chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got herpes zoster the virus after receiving both doses of Shingrix / Suspected vaccination failure; herpes zoster; This serious case was reported by a non-health professional via sales rep and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: got herpes zoster the virus after receiving both doses of Shingrix / Suspected vaccination failure) (serious criteria GSK medically significant) and herpes zoster (Verbatim: herpes zoster). The outcome of the vaccination failure was unknown and the outcome of the herpes zoster was not reported.   It was unknown if the reporter considered the vaccination failure and herpes zoster to be related to Shingrix and Shingrix.  It was unknown if the company considered the vaccination failure and herpes zoster to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 22-MAY-2024 The clinic manager was informed that a patient took both series of Shingrix vaccine from the same lot number and experienced potential side effects and actually got herpes zoster the virus after receiving both doses of Shingrix vaccine. The doctor wanted him/her to report incident was not able to spoke with the provider directly only clinical manager. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 22-MAY-2024 This case was reported by a patient via interactive digital media. The patient got the shingles vaccine and then he/she got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: pain at the injeciton site; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at the injeciton site). The outcome of the injection site pain was resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-MAY-2024 The pharmacist reported that they had a patient who received 2 doses of Shingrix at their pharmacy with a similar reaction as pain at the injection site.  The reporter reported that after Shingrix first dose, the patient had pain for more than 6 months and after pain level went down. The patient received Shingrix second dose, and everything was okay.  It was reported that the pain did not bother the patient anymore. This case had been linked with US2024AMR063506, reported by same reporter.; Sender's Comments:  US-GSK-US2024AMR063506:same reporter, Different patient
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: a couple of days this residual pain raised and it is around the injection site.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In JAN-2024, the patient received the 1st dose of Shingrix (unknown arm). In JAN-2024, several days after receiving Shingrix, the patient experienced injection site pain (Verbatim: a couple of days this residual pain raised and it is around the injection site.). The outcome of the injection site pain was not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-MAY-2024 The pharmacist reported that a 61 year old patient received 1st Shingrix dose approximately in January 2024 at another pharmacy.  At that time when the vaccine was given, it hurt but then the pain subsisted and then a couple of days this residual pain raised and it was around the injection site. The pharmacist reported that, the pain happens specially when the patient try to lifts or turns his arm.  The pain increased when the angle gets larger.  It had been 2 to 3 months at the same level on the upper arm.; Sender's Comments:  US-GSK-US2024AMR063496:same reporter, Different patient
Age: 0.5
Sex: M
Vaccine: RV1
Symptoms: Extra dose administered
Clinical narrative: Rotarix that was inadvertently administered a 3rd dose to a 6 month old; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 6-month-old male patient who received Rota (Rotarix liquid formulation) (batch number Y4NG3, expiry date 03-OCT-2025) for prophylaxis.   Previously administered products included Rotarix (1st dose received on an unknown date) and Rotarix (2nd dose received on an unknown date).   On 13-MAY-2024, the patient received the 3rd dose of Rotarix liquid formulation. On 13-MAY-2024, an unknown time after receiving Rotarix liquid formulation, the patient experienced extra dose administered (Verbatim: Rotarix that was inadvertently administered a 3rd dose to a 6 month old). 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: 13-MAY-2024 and 15-MAY-2024 The reporter stated that Rotarix was administered to a patient who was supposed to be getting the last dose of Rotateq. The reporter stated that Rotarix that was inadvertently administered a 3rd dose to a patient, which led to extra dose administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: U
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: patient did not recived 3rd 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 patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 2 doses 10 years ago).   On an unknown date, the patient did not receive the 3rd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: patient did not recived 3rd 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: 17-MAY-2024 The reporter had a question about Twinrix vaccine recommendations about the administration of dosing, he/she knew that it was 3 dose series taken 0, 1 and 6 months later, his/her question was about a patient had received the first 2 doses and never received the third dose. Till the time of reporting, the patient did not receive 3rd dose of Twinrix, which led to incomplete course of vaccination. The administration of the vaccine was long time ago and in another facility, the reporter said that she did not count with batch numbers, patient initials, gender nor DOB (date of birth). The reporter did not consent to follow up
