chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: On 11/13/2024 myarm had swelled at the injection site and under my arm. It was red, hot and itching. I had the moderna vaccine for the 5 shots before,  this was my first Pfizer vaccine.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Nausea, Pyrexia
Clinical narrative: pt experienced severe weakness, nausea and a low grade fever which lasted a couple of days -- he says that these symptoms have progressively gotten worse with each COVID (moderna) vaccination he gets.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardioversion, Chest X-ray, Electrocardiogram, Heart rate increased
Clinical narrative: Sever A-fib elevated heart rate approx 200bps requiring  electric shock fever pulmonary edema
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary oedema, Pyrexia
Clinical narrative: Sever A-fib elevated heart rate approx 200bps requiring  electric shock fever pulmonary edema
Sex: F
Vaccine: RSV
Symptoms: Decreased appetite, Exposure during pregnancy, Headache, Injection site nodule, Injection site reaction
Clinical narrative: feels like a knot that's hot to the touch where the injection site was; feels like a knot that's hot to the touch where the injection site was; swelling/where the injection site was; developed this rash that is red//where the injection site was; nausea; vomiting; headache; slight fever (99.5); don't feel hungry; This is a spontaneous report received from a Consumer or other non HCP.  A 25-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 07Nov2024 as dose number unknown, single (Lot number: LN5472) for maternal immunisation. The patient's relevant medical history included: "drug allergy" (unspecified if ongoing). The patient was 32 weeks pregnant at the time of exposure to rsv vaccine prot.subunit pref 2v. The patient was 32 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 27Dec2024. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE RASH (non-serious) with onset Nov2024, outcome "not recovered", described as "developed this rash that is red//where the injection site was"; DECREASED APPETITE (non-serious) with onset Nov2024, outcome "recovered" (10Nov2024), described as "don't feel hungry"; VACCINATION SITE WARMTH (non-serious), VACCINATION SITE NODULE (non-serious) all with onset Nov2024, outcome "not recovered" and all described as "feels like a knot that's hot to the touch where the injection site was"; HEADACHE (non-serious) with onset Nov2024, outcome "recovered" (10Nov2024); NAUSEA (non-serious) with onset Nov2024, outcome "recovered" (10Nov2024); PYREXIA (non-serious) with onset Nov2024, outcome "recovered" (10Nov2024), described as "slight fever (99.5)"; VACCINATION SITE SWELLING (non-serious) with onset Nov2024, outcome "not recovered", described as "swelling/where the injection site was"; VOMITING (non-serious) with onset Nov2024, outcome "recovered" (10Nov2024). Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of vaccination site warmth, vaccination site nodule, vaccination site swelling, vaccination site rash, nausea, vomiting, headache, pyrexia, decreased appetite. Additional information: when patient was at the office 07Nov2024. Over the weekend (in Nov2024), patient developed this rash that was red, had some swelling, and feels like a knot that's hot to the touch where the injection site was. Patient had some weird symptoms develop over the weekend too which was nausea, vomiting, headache, and a slight fever (99.5). All of those symptoms have gone away, patient just don't feel hungry today even though patient couldn't keep any food down yesterday. The only symptoms left are the ones at the injection site.
