chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC20, RV5
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Called parent, told to come in, dose was invalid.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Headache, Tongue disorder
Clinical narrative: Client complained of headache and feeling dizzy after administration of Hep B vaccine. Client was monitored for adverse vaccine side effects by Nursing staff. Client denied difficulty breathing, or itching. No swelling noted to face, including eyes and mouth. 1454 hrs Vital  signs - B/P 127/82, pulse 67, resp 17, o2 sat 96 %. Nursing continued to monitor. Client alert and oriented (no changes from baseline). Client sitting relaxed in medical chair for monitoring. Client talked on cell phone intermittently.1526 hrs Client complained of tongue feeling thick. 911 was called by RN staff. This RN administered Epi Pen adult 0.3 mg to left vastus lateralis. Client tolerated procedure well. 1530 Vital Signes B/P 158/93, pulse 68, O2 sat 99%, client alert and oriented ( no change from baseline). Client denies shortness of breath. 1635 hrs  Vital signs  B/P 157/91, pulse 109, O2 Sat 100 %. Client alert and oriented (no change from baseline).1542 hrs EMS arrived Report given to EMS. Client was taken to ER via ambulance for evaluation.
Age: 67.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Confusional state, Hypoaesthesia, Mobility decreased, Paraesthesia, Pneumonia
Clinical narrative: Numbness, tingling, unable to lift L arm, confusion
Age: 67.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Blood sodium decreased, Fatigue, Hemiparesis, Hypoaesthesia, Mobility decreased
Clinical narrative: Numbness, tingling, unable to lift L arm, confusion
Age: 67.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Nervous system disorder
Clinical narrative: Numbness, tingling, unable to lift L arm, confusion
Age: 67.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Confusional state, Hypoaesthesia, Mobility decreased, Paraesthesia, Pneumonia
Clinical narrative: fatigue, low sodium , neurologic decline, L side weakness, numbness, unable to lift L arm
Age: 67.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Blood sodium decreased, Fatigue, Hemiparesis, Hypoaesthesia, Mobility decreased
Clinical narrative: fatigue, low sodium , neurologic decline, L side weakness, numbness, unable to lift L arm
Age: 67.0
Sex: F
Vaccine: PNC20, PNC20
Symptoms: Nervous system disorder
Clinical narrative: fatigue, low sodium , neurologic decline, L side weakness, numbness, unable to lift L arm
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Above vaccines usually given at 12 months of age were mistakenly given at 2 months of age. Merck was contacted for clinical guidance. Was advised to repeat above vaccines at appropriate age interval. Parents were notified.
Sex: U
Vaccine: MMR
Symptoms: Arthralgia, Feeling cold, Neuropathy peripheral
Clinical narrative: Cold water sensation for 1-2s, 2-3x every hour on lower thigh above the knee.  Peripheral neuropathy in left toes and left fingers, joint pain in left ankle, left knee and left hand.
Sex: M
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: No additional AEs were reported.; He had MMR vaccination on April 2nd and then he got another one today; then supposed to receive VARIVAX but instead received another dose of MMR II; This spontaneous report was received from a healthcare professional and refers to a male patient of unknown age. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 02-APR-2024, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), lot number X012186, expiration date not reported but upon  internal validation established as 19-JUL-2024, and then he supposed to receive a dose of varicella virus vaccine live (oka/merck)(VARIVAX) but instead the patient received another dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), lot number X023322, expiration date not provided but upon internal validation 22-AUG-2024 (dose, route and anatomical location were not reported for the suspect vaccines), (inappropriate schedule of product administration and wrong product administered) for prophylaxis. No additional adverse events were reported.
