chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site discharge, No adverse event
Clinical narrative: a lot of the vaccine ran down the patient's arm with no reported adverse event; a lot of the vaccine ran down the patient's arm with no reported adverse event; a lot of the vaccine ran down the patient's arm/ didn't get most of the dose with no reported adverse event; Initial information received on 07-Jun-2024 regarding an unsolicited valid non-serious case received from a Pharmacist.  This case involves a 63 years old male patient where a lot of the diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] vaccine ran down the patient's arm with no reported adverse event and didn't get most of the dose with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection (lot- U7837AA and expiration date- 25-Jul-2025) via unknown route in Arm NOS (not specified) (dose, strength: not provided) for Immunisation (accidental exposure to product), (exposure via skin contact) and (incorrect dose administered) (latency- same day for all events).  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: 11.0
Sex: M
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was placed in the fridge, max/low temperature reached: 1.0 c or 34.3 f for less than an hour with no reported adverse event; vaccine was administered post excursion with no reported adverse event; Initial information received on 07-Jun-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11-year-old male patient and was administered meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] after excursion as vaccine was placed in the fridge, max/low temperature reached: 1.0 c or 34.3 f for less than an hour 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 HPV vaccine VLP RL1 4V (YEAST) (Gardasil); and diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (Adacel) for Prophylactic vaccination (immunisation).  On 05-Jun-2024, the patient received a 0.5 ml dose of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine Solution for injection of Frequency: once Strength: standard lot U7945BB expiry date: 30-Mar-2026 via intramuscular route in the left arm as immunisation and vaccines were placed in the fridge, max/low temperature reached: 1.0 c or 34.3 f for less than an hour with no reported adverse event (product storage error) (unknown latency) and vaccine was administered post excursion with no reported adverse event (poor quality product administered) (latency : same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pentacel was given 4 days after it was expired with no adverse event; Initial information received on 07-Jun-2024 regarding an unsolicited valid  non-serious case received from a physician.  This case involves an unknown age and unknown gender patient who received Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] 4 days after it was expired with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of Suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine (with an unknown strength, expiry date, batch number) via unknown route in unknown administration site for immunization.  Information regarding batch number and expiration date corresponding to the one at time of event occurrence was requested..  On an unknown date,  the patient received Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine 4 days after it was expired with no adverse event (expired product administered) (latency: same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: M
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccines were placed in the fridge, Max/Low Temperature reached: 1.0 C or 34.3 F for less than an hour with no reported AE; vaccines were administered post excursion with no reported AE; Initial information received on 07-Jun-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to 2024SA174302, 2024SA174880, 2024SA174457, 2024SA173862, 2024SA174302, 2024SA174224, 2024SA175039, 2024SA173884, 2024SA174753.  This case involves a 12 years old male patient who received Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] vaccines were placed in the fridge, max/low temperature reached: 1.0 c or 34.3 f for less than an hour with no reported adverse event and vaccines were administered post excursion 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 Hpv Vaccine Vlp Rl1 4v (Yeast) (Gardasil) for Prophylactic vaccination; and Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular 5-Component, Tetanus Vaccine Toxoid (Adacel) for Prophylactic vaccination.  On 05-Jun-2024, the patient received a dose of 0.5 ml of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine (Solution for injection) (lot U7945BB,Expiry date: 30-Mar-2026,strength was unknown) via intramuscular route in the left arm for prophylactic vaccination (Immunization) and vaccines were placed in the fridge, max/low temperature reached: 1.0 c or 34.3 f for less than an hour with no reported ae (product storage error) (unknown latency) and vaccines were administered post excursion with no reported ae (poor quality product administered) (latency : same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: M
Vaccine: MEN
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Max/Low Temperature reached: 1.0 C or 34.3 F for less than an hour due to human error with no reported adverse event; menquadfi was administered post excursion with no reported adverse event; Initial information received on 07-Jun-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17 years old male patient (Patient 5) who had administered Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi] after it was exposed to max/low temperature reached: 1.0 Celsius or 34.3 Fahrenheit for less than an hour due to human error 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 MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA) for Prophylactic vaccination.  On 23-May-2024, the patient received a 0.5 ml (millimeter) dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine (strength: standard, frequency: once, expiry date: 30-Mar-2026 and lot U7945BB) via intramuscular route in the left arm as immunization and was administered post excursion with no reported adverse event (poor quality product administered) (same day latency).  On an unknown date the max/low temperature reached: 1.0 ccelsus or 34.3 f for less than an hour due to human error with no reported adverse event (product storage error).  Human Error: Yes, the extended stability data does not cover the excursion.   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: 17.0