Sex: F
Vaccine: RSV
Symptoms: Injection site swelling, Injection site warmth, Nausea, Pyrexia, Rash erythematous
Clinical narrative: feels like a knot that's hot to the touch where the injection site was; feels like a knot that's hot to the touch where the injection site was; swelling/where the injection site was; developed this rash that is red//where the injection site was; nausea; vomiting; headache; slight fever (99.5); don't feel hungry; This is a spontaneous report received from a Consumer or other non HCP.  A 25-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 07Nov2024 as dose number unknown, single (Lot number: LN5472) for maternal immunisation. The patient's relevant medical history included: "drug allergy" (unspecified if ongoing). The patient was 32 weeks pregnant at the time of exposure to rsv vaccine prot.subunit pref 2v. The patient was 32 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 27Dec2024. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE RASH (non-serious) with onset Nov2024, outcome "not recovered", described as "developed this rash that is red//where the injection site was"; DECREASED APPETITE (non-serious) with onset Nov2024, outcome "recovered" (10Nov2024), described as "don't feel hungry"; VACCINATION SITE WARMTH (non-serious), VACCINATION SITE NODULE (non-serious) all with onset Nov2024, outcome "not recovered" and all described as "feels like a knot that's hot to the touch where the injection site was"; HEADACHE (non-serious) with onset Nov2024, outcome "recovered" (10Nov2024); NAUSEA (non-serious) with onset Nov2024, outcome "recovered" (10Nov2024); PYREXIA (non-serious) with onset Nov2024, outcome "recovered" (10Nov2024), described as "slight fever (99.5)"; VACCINATION SITE SWELLING (non-serious) with onset Nov2024, outcome "not recovered", described as "swelling/where the injection site was"; VOMITING (non-serious) with onset Nov2024, outcome "recovered" (10Nov2024). Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of vaccination site warmth, vaccination site nodule, vaccination site swelling, vaccination site rash, nausea, vomiting, headache, pyrexia, decreased appetite. Additional information: when patient was at the office 07Nov2024. Over the weekend (in Nov2024), patient developed this rash that was red, had some swelling, and feels like a knot that's hot to the touch where the injection site was. Patient had some weird symptoms develop over the weekend too which was nausea, vomiting, headache, and a slight fever (99.5). All of those symptoms have gone away, patient just don't feel hungry today even though patient couldn't keep any food down yesterday. The only symptoms left are the ones at the injection site.
Sex: F
Vaccine: RSV
Symptoms: Vomiting
Clinical narrative: feels like a knot that's hot to the touch where the injection site was; feels like a knot that's hot to the touch where the injection site was; swelling/where the injection site was; developed this rash that is red//where the injection site was; nausea; vomiting; headache; slight fever (99.5); don't feel hungry; This is a spontaneous report received from a Consumer or other non HCP.  A 25-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 07Nov2024 as dose number unknown, single (Lot number: LN5472) for maternal immunisation. The patient's relevant medical history included: "drug allergy" (unspecified if ongoing). The patient was 32 weeks pregnant at the time of exposure to rsv vaccine prot.subunit pref 2v. The patient was 32 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 27Dec2024. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE RASH (non-serious) with onset Nov2024, outcome "not recovered", described as "developed this rash that is red//where the injection site was"; DECREASED APPETITE (non-serious) with onset Nov2024, outcome "recovered" (10Nov2024), described as "don't feel hungry"; VACCINATION SITE WARMTH (non-serious), VACCINATION SITE NODULE (non-serious) all with onset Nov2024, outcome "not recovered" and all described as "feels like a knot that's hot to the touch where the injection site was"; HEADACHE (non-serious) with onset Nov2024, outcome "recovered" (10Nov2024); NAUSEA (non-serious) with onset Nov2024, outcome "recovered" (10Nov2024); PYREXIA (non-serious) with onset Nov2024, outcome "recovered" (10Nov2024), described as "slight fever (99.5)"; VACCINATION SITE SWELLING (non-serious) with onset Nov2024, outcome "not recovered", described as "swelling/where the injection site was"; VOMITING (non-serious) with onset Nov2024, outcome "recovered" (10Nov2024). Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of vaccination site warmth, vaccination site nodule, vaccination site swelling, vaccination site rash, nausea, vomiting, headache, pyrexia, decreased appetite. Additional information: when patient was at the office 07Nov2024. Over the weekend (in Nov2024), patient developed this rash that was red, had some swelling, and feels like a knot that's hot to the touch where the injection site was. Patient had some weird symptoms develop over the weekend too which was nausea, vomiting, headache, and a slight fever (99.5). All of those symptoms have gone away, patient just don't feel hungry today even though patient couldn't keep any food down yesterday. The only symptoms left are the ones at the injection site.