Sex: U
Vaccine: HEP, HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE/PQC reported.; HBP calling to report adverse event regarding a patient administered RECOMBIVAX HB.  HBP stated that the patient was born on 4/16/2024 and received their first dose of a HEPATITIS B vaccine manufactured by GSK.  Then the patient was seen at a separat; This spontaneous report as received from an office manager and refers to a 3-day-old patient. No information on patient's medical history, current conditions and concomitant medications was provided.  On 16-APR-2024 the patient was vaccinated with first dose of hepatitis b vaccine rhbsag (yeast) (ENGERIX) for prophylaxis (exact dose, route and site of administration, lot number and expiration date were not provided). On 19-APR-2024, the patient was seen at a separate facility, in which was vaccinated with first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 0.5 milliliter for prophylaxis (route and site of administration, lot number and expiration date were not provided) (extra dose administered). Reporter confirmed the patient has not had any symptoms or medical concerns after being administered the hepatitis b vaccine (recombinant)(RECOMBIVAX HB) earlier than recommended (no adverse event).
Age: 33.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Syncope
Clinical narrative: syncope; This spontaneous report was received from a business professional via a company representative and referred to a 33-year-old female.  The patient's medical history was not reported. The patient's concurrent condition included  fasting. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  On the same day, the patient experienced light headedness and syncope within 15 minutes. On an unknown date, the patient recovered from the event of syncope.    The causal relationship between syncope and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.   Upon internal review, the event syncope was determined to be medically significant.  Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; shingles and right now going through it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles and right now going through it). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be related to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-JUN-2024 The reporter said sadly everyone he/she knew who got the Shingles vaccine shots got the shingles later and maybe in a milder case the if they had not. The reporter said right now (during the reporting days) he/she was going through shingles and said swear it brought on by stress, but like everything else no one really knew, but get the shot anyway. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK Shingles vaccine.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles in left eye; I have it in my head, face and into my left eye right now; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 59-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: shingles in left eye) (serious criteria GSK medically significant) and shingles (Verbatim: I have it in my head, face and into my left eye right now). The outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and shingles were not reported.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be related to Shingrix and Shingrix. The company considered the ophthalmic herpes zoster to be unrelated to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt date: 27-JUN-2024 The patient self-reported this case. For those of who saying get the vaccine, he/she had shingles twice so as soon as he/she turned 59 he/she got both Shingrix shots and guess what, he/she have it in his/her head, face and into his/her left eye right now, by far the worst place to have them and the other times it was around the side. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix (2 doses). Ophthalmic herpes zoster is an unlisted event which is considered unrelated to GSK vaccine Shingrix (2 doses).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles occurred when patient was 87 years old, 1 month after vaccination.; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of shingles in a 87-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 month after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles occurred when patient was 87 years old, 1 month after vaccination.). The outcome of the shingles was resolved.   The reporter considered the shingles to be related to Shingrix.     The company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-JUN-2024 The patient experienced shingles occurred  1 month after vaccination.   The patient was treated with antivirals within 72 hours.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient is a HCP who received dose 1 of Shingrix more than one year ago and has not yet received dose 2.; This non-serious case was reported by a nurse via sales rep and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose more than one year ago).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Patient is a HCP who received dose 1 of Shingrix more than one year ago and has not yet received dose 2.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date 28 Jun 2024: The patient was a HCP who received dose 1 of Shingrix more than one year ago and had not yet received dose 2. Till the time of reporting patient did not receive 2nd dose which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: urine was darker; pain at the injection site; she began to experience achiness; joint pain; headache; upset stomach; nausea; acid reflux; pressure in the middle of her chest; having chills/ shivering; fever of 102.4 degrees Fahrenheit; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (For tolerance of 1st dose refer case US2024078060). Concurrent medical conditions included esophageal irritation, hiatal hernia and gastritis.   