chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch); Mild injection site swelling; Mild fever (100.4 to 101.2 °F); Mild fatigue and no interference with activity; Mild muscle pain and no interference with activity; Joint pain and no interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE SWELLING (Mild injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 °F)), FATIGUE (Mild fatigue and no interference with activity) and MYALGIA (Mild muscle pain and no interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE SWELLING (Mild injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 °F)), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity) and ARTHRALGIA (Joint pain and no interference with activity). At the time of the report, VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE SWELLING (Mild injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 °F)), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Mild muscle pain and no interference with activity) and ARTHRALGIA (Joint pain and no interference with activity) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Body temperature: 100.4 to 101.2 degree Fahrenheit.         No concomitant medications were reported.  Patient had experienced the symptoms during the 2 days after COVID-19 vaccination, which occurred on Thursday, Dec 21, 2023, and Friday, Dec 22, 2023.  No treatment medications were reported.  The Subject ID was reported as 21378-97052 and the Agency Subject ID was reported as 5471817.   This case was linked to US-MODERNATX, INC.-MOD-2024-756099 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756099:Master case
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Myalgia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Mild malaise/feeling sick and no interference with activity; Moderate injection site pain interfering with activity/ Moderate injection site tenderness (tenderness with movement); Mild injection site swelling; Moderate fatigue with some interference with activity; Moderate muscle pain with some interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/ Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE SWELLING (Mild injection site swelling), FATIGUE (Moderate fatigue with some interference with activity) and MYALGIA (Moderate muscle pain with some interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/ Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE SWELLING (Mild injection site swelling), FATIGUE (Moderate fatigue with some interference with activity) and MYALGIA (Moderate muscle pain with some interference with activity). At the time of the report, MALAISE (Mild malaise/feeling sick and no interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/ Moderate injection site tenderness (tenderness with movement)), VACCINATION SITE SWELLING (Mild injection site swelling), FATIGUE (Moderate fatigue with some interference with activity) and MYALGIA (Moderate muscle pain with some interference with activity) outcome was unknown.            Concomitant medications were not reported.  The patient experienced events anytime during the 2 days after COVID-19 vaccination, which occurred on Sunday, 17-Dec-2023 and Monday, 18-Dec-2023.  No treatment information was provided.  Subject ID was reported. Subject ID was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-756177 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756177:Same reporter (Patient)
Age: 0.33
Sex: M
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Immunization error, this medication should not have been given to infant.
Age: 68.0
Sex: M
Vaccine: RSV
Symptoms: Asthenia, Nausea, Pain
Clinical narrative: Three days weak, nauseous, body aches
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Decreased appetite, Fatigue, Headache, Palpitations
Clinical narrative: Terrific headache, fatigue - very sleepy, weak, no appetite, heart palpatations fever, 3 days -
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Pyrexia, Somnolence
Clinical narrative: Terrific headache, fatigue - very sleepy, weak, no appetite, heart palpatations fever, 3 days -
Age: 4.0
Sex: F
Vaccine: FLU4, MMRV, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient did not have any reaction, but was noted to have received wrong vaccine during chart review
Age: 32.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Arthralgia, Injection site induration, Injection site pain, Injection site swelling, Pain
Clinical narrative: Persitent and worsening pain in the arm and shoulder/then in November 2023 pain recurred and worsened at injection, involving shoulder pain/painful when raising arm; Hard spot/bump at the injection site; Pain/Soreness; This spontaneous report was received from a medical assistant via company representative regarding a 32-year-old female patient.  The patient's medical history was not reported. Her concurrent conditions included sulfonamide allergy, acne, anxiety, depression, and hair disorder. Concomitant therapies included methylphenidate (RITALIN), spironolactone, alprazolam and escitalopram oxalate (LEXAPRO).  