chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash vesicular, Urticaria
Clinical narrative: rash back of neck and spreading; few small chicken pox size hives across back of neck between hairline and collar/ some on front neck as well; This non-serious case was reported by a consumer via sales rep and described the occurrence of rash in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number lot (10) 3959S, expiry date 12-DEC-2025) for prophylaxis.   On 13-MAR-2024, the patient received the 1st dose of Shingrix (left arm). On 14-MAR-2024, 1 days after receiving Shingrix, the patient experienced rash (Verbatim: rash back of neck and spreading). In MAR-2024, the patient experienced hives (Verbatim: few small chicken pox size hives across back of neck between hairline and collar/ some on front neck as well). The outcome of the rash and hives were not resolved.   The reporter considered the rash to be related to Shingrix. It was unknown if the reporter considered the hives to be related to Shingrix.     The company considered the rash to be related to Shingrix. It was unknown if the company considered the hives to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-MAR-2024 The patient was a healthy adult who received first dose of Shingrix and had rash back of neck and spreading which was not serious. Rash back of neck and spreading was reported as worsened. Less than a week after, the patient started with few small chicken pox size hives across back of neck between hairline and collar. Everyday increase in number and height and area covered.  Today (on the day of reporting) was day 4 and there were some on front of neck as well. Not as inflamed or red or itchy or scabby as chicken pox, but reminiscent of it, nonetheless. Not itchy. Not irritating. Just concerned since spreading. No other product received by the patient.
Sex: U
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose was due in October and they never got it; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (Received 1st dose of Twinrix on an unknown dae).   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: 2nd dose was due in October and they never got it). 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: 20-MAR-2024 The other health professional reported that, the patient had the first dose of Twinrix and they did not come back for the second dose, the 2nd dose was due in October and the patient never got it which led to incomplete course of vaccination. The patient was coming for the 2nd dose but the reporter wanted to know what the interval after the 2nd dose for the 3rd dose should be. Lot number, expiration date, administration date was not confirmed.
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Injection site pain, Myalgia
Clinical narrative: Injection site pain; neck muscle soreness; shoulder soreness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain 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 injection site pain (Verbatim: Injection site pain), muscle soreness (Verbatim: neck muscle soreness) and shoulder soreness (Verbatim: shoulder soreness). The outcome of the injection site pain, muscle soreness and shoulder soreness were not reported.   It was unknown if the reporter considered the injection site pain, muscle soreness and shoulder soreness to be related to Arexvy.     It was unknown if the company considered the injection site pain, muscle soreness and shoulder soreness to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-MAR-2024 This case was reported by a consumer via (Open field AE monitoring) interactive digital media. The patient experienced injection site pain, neck muscle soreness and shoulder soreness.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: got shingles shots, and even though arm gets so sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: got shingles shots, and even though arm gets so sore). The outcome of the pain in arm was resolved (duration 3 days).   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.   It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Linked case(s) involving the same patient: US2024AMR038204   Additional Information: GSK Receipt Date: 09-MAR-2024 This case was reported via interactive digital media. The patient's got Shingles shots, and reporter stated that even though your arm gets so sore, and that lasted about 3 days for each shot, it was no where as bad as the pain from shingles. The reporter mentioned, get the shots. This was 1 of the 4 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR038177:Same reporter, diffrent patient US-GSK-US2024AMR032141:Same reporter,diffrent patient US-GSK-US2024AMR038204:same reporter, unspecifed patient with further unspecified dose US-GSK-US2024AMR032141:same reporter, different patient
Sex: U
Vaccine: RSV
Symptoms: Cough, Head discomfort, Pain
Clinical narrative: head is going to burst; ribcage when you cough; Painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of head discomfort 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 head discomfort (Verbatim: head is going to burst), cough (Verbatim: ribcage when you cough) and pain (Verbatim: Painful). The outcome of the head discomfort, cough and pain were not reported.   It was unknown if the reporter considered the head discomfort, cough and pain to be related to Arexvy.     It was unknown if the company considered the head discomfort, cough and pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-MAR-2024 This case was reported by a consumer via (Open field AE monitoring) interactive digital media. The reporter stated that was much better that the actual symptoms.  They were painful.  The reporter stated that your head was going to burst or your ribcage when you cough.  The reporter literally had to roll into.
