chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, UNK
Symptoms: Peripheral swelling
Clinical narrative: Fatigue; wet bed; injection site swelling x one month; Lethargy; Site redness; This report was identified from a line listing obtained on request by the Company from the FDA (Agency number 800439) under the Freedom of Information Act refers to a 12 year old female patient. The patient's historical drug included nystatin and concurrent condition included nystatin local allergy. Historical condition and concomitant medications were not reported. On 03-JUL-2018, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot # N023952, expiration date was not reported, but upon internal validation established as 12-JUL-2020 (strength and dose not reported) via intramuscular route in unspecified arm for prophylaxis. Other suspect therapies included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (also reported as "TDAP"), lot # TB2R2, expiration date was not reported and meningococcal vaccine (unspecified), lot # U5848AA, expiration date was not reported (strength, dose and indication not reported) via intramuscular route in unspecified arm on 03-JUL-2018. On 04-JUL-2018 (also reported as following day of vaccination), the patient experienced fatigue, lethargy, local reaction as arm swelling for month (injection site swelling) and had wet bed (enuresis). The outcome of fatigue, lethargy, injection site swelling and enuresis was reported as resolved.  The causality assessment was not provided by the reporter.   Follow up information was received from a nurse (vaccine provider) on 13-DEC-2019. The patient was 11 years old at the time of vaccination and onset of the events (previously reported as 12 years old). The patient did not have any illness at the time of vaccination. On 03-JUL-2018, the patient was vaccinated with meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) (previously reported as "meningococcal vaccine (unspecified)"). It was reported that vaccines were purchased with private funds. On 04-JUL-2018, the patient experienced "site redness" (injection site redness). On an unknown date, the patient recovered from the event injection site redness (reported as "event abated after stopping drug").  The relatedness between the events and the suspect therapies was unknown.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, UNK
Symptoms: Enuresis, Fatigue, Injection site erythema, Injection site swelling, Lethargy
Clinical narrative: Fatigue; wet bed; injection site swelling x one month; Lethargy; Site redness; This report was identified from a line listing obtained on request by the Company from the FDA (Agency number 800439) under the Freedom of Information Act refers to a 12 year old female patient. The patient's historical drug included nystatin and concurrent condition included nystatin local allergy. Historical condition and concomitant medications were not reported. On 03-JUL-2018, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot # N023952, expiration date was not reported, but upon internal validation established as 12-JUL-2020 (strength and dose not reported) via intramuscular route in unspecified arm for prophylaxis. Other suspect therapies included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (also reported as "TDAP"), lot # TB2R2, expiration date was not reported and meningococcal vaccine (unspecified), lot # U5848AA, expiration date was not reported (strength, dose and indication not reported) via intramuscular route in unspecified arm on 03-JUL-2018. On 04-JUL-2018 (also reported as following day of vaccination), the patient experienced fatigue, lethargy, local reaction as arm swelling for month (injection site swelling) and had wet bed (enuresis). The outcome of fatigue, lethargy, injection site swelling and enuresis was reported as resolved.  The causality assessment was not provided by the reporter.   Follow up information was received from a nurse (vaccine provider) on 13-DEC-2019. The patient was 11 years old at the time of vaccination and onset of the events (previously reported as 12 years old). The patient did not have any illness at the time of vaccination. On 03-JUL-2018, the patient was vaccinated with meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) (previously reported as "meningococcal vaccine (unspecified)"). It was reported that vaccines were purchased with private funds. On 04-JUL-2018, the patient experienced "site redness" (injection site redness). On an unknown date, the patient recovered from the event injection site redness (reported as "event abated after stopping drug").  The relatedness between the events and the suspect therapies was unknown.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, UNK
Symptoms: Local reaction, Peripheral swelling
