chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Glucose urine absent, Glutathione decreased, Hallucination, Irritability, Loss of consciousness
Clinical narrative: Absence & Tonic Clonic Seizures & blackouts, memory loss, sleep walking, excessively fatigued & stressed, confusion, unexplained stiffness & soreness, irritability, anxiety, shaky hands & repetitive hand motions, acne, complains of being cold even when room temp is 74 degrees, sinus infections, vision problems, 1 hallucination. She was diagnosed with Epilepsy 10-19-11. Neurologist gave no info with the diagnosis. 2nd Neurologist we saw said that the Epilepsy was caused by a genetic mutation and told her that she needed to have an eye exam after looking at her eyes. She is now seeing a 3rd Neurologist & taking Lamictal XR 300mg twice daily & Aptiom 600mg once daily. She has had a few break-thru seizures even while taking her meds.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Lymphadenopathy, Musculoskeletal stiffness, Neutrophil count decreased, Nuclear magnetic resonance imaging abnormal, Oestradiol increased
Clinical narrative: Absence & Tonic Clonic Seizures & blackouts, memory loss, sleep walking, excessively fatigued & stressed, confusion, unexplained stiffness & soreness, irritability, anxiety, shaky hands & repetitive hand motions, acne, complains of being cold even when room temp is 74 degrees, sinus infections, vision problems, 1 hallucination. She was diagnosed with Epilepsy 10-19-11. Neurologist gave no info with the diagnosis. 2nd Neurologist we saw said that the Epilepsy was caused by a genetic mutation and told her that she needed to have an eye exam after looking at her eyes. She is now seeing a 3rd Neurologist & taking Lamictal XR 300mg twice daily & Aptiom 600mg once daily. She has had a few break-thru seizures even while taking her meds.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Pain, Petit mal epilepsy, Progesterone decreased, Protein urine absent, Scan with contrast abnormal
Clinical narrative: Absence & Tonic Clonic Seizures & blackouts, memory loss, sleep walking, excessively fatigued & stressed, confusion, unexplained stiffness & soreness, irritability, anxiety, shaky hands & repetitive hand motions, acne, complains of being cold even when room temp is 74 degrees, sinus infections, vision problems, 1 hallucination. She was diagnosed with Epilepsy 10-19-11. Neurologist gave no info with the diagnosis. 2nd Neurologist we saw said that the Epilepsy was caused by a genetic mutation and told her that she needed to have an eye exam after looking at her eyes. She is now seeing a 3rd Neurologist & taking Lamictal XR 300mg twice daily & Aptiom 600mg once daily. She has had a few break-thru seizures even while taking her meds.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Seizure, Sinusitis, Somnambulism, Stereotypy, Stress
Clinical narrative: Absence & Tonic Clonic Seizures & blackouts, memory loss, sleep walking, excessively fatigued & stressed, confusion, unexplained stiffness & soreness, irritability, anxiety, shaky hands & repetitive hand motions, acne, complains of being cold even when room temp is 74 degrees, sinus infections, vision problems, 1 hallucination. She was diagnosed with Epilepsy 10-19-11. Neurologist gave no info with the diagnosis. 2nd Neurologist we saw said that the Epilepsy was caused by a genetic mutation and told her that she needed to have an eye exam after looking at her eyes. She is now seeing a 3rd Neurologist & taking Lamictal XR 300mg twice daily & Aptiom 600mg once daily. She has had a few break-thru seizures even while taking her meds.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Tremor, Urine ketone body absent, Visual impairment, White blood cells urine negative
Clinical narrative: Absence & Tonic Clonic Seizures & blackouts, memory loss, sleep walking, excessively fatigued & stressed, confusion, unexplained stiffness & soreness, irritability, anxiety, shaky hands & repetitive hand motions, acne, complains of being cold even when room temp is 74 degrees, sinus infections, vision problems, 1 hallucination. She was diagnosed with Epilepsy 10-19-11. Neurologist gave no info with the diagnosis. 2nd Neurologist we saw said that the Epilepsy was caused by a genetic mutation and told her that she needed to have an eye exam after looking at her eyes. She is now seeing a 3rd Neurologist & taking Lamictal XR 300mg twice daily & Aptiom 600mg once daily. She has had a few break-thru seizures even while taking her meds.
Age: 70.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Pain in extremity, Rash
Clinical narrative: Patient experienced redness/rash along with arm pain following vaccination. On a regular visit to her doctor, the doctor encouraged her to return to the pharmacy to report the reaction. Patient presented to the pharmacy with slight redness around the front and side of arm, and down the back of her arm, 1 week following vaccination. Patient stated reaction had begun to subside and felt better after warm baths.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation, Injection site erythema, Injection site inflammation, Skin irritation
Clinical narrative: Local redness and inflammation that spread from left deltoid area to around the left armpit area. The size of the irritation around the armpit was the size of a quarter. It was also red and inflammed in this area.
