chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Rash
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 66 year old female patient. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not provided. On an unknown date the patient was vaccinated with an unspecified hepatitis b vaccine (manufacturer unknown), (route of administration, dose #, lot #, expiration date and indication were not provided). On an unknown date, the patient experienced rash and fever. No treatment was given. At the time of reporting the patient had recovered from the rash and fever. The reporter did not assess the relationship between the events and the hepatitis b vaccine (manufacturer unknown).
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9, one intramuscular dose, for prophylaxis (with either lot # N014464, expiry date: 31-JAN-2020; lot# N020352, expiry date: 10-APR-2020; or N014464, expiry date: 19-DEC-2019). The vaccines underwent a temperature of 47 Fahrenheit degrees (°F) to 77°F (50.7°F), by a time frame of 1 hour 30 minutes, with no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1801USA008096: US-009507513-1801USA008097:
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 07-AUG-2014 the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 02-JAN-2016 the patient was treated by a physician for the onset of a blistery rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of these malfunctions, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9, one intramuscular dose, for prophylaxis (with either lot # N014464, expiry date: 31-JAN-2020; lot# N020352, expiry date: 10-APR-2020; or N014464, expiry date: 19-DEC-2019). The vaccines underwent a temperature of 47 Fahrenheit degrees (°F) to 77°F (50.7°F), by a time frame of 1 hour 30 minutes, with no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1801USA001401: US-009507513-1801USA008097:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9, one intramuscular dose, for prophylaxis (with either lot # N014464, expiry date: 31-JAN-2020; lot# N020352, expiry date: 10-APR-2020; or N014464, expiry date: 19-DEC-2019). The vaccines underwent a temperature of 47 Fahrenheit degrees (°F) to 77°F (50.7°F), by a time frame of 1 hour 30 minutes, with no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1801USA001401: US-009507513-1801USA008096:
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Aspiration bone marrow, Cough, Differential white blood cell count, Full blood count, Immune thrombocytopenic purpura
Clinical narrative: 9/29/17 vaccination with MMR, VZV, HepA, influenza. 10/19/17 hospitalization with ~7 day history of petechial rash. No illnesses in last several months. Platelets <10. Presumed ITP (immune thrombocytopenia); treated with IVIG (completed 10/20). CBC/manual diff on 10/19/2017 without any atypical lymphocytes. 10/22/17 manual diff showed 4% atypical lymphocytes. 10/24/17 underwent bone marrow aspirate. 10/25/17 developed fever, dry cough; ITP treated with WinRho for persistent thrombocytopenia (platelets improved after this). Mother and father also with upper respiratory infection symptoms around this time. Resp viral panel negative.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Immunoglobulin therapy, Lymphocyte morphology abnormal, Petechiae, Platelet count decreased, Pyrexia
Clinical narrative: 9/29/17 vaccination with MMR, VZV, HepA, influenza. 10/19/17 hospitalization with ~7 day history of petechial rash. No illnesses in last several months. Platelets <10. Presumed ITP (immune thrombocytopenia); treated with IVIG (completed 10/20). CBC/manual diff on 10/19/2017 without any atypical lymphocytes. 10/22/17 manual diff showed 4% atypical lymphocytes. 10/24/17 underwent bone marrow aspirate. 10/25/17 developed fever, dry cough; ITP treated with WinRho for persistent thrombocytopenia (platelets improved after this). Mother and father also with upper respiratory infection symptoms around this time. Resp viral panel negative.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Respiratory symptom, Respiratory viral panel, Thrombocytopenia
Clinical narrative: 9/29/17 vaccination with MMR, VZV, HepA, influenza. 10/19/17 hospitalization with ~7 day history of petechial rash. No illnesses in last several months. Platelets <10. Presumed ITP (immune thrombocytopenia); treated with IVIG (completed 10/20). CBC/manual diff on 10/19/2017 without any atypical lymphocytes. 10/22/17 manual diff showed 4% atypical lymphocytes. 10/24/17 underwent bone marrow aspirate. 10/25/17 developed fever, dry cough; ITP treated with WinRho for persistent thrombocytopenia (platelets improved after this). Mother and father also with upper respiratory infection symptoms around this time. Resp viral panel negative.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Complication associated with device, Ear swelling, Eye swelling, Injection site pain, Malaise
Clinical narrative: Patient received the first injection of SHINGRIX on 01/19 around noon and later that evening she had some achiness, malaise, stiff neck, pain at the injection site. As time went on, she experience right ear and right eye swelling and also itching. The itching was at the same site on top of her head where she had shingles in the past. She also reported the roof of her mouth being sore and having some swelling in her mouth. She stated she was not able to wear a dental appliance because of the swelling. The patient was treating the pain and soreness with over the counter ibuprofen. No visits to the doctor was reported.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Mouth swelling, Musculoskeletal stiffness, Oral pain, Pain, Pruritus
Clinical narrative: Patient received the first injection of SHINGRIX on 01/19 around noon and later that evening she had some achiness, malaise, stiff neck, pain at the injection site. As time went on, she experience right ear and right eye swelling and also itching. The itching was at the same site on top of her head where she had shingles in the past. She also reported the roof of her mouth being sore and having some swelling in her mouth. She stated she was not able to wear a dental appliance because of the swelling. The patient was treating the pain and soreness with over the counter ibuprofen. No visits to the doctor was reported.
