chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: RECEIVED VACCINE WHILE UNDER 18; RECEIVED ONLY 0.3 ML OF THE DOSE AND REFUSED TO GET THE REST OF IT; This spontaneous report received from a pharmacist concerned a 14 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821281 expiry: UNKNOWN) 0.3 ml, administered on 19-JUL-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 19-JUL-2021, the subject experienced received vaccine while under 18. On 19-JUL-2021, the subject experienced received only 0.3 ml of the dose and refused to get the rest of it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received vaccine while under 18 and received only 0.3 ml of the dose and refused to get the rest of it was not reported. This report was non-serious.
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: RECEIVED VACCINE WHILE UNDER 18; RECEIVED ONLY 0.3 ML OF THE DOSE AND REFUSED TO GET THE REST OF IT; This spontaneous report received from a pharmacist concerned a 14 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821281 expiry: UNKNOWN) 0.3 ml, administered on 19-JUL-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 19-JUL-2021, the subject experienced received vaccine while under 18. On 19-JUL-2021, the subject experienced received only 0.3 ml of the dose and refused to get the rest of it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received vaccine while under 18 and received only 0.3 ml of the dose and refused to get the rest of it was not reported. This report was non-serious.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chest pain, Echocardiogram normal, Electrocardiogram normal, Haemodynamic test normal, Intensive care
Clinical narrative: 7/17/21 (after receiving 2nd dose vaccine 7/16) developed fever, chills, "weakness", "lack of energy", fatigue and unilateral nasal congestion, which treated with acetaminophen.  Symptoms resolved by noon 7/18/21.  3/19/21 woke up with mild sore throat, moderately severe (3-5/10) distal sternal sub sternal pain which intensified when he was supine or moving.  Came to ED  for evaluation....where pain that was localized to the left precordium resolved shortly after arrival.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: 7/17/21 (after receiving 2nd dose vaccine 7/16) developed fever, chills, "weakness", "lack of energy", fatigue and unilateral nasal congestion, which treated with acetaminophen.  Symptoms resolved by noon 7/18/21.  3/19/21 woke up with mild sore throat, moderately severe (3-5/10) distal sternal sub sternal pain which intensified when he was supine or moving.  Came to ED  for evaluation....where pain that was localized to the left precordium resolved shortly after arrival.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Blood creatine phosphokinase MB increased, Blood fibrinogen, Bundle branch block left, C-reactive protein increased
Clinical narrative: 7/17/21 (after receiving 2nd dose vaccine 7/16) developed fever, chills, "weakness", "lack of energy", fatigue and unilateral nasal congestion, which treated with acetaminophen.  Symptoms resolved by noon 7/18/21.  3/19/21 woke up with mild sore throat, moderately severe (3-5/10) distal sternal sub sternal pain which intensified when he was supine or moving.  Came to ED  for evaluation....where pain that was localized to the left precordium resolved shortly after arrival.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chest pain, Chills, Echocardiogram normal, Ejection fraction normal, Electrocardiogram normal
Clinical narrative: 7/17/21 (after receiving 2nd dose vaccine 7/16) developed fever, chills, "weakness", "lack of energy", fatigue and unilateral nasal congestion, which treated with acetaminophen.  Symptoms resolved by noon 7/18/21.  3/19/21 woke up with mild sore throat, moderately severe (3-5/10) distal sternal sub sternal pain which intensified when he was supine or moving.  Came to ED  for evaluation....where pain that was localized to the left precordium resolved shortly after arrival.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Fibrin D dimer, International normalised ratio increased, Nasal congestion, Oropharyngeal pain
Clinical narrative: 7/17/21 (after receiving 2nd dose vaccine 7/16) developed fever, chills, "weakness", "lack of energy", fatigue and unilateral nasal congestion, which treated with acetaminophen.  Symptoms resolved by noon 7/18/21.  3/19/21 woke up with mild sore throat, moderately severe (3-5/10) distal sternal sub sternal pain which intensified when he was supine or moving.  Came to ED  for evaluation....where pain that was localized to the left precordium resolved shortly after arrival.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pain, Platelet count decreased, Prothrombin time prolonged, Pyrexia, QRS axis abnormal
