chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: swelling at the site of his Shingrix injection; warmth at injection site; itching at the site of his Shingrix injection; redness at the site of his Shingrix injection; rash at the site of his Shingrix injection; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In AUG-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). In AUG-2023, 2 days after receiving Shingrix, the patient experienced injection site rash (Verbatim: rash at the site of his Shingrix injection), injection site erythema (Verbatim: redness at the site of his Shingrix injection), injection site swelling (Verbatim: swelling at the site of his Shingrix injection), injection site itching (Verbatim: itching at the site of his Shingrix injection) and injection site warmth (Verbatim: warmth at injection site).  The outcome of the injection site rash, injection site erythema, injection site swelling, injection site itching and injection site warmth were not resolved.   It was unknown if the reporter considered the injection site rash, injection site erythema, injection site swelling, injection site itching and injection site warmth to be related to Shingrix.     It was unknown if the company considered the injection site rash, injection site erythema, injection site swelling, injection site itching and injection site warmth to be related to Shingrix.   Additional Information: GSK receipt date: 31-AUG-2023 The patient called to ask if his rash, redness, swelling and itching at the site of his Shingrix injection was a sign of a serious allergic reaction.   The patient received his 1st Shingrix dose about one and a half weeks ago.   Two days later these symptoms began and still remain. No consent as he had not discussed this with his doctor yet.  The patient referred to his health care professional (HCP). The reporter did not consent to follow-up.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Menveo + reconstitution with Sterile water; Menveo + reconstitution with Sterile water; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMZA74888, expiry date 30-NOV-2023) for prophylaxis.   On 31-AUG-2023, the patient received Menveo. On 31-AUG-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo + reconstitution with Sterile water) and inappropriate dose of vaccine administered (Verbatim: Menveo + reconstitution with Sterile water).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 31-Aug-2023 The case was reported by the pharmacist. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. A pharmacist reconstituted Menveo (lyophilized part) with sterile water and was administered to patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Tenderness
Clinical narrative: soreness; tenderness; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23-MAY-2023, the patient received the 1st dose of Shingrix (left deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: soreness) and tenderness (Verbatim: tenderness).  The outcome of the pain and tenderness were unknown.   It was unknown if the reporter considered the pain and tenderness to be related to Shingrix.     It was unknown if the company considered the pain and tenderness to be related to Shingrix.   Linked case(s) involving the same patient:  US2023119283   Additional Information: GSK Receipt Date: 31-AUG-2023 The reporter was the patient.   The patient received the 1st dose of Shingrix and experienced soreness and tenderness.   The patient received the second dose around August 18, 2023.  Both doses of the vaccine were administered in the upper left arm. The reporter consented to follow up. For tolerance of 2nd dose refer case US2023119283, reported by same reporter.; Sender's Comments:  US-GSK-US2023119283:2nd dose
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Stored in the home refrigerator and sent to the group home where the patient lives; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 36-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2B723, expiry date 17-OCT-2025) for prophylaxis.   On 27-AUG-2023, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Stored in the home refrigerator and sent to the group home where the patient lives).  