chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: This spontaneous report was received from a Medical Assistant via a company representative referring to a 66 year old female patient. the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were unknown by reporter. The patient received a dose of PREVNAR 13. On an unknown date in 2008, the patient was vaccinated with an initial dose of PNEUMOVAX 23 for prophylaxis (strength, route, lot # and expiration date were not reported). On 15-JAN-2018, the patient recieved her second dose of PNEUMOVAX 23 lot # N025656, expiration date on 19-APR-2019, for prophylaxis (strength and route were not provided). After the second dose of  PNEUMOVAX 23, the patient returned to the office the following day, on 16-JAN-2018, with an injection site reaction that was red swollen reaction and warm to the touch. On 17-JAN-2018, the patient returned to the office again. Only the red swollen reaction had spread down her arm and was painful to touch. The office sent the patient to an unspecified hospital for the day; however, it could not be confirmed if the patient was admitted or not but in January 2018, the patient was posssibly hospitalized. At the hospital, the patient was given an unspecified antibiotic intravenously, BENADRYL, ROCEPHIN and SOLU-MEDROL. On Thursday 18-JAN-2018, the patient reported that she was recovering from the injection site erythema, injection site swelling, injection site warmth, erythema, peripheral swelling and pain in extremity. The causality assessment between the events and the vaccination with PNEUMOVAX 23 was not provided.
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: This spontaneous report was received from a Medical Assistant via a company representative referring to a 66 year old female patient. the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were unknown by reporter. The patient received a dose of PREVNAR 13. On an unknown date in 2008, the patient was vaccinated with an initial dose of PNEUMOVAX 23 for prophylaxis (strength, route, lot # and expiration date were not reported). On 15-JAN-2018, the patient recieved her second dose of PNEUMOVAX 23 lot # N025656, expiration date on 19-APR-2019, for prophylaxis (strength and route were not provided). After the second dose of  PNEUMOVAX 23, the patient returned to the office the following day, on 16-JAN-2018, with an injection site reaction that was red swollen reaction and warm to the touch. On 17-JAN-2018, the patient returned to the office again. Only the red swollen reaction had spread down her arm and was painful to touch. The office sent the patient to an unspecified hospital for the day; however, it could not be confirmed if the patient was admitted or not but in January 2018, the patient was posssibly hospitalized. At the hospital, the patient was given an unspecified antibiotic intravenously, BENADRYL, ROCEPHIN and SOLU-MEDROL. On Thursday 18-JAN-2018, the patient reported that she was recovering from the injection site erythema, injection site swelling, injection site warmth, erythema, peripheral swelling and pain in extremity. The causality assessment between the events and the vaccination with PNEUMOVAX 23 was not provided.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Bacterial infection, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Information has been received from a pharmacist and an infection control nurse referring to a 72 year old female patient. Information regarding patient's medical history and concurrent conditions were not reported. On 11-JAN-2018 (also reported as on "19-JAN-2018" by the nurse), the patient was vaccinated with the 1st dose of PNEUMOVAX 23 (lot # N019348, expiry date 08-FEB-2019) for routine vaccination. It was reported that the patient also was vaccinated with a dose of PREVNAR 13 on an unknown date more than a year prior to receiving PNEUMOVAX 23. Concomitant therapies included fluticasone propionate (FLONASE) and ipratropium bromide. The pharmacist reported that on 11-JAN-2018, the patient also experienced an unspecified swollen and tender arm after receiving PNEUMOVAX 23.  The nurse reported that the patient experienced redness, swelling, pain and heat at the injection site when she received pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The nurse stated that the patient reported back to office at 48 hours post vaccination on "19-JAN-2018", with what was termed "like a bacterial infection". The patient was treated with cephalexin (KEFLEX) and the infection was resolving. The outcome of an unspecified swollen and tender arm was unknown. At the reporting time, the causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events was unknown.  The nurse reiterating requested for lot check to determine "contamination" of the vaccine.  This is one of three repots from the same reporter source, linked to cases # 1801USA007902 and 1801USA008061.; Sender's Comments:  US-009507513-1801USA008061: US-009507513-1801USA007902:
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Peripheral swelling, Product quality issue, Tenderness
