chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: TYP
Symptoms: Abdominal discomfort, Decreased appetite, Fatigue, Headache, Nausea
Clinical narrative: STOMACH DISCOMFORT; VOMITING; HEADACHE; NAUSEOUS; TIREDNESS; NO APPETITE; This spontaneous case (802918-1) was extracted through VAERS database on 24-May-2019. The case was reported by a consumer. It describes a 47-year-old female consumer who had vomiting, headache, tiredness, nauseous, no appetite, and stomach discomfort, after the administration of oral Vivotif (lot no: 3003237) for an unknown indication.   Case report: The consumer took the first dose of Vivotif on 22-Feb-2019 with cold water and did not eat for 2 hours. On 23-Feb-2019, she vomited for several times, and experienced headache, tiredness, and nausea. She was not able to get up from the bed due to reported events. She also had no appetite. At noon, she took Zofran (ondansetron) to stop vomiting. On 24-Feb-2019, she still had mild headache and stomach discomfort, but she felt much better. On 25-Feb-2019, she was back to normal, but she did not take the second dose.   The consumer had not taken any concomitant medication and she had no current illness.  The consumer had seasonal allergies for which she took over the counter (OTC) medicines as needed.  She had no laboratory test.  Action taken with Vivotif was unknown.  The consumer had recovered from the reported events.  Company's Comment: In this case, it was reported that the consumer had vomiting, headache, tiredness, nauseous, no appetite, and stomach discomfort after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, vomiting, tiredness, headache, nausea, abdominal discomfort are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had vomiting, headache, tiredness, nauseous, no appetite, and stomach discomfort after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, vomiting, tiredness, headache, nausea, abdominal discomfort  are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Vomiting
Clinical narrative: STOMACH DISCOMFORT; VOMITING; HEADACHE; NAUSEOUS; TIREDNESS; NO APPETITE; This spontaneous case (802918-1) was extracted through VAERS database on 24-May-2019. The case was reported by a consumer. It describes a 47-year-old female consumer who had vomiting, headache, tiredness, nauseous, no appetite, and stomach discomfort, after the administration of oral Vivotif (lot no: 3003237) for an unknown indication.   Case report: The consumer took the first dose of Vivotif on 22-Feb-2019 with cold water and did not eat for 2 hours. On 23-Feb-2019, she vomited for several times, and experienced headache, tiredness, and nausea. She was not able to get up from the bed due to reported events. She also had no appetite. At noon, she took Zofran (ondansetron) to stop vomiting. On 24-Feb-2019, she still had mild headache and stomach discomfort, but she felt much better. On 25-Feb-2019, she was back to normal, but she did not take the second dose.   The consumer had not taken any concomitant medication and she had no current illness.  The consumer had seasonal allergies for which she took over the counter (OTC) medicines as needed.  She had no laboratory test.  Action taken with Vivotif was unknown.  The consumer had recovered from the reported events.  Company's Comment: In this case, it was reported that the consumer had vomiting, headache, tiredness, nauseous, no appetite, and stomach discomfort after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, vomiting, tiredness, headache, nausea, abdominal discomfort are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had vomiting, headache, tiredness, nauseous, no appetite, and stomach discomfort after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, vomiting, tiredness, headache, nausea, abdominal discomfort  are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Anaemia, Arthralgia, Blood thyroid stimulating hormone, Borrelia test negative, Feeling abnormal