Age: 72.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Influenza like illness
Clinical narrative: he felt like he actually had COViD and flu at the same time; This is a spontaneous report received from a Consumer or other non HCP.  A 72-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 12Nov2024 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years, in arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 12Nov2024). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 12Nov2024 at 19:00, outcome "unknown", described as "he felt like he actually had COViD and flu at the same time". Therapeutic measures were not taken as a result of influenza like illness.  Additional information: Revived both COVID and flu vaccination at the same time and felt awful by the evening. Patient felt like he actually had COVID and flu at the same time. It was unknown if the patient received any other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting. It was unknown if the patient was taking any other medications within 2 weeks of the event starting.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive with COVID-19; Tested positive with COVID-19; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Oct2024 as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 4, SINGLE, Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, SINGLE, Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Unknown Manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "Tested positive with COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2024) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient had been administered with Pfizer COVID-19 Vaccine two and a half weeks ago (Oct2024), he had his 5th booster shot, it was a Pfizer covid vaccine administered at his local hospital then tested positive with COVID-19 and took Paxlovid.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Caller mentioned she was prescribed with Paxlovid as she tested positive for COVID-19 today, but she had the Pfizer COVID-19 Vaccine last Friday; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A female patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 08Nov2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset 13Nov2024, outcome "unknown", described as "Caller mentioned she was prescribed with Paxlovid as she tested positive for COVID-19 today, but she had the Pfizer COVID-19 Vaccine last Friday". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19. Additional information: The reporter mentioned she was prescribed with Paxlovid as she tested positive for COVID-19 today (13Nov2024), but she had the Pfizer COVID-19 Vaccine last Friday (08Nov2024). She wanted to know if it was safe to take Paxlovid even with she receiving the COVID-19 Vaccine. She added her son had COVID-19, so that she probably got it from him. She then inquired on if she could stop treatment after 2 days in case she felt better.  The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis; Shingles; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown"; HERPES ZOSTER (non-serious), outcome "unknown", described as "Shingles". The patient had three vaccines shots since COVID started. The reported assumed that it was COVID shots but did not know which ones. The patient was claiming after they had these side effects that they got shingles and now rheumatoid arthritis they say, and he was wondering if these vaccines are going to do these conditions.
Sex: U
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Musculoskeletal discomfort
Clinical narrative: Feel like it's going to fly off my shoulders; Can't get warm; I am staying cold; Head is really hurting; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "unknown", described as "Feel like it's going to fly off my shoulders"; FEELING COLD (non-serious), outcome "unknown", described as "Can't get warm; I am staying cold"; HEADACHE (non-serious), outcome "unknown", described as "Head is really hurting". Additional information: Consumer stated, "I took Comirnaty shot yesterday, I feel like it's going to fly off my shoulders and I can't get warm, I am staying cold. My head is really hurting. I feel like it's going to fly off my shoulders. What can I do about it?" When paraphrased the concern, consumer confirmed the same.  Batch/lot number is not provided, and it cannot be obtained.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Contracted COVID-19/Subsequent infection; Contracted COVID-19/Subsequent infection; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2024-776152 (Moderna).  A patient (age and gender not provided) received BNT162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (SPIKEVAX), as dose 1, single) for covid-19 immunisation. The patient's relevant medical history included: "Headache (Few migraines)" (ongoing); "Tinnitus" (ongoing), notes: briefly earlier in the year prior to the first Moderna vaccine. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Contracted COVID-19/Subsequent infection". The patient contracted Covid over a year following Moderna vaccine and a Pfizer booster. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.    Company comment: The medical history of headache and tinnitus and event COVID-19 could be confounders for the events. The benefit-risk relationship of product is not affected by this report.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400146003 same patient/drug, different event;