Clinical narrative: Information has been received from a pharmacist and an infection control nurse referring to a 72 year old female patient. Information regarding patient's medical history and concurrent conditions were not reported. On 11-JAN-2018 (also reported as on "19-JAN-2018" by the nurse), the patient was vaccinated with the 1st dose of PNEUMOVAX 23 (lot # N019348, expiry date 08-FEB-2019) for routine vaccination. It was reported that the patient also was vaccinated with a dose of PREVNAR 13 on an unknown date more than a year prior to receiving PNEUMOVAX 23. Concomitant therapies included fluticasone propionate (FLONASE) and ipratropium bromide. The pharmacist reported that on 11-JAN-2018, the patient also experienced an unspecified swollen and tender arm after receiving PNEUMOVAX 23.  The nurse reported that the patient experienced redness, swelling, pain and heat at the injection site when she received pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The nurse stated that the patient reported back to office at 48 hours post vaccination on "19-JAN-2018", with what was termed "like a bacterial infection". The patient was treated with cephalexin (KEFLEX) and the infection was resolving. The outcome of an unspecified swollen and tender arm was unknown. At the reporting time, the causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events was unknown.  The nurse reiterating requested for lot check to determine "contamination" of the vaccine.  This is one of three repots from the same reporter source, linked to cases # 1801USA007902 and 1801USA008061.; Sender's Comments:  US-009507513-1801USA008061: US-009507513-1801USA007902:
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Bacterial infection, Cellulitis, Erythema, Feeling hot, Pain
Clinical narrative: This spontaneous report was received from a pharmacist and a control nurse via a company representative and refers to a 70 years old non-pregnant female patient. The patient's pertinent medical history, and concurrent conditions were not reported. The patient's historical drugs included PREVNAR 13, more than a year ago. Concomitant therapies included acetazolamide, aspirin(manufacturer unknown), vitamin b complex, calcium, naproxen(NAPROSYN), turmeric, ascorbic acid, vitamin e and vitamin d. On 09-JAN-2018 (also reported as 19-JAN-2018), the patient was vaccinated with PNEUMOVAX 23 (dose and route of administration were not reported, lot # N019348 and expiration date: 08-FEB-2019) for routine vaccination. On 11-JAN-2018 (reported as 48 hours post vaccination with PNEUMOVAX 23), the patient experienced a problem with cellulitis; the signs were reported as redness, swelling, pain and heat with what was termed "like a bacterial infection". The patient sought medical attention by a physician office visit on the same date but, it was unknown if laboratory diagnostic tests were performed. As treatment for the event, the patient received cephalexin (KEFLEX) and doxycycline. At the time of this report, the patient was recovering from the event cellulitis.  The reporting nurse request a lot check to determine contamination and offered to send a sample if it would help with the investigation. The nurse stated that the vaccine was quarantined. Additionally, the clinic had many sites but the reactions only occurred in one site. The causality between cellulitis and PNEUMOVAX 23 was not reported. Upon internal review, cellulitis was considered medically significant.  This is one of three reports from the same reporter.; Sender's Comments: US-009507513-1801USA007997: US-009507513-1801USA007902:
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: This spontaneous report was received from a pharmacist and a control nurse via a company representative and refers to a 70 years old non-pregnant female patient. The patient's pertinent medical history, and concurrent conditions were not reported. The patient's historical drugs included PREVNAR 13, more than a year ago. Concomitant therapies included acetazolamide, aspirin(manufacturer unknown), vitamin b complex, calcium, naproxen(NAPROSYN), turmeric, ascorbic acid, vitamin e and vitamin d. On 09-JAN-2018 (also reported as 19-JAN-2018), the patient was vaccinated with PNEUMOVAX 23 (dose and route of administration were not reported, lot # N019348 and expiration date: 08-FEB-2019) for routine vaccination. On 11-JAN-2018 (reported as 48 hours post vaccination with PNEUMOVAX 23), the patient experienced a problem with cellulitis; the signs were reported as redness, swelling, pain and heat with what was termed "like a bacterial infection". The patient sought medical attention by a physician office visit on the same date but, it was unknown if laboratory diagnostic tests were performed. As treatment for the event, the patient received cephalexin (KEFLEX) and doxycycline. At the time of this report, the patient was recovering from the event cellulitis.  The reporting nurse request a lot check to determine contamination and offered to send a sample if it would help with the investigation. The nurse stated that the vaccine was quarantined. Additionally, the clinic had many sites but the reactions only occurred in one site. The causality between cellulitis and PNEUMOVAX 23 was not reported. Upon internal review, cellulitis was considered medically significant.  This is one of three reports from the same reporter.; Sender's Comments: US-009507513-1801USA007997: US-009507513-1801USA007902:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a physician, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 03-JUL-2017, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly (frequency, lot # and expiration date were not provided) for prophylaxis. Furthermore on 22-JAN-2018, the reporter stated that the patient experienced an interrupted dosing schedule in the human papillomavirus (HPV) vaccination series with the second dose of GARDASIL 9 intramuscularly (frequency, lot # and expiration date were not provided) for prophylaxis. No adverse effects reported.
