chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Drug intolerance, Feeling hot, Heart rate increased, Hypoaesthesia, Insomnia
Clinical narrative: his brother had shoulder surgery in April 2023 for a torn cuff; His brother has insomnia and cannot sleep more than 3 hours per night; body rejects drugs prescribed medication; about 72 hours later his bother started getting numbness in face; about 72 hours later his bother started an increased heartbeat; about 72 hours later his bother started his head was hot; about 72 hours later his bother started his head was hot spinning; This non-serious case was reported by a consumer via call center representative and described the occurrence of rotator cuff tear in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAR-2023, the patient received Shingrix (unknown arm). In MAR-2023, 72 hrs after receiving Shingrix, the patient experienced numbness facial (Verbatim: about 72 hours later his bother started getting numbness in face), heartbeats increased (Verbatim: about 72 hours later his bother started an increased heartbeat), feeling hot (Verbatim: about 72 hours later his bother started his head was hot) and head spinning (Verbatim: about 72 hours later his bother started his head was hot spinning). On an unknown date, the patient experienced rotator cuff tear (Verbatim: his brother had shoulder surgery in April 2023 for a torn cuff), insomnia (Verbatim: His brother has insomnia and cannot sleep more than 3 hours per night) and drug intolerance (Verbatim: body rejects drugs prescribed medication). The patient was treated with gabapentin. The outcome of the rotator cuff tear was not reported and the outcome of the numbness facial, heartbeats increased, feeling hot, head spinning, insomnia and drug intolerance were not resolved.   It was unknown if the reporter considered the rotator cuff tear, numbness facial, heartbeats increased, feeling hot, head spinning, insomnia and drug intolerance to be related to Shingrix.     It was unknown if the company considered the rotator cuff tear, numbness facial, heartbeats increased, feeling hot, head spinning, insomnia and drug intolerance to be related to Shingrix.   Additional Information: GSK receipt date: 27-MAR-2024 The reporter was the brother of the patient.  The reporter reported that the patient had received the Shingrix vaccine (unknown if it was the first or second dose). At the same time the patient received the Shingrix vaccine, the reporter reported the patient had received an unknown booster vaccine. It was not known if the injections were the same or opposite arms. About 72 hours later the patient experienced numbness in face, an increased heartbeat, his head was hot and spinning. The reporter also reported that the patient's body had rejects all drugs such as the gabapentin prescribed by his doctor to help these symptoms. The reporter reported that the doctors could not figure out what was causing these symptoms. No other details was known. The reporter did not consent to follow-up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Rotator cuff syndrome, Vertigo
Clinical narrative: his brother had shoulder surgery in April 2023 for a torn cuff; His brother has insomnia and cannot sleep more than 3 hours per night; body rejects drugs prescribed medication; about 72 hours later his bother started getting numbness in face; about 72 hours later his bother started an increased heartbeat; about 72 hours later his bother started his head was hot; about 72 hours later his bother started his head was hot spinning; This non-serious case was reported by a consumer via call center representative and described the occurrence of rotator cuff tear in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAR-2023, the patient received Shingrix (unknown arm). In MAR-2023, 72 hrs after receiving Shingrix, the patient experienced numbness facial (Verbatim: about 72 hours later his bother started getting numbness in face), heartbeats increased (Verbatim: about 72 hours later his bother started an increased heartbeat), feeling hot (Verbatim: about 72 hours later his bother started his head was hot) and head spinning (Verbatim: about 72 hours later his bother started his head was hot spinning). On an unknown date, the patient experienced rotator cuff tear (Verbatim: his brother had shoulder surgery in April 2023 for a torn cuff), insomnia (Verbatim: His brother has insomnia and cannot sleep more than 3 hours per night) and drug intolerance (Verbatim: body rejects drugs prescribed medication). The patient was treated with gabapentin. The outcome of the rotator cuff tear was not reported and the outcome of the numbness facial, heartbeats increased, feeling hot, head spinning, insomnia and drug intolerance were not resolved.   It was unknown if the reporter considered the rotator cuff tear, numbness facial, heartbeats increased, feeling hot, head spinning, insomnia and drug intolerance to be related to Shingrix.     It was unknown if the company considered the rotator cuff tear, numbness facial, heartbeats increased, feeling hot, head spinning, insomnia and drug intolerance to be related to Shingrix.   Additional Information: GSK receipt date: 27-MAR-2024 The reporter was the brother of the patient.  The reporter reported that the patient had received the Shingrix vaccine (unknown if it was the first or second dose). At the same time the patient received the Shingrix vaccine, the reporter reported the patient had received an unknown booster vaccine. It was not known if the injections were the same or opposite arms. About 72 hours later the patient experienced numbness in face, an increased heartbeat, his head was hot and spinning. The reporter also reported that the patient's body had rejects all drugs such as the gabapentin prescribed by his doctor to help these symptoms. The reporter reported that the doctors could not figure out what was causing these symptoms. No other details was known. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Therapeutic response unexpected
