chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Blood test, Dyskinesia, Ear infection, Electroencephalogram, Erythema
Clinical narrative: FIRST HE DEVELOPED LOCAL REDNESS AND SWELLING AT INJECTION SITE, THEN HE DEVELOPED DIARRHEA. FEW DAYS LATER HE DEVELOPED TWITCHING OF EYES AND BODY. HE WAS SEEN IN THE OFFICE ON 2/4/2019. BLOOD W/U WAS ORDERED. ON 2/5/2019 HE WAS ADMITTED TO HOSPITAL EEG AND MRI WAS DONE. HE ALSO DEVELOPED A FEVER IN THE HOSPITAL.
Age: 3.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Excessive eye blinking, Gait disturbance, Induration, Injection site warmth, Muscle spasms
Clinical narrative: FIRST HE DEVELOPED LOCAL REDNESS AND SWELLING AT INJECTION SITE, THEN HE DEVELOPED DIARRHEA. FEW DAYS LATER HE DEVELOPED TWITCHING OF EYES AND BODY. HE WAS SEEN IN THE OFFICE ON 2/4/2019. BLOOD W/U WAS ORDERED. ON 2/5/2019 HE WAS ADMITTED TO HOSPITAL EEG AND MRI WAS DONE. HE ALSO DEVELOPED A FEVER IN THE HOSPITAL.
Age: 3.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Muscle twitching, Nuclear magnetic resonance imaging, Seizure like phenomena, Swelling, Tic
Clinical narrative: FIRST HE DEVELOPED LOCAL REDNESS AND SWELLING AT INJECTION SITE, THEN HE DEVELOPED DIARRHEA. FEW DAYS LATER HE DEVELOPED TWITCHING OF EYES AND BODY. HE WAS SEEN IN THE OFFICE ON 2/4/2019. BLOOD W/U WAS ORDERED. ON 2/5/2019 HE WAS ADMITTED TO HOSPITAL EEG AND MRI WAS DONE. HE ALSO DEVELOPED A FEVER IN THE HOSPITAL.
Age: 3.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Blepharospasm, Blood test, Diarrhoea, Electroencephalogram, Injection site erythema
Clinical narrative: FIRST HE DEVELOPED LOCAL REDNESS AND SWELLING AT INJECTION SITE, THEN HE DEVELOPED DIARRHEA. FEW DAYS LATER HE DEVELOPED TWITCHING OF EYES AND BODY. HE WAS SEEN IN THE OFFICE ON 2/4/2019. BLOOD W/U WAS ORDERED. ON 2/5/2019 HE WAS ADMITTED TO HOSPITAL EEG AND MRI WAS DONE. HE ALSO DEVELOPED A FEVER IN THE HOSPITAL.
Age: 3.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Injection site swelling, Muscle twitching, Nuclear magnetic resonance imaging normal, Pyrexia
Clinical narrative: FIRST HE DEVELOPED LOCAL REDNESS AND SWELLING AT INJECTION SITE, THEN HE DEVELOPED DIARRHEA. FEW DAYS LATER HE DEVELOPED TWITCHING OF EYES AND BODY. HE WAS SEEN IN THE OFFICE ON 2/4/2019. BLOOD W/U WAS ORDERED. ON 2/5/2019 HE WAS ADMITTED TO HOSPITAL EEG AND MRI WAS DONE. HE ALSO DEVELOPED A FEVER IN THE HOSPITAL.
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Injection site cellulitis
Clinical narrative: Admitted 1/27-1/29/19 for Left Arm cellulitis, originating from site of injection. Treated with clindamycin.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Neck pain, Pain, Pain in extremity
Clinical narrative: 3 hours after shot, left arm started hurting a lot and got worse during the afternoon. Next morning right side of neck was hurting and difficult to move neck freely without discomfort. Mild headaches came and went. Used heating pad on and off for neck. Ice pack for headache. Steady improvement but Monday morning still slight neck issues. Have submitted note to the doctor for discussion.