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: Headache; Muscle ache; Fever; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 2024-NVX-US-00829 (Novavax).  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "PRE-DIABETES" (ongoing); "ACID REFLUX" (ongoing); "HEARTBURN" (ongoing); "COVID-19" (ongoing); "she tested twice and both tests were positive" (not ongoing); "she tested twice and both tests were positive" (not ongoing). There were no concomitant medications. Past drug history included: Wegovy for Pre-diabetes; Wegovy for Weight loss; Zegerid [glimepiride] for Drug use for unknown indication. Vaccination history included: Influenza vaccine, administration date: Oct2024, for Drug use for unknown indication. The following information was reported: HEADACHE (non-serious), outcome "unknown"; MYALGIA (non-serious), outcome "unknown", described as "Muscle ache"; PYREXIA (non-serious), outcome "unknown", described as "Fever". Relevant laboratory tests and procedures are available in the appropriate section. Additional information (as reported): Past therapies included 3 Pfizer products (Drug use for unknown indication) on unknown dates; 3 Moderna products (Drug use for unknown indication) on unknown dates; 5 Pfizer products (Drug use for unknown indication) on Oct2024; Influenza vaccine (Drug use for unknown indication) on Oct2024; Wegovy for pre-diabetes and weight loss on unknown dates; and Zegerid (Glimepiride) (Drug use for unknown indication) on unknown dates. The events Headache, Myalgia, and Pyrexia were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) and Headache, Myalgia and Pyrexia is considered Possible.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Bone densitometry, Bone density abnormal, Malaise
Clinical narrative: didn't felt good; bone density wasn't great; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): 10000073651 (Genentech).  A 68-year-old female patient received BNT162b2 (BNT162B2), on 02Aug2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Acid reflux" (unspecified if ongoing); "Other urticaria" (ongoing), notes: concurrent condition; "peripheral veins" (ongoing), notes: concurrent condition; "Penicillin allergy" (ongoing), notes: concurrent condition; "Latex allergy" (ongoing), notes: concurrent condition; "Mecrylate allergy" (ongoing), notes: concurrent condition. Concomitant medication(s) included: AMLODIPINE; OMEPRAZOLE; PRAVASTATIN; GABAPENTIN; BIOTIN; MULTIVITAMIN [VITAMINS NOS]; ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]; CALCIUM. Past drug history included: Amoxicillin for allergy; Hydrocodone for allergy; Clindamycin for allergy; Metronidazole for allergy; Morphine for allergy; Omnicef for allergy; Percocet for allergy. The following information was reported: MALAISE (non-serious), outcome "not recovered", described as "didn't felt good"; BONE DENSITY ABNORMAL (non-serious), outcome "not recovered", described as "bone density wasn't great". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Caller had his booster shot but still got covid; Caller had his booster shot but still got covid; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  A male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller had his booster shot but still got covid". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Caller had his booster shot but still got covid and was prescribed Paxlovid and enrolled into the program. Caller had his booster shot but still got covid and was prescribed Paxlovid.  Batch/lot number is not provided, and it cannot be obtained.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Pediatric dose of Hepatitis B vaccine Administered to adult patient.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Testicular pain, Testicular swelling, Ultrasound scan
Clinical narrative: Testicular swelling bilaterally & bilateral testicular pain
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Haemorrhage, Immediate post-injection reaction
Clinical narrative: Immediate bleeding and bruising. I have had a very deep and dark bruise for the last 14 days and it will still be there for a while
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling and numbness on left side of face, head and ear. Has been continuing for around 2 months after the shot
Age: 63.0
Sex: F
Vaccine: PNC21, VARZOS
Symptoms: Pruritus, Swelling, Swelling face, Urticaria
Clinical narrative: Face and neck swelling, throat did not close up. Full body hives and itching.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Wide spread urticaria on body,legs, side and bottom of feet, Gu area left inner arm
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient reported redness, swelling, itching, and pain at the injection site for several days after the vaccination. Patient returned today for another vaccination (1 week after the last) and her arm still appeared to be a bit red and swollen, and she states it still itches a bit.
