chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: M
Vaccine: UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: consumer was given an expired dose of pentacel with no reported adverse event; Initial information received on 12-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 months old male patient who was given an expired dose of Diphtheria/Tetanus/5 Hybrid AC Pertussis/ IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  On 12-Oct-2023, the patient received a, expired 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/ IPV(VERO)/HIB(PRP/T) Vaccine (lot UJ785AA, Expiry date: 09-Oct-2023 with unknown strength)  via intramuscular route in the left thigh as immunization with no reported adverse event (expired product administered) (Latency: same day).  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.
Sex: F
Vaccine: FLUC3
Symptoms: Dyspnoea, Erythema, Hypersensitivity, Throat tightness
Clinical narrative: Shortness of breath; Throat closing on injection side only; Erythema on injection arm; Allergic reaction to the flu vaccine; This spontaneous case was received on 05-Oct-2023, from other non-healthcare professional (consumer) via Regulatory Communications (reference number: SEQW23-03021), and concerned a female patient of an unreported age.  The patient's medical history and concomitant medications were not reported.  On 09-Nov-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration: intramuscular, and anatomical location: not reported) for influenza immunization. The batch number reported was 308434.   On an unspecified date, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient experienced allergic reaction, and developed erythema on injection arm, throat was closing on injection side only, and experienced shortness of breath.  On an unspecified date, the patient called pharmacy who told her to take Benadryl (diphenhydramine hydrochloride). The patient took Benadryl, and the reaction was gone the next day.  On an unspecified date, the patient recovered from the events.  The reporter assessed the events to be related to Flucelvax Quadrivalent. The patient reported having an allergic reaction to the flu vaccine.  The case was assessed as non-serious.  Company comment: The patient was vaccinated with Flucelvax Quadrivalent. On an unspecified date, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient experienced dyspnoea, throat tightness, erythema and hypersensitivity. The patient called pharmacy who told her to take Benadryl (diphenhydramine hydrochloride). The patient took Benadryl, and the reaction was gone the next day. Causal role of the suspect vaccine is unassessable for all events, due to insufficient information about temporal relationship.; Reporter's Comments: The patient reported having an allergic reaction to the flu vaccine.; Sender's Comments: The patient was vaccinated with Flucelvax Quadrivalent. On an unspecified date, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient experienced dyspnoea, throat tightness, erythema and hypersensitivity. The patient called pharmacy who told her to take Benadryl (diphenhydramine hydrochloride). The patient took Benadryl, and the reaction was gone the next day. Causal role of the suspect vaccine is unassessable for all events, due to insufficient information about temporal relationship.
Sex: F
Vaccine: FLUC3
Symptoms: Alopecia
Clinical narrative: Hair loss / it has gotten worse; This spontaneous case was received on 05-Oct-2023 from other non-healthcare professional (consumer) via Regulatory Communications (reference number: SEQW23-03063) and concerned a female patient of unreported age.  The patient's medical history and concomitant medications were not reported.  On 28-Sep-2023, at 05:01 pm, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration and anatomical location: not reported) for flu vaccination. The batch number reported was 370647 and the expiry date was 24-May-2024.  On an unspecified date in Oct-2023, reported as three to four days after receiving Flucelvax Quadrivalent, the patient was experiencing hair loss. As reported, the vaccine was the only thing that went into the patient's body, and she had not changed any of her eating habits or medications.   On 05-Oct-2023, the hair loss had gotten worse and was noticed. The patient did not receive any treatment for the event of hair loss.  At the time of initial reporting on 05-Oct-2023, the patient had not recovered from the event of hair loss. As reported, the event was unresolved and ongoing.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  This case is linked with case 202304656 (the same reporter).  Company comment: A patient of unreported age was vaccinated with the suspect product Flucelvax Quadrivalent. The patient developed alopecia three to four days after vaccination, by report. Based on biological implausibility, causal role of the suspect vaccine is assessed as not related.; Sender's Comments: A patient of unreported age was vaccinated with the suspect product Flucelvax Quadrivalent. The patient developed alopecia three to four days after vaccination, by report. Based on biological implausibility, causal role of the suspect vaccine is assessed as not related.