Age: 1.67
Sex: M
Vaccine: VARCEL
Symptoms: Allodynia, Asthma, Back pain, Herpes zoster, Neurological examination normal
Clinical narrative: Information has been received from the authors in a published literature article, regarding a 3 year old male child. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, at the age of 20 months, the patient was vaccinated with varicella virus vaccine live (oka/merck) (manufacturer unknown) (dose, strength, frequency, route of administration, lot number and expiration date were not provided) in the right arm for prophylaxis. On unknown date, at age 3 years 3 months, the patient went to the emergency department because of lower back pain and a new rash of 3 days duration. The rash consisted of around 25 vesicles located to the left of the spine along dermatomes L4-S1, with a few vesicles on the left leg. He complained of pain and itchiness at the rash site and was reluctant to walk in the emergency department. He had experienced no changes in bowel or bladder function. After admission, a neurologic examination revealed no deficits, but did reveal allodynia to light touch in the distribution of rash. He had full strength in all limbs, no apparent sensory deficits and normal muscle stretch reflexes. Because a screening polymerase chain reaction (PCR) test of the rash was positive for varicella zoster virus (VZV) and the patient was diagnosed with herpes zoster (shingles). The patient was treated with acyclovir suspension for 10 days. His rash and other symptoms slowly resolved with no further complaints on an unknown date. The author considered the events to be related to the suspect therapy. The child had never had wild-type varicella nor had he been exposed to family members with herpes zoster. In follow-up, the child developed signs of asthma, but no evidence of autoimmune diseases or neuralgia. The author stated in some immunized children, virus reactivates within a few months to a few years to cause the dermatomal exanthem known as herpes zoster (shingles). Herpes zoster induced by varicella vaccination usually occurs within months to a few years after the vaccination in immunocompetent children. This is one of 3 cases from the same literature article 1901USA011678, 1902USA002563 and 1902USA002564. A copy of the published article is attached as further documentation of the patient's experience. Sender's Comments: US-009507513-1902USA002563: US-009507513-1902USA002564.
Age: 1.67
Sex: M
Vaccine: VARCEL
Symptoms: Polymerase chain reaction positive, Rash, Rash pruritic, Rash vesicular, Varicella virus test positive
Clinical narrative: Information has been received from the authors in a published literature article, regarding a 3 year old male child. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, at the age of 20 months, the patient was vaccinated with varicella virus vaccine live (oka/merck) (manufacturer unknown) (dose, strength, frequency, route of administration, lot number and expiration date were not provided) in the right arm for prophylaxis. On unknown date, at age 3 years 3 months, the patient went to the emergency department because of lower back pain and a new rash of 3 days duration. The rash consisted of around 25 vesicles located to the left of the spine along dermatomes L4-S1, with a few vesicles on the left leg. He complained of pain and itchiness at the rash site and was reluctant to walk in the emergency department. He had experienced no changes in bowel or bladder function. After admission, a neurologic examination revealed no deficits, but did reveal allodynia to light touch in the distribution of rash. He had full strength in all limbs, no apparent sensory deficits and normal muscle stretch reflexes. Because a screening polymerase chain reaction (PCR) test of the rash was positive for varicella zoster virus (VZV) and the patient was diagnosed with herpes zoster (shingles). The patient was treated with acyclovir suspension for 10 days. His rash and other symptoms slowly resolved with no further complaints on an unknown date. The author considered the events to be related to the suspect therapy. The child had never had wild-type varicella nor had he been exposed to family members with herpes zoster. In follow-up, the child developed signs of asthma, but no evidence of autoimmune diseases or neuralgia. The author stated in some immunized children, virus reactivates within a few months to a few years to cause the dermatomal exanthem known as herpes zoster (shingles). Herpes zoster induced by varicella vaccination usually occurs within months to a few years after the vaccination in immunocompetent children. This is one of 3 cases from the same literature article 1901USA011678, 1902USA002563 and 1902USA002564. A copy of the published article is attached as further documentation of the patient's experience. Sender's Comments: US-009507513-1902USA002563: US-009507513-1902USA002564.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: This spontaneous report was received from a nurse practitioner via physician via Pfizer refers to a currently 70 years old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, anatomical location, route, lot# and expiry date were not reported) for prophylaxis. On an unknown date, the patient experienced allergy while on therapy with PNEUMOVAX 23. The outcome of the event was unknown. The causal relationship between the event of drug hypersensitivity and the therapy with PNEUMOVAX was related.  This case is related to case# 1902USA003392 (Same patient link).
