chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included flank pain. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced shingles, rash and feeling bad. On an unknown date, the outcome of the shingles, rash and feeling bad were unknown. The reporter considered the shingles, rash and feeling bad to be unrelated to SHINGRIX. Additional details were provided as follows: This case was reported by the wife of the patient. The age at the vaccination was not reported. It was reported that while experiencing flank pain the patient received second dose of SHINGRIX. A day later he was diagnosed with Shingles. he patient had what she described as an atypical rash that does not have blisters, did not itched or burn and he just felt bad. She indicated that she believed her husband was getting shingles prior to receiving the second dose of the medication and does not feel that SHINGRIX was responsible for causing this episode. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Diarrhoea, Dyspnoea, Fatigue, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle spasm in a elderly male 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 muscle spasm, joint pain, fatigue, vomiting, diarrhea, headache, difficulty breathing, cold and muscle contractions involuntary. On an unknown date, the outcome of the muscle spasm, joint pain, fatigue, vomiting, diarrhea, headache, difficulty breathing, cold and muscle contractions involuntary were unknown. It was unknown if the reporter considered the muscle spasm, joint pain, fatigue, vomiting, diarrhea, headache, difficulty breathing, cold and muscle contractions involuntary to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced cold, muscle spasms, muscles contracting, achy joints, fatigue, vomiting, diarrhea, headaches, trouble breathing and muscles and nerves on the right side of his chest spasmed after receiving SHINGRIX vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Muscle contractions involuntary, Muscle spasms, Nasopharyngitis, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle spasm in a elderly male 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 muscle spasm, joint pain, fatigue, vomiting, diarrhea, headache, difficulty breathing, cold and muscle contractions involuntary. On an unknown date, the outcome of the muscle spasm, joint pain, fatigue, vomiting, diarrhea, headache, difficulty breathing, cold and muscle contractions involuntary were unknown. It was unknown if the reporter considered the muscle spasm, joint pain, fatigue, vomiting, diarrhea, headache, difficulty breathing, cold and muscle contractions involuntary to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced cold, muscle spasms, muscles contracting, achy joints, fatigue, vomiting, diarrhea, headaches, trouble breathing and muscles and nerves on the right side of his chest spasmed after receiving SHINGRIX vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Ocular hyperaemia, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a elderly female 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 muscle pain, fatigue, pain in arm, general body pain and eye red. On an unknown date, the outcome of the muscle pain, fatigue, pain in arm, general body pain and eye red were unknown. It was unknown if the reporter considered the muscle pain, fatigue, pain in arm, general body pain and eye red to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced muscle pain, fatigue, red eyes, pain in her arm and body and wiped out feeling after receiving a dose of SHINGRIX. The reporter consented to follow up.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 63-year-old male patient who received SHRINGIX for prophylaxis. On 24th January 2019, the patient received the 2nd dose of SHINGRIX. On 24th January 2019, immediately after receiving SHINGRIX, the patient experienced injection site erythema and injection site itching. On 7th February 2019, the patient experienced rash. On an unknown date, the outcome of the injection site erythema and injection site itching were unknown and the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the injection site erythema, injection site itching and rash to be related to SHINGRIX. Additional details were provided as follows: The reporter was the wife of the patient. The patient experienced injection site reaction consisting of itching and redness which began immediately after the injection. Two weeks later, the patient reported rash which began on the trunk of the body, and spread to arms and head. The rash was becoming worse and spreading. The reporter gave consent to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Skin exfoliation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a 50-year-old female patient who received SHINGRIX for prophylaxis. On 29th August 2018, the patient received SHINGRIX. On 15th September 2018, 17 days after receiving SHINGRIX, the patient experienced rash, skin peeling and pruritus. SHINGRIX was continued with no change. On 29th September 2018, the outcome of the rash, skin peeling and pruritus were recovered/resolved. It was unknown if the reporter considered the rash, skin peeling and pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left deltoid. The patient experienced rash that appeared from neck to feet, the layers of skin peeled and itching after a dose of SHINGRIX. The condition lasted for 2 weeks.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site hypersensitivity, Mobility decreased, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a male patient who received SHINGRIX for prophylaxis. Illness at time of vaccination included nasal stuffiness. On 19th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). In February 2019, less than a week after receiving SHINGRIX, the patient experienced influenza-like symptoms, mobility decreased, pain, tiredness and injection site hypersensitivity. On an unknown date, the outcome of the influenza-like symptoms, mobility decreased, pain and tiredness were recovered/resolved and the outcome of the injection site hypersensitivity was unknown. The reporter considered the influenza-like symptoms, mobility decreased, pain and tiredness to be unrelated to SHINGRIX. The reporter considered the injection site hypersensitivity to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of SHINGRIX on the left arm. The patient experienced flu which was as clarified as flu like symptoms, such as could hardly move, aches and pains and extremely tired. He does not believe the symptoms are related to the vaccine, but states he did not get tested for the flu. He felt better on the day of reporting, and stated the only thing related to the injection itself was a little sensitivity at the site.