The outcome of the incorrect storage of drug 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-SEP-2023 The reporter reported that administration of the Boostrix vaccine that had an unknown time and temperature excursion. The reporter reported that the Boostrix vaccine was delivered to a patient's family as it was stored in the home refrigerator and sent to the group home where the patient lives and sent to their pharmacy for administration by the group home pharmacy which was 40 miles away in a cooler, which led to Incorrect storage of drug. The reporter consented to follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: patient that received 3 Shingrix Vaccine doses; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 2018) and Shingrix (received 2nd dose on 2018 ).   On 01-SEP-2023, the patient received the 3rd dose of Shingrix (intramuscular). On 01-SEP-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: patient that received 3 Shingrix Vaccine doses).  The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 01-SEP-2023 Recommended dose was 2 Shingrix vaccines per Package insert content. The patient received 3rd dose of Shingrix, which led extra dose administration. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Breast cancer, Pain in extremity, Psoriatic arthropathy
Clinical narrative: Breast cancer; Sore arm with all 4; After dose 2 exacerbation of psoriatic arthritis symptoms; This spontaneous case was reported by a non-health professional and describes the occurrence of PSORIATIC ARTHROPATHY (After dose 2 exacerbation of psoriatic arthritis symptoms) and BREAST CANCER (Breast cancer) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21A, 012L20A and 039K20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy (Sulfa allergy), Drug allergy (Zofran allergy) and Psoriatic arthritis (psoriatic arthritis symptoms).   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced PSORIATIC ARTHROPATHY (After dose 2 exacerbation of psoriatic arthritis symptoms) (seriousness criterion medically significant). On an unknown date, the patient experienced BREAST CANCER (Breast cancer) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Sore arm with all 4). At the time of the report, PSORIATIC ARTHROPATHY (After dose 2 exacerbation of psoriatic arthritis symptoms) had resolved with sequelae and BREAST CANCER (Breast cancer) and PAIN IN EXTREMITY (Sore arm with all 4) outcome was unknown.            Concomitant medication information was not reported.  Patient had received increased dose of autoimmune medication.  Patient had received Covid-19 treatment from 14-Aug-2023 to18-Aug-2023.  Company Comment This spontaneous case concerns a patient of unknown age and gender, with medical history of Drug allergies and Psoriatic arthritis who experienced the seriousness medically significant unexpected events of psoriatic arthropathy, breast cancer and the unexpected non-serious event of pain in extremity in the context of 3rd. dose of  mRNA-1273 vaccine. After 2nd. dose the patient referred exacerbation of psoriatic arthritis symptoms; approximately one month after 3rd. dose, the informed that the patient was diagnosticated breast cancer. As per data available to date, there is no evidence that mRNA-1273 vaccine can cause cancer or relapses and vaccine does not modify DNA. On the other hand, COVID-19 mRNA vaccines are recommended in cancer patients as protection from a possible SARS-COV-2 infection. The medical history of Psoriatic arthritis is a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2023-739305 (Patient Link).
Sex: U
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: Sore arm with all 4; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm with all 4) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     The patient's past medical history included Breast cancer in October 2021. Concurrent medical conditions included Sulfonamide allergy (Sulfa), Drug allergy (Zofran) and Psoriatic arthritis.    On 04-Nov-2022 at 12:00 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm with all 4). At the time of the report, PAIN IN EXTREMITY (Sore arm with all 4) outcome was unknown.            Concomitant medication was not reported.  Patient received monovalent doses of Moderna. Dose 1 on 28-Dec-2020; Batch/Lot No: 039K20A. Dose 2 on 29-Jan-2021; Batch/Lot No: 012L20A and Dose 3 on 02-Sep-2021; Batch/Lot No: 002F21A.  Patient received unspecified drug from 14-AUG-2023 to 18-AUG-2023 for treatment of COVID-19.  Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-738998 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738998:Monovalent case
Sex: U
Vaccine: PNC20
Symptoms: Cellulitis, Erythema, Pain