Sex: M
Vaccine: VARZOS
Symptoms: Blindness unilateral, Herpes zoster, Necrotising retinitis, Visual impairment
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent condition, or concomitant medication. The patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 23-MAY-2012 by a physician for routine health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster (onset unknown). On an unknown date, "shortly after" receiving the ZOSTAVAX, the patient developed reduced vision eventually leading to partial blindness in one eye. Thereafter, the patient was diagnosed with retinal necrosis of his left eye. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review, reduced vision eventually leading to partial blindness in one eye/retinal necrosis of his left eye was determined to be medically significant. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Cold urticaria
Clinical narrative: Cold Urticaria.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Adverse reaction
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2018-01-23.
Age: 55.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Employee states that the day after she recieved the flu shot in her right deltoid, she had redness,increased heat and  swelling in her right upper arm with pain radiating to her fingers. She self treated with Tylenol, Blue Emu and Vicks. The red, hot swollen area resolved but she states she continues to have pain in the right arm/shoulder. She was seen by PCP who referred her back to occ health. Also using Penetrex and was sent to PT by occ health. Pain remains.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Haematochezia
Clinical narrative: Blood mixed with stool each day for 3 days after vaccine was administered.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Crying, Injection site erythema, Injection site inflammation, Irritability, Pyrexia
Clinical narrative: Patient was fussy and crying a lot. I looked at the injection site and it was red and inflamed. I took her temperature and she had a fever of 101.8. I gave her Tylenol and the temperature decreased to 100.8 and then increased again in a few hours. This went on for 24 hours until the fever broke.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient presented to office approximately 24 hours after IM injection of annual flu vaccine. No fever or resp distress. Injection site with approx. 7x6cm erythematous area below injection site, mildly warm to touch, nonfluctuant, not raised, mild tenderness to touch. No bogginess.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness and some swelling with heat around the injection site. Noticed it the morning after the injection was given. No treatment given. Outcome not determined at this point.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age or gender. No information was provided regarding the patient's concomitant medications, pertinent medical history, drug reactions or allergies. On an unspecified date in approximately 2013 (reported as "about 5 years ago"), the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (exact dose, lot# and expiration date were not reported) for prophylaxis. On 20-JAN-2018, the patient was vaccinated with the second dose of ZOSTAVAX subcutaneously (exact dose, lot# and expiration date were not reported). No adverse effects were reported. No product quality complaint (PQC) was involved.
Age: 17.0
Sex: M
Vaccine: HEP, HPV9, MENB, MNQ
Symptoms: Computerised tomogram, Fall, Head injury, Hyperhidrosis, Retching
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 17 year old male patient. The patient did not have any drug reactions or allergies. He was healthy at the time of the vaccination. No information regarding concomitant medications was provided. On 09-JAN-2018, the patient was vaccinated with GARDASIL 9 lot # N022584, expiry date 15-JUN-2020, TRUMENBA lot # S58879, expiry date 30-JUN-2019 both in the left arm, MENACTRA lot # U5766AE, expiry date 02-DEC-2018 and with hepatitis b vaccine (manufacturer unknown) lot # reported as Z2497 and expiry date 19-FEB-2020, both in the right arm (dose and route of administration were not reported for all). The patient was sitting on the exam table when he received the vaccinations. On the same date (reported as "one minute later"), the patient fell off the table, split his head, had 2 seizures, was retching (also reported as wretching) and became sweaty. The patient took 45 minutes to "come around". The patient was sent to the emergency room, where he received stitches and a computed tomography (CT) scan (result was not provided), and was released. Unspecified treatment was given for the events. He went back to school the next day. The patient was seen by the physician, and had no lingering symptoms. The outcome of the events was reported as recovered on an unknown date in January 2018. The causality assessment was not provided. Upon internal review, the event of seizures was considered to be medically significant.