Clinical narrative: RASH ON THE LEGS AND ARMS; FELT POORLY; GENERALIZED MALAISE; ARTHRALGIAS (ESPECIALLY IN THE HANDS AND KNEES); MYALGIAS; This spontaneous case report (818955-1) was extracted through VAERS database on 27-Sep-2019. The case was reported by a consumer via health authority. This report described a 15-year-old female consumer who experienced rash on the legs and arms (PT: Rash), generalized malaise (PT: Malaise), arthralgias (especially in the hands and knees) (PT: Arthralgia), myalgias (PT: Myalgia) and felt poorly (PT: Feeling abnormal) while being on oral Vivotif for an unknown indication.  Case report: The consumer developed rash on the legs and arms 24 hours after the second dose of the Vivotif. Thus, she took Benadryl (diphenhydramine), which helped her. On 01-May-2019, she took the third dose. On 02-May-2019, she developed generalized malaise, arthralgia (especially in the hands and knees) without joint effusion or redness, and myalgias. After the third dose, the vaccine was discontinued. It was also reported that she felt poorly for 3 days and then symptoms began to improve. She felt better by 10 Jun.   The consumer's medical history included obesity, allergic rhinitis and general anxiety disorder.  Concomitant medications included oral Zyrtec (cetirizine; 10 mg; once a day), oral Zoloft (sertraline; 100 mg; once a day) and oral Topamax (topiramide; 50 mg; every night at bedtime).  Laboratory test included blood thyroid stimulating hormone, borrelia test, full blood count, metabolic function test. All tests were normal except hemoglobin, which was found to be 11.2. Hence, the consumer had mild anemia. All the tests were conducted on 06-May-2019.  Action taken with Vivotif with respect to the reported events was vaccine discontinued.  The consumer was recovered from the events on 10-Jun-2019.  Company's Comment: In this case, it was reported that the consumer experienced rash on the legs and arms, generalized malaise, arthralgias (especially in the hands and knees), myalgias and felt poorly after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer experienced rash on the legs and arms, generalized malaise, arthralgias (especially in the hands and knees), myalgias and felt poorly after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Full blood count normal, Haemoglobin decreased, Malaise, Metabolic function test normal, Myalgia
Clinical narrative: RASH ON THE LEGS AND ARMS; FELT POORLY; GENERALIZED MALAISE; ARTHRALGIAS (ESPECIALLY IN THE HANDS AND KNEES); MYALGIAS; This spontaneous case report (818955-1) was extracted through VAERS database on 27-Sep-2019. The case was reported by a consumer via health authority. This report described a 15-year-old female consumer who experienced rash on the legs and arms (PT: Rash), generalized malaise (PT: Malaise), arthralgias (especially in the hands and knees) (PT: Arthralgia), myalgias (PT: Myalgia) and felt poorly (PT: Feeling abnormal) while being on oral Vivotif for an unknown indication.  Case report: The consumer developed rash on the legs and arms 24 hours after the second dose of the Vivotif. Thus, she took Benadryl (diphenhydramine), which helped her. On 01-May-2019, she took the third dose. On 02-May-2019, she developed generalized malaise, arthralgia (especially in the hands and knees) without joint effusion or redness, and myalgias. After the third dose, the vaccine was discontinued. It was also reported that she felt poorly for 3 days and then symptoms began to improve. She felt better by 10 Jun.   The consumer's medical history included obesity, allergic rhinitis and general anxiety disorder.  Concomitant medications included oral Zyrtec (cetirizine; 10 mg; once a day), oral Zoloft (sertraline; 100 mg; once a day) and oral Topamax (topiramide; 50 mg; every night at bedtime).  Laboratory test included blood thyroid stimulating hormone, borrelia test, full blood count, metabolic function test. All tests were normal except hemoglobin, which was found to be 11.2. Hence, the consumer had mild anemia. All the tests were conducted on 06-May-2019.  Action taken with Vivotif with respect to the reported events was vaccine discontinued.  The consumer was recovered from the events on 10-Jun-2019.  Company's Comment: In this case, it was reported that the consumer experienced rash on the legs and arms, generalized malaise, arthralgias (especially in the hands and knees), myalgias and felt poorly after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer experienced rash on the legs and arms, generalized malaise, arthralgias (especially in the hands and knees), myalgias and felt poorly after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible.