Age: 5.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Petechiae
Clinical narrative: Pt returned to clinic roughly 20 minutes after receiving the vaccines and had developed a petechial rash over the majority of her body. Denied anaphylaxis, severe headache, change in vision, abdominal pain, n/v or leg pain/swelling. Recommended pt f/u immediately to Urgent Care for further evaluation and possible treatment.  Advised to call EMS if pt develops anaphylaxis while in route.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Eye movement disorder, Transient ischaemic attack
Clinical narrative: diagnosed with TIA, left eye froze and BP skyrocketed
Age: 65.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Blepharospasm, Chills, Electric shock sensation, Injection site discolouration, Injection site erythema
Clinical narrative: Body Aches, chills, SEVERE headache/ migraine- felt like electric shocks going up the back of my head and made my eye twitch, severe neck stiffness and pain, severe skin reaction- very large 4 inch diameter red welt at injection site, hot to touch and EXTREMELY PAINFUL - 3 weeks later there is still slight arm discoloration at injection site and it is sensitive / painful to touch
Age: 65.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Injection site pain, Injection site reaction, Injection site warmth, Migraine, Musculoskeletal stiffness
Clinical narrative: Body Aches, chills, SEVERE headache/ migraine- felt like electric shocks going up the back of my head and made my eye twitch, severe neck stiffness and pain, severe skin reaction- very large 4 inch diameter red welt at injection site, hot to touch and EXTREMELY PAINFUL - 3 weeks later there is still slight arm discoloration at injection site and it is sensitive / painful to touch
Age: 65.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Neck pain, Pain, Urticaria
Clinical narrative: Body Aches, chills, SEVERE headache/ migraine- felt like electric shocks going up the back of my head and made my eye twitch, severe neck stiffness and pain, severe skin reaction- very large 4 inch diameter red welt at injection site, hot to touch and EXTREMELY PAINFUL - 3 weeks later there is still slight arm discoloration at injection site and it is sensitive / painful to touch
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Gaze palsy, Loss of consciousness, Seizure, Tremor, Vomiting
Clinical narrative: Patient received vaccination. Shortly after receiving the vaccination she passed out with eyes rolling back of head and shaking (suspected seizure) she came through in under 20 seconds. After becoming alert again about 1 minute later she started vomiting. She vomited twice over a 5 minutes span.  Released to parental care. Father is registered nurse and family was planning to see pediatrician.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Pain, Swelling
Clinical narrative: Localized swelling and pain
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Skin discolouration, Skin mass, Skin warm
Clinical narrative: Knot under skin, swollen, redness, itchy, hot to touch, uneven borders, uneven coloring
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Swelling
Clinical narrative: Knot under skin, swollen, redness, itchy, hot to touch, uneven borders, uneven coloring
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Influenza virus test negative, Nausea, Night sweats
Clinical narrative: Fever Headache Bodyaches night sweats nausea fatigue
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Fever Headache Bodyaches night sweats nausea fatigue
Age: 63.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Blood test, COVID-19, Deep vein thrombosis, Headache, Malaise
Clinical narrative: Unsure if these events are related to the vaccine(s) but felt they should be reported to you.  I started getting covid-19 symptoms (runny nose, headache, general body aches and low grade fever) approximately 48 hrs after my husband had the same symptoms. I tested positive for covid-19 on November 2nd. Felt ill for about 5 days and noticed that my left leg was beginning to swell. I went to the ER on the night of Nov 7 and after an ultrasound was found to have several dvt's in my left lower extremity. I have a history of 3 DVTs with subsequent Pulmonary Embolism but not for 30 years. (They occurred in 1983, 1988, 1993.) In 1983, it occurred 2 months after beginning the BCP. In 1988 and 1993, both events followed long plane flights and illness/dehydration. No further episodes since then.
Age: 63.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Pain, Peripheral swelling, Pyrexia, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Unsure if these events are related to the vaccine(s) but felt they should be reported to you.  I started getting covid-19 symptoms (runny nose, headache, general body aches and low grade fever) approximately 48 hrs after my husband had the same symptoms. I tested positive for covid-19 on November 2nd. Felt ill for about 5 days and noticed that my left leg was beginning to swell. I went to the ER on the night of Nov 7 and after an ultrasound was found to have several dvt's in my left lower extremity. I have a history of 3 DVTs with subsequent Pulmonary Embolism but not for 30 years. (They occurred in 1983, 1988, 1993.) In 1983, it occurred 2 months after beginning the BCP. In 1988 and 1993, both events followed long plane flights and illness/dehydration. No further episodes since then.