Sex: M
Vaccine: FLUC3
Symptoms: Alopecia
Clinical narrative: Hair loss / it has gotten worse; This spontaneous case was received on 05-Oct-2023 from other non-healthcare professional (consumer) (reference number: SEQW23-03063) and concerned a male patient of unreported age.  The patient's medical history and concomitant medications were not reported.  On 28-Sep-2023, at 05:02 pm, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose, route of administration and anatomical location: not reported) for flu vaccination. The batch number reported was 370647 and the expiry date was 24-May-2024.  On an unspecified date in Oct-2023, reported as three to four days after receiving Flucelvax Quadrivalent, the patient was experiencing hair loss. As reported, the vaccine was the only thing that went into the patient's body, and he had not changed any of his eating habits or medications.  On 05-Oct-2023, the hair loss had gotten worse and was noticed. The patient did not receive any treatment for the event of hair loss.  At the time of initial reporting on 05-Oct-2023, the patient had not recovered from the event of hair loss. As reported, the event was unresolved and ongoing.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  This case is linked with the case 202304654 (the same reporter).  Company comment: On an unspecified date in Oct-2023, reported as three to four days after receiving Flucelvax Quadrivalent, the patient was experiencing hair loss. The patient's medical history and concomitant medications were not reported. Due to insufficient information regarding diagnostic findings and medical history, causal role of the suspect vaccine is unassessable.; Sender's Comments: On an unspecified date in Oct-2023, reported as three to four days after receiving Flucelvax Quadrivalent, the patient was experiencing hair loss. The patient's medical history and concomitant medications were not reported. Due to insufficient information regarding diagnostic findings and medical history, causal role of the suspect vaccine is unassessable.
Age: 49.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site inflammation
Clinical narrative: A softball size inflammation under the injection site; This spontaneous case was received on 06-Oct-2023 from a pharmacist via Communications (reference number: SEQW23-03074) with additional information received on 09-Oct-2023 (being processed together) and concerned a 49-year-old female patient.  The patient's medical history and concomitant medications were not reported. The patient's procedures included an adenoidectomy. The patient had no known allergies.  On 05-Oct-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose:0.5ml; route of administration and anatomical location: not reported) for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and B contained in the vaccine, as reported. The batch number reported was 370661 and the expiry date 30-Jun-2024.  On the same date, after receiving Flucelvax Quadrivalent, the patient had a softball-sized inflammation under the injection site. The patient went to the emergency room and took Benadryl (diphenhydramine hydrochloride).   On 06-Oct-2023, the next day, the patient felt better.  On 07-Oct-2023, the patient recovered from the event.  The reporter Assessed the event of vaccination site inflammation as related to Flucalvax Quadrivalent. As reported, the patient was given Flucelvax vaccine yesterday and had a reaction to it.  This case was assessed as non-serious.  Company comment: On the same date, after receiving Flucelvax Quadrivalent, the patient had a softball-sized inflammation under the injection site. The patient's medical history and concomitant medications were not reported. The patient went to the emergency room and took Benadryl. The next day, the patient felt better. Causal role of the suspect vaccine is assessed as possibly related for vaccination site inflammation, based on chronological and anatomical plausibility.; Reporter's Comments: The patient was given Flucelvax vaccine yesterday and had a reaction to it.; Sender's Comments: On the same date, after receiving Flucelvax Quadrivalent, the patient had a softball-sized inflammation under the injection site. The patient's medical history and concomitant medications were not reported. The patient went to the emergency room and took Benadryl. The next day, the patient felt better. Causal role of the suspect vaccine is assessed as possibly related for vaccination site inflammation, based on chronological and anatomical plausibility.
Age: 77.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Chills, Urinary incontinence
Clinical narrative: It woke me up around 12-2 am with a cold shiver and chills. I got up and got another shirt on over my nightgown and another blanket and went to bed. I felt the need to urinate and before I could get there it was like a balloon popped and it went everywhere. I had no control over it at all. It felt like a balloon popped and it all gushed out. Not at all like the feeling when you normally use the bathroom. My chills went away shortly after that. Lingering fatigue. Its been 6 days and I'm starting to feel better.  I also believe there was an error in my vaccination. The person who gave me the shot had just been in a disagreement with a coworker and I believe they were distracted and gave me an overdose.