Sex: F
Vaccine: TYP
Symptoms: Rash
Clinical narrative: RASH ON THE LEGS AND ARMS; FELT POORLY; GENERALIZED MALAISE; ARTHRALGIAS (ESPECIALLY IN THE HANDS AND KNEES); MYALGIAS; This spontaneous case report (818955-1) was extracted through VAERS database on 27-Sep-2019. The case was reported by a consumer via health authority. This report described a 15-year-old female consumer who experienced rash on the legs and arms (PT: Rash), generalized malaise (PT: Malaise), arthralgias (especially in the hands and knees) (PT: Arthralgia), myalgias (PT: Myalgia) and felt poorly (PT: Feeling abnormal) while being on oral Vivotif for an unknown indication.  Case report: The consumer developed rash on the legs and arms 24 hours after the second dose of the Vivotif. Thus, she took Benadryl (diphenhydramine), which helped her. On 01-May-2019, she took the third dose. On 02-May-2019, she developed generalized malaise, arthralgia (especially in the hands and knees) without joint effusion or redness, and myalgias. After the third dose, the vaccine was discontinued. It was also reported that she felt poorly for 3 days and then symptoms began to improve. She felt better by 10 Jun.   The consumer's medical history included obesity, allergic rhinitis and general anxiety disorder.  Concomitant medications included oral Zyrtec (cetirizine; 10 mg; once a day), oral Zoloft (sertraline; 100 mg; once a day) and oral Topamax (topiramide; 50 mg; every night at bedtime).  Laboratory test included blood thyroid stimulating hormone, borrelia test, full blood count, metabolic function test. All tests were normal except hemoglobin, which was found to be 11.2. Hence, the consumer had mild anemia. All the tests were conducted on 06-May-2019.  Action taken with Vivotif with respect to the reported events was vaccine discontinued.  The consumer was recovered from the events on 10-Jun-2019.  Company's Comment: In this case, it was reported that the consumer experienced rash on the legs and arms, generalized malaise, arthralgias (especially in the hands and knees), myalgias and felt poorly after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer experienced rash on the legs and arms, generalized malaise, arthralgias (especially in the hands and knees), myalgias and felt poorly after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Nausea, Pain
Clinical narrative: Breast pain; Felt really bad/he had a bad reaction to your; Exhausted; Upset stomach; Hurts all over; sick; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 70-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 25th February 2020, the patient received the 1st dose of Shingles vaccine. On 27th February 2020, 2 days after receiving Shingles vaccine, the patient experienced feeling bad, exhaustion, upset stomach, general body pain and sickness. On an unknown date, the patient experienced breast pain. On an unknown date, the outcome of the feeling bad, exhaustion, upset stomach, general body pain, sickness and breast pain were unknown.   It was unknown if the reporter considered the feeling bad, exhaustion, upset stomach, general body pain, sickness and breast pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient received shingrix and felt really bad exhausted, upset stomach, just hurts all over.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Breast pain, Fatigue, Feeling abnormal, Malaise
Clinical narrative: Breast pain; Felt really bad/he had a bad reaction to your; Exhausted; Upset stomach; Hurts all over; sick; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 70-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 25th February 2020, the patient received the 1st dose of Shingles vaccine. On 27th February 2020, 2 days after receiving Shingles vaccine, the patient experienced feeling bad, exhaustion, upset stomach, general body pain and sickness. On an unknown date, the patient experienced breast pain. On an unknown date, the outcome of the feeling bad, exhaustion, upset stomach, general body pain, sickness and breast pain were unknown.   It was unknown if the reporter considered the feeling bad, exhaustion, upset stomach, general body pain, sickness and breast pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient received shingrix and felt really bad exhausted, upset stomach, just hurts all over.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain
Clinical narrative: Breast pain; Felt really bad/he had a bad reaction to your; Exhausted; Upset stomach; Hurts all over; sick; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 70-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 25th February 2020, the patient received the 1st dose of Shingles vaccine. On 27th February 2020, 2 days after receiving Shingles vaccine, the patient experienced feeling bad, exhaustion, upset stomach, general body pain and sickness. On an unknown date, the patient experienced breast pain. On an unknown date, the outcome of the feeling bad, exhaustion, upset stomach, general body pain, sickness and breast pain were unknown.   It was unknown if the reporter considered the feeling bad, exhaustion, upset stomach, general body pain, sickness and breast pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient received shingrix and felt really bad exhausted, upset stomach, just hurts all over.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had a sore arm.  For tolerance after 2nd dose refer case US2020AMR044290. This is 1 of the 4 linked cases reported by the same reporter.
Sex: F
Vaccine: MMRV, UNK
Symptoms: Accidental exposure to product, Exposure via eye contact, No adverse event
Clinical narrative: The healthcare worker experienced no symptoms.; an unspecified healthcare worker was splashed in the eye with PROQUAD; an unspecified healthcare worker was splashed in the eye with PROQUAD; an unspecified healthcare worker was splashed in the eye with PROQUAD; This spontaneous report was received from a nurse concerning to a female patient of an unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On 17-MAR-2020, the healthcare worker was splashed in the eye with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S002503, expiration date 23-JUL-2020) while attempting to administer the vaccine to a child.  The vaccine was reconstituted with a sterile water diluent (MSD) (Lot # and expiry date unknown). The patient experienced no symptoms. She would be evaluated at an unspecified healthcare location.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2003USA007123:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: patient was inadvertently administered a dose of PNEUMOV AX 23 which expired; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.           On 18-MAR-2020, the patient was inadvertently vaccinated with a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) lot# R007721 which expired on 01-MAR-2020 (dose and route were not provided) for prophylaxis.