Clinical narrative: 7/17/21 (after receiving 2nd dose vaccine 7/16) developed fever, chills, "weakness", "lack of energy", fatigue and unilateral nasal congestion, which treated with acetaminophen.  Symptoms resolved by noon 7/18/21.  3/19/21 woke up with mild sore throat, moderately severe (3-5/10) distal sternal sub sternal pain which intensified when he was supine or moving.  Came to ED  for evaluation....where pain that was localized to the left precordium resolved shortly after arrival.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Serum ferritin normal, Troponin
Clinical narrative: 7/17/21 (after receiving 2nd dose vaccine 7/16) developed fever, chills, "weakness", "lack of energy", fatigue and unilateral nasal congestion, which treated with acetaminophen.  Symptoms resolved by noon 7/18/21.  3/19/21 woke up with mild sore throat, moderately severe (3-5/10) distal sternal sub sternal pain which intensified when he was supine or moving.  Came to ED  for evaluation....where pain that was localized to the left precordium resolved shortly after arrival.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Dyspnoea
Clinical narrative: Patient developed cough, loss of taste or smell, shortness of breath, headache, and nasal congestion on 07/16.  She was tested for COVID on 07/19 and found to be positive.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, SARS-CoV-2 test positive
Clinical narrative: Patient developed cough, loss of taste or smell, shortness of breath, headache, and nasal congestion on 07/16.  She was tested for COVID on 07/19 and found to be positive.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Restless legs syndrome
Clinical narrative: Restless legs for 3 evenings. The first evening was the worst. They gradually improved. I still have a tingling sensation in my legs.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Nasal congestion, Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: patient developed sore throat and nasal congestion on 7/15/2021.  She tested positive for COVID on 7/19/2021
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Positive COVID-19 test on 7/20/2021, despite being full vaccinated.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypertension, Hypoaesthesia, Pain in extremity
Clinical narrative: Stabbing pains in right hip, numbness upper right leg, pain in leg down to knee. After shot got high blood pressure.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: Rash of small red bumps starting on the chest and spreading up the next and across the back over 4 days to date
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: + COVID testing despite being fully vaccinated
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Hyperhidrosis, Hypersomnia
Clinical narrative: On day 2 after first vaccine in the middle of the night I developed a burning itching rash on the bottom of my feet and the palms of my hands that got me up out of bed to apply cold water and as that didn't help, I tried witch hazel which helped enough that I was able to get back to sleep.  The next day I had a rash on both sides of my torso, on the backs of my hands and at the base of the upper side of my toes.  Also from my armpits on both arms past my elbows.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Pain, Pyrexia, Sleep disorder
Clinical narrative: On day 2 after first vaccine in the middle of the night I developed a burning itching rash on the bottom of my feet and the palms of my hands that got me up out of bed to apply cold water and as that didn't help, I tried witch hazel which helped enough that I was able to get back to sleep.  The next day I had a rash on both sides of my torso, on the backs of my hands and at the base of the upper side of my toes.  Also from my armpits on both arms past my elbows.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site nodule
Clinical narrative: Itchy injection site, hard knot at injection site
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac stress test, Chest discomfort, Malaise, Myalgia, Palpitations
Clinical narrative: Expected fever, myalgia, malaise for a couple days after the second dose. Approximately April 2021 I started to notice palpitations and vague chest discomfort that was not associated with exertion. It resolved in late June 2021, and I had a normal stress test on July 14. I have no symptoms now.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Expected fever, myalgia, malaise for a couple days after the second dose. Approximately April 2021 I started to notice palpitations and vague chest discomfort that was not associated with exertion. It resolved in late June 2021, and I had a normal stress test on July 14. I have no symptoms now.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Computerised tomogram, Electroencephalogram, Fatigue
Clinical narrative: 1st Dose: Headaches, swollen lymph nodes  2nd Dose: Fatigue, body aches. Chest pains bad enough I went to the ER, 2 days later I went back to the ER because I my eye swelled shut, and my neck swelled up, and I had severe pain when I tried to swallow.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Odynophagia, Pain, Swelling, Swelling of eyelid