Age: 17.0
Sex: M
Vaccine: HEP, HPV9, MENB, MNQ
Symptoms: Seizure, Suture insertion
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 17 year old male patient. The patient did not have any drug reactions or allergies. He was healthy at the time of the vaccination. No information regarding concomitant medications was provided. On 09-JAN-2018, the patient was vaccinated with GARDASIL 9 lot # N022584, expiry date 15-JUN-2020, TRUMENBA lot # S58879, expiry date 30-JUN-2019 both in the left arm, MENACTRA lot # U5766AE, expiry date 02-DEC-2018 and with hepatitis b vaccine (manufacturer unknown) lot # reported as Z2497 and expiry date 19-FEB-2020, both in the right arm (dose and route of administration were not reported for all). The patient was sitting on the exam table when he received the vaccinations. On the same date (reported as "one minute later"), the patient fell off the table, split his head, had 2 seizures, was retching (also reported as wretching) and became sweaty. The patient took 45 minutes to "come around". The patient was sent to the emergency room, where he received stitches and a computed tomography (CT) scan (result was not provided), and was released. Unspecified treatment was given for the events. He went back to school the next day. The patient was seen by the physician, and had no lingering symptoms. The outcome of the events was reported as recovered on an unknown date in January 2018. The causality assessment was not provided. Upon internal review, the event of seizures was considered to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 26-JAN-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 18-DEC-2006, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous, 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 27-AUG-2016, the patient was treated at a hospital for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed acetaminophen, hydrocodone bitartrate (NORCO) and acyclovir for management of his painful breakouts. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. 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.
Age: 3.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Body temperature increased, Fatigue, Febrile convulsion, Generalised tonic-clonic seizure, Upper respiratory tract infection
Clinical narrative: 23 hour after the vaccination pt. was fatigued, temp. and had a tonic clonic seizure. T. max was 103.5 by EMT. Hospital evaluation was normal with Dx of febrile seizure. All Sx's resolved after seizure with no other illness. Pt. was quickly back to baseline. However, he did develop URI Sx's in the next 24 hours.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Rash, Rash erythematous
Clinical narrative: Red rash in different spots on arm of injection, swollen arm, painful.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Insomnia, Loss of personal independence in daily activities, Musculoskeletal pain, Pain in extremity
Clinical narrative: Severe throbbing upper arm and shoulder pain for 7 days. Dull to moderate ache continuing to present day with off and on again sharp pain that interferes with everyday activity and sleeping at night.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Electrocardiogram, Presyncope, Tremor
Clinical narrative: Presyncope, shaking, supportive treatment, EKG. Did not resolve 40 minutes sent to ER.
Age: 54.0
Sex: F
Vaccine: FLUC4
Symptoms: Palpitations
Clinical narrative: Patient states that approximately 5 minutes after her influenza vaccine injection, she started having a racing heart. This continued for about one hour after it began. She states she has never had this reaction in the past when receiving a vaccine. She states she has not experienced it prior to the vaccine or since this one instance.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Electrocardiogram, Guillain-Barre syndrome
Clinical narrative: 28 Jan 2017 admitted medical center transfer to another hospital for Guillain-Barre syndrome (GBS) d/c 07 Mar 2017 to home health and physical therapy. Currently with Dr.
Age: 54.0
Sex: M
Vaccine: FLUX
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: 28 Jan 2017 admitted medical center transfer to another hospital for Guillain-Barre syndrome (GBS) d/c 07 Mar 2017 to home health and physical therapy. Currently with Dr.