On 21-FEB-2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter (lot number U039529 has been verified to be a valid lot number (capture in bacth field due to e2b error), expiration date reported and validated as 09-AUG-2024). On 19-APR-2023, she received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter (lot number U039529 has been verified to be a valid lot number, expiration date reported and validated as 09-AUG-2024). It was mentioned that she "did fine" after the first two doses. Then, on 22-AUG-2023, she was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter (lot number W014209 has been verified to be a valid lot number, expiration date reported and validated as 06-JAN-2025). All the suspect vaccine doses were administered intramuscularly in the left deltoid as prophylaxis. There were no issues at the time of the vaccine administration, it was uneventful as well and the patient tolerated it well.  For two and a half weeks after the third dose, she had no reaction. Then, on an unspecified day in September 2023 (also reported as mid-September 2023), the patient experienced pain, soreness (vaccination site pain) and she noticed a bit of a hard spot/bump at the injection site (vaccination site mass). However, there was nothing visible such as a bump or redness at the vaccination site. As treatment, the patient was advised to take acetaminophen (TYLENOL) or ibuprofen and diphenhydramine (BENADRYL) as needed (PRN). She stated that soreness and bump resolved after a few days. Afterward, on an unspecified day in November 2023, she noticed a persistent and worsening pain in the arm and shoulder (pain in extremity); which was painful when raising arm. There were no recent changes in medications, activities and there were no other recent vaccines. In addition, the patient denied any other symptom, including redness, rash, shortness of breath (SOB) or bump at the vaccination site. At the reporting time, the patient was recovering from persistent and worsening pain in the arm and shoulder (pain in extremity).  The causality between the events and the suspect vaccine was reported as related.
Age: 32.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Pain in extremity
Clinical narrative: Persitent and worsening pain in the arm and shoulder/then in November 2023 pain recurred and worsened at injection, involving shoulder pain/painful when raising arm; Hard spot/bump at the injection site; Pain/Soreness; This spontaneous report was received from a medical assistant via company representative regarding a 32-year-old female patient.  The patient's medical history was not reported. Her concurrent conditions included sulfonamide allergy, acne, anxiety, depression, and hair disorder. Concomitant therapies included methylphenidate (RITALIN), spironolactone, alprazolam and escitalopram oxalate (LEXAPRO).  On 21-FEB-2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter (lot number U039529 has been verified to be a valid lot number (capture in bacth field due to e2b error), expiration date reported and validated as 09-AUG-2024). On 19-APR-2023, she received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter (lot number U039529 has been verified to be a valid lot number, expiration date reported and validated as 09-AUG-2024). It was mentioned that she "did fine" after the first two doses. Then, on 22-AUG-2023, she was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter (lot number W014209 has been verified to be a valid lot number, expiration date reported and validated as 06-JAN-2025). All the suspect vaccine doses were administered intramuscularly in the left deltoid as prophylaxis. There were no issues at the time of the vaccine administration, it was uneventful as well and the patient tolerated it well.  For two and a half weeks after the third dose, she had no reaction. Then, on an unspecified day in September 2023 (also reported as mid-September 2023), the patient experienced pain, soreness (vaccination site pain) and she noticed a bit of a hard spot/bump at the injection site (vaccination site mass). However, there was nothing visible such as a bump or redness at the vaccination site. As treatment, the patient was advised to take acetaminophen (TYLENOL) or ibuprofen and diphenhydramine (BENADRYL) as needed (PRN). She stated that soreness and bump resolved after a few days. Afterward, on an unspecified day in November 2023, she noticed a persistent and worsening pain in the arm and shoulder (pain in extremity); which was painful when raising arm. There were no recent changes in medications, activities and there were no other recent vaccines. In addition, the patient denied any other symptom, including redness, rash, shortness of breath (SOB) or bump at the vaccination site. At the reporting time, the patient was recovering from persistent and worsening pain in the arm and shoulder (pain in extremity).  The causality between the events and the suspect vaccine was reported as related.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Myalgia, Peripheral swelling, Pyrexia
Clinical narrative: Low grade fever coming in waves, swollen upper arm and pain in muscles, fever dreams
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis, Ultrasound Doppler abnormal
Clinical narrative: Blood clots in my left leg, taking Xarelto 10 mg
Sex: F
Vaccine: UNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: was given a pediatric hep a vaccine instead of adult hep a vaccine
Age: 44.0
Sex: M
Vaccine: HPV9
Symptoms: Erythema, Pruritus, Sensitive skin, Urticaria