Sex: U
Vaccine: RSV
Symptoms: Illness
Clinical narrative: sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness 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 sickness (Verbatim: sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Arexvy.     It was unknown if the company considered the sickness to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-MAR-2024 This case was reported by a consumer via (Open field AE monitoring) interactive digital media. The patient had RSV vaccine and was sick.
Sex: U
Vaccine: RSV
Symptoms: Nasopharyngitis, Pyrexia, Rhinorrhoea, Sneezing
Clinical narrative: sneezing; running nose; cold flu; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sneezing 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 sneezing (Verbatim: sneezing), runny nose (Verbatim: running nose) and febrile cold (excl flu like illness) (Verbatim: cold flu). The outcome of the sneezing, runny nose and febrile cold (excl flu like illness) were not reported.   It was unknown if the reporter considered the sneezing, runny nose and febrile cold (excl flu like illness) to be related to Arexvy.     It was unknown if the company considered the sneezing, runny nose and febrile cold (excl flu like illness) to be related to Arexvy.   Additional Information: GSK Receipt Date: 22-MAR-2024 This case was reported by a consumer via (Open field AE monitoring) interactive digital media. The reporter asked that was it possible that he/she got sneezing, running nose and cold flu symptoms after the vaccine. That was how he/she was feeling.
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: I gave the dTap (infanrix) and it was expired, on the third of March; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a infant male patient who received DTPa (Infanrix) (batch number Y4259, expiry date 03-MAR-2024) for prophylaxis.   On an unknown date, the patient received the 1st dose of Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: I gave the dTap (infanrix) and it was expired, on the third of March). 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: 18-MAR-2024 The nurse reported that the patient was received dTap (Infanrix) vaccine and it was expired on the 3rd March , which led to expired vaccine used. The reporter mentioned that patient had 1 year but the date of birth was bigger than that. The vaccine administration facility is the same as primary reporter. The reporter consent to follow up.
Age: 64.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received his second dose of Havrix at day 32 instead of 6 months after the first dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 64-year-old male patient who received HAV (Havrix) (batch number 772YT, expiry date 23-SEP-2025) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact (Havrix).   On 09-MAR-2024, the patient received the 2nd dose of Havrix. On 09-MAR-2024, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: received his second dose of Havrix at day 32 instead of 6 months after the first dose). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 19-MAR-2024 The pharmacist reported that the patient received his second dose of Havrix at day 32 instead of 6 months after the first dose.  The reporter consented to follow up via email. The patient received 2nd dose of Havrix earlier than recommended interval, which led to shortening of vaccination schedule.
Sex: F
Vaccine: MNQ
Symptoms: Product packaging confusion
Clinical narrative: Menveo One-Vial Presentation (pink) and the Menveo Two-Vial Presentation (orange) are very similar in color and could be easily confused; This non-serious case was reported by a other health professional via call center representative and described the occurrence of product packaging confusion in a female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced product packaging confusion (Verbatim: Menveo One-Vial Presentation (pink) and the Menveo Two-Vial Presentation (orange) are very similar in color and could be easily confused). The outcome of the product packaging confusion was unknown.   Additional Information: GSK Receipt Date: 19-MAR-2024 The nurse reported that the caps on the Menveo one-vial presentation (pink) and the Menveo two-vial presentation (orange) were very similar in color and could be easily confused which led to product packaging confusion. Nothing else was reported. Product quality complain was ruled out.
