chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity, Periorbital swelling, Skin warm, Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of skin warm in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 13th March 2019, the patient received the 1st dose of SHINGRIX. On 13th March 2019, immediately after receiving SHINGRIX, the patient experienced skin warm, injected limb mobility decreased and pain in arm. On 14th March 2019, the patient experienced headache, diarrhea, appetite absent and weight loss. On 15th March 2019, the patient experienced sleepiness. On 19th March 2019, the patient experienced swelling of eyelid, facial swelling and allergic reaction. On 20th March 2019, the patient experienced periocular swelling. In March 2019, the outcome of the skin warm, injected limb mobility decreased, pain in arm, headache, diarrhea and appetite absent were recovered/resolved and the outcome of the sleepiness was recovered/resolved. On an unknown date, the outcome of the weight loss was unknown and the outcome of the swelling of eyelid, facial swelling, allergic reaction and periocular swelling were recovering/resolving. It was unknown if the reporter considered the skin warm, injected limb mobility decreased, pain in arm, headache, diarrhea, appetite absent, weight loss, sleepiness, swelling of eyelid, facial swelling, allergic reaction and periocular swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in her upper left arm. Immediately following the vaccination, the patient started having fever in her arm and had trouble lifting it. On 13th March 2019 at night, the patient could not sleep on her left side because her arm hurt too bad. On the next day, the patient had a headache and severe diarrhea. She had no appetite over the next few days and lost 5 pounds. On 15th March 2019, 2 days later, the patient slept for 6 hours during the day. On 19th March 2019, after 6 days, the patient's left eyelid began swelling and the bottom of her face. On 20th March 2019, there was swelling all around her eye and down her cheek. She saw her eye doctor and was told it was an allergic reaction. The patient's arm was no longer hurting, but she could felt where she got the injection if she rub it. Emergency room visit was required. The consent to follow up was given.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face, Swelling of eyelid, Weight decreased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of skin warm in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 13th March 2019, the patient received the 1st dose of SHINGRIX. On 13th March 2019, immediately after receiving SHINGRIX, the patient experienced skin warm, injected limb mobility decreased and pain in arm. On 14th March 2019, the patient experienced headache, diarrhea, appetite absent and weight loss. On 15th March 2019, the patient experienced sleepiness. On 19th March 2019, the patient experienced swelling of eyelid, facial swelling and allergic reaction. On 20th March 2019, the patient experienced periocular swelling. In March 2019, the outcome of the skin warm, injected limb mobility decreased, pain in arm, headache, diarrhea and appetite absent were recovered/resolved and the outcome of the sleepiness was recovered/resolved. On an unknown date, the outcome of the weight loss was unknown and the outcome of the swelling of eyelid, facial swelling, allergic reaction and periocular swelling were recovering/resolving. It was unknown if the reporter considered the skin warm, injected limb mobility decreased, pain in arm, headache, diarrhea, appetite absent, weight loss, sleepiness, swelling of eyelid, facial swelling, allergic reaction and periocular swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in her upper left arm. Immediately following the vaccination, the patient started having fever in her arm and had trouble lifting it. On 13th March 2019 at night, the patient could not sleep on her left side because her arm hurt too bad. On the next day, the patient had a headache and severe diarrhea. She had no appetite over the next few days and lost 5 pounds. On 15th March 2019, 2 days later, the patient slept for 6 hours during the day. On 19th March 2019, after 6 days, the patient's left eyelid began swelling and the bottom of her face. On 20th March 2019, there was swelling all around her eye and down her cheek. She saw her eye doctor and was told it was an allergic reaction. The patient's arm was no longer hurting, but she could felt where she got the injection if she rub it. Emergency room visit was required. The consent to follow up was given.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased, Heart rate increased