Clinical narrative: Within about a day after I received this vaccination, my skin started itching itching all over, particularly on my arms and legs, my feet, my torso, and my groin area. When I scratch it, it seemed hyper-sensitive, and I got red marks that would take a while to go away. I was about to leave on a trip, and I wasn't able to schedule an appointment with my primary care physician, so I went to an urgent care clinic, and later a dermatolost, once I arrived in my destination. They both diagnosed me as having hives of unknown origin, and they told me to start taking an antihistimine every day as well as to use a particular type of skin cream. It's been 3 months now, and although the problem has improved, it has not gone away. Understandably, I've opted not to get the 2nd and 3rd dose of this vaccine, since I fear that whatever marginal benefit I might receive from it (considering my age, at the upper threshold of people who usually get the HPV vaccine) might be outweighed by the risk of worsening this problem if the vaccine is in fact what caused it.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling
Clinical narrative: Swelling of Left thigh and knee. Soft , no erythema, not painful to touch. Patient's Mother was advised to apply ice pack to thigh PRN. Benadryl for swelling . Call if the area becomes more swollen, becomes red or painful
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Chills, Cough, Headache, Pyrexia, Respiratory symptom
Clinical narrative: 2 days of upper respiratory symptoms including general malaise, fevers/chills, congestion, rhinorrhea, headache, cough
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19-2
Symptoms: Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: 2 days of upper respiratory symptoms including general malaise, fevers/chills, congestion, rhinorrhea, headache, cough
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient received 2023-2024 dose of covid vaccine (Pfizer).  Guardian present failed to alert staff/MD that patient has already received 2023-2024 dose elsewhere previously this season (Moderna) which had not been reported to PCP (was administered by Pharmacy 3 months previously).  2ish hours later other guardian called to notify office of occurance and previous administration.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated
Age: 23.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient received Flu and Covid vaccine in October 2023 and when asked at her physical appointment in January stated she didn't have these and wanted to proceed. When nurse went to document, Data came up and showed she had these in October 2023.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Ejection fraction, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated with 1 booster
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: hospitalized with covid; fully vaccinated with 1 booster
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Fatigue, Headache, Pain
Clinical narrative: fatigue, dizzyness, headache, bodyaches, fever, cough
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fatigue, dizzyness, headache, bodyaches, fever, cough
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy
Clinical narrative: Lethargy charted 1-13 and provider updated. Vitals stable- continuing to monitor. Nursing assessment  1-14 does not indicate any worsening and seems to be improving.
Age: 19.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There were no adverse reactions to the vaccine. Pt states she was feeling well.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in my left ear.  Has not stopped .
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered one day after beyond use date.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: Patient was given an expired vaccine.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Laboratory test normal, Pericarditis
Clinical narrative: Chest pains during breakfast and I thought I was having a heart attack. Called ambulance & transported to Hospital. Spent 2 nights in the hospital w/ many medical/diagnostic tests. Diagnosis: "Pericarditis",  inflammation of the sack around the heart. No previous heart problems.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient was given dose of pediatric Moderna COVID vaccine instead of requested flu vaccine at clinic.  he had received Pfizer COVID vaccine 1 month prior.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient noticed site of injection was red, slightly swollen, and sore. Called pharmacy right away.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: peripheral neuropathy
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented with site reactions including redness, swelling, and warm to the touch. Recommended patient take Benadryl and follow up with MD if symptoms persist.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests normal, Magnetic resonance imaging normal, Tinnitus
Clinical narrative: After about 6 hours from the vaccine, I started getting sever tinnitus which was overwhelming. Over the next few days it did not resolve, and I have a permanent high pitched whistle that cannot be drowned out by any noise.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain, Tinnitus
Clinical narrative: pt. experienced ASE including "buzzing in ears" and body aches from days 2-6  post vaccine. Pt. states "felt horrible" and slept for 3 days with increase in  depression symptoms.  Pt. agreeable to continue with vaccinations as ordered but wanted to alert  medical team to ASE.