Sex: U
Vaccine: FLUX, PPV
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This spontaneous report was received from a pharmacist via Pfizer (MFR control# 2017487097) regarding a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapy was not reported. The patient's historical vaccine included PREVNAR 13. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, strength, anatomical location, route, lot/batch and expiration date were not reported) and high dose flu vaccine influenza virus vaccine (unspecified) for prophylaxis. On an unknown date, the patient had heat (vaccination site warmth), swelling (vaccination site swelling) and rash (vaccination site erythema) after receiving PNEUMOVAX 23. The outcome of vaccination site warmth, vaccination site swelling, and vaccination site erythema were considered to be recovered as the patient called on 30-OCT-2017 (reported as two days back) and informed that everything were back to normal. Causality assessment was not provided by the reporter.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's medical history, concurrent diseases, drug allergies/reactions and concomitant therapies were not reported. On 30-JAN-2019, the patient received a dose of ROTATEQ lot # N012757, expiry date: 27-JAN-2019; given orally for prophylaxis. Patient had no known adverse effects. Product quality complaint was not involved.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: This spontaneous report was received from a male patient of unknown gender via nurse practitioner regarding himself. Concurrent condition included prevention of pneumococcal disease. The patient's medical history included high blood pressure. Concomitant medications included unspecified high blood pressure medication. On an unknown date in December 2018 (reported as about a month ago), the patient was vaccinated with first dose of PNEUMOVAX 23 (strength, dose, anatomical location, lot# and expiry date were not reported) for prevention of pneumococcal disease. On an unknown date in December 2018 (reported as since the time of vaccination), the patient experienced pain in the shoulder of the arm where patient received the shot. The patient also reported that "the pain has gotten worse and it had become hard to move his arm". The patient sought medical attention. The patient did not receive any treatment. No lab test were performed. At the time of reporting, the outcome of the event was not recovered. Causality assessment was not provided. No Product Quality Complaint (PQC) was involved.
Sex: F
Vaccine: MMR
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report was received from the patient's mother and refers to a currently 15-year-old female patient. The patient's concurrent conditions and concomitant medications were not reported. The patient's medical history included combination vaccine for the prevention of diphtheria, tetanus, pertussis, and polio (manufacturer unknown). On an unknown date, the patient was vaccinated with the first dose of M-M-R II (exact dose, route of administration, lot# and expiration date were not specified) for prophylaxis. The reporter said she had been hesitant about having her daughter get a second shot of the M-M-R II because her daughter "reacted as a baby" after getting one dose of another combination vaccine for the prevention of diphtheria, tetanus, pertussis, and polio (manufacturer unknown). It was unclear from the reporter if her daughter never got a second dose for the M-M-R II solely over the mother's concern that her daughter (as a baby) had an unspecified reaction to an unknown combination vaccine for the prevention of diphtheria, tetanus, pertussis, and polio or if the daughter possibly had some kind of unknown reaction to the first dose of the M-M-R II. The outcome of the event was unknown. The relatedness between the event and M-M-R II was not reported.
Sex: F
Vaccine: HPV4
Symptoms: Coma, Seizure
Clinical narrative: This spontaneous report was received from a consumer via Pfizer (MFR control# 2017532915) regarding her relative, a female patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with first dose of GARDASIL (lot #, expiration date not reported) for prophylaxis. On an unknown date, after receiving the first shot of 3 shot series of GARDASIL, the patient had 18 seizures back to back in one day. On an unknown date, the patient was brought to the hospital and was life flighted where she was in a coma for 8 months. The patient was tried to be taken off the medication in June 2014 (reported as 3.5 years ago as on 11-DEC-2017). Outcome of the events was unknown. Causality was not reported for the events. Upon internal review, coma and seizure was determined to be medically significant.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from register nurse referring to a patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 06-FEB-2019, the patient was vaccinated with M-M-R II lot # R013129 Expiration date 03-FEB-2019 (strength, dosage, frequency were not reported) for prophylaxis. No adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug and allergy history or concomitant medications. On an unknown date, the patient was vaccinated with M-M-R II, intramuscularly (strength, dose, frequency, lot# and expiration date were not provided) for prophylaxis (incorrect route of product administration).