Age: 63.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Ultrasound Doppler abnormal
Clinical narrative: Unsure if these events are related to the vaccine(s) but felt they should be reported to you.  I started getting covid-19 symptoms (runny nose, headache, general body aches and low grade fever) approximately 48 hrs after my husband had the same symptoms. I tested positive for covid-19 on November 2nd. Felt ill for about 5 days and noticed that my left leg was beginning to swell. I went to the ER on the night of Nov 7 and after an ultrasound was found to have several dvt's in my left lower extremity. I have a history of 3 DVTs with subsequent Pulmonary Embolism but not for 30 years. (They occurred in 1983, 1988, 1993.) In 1983, it occurred 2 months after beginning the BCP. In 1988 and 1993, both events followed long plane flights and illness/dehydration. No further episodes since then.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling of body temperature change, Gait inability, Headache, Hyperhidrosis
Clinical narrative: - Nauseus - Throbbing Headache - Hot & Cold sweats - Couldn't walk - Injection pain site - severe malaise/dizziness - light headed. Patients MD stated it might be a allergie.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Malaise, Nausea
Clinical narrative: - Nauseus - Throbbing Headache - Hot & Cold sweats - Couldn't walk - Injection pain site - severe malaise/dizziness - light headed. Patients MD stated it might be a allergie.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Product storage error
Clinical narrative: Administration after temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a female patient who received DTPa (Infanrix) (batch number 5ST5M, expiry date 24-MAR-2026) for prophylaxis.   On 18-OCT-2024, the patient received Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced incorrect storage of drug (Verbatim: Administration after temperature excursion). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-OCT-2024 The reporter stated that their fridge had a temperature excursion, so just called for some of the vaccine, to make sure that they were ok. The reporter did run them, through the online calculator, and it said that everything it was ok, but there was a couple that they had administered which led to incorrect storage of drug. The Healthcare professional mentioned the excursion was for Fluarix, Pediarix, Flulaval, Infanrix, Menveo (1 vial) and Boostrix. Healthcare professional reported to administer this vaccines to 13 different patients. The Healthcare professional mentioned that all of this patients received the vaccines on 18th October 2024. This was 1 of the 13 cases, reported by the same reporter.
Age: 2.0
Sex: F
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: Administration after temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 2-year-old female patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number PG52S, expiry date 30-JUN-2025) for prophylaxis.   On 18-OCT-2024, the patient received Fluarix 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced incorrect storage of drug (Verbatim: Administration after temperature excursion). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-OCT-2024 The reporter stated that their fridge had a temperature excursion, so just called for some of the vaccine, to make sure that they were ok. The reporter did run them, through the online calculator, and it said that everything it was ok, but there was a couple that they had administered which led to incorrect storage of drug. The Healthcare professional mentioned the excursion was for Fluarix, Pediarix, Flulaval, Infanrix, Menveo (1 vial) and Boostrix. Healthcare professional reported to administer this vaccines to 13 different patients. The Healthcare professional mentioned that all of this patients received the vaccines on 18th October 2024. This was 1 of the 13 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR133246:same reporter, Different Patient US-GSK-US2024AMR133247:same reporter, Different Patient US-GSK-US2024AMR133247:same reporter, Different Patient US-GSK-US2024AMR133249:same reporter, Different Patient US-GSK-US2024AMR133250:same reporter, Different Patient US-GSK-US2024AMR133251:same reporter, Different Patient US-GSK-US2024AMR133252:same reporter, Different Patient US-GSK-US2024AMR133253:same reporter, Different Patient US-GSK-US2024AMR133244:same reporter, Different Patient US-GSK-US2024AMR133243:same reporter, Different Patient US-GSK-US2024129452:same reporter, Different Patient US-GSK-US2024AMR133245:same reporter, Different Patient
Age: 2.0
Sex: F