Clinical narrative: Fatigue; wet bed; injection site swelling x one month; Lethargy; Site redness; This report was identified from a line listing obtained on request by the Company from the FDA (Agency number 800439) under the Freedom of Information Act refers to a 12 year old female patient. The patient's historical drug included nystatin and concurrent condition included nystatin local allergy. Historical condition and concomitant medications were not reported. On 03-JUL-2018, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot # N023952, expiration date was not reported, but upon internal validation established as 12-JUL-2020 (strength and dose not reported) via intramuscular route in unspecified arm for prophylaxis. Other suspect therapies included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (also reported as "TDAP"), lot # TB2R2, expiration date was not reported and meningococcal vaccine (unspecified), lot # U5848AA, expiration date was not reported (strength, dose and indication not reported) via intramuscular route in unspecified arm on 03-JUL-2018. On 04-JUL-2018 (also reported as following day of vaccination), the patient experienced fatigue, lethargy, local reaction as arm swelling for month (injection site swelling) and had wet bed (enuresis). The outcome of fatigue, lethargy, injection site swelling and enuresis was reported as resolved.  The causality assessment was not provided by the reporter.   Follow up information was received from a nurse (vaccine provider) on 13-DEC-2019. The patient was 11 years old at the time of vaccination and onset of the events (previously reported as 12 years old). The patient did not have any illness at the time of vaccination. On 03-JUL-2018, the patient was vaccinated with meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) (previously reported as "meningococcal vaccine (unspecified)"). It was reported that vaccines were purchased with private funds. On 04-JUL-2018, the patient experienced "site redness" (injection site redness). On an unknown date, the patient recovered from the event injection site redness (reported as "event abated after stopping drug").  The relatedness between the events and the suspect therapies was unknown.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Gait inability, Impaired work ability, Joint swelling, Pain, Renal pain
Clinical narrative: "feeling like they are eating themselves from the inside."; Right knee swelling, left knee became swollen /Left knee swelling; Left knee , pain, left knee become painful; couldn´t walk; This case was reported by a consumer via call center representative and described the occurrence of swelling of knees in a male patient who received Herpes zoster (Shingrix) (batch number 49R72, expiry date 13th March 2021) for prophylaxis.   On 23rd October 2018, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 27th October 2018, 4 days after receiving Shingrix, the patient experienced swelling of knees (serious criteria disability), knee pain (serious criteria disability) and unable to walk. On an unknown date, the patient experienced feeling abnormal. On an unknown date, the outcome of the swelling of knees, knee pain and unable to walk were recovering/resolving and the outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the swelling of knees, knee pain, unable to walk and feeling abnormal to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received vaccine in right arm. On 25th or 26th October 2018, the patient's knees started bothering him and that on 27th October 2018 his right knew swelled, was painful, and patient couldn't walk. A week later patient's left knee became swollen, painful, and he couldn't walk.  On 29th October 2018, he worked his last day, and went out on a leave of absence on 2nd November 2018 and not able to return to work at the time of reporting due to his knees feeling like they were eating themselves from the inside. The patient seeking medical treatment, test results negative.  The patient was out of work on disability due to this knee issue, and never had a problem with his knees before. The emergency room visit was required. The patient did not provided date of birth. The patient might call later to update the case with additional information once he talked with his physicians. The reporter did not consented to follow up. This is 1 of the 2 linked cases reported by the same reporter.      Lab Comments: On an unknown date in 2018, lab test was performed.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Feeling abnormal, Gait inability, Impaired work ability, Joint swelling
Clinical narrative: "feeling like they are eating themselves from the inside."; Right knee swelling, left knee became swollen /Left knee swelling; Left knee , pain, left knee become painful; couldn´t walk; This case was reported by a consumer via call center representative and described the occurrence of swelling of knees in a male patient who received Herpes zoster (Shingrix) (batch number 49R72, expiry date 13th March 2021) for prophylaxis.   On 23rd October 2018, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 27th October 2018, 4 days after receiving Shingrix, the patient experienced swelling of knees (serious criteria disability), knee pain (serious criteria disability) and unable to walk. On an unknown date, the patient experienced feeling abnormal. On an unknown date, the outcome of the swelling of knees, knee pain and unable to walk were recovering/resolving and the outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the swelling of knees, knee pain, unable to walk and feeling abnormal to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received vaccine in right arm. On 25th or 26th October 2018, the patient's knees started bothering him and that on 27th October 2018 his right knew swelled, was painful, and patient couldn't walk. A week later patient's left knee became swollen, painful, and he couldn't walk.  