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of increased blood pressure in a 76-year-old male patient who received SHINGRIX for prophylaxis. On 19th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 20th March 2019, 1 days after receiving SHINGRIX, the patient experienced increased blood pressure and high pulse rate. On an unknown date, the outcome of the increased blood pressure and high pulse rate were recovering/resolving. It was unknown if the reporter considered the increased blood pressure and high pulse rate to be related to SHINGRIX. Additional details were provided as follows: The lot and expiration date were not provided. The anatomical site of administration (which arm) was not provided.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Blindness unilateral, Inappropriate schedule of product administration, Inflammation
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of unilateral blindness in a 64-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On 22nd February 2019, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced unilateral blindness (serious criteria GSK medically significant), inflammation and drug dose administration interval too long. The patient was treated with prednisone. On an unknown date, the outcome of the unilateral blindness, inflammation and drug dose administration interval too long were unknown. It was unknown if the reporter considered the unilateral blindness and inflammation to be related to SHINGRIX. Additional details were reported as follows: After receiving 1st dose of SHINGRIX, the patient developed inflammatory condition that had caused blindness in one eye. The patient did not receive 2nd dose within the six month time frame, which led to lengthening of vaccination schedule. No further details were provided.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary mass, Breast pain, Erythema, Injection site erythema, Injection site mass
Clinical narrative: Patient received vaccine to R Deltoid at 10:20am, by the evening developed moderate pain to entire right arm extending from right side of neck to fingers, to side of right breast. Patient also reports entire area is tender to touch. Patient reports "quarter dollar" sized redness to injection site with lump, and "quarter sized" redness, lump to anterior axilla near shoulder. Patient with no N/V, no fever/chills, no red streaks.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Neck pain, Pain in extremity, Tenderness
Clinical narrative: Patient received vaccine to R Deltoid at 10:20am, by the evening developed moderate pain to entire right arm extending from right side of neck to fingers, to side of right breast. Patient also reports entire area is tender to touch. Patient reports "quarter dollar" sized redness to injection site with lump, and "quarter sized" redness, lump to anterior axilla near shoulder. Patient with no N/V, no fever/chills, no red streaks.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: The injection arm/site was swollen, red, warm and redness spread beyond the site of injection and she had fever.
Age: 37.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Myalgia, Pyrexia
Clinical narrative: Overnight: low-grade fever, chills. 24 hours (or more?): stomach discomfort (mild), muscle aches (gluteals).
Age: 0.58
Sex: M
Vaccine: DTAPIPV, PNC13
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There were no adverse events that occured or reported.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Pt called to make me aware that almost 72 hours after immunization, she was having a red ring around area and it was itchy and sore. Pt was told that this is a normal reaction but we would report it. She was told she could take TYLENOL for pain or use an ice pack. It was recommended to try a moisturizer to see if this would help with the itching.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician (also reported as "pharmacist") refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 28-FEB-2019, the patient was vaccinated with one expired dose of M-M-R II (rHA) injection, lot # R002930, expiration date 31-JAN-2019 (dose, route of administration and vaccination site were not reported) for prophylaxis. There was no adverse event reported. Product quality complaint was not involved.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, a male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In February 2017, at age 64, the patient was administered the ZOSTAVAX vaccine by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by nurse practitioner for the following injury resulting from his ZOSTAVAX use: Shingles and post herpetic neuralgia. The outcome of the shingles and post herpetic neuralgia is unknown. The patient claimed damages as a result of: injury to themselves, loss of consortium, and economic losses. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 13-year-old male patient. No information regarding the patient's concurrent condition, medical history, concomitant medications and drug reactions or allergies was provided. On 28-AUG-2017, the patient was vaccinated with the 1st dose of GARDASIL 9 (dose, lot number and expiration date were not provided) intramuscularly for prophylaxis. On 27-MAR-2019, the patient was vaccinated with the 2nd dose of GARDASIL 9 (dose not provided) lot number R009614, expiration date 30-NOV-2020, intramuscularly for prophylaxis.  No adverse effect reported.
