chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: I received my second Shingrix shot, in my upper, outer left arm, at my local pharmacy. I've received several shots from this pharmacist over the years and never had any problems, but nearly a year after receiving this shot, the injection site continues to be uncomfortable. There is a small eruption, like a mosquito bite, which itches severely, and chronically, yet is too painful to itch. I hate to think I will have this problem for the rest of my life.
Age: 64.0
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Mass, Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: After receiving flu shot in Sept 2018, I developed guillan barre type symptoms which lasted 2 month. Also have had a painful lump and shoulder pain/ Immobility in left arm
Age: 46.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Rash, Swelling
Clinical narrative: redness, warmth, swelling, rash
Age: 18.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Discomfort, Headache, Injection site swelling, Lip swelling, Swelling face
Clinical narrative: Pt developed swelling at site of MENACTRA vaccination on L deltoid. Also discomfort. Pt also developed swelling of lips & cheek on R side as well as headache. Pt took Benadryl last night. Symptoms somewhat improved, less swelling today, but still not resolved.
Age: 63.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient called on 9/5/15 in the morning to inform me of her immunization. She states that her arm where Boostrix was administered is red, swollen, and painful. She said her MD gave her antibiotics.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Product preparation error
Clinical narrative: inappropriate reconstitution technique; Inappropriate dose of vaccine administered; shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number TT9BR, expiry date 13th September 2021) for prophylaxis.  On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix vaccine with the wrong diluent (sterile water), which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter gave permission to follow up.   Follow up information was received from the pharmacist on 28th August 2019: The patient's demographic details were updated. The patient was having no known drug allergy and medical history was unknown. On 14th July 2019, the patient received the 1st dose of Shingrix intramuscularly. On 15th July 2019, 1 day after receiving Shingrix, the patient experienced shingles. Shingrix was discontinued. The outcome of the shingles was resolved in 2 weeks. The reporter considered the shingles to be probably related to Shingrix. The case was considered as medication error associated with adverse event. The pharmacist prepared vaccine with incorrect diluent and patient developed shingles. The reporter was unsure of what outcomes to expect in term of harm and efficacy when vaccine is administerd with wrong diluent. The reporter stated that, the patient was instructed to wait a few years before reconsidering restarting the vaccine series. The VAERS details were updated.
Age: 64.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incorrect dose administered, Product preparation error
Clinical narrative: inappropriate reconstitution technique; Inappropriate dose of vaccine administered; shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number TT9BR, expiry date 13th September 2021) for prophylaxis.  On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix vaccine with the wrong diluent (sterile water), which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter gave permission to follow up.   Follow up information was received from the pharmacist on 28th August 2019: The patient's demographic details were updated. The patient was having no known drug allergy and medical history was unknown. On 14th July 2019, the patient received the 1st dose of Shingrix intramuscularly. On 15th July 2019, 1 day after receiving Shingrix, the patient experienced shingles. Shingrix was discontinued. The outcome of the shingles was resolved in 2 weeks. The reporter considered the shingles to be probably related to Shingrix. The case was considered as medication error associated with adverse event. The pharmacist prepared vaccine with incorrect diluent and patient developed shingles. The reporter was unsure of what outcomes to expect in term of harm and efficacy when vaccine is administerd with wrong diluent. The reporter stated that, the patient was instructed to wait a few years before reconsidering restarting the vaccine series. The VAERS details were updated.
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, White blood cell count normal
Clinical narrative: redness and swelling of injection site; redness and swelling of injection site; wich also traveled down the arm toward elbow; wich also traveled down the arm toward elbow; This spontaneous report was received from a nurse and refers to a 63 year old female patient. The patient's concurrent conditions included anxiety, hypercholesterolaemia, gastrooesophageal reflux disease (GERD), vitamin b12 deficiency, vitamin d deficiency, fatigue, left hip discomfort and allergy to penicillin. The patient's concomitant therapies included ascorbic acid, aspirin, vitamin d, fluticasone propionate (FLONASE), lorazepam (ATIVAN), magnesium, omeprazole (PRILOSEC) and pravastatin. Information regarding the patient's pertinent medical history was not provided.  On 21-AUG-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) intramuscular, lot # S005857, expiration date 03-DEC-2020 (strength, dose and anatomical location were not provided) for routine vaccination. On the same date, the patient experienced redness and swelling at injection site of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), which also traveled down the arm toward elbow (injection site erythema)(peripheral swelling)(erythema)(injection site swelling). On an unknown date in August 2019, the patient's white blood cell count (WBC) was 9.2 (units were not provided).  It was reported that the patient sought medical attention, and treatment with doxycline was given to the patient for the event.  The outcome of injection site erythema, peripheral swelling, erythema and injection site swelling was reported as resolving. The causality between the events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not provided.