Clinical narrative: concern of cellulitis; Redness; Pain; This is a spontaneous report received from contactable reporter(s) (Nurse).  A 77-year-old patient received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Relevant past drug history was reported as having allergy reaction with unknown drug. The following information was reported: CELLULITIS (medically significant), outcome "unknown", described as "concern of cellulitis"; ERYTHEMA (non-serious), outcome "unknown", described as "Redness"; PAIN (non-serious), outcome "unknown". Clinical course was as follows: Reporter stated that patient experienced "redness, duration, pain and concern of cellulitis." It was unknown if therapeutic measures were taken as a result of cellulitis, erythema, pain. It was unknown if patient received any other vaccines within 4 weeks PRIOR to or at same date as pneumococcal 20-valent conjugate vacccine (diphtheria CRM197 protein). It was also unknown if patient was taking any other medications within 2 weeks of the event's onset dates.   The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and etiology, the event "concern of cellulitis" is not considered related to the suspect vaccine PREVNAR 20, but rather an infectious coincidental condition. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 77.0
Sex: F
Vaccine: PNC20
Symptoms: Vaccination site cellulitis
Clinical narrative: Cellulitis; This is a spontaneous report received from contactable reporter (Nurse).  A 77-year-old female patient (not pregnant) received pneumococcal 20-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 20), on 21Aug2023 as dose 1, single (Lot number: GT0538) at the age of 77 years, in right deltoid for immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing); "Thyroid disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE CELLULITIS (non-serious) with onset 26Aug2023, outcome "recovering", described as "Cellulitis". Therapeutic measures were taken as a result of vaccination site cellulitis. Additional information: It was unknown if the patient received another vaccine within four weeks prior to the vaccine; or other medications within two weeks prior to the vaccine. The patient had no known drug allergies. The patient experienced pain, induration, redness, with possible cellulitis. The patient was treated with antibiotics.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a few sore arms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 Immunization, reaction(s): "a few sore arms". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "a few sore arms". Additional information: Patient stated that his wife and him have received COVID 19 shots and boosters from this company and they have had practically NO side effects to date; apart from a few sore arms for a day or two.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300149591 same patient/AE, vaccine different dose;
Age: 75.0
Sex: F
Vaccine: FLU3, RSV
Symptoms: Dizziness, Syncope
Clinical narrative: fainted; Dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 75-year-old female patient (not pregnant) received PF-06928316 (ABRYSVO), on 03Sep2023 at 15:45 as dose number unknown, single (Batch/Lot number: unknown) at the age of 75 years, in arm for immunisation; influenza vaccine inact split 3v (FLUZONE HIGH DOSE), on 03Sep2023 as dose number unknown, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; LISINOPRIL; ALENDRONATE. No known allergy. The following information was reported: DIZZINESS (non-serious) with onset 04Sep2023 at 10:30, outcome "recovered" (04Sep2023); SYNCOPE (medically significant) with onset 04Sep2023 at 10:30, outcome "recovered" (04Sep2023), described as "fainted". Therapeutic measures were not taken as a result of syncope, dizziness.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Interchange of vaccine products
Clinical narrative: Never ending headache; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 as dose 4 (booster), single (Lot number: G10446) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: modrena covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Batch/Lot: 032H21A, Location of injection: Left arm), administration date: 11Jan2022, for COVID-19 immunisation; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 15Nov2022, outcome "not recovered"; HEADACHE (non-serious) with onset 20Nov2022, outcome "not recovered", described as "Never ending headache". The event "never ending headache" required physician office visit. Therapeutic measures were taken as a result of headache.  Additional Information: Patient got vaccine at Doctor's office/urgent care. Patient had treatment with mucous relief ER 600, azithromycin, diclofenac. Patient did not have COVID prior vaccination nor he was tested COVID post vaccination.
