chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a 24 year old patient, gender not provided.  No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications. On 07-AUG-2012, the patient was vaccinated with GARDASIL or CERVARIX as a first dose (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis (product origin unknown). On 14-NOV-2018,  the patient received a dose of GARDASIL 9 lot number N035957, expiration date on 10-OCT-2020 (strength, dose, route of administration, and anatomical location, were not reported) for prophylaxis.(interchange of vaccine products).  No adverse effects were reported.  The outcome of product origin unknown was not reported. The reporter did not assess the causal relationship between suspect vaccines with the event of product origin unknown .
Age: 1.0
Sex: U
Vaccine: HIBV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB, lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9, lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 12-month-old patient of unknown gender. On 27-FEB-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB, lot number N034005 (expiration date 31-JAN-2020) and a dose of VARIVAX, lot number N021720 (expiration date: 10-AUG-2019) (doses, routes and anatomical locations of administration were not provided for both vaccines) for prophylaxis. This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Age: 1.0
Sex: U
Vaccine: HIBV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 12-month-old patient of unknown gender. On 12-JUN-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N031492 (expiration date 02-MAY-2020) and a dose of VARIVAX lot number N021720 (expiration date: 10-AUG-2019) (doses, routes and anatomical locations of administration were not provided for both vaccines) for prophylaxis. This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 17-DEC-2018, the patient was vaccinated with improperly stored dose of ROTATEQ, lot # R000911, expiration date on 28-FEB-2019 orally, for prophylaxis (strength, dose and anatomical location were not reported). The vaccine was improperly stored at a temperature of 8.62 degrees C during a time frame of 30 minutes. Previous temperature excursion reported were: below 0 degrees C (-0.58 degrees C) for 1.75 hours (1 cycle) and 0 degrees C to 1 degrees C for 10.25 hours. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
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, allergy history or concomitant medications. On 19-DEC-2018, the patient was vaccinated with an expired dose of ZOSTAVAX 19400 PFU, (dose, frequency and route of administration were not provided) lot # N025703, expiration date 19-DEC-2018 for prophylaxis. No adverse event was reported.
Sex: U
Vaccine: PPV
Symptoms: Cellulitis, Drug hypersensitivity
Clinical narrative: This spontaneous report as received from a other health professional refers to a 68-year old patient of unknown gender. The patient's medical history, concurrent condition and concomitant medications were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (Lot#, expiry date not reported) for aftercare prophylaxis after liver transplant. On 05-DEC-2018 the patient experienced drug hypersensitivity and cellulitis. The outcome of drug hypersensitivity and cellulitis was unknown. The reporter considered cellulitis and drug hypersensitivity to be related to PNEUMOVAX 23.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse regarding unspecified patients of unspecified age and gender. The patients' medical history, concurrent conditions and concomitant medication were not reported. The nurse reported that between 11-DEC-2018 and 20-DEC-2018 unspecified patients received improperly stored RECOMBIVAX HB, intramuscular injection for prophylaxis, (Lot: R001084; Expiration date 07-NOV-2020) (dose, strength, anatomical site of vaccination and frequency were not reported). No adverse effects reported. It was also reported that temperature was: 9 degrees C to 25 degrees C (15.4 C), the time frame was 30 Minutes. A digital data logger was involved.
Sex: M
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report was received from an unknown reporter via a company representative, referring to a male patient of unknown age. The information regarding the patient's medical history, concurrent conditions or concomitant medication was unknown by the reporter. On an unspecified date, the patient received an injection of PNEUMOVAX 23 (strength, route, dose, lot # and expiration date unknown by the reporter) for prophylaxis. On an unspecified date, the patient had a "significant injection site reaction to PNEUMOVAX 23 and sought medical attention" (injection site reaction). It was reported that the patient received treatment for the event, it was unknown by the reporter if the patient had any lab diagnostics/studies performed. The outcome of the event and the causality assessment between the event and the PNEUMOVAX 23 was not reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 20-DEC-2018 the patient was vaccinated with an expired dose of ROTATEQ (lot # N010709, expiration date: 05-DEC-2018, strength and frequency were unknown) orally for prophylaxis (expired vaccine used). No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history, concomitant therapies, drug allergies/reaction and concurrent conditions were not reported. The reporter stated that on 21-DEC-2018 a patient was vaccinated with an expired dose of ZOSTAVAX (expired product administered) lot # N025704,expiry date 16-DEC-2018, subcutaneous (dose, frequency unknown by reporter) for prophylaxis. Other suspect therapies included sterile diluent (MERCK STERILE DILUENT) (dose, frequency, lot# and expiration date unknown by reporter). No adverse effects was reported. The outcome of the events expired product administered and no adverse effects was unknown.