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling, White blood cell count normal
Clinical narrative: redness and swelling of injection site; redness and swelling of injection site; wich also traveled down the arm toward elbow; wich also traveled down the arm toward elbow; This spontaneous report was received from a nurse and refers to a 63 year old female patient. The patient's concurrent conditions included anxiety, hypercholesterolaemia, gastrooesophageal reflux disease (GERD), vitamin b12 deficiency, vitamin d deficiency, fatigue, left hip discomfort and allergy to penicillin. The patient's concomitant therapies included ascorbic acid, aspirin, vitamin d, fluticasone propionate (FLONASE), lorazepam (ATIVAN), magnesium, omeprazole (PRILOSEC) and pravastatin. Information regarding the patient's pertinent medical history was not provided.  On 21-AUG-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) intramuscular, lot # S005857, expiration date 03-DEC-2020 (strength, dose and anatomical location were not provided) for routine vaccination. On the same date, the patient experienced redness and swelling at injection site of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), which also traveled down the arm toward elbow (injection site erythema)(peripheral swelling)(erythema)(injection site swelling). On an unknown date in August 2019, the patient's white blood cell count (WBC) was 9.2 (units were not provided).  It was reported that the patient sought medical attention, and treatment with doxycline was given to the patient for the event.  The outcome of injection site erythema, peripheral swelling, erythema and injection site swelling was reported as resolving. The causality between the events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not provided.
Age: 78.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Magnetic resonance imaging normal, X-ray limb normal
Clinical narrative: Pain/ pain at the injection site; movement limited; muscle soreness; painful arm; daily activities are hindered; Pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain, movements reduced, muscle soreness, pain in arm, activities of daily living impaired and pain. On an unknown date, the outcome of the injection site pain, movements reduced, muscle soreness, pain in arm, activities of daily living impaired and pain were unknown.   It was unknown if the reporter considered the injection site pain, movements reduced, muscle soreness, pain in arm, activities of daily living impaired and pain to be related to Shingrix.  Additional details were provided as follows: The patient experiencinced pain at the injection site, painful arm and muscle pain after receiving the first dose of Shingrix vaccine. The reporter stated that It had been 3 months now and there was no improvement at time of reporting. The patient daily activities are hindered and his movement was limited due to the pain. The patient went to see an orthopedic physician 2 week after he started experiencing pain. The patient underwent MRI and Xrays, and everything came out normal. The patient bones and joints were okay as well. The reporter was consented to follow up. No further details were provided.
Age: 78.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Hypokinesia, Injection site pain, Loss of personal independence in daily activities, Magnetic resonance imaging normal, Myalgia
Clinical narrative: Pain/ pain at the injection site; movement limited; muscle soreness; painful arm; daily activities are hindered; Pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain, movements reduced, muscle soreness, pain in arm, activities of daily living impaired and pain. On an unknown date, the outcome of the injection site pain, movements reduced, muscle soreness, pain in arm, activities of daily living impaired and pain were unknown.   It was unknown if the reporter considered the injection site pain, movements reduced, muscle soreness, pain in arm, activities of daily living impaired and pain to be related to Shingrix.  Additional details were provided as follows: The patient experiencinced pain at the injection site, painful arm and muscle pain after receiving the first dose of Shingrix vaccine. The reporter stated that It had been 3 months now and there was no improvement at time of reporting. The patient daily activities are hindered and his movement was limited due to the pain. The patient went to see an orthopedic physician 2 week after he started experiencing pain. The patient underwent MRI and Xrays, and everything came out normal. The patient bones and joints were okay as well. The reporter was consented to follow up. No further details were provided.