Age: 77.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Chills, Fatigue, Sleep disorder, Urinary incontinence
Clinical narrative: It woke me up around 12-2 am with a cold shiver and chills. I got up and got another shirt on over my nightgown and another blanket and went to bed. I felt the need to urinate and before I could get there it was like a balloon popped and it went everywhere. I had no control over it at all. It felt like a balloon popped and it all gushed out. Not at all like the feeling when you normally use the bathroom. My chills went away shortly after that. Lingering fatigue. Its been 6 days and I'm starting to feel better.  I also believe there was an error in my vaccination. The person who gave me the shot had just been in a disagreement with a coworker and I believe they were distracted and gave me an overdose.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bacterial test negative, Chlamydia test negative, Fungal test negative, Genital pain, Human papilloma virus test
Clinical narrative: 10/06/2021 began having pain in the vulvar region approximately with redness and some linear breaks in the skin.  Pain was much worse with contact, and limited to the external genital region, I.e. not involving the vaginal canal. Pain felt like burning and there was also itching. No discharge, pus, odor, or bleeding.  Was prescribed diclofenac (VOLTAREN) 1 % Gel, Apply 2 g topically 4 (four) times daily (Patient not taking: Reported on 10/26/2021), Disp: 50 g, Rfl: 3 ?  estradioL (Estrace) 0.01 % (0.1 mg/gram) vaginal cream, Place 1 g vaginally At Bedtime Start off nightly for 1wk and then transition to twice a week., Disp: 1 each, Rfl: 3. Symptons got better but never fully went away. At the present time I am still experiencing the same symptoms.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Human papilloma virus test positive, Neisseria test negative, Pain, Parasitic test, Skin wound
Clinical narrative: 10/06/2021 began having pain in the vulvar region approximately with redness and some linear breaks in the skin.  Pain was much worse with contact, and limited to the external genital region, I.e. not involving the vaginal canal. Pain felt like burning and there was also itching. No discharge, pus, odor, or bleeding.  Was prescribed diclofenac (VOLTAREN) 1 % Gel, Apply 2 g topically 4 (four) times daily (Patient not taking: Reported on 10/26/2021), Disp: 50 g, Rfl: 3 ?  estradioL (Estrace) 0.01 % (0.1 mg/gram) vaginal cream, Place 1 g vaginally At Bedtime Start off nightly for 1wk and then transition to twice a week., Disp: 1 each, Rfl: 3. Symptons got better but never fully went away. At the present time I am still experiencing the same symptoms.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vulvovaginal burning sensation, Vulvovaginal erythema, Vulvovaginal pain, Vulvovaginal pruritus
Clinical narrative: 10/06/2021 began having pain in the vulvar region approximately with redness and some linear breaks in the skin.  Pain was much worse with contact, and limited to the external genital region, I.e. not involving the vaginal canal. Pain felt like burning and there was also itching. No discharge, pus, odor, or bleeding.  Was prescribed diclofenac (VOLTAREN) 1 % Gel, Apply 2 g topically 4 (four) times daily (Patient not taking: Reported on 10/26/2021), Disp: 50 g, Rfl: 3 ?  estradioL (Estrace) 0.01 % (0.1 mg/gram) vaginal cream, Place 1 g vaginally At Bedtime Start off nightly for 1wk and then transition to twice a week., Disp: 1 each, Rfl: 3. Symptons got better but never fully went away. At the present time I am still experiencing the same symptoms.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Joint swelling, Lip swelling, Peripheral swelling, Pharyngeal swelling
Clinical narrative: My lips, tongue, throat, hands, fingers, ankles, feet and toes were severely swollen.  I got the Moderna shot on 10/6/2023 and on 10/15/2023 ended up in the Emergency Room.  However, I thought the severe swelling was from a pill increase on my depacote from three to four pills to be taken at night for my bi-polar.  As you probably know, there is basically nothing an ER can do for this reaction but to let the medicine run its course through your body.  I started to take a Benadryl on 10/17/2023 for the swelling in my ankles, fever and toes.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: My lips, tongue, throat, hands, fingers, ankles, feet and toes were severely swollen.  I got the Moderna shot on 10/6/2023 and on 10/15/2023 ended up in the Emergency Room.  However, I thought the severe swelling was from a pill increase on my depacote from three to four pills to be taken at night for my bi-polar.  As you probably know, there is basically nothing an ER can do for this reaction but to let the medicine run its course through your body.  I started to take a Benadryl on 10/17/2023 for the swelling in my ankles, fever and toes.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitis. This shot made the tinnitis that began with my first covid shot worse.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Autonomic nervous system imbalance, Cardiac monitoring, Cardiac stress test, Echocardiogram, Fatigue
Clinical narrative: Heart monitors, full cardiac work up due to VT, SVT, tachycardia. Placed on beta blockers. Fatigue, tachycardia, high  resting heart rate, dysautonomia  symptoms
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Heart rate increased, Magnetic resonance imaging heart, Tachycardia, Ultrasound abdomen
Clinical narrative: Heart monitors, full cardiac work up due to VT, SVT, tachycardia. Placed on beta blockers. Fatigue, tachycardia, high  resting heart rate, dysautonomia  symptoms
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Muscle spasms
Clinical narrative: Diarrhea with cramping, treated with fluids& hyoscyamine, resolved within 4 hs
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: Had between cycle menstrual bleeding for the first time in my life, has lasted 7 days so far and is still on going.