Sex: F
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: laceration on her arm; MENQUADFI placed in the fridge at the same time max/low temperature reached: 1.0 c or 34.3 f duration out of labelled range: less than an hour with no adverse event; vaccine was administered post excursion with no adverse event; Initial information received on 07-Jun-2024 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to multiple cluster cases.  This case involves a 17 years old female patient, menquadfi placed in the fridge at the same time max/low temperature reached: 1.0 c or 34.3 f duration out of labelled range: less than an hour, vaccine was administered post excursion and laceration on her arm.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA) for Prophylactic vaccination.  On 28-May-2024, the patient received 0.5 ml of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE, Solution for injection lot U7945BB, expiry date-30-MAR-2026 via intramuscular route in unknown administration site for immunization (strength unknown), vaccine was administered post excursion with no adverse event (poor quality product administered) (latency same day).  On an unknown date the patient had laceration on her arm (skin laceration) and menquadfi placed in the fridge at the same time max/low temperature reached: 1.0 c or 34.3 f duration out of labelled range: less than an hour with no adverse event (product storage error) (unknown latency).  Action taken: not applicable.  An unknown corrective treatment was received for the event (laceration on her arm).  At time of reporting, the outcome was Unknown for the event skin laceration  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 and Module of the 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: 12.0
Sex: M
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was placed in the fridge, max/low temperature reached: 1.0 c or 34.3 f for less than an hour with no reported adverse event; vaccine was administered post excursion with no reported adverse event; Initial information received on 07-Jun-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12-year-old male patient and was administered meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] after excursion as vaccine was placed in the fridge, max/low temperature reached: 1.0 c or 34.3 f for less than an hour 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 HPV vaccine VLP RL1 4V (YEAST) (Gardasil); and diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (Adacel) for Prophylactic vaccination (immunisation).  On 30-May-2024, the patient received a 0.5 ml dose of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine Solution for injection of Frequency: once Strength: standard lot U7945BB expiry date: 30-Mar-2026 via intramuscular route in the right thigh as immunisation and vaccines were placed in the fridge, max/low temperature reached: 1.0 c or 34.3 f for less than an hour with no reported adverse event (product storage error) (unknown latency) and vaccine was administered post excursion with no reported adverse event (poor quality product administered) (latency : same day).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 12.0
Sex: M
Vaccine: MEN
Symptoms: No adverse event, Product storage error
Clinical narrative: Temperature excursion at 1.0 C or 34.3 F for less than an hour (with no reported adverse event); Menquadfi was administered to patient after this excursion (with no reported adverse event); Initial information was received on 07-Jun-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to multiple cluster cases.  This case involves a 12-year-old male patient and was administered meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] after temperature excursion at 1.0 C or 34.3 F for less than an hour with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Jun-2024, the patient received a 0.5 ml dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection (lot U7945BB, expiry date: 30-Mar-2026, Frequency: once Strength: standard) via intramuscular route in the right arm as Immunisation and vaccine was administered post excursion with no reported adverse event (poor quality product administered) (latency: same day).  On an unknown date, temperature excursion at 1.0 C or 34.3 F for less than an hour with no adverse event (product storage error).  This situation is due to human error. Reason: A lot of vaccines were delivered and they were placed in the fridge at the same time, and it's a bit compensating for the products.  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: 74.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Asthenia, Dyspnoea, Emphysema, Fatigue, Palpitations
Clinical narrative: Patient was in pharmacy and informed us 23 days after receiving the vaccination. She starting experiencing symptoms the next morning after receiving the vaccine. She had hives, shortness of breath, fever, weakness, fatigue, heart was pounding and these symptoms last for a week before she started feeling better. She said she went in to her doctor to get labs/tests done and found out she had emphysema. Patient said she is doing fine now.