Age: 99.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalization related to COVID 19 following completion of primary vaccine series
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalization related to COVID 19 following completion of primary vaccine series
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs or PQC reported.; Caller reported expired dose of VAQTA was administered.  No other information provided.  No additional AEs or PQC reported.; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 29-DEC-2023 the patient was vaccinated with expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # W017819 and expiration date 27-DEC-2023, 1 milliliter, intramuscular for prophylaxis (dose number and site of administration were not provided) (expired product administered and no adverse event).
Age: 21.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Chest discomfort, Chest pain, Electrocardiogram abnormal, Enzyme abnormality, Fatigue
Clinical narrative: My son has no prior heart problems  and has completed triathlons and other things with no heart issues. He is very healthy. He said that right after he got the MP vaccine, he started to notice some chest pressure. He thought it was stress because he was flying for a semester abroad in one week.  He flew on 1/8/2024.  The next morning, his chest pain worsened to become very noticeable. He felt extreme fatigue and one arm fell asleep. He got a doctor's appt for the next morning, Their EKG and enzyme tests showed problems and they called an ambulance and had him hospitalized. He is currently in the hospital for Myocarditis. I do not know his doctor's name. They do not speak same language. My son speaks pretty good and has been the one communicating with them. They have performed Ultrasound, MRI, and other tests. I have requested copies. Please contact them for more information or I  can get you more information as I get it.   The only other contributing factor other than his MP vaccine was that several days prior to receiving the MP vaccine, he got a Heplisav-B vaccine. (on 12/28). That was given at pharmacy.  He had no reaction to the hep B at all.  He got it because some prior blood work showed his immunity had worn off to that.
Age: 21.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Foreign travel, Hypoaesthesia, Immediate post-injection reaction, Laboratory test, Magnetic resonance imaging
Clinical narrative: My son has no prior heart problems  and has completed triathlons and other things with no heart issues. He is very healthy. He said that right after he got the MP vaccine, he started to notice some chest pressure. He thought it was stress because he was flying for a semester abroad in one week.  He flew on 1/8/2024.  The next morning, his chest pain worsened to become very noticeable. He felt extreme fatigue and one arm fell asleep. He got a doctor's appt for the next morning, Their EKG and enzyme tests showed problems and they called an ambulance and had him hospitalized. He is currently in the hospital for Myocarditis. I do not know his doctor's name. They do not speak same language. My son speaks pretty good and has been the one communicating with them. They have performed Ultrasound, MRI, and other tests. I have requested copies. Please contact them for more information or I  can get you more information as I get it.   The only other contributing factor other than his MP vaccine was that several days prior to receiving the MP vaccine, he got a Heplisav-B vaccine. (on 12/28). That was given at pharmacy.  He had no reaction to the hep B at all.  He got it because some prior blood work showed his immunity had worn off to that.
Age: 21.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Myocarditis, Stress, Ultrasound scan
Clinical narrative: My son has no prior heart problems  and has completed triathlons and other things with no heart issues. He is very healthy. He said that right after he got the MP vaccine, he started to notice some chest pressure. He thought it was stress because he was flying for a semester abroad in one week.  He flew on 1/8/2024.  The next morning, his chest pain worsened to become very noticeable. He felt extreme fatigue and one arm fell asleep. He got a doctor's appt for the next morning, Their EKG and enzyme tests showed problems and they called an ambulance and had him hospitalized. He is currently in the hospital for Myocarditis. I do not know his doctor's name. They do not speak same language. My son speaks pretty good and has been the one communicating with them. They have performed Ultrasound, MRI, and other tests. I have requested copies. Please contact them for more information or I  can get you more information as I get it.   The only other contributing factor other than his MP vaccine was that several days prior to receiving the MP vaccine, he got a Heplisav-B vaccine. (on 12/28). That was given at pharmacy.  He had no reaction to the hep B at all.  He got it because some prior blood work showed his immunity had worn off to that.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalization related to COVID 19 following completion of primary vaccine series
Age: 75.0
Sex: F
Vaccine: RSV
Symptoms: Immediate post-injection reaction, Pain in extremity
Clinical narrative: Patient states had severe pain traveling down arm immediately after receiving vaccine.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Back pain, Immediate post-injection reaction, Sleep disorder
Clinical narrative: It got sore right away. Ten times a night I had to wake up because of the pain. From one shoulder to the other and down my back.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered one day after beyond use date.
