chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 29-JUN-2016, the patient was treated at a medical facility for a severe vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: 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 concomitant medications, concurrent conditions or medical history. On or about 07-MAY-2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 29-DEC-2014, the patient was treated at a physician's office for a persistent and severe vesicular rash, which was diagnosed as post-herpetic neuralgia. He was prescribed tramadol for management of his painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was recommended and prescribed the ZOSTAVAX for long-term prevention against shingles. On or about 09-MAY-2011, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. Instead, the patient contracted a persistent strain of shingles, or severe herpes zoster. On or about 16-JUN-2016, the patient was treated for injuries associated with the shingles. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient suffered and continues to suffer painful and ongoing injuries and damages, and required and continues to require extensive medical care and treatment. As a further proximate result of the ZOSTAVAX, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On 17-JUL-2013, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at physician office as recommended by her physicians for the long-term prevention of shingles. The vaccine did not prevent shingles as intended; instead the patient contracted a persistent strain of shingles  or herpes zoster. On or about 16-APR-2016, the patient was treated for and was diagnosed with shingles. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In approximately March 2016, the patient saw television advertisements related to ZOSTAVAX which induced her to ask her physician to prescribe her the ZOSTAVAX. On or about April 2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended. Instead, the patient contracted a persistent strain of shingles, or herpes zoster. On or about August 2016, the patient was treated by a physician and was diagnosed with shingles. The outcome of the events is unknown. As a direct and proximate result of the defective ZOSTAVAX, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 09-JUN-2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided). The ZOSTAVAX did not prevent shingles as intended. On or about 01-NOV-2011 [conflicting information: prior to vaccination with ZOSTAVAX], the patient was diagnosed with shingles, or herpes zoster. He was treated by a physician for the sudden onset of herpes zoster, or shingles. The outcome of the events is unknown. The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On 22-JAN-2010, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended by her physician for the long-term prevention of shingles and as a preventative measure prior to having surgery. The ZOSTAVAX did not prevent shingles as intended. Instead, the patient contracted a persistent strain of shingles, or herpes zoster. On approximately 19-MAY-2011, the patient was treated by a physician for the onset of herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the defective ZOSTAVAX, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Back pain, Blood test, Chronic fatigue syndrome, Computerised tomogram, Feeling hot
Clinical narrative: This spontaneous report was received from an approximately 11 year old female patient, reporting on herself. The patient did not have pertinent medical history and had a drug allergy/reaction to BENADRYL. The patient's concomitant medications included ZOLOFT and unspecified anti-nausea medications. On an unknown date in 2010 (reported as "when she was 11"), the patient received her first dose of GARDASIL, 0.5 ml per intramuscular route with administration schedule of 0, 2 months and 6 months, for prevention of Human Papilloma Virus (HPV) (anatomical location, lot number and expiration date were not reported). Since the administration of GARDASIL in 2010, the patient had suffered from a migraine that had not gone away, which was constant and not intermittent; the patient also developed chronic fatigue syndrome and passed out quite often for no apparent reason. The patient also reported that on an unknown date, her head swelled in certain areas and got hot, and she also had neck and back pain. On an unknown date, the patient was hospitalized for 5 days. The patient sought medical attention and several lab diagnostics and studies were performed, including blood panel, magnetic resonance imaging (MRI), computerized axial tomography (CAT) scan and "DAG" for migraines; however, the results were not reported. Furthermore, the patient could no longer work or go to school and could barely leave her house. It was reported that the patient received her last GARDASIL on 10-DEC-2014. By the time of the reporting, she had not recovered from the events. The reporter did not assess the causal relationship between GARDASIL and the events. Upon internal review, chronic fatigue syndrome, head swelled in certain areas and got hot, migraine, and passed out were considered to be disabling events.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Impaired work ability, Laboratory test, Loss of consciousness, Loss of personal independence in daily activities, Migraine