Age: 78.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Pain, Pain in extremity, X-ray normal
Clinical narrative: Pain/ pain at the injection site; movement limited; muscle soreness; painful arm; daily activities are hindered; Pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site pain, movements reduced, muscle soreness, pain in arm, activities of daily living impaired and pain. On an unknown date, the outcome of the injection site pain, movements reduced, muscle soreness, pain in arm, activities of daily living impaired and pain were unknown.   It was unknown if the reporter considered the injection site pain, movements reduced, muscle soreness, pain in arm, activities of daily living impaired and pain to be related to Shingrix.  Additional details were provided as follows: The patient experiencinced pain at the injection site, painful arm and muscle pain after receiving the first dose of Shingrix vaccine. The reporter stated that It had been 3 months now and there was no improvement at time of reporting. The patient daily activities are hindered and his movement was limited due to the pain. The patient went to see an orthopedic physician 2 week after he started experiencing pain. The patient underwent MRI and Xrays, and everything came out normal. The patient bones and joints were okay as well. The reporter was consented to follow up. No further details were provided.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Diarrhoea, Injection site swelling
Clinical narrative: Pt came down with local swelling around the injection site, chills, and diarrhea.  She recovered the following day.
Age: 0.42
Sex: F
Vaccine: DTAP, HIBV, RV1
Symptoms: Febrile convulsion
Clinical narrative: Fevers Seizures
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pruritus, Scab, Tenderness
Clinical narrative: Felt nothing when i got the shot. After a day or two there was tenderness and redness about 2" in diameter and a firm area under skin. Appeared worse after a week and became itchy.  Had it looked at on 08/17 at Dr's office and no sign of infection. Still red and firm, no open area. Started to look like a scab under skin, covered with coco oil and a bandaid to soften because it was itchy and i scratched scab edge. No bleeding. I think when scab dried it became itchy and i scratched it again, more came up around edge. Now there is a crater with another scab that is 1/2" in size with a firm, tender area below it.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Blood test, Dizziness, Electrocardiogram, Loss of consciousness, Nausea
Clinical narrative: Patient suddenly experienced nausea, dizziness, passed out, vomited, called 911, taken to hospital by Ambulance.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Urine analysis, Vomiting
Clinical narrative: Patient suddenly experienced nausea, dizziness, passed out, vomited, called 911, taken to hospital by Ambulance.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: tinnitus-ringing in ear ongoing
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effect; The patient received one dose each of PROQUAD and VARIVAX on 06-AUG-2019; Information has been received from a nurse referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.  On 06-AUG-2019, the patient received one dose each of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (therapy type: rHA, lot # S005880, expiration date reported as 31-AUG-2020, but upon internal validation established as 25-AUG-2020, strength, dose and route were unknown) and varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # R029519, expiration date reported as 31-OCT-2020, but upon internal validation established as 14-OCT-2020, strength, dose and route were unknown) (overdose) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse affects; improperly stored MMR II was administered; This spontaneous report was received from a pharmacy technician referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was not provided.  On 14-AUG-2019, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (product storage error) (dose was not reported) lot # R027063, expiration date: 20-SEP-2020, subcutaneously for prophylaxis. There were no previous temperatures excursion. The vaccine was exposed at 70 Fahrenheit degrees for 4 days. Data digital logger was involved. No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; a MMR II vaccine that expired on 08/24/2019 was administered on 08/26/2019; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.      On 26-AUG-2019, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) (1 injection, lot # N023146, expiration date: 24-AUG-2019; route was not reported) for prophylaxis (expired product administered). No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; a patient was administered an improperly stored ROTATEQ.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication and drug reactions/allergies were not reported.  On 22-AUG-2019, the patient received improperly stored rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot# S010702 with expiration date 16-JAN-2021; dose, frequency, route of administration were not reported) for prophylaxis (Product storage error). The temperature and time frame were unknown (late shipment). Information of previous temperature excursion was not provided. No adverse effects were reported. The call was not because of Data logger.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: an improperly stored dose of GARDASIL 9 was administered; NO adverse effect reported; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions or allergies was not provided.    On 28-AUG-2019, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1614897 with an expiration date in 20-SEP-2021), dose 2, for prophylaxis, (strength, dose and frequency were not provided), that underwent a temperature excursion of 48 degrees Fahrenheit during a time frame of 4 hours and 15 minutes. Digital data logger was involved. No previous temperature excursion was reported and no adverse effects were reported either.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product quality issue, Syringe issue
Clinical narrative: NO ADVERSE EVENT; GARDASIL syringe broke off of the syringe during GARDASIL 9 administration to a patient; after the administrarion was completed, the nurse inspected the tray that the GARDASIL 9 syringe came from and discovered that the rest of the finger flange was there in the tray; Product quality complaint; This spontaneous report was received from a registered nurse and concerns to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.          On 30-AUG-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # R029512 and expiration date 08-JUL-2021, for prophylaxis (dosage schedule, route, and anatomical location were not reported).  During the administration a piece of the finger flange of a pre-filled hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) syringe broke off of the syringe (product quality issue and poor quality device used). However, the patient received the complete dose. After the administration was completed, the nurse inspected the tray that the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) syringe came from and discovered that the rest of the finger flange was there in the tray (product physical issue). The syringe don't have any crack but the syringe was broken into 2 or more pieces, the finger flange was broken into several pieces, some pieces were found later in the plastic syringe tray. The exact location of the breakage was between the finger flange and the body of the syringe. Also the finger flange itself was broken into several pieces. The  tip of the syringe or Luer was not lock adaptor loose or broken off of the syringe tip. The cellophane cover of the syringe tray was intact and completely sealed.   The outcome of poor quality device used, no adverse event, product quality issue and product physical issue was unknown.  The causality between product quality issue and product physical issue and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  was not provided.