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalization related to COVID 19 following completion of primary vaccine series
Age: 77.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: PATIENT STATED SHE FELT SWELLING IN HER ARM AND  HAD A FEVER FOR A COUPLE DAYS.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered one day after beyond use date.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered one day after beyond use date.
Age: 77.0
Sex: M
Vaccine: RSV
Symptoms: Immediate post-injection reaction, Pain
Clinical narrative: Patient states had severe pain immediately after vaccine was administered. No visible reaction besides pain.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered one day after beyond use date.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Hospitalization related to COVID 19 following completion of primary vaccine series
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered 2 days after beyond use date.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Back pain, Condition aggravated, Dizziness, Hot flush
Clinical narrative: temperature around 99.9/100 the night of getting the vaccine 1/11/24; history of migraines but worsening migraines, feeling dizziness and lightheaded, also with joint pain, and pain in back and neck; feeling hot flashes.  Fevers continued for the next 3-4 days, Tmax 103.9.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Migraine, Neck pain, Pyrexia
Clinical narrative: temperature around 99.9/100 the night of getting the vaccine 1/11/24; history of migraines but worsening migraines, feeling dizziness and lightheaded, also with joint pain, and pain in back and neck; feeling hot flashes.  Fevers continued for the next 3-4 days, Tmax 103.9.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered 6 days after beyond use date.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia oral
Clinical narrative: Patient came to our pharmacy solely because we had novavax and she only wanted novavax covid vaccine.  The rph administered the vaccine and told pt to wait in waiting area.  Her lips became tingley and RPH called 911.  Ambulance came, patient observed by paramedics, deemed ok to leave.  Called pt a few hours later and she was feeling better, just a sore arm.  Will follow up with her tomorrow morning as well.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Pollakiuria, Skeletal injury, Syncope
Clinical narrative: PATIENT STATED THAT WITHIN 24 HOURS OF VACCINATION, HE WAS EXPERIENCE CHILLS, FREQUENT URINATIONS, AND DIZZINESS. HE STATED THAT HE WAS SO DIZZY THAT HE COLLASPED AND INJURED HIS TAILBONE.
Age: 70.0
Sex: M
Vaccine: RSV, VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events. Shringrix was accidentally given outside of recommendations since this patient's Shingrix 2-shot series had already been completed.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs were reported; Nurse reported that a patient received an expired MMR II today.   No additional AEs were reported. No further information provided.  No PQC.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.  On 08-JAN-2024 the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status: rHA) lot # W017556 and expiration date 07-JAN-2024 for prophylaxis (exact dose, dose number, route and site of administration were not reported) (expired product administered and no adverse event).
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Balance disorder, Blood glucose increased, Blood pressure increased, Dizziness, Fear
Clinical narrative: Reactions from 01/05/2024 10pm to 01/06/2024 3am. First: serious violent shaking of hand, arms, upper body, felt very cold, and could not warm up. Lost control of my bladder, peed in my pants excessively five times, every time I stood up to go to the bathroom. Second: My upper body skin, arms, chest, face, and neck were hot to the touch (similar to sunburn), did not sweat. I wiped myself down with alcohol, baby wipes trying to cool down, to no avail. My blood glucose stayed higher than normal. My blood pressure went much higher than normal 162/90/101, 157/83/96, 160/81/97. No nausea, no vomiting. Very dizzy, stumbled, and could not control use of my legs/balance while trying to use 4-wheel walker. Very scared, live alone.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Feeling cold, Gait disturbance, Musculoskeletal disorder, Skin warm, Tremor
Clinical narrative: Reactions from 01/05/2024 10pm to 01/06/2024 3am. First: serious violent shaking of hand, arms, upper body, felt very cold, and could not warm up. Lost control of my bladder, peed in my pants excessively five times, every time I stood up to go to the bathroom. Second: My upper body skin, arms, chest, face, and neck were hot to the touch (similar to sunburn), did not sweat. I wiped myself down with alcohol, baby wipes trying to cool down, to no avail. My blood glucose stayed higher than normal. My blood pressure went much higher than normal 162/90/101, 157/83/96, 160/81/97. No nausea, no vomiting. Very dizzy, stumbled, and could not control use of my legs/balance while trying to use 4-wheel walker. Very scared, live alone.