Age: 13.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Syncope
Clinical narrative: Pt experienced multiple syncopal episodes after being vaccinated. Pt was monitored by the provider, and eventually released to self care.
Age: 53.0
Sex: F
Vaccine: MNQ
Symptoms: Dyspnoea, Injection site erythema, Injection site infection, Injection site pain, Injection site warmth
Clinical narrative: Patient called clinic earlier today and reported she noted redness and pain at the injection site starting on 08/12/2017. She reported low grade fever of 100.1 oral, shortness of breath, body aches,  and neck stiffness starting today 08/14/2017. She was asked to report to the ER for STAT evaluation. She opted to see her PCP today and reported she has shortness of breath almost daily due to her sarcoidosis. She was seen by her PCP today. She came to Rediclinic after her PCP visit  and she was in No acute distress. Immunization site: redness/erythematous circular patch at the injection site 7.5 cm X 6 cm with mild overlying warmth, tender to touch. Patient was treated for her chest congestion and vaccine site reaction -suspected infection by her PCP with azithromycin (ZPACK) and prednisone 10 mg one PO QD X 10 days.
Age: 53.0
Sex: F
Vaccine: MNQ
Symptoms: Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: Patient called clinic earlier today and reported she noted redness and pain at the injection site starting on 08/12/2017. She reported low grade fever of 100.1 oral, shortness of breath, body aches,  and neck stiffness starting today 08/14/2017. She was asked to report to the ER for STAT evaluation. She opted to see her PCP today and reported she has shortness of breath almost daily due to her sarcoidosis. She was seen by her PCP today. She came to Rediclinic after her PCP visit  and she was in No acute distress. Immunization site: redness/erythematous circular patch at the injection site 7.5 cm X 6 cm with mild overlying warmth, tender to touch. Patient was treated for her chest congestion and vaccine site reaction -suspected infection by her PCP with azithromycin (ZPACK) and prednisone 10 mg one PO QD X 10 days.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: Unusual itching on feet, lower abdomen, and back. Red welts lower abdomen, lower back, both forearms. Started BENADRYL 25 mg, 2-hours after welts appeared, continued every 4 hours x 2. After 6-hours, much improved, no more welts, just itchy red spots. After 24 hours, moderate itching on hands and feet, with minimal rash. After 36 hours, itching started again, slight redness, took BENADRYL 25 mg, 1 x. After 48 hours, no symptoms.
Age: 1.08
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Chest X-ray, Ear infection, Pneumonia, Pyrexia
Clinical narrative: Fever to 103F, ear infection, pneumonia.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Acute stress disorder, Blood glucose normal, Blood pressure decreased, Cold sweat, Dizziness
Clinical narrative: Immediately after injection patient was light headed, became nauseous. He never lost consciousness. He started to get better after about 15 minutes, but was clammy. I checked his BP which was low, slightly above 90/60 and pulse registered as low. EMS was called to check him out. He was cleared and it is thought that it is a stress reaction.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Heart rate decreased, Immediate post-injection reaction, Nausea
Clinical narrative: Immediately after injection patient was light headed, became nauseous. He never lost consciousness. He started to get better after about 15 minutes, but was clammy. I checked his BP which was low, slightly above 90/60 and pulse registered as low. EMS was called to check him out. He was cleared and it is thought that it is a stress reaction.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Back pain, Chest pain
Clinical narrative: Patient received flu shot at pharmacy about 11:30 am. Within about 10 minutes of receiving the shot, the patient stated she was having some chest pain and back pain. She did state the back pain was more intense. She stated she did not know if it was from the shot, but she felt fine before. She did state she had flu shots before with no problems. We called for an ambulance. While waiting EMT's to arrive the patient stated she did have a stent put in earlier in the year, but had no problems recently. She stated she did have prescription of nitroglycerin, but did not have it with her. I checked her file, she had a prescription for nitroglycerin 0.4mg she had picked up back in February. I gave her one nitroglycerin 0.4mg tablet. By the time the EMT's arrived she state she the chest pains had only slightly lessened she thought, but no changes in the back pain. The EMT's took her outside to assess her and then took her on to the hospital.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site pain, Lymphadenopathy, Malaise, Nasal congestion, Oropharyngeal pain
Clinical narrative: Fever, sore throat, stuffy nose, soreness at  injection site, swollen glands, general ill feeling.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Pyrexia
Clinical narrative: Fever, sore throat, stuffy nose, soreness at  injection site, swollen glands, general ill feeling.
Age: 1.25
Sex: M
Vaccine: HEPA
Symptoms: Injection site urticaria, Injection site warmth
Clinical narrative: Giant hive at injection site warm to the touch. About 3 inches in diameter.