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Left arm pain when lifting arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   In JAN-2024, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: Left arm pain when lifting arm). The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-MAY-2024 The patient received Shingrix dose and reported that after the injection he developed pain in left arm that remained ongoing.  The pain happened when he lifts his arm. The reporter did not know exactly when the pain started, just that it was after the vaccine was received. The patient did not receive a second dose.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Medical assistant administered a pediatric dose of Engerix-B to an adult patient; Medical assistant administered a pediatric dose of Engerix-B to an adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 38-year-old female patient who received HBV (Engerix B) (batch number ZP72S, expiry date 15-DEC-2024) for prophylaxis.   On 21-MAY-2024, the patient received Engerix B. On 21-MAY-2024, an unknown time after receiving Engerix B, the patient experienced underdose (Verbatim: Medical assistant administered a pediatric dose of Engerix-B to an adult patient) and adult use of a child product (Verbatim: Medical assistant administered a pediatric dose of Engerix-B to an adult patient). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date: 21-MAY-2024 A medical assistant reported that she administered a pediatric dose of Engerix-B to an adult patient which led to Underdose and Adult use of a child product. The vaccine administration facility was the same as primary reporter.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Rhinorrhoea
Clinical narrative: cold; runny nose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NASOPHARYNGITIS (cold) and RHINORRHOEA (runny nose) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Down's syndrome.    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 NASOPHARYNGITIS (cold) and RHINORRHOEA (runny nose). At the time of the report, NASOPHARYNGITIS (cold) and RHINORRHOEA (runny nose) 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.   It was unknown if the patient receives any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Dosage text for suspect drug was reported as unknown.  Suspect vaccine dosage text was reported as unknown. Patient receives last dose was end of Sep-2023 States that after the past vaccines should would get a cold, a runny nose, and it would eventually clear up, she would never get a fever.  Treatment information was not provided.  Reporter causality was not reported.   This case was linked to MOD-2024-768183 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in an 82-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Heart disorder. Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) 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.   It was reported that patient took one of the earlier Moderna COVID vaccines. Also, it was reported that patient took the senior booster dosage in the first week of October 2023. Reporter also stated that she had previous doses of Moderna.   Her last vaccine was the third or fourth dose in the series and one of the Moderna COVID vaccines batch number was reported by patient as AU383413. She received the Moderna vaccine every year when it was available.  Patient read an online article on Dec-2023 in which it was stated that there was a lapse at the Moderna manufacturing plant that they did not clean the machines from the Green Monkey cancer virus that they were working on, and they went ahead and did not clean the machines and then they started on the COVID vaccine.   It was reported that total two article patient read regarding Moderna COVID vaccines.  After gone through the online article patient felt anxiety from Dec-2023 and later due to anxiety patient was on anxiety medication.    She was on anxiety medication in January or February of 2024 when she read the article on 15-Dec-2023.  No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 22-May-2024: Live follow up received in which PQC number and reference number added.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Rhinorrhoea
Clinical narrative: cold; runny nose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NASOPHARYNGITIS (cold) and RHINORRHOEA (runny nose) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concurrent medical conditions included Down's syndrome (on a feeding pump and had a lot of medical issues.).    In September 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (cold) and RHINORRHOEA (runny nose). At the time of the report, NASOPHARYNGITIS (cold) and RHINORRHOEA (runny nose) had resolved.            It was unknown if the patient receives 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. Patient receives last dose was end of Sep-2023 States that after the past vaccines should would get a cold, a runny nose, and it would eventually clear up, she would never get a fever.  Treatment information was not provided.  Reporter causality was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-768182 (E2B Linked Report). This case was linked to MOD-2024-768209 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-768182:Same reporter other patient
