chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Received First Dose in Aug 2024, and Received Second Dose Jan 2025; Initial report received on 13-Jan-2025.  A consumer reported that he, a male, (race, ethnicity not reported) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization in Aug-2024 and received the second dose on 13-Jan-2025.  No medical history or concomitant medications were reported.    In Aug-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (NDC #43528-002-01, lot #, expiration date, and , site not reported) intramuscularly.   On 13-Jan-2025, the patient received dose 2 of HEPLISAV-B intramuscularly.    No adverse reactions were reported.  No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 17 Year Old Received 1st Dose of HEPLISAV-B; Initial report received on 13-Jan-2025.  A pharmacist reported that a 17-year-old female patient (race, ethnicity not reported) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization when she was 17 years old.  No medical history or concomitant medications were reported.    On 02-Jan-2025, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #944942, expiration date 07-Jan-2027, NDC # 43528-0003-05) intramuscularly in the right deltoid.   The patient was 17 years old at the time.  No adverse effects were reported.  No other information was available.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Back pain, Blister, Headache, Meningism, Neck pain
Clinical narrative: Has not received second dose of HEPLISAV-B yet; Neck Pain; Back Pain; Severe Headache; Herpetic Rash (Water Blisters); Meningitis Like Reaction; Initial report received on 13-Jan-2025.  A pharmacist reported that a 48-year-old female patient (race, ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and developed a herpetic rash, water blisters, severe headache, neck pain, back pain and a meningitis-type of reaction.  At the time of the report, the patient has not had the second dose in the series yet.  The patient is allergic to non-steroidal anti-inflammatory (NSAID) medications and aspirin.     On 22-Aug-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot # 944942, expiration date 03-Jan-2027, NDC # 43528-0003-05)] intramuscularly in the left arm.    On 23-Aug-2024, one day after receiving HEPLISAV-B, the patient had reactions like a herpetic rash, water blisters, and a severe headache.  The water blisters lasted two days.  The patient had neck, back, and head pain for one month.  The patient stated the reaction was like a meningitis-type of reaction.    On-13-Jan-2025, the patient presented to the pharmacy wanting to receive the second dose in the series.  As of the date of this report, the patient has not received the second dose of the HEPLISAV-B series.  The patient was advised by the pharmacist that she will need to obtain the next dose under "medical supervision."  No additional information was reported.    Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Rash vesicular
Clinical narrative: Has not received second dose of HEPLISAV-B yet; Neck Pain; Back Pain; Severe Headache; Herpetic Rash (Water Blisters); Meningitis Like Reaction; Initial report received on 13-Jan-2025.  A pharmacist reported that a 48-year-old female patient (race, ethnicity not reported) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and developed a herpetic rash, water blisters, severe headache, neck pain, back pain and a meningitis-type of reaction.  At the time of the report, the patient has not had the second dose in the series yet.  The patient is allergic to non-steroidal anti-inflammatory (NSAID) medications and aspirin.     On 22-Aug-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot # 944942, expiration date 03-Jan-2027, NDC # 43528-0003-05)] intramuscularly in the left arm.    On 23-Aug-2024, one day after receiving HEPLISAV-B, the patient had reactions like a herpetic rash, water blisters, and a severe headache.  The water blisters lasted two days.  The patient had neck, back, and head pain for one month.  The patient stated the reaction was like a meningitis-type of reaction.    On-13-Jan-2025, the patient presented to the pharmacy wanting to receive the second dose in the series.  As of the date of this report, the patient has not received the second dose of the HEPLISAV-B series.  The patient was advised by the pharmacist that she will need to obtain the next dose under "medical supervision."  No additional information was reported.    Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Had The First Dose, and Have Not Had The Second Dose; Initial report received on 17-Jan-2025.    A consumer reported that she, a female (age, race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization but has not received the second dose yet.   No medical history was reported.      No medical history or concomitant medications were reported.    On 22-Nov-2024, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot #, expiration date, and NDC #, not reported)] intramuscularly.      At the time of this report, the patient has not received the second dose yet.   No other information was available.      Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Polyarthritis
Clinical narrative: Autoimmune polyarthritis/inflammation; Vaccine overdose; This spontaneous case was reported by a patient and describes the occurrence of POLYARTHRITIS (Autoimmune polyarthritis/inflammation) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Gluten sensitivity (I developed a gluten allergy a few months after this event).    On 21-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 milliliter. On 21-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced OVERDOSE (Vaccine overdose). On 06-Oct-2022, the patient experienced POLYARTHRITIS (Autoimmune polyarthritis/inflammation) (seriousness criterion medically significant). At the time of the report, POLYARTHRITIS (Autoimmune polyarthritis/inflammation) had not resolved and OVERDOSE (Vaccine overdose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient developed a significant autoimmune polyarthritis/inflammation. He had been on many different unsuccessful medical therapies and surgical interventions.; Reporter's Comments: The benefit-risk relationship of the product is not affected by this report.