Sex: U
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of nausea in an unspecified number of the adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced nausea. On an unknown date, the outcome of the nausea was unknown. It was unknown if the reporter considered the nausea to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per the vaccine indication. The healthcare professional reported that the patients experienced nausea post 1st dose of SHINGRIX. No further information was available.
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Cough, Fatigue, Injection site swelling
Clinical narrative: This is a spontaneous report from a consumer or other non HCP. This report was received via a sales representative. A 18-years-old female patient received TRUMENBA, via an unspecified route of administration on 14Feb2019 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fatigue non-serious on an unspecified date with outcome of unknown, coughing non-serious on an unspecified date with outcome of unknown, swelling at injection site non-serious on an unspecified date with outcome of unknown , joint pain non-serious on an unspecified date with outcome of unknown. The information on the batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a contactable other healthcare professional via a Pfizer sales representative. A female patient of an unspecified age started to receive PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunization. Medical history included respiratory syncytial virus (RSV) infection at around 12 months old. The patient's concomitant medications were not reported. The reporter had a friend that had twin daughters that are 13. One of the twins had RSV at around 12 months old. She had the recommended pneumococcal vaccines as a baby per the Centers for Disease Control recommendations. She had pneumonia yearly at time of the report for several years. The outcome of the event was unknown. Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded. Further information like confirmative pathological/serotype results are needed for full medical assessment.
Sex: U
Vaccine: PNC13
Symptoms: Influenza like illness
Clinical narrative: This is a spontaneous report from a non-contactable physician. This report was received via a sales representative. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced flu like symptoms for 3 days following vaccination on an unspecified date with outcome of unknown. The reported event was considered non serious. No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site rash, Rash
Clinical narrative: Rash around injection site and on abdomen on same side, chills, pain around injection site.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Redness, swelling, warmth and itching. MEDROL DOSE PAK, antibiotics if needed, CLARITIN.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Nausea, Pyrexia
Clinical narrative: Fever, chills, aching joints, nausea.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Nodule, Pain, Pruritus
Clinical narrative: She felt a knot and it kept itching. It was sore in the beginning and there was redness. The itching continued for a while.
Age: 1.67
Sex: F
Vaccine: MMRV
Symptoms: Rash morbilliform
Clinical narrative: Patient has measles type rash which started 1 week post PROQUAD vaccination.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Pain in extremity
Clinical narrative: Immunizations were given at 7:40 AM, at 7:50 AM, she complained of right arm pain. At 11:28 AM she returned to clinic C/O "severe arm pain" "9" on pain scale. Ice packs were applied. Pain Level "6" after ice packs. At 1:18 PM she complained of worse pain "9" again. Client's mother came to clinic and gave client Ibuprofen 600 mg. Client was sent home with her mother. Instructed if pain worsen, swelling, or redness develops, go to ER. Mom verbalized understanding.