Age: 66.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site rash, Rash erythematous, Rash papular, Rash pruritic, Vaccination site erythema
Clinical narrative: 2.5 inch raised red itchy patch at the injection site; 2.5 inch raised red itchy patch at the injection site; 2.5 inch raised red itchy patch at the injection site; the area is itchy and hot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 66-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Aug2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3 (Booster); Single, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 4 (Booster); Single, Manufacturer unknown), for Covid-19 immunization. The following information was reported: VACCINATION SITE RASH (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset Sep2023, outcome "recovering" and all described as "2.5 inch raised red itchy patch at the injection site"; VACCINATION SITE WARMTH (non-serious) with onset Sep2023, outcome "recovering", described as "the area is itchy and hot". Therapeutic measures were taken as a result of vaccination site rash, vaccination site erythema, vaccination site pruritus, vaccination site warmth.  Additional information: The patient was a physician and he received the Prevnar 20 vaccine 9 or 10 days ago. The patient had developed a 2.5 inch raised red itchy patch at the injection site. It was very red this weekend which was a week later and it scared the reporter. The area was itchy and hot and it was not as bad now but it was still bothering the patient. The patient put ice on it and it was a little better but it was still light red and pink and it was still bothering him but not as bad. The reporter just concerned because this was just the start of vaccine season, and the reporter was worried about the patient getting the Covid shot due to this reaction, along with the RSV and Flu vaccines. The patient never had a reaction, and he had had 4 Covid shots and after this reaction.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 66.0
Sex: M
Vaccine: PNC20
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: 2.5 inch raised red itchy patch at the injection site; 2.5 inch raised red itchy patch at the injection site; 2.5 inch raised red itchy patch at the injection site; the area is itchy and hot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 66-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Aug2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3 (Booster); Single, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 4 (Booster); Single, Manufacturer unknown), for Covid-19 immunization. The following information was reported: VACCINATION SITE RASH (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious) all with onset Sep2023, outcome "recovering" and all described as "2.5 inch raised red itchy patch at the injection site"; VACCINATION SITE WARMTH (non-serious) with onset Sep2023, outcome "recovering", described as "the area is itchy and hot". Therapeutic measures were taken as a result of vaccination site rash, vaccination site erythema, vaccination site pruritus, vaccination site warmth.  Additional information: The patient was a physician and he received the Prevnar 20 vaccine 9 or 10 days ago. The patient had developed a 2.5 inch raised red itchy patch at the injection site. It was very red this weekend which was a week later and it scared the reporter. The area was itchy and hot and it was not as bad now but it was still bothering the patient. The patient put ice on it and it was a little better but it was still light red and pink and it was still bothering him but not as bad. The reporter just concerned because this was just the start of vaccine season, and the reporter was worried about the patient getting the Covid shot due to this reaction, along with the RSV and Flu vaccines. The patient never had a reaction, and he had had 4 Covid shots and after this reaction.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Sex: F
Vaccine: PNC20
Symptoms: Burning sensation, Vaccination site pain
Clinical narrative: burning in her arm at the site of injection; burning in her arm at the site of injection and under her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 24May2023 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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "burning in her arm at the site of injection"; BURNING SENSATION (non-serious), outcome "unknown", described as "burning in her arm at the site of injection and under her arm".  Additional information: the patient was still having these side effects. She wanted to know what is wrong with her arm and if she needs to take any other vaccines.   The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: Ended up having a year and half with a mini stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Completed; unknown Manufacturer, Batch/ Lot number not reported), for COVID-19 IMMUNIZATION. The following information was reported: TRANSIENT ISCHAEMIC ATTACK (hospitalization, medically significant) with onset 2022, 2 days after the suspect product(s) administration, outcome "unknown", described as "Ended up having a year and half with a mini stroke". Therapeutic measures were taken as a result of transient ischaemic attack.  Clinical Course: Reporter was calling to report a potential adverse event. The patient mentioned about a year ago, may be even a little longer, that about two days after they have their Pfizer booster, they ended up having a year and half with a mini stroke.  When probed to clarify is the patient also the reporter, reporter stated, "So, the reporter is the person with the issue, correct. Okay yes, it needs to be a patient." The reporter was unsure about the facility type in which patient was vaccinated - it could have been a pharmacy or a clinic. Name of the facility was unknown. Regarding the indication, it was stated that it was just the booster shot. Reporter not sure of other medications taken, lab test, route of administration, anatomical location of the vaccine administration, date of administration, other vaccines taken within 4 weeks of Pfizer Covid-19 Booster vaccine. When enquired about the date of event, it was stated, "I am not sure. It was sometime last year in 2022. When enquired about the treatment, it was stated that patient was in the hospital and dates or details were unknown for hospitalization.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: RSV
Symptoms: Device connection issue
Clinical narrative: Abrysvo vaccine is defective/could not insert the devices/little plastic pieces came out from the device; Due to unable to insertion for syringes I had to destroy 2 shots; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from product quality group, Program ID.  A patient (no qualifiers provided) received PF-06928316 (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: DEVICE DEFECTIVE (non-serious), described as "Abrysvo vaccine is defective/could not insert the devices/little plastic pieces came out from the device"; DEVICE USE ISSUE (non-serious), described as "Due to unable to insertion for syringes I had to destroy 2 shots".  Additional information: The pharmacist mentioned that the syringe of the Abrysvo vaccine is defective, and as a result, a patient was not able to get a dose of the product. She said that when pushed, the little plastic pieces came out and were no longer usable. She wants to get a replacement.  The pharmacist tried to prepare for injection for Abrysvo for patients and could not insert the devices and little plastic pieces came out from the device. Due to unable to insertion for syringes, the pharmacist had to destroy 2 shots.     The information on the batch/lot number for PF-06928316 has been requested and will be submitted if and when received.