Clinical narrative: No herpes outbreaks since receiving the vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of unexpected therapeutic effect in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes simplex type ii (have had usually one or two herpes type 2 outbreaks a year).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced unexpected therapeutic effect (Verbatim: No herpes outbreaks since receiving the vaccine). The outcome of the unexpected therapeutic effect was unknown.   Additional Information: GSK Receipt Date: 01-APR-2024 The patient was the reporter. The patient received the Shingrix vaccine 3 years ago (from the date of reporting) and stated that she has not had any herpes type 2 outbreaks since receiving the vaccination. Before receiving the Shingrix vaccine she would have usually one or two outbreaks a year. The caller (reporter) stated that she lives a healthy lifestyle as she got lots of sleep, had a good diet and did moderate exercise. The patient called to report this as she stated it was a remarkable benefit and she hopes that her reporting this could contribute to more research in possibly developing a Herpes vaccine. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: left arm pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-APR-2024, the patient received the 2nd dose of Shingrix. On 01-APR-2024, less than a day after receiving Shingrix, the patient experienced pain in arm (Verbatim: left arm pain). The outcome of the pain in arm was unknown.   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: 01-APR-2024 The reporter was the patient who received his second dose of Shingrix today (on the day of reporting) and reported left arm pain. The reporter did not consent to follow-up.
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: second dose of Arexvy was inadvertently given to a patient today on 02-April-2024; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 73-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number HM9849) for prophylaxis.   Previously administered products included Arexvy (received 1st dose on 21th September 2023).   On 02-APR-2024, the patient received the 2nd dose of Arexvy. On 02-APR-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: second dose of Arexvy was inadvertently given to a patient today on 02-April-2024). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 02-APR-2024 The pharmacist called and reported that second dose of Arexvy was inadvertently given to a patient today (on the day of reporting), which led to extra dose administered. The vaccine administration facility was the same as primary reporter The reporter consented to follow up via email.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Gait inability, Pain in extremity, Rash, Varicella zoster virus infection
Clinical narrative: while in the hospital for "not walking".; it was probably zoster.; rash approximately 2 weeks in the top of her left foot, a rash on her back, and one blister on her left arm; rash approximately 2 weeks in the top of her left foot, a rash on her back, and one blister on her left arm; still having pain in her foot; This spontaneous report was received from a physician via a company representative and concerned to a 3-year-old female patient. The patient did not have a pertinent medical history, drug reactions and or allergies, concurrent conditions, or concomitant medications.   On 25-MAY-2021, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, lot #T028308, expiration date: 20-AUG-2022, administered for prophylaxis in the left leg when she was a 1 year old (strength, and route of administration were not provided).  On an unknown date in 2024, the patient was "not walking" (Gait inability) for which she was admitted to the hospital. Moreover, on an unspecified date in March 2024 (also reported as approximately 2 weeks ago)  while inpatient, she developed a rash on the top of her left foot, a rash on her back, and one blister on her left arm. The physician did not have any details regarding the patient's hospitalization, but confirmed that she saw her in her office on an unspecified date in 2024, after she was discharged (on another unspecified date in 2024). The physician stated, that she had another colleague look at the rash with her and they thought it was probably zoster (Varicella zoster virus infection). She stated they did not culture or treat the rash and just used their clinical judgement, she also added that it was ''interesting because it was all a left sided rash'' (as the patient had been vaccinated in her left leg). The physician stated that since she initially saw the patient, the lesion on the arm (blister) was resolved on an unspecified date in 2024, the back was improved, and the foot was almost completely healed and that she had improved enough that there was nothing to sample at this point, so she was recovering from the event of rash, but was still having pain in her foot (pain in extremity) (onset, unspecified date in 2024), so she had not recovered from this event. At the time of reporting, the outcome of gait inability had not been reported.   The causal relationship between varicella virus vaccine live (oka/merck) (VARIVAX) and all the events was not provided.