Clinical narrative: 1st Dose: Headaches, swollen lymph nodes  2nd Dose: Fatigue, body aches. Chest pains bad enough I went to the ER, 2 days later I went back to the ER because I my eye swelled shut, and my neck swelled up, and I had severe pain when I tried to swallow.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Computerised tomogram head normal, Disturbance in attention, Feeling abnormal, Headache
Clinical narrative: She developed headache and vertigo 30 minutes after Pfizer Covid vaccine 1st dose. She has continued to have daily headaches accompanied by debilitating vertigo as well as brain fog/concentration deficits for the nearly 2 months since her dose. She has no history of headaches or vertigo prior. She is no longer able to drive safely and has had to daily nursing school admission for a semester. We have just started to treat her for possible vestibular migraines prophylactically.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired driving ability, Laboratory test normal, Loss of personal independence in daily activities, New daily persistent headache, Vertigo
Clinical narrative: She developed headache and vertigo 30 minutes after Pfizer Covid vaccine 1st dose. She has continued to have daily headaches accompanied by debilitating vertigo as well as brain fog/concentration deficits for the nearly 2 months since her dose. She has no history of headaches or vertigo prior. She is no longer able to drive safely and has had to daily nursing school admission for a semester. We have just started to treat her for possible vestibular migraines prophylactically.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Somnolence
Clinical narrative: Extreme fatigue and sleepiness.  Numbness in 3 right toes and part of foot.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Dehydration, Stomatitis
Clinical narrative: Patient received first Moderna vaccine on April 28th. Did not complain of any adverse effects.  Patient received second Moderna vaccine on May 26th at approximately 11am. Spoke to son at 11pm that night and reported that she felt fine, her arm felt fine, the only complaint was "mouth feels funky" and she felt dehydrated. Was in typical spirits.  She passed on May 27th. Time of death cannot be confirmed as an autopsy was not completed but the assumption is between 6-9am. This would have been less than 24 hours after she received the second vaccine.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Antibody test, Back pain, Blood test, Chills
Clinical narrative: 7/11/21: Nausea, Muscle Pain, Back Pain, Fatigue 7/12/21 - present, onset of irregular heartbeat (at least 1-5 occurrences/hour) 7/17/21-7/18/21 afternoon: Irregular heartbeat and lightheadedness, back pain, nausea, fatigue, stomach pain in am/ Back pain, nausea, fatigue, stomach pain, fever, chills, body ache/muscle pain from 4 pm after 7/18/21 Negative Covid Result (urgent care - rapid test) 7/19/21: Irregular heartbeat and lightheadedness, back pain, nausea, fatigue, stomach pain, fever, headache, restlessness, body ache/muscle pain 7/20/21: Irregular heartbeat and lightheadedness, back pain, nausea, fatigue, stomach pain, fever, body ache/muscle pain, congestion
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram, Fatigue, Headache, Heart rate irregular
Clinical narrative: 7/11/21: Nausea, Muscle Pain, Back Pain, Fatigue 7/12/21 - present, onset of irregular heartbeat (at least 1-5 occurrences/hour) 7/17/21-7/18/21 afternoon: Irregular heartbeat and lightheadedness, back pain, nausea, fatigue, stomach pain in am/ Back pain, nausea, fatigue, stomach pain, fever, chills, body ache/muscle pain from 4 pm after 7/18/21 Negative Covid Result (urgent care - rapid test) 7/19/21: Irregular heartbeat and lightheadedness, back pain, nausea, fatigue, stomach pain, fever, headache, restlessness, body ache/muscle pain 7/20/21: Irregular heartbeat and lightheadedness, back pain, nausea, fatigue, stomach pain, fever, body ache/muscle pain, congestion
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: 7/11/21: Nausea, Muscle Pain, Back Pain, Fatigue 7/12/21 - present, onset of irregular heartbeat (at least 1-5 occurrences/hour) 7/17/21-7/18/21 afternoon: Irregular heartbeat and lightheadedness, back pain, nausea, fatigue, stomach pain in am/ Back pain, nausea, fatigue, stomach pain, fever, chills, body ache/muscle pain from 4 pm after 7/18/21 Negative Covid Result (urgent care - rapid test) 7/19/21: Irregular heartbeat and lightheadedness, back pain, nausea, fatigue, stomach pain, fever, headache, restlessness, body ache/muscle pain 7/20/21: Irregular heartbeat and lightheadedness, back pain, nausea, fatigue, stomach pain, fever, body ache/muscle pain, congestion
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Restlessness, SARS-CoV-2 test negative, Urine analysis