On 17-JUN-2024, the patient received the 2nd dose of Shingrix. In JUN-2024, less than a week after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at the injection site), pain (Verbatim: she began to experience achiness), joint pain (Verbatim: joint pain), headache (Verbatim: headache), upset stomach (Verbatim: upset stomach), nausea (Verbatim: nausea), esophageal acid reflux (Verbatim: acid reflux) and chest pressure (Verbatim: pressure in the middle of her chest). On 18-JUN-2024, the patient experienced chills (Verbatim: having chills/ shivering), fever (Verbatim: fever of 102.4 degrees Fahrenheit) and dark urine (Verbatim: urine was darker). Rechallenge with Shingrix was positive. The outcome of the injection site pain, pain, joint pain and headache were unknown and the outcome of the chills and fever were resolved (duration 2 hrs) and the outcome of the upset stomach, nausea, esophageal acid reflux, chest pressure and dark urine were not resolved.   It was unknown if the reporter considered the injection site pain, pain, joint pain, headache, chills, fever, upset stomach, nausea, esophageal acid reflux, chest pressure and dark urine to be related to Shingrix.     It was unknown if the company considered the injection site pain, pain, joint pain, headache, chills, fever, upset stomach, nausea, esophageal acid reflux, chest pressure and dark urine to be related to Shingrix.   Linked case(s) involving the same patient:  US2024078060   Additional Information: GSK Receipt Date: 21-JUN-2024 The patient reported that she received her 2nd dose and experienced the achiness, headache, joint pain, and pain at the injection site. The 2nd day she was having chills, shivering and fever of 102.4 degrees Fahrenheit. This lasted 2 hours. She was also experiencing an upset stomach with nausea, acid reflux and pressure in the middle of her chest which she described as like reflux. The stomach issues were still present, but she did have a history of gastritis, acid reflux and hiatal hernia and she had taken an Advil to bring down her fever, so she admited this could be the cause of the stomach problems. She stated that on the day after her 2nd dose, she noticed her urine was darker than normal and it has persisted till day of reporting. For tolerance of 1st dose refer case US2024078060.; Sender's Comments:  US-GSK-US2024078060:Another 1st dose case
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site pain, Pain
Clinical narrative: pain at injection site; headache; joint pain; achiness; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included esophageal irritation, hiatal hernia and gastritis. Concomitant products included ibuprofen (Advil).   In JAN-2024, the patient received the 1st dose of Shingrix. In JAN-2024, 1 day after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at injection site), headache dull (Verbatim: headache), joint pain (Verbatim: joint pain) and pain (Verbatim: achiness). The outcome of the injection site pain, headache dull, joint pain and pain were resolved.   It was unknown if the reporter considered the injection site pain, headache dull, joint pain and pain to be related to Shingrix.     It was unknown if the company considered the injection site pain, headache dull, joint pain and pain to be related to Shingrix.   Linked case(s) involving the same patient:  US2024AMR082186   Additional Information: GSK Receipt Date: 21-JUN-2024 The patient reported that she received her first Shingrix dose in January of 2024. The following day she began to experience achiness, joint pain, pain at the injection site and a dull headache. These symptoms lasted 2 to 3 days. For tolerance of 2md dose refer case US2024AMR082186.; Sender's Comments:  US-GSK-US2024AMR082186:Another dose case
Sex: U
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: mal administration of Kinrix instead of Pediarix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: mal administration of Kinrix instead of Pediarix). The outcome of the wrong vaccine administered 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-JUN-2024 Healthcare professional reported mal administration of Kinrix instead of Pediarix which led to wrong vaccine administered.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Menveo vaccine which was reconstituted with sterile saline diluent instead of the liquid conjugate provided by GSK.; This non-serious case was reported by a physician via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 21-JUN-2024, the patient received Menveo. On 21-JUN-2024, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo vaccine which was reconstituted with sterile saline diluent instead of the liquid conjugate provided by GSK.). The outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 21-JUN-2024 The patient got a Menveo vaccine which was reconstituted with sterile saline diluent instead of the liquid conjugate provided by GlaxoSmithKline, which led to wrong solution used in drug reconstitution. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure / he has had shingles twice since vaccination (dates unknown); He has had shingles twice since vaccination (dates unknown); This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure / he has had shingles twice since vaccination (dates unknown)) (serious criteria GSK medically significant) and shingles (Verbatim: He has had shingles twice since vaccination (dates unknown)). The outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   The company considered the vaccination failure to be related to Shingrix and Shingrix. It was unknown if the company considered the shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 25-JUN-2024 The reporter was the patient. The patient received both doses of Shingrix on an unknown dates.  He had shingles twice since vaccination (dates unknown).  Nothing else was reported. This report was being filed with minimal information as the patient declined to provide details of event. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting The reporter did not consent to follow-up.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix (1st and 2nd doses).
