chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Deafness, Tinnitus
Clinical narrative: Information has been received from a lawyer and a consumer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medications were not provided. In or around 01-NOV-2016, the patient was inoculated with ZOSTAVAX vaccine for routine health maintenance and for its intended purpose: The prevention of shingles. Shortly after receiving ZOSTAVAX vaccine, the patient suffered tinnitus and hearing loss. As a direct and proximate result of ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. Upon internal review hearing loss was considered medically significant. Hearing loss and tinnitus were reported to be disabling. Additional information has been requested.
Sex: F
Vaccine: HEPAB, PPV
Symptoms: Injection site cellulitis
Clinical narrative: Had a cellulitis like reaction at the injection site; Information has been received from a pharmacist, concerning a female patient of an unknown age. The patient's pertinent medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were unknown by the reporter.  In approximately March 2019 (reported as about a month ago), the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, route of administration, anatomical location, lot number and expiration date were not provided), for prophylaxis, and a dose of hepatitis a virus vaccine inactivated, hepatitis b virus vaccine rhbsag (yeast) (TWINRIX) (indication, strength, route of administration, anatomical location, lot number and expiration date were not provided).   About a day later, the patient experienced a cellulitis like reaction at the injection site (injection site cellulitis); therefore, patient sought medical attention and was treated with cefalexin (KEFLEX) and ibuprofen, from an unspecified clinician.  At the time of the report, the outcome of the patient regarding the adverse event, as well as, if laboratory diagnostics or studies were performed were unknown by reporter. The causal relationship between injection site cellulitis and suspect vaccines was not provided.
Sex: M
Vaccine: MMR
Symptoms: Encephalitis
Clinical narrative: This spontaneous report was received from the patient´s mother regarding her son, an approximately 1-year-old male patient. It was reported that the patient had no concomitant medication, pertinent medical history or drug reactions/allergies. On an unspecified date in 2014, the patient received the first dose of M-M-R II in his thigh for prophylaxis (dose, route, therapy type, lot number and expiration were unknown by the reporter). Regarding the indication for the vaccine, it was reported that it was because: "she didn't know the truth about vaccinations". On an unspecified date in 2014, one day after the vaccination, the patient developed encephalitis. It was reported that the patient sought medical attention and receive treatment for the event, however, no laboratory diagnostics or studies were performed. At the time of reporting the patient had not recovered from the encephalitis. There was no causality assessment provided between M-M-R II and the encephalitis. This is one of two reports from the same reporter (Information captured in MARRS case # 1904USA006023). Upon internal review, the encephalitis was considered to be a medically significant event. Sender's Comments: US-009507513-1904USA006023.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, an female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 15-MAY-2009, at age 75, the patient was administered the ZOSTAVAX by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from her ZOSTAVAX use: Herpes zoster ophthalmicus. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the Herpes zoster ophthalmicus is unknown. Upon internal review, Herpes zoster ophthalmicus was determined to be medically significant. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received regarding a case in litigation from a lawyer, an female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 20-NOV-2016, at age 69, the patient was administered the zoster vaccine live (ZOSTAVAX) by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the Herpes zoster is unknown.  Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received regarding a case in litigation from a lawyer, and 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 prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 19-SEP-2016, at age 60, the patient was administered the zoster vaccine live (ZOSTAVAX) by a registered nurse (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from his zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to themselves, and economic losses. The outcome of the Herpes zoster is unknown.  Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received regarding a case in litigation from a lawyer, and a  female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 08-AUG-2008, at age 70, the patient was administered the zoster vaccine live (ZOSTAVAX) by a pharmacist (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the Herpes zoster is unknown.  Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; Information has been received regarding a case in litigation from a lawyer, a female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 19-MAY-2016, at age 63, the patient was administered the zoster vaccine live (ZOSTAVAX) by a healthcare provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the Herpes zoster is unknown.  Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received regarding a case in litigation from a lawyer, and a  female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 23-APR-2015, at age 68, the patient was administered the zoster vaccine live (ZOSTAVAX) by a pharmacist (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: shingles. The patient claimed damages as a result of: injury to themselves, and economic losses. The outcome of the shingles is unknown.  Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic 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 prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 06-JAN-2009, at age of 65 years, the patient was administered the ZOSTAVAX (dosage, site and route of administration and lot number not provided) by a healthcare provider at a physician's office. On an unknown date, the patient was treated by a healthcare provider at a physician's office for the following injury resulting from his ZOSTAVAX use: Herpes zoster ocular. The patient claimed damages as a result of: injury to himself, loss of consortium, loss of services, and economic losses. The outcome of the Herpes zoster ocular is unknown. Upon internal review, Herpes zoster ocular was determined to be medically significant. Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; Administered Zostavax at age 36; 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. The patient was prescribed the zoster vaccine live (ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In December 2015, at age 36, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the events is unknown.  Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received regarding a case in litigation from a lawyer, a female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 31-MAY-2017, at age 58, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Shingles. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown.  Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: No adverse effects; One patient received properly stored M-M-R II which was reconstitued with properly stored preservative free normal saline instead of the sterile diluent; One patient received properly stored M-M-R II which was reconstitued with properly stored preservative free normal saline instead of the sterile diluent; This spontaneous report was received from a medical student and refers to a 19 year old patient of unknown gender. The patient's medical history, concomitant medications, drug reactions or allergies were not reported.  On 13-APR-2019, the patient was vaccinated with a properly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R031681, expiration date: 01-NOV-2020 (dose, frequency, route of administration and anatomical location were not provided) as prophylaxis. On that day, the vaccine was reconstituted with a properly stored preservative free normal saline (lot# and expiration date not provided), instead of the sterile diluent (wrong technique in product usage process, product preparation error).  No adverse effects were reported.
Sex: M
Vaccine: HPVX
Symptoms: Diplegia, Fall, Mobility decreased
Clinical narrative: This spontaneous report was received from a nurse practitioner, via company representative, referring to a male adolescent patient (age reported as "16 or 17 years old"). The patient's medical history, concomitant medications and concurrent conditions were not disclosed. On an unknown date, the patient was vaccinated with an unspecified human papillomavirus (HPV) vaccine (manufacturer unknown) (product origin unknown) (dose, frequency, route, anatomical location, lot # and expiration date were not reported). The nurse reported that while attending a track meeting, she noticed one of the runners (patient) had problems with the way he was running and he fell down. After approaching the patient, his mother told the nurse that he has been having intermittent paralysis of his legs ever since he received an unspecified HPV vaccine. The reporter considered this to be a disabling event, since it was affecting the patient's mobility. The outcome of diplegia, product origin unknown and fall was unknown. By the time of this report, the causality assessment between the unspecified HPV vaccine and the events was not provided. Upon internal review, diplegia was determined to be medically significant.
Sex: M
Vaccine: MMRV
Symptoms: Hypoacusis
Clinical narrative: Information has been received from a physician concerning a male patient of unknown age. Information about concurrent condition, concomitant medication, drug allergies/reactions and medical history of the patient was unknown. On 27-JAN-2016, the patient received PROQUAD (strength, dose, route of administration, lot# and expiration date were not reported) diluted with sterile diluent (MERCK) for prophylaxis. From unspecified date in April 2016, the patient experienced waxing and waning hearing loss. The outcome of the event was reported as not recovered/not resolved. Causality assessment was not provided. Upon internal review, waxing and waning hearing loss was determined to be medically significant.
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: lot of pain in his arm and trouble lifting his arm; lot of pain in his arm and trouble lifting his arm; This spontaneous report was received from a male pharmacist referring to himself of unknown age. His pertinent medical history, concomitant medications and drug reactions/allergies were unknown. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscularly for prophylaxis (strength, dose, unit, anatomical location, lot # and expiration date were not reported). On an unknown date, the patient experienced a lot of pain in his arm and had trouble lifting his arm (pain in extremity and injected limb mobility decreased). The patient did not seek medical attention and was not treated for the events. The event was not cancer and no overdose was reported. The outcome of pain in extremity and injected limb mobility decreased was reported as recovered/resolved. Causality assessment of the events was not reported. No product quality complaint (PQC) was involved.