Age: 0.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Adult dose was given at 1.0 ml instead of pediatric dose of 0.5 ml.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Patient had a sore arm and was fatigued/tired for over 5 days.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Feeling abnormal, Hypotension
Clinical narrative: Dizziness. Low blood pressure, diarrhea, and stomach ache, not feeling his usual self.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Chest pain, Musculoskeletal pain, Pain in extremity, X-ray
Clinical narrative: Pain in shoulder, hand, chest. Treatment: pain medication (ibuprofen), anti-nausea medication, Physical therapy.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Feeling abnormal, Malaise
Clinical narrative: Patient reported feeling very debilitated, weak, fatigued she felt out of it and could not think well. She lost track of periods of time, and cannot remember much of that night. Chilled, shakes and body aches. This lasted until am of 3/28/19 when she felt better but still shaky and weak. She felt too sick to go to the Doctor's office or hospital.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Memory impairment, Mental impairment, Pain, Tremor
Clinical narrative: Patient reported feeling very debilitated, weak, fatigued she felt out of it and could not think well. She lost track of periods of time, and cannot remember much of that night. Chilled, shakes and body aches. This lasted until am of 3/28/19 when she felt better but still shaky and weak. She felt too sick to go to the Doctor's office or hospital.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Middle insomnia, Tremor
Clinical narrative: 2nd dose of SHINGRIX vaccine. Awoke in middle of night with severe, uncontrolled shaking that lasted 5-10 minutes. I have epilepsy and I don't know if what I experienced was a seizure. I finally went back to sleep and the shaking subsided sometime after I fell asleep.
Age: 2.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, redness, fever on injection site. Half of both thighs are angry red, puffy, and feverish. Knots in leg.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin irritation, Skin warm
Clinical narrative: PT REPORTED THAT THE NORMAL REDNESS AND IRRATATION ASSOCIATED WITH VACCINES HAS BECOME WARM TO THE TOUCH AND IS SPREADING OUTWARD.
Age: 1.83
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Breath sounds abnormal, Drooling, Hypotonia, Seizure
Clinical narrative: MOM STATES HERSELF, DAD AND PATIENT WERE RIDING IN THE CAR AND PATIENT STARTED MAKING A WEIRD GURGLING SOUND, MOM TURNED AROUND AND SAW DROOL COMING OUT OF HER MOUTH AND THEN SHE MADE THE SOUND AGAIN SO MOM AND DAD PULLED OVER. DAD GRABBED HER OUT OF THE CAR SEAT AND SHE WAS LIMP AND STILL DROOLING, DAD SHOOK HER AND CALLED HER NAME AND SHE STARTED BECOMING COHERENT. DISCUSSED AS SEIZURE ACTIVITY.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Mouth ulceration, Pain, Pain in extremity
Clinical narrative: 15 hours later after vaccine pt had chills, aching, headache, and sore arm that got better on Sunday. Sunday afternoon it felt like she had scratched the roof of her mouth and by Monday she had white ulcer sores throughout the mucal tissue of her mouth and upper and lower lips on the inside. On Tuesday she went to urgent care and they looked and they ordered a compound that was filled at compounding pharmacy. Pt said it contained an antiviral, lidocaine, and antibacterial and it was used 3-4 times daily for 3-4 days and she has tapered off to once daily as of today.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Influenza like illness, Myalgia, Nausea
Clinical narrative: Nausea, upset stomach, vomiting, diarrhea, swelling around arm area and chest, flu-like, chest, back, leg, arm muscle soreness.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling, Swelling, Vomiting
Clinical narrative: Nausea, upset stomach, vomiting, diarrhea, swelling around arm area and chest, flu-like, chest, back, leg, arm muscle soreness.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Granuloma, Injection site erythema, Muscle atrophy, Ultrasound scan abnormal, Vaccination site mass
Clinical narrative: Patient received vaccine due to nail puncture. Within 1-day lump at vaccination site started and it was more prominent by day 2. The vaccination site was red and warm to touch. Patient went to doctor on 2/15 doctor and they recommended the use of an ice pack and to take it easy. Patient still has lump at vaccination site but since then has also developed muscle wasting. Patient had another doctor visit on 3/4, a sonogram was performed and it was determined that it was a granuloma. Doctor recommended to continue use of ice pack and prescribed Diclofenac 1mg topical cream 4 times a day; the cream did not help. On 3/8  sent to ultrasound and determined it was granuloma; per doctor, surgery is not an option because of VWD. On 3/29, patient has appointment with orthopedic doctor (Dr) and for a CT scan. Patient scheduled to start physical therapy at Rehabilitation the week of 4/3. Patient has received the Tdap vaccination before with no problem.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Vaccination site warmth