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired medication administered; 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 female patient who received Men B NVS (Bexsero) (expiry date 31-MAR-2024) for prophylaxis.   On 01-APR-2024, the patient received Bexsero. On 01-APR-2024, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired medication administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-APR-2024 The office manager called to inform about Bexsero vaccine that it looked like the medication expired yesterday (day before reporting), but it was given to a patient today (on the day of reporting), which led to an expired vaccine used. The vaccine administration facility was the same as primary reporter. The reporter consent to follow up.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Headache, Inappropriate schedule of product administration, Tinnitus, Vision blurred
Clinical narrative: Patient had his first dose on 26Apr2023/asking if it is safe to give a 2nd dose; headache; blurry vision; ringing in her ears; This is a spontaneous report received from an Other HCP from medical information team.  A 17-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), on 26Apr2023 as dose 1, single (Batch/Lot number: unknown) for immunisation; meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), on 26Apr2023 as dose number unknown, single) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VISION BLURRED (non-serious) with onset 26Apr2023, outcome "recovered" (27Apr2023), described as "blurry vision"; HEADACHE (non-serious) with onset 26Apr2023, outcome "recovered" (27Apr2023); TINNITUS (non-serious) with onset 26Apr2023, outcome "recovered" (27Apr2023), described as "ringing in her ears"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Patient had his first dose on 26Apr2023/asking if it is safe to give a 2nd dose".  Additional information: HCP called in and is asking if it is safe to give a 2nd dose to a 17-year-old male patient. He had a previous reaction last year with a combination of MCV4 and Men B vaccine. Patient had his first dose on 26Apr2023. On 02Apr2024, the reporter wanted to know if they can apply a second dose of Men B which is the Trumenba vaccine since a patient of the doctor had a previous reaction but that was last year. The issue they have is that the patient received 2 vaccines last year, Menactra and Trumenba and they don't know what caused the side effect if it was Menactra or Trumenba. She did have reaction to it. She had a headache, blurry vision and ringing in her ears that lasted about 2 days. That was 26Apr2023. The patient was behind on her 2nd dose and came back yesterday and wanted to get the 2nd dose of Meningitis B and they checked her file and saw she had the reaction previous. They didn't apply the vaccine because they want to make sure that it's safe to do the 2nd dose.   Follow-up (02Apr2024, 03Apr2024, 04Apr2024): This is a spontaneous follow-up report received from same Other-HCP. Updated information: reporter details, patient details (gender updated to female), new suspect drug (Menactra), concomitant medications removed, new events (headache, blurry vision, ringing in her ears).  The information on the batch/lot number for meningococcal group b Rlp2086 will be requested and submitted if and when received.