Age: 26.0
Sex: F
Vaccine: HEPA, TDAP, HEPA, TDAP
Symptoms: Erythema, Rash, Rash macular
Clinical narrative: Patient recently seen in clinic on 02/15/19 for Hepatitis A & Tdap Vaccine to plan for travel out of country March 26, 2019. Hep A vaccine given to right deltoid, and patient reports symptoms of rash to right side starting on right hip, then appearing at right axilla, right buttock and then to right middle finger started two days after receiving vaccine. Patient telephoned on 02/20/19 to state rash, to which at that time she was encouraged to return to clinic for evaluation, but states she "decided to wait because it wasn't bothering me." Patient then reports rash to left middle finger appeared on 2/25/19. Reports after being seen in clinic on 02/15/19 that she sunbathed and has frequently spent time in sun since, states used tanning 15 SPF oil. On physical exam, all systems within normal limits except for skin listed below: 1. Right lateral hip with macular, nonpainful, nonpruritic light brown erythema extending 7cm x1cm. No drainage, tenderness, edema noted. 2. Right lateral axilla with macular, nonpainful, nonpruritic light brown erythema extending 2cmx1cm. No drainage, tenderness, edema noted. 3. Right buttock with deep brown macular, nonpainful, nonpruritic 1cm x1cm. No drainage, tenderness, edema noted. 4. Right hand 3rd anterior digit with light brown macular, mildly pruritic raised rash 3cmx2cm with scaling present. No drainage, tenderness, edema noted. 5. Left anterior surface of hand at 3rd digit with light brown macular, mildly pruritic raised rash extending across left 3rd digit anteriorly.  No drainage, tenderness, edema noted. Out come:  consulted with Collaborating Physician Dr. Patient in no acute distress. Recommended referral of patient to ER for further evaluation of vaccine related reaction. Referral form given to patient. Patient states she will go to Hospital ER.
Age: 26.0
Sex: F
Vaccine: HEPA, TDAP, HEPA, TDAP
Symptoms: Rash pruritic, Skin discolouration
Clinical narrative: Patient recently seen in clinic on 02/15/19 for Hepatitis A & Tdap Vaccine to plan for travel out of country March 26, 2019. Hep A vaccine given to right deltoid, and patient reports symptoms of rash to right side starting on right hip, then appearing at right axilla, right buttock and then to right middle finger started two days after receiving vaccine. Patient telephoned on 02/20/19 to state rash, to which at that time she was encouraged to return to clinic for evaluation, but states she "decided to wait because it wasn't bothering me." Patient then reports rash to left middle finger appeared on 2/25/19. Reports after being seen in clinic on 02/15/19 that she sunbathed and has frequently spent time in sun since, states used tanning 15 SPF oil. On physical exam, all systems within normal limits except for skin listed below: 1. Right lateral hip with macular, nonpainful, nonpruritic light brown erythema extending 7cm x1cm. No drainage, tenderness, edema noted. 2. Right lateral axilla with macular, nonpainful, nonpruritic light brown erythema extending 2cmx1cm. No drainage, tenderness, edema noted. 3. Right buttock with deep brown macular, nonpainful, nonpruritic 1cm x1cm. No drainage, tenderness, edema noted. 4. Right hand 3rd anterior digit with light brown macular, mildly pruritic raised rash 3cmx2cm with scaling present. No drainage, tenderness, edema noted. 5. Left anterior surface of hand at 3rd digit with light brown macular, mildly pruritic raised rash extending across left 3rd digit anteriorly.  No drainage, tenderness, edema noted. Out come:  consulted with Collaborating Physician Dr. Patient in no acute distress. Recommended referral of patient to ER for further evaluation of vaccine related reaction. Referral form given to patient. Patient states she will go to Hospital ER.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given a double dose of the powder for the SHINGRIX vaccine.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling, pain three day after injection and redness after 1 week.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Seizure
Clinical narrative: Has cluster (#7) of seizures morning after flu shot. One seizure lasted 3 minutes. Has epilepsy, but has never had this many seizures.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Fatigue, Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: Pain, Redness, Swelling, Heat at the injection site. Chills, Body aches, Tiredness, nausea, for 2 days after the injection. Difficulty raising arm up above 90 degrees. Firm knot about the size of a plum, soreness, heat, and redness at the injection site still after 5 days.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth, Mobility decreased, Nausea, Pain
Clinical narrative: Pain, Redness, Swelling, Heat at the injection site. Chills, Body aches, Tiredness, nausea, for 2 days after the injection. Difficulty raising arm up above 90 degrees. Firm knot about the size of a plum, soreness, heat, and redness at the injection site still after 5 days.