Age: 17.0
Sex: F
Vaccine: HEPA, HPV9, IPV, MENB, MMR, MNQ, TDAP
Symptoms: Depressed level of consciousness, Hyperhidrosis, Immediate post-injection reaction, Nausea, Skin discolouration
Clinical narrative: Guardian stated that patient had not eaten all day and had arrived this morning from being on an airplane for 15 hours. Patient was given lollipop and began to lick on it. Immediately after all immunizations were given, patient turned greenish and leaned back in the chair, broke out in sweat, and closed eyes. Nurse immediately got cold wet paper towels and began to wipe face and arms. Other nurse brought cold water bottle, cold packs and applied to neck and arms. Patient felt sick at stomach and attempted to vomit in the trash can. Guardian assisted patient with taking small sips of cold water. At no time did patient fall or hit head on anything. Patient drifted in and out of semi-consciousness for about 20 minutes. Patient remained seated in treatment room for at least 45 minutes, then stated that she felt ok. Patient was assisted by nurse as she ambulated to waiting area and was assisted by guardian and husband out of the waiting area. Guardian stated that they would watch her closely and get her something to eat.
Age: 0.42
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Wrong patient received medication
Clinical narrative: Accidentally sibling vaccines to this patient.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Computerised tomogram, Mobility decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging
Clinical narrative: The night of the injection started having pain in the shoulder and got worse. Went to ER 9/21/2017 and was given ABX. Then got better after a week then got worse 4-5 weeks after that to the point she couldn't raise her arm up. She was admitted to the hospital toward the end of November and kept for 4 days. Gave ABX and gave MRI, xray, cat scan. It got better the middle of December. Has a little lingering pain.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: X-ray
Clinical narrative: The night of the injection started having pain in the shoulder and got worse. Went to ER 9/21/2017 and was given ABX. Then got better after a week then got worse 4-5 weeks after that to the point she couldn't raise her arm up. She was admitted to the hospital toward the end of November and kept for 4 days. Gave ABX and gave MRI, xray, cat scan. It got better the middle of December. Has a little lingering pain.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Flu vaccine 0.25 ml was given to 12 year old instead of 0.50 ml dose. Recalled several times to get .5 Flu dose. Has not yet been revaccinated.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pallor, Unresponsive to stimuli
Clinical narrative: Pt's parents had waited 15mins after vaccination to monitor for any adverse effects, the Pt father came into the immunization clinic after the 15 mins and reported she was pale and unresponsive. The nurse was notified as well as the Nurse Practitioner, and the Doctor on duty, Pt lungs and heart rate were all normal according to the Nurse Practitioner and O2 stats were taken and was at 100%. The ambulances were called and the patient was transported to the ER for further monitoring.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Right arm redness and soreness. Pt given APAP and Ibuprofen to alternate. Advised pt to ice her arm today to bring down the swelling. Suggested CLARITIN or BENADRYL at bedtime as well.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discolouration, Vaccination site erythema, Vaccination site rash
Clinical narrative: Mother reports erythema and "bumps" at vaccine administration site following vaccination. Now is a well demarcated, annular hypopigmented patch, non palpable, non tender, measures 8 cm x 5.5 cm
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Right thigh became red, swollen, hardened, hot to the touch and extremely itchy.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth, Rash
Clinical narrative: The patient came into the pharmacy 1/22/18 saying he has a rash on his arm from the shot. He lifted his sleeve and there was a red, warm cellulitis reaction starting approximately 1 inch below injection site, travelling all the way down his arm to the elbow. He said it didn't hurt so he wasn't worried about it. I encouraged him to call and follow up with his doctor.
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, FLU4, PNC13, RV5
Symptoms: Peripheral swelling, Pruritus, Pyrexia, Urticaria, Vomiting
Clinical narrative: Vaccines were given on 1/17/2018, patient came in on 1/19/2018- Doctors note- 24hrs after started with hives, swollen feet, seems itchy, fever starting yesterday, 2 episodes of vomiting , no respiratory distress no mouth swelling.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: Patient hospitalized.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Injection site erythema, Injection site haemorrhage, Injection site swelling, Injection site warmth
Clinical narrative: Patient first reported excess bleeding through her bandaid, which she controlled through pressure. Then she noticed by the following day that her arm was red. She returned to the pharmacy about 48 hours after the vaccines were given to show the pharmacist the reaction. At this time her upper arm was red/pink and a bit swollen and warm to the touch. We referred her to the doctor because it was warm, but when she went in they were not concerned. We've now told the patient to control the swelling with ice every 15 minutes as well as with TYLENOL and diphenhydramine.
Age: 10.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Abdominal pain upper, Headache, Injected limb mobility decreased, Injection site erythema, Nausea
Clinical narrative: Pt. arm was sore, entire arm hurt and had some redness at injection site and had trouble raising/moving arm. Pt. reported being nauseous, with headaches, stomach pains, and fever up to 104 x 3 days. Meds: Ibuprofen.