Sex: U
Vaccine: RSV
Symptoms: Device breakage
Clinical narrative: Lower cap broke off the diluent; little plastic on the luer lock and the piece on the glass it came off; This is a spontaneous report received from a Pharmacist from product quality group, Program ID.  No patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose 1, single (Batch/Lot number: unknown) for immunisation, Device Lot Number: HN8587, Device Expiration Date: 01Sep2026. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE MALFUNCTION (non-serious), outcome "unknown", described as "Lower cap broke off the diluent"; DEVICE ISSUE (non-serious), outcome "unknown", described as "little plastic on the luer lock and the piece on the glass it came off". Additional information: NDC Number: 0069-0250-01.  Causality for "lower cap broke off the diluent" and "little plastic on the luer lock and the piece on the glass it came off" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Myocardial infarction, Type 2 diabetes mellitus
Clinical narrative: Type 2 diabetes; heart attack; cardiac issues; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  An 81-year-old patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 5 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 6 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 7 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 8 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: TYPE 2 DIABETES MELLITUS (medically significant), outcome "unknown", described as "Type 2 diabetes"; MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heart attack"; CARDIAC DISORDER (medically significant), outcome "unknown", described as "cardiac issues". Therapeutic measures were taken as a result of myocardial infarction, cardiac disorder. Clinical course: Patient has received all 10 of the Pfizer COVID vaccines and boosters with the last most recent in Sep2024. Patient was 81 years old and have Type 2 diabetes and cardiac issues to include having a heart attack in Nov2023 and implant of a stent and then the implant of a cardiac defibrillator in Aug2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: Patient received Abrysvo, after having received Arexvy the year prior.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time normal, Beta-2 glycoprotein antibody negative, Blood immunoglobulin G normal, Blood immunoglobulin M, Brain natriuretic peptide normal
Clinical narrative: DVT x 4 (femoral, greater/lessersaphenous and popliteal) resulting in marked swelling and purplish discolorationof left leg from ankle to groin. Symptoms were present for appoximately 2 weeks.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchial secretion retention, Cardiolipin antibody, Chest X-ray abnormal, Colonoscopy normal, Computerised tomogram thorax abnormal
Clinical narrative: DVT x 4 (femoral, greater/lessersaphenous and popliteal) resulting in marked swelling and purplish discolorationof left leg from ankle to groin. Symptoms were present for appoximately 2 weeks.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram thorax normal, Deep vein thrombosis, Emphysema, Glomerular filtration rate normal, Hepatic cyst
Clinical narrative: DVT x 4 (femoral, greater/lessersaphenous and popliteal) resulting in marked swelling and purplish discolorationof left leg from ankle to groin. Symptoms were present for appoximately 2 weeks.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test, Peripheral swelling, Positron emission tomogram abnormal, Prothrombin time normal, Pulmonary mass
Clinical narrative: DVT x 4 (femoral, greater/lessersaphenous and popliteal) resulting in marked swelling and purplish discolorationof left leg from ankle to groin. Symptoms were present for appoximately 2 weeks.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Scan with contrast abnormal, Skin discolouration, Superficial vein thrombosis, Troponin normal, Ultrasound Doppler abnormal
Clinical narrative: DVT x 4 (femoral, greater/lessersaphenous and popliteal) resulting in marked swelling and purplish discolorationof left leg from ankle to groin. Symptoms were present for appoximately 2 weeks.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count increased
Clinical narrative: DVT x 4 (femoral, greater/lessersaphenous and popliteal) resulting in marked swelling and purplish discolorationof left leg from ankle to groin. Symptoms were present for appoximately 2 weeks.
Age: 89.0
Sex: M
Vaccine: COVID19, FLU3, RSV
Symptoms: Asthenia, Dysarthria, Endotracheal intubation, Eyelid ptosis, Fatigue
Clinical narrative: Patient developed left eyelid droop, trouble talking, weakness and fatigue. Myasthenia gravis was the diagnosis and patient started on IVIG after stroke was ruled out. Ended up with respiratory failure leading to intubation.
Age: 89.0
Sex: M
Vaccine: COVID19, FLU3, RSV
Symptoms: Immunoglobulin therapy, Myasthenia gravis, Respiratory failure
Clinical narrative: Patient developed left eyelid droop, trouble talking, weakness and fatigue. Myasthenia gravis was the diagnosis and patient started on IVIG after stroke was ruled out. Ended up with respiratory failure leading to intubation.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Deep vein thrombosis, Platelet count decreased, Pulmonary embolism, Thrombosis
Clinical narrative: TTS
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis with thrombocytopenia syndrome
Clinical narrative: TTS
Age: 52.0
Sex: M
Vaccine: COVID19, FLU3
Symptoms: Paraesthesia
Clinical narrative: Patient received dose on a Thursday. Patient began feeling side effect on Saturday of tingling along the left arm from shoulder to hand.