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age, Splenectomy
Clinical narrative: she had the splenectomy after her first bexsero dose; Inappropriate age at vaccine administration; This serious case was reported by a pharmacist via call center representative and described the occurrence of splenectomy in a 49-year-old female patient who received Men B NVS (Bexsero) (batch number PX7E2, expiry date 30-SEP-2026) for prophylaxis.   On 13-NOV-2023, the patient received the 1st dose of Bexsero. On 13-NOV-2023, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). On an unknown date, the patient experienced splenectomy (Verbatim: she had the splenectomy after her first bexsero dose) (serious criteria clinically significant/intervention required). The outcome of the splenectomy and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the splenectomy and inappropriate age at vaccine administration to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the splenectomy and inappropriate age at vaccine administration to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-MAR-2024 The pharmacist reported that the patient received her first dose of Bexsero vaccine on 127 days ago at incorrect age which led to Inappropriate age at vaccine administration.  The reported that she then had her spleen removed and wants to get another dose of Bexsero. The reported that possible adverse event is reported as she had the splenectomy after her first Bexsero dose.  The reporter consented to follow up.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: administered the 0.5ml dose/underdose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 19-year-old male patient who received HBV (Engerix B adult) (batch number 25k3m, expiry date 02-JUN-2024) for prophylaxis.   The patient's past medical history included hepatitis b (was exposed to Hepatitis B (via blood)).   On 18-MAR-2024, the patient received Engerix B adult .5 ml. On 18-MAR-2024, an unknown time after receiving Engerix B adult, the patient experienced underdose (Verbatim: administered the 0.5ml dose/underdose). The outcome of the underdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-MAR-2024 The registered pharmacist reported that the patient was exposed to Hepatitis B via blood and was administered Engerix B 20 mcg (10 mcg) last night (before the day of reporting). They saw a prescribing information that a 1 ml dose should had been administered. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received 3rd dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number 4J2NK, expiry date 25-JAN-2026) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 25th August 2023) and Shingrix (received 2nd dose on 4th November 2023).   On 11-MAR-2024, the patient received the 3rd dose of Shingrix. On 11-MAR-2024, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: received 3rd dose of Shingrix ). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date:19-MAR-2024 On 11-MAR-2024, the patient received the 3rd dose of Shingrix, which led to extra dose administered. The reporter consented to follow up.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: a vaccine that was administered that was expired; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 9-month-old male patient who received HBV (Engerix B) (batch number 7B2YL, expiry date 25-FEB-2024) for prophylaxis.   On 19-MAR-2024, the patient received Engerix B. On 19-MAR-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: a vaccine that was administered that was expired). 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: 19-MAR-2024 A medical assistant called saying the following he/she needed advice or how to proceed with a vaccine that was administered that was expired.  According to reporter, patient administered expired vaccine that day which led to expired vaccine used.  The vaccine administration facility was the same as primary reporter.
Age: 23.0
Sex: F
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: giving inadvertently a single pediatric dose of Havrix to a 23-year-old adult; giving inadvertently a single pediatric dose of Havrix to a 23-year-old adult; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 23-year-old female patient who received HAV (Havrix pediatric) (batch number X2233, expiry date 14-NOV-2025) for prophylaxis.   On 20-MAR-2024, the patient received Havrix pediatric. On 20-MAR-2024, an unknown time after receiving Havrix pediatric, the patient experienced accidental underdose (Verbatim: giving inadvertently a single pediatric dose of Havrix to a 23-year-old adult) and adult use of a child product (Verbatim: giving inadvertently a single pediatric dose of Havrix to a 23-year-old adult). The outcome of the accidental underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 20-MAR-2024 The reporter was a medical assistant. The reporter called to request information on giving inadvertently a single pediatric dose of Havrix to a adult, this happened at the time of reporting, which led to accidental underdose and adult use of a child product. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient was administered 2 doses (of Shingrix)-the doses were only 4 weeks apart; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: patient was administered 2 doses (of Shingrix)-the doses were only 4 weeks apart). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 22-MAR-2024 A patient was administered 2 doses (of Shingrix) and the doses were only 4 weeks apart. The reporter dropped chat before any additional information could be obtained. The reporter did not consent to follow-up. The patient received 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Inappropriate dose of vaccine administered; there are 5 diluntes and only 4 powder vial/Incorrect preparation; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered) and inappropriate preparation of medication (Verbatim: there are 5 diluntes and only 4 powder vial/Incorrect preparation). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK Receipt Date: 22-MAR-2024 Healthcare professional (HCP) called to report that there was not an identifiable event for error, when they opened the Shignrix box they found a mismatch, there were 5 diluntes and only 4 powder vials, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. They did not know if an actual patient received the incomplete dose, but reporter asked if the all patients should re-vaccinate. The reporter did not consent to follow-up. The Vaccine Administration Facility is the same as Primary Reporter. Healthcare professional (HCP) mentioned that was not a PQC since she had checked before and all the components were on the box. Healthcare professional (HCP) purchased the vaccines from Wholesaler.  Healthcare professional (HCP) declined to add contact information within medical database. Healthcare professional (HCP) was inquired about age of the patients, lot number of the vaccine but she said that was not an identifiable event for error and Medical information (MI) couldn't collect further adverse event (AE) details.