Age: 46.0
Sex: M
Vaccine: FLUX
Symptoms: Aldolase normal, Anti-cyclic citrullinated peptide antibody negative, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Asthenia
Clinical narrative: About 2 weeks s/p influenza vaccine, pt developed weakness and myalgia. Symptoms: Myalgia(M791), Weakness (R531).
Age: 46.0
Sex: M
Vaccine: FLUX
Symptoms: Blood calcium normal, Blood creatine phosphokinase MB, Blood creatine phosphokinase normal, Blood glucose normal, Blood lactic acid normal
Clinical narrative: About 2 weeks s/p influenza vaccine, pt developed weakness and myalgia. Symptoms: Myalgia(M791), Weakness (R531).
Age: 46.0
Sex: M
Vaccine: FLUX
Symptoms: Blood thyroid stimulating hormone normal, Blood urea normal, Blood uric acid normal, Borrelia test negative, Bursitis
Clinical narrative: About 2 weeks s/p influenza vaccine, pt developed weakness and myalgia. Symptoms: Myalgia(M791), Weakness (R531).
Age: 46.0
Sex: M
Vaccine: FLUX
Symptoms: C-reactive protein increased, Chest X-ray normal, Electrocardiogram normal, Electromyogram abnormal, Full blood count normal
Clinical narrative: About 2 weeks s/p influenza vaccine, pt developed weakness and myalgia. Symptoms: Myalgia(M791), Weakness (R531).
Age: 46.0
Sex: M
Vaccine: FLUX
Symptoms: Joint effusion, Laboratory test normal, Metabolic function test normal, Myalgia, Myoglobin urine absent
Clinical narrative: About 2 weeks s/p influenza vaccine, pt developed weakness and myalgia. Symptoms: Myalgia(M791), Weakness (R531).
Age: 46.0
Sex: M
Vaccine: FLUX
Symptoms: Myopathy, Nuclear magnetic resonance imaging abnormal, Parvovirus B19 test positive, Red blood cell sedimentation rate increased, Rheumatoid factor negative
Clinical narrative: About 2 weeks s/p influenza vaccine, pt developed weakness and myalgia. Symptoms: Myalgia(M791), Weakness (R531).
Age: 46.0
Sex: M
Vaccine: FLUX
Symptoms: Spinal X-ray abnormal, Tendonitis, Treponema test negative, Troponin normal, Urine ketone body present
Clinical narrative: About 2 weeks s/p influenza vaccine, pt developed weakness and myalgia. Symptoms: Myalgia(M791), Weakness (R531).
Age: 46.0
Sex: M
Vaccine: FLUX
Symptoms: X-ray limb abnormal, X-ray of pelvis and hip abnormal
Clinical narrative: About 2 weeks s/p influenza vaccine, pt developed weakness and myalgia. Symptoms: Myalgia(M791), Weakness (R531).