Age: 86.0
Sex: F
Vaccine: UNK
Symptoms: Injection site swelling, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: sore arm; arm is stiff if I try to reach; swelling injection; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm), MUSCULOSKELETAL STIFFNESS (arm is stiff if I try to reach) and VACCINATION SITE SWELLING (swelling injection) in an 86-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu. Past adverse reactions to the above products included No adverse event with Flu.    On 09-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced PAIN IN EXTREMITY (sore arm), MUSCULOSKELETAL STIFFNESS (arm is stiff if I try to reach) and VACCINATION SITE SWELLING (swelling injection). At the time of the report, PAIN IN EXTREMITY (sore arm) and VACCINATION SITE SWELLING (swelling injection) had not resolved and MUSCULOSKELETAL STIFFNESS (arm is stiff if I try to reach) outcome was unknown.            No relevant concomitant medications were reported. Patient had received Moderna doses Dose 1 on 2-Feb-2021 batch 004MA0A, Dose 2 on 02-Mar-2021 batch 014M20A, Dose 3 on 05-Nov-2021 batch Q77C21B, Dose 4 on 06-May-2022 batch Q49L21A, Dose 5 on 07-Oct-2022 batch 06VF22A. Patient was not taking any treatment medications.   This case was linked to MOD-2023-745753, MOD-2023-745729 (Patient Link).
Age: 49.0
Sex: M
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: left arm is a little sore; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (left arm is a little sore) in a 49-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: FLU Shot 1 week before Spikevax (FLU Shot 1 week before Spikevax) in 2023. Past adverse reactions to the above products included No adverse event with FLU Shot 1 week before Spikevax.    On 12-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 12-Oct-2023, after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced PAIN IN EXTREMITY (left arm is a little sore). At the time of the report, PAIN IN EXTREMITY (left arm is a little sore) had not resolved.            No concomitant medication was reported. The patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine.  The dosage text was reported as unknown. It was reported that the spikevax was administered on the left upper arm yesterday, but it was not given in the center of the upper arm. It was more to the side. It still went in the muscle. The left arm was a little sore but it was nothing. The patient had about 5 previous shots and had sore arm for 1 day. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745550 (Patient Link).
Age: 91.0
Sex: F
Vaccine: UNK
Symptoms: Feeding disorder, Pain in extremity, Pyrexia
Clinical narrative: Severe soreness on the arm (right) could not eat 2 days; could not eat 2 days; fever; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Severe soreness on the arm (right) could not eat 2 days), FEEDING DISORDER (could not eat 2 days) and PYREXIA (fever) in a 91-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3834B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 12-Oct-2023, the patient experienced PAIN IN EXTREMITY (Severe soreness on the arm (right) could not eat 2 days), FEEDING DISORDER (could not eat 2 days) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (Severe soreness on the arm (right) could not eat 2 days) and PYREXIA (fever) was resolving and FEEDING DISORDER (could not eat 2 days) outcome was unknown.            No concomitant medication was reported.  No treatment information was reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; administered an expired dose of PROQUAD; This spontaneous report was received from a nurse and refers to a 4-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies were not reported.   On 18-SEP-2023, the patient was vaccinated an expired dose of with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 milliliter, (lot #W006583 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date: 23-AUG-2023), administered as prophylaxis (strength, and route of administration were not provided) (expired product administered) that was reconstituted with albumin human (+) phenol (+) sodium chloride (STERILE DILUENT FOR ALLERGENIC EXTRACT) (not expired, concomitant medications). No temperature excursion (TE)s reported. No symptoms reported. No additional AE/PQC (no adverse event).
Sex: F
Vaccine: RSV
Symptoms: Hypoxia, Respiratory failure
Clinical narrative: Respiratory failure; Hypoxia; This serious case was reported by a other health professional via sales rep and described the occurrence of respiratory failure in a 78-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 9B432, expiry date 05-NOV-2024) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 10 min after receiving Arexvy, the patient experienced respiratory failure (Verbatim: Respiratory failure) (serious criteria GSK medically significant) and hypoxia (Verbatim: Hypoxia) (serious criteria GSK medically significant).  The outcome of the respiratory failure and hypoxia were not reported.   It was unknown if the reporter considered the respiratory failure and hypoxia to be related to Arexvy.     It was unknown if the company considered the respiratory failure and hypoxia to be related to Arexvy.   Additional Information: GSK Receipt Date: 12-OCT-2023 The reporter reported that the doctor prescribed Arexvy and pharm d administered, and the patient had respiratory failure with hypoxia 10 to 15 minutes following the administration of a dose of Arexvy. The reporter consented to follow up.