Sex: F
Vaccine: HPV9
Symptoms: Vaccination site mass
Clinical narrative: "on an unspecified date in March 2020, about one month after the GARDASIL 9 was administered the patient experienced a 4 X 2 centimeter lump at the administration site." The physician reports that " the lump is not red or painful."; This spontaneous report was received from a physician and refers to a female patient of unknown age. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On an unknown date in February 2020, the patient was received the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (route of administration, frequency, lot/batch # and expiration date were not reported).        On an unknown date in March 2020, also reported as "about one month after the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was administered" the patient experienced a 4 X 2 centimeter lump at the administration site, the physician reports that the lump was not red or painful (vaccination site mass). The outcome of vaccination site mass was reported as not resolved.  The causality assessment between vaccination site mass and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects were reported.; two patients received improperly stored PROQUAD; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On 28-FEB-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S022109 with expiration date of 12-JAN-2021, for prophylaxis (route of administration and frequency were not reported). The sterile diluent (STERILE DILUENT MRK) used to reconstitute measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was properly stored.    No adverse effects were reported.    It was stated that the vaccines underwent a temperature excursion of 47°C (degrees Celsius) to 8°C (-7C) for 41 minutes on 20-DEC-2019. Previous temperature excursion was done. The call was because of a "data logger".  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2004USA000404: US-009507513-2004USA000405:
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to an 81-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In 2016, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (the dosage regimen was not reported) for prophylaxis. In 2016, the patient suffered shingles (herpes zoster). As a result of her receipt of zoster vaccine live (ZOSTAVAX), the patient had been caused to suffer serious and dangerous side effects including shingles, as well as other severe personal injuries which were permanent and lasting in nature, physician pain and mental anguish including diminished enjoyment of life, the needed for lifelong medical treatment, monitoring and /or medication.  At the time of the report, the outcome of shingles was not recovered. The reporter considered the event previously mentioned to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information was received from a lawyer regarding a case in litigation referring to a 66 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 05-OCT-2013, the patient was vaccinated with zoster vaccine live(ZOSTAVAX)(strength, route, dosage schedule, lot number and expiration date were not reported) for prophylaxis. As a result of receipt of zoster vaccine live(ZOSTAVAX), on 12-OCT-2013, patient was caused to suffer shingles, including any and all of its sequelae. As a result of receipt of zoster vaccine live(ZOSTAVAX), patient has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).  As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information was received from a lawyer regarding a case in litigation referring to a 66 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2016 (also reported as when the patient was 63 year old (conflicting information)), the patient was vaccinated with zoster vaccine live(ZOSTAVAX)(strength, route, dosage schedule, lot number and expiration date were not reported) for prophylaxis. As a result of receipt of zoster vaccine live(ZOSTAVAX), in April 2017, patient was caused to suffer shingles, including any and all of its sequelae. As a result of receipt of zoster vaccine live(ZOSTAVAX), patient has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).  As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications.
Age: 60.0
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 61 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 02-SEP-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for prophylaxis (age at vaccination was reported as 60 years old). As a result of her receipt of zoster vaccine live (ZOSTAVAX), on 27-JUL-2016, the patient was caused to suffer shingles, including any and all of its sequelae and had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain. As a result of her receipt of zoster vaccine live (ZOSTAVAX), the patient suffered shingles and other related health complications. In addition, the patient requires and will continue to require healthcare and services. The patient has incurred and will continue to incur medical and related expenses. The patient also has suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The patient's direct medical losses and costs include physician care, monitoring, and treatment. The patient has incurred and will continue to incur mental and physical pain and suffering. The outcome of the event was considered not recovered/not resolved. The event was considered related to zoster vaccine live (ZOSTAVAX).   The lawyer considered the event to be medically significant and disability.
Age: 61.0
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 61 years old (also reported as 62 years old when administered vaccine) female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date in 2006, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for prophylaxis. As a result of zoster vaccine live (ZOSTAVAX), in 2006, the patient was caused to suffer shingles, including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), the patient had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. The patient required and would continue to require healthcare and services. The patient had incurred and would continue to incur medical and related expenses. The patient also had suffered and would continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The patient had incurred and would continue to incur mental and physical pain and suffering. The outcome of the event shingles was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the event shingles to be disability and medically significant.
Age: 61.0
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 61 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On 03-JAN-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for prophylaxis. As a result of zoster vaccine live (ZOSTAVAX), on 22-SEP-2014, the patient was caused to suffer shingles, including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), the patient had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. The patient required and would continue to require healthcare and services. The patient had incurred and would continue to incur medical and related expenses. The patient also had suffered and would continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The patient had incurred and would continue to incur mental and physical pain and suffering. The outcome of the event shingles was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the event shingles to be disability and medically significant.