Age: 1.33
Sex: M
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The combo vaccine was given DTAP/IPV versus the scheduled DTAP. This was found on inventory. Patient did not have any adverse events noted per mother when informed.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Syncope
Clinical narrative: Patient was given vaccine and 5-6 minutes later, pt began to walk out the exam room and felt suddenly weak. Pt collapse without losing consciousness, shortly after pt was monitored for 15 minutes and given juice to take home. Parents were present during exam.
Age: 11.0
Sex: M
Vaccine: HPV9, MENB, TDAP
Symptoms: Wrong product administered
Clinical narrative: Patient was given the Meningococcal B instead MCV4 ACWY. I spoke with provider NP and she said it's okay that Men B was given early he will get second those when he is 16, but pt does need MCV4 per school protocol. I called mom to let her know about the incident, mom was okay, and we scheduled a nurse visit so he can get the correct vaccine.
Age: 79.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: The pharmacist administered an additional dose of Prevnar 20 even though patient has already received dose in 7/31/24.
Age: 79.0
Sex: F
Vaccine: PNC20
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pharmacist administered additional dose of Prevnar 20 even though patient received dose on 7/31/24. No reported adverse events associated with double dose per patient.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Headache, Nausea, Oropharyngeal pain
Clinical narrative: Coughing, Nausea, Head- Ache, Sore Throat
Age: 80.0
Sex: F
Vaccine: RVX, VARZOS
Symptoms: Arthralgia, Back pain, Headache, Pain in extremity
Clinical narrative: pain in arm, leg; back pain; pain in head; pain in shoulder; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in extremity in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 23-JUL-2024, the patient received the 1st dose of Shingrix (unknown arm) and RSV vaccine (unknown arm). On 23-JUL-2024, less than a day after receiving Shingrix and RSV vaccine, the patient experienced pain in extremity (Verbatim: pain in arm, leg), back pain (Verbatim: back pain), headache (Verbatim: pain in head) and shoulder pain (Verbatim: pain in shoulder). The outcome of the pain in extremity, back pain, headache and shoulder pain were not reported.   It was unknown if the reporter considered the pain in extremity, back pain, headache and shoulder pain to be related to Shingrix and RSV vaccine.     It was unknown if the company considered the pain in extremity, back pain, headache and shoulder pain to be related to Shingrix and RSV vaccine.   Linked case(s) involving the same patient:  US2025010275   Additional Information: GSK Receipt Date: 27-JAN-2025 The reporter reported that the patient received the Shingrix 1st dose and Arexvy on 23rd July 2024 and the 2nd dose of Shingrix on 24th January 2025. Later on the day of 1st vaccination she experienced the pain in arm, head, shoulder, back and legs.; Sender's Comments:  US-GSK-US2025010275:Dose 2
Age: 63.0
Sex: M
Vaccine: PNC21
Symptoms: Anxiety, Confusional state, Fatigue, Headache, Injection site pain
Clinical narrative: he didn't feel good; he was unable to ride his bike; he felt unusually tired/ exhausted/ exhausted just doing his regular daily activities; headache; little bit of confusion; he's worried; injection site is a little sore; This spontaneous report was received from a consumer and referrint to himself as a 63-year-old male patient. He was very active and bikes frequently, he has never experienced a vaccine reaction, he has had two COVID vaccines, shingles, and flu.  On 27-JAN-2025 18:00:00, the patient was vaccined with pneumococcal 21v conj vaccine (crm197) (CAPVAXIVE) injection, administered for prophylaxis (dose, injection site, vaccination scheme, strength, lot #, expiration date, and route of administration were not provided).  On 28-JAN-2025, at night, he felt unusually tired after his regular bikeride. On Wednesday, 29-JAN-2025, he again felt exhausted after his regular bikeride, which was not normal for him  (fatigue). He reported that, on Thursday 30-JAN-2025, he felt better in the morning but felt exhausted just doing his regular daily activities; he further described this exhaustion as "not horrible" but it made him wonder what was going on and if it could be from the vaccine. On the same date, he was so exhausted that he canceled plans because he didn't feel good (malaise), he was unable to ride his bike (exercise tolerance decreased), and he took a four-hour nap, none of which are normal for him. He also reported that on an unspecified date in January 2025, he had a little bit of confusion, a headache, and the injection site is a little sore (vaccination site pain) but was nothing bad. When asked about the soreness he reported that there was not redeness or anything visible at the injection site and that the soreness is the same soreness he has experienced in the past after a vaccine. He reported that, for him not to go biking on 30-JAN-2025 was really bad and he was worried (anxiety) that the exhaustion won't go away. He reported no fever but that he had a very good appetite. At the time of reporting, he had not recovered from fatigue, the outcome of the rest of the events was not reported.  The causal relationship between the events and the suspect vaccine was not reported.  Lot # is being requested and will be submitted if received.