Age: 57.0
Sex: M
Vaccine: FLUC4
Symptoms: Diplopia, Paraesthesia, Peripheral swelling
Clinical narrative: Tingling in left hand. Double vision. Bump on back of hand.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Mass
Clinical narrative: Patient reported hard lump that had grown from golf-ball size to size of baseball from 01/25-01/26. Said it was not painful until 01/26. Pt went to an.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Patient had redness and warmness from injection site down to elbow. Prescriber stated it was cellulitis.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Pallor, Vaccination site erythema, Vaccination site reaction
Clinical narrative: Erythematous, non-raised, blanching 9 cm x 9 cm area around vaccination site. No warmth to touch. Injection sites 1 cm apart. Redness started 1/25/18 and worsened 1/26/18. Advised on OTC BENADRYL and ibuprofen for pain. Denied any respiratory or GI sxs.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abnormal faeces, Diarrhoea, Frequent bowel movements
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of loose stools in a 65-year-old male patient who received SHINGRIX. The patient's past medical history included gastrointestinal disorder (bowel problems and suspected that the patient had irritable bowel disease). Previously administered products included ZOSTAVAX (received 2 to 3 years before the reporting date). Concomitant products included amlodipine, atenolol, Baby Aspirin, Losartan, simvastatin, JANTOVEN and hydrochlorothiazide. On 16th January 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 18th January 2018, 2 days after receiving SHINGRIX, the patient experienced loose stools and stool odor abnormal. On 23rd January 2018, the patient experienced upset stomach. On an unknown date, the outcome of the loose stools was not recovered/not resolved and the outcome of the stool odor abnormal and upset stomach were unknown. The reporter considered the loose stools, stool odor abnormal and upset stomach to be possibly related to SHINGRIX. Additional details were provided as follows: The reporter stated that her husband received SHINGRIX in the left deltoid. The patient started experiencing frequent, almost uncontrollable, loose stools. They occurred off and on over the next few days. They thought he was getting better, but the day before reporting date (7 days after vaccination), he had a bad bout and had been experiencing an upset stomach. The patient's loose stools also had a funny metallic or medicinal smell.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Rash
Clinical narrative: Rash on both cheeks. No fever.
Age: 42.0
Sex: F
Vaccine: FLU4, HEPAB, MMR, VARCEL
Symptoms: Drug administered at inappropriate site, Injection site pain
Clinical narrative: Right and left deltoid  injection site  pain was normal at first but  lasted much longer. Left deltoid area pain lasted for 2 to 3 days. Right deltoid area pain continues to hurt. Denies any redness or swelling. Client feels the injection site was given high up in the arm.
Age: 0.33
Sex: M
Vaccine: DTAP
Symptoms: Seizure
Clinical narrative: An hour after he received the vaccine he had a seizure, no fever at the time. The following day he had two more seizures, one at home while eating and one at the emergency room. He had no fever at the time of any of the seizures. The Doctors indicated these were not febrile seizures.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased
Clinical narrative: Temp to 101 on afternoon of flu vaccine. No other SX.
Age: 1.25
Sex: M
Vaccine: HEPA, HEPA, PNC13
Symptoms: Pyrexia, Seizure
Clinical narrative: Information has been received from a medical assistant, referring to a 15 month old male patient. The patient's medical history and concomitant therapies were not reported. As concurrent conditions was reported an allergy to egg whites. On 22-JAN-2018, the patient was vaccinated with a dose of VAQTA lot # N020950, expiration date on 17-OCT-2018, 25U/0.5 ml, intramuscularly (anatomical location was not reported) for prophylaxis. Later, on the same day (On 22-JAN-2018), the patient developed "a fever of 100.6 that went to 102 Fahrenheit" and had a seizure (type and duration of seizure not provided) and was hospitalized. The patient was treated with given TYLENOL and MOTRIN for the fever, doses and frequencies not provided. It was reported that on an unspecified date in January 2018, the patient made a full recovery from the events. The causality between the events and the vaccination with VAQTA was not reported. Upon internal review, the seizure was considered as a medically significant event.
Age: 1.25
Sex: M
Vaccine: HEPA, HEPA, PNC13
Symptoms: Febrile convulsion, Pyrexia, Tonsillitis
Clinical narrative: Information has been received from a medical assistant, referring to a 15 month old male patient. The patient's medical history and concomitant therapies were not reported. As concurrent conditions was reported an allergy to egg whites. On 22-JAN-2018, the patient was vaccinated with a dose of VAQTA lot # N020950, expiration date on 17-OCT-2018, 25U/0.5 ml, intramuscularly (anatomical location was not reported) for prophylaxis. Later, on the same day (On 22-JAN-2018), the patient developed "a fever of 100.6 that went to 102 Fahrenheit" and had a seizure (type and duration of seizure not provided) and was hospitalized. The patient was treated with given TYLENOL and MOTRIN for the fever, doses and frequencies not provided. It was reported that on an unspecified date in January 2018, the patient made a full recovery from the events. The causality between the events and the vaccination with VAQTA was not reported. Upon internal review, the seizure was considered as a medically significant event.
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 of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 05-FEB-2009 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 08-MAY-2017, the patient was treated for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 09-JUN-2017, the patient sought subsequent treatment from a physician for ongoing and worsening symptoms of shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. 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.