Clinical narrative: Patient received vaccine due to nail puncture. Within 1-day lump at vaccination site started and it was more prominent by day 2. The vaccination site was red and warm to touch. Patient went to doctor on 2/15 doctor and they recommended the use of an ice pack and to take it easy. Patient still has lump at vaccination site but since then has also developed muscle wasting. Patient had another doctor visit on 3/4, a sonogram was performed and it was determined that it was a granuloma. Doctor recommended to continue use of ice pack and prescribed Diclofenac 1mg topical cream 4 times a day; the cream did not help. On 3/8  sent to ultrasound and determined it was granuloma; per doctor, surgery is not an option because of VWD. On 3/29, patient has appointment with orthopedic doctor (Dr) and for a CT scan. Patient scheduled to start physical therapy at Rehabilitation the week of 4/3. Patient has received the Tdap vaccination before with no problem.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Chest pain, Depressed level of consciousness, Dizziness, Dyspnoea, Flushing
Clinical narrative: Employee suddenly felt nauseous, dizzy, flush and was seeing "spots". She felt like she was going to pass out. She continued to complain of dizziness and nausea while in nurse office. Vital signs done at 1010 were blood pressure of 115/72, oral temperature of 97.8 degrees, pulse of 160 manually done and respirations of 22. Cool rags were applied to the back of her neck with little relief. Assessment of injection site noted no abnormalities. Employee attempted to lay down and then she stated she could not breath through her nose. Manual pulse done at at 1015 with result of 88. She then reported right sided, sharp pain in the mid-thorax area. Upon listening to heart tones and breath sounds, heart rate regular and breath sounds clear in all fields. She continued to have significant nasal congestion, which she reported as worse than earlier in the morning. Repeated manual pulse at 1020 with result of 120. Pulse regular and heart tones regular rate. Employee reports that seeing the spots has diminished as well as the nausea has improved. Gave her 240ml of water to drink. Employee had no issue with keeping down the water. Vital signs repeated at 1106 with results of pulse of 76 (manually), blood pressure of 116/79 and oral temperature of 97.8 degrees. Employee transported by family to emergency room for care at 1135.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Nasal congestion, Nausea, Visual impairment
Clinical narrative: Employee suddenly felt nauseous, dizzy, flush and was seeing "spots". She felt like she was going to pass out. She continued to complain of dizziness and nausea while in nurse office. Vital signs done at 1010 were blood pressure of 115/72, oral temperature of 97.8 degrees, pulse of 160 manually done and respirations of 22. Cool rags were applied to the back of her neck with little relief. Assessment of injection site noted no abnormalities. Employee attempted to lay down and then she stated she could not breath through her nose. Manual pulse done at at 1015 with result of 88. She then reported right sided, sharp pain in the mid-thorax area. Upon listening to heart tones and breath sounds, heart rate regular and breath sounds clear in all fields. She continued to have significant nasal congestion, which she reported as worse than earlier in the morning. Repeated manual pulse at 1020 with result of 120. Pulse regular and heart tones regular rate. Employee reports that seeing the spots has diminished as well as the nausea has improved. Gave her 240ml of water to drink. Employee had no issue with keeping down the water. Vital signs repeated at 1106 with results of pulse of 76 (manually), blood pressure of 116/79 and oral temperature of 97.8 degrees. Employee transported by family to emergency room for care at 1135.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report as received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX with lot # R017944, expiration date 24-JUN-2020, lot# N026073, expiration date 20-SEP-2019, lot# N023960, expiration date 01-SEP-2019 (dose and route of administration were not reported) or PROQUAD with lot# R017800, expiration date 19-DEC-2019 and lot# N035934, expiration date 16-JUN-2019 (dose and route of administration were not reported). The vaccines were reconstituted with properly stored sterile diluent, lot# R022280, expiration date 06-OCT-2019. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 6 to 14 degrees Fahrenheit for 15 minutes and between 15 to 46 (also reported as 20) degrees Fahrenheit for 1 hour and 15 minutes. Data logger was involved. There were no previous excursions reported. Product quality complaint (PQC) was not involved. The case is non-valid due to lack of the patients' identifiers. Follow up information was received from a nurse on 27-MAR-2019. The Nurse stated that she had spoken with management after calling in the data logger excursion. Management denied permission to provide patient identifiers and dates of vaccination for the patients that were vaccinated with the above products after being involved in a data logger excursion. No further information is available.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # R017639 with expiration date on 20-JUN-2020; lot # R023504 with expiration date 16-AUG-2020; or lot # R009411 with expiration date on 29-MAR-2020 (reported as 29-JUN-2019), (strength, dose, route, anatomical location were not provided) for prophylaxis. The vaccines were exposed to the following temperature excursions: In the range 15°F to 46°F (26.28) for 1 hour and 35 minutes; in the range 15°F to 46°F (24.15F) for 71 minutes; and in the range 15°F to 46°F (25.52F) for 118 minutes. There was previous temperature excursion in the range 6°F to 14°F for 230 minutes, and in the range 15°F to 46°F (21F) for 3 hours and 50 minutes. It was reported that digital data logger was involved. The vaccines were reconstituted with properly stored sterile diluent. No adverse effects were reported. Follow-up information was received from the reporting nurse on 25-MAR-2019. It was reported that only one patient was vaccinated. On 18-MAR-2019, a patient who is currently 4 years-old (unknown gender), was vaccinated with (improperly stored) VARIVAX, lot # R017639 with expiration date on 20-JUN-2020 (strength, dose, route and anatomical location were not provided) for prophylaxis.
Age: 0.33
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 4 month old patient of unknown gender. The patient's concurrent conditions, medical history, historical or concomitant drugs were not reported. On 25-MAR-2019, the patient was vaccinated with a dose of M-M-R II 0.5 mL, intramuscularly, lot # R019391, expiration date 05-JUL-2020, for prophylaxis; the vaccine was diluted in sterile diluent (lot # and expiration date not reported).
Sex: U
Vaccine: PPV, RV5
Symptoms: Product storage error
Clinical narrative: This non-valid spontaneous report was received from a physician referring to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were inadvertently vaccinated with an improperly stored doses of ROTATEQ oral, with lot # R016792 (expiration date 29-APR-2020), lot # R012954 (expiration date 04-DEC-2019) (strength, dose, frequency, and anatomical location were unknown) and with PNEUMOVAX 23 lot # R018135 (expiration date 15-JUN-2020), lot # R007722 (expiration date 10-MAR-2020) (strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis. The administered doses of the vaccines were stored at the following temperature: 33.4 Fahrenheit for 2 hours and 5 minutes. There was a digital data logger involved and there was previous temperature excursion of 49.5 Fahrenheit for 22 hours.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, a male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 26-OCT-2012, at age 62, the patient was administered the ZOSTAVAX vaccine by a pharmacist (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from his ZOSTAVAX use: Shingles. The outcome of the shingles is unknown. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning an adult female patient of unknown age. 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 the long-term prevention of shingles and zoster-related conditions. In September 2015, at age 57, the patient was administered the ZOSTAVAX by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from her ZOSTAVAX use: Herpes zoster. The outcome of the herpes zoster is unknown. The patient claimed damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. Additional information has been requested.
Age: 44.0
Sex: M
Vaccine: HPV9
Symptoms: Abdominal distension, Abdominal pain, Abdominal pain upper, Dizziness, Headache
Clinical narrative: This spontaneous report as received from a consumer refers to a 44 year old male patient with drug hypersensitivity. On 28-FEB-2019 the patient was vaccinated with GARDASIL 9 dose 1 in the left deltoid for prophylaxis. Concomitant therapies included ZYRTEC. On 2019 the patient experienced dizziness, headache, abdominal pain upper, nausea, abdominal pain and abdominal distension. The outcome of abdominal distension, headache, nausea, abdominal pain upper, dizziness and abdominal pain was reported as not recovered/not resolved.