Age: 67.0
Sex: F
Vaccine: RSV
Symptoms: Urinary incontinence
Clinical narrative: Reactions from 01/05/2024 10pm to 01/06/2024 3am. First: serious violent shaking of hand, arms, upper body, felt very cold, and could not warm up. Lost control of my bladder, peed in my pants excessively five times, every time I stood up to go to the bathroom. Second: My upper body skin, arms, chest, face, and neck were hot to the touch (similar to sunburn), did not sweat. I wiped myself down with alcohol, baby wipes trying to cool down, to no avail. My blood glucose stayed higher than normal. My blood pressure went much higher than normal 162/90/101, 157/83/96, 160/81/97. No nausea, no vomiting. Very dizzy, stumbled, and could not control use of my legs/balance while trying to use 4-wheel walker. Very scared, live alone.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Rash
Clinical narrative: Arm Rash ~ 48 hours after injection
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Rash macular
Clinical narrative: Patient had mild rash development localized around site of vaccination. today is 1/15/2024. patient states that rash has persisted since day after administration (1/2/2024). Rash size was about 1-1.5 in splotchy patch around administration site. patient states that area was itchy for about a week. the red area has began to diminish slightly.
Age: 0.42
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: HepB administered on 09-AUG-2008 and on 13-FEB-2009 (label schedule: 0,1,6 months); HepB administered on 09-AUG-2008 and on 15-NOV-2008 (label schedule: 0,1,6 months); This spontaneous report has been received from an other healthcare professional, via medical records from a case in litigation for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (2312USA007705), concerning a 9-month-old female patient.  Her medical history and concurrent conditions were not reported. Historical vaccines included haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) (reported as Hib vaccine), diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (DTAP), pneumococcal vaccine conj 7v (crm197) (PREVNAR), polio vaccine (IPV), and rotavirus vaccine (+) live (+) oral (+) pentavalent (ROTATEQ). The patient's concurrent conditions. Concomitant medications included haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown), rotavirus vaccine (+) live (+) oral (+) pentavalent (ROTATEQ), diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (DTAP) and pneumococcal vaccine conj 7v (crm197) (PREVNAR).   On 09-AUG-2008, the patient was vaccinated with first dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (reported as HepB vaccine) intramuscular injection, administered for prophylaxis (exact dose, strength, lot #, expiry date, and route of administration were not provided). On 15-NOV-2008, the patient received second dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (inappropriate schedule of product administration). On 13-FEB-2009, the patient received third dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (inappropriate schedule of product administration).   This is one of several reports regarding the same patient.; Sender's Comments:  US-009507513-2312USA007705:Source case
Age: 0.08
Sex: F
Vaccine: HIBV
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: fourth dose of HIB vaccine administered; third dose administred to less than 12-month old patient; first dose before 2 months of age; This spontaneous report has been received from an other healthcare professional, via medical records from a case in litigation for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (MARRS # 2312USA007705), concerning an 8-week-old female patient.  Her medical history and concurrent conditions were not reported. Concomitant medications included rotavirus vaccine (+) live (+) oral (+) pentavalent (ROTATEQ), diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (DTAP), polio vaccine inact (IPV) and pneumococcal vaccine conj 7v (crm197) (PREVNAR).   On 09-APR-2008, the patient was vaccinated with first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate (manufacturer unknown) (reported as Hib vaccine) intramuscular injection, administered for prophylaxis (exact dose, strength, lot #, expiry date, and route of administration were not provided) (product administered to patient of inappropriate age). On 09-JUN-2008, the patient received second dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown). On 09-AUG-2008, the patient received third dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) (product administered to patient of inappropriate age). On 30-JUL-2009, the patient received fourth dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) (extra dose administered).  This is one of several reports regarding the same patient.; Sender's Comments:  US-009507513-2312USA007705:Source case