Sex: U
Vaccine: RSV
Symptoms: Device connection issue, Syringe issue
Clinical narrative: she describe how they were defective is that a glass piece did not allow for the attachment of the syringe/The syringe kept breaking when using it.; This is a spontaneous report received from an Other HCP.  A patient (age and gender not provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HA3218, Expiration Date: Mar2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYRINGE ISSUE (non-serious), described as "she describe how they were defective is that a glass piece did not allow for the attachment of the syringe/The syringe kept breaking when using it.". Additional information: NDC number of Abrysvo: 0069-0250-01. She describe Kits, She is interested for the replacement of doses and how she describe how they were defective is that a glass piece did not allow for the attachment of the syringe. She may have a needle but just did not allow for the attachment. If the product is given to any patient: Reporter stated, "No, it was not given as we are not able to dilute." LOT#: Reporter stated, "HR4390." Expiration date: Reporter stated, "Feb2025." NDC#: Reporter stated, "0069-0344-01." UPC#: Reporter stated, "I am trying to find that I am not able to see it." Product details for diluent: LOT#: Reporter stated, "HA3218." Expiration date: Reporter stated,  "Mar2025." NDC#: Reporter stated, "0069-0250-01." Product details for adaptor: Reporter stated, "Unfortunately they tossed the thing here. Only thing I have is the needles or the syringes." When clarified the product details for the syringe, reporter stated, "That is what on the box, but on the syringe it is HA3218. Yes, the syringe where the diluent is in, diluent yes." When clarified the NDC#: Reporter stated, on the syringe the NDC# is 0069-0250-01."Purchase detail: Reporter stated, "We Purchase it through vaccine shop. So, we have the direct person that we go through." Is a sample of the product available to be returned, if requested: Reporter stated, "Yes, we just have the syringe part of it is all we have  to send back, yes." Packaging sealed and intact: Reporter stated, "No, it is not sealed that is how we found out that it was not right because we had opened it."  Causality for "she describe how they were defective is that a glass piece did not allow for the attachment of the syringe/the syringe kept breaking when using it." was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).
Age: 63.0
Sex: M
Vaccine: PNC20
Symptoms: Death, Guillain-Barre syndrome, Immunoglobulin therapy, Laboratory test abnormal, Treatment failure
Clinical narrative: Guillain Barre syndrome; This is a spontaneous report received from an Other HCP.  A 63-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 06Mar2024 at 20:36 as dose number unknown, 0.5 ml single (Lot number: HG7740, Expiration Date: 30Apr2025) at the age of 63 years intramuscular, in left arm for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMLODIPINE; ASPIRIN [ACETYLSALICYLIC ACID]; ATORVASTATIN; HYDROCHLOROTHIAZIDE; LANTUS; METFORMIN; METOPROLOL. The following information was reported: GUILLAIN-BARRE SYNDROME (death, hospitalization) with onset 16Mar2024, outcome "fatal", described as "Guillain Barre syndrome". The patient was hospitalized for guillain-barre syndrome (start date: Mar2024, discharge date: 2024). The patient underwent the following laboratory tests and procedures: lab work: (Mar2024) abnormal, notes: Reporter stated, "They are abnormal, there is like over a hundred lab.". Therapeutic measures were taken as a result of guillain-barre syndrome. The patient date of death was 04Apr2024. Reported cause of death: "Guillain Barre syndrome". It was not reported if an autopsy was performed. Clinical details: Treatment for Guillain barre syndrome included IVIg, unfortunately, it does not work. Causality was reported as "Yes" by the reporter. NDC number of Prevnar 20: 0005200001.; Sender's Comments: There is not a reasonable possibility that the reported event Guillain Barre syndrome was related to the suspect product event most likely due to patient underlying contributory factors.; Reported Cause(s) of Death: Guillain Barre syndrome
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Pharmacist.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Aug2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "menopause" (unspecified if ongoing). The 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 Apr2024, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 07Apr2024.   The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: A causal relationship to the suspect drug BNT162B2 cannot be excluded for event drug ineffective. This case will be reassessed upon receipt of additional information.