Age: 1.5
Sex: F
Vaccine: DTAP
Symptoms: Product storage error
Clinical narrative: Vaccine stored outside recommended conditions and administered to patient; 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 1-year-old female patient who received DTPa (Infanrix) (batch number 9PT2F, expiry date 10-MAR-2026) for prophylaxis.   On 24-JUN-2024, the patient received Infanrix. On an unknown date, an unknown time after receiving Infanrix, the patient experienced incorrect storage of drug (Verbatim: Vaccine stored outside recommended conditions and administered to patient). 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: 25-JUN-2024 The medical assistant reported that they had an excursion on their vaccine and it administered to the patient. The temperature excursion of the Infanrix vaccine was 34.5 degree Fahrenheit and time was 82 hours 50 minutes. The vaccines were considered as part of a low temperature excursion but still viable and administered to the patient, which led to incorrect storage of drug. This case had been link with US2024079221, reported by the same reporter.; Sender's Comments:  US-GSK-US2024079221:Same reporter
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: She had previously finished her MENVEO series in May of 2023.; 18-year-old female patient was supposed to receive a Meningitis B vaccine but received MENVEO instead; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (patient previously finished her MENVEO series in May of 2023).   On 25-JUN-2024, the patient received the 3rd dose of Menveo. On 25-JUN-2024, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: She had previously finished her MENVEO series in May of 2023.) and wrong vaccine administered (Verbatim: 18-year-old female patient was supposed to receive a Meningitis B vaccine but received MENVEO instead). The outcome of the extra dose administered and wrong vaccine administered were unknown.   Additional Information: GSK receipt date 26 Jun 2024: The nurse reported that the patient was supposed to receive a Meningitis B vaccine but received MENVEO instead, which led to wrong vaccine administered. She had previously finished her MENVEO series in May of 2023, which led to extra dose administered. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Liver transplant
Clinical narrative: Liver transplant; This serious case was reported by a consumer via call center representative and described the occurrence of liver transplant in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included radioembolization. Concurrent medical conditions included hepatic cancer.   In MAR-2023, the patient received the 1st dose of Shingrix. In SEP-2023, between 5 and 7 months after receiving Shingrix, the patient experienced liver transplant (Verbatim: Liver transplant) (serious criteria clinically significant/intervention required). The outcome of the liver transplant was unknown.   It was unknown if the reporter considered the liver transplant to be related to Shingrix.     The company considered the liver transplant to be unrelated to Shingrix.   Additional Information: GSK receipt date: 26-JUN-2024 The patient received his second dose June 26, 2024.   The patient's doctor advised the patient to hold off on getting any further vaccinations because the patient had a liver transplant in September 2023. The liver cancer was pre-existing to Shingrix.   The liver cancer was treated with Radioembolization,  Subsequently, the patient had a liver transplant in September 2023 Consented to follow up.; Sender's Comments: Liver transplant is an unlisted event which is considered unrelated to GSK vaccine Shingrix.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cardiac stress test, Decreased appetite, Fatigue, Myocardial necrosis marker
Clinical narrative: severe loss of appetite; general weakness; 4 Ibs of weight loss; fatigue; This spontaneous case was reported by a patient and describes the occurrence of DECREASED APPETITE (severe loss of appetite), ASTHENIA (general weakness), WEIGHT DECREASED (4 Ibs of weight loss) and FATIGUE (fatigue) in a 74-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3920B) for COVID-19 prophylaxis.     The patient's past medical history included Prediabetes. Concurrent medical conditions included Hypertension, Hypercholesterolemia, Hypothyroidism, Obstructive sleep apnoea syndrome, Coronary artery calcification on 03-May-2024, Glaucoma on 03-May-2024 and Carotid occlusion (occlusion of right internal carotid).    On 09-Apr-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 18-Apr-2024, the patient experienced DECREASED APPETITE (severe loss of appetite), ASTHENIA (general weakness), WEIGHT DECREASED (4 Ibs of weight loss) and FATIGUE (fatigue). On 23-Apr-2024, DECREASED APPETITE (severe loss of appetite), ASTHENIA (general weakness), WEIGHT DECREASED (4 Ibs of weight loss) and FATIGUE (fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2024, Myocardial necrosis marker: cardiac enzymes were normal. On 03-May-2024, Cardiac stress test: stress was normal. On an unknown date, Weight: 4 Ibs decreased/ Weight loss.