Sex: F
Vaccine: RSV, RSV
Symptoms: Blister, Burning sensation, Erythema, Injection site exfoliation, Injection site scar
Clinical narrative: The injection site had peeled and healed with scar; The injection site had peeled and healed with scar; Redness and swelling turned into blister/burn and rash; Redness and swelling turned into blister/burn and rash; Redness and swelling turned into blister/burn and rash; Redness and swelling turned into blister/burn and rash; rash/still have a rash on my body; This non-serious case was reported by a consumer and described the occurrence of injection site exfoliation in a 61-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 79T9F) for prophylaxis.   On 05-DEC-2023, the patient received Arexvy. On 07-DEC-2023, 2 days after receiving Arexvy, the patient experienced erythema (Verbatim: Redness and swelling turned into blister/burn and rash), swelling (Verbatim: Redness and swelling turned into blister/burn and rash), blister (Verbatim: Redness and swelling turned into blister/burn and rash), burn (Verbatim: Redness and swelling turned into blister/burn and rash) and rash (Verbatim: rash/still have a rash on my body). On an unknown date, the patient experienced injection site exfoliation (Verbatim: The injection site had peeled and healed with scar) and injection site scar (Verbatim: The injection site had peeled and healed with scar). The outcome of the injection site exfoliation was resolved and the outcome of the injection site scar was not reported and the outcome of the erythema, swelling, blister, burn and rash were not resolved.   It was unknown if the reporter considered the injection site exfoliation, injection site scar, erythema, swelling, blister, burn and rash to be related to Arexvy.     It was unknown if the company considered the injection site exfoliation, injection site scar, erythema, swelling, blister, burn and rash to be related to Arexvy.   Additional Information: GSK Receipt Date: 05-JAN-2024 The patient reported that she had received Arexvy vial 10pk kit and had redness and swelling and its turned into the blister, burn and rash. The patient visited primary care physician and received cream for rash over, but the doctor said needed it to work its way through her system.  The injection site had peeled and healed with a scar, but she still have a rash on her body. The patient reported that the symptoms were treated. The reporter consented to follow-up.
Sex: F
Vaccine: RSV, RSV
Symptoms: Rash, Swelling
Clinical narrative: The injection site had peeled and healed with scar; The injection site had peeled and healed with scar; Redness and swelling turned into blister/burn and rash; Redness and swelling turned into blister/burn and rash; Redness and swelling turned into blister/burn and rash; Redness and swelling turned into blister/burn and rash; rash/still have a rash on my body; This non-serious case was reported by a consumer and described the occurrence of injection site exfoliation in a 61-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 79T9F) for prophylaxis.   On 05-DEC-2023, the patient received Arexvy. On 07-DEC-2023, 2 days after receiving Arexvy, the patient experienced erythema (Verbatim: Redness and swelling turned into blister/burn and rash), swelling (Verbatim: Redness and swelling turned into blister/burn and rash), blister (Verbatim: Redness and swelling turned into blister/burn and rash), burn (Verbatim: Redness and swelling turned into blister/burn and rash) and rash (Verbatim: rash/still have a rash on my body). On an unknown date, the patient experienced injection site exfoliation (Verbatim: The injection site had peeled and healed with scar) and injection site scar (Verbatim: The injection site had peeled and healed with scar). The outcome of the injection site exfoliation was resolved and the outcome of the injection site scar was not reported and the outcome of the erythema, swelling, blister, burn and rash were not resolved.   It was unknown if the reporter considered the injection site exfoliation, injection site scar, erythema, swelling, blister, burn and rash to be related to Arexvy.     It was unknown if the company considered the injection site exfoliation, injection site scar, erythema, swelling, blister, burn and rash to be related to Arexvy.   Additional Information: GSK Receipt Date: 05-JAN-2024 The patient reported that she had received Arexvy vial 10pk kit and had redness and swelling and its turned into the blister, burn and rash. The patient visited primary care physician and received cream for rash over, but the doctor said needed it to work its way through her system.  The injection site had peeled and healed with a scar, but she still have a rash on her body. The patient reported that the symptoms were treated. The reporter consented to follow-up.