Sex: M
Vaccine: LYME
Symptoms: Pain
Clinical narrative: Back in 1998 or 1999 had shots from a drug called LYMERIX from my Dr. for Lyme disease because I work outside a lot having a lot of pain and other symptoms just found out that the FDA took it off the market around 2002 what can I do?
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site reaction, Swelling
Clinical narrative: Pt was given ZOSTAVAX (R) zoster vaccine live on 7/24/17. The next day, pt complained of redness and swelling. Pt went to ER and her PCP, her PCP confirmed that vaccine was given properly and she was experiencing an injection site reaction.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Inflammation, Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: Significant erythema, edema, warmth to injection site and 9cm surrounding area. Oral DECADRON in office given for inflammation.
Age: 27.0
Sex: F
Vaccine: RAB
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Pt. states that around 4 pm on day of vaccine, her right arm became very sore. It is still sore, and the muscle near deltoid has pain when she raises arm above head. She also felt "achey" for 2 1/2 days following vaccination.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Rash generalised
Clinical narrative: Mother called a little after 3 pm to report son was covered all over with a rash and wanted to know if she could give him BENADRYL or if we could give him a steroid shot. Says he woke up this morning with a rash on his arms and his legs and this afternoon it's on his neck and chest area. Explained to mother we did not give steroids and had no in house MD. Encouraged to take child to Dr or ER or walk in health care for further evaluation. Also requested she call back and let us know what happens. Stated it would probably be Monday before she called back.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Dyspnoea, Feeling hot, Head discomfort, Loss of consciousness
Clinical narrative: Patient became warm, and "breathing and head felt heavy" then things went dark.
Age: 54.0
Sex: U
Vaccine: MMR
Symptoms: Arthralgia, Body temperature increased, Erythema, Headache, Induration
Clinical narrative: (Sore arm, redness, swollen, hard, hot), joint/muscle achiness. Severe low grade temp 100.5; headache; sensitive to touch all over body; minor nausea.
Age: 54.0
Sex: U
Vaccine: MMR
Symptoms: Myalgia, Nausea, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: (Sore arm, redness, swollen, hard, hot), joint/muscle achiness. Severe low grade temp 100.5; headache; sensitive to touch all over body; minor nausea.
Age: 54.0
Sex: U
Vaccine: MMR
Symptoms: Tenderness, Urine analysis abnormal
Clinical narrative: (Sore arm, redness, swollen, hard, hot), joint/muscle achiness. Severe low grade temp 100.5; headache; sensitive to touch all over body; minor nausea.
Age: 1.25
Sex: F
Vaccine: HIBV, VARCEL
Symptoms: Hypophagia, Injection site erythema, Injection site swelling, Irritability
Clinical narrative: Noted a small red bump; cranky x 3 days; no fever; clingy; no itchy; eating less; no rashes; no known insect bites; varicella vaccine was given in that spot 8 days ago.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Lumbar puncture abnormal, Mobility decreased, Pain
Clinical narrative: Unable to get out of bed. Transport to medical center via ambulance. Severe pain in lower region and unable to ambulate. 22 days inpatient stay.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Dizziness, Loss of consciousness, Pallor
Clinical narrative: Loss of consciousness, Dizziness. Extreme paleness. Weakness.
Age: 18.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Erythema, Injection site swelling, Swelling face
Clinical narrative: Localized swelling at injection site of the varicella. Cheeks also puffy, erythematous.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Adverse reaction, Pain
Clinical narrative: RCV'd vaccines on 8-11-17, RXN started that evening, worse on 8-12-17, mom applied hydrocortisones, ice packs, ADVIL for pain, RXN was 2 cm in diameter appeared to be getting better on 8-14-17, no abx.
Age: 18.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Lymphadenopathy, Malaise, Pyrexia
Clinical narrative: Generalized lymphadenopathy, low grade fever, malaise.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pain
Clinical narrative: Bruising, soreness.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Local reaction at the site of inj arm swollen, tender and red. Child also c/o headache. Recommend ice therapy, rest, and TYLENOL, or MOTRIN. PRN for fever or pain.
Age: 42.0
Sex: M
Vaccine: MMR, TDAP, VARCEL
Symptoms: Arthralgia, Back pain, Fatigue, Grip strength decreased, HIV test
Clinical narrative: After two days from receiving these shots, I found myself literally paralyzed from the waist up, unable to move my upper body especially arms and my hands. Was in bed for 24hrs until a roommate found me and helped me up. Subsequent issues followed intense pain (again mostly upper body), a fever and headache that lasted a day, now suffering from joint pain and fatigue. Can't even firmly hold a pen on my right hand to assume writing. Have intense and piercing pain o my back and hips, feels like I have sharp objects embedded into my skin especially in the joints area.