Age: 63.0
Sex: M
Vaccine: PNC21
Symptoms: Loss of personal independence in daily activities, Malaise
Clinical narrative: he didn't feel good; he was unable to ride his bike; he felt unusually tired/ exhausted/ exhausted just doing his regular daily activities; headache; little bit of confusion; he's worried; injection site is a little sore; This spontaneous report was received from a consumer and referrint to himself as a 63-year-old male patient. He was very active and bikes frequently, he has never experienced a vaccine reaction, he has had two COVID vaccines, shingles, and flu.  On 27-JAN-2025 18:00:00, the patient was vaccined with pneumococcal 21v conj vaccine (crm197) (CAPVAXIVE) injection, administered for prophylaxis (dose, injection site, vaccination scheme, strength, lot #, expiration date, and route of administration were not provided).  On 28-JAN-2025, at night, he felt unusually tired after his regular bikeride. On Wednesday, 29-JAN-2025, he again felt exhausted after his regular bikeride, which was not normal for him  (fatigue). He reported that, on Thursday 30-JAN-2025, he felt better in the morning but felt exhausted just doing his regular daily activities; he further described this exhaustion as "not horrible" but it made him wonder what was going on and if it could be from the vaccine. On the same date, he was so exhausted that he canceled plans because he didn't feel good (malaise), he was unable to ride his bike (exercise tolerance decreased), and he took a four-hour nap, none of which are normal for him. He also reported that on an unspecified date in January 2025, he had a little bit of confusion, a headache, and the injection site is a little sore (vaccination site pain) but was nothing bad. When asked about the soreness he reported that there was not redeness or anything visible at the injection site and that the soreness is the same soreness he has experienced in the past after a vaccine. He reported that, for him not to go biking on 30-JAN-2025 was really bad and he was worried (anxiety) that the exhaustion won't go away. He reported no fever but that he had a very good appetite. At the time of reporting, he had not recovered from fatigue, the outcome of the rest of the events was not reported.  The causal relationship between the events and the suspect vaccine was not reported.  Lot # is being requested and will be submitted if received.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash; This non-serious case was reported by a physician via sales rep and described the occurrence of rash in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: Rash). The outcome of the rash was unknown.   The reporter considered the rash to be related to Shingrix.     The company considered the rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-JAN-2025 The reporter reported that patients said they had gotten a rash after the Shingrix vaccine and worry if it was shingles. The reporter wanted to know could this be the case.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: My brother in law got the shingles shot and got shingles six weeks later/ suspected vaccination failure; Shingles; Feeling miserable; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 6 weeks after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: My brother in law got the shingles shot and got shingles six weeks later/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and feeling miserable (Verbatim: Feeling miserable). The outcome of the vaccination failure, shingles and feeling miserable were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles and feeling miserable to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-JAN-2025 This case was reported via interactive digital media. Reporter reported that the brother in law got the shingles shot and got shingles six weeks later. He was miserable. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingles vaccine.
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Dizziness, Dyspnoea, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: soreness on the left arm; swelling on the left arm; muscle pain on her left arm; felt like she was going to faint; vomit; could not breathe; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Pneumococcal vaccine for prophylaxis.   On 21-JAN-2025, the patient received the 1st dose of Shingrix (left arm) and Pneumococcal vaccine (right arm). In JAN-2025, 3 days after receiving Shingrix, the patient experienced muscle pain (Verbatim: muscle pain on her left arm), felt faint (Verbatim: felt like she was going to faint), vomiting (Verbatim: vomit) and difficulty breathing (Verbatim: could not breathe). On 21-JAN-2025, the patient experienced pain in arm (Verbatim: soreness on the left arm) and swelling arm (Verbatim: swelling on the left arm). The outcome of the pain in arm, swelling arm, muscle pain, felt faint, vomiting and difficulty breathing were unknown.   It was unknown if the reporter considered the pain in arm, swelling arm, muscle pain, felt faint, vomiting and difficulty breathing to be related to Shingrix.     It was unknown if the company considered the pain in arm, swelling arm, muscle pain, felt faint, vomiting and difficulty breathing to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-JAN-2025 Patient was the reporter. Patient received her first dose of Shingrix on 21st January 2025.  She received the dose on her left arm and she received a pneumonia vaccine on her right arm.  She experienced soreness and swelling on the left arm the same day.  3 days later, she felt muscle pain on her left arm and felt like she was going to faint, vomit, and could not breathe. It was unknown if the reporter considered the pain in arm, swelling arm, muscle pain, felt faint, vomiting and difficulty breathing to be related to Pneumococcal vaccine.