Age: 74.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Pyrexia, Urticaria
Clinical narrative: Patient was in pharmacy and informed us 23 days after receiving the vaccination. She starting experiencing symptoms the next morning after receiving the vaccine. She had hives, shortness of breath, fever, weakness, fatigue, heart was pounding and these symptoms last for a week before she started feeling better. She said she went in to her doctor to get labs/tests done and found out she had emphysema. Patient said she is doing fine now.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Malaise, Peripheral swelling, Pruritus
Clinical narrative: Local reaction on arm - warmth, redness, swelling, itching. Started out small about 24 hours post vaccine and reported at 48 hours post vaccine and had doubled in size. No systemic symptoms aside from slight malaise.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Local reaction on arm - warmth, redness, swelling, itching. Started out small about 24 hours post vaccine and reported at 48 hours post vaccine and had doubled in size. No systemic symptoms aside from slight malaise.
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Injection was administered after expiration date. Expiration date for vaccine was 05/11/2024 and vaccine was given 06/11/2024
Age: 61.0
Sex: M
Vaccine: PNC20
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: Patient called the facility to report that was having pain in the injection shoulder.  It was hot to the touch and was not able to raise arm over head.  follow up information the day after taking NSAIDs patient reported that heat was down and more mobility of the arm
Age: 0.17
Sex: F
Vaccine: DTAP, HEP, HIBV, HPV9, IPV, RV1
Symptoms: Unevaluable event
Clinical narrative: Unknown, following up with pt twice daily.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Crying, Eye movement disorder, Loss of consciousness, Pallor, Presyncope
Clinical narrative: - see in enclosed copy of the pt. visit on 5/28/2024 under patient instruction for description of what occurred - also see patient case of 5/31/24 spoke to mom, Pt is well. No problems  note after the shots he did well and he walked out to car with mom in the car while still in parking lot mom looked back at him and he looked pale and his eyes rolled up in head and he passed out no jerking seen she immediately got him out and as soon as she picked him out of seat he awoke and was crying she brought him back in to the office and he was pale but had a vigorous cry and he felt hot we applied ice bags to back of neck and front of abdomen as he lay against mom crying over the next few minutes he became calm and his color came back to normal and he was no longer feeling hot and he took a lollipop and was walking and talking well and his heart beat was normal rate at 90 bpm and regular rate and rhythm mom then took him home she said the car should be cool now as she had left it runnnig when she brought him back in to the office I told mom I felt this was a vasovagal event mom said her older son always would get dizzy and not feel well after shots
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Skin warm
Clinical narrative: - see in enclosed copy of the pt. visit on 5/28/2024 under patient instruction for description of what occurred - also see patient case of 5/31/24 spoke to mom, Pt is well. No problems  note after the shots he did well and he walked out to car with mom in the car while still in parking lot mom looked back at him and he looked pale and his eyes rolled up in head and he passed out no jerking seen she immediately got him out and as soon as she picked him out of seat he awoke and was crying she brought him back in to the office and he was pale but had a vigorous cry and he felt hot we applied ice bags to back of neck and front of abdomen as he lay against mom crying over the next few minutes he became calm and his color came back to normal and he was no longer feeling hot and he took a lollipop and was walking and talking well and his heart beat was normal rate at 90 bpm and regular rate and rhythm mom then took him home she said the car should be cool now as she had left it runnnig when she brought him back in to the office I told mom I felt this was a vasovagal event mom said her older son always would get dizzy and not feel well after shots
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy bone marrow abnormal, Plasma cell myeloma
Clinical narrative: (See attached)
Age: 17.0
Sex: F
Vaccine: COVID19, MENB, MNQ
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Pt had fever of 101-came down with acetaminophen. Also experienced body aches & sore arms.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Bursitis, Injury, Pain