Clinical narrative: 7/11/21: Nausea, Muscle Pain, Back Pain, Fatigue 7/12/21 - present, onset of irregular heartbeat (at least 1-5 occurrences/hour) 7/17/21-7/18/21 afternoon: Irregular heartbeat and lightheadedness, back pain, nausea, fatigue, stomach pain in am/ Back pain, nausea, fatigue, stomach pain, fever, chills, body ache/muscle pain from 4 pm after 7/18/21 Negative Covid Result (urgent care - rapid test) 7/19/21: Irregular heartbeat and lightheadedness, back pain, nausea, fatigue, stomach pain, fever, headache, restlessness, body ache/muscle pain 7/20/21: Irregular heartbeat and lightheadedness, back pain, nausea, fatigue, stomach pain, fever, body ache/muscle pain, congestion
Age: 58.0
Sex: M
Vaccine: UNK
Symptoms: Urticaria cholinergic
Clinical narrative: cholinergic urticara of neck
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy lymph gland, Cancer surgery, Laboratory test, Magnetic resonance imaging, Malignant melanoma
Clinical narrative: Recurrence of melanoma- cancer found in R axillary lymph node; treatment: surgery, immunotherapy; outcome: ongoing immunotherapy
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Mammogram, Metastases to lymph nodes, Neoplasm recurrence, Positron emission tomogram, Therapeutic procedure
Clinical narrative: Recurrence of melanoma- cancer found in R axillary lymph node; treatment: surgery, immunotherapy; outcome: ongoing immunotherapy
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: Recurrence of melanoma- cancer found in R axillary lymph node; treatment: surgery, immunotherapy; outcome: ongoing immunotherapy
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test abnormal, Epstein-Barr virus infection reactivation, Fatigue
Clinical narrative: I grew incredibly fatigued after my initial side effects wore off. It felt like I could never get quite enough sleep to feel rested no matter how much I slept. After my second follow up shot, the fatigue became nearly debilitating. I went to the doctor to learn what might be wrong. My bloodwork showed I had a mono reactivation.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: Patient's symptoms were very painful chest pains. He felt like his chest was on fire, especially around his heart.
Age: 0.75
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No further details provided. No other AEs reported; a 9 month old patient received a dose of VAQTA; This spontaneous report has been received from a medical assistant, concerning a 9-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 21-JUN-2021, the patient was vaccinated with hepatitis a vaccine, inactivated(VAQTA) lot # T035721 with expiration date 15-APR-2022, (dose, frequency, route and anatomical location were not provided)  for prophylaxis (product administered to patient of inappropriate age). No further details provided, no other adverse events reported.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; pneumovax 23 was improperly stored and administered; This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 11-MAY-2021, the patient was vaccinated with improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # T033831 with expiration date 12-JUL-2021, 0.5 milliliter (frequency, route and anatomical location were not provided) for prophylaxis. No additional adverse event reported. The vaccine was stored at a temperature of 9.65 centigrade with a time frame of 192 hours and no previous temperature excursion. Digital data logger was involved.
Age: 87.0
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient who was previously administered with an unspecified PNEUMOCOCCAL Vaccine '10 years ago' was administered the PNEUMOV AX 23 Vaccine at '87 years old' on unspecified date; No additional AE; This spontaneous report was received from a healthcare business partner (HBP) on physician behalf.  HBP was reporting on 87-year-old patient of non-informed gender. There was no information about the patients concurrent conditions, drug reactions or allergies and concomitant therapies provided. The patients medical history includes pneumococcal vaccination 10 years ago, exact date was unknown, with unknown pneumococcal vaccine.   On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, exact dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. According to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prescribing information, the vaccine should be administered as a single dose (product use issue).  No additional adverse events were reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: no adverse event; A child received a dose of VARIVAX and PROQUAD concomitantly; A child received a dose of VARIVAX and PROQUAD concomitantly; A child received a dose of VARIVAX and PROQUAD concomitantly/The child was supposed to only receive PROQUAD; This spontaneous report was received from a medical assistant and refers to a 4 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 06-JUL-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # T028298, expiration date 16-FEB-2022, 0.5 milliliter once; concomitantly with varicella virus vaccine live (oka/merck)(VARIVAX) lot # T032317, expiration date 22-SEP-2022, 0.5 milliliter once, (administration routes were not reported) for prophylaxis; and the patient was supposed to received only measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). No adverse events were reported.