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Joint range of motion decreased, Musculoskeletal pain, Shoulder injury related to vaccine administration, X-ray normal
Clinical narrative: Patient is experiencing SIRVA (shoulder injury related to vaccine administration). She has shoulder pain that began the same day of the vaccination. It has been associated with weakness and limited range of motion. She notes some range of motion improvement overall since it began. She has been seen by her PCP with negative Xrays, given VOLTAREN gel and started with PT. She continues to do PT currently without much improvement thus far.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Pt states pain in left arm ever since the injection. Pt rates pain as a 3-4 on the pain scale, he can't lay on his left side. Pain has not improved or regressed in the last 2 months.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Swelling
Clinical narrative: Red with swelling.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Hypersomnia, Pain in extremity
Clinical narrative: Headache lasting over 15 hours, severe chills, pain in injection arm, fatigue resulting in 13 hours of sleep.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Impaired work ability, Injected limb mobility decreased, Injection site pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Severe pain while shot being given. I noticed that the injection was given very high on my left arm, seemed higher than the deltoid muscle. It was almost at the top of my shoulder. I expected my arm to be somewhat sore that day, and it was. That evening when I went to bed, pain in my same arm awakened me. Thought that was a little odd. Since then, Dec. 10th, 2018, my arm has not been the same. I have given it some time, thinking maybe I was just very sensitive, but at this point, I am having trouble moving my arm. There is pain from shoulder down and quivering at times. It has awakened me every night. I called out of work today. I have not contacted a physician yet, because I thought it would resolve and it was Christmas - very busy time. I called insurance provider today, my insurance provider and they advised me to contact Rx company- since that is who contracted with the Pharmacy where I received the vaccine. Was having a hard time getting through to them. I read my paper work from pharmacy and found this contact.
Age: 58.0
Sex: F
Vaccine: FLUC4
Symptoms: Sleep disorder, Tremor
Clinical narrative: Severe pain while shot being given. I noticed that the injection was given very high on my left arm, seemed higher than the deltoid muscle. It was almost at the top of my shoulder. I expected my arm to be somewhat sore that day, and it was. That evening when I went to bed, pain in my same arm awakened me. Thought that was a little odd. Since then, Dec. 10th, 2018, my arm has not been the same. I have given it some time, thinking maybe I was just very sensitive, but at this point, I am having trouble moving my arm. There is pain from shoulder down and quivering at times. It has awakened me every night. I called out of work today. I have not contacted a physician yet, because I thought it would resolve and it was Christmas - very busy time. I called insurance provider today, my insurance provider and they advised me to contact Rx company- since that is who contracted with the Pharmacy where I received the vaccine. Was having a hard time getting through to them. I read my paper work from pharmacy and found this contact.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Developed rash, back of neck left side-red, bumpy, itchy. Had not seen MD when patient reported to us (1 week later), rash going away. States she has been on ADDERALL for months.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Alcohol test negative, Blood glucose normal, Computerised tomogram head normal, Drug screen negative, Full blood count normal
Clinical narrative: Generalized seizure lasting 4-5 minutes on 12/26/18 at 130 AM. Mother found him convulsing in sleep. Incoherent and lethargic when seizing stopped. EMS arrived 15 min after seizure. He was oriented at this time. Blood sugars normal. Taken to ER. CT of head and all labs WNL.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Incoherent, Lethargy, Metabolic function test normal, Seizure
Clinical narrative: Generalized seizure lasting 4-5 minutes on 12/26/18 at 130 AM. Mother found him convulsing in sleep. Incoherent and lethargic when seizing stopped. EMS arrived 15 min after seizure. He was oriented at this time. Blood sugars normal. Taken to ER. CT of head and all labs WNL.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a healthcare worker regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported. On 03-DEC-2018, the patient was vaccinated with improperly stored VARIVAX injection, for prophylaxis, lot number R009821 with expiration date in 03-APR-2020 which was reconstituted with properly stored Merck Sterile Diluent (dose, strength and anatomical location not reported). The VARIVAX was stored at a temperature range of -9 degrees Celsius (degrees C) to 8 degrees C (2.8C) for the time frame of 37 hours. There was no previous temperature excursion and the call was because of a data logger. No adverse effects reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1812USA010605; US-009507513-1812USA010604; US-009507513-1812USA010606; US-009507513-1812USA010603.