Age: 10.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Pt. arm was sore, entire arm hurt and had some redness at injection site and had trouble raising/moving arm. Pt. reported being nauseous, with headaches, stomach pains, and fever up to 104 x 3 days. Meds: Ibuprofen.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased, Erythema, Full blood count normal, Hypersomnia, Influenza virus test negative
Clinical narrative: About 14 hours after vaccines, patient felt very warm to touch and cheeks were pink. Rectal temp was 105.2. TYLENOL was given and 45 minutes later rectal temp was 104.4. The day after vaccines he slept more than normal, was a little fussy, and didn't want to be put down. 2 days after vaccines, temp was 101.2 rectal. Three days after vaccines temp was 100.4 rectal.  Four days after vaccine temp was 99.8 rectal.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Irritability, Skin warm
Clinical narrative: About 14 hours after vaccines, patient felt very warm to touch and cheeks were pink. Rectal temp was 105.2. TYLENOL was given and 45 minutes later rectal temp was 104.4. The day after vaccines he slept more than normal, was a little fussy, and didn't want to be put down. 2 days after vaccines, temp was 101.2 rectal. Three days after vaccines temp was 100.4 rectal.  Four days after vaccine temp was 99.8 rectal.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: My left arm has hurt ever since getting the shot. It is painful to lay on. Also, I am having pain when raising my arm that is limiting movement.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Throat irritation, Wheezing
Clinical narrative: *Please note, I did not have a cold or any symptoms of a cold prior to the injection. At approximately 7:00 pm, (5 hours after my flu shot) I started feeling the need to frequently clear my throat to clear mucous. Concurrently I was wheezing (raspiness when breathing in and out). The wheezing was not to the point where I felt my breathing was dangerously restricted, however it was very irritating and my airway was not completely clear. I was worried it would progress but thankfully it didn't. I took a ZYRTEC and this helped. I decided I did not need to seek medical care since it eased up. I went to sleep and when I woke I felt better.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Musculoskeletal pain
Clinical narrative: Decreased mobility, shoulder pain. Has been using heat/ice and prescribed medication.
Age: 65.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and little swell at the injection sites.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling at the injection site, redness, hardness. Body aches all over. Light-headedness.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Pain
Clinical narrative: Pain and swelling at the injection site, redness, hardness. Body aches all over. Light-headedness.
Age: 22.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Chest discomfort
Clinical narrative: Patient said (according to witness) chest tightness.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Seizure like phenomena, Syncope
Clinical narrative: After the flu shot was given, the patient fainted twice, hit his head on the pharmacy bench, and looked like he was trying to have a seizure. The paramedics were called to the pharmacy to evaluate the patient. The paramedics gave the parents the option to take him to the hospital, follow up with urgent care or the pediatrician in the morning. The parents didn't have the paramedics take him to the hospital.
Age: 48.0
Sex: F
Vaccine: HEPAB, PPV
Symptoms: Injected limb mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Initially can't move arm because it was sore in stiff.
Age: 15.0
Sex: F
Vaccine: FLUC4
Symptoms: Loss of consciousness, Visual impairment
Clinical narrative: Patient passed out approximately about 5 minutes after receiving flu shot. She got up from a sitting position to leave and experienced vision darkness before passing out. Once patient was placed on the floor, she was awake and alert. Spoke with patient's mom 3 days later, patient is doing fine.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Electrocardiogram normal
Clinical narrative: On 01/09/2018, pt reported to ED at around 7:49pm with complaints of shortness of breath. EKG was performed resulted in "Normal Sinus Rhythm." Experienced 1 attack of SOB when being prepped for EKG. After evaluation pt. was discharged from ED at 8:23pm.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Pt. rec'd 1 year IMM in office on 01-08-18. Returned for O.V. on 01-17-18 D/T rash (LT) arm which appeared 01-17-18. Afebrile; (LT) posterior arm with approximate 1" x 1.5" area of erythema; no induration, no warmth; non-tender to touch, no fluctuance. Not cellulitis. TX: Monitor. Ok for 5yr IMM.
Age: 19.0
Sex: F
Vaccine: SMALL
Symptoms: Angina pectoris, Echocardiogram, Electrocardiogram, Myocarditis, Troponin I
Clinical narrative: This is a Legacy Sanofi Pasteur case previously reported under mfg # 2017SA178009. Initial solicited report received from an investigator (Health Agency) in the trial on 21 September 2017. This case involves a 19 year-old female subject with no significant medical history. The subject's concomitant medication was not reported. On 18 October 2016, 28 days after receiving a dose of ACAM2000 on 20 September 2016 (lot number, site of administration not reported) the subject was diagnosed with I20.9 angina pectoris, unspecified. The lab data of Troponin I result, ECG, and Echocardiogram was not available. MRI of brain, spinal cord and heart and lumbar puncture were not performed. The subject's treatments were not reported. Outcome of the event, I20.9 angina pectoris, unspecified was not reported. Relationship to investigational product according to company: associated. List of documents held by sender: none. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Adjudication Committee consensus received on 09JAN2018: A consensus was determined by this study protocol adjudication committee: Based on the information received the case meets the case definition for subclinical myopericarditis, but does not meet the case definition for myocarditis or pericarditis. As a result of the adjudication committee consensus review - the event of subclinical myopericarditis (myocarditis) was added to this case.