Age: 53.0
Sex: M
Vaccine: PNC, PPV
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: that he received PNEUMOVAX 23 at age 53 years old and PREVNAR at age 60 years old.; that he received PNEUMOVAX 23 at age 53 years old and PREVNAR at age 60 years old.; no adverse effect reported; This spontaneous report was received from a pharmacist via a company representative, regarding himself, a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported.  On an unspecified date, the patient received a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) administered for prophylaxis at age of 53 years old (route, dose, location of administration, lot # and expiration date were not reported). On an unspecified date, the patient received a dose of pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197) (PREVNAR) (Interchange of vaccine products) (route, indication, dose, location of administration, lot # and expiration date were not reported). No adverse events were reported.   The outcome of interchange of vaccine products and the causal relationship between the event and both vaccines were not provided.
Sex: U
Vaccine: HEPAB, TDAP
Symptoms: Fatigue, Limb discomfort, Pain in extremity, Pruritus generalised, Rash
Clinical narrative: fatigue; limb discomfort; pain in arm; pruritus; rash; urticaria; This case was reported by a consumer and described the occurrence of fatigue in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   On an unknown date, the patient received Boostrix and Twinrix. On an unknown date, unknown after receiving Boostrix and Twinrix, the patient experienced fatigue, limb discomfort, pain in arm, generalized pruritus, rash and urticaria. On an unknown date, the outcome of the fatigue, limb discomfort, pain in arm, generalized pruritus, rash and urticaria were unknown.   It was unknown if the reporter considered the fatigue, limb discomfort, pain in arm, generalized pruritus, rash and urticaria to be related to Boostrix and Twinrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fatigue, limb discomfort, pain in arm, generalized pruritus, rash and urticaria after receiving a dose of Boostrix and a dose of Twinrix. No additional information was provided.
Sex: U
Vaccine: HEPAB, TDAP
Symptoms: Urticaria
Clinical narrative: fatigue; limb discomfort; pain in arm; pruritus; rash; urticaria; This case was reported by a consumer and described the occurrence of fatigue in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   On an unknown date, the patient received Boostrix and Twinrix. On an unknown date, unknown after receiving Boostrix and Twinrix, the patient experienced fatigue, limb discomfort, pain in arm, generalized pruritus, rash and urticaria. On an unknown date, the outcome of the fatigue, limb discomfort, pain in arm, generalized pruritus, rash and urticaria were unknown.   It was unknown if the reporter considered the fatigue, limb discomfort, pain in arm, generalized pruritus, rash and urticaria to be related to Boostrix and Twinrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fatigue, limb discomfort, pain in arm, generalized pruritus, rash and urticaria after receiving a dose of Boostrix and a dose of Twinrix. No additional information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Fatigue, Groin pain, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced upset stomach, lymphadenopathy inguinal, joint pain, headache, fatigue and groin pain. On an unknown date, the outcome of the upset stomach, lymphadenopathy inguinal, joint pain, headache, fatigue and groin pain were unknown. It was unknown if the reporter considered the upset stomach, lymphadenopathy inguinal, joint pain, headache, fatigue and groin pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient asked was there any reports of swollen groin glands. The patient had been experiencing stomach, joint, headache and fatigue for 4 days. Everything seems much better but now patient's groin hurts.
Sex: U
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced upset stomach, lymphadenopathy inguinal, joint pain, headache, fatigue and groin pain. On an unknown date, the outcome of the upset stomach, lymphadenopathy inguinal, joint pain, headache, fatigue and groin pain were unknown. It was unknown if the reporter considered the upset stomach, lymphadenopathy inguinal, joint pain, headache, fatigue and groin pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient asked was there any reports of swollen groin glands. The patient had been experiencing stomach, joint, headache and fatigue for 4 days. Everything seems much better but now patient's groin hurts.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a patient who received SHINGRIX for prophylaxis. In April 2019, the patient received SHINGRIX. In April 2019, less than a day after receiving SHINGRIX, the patient experienced tiredness and muscle soreness. On an unknown date, the outcome of the tiredness and muscle soreness were unknown. It was unknown if the reporter considered the tiredness and muscle soreness to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient just had the dose of SHINGRIX and experienced very tired and sore muscles. The patient was asking on the normal side effects of Shingles vaccine that how long would the tiredness and muscle aches normally last. The patient was just curious as how to go about the week.