Age: 68.0
Sex: M
Vaccine: 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 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 14Feb2021 at 15:45 as dose 1, single (Batch/Lot number: unknown) at the age of 66 years in left arm and on 07Mar2021 at 11:30 as dose 2 , single (Batch/Lot number: unknown) at the age of 66 years in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood Pressure" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "Opioids Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "known allergies: Morphine". The following information was reported: COVID-19 (medically significant) with onset 2024, outcome "unknown", described as "COVID 19"; DRUG INEFFECTIVE (medically significant) with onset 2024, outcome "unknown", described as "COVID 19 ". Also reported that Paxlovid was administered as covid-19 treatment on 04Apr2024. Therapeutic measures were taken as a result of drug ineffective, covid-19.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: 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 50-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.Patient had no known allergies. 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 31Mar2024 to 04Apr2024.   The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: RSV
Symptoms: Dysphonia, Malaise
Clinical narrative: I am sick; I normally don't sound like this; 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: ILLNESS (non-serious), outcome "unknown", described as "I am sick"; DYSPHONIA (non-serious), outcome "unknown", described as "I normally don't sound like this". Additional information: Patient called for assistance with RSV vaccine Abrysvo. During the call the patient stated, "excuse me I'm sick. I normally don't sound like this."    No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: got the shot last week and felt like I had the real Covid for 2 days; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An adult 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: COVID-19 (non-serious), outcome "unknown", described as "got the shot last week and felt like I had the real Covid for 2 days".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Suspected COVID-19
Clinical narrative: got the shot last week and felt like I had the real Covid for 2 days; This is a spontaneous report received from a Consumer or other non HCP, Program ID. An adult 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: COVID-19 (non-serious), outcome "unknown", described as "got the shot last week and felt like I had the real Covid for 2 days".  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: pain and numbness on my left arm/Sharp pain and shock continue to happen when lifting items or working; pain and numbness on my left arm; This is a spontaneous report received from a Consumer or other non HCP, Program ID.  An adult 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain and numbness on my left arm/Sharp pain and shock continue to happen when lifting items or working"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "pain and numbness on my left arm". Additional information: Since the Pfizer Covid shot, patient was having pain and numbness on left arm. This has been happening for a while. Patient thought it will go away but it never did. Sharp pain and shock continue to happen when lifting items or working. Patient was a  truck driver and this has been affecting ability to work and perform daily activities. Patient/s wife and kids took the Covid vaccine but didn't have issues, except patient with pain.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Adacel was exposed to 32c upto 26 hours and was administered to a patient post excursion with no reported adverse event; Adacel was exposed to 32c upto 26 hours and was administered to a patient post excursion with no reported adverse event; Initial information received on 04-Apr-2024 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves an unknown age and unknown gender patient who was administered with Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] post excursion no reported adverse event and it was reported that adacel was exposed to 32 degree Celsius (c) upto 26 hours.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 03-Apr-2024, the patient had received (dose and units unknown) of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine (Suspension for injection) (lot U7948BA; expiration date and strength not reported) via unknown route in unknown administration site for immunization (poor quality product administered) (Latency: same day).  On an unknown date it was reported that Diphtheria-2/Tetanus/5 AC Pertussis Vaccine was exposed to 32c upto 26 hours and was administered to a patient post excursion with no reported adverse event (product storage error) (unknown latency)   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: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Allergy to vaccine, Dermatitis allergic, Immunisation reaction, Injection site erythema, Injection site pain
Clinical narrative: "PT came in to have her TB injection read. TB test negative and recorded, however. PT mentioned that her shoulder was tender where she had gotten a TDap injection on 4/8/24. Injection site was red, hot to the touch, tender, swollen, rash site about 3" in diameter. I had my urgent care physician on site review site, determined it was a reaction to the vaccine. Pt has had a Td before with no issue, added pertusses to her allergy list. Reaction reported. Precautions given to pt. Suggested pt take ibuprofen and ice pack to treat, return to clinic to re-evaluate if not resolving". Observation from MA.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Mycobacterium tuberculosis complex test negative, Pruritus