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Rash, Respiration abnormal, Urticaria
Clinical narrative: Hives, rash, breathing abnormality. Treated at home with 5mL of generic BENADRYL at 4:30pm. Treated at local urgent care facility at 5pm, held in observation until 8pm. Was given steroid and BENADRYL. Prescribed steroid for home administration and epinephrine pen for use at home as needed.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt noticed redness on right medial aspect of right arm, tender to touch.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient received a Hep B, was suppose to be Hep A, Hep B series was completed.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Hypophagia, Influenza like illness, Injection site erythema
Clinical narrative: Around 1pm patient received the vaccine and went to bed around 9pm. Normal temperature is 97.5 but had fever since temperature was at 99.7. Patient felt nauseous but did not take any medication. Next day, called doctor on, the next day. Patient felt like had flu, headache, fever, could not eat very much, and nauseous. Eventually took all regular meds, took Tylenol and Aspirin to help for fever. Still had fever on 2nd day in the morning but by 10am did not have fever. Went to the doctor and patient was told to take it easy; no meds were given. Headache lasted through the 3rd day. Today feeling much better, not energetic but ok. Patient had redness, soreness at site of vaccination; there was no swelling like after the first dose. Patient feels she is on her way to recovery.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Around 1pm patient received the vaccine and went to bed around 9pm. Normal temperature is 97.5 but had fever since temperature was at 99.7. Patient felt nauseous but did not take any medication. Next day, called doctor on, the next day. Patient felt like had flu, headache, fever, could not eat very much, and nauseous. Eventually took all regular meds, took Tylenol and Aspirin to help for fever. Still had fever on 2nd day in the morning but by 10am did not have fever. Went to the doctor and patient was told to take it easy; no meds were given. Headache lasted through the 3rd day. Today feeling much better, not energetic but ok. Patient had redness, soreness at site of vaccination; there was no swelling like after the first dose. Patient feels she is on her way to recovery.
Age: 73.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site pain
Clinical narrative: Site pain.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Patient was given expired vaccine. Vaccine expired on 01/30/2019.
Age: 13.0
Sex: F
Vaccine: HEPA, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Peripheral swelling
Clinical narrative: WOKE UP ON 2/82019 W/ SWOLLEN RT. FOREARM THAT WAS RED, HOT, TENDER, BELOW INJECTION SITE ON RT. DELTOID AND MEDIAL BICEPS AREA. NO TREATMENT OR RX GIVEN. THE SYMPTOMS WENT AWAY BY THE EVENING OF 2/9/2019. ON PE 2/11/19 - THE RT. ARM WAS COMPLETELY NL W/ F.R.O.M. W/O ANY PAIN, NL SENSORY/MOTOR EXAM. P.S: PT. WAS ON AMOXICILLIN 875 MG BID FOR AROM, DX 2/7/19.
Age: 77.0
Sex: M
Vaccine: TDAP
Symptoms: Swelling, Tenderness
Clinical narrative: Swelling and tenderness.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Muscle spasms
Clinical narrative: Severe low back pain; muscle spasm.
Sex: F
Vaccine: VARZOS
Symptoms: Neoplasm malignant
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of cancer in a female patient who received SHINGRIX for prophylaxis. In October 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced cancer (serious criteria GSK medically significant). On an unknown date, the outcome of the cancer was unknown. It was unknown if the reporter considered the cancer to be related to SHINGRIX. Additional details were provided as follows: The patient's initials and date of birth were unknown. The age at vaccination was not reported. The reporter was unsure if the SHINGRIX was administered by the reporting facility. The patient was diagnosed with cancer after receiving SHINGRIX. The reporter stated that the patient contacted the pharmacy while calling around trying to find a place where the vaccine was available. The reporter was also unsure of any additional details about the patient's cancer diagnosis. The reporter consented to follow up.