Sex: M
Vaccine: VARZOS
Symptoms: Cold sweat, Influenza like illness
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of cold sweat in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced cold sweat and influenza-like symptoms. On an unknown date, the outcome of the cold sweat and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the cold sweat and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported, but he was in early 50s at the time of reporting. After receiving the SHINGRIX dose the patient had cold sweats and felt like symptoms for about 36 hours. The reporter did not agree to follow up from GSK. For tolerance of 2nd dose refer linked case US2019GSK065585.
Sex: M
Vaccine: VARZOS
Symptoms: Cold sweat, Influenza like illness, Vaccine positive rechallenge
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of cold sweat in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of cold sweat (1st dose received on an unknown date, refer case US2019GSK064951). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced cold sweat and influenza-like symptoms. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the cold sweat and influenza-like symptoms were unknown. It was unknown if the reporter considered the cold sweat and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter said the patient was administered with 2nd dose at the appropriate time. The patient displayed similar but less severe symptoms. The reporter did not agree to follow up from GSK.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a several other adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The reporter had a lot of other people report, they also had soreness. No new adverse event report filed for these a lot of other people and soreness. The reporter also experienced soreness (refer case US2019GSK050679) and stated she expected it as it was a common side effect. The reporter requested to stop further follow up.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Endodontic procedure, Malaise, Nasopharyngitis, Tooth infection
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a elderly female patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. In October 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season. In October 2018, less than a year after receiving SHINGRIX and less than a month after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced sickness, tooth infection and cold. On an unknown date, the outcome of the sickness, tooth infection and cold were not reported. It was unknown if the reporter considered the sickness, tooth infection and cold to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: The reporter was patient's husband, who also had received 1st dose of SHINGRIX in August 2018, but they thought, it was October 2018. In October 2018, the patient also received flu vaccine. In October 2018, less than a year after 1st dose of SHINGRIX and less than a month after flu vaccine, the patient got sick, with a cold and then a tooth infection that required a root canal because it took so long to figure out what was going on. The patient was so ill, hence she waited and at the time of reporting, it had been 8 months after 1st dose of SHINGRIX and the patient's husband wondered if the patient could get 2nd dose of SHINGRIX. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Blepharospasm, Chills, Diplopia, Dizziness, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. On 4th April 2019, the patient received SHINGRIX. On 4th April 2019, less than a day after receiving SHINGRIX, the patient experienced fever, shivering and sleeplessness. In April 2019, the patient experienced migraine, nausea, vomiting, dizziness, double vision, eyelid twitching and headache. On an unknown date, the outcome of the fever, shivering, sleeplessness, nausea, vomiting, dizziness, double vision, eyelid twitching and headache were unknown and the outcome of the migraine was not recovered/not resolved. It was unknown if the reporter considered the fever, shivering, sleeplessness, migraine, nausea, vomiting, dizziness, double vision, eyelid twitching and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that her husband received SHINGRIX. That night he had fever, shivering and could not sleep. The patient then got very severe migraines in his left temple and his right eyelid shutdown. He had been to the emergency room (ER) several times for his severe headache. The patient also had nausea, vomiting, dizziness and double vision and was at the ER again when this call was made. ER visit required. The reporter disconnected before they could get any of her contact information or ask any further questions. The reporter stated before hanging up that she would call back.
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Migraine, Nausea, Pyrexia, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received SHINGRIX for prophylaxis. On 4th April 2019, the patient received SHINGRIX. On 4th April 2019, less than a day after receiving SHINGRIX, the patient experienced fever, shivering and sleeplessness. In April 2019, the patient experienced migraine, nausea, vomiting, dizziness, double vision, eyelid twitching and headache. On an unknown date, the outcome of the fever, shivering, sleeplessness, nausea, vomiting, dizziness, double vision, eyelid twitching and headache were unknown and the outcome of the migraine was not recovered/not resolved. It was unknown if the reporter considered the fever, shivering, sleeplessness, migraine, nausea, vomiting, dizziness, double vision, eyelid twitching and headache to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that her husband received SHINGRIX. That night he had fever, shivering and could not sleep. The patient then got very severe migraines in his left temple and his right eyelid shutdown. He had been to the emergency room (ER) several times for his severe headache. The patient also had nausea, vomiting, dizziness and double vision and was at the ER again when this call was made. ER visit required. The reporter disconnected before they could get any of her contact information or ask any further questions. The reporter stated before hanging up that she would call back.