Clinical narrative: "PT came in to have her TB injection read. TB test negative and recorded, however. PT mentioned that her shoulder was tender where she had gotten a TDap injection on 4/8/24. Injection site was red, hot to the touch, tender, swollen, rash site about 3" in diameter. I had my urgent care physician on site review site, determined it was a reaction to the vaccine. Pt has had a Td before with no issue, added pertusses to her allergy list. Reaction reported. Precautions given to pt. Suggested pt take ibuprofen and ice pack to treat, return to clinic to re-evaluate if not resolving". Observation from MA.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Rash, Skin discolouration, Skin warm
Clinical narrative: "PT came in to have her TB injection read. TB test negative and recorded, however. PT mentioned that her shoulder was tender where she had gotten a TDap injection on 4/8/24. Injection site was red, hot to the touch, tender, swollen, rash site about 3" in diameter. I had my urgent care physician on site review site, determined it was a reaction to the vaccine. Pt has had a Td before with no issue, added pertusses to her allergy list. Reaction reported. Precautions given to pt. Suggested pt take ibuprofen and ice pack to treat, return to clinic to re-evaluate if not resolving". Observation from MA.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Myalgia
Clinical narrative: pain and swelling at injection site (left arm); moderate to severe pain in left pectoral muscle area
Age: 72.0
Sex: M
Vaccine: COVID19-2, RSV, VARZOS
Symptoms: Gait disturbance, Micturition urgency, Muscular weakness, Restless legs syndrome
Clinical narrative: Vaccines were administered to patient on 3/30/24. Starting 3/31/24 patient began to experience weakness in the right leg and difficultly walking. This resolved after a few days. Since then patient reports restless leg syndrome on the right leg. He reports also experiencing an increase in the urge to urinate.  Patient did not seek medical care and only reported these symptoms to the pharmacy on 4/11/24. He was encouraged to see his doctor for an exam.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Tinnitus
Clinical narrative: Redness and swelling at vaccine site within 30 minutes of receiving vaccine. Rash at site of vaccine 3 days after vaccine. Tinnitus started 3 days after receiving vaccine.
Age: 18.0
Sex: F
Vaccine: DTAP, HEP, HPV9
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: DTaP was given to 18 year old patient instead of TDaP. Per system: If the inadvertent administration of DTaP instead of Tdap as part of the catch-up series occurred in a child age ?10 years, the DTaP counts as the adolescent Tdap dose (as well as the catch-up dose). at 3:30pm, patient was called to see if she had any symptoms, and was notified of this error.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Around 2 weeks after receiving my 2nd Moderna Covid 19 vaccine I developed tinnitus in both my ears.  I had never had any ear issues up until that point in my life.  After a little research, I discovered others experiencing the same injury after receiving Covid-19 vaccines.  My symptoms are constant, never go away.  The ?volume? has increased in my left ear over that past 6 months.  The constant ringing is a large hindrance in my life.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Pain, Pain in extremity
Clinical narrative: Patient has sometimes has sharp shooting pain in arm and two numb fingers in hand since the vaccine.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Patient uncooperative, Underdose
Clinical narrative: THIS WRITER ADVISED MOTHER TO HOLD PATIENT ON HER LAP AND HOLD PATIENT TIGHTLY TO PREVENT INJURY TO PATIENT/MOTHER/NURSE. AS THIS NURSE WAS INJECTING MMRV SUBQ INTO LEFT ARM,  MOM DID NOT ADEQUENTLY SECURE PATIENT'S ARM. THEREFORE PATIENT MOVED HIS ARM AND NEEDLE CAME OUT OF ARM WHILE VACCINE WAS BEING PUSHED. THIS WRITER WAS UNSURE HOW MUCH VACCINE WAS INJECTED. THEREFORE, I CONSULTED WITH DR PEDIATRICIAN AND DR PEDIATRICIAN WHO THEN GOT THEIR RESOURCE FROM IMMUNIZE.ORG WHICH STATES, "When injectable vaccine volume is lost (patient moves, syringe leaks), it may be difficult to judge how much vaccine the patient actually received. Use your discretion to determine whether an adequate dose was given. In general, you should treat this as a nonstandard injectable dose and should not count it. If it was an inactivated vaccine, you should re-immunize the person as soon as possible. In the case of Shingrix (RZV; GSK) if the person is still in the office the dose can be repeated immediately; however, if the repeat Shingrix dose cannot be given on the same day CDC recommends that it should be given 4 weeks after the invalid dose. If it was a live vaccine, you can give another dose if you detect the error on the same clinic day; otherwise, you should wait 28 days to give the next dose. However, if part of a dose of an oral vaccine (rotavirus) was spit out by an infant, count the dose and do not administer a second dose. If a person sneezes after live attenuated influenza vaccine (Flumist; AstraZeneca) the dose can be counted as valid."