Age: 17.0
Sex: M
Vaccine: HPV4, MENB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt given shot at another office with PCP-and come into our office for 2nd BEXSERO shot and stated Left arm where BEXSERO #4 was given became site became red swollen x 2 days.
Sex: M
Vaccine: FLUC4
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial spontaneous case, was received on 23-Oct-2017, from a pharmacist, concerning an adult male patient of unspecified age. The patient had no relevant medical history and concomitant medications. On 23-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, batch number: 195210A, expiry date: Mar-2018, route of administration: intramuscular, anatomical location: left deltoid). It was reported that, vaccine was at a maximum temperature of 55F overnight and it was administered. The pharmacist stated that the refrigerator was at 40.6F last night, but that morning the temperature was 55F and that was the first-time excursion. It was reported that, the patient did not experience any adverse events after the administration of the vaccine. The outcome of the events was not reported. This report was assessed as non-serious. Follow-up report received on 27-Nov-2017: Patient's initial was changed. Gender of the patient was added as male. Date of birth was updated. Route of administration (intramuscular), anatomical location (left deltoid) was added. It was reported that, the patient did not experience any adverse events after the administration of the vaccine. Amended narrative accordingly.
Age: 2.0
Sex: F
Vaccine: HIBV, VARCEL
Symptoms: Injection site reaction, Rash, Rash macular
Clinical narrative: I started giving the next injection and noticed red blotches on childs leg and chest and upper arm. I immediately got PA and then gave child 1 teaspoon of BENADRYL, oral.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Mom states child got Flu shot in clinic around 930 1000 on 1/23/18. States child was fine at home all night. States he woke up next morning and arm was red; swollen. Went to school. Had no fever, not other symptoms. School nurse outlined swelling and redness put warm compress on arm. Area still red on 1/26/18 at 1700, swelling down.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Accidental exposure to product, Needle issue, No adverse event, Syringe issue, Underdose
Clinical narrative: Case number PHEH2016US0380840, is an initial spontaneous report received from a pharmacist on 20 Nov 2016. This is also a quality complaint report (AQWA number 1018078). This report refers to a 51 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with one single dose of FLUCELVAX QUADRIVALENT (batch number: 186868, expiry date: May 2017) at dose of 0.5 ml intramuscularly on 20 Nov 2016. On the same day while vaccination, as the pharmacist injected the last part of injection, it shot out of the syringe and sprayed onto the patient. The pharmacist did not know if it was a faulty syringe or not. The patient did not get the entire dose. The pharmacist was not sure where the leak occurred from. It happened so fast and it just sprayed everywhere. It was reported that the needle and syringe were fully secured together. It was started that, the subject was given second vaccine since the initial dosage leaked during administration (drug administration error) sure if this would constitute a potential over dosage. Upon follow up it was stated that syringe or needle was faulty and did not deliver full dose. No adverse event was reported following this administration error (underdose and accidental exposure to product). Combined follow up report received from pharmacist on 20 Nov 2016 and on 12 Dec 2016: new event added (drug administration error) and updated narrative accordingly. Follow up received from pharmacist on 19 Dec 2016: Added new event syringe issue and update narrative accordingly.
Age: 1.33
Sex: M
Vaccine: DTP
Symptoms: Bacterial test, Chest X-ray, Lethargy, Seizure, Urine analysis
Clinical narrative: Seizure lasting approximately 10 minutes. Excessive vomiting. Lethargic.
Age: 1.33
Sex: M
Vaccine: DTP
Symptoms: Vomiting
Clinical narrative: Seizure lasting approximately 10 minutes. Excessive vomiting. Lethargic.
Age: 8.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Pruritus, Rash, Swelling
Clinical narrative: Rash with intense itching; redness, swelling.
Age: 34.0
Sex: U
Vaccine: FLUA3, FLUA3
Symptoms: Dry mouth, Heart rate abnormal, Insomnia, Pruritus, Tachycardia
Clinical narrative: Tachycardia, dry mouth, itching, weak heart rate, insomnia x3 days.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Blister
Clinical narrative: Patient developed a varicella like blister approximately 2 inches away from injection site. Referred patient to primary care provider for diagnosis and treatment.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Diffuse redness, tissue swelling, warmness to touch, tenderness to touch.