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I have a patient that got a dose like 10 years ago, only one, but got another one". According to reporter, the 1st dose was received in the year 2000, and the 2nd dose in 21/Mar/2024; 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 female patient who received HBV (Engerix B) (batch number C44K4) for prophylaxis.   Previously administered products included Engerix B (received 1st dose in 2000).   On 21-MAR-2024, the patient received the 2nd dose of Engerix B. On 21-MAR-2024, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: I have a patient that got a dose like 10 years ago, only one, but got another one". According to reporter, the 1st dose was received in the year 2000, and the 2nd dose in 21/Mar/2024). The outcome of the drug dose administration interval too long 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: 22-MAR-2024 The reporter called to inform the following about Engerix-B. The reporter had a patient that got a dose like 10 years ago, only one but got another one.  The reporter consented to follow up. The patient received 2nd dose of Engeix-B later than the recommended schedule, which led to lengthening of vaccination schedule.
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Medical assistant calls today 3-22-2024 to report in 1-23-2024 a dose of Kinrix was administered to a 5-month-old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-month-old male patient who received DTPa-IPV (Kinrix) (batch number F5492, expiry date 27-OCT-2024) for prophylaxis.   On 23-JAN-2024, the patient received Kinrix. On 23-JAN-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Medical assistant calls today 3-22-2024 to report in 1-23-2024 a dose of Kinrix was administered to a 5-month-old patient). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-MAR-2024 The reporter was medical assistant. The reporter reported that a dose of Kinrix was administered to a 5-month-old patient, which led to inappropriate age at vaccine administration. The reporter consented to follow up via email.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: accidentally administered the AS01B adjuvant suspension without adding it to the powder vial; Inappropriate dose of vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 7X5Y9, expiry date 02-NOV-2025) for prophylaxis.   On 21-MAR-2024, the patient received Shingrix. On 21-MAR-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: accidentally administered the AS01B adjuvant suspension without adding it to the powder vial) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 22-MAR-2024 The reporter stated that the accidentally administered the AS01B adjuvant suspension to a patient without adding it to the Shingrix powder vial, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter didn't realize there were 2 vials. This occurred yesterday afternoon. The reporter consented to follow up.  Registered nurse (RN) responded yes to providng patient details but stated that they don't have permission to give it out yet.
