: 2) of suspect HIB (PRP/T) vaccine (Powder and solvent for solution for injection) (lot UJ863AC, expiry date: March-2024, strength unknown) via intramuscular route in the left leg for immunization with no reported adverse event (expired product administered) (Latency: same day)  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.