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Swelling
Clinical narrative: The area present  swelling, redness.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injection site pain, Musculoskeletal pain
Clinical narrative: Pt complains of soreness at injection site that evening and next day. Soreness went away after 2 days. A few weeks later, pt developed pain ache in shoulder, elbow, and outer left hip area. Pain in elbow, hip and shoulder lasted 10 days. There was still pain in the upper left bicep area.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chest discomfort, Dyspnoea, Erythema, Malaise, Mouth swelling
Clinical narrative: WITHIN SECONDS, PATIENT TOLD ME THAT SHE WAS NOT FEELING WELL. SHE COMPLAINED ABOUT A HEAVINESS IN HER CHEST, HER THROAT FELT "FUNNY" AND FELT LIKE IT WAS CLOSING AND SHE WAS TURNING A BRIGHT RED, SPLOTCHY COLOR ON HER FACE AND CHEST. I NOTICED SWELLING AROUND HER MOUTH AND SHE COMPLAINED ABOUT FEELING WORSE. I INJECTED HER WITH 0.3 MG EPINEPHRINE IN HER LEFT THIGH AND SHE IMMEDIATELY FELT BETTER AND REDNESS WENT AWAY AND BREATHING DIFFICULTY RESOLVED.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Rash macular, Throat tightness
Clinical narrative: WITHIN SECONDS, PATIENT TOLD ME THAT SHE WAS NOT FEELING WELL. SHE COMPLAINED ABOUT A HEAVINESS IN HER CHEST, HER THROAT FELT "FUNNY" AND FELT LIKE IT WAS CLOSING AND SHE WAS TURNING A BRIGHT RED, SPLOTCHY COLOR ON HER FACE AND CHEST. I NOTICED SWELLING AROUND HER MOUTH AND SHE COMPLAINED ABOUT FEELING WORSE. I INJECTED HER WITH 0.3 MG EPINEPHRINE IN HER LEFT THIGH AND SHE IMMEDIATELY FELT BETTER AND REDNESS WENT AWAY AND BREATHING DIFFICULTY RESOLVED.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site haemorrhage, Injection site swelling
Clinical narrative: Vaccine administered intramuscularly in left arm. Arm began to swell around injection site immediately after need was removed. Small area of ecchymosis developed just below injection site with swelling around the injection site, about 2 to 2.5 inches in diameter. Ice was immediately applied for 15 minutes. Patient was observed for 15 minutes. Swelling did improve after the 15 minutes of icing. No additional rash, swelling, itching developed. The patient had no trouble breathing, no itching or swelling of face, lips or throat, no dizziness. She was instructed to take Benadryl and ibuprofen when she got home, to go to the ER for worsening swelling, new rash, itching of body, dizziness, swelling or itching of mouth, lips, face or throat. She was instructed to follow-up with her PCP the next day if not continuing to improve. I did attempt to call patient today for an update, but was not able to speak with her as of now. I did leave a message asking her to call back with an update.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Computerised tomogram normal, Dizziness, Dysarthria, Influenza, Laboratory test normal
Clinical narrative: Got the flu in December (strand B). Never fully recovered; low grade fevers throughout month of December and first week of January. Experienced severe dizziness as of January 5. Vertigo was ruled out along with any other neurological diseases of the brain. Speech is slurred and dizziness is still present. Can't walk independently; required assistance for most ADL's.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of personal independence in daily activities, Lumbar puncture normal, Nuclear magnetic resonance imaging normal, Pyrexia, Walking aid user
Clinical narrative: Got the flu in December (strand B). Never fully recovered; low grade fevers throughout month of December and first week of January. Experienced severe dizziness as of January 5. Vertigo was ruled out along with any other neurological diseases of the brain. Speech is slurred and dizziness is still present. Can't walk independently; required assistance for most ADL's.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Blood pressure decreased, Injected limb mobility decreased, Injection site discomfort, Injection site pain, Pain
Clinical narrative: Patient said the pain and discomfort in her left shoulder started on 1/27/18 in the evening. She had a drop in blood pressure and severe pain. She went to the ER and had x-rays taken to ensure the tip of the syringe had not broken off. It did not, and she was given pain medication, monitored, and then discharged. The pain has subsided (1/29/18) a bit but, she is having difficulty lifting her left arm higher than a few inches. She was referred back to her PCP for follow-up.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: X-ray limb normal
Clinical narrative: Patient said the pain and discomfort in her left shoulder started on 1/27/18 in the evening. She had a drop in blood pressure and severe pain. She went to the ER and had x-rays taken to ensure the tip of the syringe had not broken off. It did not, and she was given pain medication, monitored, and then discharged. The pain has subsided (1/29/18) a bit but, she is having difficulty lifting her left arm higher than a few inches. She was referred back to her PCP for follow-up.