Age: 42.0
Sex: M
Vaccine: MMR, TDAP, VARCEL
Symptoms: Headache, Laboratory test, Mobility decreased, Pain, Paralysis
Clinical narrative: After two days from receiving these shots, I found myself literally paralyzed from the waist up, unable to move my upper body especially arms and my hands. Was in bed for 24hrs until a roommate found me and helped me up. Subsequent issues followed intense pain (again mostly upper body), a fever and headache that lasted a day, now suffering from joint pain and fatigue. Can't even firmly hold a pen on my right hand to assume writing. Have intense and piercing pain o my back and hips, feels like I have sharp objects embedded into my skin especially in the joints area.
Age: 42.0
Sex: M
Vaccine: MMR, TDAP, VARCEL
Symptoms: Pyrexia, Sensation of foreign body
Clinical narrative: After two days from receiving these shots, I found myself literally paralyzed from the waist up, unable to move my upper body especially arms and my hands. Was in bed for 24hrs until a roommate found me and helped me up. Subsequent issues followed intense pain (again mostly upper body), a fever and headache that lasted a day, now suffering from joint pain and fatigue. Can't even firmly hold a pen on my right hand to assume writing. Have intense and piercing pain o my back and hips, feels like I have sharp objects embedded into my skin especially in the joints area.
Age: 73.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Arthralgia, Asthenia, Burning sensation, Cough, Diarrhoea
Clinical narrative: Patient says within 2 days after receiving vaccine, he felt weak, stomach sick to the stomach, sneezing, coughing/wheezing, sore joints, both feet sore/uncomfortable, burning in feet, nausea, diarrhea, feeling faint, can't stand up or down, stiff feeling. He got ZOSTAVAX and FLUZONE HD on 8/3/17. He did not see or speak to MD yet. Told pt to see doctor and let him know.
Age: 73.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Dizziness, Dysstasia, Musculoskeletal stiffness, Nausea, Pain in extremity
Clinical narrative: Patient says within 2 days after receiving vaccine, he felt weak, stomach sick to the stomach, sneezing, coughing/wheezing, sore joints, both feet sore/uncomfortable, burning in feet, nausea, diarrhea, feeling faint, can't stand up or down, stiff feeling. He got ZOSTAVAX and FLUZONE HD on 8/3/17. He did not see or speak to MD yet. Told pt to see doctor and let him know.
Age: 73.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Sneezing, Wheezing
Clinical narrative: Patient says within 2 days after receiving vaccine, he felt weak, stomach sick to the stomach, sneezing, coughing/wheezing, sore joints, both feet sore/uncomfortable, burning in feet, nausea, diarrhea, feeling faint, can't stand up or down, stiff feeling. He got ZOSTAVAX and FLUZONE HD on 8/3/17. He did not see or speak to MD yet. Told pt to see doctor and let him know.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: 8/9/17-Redness and sore to touch. 8/9/17 at evening went to clinic-BACTRIM DS. 8/10/17 went to PCP and he took off BACTRIM DS and suggested steroid shot. 8/14/17-Reddness and soreness gone, light pink under skin.
Age: 33.0
Sex: M
Vaccine: FLU4, MMR, PPV
Symptoms: Injection site pain
Clinical narrative: Pain at injections site due to 3 shots. Possible allergic reactions.
Sex: U
Vaccine: PPV, PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported. On 03-MAR-2017 the patient was vaccinated with PNEUMOVAX 23 from lot # K021881 expiration date 30-JUL-2016 (expired product administered). No adverse effects reported. No PQC involved. No further information provided.
Age: 19.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Dizziness, Dizziness postural, Dyspnoea, Feeling hot, Immediate post-injection reaction
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 19-year-old male patient who received BEXSERO (batch number 16B101, expiry date 28th February 2019). Concurrent medical conditions included acne and poison ivy rash. Concomitant products included Tretinoin Cream. On 2nd August 2017, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 2nd August 2017, immediately after receiving BEXSERO, the patient experienced injection site pain. On 3rd August 2017, the patient experienced poison ivy rash, light headedness, feeling of warmth facial, facial swelling and condition aggravated. The patient was treated with Steroids. BEXSERO was discontinued. In August 2017, the outcome of the injection site pain, light headedness, feeling of warmth facial and facial swelling were recovered/resolved. On an unknown date, the outcome of the poison ivy rash and condition aggravated were not recovered/not resolved. The reporter considered the injection site pain to be related to BEXSERO. The reporter considered the poison ivy rash, light headedness, feeling of warmth facial, facial swelling and condition aggravated to be almost certainly related to BEXSERO. Additional details were reported as follows: This case was reported by clinical manager. Tretinoin cream was still listed as an active medication for the patient, but it was not been filled since 2015. The patient worked in landscaping and had a poison ivy rash on his face and other parts of his body all summer. At 14:51, the patient received BEXSERO in the left deltoid. The patient experienced soreness at the injection site immediately, but no other symptoms on the same day. On 3rd August 2017 (one day after vaccination), the patient was seen at the office for swelling in his cheeks, dizziness, felt light headed and a warm feeling in his face. The patient did not had any swelling of the mouth, tongue or throat. The patient's poison ivy rash was also discussed the same day. It had not been discussed the day he had the injection. The nurse practitioner who saw the patient, believed he experienced a reaction to BEXSERO (continued reaction) and had recommended not to complete the series. The office followed-up with the patient's mother in the morning of the reporting day. The mother reported that the patient's symptoms had resolved, except poison ivy rash which gotten worse in the past 2 days and was on his face, legs, arms, ears and genital area. The patient had now been prescribed a 5 day course of steroids for the poison ivy rash. The office had also completed a VAERS report.