Age: 36.0
Sex: M
Vaccine: MNQ
Symptoms: Body temperature increased, Chills, Influenza virus test negative, Pain in extremity, Tremor
Clinical narrative: Temperature 103, chills, shaking, right arm pain.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Apnoeic attack, Chest X-ray, Ear infection, Electrocardiogram, Injection site erythema
Clinical narrative: After receiving the shot on 22May, around 12pm he started becoming lethargic and started to develop a fever. On the 23rd, the injection site was red and swollen. He flinched when I would touch the site. There was also a ring around the site. On the 24th his fever had reached 103F. I gave him MOTRIN to lower his fever. On the 25th, in the morning his fever was down to 100F but by 12pm it had spiked to 103.7F. On the 26th, his fever finally broke but he was now covered in a rash. On the 29th, we went to his doctor and ER because the night before I woke up to him not breathing and his lips were dark. After we finally woke him up, he took a deep breath. At the ER he was diagnosed with an ear infection and an Apneic episode. As of today, (11Feb2019) he is still having episodes where he will stop breathing but not as a severe as the one that happened on the 28/29 May.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site pain, Injection site swelling, Lethargy, Lip discolouration, Pyrexia
Clinical narrative: After receiving the shot on 22May, around 12pm he started becoming lethargic and started to develop a fever. On the 23rd, the injection site was red and swollen. He flinched when I would touch the site. There was also a ring around the site. On the 24th his fever had reached 103F. I gave him MOTRIN to lower his fever. On the 25th, in the morning his fever was down to 100F but by 12pm it had spiked to 103.7F. On the 26th, his fever finally broke but he was now covered in a rash. On the 29th, we went to his doctor and ER because the night before I woke up to him not breathing and his lips were dark. After we finally woke him up, he took a deep breath. At the ER he was diagnosed with an ear infection and an Apneic episode. As of today, (11Feb2019) he is still having episodes where he will stop breathing but not as a severe as the one that happened on the 28/29 May.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Rash generalised, Respiratory arrest, Sleep study
Clinical narrative: After receiving the shot on 22May, around 12pm he started becoming lethargic and started to develop a fever. On the 23rd, the injection site was red and swollen. He flinched when I would touch the site. There was also a ring around the site. On the 24th his fever had reached 103F. I gave him MOTRIN to lower his fever. On the 25th, in the morning his fever was down to 100F but by 12pm it had spiked to 103.7F. On the 26th, his fever finally broke but he was now covered in a rash. On the 29th, we went to his doctor and ER because the night before I woke up to him not breathing and his lips were dark. After we finally woke him up, he took a deep breath. At the ER he was diagnosed with an ear infection and an Apneic episode. As of today, (11Feb2019) he is still having episodes where he will stop breathing but not as a severe as the one that happened on the 28/29 May.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Pruritus
Clinical narrative: Patient describes having raised blisters primarily on his left palm. There are a few on his right as well. No pain associated with the blisters. They do itch.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister
Clinical narrative: Patient describes having raised blisters primarily on his left palm. There are a few on his right as well. No pain associated with the blisters. They do itch.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Chest X-ray normal, Cough, Dyspnoea, Electrocardiogram normal, Headache
Clinical narrative: Patient experienced nonproductive cough, nasal congestion, rhinitis and mild headache over the following 8 hours after receiving the vaccination. Symptoms progressed to nausea and vomiting and shortness of breath over the next 36 hours. Initially seen and treated with MUCINEX/SUDAFED, ibuprofen and acetaminophen, the following day he was seen again and treated with ZOFRAN/albuterol. EKG and chest x-ray were performed on the second day which were normal.
Age: 25.0
Sex: M
Vaccine: SMALL
Symptoms: Nasal congestion, Nausea, Rhinitis, Vomiting
Clinical narrative: Patient experienced nonproductive cough, nasal congestion, rhinitis and mild headache over the following 8 hours after receiving the vaccination. Symptoms progressed to nausea and vomiting and shortness of breath over the next 36 hours. Initially seen and treated with MUCINEX/SUDAFED, ibuprofen and acetaminophen, the following day he was seen again and treated with ZOFRAN/albuterol. EKG and chest x-ray were performed on the second day which were normal.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site vesicles
Clinical narrative: A fluid blister has formed close to injection site with no pain per patient.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Pruritus, Rash
Clinical narrative: Rash broke out on mainly left arm some on left arm spot leg. Itches and burns also.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Lip pain, Oral pain, Rash
Clinical narrative: Patient presented on Monday 2/11 stating the day after receiving SHINGRIX she had mouth, lip, chin, and facial pain with raised bumps that she thought were shingles. I advised setting an appointment with primary care to have the rash evaluated.
Age: 42.0
Sex: M
Vaccine: RAB
Symptoms: Rash
Clinical narrative: Rash occurred on left leg almost immediately. When patient returned to clinic on 2/11/19, the rash continued on the left leg and appeared on the right leg.
Sex: F
Vaccine: FLUA3
Symptoms: Expired product administered
Clinical narrative: This spontaneous case, initially received on 20-Aug-2018 was reported by a physician and concerns a female patient of an unspecified age. On an unspecified date, the patient received last year's FLUAD (TIV) (batch number: 179201, expiry date: 30-Jun-2018, dose, route of administration, anatomical location: not reported). The reporter assessed the case as non-serious.