Age: 24.0
Sex: F
Vaccine: HPV9, HPV9, HPV4, HPV9
Symptoms: Blood test, Electrocardiogram, Fatigue, Feeling abnormal, Headache
Clinical narrative: Pt received GARDASIL injection at Pharmacy. Within 4 days, pt started experiencing the following symptoms: muscle weakness, head fog, syncope, fatigue and vision disturbances.
Age: 24.0
Sex: F
Vaccine: HPV9, HPV9, HPV4, HPV9
Symptoms: Loss of personal independence in daily activities, Malaise, Syncope, Vision blurred
Clinical narrative: Pt received GARDASIL injection at Pharmacy. Within 4 days, pt started experiencing the following symptoms: muscle weakness, head fog, syncope, fatigue and vision disturbances.
Age: 24.0
Sex: F
Vaccine: HPV9, HPV9, HPV4, HPV9
Symptoms: Blood test, Headache, Loss of personal independence in daily activities, Syncope, Vision blurred
Clinical narrative: Pt received GARDASIL injection at Pharmacy. Within 4 days, pt started experiencing the following symptoms: muscle weakness, head fog, syncope, fatigue and vision disturbances.
Age: 24.0
Sex: F
Vaccine: HPV9, HPV9, HPV4, HPV9
Symptoms: Fatigue, Feeling abnormal, Laboratory test normal, Muscular weakness, Syncope
Clinical narrative: Pt received GARDASIL injection at Pharmacy. Within 4 days, pt started experiencing the following symptoms: muscle weakness, head fog, syncope, fatigue and vision disturbances.
Age: 24.0
Sex: F
Vaccine: HPV9, HPV9, HPV4, HPV9
Symptoms: Visual impairment, White blood cell count increased
Clinical narrative: Pt received GARDASIL injection at Pharmacy. Within 4 days, pt started experiencing the following symptoms: muscle weakness, head fog, syncope, fatigue and vision disturbances.
Age: 24.0
Sex: F
Vaccine: HPV9, HPV9, HPV4, HPV9
Symptoms: Abdominal pain upper, Anxiety, Arthralgia, Chest X-ray, Condition aggravated
Clinical narrative: Pt received GARDASIL injection at Pharmacy. Within 4 days, pt started experiencing the following symptoms: muscle weakness, head fog, syncope, fatigue and vision disturbances.
Age: 24.0
Sex: F
Vaccine: HPV9, HPV9, HPV4, HPV9
Symptoms: Confusional state, Dizziness, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory
Clinical narrative: Pt received GARDASIL injection at Pharmacy. Within 4 days, pt started experiencing the following symptoms: muscle weakness, head fog, syncope, fatigue and vision disturbances.
Age: 24.0
Sex: F
Vaccine: HPV9, HPV9, HPV4, HPV9
Symptoms: Fatigue, Feeling abnormal, Hypertension, Joint injury, Loss of consciousness
Clinical narrative: Pt received GARDASIL injection at Pharmacy. Within 4 days, pt started experiencing the following symptoms: muscle weakness, head fog, syncope, fatigue and vision disturbances.
Age: 24.0
Sex: F
Vaccine: HPV9, HPV9, HPV4, HPV9
Symptoms: Malaise, Palpitations, Syncope
Clinical narrative: Pt received GARDASIL injection at Pharmacy. Within 4 days, pt started experiencing the following symptoms: muscle weakness, head fog, syncope, fatigue and vision disturbances.
Age: 24.0
Sex: F
Vaccine: HPV9, HPV9, HPV4, HPV9
Symptoms: Blood test, Electrocardiogram, Fatigue, Feeling abnormal, Headache
Clinical narrative: 12/30/2017 vaccine given. 01/01/2018 (approx) flew back to school. 01/02/2018 very cold, had to dig car out of snow bank, had no heat in her coop room. 01/03/2018  evening, syncope [had been doing kitchen cleanup at her coop (though had not had supper); hit hip on counter edge which hurt a lot. Started feeling kind of LH, dizzy. While telling person she was working with that she was not feeling very well and going to rest for a bit she passed out and other person caught her, lowered her to floor, elevated her legs. She woke up, rested on floor for a while, not really confused but a little for maybe 1-2 min. No injury, no convulsive activity seen. Had lemonade and sugary cereal & some other things to eat. Someone checked her BP and said it was high, then later rechecked and said was normal. Also, she thinks they said pulse was normal. Later took shower & felt faint again.  Other factors that day: anxious about school & had stomach aches she gets with anxiety; period started. Since 01/03/2017 has not felt back to normal, despite rest, attention to diet & fluid intake, heat in her room. Has continued with mutiple symptoms, especially profound fatigue and episodic LH, dizzy, palpitations. Has had to with draw from school for Winter Term. 01/05/18 Supine BP 122/76  P 67. 01/05/18 Sit BP 118/80 P 90. 01/05/18 Stand BP 118/86 P 97.