On 29th October 2018, he worked his last day, and went out on a leave of absence on 2nd November 2018 and not able to return to work at the time of reporting due to his knees feeling like they were eating themselves from the inside. The patient seeking medical treatment, test results negative.  The patient was out of work on disability due to this knee issue, and never had a problem with his knees before. The emergency room visit was required. The patient did not provided date of birth. The patient might call later to update the case with additional information once he talked with his physicians. The reporter did not consented to follow up. This is 1 of the 2 linked cases reported by the same reporter.      Lab Comments: On an unknown date in 2018, lab test was performed.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Laboratory test normal
Clinical narrative: "feeling like they are eating themselves from the inside."; Right knee swelling, left knee became swollen /Left knee swelling; Left knee , pain, left knee become painful; couldn´t walk; This case was reported by a consumer via call center representative and described the occurrence of swelling of knees in a male patient who received Herpes zoster (Shingrix) (batch number 49R72, expiry date 13th March 2021) for prophylaxis.   On 23rd October 2018, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 27th October 2018, 4 days after receiving Shingrix, the patient experienced swelling of knees (serious criteria disability), knee pain (serious criteria disability) and unable to walk. On an unknown date, the patient experienced feeling abnormal. On an unknown date, the outcome of the swelling of knees, knee pain and unable to walk were recovering/resolving and the outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the swelling of knees, knee pain, unable to walk and feeling abnormal to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received vaccine in right arm. On 25th or 26th October 2018, the patient's knees started bothering him and that on 27th October 2018 his right knew swelled, was painful, and patient couldn't walk. A week later patient's left knee became swollen, painful, and he couldn't walk.  On 29th October 2018, he worked his last day, and went out on a leave of absence on 2nd November 2018 and not able to return to work at the time of reporting due to his knees feeling like they were eating themselves from the inside. The patient seeking medical treatment, test results negative.  The patient was out of work on disability due to this knee issue, and never had a problem with his knees before. The emergency room visit was required. The patient did not provided date of birth. The patient might call later to update the case with additional information once he talked with his physicians. The reporter did not consented to follow up. This is 1 of the 2 linked cases reported by the same reporter.      Lab Comments: On an unknown date in 2018, lab test was performed.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Adverse reaction
Clinical narrative: "feeling like they are eating themselves from the inside."; Right knee swelling, left knee became swollen /Left knee swelling; Left knee , pain, left knee become painful; couldn´t walk; This case was reported by a consumer via call center representative and described the occurrence of swelling of knees in a male patient who received Herpes zoster (Shingrix) (batch number 49R72, expiry date 13th March 2021) for prophylaxis.   On 23rd October 2018, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 27th October 2018, 4 days after receiving Shingrix, the patient experienced swelling of knees (serious criteria disability), knee pain (serious criteria disability) and unable to walk. On an unknown date, the patient experienced feeling abnormal. On an unknown date, the outcome of the swelling of knees, knee pain and unable to walk were recovering/resolving and the outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the swelling of knees, knee pain, unable to walk and feeling abnormal to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received vaccine in right arm. On 25th or 26th October 2018, the patient's knees started bothering him and that on 27th October 2018 his right knew swelled, was painful, and patient couldn't walk. A week later patient's left knee became swollen, painful, and he couldn't walk.  On 29th October 2018, he worked his last day, and went out on a leave of absence on 2nd November 2018 and not able to return to work at the time of reporting due to his knees feeling like they were eating themselves from the inside. The patient seeking medical treatment, test results negative.  The patient was out of work on disability due to this knee issue, and never had a problem with his knees before. The emergency room visit was required. The patient did not provided date of birth. The patient might call later to update the case with additional information once he talked with his physicians. The reporter did not consented to follow up. This is 1 of the 2 linked cases reported by the same reporter.      Lab Comments: On an unknown date in 2018, lab test was performed.