Sex: U
Vaccine: HPV9, MMR, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: multiple unspecified patients might have been administered improperly stored vaccines; No adverse effects; This spontaneous report has been received from a nurse referring to multiple unspecified patients of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On multiple unspecified dates, the patients might have been administered improperly stored vaccines of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (lot# R028382 has been verified to be a valid lot number, expiration date reported as 03-OCT-2020, but upon internal validation established as 10-MAR-2020; lot# R014690 has been verified to be a valid lot number and expiration date was 23-MAY-2020; strength, dose, frequency and route were not reported), HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot# R020947 has been verified to be a valid lot number, expiration date reported as 09-MAY-2021, but upon internal validation established as 04-MAY-2021; lot# R023606 has been verified to be a valid lot number and expiration date was 06-MAY-2021, lot# R029117 has been verified to be a valid lot number and expiration date was 10-JUL-2021; strength, dose, frequency and route were not reported) and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (lot# R035672 has been verified to be a valid lot number and expiration date was 19-SEP-2020, lot# R034878 has been verified to be a valid lot number and expiration date was 11-SEP-2020; strength, dose, frequency and route were not reported) for prophylaxis. The administered doses experienced temperature excursions of below 36 Fahrenheit (F) degree (33.3F) for 46 minutes, above 47F (53.6 F) for 33 minutes and above 47F (51.4F) for 1 hour 1 minute, which were detected by a data logger. There was no previous temperature excursion. The diluent used to reconstitute the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was properly stored. No adverse effects were reported.   This is a non-valid case due to no patients' identifier.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.      In 2018, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient experienced shingles (date unspecified) and was treated by a healthcare provider and was hospitalized due to the event (date unspecified).  As a direct and proximate result of patient use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was considered as not resolved. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.      On 29-OCT-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient experienced shingles (date unspecified), was treated and was hospitalized due to the event (date unspecified).  As a direct and proximate result of patient use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was considered as not resolved. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.      In 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient experienced shingles (date unspecified), was treated by a physician and was hospitalized due to the event (date unspecified).  As a direct and proximate result of patient use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was considered as not resolved. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.      In 2008, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient experienced shingles (date unspecified), was treated by a physician and was hospitalized due to the event (date unspecified).  As a direct and proximate result of patient use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was considered as not resolved. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.      In 2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient experienced herpes zoster (date unspecified), was treated by a health care provider and was hospitalized due to the event (date unspecified).  As a direct and proximate result of patient use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was considered as not resolved. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.     On or about 04-OCT-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of herpes zoster was unknown.    Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Tinnitus, Visual impairment
Clinical narrative: herpes zoster outbreaks; vision issues; tinnitus; Information has been received from a male patient of unknown age and a lawyer referring to himself. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On or about 16-APR-2016, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for routine health maintenance and the prevention of shingles (herpes zoster).  On an unknown date, the patient experienced with recurrent herpes zoster outbreaks, vision issues and tinnitus. The patient did not recover from all the events.   The reporter considered the events were disability.  The reporter considered the events were related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.     In 2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated by a physician for shingles. As a direct and proximate result of use of zoster vaccine live (ZOSTAVAX), patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of herpes zoster was unknown.   Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster starting from the umbilical area which wrapped to the right, lower and middle portion; Information has been received from a male patient of unknown age and a lawyer referring to himself. The patient's medical history, concurrent condition and concomitant therapy were not reported.  On or about 02-SEP-2017, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) (strength, dose, frequency, route, lot# and expiration date were unknown) for routine health maintenance and the prevention of shingles (herpes zoster).  On an unknown date, the patient experienced herpes zoster starting from the umbilical area which wrapped to the right, lower and middle portion. The patient did not recover from the event.   The reporter considered the event were disability.  The reporter considered the event was related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; one dose of expired PNEUMOVAX23 was administered; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medication and drug reactions or allergies were not reported.  On 03-SEP-2019, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # N025656 and expiration date: 19-APR-2019) for prophylaxis (strength, dose, unit, route and anatomical location were not reported) (expired product administered). No adverse effects were reported. The outcome of expired product administered was unknown.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Peripheral swelling, Post herpetic neuralgia, Rash, Rash pruritic