Age: 24.0
Sex: F
Vaccine: HPV9, HPV9, HPV4, HPV9
Symptoms: Loss of personal independence in daily activities, Malaise, Syncope, Vision blurred
Clinical narrative: 12/30/2017 vaccine given. 01/01/2018 (approx) flew back to school. 01/02/2018 very cold, had to dig car out of snow bank, had no heat in her coop room. 01/03/2018  evening, syncope [had been doing kitchen cleanup at her coop (though had not had supper); hit hip on counter edge which hurt a lot. Started feeling kind of LH, dizzy. While telling person she was working with that she was not feeling very well and going to rest for a bit she passed out and other person caught her, lowered her to floor, elevated her legs. She woke up, rested on floor for a while, not really confused but a little for maybe 1-2 min. No injury, no convulsive activity seen. Had lemonade and sugary cereal & some other things to eat. Someone checked her BP and said it was high, then later rechecked and said was normal. Also, she thinks they said pulse was normal. Later took shower & felt faint again.  Other factors that day: anxious about school & had stomach aches she gets with anxiety; period started. Since 01/03/2017 has not felt back to normal, despite rest, attention to diet & fluid intake, heat in her room. Has continued with mutiple symptoms, especially profound fatigue and episodic LH, dizzy, palpitations. Has had to with draw from school for Winter Term. 01/05/18 Supine BP 122/76  P 67. 01/05/18 Sit BP 118/80 P 90. 01/05/18 Stand BP 118/86 P 97.
Age: 24.0
Sex: F
Vaccine: HPV9, HPV9, HPV4, HPV9
Symptoms: Blood test, Headache, Loss of personal independence in daily activities, Syncope, Vision blurred
Clinical narrative: 12/30/2017 vaccine given. 01/01/2018 (approx) flew back to school. 01/02/2018 very cold, had to dig car out of snow bank, had no heat in her coop room. 01/03/2018  evening, syncope [had been doing kitchen cleanup at her coop (though had not had supper); hit hip on counter edge which hurt a lot. Started feeling kind of LH, dizzy. While telling person she was working with that she was not feeling very well and going to rest for a bit she passed out and other person caught her, lowered her to floor, elevated her legs. She woke up, rested on floor for a while, not really confused but a little for maybe 1-2 min. No injury, no convulsive activity seen. Had lemonade and sugary cereal & some other things to eat. Someone checked her BP and said it was high, then later rechecked and said was normal. Also, she thinks they said pulse was normal. Later took shower & felt faint again.  Other factors that day: anxious about school & had stomach aches she gets with anxiety; period started. Since 01/03/2017 has not felt back to normal, despite rest, attention to diet & fluid intake, heat in her room. Has continued with mutiple symptoms, especially profound fatigue and episodic LH, dizzy, palpitations. Has had to with draw from school for Winter Term. 01/05/18 Supine BP 122/76  P 67. 01/05/18 Sit BP 118/80 P 90. 01/05/18 Stand BP 118/86 P 97.
Age: 24.0
Sex: F
Vaccine: HPV9, HPV9, HPV4, HPV9
Symptoms: Fatigue, Feeling abnormal, Laboratory test normal, Muscular weakness, Syncope
Clinical narrative: 12/30/2017 vaccine given. 01/01/2018 (approx) flew back to school. 01/02/2018 very cold, had to dig car out of snow bank, had no heat in her coop room. 01/03/2018  evening, syncope [had been doing kitchen cleanup at her coop (though had not had supper); hit hip on counter edge which hurt a lot. Started feeling kind of LH, dizzy. While telling person she was working with that she was not feeling very well and going to rest for a bit she passed out and other person caught her, lowered her to floor, elevated her legs. She woke up, rested on floor for a while, not really confused but a little for maybe 1-2 min. No injury, no convulsive activity seen. Had lemonade and sugary cereal & some other things to eat. Someone checked her BP and said it was high, then later rechecked and said was normal. Also, she thinks they said pulse was normal. Later took shower & felt faint again.  Other factors that day: anxious about school & had stomach aches she gets with anxiety; period started. Since 01/03/2017 has not felt back to normal, despite rest, attention to diet & fluid intake, heat in her room. Has continued with mutiple symptoms, especially profound fatigue and episodic LH, dizzy, palpitations. Has had to with draw from school for Winter Term. 01/05/18 Supine BP 122/76  P 67. 01/05/18 Sit BP 118/80 P 90. 01/05/18 Stand BP 118/86 P 97.