Clinical narrative: Vaccine injury per HCP; Bursitis; Pain; left shoulder pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 65-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 13-SEP-2023, the patient received the 1st dose of Arexvy (intramuscular, left deltoid). On 27-SEP-2023, 14 days after receiving Arexvy, the patient experienced shoulder pain (Verbatim: left shoulder pain). On 01-OCT-2023, the patient experienced pain (Verbatim: Pain). On an unknown date, the patient experienced injury (Verbatim: Vaccine injury per HCP) and bursitis (Verbatim: Bursitis). The outcome of the shoulder pain was resolved and the outcome of the injury and pain were not resolved and the outcome of the bursitis was not reported.   The reporter considered the shoulder pain to be related to Arexvy. It was unknown if the reporter considered the injury, pain and bursitis to be related to Arexvy.     The company considered the shoulder pain to be related to Arexvy. It was unknown if the company considered the injury, pain and bursitis to be related to Arexvy.   Additional Information: GSK Receipt Date: 03-JUN-2024 and 05-JUN-2024 The patient received the Arexvy vaccine and stated 2 weeks after receiving the vaccine she started having left shoulder pain that resolved to her receiving physical therapy and multiple visits to her healthcare provider to receive steroids shots to her left shoulder.  These adverse events had resolved.  The reporter also mentioned wanting compensation for vaccine injury.  Reporter stated she was trying to find a lawyer. The patient did say that the orthopedic doctor said her shoulder pain was caused by the vaccine and that she has bursitis.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: tingling in hand; severe pain in arm; pain in shoulder; radiates down the length of her arm; Arm nearly immobile/unable to use that arm; had to quit her job; This non-serious case was reported by a consumer via call center representative and described the occurrence of tingling of extremity in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In JAN-2024, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On an unknown date, 2 weeks after receiving Shingrix, the patient experienced tingling of extremity (Verbatim: tingling in hand), pain in arm (Verbatim: severe pain in arm), shoulder pain (Verbatim: pain in shoulder), radiating pain (Verbatim: radiates down the length of her arm), mobility decreased (Verbatim: Arm nearly immobile/unable to use that arm) and activities of daily living impaired (Verbatim: had to quit her job). The outcome of the tingling of extremity, pain in arm, shoulder pain, radiating pain, mobility decreased and activities of daily living impaired were unknown.   It was unknown if the reporter considered the tingling of extremity, pain in arm, shoulder pain, radiating pain, mobility decreased and activities of daily living impaired to be related to Shingrix.     It was unknown if the company considered the tingling of extremity, pain in arm, shoulder pain, radiating pain, mobility decreased and activities of daily living impaired to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-JUN-2024 The patient reported that she received her first Shingrix dose in January of 2024. About two weeks after the vaccine, she began having sharp pain in the left shoulder/arm (same arm as the vaccine). She explained that it has gotten progressively worse to the point that she was unable to use that arm and had to quit her job. She stated that the pain now started at her shoulder and radiates down the length of her arm, with tingling in her hand. She was planning to report this to VAERS and will possibly seek legal action.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Impaired work ability, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: tingling in hand; severe pain in arm; pain in shoulder; radiates down the length of her arm; Arm nearly immobile/unable to use that arm; had to quit her job; This non-serious case was reported by a consumer via call center representative and described the occurrence of tingling of extremity in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In JAN-2024, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On an unknown date, 2 weeks after receiving Shingrix, the patient experienced tingling of extremity (Verbatim: tingling in hand), pain in arm (Verbatim: severe pain in arm), shoulder pain (Verbatim: pain in shoulder), radiating pain (Verbatim: radiates down the length of her arm), mobility decreased (Verbatim: Arm nearly immobile/unable to use that arm) and activities of daily living impaired (Verbatim: had to quit her job). The outcome of the tingling of extremity, pain in arm, shoulder pain, radiating pain, mobility decreased and activities of daily living impaired were unknown.   It was unknown if the reporter considered the tingling of extremity, pain in arm, shoulder pain, radiating pain, mobility decreased and activities of daily living impaired to be related to Shingrix.     It was unknown if the company considered the tingling of extremity, pain in arm, shoulder pain, radiating pain, mobility decreased and activities of daily living impaired to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-JUN-2024 The patient reported that she received her first Shingrix dose in January of 2024. About two weeks after the vaccine, she began having sharp pain in the left shoulder/arm (same arm as the vaccine). She explained that it has gotten progressively worse to the point that she was unable to use that arm and had to quit her job. She stated that the pain now started at her shoulder and radiates down the length of her arm, with tingling in her hand. She was planning to report this to VAERS and will possibly seek legal action.
Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Paraesthesia
Clinical narrative: tingling in hand; severe pain in arm; pain in shoulder; radiates down the length of her arm; Arm nearly immobile/unable to use that arm; had to quit her job; This non-serious case was reported by a consumer via call center representative and described the occurrence of tingling of extremity in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In JAN-2024, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On an unknown date, 2 weeks after receiving Shingrix, the patient experienced tingling of extremity (Verbatim: tingling in hand), pain in arm (Verbatim: severe pain in arm), shoulder pain (Verbatim: pain in shoulder), radiating pain (Verbatim: radiates down the length of her arm), mobility decreased (Verbatim: Arm nearly immobile/unable to use that arm) and activities of daily living impaired (Verbatim: had to quit her job). The outcome of the tingling of extremity, pain in arm, shoulder pain, radiating pain, mobility decreased and activities of daily living impaired were unknown.   It was unknown if the reporter considered the tingling of extremity, pain in arm, shoulder pain, radiating pain, mobility decreased and activities of daily living impaired to be related to Shingrix.     It was unknown if the company considered the tingling of extremity, pain in arm, shoulder pain, radiating pain, mobility decreased and activities of daily living impaired to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-JUN-2024 The patient reported that she received her first Shingrix dose in January of 2024. About two weeks after the vaccine, she began having sharp pain in the left shoulder/arm (same arm as the vaccine). She explained that it has gotten progressively worse to the point that she was unable to use that arm and had to quit her job. She stated that the pain now started at her shoulder and radiates down the length of her arm, with tingling in her hand. She was planning to report this to VAERS and will possibly seek legal action.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: forgot to get her second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 12-SEP-2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: forgot to get her second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 04-JUN-2024 The patient self reported this case. The patient received 1st dose of Shingrix and forgot to get her second dose on MAR-2024, therefore she did not completed the vaccine series, which led to incomplete course of vaccination.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE/PQC.; Vaccine expired on 16AUG2023 and was administered on 17AUG2023.; The dose received was the patient's first dose of MMR-II at the age of 4-years-old. HCP refused to provide; This spontaneous report was received from a physician and refers to a 4-year-old female patient.  The patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 17-AUG-2024, the patient was inadvertently vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, at the age of 4-years-old, Lot number was not provided but expiration date was reported as 16-AUG-2023 (strength, exact dose and route of administration were not provided) administered for prophylaxis (Expired product administered and Product administered to patient of inappropriate age). The health care professional refused to provide patient demographics. Operator of device was reported as health professional. No additional information was provided. No additional adverse event or product quality complaint reported.  Lot # is being requested and will be submitted if received.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: No symptoms reported for patient; Registered nurse called to report Gardasil 9 pre-filled syringe was leaking from the Luer lock while administering the product to a patient.; Registered nurse called to report Gardasil 9 pre-filled syringe was leaking from the Luer lock while administering the product to a patient.; Caller states the patient did not receive full dose of the vaccine; This spontaneous report was received from a registered nurse concerning a 12-years-old male patient. Patient's concurrent conditions, pertinent medical history and concomitant therapies were not provided.  On 29-MAY-2024, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #2014790, expiration date: 22-APR-2026, administered for prophylaxis (strength, route of administration, and anatomical location were not provided) with a prefilled syringe that was leaking from the luer lock (poor quality device used/ product leakage). The patient did not receive the full dose of the vaccine (accidental underdose).  No symptoms reported for the patient.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose of Engerix-B today (June 4th 2024), this is the patients second dose; 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 36-year-old male patient who received HBV (Engerix B) (batch number N73FA, expiry date 31-MAY-2024) for prophylaxis.   