Age: 28.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Paraesthesia oral
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of tingling lips in a 28-year-old female patient who received SHINGRIX for prophylaxis. On 12th April 2019, the patient received SHINGRIX. On 12th April 2019, less than a day after receiving SHINGRIX, the patient experienced tingling lips, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the tingling lips was recovering/resolving and the outcome of the inadvertent exposure to vaccine and exposure via skin contact were unknown. It was unknown if the reporter considered the tingling lips to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) called on behalf of self. The reporter stated that while reconstituting SHINGRIX all the contents of the second vial sprayed them in the face and around their mouth, which led to inadvertent exposure to vaccine and exposure via skin contact. The HCP reported they washed their face with soap and water for several minutes. The HCP reported they began to experience tingling around their mouth, which was reported as beginning to improve. The reporter was consented to follow up.
Sex: U
Vaccine: TTOX
Symptoms: Allergy to vaccine, Urticaria
Clinical narrative: Welts; Allergy to vaccine; Initial information received on 11-Apr-2019 regarding an unsolicited valid non-serious case received from a physician via other company (Pfizer) (manufacturer report number: 2019128091).  This case involves adult patient of unknown demographics (174.998 kg) who experienced welts and allergy to vaccine, while he/she received vaccine TETANUS TOXOID.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.   On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer (lot number, expiry date, dose, dose in series, route and site of administration were not reported).  On an unknown date, the patient developed a non-serious welts (urticaria) and allergy to vaccine following the administration of TETANUS TOXOID.  No Lab data was reported.  Final diagnosis was allergy to vaccine and welts.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for welts and for allergy to vaccine.  Documents held by the sender: none.
Sex: M
Vaccine: DTAP, MMR
Symptoms: Autism spectrum disorder, Developmental regression
Clinical narrative: Initial information received on 12-Apr-2019 regarding an unsolicited valid serious case received from a non-healthcare professional (patient's mother) via phone. This case involves adult male patient of unknown demographics who experienced regress into autism, while he received vaccines MMR and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect MMR not produced by Sanofi Pasteur (lot number, expiry date, dose, dose in series, route and site of administration were not reported). On an unknown date, the patient developed a serious regress into autism and (Condition aggravated) following the administration of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and MMR. This event was assessed as medically significant. It was reported that MMR was killing more children than the measles. It was also mentioned by the reporter that the measles outbreak which she believes was caused by the vaccine. No Lab data was reported. Final diagnosis was her son regress into autism. It was not reported if the patient received a corrective treatment. The patient was not yet Recovered / Resolved on an unknown date from autism. Documents held by the sender: none. Sender's Comments: Patient presented with autism after vaccination with DTAP and MMR vaccine. Time to onset is unknown. Moreover, further information including patient's medical history, concomitant medications, condition at time of vaccination, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information, the role of the vaccine cannot be assessed.
Sex: F
Vaccine: RAB
Symptoms: Extra dose administered
Clinical narrative: Typhoid vaccine was intended as the second vaccine today, but instead Imovax was mistakenly administered the second time.; instead Imovax was mistakenly administered the second time; Initial information received on 12-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 16 years old female patient who was second time vaccinated with 1.0 ml RABIES (HDC) VACCINE [IMOVAX RABIES] (formulation: Powder and solvent for suspension for injection) (lot number not reported) via unknown route in unknown administration site.instead TYPHOID VACCINE and RABIES (HDC) VACCINE [IMOVAX RABIES] on an unknown date. On 05-Apr-2019, the patient received a first dose of suspect RABIES (HDC) VACCINE (lot: N1K303M) via unknown route in unknown administration site  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to wrong vaccine administered and vaccine overdose (Typhoid vaccine was intended as the second vaccine today, but instead Imovax was mistakenly administered the second time).  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Wrong product administered
Clinical narrative: an 11 yr old girl recieved Daptacel by mistake instead of the Adacel; an 11 yr old girl recieved Daptacel by mistake instead of the Adacel; Initial information received on 12-Apr-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 11 years old female patient who was vaccinated with once 0.5 ml DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot: 5553K, expiry date: 01-Feb-2021) via intramuscular route in the left arm instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number not reported) on an unknown date (reported as today).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Immunisation.  It was an actual medication error due to Inappropriate age at vaccine administration and wrong vaccine administered.  It was unknown if any adverse event occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Skin reaction, Urticaria