Age: 24.0
Sex: F
Vaccine: HPV9, HPV9, HPV4, HPV9
Symptoms: Visual impairment, White blood cell count increased
Clinical narrative: 12/30/2017 vaccine given. 01/01/2018 (approx) flew back to school. 01/02/2018 very cold, had to dig car out of snow bank, had no heat in her coop room. 01/03/2018  evening, syncope [had been doing kitchen cleanup at her coop (though had not had supper); hit hip on counter edge which hurt a lot. Started feeling kind of LH, dizzy. While telling person she was working with that she was not feeling very well and going to rest for a bit she passed out and other person caught her, lowered her to floor, elevated her legs. She woke up, rested on floor for a while, not really confused but a little for maybe 1-2 min. No injury, no convulsive activity seen. Had lemonade and sugary cereal & some other things to eat. Someone checked her BP and said it was high, then later rechecked and said was normal. Also, she thinks they said pulse was normal. Later took shower & felt faint again.  Other factors that day: anxious about school & had stomach aches she gets with anxiety; period started. Since 01/03/2017 has not felt back to normal, despite rest, attention to diet & fluid intake, heat in her room. Has continued with mutiple symptoms, especially profound fatigue and episodic LH, dizzy, palpitations. Has had to with draw from school for Winter Term. 01/05/18 Supine BP 122/76  P 67. 01/05/18 Sit BP 118/80 P 90. 01/05/18 Stand BP 118/86 P 97.
Age: 24.0
Sex: F
Vaccine: HPV9, HPV9, HPV4, HPV9
Symptoms: Abdominal pain upper, Anxiety, Arthralgia, Chest X-ray, Condition aggravated
Clinical narrative: 12/30/2017 vaccine given. 01/01/2018 (approx) flew back to school. 01/02/2018 very cold, had to dig car out of snow bank, had no heat in her coop room. 01/03/2018  evening, syncope [had been doing kitchen cleanup at her coop (though had not had supper); hit hip on counter edge which hurt a lot. Started feeling kind of LH, dizzy. While telling person she was working with that she was not feeling very well and going to rest for a bit she passed out and other person caught her, lowered her to floor, elevated her legs. She woke up, rested on floor for a while, not really confused but a little for maybe 1-2 min. No injury, no convulsive activity seen. Had lemonade and sugary cereal & some other things to eat. Someone checked her BP and said it was high, then later rechecked and said was normal. Also, she thinks they said pulse was normal. Later took shower & felt faint again.  Other factors that day: anxious about school & had stomach aches she gets with anxiety; period started. Since 01/03/2017 has not felt back to normal, despite rest, attention to diet & fluid intake, heat in her room. Has continued with mutiple symptoms, especially profound fatigue and episodic LH, dizzy, palpitations. Has had to with draw from school for Winter Term. 01/05/18 Supine BP 122/76  P 67. 01/05/18 Sit BP 118/80 P 90. 01/05/18 Stand BP 118/86 P 97.
Age: 24.0
Sex: F
Vaccine: HPV9, HPV9, HPV4, HPV9
Symptoms: Confusional state, Dizziness, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory
Clinical narrative: 12/30/2017 vaccine given. 01/01/2018 (approx) flew back to school. 01/02/2018 very cold, had to dig car out of snow bank, had no heat in her coop room. 01/03/2018  evening, syncope [had been doing kitchen cleanup at her coop (though had not had supper); hit hip on counter edge which hurt a lot. Started feeling kind of LH, dizzy. While telling person she was working with that she was not feeling very well and going to rest for a bit she passed out and other person caught her, lowered her to floor, elevated her legs. She woke up, rested on floor for a while, not really confused but a little for maybe 1-2 min. No injury, no convulsive activity seen. Had lemonade and sugary cereal & some other things to eat. Someone checked her BP and said it was high, then later rechecked and said was normal. Also, she thinks they said pulse was normal. Later took shower & felt faint again.  Other factors that day: anxious about school & had stomach aches she gets with anxiety; period started. Since 01/03/2017 has not felt back to normal, despite rest, attention to diet & fluid intake, heat in her room. Has continued with mutiple symptoms, especially profound fatigue and episodic LH, dizzy, palpitations. Has had to with draw from school for Winter Term. 01/05/18 Supine BP 122/76  P 67. 01/05/18 Sit BP 118/80 P 90. 01/05/18 Stand BP 118/86 P 97.
Age: 24.0
Sex: F
Vaccine: HPV9, HPV9, HPV4, HPV9
Symptoms: Fatigue, Feeling abnormal, Hypertension, Joint injury, Loss of consciousness
Clinical narrative: 12/30/2017 vaccine given. 01/01/2018 (approx) flew back to school. 01/02/2018 very cold, had to dig car out of snow bank, had no heat in her coop room. 01/03/2018  evening, syncope [had been doing kitchen cleanup at her coop (though had not had supper); hit hip on counter edge which hurt a lot. Started feeling kind of LH, dizzy. While telling person she was working with that she was not feeling very well and going to rest for a bit she passed out and other person caught her, lowered her to floor, elevated her legs. She woke up, rested on floor for a while, not really confused but a little for maybe 1-2 min. No injury, no convulsive activity seen. Had lemonade and sugary cereal & some other things to eat. Someone checked her BP and said it was high, then later rechecked and said was normal. Also, she thinks they said pulse was normal. Later took shower & felt faint again.  Other factors that day: anxious about school & had stomach aches she gets with anxiety; period started. Since 01/03/2017 has not felt back to normal, despite rest, attention to diet & fluid intake, heat in her room. Has continued with mutiple symptoms, especially profound fatigue and episodic LH, dizzy, palpitations. Has had to with draw from school for Winter Term. 01/05/18 Supine BP 122/76  P 67. 01/05/18 Sit BP 118/80 P 90. 01/05/18 Stand BP 118/86 P 97.