Age: 68.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain, Mobility decreased, Nausea, Pain
Clinical narrative: This spontaneous case, initially received from other non-healthcare professional (consumer) on 11-Jul-2018, concerns a 68-year-old, elderly, female patient. The patient's current condition included high cholesterol (reported as medical history) (since an unspecified date). The patient's concomitant medications included LIVALO for cholesterol and ZANTAC for an unknown indication. On 02-Feb-2018, the patient was administered FLUAD [dose: 0.5 ml, anatomical location: left arm, route of administration, batch number and expiry date: not reported]. On the same day, immediately after vaccination, the patient experienced pain at injection site and nausea for few hours. No bruising or swelling were observed. On an unspecified date in 2018, the patient experienced extreme pain and was unable to scratch her back. Patient consulted a cardiologist and was advised to visit her primary care physician (PCP). Patient was given antibiotics (unspecified). It was reported that, the patient's condition had worsened a little over the time. At the time of this report, the patient had not recovered from the events. The reporter assessed the case as non-serious.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MNQ, PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to an unspecified patient of unknown age and unknown gender. Information about pertinent medical history, concurrent conditions and drug reactions/allergies was not provided. Concomitant medication included sterile diluent. On 15-JAN-2019, the patient inadvertently received an expired dose of VARIVAX (injection, lot number: N001528, expiration date: 13-JAN-2019; strength, frequency and route unspecified) for prophylaxis. Lot number and expiration for sterile diluent injection used to reconstitute the vaccine were reported as N030026, expiration date 04-JUN-2020. No adverse effects were reported.
Sex: U
Vaccine: RV5, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 05-FEB-2019, the patient was inadvertently vaccinated with a dose of ROTATEQ (lot# N011648, expiration date of 01-DEC-2018, strength, dose and frequency were unknown) orally for prophylaxis (Expired product administered). No adverse event was reported. No product quality compliant (PQC) was involved.
Age: 17.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: This spontaneous report as received from a nurse refers to a 17-year-old patient of unknown gender. No information regarding patient's pertinent medical history, drug reactions, allergies, concomitant medications was provided. On 30-JAN-2019, the patient was vaccinated with a partial dose of GARDASIL 9, lot number R024264, expiration date 29-10-2019 (dose, dose number, route of administration were not provided) for prophylaxis. The nurse reported that during vaccine administration on 30-JAN-2019, after the dose was drawn from the vial into a syringe, the hub of the needle separated from the syringe and some of the medicine came out of the syringe. As a result, a partial dose was given to the patient. There was no adverse event reported.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Herpes zoster, Pain, Pruritus, Rash
Clinical narrative: This spontaneous report was received from a 77-year-old non-pregnant female patient regarding herself. Patient did not have any medical history and had no drug reactions/allergies. Concomitant medication included ZYRTEC. On 13-MAY-2014, the patient was vaccinated with ZOSTAVAX shot for preventions of shingles (dosage schedule was not reported). Since the shot, the patient had a total of 4 outbreaks of "mild" shingles. First outbreak was on 20-MAY-2016. Second was on 23-JUL-2016. Third outbreak began on 26-JAN-2017. The fourth was just this month, 10-JAN-2019. Each attack was a "mild" outbreak of shingles appearing somewhere on her waist. It started in the front, then moved to her right side, and was currently on her back. Each time she had a break out she was treated with calamine lotion for itching, ice packs on the rash, a 10-day regimen of valacyclovir (manufacturer and dose unspecified) and fluticasone propionate cream 0.05% (manufacturer unspecified) for the itching and pain. The patient reported that last time she took the "purple pills" (valacyclovir), she got a blood pressure reading of 192/87 on 10-JAN-2019 and prior to this reading 130/80 was her normal blood pressure range. The patient also added that the attacks were relatively mild compared to what she had seen on television. The patient reported that the shingles had all appeared in her waist area, the rash was circumventing her waist, center, right side and back. She had to wear loose underwear and put ice in the small of her back on the rash. The patient sought medical attention by visiting the physician's office. Outcome of the events "First Shingles outbreak", "Second outbreak was on 23-JUL-2016" and "Third outbreak of shingles began on 26-JAN-2017" was unknown. Outcome of the event "The fourth outbreak of shingles was just this month, 10-JAN-2019" was reported as not recovered. Causality of the events were not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Pneumonia