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: The patient received a third shingle vaccine after they received their first (02/06/2020) and second (08/17/2020) in 2020. The patient was contacted after this was discovered and they reported no issues at the time.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Conjunctivitis, Dizziness, Fatigue, Headache, Malaise
Clinical narrative: I did not experience any adverse event immediately after treatment. Aug 2021, I had conjunctivitis and was sick in bed for two weeks. Tested neg for Covid-19, however, had all the symptoms, fatigue, massive headache, nausea, dizziness, muscle pain.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Myalgia, Nausea, Petechiae, Rash
Clinical narrative: I did not experience any adverse event immediately after treatment. Aug 2021, I had conjunctivitis and was sick in bed for two weeks. Tested neg for Covid-19, however, had all the symptoms, fatigue, massive headache, nausea, dizziness, muscle pain.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: I did not experience any adverse event immediately after treatment. Aug 2021, I had conjunctivitis and was sick in bed for two weeks. Tested neg for Covid-19, however, had all the symptoms, fatigue, massive headache, nausea, dizziness, muscle pain.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Drug eruption, Rash
Clinical narrative: Drug rash that appears on torso, chest, neck,  and back, also prominent in front of arm pits.  On-going rash, taking antihistamine.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: PT REPORTS PAIN ON LEFT ARM AT INJECTION SITE, HARD FOR PATIENT TO MOVE THE ARM.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Anxiety, Feeling abnormal, Gait disturbance, Pain in extremity
Clinical narrative: On 04-09-24, after my shower getting ready for work, around 8:30 am , my right toes starting hurting so bad I could not walk.  I made myself walk around and they started to feel better.   On my left hand, my 3rd finger had a screaming sharp pain going on one side of the the finger.  It finally stopped.  I went to work at 9:30 am.   As the day continued, I started to feel like I could possible die.  I just felt terrible.   I went home at 1:30  pm.  I  slept the rest of the day.  I took 1 Ibuprofen and 1 Acetaminophen when I went to bed.   I went to work 04-11-24.  I feel better however I still don't feel like me.   Maybe in the next couple of days I will be feel like me again.
Age: 59.0
Sex: F
Vaccine: RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: NO ADVERSE REACTIONS., RSV WAS ADMINISTERED TO PT LESS THAN 60 YEARS OLD. NO COMPLAINS, NO ADVERSE EVENTS WERE REPORTED. SPOKED  TO PT ,SHE HAS NO COMPLAINTS
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Electrocardiogram, Full blood count, Headache
Clinical narrative: vaccine given 2 days after vaccination date. night of vaccination pt experienced HA, neck pain, chills, chest tightness, L arm pain. symptoms persistent to 4/11 but much improved
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Metabolic function test, Neck pain, Pain in extremity, Red blood cell sedimentation rate normal
Clinical narrative: vaccine given 2 days after vaccination date. night of vaccination pt experienced HA, neck pain, chills, chest tightness, L arm pain. symptoms persistent to 4/11 but much improved
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Syringe issue, Underdose
Clinical narrative: Upon administering vaccine (Boostrix) at approximately 1:15 PM, medication/vaccine squirted outward instead of into the injection site (minimal amount given to patient). Dose was wasted and patient was revaccinated one inch above initial injection site. Patient tolerated vaccine fine with no symptoms after fifteen-minute waiting period. It is unknown what caused leaking/squirting of medication from syringe; cap was screwed on to ensure adequate seal and assessed for leaking before administration. It is possible cap was twisted too many times/too tightly or there was damage to needle prior to use.