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Nausea
Clinical narrative: High fever; chills; fatigue; arthralgia; decrease appetite; nausea; This non-serious case was reported by a consumer and described the occurrence of fever in a 39-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) for prophylaxis.   Concomitant products included paracetamol.   On 04-OCT-2023, the patient received FluLaval Quadrivalent 2023-2024 season. On 04-OCT-2023, less than a day after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced fever (Verbatim: High fever), chills (Verbatim: chills), fatigue (Verbatim: fatigue), arthralgia (Verbatim: arthralgia), decreased appetite (Verbatim: decrease appetite) and nausea (Verbatim: nausea).  The outcome of the fever, chills, fatigue, arthralgia, decreased appetite and nausea were not resolved.   It was unknown if the reporter considered the fever, chills, fatigue, arthralgia, decreased appetite and nausea to be related to FluLaval Quadrivalent 2023-2024 season and Flulaval Tetra Pre-Filled Syringe Device.     It was unknown if the company considered the fever, chills, fatigue, arthralgia, decreased appetite and nausea to be related to FluLaval Quadrivalent 2023-2024 season and Flulaval Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 08-OCT-2023 The reporter self-reported. The symptoms were not treated. The reporter did not consent to follow up.
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: High fever; chills; fatigue; arthralgia; decrease appetite; nausea; This non-serious case was reported by a consumer and described the occurrence of fever in a 39-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) for prophylaxis.   Concomitant products included paracetamol.   On 04-OCT-2023, the patient received FluLaval Quadrivalent 2023-2024 season. On 04-OCT-2023, less than a day after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced fever (Verbatim: High fever), chills (Verbatim: chills), fatigue (Verbatim: fatigue), arthralgia (Verbatim: arthralgia), decreased appetite (Verbatim: decrease appetite) and nausea (Verbatim: nausea).  The outcome of the fever, chills, fatigue, arthralgia, decreased appetite and nausea were not resolved.   It was unknown if the reporter considered the fever, chills, fatigue, arthralgia, decreased appetite and nausea to be related to FluLaval Quadrivalent 2023-2024 season and Flulaval Tetra Pre-Filled Syringe Device.     It was unknown if the company considered the fever, chills, fatigue, arthralgia, decreased appetite and nausea to be related to FluLaval Quadrivalent 2023-2024 season and Flulaval Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 08-OCT-2023 The reporter self-reported. The symptoms were not treated. The reporter did not consent to follow up.
Age: 33.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pyrexia
Clinical narrative: patient developed shingles; had a fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 33-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concomitant products included upadacitinib (Rinvoq).   In JUN-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: patient developed shingles) and fever (Verbatim: had a fever).  The outcome of the shingles and fever were unknown.   It was unknown if the reporter considered the shingles and fever to be related to Shingrix.     It was unknown if the company considered the shingles and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-OCT-2023 This case was reported by patient for herself. The patient was receiving Shingrix vaccine because the patient receives Rinvoq and was at an increased risk for shingles. The patient received the 1st Shingrix dose in last week of June 2023 and was to receive the second dose on 22nd September 2023, but had a fever and canceled the vaccination. A couple of days later, the patient developed shingles. At the time of call, the patient had not yet received the second dose. The reporter consented to follow up with Healthcare professional (MD).
Sex: U
Vaccine: FLU4
Symptoms: Accidental exposure to product, Device connection issue, Device leakage, No adverse event, Wrong technique in device usage process
Clinical narrative: nurse was administering the fluzone hd vaccine and didn't screw a needle on tight enough, so some of the vaccine came out the side and went in the patient's eye with no reported adverse event; nurse did not attach the syringe needle properly with no reported adverse event; Initial information received on 10-Oct-2023 regarding an unsolicited valid non-serious case received via pharmacist.  This case involves an unknown age and unknown gender patient and reporter reported nurse was administering the fluzone hd vaccine and didn't screw a needle on tight enough, so some of the vaccine came out the side and went in the patient's eye with no reported adverse event and nurse did not attach the syringe needle properly with no reported adverse event after receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 10-Oct-2023, the patient received an unknown dose of suspect influenza quadrival A-B high dose HV vaccine (strength, form, lot number, expiry date: unknown) not reported via unknown route in unknown administration site for prophylactic vaccination (immunization) and nurse was administering the fluzone hd vaccine and didn't screw a needle on tight enough, so some of the vaccine came out the side and went in the patient's eye with no reported adverse event (accidental exposure to product) and nurse did not attach the syringe needle properly with no reported adverse event (wrong technique in device usage process) (latency: same day)  Action taken with quadrivalent influenza vaccine (Fluzone High-Dose Quadrivalent) 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.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Fever of 100.7 Fatigue Chills Headache  Tiredness
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: 102 degree fever, heavy flu like symptoms.  4th covid vaccine, always followed by same, intense flu symptoms lasting 2 - 3 days.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injected limb mobility decreased, Injection site pain, Myalgia, Pain in extremity
Clinical narrative: While receiving the shot, I felt a strong pain down my left arm to my wrist. It felt unusual, and I thought the tech inserted the shot very high in my arm. Normally it is given right in the meaty part of the arm. After an hour of receiving the shot, my left arm was extremely sore. It was not the normal soreness I felt from receiving the shot every year, this felt like a strange pain almost at the shoulder area and joint of my arm. After three days, my arm still felt too sore to lift and while lying down I felt pain. Now it has been two weeks since getting the shot and I am still having trouble with my arm. It hurts to lift it in certain positions. There is a constant achy feeling in the muscles around my shoulder.  It is very sore where the shot was entered into my arm. I am wondering if others have felt this from this specific shot or if the person who gave me the shot did something incorrectly. I have never experienced this before and as a teacher, I get the flu shot every year.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: after shot, left arm became sore and tight at site of injection. The day after injection, arm became significantly more swollen and hot to the touch. site became very sore. Day 3, site is still swollen, but has gone down. site still warm to the touch.