Sex: U
Vaccine: MMR, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse etfects reported; patient received improperly stored dose of MMR II; This spontaneous report was received from a nurse and refers to a 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 19-AUG-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R024905, expiration date 30-AUG-2020, albumin status rHA (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the highest temperature excursion of above 47 degrees Fahrenheit (54 degrees Fahrenheit) for 17 hours and 15 minutes on 12-JUL-2019. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.  This is an amended report. This report was previously submitted with the incorrect Worldwide unique case identification number "US-009507513-1911USA004662", and this new follow-up is to provide the correct identification number "US-009507513-1912USA000779". "US-009507513-1911USA004662" is a number of linked report (same reporter link).; Sender's Comments:  US-009507513-1911USA004662:
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood lactate dehydrogenase normal, Cytomegalovirus test negative, Dry mouth, Dysphagia, Eye pruritus
Clinical narrative: swollen face; swollen neck; swollen lymph nodes; dry mouth; esophagus pressure; This case was reported by a consumer via call center representative and described the occurrence of facial swelling in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number GH455, expiry date 29th January 2022) for prophylaxis.   Concurrent medical conditions included chronic lymphocytic leukemia (recently diagnosed with chronic lymphocytic leukemia last month).   On 30th November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 5th December 2019, 5 days after receiving Shingrix, the patient experienced facial swelling, neck swelling, enlargement of lymph nodes, dry mouth and esophageal discomfort. On an unknown date, the outcome of the facial swelling, neck swelling, enlargement of lymph nodes, dry mouth and esophageal discomfort were recovering/resolving.   It was unknown if the reporter considered the facial swelling, neck swelling, enlargement of lymph nodes, dry mouth and esophageal discomfort to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in right deltoid. The patient started having face and neck swelling, dry mouth and esophagus pressure. On 6th December 2019, the patient woke up with increased swelling and went to the emergency room. The patient received no interventions at the emergency room, and the symptoms persist, but had improved at the time of reporting. The patient had a pre-existing appointment with his oncologist, was recently diagnosed with chronic lymphocytic leukemia last month and had blood work drawn at that time to evaluate these symptoms. Emergency room visit was required. The patient stated he might call back later to provide this consent and physician information. The reporter did not consented to follow up.      Lab Comments: on an unknown date lab test was performed.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Full blood count normal, Lymphadenopathy, Metabolic function test normal, Mononucleosis heterophile test negative, Parotid gland enlargement
Clinical narrative: swollen face; swollen neck; swollen lymph nodes; dry mouth; esophagus pressure; This case was reported by a consumer via call center representative and described the occurrence of facial swelling in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number GH455, expiry date 29th January 2022) for prophylaxis.   Concurrent medical conditions included chronic lymphocytic leukemia (recently diagnosed with chronic lymphocytic leukemia last month).   On 30th November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 5th December 2019, 5 days after receiving Shingrix, the patient experienced facial swelling, neck swelling, enlargement of lymph nodes, dry mouth and esophageal discomfort. On an unknown date, the outcome of the facial swelling, neck swelling, enlargement of lymph nodes, dry mouth and esophageal discomfort were recovering/resolving.   It was unknown if the reporter considered the facial swelling, neck swelling, enlargement of lymph nodes, dry mouth and esophageal discomfort to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in right deltoid. The patient started having face and neck swelling, dry mouth and esophagus pressure. On 6th December 2019, the patient woke up with increased swelling and went to the emergency room. The patient received no interventions at the emergency room, and the symptoms persist, but had improved at the time of reporting. The patient had a pre-existing appointment with his oncologist, was recently diagnosed with chronic lymphocytic leukemia last month and had blood work drawn at that time to evaluate these symptoms. Emergency room visit was required. The patient stated he might call back later to provide this consent and physician information. The reporter did not consented to follow up.      Lab Comments: on an unknown date lab test was performed.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Swelling, Throat irritation