On 04-JUN-2024, the patient received the 2nd dose of Engerix B. On 04-JUN-2024, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Patient received an expired dose of Engerix-B today (June 4th 2024), this is the patients second dose). 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: 04-JUN-2024 The patient received an expired dose of Engerix-B , which led to expired vaccine used. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Accidently administrate the expire vaccine, Menveo; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA910A, expiry date 31-MAR-2024) for prophylaxis.   On 04-JUN-2024, the patient received Menveo. On 04-JUN-2024, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Accidently administrate the expire vaccine, Menveo). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 05-JUN-2024 The pharmacist reported that, they accidently administered the expired Menveo vaccine, it was expired on 31st March 2024, and they administered it day before reporting (yesterday), which led to expired vaccine used. The reporter asked was there any data on it whether they should re-administer the vaccine. The pharmacist also mentioned that the vaccines was the Menveo 2 vial presentation. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: an employee received Boostrix and it was expired by 4 months; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 06-JUN-2024, the patient received Boostrix. On 06-JUN-2024, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: an employee received Boostrix and it was expired by 4 months). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 07-JUN-2024 The registered pharmacist reported that an employee received Boostrix the day before reporting and it was expired by 4 months, which led to expired vaccine used.  The pharmacist had no details about patient other than gender, no vaccine details. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Initial insomnia, Insomnia
Clinical narrative: Insomnia: started two years ago, not sure if related to COVID vaccine or something new, problem with both, falling and staying asleep. Takes Clonazepam as needed. Pulmonologist and endocrinologist are aware of her sleeping issues. They are going to refer her to a clinic able to perform a sleep study.
Sex: U
Vaccine: HIBV
Symptoms: Device connection issue
Clinical narrative: The needle hub disconnected from the luer when the cap was removed from the needle.
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Injected limb mobility decreased, Injection site discomfort, Injection site pain, Pain, Product administered at inappropriate site
Clinical narrative: I have received vaccination of two products on October 13, 2023 at Pharmacy which reads as 1) Fluzone Quadrivalent 05 ML INJ SANO, NDC: 49281-0423-50, Disp. Qty:0.5 and 2) Comirnaty 30 MCG/0.3ML INJ PFIZ, NDC: 00069-2362-10, Disp. Qty:0.3 administered by staff. This was my 4th COVID-19 vaccine and 1st Seasonal Flu vaccine. Previous COVID vaccine are Moderna 04/24/21, Moderna 05/22/21, Moderna 12/20/21 The vaccination was placed in the left hand 2 inches below shoulder line. I remember it made me curious of the higher location than usual, but I trusted what doctor is doing. At one jab I felt that needle was pushed to hard that it hit a hard substance under the skin. I did not have any injury, bruises or heavy workout on the upper body in the period since vaccination. I do not recall how many days passed since vaccination when I started to notice that while lying face down, hands forward I felt nagging pain in the shoulder area. I was my first observation of shoulder issue. Next itme I expressly shared concern about shoulder pain to my colleges after I-Fly activity in the middle of December 2023. At that time it was already painful to turn hand behind the back, insert hand into jacket sleeve, and feeling general limited range of motion of the left hand. Tipping point of existing bodily problem I felt in April while giving high-five with left hand at the finish line of half-marathon race. The hand was frozen, with pain passing through the body. As for myself I have acknowledged that it's not cold or cold air draught related issue and something deeper. By massaging the area I don't feel muscle pain, the uncomfortable state inside the shoulder is radiating from inner shoulder structure. I believe I have found a cause of the problem, name Shoulder Injury Related to Vaccine Administration, and after reading about I have all symptoms and a cause that has triggered it. I don't have health Insurance, as I rely and support myself on my own. I see doctors in emergency cases only. Vaccination was a job related requirement. I did not do any tests related to the injury.