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Condition aggravated, Hyperaesthesia, Insomnia, Paraesthesia, Sensitive skin
Clinical narrative: Gradual increase in my skin burning/paraesthesia now the majority of skin is extremely sensitive to light touch in examples my clothing. It waxes and wanes much worse evenings and night time.  My insomnia is much different, I wake up after 3-4 hours wide awake for hours about 2-3 week.
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Skin burning sensation
Clinical narrative: Gradual increase in my skin burning/paraesthesia now the majority of skin is extremely sensitive to light touch in examples my clothing. It waxes and wanes much worse evenings and night time.  My insomnia is much different, I wake up after 3-4 hours wide awake for hours about 2-3 week.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Impaired driving ability, Impaired work ability, Injected limb mobility decreased, Loss of personal independence in daily activities
Clinical narrative: Right arm became immobile with swelling up the right side of neck. 37 weeks pregnant, unable to get out of bed for bathroom without assistance given significant pain and swelling in arm.  Unable to drive to work, assist children or do housework.   Took aspirin and Tylenol without relief. Used topical lidocaine without relief.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: Right arm became immobile with swelling up the right side of neck. 37 weeks pregnant, unable to get out of bed for bathroom without assistance given significant pain and swelling in arm.  Unable to drive to work, assist children or do housework.   Took aspirin and Tylenol without relief. Used topical lidocaine without relief.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Diarrhoea, Dizziness, Hypoaesthesia, Nausea, Pruritus
Clinical narrative: N/V/D, numbness in all extremities, itchy throat and ears, dizziness
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Throat irritation, Vomiting
Clinical narrative: N/V/D, numbness in all extremities, itchy throat and ears, dizziness
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Death, Endotracheal intubation
Clinical narrative: Pt presents via EMS with altered mental status and reported hypoxia at the nursing facility. Acute hypoxic respiratory failure due to COVID pneumonia along with obstructive sleep apnea, obesity hypoventilation, has been on BiPAP for the past week, emergently intubated, currently with persistent respiratory acidosis and poor oxygenation, remains on sedation and paralytics, discussed with family and they decided to pursue for comfort care. Patient terminally extubated at 1535. Patient time of death 1555. Cause of death is Covid-19, onset 3 weeks. Received decadron.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoventilation, Hypoxia, Mental status changes, Obesity, Obstructive sleep apnoea syndrome
Clinical narrative: Pt presents via EMS with altered mental status and reported hypoxia at the nursing facility. Acute hypoxic respiratory failure due to COVID pneumonia along with obstructive sleep apnea, obesity hypoventilation, has been on BiPAP for the past week, emergently intubated, currently with persistent respiratory acidosis and poor oxygenation, remains on sedation and paralytics, discussed with family and they decided to pursue for comfort care. Patient terminally extubated at 1535. Patient time of death 1555. Cause of death is Covid-19, onset 3 weeks. Received decadron.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Positive airway pressure therapy, Respiratory acidosis
Clinical narrative: Pt presents via EMS with altered mental status and reported hypoxia at the nursing facility. Acute hypoxic respiratory failure due to COVID pneumonia along with obstructive sleep apnea, obesity hypoventilation, has been on BiPAP for the past week, emergently intubated, currently with persistent respiratory acidosis and poor oxygenation, remains on sedation and paralytics, discussed with family and they decided to pursue for comfort care. Patient terminally extubated at 1535. Patient time of death 1555. Cause of death is Covid-19, onset 3 weeks. Received decadron.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: On Oct 15th, patient called and said he wanted "to file a grievance".  He said on Oct 8th at the time of COVID  Comirnaty 12+ SDV administration, he jumped when the vaccine was given and immediately felt a shooting pain. He described there was pain in his left shoulder and shoulder blade area and numbness going down his arm. He said the pain had not subside and has continued for the next week. The patient was contacted Oct 17th and 18th and is still reporting the same signs and symptoms. Another pharmacist was on duty on Oct 15th and he was advised to seek medical attention from his primary physician. I continued to advise the patient to do that on Oct 17th and 18th when I followed up with him. I also suggested patient can try to alternate between ibuprofen and acetaminophen as well as applying an ice pack and/or heating pad to area to see what would help provide the most relief since I'm unaware what type of pain he is experiencing. His primary physican has been notified of incident.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Atypical pneumonia, COVID-19, Cough, Dyspnoea