Age: 17.0
Sex: F
Vaccine: TYP, YF
Symptoms: Jaundice, Malaise, Pyrexia
Clinical narrative: Day 2- fever and malaise leading to Jaundice on day 5. Patient is still undergoing treatment/support.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Pruritus, Swelling
Clinical narrative: Localized swelling and itching treated with oral antistamines and topical steroid cream.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I received the SHINGRIX (shingles) vaccine in May 2018.  I received the second shot in July 2018. I was diagnosed with Shingles in February 2019.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: Patient had chills and felt ill night of shot. Then had red swollen injection site two days after injection. Doctor sent in prescription for BACTRIM.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Bruising at injection site (less than 1 inch diameter) - pain. Rash below injection site (round - about 3 inches in diameter) - redness, itching, and pain. Itching in the armpit area.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Bruising at injection site (less than 1 inch diameter) - pain. Rash below injection site (round - about 3 inches in diameter) - redness, itching, and pain. Itching in the armpit area.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the first dose of ROTATEQ orally (PO) (strength, dose, frequency, lot# and expiration date not reported) for prophylaxis. On 07-FEB-2019, the patient was vaccinated with the second dose of ROTATEQ PO (strength, dose, frequency not reported) with lot# N013992 and expiration date 27-JAN-2019 (expired vaccine used). No adverse effect reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 19-JAN-2010, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a health care provider for the following injury resulting from her use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2014, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a health care provider for the following injury resulting from her use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 87-year-old female patient who received SHINGRIX for prophylaxis. On 19th February 2019, the patient received the 2nd dose of SHINGRIX. On 19th February 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm. The patient was treated with Ice Pack (No Medication) and TYLENOL. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient had arm achy very much. The patient asking any relief suggestions. The patient did ice for a half and an hour, and took one TYLENOL.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Decreased appetite, Fatigue, Feeling hot, Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of exhaustion in a 67-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included Shingles vaccine (had the other shingles vaccination several years ago with no adverse effects). On 20th February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, less than a day after receiving SHINGRIX, the patient experienced poor quality sleep, joint pain, feeling hot, influenza like illness, appetite absent and activities of daily living impaired. On 20th February 2019, the patient experienced exhaustion. On an unknown date, the outcome of the exhaustion, poor quality sleep, joint pain, feeling hot, influenza like illness, appetite absent and activities of daily living impaired were unknown. It was unknown if the reporter considered the exhaustion, poor quality sleep, joint pain, feeling hot, influenza like illness, appetite absent and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The patient reported that the SHINGRIX injection was pain free and she was not sufficiently warned of the adverse effects. After receiving the first dose, the patient went to gym shortly and suddenly became overwhelmed by exhaustion while on treadmill. She went home, cancelling activities for the rest of the day. The night was horrific and she experienced impaired quality of sleep, flu-like joint pain, sensation of fever without actual fever, no appetite (skipped lunch and dinner). Next morning, she could barely get out of bed and could barely function. She was asking about how long would the adverse events last. She could not imagine subjecting herself to a second shot in 2-6 months.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Poor quality sleep
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of exhaustion in a 67-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included Shingles vaccine (had the other shingles vaccination several years ago with no adverse effects). On 20th February 2019, the patient received the 1st dose of SHINGRIX. In February 2019, less than a day after receiving SHINGRIX, the patient experienced poor quality sleep, joint pain, feeling hot, influenza like illness, appetite absent and activities of daily living impaired. On 20th February 2019, the patient experienced exhaustion. On an unknown date, the outcome of the exhaustion, poor quality sleep, joint pain, feeling hot, influenza like illness, appetite absent and activities of daily living impaired were unknown. It was unknown if the reporter considered the exhaustion, poor quality sleep, joint pain, feeling hot, influenza like illness, appetite absent and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The patient reported that the SHINGRIX injection was pain free and she was not sufficiently warned of the adverse effects. After receiving the first dose, the patient went to gym shortly and suddenly became overwhelmed by exhaustion while on treadmill. She went home, cancelling activities for the rest of the day. The night was horrific and she experienced impaired quality of sleep, flu-like joint pain, sensation of fever without actual fever, no appetite (skipped lunch and dinner). Next morning, she could barely get out of bed and could barely function. She was asking about how long would the adverse events last. She could not imagine subjecting herself to a second shot in 2-6 months.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Disturbance in attention, Fatigue, Impaired work ability