Sex: U
Vaccine: RSV
Symptoms: Nasopharyngitis, Secretion discharge, Urinary tract infection, Urinary tract infection bacterial
Clinical narrative: cold; mucus; UTI; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received PF-06928316 (ABRYSVO), in 2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "COPD" (ongoing), notes: also have COPD but breathing okay. The patient's concomitant medications were not reported. The following information was reported: URINARY TRACT INFECTION BACTERIAL (non-serious) with onset 2023, outcome "unknown", described as "UTI"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold"; SECRETION DISCHARGE (non-serious), outcome "unknown", described as "mucus". Therapeutic measures were taken as a result of urinary tract infection bacterial.  Additional information: Patient had the RSV vaccine 3 days ago (unknown date) and had UTI at the same time and patient was on Keflex. Patient had symptoms of Cold that be reaction to shot. Patient had a lot of mucus and was sorry that he/she took the shot.  The information on the batch/lot number for PF-06928316 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Biopsy, Headache, Hypoaesthesia, Magnetic resonance imaging, Muscular weakness
Clinical narrative: facial numbness; headaches; shooting pain; weakness in my legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "facial numbness"; HEADACHE (non-serious), outcome "unknown", described as "headaches"; PAIN (non-serious), outcome "unknown", described as "shooting pain"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "weakness in my legs". The events "facial numbness", "headaches", "shooting pain" and "weakness in my legs" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypoaesthesia, headache, pain, muscular weakness. Additional information: The patient experienced numerous neurological symptoms (facial numbness, headaches, shooting pain, weakness in legs) since receiving the vaccine and boosters. The patient had numerous studies done, including a temporal artery biopsy and multiple MRIs. No one can identify what is happening. The primary care physician suspected vaccine injury. It is very disconcerting to have these symptoms. The patient has been given numerous medications in hopes of alleviating symptoms and nothing has helped.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: facial numbness; headaches; shooting pain; weakness in my legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "facial numbness"; HEADACHE (non-serious), outcome "unknown", described as "headaches"; PAIN (non-serious), outcome "unknown", described as "shooting pain"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "weakness in my legs". The events "facial numbness", "headaches", "shooting pain" and "weakness in my legs" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hypoaesthesia, headache, pain, muscular weakness. Additional information: The patient experienced numerous neurological symptoms (facial numbness, headaches, shooting pain, weakness in legs) since receiving the vaccine and boosters. The patient had numerous studies done, including a temporal artery biopsy and multiple MRIs. No one can identify what is happening. The primary care physician suspected vaccine injury. It is very disconcerting to have these symptoms. The patient has been given numerous medications in hopes of alleviating symptoms and nothing has helped.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Liver disorder
Clinical narrative: liver issues; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Dec2020 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: LIVER DISORDER (non-serious), outcome "recovering", described as "liver issues". The event "liver issues" required physician office visit.  Additional information: patient had suffered significant liver issues since receiving the first dose of the Covid vaccine in Dec2020. Patient's liver was still healing and patient still had checkups with a hepatologist at the (Facility Name withheld) in (City Name withheld). It was slowly starting to get better but patient was still not 100% back to normal by any means.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: Fluzone exposure during pregnancy, with no reported adverse event; Initial information received on 31-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 24 years old pregnant female patient who was exposed to vaccine Influenza Quadrival A-B Vaccine Preserved [Fluzone Quadrivalent] with no reported adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported Fluzone exposure during pregnancy, with no reported adverse event occurred at 9 weeks of pregnancy and the patient was exposed Influenza Quadrival A-B Vaccine Preserved at 9 weeks of pregnancy, during first pregnancy trimester for Influenza Quadrival A-B Vaccine Preserved.  The date of last menstrual period was reported as 13-Jul-2023. The estimated due date is 13-Apr-2024. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.  On 31-Aug-2023, the pregnant patient received an unknown dose of suspect Influenza Quadrival A-B Multidose Vaccine Preserved (exposure during pregnancy) (latency: same day) (strength: unknown , expiry date: Jun-2024, lot UT8040NA) via intramuscular route in the G. deltoid NOS (Not otherwise specified) as Influenza immunization.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  Additionally, at time of reporting, the pregnancy is still ongoing.