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (fever) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) 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.   The concomitant medication was not reported by reporter. It was reported that patient got a terrible fever.  The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-768183 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-768183:Same reporter other patient
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomited; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 25-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "vomited".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400173361 same drug/event, different patient;
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had a reaction which was like having covid again; had a reaction which was like having covid again; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose 3 (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: "Alpha Gal", start date: 2012 (ongoing); "Covid", start date: 2020 (unspecified if ongoing), notes: I had covid in the fall of 2020 before the vaccines became available. 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 "had a reaction which was like having covid again". Clinical course: Patient liked to get some information about the ingredients in our Covid Vaccines. patient would like to know if there were any mammal or mammal by-products in the vaccine. The reason patient was asking was that patient was diagnosed with Alpha Gal in Jan of this year; however, actually had it since 2012 and was misdiagnosed with IBS-D. Patient had Covid in the fall of 2020 before the vaccines became available and had all of the Covid vaccines except for the 2023. With each vaccines patient had a reaction which was like having Covid again. With the last vaccine patient took in 2022 the reaction was so bad that patient could not get out of bed for 24 hours. That was why patient had been hesitant to get any vaccines since. Now that patient knew that patient had Alpha Gal, was wondering if reactions are possibly from mammal or mamma' by-products being in the vaccines or a vaccine reaction. Would we also be able to send patient a list of our other vaccines that contain mammal or mammal by-products that can shared with patient's Alpha Gal groups. Unfortunately, mammal and mammal-by-products are in so many things that the medical community and public was not aware. This information would be greatly appreciated.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400068223 same patient/product, different dose/event;US-PFIZER INC-202400175579 same patient/product, different dose/event;US-PFIZER INC-202400175581 same patient/vaccine, different dose/event;
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had a reaction which was like having covid again; had a reaction which was like having covid again; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown) and in 2022 as dose 4 (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: "Alpha Gal", start date: 2012 (ongoing), notes: Patient was diagnosed with Alpha Gal in Jan of this year however, patient actually had it since 2012; "covid", start date: 2020 (unspecified if ongoing), notes: Patient had Covid in the fall of 2020. 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 "had a reaction which was like having covid again". Clinical course: Patient liked to get some information about the ingredients in our Covid Vaccines. patient would like to know if there were any mammal or mammal by-products in the vaccine. The reason patient was asking was that patient was diagnosed with Alpha Gal in Jan of this year; however, actually had it since 2012 and was misdiagnosed with IBS-D. Patient had Covid in the fall of 2020 before the vaccines became available and had all of the Covid vaccines except for the 2023. With each vaccines patient had a reaction which was like having Covid again. With the last vaccine patient took in 2022 the reaction was so bad that patient could not get out of bed for 24 hours. That was why patient had been hesitant to get any vaccines since. Now that patient knew that patient had Alpha Gal, was wondering if reactions are possibly from mammal or mamma' by-products being in the vaccines or a vaccine reaction. Would we also be able to send patient a list of our other vaccines that contain mammal or mammal by-products that can shared with patients Alpha Gal groups. Unfortunately, mammal and mammal-by-products are in so many things that the medical community and public was not aware. This information would be greatly appreciated.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400068223 same patient/vaccine, different dose and AE;US-PFIZER INC-202400175579 same patient/vaccine, different dose and AE;US-PFIZER INC-202400175580 same patient/vaccine, different dose and AE;
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Oct2023 at 14:00 as dose 6 (booster), single (Lot number: GH9703) at the age of 64 years, in left arm for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single), as dose 2, single), as dose 3 (booster), single), as dose 4 (booster), single) and as dose 5 (booster), single) for covid-19 immunisation; COVID-19 vaccine prot. subunit (nvx cov 2373) (NOVAVAX COVID-19 VACCINE), on 21Mar2024 at 15:00 as dose 7 (booster), single), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoarthritis" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "high intraocular pressure" (unspecified if ongoing); "known allergies: Sulfa drugs and preservatives" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid treatment from 14May2024 to 19May2024).