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   No Concomitant medications provided by the reporter. No treatment medications provided by the reporter.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: severe loss of appetite; general weakness; 4 Ibs of weight loss; fatigue; This spontaneous case was reported by a patient and describes the occurrence of DECREASED APPETITE (severe loss of appetite), ASTHENIA (general weakness), WEIGHT DECREASED (4 Ibs of weight loss) and FATIGUE (fatigue) in a 74-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3920B) for COVID-19 prophylaxis.     The patient's past medical history included Prediabetes. Concurrent medical conditions included Hypertension, Hypercholesterolemia, Hypothyroidism, Obstructive sleep apnoea syndrome, Coronary artery calcification on 03-May-2024, Glaucoma on 03-May-2024 and Carotid occlusion (occlusion of right internal carotid).    On 09-Apr-2024, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 18-Apr-2024, the patient experienced DECREASED APPETITE (severe loss of appetite), ASTHENIA (general weakness), WEIGHT DECREASED (4 Ibs of weight loss) and FATIGUE (fatigue). On 23-Apr-2024, DECREASED APPETITE (severe loss of appetite), ASTHENIA (general weakness), WEIGHT DECREASED (4 Ibs of weight loss) and FATIGUE (fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2024, Myocardial necrosis marker: cardiac enzymes were normal. On 03-May-2024, Cardiac stress test: stress was normal. On an unknown date, Weight: 4 Ibs decreased/ Weight loss.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   No Concomitant medications provided by the reporter. No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 infection; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19 infection) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna (Batch number: 010M20A, Dose : 1) on 28-Jan-2021, Moderna (Batch number: 011A21A, Dose: 2) on 25-Feb-2021, Moderna (Batch number: 040021A, Dose: 3) on 02-Nov-2021, Moderna (Batch number:00SM21A, Dose: 4) on 24-Apr-2022, Moderna (Batch number: AS7146B, Dose: 5) on 04-Oct-2022, MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) (Batch number: Unknown and Dose: 6) on 13-Oct-2023. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5), Moderna, Moderna, Moderna, Moderna and Moderna.    On 11-Mar-2024, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 28-Jun-2024,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced COVID-19 (COVID-19 infection). At the time of the report, COVID-19 (COVID-19 infection) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jun-2024, SARS-CoV-2 test: (Negative) tested negative in the morning. On 28-Jun-2024, SARS-CoV-2 test: Positive.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications provided by the reporter.  Patient developed symptom on 27-Jun-2024. But Patient did not have muscle aches or fever. From 28-Jun-2024 to 30-Jun-2024 patient had a bad cough, rhinitis, sneezing, fatigue and respiratory symptoms. On 01-Jul-2024 it was reported that patient slept well first time at last night and patient weak up at 4:00 AM. Patient also reported that she had a bad sore throat. On 01-Jul-2024 the day of reporting the patient stated that she had no sore throat and she had less cough, and she felt better and stated that it was quick recovery.  No treatment medications provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-770561 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2024: Live non-significant follow-up received in which new reference number added. On 01-Jul-2024: Live significant follow up received in which event outcome was updated. On 02-Jul-2024: Live non-significant information received in which new reference number was added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-770561:Husband Case
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac disorder
Clinical narrative: cardiac issue; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), in 2021 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: CARDIAC DISORDER (non-serious), outcome "recovered", described as "cardiac issue".  Additional information: The patient received two doses of the Pfizer COVID-19 vaccine in 2021. The patient reported that they were not fully vaccinated and had a cardiac issue. Their doctor said it could have had something to do with the Pfizer vaccine, but they fixed it (as reported).  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400204905 same patient, different dose and event;
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Atrial flutter
Clinical narrative: cardiac issue; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), in 2021 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: CARDIAC DISORDER (non-serious), outcome "recovered", described as "cardiac issue".  Additional information: The patient received two doses of the Pfizer COVID-19 vaccine in 2021. The patient reported that they were not fully vaccinated and had a cardiac issue. Their doctor said it could have had something to do with the Pfizer vaccine, but they fixed it (as reported).  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400204905 same patient, different dose and event;