Clinical narrative: swollen face; swollen neck; swollen lymph nodes; dry mouth; esophagus pressure; This case was reported by a consumer via call center representative and described the occurrence of facial swelling in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number GH455, expiry date 29th January 2022) for prophylaxis.   Concurrent medical conditions included chronic lymphocytic leukemia (recently diagnosed with chronic lymphocytic leukemia last month).   On 30th November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 5th December 2019, 5 days after receiving Shingrix, the patient experienced facial swelling, neck swelling, enlargement of lymph nodes, dry mouth and esophageal discomfort. On an unknown date, the outcome of the facial swelling, neck swelling, enlargement of lymph nodes, dry mouth and esophageal discomfort were recovering/resolving.   It was unknown if the reporter considered the facial swelling, neck swelling, enlargement of lymph nodes, dry mouth and esophageal discomfort to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in right deltoid. The patient started having face and neck swelling, dry mouth and esophagus pressure. On 6th December 2019, the patient woke up with increased swelling and went to the emergency room. The patient received no interventions at the emergency room, and the symptoms persist, but had improved at the time of reporting. The patient had a pre-existing appointment with his oncologist, was recently diagnosed with chronic lymphocytic leukemia last month and had blood work drawn at that time to evaluate these symptoms. Emergency room visit was required. The patient stated he might call back later to provide this consent and physician information. The reporter did not consented to follow up.      Lab Comments: on an unknown date lab test was performed.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Dry mouth, Lymphadenopathy, Oesophageal discomfort, Swelling
Clinical narrative: swollen face; swollen neck; swollen lymph nodes; dry mouth; esophagus pressure; This case was reported by a consumer via call center representative and described the occurrence of facial swelling in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number GH455, expiry date 29th January 2022) for prophylaxis.   Concurrent medical conditions included chronic lymphocytic leukemia (recently diagnosed with chronic lymphocytic leukemia last month).   On 30th November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 5th December 2019, 5 days after receiving Shingrix, the patient experienced facial swelling, neck swelling, enlargement of lymph nodes, dry mouth and esophageal discomfort. On an unknown date, the outcome of the facial swelling, neck swelling, enlargement of lymph nodes, dry mouth and esophageal discomfort were recovering/resolving.   It was unknown if the reporter considered the facial swelling, neck swelling, enlargement of lymph nodes, dry mouth and esophageal discomfort to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in right deltoid. The patient started having face and neck swelling, dry mouth and esophagus pressure. On 6th December 2019, the patient woke up with increased swelling and went to the emergency room. The patient received no interventions at the emergency room, and the symptoms persist, but had improved at the time of reporting. The patient had a pre-existing appointment with his oncologist, was recently diagnosed with chronic lymphocytic leukemia last month and had blood work drawn at that time to evaluate these symptoms. Emergency room visit was required. The patient stated he might call back later to provide this consent and physician information. The reporter did not consented to follow up.      Lab Comments: on an unknown date lab test was performed.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Swelling face
Clinical narrative: swollen face; swollen neck; swollen lymph nodes; dry mouth; esophagus pressure; This case was reported by a consumer via call center representative and described the occurrence of facial swelling in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number GH455, expiry date 29th January 2022) for prophylaxis.   Concurrent medical conditions included chronic lymphocytic leukemia (recently diagnosed with chronic lymphocytic leukemia last month).   On 30th November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 5th December 2019, 5 days after receiving Shingrix, the patient experienced facial swelling, neck swelling, enlargement of lymph nodes, dry mouth and esophageal discomfort. On an unknown date, the outcome of the facial swelling, neck swelling, enlargement of lymph nodes, dry mouth and esophageal discomfort were recovering/resolving.   