Sex: F
Vaccine: HPV9
Symptoms: Incomplete course of vaccination
Clinical narrative: had received her first 2 doses in a 3 dose series of GARDASIL9 in 2015 and has not yet received a third dose; no additional AE; This spontaneous report was received from a registered nurse and refers to a 22-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown dates in 2015, the patient received 2 doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 mL (route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. It was reported that she had not yet received a third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (inappropriate schedule of vaccine administered). There was no additional adverse event reported.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient received two doses of GARDASIL (4vHPV) when she was in her 20s (unspecified date/lots). Caller is not sure if the patient received the third dose.; The patient received two doses of GARDASIL (4vHPV) when she was in her 20s (unspecified date/lots). Caller is not sure if the patient received the third dose.; No additional AE reported; This spontaneous report was received from an office manager (also reported as healthcare business professional (HBP)) and refers to a 36-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown dates (reported as "when she was In her 20s"), the patient received two doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) 0,5 mL (route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. It was unknown whether the patient received the third dose of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (inappropriate schedule of vaccine administered). No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No signs or symptoms reported/ No other AE or PQC reported; VARIVAX was administered after a temperature excursion; This spontaneous report was received from a physician via a healthcare business professional referring to a specified patient of unknown age or gender.  On 01-JUL-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # T032318, expiration date on 22-SEP-2022, after a temperature excursion occurred, for prophylaxis (dose, route, location were not reported). No signs or symptoms were reported. The record of the temperatures were: 15°F to 46°F (30.3F) for 6 hours 30 minutes and 0 seconds; 6°F to 14°F (14.1F) for 5 hours 0 minutes and 0 seconds; 15°F to 46°F (16.6F) for 14 hours 0 minutes and 0 seconds; 15°F to 46°F (19.7F) for 1 hour 0 minutes and 0 seconds. Time frame of 26 Hours 30 Minutes 0 Seconds (cumulative). There were no previous temperature excursion and the call was done because of a data logger.
Sex: U
Vaccine: PPV, UNK
Symptoms: Expired product administered
Clinical narrative: Per nurse a patient was given expired PNU 23 that was expired; Information has been received from a registered nurse regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 14-JUL-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, lot number: S034299 with expiration date on 01-JUL-2021 (dose, frequency, route of administration and anatomical location were not reported) (expired vaccine used). No other concerns or issues were noted by the nurse.  This is one of two cases received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S034299; expirationdate: 01-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2107USA004708:
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Hysterectomy, Neoplasm malignant, Papilloma viral infection
Clinical narrative: The patient then underwent a hysterectomy and was hospitalized following the procedure; contracted Human Papillomavirus and ended up with cancer; contracted Human Papillomavirus and ended up with cancer; This spontaneous report has been received from a nurse, via a field-based representative, concerning a female patient who at the reporting time was 31 years old. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were unknown by the reporter.   On an unspecified date (reported as "when she was 14 years old"), the patient completed the vaccination scheme of Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) 0.5 milliliters (ml) injection administered intramuscularly (anatomical site of vaccination was not provided; lot number, and expiration date were unknown by the reporter) as prophylaxis.   On an unspecified date, the patient contracted human papillomavirus (papilloma viral infection) and experienced cancer (neoplasm malignant). Then, as a treatment for cancer, the patient underwent a hysterectomy and was hospitalized following the procedure. The reporter stated that the patient was doing better, however the outcome of the events was reported as unknown.   It was reported that the physician who treated the patient stated the human papillomavirus type was a type contained within Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL), as far what the vaccine covered.   The reporter's causality assessment between the events and Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) was not provided.  Upon internal review, hysterectomy and neoplasm malignant were determined to be medically significant events.