Clinical narrative: post herpetic neuralgia; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.     On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for the prevention of shingles (herpes zoster). On an unknown date, after injection, the patient suffered a swollen arm and a painful itchy blistering rash. As a result of her symptoms, patient presented to a medical provider and was diagnosed with shingles, as well as, post herpetic neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries and suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.    Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: post herpetic neuralgia; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.     On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for the prevention of shingles (herpes zoster). On an unknown date, after injection, the patient suffered a swollen arm and a painful itchy blistering rash. As a result of her symptoms, patient presented to a medical provider and was diagnosed with shingles, as well as, post herpetic neuralgia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), patient sustained severe and permanent personal injuries and suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.    Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effect reported; one dose of expired M-M-R II with no prior temperature excursion was reconstituted with properly stored and not expired STERILE DILUENT; This spontaneous report was received from a registered nurse and refers to a 12 month old patient of unknow gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 06-AUG-2019, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), lot number N020925 with expiration date 01-AUG-2019 with no prior temperature excursion  and reconstituted with properly stored sterile diluent. No adverse effect was reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse Effects; Improperly stored dose of GARDASIL9 was administered; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medication, were not reported.  The reporter stated that, on either 16-JUL-2019, 22-JUL-2019 or 29-JUL-2019, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R020947, expiration date 04-MAY-2021, for prophylaxis (strength, dose, route, anatomical site and frequency were unknown), which has a temperature excursion of 47F for 3 hours and 15 minutes on 10-MAY-2019, and a temperature excursion of 36F for 2 minutes on 20-JUN-2019. The reporter stated that the vaccine had no previous temperature excursion and no adverse effects were reported.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration, Mobility decreased, Pain in extremity
Clinical narrative: Inappropriate schedule of vaccine; soreness; couldn't lift arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm, mobility decreased and drug dose administration interval too short. On an unknown date, the outcome of the pain in arm and mobility decreased were recovered/resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient received 1st dose 58 days ago from the reporting dtae and went to the pharmacy to get the second dose two days shy of the 60 day minimum recommendation, which might led to shortening of vaccination schedule. The patient never had a sore arm like with the first dose of Shingrix. He couldn't lift his arm at all after the vaccination.  The issue resolved after 1.5 days. The patient reported that he was in shape guy and his arm was very sore. The patient does not want follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Inappropriate Schedule of Vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (1st dose received in October 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were received as follows: The age at vaccination was not applicable for this report. The reporter asked how proceed with Shingrix 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site pain, Injection site reaction, Injection site swelling, Rash macular
Clinical narrative: Swelling of entire upper left leg 2 days after DTAP.  Told to come in to office. Told there was no treatment option. Swelling continued into night and next day. Doctor said he had seen this reaction once every 10 years (32 years in practice)  Told to monitor and measure it. Child complained of pain in relation to swelling. Bright red blotches on upper left leg.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Hypersensitivity, Pruritus, Rash
Clinical narrative: Patient started having an allergic reation (localized rash) within 5 minutes of the injection when they came back and noticed some redness and ithcing. Patient stated no other symptoms. Patient was offered Benadryl but prefered to take zyrtec at home when she got home. Patient was told to take immeditely and also given topical benadrl to help alleviate some of the rash and itchiness and told to call back if any other symptoms.
Age: 0.42
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site abscess, Injection site nodule, Surgery
Clinical narrative: Mom reported at clinic visit 08/23/2018 "child had a knot" on right thigh post June 7, 2018 vaccinations- 3 months.  Visited the Primary Care Physician-
Age: 59.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Malaise, Nausea
Clinical narrative: Persistent ache upper left arm; general body ache; fatigue; headache; nausea; malaise  lasting several days
Age: 59.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pain
Clinical narrative: Persistent ache upper left arm; general body ache; fatigue; headache; nausea; malaise  lasting several days