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, Illness, Vomiting
Clinical narrative: Still sick/was really sick & could not let head up off the bed; Threw up; I can't drive; I am afraid to drive; I have this feeling that it's like a fog; I am not clear; I am afraid to do anything; I can't remember stuff; This is a spontaneous report received from a Consumer or other non HCP.  A 90-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 15May2024 as dose 1, single (Batch/Lot number: unknown) at the age of 90 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "I have had COVID, I got COVID two years ago", start date: 2022 (unspecified if ongoing), notes: I have had COVID, I got COVID two years ago; "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID taken for thyroid disorder. The patient also took other concomitant therapy. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 2021, for COVID-19 immunization; Pfizer biontech covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization; Pfizer biontech covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Pfizer biontech covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization; Pfizer biontech covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE), for COVID-19 immunization.  The following information was reported: BRAIN FOG (non-serious) with onset May2024, outcome "not recovered", described as "I can't drive; I am afraid to drive; I have this feeling that it's like a fog; I am not clear; I am afraid to do anything; I can't remember stuff"; ILLNESS (non-serious) with onset May2024, outcome "not recovered", described as "Still sick/was really sick & could not let head up off the bed"; VOMITING (non-serious) with onset May2024, outcome "recovered" (May2024), described as "Threw up". Therapeutic measures were taken as a result of vomiting.  Additional information: The patient stated, "I got another COVID shot (Pfizer COVID-19 Vaccine Booster) on 15th of this month and I am still sick from it and I have had five other shots (Pfizer COVID-19 Vaccine) and they didn't affect me like this and I just wanted to report it because I am never going to get another one because I have been so sick. I threw up for two days and then I got a pill (Ondansetron) for throwing up. I have got this fog. So, I can't drive, and I can walk but I have this feeling that it's like a fog, I am not dizzy and it's like I am not clear and I am afraid to drive, I am afraid to do anything and I just want to report it to you because I have really been sick."  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, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I got COVID two years; I was very sick; I got COVID two years; I was very sick; This is a spontaneous report received from a Consumer or other non HCP.  An 89-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), in 2021 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: "Thyroid" (ongoing). Concomitant medication(s) included: ARMOUR THYROID taken for thyroid disorder. The patient also took other concomitant therapy. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "I got COVID two years; I was very sick". Clinical course: She got five of the Pfizer shots. When asked about e-mail address: Consumer stated, she don't, she got rid of her computer just recently because it was 18 years old and she just don't use it anymore. They would have to get her on the phone. She do have a cell phone if they want the cell phone, she could give that. She don't have an email address. She was retired great grandmother. When asked about date of vaccination (First Pfizer COVID-19 Vaccine): Consumer stated, That was like in 21. So, she couldn't tell them that date, but she could not give it but she had five and this was the sixth and she never had this problem she had COVID, she got COVID two years ago from her children they brought it to her and she was very sick with that but that was understandable but she had not been sick from the shots until this time. When probed to clarify that consumer was unable to provide product details for all five Pfizer COVID-19 vaccine, consumer stated, No, she could not. She would have to go into the clinic and get all that if they have to have that she can do that but she could not do it until Tuesday after the holiday and she could get them but she could not get them until the holiday is over. When asked about other medical conditions and medication: Consumer stated, The only medication she take was for thyroid and she had been taking it since she was 14 years old, that was the only medication she take. She was taking Vitamins and stuff like that she did not take any other medication she had no heart trouble, no diabetes nothing like that. Patient have not had any shots for a couple of years.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400178464 same reporter/patient/product, different event;
Sex: M