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: cardiac issue; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), in 2021 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: CARDIAC DISORDER (non-serious), outcome "recovered", described as "cardiac issue".  Additional information: The patient received two doses of the Pfizer COVID-19 vaccine in 2021. The patient reported that they were not fully vaccinated and had a cardiac issue. Their doctor said it could have had something to do with the Pfizer vaccine, but they fixed it (as reported).  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400204905 same patient, different dose and event;
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy
Clinical narrative: Chronic Inflammatory Demyelinating Polyneuropathy; This is a spontaneous report received from a Consumer or other non HCP.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Jan2022 as dose 2, single (Batch/Lot number: unknown) at the age of 48 years, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1), for COVID-19 immunisation. The following information was reported: CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (medically significant) with onset Mar2022, outcome "not recovered", described as "Chronic Inflammatory Demyelinating Polyneuropathy". The clinical course was reported as follows: Approximately 2 months after receiving second COVID-19 shot, the patient started to notice tingling and numbness of toes/feet. Over time progression worsened eventually impacting mobility. In Jun2024, condition was diagnosed as Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). The patient was waiting for insurance to pre-authorization infusion treatment for CIDP. She reported she wasn't sure if this was coincidence or might be adverse event related to COVID vaccine. Therapeutic measures were not taken as a result of chronic inflammatory demyelinating polyradiculoneuropathy.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400205513 same reporter/drug, similar AE, and different patient;
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Pyrexia
Clinical narrative: sever dizziness and chest pain; sever dizziness and chest pain; I started to run a fever; This is a spontaneous report received from a Consumer or other non HCP, Program ID:.  An adult patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 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: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset Oct2023, outcome "unknown", described as "I started to run a fever"; DIZZINESS (medically significant), CHEST PAIN (medically significant) all with onset Oct2023, outcome "unknown" and all described as "sever dizziness and chest pain". The events "sever dizziness and chest pain" and "i started to run a fever" required emergency room visit.  Clinical course: So, back in October, patient received the 4th Covid shot from Name withheld. That evening patient started to run a fever, then the next morning sever dizziness and chest pain. Patient went to the emergency room and for 8 hours, the doctors could not find anything wrong with the patient. The only thing we could figure was had a reaction to the shot. Now it just received a bill for almost (Amount withheld) after insurance. Before the shot, patient was fine. Then patient got the shot and end up in the ER. patient thought to get some compensation.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: product was never reconstituted, staff member gave only diluent to patient with no reported adverse event; Initial information received on 27-Jun-2024 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves Infant and unknown gender patient for whom DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] was never reconstituted, staff member gave only diluent to patient with no reported adverse event.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On 27-Jun-2024, the patient received suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE Suspension for injection via intramuscular route in unknown administration site for immunization (strength, dose, batch number and expiry date unknown) was never reconstituted, staff member gave only diluent to patient with no reported adverse event (single component of a two-component product administered) (latency same day).  Information on batch number corresponding to the one at time of event occurrence was requested.   It is unknown if there were lab data/results available.