Clinical narrative: Information has been received regarding a case in litigation from a lawyer and female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2018, the patient was inoculated with the ZOSTAVAX vaccine (lot number, dosage and route of administration not provided) for routine health maintenance and for the prevention of shingles. Shortly after receiving the ZOSTAVAX, the patient developed difficulty breathing. In response to these complaints, the patient presented to a physician and was diagnosed as suffering from pneumonia. As a result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. As a direct and proximate result of ZOSTAVAX vaccine, the patient's symptoms and diagnose(s) have resulted in physical limitations not present prior to using the ZOSTAVAX. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate consequence of the ZOSTAVAX, the patient sustained serious personal injuries and related losses including, but not limited to, the following: The patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. The outcome of the events was considered to be not recovered. Upon internal review, pneumonia was determined to be medically significant. Pneumonia was considered to be disabling. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive
Clinical narrative: This spontaneous report was received from a nurse practitioner and refers to a 22-year-old female patient. The patient had no pertinent medical history, concomitant medications or drug reactions and allergies. On 28-JUN-2010, the patient was vaccinated with the first dose of GARDASIL intramuscularly (exact dose, site of administration, lot# and expiration date were not reported) for prophylaxis. On 17-SEP-2010, the patient received the second dose and on 11-JUN-2011, the third dose of GARDASIL intramuscularly (exact doses, site of administration, lot# and expiration dates were not reported). On 10-JAN-2019, the reporter performed a papanicolaou test which revealed the patient was positive for high risk human papillomavirus (HPV) types 16 and 18. The patient did not sought medical attention. No treatment was given for the event. The outcome of the event was reported as not recovered. The relatedness between the event and GARDASIL was not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a 67 year old male patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX vaccine by a healthcare provider for long term prevention of shingles and zoster related conditions. In 2009, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 28-DEC-2015, the patient was treated by a physician for shingles. The patient claims damages including: injury to himself, loss of consortium, loss of services and economic losses. The outcome of the shingles was unknown. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician and refers to a 1-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 04-FEB-2019, the patient was vaccinated with a dose of improperly stored VARIVAX, lot# R009820, expiration date 03-APR-2020, (dose, route of administration were not reported) for prophylaxis. VARIVAX was improperly stored between 6 to 14 (13.8 F) degrees Fahrenheit for 1 hour and 20 minutes and between 15 to 46 (27.1) degrees Fahrenheit for 2 hours (date was not provided). Previous temperature excursion was also reported to be between 15 to 46 degrees Fahrenheit for 1 hour and 30 minutes and between 47 to 77 (54F) degrees Fahrenheit for 12 hours (date was not provided). Data logger was not involved. No adverse effects were reported. This report is one of two reports received from the same reporter (MARRS #1902USA002295). Sender's Comments: US-009507513-1902USA002295.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from the patient's mother via a pharmacist refers to a currently 4-month-old male patient. The patient had no pertinent medical history, drug reactions or allergies or concomitant therapies. On 21-NOV-2018, the patient was vaccinated with the first dose and on 03-DEC-2018, with the second dose of ROTATEQ lot # R013289, expiration date: 03-OCT-2019, orally for prophylaxis (exact doses were not reported). On an unknown date, after receiving ROTATEQ, the patient experienced fever (it was unspecified if fever was after the first dose, the second dose or after both doses of ROTATEQ). The fever went away without any treatment within a "few hours." No treatment was given for the event. No lab diagnostics or studies were performed. The relatedness between the event and ROTATEQ was not reported.