Clinical narrative: skin had a reaction; broke out in hives; Initial information received on 12-Apr-2019 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional by phone.  This case involves a 11 years old male patient who experienced skin had a reaction and broke out in hives, while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.   On an unspecified date of February 2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number:U6302AA and expiry date: 30-Jun-2019).  On an unknown date, the patient developed a non-serious skin had a reaction (skin reaction) and broke out in hives (urticaria) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No Lab data was reported.  Final diagnosis was broke out in hives and skin had a reaction.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for both the events.  Documents held by the sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: the DTAP/IPV portion of the Pentacel was administered and later that day had the patient administered with the actual ActHIB vaccine (not the ActHIB portion that comes with the Pentacel); Initial information received on 12-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient of unknown demography who she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and reported that the DTAP/IPV portion of the Pentacel was administered and later that day had the patient administered with the actual ActHib vaccine (not the ActHib portion that comes with the Pentacel).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to inappropriate reconstitution technique.  It was not reported whether the patient experienced any adverse events following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 28.0
Sex: F
Vaccine: RAB
Symptoms: Throat irritation, Throat tightness
Clinical narrative: Patient returned to the clinic 40 minutes(0720) after receiving the Rabies vaccine with c/o" A feeling of tightness and itching in the back of her throat". Patient was taken to the clinics treatment room and 0.3 mg of Epinephrine (Epi-Pen) was administered to the outer right thigh(Per the provider present) @0725 Patient also received 50 mg of Benadryl IM to the right deltoid(0727). Vital signs were monitored every 10 mins. and remained stable. The patients lungs were clear upon auscultation and no wheezing or stridor noted. The patient's throat was clear and without signs of swelling. Patient able to speak without difficulty and was alert and oriented. Patient  remained in the treatment room and monitored for 2.5 hours post medication. Patient was released with instructions to return to the clinic or report to the emergency if the symptoms should return
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site mass, Injection site pruritus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 81-year-old female patient who received SHINGRIX (batch number BF4J5, expiry date 5th July 2021) for prophylaxis. Concomitant products included SHINGRIX and Cortisone Topical Cream. On 2nd April 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 3rd April 2019, 1 days after receiving SHINGRIX, the patient experienced injection site lump and injection site itching. On an unknown date, the outcome of the injection site lump and injection site itching were not recovered/not resolved. It was unknown if the reporter considered the injection site lump and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX on 30th January 2019 with no issue. On 2nd day after vaccination, the patient developed bumps and itching around the site of the injection. The reporter told to the patient to put Cortisone cream on around the site of the injection.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Diarrhoea, Inflammation, Injection site erythema, Injection site inflammation
Clinical narrative: Red, inflamed area at/near injection site, pain in joint (L Shoulder), diarrhea, pain in (L) hip, (L)knee, (L) ankle. Inflammation duration 1 week, Shoulder pain 5 days. Other joint pain < 5 days.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Red, inflamed area at/near injection site, pain in joint (L Shoulder), diarrhea, pain in (L) hip, (L)knee, (L) ankle. Inflammation duration 1 week, Shoulder pain 5 days. Other joint pain < 5 days.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Malaise, Pyrexia
Clinical narrative: Fever, chills, headache, general malaise. Symptoms started on the evening of receiving the vaccine and have continued so far for 72hrs.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Hyperhidrosis, Injection site pain, Injection site swelling, Lymphadenopathy, Pain in extremity
Clinical narrative: vomited within a few minutes of receiving vaccines. felt warm and diaphoretic.  vomited x 1 and felt better. awoke .  Awoke next morning  -pain under arms. Looked normal. Applied a warm rag . went to school.  When he arrived home after school, noted swelling under left arm.  in our office the following day,  normal VS. Normal face and normal ROM of neck.  No cervical nodes. Distal left & right arms normal. Proximal area of right & left deltoids with mild, slightly tender induration . No erythema.   Left axilla swollen but soft. Mild tenderness. + 1 cm tender axillary node.. Full ROM of upper extremities.  No rash.