It was unknown if the reporter considered the facial swelling, neck swelling, enlargement of lymph nodes, dry mouth and esophageal discomfort to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in right deltoid. The patient started having face and neck swelling, dry mouth and esophagus pressure. On 6th December 2019, the patient woke up with increased swelling and went to the emergency room. The patient received no interventions at the emergency room, and the symptoms persist, but had improved at the time of reporting. The patient had a pre-existing appointment with his oncologist, was recently diagnosed with chronic lymphocytic leukemia last month and had blood work drawn at that time to evaluate these symptoms. Emergency room visit was required. The patient stated he might call back later to provide this consent and physician information. The reporter did not consented to follow up.      Lab Comments: on an unknown date lab test was performed.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Eye injury, Herpes zoster, Hypoaesthesia, Pain, Pain in extremity
Clinical narrative: eye and vision damage; eye and vision damage; many shingles outbreaks; tremendous pain; numbness in her left leg; tingling sensations in her skin; This initial spontaneous report was received on 10-DEC-2019, from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 11-SEP-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving the zoster vaccine live (ZOSTAVAX) vaccination, she experienced many shingles outbreaks, beginning in January 2018. These shingles outbreaks had caused tremendous pain, scarring and also eye and vision damage. These injuries were caused by zoster vaccine live (ZOSTAVAX). The patient continued to have reoccurring shingles outbreaks as a result of the zoster vaccine live (ZOSTAVAX) vaccination, including extreme pain and numbness in her left leg which all resulted in medical treatment. Pain and tingling sensation in her skin, also as a result of zoster vaccine live (ZOSTAVAX) were permanent and continued. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) administration, the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX) and caused by the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition and had suffered economic losses due to her inability to work.  At the time of the report the patient's outcome was not recovered. The adverse events were considered as medically significant and disabling as the reporter considered the case as serious and the patient's inability to work.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain of skin, Paraesthesia, Scar, Visual impairment
Clinical narrative: eye and vision damage; eye and vision damage; many shingles outbreaks; tremendous pain; numbness in her left leg; tingling sensations in her skin; This initial spontaneous report was received on 10-DEC-2019, from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 11-SEP-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving the zoster vaccine live (ZOSTAVAX) vaccination, she experienced many shingles outbreaks, beginning in January 2018. These shingles outbreaks had caused tremendous pain, scarring and also eye and vision damage. These injuries were caused by zoster vaccine live (ZOSTAVAX). The patient continued to have reoccurring shingles outbreaks as a result of the zoster vaccine live (ZOSTAVAX) vaccination, including extreme pain and numbness in her left leg which all resulted in medical treatment. Pain and tingling sensation in her skin, also as a result of zoster vaccine live (ZOSTAVAX) were permanent and continued. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) administration, the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX) and caused by the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition and had suffered economic losses due to her inability to work.  At the time of the report the patient's outcome was not recovered. The adverse events were considered as medically significant and disabling as the reporter considered the case as serious and the patient's inability to work.
Age: 86.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hallucination, Inappropriate schedule of product administration, Injection site pain
Clinical narrative: arm pain; Inappropriate Schedule of Vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 29th November 2019, the patient received the 2nd dose of Shingrix. On 29th November 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was provided as follows: The patirnt experienced arm pain after receiving 2nd dose of Shingrix (but regarding this thing she didn't request medical information, she was much more worried about the inappropriate schedule of the vaccine). The patient received 2nd dose earlier than the recommended interval, which led to shortening of vaccination schedule. The health care professional also clarified that she did not administered the vaccine to the patient. The reporter consented to follow up. This case is linked with US2019218888, reported by same reporter for same patient.