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Vomiting
Clinical narrative: soreness on the left arm; swelling on the left arm; muscle pain on her left arm; felt like she was going to faint; vomit; could not breathe; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Pneumococcal vaccine for prophylaxis.   On 21-JAN-2025, the patient received the 1st dose of Shingrix (left arm) and Pneumococcal vaccine (right arm). In JAN-2025, 3 days after receiving Shingrix, the patient experienced muscle pain (Verbatim: muscle pain on her left arm), felt faint (Verbatim: felt like she was going to faint), vomiting (Verbatim: vomit) and difficulty breathing (Verbatim: could not breathe). On 21-JAN-2025, the patient experienced pain in arm (Verbatim: soreness on the left arm) and swelling arm (Verbatim: swelling on the left arm). The outcome of the pain in arm, swelling arm, muscle pain, felt faint, vomiting and difficulty breathing were unknown.   It was unknown if the reporter considered the pain in arm, swelling arm, muscle pain, felt faint, vomiting and difficulty breathing to be related to Shingrix.     It was unknown if the company considered the pain in arm, swelling arm, muscle pain, felt faint, vomiting and difficulty breathing to be related to Shingrix.   Additional Information: GSK Receipt Date: 24-JAN-2025 Patient was the reporter. Patient received her first dose of Shingrix on 21st January 2025.  She received the dose on her left arm and she received a pneumonia vaccine on her right arm.  She experienced soreness and swelling on the left arm the same day.  3 days later, she felt muscle pain on her left arm and felt like she was going to faint, vomit, and could not breathe. It was unknown if the reporter considered the pain in arm, swelling arm, muscle pain, felt faint, vomiting and difficulty breathing to be related to Pneumococcal vaccine.
Age: 44.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Off label use, Product administered to patient of inappropriate age
Clinical narrative: 44-year-old patient prescribed ACTHIB by another provider with no reported adverse event; Initial information received on 29-Jan-2025 regarding an unsolicited valid  non-serious case received from a nurse.  This case involves a 44 years old and unknown gender patient who was prescribed with haemophilus type B (HIB) vaccine [ACT-HIB] by another provider with no reported adverse event.   The patient's past medical history included Sinusitis bacterial. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Multiple sclerosis.  On an unknown date, the patient was prescribed with HIB (PRP/T) vaccine Powder and solvent for solution for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunization) (off label use).   Reportedly, the nurse reported that they do not know the exact reason the patient was prescribed ACTHIB for. The patient did not know their vaccination status.   Information on the batch number was requested corresponding to the one at time of event occurrence.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Hypoxia, Platelet count decreased, Renal impairment
Clinical narrative: Reported Symptoms: 10013963:DYSPNEA; Narrative: Pt admitted to the hospital with chills, difficulty breathing after receiving Covid and Influenza vaccines earlier in the day. he was diagnosed with hypoxia, elevated kidney function, low plts and worsening of his AS -moderate AS other Relevant HX: Pt admitted to the hospital with chills, difficulty breathing after receiving Covid and Influenza vaccine earlier in the day. he was diagnosed with hypoxia, elevated kidney function, low plts and worsening of his AS -moderate AS Other: DYSPNEA
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash, Respiratory tract congestion
Clinical narrative: Reported Symptoms: 10037087:PRURITUS; 10037844:RASH; 10052251:RESPIRATORY TRACT CONGESTION; Narrative: Other Relevant HX: Other: THROAT CONGESTION
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Reported Symptoms: 10037844:RASH; Narrative: Other Relevant HX:
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sensory disturbance, Skin burning sensation
Clinical narrative: Reported Symptoms: 10047904:WEIRD FEELING; 10079791:BURNING SENSATION SCALP; Narrative: Other Relevant HX: Other: spider web feeling in skin, scalp burning
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Rash
Clinical narrative: Reported Symptoms: 10024570:LIP SWELLING; 10037844:RASH; Narrative: Other Relevant HX: Other: LIP SWELLING
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Reported Symptoms: Narrative: Patient received his influenza vaccine on 9/16/2024 at the clinic. He came in on 10/3/24 and received a second influenza vaccine, also at the clinic. Patient was notified the next day that he received a second vaccine for the 2024-2025 season. Patient did not report any adverse events. Other Relevant HX: Patient received his influenza vaccine on 9/16/2024 at the clinic. He came in on 10/3/14 and received a second influenza vaccine, also at the clinic. Patient was notified the next day that he received a second vaccine for the 2024-2025 season. Patient did not report any adverse events. Other: N/A