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Wrong technique in product usage process
Clinical narrative: I have received vaccination of two products on October 13, 2023 at Pharmacy which reads as 1) Fluzone Quadrivalent 05 ML INJ SANO, NDC: 49281-0423-50, Disp. Qty:0.5 and 2) Comirnaty 30 MCG/0.3ML INJ PFIZ, NDC: 00069-2362-10, Disp. Qty:0.3 administered by staff. This was my 4th COVID-19 vaccine and 1st Seasonal Flu vaccine. Previous COVID vaccine are Moderna 04/24/21, Moderna 05/22/21, Moderna 12/20/21 The vaccination was placed in the left hand 2 inches below shoulder line. I remember it made me curious of the higher location than usual, but I trusted what doctor is doing. At one jab I felt that needle was pushed to hard that it hit a hard substance under the skin. I did not have any injury, bruises or heavy workout on the upper body in the period since vaccination. I do not recall how many days passed since vaccination when I started to notice that while lying face down, hands forward I felt nagging pain in the shoulder area. I was my first observation of shoulder issue. Next itme I expressly shared concern about shoulder pain to my colleges after I-Fly activity in the middle of December 2023. At that time it was already painful to turn hand behind the back, insert hand into jacket sleeve, and feeling general limited range of motion of the left hand. Tipping point of existing bodily problem I felt in April while giving high-five with left hand at the finish line of half-marathon race. The hand was frozen, with pain passing through the body. As for myself I have acknowledged that it's not cold or cold air draught related issue and something deeper. By massaging the area I don't feel muscle pain, the uncomfortable state inside the shoulder is radiating from inner shoulder structure. I believe I have found a cause of the problem, name Shoulder Injury Related to Vaccine Administration, and after reading about I have all symptoms and a cause that has triggered it. I don't have health Insurance, as I rely and support myself on my own. I see doctors in emergency cases only. Vaccination was a job related requirement. I did not do any tests related to the injury.
Sex: U
Vaccine: TDAP
Symptoms: Needle issue
Clinical narrative: Allegedly a pharmacy patient who obtained a vaccine for Boostrix came back into the pharmacy with a needle that she alleges was in her arm after the injection.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Drug hypersensitivity, Injection site discolouration
Clinical narrative: Shingles Shingrix SDV MultiPack Lot 29Z52 0.5 mL administered to Left Deltoid on 06/04/2024, presented 6/10/2024 with 3 day h/o a localized 4 inch diameter circular uniform hyperpigmented patch to left upper arm at injection site.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Discomfort, Pain
Clinical narrative: Body ache, discomfort, temp 100
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Chronic obstructive pulmonary disease, Condition aggravated, Confusional state
Clinical narrative: Admit date: 6/5/2024  Discharge date: 06/07/2024  Admitting Physician: DO  Attending Physician at the Time of Discharge: DO  Primary Care Physician: MD Reason for Admission: AMS, weakness, shortness of breath   Brief Summary of Hospital Stay: 83 y.o. female with PMH of CAD s/p CABG, generalized anxiety, GERD, hypothyroidism, with a hiatal hernia surgeries, asthma who presents to the ER with confusion, weakness, shortness for breath, cough. Patient found to be COVID positive and was in COPD exacerbation. Started on remdesivir, prednisone 40 mg, albuterol nebs q4h, and antitussives. She had mild hyponatremia, treated with IVF and increasing oral intake. Suspected due to poor oral intake in the setting of COVID infection. She improved with above treatment. P.T. and OT evaluated patient and recommended home therapy. Currently, stable to discharge home with home therapy.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Hyponatraemia, Hypophagia, Mental status changes