Vaccine: 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.  A 31-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "G6pd deficiency" (unspecified if ongoing); "thrombocytopenia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Drug allergy". The following information was reported: COVID-19 (medically significant) with onset May2024, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset May2024, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 15May2024 to 19May2024.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a Consumer or other non HCP.  A 60-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 18May2024 at 09:00, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective. Additional information: Negative test after finishing Paxlovid. Positive test four days later with return of symptoms  No follow-up attempts are possible.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: 15 children got administered a vial of ACTHIB with no reported adverse event; Initial information received on 22-May-2024 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves 15 children (unknown gender) patient who got administered a vial 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.  On an unknown date, the patient(s) received a dose of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection lot number not reported via unknown route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation (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.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: pentacel was administered by diluting it with sterile water and not the HIB component with no reported adverse event; Initial information received on 23-May-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 2 years old female patient who was administered Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] by diluting it with sterile water and not with the HIB component with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine (Suspension for injection) by diluting it with sterile water and not the HIB component with no reported adverse event (product preparation error) (latency-same day) (lot UJ980AB, strength: standard, frequency: once; expiry date not reported) via intramuscular route in the left arm for Immunization.  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.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pain, Pyrexia
Clinical narrative: Pt stated after he received the vaccine, he developed fever, dizziness, and body aches  The fever lasted until Sunday, 05/26/24. He reported a fever of 105   He is no longer symptomatic.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Heart rate increased, Hypertension, Hyperventilation, Pruritus
Clinical narrative: Full fire body rash,swollen tongue, hives and hyperventilating. I felt like I was going to die. I took benadryl to help the itching. I went to emergency room at 11am. My boyfriend dropped me off. Adavan was given. I had a rapid heart rate and high blood pressure. They put anaphylaxsis on my discharge papers and sent me home. They gave me script for epi-pens. Papers say drug interaction.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swollen tongue, Urticaria
Clinical narrative: Full fire body rash,swollen tongue, hives and hyperventilating. I felt like I was going to die. I took benadryl to help the itching. I went to emergency room at 11am. My boyfriend dropped me off. Adavan was given. I had a rapid heart rate and high blood pressure. They put anaphylaxsis on my discharge papers and sent me home. They gave me script for epi-pens. Papers say drug interaction.
Age: 33.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration
Clinical narrative: Patient received vaccine outside of ACIP/CDC guidelines
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: PATIENT CALLED COMPLAINING OF A WIDESPREAD RASH AND HIVES ON HER TORSO.  SUGGESTED ANTIHISTAMINE FOR SYMPTOMS. POSSIBLE ALLERGIC REACTION. SUGGESTED CALLING PHYSICIAN OR SEEKING URGENT CARE FOR MORE SEVERE SYMPTOMS.
Age: 79.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Comirnaty NF has been given at pharmacy on 5/24/2024, and found that the vaccine was expired on 5/4/2024. No adverse effects has been reported.
Age: 11.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects or allergic reaction. Vaccine administered post approved age range.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blood glucose normal, Syncope
Clinical narrative: Syncopal event (lasting seconds) 5 minutes after vaccine administration
Age: 44.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Arthralgia, Asthenia, Blood test, Injected limb mobility decreased, Magnetic resonance imaging head
Clinical narrative: Developed intense pain in shoulder about 48 hours after vaccination, and swelling on both sides, with swelling more prominent on the left side. Swelling and pain continued to spread to lower arms and hands, and continued following up with doctor's. Within 2 weeks of vaccination weakness began in the left hand, then right hand and shoulder. Pain has continued to this point, and weakness has gotten to the point that I can no longer lift the right arm up. The left side also has limited strength. Swelling is still prominent on the left side, and there are visible marks still visible where the vaccines were administered.
Age: 44.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Muscular weakness, Pain in extremity, Peripheral swelling, Scan with contrast, Swelling
Clinical narrative: Developed intense pain in shoulder about 48 hours after vaccination, and swelling on both sides, with swelling more prominent on the left side. Swelling and pain continued to spread to lower arms and hands, and continued following up with doctor's. Within 2 weeks of vaccination weakness began in the left hand, then right hand and shoulder. Pain has continued to this point, and weakness has gotten to the point that I can no longer lift the right arm up. The left side also has limited strength. Swelling is still prominent on the left side, and there are visible marks still visible where the vaccines were administered.