Age: 24.0
Sex: F
Vaccine: HPV9, HPV9, HPV4, HPV9
Symptoms: Malaise, Palpitations, Syncope
Clinical narrative: 12/30/2017 vaccine given. 01/01/2018 (approx) flew back to school. 01/02/2018 very cold, had to dig car out of snow bank, had no heat in her coop room. 01/03/2018  evening, syncope [had been doing kitchen cleanup at her coop (though had not had supper); hit hip on counter edge which hurt a lot. Started feeling kind of LH, dizzy. While telling person she was working with that she was not feeling very well and going to rest for a bit she passed out and other person caught her, lowered her to floor, elevated her legs. She woke up, rested on floor for a while, not really confused but a little for maybe 1-2 min. No injury, no convulsive activity seen. Had lemonade and sugary cereal & some other things to eat. Someone checked her BP and said it was high, then later rechecked and said was normal. Also, she thinks they said pulse was normal. Later took shower & felt faint again.  Other factors that day: anxious about school & had stomach aches she gets with anxiety; period started. Since 01/03/2017 has not felt back to normal, despite rest, attention to diet & fluid intake, heat in her room. Has continued with mutiple symptoms, especially profound fatigue and episodic LH, dizzy, palpitations. Has had to with draw from school for Winter Term. 01/05/18 Supine BP 122/76  P 67. 01/05/18 Sit BP 118/80 P 90. 01/05/18 Stand BP 118/86 P 97.
Age: 22.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse concerning a 22 year old female patient. Patient's current conditions included gastrooesophageal reflux disease, irritable bowel syndrome and diabetes. Concomitant therapies included insulin glargine (LANTUS) and insulin lispro (HUMALOG). The patient had not drug reactions nor allergies. On 26-JUN-2015, the patient was vaccinated with the first dose of GARDASIL 9 lot # K009902 and expiration date of 06-MAR-2017, as routine vaccination (dose and route of administration were not reported). Subsequently, on 11-APR-2016, the patient was vaccinated with the second dose of GARDASIL 9 non-valid lot # K008931 and expiration date of 04-MAR-2017, as routine vaccination (dose and route of administration were not reported). On 17-JAN-2018, the patient was vaccinated with the third dose of GARDASIL 9 lot # N004798 and expiration date of 31-OCT-2019, as routine vaccination in left gluteus medium (dose was not reported). There was no illnes at time of vaccination. On the same day, two pregnancy tests were performed: The first one , after recomended timeframe faint positive and the repeated pregnancy test, which was performed after the third dose of GARDASIL 9 was administered, faint positive at 3 to 4 minutes(exposure during pregnancy). The patient was referred to obstetrician-gynecologist (OB-GYN) office. The patient became pregnant with last menstrual period (LMP) of 25-DEC-2017, and estimated date of delivery (EDD) of 01-OCT-2018. Initial exposure to GARDASIL 9 was at 3 weeks. Patient sought medical attention at physician's office. The pregnancy outcome was outcome pending.The outcome of type 1 diabetes mellitus, was unknown. The causal relationship between type 1 diabetes mellitus and therapy with GARDASIL 9 was not reported. Consent was signed. Experts on GARDASIL 9 were contacted an stated no intervention was needed. No need to repeat.
Age: 22.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse concerning a 22 year old female patient. Patient's current conditions included gastrooesophageal reflux disease, irritable bowel syndrome and diabetes. Concomitant therapies included insulin glargine (LANTUS) and insulin lispro (HUMALOG). The patient had not drug reactions nor allergies. On 26-JUN-2015, the patient was vaccinated with the first dose of GARDASIL 9 lot # K009902 and expiration date of 06-MAR-2017, as routine vaccination (dose and route of administration were not reported). Subsequently, on 11-APR-2016, the patient was vaccinated with the second dose of GARDASIL 9 non-valid lot # K008931 and expiration date of 04-MAR-2017, as routine vaccination (dose and route of administration were not reported). On 17-JAN-2018, the patient was vaccinated with the third dose of GARDASIL 9 lot # N004798 and expiration date of 31-OCT-2019, as routine vaccination in left gluteus medium (dose was not reported). There was no illnes at time of vaccination. On the same day, two pregnancy tests were performed: The first one , after recomended timeframe faint positive and the repeated pregnancy test, which was performed after the third dose of GARDASIL 9 was administered, faint positive at 3 to 4 minutes(exposure during pregnancy). The patient was referred to obstetrician-gynecologist (OB-GYN) office. The patient became pregnant with last menstrual period (LMP) of 25-DEC-2017, and estimated date of delivery (EDD) of 01-OCT-2018. Initial exposure to GARDASIL 9 was at 3 weeks. Patient sought medical attention at physician's office. The pregnancy outcome was outcome pending.The outcome of type 1 diabetes mellitus, was unknown. The causal relationship between type 1 diabetes mellitus and therapy with GARDASIL 9 was not reported. Consent was signed. Experts on GARDASIL 9 were contacted an stated no intervention was needed. No need to repeat.