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: door was left open too long min/max temperature reached: 46.8° fahrenheit duration out of labelled range: 20 minutes with no adverse event; min/max temperature reached: 46.8° fahrenheit duration out of labelled range: 20 minutes and was administered with no adverse event; Initial information received on 07-Jun-2024 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who was administered IPV (VERO) [IMOVAX POLIO] for which door was left open too long min/max temperature reached: 46.8° fahrenheit duration out of labelled range: 20 minutes with no adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was reported that the patient received an unknown dose of suspect IPV (VERO) (suspension for injection) (lot W1B511M,Expiry date: 08-Sep-2025, strength was unknown) via unknown route in unknown administration site for prophylactic vaccination (Immunization) and door was left open too long min/max temperature reached: 46.8° fahrenheit duration out of labelled range: 20 minutes with no adverse event (product storage error) and (poor quality product administered) (unknown latency).  Reportedly "Human error? Yes Does extended stability data cover the excursion? No, for the opened IPOL and yes for the others This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.There is no patient information on this adverse reaction, this was supposed to be disregarded.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Additional information was received on 17-Jun-2024 from a other health professional: Event of poor quality product administered was added. Number of patient added. case was upgraded from non-Valid to Valid. Text amended
Age: 66.0
Sex: M
Vaccine: PNC20, RSV, PNC20, RSV, PNC, RSV
Symptoms: Balance disorder, Blood glucose normal, Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia
Clinical narrative: Patient reported feeling numbness in fingers and legs about 48 hours after receiving vaccination. He also reported elevated blood glucose levels to (125-130 from his usual 95-99) for 3-4 weeks after receiving vaccination. Over a period of a few weeks, patient had worsening numbness and tingling with numbness spreading up to the knees. Patient began to have balance issues, so he went to his primary care doctor on 7/2/24 where the doctor suspected Guillain-Barre syndrome. The primary care doctor gave a referral to a neurologist for the patient to follow-up with. The patient reports his glucose levels returning to normal, but has not had any improvement in his numbness and tingling.
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC20, RV1
Symptoms: Respiratory viral panel, Urticaria, Viral test negative
Clinical narrative: My daughter received the above vaccinations on Monday 7.1.24 at 0830 and started to break out in hives all over her body the next day.  We noticed the hives around 2:30 pm and wanted to see if they would worsen.  By 3-4:30 pm the hives were spreading and we went to the ER.  They confirmed it was hives; she has not experienced any breathing issues, or appears bothered by the hives, however they are continuing to spread throughout her body, coming and going.  The ER gave her a respiratory panel and she was negative for all viruses.  Her hives are continuing and I'm hoping they stop by Friday, as it is very concerning.
Age: 48.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 63.0
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: Patient was mistakenly given an unscheduled dose via intramuscular injection of Moderna vaccine that wasn't due. He cooperatively received a due/scheduled vaccine of Shingrix (Shingles) vaccine.  Patient had no c/o pain or discomfort. No shortness of breath or coughing. Skin was warm, dry, intact. No hives. Alert and oriented x 4. Gait is stable. No gastrointestinal, and no c/o nausea or vomiting.
Age: 34.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 77.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site pain, Injection site swelling, Lethargy, Malaise, Pyrexia
Clinical narrative: pt reports feeling extremely sick a few hours after receiving the vaccines.  she reports that the injection site has "swelled up" and is painful.  She also reports feeling very lethargic and claims to be "feeling really sick with a moderate fever".  currently reports the rxn was severe about 8-10 hrs ago and reports that she is getting slightly better.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: Unknown
Age: 64.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 31.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Unevaluable event
Clinical narrative: NONE
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Dizziness, Full blood count normal, Headache, Injection site pain
Clinical narrative: dizziness, headache, injection site swelling/ pain, body aches, chills, nausea
Age: 38.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site swelling, Metabolic function test normal, Nausea, Pain
Clinical narrative: dizziness, headache, injection site swelling/ pain, body aches, chills, nausea
Age: 71.0
Sex: F
Vaccine: FLU4, PNC20
Symptoms: Imaging procedure, Muscular weakness, Product administered at inappropriate site
Clinical narrative: Vaccine administered to high on her left shoulder and Patient reported she had significant weakness in her arms throughout the day on Friday 12/1 however, has had improvement since then.
Age: 1.67
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20
Symptoms: Vaccination error
Clinical narrative: HIB given but not ordered for this patient.