Age: 44.0
Sex: F
Vaccine: PNC20, TDAP
Symptoms: Ultrasound Doppler
Clinical narrative: Developed intense pain in shoulder about 48 hours after vaccination, and swelling on both sides, with swelling more prominent on the left side. Swelling and pain continued to spread to lower arms and hands, and continued following up with doctor's. Within 2 weeks of vaccination weakness began in the left hand, then right hand and shoulder. Pain has continued to this point, and weakness has gotten to the point that I can no longer lift the right arm up. The left side also has limited strength. Swelling is still prominent on the left side, and there are visible marks still visible where the vaccines were administered.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cyst, Dysmenorrhoea, Endometriosis, Laboratory test normal
Clinical narrative: Painful cycles, cramping, erratic periods a month after the vaccines second dose.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Ultrasound scan abnormal, Uterine leiomyoma
Clinical narrative: Painful cycles, cramping, erratic periods a month after the vaccines second dose.
Age: 9.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness postural, Presyncope, Syncope
Clinical narrative: Patient had a vasovagal episode with brief syncope that resolved within 15-20 seconds upon lying flat. Given water and vital signs were monitored. Upon standing he felt dizziness and required continued monitoring for approximately 90 minutes. He had complete resolution of symptoms after eating a small meal.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: tender/ warm to touch, knot started 10 hrs after injection with redness (3 inches), Redness decreased in size to 2 inches in 24 hrs but soreness and indirection persists at 96 hrs
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Biopsy breast, Breast cyst, Breast mass, Breast pain
Clinical narrative: I warned pharmacist I had a reaction to the first Moderna vaccine, she said she would keep me longer to monitor me. My throat closed within 3 minutes of the dose being given. She laid me on the ground on my side and administered an epi-pen from pharmacy inventory. She did not even state what kind of epi-pen she gave to me. I have 5 lesions in my brain (MRI) captured, I believe she hit a vein and moderna shot went directly to my brain. After this 2nd Moderna dose all of my leg,heart and main neurological problems started. Tingling burning in hands and feet,  numbness in all limbs,tremors in hands and legs, heart rate spiking dropping drastically some nights average BPM asleep is 170. Have extreme right leg GAIT after this Moderna 2nd dose. This 2nd vaccine also caused severe insomnia,severe breast and lymph pains, mass and cysts grew in my left breast and ovaries. I am being treated by a PCP, cardiologist, rheumatologist, OB and new neurologist on June 18th (4th) i've seen since this vaccine.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Cancer screening, Cardiac disorder, Condition aggravated, Depression
Clinical narrative: I warned pharmacist I had a reaction to the first Moderna vaccine, she said she would keep me longer to monitor me. My throat closed within 3 minutes of the dose being given. She laid me on the ground on my side and administered an epi-pen from pharmacy inventory. She did not even state what kind of epi-pen she gave to me. I have 5 lesions in my brain (MRI) captured, I believe she hit a vein and moderna shot went directly to my brain. After this 2nd Moderna dose all of my leg,heart and main neurological problems started. Tingling burning in hands and feet,  numbness in all limbs,tremors in hands and legs, heart rate spiking dropping drastically some nights average BPM asleep is 170. Have extreme right leg GAIT after this Moderna 2nd dose. This 2nd vaccine also caused severe insomnia,severe breast and lymph pains, mass and cysts grew in my left breast and ovaries. I am being treated by a PCP, cardiologist, rheumatologist, OB and new neurologist on June 18th (4th) i've seen since this vaccine.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Heart rate decreased, Heart rate increased, Hypoaesthesia, Insomnia