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: Administration after temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a female patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number PG52S, expiry date 30-JUN-2025) for prophylaxis.   On 18-OCT-2024, the patient received Fluarix 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced incorrect storage of drug (Verbatim: Administration after temperature excursion). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-OCT-2024 The reporter stated that their fridge had a temperature excursion, so just called for some of the vaccine, to make sure that they were ok. The reporter did run them, through the online calculator, and it said that everything it was ok, but there was a couple that they had administered which led to incorrect storage of drug. The Healthcare professional mentioned the excursion was for Fluarix, Pediarix, Flulaval, Infanrix, Menveo (1 vial) and Boostrix. Healthcare professional reported to administer this vaccines to 13 different patients. The Healthcare professional mentioned that all of this patients received the vaccines on 18th October 2024. This was 1 of the 13 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR133246:Original Case : US2024129452 US-GSK-US2024AMR133247:Original Case : US2024129452 US-GSK-US2024AMR133248:Original Case : US2024129452 US-GSK-US2024AMR133249:Original Case : US2024129452 US-GSK-US2024AMR133250:Original Case : US2024129452 US-GSK-US2024AMR133251:Original Case : US2024129452 US-GSK-US2024AMR133252:Original Case : US2024129452 US-GSK-US2024AMR133253:Original Case : US2024129452 US-GSK-US2024129452:Original Case : US2024129452 US-GSK-US2024AMR133243:Original Case : US2024129452 US-GSK-US2024AMR133242:Original Case : US2024129452 US-GSK-US2024AMR133245:Original Case : US2024129452
Age: 2.0
Sex: U
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: Administration after temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 2-year-old patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number PG52S, expiry date 30-JUN-2024) for prophylaxis.   On 18-OCT-2024, the patient received Fluarix 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced incorrect storage of drug (Verbatim: Administration after temperature excursion). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-OCT-2024 The reporter stated that their fridge had a temperature excursion, so just called for some of the vaccine, to make sure that they were ok. The reporter did run them, through the online calculator, and it said that everything it was ok, but there was a couple that they had administered which led to incorrect storage of drug. The Healthcare professional mentioned the excursion was for Fluarix, Pediarix, Flulaval, Infanrix, Menveo (1 vial) and Boostrix. Healthcare professional reported to administer this vaccines to 13 different patients. The Healthcare professional mentioned that all of this patients received the vaccines on 18th October 2024. This was 1 of the 13 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR133246:Same Reporter, Different Patient US-GSK-US2024AMR133247:Same Reporter, Different Patient US-GSK-US2024AMR133248:Same Reporter, Different Patient US-GSK-US2024AMR133249:Same Reporter, Different Patient US-GSK-US2024AMR133250:Same Reporter, Different Patient US-GSK-US2024AMR133251:Same Reporter, Different Patient US-GSK-US2024AMR133252:Same Reporter, Different Patient US-GSK-US2024AMR133253:Same Reporter, Different Patient US-GSK-US2024AMR133244:Same Reporter, Different Patient US-GSK-US2024AMR133243:Same Reporter, Different Patient US-GSK-US2024AMR133242:Same Reporter, Different Patient US-GSK-US2024129452:Same Reporter, Different Patient
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: Administration after temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 4-year-old female patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number PG52S, expiry date 30-JUN-2025) for prophylaxis.   On 18-OCT-2024, the patient received Fluarix 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced incorrect storage of drug (Verbatim: Administration after temperature excursion). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-OCT-2024 The reporter stated that their fridge had a temperature excursion, so just called for some of the vaccine, to make sure that they were ok. The reporter did run them, through the online calculator, and it said that everything it was ok, but there was a couple that they had administered which led to incorrect storage of drug. The Healthcare professional mentioned the excursion was for Fluarix, Pediarix, Flulaval, Infanrix, Menveo (1 vial) and Boostrix. Healthcare professional reported to administer this vaccines to 13 different patients. The Healthcare professional mentioned that all of this patients received the vaccines on 18th October 2024. This was 1 of the 13 cases, reported by the same reporter.