Clinical narrative: recent Covid diagnosis on 01/05/22 ( treated with 2 rounds of antibiotics) who presented to ER with c/o cough, fatigue, and SOB. CTA chest in the emergency room showed atypical multifocal pneumonia with no PE. Received dexamethasone. Mild hypoxia. Discharged home on home Oxygen.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hypoxia
Clinical narrative: recent Covid diagnosis on 01/05/22 ( treated with 2 rounds of antibiotics) who presented to ER with c/o cough, fatigue, and SOB. CTA chest in the emergency room showed atypical multifocal pneumonia with no PE. Received dexamethasone. Mild hypoxia. Discharged home on home Oxygen.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Cough, Creatinine renal clearance decreased, Death
Clinical narrative: Presents to ED c/o cough/SOB/diarrhea; had been dx'd with COVID 2 days prior to arrival; req BiPAP, unable to give Remdesivir d/t low creatinine clearance d/t nephrectomy, on Rocephin & Zithromax, Dexamethasone, Baricitinib for COVID pneumonia.  Continued to worsen, req intubation, dialysis, family withdrew care and expired.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Dialysis, Diarrhoea, Dyspnoea, Endotracheal intubation, Nephrectomy
Clinical narrative: Presents to ED c/o cough/SOB/diarrhea; had been dx'd with COVID 2 days prior to arrival; req BiPAP, unable to give Remdesivir d/t low creatinine clearance d/t nephrectomy, on Rocephin & Zithromax, Dexamethasone, Baricitinib for COVID pneumonia.  Continued to worsen, req intubation, dialysis, family withdrew care and expired.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Positive airway pressure therapy
Clinical narrative: Presents to ED c/o cough/SOB/diarrhea; had been dx'd with COVID 2 days prior to arrival; req BiPAP, unable to give Remdesivir d/t low creatinine clearance d/t nephrectomy, on Rocephin & Zithromax, Dexamethasone, Baricitinib for COVID pneumonia.  Continued to worsen, req intubation, dialysis, family withdrew care and expired.
Age: 77.0
Sex: F
Vaccine: PNC20
Symptoms: Asthenia, Pain, Pruritus, Urticaria
Clinical narrative: welts (size of cough cup - 4inches, and two smaller welts above about the size of a dime), itching, waves of weakness then pain.  Will be taking benadryl.
Age: 43.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Balance disorder, Dizziness, Fall, Vertigo
Clinical narrative: Started feeling dizzy around 9PM, woke up the next morning with balance issues and falling due to dizziness, went to PCP and diagnosed with Vertigo. Lasted days.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Chest X-ray normal, Dyspnoea, Pain, Pyrexia
Clinical narrative: To ED c/o body aches, 101 fever, SOB; tx: Levaquin, Lovenox, Singulair, Zinc, CXR negative for pneumonia, did not qualify for remdesivir or steroid tx, no O2 required. Tx'd for CHF and then D/c home
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia oral, Throat tightness
Clinical narrative: Throat Closing, lips tingling
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray abnormal, Death, Hypoxia, Mental status changes
Clinical narrative: to ED c/o hypoxia with AMS, being non-compliant at rehab where he had been dx'd with COVID few days prior; CXR + pneumonia, tx'd with BiPAP, maxipime, solu-medrol, decadron. Pt non compliant and refusing med, bipap, wife wants pt tx'd to hospice, pt expires in hospital prior to discharge
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia, Positive airway pressure therapy, Treatment noncompliance
Clinical narrative: to ED c/o hypoxia with AMS, being non-compliant at rehab where he had been dx'd with COVID few days prior; CXR + pneumonia, tx'd with BiPAP, maxipime, solu-medrol, decadron. Pt non compliant and refusing med, bipap, wife wants pt tx'd to hospice, pt expires in hospital prior to discharge
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reaction. She was give Pfizer 5-11 in error. Mother was notified and has no questions or concerns
Age: 20.0
Sex: F
Vaccine: FLU4, TYP, YF
Symptoms: Auscultation, Circumoral swelling, Cough, Dyspnoea, Hypersensitivity
Clinical narrative: At approximately 1409 allergic reaction began.  The patient was immediately assessed and vital signs were taken. The patient developed redness, warmth, and swelling at the site of the immunization injection. The patient then progressively developed a persistent cough, auditory and auscultated wheeze , shortness of breath, and swelling around the mouth. The patient also reported an itchy throat. The patient was given 25mg of IM Benadryl at 1425 and an additional 25mg at 1440. at 1445 a 0.3mg of Epinephrine via an EpiPen was administered and then the patient was immediately transported to the Emergency Department for further evaluation and treatment. At 1510 arrived at ED and at 1741 discharged.