Age: 86.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: arm pain; Inappropriate Schedule of Vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 29th November 2019, the patient received the 2nd dose of Shingrix. On 29th November 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was provided as follows: The patirnt experienced arm pain after receiving 2nd dose of Shingrix (but regarding this thing she didn't request medical information, she was much more worried about the inappropriate schedule of the vaccine). The patient received 2nd dose earlier than the recommended interval, which led to shortening of vaccination schedule. The health care professional also clarified that she did not administered the vaccine to the patient. The reporter consented to follow up. This case is linked with US2019218888, reported by same reporter for same patient.
Age: 61.0
Sex: M
Vaccine: MMR
Symptoms: Back pain
Clinical narrative: Extreme backpain
Age: 1.58
Sex: M
Vaccine: DTAP
Symptoms: Crying, Muscle spasms, Pain, Pyrexia, Screaming
Clinical narrative: Non-stop screaming and crying in pain, fever of 104F, writhing in pain, vomiting, muscle spasms and convulsions, crying non-stop for 3 days, stopped talking, had a hard time talking and using words that he had already mastered for a week after
Age: 1.58
Sex: M
Vaccine: DTAP
Symptoms: Seizure, Speech disorder, Vomiting
Clinical narrative: Non-stop screaming and crying in pain, fever of 104F, writhing in pain, vomiting, muscle spasms and convulsions, crying non-stop for 3 days, stopped talking, had a hard time talking and using words that he had already mastered for a week after
Age: 37.0
Sex: F
Vaccine: UNK
Symptoms: Injection site discolouration, Injection site pain, Injection site pruritus, Muscular weakness, Musculoskeletal disorder
Clinical narrative: My arm hurt at the muscle, had dead arm but it usually does. The spot was itchy and that was new. This time weeks after, I still have a discolored circle on my shoulder and my muscle hurts where the shot was injected. My arm is also weaker.  I?m not sure which flu shot.
Sex: F
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effect reported.; GARDASIL9 was administered on 22-NOV-2019, two days after the expiration date, which was 20-NOV-2019.; This spontaneous report was received from a Registered Nurse referring to a 22 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 22-NOV-2019, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscularly, with lot # N009801, two days after the expiration date, which was 20-NOV-2019. No additional adverse effect reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: a patient was administered an improperly stored VARIVAX; No additional adverse events; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender.   The patient's concurrent conditions and medical history were not reported. Concomitant medications included sterile diluent.  On 05-DEC-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, frequency, route of administration and anatomical location were not reported) lot # R024265, expiration date 27-NOV-2020, for prophylaxis; which was reconstituted in a properly stored sterile diluent. The administered dose of the vaccine experienced a temperature excursion from -14 Celsius degrees (°C) to -10°C (-12°C) for 30 minutes and from -9°C to 8°C (-2°C) for 1 hour. There was no previous temperature excursion and this report was not called because of a data logger. There were no adverse events reported. No product quality complaint was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness, Herpes zoster, Tinnitus, Vertigo positional
Clinical narrative: herpes zoster; benign paroxysmal vertigo; bilateral tinnitus; hearing loss; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age.  No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or around 04-AUG-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).  On an unknown (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), the patient suffered herpes zoster along the left side of abdomen, benign paroxysmal positional vertigo, bilateral tinnitus and hearing loss(deafness).  As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the product.  The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition.  As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries.  Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  As a direct and proximate result of the Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The outcome of the events were considered not recovered/not resolved.  The events were considered related to zoster vaccine live (ZOSTAVAX).  All the events were considered to be disabling.  Upon internal review, the event deafness was considered to be medically significant.  Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Acute respiratory failure, Cardiac failure congestive, Hypoxia, Pneumonia, Sepsis
Clinical narrative: pneumonia; acute chronic respiratory failure; sepsis; congestive heart failure; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In or around 05-OCT-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. Shortly, on an unknown date, after receiving zoster vaccine live (ZOSTAVAX), the pt. was hospitalized and diagnosed with sepsis, acute chronic respiratory failure with hypoxia, pneumonia and congestive heart failure. As a direct and proximate result of use of defective zoster vaccine live (ZOSTAVAX), the pt's symptoms have resulted in physical limitations, not present prior to vaccination, The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Further, as a tragic consequence the pt suffered severe serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental aguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  The outcome of pneumonia, cardiac failure congestive, sepsis and acute respiratory failure was not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The reporter considered the events to be disabling.  Upon internal review, all the event was considered to be medically significant.  Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Anxiety, Blood aluminium normal, Cognitive disorder, Feeling abnormal, Inappropriate schedule of product administration
Clinical narrative: 1st dose in November 2016, 2nd dose 3-4 months later and 3rd dose in March 2017.; brain is in a fog; has cognitive impairment, is anxious and withdrawn; has cognitive impairment, is anxious and withdrawn/teenage angst; has cognitive impairment, is anxious and withdrawn; He mumbles when he talks/When he talks, he says he doesn't know what to say; This spontaneous report was received from a consumer referring to a 15 years old male patient. The patient had no concomitant medications, pertinent medical history and drug reactions/allergies.     In November 2016, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, lot # and expiration date were not provided) intramuscularly for prophylaxis. The second dose  was administered 3-4 months later and the third dose  was administered in March 2017 (via intramuscular; dose detail, lot number and expire date were unknown) (inappropriate schedule of product administration).        In 2017 (reported as after 2nd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)), the patient was noticed different and had cognitive impairment, was anxious and withdrawn. The patient felt the shot going through his veins. He mumbled when he talked. When he talked, he said he didn't know what to say since he said his brain was in a fog. His teachers at school said he was like a different person. At first the reporter thought it was teenage angst. The patient sought for medical attention. The patient went to a mental therapist who prescribed fluoxetine hydrochloride (PROZAC) and sertraline hydrochloride (ZOLOFT). That didn't help so they were discontinued. He went to a Neurologist who did lab panel for aluminum which didn't show anything. The patient tried probiotics, changing diet to fruits and vegetables, yogurt, lemongrass, elderberry, epsom salt baths, cilantro, fish oil supplements, Cannabidiol (CBD) oil and deep tissue massage. Nothing seemed to help. The outcome of the events was not recovered. The causality assessment was not provided.  Upon internal review, brain was in a fog was determined to be medically significant.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Social avoidant behaviour, Speech disorder
Clinical narrative: 1st dose in November 2016, 2nd dose 3-4 months later and 3rd dose in March 2017.; brain is in a fog; has cognitive impairment, is anxious and withdrawn; has cognitive impairment, is anxious and withdrawn/teenage angst; has cognitive impairment, is anxious and withdrawn; He mumbles when he talks/When he talks, he says he doesn't know what to say; This spontaneous report was received from a consumer referring to a 15 years old male patient. The patient had no concomitant medications, pertinent medical history and drug reactions/allergies.     In November 2016, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, lot # and expiration date were not provided) intramuscularly for prophylaxis. The second dose  was administered 3-4 months later and the third dose  was administered in March 2017 (via intramuscular; dose detail, lot number and expire date were unknown) (inappropriate schedule of product administration).        In 2017 (reported as after 2nd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)), the patient was noticed different and had cognitive impairment, was anxious and withdrawn. The patient felt the shot going through his veins. He mumbled when he talked. When he talked, he said he didn't know what to say since he said his brain was in a fog. His teachers at school said he was like a different person. At first the reporter thought it was teenage angst. The patient sought for medical attention. The patient went to a mental therapist who prescribed fluoxetine hydrochloride (PROZAC) and sertraline hydrochloride (ZOLOFT). That didn't help so they were discontinued. He went to a Neurologist who did lab panel for aluminum which didn't show anything. The patient tried probiotics, changing diet to fruits and vegetables, yogurt, lemongrass, elderberry, epsom salt baths, cilantro, fish oil supplements, Cannabidiol (CBD) oil and deep tissue massage. Nothing seemed to help. The outcome of the events was not recovered. The causality assessment was not provided.  Upon internal review, brain was in a fog was determined to be medically significant.