Age: 1.0
Sex: U
Vaccine: HIBV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB, lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9, lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 12-month-old patient of unknown gender. On 06-JUN-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB, lot number N031492 (expiration date 02-MAY-2020) and a dose of VARIVAX, lot number N021720 (expiration date: 10-AUG-2019) (doses, routes and anatomical locations of administration were not provided for both vaccines) for prophylaxis. This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Age: 1.0
Sex: U
Vaccine: HIBV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB, lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 12-month-old patient of unknown gender. On 24-MAY-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N031492 (expiration date 02-MAY-2020) and a dose of VARIVAX lot number N027002 (expiration date: 28-SEP-2019) (doses, routes and anatomical locations of administration were not provided for both vaccines) for prophylaxis. This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Age: 3.0
Sex: U
Vaccine: HIBV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 3-year-old patient of unknown gender. On 06-MAR-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and a dose of VARIVAX lot number N021720 (expiration date: 10-AUG-2019) (doses, routes and anatomical locations of administration were not provided for both vaccines) for prophylaxis. This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer and a consumer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 20-DEC-2014, a healthcare provider at a pharmacy administered the ZOSTAVAX vaccine to the patient (lot# and route not provided). The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about 06-SEP-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries.  As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: 12-10-18 at 9:39 AM Patient called complaining of increased redness, swelling and warmth over right arm from injection site wrapping around arm and almost reaching elbow, with limited ROM in right arm per patient, patient states she received pneumonia and flu vaccine on 12-7-18. Recommended patient come in to walk-in this AM for evaluation, patient voiced understanding and agrees with plan of care. 12-14-18 at 3:51 PM Pt called and said had gone to the ER, they suspected cellulitis and was put on KEFLEX. Wasn't able to start ABx till Tue (11th) because of allergies and what the original Rx was. She said the swelling, redness and hardness has gone but still has pain on the backside of the arm from the elbow up to shoulder. She said it was a very painful experience and never had a reaction like that. She says if the pain persists, will come in on Monday. I told her I was going to fill out a report about this. Emergency Department (ED) 12-10-18 at 11:35 AM: HPI: Female who presents with report of redness, swelling, tenderness in the right deltoid region. She tells me that she received a flu shot and PNEUMOVAX shot the day before yesterday. They were both in the right deltoid region. She told me that the flu shot went "just fine", but the PNEUMOVAX she "really felt it when it went in". The next day, she developed redness, swelling, erythema in the injection area which she feels as though is getting worse despite TYLENOL and ibuprofen. No other frank signs or symptoms associated with this such as fever, chills, numbness, tingling and neurovascular dysfunction. ED Course: The redness, swelling, tenderness seems to be more of a local reaction to the vaccines as opposed to an infection. In discussion with the patient though, I am not opposed to prescribing a short course of KEFLEX with primary care follow-up. The patient is very much in agreement with this plan. This does not appear to be an allergic reaction. No pruritus, no systemic signs or symptoms. Recommend continuing TYLENOL/ibuprofen and adding a warm compress as well. She verbalizes an agreement and understanding. Follow-up with primary care, otherwise return to the ED for any emergency problems or concerns.
Age: 44.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: 12-10-18 at 9:39 AM Patient called complaining of increased redness, swelling and warmth over right arm from injection site wrapping around arm and almost reaching elbow, with limited ROM in right arm per patient, patient states she received pneumonia and flu vaccine on 12-7-18. Recommended patient come in to walk-in this AM for evaluation, patient voiced understanding and agrees with plan of care. 12-14-18 at 3:51 PM Pt called and said had gone to the ER, they suspected cellulitis and was put on KEFLEX. Wasn't able to start ABx till Tue (11th) because of allergies and what the original Rx was. She said the swelling, redness and hardness has gone but still has pain on the backside of the arm from the elbow up to shoulder. She said it was a very painful experience and never had a reaction like that. She says if the pain persists, will come in on Monday. I told her I was going to fill out a report about this. Emergency Department (ED) 12-10-18 at 11:35 AM: HPI: Female who presents with report of redness, swelling, tenderness in the right deltoid region. She tells me that she received a flu shot and PNEUMOVAX shot the day before yesterday. They were both in the right deltoid region. She told me that the flu shot went "just fine", but the PNEUMOVAX she "really felt it when it went in". The next day, she developed redness, swelling, erythema in the injection area which she feels as though is getting worse despite TYLENOL and ibuprofen. No other frank signs or symptoms associated with this such as fever, chills, numbness, tingling and neurovascular dysfunction. ED Course: The redness, swelling, tenderness seems to be more of a local reaction to the vaccines as opposed to an infection. In discussion with the patient though, I am not opposed to prescribing a short course of KEFLEX with primary care follow-up. The patient is very much in agreement with this plan. This does not appear to be an allergic reaction. No pruritus, no systemic signs or symptoms. Recommend continuing TYLENOL/ibuprofen and adding a warm compress as well. She verbalizes an agreement and understanding. Follow-up with primary care, otherwise return to the ED for any emergency problems or concerns.