Age: 62.0
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 62 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On 23-MAY-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for prophylaxis. As a result of zoster vaccine live (ZOSTAVAX), on 26-AUG-2013, the patient was caused to suffer shingles, including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), the patient had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications.The patient required and would continue to require healthcare and services. The patient had incurred and would continue to incur medical and related expenses. The patient also had suffered and would continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The patient had incurred and would continue to incur mental and physical pain and suffering. The outcome of the event shingles was considered to be not recovered and causal relationship was assessed as related.   The lawyer considered the event shingles to be disability and medically significant.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: suffer shingles, including any and all of its sequelae; Information has been received from a lawyer regarding a case in litigation. This case refers to a 51 year old male patient (pt). The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided. On 12-FEB-2016, the patient was administered zoster vaccine live (ZOSTAVAX) by unknown route, for prophylaxis. As a result of this administration, on 23-FEB-2016, the pt suffered shingles, including any and all of its sequelae. His spouse also suffered loss of consortium damages. Additionally, pt suffered severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages, and suffered serious and dangerous side effects including shingles, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. Pt required and/or would required more health care and services and did incur medical, health, incidental and related expenses. also, he would, in the future, be required to obtain further medical and/or hospital care, attention and services. At reporting time, pt was not recovered from herpes zoster and it was considered to be related to Zoster Vaccine Live (ZOSTAVAX). Herpes zoster was considered to be a disabling event.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation. This case refers to a 74 year old female patient (pt). The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided.  In November 2016, the pt was administered zoster vaccine live (ZOSTAVAX) by unknown route, for prophylaxis. As a result of this administration, in January 2017, the pt suffered shingles, including any and all of its sequelae. Additionally, pt suffered severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages, and suffered serious and dangerous side effects including shingles, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. Pt required and/or would required more health care and services and did incur medical, health, incidental and related expenses. Also, she would, in the future, be required to obtain further medical and/or hospital care, attention and services. At reporting time, pt was not recovered from herpes zoster and it was considered to be related to Zoster Vaccine Live (ZOSTAVAX). Herpes zoster was considered to be a disabling event.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a 67-year-old male patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in September 2012, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (the dosage regimen was not reported) for prophylaxis at a pharmacy/drug store. On 12-DEC-2012, the patient suffered shingles (herpes zoster). As a result of his receipt of zoster vaccine live (ZOSTAVAX), the patient caused to suffer serious and dangerous side effects including shingles, as well as other severe personal injuries which were permanent and lasting in nature, physician pain and mental anguish including diminished enjoyment of life, the needed for lifelong medical treatment, monitoring and /or medication.  At the time of the report, the outcome of shingles (herpes zoster) was not recovered. The reporter considered the event previously mentioned to be related to Zoster Vaccine Live (ZOSTAVAX).
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a 77-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 23-APR-2012, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (the dosage regimen was not reported) for prophylaxis at a pharmacy/drug store. In September 2012, the patient suffered shingles (herpes zoster). As a result of her receipt of zoster vaccine live (ZOSTAVAX), the patient caused to suffer serious and dangerous side effects including shingles, as well as other severe personal injuries which were permanent and lasting in nature, physician pain and mental anguish including diminished enjoyment of life, the needed for lifelong medical treatment, monitoring and /or medication.  At the time of the report, the outcome of shingles (herpes zoster) was not recovered. The reporter considered the event previously mentioned to be related to Zoster Vaccine Live (ZOSTAVAX).
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Cardiac failure congestive, Herpes zoster
Clinical narrative: Cardiac failure congestive; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72 years old male patient. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown day in June 2015, the patient was vaccinated for prophylaxis with zoster vaccine live (ZOSTAVAX) for prophylaxis (dose, route, anatomical location, lot number and expiration date were not provided) at his physician's Office. On an unknown date (also reported as 08-JUN-2012, conflicting information due to onset date of the adverse event was reported prior vaccination date), the patient experienced herpes zoster (shingles) and cardiac failure congestive. As a result of the zoster Vaccine Live (ZOSTAVAX) vaccination, the patient's symptoms have resulted in severe pain, suffering, and emotional distress, as well as to incur substantial economic damages. In addition, the patient sustained severe and permanent personal injuries. The outcome of the events of cardiac failure congestive and shingles was considered as not recovered. The reporter considered the events to be related to zoster Vaccine Live (ZOSTAVAX).   Upon internal review, the event of cardiac failure congestive was determined to be medically significant. The events of cardiac failure congestive and shingles were considered to be disabling.