Sex: F
Vaccine: RSV, RSV
Symptoms: Abdominal discomfort, Confusional state, Disturbance in attention, Dizziness, Hot flush
Clinical narrative: The injection site had peeled and healed with scar; The injection site had peeled and healed with scar; Redness and swelling turned into blister/burn and rash; Redness and swelling turned into blister/burn and rash; Redness and swelling turned into blister/burn and rash; Redness and swelling turned into blister/burn and rash; rash/still have a rash on my body; This non-serious case was reported by a consumer and described the occurrence of injection site exfoliation in a 61-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 79T9F) for prophylaxis.   On 05-DEC-2023, the patient received Arexvy. On 07-DEC-2023, 2 days after receiving Arexvy, the patient experienced erythema (Verbatim: Redness and swelling turned into blister/burn and rash), swelling (Verbatim: Redness and swelling turned into blister/burn and rash), blister (Verbatim: Redness and swelling turned into blister/burn and rash), burn (Verbatim: Redness and swelling turned into blister/burn and rash) and rash (Verbatim: rash/still have a rash on my body). On an unknown date, the patient experienced injection site exfoliation (Verbatim: The injection site had peeled and healed with scar) and injection site scar (Verbatim: The injection site had peeled and healed with scar). The outcome of the injection site exfoliation was resolved and the outcome of the injection site scar was not reported and the outcome of the erythema, swelling, blister, burn and rash were not resolved.   It was unknown if the reporter considered the injection site exfoliation, injection site scar, erythema, swelling, blister, burn and rash to be related to Arexvy.     It was unknown if the company considered the injection site exfoliation, injection site scar, erythema, swelling, blister, burn and rash to be related to Arexvy.   Additional Information: GSK Receipt Date: 05-JAN-2024 The patient reported that she had received Arexvy vial 10pk kit and had redness and swelling and its turned into the blister, burn and rash. The patient visited primary care physician and received cream for rash over, but the doctor said needed it to work its way through her system.  The injection site had peeled and healed with a scar, but she still have a rash on her body. The patient reported that the symptoms were treated. The reporter consented to follow-up.
Sex: F
Vaccine: RSV, RSV
Symptoms: Hyperhidrosis, Injection site erythema, Injection site rash, Nausea, Rash
Clinical narrative: The injection site had peeled and healed with scar; The injection site had peeled and healed with scar; Redness and swelling turned into blister/burn and rash; Redness and swelling turned into blister/burn and rash; Redness and swelling turned into blister/burn and rash; Redness and swelling turned into blister/burn and rash; rash/still have a rash on my body; This non-serious case was reported by a consumer and described the occurrence of injection site exfoliation in a 61-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 79T9F) for prophylaxis.   On 05-DEC-2023, the patient received Arexvy. On 07-DEC-2023, 2 days after receiving Arexvy, the patient experienced erythema (Verbatim: Redness and swelling turned into blister/burn and rash), swelling (Verbatim: Redness and swelling turned into blister/burn and rash), blister (Verbatim: Redness and swelling turned into blister/burn and rash), burn (Verbatim: Redness and swelling turned into blister/burn and rash) and rash (Verbatim: rash/still have a rash on my body). On an unknown date, the patient experienced injection site exfoliation (Verbatim: The injection site had peeled and healed with scar) and injection site scar (Verbatim: The injection site had peeled and healed with scar). The outcome of the injection site exfoliation was resolved and the outcome of the injection site scar was not reported and the outcome of the erythema, swelling, blister, burn and rash were not resolved.   It was unknown if the reporter considered the injection site exfoliation, injection site scar, erythema, swelling, blister, burn and rash to be related to Arexvy.     It was unknown if the company considered the injection site exfoliation, injection site scar, erythema, swelling, blister, burn and rash to be related to Arexvy.   Additional Information: GSK Receipt Date: 05-JAN-2024 The patient reported that she had received Arexvy vial 10pk kit and had redness and swelling and its turned into the blister, burn and rash. The patient visited primary care physician and received cream for rash over, but the doctor said needed it to work its way through her system.  The injection site had peeled and healed with a scar, but she still have a rash on her body. The patient reported that the symptoms were treated. The reporter consented to follow-up.