Clinical narrative: Admit date: 6/5/2024  Discharge date: 06/07/2024  Admitting Physician: DO  Attending Physician at the Time of Discharge: DO  Primary Care Physician: MD Reason for Admission: AMS, weakness, shortness of breath   Brief Summary of Hospital Stay: 83 y.o. female with PMH of CAD s/p CABG, generalized anxiety, GERD, hypothyroidism, with a hiatal hernia surgeries, asthma who presents to the ER with confusion, weakness, shortness for breath, cough. Patient found to be COVID positive and was in COPD exacerbation. Started on remdesivir, prednisone 40 mg, albuterol nebs q4h, and antitussives. She had mild hyponatremia, treated with IVF and increasing oral intake. Suspected due to poor oral intake in the setting of COVID infection. She improved with above treatment. P.T. and OT evaluated patient and recommended home therapy. Currently, stable to discharge home with home therapy.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Admit date: 6/5/2024  Discharge date: 06/07/2024  Admitting Physician: DO  Attending Physician at the Time of Discharge: DO  Primary Care Physician: MD Reason for Admission: AMS, weakness, shortness of breath   Brief Summary of Hospital Stay: 83 y.o. female with PMH of CAD s/p CABG, generalized anxiety, GERD, hypothyroidism, with a hiatal hernia surgeries, asthma who presents to the ER with confusion, weakness, shortness for breath, cough. Patient found to be COVID positive and was in COPD exacerbation. Started on remdesivir, prednisone 40 mg, albuterol nebs q4h, and antitussives. She had mild hyponatremia, treated with IVF and increasing oral intake. Suspected due to poor oral intake in the setting of COVID infection. She improved with above treatment. P.T. and OT evaluated patient and recommended home therapy. Currently, stable to discharge home with home therapy.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Angiogram pulmonary abnormal, COVID-19, Chronic obstructive pulmonary disease, Dyspnoea
Clinical narrative: Admit date: 6/6/2024  Discharge date: 6/8/2024   Admitting Physician: DO   Attending Physician at the Time of Discharge: MD  Primary Care Physician: MD  Reason for Admission: hypoxia   Brief Summary of Hospital Stay:  Patient with suspected COPD (chronic obstructive pulmonary disease) due to long term and current smoking with evidence of anatomic Pulmonary emphysema on imaging.  Presented with increased shortness of breath, some initial evidence of Acute respiratory failure with hypoxia as he needed supplemental oxygen at first.  This appeared to be due to a COVID-19.  Computed tomography angiogram chest found no pneumonia, pulmonary embolism but noted emphysema.  On clinical exam he was not wheezing to suggest acute exacerbation or COPD.  Due to the initial hypoxia and relative high risk for complication was started on REMDESIVIR and DECADRON but the patient was very quickly weaned off supplemental oxygen so was not beneficial to continue these medications.  On the day of discharge the patient Alert, in no distress. No supplemental oxygen. Discharged to Home.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Emphysema, Hypoxia
Clinical narrative: Admit date: 6/6/2024  Discharge date: 6/8/2024   Admitting Physician: DO   Attending Physician at the Time of Discharge: MD  Primary Care Physician: MD  Reason for Admission: hypoxia   Brief Summary of Hospital Stay:  Patient with suspected COPD (chronic obstructive pulmonary disease) due to long term and current smoking with evidence of anatomic Pulmonary emphysema on imaging.  Presented with increased shortness of breath, some initial evidence of Acute respiratory failure with hypoxia as he needed supplemental oxygen at first.  This appeared to be due to a COVID-19.  Computed tomography angiogram chest found no pneumonia, pulmonary embolism but noted emphysema.  On clinical exam he was not wheezing to suggest acute exacerbation or COPD.  Due to the initial hypoxia and relative high risk for complication was started on REMDESIVIR and DECADRON but the patient was very quickly weaned off supplemental oxygen so was not beneficial to continue these medications.  On the day of discharge the patient Alert, in no distress. No supplemental oxygen. Discharged to Home.
Age: 56.0
Sex: F
Vaccine: PNC20, TD
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: 3 weeks post TDAP; Pt still with significant pain in the left deltoid and decreased ROM 2/2 pain.