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Reported Symptoms:  Narrative: Patient received a trivalent influenza vaccine on 9/12/24. She came in again on 10/9/24 and received a trivalent high dose influenza vaccine. Patient was called on 10/16/24 to tell her that she received a second dose and she stated that she had forgotten about receiving the first dose. Patient reported no adverse events. Patient should have initially received the high dose based on her age. Other Relevant HX: Patient received a trivalent influenza vaccine on 9/12/24. She came in again on 10/9/24 and received a trivalent high dose influenza vaccine. Patient was called on 10/16/24 to tell her that she received a second dose and she stated that she had forgotten about receiving  the first dose. Patient reported no adverse events. Patient should have initially received the high dose based on her age. Other: N/A
Age: 82.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Reported Symptoms: Narrative: Patient received his RSV vaccine on 12/21/2023. Patient came in to the facility on 10/29/24 and received a second RSV vaccine. RSV is only indicated as a single lifetime dose vaccine. Patient did not report any adverse events. Other Relevant HX: Patient received his RSV vaccine on 12/21/2023. Patient came in to the facility on 10/29/24 and received a second RSV vaccine. RSV is only indicated as a single lifetime dose vaccine. Patient did not report any adverse events. Other; N/A
Age: 69.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Reported Symptoms: Narrative: Patient received his RSV vaccine on 10/31/2023 at the clinic. He came in on 10/28/24 and received a second dose of the RSV vaccine. RSV is only indicated as a single lifetime dose vaccine. Patient has not reported any adverse events. Other Relevant HX: Patient received his RSV vaccine on 10/31/2023 at the clinic. He came in on 10/28/24 and received a second dose of the RSV vaccine. RSV is only indicated as a single lifetime dose vaccine. Patient has not reported any adverse events. Other: N/A
Age: 54.0
Sex: M
Vaccine: PNC20
Symptoms: Erythema multiforme, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Reported Symptoms: 10015218:ERYTHEMA MULTIFORME 10019211:HEADACHE; 10037087:PRURITUS; 10047700:VOMITING; Narrative: On 10/8/24 the patient received Prevnar 20 in the left deltoid. On 10/11/24 the patient returned to the primary care clinic with a red spot on the bicep area where he received the injection. The 10/11/24 PCP notes that "pt c/o Lt bicep circular redness, swollen, warm and tender to touch x 3 days. Pt just received a Pneumococcal Vaccine in that area 10/8/24. Pt also report feeling nauseated, h/a, soreness in the area. Redness is spreading down his arm. No fever/chills, no SOB, no sore throat or wheezes. Pt has been icing and taking Tylenol and Ibuprofen with no relief."  The PCP then gave Benadryl and solumedrol IM and also wrote a prescription for cephalexin, Benadryl and prednisone. Other Relevant HX: Other:
Age: 54.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site warmth, Nausea, Pruritus, Vomiting
Clinical narrative: Reported Symptoms: 10015218:ERYTHEMA MULTIFORME 10019211:HEADACHE; 10037087:PRURITUS; 10047700:VOMITING; Narrative: On 10/8/24 the patient received Prevnar 20 in the left deltoid. On 10/11/24 the patient returned to the primary care clinic with a red spot on the bicep area where he received the injection. The 10/11/24 PCP notes that "pt c/o Lt bicep circular redness, swollen, warm and tender to touch x 3 days. Pt just received a Pneumococcal Vaccine in that area 10/8/24. Pt also report feeling nauseated, h/a, soreness in the area. Redness is spreading down his arm. No fever/chills, no SOB, no sore throat or wheezes. Pt has been icing and taking Tylenol and Ibuprofen with no relief."  The PCP then gave Benadryl and solumedrol IM and also wrote a prescription for cephalexin, Benadryl and prednisone. Other Relevant HX: Other:
Age: 75.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Reported Symptoms: 10048055:WRONG DRUG ADMINISTERED; Narrative: Other Relevant HX: Other Incorrect medication given
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Dizziness, Dyspnoea, Paraesthesia, Syncope
Clinical narrative: Reported Symptoms: 10011232:COUGHING; 10013573:DIZZINESS; 10040604:SHORTNESS OF BREATH; 10042772:SYNCOPE; 10043876:TINGLING; 10047700:VOMITING; Narrative: Patient presented to primary care clinic on 10/1/24 stating that she had been wheezing since receiving the Shingles vaccine the day prior. Staff observed the patient gasping for air and having difficulty speaking. Pt also reported hand tingling, dizziness, and nausea. A code assist was called and patient was treated for allergic reaction with benadryl, famotidine, and solumedrol. Other Relevant HX: Other: hand tingling, shortness of breath