Age: 33.0
Sex: F
Vaccine: TDAP, YF
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: About 24 hours after receiving the vaccine, starting having chills; then later in the evening felt feverish, oral T=100F, and had arm significant pain to touch and with movement.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Rash
Clinical narrative: Patient said his arm swelled up and he got a rash on his arm. Then a couple of days later, he got a rash on his other arm and some other places on his body. He did not treat the rash with anything. He said the swelling on the arm went down but he still has places with a rash.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Loss of personal independence in daily activities, Pain, Post herpetic neuralgia
Clinical narrative: Information has been received on 26-JAN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions and concomitant medications are unknown. The patient had a medical history of a skin condition in 2013 that was inconclusively determined that it could be shingles. The patient was informed that the ZOSTAVAX could be effective in preventing the recurrence of shingles if the episode was herpes zoster. On or about 13-AUG-2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous, as recommended for routine adult health maintenance and for the prevention of future shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster that persisted for years in duration. On or about 28-DEC-2013, the patient was treated by a physician and again further treated by another physician for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. On or about 22-SEP-2014, the patient was again treated by a physician for ongoing and worsening symptoms of shingles, at which time she was given the additional diagnosis of post-herpetic neuralgia, a chronic condition of residual pain and nerve damage secondary to zoster infections. The patient was hospitalized for the severity of her post-herpetic neuralgia. On or about 08-AUG-2016, the patient sought subsequent treatment for ongoing and uncontrolled symptoms of post-herpetic interfering with her daily life. The patient has been prescribed NORCO, VALTREX and hydrocodone for management of her painful breakouts. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. 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: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received on 26-JAN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions and concomitant medications are unknown. The patient had a medical history of a skin condition in 2013 that was inconclusively determined that it could be shingles. The patient was informed that the ZOSTAVAX could be effective in preventing the recurrence of shingles if the episode was herpes zoster. On or about 13-AUG-2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous, as recommended for routine adult health maintenance and for the prevention of future shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster that persisted for years in duration. On or about 28-DEC-2013, the patient was treated by a physician and again further treated by another physician for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. On or about 22-SEP-2014, the patient was again treated by a physician for ongoing and worsening symptoms of shingles, at which time she was given the additional diagnosis of post-herpetic neuralgia, a chronic condition of residual pain and nerve damage secondary to zoster infections. The patient was hospitalized for the severity of her post-herpetic neuralgia. On or about 08-AUG-2016, the patient sought subsequent treatment for ongoing and uncontrolled symptoms of post-herpetic interfering with her daily life. The patient has been prescribed NORCO, VALTREX and hydrocodone for management of her painful breakouts. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. 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: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies, and concomitant medications were not reported. The pharmacist reported that on 23-JAN-2018, the patient was vaccinated with an expired dose of PNEUMOVAX 23 for prophylaxis, lot number M029681 and expiration date 22-JAN-2018 (strength, dose and route of administration were not reported). No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 26-JAN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 28-NOV-2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous, 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 12-JAN-2015, the patient was treated at an urgent care facility for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed valacyclovir for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. 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.
Age: 67.0
Sex: M
Vaccine: FLU4
Symptoms: Colitis, Influenza, Influenza like illness, Malaise
Clinical narrative: Colitis-annoying an uncomfortable mild flu like symptoms malaise and got type A flu.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Skin warm
Clinical narrative: Rash. Area red and hot to touch per telephone call 10-16-17 0836.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Peripheral swelling
Clinical narrative: Pain at site of injection around 8:00 PM. No discomfort prior to that. Progressively worsened all night. Swelling down to elbow. Went to ER at 5:00 AM due to extreme pain. Treated with steroids and BENADRYL through IV. Left around 7:30. Swelling continued over next few days and traveled down through hand. By 1-22 arm was normal.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Nausea, Syncope
Clinical narrative: W/in 1-2 min of vaccination pt had syncope episode < 1 min. Some nausea x 15-20 minutes. Observed x 30-40 min. Back to baseline x 15-20 min prior to discharge home.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle spasms, Muscle tightness, Swelling, Tongue spasm
Clinical narrative: Employee experienced swelling, tightness and spasms in the neck and tongue.