Sex: U
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: patient received a dose that was reconstituted with a different diluent; Inappropriate dose of vaccine administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA984A, expiry date 30-SEP-2024) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: patient received a dose that was reconstituted with a different diluent) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 25-MAR-2024 Healthcare professional (HCP) mentioned that they used the 2 vial presentation of Menveo in her facility and she realized that there was an extra vial of the Menveo diluent so she assumed that a patient received a dose that was reconstituted with a different diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The healthcare professional (HCP) asked for recommendations on this topic. The healthcare professional (HCP) mentioned that there were 3 patients who were vaccinated the same day but they were not able to determine which patient received the improperly reconstituted vaccine. The reporter confirmed during the call that the 3 patients would be re-vaccinated, meaning that two of them are going to receive and extra dose of Menveo.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPERSENSITIVITY (allergic reaction) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. ASKU) 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 HYPERSENSITIVITY (allergic reaction). At the time of the report, HYPERSENSITIVITY (allergic reaction) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The reporter stated that she called one time for a patient (unknown age or gender) with an allergic reaction (no further information was provided or details were obtained).  It was reported side effect for a patient.  The patient who was reporting extreme side effects from the drug, so Patient asked how we deal with this. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-763922 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-763922:Same reporter/different patient (AE1)
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Echocardiogram, Hyperventilation, Magnetic resonance imaging, Magnetic resonance imaging head
Clinical narrative: hyperventilation; This spontaneous case was reported by a patient and describes the occurrence of HYPERVENTILATION (hyperventilation) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 042L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) dosage was changed to 1 dosage form. On 01-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPERVENTILATION (hyperventilation). At the time of the report, HYPERVENTILATION (hyperventilation) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Negative. On an unknown date, Echocardiogram: Echocardiagram showed negative indications of any disease, defects or insufficiencies.. On an unknown date, Magnetic resonance imaging: Lung MRI showed negative indications of any disease, defects or insufficiencies.. On an unknown date, Magnetic resonance imaging head: Brain MRI showed negative indications of any disease, defects or insufficiencies..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   The patient did not experience any additional symptoms/events. It had taken 3 years and multiple tests to eliminate any underlying cause for the hypertension. They started concurrent with the vaccines. The patient had no medical history, concomitant disease or risk factor. No treatment medication was reported.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Apathy, Brain fog
Clinical narrative: brain fog; lack of motivation; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 26Apr2021 at 10:54 as dose 2, single (Lot number: EW0162) at the age of 55 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE; Lot number: EN6200), administration date: 29Mar2021, when the patient was 55-year-old, for COVID-19 immunization, reaction(s): "greater fatigue", "brain fog", "lack of motivation". The following information was reported: BRAIN FOG (non-serious) with onset 2021, outcome "unknown"; APATHY (non-serious) with onset 2021, outcome "unknown", described as "lack of motivation".  Additional information: There Were complications that aroused from receiving this vaccine, such as brain fog and the lack of motivation and the virus keeps mutating.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 39-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Dec2023 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 39 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Vasculitis" (unspecified if ongoing) and had no known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2024, outcome "recovered" (21Mar2024) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Mar2024) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 16Mar2024 to 21Mar2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 41-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 18Mar2024 to 22Mar2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Physician from medical information team.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "quadruple bypass" (unspecified if ongoing); "cardiovascular disease" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "2 episodes of acute kidney failure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The event "covid-19" required physician office visit. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical courses: Caller mentioned he has taken all the Pfizer Vaccine for COVID-19, all them, all boosters except the last one. He was bound for the hospital and his own physician prescribed him with the Pfizer oral COVID-19 5 days medication.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2, BNT162b2 omi ba.4-5 in this patient cannot be completely excluded.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single) and as dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 22Mar2024 to 27Mar2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: PNC20
Symptoms: Erectile dysfunction
Clinical narrative: Erectile disfunction; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), 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: ERECTILE DYSFUNCTION (medically significant), outcome "unknown", described as "Erectile disfunction". Clinical course: A Patient calls for information about if the administration of the Prevnar 20 vaccine was related with erectile disfunction. The Patient reported that he had been administered with the Prevnar 20 vaccine and he was suffering of erectile disfunction. Patient would like to know if there was a way to remove Prevnar 20 from the body due to an erectile dysfunction side effect he thinks that may have been caused by the vaccine. Patient also asked if erectile dysfunction is a side effect of Prevnar 20. Also asked how long the vaccine stays in the body. Caller would like to know what the difference between the Prevnar 20 and COVID vaccine.  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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 01Nov2023 as dose 1, single (Lot number: HF9300) at the age of 59 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Single, Lot number: EN6200), administration date: 17Feb2021, when the patient was 57-year-old, for Covid-19 immunization; BNT162b2 (Dose 2, Single, Lot number: EN6206), administration date: 10Mar2021, when the patient was 57-year-old, for COVID-19 immunization; BNT162b2 (Dose 3 (Booster), Single, Lot number: EW0179, Anatomical location: Left arm), administration date: 21Sep2021, when the patient was 57-year-old, for COVID-19 immunization; moderna (Dose 4 (Booster), Single, Lot number: 056A22A, Anatomical location: Left arm), administration date: 25Apr2022, when the patient was 58-year-old, for COVID-19 immunization; BNT162b2;BNT162b2 omi ba.4-5 (Dose 5 (Booster), Single, Lot number: GJ6665, Anatomical location: Left arm), administration date: 16Oct2022, when the patient was 58-year-old, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 16Mar2024 to 21Mar2024.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Severe persistent arm pain since the vaccination date
Age: 31.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: MA administered DTap-IPV (Quadracel) to a 31 year old patient.