Sex: U
Vaccine: FLUN4
Symptoms: Illness
Clinical narrative: BEEN SICK AFTER RECEIVING FLUMIST; A spontaneous report has been received from a consumer. The report concerns a patient of unknown gender (age not provided).    No medical history was reported.     No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) 0.2 ml, via unspecified route, on 19-DEC-2015.     No malfunction has been reported for FLUMIST QUADRIVALENT.    On 19-DEC-2015, the patient experienced been sick after receiving flumist (preferred term: Sick relative).     The outcome of the event was unknown.    The event was considered non-serious.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Product Role: Suspect
Sex: F
Vaccine: FLUN4
Symptoms: Abdominal pain, Diarrhoea, Pyrexia, Rhinorrhoea, Vomiting
Clinical narrative: DIARRHEA; VOMITING; ABDOMINAL PAIN; LIGHT FEVER; RUNNY NOSE; A spontaneous report has been received from a consumer. The report concerns a female patient.    No medical history was reported.     No concomitant products were reported.    No malfunction has been reported for FLUMIST QUADRIVALENT.    On an unknown date, the patient experienced diarrhea (preferred term: Diarrhoea). On an unknown date, the patient experienced vomiting (preferred term: Vomiting). On an unknown date, the patient experienced abdominal pain (preferred term: Abdominal pain). On an unknown date, the patient experienced light fever (preferred term: Pyrexia). On an unknown date, the patient experienced runny nose (preferred term: Rhinorrhoea).     It is unknown if any action was taken with Flumist Quadrivalent (influenza vaccine live reassort 4v).     The outcome of the event(s) of diarrhea, vomiting, abdominal pain, light fever and runny nose was unknown.     The events were considered non-serious.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Product Role: Suspect
Age: 24.0
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Received First Dose of Heplisav-B and Second Dose with Engerix; Initial Report Received on 11-Jun-2021  An advanced nurse practitioner reported that a 24 year-old female (race and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and Engerix as the second dose of the series.  No relevant medical history was reported. The patient had no known allergies.   No relevant concomitant medications were reported.  On 27-Apr-2021, the patient received the first dose of HEPLISAV-B from a medical doctor's office (Lot # 934599, expiration date 22-Feb-2022, NDC # 43528-0003-05; route and site were not reported).   On 09-Jun-2021, the patient received the second dose with Engerix.   At the time of reporting, no adverse effects were reported. No other information was provided.    Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 20.0
Sex: U
Vaccine: HEP
Symptoms: Injection site pain
Clinical narrative: First Dose Heplisav-B Second Dose Engerix; Typical Injection Site Pain; Initial Report Received on 11-Jun-2021  A pharmacy technician in the US (TX) reported that a 20 year-old female (race and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and Engerix as the second dose of the series.  No relevant medical history was reported.   No relevant concomitant medications were reported.  On 27-Apr-2021, the patient received the first dose of HEPLISAV-B (Lot # 934600, expiration date 28-Feb-2022, NDC # 4352806050; route and site were not reported).   On 10-Jun-2021, the patient received the second dose with Engerix.   At the time of reporting, the reported stated there have been no adverse reaction except for typical site pain, but nothing more extreme than that. No other information was provided.   Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 22.0
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products
Clinical narrative: First Dose Heplisav-B Second Dose Engerix; Initial Report Received on 14-Jun-2021  A licensed practical nurse reported that a 22 year-old female (race and ethnicity not provided) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and Engerix as the second dose of the series.  No relevant medical history was reported. The patient did not have any allergies.  No relevant concomitant medications were reported.   On 14-May-2021, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, and site were not reported) at a different facility (unspecified).   On 14-Jun-2021, the patient received the second dose with Engerix (Lot #9P9B5, expiration date 07-Feb-2022).   At the time of reporting, no other information was provided.   Company Comment:  The company assessed the event as non serious.; Sender's Comments: The company assessed the event as non serious.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Received 3 Doses of Heplisav-B; Initial Report Received on 02-July-2021   A registered nurse reported that a 38-year-old female (race, and ethnicity not provided) received a third dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.    No relevant medical history was reported.  The patient was not pregnant at the time of vaccination.    No relevant concomitant medications were reported.   On 17-Nov-2020 the patient received the first dose of HEPLISAV-B (Lot # 934600, expiration date 28-Feb-2022, NDC #43528-003-01, serial number and route were not reported) in the right deltoid.   On 12-Dec-2020 the second dose of HEPLISAV-B (Lot # 934600, expiration date 28-Feb-2022, NDC #43528-003-01, serial number and route were not reported) in the right deltoid.  On 24-May-2021, a third dose of HEPLISAV-B (Lot # 934967, expiration date 11-Apr-2022, NDC #43528-003-01, serial number 824687756125, route was not reported) in the right deltoid.  The patient did not report any adverse reactions or issues related to "this incident."   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Have had the shingles 7 times; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by patient. Age at vaccination was not reported. The patient had one shot and had the shingles 7 times.
Sex: U
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Vaccination failure
Clinical narrative: I know more than one person that took the shingles shot only to get shingles a month or two later / Suspect vaccination failure; I know more than one person that took the shingles shot only to get shingles a month or two later; your immune system is weakened; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, between 1 and 3 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and decreased immune responsiveness. On an unknown date, the outcome of the vaccination failure, shingles and decreased immune responsiveness were unknown.   The reporter considered the vaccination failure, shingles and decreased immune responsiveness to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not applicable for this report. The reporter stated that shingles were something you got after you took the shot and your immune system was weakened. The reporter know more than one person that took the shingles shot only to get shingles a month or two later. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: I felt bad for about 3 or 4 days; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was recovered/resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.  Additional information was provided as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient felt bad for about 3 or 4 days after vaccination. No other information was reported.