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: This spontaneous report was received from a consumer via Pfizer refers to her daughter of unknown age. The patient concurrent condition, concomitant medication and medical history were unknown. On an unknown date, the patient was vaccinated with GARDASIL (strength, dose, frequency, route of administration, lot # and expiry date unspecified) for prophylaxis. On an unknown date, the patient died (death). The consumer also reported about 354 deaths due to GARDASIL. The consumer reported that her daughter's information was on goggle. It was unable to clarify if reporter was referring to her daughter  as one of the 354 deaths. The cause of death was not reported. It was unknown if autopsy was done. Causality assessment was also not reported.; Reported Cause(s) of Death: unknown.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received SHINGRIX for prophylaxis. On 31st January 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced headache, pain and shivering. On an unknown date, the outcome of the headache, pain and shivering were unknown. It was unknown if the reporter considered the headache, pain and shivering to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX the day before reporting and feel achy headache and shivering. The patient just wondered how soon these symptoms would subside.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. On 29th January 2019, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site warmth and tiredness. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site warmth and tiredness were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site warmth and tiredness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had the SHINGRIX shot this past Tuesday afternoon, and experienced a large red spot under the shot now, it was warm and it was sore to the touch. The patient also felt a little bit more tired than usual. The patient was asking if this was natural or he should be concerned about this.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a physician and described the occurrence of shingles in a 76-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a year after receiving SHINGRIX, the patient experienced shingles. The patient was treated with VALTREX. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The patient developed shingles in October 2018. It was relatively mild and she received VALTREX within 72 hours and it resolved completely. The reporter was asking when the patient should receive her 2nd dose of the SHINGRIX vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of anaphylactic reaction to vaccine in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced anaphylactic reaction to vaccine (serious criteria GSK medically significant), throat constriction, swelling arm, erythema of extremities, pain in arm and skin warm. On an unknown date, the outcome of the anaphylactic reaction to vaccine, throat constriction, swelling arm, erythema of extremities and skin warm were unknown and the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the anaphylactic reaction to vaccine, throat constriction, swelling arm, erythema of extremities, pain in arm and skin warm to be related to SHINGRIX. Additional details were reported as follows: The patient was reporter's one of the pharmacist. The age at vaccination was not reported. After vaccination, the patient experienced anaphylactic reaction including throat closing. Also, the patient's upper arm had significant swelling, redness, heat and pain. The patient did not seek medical attention but at the time of reporting, the patient had significant pain. The reporter did not agree to be follow up from GlaxoSmithKline.
Sex: F
Vaccine: VARZOS
Symptoms: Throat tightness
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of anaphylactic reaction to vaccine in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced anaphylactic reaction to vaccine (serious criteria GSK medically significant), throat constriction, swelling arm, erythema of extremities, pain in arm and skin warm. On an unknown date, the outcome of the anaphylactic reaction to vaccine, throat constriction, swelling arm, erythema of extremities and skin warm were unknown and the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the anaphylactic reaction to vaccine, throat constriction, swelling arm, erythema of extremities, pain in arm and skin warm to be related to SHINGRIX. Additional details were reported as follows: The patient was reporter's one of the pharmacist. The age at vaccination was not reported. After vaccination, the patient experienced anaphylactic reaction including throat closing. Also, the patient's upper arm had significant swelling, redness, heat and pain. The patient did not seek medical attention but at the time of reporting, the patient had significant pain. The reporter did not agree to be follow up from GlaxoSmithKline.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Nodule, Pain
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of nodule in a adult female patient who received SHINGRIX for prophylaxis. On 30th January 2019, the patient received the 1st dose of SHINGRIX. On 31st January 2019, 1 days after receiving SHINGRIX, the patient experienced nodule and induration. On an unknown date, the outcome of the nodule and induration were unknown. It was unknown if the reporter considered the nodule and induration to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. On Wednesday, the patient received SHINGRIX. A following day of vaccination, the patient experienced a hard red nodule. The nodule was growing in size each day and it was painful. The reporter did not agree to follow up from GSK.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature, Hypoaesthesia, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old male patient who received SHINGRIX (batch number PK9BY, expiry date unknown) for prophylaxis. On 28th September 2018, the patient received the 1st dose of SHINGRIX. On 30th September 2018, 2 days after receiving SHINGRIX, the patient experienced injection site pain, numbness in fingers and injection site warmth. On an unknown date, the outcome of the injection site pain, numbness in fingers and injection site warmth were recovered/resolved. It was unknown if the reporter considered the injection site pain, numbness in fingers and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine in an unknown arm. The expiration date could not be located. The patient experienced numbness in his fingers and toes, about 2 days after the injection. The patient also had a mild temperature and pain at injection site. The reporter consented to follow up. The reported batch number for SHINGRIX (EK9BY) did not exist and was updated to PK9BY as per sales database. For tolerance to 2nd dose refer case US2019019199.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Erythema, Pruritus
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of vesicles in a 54-year-old female patient who received SHINGRIX (batch number N79Z5, expiry date 10th April 2021) for prophylaxis. On 10th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In January 2019, less than a month after receiving SHINGRIX, the patient experienced vesicles, erythema of extremities, burning finger and pruritus. On an unknown date, the outcome of the vesicles, erythema of extremities, burning finger and pruritus were not recovered/not resolved. It was unknown if the reporter considered the vesicles, erythema of extremities, burning finger and pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX on left deltoid. On 30th January 2019, the patient reported to have 2 erythematous vesicles on her left index finger that are burning and pruritic. The reporter did not consent to follow-up.