Age: 61.0
Sex: F
Vaccine: MMR
Symptoms: Ear pain, Pain in jaw, Swelling face
Clinical narrative: Patient awoke 2 days after vaccine given with pain in left jaw up into ear, swelling in left jaw also. Soreness in left jaw area remains at this time.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Head injury, Loss of consciousness
Clinical narrative: Stood up and walked a few feet away following vaccination, then passed out and hit head on door frame.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Cold sweat, Fall, Incomplete course of vaccination, Injection site pain, Loss of consciousness
Clinical narrative: My son was telling the nurse how bad the medicine in the shot hurt, when suddenly he went stiff, fell backward, went sheet white for about a minute before waking up very clammy and very pale.   He said he feel asleep when he woke up. He didn't know where he was. The doctor gave him a popsicle and popcorn. Checked his blood pressure. I feed him a big lunch and he's been fine since.  Will NOT be giving him the second dose though. He did eat breakfast but had not had lunch yet.  Our appt was at 11:10. Shot was given around noon.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Memory impairment, Musculoskeletal stiffness, Pallor
Clinical narrative: My son was telling the nurse how bad the medicine in the shot hurt, when suddenly he went stiff, fell backward, went sheet white for about a minute before waking up very clammy and very pale.   He said he feel asleep when he woke up. He didn't know where he was. The doctor gave him a popsicle and popcorn. Checked his blood pressure. I feed him a big lunch and he's been fine since.  Will NOT be giving him the second dose though. He did eat breakfast but had not had lunch yet.  Our appt was at 11:10. Shot was given around noon.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal discomfort, Bowel movement irregularity, Chest discomfort, Feeling hot, Nausea
Clinical narrative: "Chest area felt tight", stomach upset, slight nausea, felt hot but did not check temp, no vomiting, no diarrhea. Had bowel movement (does not normally have one at night). Had gone out to dinner that night, "probably ate too much" and had 2 glasses of wine. No SOB, symptoms lasted until 4:30 AM. Feeling better (called 10/11/2018). Advised calling MD to report symptoms and advised calling 911 in future for chest tightness.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: History of fainting with injections. Briefly felt faint a few minutes after vaccination.
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: This serious spontaneous case, initially received from a pharmacist on 10-Oct-2018, concerning a female patient of unspecified age. On an unspecified date (reported as few years ago), the patient was administered influenza vaccine [dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported]. On an unspecified date, after vaccination, the patient experienced a near anaphylaxis reaction. At the time of this report, the outcome of the event was not reported.
Sex: F
Vaccine: FLUA3
Symptoms: Influenza
Clinical narrative: This serious spontaneous case, initially received from a pharmacist on 15-Oct-2018, concerns a female patient of unspecified age. The patient's concomitant medication included two steroid injections on the same day (reported as morning) before flu vaccine administration. On an unspecified date, the patient was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported]. On an unspecified date, 10 days after vaccination, the patient got flu. At the time of this report, the outcome of the event was not reported. The reporter assessed the case as non-serious. non-significant follow up report received on 15-Nov-2018: No new information was received. Hence, no changes were made in narrative.