Age: 19.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Injection site pain, Swelling face, Throat irritation, Throat tightness, Vision blurred
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 19-year-old male patient who received BEXSERO (batch number 16B101, expiry date 28th February 2019). Concurrent medical conditions included acne and poison ivy rash. Concomitant products included Tretinoin Cream. On 2nd August 2017, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 2nd August 2017, immediately after receiving BEXSERO, the patient experienced injection site pain. On 3rd August 2017, the patient experienced poison ivy rash, light headedness, feeling of warmth facial, facial swelling and condition aggravated. The patient was treated with Steroids. BEXSERO was discontinued. In August 2017, the outcome of the injection site pain, light headedness, feeling of warmth facial and facial swelling were recovered/resolved. On an unknown date, the outcome of the poison ivy rash and condition aggravated were not recovered/not resolved. The reporter considered the injection site pain to be related to BEXSERO. The reporter considered the poison ivy rash, light headedness, feeling of warmth facial, facial swelling and condition aggravated to be almost certainly related to BEXSERO. Additional details were reported as follows: This case was reported by clinical manager. Tretinoin cream was still listed as an active medication for the patient, but it was not been filled since 2015. The patient worked in landscaping and had a poison ivy rash on his face and other parts of his body all summer. At 14:51, the patient received BEXSERO in the left deltoid. The patient experienced soreness at the injection site immediately, but no other symptoms on the same day. On 3rd August 2017 (one day after vaccination), the patient was seen at the office for swelling in his cheeks, dizziness, felt light headed and a warm feeling in his face. The patient did not had any swelling of the mouth, tongue or throat. The patient's poison ivy rash was also discussed the same day. It had not been discussed the day he had the injection. The nurse practitioner who saw the patient, believed he experienced a reaction to BEXSERO (continued reaction) and had recommended not to complete the series. The office followed-up with the patient's mother in the morning of the reporting day. The mother reported that the patient's symptoms had resolved, except poison ivy rash which gotten worse in the past 2 days and was on his face, legs, arms, ears and genital area. The patient had now been prescribed a 5 day course of steroids for the poison ivy rash. The office had also completed a VAERS report.
Age: 19.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Condition aggravated, Dermatitis contact, Dizziness, Feeling hot, Immediate post-injection reaction
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 19-year-old male patient who received BEXSERO (batch number 16B101, expiry date 28th February 2019). Concurrent medical conditions included acne and poison ivy rash. Concomitant products included Tretinoin Cream. On 2nd August 2017, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 2nd August 2017, immediately after receiving BEXSERO, the patient experienced injection site pain. On 3rd August 2017, the patient experienced poison ivy rash, light headedness, feeling of warmth facial, facial swelling and condition aggravated. The patient was treated with Steroids. BEXSERO was discontinued. In August 2017, the outcome of the injection site pain, light headedness, feeling of warmth facial and facial swelling were recovered/resolved. On an unknown date, the outcome of the poison ivy rash and condition aggravated were not recovered/not resolved. The reporter considered the injection site pain to be related to BEXSERO. The reporter considered the poison ivy rash, light headedness, feeling of warmth facial, facial swelling and condition aggravated to be almost certainly related to BEXSERO. Additional details were reported as follows: This case was reported by clinical manager. Tretinoin cream was still listed as an active medication for the patient, but it was not been filled since 2015. The patient worked in landscaping and had a poison ivy rash on his face and other parts of his body all summer. At 14:51, the patient received BEXSERO in the left deltoid. The patient experienced soreness at the injection site immediately, but no other symptoms on the same day. On 3rd August 2017 (one day after vaccination), the patient was seen at the office for swelling in his cheeks, dizziness, felt light headed and a warm feeling in his face. The patient did not had any swelling of the mouth, tongue or throat. The patient's poison ivy rash was also discussed the same day. It had not been discussed the day he had the injection. The nurse practitioner who saw the patient, believed he experienced a reaction to BEXSERO (continued reaction) and had recommended not to complete the series. The office followed-up with the patient's mother in the morning of the reporting day. The mother reported that the patient's symptoms had resolved, except poison ivy rash which gotten worse in the past 2 days and was on his face, legs, arms, ears and genital area. The patient had now been prescribed a 5 day course of steroids for the poison ivy rash. The office had also completed a VAERS report.