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of joint pain in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (for tolerance of 1st dose refer case US2019GSK037379). On 19th February 2019, the patient received the 2nd dose of SHINGRIX. On 19th February 2019, less than a day after receiving SHINGRIX, the patient experienced joint pain, pain of skin, general body pain, injection site pain and loss of energy. On 21st February 2019, the patient experienced concentration loss and tiredness. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the joint pain, pain of skin, general body pain, injection site pain, concentration loss and tiredness were unknown and the outcome of the loss of energy was not recovered/not resolved. It was unknown if the reporter considered the joint pain, pain of skin, general body pain, injection site pain, loss of energy, concentration loss and tiredness to be related to SHINGRIX. Additional details were provided as follows: The age group was not reported. The patient just received SHINGRIX and experienced pain and tenderness at site of injection, significant loss of energy, significant body pain, joint pain and skin pain. On 3rd day of vaccination, the patient had loss of concentration and progressive weakness and tiredness. The patient was asking a way to reduce the significant side effects and those events were enough to lose time off work. This case has been linked with US2019GSK037379, reported for same patient.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pain of skin, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of joint pain in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (for tolerance of 1st dose refer case US2019GSK037379). On 19th February 2019, the patient received the 2nd dose of SHINGRIX. On 19th February 2019, less than a day after receiving SHINGRIX, the patient experienced joint pain, pain of skin, general body pain, injection site pain and loss of energy. On 21st February 2019, the patient experienced concentration loss and tiredness. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the joint pain, pain of skin, general body pain, injection site pain, concentration loss and tiredness were unknown and the outcome of the loss of energy was not recovered/not resolved. It was unknown if the reporter considered the joint pain, pain of skin, general body pain, injection site pain, loss of energy, concentration loss and tiredness to be related to SHINGRIX. Additional details were provided as follows: The age group was not reported. The patient just received SHINGRIX and experienced pain and tenderness at site of injection, significant loss of energy, significant body pain, joint pain and skin pain. On 3rd day of vaccination, the patient had loss of concentration and progressive weakness and tiredness. The patient was asking a way to reduce the significant side effects and those events were enough to lose time off work. This case has been linked with US2019GSK037379, reported for same patient.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 74-year-old male patient who received SHINGRIX (batch number E3Z7E, expiry date 18th May 2021) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 14th August 2018, for tolerance, refer case: US2019032539). On 18th January 2019, the patient received the 2nd dose of SHINGRIX. On 19th January 2019, 1 days after receiving SHINGRIX, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was not recovered/not resolved. It was unknown if the reporter considered the generalized rash to be related to SHINGRIX. Additional details were provided as follows: A day or two after receiving SHINGRIX, the patient had rash all over his body. The reporter gave consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Loss of personal independence in daily activities, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of joint pain 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, unknown after receiving SHINGRIX, the patient experienced joint pain, general body pain, weakness and activities of daily living impaired. On an unknown date, the outcome of the joint pain, general body pain, weakness and activities of daily living impaired were unknown. It was unknown if the reporter considered the joint pain, general body pain, weakness and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced significant weakness, body pain, joint pain that was significant enough to lose time off work. This case has been linked with US2019GSK032959, reported for same patient.