Age: 1.33
Sex: F
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: Administration after temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a female patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number PG52S, expiry date 30-JUN-2024) for prophylaxis.   On 18-OCT-2024, the patient received Fluarix 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced incorrect storage of drug (Verbatim: Administration after temperature excursion). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-OCT-2024 The reporter stated that their fridge had a temperature excursion, so just called for some of the vaccine, to make sure that they were ok. The reporter did run them, through the online calculator, and it said that everything it was ok, but there was a couple that they had administered which led to incorrect storage of drug. The Healthcare professional mentioned the excursion was for Fluarix, Pediarix, Flulaval, Infanrix, Menveo (1 vial) and Boostrix. Healthcare professional reported to administer this vaccines to 13 different patients. The Healthcare professional mentioned that all of this patients received the vaccines on 18th October 2024. This was 1 of the 13 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR133242:Original Case : US2024129452
Age: 0.58
Sex: F
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: Administration after temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 7-month-old female patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number PG52S, expiry date 30-JUN-2025) for prophylaxis.   On 18-OCT-2024, the patient received Fluarix 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced incorrect storage of drug (Verbatim: Administration after temperature excursion). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-OCT-2024 The reporter stated that their fridge had a temperature excursion, so just called for some of the vaccine, to make sure that they were ok. The reporter did run them, through the online calculator, and it said that everything it was ok, but there was a couple that they had administered which led to incorrect storage of drug. The Healthcare professional mentioned the excursion was for Fluarix, Pediarix, Flulaval, Infanrix, Menveo (1 vial) and Boostrix. Healthcare professional reported to administer this vaccines to 13 different patients. The Healthcare professional mentioned that all of this patients received the vaccines on 18th October 2024. This was 1 of the 13 cases, reported by the same reporter.
Age: 0.67
Sex: M
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Administration after temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 8-month-old male patient who received Flu Seasonal TIV Quebec (FluLaval 2024-2025 season) (batch number 495MK, expiry date 30-JUN-2025) for prophylaxis.   On 18-OCT-2024, the patient received FluLaval 2024-2025 season. On an unknown date, an unknown time after receiving FluLaval 2024-2025 season, the patient experienced incorrect storage of drug (Verbatim: Administration after temperature excursion). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-OCT-2024 The reporter stated that their fridge had a temperature excursion, so just called for some of the vaccine, to make sure that they were ok. The reporter did run them, through the online calculator, and it said that everything it was ok, but there was a couple that they had administered which led to incorrect storage of drug. The Healthcare professional mentioned the excursion was for Fluarix, Pediarix, Flulaval, Infanrix, Menveo (1 vial) and Boostrix. Healthcare professional reported to administer this vaccines to 13 different patients. The Healthcare professional mentioned that all of this patients received the vaccines on 18th October 2024. This was 1 of the 13 cases, reported by the same reporter.
Age: 0.5
Sex: M
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: Administration after temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 6-month-old male patient who received Flu Seasonal TIV Dresden (Fluarix 2024-2025 season) (batch number PG52S, expiry date 30-JUN-2024) for prophylaxis.   On 18-OCT-2024, the patient received Fluarix 2024-2025 season. On an unknown date, an unknown time after receiving Fluarix 2024-2025 season, the patient experienced incorrect storage of drug (Verbatim: Administration after temperature excursion). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-OCT-2024 The reporter stated that their fridge had a temperature excursion, so just called for some of the vaccine, to make sure that they were ok. The reporter did run them, through the online calculator, and it said that everything it was ok, but there was a couple that they had administered which led to incorrect storage of drug. The Healthcare professional mentioned the excursion was for Fluarix, Pediarix, Flulaval, Infanrix, Menveo (1 vial) and Boostrix. Healthcare professional reported to administer this vaccines to 13 different patients. The Healthcare professional mentioned that all of this patients received the vaccines on 18th October 2024. This was 1 of the 13 cases, reported by the same reporter.