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Vomiting
Clinical narrative: Vomiting about 20 minutes after injection
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia
Clinical narrative: Fever 105 at 16 hours post vaccine.  Treated supportively with Tylenol and Motrin after ER visit done to rule out sepsis.
Sex: F
Vaccine: VARZOS
Symptoms: Nodule, Skin mass
Clinical narrative: Pt presented to pharmacy today with golf ball size round red knot on arm. Told her to continue watching
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest, Death, Resuscitation, Seizure like phenomena, Syncope
Clinical narrative: Clinic called on 3/22/24, Mom states that patient has suddenly passed away over the weekend (3/16-17). Mom states patient was perfectly fine and outside playing at her dad's house over the weekend, when all of a sudden she collapsed. Mom states that she had seizure like activity and her heart stopped beating. Mom states that they tried, but could never get it to restart. It was ruled that her heart just stopped. Mom calling to notify PCP of this and to let her know that the there is an investigation underway to determine cause of death. Mom states that she wanted to know if the investigator had reached out to our clinic as they had questions about what vaccines patient has received this year and wanted to know who patients PCP was. Apologized to mom for her loss and informed her that PCP would be notified. Mom verbalized understanding and had no further questions or concerns.
Age: 55.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Infection, Inflammation, Peripheral swelling, Skin warm
Clinical narrative: Red swollen arm, heat producing, inflamed, infection
Sex: U
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: effected my back/ extreme paid/ I have to set down 15 minutes until it quits hurting; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation, reaction(s): "no side effects"; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation, reaction(s): "no side effects"; Bnt162b2, bnt162b2 omi ba.4-5 (DOSE 3 (BOOSTER), lot number unknown), for COVID-19 immunisation, reaction(s): "jaw issue". The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "effected my back/ extreme paid/ I have to set down 15 minutes until it quits hurting".  Additonal information: Patient had side effects when taking the COVID boosters. Patient  took the first 2 shots with no side effects. The second booster effected patient's back. Had extreme paid for months and still after 30 minutes standing patient had to set down 15 minutes until it quits hurting.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400040641 same patient/drug, different dose/event;US-PFIZER INC-PV202400040643 same patient/drug, different dose/event;
Sex: U
Vaccine: RSV
Symptoms: Drug ineffective, Pneumonia
Clinical narrative: I've had pneumonia twice and was in the hospital; I've had pneumonia twice and was in the hospital; I've had pneumonia twice and was in the hospital; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), 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: PNEUMONIA (hospitalization, medically significant), DRUG INEFFECTIVE (hospitalization, medically significant), DISEASE RECURRENCE (hospitalization, medically significant), outcome "unknown" and all described as "I've had pneumonia twice and was in the hospital". Caller called in seeking assitance with the Abrysvo vaccine.   No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: use of product after its expiry with no reported adverse event; Initial information received on 26-Mar-2024 regarding an unsolicited valid  non-serious case received from a other health professional via call center.  This case involves a 6 months old male patient who was administered with expired 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 CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination; and Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 5-Component, Polio Vaccine INACT 3V (MRC 5), Tetanus Vaccine Toxoid (Quadracel) for Prophylactic vaccination.  On 22-Mar-2024, the patient was administered with expired 0.5 ml total (dose: 3)  standard dose of suspect HIB (PRP/T) Vaccine (Powder and solvent for solution for injection) (lot UJ854AA; expiry date: 15-Mar-2024) via intramuscular route in the upper left thigh for Immunisation 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.