Sex: M
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Coordination abnormal, Dysarthria, Hemiparesis
Clinical narrative: acute cerebrovascular accident; 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. On or around 10-OCT-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided) for routine adult health maintenance for the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), he suffered left sided weakness with difficulty with coordination and slurred speech. Therefore, the patient was hospitalized and diagnosed with acute cerebrovascular accident. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), patient's symptoms had resulted in physical limitation not present prior to using zoster vaccine live (ZOSTAVAX). He also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. Pt sustained severe and permanent personal injuries; besides, he 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. The outcome of the cerebrovascular accident was not recovered. The reporter assessed that the events were related to zoster vaccine live (ZOSTAVAX).  Upon internal review, cerebrovascular accident was considered to be medically significant.  Reporter considered cerebrovascular accident to be a disabling event.
Sex: F
Vaccine: HPV9, UNK
Symptoms: Histiocytic necrotising lymphadenitis, Pathology test, Swelling
Clinical narrative: The patient developed a bump on lhe inside of the arm/ the bump grew larger and the patient had the bump excised/ the bump was sent to the lab for pathology and the report shows that is it kikuchi disease; This spontaneous report was received from a medical assistant referring to a 12-year-old female patient. The patient did not has any pertinent concurrent condition, medical history, concomitant medication or previous drug reactions or allergies.  On 27-FEB-2020, the patient was vaccinated with a standard dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), intramuscularly, as prophylaxis (concentration, number of administered dose; lot number R027576 and expiration date 23-JUN-2021).  On 02-MAR-2020, the patient developed a bump on the inside of the arm, not where the vaccine was administered. On 10-MAR-2020, the patient sought medical attention from the physician who used a low set heating pad with a 4 inch ace wrap around the bump, the bump grew larger and the patient had the bump excised on 24-MAR-2020 and she had no longer the bump inside the arm. The bump was sent to the laboratory for pathology and the report showed that was kikuchi disease (histiocytic necrotising lymphadenitis).   At the time of this report, the outcome of histiocytic necrotising lymphadenitis was not reported.     The causality assessment between therapy with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) ( GARDASIL 9) and the aforementioned event was not reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: R027576; expirationdate: 23-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: F
Vaccine: VARZOS
Symptoms: Deafness bilateral, Deafness neurosensory
Clinical narrative: bilateral sensorineural hearing loss; This initial spontaneous report was received from a lawyer and a female patient of unknown age regarding a case in litigation on 27-MAR-2020. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On or around 21-AUG-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered hearing loss in both ears, she was diagnosed with bilateral sensorineural hearing loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms had resulted in physical limitations not present prior to vaccination. She also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient sustained severe, 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 had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, the outcome of the event was considered as not recovered. The reporters considered bilateral sensorineural hearing loss to be related to Zoster Vaccine Live (ZOSTAVAX).      The reporters considered bilateral sensorineural hearing loss to be a disabling event. Upon internal review, bilateral sensorineural hearing loss was determined to be medically significant.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse symptoms reported; The patient received an improperly stored dose of ROTATEQ on 3/3/20; This spontaneous report has been received from a medical assistant regarding a patient of unknown age and gender. The patient's pertinent medical history, drug allergies or reactions, and concomitant therapies were not reported.  On 03-MAR-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, administered orally (PO) (strength, dose and vaccination scheme were not reported; lot number was 1660112, expiration date was on 18-OCT-2020) as prophylaxis (incorrect product storage). No adverse symptoms were reported.  The suspect rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was exposed to a highest temperature above 47 degrees Fahrenheit (°F) (52.1 °F) for a time frame of 15 minutes. There was a previous temperature excursion, at a highest temperature above 47 °F (55 °F) for 21 minutes. In addition, a digital data logger was involved.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information provided; The patient was administered an improperly stored dose of ROTATEQ / Temperature ABOVE 47°F 52. F / Time frame 15 minutes / Previous temperature excursion? Yes ABOVE 47°F 55F 21 minutes; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications were not reported.  On 09-MAR-2020, an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, lot number 1660112 with expiration date 18-OCT-2020 (which had been verified to be valid lot number and expiration date for rotavirus vaccine, live, oral, pentavalent) was administered to the patient by oral route for prophylaxis (dose was not reported); the vaccine had temperature excursions of 55 degree Fahrenheit (F) for 21 minutes and 52.1 F for 15 minutes (which were both above 47 F), which were detected by the data logger. No adverse event was reported.