Age: 20.0
Sex: M
Vaccine: FLUC4
Symptoms: Chest pain, Confusional state, Dizziness, Dyspnoea, Headache
Clinical narrative: Pt complained of headache, difficulty breathing, dizziness, confusion and chest pain.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Muscular weakness, Pain
Clinical narrative: Patient is a 58-year-old female who presents with complaint of left upper arm pain and weakness ever since December 5 and she received a flu shot in that arm. It's been now almost 2 months. She states that she can move her shoulder well but if she tries to lift her arm with her arm out at a slight angle it feels very weak and has a lot of pain. There is no tenderness anymore in the area but initially she had tenderness. There is no swelling or redness. She took ibuprofen for a few days which seemed to help a little bit overall it's still present. She is taking about getting a massage in the area to see if this helps.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 08-DEC-2017, the patient was vaccinated with one dose of expired RECOMBIVAX HB intramuscularly, for prophylaxis (lot # L048208, expiration date: 15-SEP-2017; dose not reported).  No adverse effects reported. Additionally, no product quality complaint (PQC) was involved.
Sex: M
Vaccine: HEP, HEPA
Symptoms: Hepatitis A antibody negative
Clinical narrative: This spontaneous report was received from a male patient of unknown age, reporting on himself. Information on patient's medical history, concurrent conditions or concomitant therapies was not reported. In approximately 2015 (reported as "two years ago"), the patient was vaccinated with RECOMBIVAX (dose number, lot number and expiration date were not provided) for prophylaxis, and also received a dose of VAQTA (dose number, lot number and expiration date were not provided) for prevention of hepatitis A. On an unknown date, after the vaccinations, the patient had bloodwork done and the results were "non-reactive to Hepatitis A". The outcome of the patient's Hepatitis A antibody negative was not reported. The patient did not assess a causal relationship between the patient's Hepatitis A antibody negative and the vaccination with RECOMBIVAX and VAQTA.
Sex: F
Vaccine: PPV
Symptoms: Incorrect dose administered, Tooth infection
Clinical narrative: This spontaneous report was received from a 66 year old female patient reporting about herself. The patient's concurrent conditions included unspecified drug reactions or allergies. The patient's medical history included anaphylactic reaction and toothache. Information concerning the patient's concomitant medications was not provided. On 22-DEC-2017, the patient was vaccinated with half a dose of PNEUMOVAX 23 for prophylaxis (lot number, expiration date, anatomical location or route of administration were not reported). The patient informed that her allergist recommended to administer the half dose and to return later for a final dose of PNEUMOVAX 23 because she had a history of anaphylaxis. On an unknown date, after receiving PNEUMOVAX 23 the patient experienced a tooth infection and was being treated with an unspecified antibiotic. At the reporting time, the patient was recovering from tooth infection. The causal assessment between tooth infection and PNEUMOVAX 23 was not reported by the patient.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Erythema, Injection site erythema, Injection site reaction, Local reaction
Clinical narrative: This spontaneous report was received from a Nurse referring to a 67 year old female patient. The patient's concurrent conditions included hypertension. The patient did not have drug reactions or allergies. On 08-JAN-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # N020688, expiration date on 09-MAR-2019 (strength, dose number and route of administration were not provided) for prophylaxis. On 08-JAN-2018, the patient experienced a large localized reaction a couple hours after receiving PNEUMOVAX 23. The nurse reported patient had two red spots on deltoid where injection was administered that traveled to outer aspect of breast into axilla and was painful and warm. It was reported that treatment unspecified was given. At the time of the report, the outcome of erythema, injection site erythema, injection site discoloration, injection site reaction, axillary pain and feeling hot was reported as not recovered; however the nurse reported patient was doing better but reaction was still painful and now pink in color. The reporter did not assess the relatedness between erythema, injection site erythema, injection site discoloration, injection site reaction, axillary pain and feeling hot and PNEUMOVAX 23.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: This spontaneous report was received from a Nurse referring to a 67 year old female patient. The patient's concurrent conditions included hypertension. The patient did not have drug reactions or allergies. On 08-JAN-2018, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # N020688, expiration date on 09-MAR-2019 (strength, dose number and route of administration were not provided) for prophylaxis. On 08-JAN-2018, the patient experienced a large localized reaction a couple hours after receiving PNEUMOVAX 23. The nurse reported patient had two red spots on deltoid where injection was administered that traveled to outer aspect of breast into axilla and was painful and warm. It was reported that treatment unspecified was given. At the time of the report, the outcome of erythema, injection site erythema, injection site discoloration, injection site reaction, axillary pain and feeling hot was reported as not recovered; however the nurse reported patient was doing better but reaction was still painful and now pink in color. The reporter did not assess the relatedness between erythema, injection site erythema, injection site discoloration, injection site reaction, axillary pain and feeling hot and PNEUMOVAX 23.