Age: 5.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: ADACEL (Tdap) vaccine that was given instead of DAPTACEL (DTap) with no reported adverse event; Initial information received on 01-Sep-2023 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 5-year-old female patient, diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel] vaccine that was given instead of diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] (dtap) with no reported adverse event and.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis A vaccine for Prophylactic vaccination; and polio vaccine for Prophylactic vaccination.  On an unknown date, the patient received an unknown dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine Suspension for injection (strength, lot number, expiry date: unknown) not reported via unknown route in unknown administration site for Prophylactic Vaccination (immunization).  On 21-Aug-2023, the patient received dose 1 of 0.5 ml total dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine Suspension for injection (lot: U7870AB, Expiry date: 23-Aug-2023) via intramuscular route in the left thigh for for Prophylactic Vaccination (immunization) and adacel (tdap) vaccine that was given instead of daptacel (dtap) with no reported adverse event (wrong product administered) (latency: same day)  Action taken with diphtheria, tetanus and acellular pertussis vaccine (Adacel) and diphtheria, tetanus and acellular pertussis vaccine (Daptacel) was not applicable.  Outcome: Unknown  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.
Sex: U
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: act-hib had been reconstituted with Sterile Water for Injection, rather than the diluent that is included with acthib with no reported adverse event; Initial information received on 01-Sep-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a Child of unknown gender who was administered HIB (PRP/T) vaccine [ACT-HIB] that had been reconstituted with sterile water for injection, rather than the diluent that is included with 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 01-Sep-2023 at 1:30 pm, the patient received 0.5 mL dose of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (batch number; expiry date: not reported) via unknown route in unknown administration site for Immunization that had been reconstituted with sterile water for injection, rather than the diluent that is included with acthib with no reported adverse event (product preparation error) (same day latency).  Information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   No further details were available from the reporter.   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: 0.33
Sex: F
Vaccine: UNK
Symptoms: Medication error, No adverse event, Product preparation error, Single component of a two-component product administered
Clinical narrative: the powdered Hib portion of pentacel was administered, reconstituted with the wrong diluent with no reported adverse event; the powdered Hib portion of pentacel was administered, reconstituted with the wrong diluent with no reported adverse event; Initial information was received on 01-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 months old female patient to whom the powdered Hib portion of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [PENTACEL (VERO)] was administered, reconstituted with the wrong diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included rotavirus vaccine live reassort oral 5V (Rotateq) and pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination.  On 30-Aug-2023, the patient received a 0.5 ml, total (once) (dose 2) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (Suspension for injection) (lot UJ865AA, expiry date: 31-Mar-2024, strength: standard) via intramuscular route in the left thigh for Immunisation and the powdered hib portion of pentacle was administered, reconstituted with the wrong diluent with no reported adverse event (product preparation error) (single component of a two-component product administered) (Latency: same day).  Reportedly, HCP asks if they can still use the liquid DTaP-IPV portion of the PENTACEL vaccine that was not initially used and then use a standalone ACT-HIB for the Hib component. Also, it was reconstituted with lidocaine HCl, sodium chloride 7mg.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Chest X-ray normal