Age: 20.0
Sex: F
Vaccine: FLU4, TYP, YF
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Throat irritation, Wheezing
Clinical narrative: At approximately 1409 allergic reaction began.  The patient was immediately assessed and vital signs were taken. The patient developed redness, warmth, and swelling at the site of the immunization injection. The patient then progressively developed a persistent cough, auditory and auscultated wheeze , shortness of breath, and swelling around the mouth. The patient also reported an itchy throat. The patient was given 25mg of IM Benadryl at 1425 and an additional 25mg at 1440. at 1445 a 0.3mg of Epinephrine via an EpiPen was administered and then the patient was immediately transported to the Emergency Department for further evaluation and treatment. At 1510 arrived at ED and at 1741 discharged.
Age: 94.0
Sex: F
Vaccine: FLU4
Symptoms: Cerebrovascular accident, Death, Dysphagia, General physical health deterioration
Clinical narrative: Patient experienced a stroke roughly 15 minutes after receiving the vaccine. She did not receive any treatment (patient is on hospice). She did improve and was able to start talking but continued to have trouble swallowing. She eventually had worse symptoms and passed away 7 days after the initial adverse event.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: HPV Vaccine was administered at an interval of 7 weeks and 6 days from previous dose and should of been 12 weeks apart.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19 pneumonia, Cough, Diarrhoea, Dyspnoea
Clinical narrative: to ED c/o SOB, weakness, fever, cough, diarrhea; + COVID pneumonia and sepsis, TX: zithromax, merrem, remdesevir, Vit C, Zinc, Singulair, Solu-medrol, lovenox, O2 15 lpm, abx stopped d/t procalcitonin less than 0.25.; upon discharge home, O2 decrease 2 lpm
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Procalcitonin, Pyrexia, SARS-CoV-2 test positive, Sepsis
Clinical narrative: to ED c/o SOB, weakness, fever, cough, diarrhea; + COVID pneumonia and sepsis, TX: zithromax, merrem, remdesevir, Vit C, Zinc, Singulair, Solu-medrol, lovenox, O2 15 lpm, abx stopped d/t procalcitonin less than 0.25.; upon discharge home, O2 decrease 2 lpm
Age: 41.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Feeling abnormal, Feeling cold, Headache, Immunisation reaction, Pain
Clinical narrative: Covid arm very sore for 3 days. Woke up feeling achy, needing to stretch, head hurting and feeling fuzzy. very cold.
Age: 41.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Pain in extremity
Clinical narrative: Covid arm very sore for 3 days. Woke up feeling achy, needing to stretch, head hurting and feeling fuzzy. very cold.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Central venous catheterisation, Cough, Electrolyte substitution therapy, Renal transplant
Clinical narrative: o ED from Dr. office for IV fluids and PICC line for electrolyte replacement after recent COVID dx's 1/17/23; + cough, TX: merrem, already on prednisone for renal transplant.  Discharged home on room air
Age: 11.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Abdominal discomfort, Pain, Pain in extremity, Vomiting
Clinical narrative: Covid and flu arms hurting within a hour. Covid arm still hurting (over 24 hours later). Woke in the middle of the night throwing up. Feels achy and sore. Stomach still upset. fever of 100
Age: 28.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: Chills, Inflammation, Joint swelling, Myalgia, Nausea
Clinical narrative: Fever, nausea, sore throat, chills, inflammation, muscle aches, and swelling around the knees
Age: 28.0
Sex: M
Vaccine: COVID19-2, FLUA4
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Fever, nausea, sore throat, chills, inflammation, muscle aches, and swelling around the knees
Age: 13.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Pain, Pain in extremity, Vomiting
Clinical narrative: arms hurting. covid arm still hurts over 24 hours later. woke in the middle of the night throwing up. Next morning just achy and sore arm.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache
Clinical narrative: Diarrhea, headache, chills