Clinical narrative: I warned pharmacist I had a reaction to the first Moderna vaccine, she said she would keep me longer to monitor me. My throat closed within 3 minutes of the dose being given. She laid me on the ground on my side and administered an epi-pen from pharmacy inventory. She did not even state what kind of epi-pen she gave to me. I have 5 lesions in my brain (MRI) captured, I believe she hit a vein and moderna shot went directly to my brain. After this 2nd Moderna dose all of my leg,heart and main neurological problems started. Tingling burning in hands and feet,  numbness in all limbs,tremors in hands and legs, heart rate spiking dropping drastically some nights average BPM asleep is 170. Have extreme right leg GAIT after this Moderna 2nd dose. This 2nd vaccine also caused severe insomnia,severe breast and lymph pains, mass and cysts grew in my left breast and ovaries. I am being treated by a PCP, cardiologist, rheumatologist, OB and new neurologist on June 18th (4th) i've seen since this vaccine.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Lymph node pain, Magnetic resonance imaging, Mammogram, Nervous system disorder
Clinical narrative: I warned pharmacist I had a reaction to the first Moderna vaccine, she said she would keep me longer to monitor me. My throat closed within 3 minutes of the dose being given. She laid me on the ground on my side and administered an epi-pen from pharmacy inventory. She did not even state what kind of epi-pen she gave to me. I have 5 lesions in my brain (MRI) captured, I believe she hit a vein and moderna shot went directly to my brain. After this 2nd Moderna dose all of my leg,heart and main neurological problems started. Tingling burning in hands and feet,  numbness in all limbs,tremors in hands and legs, heart rate spiking dropping drastically some nights average BPM asleep is 170. Have extreme right leg GAIT after this Moderna 2nd dose. This 2nd vaccine also caused severe insomnia,severe breast and lymph pains, mass and cysts grew in my left breast and ovaries. I am being treated by a PCP, cardiologist, rheumatologist, OB and new neurologist on June 18th (4th) i've seen since this vaccine.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Ovarian cyst, Paraesthesia, Smear cervix, Throat tightness, Tremor
Clinical narrative: I warned pharmacist I had a reaction to the first Moderna vaccine, she said she would keep me longer to monitor me. My throat closed within 3 minutes of the dose being given. She laid me on the ground on my side and administered an epi-pen from pharmacy inventory. She did not even state what kind of epi-pen she gave to me. I have 5 lesions in my brain (MRI) captured, I believe she hit a vein and moderna shot went directly to my brain. After this 2nd Moderna dose all of my leg,heart and main neurological problems started. Tingling burning in hands and feet,  numbness in all limbs,tremors in hands and legs, heart rate spiking dropping drastically some nights average BPM asleep is 170. Have extreme right leg GAIT after this Moderna 2nd dose. This 2nd vaccine also caused severe insomnia,severe breast and lymph pains, mass and cysts grew in my left breast and ovaries. I am being treated by a PCP, cardiologist, rheumatologist, OB and new neurologist on June 18th (4th) i've seen since this vaccine.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound breast
Clinical narrative: I warned pharmacist I had a reaction to the first Moderna vaccine, she said she would keep me longer to monitor me. My throat closed within 3 minutes of the dose being given. She laid me on the ground on my side and administered an epi-pen from pharmacy inventory. She did not even state what kind of epi-pen she gave to me. I have 5 lesions in my brain (MRI) captured, I believe she hit a vein and moderna shot went directly to my brain. After this 2nd Moderna dose all of my leg,heart and main neurological problems started. Tingling burning in hands and feet,  numbness in all limbs,tremors in hands and legs, heart rate spiking dropping drastically some nights average BPM asleep is 170. Have extreme right leg GAIT after this Moderna 2nd dose. This 2nd vaccine also caused severe insomnia,severe breast and lymph pains, mass and cysts grew in my left breast and ovaries. I am being treated by a PCP, cardiologist, rheumatologist, OB and new neurologist on June 18th (4th) i've seen since this vaccine.