Clinical narrative: Presented with Acute hypoxemic respiratory failure secondary to COVID-19 /possible viral sepsis Tx with remdesivir, decadron, antibiotics, lovenox, singulairzinc; Chest x-ray no  evidence of pneumonia.  On room air at D/C
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Hyperkalaemia, Oxygen saturation decreased, Productive cough
Clinical narrative: Symptom onset 12/6/2021, sxs included productive cough, SOB, c/p, and fevers.   received cefepime and decadron.  Was found to be hyperkalemic (most likely 2/2 missed HD), received NaHCO3 and insulin 10U in ED, resolved.  Started her on remdesivir x5 days, montelukast, and zinc.  Next day pt continued to desat and require supplemental O2 more often; started on decadron per COVID 19 txt guidelines.  SOB and coughs improved with cough medications, remdesivir, and decadron; able to tolerate RA, d/c'ed decadron (12/9-12/12), received full five days of remdesivir during admission.  Pt stable by d/c on RA (with intermittent 2L NC for comfort, no hypoxia noted),
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Symptom onset 12/6/2021, sxs included productive cough, SOB, c/p, and fevers.   received cefepime and decadron.  Was found to be hyperkalemic (most likely 2/2 missed HD), received NaHCO3 and insulin 10U in ED, resolved.  Started her on remdesivir x5 days, montelukast, and zinc.  Next day pt continued to desat and require supplemental O2 more often; started on decadron per COVID 19 txt guidelines.  SOB and coughs improved with cough medications, remdesivir, and decadron; able to tolerate RA, d/c'ed decadron (12/9-12/12), received full five days of remdesivir during admission.  Pt stable by d/c on RA (with intermittent 2L NC for comfort, no hypoxia noted),
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray abnormal, Cough, Dyspnoea, Lung infiltration
Clinical narrative: Presented with SOB/cough; CXR: Patchy infiltrates within the lung bases bilaterally; Tx with zithromax, rocephin, remdesivir, decadron; initially increased FIO2 to 6LPM but back down to 3 LPM at discharge;
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Acute myocardial infarction, C-reactive protein, COVID-19, Fibrin D dimer
Clinical narrative: Presented with abd pain; dx Type 2 NSTEMI due to demand iscemia from Covid 19 infection; Labs: D dimer 1.27; CRP 0.45, Ferritin 121; Tx: Vit D3, Decadron, lovenox, singulair, zinc; O2 remained on room air
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial ischaemia, Serum ferritin normal, Vitamin D
Clinical narrative: Presented with abd pain; dx Type 2 NSTEMI due to demand iscemia from Covid 19 infection; Labs: D dimer 1.27; CRP 0.45, Ferritin 121; Tx: Vit D3, Decadron, lovenox, singulair, zinc; O2 remained on room air
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood lactic acid, C-reactive protein, COVID-19 pneumonia, Chest X-ray abnormal, Dyspnoea
Clinical narrative: presented with altered mental status and SOB; positive for COVID-19 pneumonia;CXR revealed bilateral opacities subjectively they are mild in nature. admitted to the hospital and was noted to have drop in oxygen saturation up to 86% on ambulation. Labs: D-Dimer was negative, serum WBC negative, lactic unremarkable.  CRP 6.35, Procal 0.07  Tx: IV dexamethasone and remdesivir, also rec'd maxipine, Vit C, Lovenox, Singulair, and zind.  His oxygenation has improved;  room air at d/c.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Fibrin D dimer normal, Lung opacity, Mental status changes, Oxygen saturation decreased, Procalcitonin
Clinical narrative: presented with altered mental status and SOB; positive for COVID-19 pneumonia;CXR revealed bilateral opacities subjectively they are mild in nature. admitted to the hospital and was noted to have drop in oxygen saturation up to 86% on ambulation. Labs: D-Dimer was negative, serum WBC negative, lactic unremarkable.  CRP 6.35, Procal 0.07  Tx: IV dexamethasone and remdesivir, also rec'd maxipine, Vit C, Lovenox, Singulair, and zind.  His oxygenation has improved;  room air at d/c.