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Flu Seasonal QIV Dresden for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved. It was unknown if the reporter considered the injection site pain to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. After receiving flu vaccine, the patient experienced usual reactions included hurting at the injection site for a couple of days and then it would have resolved. This case has been linked with US2019032498, reported for same patient.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site pain, Injection site pruritus, Injection site rash, Injection site vesicles
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (about 15 years ago when she was forty). Previously administered products included Flu vaccine (for tolerance of 1st dose refer case US2019GSK037431). On 9th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 9th January 2019, several hours after receiving SHINGRIX, the patient experienced injection site pain and muscle tightness. In January 2019, the patient experienced injection site rash, injection site blisters, injection site itching and injection site discoloration. The patient was treated with Alcohol. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, muscle tightness, injection site rash, injection site blisters and injection site itching were recovered/resolved and the outcome of the injection site discoloration was unknown. It was unknown if the reporter considered the injection site pain, muscle tightness, injection site rash, injection site blisters, injection site itching and injection site discoloration to be related to SHINGRIX. Additional details were provided as follows: The patient received dose of SHINGRIX late morning and by early evening she was experiencing pain, soreness and tight muscles around the injection site. About 1.5 to 2 weeks later, she broke out in a rash on her left arm around the injection site. The rash was itchy. The area was darker initially in color and slightly itched and then the rash presented itself. The patient applied alcohol to the area to dry it up and it was finally drying up. After applying alcohol, the area turned bright red but dried up. The reporter gave consent to follow up. This case has been linked with US2019GSK037431, reported for same patient.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle tightness, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (about 15 years ago when she was forty). Previously administered products included Flu vaccine (for tolerance of 1st dose refer case US2019GSK037431). On 9th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 9th January 2019, several hours after receiving SHINGRIX, the patient experienced injection site pain and muscle tightness. In January 2019, the patient experienced injection site rash, injection site blisters, injection site itching and injection site discoloration. The patient was treated with Alcohol. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, muscle tightness, injection site rash, injection site blisters and injection site itching were recovered/resolved and the outcome of the injection site discoloration was unknown. It was unknown if the reporter considered the injection site pain, muscle tightness, injection site rash, injection site blisters, injection site itching and injection site discoloration to be related to SHINGRIX. Additional details were provided as follows: The patient received dose of SHINGRIX late morning and by early evening she was experiencing pain, soreness and tight muscles around the injection site. About 1.5 to 2 weeks later, she broke out in a rash on her left arm around the injection site. The rash was itchy. The area was darker initially in color and slightly itched and then the rash presented itself. The patient applied alcohol to the area to dry it up and it was finally drying up. After applying alcohol, the area turned bright red but dried up. The reporter gave consent to follow up. This case has been linked with US2019GSK037431, reported for same patient.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of patchy rash in a 74-year-old male patient who received SHINGRIX for prophylaxis. On 14th August 2018, the patient received the 1st dose of SHINGRIX. On 16th August 2018, 2 days after receiving SHINGRIX, the patient experienced patchy rash. On an unknown date, the outcome of the patchy rash was recovered/resolved. It was unknown if the reporter considered the patchy rash to be related to SHINGRIX. Additional details were provided as follows: The patient experienced patchy rash primarily on the left arm. The rash appeared about 2 to 3 days after the injection and resolved after 2 weeks. The lot number and expiry date of 1st dose was not known at the time of reporting. The reporter gave consent to follow up. For tolerance after 2nd dose of SHINGRIX, refer case US2019GSK037247.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Muscular weakness, Neuropathy peripheral, Sensitive skin
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of peripheral neuropathy in a 68-year-old female patient who received SHINGRIX for prophylaxis. On 1st December 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced peripheral neuropathy (serious criteria GSK medically significant), weakness of arms, strength loss of and sensitive skin. The patient was treated with gabapentin, naproxen and corticosteroid nos (Corticosteroids Nos). On an unknown date, the outcome of the peripheral neuropathy, weakness of arms, strength loss of and sensitive skin were not recovered/not resolved. It was unknown if the reporter considered the peripheral neuropathy, weakness of arms, strength loss of and sensitive skin to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After vaccination, the patient experienced neuropathy, weakness, loss of strength, and sensitivity to touch in the anterior part of the left forearm. The patient was given a course of corticosteroids, naproxen and gabapentin to help alleviate the symptoms but with no relief at the time of reporting.