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting, Wheezing
Clinical narrative: Reported Symptoms: 10011232:COUGHING; 10013573:DIZZINESS; 10040604:SHORTNESS OF BREATH; 10042772:SYNCOPE; 10043876:TINGLING; 10047700:VOMITING; Narrative: Patient presented to primary care clinic on 10/1/24 stating that she had been wheezing since receiving the Shingles vaccine the day prior. Staff observed the patient gasping for air and having difficulty speaking. Pt also reported hand tingling, dizziness, and nausea. A code assist was called and patient was treated for allergic reaction with benadryl, famotidine, and solumedrol. Other Relevant HX: Other: hand tingling, shortness of breath
Age: 74.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Reported Symptoms: Narrative: Patient received his RSV vaccine outside of the clinic on 10/25/23. Patient was then again given an RSV vaccine on 11/20/2024. Patient was asked if he had received this vaccine before and he stated no. The chart was not reviewed prior to administering which shows that he did receive the vaccine in 2023. It is possible that the patient believed it was an annual vaccine, this has been a common misconception by patients. Patient is additionally 74 years of age and does not appear to meet any of the requirements to receive the vaccine before 75 years of age. Patient is not reporting any adverse effects. Other Relevant HX: Other: N/A
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Reported Symptoms: Narrative: Patient received his zoster vaccine on 1/8/24 and 7/8/24. Shingrix is only intended to be given as a 2 dose series. Patient was intended to receive the Arexvy vaccine today however due to similarities in packaging the patient was accidentally given the Shingrix vaccine instead of Arexvy. Patient reports no adverse events. Other Relevant HX: Patient received his zoster vaccine on 1/8/24 and 7/8/24. Shingrix is only intended to be given as a 2 dose series. Patient was intended to receive the Arexvy vaccine today however due to similarities in packaging the patient was accidentally given the Shingrix vaccine instead of Arexvy. Patient reports no adverse events. Other: N/A
Age: 58.0
Sex: M
Vaccine: HEPAB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Reported Symptoms: Narrative: Patient received his first dose of Twinrix on 2/9/24, his second dose on 3/13/24, and his third dose on 6/5/24. The typical dosing schedule for Twinrix is dose #2 1 month after dose #1, and dose #2 6 months after dose #1. Patient should have received his 3rd dose in August 2024. Patient experienced no adverse events. Other Relevant HX:: Patient received his first dose of Twinrix on 2/9/24, his second dose on 3/13/24, and his third dose on 6/5/24. The typical dosing schedule for Twinrix is dose #2 1 month after dose #1, and dose #2 6 months after #1. Patient should have received his 3rd dose in August 2024. Patient experienced no adverse events. Other: N/A
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Hyperhidrosis, Malaise
Clinical narrative: Reported Symptoms: 10012703:DIAPHORESIS; 10025482:MALAISE; 10047862:WEAKNESS; Narrative: Other Relevant HX: Other: Malaise, diaphoresis, weakness
Age: 73.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Myalgia
Clinical narrative: Reported Symptoms: 10028411:MYALGIA; Narrative; Muscle pain has lasted for 4 months. Other Relevant HX: Other:
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Reported Symptoms: 10037087:PRURITUS; 10037844:RASH; Narrative: Rash and itching on arm of injection site that lasted approx one week after first dose. Patient did not come in at that time for evaluation. Resolved on own, took more than 6 days. Other Relevant HX: Other:
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia
Clinical narrative: Reported Symptoms: 10028411:MYALGIA; Narrative: Patient appears to have been given this vaccine at an outside facility. allergy was documented for continuity of care. Other Relevant HX: Other:
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Erythema multiforme, Myalgia
Clinical narrative: Reported Symptoms: 10015218:ERYTHEMA MULTIFORME; 10028411;MYALGIA; Narrative: Other Relevant HX: Other:
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Anaphylactic reaction, COVID-19 pneumonia, Cough, Death
Clinical narrative: Reported Symptoms:  10011906:DEATH; 10021143:HYPOXIA; 10084380:COVID-19 PNEUMONIA;  Narrative:  Patient received J+J vaccine in May 2021. Was seen in ED for syncope likely to dehydration; was also short of breath. Marked as anaphylaxis in chart. Later presented to ED  08/16/2021 with fever, increasing  cough, congestion, shortness of breath, decreased oral intake, admitted to COVID-19 Unit. PMH significant for CLL, colon cancer, dementia. Patient DNR/DNI code status, wishes were to transition to comfort care in the setting of rapid deterioration or suffering. Acute worsening of respiratory status despite non-invasive ventilatory support occured on 08/25/2021 AM, based on his wishes he was transitioned to comfort care and passed away at 10:02 AM on 08/25/021. Other Relevant HX: Other: Death - AHRF from COVID-19 Pneumonia