Age: 19.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Injection site pain, Swelling face
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 19-year-old male patient who received BEXSERO (batch number 16B101, expiry date 28th February 2019). Concurrent medical conditions included acne and poison ivy rash. Concomitant products included Tretinoin Cream. On 2nd August 2017, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 2nd August 2017, immediately after receiving BEXSERO, the patient experienced injection site pain. On 3rd August 2017, the patient experienced poison ivy rash, light headedness, feeling of warmth facial, facial swelling and condition aggravated. The patient was treated with Steroids. BEXSERO was discontinued. In August 2017, the outcome of the injection site pain, light headedness, feeling of warmth facial and facial swelling were recovered/resolved. On an unknown date, the outcome of the poison ivy rash and condition aggravated were not recovered/not resolved. The reporter considered the injection site pain to be related to BEXSERO. The reporter considered the poison ivy rash, light headedness, feeling of warmth facial, facial swelling and condition aggravated to be almost certainly related to BEXSERO. Additional details were reported as follows: This case was reported by clinical manager. Tretinoin cream was still listed as an active medication for the patient, but it was not been filled since 2015. The patient worked in landscaping and had a poison ivy rash on his face and other parts of his body all summer. At 14:51, the patient received BEXSERO in the left deltoid. The patient experienced soreness at the injection site immediately, but no other symptoms on the same day. On 3rd August 2017 (one day after vaccination), the patient was seen at the office for swelling in his cheeks, dizziness, felt light headed and a warm feeling in his face. The patient did not had any swelling of the mouth, tongue or throat. The patient's poison ivy rash was also discussed the same day. It had not been discussed the day he had the injection. The nurse practitioner who saw the patient, believed he experienced a reaction to BEXSERO (continued reaction) and had recommended not to complete the series. The office followed-up with the patient's mother in the morning of the reporting day. The mother reported that the patient's symptoms had resolved, except poison ivy rash which gotten worse in the past 2 days and was on his face, legs, arms, ears and genital area. The patient had now been prescribed a 5 day course of steroids for the poison ivy rash. The office had also completed a VAERS report.
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Headache, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable nurse. A 19 years old female patient of unspecified ethnicity received her first dose of TRUMENBA (lot number: R56659 and expiration date: 01Jan2019) intramuscularly given in the left deltoid, on 08Aug2017 at 0.5 ml, single as vaccine for Meningococcal B. Patient medical history included tinea corporis. Concomitant medication included ketoconazole cream (NIZORAL) topical for tinea corporis. It was reported that the patient was given the vaccine on 08Aug2017 and within an hour, patient had an absolutely severe headache. She was hysterical and her mom was calling back. On the same day, the patient also had severe leg pain, just down her left side so she was sent to ER (emergency room). Patient was placed as an urgent on the triage, and pain scale is 9. Nurse stated, due to acute pain head and left leg that is why she is pretty high on pain scale. The nurse further stated that the left leg pain started about 16:15 today, 08Aug2017, as patient had a meningitis immunization 30 minutes prior. Her oxygen saturation rate is fine 100 %, her temperature is 98.8 or 37.1 and her blood pressure was 131 over 82 on 08Aug2017. The reporter had no idea if treatment was provided for the events and confirmed that the patient was still in ER at the time of the report. Outcome of the events was unknown. The reporter believed that there is a causal relationship between meningococcal group B rlp2086 and events severe headache and severe left leg pain. The nurse further stated, "I do, yes it happened with her in an hour while she was fine, she was here for well visit, so yes I think it is related."
Age: 19.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Conversion disorder, Headache, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable nurse. A 19 years old female patient of unspecified ethnicity received her first dose of TRUMENBA (lot number: R56659 and expiration date: 01Jan2019) intramuscularly given in the left deltoid, on 08Aug2017 at 0.5 ml, single as vaccine for Meningococcal B. Patient medical history included tinea corporis. Concomitant medication included ketoconazole cream (NIZORAL) topical for tinea corporis. It was reported that the patient was given the vaccine on 08Aug2017 and within an hour, patient had an absolutely severe headache. She was hysterical and her mom was calling back. On the same day, the patient also had severe leg pain, just down her left side so she was sent to ER (emergency room). Patient was placed as an urgent on the triage, and pain scale is 9. Nurse stated, due to acute pain head and left leg that is why she is pretty high on pain scale. The nurse further stated that the left leg pain started about 16:15 today, 08Aug2017, as patient had a meningitis immunization 30 minutes prior. Her oxygen saturation rate is fine 100 %, her temperature is 98.8 or 37.1 and her blood pressure was 131 over 82 on 08Aug2017. The reporter had no idea if treatment was provided for the events and confirmed that the patient was still in ER at the time of the report. Outcome of the events was unknown. The reporter believed that there is a causal relationship between meningococcal group B rlp2086 and events severe headache and severe left leg pain. The nurse further stated, "I do, yes it happened with her in an hour while she was fine, she was here for well visit, so yes I think it is related."