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Chills, Dizziness, Fatigue, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 13th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 13th February 2019, several hours after receiving SHINGRIX, the patient experienced pain in arm and welts. On 14th February 2019, the patient experienced chills, nausea, dizziness, palpitation and blood pressure decreased. In February 2019, the patient experienced localized itching and fatigue. On an unknown date, the outcome of the pain in arm, welts, chills, nausea, dizziness, fatigue, palpitation and blood pressure decreased were recovered/resolved and the outcome of the localized itching was not recovered/not resolved. It was unknown if the reporter considered the pain in arm, welts, localized itching, chills, nausea, dizziness, fatigue, palpitation and blood pressure decreased to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the left arm. The patient experienced soreness in her left arm and a welt the size of her palm on her left arm. In the next morning, 1 day after vaccination, the patient experienced chills, nausea, dizziness, heart palpitations and a decrease in blood pressure. These symptoms lasted for approximately 12 hours. Less than a week after vaccination, the patient experienced fatigue that lasted approximately 4 days. The patient stated that the soreness and the welt was gone, but now, less than a month after vaccination, the area on her arm was itchy. The reporter consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Palpitations, Pruritus, Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 13th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 13th February 2019, several hours after receiving SHINGRIX, the patient experienced pain in arm and welts. On 14th February 2019, the patient experienced chills, nausea, dizziness, palpitation and blood pressure decreased. In February 2019, the patient experienced localized itching and fatigue. On an unknown date, the outcome of the pain in arm, welts, chills, nausea, dizziness, fatigue, palpitation and blood pressure decreased were recovered/resolved and the outcome of the localized itching was not recovered/not resolved. It was unknown if the reporter considered the pain in arm, welts, localized itching, chills, nausea, dizziness, fatigue, palpitation and blood pressure decreased to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the left arm. The patient experienced soreness in her left arm and a welt the size of her palm on her left arm. In the next morning, 1 day after vaccination, the patient experienced chills, nausea, dizziness, heart palpitations and a decrease in blood pressure. These symptoms lasted for approximately 12 hours. Less than a week after vaccination, the patient experienced fatigue that lasted approximately 4 days. The patient stated that the soreness and the welt was gone, but now, less than a month after vaccination, the area on her arm was itchy. The reporter consented to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Incorrect route of product administration, Pain, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 57-year-old female patient who received SHINGRIX (batch number K2ZY4, expiry date unknown) for prophylaxis. On 26th December 2018, the patient received SHINGRIX (subcutaneous). On 26th December 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced localized erythema and pain in arm. On an unknown date, the outcome of the intramuscular formulation administered by other route, localized erythema and pain in arm were unknown. It was unknown if the reporter considered the localized erythema and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that the patient informed her that the fill-in pharmacist who administered the dose of SHINGRIX to the patient used a subcutaneous syringe to give the vaccine in arm, which led to wrong route of vaccine administration. The pharmacist noted that it could have occurred because they have a box of subcutaneous syringes labeled Shingles, intended for use with ZOSTAVAX. Less than a year, after receiving SHINGRIX, the patient experienced big red place on arm and hurt when she moved her arm. The pharmacist intended to attempt to follow up with the fill-in pharmacist for further discussion.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Diarrhoea, Fatigue, Pain
Clinical narrative: For 6 days, I was extremely fatigued.....had diarrhea on two of those days.....chills, achy, no appetite and lost 5 pounds.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Malaise, Nausea, Vomiting
Clinical narrative: Patient said she experienced nausea, vomiting, and diarrhea shortly after the vaccination. She said that the diarrhea lasted 3 to 4 days and that overall for about 10 days she did not feel well. She said she is feeling better now and that she did not seek any treatment for her adverse reactions and that it cleared up on its own.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Nausea
Clinical narrative: Headache, Nausea, Muscle pain / aches, chills.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt. reports redness and heat at the site of injection.
Age: 78.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Pt. reports redness and heat at the site of injection.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Computerised tomogram normal, Dysarthria, Memory impairment
Clinical narrative: On 2/19 patient started slurring words so they called 911. Patient taken to ER Hospital and was admitted for 4 days. The CAT scan was normal and did not show a stroke. Patient did not receive a diagnosis although sent home with TIA instructions. Patient does not remember anything from Tuesday through Thursday night. Patient was prescribed Plavix at hospital in case it was a stroke. Patient also taking Aspirin but not Benicar. This week patient was too weak to go to the doctor but has appt for next week. Mental has come back but physical is weak.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Fever, severe body aching, extreme tiredness.
Age: 1.25
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Apnoea, Respiratory arrest, Sleep study abnormal, X-ray normal
Clinical narrative: Starting on 9/1/18, 2 days after injections, I woke up to find patient not breathing. I had to shake her a few times for her to take a breath. This happened a few times that night and again several times in various different nights. The episodes lessened as time went on. It has been 6 months and she hasn't had anymore episodes.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Red, hot swollen right arm from inside of elbow up to mid-section of upper arm. They visited the urgent care next door as it was difficult/painful for her to put her arm in the sleeve of her coat. They gave her a steroid and antibiotic. I called patient today (3/1/19) and she is doing better. The swelling has gone down some.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Chills, muscle aches, fever, head ache.