Clinical narrative: This spontaneous report was received from an approximately 11 year old female patient, reporting on herself. The patient did not have pertinent medical history and had a drug allergy/reaction to BENADRYL. The patient's concomitant medications included ZOLOFT and unspecified anti-nausea medications. On an unknown date in 2010 (reported as "when she was 11"), the patient received her first dose of GARDASIL, 0.5 ml per intramuscular route with administration schedule of 0, 2 months and 6 months, for prevention of Human Papilloma Virus (HPV) (anatomical location, lot number and expiration date were not reported). Since the administration of GARDASIL in 2010, the patient had suffered from a migraine that had not gone away, which was constant and not intermittent; the patient also developed chronic fatigue syndrome and passed out quite often for no apparent reason. The patient also reported that on an unknown date, her head swelled in certain areas and got hot, and she also had neck and back pain. On an unknown date, the patient was hospitalized for 5 days. The patient sought medical attention and several lab diagnostics and studies were performed, including blood panel, magnetic resonance imaging (MRI), computerized axial tomography (CAT) scan and "DAG" for migraines; however, the results were not reported. Furthermore, the patient could no longer work or go to school and could barely leave her house. It was reported that the patient received her last GARDASIL on 10-DEC-2014. By the time of the reporting, she had not recovered from the events. The reporter did not assess the causal relationship between GARDASIL and the events. Upon internal review, chronic fatigue syndrome, head swelled in certain areas and got hot, migraine, and passed out were considered to be disabling events.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Neck pain, Nuclear magnetic resonance imaging, Swelling
Clinical narrative: This spontaneous report was received from an approximately 11 year old female patient, reporting on herself. The patient did not have pertinent medical history and had a drug allergy/reaction to BENADRYL. The patient's concomitant medications included ZOLOFT and unspecified anti-nausea medications. On an unknown date in 2010 (reported as "when she was 11"), the patient received her first dose of GARDASIL, 0.5 ml per intramuscular route with administration schedule of 0, 2 months and 6 months, for prevention of Human Papilloma Virus (HPV) (anatomical location, lot number and expiration date were not reported). Since the administration of GARDASIL in 2010, the patient had suffered from a migraine that had not gone away, which was constant and not intermittent; the patient also developed chronic fatigue syndrome and passed out quite often for no apparent reason. The patient also reported that on an unknown date, her head swelled in certain areas and got hot, and she also had neck and back pain. On an unknown date, the patient was hospitalized for 5 days. The patient sought medical attention and several lab diagnostics and studies were performed, including blood panel, magnetic resonance imaging (MRI), computerized axial tomography (CAT) scan and "DAG" for migraines; however, the results were not reported. Furthermore, the patient could no longer work or go to school and could barely leave her house. It was reported that the patient received her last GARDASIL on 10-DEC-2014. By the time of the reporting, she had not recovered from the events. The reporter did not assess the causal relationship between GARDASIL and the events. Upon internal review, chronic fatigue syndrome, head swelled in certain areas and got hot, migraine, and passed out were considered to be disabling events.
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a male patient of unknown age. Information regarding medical history, concurrent conditions or concomitant medication was not provided. On 11-JUN-2018, the patient was vaccinated with RECOMBIVAX HB lot # M010671, expiration date 02-JUN-2018, for prophylaxis (rout of administration and dosage information were not informed). No adverse effects reported.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Arthritis, Chills, Gastrointestinal disorder, Headache
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site induration in a 56-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) for prophylaxis. On 31st May 2018, the patient received SHINGRIX (subcutaneous). On 31st May 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On 1st June 2018, the patient experienced injection site induration, fever, general body pain, headache, gastrointestinal symptom nos, arthritis, joint pain, injection site erythema, chills and influenza-like symptoms. On an unknown date, the outcome of the injection site induration, fever, general body pain, headache, gastrointestinal symptom nos, arthritis, joint pain, injection site erythema, chills and influenza-like symptoms were recovering/resolving and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the injection site induration, fever, general body pain, headache, gastrointestinal symptom nos, arthritis, joint pain, injection site erythema and chills to be unrelated to SHINGRIX. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: One day after vaccination, the patient experienced all adverse events. On 2nd June 2018, the patient came into the pharmacy to show her the injection site. At this time, the registered pharmacist (Rph) realized that the vaccine was given subcutaneously. This led to inappropriate route of vaccination. The patient reported having every reaction listed in the package insert. Most concerning was a red circle at the injection site, and the injection site was hard as a rock, also experienced fever, chills, headache, gastrointestinal symptoms, described as flu-like symptoms and also arthritis or pain in the joints along with pain all over the body. When the reporter had spoken to the patient 2 days post vaccination, the symptoms were getting better.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Influenza like illness, Injection site erythema, Injection site induration, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site induration in a 56-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) for prophylaxis. On 31st May 2018, the patient received SHINGRIX (subcutaneous). On 31st May 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On 1st June 2018, the patient experienced injection site induration, fever, general body pain, headache, gastrointestinal symptom nos, arthritis, joint pain, injection site erythema, chills and influenza-like symptoms. On an unknown date, the outcome of the injection site induration, fever, general body pain, headache, gastrointestinal symptom nos, arthritis, joint pain, injection site erythema, chills and influenza-like symptoms were recovering/resolving and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the injection site induration, fever, general body pain, headache, gastrointestinal symptom nos, arthritis, joint pain, injection site erythema and chills to be unrelated to SHINGRIX. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: One day after vaccination, the patient experienced all adverse events. On 2nd June 2018, the patient came into the pharmacy to show her the injection site. At this time, the registered pharmacist (Rph) realized that the vaccine was given subcutaneously. This led to inappropriate route of vaccination. The patient reported having every reaction listed in the package insert. Most concerning was a red circle at the injection site, and the injection site was hard as a rock, also experienced fever, chills, headache, gastrointestinal symptoms, described as flu-like symptoms and also arthritis or pain in the joints along with pain all over the body. When the reporter had spoken to the patient 2 days post vaccination, the symptoms were getting better.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site induration in a 56-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) for prophylaxis. On 31st May 2018, the patient received SHINGRIX (subcutaneous). On 31st May 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On 1st June 2018, the patient experienced injection site induration, fever, general body pain, headache, gastrointestinal symptom nos, arthritis, joint pain, injection site erythema, chills and influenza-like symptoms. On an unknown date, the outcome of the injection site induration, fever, general body pain, headache, gastrointestinal symptom nos, arthritis, joint pain, injection site erythema, chills and influenza-like symptoms were recovering/resolving and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the injection site induration, fever, general body pain, headache, gastrointestinal symptom nos, arthritis, joint pain, injection site erythema and chills to be unrelated to SHINGRIX. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: One day after vaccination, the patient experienced all adverse events. On 2nd June 2018, the patient came into the pharmacy to show her the injection site. At this time, the registered pharmacist (Rph) realized that the vaccine was given subcutaneously. This led to inappropriate route of vaccination. The patient reported having every reaction listed in the package insert. Most concerning was a red circle at the injection site, and the injection site was hard as a rock, also experienced fever, chills, headache, gastrointestinal symptoms, described as flu-like symptoms and also arthritis or pain in the joints along with pain all over the body. When the reporter had spoken to the patient 2 days post vaccination, the symptoms were getting better.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Loss of personal independence in daily activities
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever in a 72-year-old female patient who received SHINGRIX for prophylaxis. On 4th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a day after receiving SHINGRIX, the patient experienced fever, injection site pain, injection site swelling, fatigue, injection site redness and activities of daily living impaired. On an unknown date, the outcome of the fever, injection site pain, injection site swelling, fatigue, injection site redness and activities of daily living impaired were recovered/resolved. The reporter considered the fever, injection site pain, injection site swelling, fatigue and injection site redness to be possibly related to SHINGRIX. It was unknown if the reporter considered the activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The case was reported by a pharmacist intern at the patient's pharmacy. Concomitant medications were unknown. No other vaccines were given besides SHINGRIX that day. It was unknown if any vaccinations were given four weeks prior to the SHINGRIX administration date. The patient received SHINGRIX in left deltoid. All of the symptoms started within 3 to 4 hours after having the vaccine. The patient notified the pharmacy last week on 28th May 2018. The symptoms lasted from 12 to 24 hours. When asked if the symptoms were disabling to the patient, the reporter said that the patient said that she could not do anything the rest of that day due to the symptoms and just stayed home and went to sleep. No further details were provided. The patient did not take any medications for the symptoms. The patient thought the symptoms were side effects due to the SHINGRIX, and the pharmacist intern thought the symptoms were possibly due to the SHINGRIX.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of fever in a 72-year-old female patient who received SHINGRIX for prophylaxis. On 4th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, less than a day after receiving SHINGRIX, the patient experienced fever, injection site pain, injection site swelling, fatigue, injection site redness and activities of daily living impaired. On an unknown date, the outcome of the fever, injection site pain, injection site swelling, fatigue, injection site redness and activities of daily living impaired were recovered/resolved. The reporter considered the fever, injection site pain, injection site swelling, fatigue and injection site redness to be possibly related to SHINGRIX. It was unknown if the reporter considered the activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The case was reported by a pharmacist intern at the patient's pharmacy. Concomitant medications were unknown. No other vaccines were given besides SHINGRIX that day. It was unknown if any vaccinations were given four weeks prior to the SHINGRIX administration date. The patient received SHINGRIX in left deltoid. All of the symptoms started within 3 to 4 hours after having the vaccine. The patient notified the pharmacy last week on 28th May 2018. The symptoms lasted from 12 to 24 hours. When asked if the symptoms were disabling to the patient, the reporter said that the patient said that she could not do anything the rest of that day due to the symptoms and just stayed home and went to sleep. No further details were provided. The patient did not take any medications for the symptoms. The patient thought the symptoms were side effects due to the SHINGRIX, and the pharmacist intern thought the symptoms were possibly due to the SHINGRIX.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 78-year-old male patient who received SHINGRIX for prophylaxis. On 14th May 2018 13:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 14th May 2018, less than a day after receiving SHINGRIX, the patient experienced chills and injection site pain. On an unknown date, the outcome of the chills and injection site pain were recovered/resolved. The reporter considered the chills and injection site pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the wife of the patient. The patient experienced some pain at the injection site and had chills that night. The symptoms were resolved. This is 1 of 3 cases, reported by the same reporter.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pain in extremity, Rash, Tenderness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 62-year-old female patient who received SHINGRIX (batch number 9779K, expiry date 11th October 2020) for prophylaxis. On 29th May 2018, the patient received SHINGRIX .5 ml. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced rash, blister and pain in arm. On an unknown date, the outcome of the rash, blister and pain in arm were not recovered/not resolved. It was unknown if the reporter considered the rash, blister and pain in arm to be related to SHINGRIX. Additional details were provided as follows: At 09:43 AM, the patient received Shingrix on right arm. In 2018, the patient experienced six spots that she described as little blisters that hurt to the touch on the injection site arm. The reactions were reported to the pharmacist in the morning of reporting date. No additional details were available.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Rash, Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 83-year-old male patient who received SHINGRIX (batch number ML532, expiry date 13th September 2020) for prophylaxis. Concomitant products included ALTACE and XARELTO. On 2nd June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd June 2018, several hours after receiving SHINGRIX, the patient experienced injection site swelling. On 3rd June 2018, the patient experienced blotchy rash, itchy rash and erythematous rash. The patient was treated with BENADRYL. On an unknown date, the outcome of the injection site swelling, blotchy rash, itchy rash and erythematous rash were not recovered/not resolved. The reporter considered the injection site swelling, blotchy rash, itchy rash and erythematous rash to be related to SHINGRIX. Additional information was reported as follows: This case was previously not reported to anyone. The patient received the SHINGRIX vaccine in the left arm. The pharmacist reported that, on the day of reporting, the patient came back to the pharmacy and reported that, a few hours after receiving the SHINGRIX vaccine (on the day of vaccination, Saturday), he experienced swelling at the injection site. The reporter stated that, the patient on the next morning of the vaccination (Sunday) noticed a rash which went all the way down his left arm and into his groin area. On the day of reporting, the patient noticed that, the rash had spread to his forehead as well. The patient described the rash as blotchy, red and itchy. The patient had been using BENADRYL and reported to the pharmacist that the BENADRYL helped for a little while.
Age: 55.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 55-year-old female patient who received BOOSTRIX (batch number 9GM3R, expiry date 20th January 2020) for prophylaxis. Concomitant products included SHINGRIX, RESTASIS, Montelukast, duloxetine, citalopram, CARDURA, Metoprolol ER, NEXIUM, nortriptyline, topiramate and trazodone. On 30th May 2018 15:45, the patient received BOOSTRIX (intramuscular) .5 ml. On an unknown date, less than a week after receiving BOOSTRIX, the patient experienced injection site swelling, injection site erythema, injection site warmth, injection site pain and injection site lump. The patient was treated with prednisone. On an unknown date, the outcome of the injection site swelling, injection site erythema, injection site warmth, injection site pain and injection site lump were unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site warmth, injection site pain and injection site lump to be related to BOOSTRIX. Additional details were provided as follows: On 30th May 2018, the patient received 1st dose of SHINGRIX (batch number LT533, expiry date 11 December 2020) on left arm concomitantly with BOOSTRIX on upper right arm. The patient's upper right arm had swelling, and as described by the patient to the pharmacist there was a golf ball size lump at the injection site which was painful, red and producing heat. The time of onset of the event was not known. The patient visited a walk in clinic on Saturday, 2nd June 2018 and was given prednisone to help with the symptoms. The pharmacist was calling to get an extended list of ingredients in BOOSTRIX vaccine per the request of patient. No further details were provided.
Age: 72.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Eye swelling, Headache, Photophobia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 72-year-old female patient who received HAVRIX for prophylaxis. Concomitant products included DULERA. On 30th May 2018, the patient received the 1st dose of HAVRIX. On 31st May 2018, 1 days after receiving HAVRIX, the patient experienced headache, swollen eyes and photophobia. The patient was treated with TYLENOL. On an unknown date, the outcome of the headache, swollen eyes and photophobia were recovering/resolving. The reporter considered the headache, swollen eyes and photophobia to be related to HAVRIX. Additional details were provided as follows: The patient received the vaccine on the left arm. The patient reported that she experienced severe headache, sensitivity to light and swollen eyes. The patient reported that the events come and go and were still occurring at the time of reporting. The patient stated that she was seen by her dentist on 4th June 2018 because she thought the headache might be related to tooth issue but that was ruled out. The patient started receiving antibiotics and used TYLENOL three times daily to treat the pain. The patient was unable to provide full demographics for her physician. The contact details of the physician were provided.
Age: 72.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Blood test, Dental examination, Headache, Loss of personal independence in daily activities, Musculoskeletal stiffness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 72-year-old female patient who received HAVRIX for prophylaxis. Concomitant products included DULERA. On 30th May 2018, the patient received the 1st dose of HAVRIX. On 31st May 2018, 1 days after receiving HAVRIX, the patient experienced headache, swollen eyes and photophobia. The patient was treated with TYLENOL. On an unknown date, the outcome of the headache, swollen eyes and photophobia were recovering/resolving. The reporter considered the headache, swollen eyes and photophobia to be related to HAVRIX. Additional details were provided as follows: The patient received the vaccine on the left arm. The patient reported that she experienced severe headache, sensitivity to light and swollen eyes. The patient reported that the events come and go and were still occurring at the time of reporting. The patient stated that she was seen by her dentist on 4th June 2018 because she thought the headache might be related to tooth issue but that was ruled out. The patient started receiving antibiotics and used TYLENOL three times daily to treat the pain. The patient was unable to provide full demographics for her physician. The contact details of the physician were provided.
Age: 72.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Photophobia, Sleep disorder, Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 72-year-old female patient who received HAVRIX for prophylaxis. Concomitant products included DULERA. On 30th May 2018, the patient received the 1st dose of HAVRIX. On 31st May 2018, 1 days after receiving HAVRIX, the patient experienced headache, swollen eyes and photophobia. The patient was treated with TYLENOL. On an unknown date, the outcome of the headache, swollen eyes and photophobia were recovering/resolving. The reporter considered the headache, swollen eyes and photophobia to be related to HAVRIX. Additional details were provided as follows: The patient received the vaccine on the left arm. The patient reported that she experienced severe headache, sensitivity to light and swollen eyes. The patient reported that the events come and go and were still occurring at the time of reporting. The patient stated that she was seen by her dentist on 4th June 2018 because she thought the headache might be related to tooth issue but that was ruled out. The patient started receiving antibiotics and used TYLENOL three times daily to treat the pain. The patient was unable to provide full demographics for her physician. The contact details of the physician were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in aN elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, immediately after receiving SHINGRIX, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was unknown. It was unknown if the reporter considered the injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The health care professional reported she just administered SHINGRIX to the patient and the patient got a raised swollen bump at the injection site immediately after getting the vaccine. No further information was provided.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Throat tightness
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of throat tightness in a 67-year-old female patient who received SHINGRIX (batch number 54KZ4, expiry date 25th April 2020) for prophylaxis. On 16th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, less than a day after receiving SHINGRIX, the patient experienced throat tightness. On an unknown date, the outcome of the throat tightness was recovered/resolved. It was unknown if the reporter considered the throat tightness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right deltoid. The patient developed throat tightness within 2-3 hours after the vaccination.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Injected limb mobility decreased, Myalgia, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 8th May 2018 12:30, the patient received the 1st dose of SHINGIRX (intramuscular) .5 ml. On 8th May 2018, less than a day after receiving SHINGRIX, the patient experienced injected limb mobility decreased, pain in arm, chills, fever and muscle pain. On 10th May 2018, the patient experienced upper back pain. The patient was treated with MEDROL. On an unknown date, the outcome of the injected limb mobility decreased and muscle pain were unknown and the outcome of the pain in arm, chills and fever were recovered/resolved and the outcome of the upper back pain was recovering/resolving. It was unknown if the reporter considered the injected limb mobility decreased, upper back pain and muscle pain to be related to SHINGRIX. The reporter considered the pain in arm, chills and fever to be related to SHINGRIX. Additional details were provided as follows: On the day of vaccination, in the evening, the patient's left arm began to ache badly. The patient then developed chills and fever that same evening that lasted two or three days. The ache in the patient arm continued to get worse to the point that she could hardly lift it. By Thursday, 10th May 2018, the patient's arm was still aching but she had developed severe pain in her upper back more on the left side. The patient went to her physician and he told her that he thought that it was muscular due to her trying to move her arm. The back pain did not resolve, the patient went to see an orthopedist on Monday, 14th May 2018. Orthopedist prescribed her a MEDROL dose pack and told to the patient if that did not work that she should start physical therapy. The MEDROL dose pack did not work so she started physical therapy on 21st May 2018.  The upper back pain was resolving.  The arm ache lasted for approximately five days.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 8th May 2018 12:30, the patient received the 1st dose of SHINGIRX (intramuscular) .5 ml. On 8th May 2018, less than a day after receiving SHINGRIX, the patient experienced injected limb mobility decreased, pain in arm, chills, fever and muscle pain. On 10th May 2018, the patient experienced upper back pain. The patient was treated with MEDROL. On an unknown date, the outcome of the injected limb mobility decreased and muscle pain were unknown and the outcome of the pain in arm, chills and fever were recovered/resolved and the outcome of the upper back pain was recovering/resolving. It was unknown if the reporter considered the injected limb mobility decreased, upper back pain and muscle pain to be related to SHINGRIX. The reporter considered the pain in arm, chills and fever to be related to SHINGRIX. Additional details were provided as follows: On the day of vaccination, in the evening, the patient's left arm began to ache badly. The patient then developed chills and fever that same evening that lasted two or three days. The ache in the patient arm continued to get worse to the point that she could hardly lift it. By Thursday, 10th May 2018, the patient's arm was still aching but she had developed severe pain in her upper back more on the left side. The patient went to her physician and he told her that he thought that it was muscular due to her trying to move her arm. The back pain did not resolve, the patient went to see an orthopedist on Monday, 14th May 2018. Orthopedist prescribed her a MEDROL dose pack and told to the patient if that did not work that she should start physical therapy. The MEDROL dose pack did not work so she started physical therapy on 21st May 2018.  The upper back pain was resolving.  The arm ache lasted for approximately five days.
Age: 65.0
Sex: F
Vaccine: TDAP
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 66-year-old female patient who received BOOSTRIX (batch number TF422, expiry date 15th December 2019) for prophylaxis. On 31st May 2018, the patient received BOOSTRIX (intramuscular) .5 ml. On an unknown date, less than a week after receiving BOOSTRIX, the patient experienced extensive swelling of vaccinated limb and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were recovered/resolved. The reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to BOOSTRIX. Additional details were provided as follows: The reporter had a consumer that received the BOOSTRIX vaccination on left arm. The patient experienced redness and swelling at the injection site the size of a baseball. These symptoms had been present for approximately one week.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 73-year-old male patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020) for prophylaxis. Concomitant products included doxycycline and SINGULAIR. On 5th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, several hours after receiving SHINGRIX, the patient experienced fever, erythema of extremities, pain in arm and swelling arm. The patient was treated with TYLENOL. On an unknown date, the outcome of the fever, erythema of extremities, pain in arm and swelling arm were recovered/resolved. The reporter considered the fever, erythema of extremities, pain in arm and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. The patient experienced fever (body temperature 99-100 degree F) which lasted for a week. The patient also experienced red, swollen, and painful reaction on arm that lasted for 2 weeks. The reaction started within a few hours after receiving the SHINGRIX. The patient called the pharmacy and the pharmacist recommended TYLENOL for the fever and pain.
Sex: F
Vaccine: FLU4, PPV
Symptoms: Autoimmune thyroiditis, Coeliac disease, Drug hypersensitivity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of celiac disease in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. Co-suspect products included PNEUMOCOCCAL VACCINE for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose and PNEUMOCOCCAL VACCINE at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season and PNEUMOCOCCAL VACCINE, the patient experienced celiac disease (serious criteria GSK medically significant), Hashimoto's thyroiditis (serious criteria GSK medically significant) and drug hypersensitivity. On an unknown date, the outcome of the celiac disease and Hashimoto's thyroiditis were not recovered/not resolved and the outcome of the drug hypersensitivity was unknown. It was unknown if the reporter considered the celiac disease, Hashimoto's thyroiditis and drug hypersensitivity to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The patient was planning to talk with her doctor about SHINGRIX and called GlaxoSmithKline to discuss if any ingredients of SHINGRIX would be an issue with her allergies to penicillin, sulfa, or ANCEF or if celiac disease would be a contraindication to receiving SHINGRIX. The product PI (product information) was discussed, and she was referred to her HCP (healthcare professional) to address these specific inquiries and her inquiry of whether she should receive SHINGRIX or not. Towards the end of the call the patient reported that said she had allergies, celiac disease, and Hashimoto's thyroiditis and she said that she needed to get off of the phone and just before the call ended, the patient said that said she had received flu injections for years and the pneumonia injection and never called before to inquire about their ingredients prior to having received them. The patient only provided the specific mailing address for mailing of the PI to her home which she requested. The patient did not want to receive any unsolicited calls or contacts. It was unknown when the patient was diagnosed with allergies, celiac disease, or Hashimoto's relative to her having received the vaccinations for flu and pneumonia. The manufacturer of those vaccines were unknown. No further information was available.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of shingles in a 72-year-old male patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. On 4th June 2018, 2 days after receiving SHINGRIX, the patient experienced shingles and painful rash. On an unknown date, the outcome of the shingles and painful rash were unknown. It was unknown if the reporter considered the shingles and painful rash to be related to SHINGRIX. Additional details were provided as follows: This case was reported via chat. The health care professional asked if there had been any reported cases of patients who are just 2-3 days post SHINGRIX vaccination (1st dose), getting diagnosed with shingles. The health care professional had the patient who might had experienced shingles 2 to 3 days post vaccination and was trying to determine the likelihood of this occurring. The healthcare professional was not 100 percent convinced it was shingles but it was a theory. The patient had what looked similar to shingles rash on his soft palate and the reporter was just trying to figure out new onset, painful rash with only new variables being the vaccinations on Monday. The patient received SHINGRIX vaccine. The health care professional did not have vaccine information.