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Blood test normal, Computerised tomogram normal, Dyspnoea, Laboratory test normal, Pulmonary embolism
Clinical narrative: pulmonary embolism; short of breath; Initial information received on 04-Apr-2024 regarding an unsolicited valid  serious case received from a Patient.  This case involves female patient (unknown age) who and pulmonary embolism after receiving Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Tetanus Vaccine for Prophylactic vaccination.  On an unknown date in Jul- 2023, the patient received a dose of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine (Suspension for injection) (lot U7870AB, dose, strength, expiry date not reported) via unknown route in unknown administration site for Immunization.  On an unknown date in Oct-2023 (latency: 2.5 months) the patient had developed pulmonary embolism with symptom short of breath (dyspnoea) following the administration of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the events.  Seriousness criteria: Medically significant and  patient was hospitalized for the events.; Sender's Comments: Sanofi company comment dated 09-Apr-2024: This case involves female patient (unknown age) who had short of breath and pulmonary embolism after receiving Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel]. Concomitant medications included Tetanus Vaccine for Prophylactic vaccination.Further information on allergy history, previous laboratory investigations; patient's medical history, concurrent conitions, past medications, concomitant medications excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported, the role of the individual suspect vaccine cannot be assessed.
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Dyspnoea, Pulmonary embolism
Clinical narrative: pulmonary embolism; short of breath; Initial information received on 04-Apr-2024 regarding an unsolicited valid  serious case received from a Patient.  This case involves female patient (unknown age) who and pulmonary embolism after receiving Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Tetanus Vaccine for Prophylactic vaccination.  On an unknown date in Jul- 2023, the patient received a dose of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine (Suspension for injection) (lot U7870AB, dose, strength, expiry date not reported) via unknown route in unknown administration site for Immunization.  On an unknown date in Oct-2023 (latency: 2.5 months) the patient had developed pulmonary embolism with symptom short of breath (dyspnoea) following the administration of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the events.  Seriousness criteria: Medically significant and  patient was hospitalized for the events.; Sender's Comments: Sanofi company comment dated 09-Apr-2024: This case involves female patient (unknown age) who had short of breath and pulmonary embolism after receiving Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel]. Concomitant medications included Tetanus Vaccine for Prophylactic vaccination.Further information on allergy history, previous laboratory investigations; patient's medical history, concurrent conitions, past medications, concomitant medications excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported, the role of the individual suspect vaccine cannot be assessed.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Angioedema, Condition aggravated, Gastrointestinal oedema, Joint swelling
Clinical narrative: Nasal Swab/ Covid tested Positive; Nasal Swab/ Covid tested Positive; This is a spontaneous report received from a Consumer or other non HCP.  A 20-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2020 as dose 1, single (Batch/Lot number: unknown), in right arm and in May2020 as dose 2, single (Batch/Lot number: unknown) at the age of 16 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "mast cell activation syndrome" (unspecified if ongoing), notes: None other than the above mentioned mast cell activation syndrome. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Nasal Swab/ Covid tested Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) Positive.  Clinical Course: Results of tests and procedures for investigation of the patient: Date: Nov2023; Test: Unknown home test Result Positive; Lab Notes Nasal Swab. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications the patient within 2 weeks of vaccination. Prior to vaccination, the patient has not been diagnosed with COVID-19. Since the vaccination the patient has been tested for COVID-19. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mast cell activation syndrome, Pharyngeal swelling, SARS-CoV-2 test, Urticaria, Vomiting
Clinical narrative: Nasal Swab/ Covid tested Positive; Nasal Swab/ Covid tested Positive; This is a spontaneous report received from a Consumer or other non HCP.  A 20-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2020 as dose 1, single (Batch/Lot number: unknown), in right arm and in May2020 as dose 2, single (Batch/Lot number: unknown) at the age of 16 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "mast cell activation syndrome" (unspecified if ongoing), notes: None other than the above mentioned mast cell activation syndrome. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Nasal Swab/ Covid tested Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) Positive.  Clinical Course: Results of tests and procedures for investigation of the patient: Date: Nov2023; Test: Unknown home test Result Positive; Lab Notes Nasal Swab. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications the patient within 2 weeks of vaccination. Prior to vaccination, the patient has not been diagnosed with COVID-19. Since the vaccination the patient has been tested for COVID-19. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.