Age: 44.0
Sex: M
Vaccine: HPV9
Symptoms: Nausea
Clinical narrative: This spontaneous report as received from a consumer refers to a 44 year old male patient with drug hypersensitivity. On 28-FEB-2019 the patient was vaccinated with GARDASIL 9 dose 1 in the left deltoid for prophylaxis. Concomitant therapies included ZYRTEC. On 2019 the patient experienced dizziness, headache, abdominal pain upper, nausea, abdominal pain and abdominal distension. The outcome of abdominal distension, headache, nausea, abdominal pain upper, dizziness and abdominal pain was reported as not recovered/not resolved.
Age: 3.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Syringe issue, Underdose
Clinical narrative: Initial information received on 21-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 3 years old male patient who received half dose of vaccine DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 21-Mar-2019, the patient received a 0.5 ml single dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5202AA via intramuscular route in the other. It was an actual medication error due to vaccine underdose and syringe issue. The nurse drew the DAPTACEL up into a syringe from the single dose vial, the needle fell off of the syringe during administration and most of the dose was lost. It was unknown whether adverse event was experienced. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial information received on 21-Mar-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves Adult patient who experienced allergy to tetanus, while he/she received vaccine TETANUS TOXOID. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious allergy to tetanus (Unknown latency) following the administration of TETANUS TOXOID. Other relevant tests were not reported. Final diagnosis was allergy to tetanus. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for allergy to tetanus. List of documents held by sender: none.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Initial information received on 21-Mar-2019 regarding an unsolicited valid non-serious case received from a physician. This case is linked to cases 2019SA082208, 2019SA082211, 2019SA082210 and 2019SA082209 (same reporter). This case involves a 6 months old male patient who experienced 102 Fahrenheit fever (38.8 C), while he received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR 13; and ROTATEQ. On 13-Mar-2019, the patient received a 0.5 ml single dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ095AA via unknown route in the thigh NOS. On an unknown date in 2019, the patient developed a non-serious 102 Fahrenheit fever (38.8 C) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE. Relevant laboratory test results included: Body temperature - On an unknown date: 38.8 Cel [38.8]. Final diagnosis was 102 F fever (38.8 C). It was not reported if the patient received a corrective treatment. The patient's event outcome was not reported.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Initial information received on 22-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four months old male patient who was vaccinated with a 0.5 ml second dose of vaccine PENTACEL, (lot of Diluent Vial UJ108AA and Exp. Date 24-Apr-2020; lot number of HIB U1862AA and Exp. Date 11-Oct-2019) via intramuscular route in the right thigh on 15-Mar-2019. The patient's medical history not reported and concomitant medications included ROTATEQ and PREVENAR 13 both on 15-Mar-2019 for Immunisation. It was an actual medication error case due to inappropriate reconstitution technique. It was reported as diluent was administered without the powder being mixed in with ACTHIB, diluent was mixed with sterile water and given. There were no side effects. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder' compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Initial information received on 25-Mar-2019 regarding an unsolicited valid non-serious case received from Other health care professional. This case involves a 12 months old male patient who experienced received vaccine DAPTACEL. The patient's past medical history, concomitant medication and family history were not provided. On 21-Mar-2019, the patient received a 0.5ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5169AA, expiry date 16-Mar-2019 via unknown route in unknown administration site. It was an actual medication error due to expired vaccine used. It was reported that 1 year old child received an expired dose (expiry date 16-Mar-2019) of DAPTACEL on 21-Mar-2019. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Sex: F
Vaccine: RAB
Symptoms: Expired product administered
Clinical narrative: Initial information received on 25-Mar-2019 regarding an unsolicited valid non-serious case received from a physician. This case involves Adult female patient who received second dose of 0.5 mL dose of vaccine IMOVAX RABIES lot N1B051M, expiry date- 26-Feb-2019 via unknown route in the left deltoid on 14-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used. It was reported that a female patient has received four doses of IMOVAX. The second dose was 2.5 weeks expired but wasn't noticed until today after getting their fourth dose. It was unknown if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Fatigue, Headache, Malaise, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Initial information received on 25-Mar-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional via phone. This case involves a 16 years old female patient who experienced had arm pain for 2 days, stiff neck, also got a fever, feeling lousy, exhaustion and headache, while she received vaccine MENACTRA for type 2 diabetes mellitus (as reported). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On 19-Mar-2019 (Tuesday), the patient received a 0.5 ml first dose of suspect MENACTRA (lot number, expiry date and route of administration were not reported) in the left arm. On an unspecified date, the patient developed a non-serious had arm pain for 2 days, stiff neck, also got a fever, feeling lousy, exhaustion and headache following the administration of MENACTRA. No Lab data was reported. Final diagnosis was headache, exhaustion, feeling lousy, also got a fever, stiff neck and had arm pain for 2 days. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for feeling lousy, as Unknown for exhaustion, stiff neck, headache, had arm pain and fever. Documents held by the sender: none.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: Initial information received on 25-Mar-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional via phone. This case involves a 16 years old female patient who experienced had arm pain for 2 days, stiff neck, also got a fever, feeling lousy, exhaustion and headache, while she received vaccine MENACTRA for type 2 diabetes mellitus (as reported). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On 19-Mar-2019 (Tuesday), the patient received a 0.5 ml first dose of suspect MENACTRA (lot number, expiry date and route of administration were not reported) in the left arm. On an unspecified date, the patient developed a non-serious had arm pain for 2 days, stiff neck, also got a fever, feeling lousy, exhaustion and headache following the administration of MENACTRA. No Lab data was reported. Final diagnosis was headache, exhaustion, feeling lousy, also got a fever, stiff neck and had arm pain for 2 days. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for feeling lousy, as Unknown for exhaustion, stiff neck, headache, had arm pain and fever. Documents held by the sender: none.
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 25-Mar-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 17 years old female patient who was vaccinated with 0.5 ml second dose of expired vaccine MENACTRA (lot U5836BA and Exp. Date 18-Mar-2019) via intramuscular route in the right arm on 22-Mar-2019. The patient's medical history was not reported and concomitant medications included Hepatitis A Vaccine for Immunisation. It was an actual medication error case due to expired vaccine used. No specific symptoms were reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLUX, HEP, PNC13, RVX
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Initial information received on 25-Mar-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old male patient who received 1 ml vaccine PENTACEL (lot C5444AA and expiry date 27-Oct-2019) via unknown route in unknown administration site, that was prepared with two vials of DTaP-IPV with no Hib on 25-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR 13; HEPATITIS B VACCINE; ROTAVIRUS VACCINE; and INFLUENZA VACCINE. It was a case of actual medication error due to inappropriate reconstitution technique and overdose. It was not reported if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 23.0
Sex: M
Vaccine: RAB
Symptoms: Exposure via skin contact, Underdose
Clinical narrative: Initial information received on 21-Mar-2019 regarding an unsolicited valid non-serious case received from a Pharmacist. This case is linked to case 2019SA081256 (same reporter). This case involves a 23 years old male patient who was vaccinated with 1 ml second dose of vaccine IMOVAX RABIES (lot N1K30M and Exp. Date 28-OCT-2019) via intramuscular route in the right arm on 21-Mar-2019. The patient's medical history and concomitant medications were not reported. It was an actual medication error case due to vaccine underdose, wrong technique in product usage process, exposure via skin contact and accidental exposure to product. As it was reported that, after pharmacist completed the injection to the patient, she removed the plunger from the syringe to discard it and some of the reconstituted product was still inside the barrel and it leaked onto the patient. Some of the vaccine got on the patient's arm and on his toe, also reported that the patient received less than the full 1 ml dose. It was unknown whether the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 63.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: Expired product administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 26-Mar-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 63 years old female patient who was vaccinated with MENACTRA (lot: U5836BA, expiry date: 18-Mar-2019) via intramuscular route in left deltoid, on 26-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOVAX 23 for Immunisation. It was an actual medication error due to expired vaccine used and inappropriate age at vaccine administration. The patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 26-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 11 years old male patient who received an extra, unintended 0.5 ml dose of ADACEL (lot U6141AB and Exp. Date 15-Dec-2020) via unknown route in the left arm on 21-Mar-2019 (15 months later) and first dose on 25-Jan-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included GARDASIL 9 and MENACTRA for immunisation. It was an actual medication error case due to extra dose administered. It was unknown whether the patient had any adverse reactions. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.