Sex: U
Vaccine: HEP, HPVX, MNQ, PNC13
Symptoms: Product storage error
Clinical narrative: lowest temperature reached was 1.6 dregrees Celsius / total time out of range was 2 hours and 30 minutes / wasn't a consecutive time frame / patients received the vaccines involved in the excursion; This case was reported by a nurse via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B) (batch number J7H4D, expiry date unknown) for prophylaxis.   Co-suspect products included HPV 16-18 (HPV vaccine) (batch number 1659422, expiry date unknown) for prophylaxis, PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR 13) (batch number DR7158, expiry date unknown) for prophylaxis and MENACTRA (batch number U6919AA, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Engerix B, HPV vaccine, PREVNAR 13 and MENACTRA. On an unknown date, unknown after receiving Engerix B and HPV vaccine, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were reported as follows: This case was reported by a nurse. The age at vaccination was not reported. The nurse reported that the patient received Engerix B,HPV Vaccine,Prevnar 13 and Menactra. Caller stated about temperature excursion with a vaccine. Also stated that it dropped bellows 2 degrees for 2 hours and 30 minutes and that it wasn't consecutive. The agend said the only number that showed up when the caller stated was the caller confirmed the details provided by the transfer agent. Caller confirmed she was calling to obtain stability details. The caller clarified the lowest temperature reached was 1.6 degrees Celsius. She confirmed that the total time out of range was 2 hours and 30 minutes. It wasn't a consecutive time frame. She said patients received the vaccines involved in excursion. The caller does not have any patients information with her to provide. Nurse clarified that patient received 4 different vaccines that given that day so just provided lot or batch numbers.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first shingle shot August 2020 or 9 months ago.; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in August 2020 and had prostate surgery and it's been 9 month).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: This case was reported by patient himself. The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. The patient received first shingrix dose in August 2020 or 9 months ago and then had prostate surgery and it's been 9 months and patient did not received 2nd dose. The follow up was not asked.
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: started getting a headache / on the left side of my head / still feel a pulsing pain; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th July 2021, the patient received Shingrix. On 11th July 2021, 2 days after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details provided were as follows: Age at vaccination was not reported. The patient received shingrix vaccine on friday and experienced headache on sunday evening on the left side of my head and felt a pulsing pain on and off till tuesday. The patient asked if this was a side effect from vaccine because he/she normally do not get headches. No further details provided.
Sex: U
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Would it be harmful if a patient received an extra Menveo vaccination?; This case was reported by a other health professional via interactive digital media and described the occurrence of extra dose administered in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received extra dose of Menveo vaccine. Health care professional enquired that would it be harmful if patient received extra Menveo vaccination. No other information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first shingrix dose in august of 2020 / never came back in for their second dose; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in August 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, the patient never came back for 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that the clinical data center advised that the person should get it as soon as possible but it had been almost a year now. No additional information available.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: physician/gave her a shot/had already completed two rounds; This case was reported by a consumer via media and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The reporter was the patient's husband. The age at vaccination was not reported. The reporter stated that, his wife's physician gave her a shot not realizing that, she had already completed two rounds. The patient received 3rd dose of Shingrix, which led to extra dose administered. The reporter asked could 3rd shot be harmful.
Sex: U
Vaccine: MEN
Symptoms: Psychiatric symptom
Clinical narrative: psychiatric issues; This case was reported by a nurse via sales rep and described the occurrence of psychiatric symptom in a child patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced psychiatric symptom (serious criteria hospitalization). On an unknown date, the outcome of the psychiatric symptom was unknown.   It was unknown if the reporter considered the psychiatric symptom to be related to Meningococcal B vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received a Men B vaccination unsure if Bexsero or Tumenba and soon after the patient had psychiatric issues and was admitted to a hospital for those.  That was all the information that the reporter had but did speak to MSL about this. The reporter did not consent to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Dose given without powder mixed; Dose given without powder mixed; This case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The Menveo vaccine was mixed improperly dose given without powder mixed, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up.