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Fall, Heart rate decreased, Hypotension, Loss of consciousness, Pallor
Clinical narrative: Pt was injected with BOOSTRIX and within a few seconds of administration fell unconscious (father was right next to her sitting down and caught her). Pt remained unconscious for about 1 minute then regained consciousness. Then stayed conscious for a while then they lost consciousness again for a shorter duration one or two more times. 911 was called and upon arrival the vitals they took were low blood pressure and low heart rate. Pt was taken to hospital on stretcher for further evaluation. Pt said they generally felt alright when asked but did appear pale.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Headache, Hyperhidrosis, Pyrexia, Urinary incontinence
Clinical narrative: Approximately 12 hours after the immunization, I developed high fever (!03.4), I also had a bad headache I suffered severe weakness, so bad it was hard to get out of bed. I couldn't make it to the bathroom in time and I was incontinent of urine. I took Ibuprofen at 11:30 PM and 3:30 AM. My fever, was 102.7, 102.2, 102.4, 101, 101.5, and currently 100.3. I am sweating a lot at present, but I am feeling so much better now.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Patient started with a low-grade fever on 8/10 (101) that turned into a high fever by 8/11 (103) that wouldn't drop below 102 even with medication. His fever spiked to 104 at 2 AM on 8/12 and finally broke and didn't return by 4 AM. He then broke out in a rash mainly covering his torso area on 8/14 and still has it.
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: Information has been received from a registered nurse concerning unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates improperly stored doses of GARDASIL 9 lot # L037554, expiry date 25-DEC-2017 (dose unknown) were administered to the patients intramuscularly for prophylaxis. The administered doses of vaccines experienced the temperature excursion of 32 to 35 degrees Fahrenheit for 240 hours. No data logger was involved. No product quality complaint (PQC) involved. This is one of two reports received from the same reporter. Information received on 08-AUG-2017 indicated that all telephone attempts to obtain follow-up information have been unsuccessful. Sender's Comments: US-009507513-1707USA001383.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of PROQUAD (lot # reported as N044022, exp date: 01-MAY-2018, which was not valid) for prophylaxis, following a temperature excursion of 40 F for 21 days. There was no pervious temperature excursion. Data logger was involved.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age. On 08-AUG-2017, the patient was vaccinated with M-M-R II lot # M017346, expiration date 06-ABR-2018, intramuscularly, rather than the subcutaneous route, for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT).
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a nurse practitioner via a company representative referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On 03-AUG-2017 the patient was vaccinated with the third dose of GARDASIL 9 (lot # was reported as M015087, expiration date 20-OCT-2019; dose and route were unknown) for prophylaxis (inappropriate schedule of drug administration). On 29-MAR-2017 and 17-MAY-2017, the patient was respectively vaccinated with the first and second dose of GARDASIL 9 (dose and route were unknown) for prophylaxis. No adverse effects were reported.
Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a consumer referring  to herself a 28 year old female patient. On 13-JUL-2017, the patient was vaccinated with VARIVAX 1 shot one time in arm muscle, for prophylaxis.  It was reported that in August 2017 (reported as last week), the patient took a pregnancy test which showed positive for pregnancy. The LMP and EDD weeks not known. The patient stated that she was 2 weeks preganant.
Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Maternal exposure before pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a consumer referring  to herself a 28 year old female patient. On 13-JUL-2017, the patient was vaccinated with VARIVAX 1 shot one time in arm muscle, for prophylaxis.  It was reported that in August 2017 (reported as last week), the patient took a pregnancy test which showed positive for pregnancy. The LMP and EDD weeks not known. The patient stated that she was 2 weeks preganant.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: Information was received on 08-AUG-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a male patient (age unknown) was inoculated with ZOSTAVAX (dosage and lot#/expiration not reported) in June 2013 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused patient to contract a persistent strain of herpes zoster. On or about 25-JUN-2016, patient was treated by physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 13-NOV-2014 (conflicting date as prior to diagnosis date), patient was treated by physician at a clinic for ongoing and worsening symptoms of herpes zoster infections. On or about 12-DEC-2011 (conflicting date as prior to vaccination and diagnosis date), patient received subsequent treatment by physician for ongoing symptoms of shingles that were uncontrolled by previous prescriptions and treatment attempts. Patient has been prescribed valacyclovir (VALTREX) and acyclovir for management of his painful symptoms. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and  will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 62 year old female patient with arthritis. On 06-AUG-2017, the patient was vaccinated with ZOSTAVAX lot # M041669 for prophylaxis.  Concomitant therapies included fluoxetine hydrochloride (PROZAC), estradiol, hydrocodone, clonazepam, diclofenac sodium (VOLTAREN) and promethazine hydrochloride(PHENERGAN). On 07-AUG-2017, 2 days after onset of therapy the patient developed a rash generalised. The outcome of rash generalised was reported as not recovered/not resolved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. On 03-JUL-2017, the patient was vaccinated with a dose of improperly stored VARIVAX (lot # M024681, expiration date 18-MAY-2018; dose and route unknown) for prophylaxis, which was reconstituted with the properly stored sterile diluent. The vaccine was exposed to temperature excursion of -14 degrees Celsius (C) to -10 C for 287.5 hours, -9 C to 8 C for 6 hours, and 9 C to 25 C for 24 hours. Data logger involved. There was no temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA005407: US-009507513-1707USA007696:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. On 06-JUL-2017, the patient was vaccinated with a dose of improperly stored VARIVAX (lot # M024681, expiration date 18-MAY-2018; dose and route unknown) for prophylaxis, which was reconstituted with the properly stored sterile diluent. The vaccine was exposed to temperature excursion of -14 degrees Celsius (C) to -10 C for 287.5 hours, -9 C to 8 C for 6 hours, and 9 C to 25 C for 24 hours. Data logger involved. There was no temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA007696: US-009507513-1708USA005406:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. Information regarding patients' medical history, current conditions and concomitant medications were not reported. On unknown dates, the patients received improperly stored ROTATEQ (lot # M04386, expiry date: 18-JUN-2018) for prophylaxis. Nurse reported that the vaccine underwent temperature excursion at 0-1 degree Celsius for 21 minutes. There were no previous temperature excursion. Data logger was involved. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1708USA005422:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse refers to 6 unspecified patients of unknown age and gender. Information regarding patients' medical history, current conditions and concomitant medications were not reported. On multiple unknown dates, the patients received improperly stored VARIVAX (lot # N000683, expiry date: 06-JAN-2019) which was reconstitute with properly stored sterile diluent (Manufacturer unknown) via unspecified routes, for prophylaxis. Nurse reported that the vaccine underwent temperature excursion at 6-14 degree Fahrenheit (6F) for 36 hours. There were no previous temperature excursions and no digital data logger was reported. No side effects were reported. This is one of the three reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA006125: US-009507513-1708USA006124:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to multiple patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB (lot # M047666, expiry date: 24-OCT-2019; lot # N007750, expiry date: 29-NOV-2019 for prophylaxis (Incorrect product storage). Dosing details and route of administration were not reported. No concomitant medications were reported. No adverse effects were reported. On an unknown date, the vaccine was exposed to temperature of -1°C or colder (-1°C) for 11 hours 29 minutes. No previous temperature excursion were reported. This case was reported because of a data logger. No product quality complaint (PQC) was reported. No further information was provided. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1708USA006090: US-009507513-1708USA006089: US-009507513-1708USA006091: US-009507513-1708USA006088:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Poor quality drug administered, Product colour issue
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 11-AUG-2017 the patient was vaccinated with ZOSTAVAX lot # N016185 for prophylaxis.  Concomitant therapies included sterile diluent (STERILE DILUENT). On 11-AUG-2017, 1 day after onset of therapy the patient experienced poor quality drug administered and product colour issue. On an unknown date the patient experienced no adverse event.
Age: 62.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Dizziness, Pain, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age.    On 10-AUG-2017 the patient was vaccinated with PNEUMOVAX 23 lot # M042785 in the left deltoid for prophylaxis. On AUG-2017 the patient experienced pyrexia, dizziness, chills and pain. The outcome of dizziness, chills, pyrexia and pain was reported as not recovered/not resolved.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to multiple patients of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date, the patients were vaccinated with improperly stored improperly stored RECOMBIVAX HB,  lot # M036156, expiry date: 23-FEB-2019 for prophylaxis (Incorrect product storage). Dosing details and route of administration were not reported. No concomitant medications were reported. No adverse effects were reported. On an unknown date, the vaccine was exposed to temperature of -1°C or colder (-1°C) for 11 hours 29 minutes. No previous temperature excursion were reported. This case was reported because of a data logger. No product quality complaint (PQC) was reported. No further information was provided. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA005593: US-009507513-1708USA006090: US-009507513-1708USA006089: US-009507513-1708USA006091: