chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Musculoskeletal stiffness, Neck pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received SHINGRIX (batch number ZY3X4, expiry date 28th April 2020). On an unknown date, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site erythema (serious criteria hospitalization), injection site pain (serious criteria hospitalization), infection (serious criteria hospitalization) and stiff neck. The patient was treated with cephalexin. On an unknown date, the outcome of the injection site erythema and injection site pain were unchanged and the outcome of the infection and stiff neck were unknown. It was unknown if the reporter considered the injection site erythema, injection site pain, infection and stiff neck to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) reported that the patient who received a dose of SHINGRIX developed redness and soreness at the injection site which progressively got worse. After 3 days patient went to see primary care physician who prescribed antibiotic Cephalexin prophylactically for treatment of possible infection. The patient reported that the pain got worse and spread to her neck and had developed into stiffness of her neck. The patient was admitted to the hospital with suspected infection.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Infection, Injection site erythema, Injection site pain, Musculoskeletal stiffness, Neck pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received SHINGRIX (batch number ZY3X4, expiry date 28th April 2020). On an unknown date, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site erythema (serious criteria hospitalization), injection site pain (serious criteria hospitalization), infection (serious criteria hospitalization) and stiff neck. The patient was treated with cephalexin. On an unknown date, the outcome of the injection site erythema and injection site pain were unchanged and the outcome of the infection and stiff neck were unknown. It was unknown if the reporter considered the injection site erythema, injection site pain, infection and stiff neck to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) reported that the patient who received a dose of SHINGRIX developed redness and soreness at the injection site which progressively got worse. After 3 days patient went to see primary care physician who prescribed antibiotic Cephalexin prophylactically for treatment of possible infection. The patient reported that the pain got worse and spread to her neck and had developed into stiffness of her neck. The patient was admitted to the hospital with suspected infection.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV, DTAPIPV, HEPA, MMRV
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a Office manager referring to a 4 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. The patient did not took any prescription, over the counter medications, dietary supplements, or herbal remedies at the time of vaccination. On 08-MAY-2018, the patient was vaccinated with a one day expired dose of PROQUAD intramuscular in the left deltoid (Strength, dose, dose number and frequency were unknown) with lot # M044718 and expiration date 07-MAY-2018 reconstituted with sterile diluent (MERCK STERILE DILUENT), and it was reported that was also vaccinated with QUADRACEL intramuscular in the left deltoid (Strength, dose, dose number and frequency were unknown) with lot # C524BAA and VAQTA intramuscular in the left deltoid (Strength, dose, dose number and frequency were unknown) with lot # N019924 for prophylaxis.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV, DTAPIPV, HEPA, MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Office manager referring to a 4 year old female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. The patient did not took any prescription, over the counter medications, dietary supplements, or herbal remedies at the time of vaccination. On 08-MAY-2018, the patient was vaccinated with a one day expired dose of PROQUAD intramuscular in the left deltoid (Strength, dose, dose number and frequency were unknown) with lot # M044718 and expiration date 07-MAY-2018 reconstituted with sterile diluent (MERCK STERILE DILUENT), and it was reported that was also vaccinated with QUADRACEL intramuscular in the left deltoid (Strength, dose, dose number and frequency were unknown) with lot # C524BAA and VAQTA intramuscular in the left deltoid (Strength, dose, dose number and frequency were unknown) with lot # N019924 for prophylaxis.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Abdominal discomfort, Extensive swelling of vaccinated limb, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a adult female patient who received Influenza vaccine Quadrivalent. Concurrent medical conditions included splenectomy and idiopathic thrombocytopenic purpura. Concomitant products included TYLENOL. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified (intramuscular). On an unknown date, less than a day after receiving Influenza vaccine Quadrivalent, the patient experienced extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth and upset stomach. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth and upset stomach were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth and upset stomach to be related to Influenza vaccine Quadrivalent. Additional details reported as follows: The age at vaccination was not reported. The reporter approximates that within the past five years there were three yearly occasions in which the symptoms occurred within a few hours after receiving a flu vaccine of unknown name and manufacturer. The patient always had the vaccines administered into her left arm muscle, as she was right-handed. The patient cannot recall exact dosing details. The left arm would be swollen and red around the site of injection, and the area would be 4 inches or greater in diameter. That arm area was painful and would feel hot like it had a fever. The symptoms would last for another day and then resolve. In addition to the left arm symptoms, she also felt sick to her stomach described as feeling like she was getting the flu on one of the three occasions. That symptom diminished the next day after receiving the vaccine. The patient went to the doctor the day after receiving the vaccine when she had the stomach upset. The doctor told her that symptom was likely to have been caused by food poisoning instead of the flu. Once she changed and started getting her annual flu shot at a different retail pharmacy location, she did not have these symptoms and was told that the previous symptoms which had followed her previous flu vaccinations had been due to the preservatives in the vaccine products she had previously received which were no longer now included in the vaccine provided at the retail location. The patient thought the symptoms were due to the preservatives in those past flu vaccine products. This case has been linked to the case US2018082725 and US2018GSK089040, reported by the same reporter.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Abdominal discomfort, Extensive swelling of vaccinated limb, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a adult female patient who received Influenza vaccine Quadrivalent. Concurrent medical conditions included splenectomy and idiopathic thrombocytopenic purpura. Concomitant products included TYLENOL. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified (intramuscular). On an unknown date, less than a day after receiving Influenza vaccine Quadrivalent, the patient experienced extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth and upset stomach. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth and upset stomach were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth and upset stomach to be related to Influenza vaccine Quadrivalent. Additional details reported as follows: The age at vaccination was not reported. The reporter approximates that within the past five years there were three yearly occasions in which the symptoms occurred within a few hours after receiving a flu vaccine of unknown name and manufacturer. The patient always had the vaccines administered into her left arm muscle, as she was right-handed. The patient cannot recall exact dosing details. The left arm would be swollen and red around the site of injection, and the area would be 4 inches or greater in diameter. That arm area was painful and would feel hot like it had a fever. The symptoms would last for another day and then resolve. In addition to the left arm symptoms, she also felt sick to her stomach described as feeling like she was getting the flu on one of the three occasions. That symptom diminished the next day after receiving the vaccine. The patient went to the doctor the day after receiving the vaccine when she had the stomach upset. The doctor told her that symptom was likely to have been caused by food poisoning instead of the flu. Once she changed and started getting her annual flu shot at a different retail pharmacy location, she did not have these symptoms and was told that the previous symptoms which had followed her previous flu vaccinations had been due to the preservatives in the vaccine products she had previously received which were no longer now included in the vaccine provided at the retail location. The patient thought the symptoms were due to the preservatives in those past flu vaccine products. This case has been linked to the case US2018082725 and US2018GSK089040, reported by the same reporter.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a adult female patient who received Influenza vaccine Quadrivalent. Concurrent medical conditions included splenectomy and idiopathic thrombocytopenic purpura. Concomitant products included TYLENOL. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified (intramuscular). On an unknown date, less than a day after receiving Influenza vaccine Quadrivalent, the patient experienced extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth and upset stomach. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth and upset stomach were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site erythema, injection site warmth and upset stomach to be related to Influenza vaccine Quadrivalent. Additional details reported as follows: The age at vaccination was not reported. The reporter approximates that within the past five years there were three yearly occasions in which the symptoms occurred within a few hours after receiving a flu vaccine of unknown name and manufacturer. The patient always had the vaccines administered into her left arm muscle, as she was right-handed. The patient cannot recall exact dosing details. The left arm would be swollen and red around the site of injection, and the area would be 4 inches or greater in diameter. That arm area was painful and would feel hot like it had a fever. The symptoms would last for another day and then resolve. In addition to the left arm symptoms, she also felt sick to her stomach described as feeling like she was getting the flu on one of the three occasions. That symptom diminished the next day after receiving the vaccine. The patient went to the doctor the day after receiving the vaccine when she had the stomach upset. The doctor told her that symptom was likely to have been caused by food poisoning instead of the flu. Once she changed and started getting her annual flu shot at a different retail pharmacy location, she did not have these symptoms and was told that the previous symptoms which had followed her previous flu vaccinations had been due to the preservatives in the vaccine products she had previously received which were no longer now included in the vaccine provided at the retail location. The patient thought the symptoms were due to the preservatives in those past flu vaccine products. This case has been linked to the case US2018082725 and US2018GSK089040, reported by the same reporter.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever 102 degrees Celsius the next afternoon and throughout the night.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Right arm began to ache and swell later in the afternoon. The right arm was warm to touch with visible red streaks radiating down the arm.
Age: 1.17
Sex: M
Vaccine: MMR
Symptoms: Arterial disorder, Contusion, Full blood count, Immune thrombocytopenic purpura, Platelet count decreased
Clinical narrative: ITP, low platelets, bruises, broken blood vessels  one week after injection.
Sex: U
Vaccine: HEPA, HPV9, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unknown number and gender of patients. The patients' pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 03-MAY-2018  and 04-MAY-2018, the patients were vaccinated with improperly stored doses of ROTATEQ (Lot number N032569 with the expiration date 18-JUN-2019 and Lot number N034400 with the expiration date 10-MAY-2019) (dose, strength, administration route was not reported) for prophylaxis; VAQTA (Lot number N026997 with the expiration date 10-NOV-2018)  (dose, strength, administration route was not reported) for prophylaxis and GARDASIL 9 (lot number N013276 with the expiration date 21-JAN-2020) (dose, strength, administration route was not reported) for prophylaxis some of the patients. The nurse also reported that since 08-MAY-2018, another patients also were vaccinated with improperly stored doses of ROTATEQ (dose, strength, administration route was not reported)  (lot number and expiration dates reported as: N032569, 18-JUN-2019 and N034400, 10-MAY-2019) for prophylaxis, and VAQTA (dose, strength, administration route was not reported) (lot number and expiration date: N026997, 10-NOV-2018) for prophylaxis. Temperature excursion was at 0 degrees C to 1 degrees C for 1 hour and 11 minutes, without previous exposures, also -1.5 Celsius for 6 hours and 43 minutes; 9 Celsius to 25 Celsius (9.5 Celsius) for 1 hours and 23 minutes, with no previous temperature excursion, the call was due a data logger. No adverse effects were reported. This is a non valid case due to lack of patient identifiers.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to a 17 year old patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown date, the patient was vaccinated with PROQUAD (Strength, route, dose, frequency, and anatomical location were unknown) lot # N020620 and expiration date 22-JAN2019 for prophylaxis reconstituted with sterile diluent (MERCK). No adverse effects were reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Physician Assistant, referring to an unspecified number of patients of unknown age and gender. Their historical condition, concurrent condition, concomitant therapy, historical drugs or allergies were not reported. On unknown dates, the patients may had received an improperly stored doses of PEDVAXHIB injection, intramuscular route, with lot number N024571, expiration date 01-MAY-2020 (strength, dose and frequency were not reported) for prophylaxis. No adverse effects were reported. The administered dose of the vaccine experienced a temperature excursion 9 degrees to 25 degrees Celsius for 12 hours 28 minutes, as recorded by a data logger. No product quality complaint was filed.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 26-AUG-2009 the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), administered at a health care facility (by an unspecified health care professional), as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 05-AUG-2014, the patient was treated by a physician at a health care facility for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. On or about 25-AUG-2014, the patient sought subsequent treatment from a physician at a health care facility for ongoing and worsening symptoms of shingles and persistent pain which was diagnosed as post-herpetic neuralgia, a chronic condition of pain and nerve damages secondary to zoster infections.  On or about 08-OCT-2015, the patient sought additional treatments at the health care facility for uncontrolled symptoms of post-herpetic neuralgia. The patient has been prescribed gabapentin and acyclovir for management of her painful and persistent symptoms. 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 direct and proximate result of these malfunctions, 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 is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 09-JAN-2009 the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), administered at a clinic (by an unspecified health care professional), as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 06-JUN-2016, the patient was treated (by an unspecified health care professional) at a medical center for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. On or about 22-JUN-2016, the patient sought subsequent treatment at a medical center for ongoing and worsening symptoms, which was diagnosed as post-herpetic neuralgia, a chronic condition of pain and nerve damage secondary to zoster infections. On or about 18-NOV-2016, the patient was again treated at the medical center for new and progressive outbreaks of shingles. The patient has been prescribed valacyclovir for management of his painful symptoms. 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 direct and proximate result of these malfunctions, 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 is unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 19-APR-2013,  the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), administered by a physician, as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 01-MAR-2016, the patient was treated (by an unspecified health care professional) at the neurology medical group office for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. On or about 20-JUN-2016, the patient sought subsequent treatment at the neurology medical group office for continued and worsening symptoms of shingles pain, which was diagnosed as post-herpetic neuralgia, a chronic condition of pain and nerve damage secondary to zoster infections. On or about the dates of 26-AUG-2016, 15-MAR-2017, and 17-APR-2017, the patient sought additional treatment at the neurology medical group office for post-herpetic neuralgia across the right flank and back that was uncontrolled by pain medication. The patient has been prescribed gabapentin in increasing dosages in attempts to curb his painful symptoms. 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 direct and proximate result of these malfunctions, 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 is unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal, Therapeutic procedure
Clinical narrative: This spontaneous report as received from a 28 year old female consumer referring herself. Information about patient's concurrent conditions, medical history or concomitant medication were unknown by the reporter. On an unspecified date, reported as before the patient was 18 years old, the patient was vaccinated with one dose of GARDASIL, for HPV prevention (dose, route of administration, lot number and expiration date were not reported) in the HPV vaccination series. It was unknown how many doses of GARDASIL the patient received, and it was unknown if the patient completed the HPV vaccination series. On an unspecified date in 2005 (reported as when she was 15 years old), the patient gave birth to a child. However, it was unknown if she received the GARDASIL before she was 15 years old. Then, on unspecified dates, the patient had multiple abnormal papanicolaou (PAP) tests that showed she had the human papillomavirus. Consequently, the patient sought medical attention and received multiple treatments for HPV that were described as scrapings; but no further clarifying information was provided. The outcome of all the above events and the causal relationship between the events and GARDASIL were unknown at the time of reporting.
Sex: U
Vaccine: HPV4
Symptoms: Incomplete course of vaccination, Vaccination complication
Clinical narrative: This literature market report has been received from the authors of a published literature article. This case was referring to one patient who was vaccinated with an unidentified Merck hpv vaccine administered (name and lot number not provided) on an unknown date. The patient reported of experiencing had side effect from the vaccine dose and did not plan to get the rest vaccine series (Inappropriate schedule of vaccine administered).
Age: 4.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a licensed practical nurse regarding a 4 year old patient of unknown gender. The patient's concomitant therapies sterile diluent (DILUENT MRK).The patient's medical history, concurrent conditions and drug reactions/allergies were not provided. On an unspecified date, the patient was vaccinated with ZOSTAVAX 19400 PFU, subcutaneously in the left upper thigh, lot # N025568 with expiration date 08-DEC-2018 for prophylaxis instead of the intended PROQUAD. The nurse reported that this was a medication error, and not product confusion. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an unspecified number of patients of unknown age and gender. The concurrent conditions, medical history and concomitant therapies of the patients were not reported. Since February 2018, the patients were vaccinated with an inappropriate storage dose of VARIVAX (strength, dose, route of administration were unknown) with lot # N030571 and expiration date of 31-OCT-2019 for prophylaxis, which were stored at a temperature range from -14 Celsius degrees (°C)  to -10°C for 15 hours. There was a digital data logger involved, but there was no previous temperature excursion. No adverse effects were reported.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Lip swelling, Urticaria
Clinical narrative: Bottom lip began swelling with diffuse uticaric rash.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Extreme redness, swelling and pain at injection site the following morning; feeling of total exhaustion; swelling and pain continues three days later.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash, Pruritus, Skin lesion
Clinical narrative: Patient followed up in clinic on 12/18/2017. Had rash at injection site along with pruritus on left upper arm and skin lesion. Was given fluocinonide cream and hydroxyzine along with ice therapy.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal disorder, Musculoskeletal pain, Myalgia, Pain in extremity
Clinical narrative: Patient's shoulder started hurting extremely bad two days after receiving vaccine. She stated that the pain started to radiate down her entire arm. She claims to have lost use of her arm for a period of time, but has since started to recover. She said it felt like the muscles all the way down to her forearm felt like they were in knots.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal disorder, Myalgia
Clinical narrative: Patient's shoulder started hurting extremely bad two days after receiving vaccine. She stated that the pain started to radiate down her entire arm. She claims to have lost use of her arm for a period of time, but has since started to recover. She said it felt like the muscles all the way down to her forearm felt like they were in knots.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Febrile convulsion, Otitis media acute, Pyrexia, Tympanic membrane hyperaemia
Clinical narrative: Febrile seizure on 5/21/18, seen in ED at Hospital and diagnosed with L AOM and fever to 103.  On f/u on 5/22/18, L ear drum slightly red but non-bulging, continued amoxicillin but more likely that febrile seizure was MMR vaccine reaction.
Age: 1.17
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given MMRV and Varicella on the same day meaning she got 2 doses of Varicella vaccine on the same day. No reaction that I know of.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 11-MAY-2018, the patient was vaccinated with Oka/Merck VARIVAX intramuscularly (lot #, expiration date, dose and strength were not provided) for prophylaxis. Other suspect therapies included sterile diluent intramuscularly (lot #, expiration date and dose were not provided) for prophylaxis. The patients did not experienced any adverse events.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
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 27-NOV-2012, 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, also known as shingles and other complications. On or about 13-JUN-2016, the patient was treated at a medical center for a blistering outbreak that was diagnosed as severe herpes zoster or shingles. He was prescribed valacyclovir for management of his painful symptoms. 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: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 17-NOV-2012, the patient was inoculated with ZOSTAVAX by a physician at the physician's office 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, also known as shingles and other complications. On or about 05-FEB-2016, the patient was treated by the same physician for a blistering outbreak that was diagnosed as severe herpes zoster or shingles.  She was prescribed acyclovir for management of her painful symptoms. 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.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Ligament sprain
Clinical narrative: Patient presented to emergency department 6 hours after vaccine administration with severe right arm pain, rated as 10/10, radiating from shoulder to elbow. Patient also reported chills but was afrebile upon presentation. Patient did not have redness or swelling around vaccine administration site. Emergency department diagnosed the pain as a shoulder sprain and prescribed tramadol 50 MG every 4 hours for pain.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, VARCEL
Symptoms: Vaccination error
Clinical narrative: Patient erroneously received a varicella vaccine at their 2 month well check. Parents counseled on symptoms to monitor for at home.
Age: 29.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Paraesthesia, Pruritus
Clinical narrative: LOCALIZED ERYTHEMA/EDEMA/TTP AT INJECTION SITE APPROX 3IN IN DIAMETER. REPORTED OROPHARYNGEAL PARESTHESIA/TINGLING/ITCHING.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Blood iron normal, Blood test normal, Epstein-Barr virus antibody positive, Fatigue
Clinical narrative: My knee joint pain started on 4/23/18 during the night. Thinking this might be related to the Exemestane I had been taking for 6 months, I stopped taking exemestane on 5/1/18. Knee and joint pain did not disappear. I had a single gout attack on 5/11/18 during night, first time ever. Fatigue started at 5/11/18, and continued to be a problem till today's date. I'm an active women, never had join paints or a gout attack before.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Gout, Inflammatory marker test, Neutrophil count increased, White blood cell count increased
Clinical narrative: My knee joint pain started on 4/23/18 during the night. Thinking this might be related to the Exemestane I had been taking for 6 months, I stopped taking exemestane on 5/1/18. Knee and joint pain did not disappear. I had a single gout attack on 5/11/18 during night, first time ever. Fatigue started at 5/11/18, and continued to be a problem till today's date. I'm an active women, never had join paints or a gout attack before.
Age: 0.08
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient received live virus varicella vaccine at 2 months of age. Parents counseled by provider.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Day 1- Evening, soreness, redness, very hot to touch, red circle at site 2 1/2 inches diameter. Day 2- Large red circle, extremely hot, treated with cold compresses, no fever, called pharmacy to report reaction. Day 3- Morning, the red circle had expanded to inside of the arm, irregular border, continued soreness, visited Clinic. FNP  made  phone calls to Doctor and  other support colleagues, it was determined the reaction was cellulitis and offered to prescribe antibiotics.  At that time, I decided to see Dr. who prescribed Augmenten  (AMOX-CLAV 875-125MG TABLET # 15, noticed  improvement after 2-3days.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Pain in extremity, Product administered at inappropriate site
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). On 23rd April 2018 11:45, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm (serious criteria other: Serious as per reporter), injected limb mobility decreased (serious criteria other: Serious as per reporter) and numbness of extremities (serious criteria other: Serious as per reporter). On 23rd April 2018, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the pain in arm, injected limb mobility decreased and numbness of extremities were recovered/resolved and the outcome of the vaccine administered at inappropriate site was unknown. The reporter considered the pain in arm, injected limb mobility decreased and numbness of extremities to be probably related to SHINGRIX. Additional details were provided as follows: The retail pharmacist stated that the patient received SHINGRIX and complained of left arm numbness, pain, decreased range of motion the day of or day after administration (left arm site of administration). The pharmacist stated the physician reported the patient received this dose of SHINGRIX in the bursa of the left shoulder, documented at pharmacy as left deltoid, which led to vaccine administered at inappropriate site. The patient sought physician for treatment on 24th April 2018, prescribed MOBIC. The patient required emergency room visit. The pharmacist stated the patient reported all symptoms were resolved at the time of reporting. The pharmacist gave permission for contact if there were further questions.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Abdominal X-ray, Abdominal pain, Irritability, Ultrasound abdomen normal, Vomiting
Clinical narrative: Rotavirus #3 administered 5/4/18. Fussiness, Abdm pain, vomiting started 5/12/18 day 8 after vaccine. Admitted Hospital 5/14/18, discharged 5/15/18 abdominal x-ray and US negative. Tolerated PO feeds and discharged 5/15/18. Sent to hospital to r/o intussusception.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: X-ray normal
Clinical narrative: Rotavirus #3 administered 5/4/18. Fussiness, Abdm pain, vomiting started 5/12/18 day 8 after vaccine. Admitted Hospital 5/14/18, discharged 5/15/18 abdominal x-ray and US negative. Tolerated PO feeds and discharged 5/15/18. Sent to hospital to r/o intussusception.
Sex: U
Vaccine: VARZOS
Symptoms: Pancreatitis
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pancreatitis in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pancreatitis (serious criteria GSK medically significant). On an unknown date, the outcome of the pancreatitis was unknown. It was unknown if the reporter considered the pancreatitis to be related to SHINGRIX. Additional information was received as follows: The pharmacist reported that the patient was receiving other medications and also got SHINGRIX. The pharmacist would like to know if SHINGRIX could cause pancreatitis.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysphagia, Headache, Injection site erythema, Injection site pain, Lip swelling
Clinical narrative: Patient reported difficulty swallowing and feels as though his lips are swelling. Patient reports difficulty swallowing, redness, pain at injection site. Patient reported difficulty swallowing and feels as though his lips are swelling. BP rechecked manually 162/94. Prior to squad arriving patient reported he is started to experienced a headache and his heart was beginning to race. SOLU-MEDROL 40mg IV given one time.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Palpitations
Clinical narrative: Patient reported difficulty swallowing and feels as though his lips are swelling. Patient reports difficulty swallowing, redness, pain at injection site. Patient reported difficulty swallowing and feels as though his lips are swelling. BP rechecked manually 162/94. Prior to squad arriving patient reported he is started to experienced a headache and his heart was beginning to race. SOLU-MEDROL 40mg IV given one time.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Headache, Pain in extremity, Pyrexia, Rash erythematous
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 65-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date 13th July 2020). On 4th May 2018, the patient received the 1st dose of SHINGRIX. On 4th May 2018, less than a day after receiving SHINGRIX, the patient experienced headache and fever. In May 2018, the patient experienced pustular rash, pain in arm, erythematous rash and blister. On an unknown date, the outcome of the headaches was recovering/resolving and the outcome of the fever was recovered/resolved and the outcome of the pustular rash was unchanged and the outcome of the pain in arm, erythematous rash and blister were unknown. It was unknown if the reporter considered the headache, fever, pustular rash, pain in arm, erythematous rash and blister to be related to SHINGRIX. Additional information was received as follows: The pharmacist reported that the patient experienced headache and low-grade fever, in the same evening on the day of vaccination. The fever lasted a few days and had resolved but the headache has improved. After 2 days, the patient also developed a pustular rash. Less than a week, the pustular rash initially presented as red and over the course of two days turned into blisters or pustules. The body temperature was recorded as 100 degree F. The reporter stated that the patient had not been able to see her physician regarding this events but she intended to do so. The reporter stated that the patient returned from country on 26th April 2018. The pharmacist was not aware of any medical intervention taken because of patient's experiences.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pustular
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 65-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date 13th July 2020). On 4th May 2018, the patient received the 1st dose of SHINGRIX. On 4th May 2018, less than a day after receiving SHINGRIX, the patient experienced headache and fever. In May 2018, the patient experienced pustular rash, pain in arm, erythematous rash and blister. On an unknown date, the outcome of the headaches was recovering/resolving and the outcome of the fever was recovered/resolved and the outcome of the pustular rash was unchanged and the outcome of the pain in arm, erythematous rash and blister were unknown. It was unknown if the reporter considered the headache, fever, pustular rash, pain in arm, erythematous rash and blister to be related to SHINGRIX. Additional information was received as follows: The pharmacist reported that the patient experienced headache and low-grade fever, in the same evening on the day of vaccination. The fever lasted a few days and had resolved but the headache has improved. After 2 days, the patient also developed a pustular rash. Less than a week, the pustular rash initially presented as red and over the course of two days turned into blisters or pustules. The body temperature was recorded as 100 degree F. The reporter stated that the patient had not been able to see her physician regarding this events but she intended to do so. The reporter stated that the patient returned from country on 26th April 2018. The pharmacist was not aware of any medical intervention taken because of patient's experiences.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: Left ear cannot hear, ringing.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Chills
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 81-year-old female patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020). On 7th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 7th May 2018, several hours after receiving SHINGRIX, the patient experienced chills. On 8th May 2018, the patient experienced chest tightness. On 8th May 2018, the outcome of the chills was recovered/resolved. On an unknown date, the outcome of the chest tightness was not recovered/not resolved. The reporter considered the chills to be almost certainly related to SHINGRIX. The reporter considered the chest tightness to be possibly related to SHINGRIX. Additional details were provided as follows: The patient's received unknown concomitant product. At 11:15, the patient received SHINGRIX on left deltoid. Last night from the reporting date, the patient experienced chills, but they had resolved by morning of the reporting date. One day after receiving SHINGRIX, the patient experienced tightness in her chest. The reporter was not sure if it was due to SHINGRIX or more of a panic reaction after reading the literature for SHINGRIX and becoming concerned.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Musculoskeletal pain, Neck pain, Nuclear magnetic resonance imaging spinal, Pain in extremity
Clinical narrative: Fever, worsening neck pain, pain radiating down arm-tingling down arm to painter finger. Severe neck pain left sided-radiating down left scapula. Burning sensation in spine and neck. Duration: 20 days. Treatment: Physical Therapy, gabapentin 100mg twice daily, hydrocodone 1-2 tabs three to four times daily PRN. Patient has known cervical disc disease and had surgery for R arm symptoms several years ago. She has had a R sided occurrence since the surgery with similarly severe symptoms a year or two ago. There are her 1st (L) sided symptoms. She saw her neurosurgeon with MRI results and PT prescribed. No surgery planned. She did take a course of methylprednisolone orally.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Fever, worsening neck pain, pain radiating down arm-tingling down arm to painter finger. Severe neck pain left sided-radiating down left scapula. Burning sensation in spine and neck. Duration: 20 days. Treatment: Physical Therapy, gabapentin 100mg twice daily, hydrocodone 1-2 tabs three to four times daily PRN. Patient has known cervical disc disease and had surgery for R arm symptoms several years ago. She has had a R sided occurrence since the surgery with similarly severe symptoms a year or two ago. There are her 1st (L) sided symptoms. She saw her neurosurgeon with MRI results and PT prescribed. No surgery planned. She did take a course of methylprednisolone orally.
Age: 56.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Loss of consciousness, Myalgia, Pyrexia
Clinical narrative: Passed out 45 min - 1 hr after vaccine fever and muscle aches.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Patient got shingles.