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site swelling
Clinical narrative: This spontaneous case, initially received from a pharmacist on 06-Nov-2018, concerns a 67-year-old, elderly female patient. The patient's current condition included nerve pain (since an unspecified date). The patient's concomitant medications included ASA and meloxicam. On 06-Nov-2018, the patient was administered FLUAD TIV [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date: not reported]. On the same day, within few minutes of vaccination, the patient experienced bulging up and raised area at the injection site. The patient was monitored and consulted her primary care physician (PCP). It was reported that, the patient was not hospitalized. On an unspecified date in 2018, within few days of vaccination, the patient had recovered from the event. The reporter assessed this case as serious (medically significant). Follow-up report received on 15-Nov-2018: Added patient's current condition nerve pain in patient tab. The outcome of the event injection site swelling was changed from not reported to recovered (within few days of vaccination). It was not sure about the indication of the concomitant medication meloxicam. The narrative was amended accordingly.
Age: 64.0
Sex: F
Vaccine: FLUA3
Symptoms: Chiropractic, Fall, Head injury, Headache, Nausea
Clinical narrative: This spontaneous case, initially received from other non-health professional on 01-Nov-2018, concerns 64-year-old, adult, female patient. The patient was allergic to Monosodium glutamate (MSG), tetracycline sulfa, and dimerol. The patient did not take any medications at the time of vaccination. On 29-Oct-2018, the patient (of age less than 65 years) was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250807 and expiry date: 30-JUN-2019] (explicitly coded as inappropriate age at vaccine administration). On 30-Oct-2018, 10 hours after the injection, the patient got up at about 3:30am to wash her hands and she fainted. The patient fell in her bathroom and hit the back of her head (reported as: on something either the wall or something). The patient got up from the floor and she immediately fainted again. The patient stated she was nauseated, and she threw up liquids. The patient had a slight headache, but the headache was not that bad. A registered nurse (RN) stated that the patient could have concussion, but the patient checked with a doctor. A RN was the one who alerted the patient to the possibility of a concussion and that the nausea and vomiting could be due to the fall rather than the vaccine. The patient had a chiropractic spinal adjustment. On 31-Oct-2018, the patient had recovered from the events. The outcome of the event- inappropriate age at vaccine administration was unknown. The reporter assessed the case as non-serious.
Age: 64.0
Sex: F
Vaccine: FLUA3
Symptoms: Product administered to patient of inappropriate age, Syncope, Vomiting
Clinical narrative: This spontaneous case, initially received from other non-health professional on 01-Nov-2018, concerns 64-year-old, adult, female patient. The patient was allergic to Monosodium glutamate (MSG), tetracycline sulfa, and dimerol. The patient did not take any medications at the time of vaccination. On 29-Oct-2018, the patient (of age less than 65 years) was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250807 and expiry date: 30-JUN-2019] (explicitly coded as inappropriate age at vaccine administration). On 30-Oct-2018, 10 hours after the injection, the patient got up at about 3:30am to wash her hands and she fainted. The patient fell in her bathroom and hit the back of her head (reported as: on something either the wall or something). The patient got up from the floor and she immediately fainted again. The patient stated she was nauseated, and she threw up liquids. The patient had a slight headache, but the headache was not that bad. A registered nurse (RN) stated that the patient could have concussion, but the patient checked with a doctor. A RN was the one who alerted the patient to the possibility of a concussion and that the nausea and vomiting could be due to the fall rather than the vaccine. The patient had a chiropractic spinal adjustment. On 31-Oct-2018, the patient had recovered from the events. The outcome of the event- inappropriate age at vaccine administration was unknown. The reporter assessed the case as non-serious.
Age: 15.0
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Injection site pain, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: This is a serious spontaneous case, initially received from other non-health professional via Novartis on 12-Nov-2018, concerning a 15-year-old, adolescent female patient. On an unspecified date, the patient was administered INN flu vaccine seasonal (dose, route of administration, anatomical location, batch number, trade name, manufacturer and expiry date: not reported). On an unspecified date after vaccination, the patient developed a huge big swollen welt at the injection site that was sore to the touch. On an unspecified date, the patient developed the flu. At the time of this report, the outcome of the event was not reported.