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Dyspnoea, General physical health deterioration, Hypophagia, Pyrexia
Clinical narrative: Reported Symptoms:  10011906:DEATH; 10021143:HYPOXIA; 10084380:COVID-19 PNEUMONIA;  Narrative:  Patient received J+J vaccine in May 2021. Was seen in ED for syncope likely to dehydration; was also short of breath. Marked as anaphylaxis in chart. Later presented to ED  08/16/2021 with fever, increasing  cough, congestion, shortness of breath, decreased oral intake, admitted to COVID-19 Unit. PMH significant for CLL, colon cancer, dementia. Patient DNR/DNI code status, wishes were to transition to comfort care in the setting of rapid deterioration or suffering. Acute worsening of respiratory status despite non-invasive ventilatory support occured on 08/25/2021 AM, based on his wishes he was transitioned to comfort care and passed away at 10:02 AM on 08/25/021. Other Relevant HX: Other: Death - AHRF from COVID-19 Pneumonia
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory tract congestion, Syncope
Clinical narrative: Reported Symptoms:  10011906:DEATH; 10021143:HYPOXIA; 10084380:COVID-19 PNEUMONIA;  Narrative:  Patient received J+J vaccine in May 2021. Was seen in ED for syncope likely to dehydration; was also short of breath. Marked as anaphylaxis in chart. Later presented to ED  08/16/2021 with fever, increasing  cough, congestion, shortness of breath, decreased oral intake, admitted to COVID-19 Unit. PMH significant for CLL, colon cancer, dementia. Patient DNR/DNI code status, wishes were to transition to comfort care in the setting of rapid deterioration or suffering. Acute worsening of respiratory status despite non-invasive ventilatory support occured on 08/25/2021 AM, based on his wishes he was transitioned to comfort care and passed away at 10:02 AM on 08/25/021. Other Relevant HX: Other: Death - AHRF from COVID-19 Pneumonia
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: Reported Symptoms: 10003239:ARTHRALGIA; 10028411:MYALGIA; Narrative: Patient experiences muscle and joint pain throughout body the next day after administration of Shingrix vaccine. Pain continues about 1 month after Shingrix administration and is not relieved by APAP. Patient states it is painful for him to move. Other Relevant HX: Other:
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema multiforme, Injection site swelling, Rash
Clinical narrative: Reported Symptoms: 10015218:ERYTHEMA MULTIFORME; 10037844:RASH; 10053425:INJECTION SITE SWELLING; Narrative: Patient presented to ED for evaluation of local reaction in 2018. Per ED, could also have other cause such as bug bite. Patient was later given the 2nd Shingrix dose in 2019 appears to have tolerated. Other Relevant HX: Other: Swelling at injection site
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Rash
Clinical narrative: Reported Symptoms: 10037844:RASH; Narrative: Patient presented to the ER at a non-facility care hospital on 09/08/2018 for redness, swelling and warmth around the area where he was given the Pneumococcal polysaccharide vaccine PPSV23 the day prior. He was given dexamethasone and famotidine with improvement in symptoms. He was discharged on famotidine and loratadine. Doses of the medications given at this outside facility was not provided. Other Relevant HX: Other: L arm redness and swelling
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Pt was hospitalized for covid and died.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Computerised tomogram thorax, Hilar lymphadenopathy, Sarcoidosis, Scan with contrast
Clinical narrative: Sarcoidosis, bilateral hilar lymphadenopathy.
Age: 0.25
Sex: M
Vaccine: PNC15
Symptoms: Brief resolved unexplained event, Cyanosis, Depressed level of consciousness, Gaze palsy, Hypotonia
Clinical narrative: 36 hours after PCV 15, had episode at home where became limp, unresponsive, eyes rolling back in head. Went to ED and difficult to arouse but did, then when in ED, again turned blue, limp, unresponsive. They believe seizure and gave anti-epileptic. Transferred to pediatric center and they said BRUE. Per mom, neurologist thinks was a seizure and will do follow up appt.
Age: 0.25
Sex: M
Vaccine: PNC15
Symptoms: Seizure, Unresponsive to stimuli
Clinical narrative: 36 hours after PCV 15, had episode at home where became limp, unresponsive, eyes rolling back in head. Went to ED and difficult to arouse but did, then when in ED, again turned blue, limp, unresponsive. They believe seizure and gave anti-epileptic. Transferred to pediatric center and they said BRUE. Per mom, neurologist thinks was a seizure and will do follow up appt.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Limb mass
Clinical narrative: Bump on right arm after vaccine administration, informed mother to put cold compress and if still bothering her, to make a follow up  in the office to get it checked. -