Age: 93.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain, Pain in extremity, X-ray limb normal
Clinical narrative: Client has had an extremely sore arm since 2 days after the vaccination. She cannot move it or use it due to the amount of pain.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Pt claims that 24 hour post injection, injection site became red, raised, swollen, hot to the touch; pt claims she had a fever; pt seen by PCP day after inj. PCP advised pt to not get 2nd dose, pt started on KEFLEX 500mg tid x 7 days possible cellulitis?
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray normal, Fatigue, Inflammatory marker test, Joint swelling, Laboratory test normal
Clinical narrative: Employee complaining of swelling in joints, hands, intermittent pain, progressive fatigue post flu vaccine in October. Employee went to primary MD and tested for rheumatoid arthritis and result was negative inflammatory markers. Chest xray was negative as well.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Peripheral swelling
Clinical narrative: Employee complaining of swelling in joints, hands, intermittent pain, progressive fatigue post flu vaccine in October. Employee went to primary MD and tested for rheumatoid arthritis and result was negative inflammatory markers. Chest xray was negative as well.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Injection site rash, Myalgia
Clinical narrative: I experienced intensive shivering, headache, muscle aches, fever of 101 degrees, pain and rash around injection site. I took 2 aspirin and eventually felt better, but I again woke up around 7 am with a fever of 100.4. I took ALEVE and now feel better again.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: I experienced intensive shivering, headache, muscle aches, fever of 101 degrees, pain and rash around injection site. I took 2 aspirin and eventually felt better, but I again woke up around 7 am with a fever of 100.4. I took ALEVE and now feel better again.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Condition aggravated, Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: This spontaneous report was received from a 67-year-old female nurse, who was reporting on herself. The patient's concurrent conditions included high blood pressure, breast cancer, allergies to shellfish, aspirin and ibuprofen. Concomitant therapies included losartan, propranolol, paroxetine and letrozole. Historical conditions included migraines and historical drugs included aspirin and ibuprofen. On 11-DEC-2018, the patient was vaccinated with PNEUMOVAX 23 injection (dose, strength, lot# with expiration date were not provided) administered intramuscularly for the prevention of pneumococcal disease. On 11-DEC-2018 (reported as "a few hours after getting the vaccination"), the patient experienced a dollar sized welt which was red, painful and itchy at the site of injection and on the inside of her arm was an apple sized area that was red and flat. On the next day, 12-DEC-2018, the patient experienced a migraine. The patient's husband told the physician about the events. The events were treated (medications unspecified). At the time of this report, the patient did not recover from the events. The relatedness between the events and the PNEUMOVAX 23 was not provided.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Migraine, Urticaria
Clinical narrative: This spontaneous report was received from a 67-year-old female nurse, who was reporting on herself. The patient's concurrent conditions included high blood pressure, breast cancer, allergies to shellfish, aspirin and ibuprofen. Concomitant therapies included losartan, propranolol, paroxetine and letrozole. Historical conditions included migraines and historical drugs included aspirin and ibuprofen. On 11-DEC-2018, the patient was vaccinated with PNEUMOVAX 23 injection (dose, strength, lot# with expiration date were not provided) administered intramuscularly for the prevention of pneumococcal disease. On 11-DEC-2018 (reported as "a few hours after getting the vaccination"), the patient experienced a dollar sized welt which was red, painful and itchy at the site of injection and on the inside of her arm was an apple sized area that was red and flat. On the next day, 12-DEC-2018, the patient experienced a migraine. The patient's husband told the physician about the events. The events were treated (medications unspecified). At the time of this report, the patient did not recover from the events. The relatedness between the events and the PNEUMOVAX 23 was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a healthcare worker regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported. On 04-DEC-2018, the patient was vaccinated with improperly stored VARIVAX injection, for prophylaxis, lot number R009821 with expiration date in 03-APR-2020 which was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) (dose, strength and anatomical location not reported). The VARIVAX was stored at a temperature range of -9 degrees Celsius (°C) to 8 °C (2.8C) for the time frame of 37 hours. There was no previous temperature excursion and the call was because of a data logger. No adverse effects reported. This is one of several reports received from the same source.; Sender's Comments:  US-009507513-1812USA010605: US-009507513-1812USA010604: US-009507513-1812USA010606: US-009507513-1812USA008007: