chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Hot flush, Impaired work ability, Nausea, Pain
Clinical narrative: feelings of severe Nausea; Abdominal Cramping; Heat Flashes; Chills; dry heaves; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema and Shingrix with an associated reaction of injection site pain (1st dose received approximately two months ago, refer case US2020AMR213725).   On 19th October 2020, the patient received the 2nd dose of Shingrix (intramuscular). In October 2020, less than a day after receiving Shingrix, the patient experienced nausea, abdominal cramp, hot flashes, chills and dry heaves. On 21st October 2020, the outcome of the nausea, abdominal cramp, hot flashes, chills and dry heaves were recovered/resolved.   It was unknown if the reporter considered the nausea, abdominal cramp, hot flashes, chills and dry heaves to be related to Shingrix. Additional details were provided as follows: The patient received his second dose of Shingrix in his left arm. By 2:00 am of 20th October 2020, the patient woke up to the feelings of severe nausea and abdominal cramping. He had dry heaves, but did not vomit. The patient also had chills and heat flashes, but no fever. The symptoms lasted through 21st October 2020. The reporter consented to follow up. The reporter had filed complaint with FDA.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR213725:same reporter, 2nd dose
Age: 55.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Retching
Clinical narrative: feelings of severe Nausea; Abdominal Cramping; Heat Flashes; Chills; dry heaves; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema and Shingrix with an associated reaction of injection site pain (1st dose received approximately two months ago, refer case US2020AMR213725).   On 19th October 2020, the patient received the 2nd dose of Shingrix (intramuscular). In October 2020, less than a day after receiving Shingrix, the patient experienced nausea, abdominal cramp, hot flashes, chills and dry heaves. On 21st October 2020, the outcome of the nausea, abdominal cramp, hot flashes, chills and dry heaves were recovered/resolved.   It was unknown if the reporter considered the nausea, abdominal cramp, hot flashes, chills and dry heaves to be related to Shingrix. Additional details were provided as follows: The patient received his second dose of Shingrix in his left arm. By 2:00 am of 20th October 2020, the patient woke up to the feelings of severe nausea and abdominal cramping. He had dry heaves, but did not vomit. The patient also had chills and heat flashes, but no fever. The symptoms lasted through 21st October 2020. The reporter consented to follow up. The reporter had filed complaint with FDA.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR213725:same reporter, 2nd dose
Age: 55.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain, Chills, Hot flush, Nausea, Retching
Clinical narrative: feelings of severe Nausea; Abdominal Cramping; Heat Flashes; Chills; dry heaves; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site erythema and Shingrix with an associated reaction of injection site pain (1st dose received approximately two months ago, refer case US2020AMR213725).   On 19th October 2020, the patient received the 2nd dose of Shingrix (intramuscular). In October 2020, less than a day after receiving Shingrix, the patient experienced nausea, abdominal cramp, hot flashes, chills and dry heaves. On 21st October 2020, the outcome of the nausea, abdominal cramp, hot flashes, chills and dry heaves were recovered/resolved.   It was unknown if the reporter considered the nausea, abdominal cramp, hot flashes, chills and dry heaves to be related to Shingrix. Additional details were provided as follows: The patient received his second dose of Shingrix in his left arm. By 2:00 am of 20th October 2020, the patient woke up to the feelings of severe nausea and abdominal cramping. He had dry heaves, but did not vomit. The patient also had chills and heat flashes, but no fever. The symptoms lasted through 21st October 2020. The reporter consented to follow up. The reporter had filed complaint with FDA.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR213725:same reporter, 2nd dose
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Fever; Chills / Shivering; Headache; This case was reported by a consumer via call center representative and described the occurrence of fever in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th August 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 10th August 2020, less than a day after receiving Shingrix, the patient experienced fever, shivering and headache. On 11th August 2020, the outcome of the fever, shivering and headache were recovered/resolved.   It was unknown if the reporter considered the fever, shivering and headache to be related to Shingrix.  Additional details were provided as follows: After received Shingrix in an unknown arm, the same night, the patient experienced fever, chills, shivering and headache.   The patient stated these symptoms lasted for 1 night and then went away.   The patient had questions about the 2nd dose and if it was better to get it at 2 months or 6 months.   She also wanted to know if the 2nd dose would produce the same/worse side effects.   No healthcare professional information was provided.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Fever; Chills / Shivering; Headache; This case was reported by a consumer via call center representative and described the occurrence of fever in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th August 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 10th August 2020, less than a day after receiving Shingrix, the patient experienced fever, shivering and headache. On 11th August 2020, the outcome of the fever, shivering and headache were recovered/resolved.   It was unknown if the reporter considered the fever, shivering and headache to be related to Shingrix.  Additional details were provided as follows: After received Shingrix in an unknown arm, the same night, the patient experienced fever, chills, shivering and headache.   The patient stated these symptoms lasted for 1 night and then went away.   The patient had questions about the 2nd dose and if it was better to get it at 2 months or 6 months.   She also wanted to know if the 2nd dose would produce the same/worse side effects.   No healthcare professional information was provided.
Age: 58.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Dizziness, Erythema, Muscle spasms, Nausea
Clinical narrative: Within 20 seconds of getting the shot I felt hot all over, dizziness, nausea, back pain and stiffness and then weakness and itchy.
Age: 58.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Asthenia, Back pain, Dizziness, Feeling hot, Immediate post-injection reaction
Clinical narrative: Within 20 seconds of getting the shot I felt hot all over, dizziness, nausea, back pain and stiffness and then weakness and itchy.
Age: 58.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Musculoskeletal stiffness, Nausea, Pruritus
Clinical narrative: Within 20 seconds of getting the shot I felt hot all over, dizziness, nausea, back pain and stiffness and then weakness and itchy.
Age: 67.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Blood test, Computerised tomogram head, Electrocardiogram, Full blood count, Hypoaesthesia
Clinical narrative: hemisensory numbness / on the right side of the body from the face till the knee; hemisensory numbness / on the right side of the body from the face till the knee; Hives / had 4 localized hives on right side of neck and shoulder; Hemi sensory symptoms / tingling; This case was reported by a physician via call center representative and described the occurrence of numbness in a 67-year-old female patient who received Rabies NVS (RabAvert) for prophylaxis.   The patient's past medical history included nephrectomy (partial nephrectomy for non aggressive kidney cancer years back). Concurrent medical conditions included renal cancer. Concomitant products included Rabies NVS (RabAvert) and Rabies NVS (RabAvert).   On 16th October 2020, the patient received the 3rd dose of RabAvert. On 16th October 2020, less than an hour after receiving RabAvert, the patient experienced hives. On 17th October 2020, the patient experienced numbness, neurological disorder nos and tingling. On an unknown date, the outcome of the numbness, neurological disorder nos, hives and tingling were recovered/resolved.   The reporter considered the numbness, neurological disorder nos, hives and tingling to be possibly related to RabAvert.  Additional details were provided as follows: The age at vaccination was not reported. HCP reported that a patient had Rabavert vaccine series for post exposure.  The patient received the 1st dose on 09th October 2020.  The 2nd dose was on 12th October 2020.  After the 3rd dose, the patient experienced within 20 minutes of getting the vaccine, hives on the right side of the neck, spreading down to the chest.  The morning of the 17th October 2020, the patient awoke with hemi sensory symptoms including numbness and tingling that started in the neck and up to the face and back, arm, down the leg, knee and out to the hand.  All of these side effects occurred on the right side of the body.  The vaccine was administered in the left deltoid.  The side effects lasted for 90 minutes and resolved.  The patient went to the ER and she had a CT and MRI and the findings were negative.  There was no sign of stroke or vascular abnormality.  Patient was scheduled for the 4th dose on the 23rd October and she doesn't want to go back and get it.  The patient has no hypertension or diabetes and was on no medications.  The patient had a partial nephrectomy for non-aggressive kidney cancer years back.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020208392:FU1 deleted
Age: 67.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Magnetic resonance imaging, Magnetic resonance imaging brain, Urticaria
Clinical narrative: hemisensory numbness / on the right side of the body from the face till the knee; hemisensory numbness / on the right side of the body from the face till the knee; Hives / had 4 localized hives on right side of neck and shoulder; Hemi sensory symptoms / tingling; This case was reported by a physician via call center representative and described the occurrence of numbness in a 67-year-old female patient who received Rabies NVS (RabAvert) for prophylaxis.   The patient's past medical history included nephrectomy (partial nephrectomy for non aggressive kidney cancer years back). Concurrent medical conditions included renal cancer. Concomitant products included Rabies NVS (RabAvert) and Rabies NVS (RabAvert).   On 16th October 2020, the patient received the 3rd dose of RabAvert. On 16th October 2020, less than an hour after receiving RabAvert, the patient experienced hives. On 17th October 2020, the patient experienced numbness, neurological disorder nos and tingling. On an unknown date, the outcome of the numbness, neurological disorder nos, hives and tingling were recovered/resolved.   The reporter considered the numbness, neurological disorder nos, hives and tingling to be possibly related to RabAvert.  Additional details were provided as follows: The age at vaccination was not reported. HCP reported that a patient had Rabavert vaccine series for post exposure.  The patient received the 1st dose on 09th October 2020.  The 2nd dose was on 12th October 2020.  After the 3rd dose, the patient experienced within 20 minutes of getting the vaccine, hives on the right side of the neck, spreading down to the chest.  The morning of the 17th October 2020, the patient awoke with hemi sensory symptoms including numbness and tingling that started in the neck and up to the face and back, arm, down the leg, knee and out to the hand.  All of these side effects occurred on the right side of the body.  The vaccine was administered in the left deltoid.  The side effects lasted for 90 minutes and resolved.  The patient went to the ER and she had a CT and MRI and the findings were negative.  There was no sign of stroke or vascular abnormality.  Patient was scheduled for the 4th dose on the 23rd October and she doesn't want to go back and get it.  The patient has no hypertension or diabetes and was on no medications.  The patient had a partial nephrectomy for non-aggressive kidney cancer years back.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020208392:FU1 deleted
Age: 67.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Computerised tomogram normal, Hypoaesthesia, Magnetic resonance imaging normal, Nervous system disorder, Paraesthesia
Clinical narrative: hemisensory numbness / on the right side of the body from the face till the knee; hemisensory numbness / on the right side of the body from the face till the knee; Hives / had 4 localized hives on right side of neck and shoulder; Hemi sensory symptoms / tingling; This case was reported by a physician via call center representative and described the occurrence of numbness in a 67-year-old female patient who received Rabies NVS (RabAvert) for prophylaxis.   The patient's past medical history included nephrectomy (partial nephrectomy for non aggressive kidney cancer years back). Concurrent medical conditions included renal cancer. Concomitant products included Rabies NVS (RabAvert) and Rabies NVS (RabAvert).   On 16th October 2020, the patient received the 3rd dose of RabAvert. On 16th October 2020, less than an hour after receiving RabAvert, the patient experienced hives. On 17th October 2020, the patient experienced numbness, neurological disorder nos and tingling. On an unknown date, the outcome of the numbness, neurological disorder nos, hives and tingling were recovered/resolved.   The reporter considered the numbness, neurological disorder nos, hives and tingling to be possibly related to RabAvert.  Additional details were provided as follows: The age at vaccination was not reported. HCP reported that a patient had Rabavert vaccine series for post exposure.  The patient received the 1st dose on 09th October 2020.  The 2nd dose was on 12th October 2020.  After the 3rd dose, the patient experienced within 20 minutes of getting the vaccine, hives on the right side of the neck, spreading down to the chest.  The morning of the 17th October 2020, the patient awoke with hemi sensory symptoms including numbness and tingling that started in the neck and up to the face and back, arm, down the leg, knee and out to the hand.  All of these side effects occurred on the right side of the body.  The vaccine was administered in the left deltoid.  The side effects lasted for 90 minutes and resolved.  The patient went to the ER and she had a CT and MRI and the findings were negative.  There was no sign of stroke or vascular abnormality.  Patient was scheduled for the 4th dose on the 23rd October and she doesn't want to go back and get it.  The patient has no hypertension or diabetes and was on no medications.  The patient had a partial nephrectomy for non-aggressive kidney cancer years back.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020208392:FU1 deleted
Age: 67.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Urticaria
Clinical narrative: hemisensory numbness / on the right side of the body from the face till the knee; hemisensory numbness / on the right side of the body from the face till the knee; Hives / had 4 localized hives on right side of neck and shoulder; Hemi sensory symptoms / tingling; This case was reported by a physician via call center representative and described the occurrence of numbness in a 67-year-old female patient who received Rabies NVS (RabAvert) for prophylaxis.   The patient's past medical history included nephrectomy (partial nephrectomy for non aggressive kidney cancer years back). Concurrent medical conditions included renal cancer. Concomitant products included Rabies NVS (RabAvert) and Rabies NVS (RabAvert).   On 16th October 2020, the patient received the 3rd dose of RabAvert. On 16th October 2020, less than an hour after receiving RabAvert, the patient experienced hives. On 17th October 2020, the patient experienced numbness, neurological disorder nos and tingling. On an unknown date, the outcome of the numbness, neurological disorder nos, hives and tingling were recovered/resolved.   The reporter considered the numbness, neurological disorder nos, hives and tingling to be possibly related to RabAvert.  Additional details were provided as follows: The age at vaccination was not reported. HCP reported that a patient had Rabavert vaccine series for post exposure.  The patient received the 1st dose on 09th October 2020.  The 2nd dose was on 12th October 2020.  After the 3rd dose, the patient experienced within 20 minutes of getting the vaccine, hives on the right side of the neck, spreading down to the chest.  The morning of the 17th October 2020, the patient awoke with hemi sensory symptoms including numbness and tingling that started in the neck and up to the face and back, arm, down the leg, knee and out to the hand.  All of these side effects occurred on the right side of the body.  The vaccine was administered in the left deltoid.  The side effects lasted for 90 minutes and resolved.  The patient went to the ER and she had a CT and MRI and the findings were negative.  There was no sign of stroke or vascular abnormality.  Patient was scheduled for the 4th dose on the 23rd October and she doesn't want to go back and get it.  The patient has no hypertension or diabetes and was on no medications.  The patient had a partial nephrectomy for non-aggressive kidney cancer years back.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020208392:FU1 deleted
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Myalgia
Clinical narrative: Chills, headache, sore muscles, stomach upset.  Duration of about 24 hours
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Dental paraesthesia, Dry mouth, Dysphagia, Dyspnoea, Flushing
Clinical narrative: Within a minute of getting this vaccine, my teeth then gums started to tingle then go numb.  Face felt flush.  Within 3 minutes my mouth got extremely dry, like cotton.  It became very hard to swallow.  It felt like a ping pong ball was in my throat as I drove home.  Breathing became difficult.   Difficulty swelling lasted about 60-90 min.  Within about an hour it started to subside.  I sipped water, did not think I could make it to the local ER.  After two hours, it seemed the event was over.  Then around 5pm that evening, I had similar symptoms again, but less severe, which lasted about 20 minutes.  Very scary.  My arm at injection site  is also very sore,.  I had body aches similar to flu that same evening which continued to the following day. Still  taking place.  I was warned that could be a side effect of the vaccination.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia oral, Influenza like illness, Injection site pain, Paraesthesia oral, Sensation of foreign body
Clinical narrative: Within a minute of getting this vaccine, my teeth then gums started to tingle then go numb.  Face felt flush.  Within 3 minutes my mouth got extremely dry, like cotton.  It became very hard to swallow.  It felt like a ping pong ball was in my throat as I drove home.  Breathing became difficult.   Difficulty swelling lasted about 60-90 min.  Within about an hour it started to subside.  I sipped water, did not think I could make it to the local ER.  After two hours, it seemed the event was over.  Then around 5pm that evening, I had similar symptoms again, but less severe, which lasted about 20 minutes.  Very scary.  My arm at injection site  is also very sore,.  I had body aches similar to flu that same evening which continued to the following day. Still  taking place.  I was warned that could be a side effect of the vaccination.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain
Clinical narrative: Pt has complained of muscle pain at site of injection for 28days. Pt had no ecchymosis,swelling nor induration ever appreciated.  Pain with raising left arm. Patient has long  ddd in neck for 1-2yrs and new  rotator cuff tendinitis in left shoulder on exam and states those were not bothering her until day of injection. Pt referred to physical therapy to help with pain. No evidence of paresthesias,weakness of left arm.
Sex: M
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Caller is the Physician. Caller stated that on 9/16/2020, the patient was administered improperly stored VARIVAX; This spontaneous report was received from a physician, referring to a male patient of unknown age. The patient's pertinent medical history, current conditions, previous drug reactions or allergies were not reported.   On 16-SEP-2020 the patient was administered improperly stored of varicella virus vaccine live (oka/merck) (VARIVAX), injection, as prophylaxis (strength, dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number T012548, which has been verified to be valid, expiration date reported and validated as 10-APR-2022); as concomitant therapy, a properly stored of sterile diluent (MERCK STERILE DILUENT) was used to reconstituted the vaccine (medication dilution). The vaccine administered, experienced multiple temperature excursions from -9 degrees Celsius (C) to 8C (6.75C), for a time frame of 6 hours, as recorded by a data logger. There was no previous temperature excursion reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE.; Customer reporting improperly stored vaccine administration of PROQUAD.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies were not reported.   On 20-OCT-2020, the patient was vaccinated with an improperly stored of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), 1 dose, as prophylaxis (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number T015600, which has been verified to be valid, expiration date reported and validated as 02-NOV-2021). The vaccine administered experienced a temperature excursion of 10 degrees Fahrenheit, for a time frame of 2 hours, as recorded by a data logger. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA010221: US-009507513-2010USA010255: US-009507513-2010USA009997:
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Expired ROTATEQ was administered to 2 month old baby; This spontaneous report was received from medical assistant, concerning a 2 months old female patient. No information was provided regarding the patient's pertinent medical history, concomitant medications and previous drug reactions or allergies.  On 26-OCT-2020, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), administered orally (lot number S001101 which was verified to be a valid lot number, expiration date reported and upon internal validation established as 21-OCT-2020) (expired product administered) for prophylaxis (strength, dose and vaccination scheme were not reported). No additional adverse events were reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Caller is a nurse reporting a temperature excursion, requesting stability data (Temp. Excursion 01765539).; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 19-OCT-2020, the patient received 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), as prophylaxis (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number T009929, which has been verified to be valid, expiration date reported and validated as 16-SEP-2021). The vaccine administered experienced a temperature excursion of -6.6 degrees Celsius, for a time frame of 1 hour and 45 minutes, as recorded by a data logger. There was no previous temperature excursion reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA010518: US-009507513-2010USA010508: US-009507513-2010USA010598: US-009507513-2010USA010384: US-009507513-2010USA010735: US-009507513-2010USA010577: US-009507513-2010USA010526: US-009507513-2010USA010709:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: patient received an improperly stored vaccine; This spontaneous report was received from a Registered Nurse and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) Subcutaneous Injection lot # T009929, expiration date 16-SEP-2021,  1 dosage form for prophylaxis (patient route of administration was not provided).  The improperly stored dose of the suspect vaccine experienced a temperature excursion of -6.6 degree Celsius (°C) for 1 hour and 45 minutes on 20-OCT-2020; no previous temperature excursion were reported.  The call was made due to a digital data logger. No adverse symptoms were reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2010USA010299: US-009507513-2010USA010508: US-009507513-2010USA010577: US-009507513-2010USA010709: US-009507513-2010USA010735:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Temperature excursion; This spontaneous report as received from a registered nurse and refers to a patient of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported.  On 20-OCT-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (Route, anatomical location were not provided, lot # S038700 expiration date 01-DEC-2021) for prophylaxis.        The vaccine had temperature excursion of -6.6 °C during 1 hour 45 min. There were not previous excursions. Digital data logger was involved.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: a temperature excursion, requesting stability data; This spontaneous report as received from a registered nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, drug reactions/allergies and concomitant therapies was not provided.    On 21-OCT-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (1 dose, lot # S038700, expiration date 01-DEC-2021; strength and route of administration were not reported) for prophylaxis (product storage error). Current temperature excursion was -6.6 Celsius degrees for 1 hour and 45 minutes. There was no previous temperature excursion. No product quality complaint (PQC) was reported. Data logger was involved.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Feeling cold, Headache, Neck pain
Clinical narrative: Fever 101.5; arm pain; neck / pain; should pain; tiredness; cold; headache; This case was reported by a consumer via call center representative and described the occurrence of fever in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date, no reaction).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced fever, pain in arm, neck pain, shoulder pain, tiredness, cold and headache. On an unknown date, the outcome of the fever, pain in arm, neck pain, shoulder pain, tiredness, cold and headache were recovered/resolved.   It was unknown if the reporter considered the fever, pain in arm, neck pain, shoulder pain, tiredness, cold and headache to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Patient received 2nd dose of Shingrix and within 10 hours, experienced awful reaction included fever 101.5, arm pain, neck pain, shoulder pain, tiredness, cold and headache and all their events got resolved within 24 hours. Patient wondered why there was a reaction to the 2nd dose and not to 1st dose of Shingrix. The reporter did not consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever 101.5; arm pain; neck / pain; should pain; tiredness; cold; headache; This case was reported by a consumer via call center representative and described the occurrence of fever in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date, no reaction).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced fever, pain in arm, neck pain, shoulder pain, tiredness, cold and headache. On an unknown date, the outcome of the fever, pain in arm, neck pain, shoulder pain, tiredness, cold and headache were recovered/resolved.   It was unknown if the reporter considered the fever, pain in arm, neck pain, shoulder pain, tiredness, cold and headache to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Patient received 2nd dose of Shingrix and within 10 hours, experienced awful reaction included fever 101.5, arm pain, neck pain, shoulder pain, tiredness, cold and headache and all their events got resolved within 24 hours. Patient wondered why there was a reaction to the 2nd dose and not to 1st dose of Shingrix. The reporter did not consented to follow up.
Age: 65.0
Sex: U
Vaccine: FLUX
Symptoms: Arthralgia, Cough, Fatigue, Headache, Hypersomnia
Clinical narrative: cough; sore throat; headache; stuffy nose; joint aches; stomach felt queasy; fever of 100.6 had to go to bed; tired; Slept until 11am; This case was reported by a consumer via interactive digital media and described the occurrence of cough in a 65-year-old patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   The patient's past medical history included influenza (had few times before vaccination). Previously administered products included Flu vaccine (received on an unknown date last year).   On 16th October 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. In October 2020, less than a week after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced sleep excessive and tiredness. On 16th October 2020, the patient experienced cough, sore throat, headache, nasal stuffiness, joint pain, feeling queasy and fever. On an unknown date, the outcome of the cough, sore throat, headache, nasal stuffiness, joint pain, feeling queasy, fever, sleep excessive and tiredness were unknown.   It was unknown if the reporter considered the cough, sore throat, headache, nasal stuffiness, joint pain, feeling queasy, fever, sleep excessive and tiredness to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were reported as follows: Patient had the flu a few times in life and until last year, never had a flu vaccine.  The patient had 1st flu vaccine last year and did not even got the sniffles. The patient received the Influenza vaccine Quadrivalent and 2 hours later, the patient had cough, sore throat, headache, stuffy nose, joint aches, stomach felt queasy, a fever of 100.6 had to go to bed. The patient was scared that I caught the rona (unspecified). Slept until 11 and was tired and that afternoon patient was mowing the lawn and trimming the hedges. Patient stated that on Sunday had clearing the trail to deer stand getting ready for this weekend's opener, who knows, next Saturday I might fall out of it and break my neck.
Age: 65.0
Sex: U
Vaccine: FLUX
Symptoms: Nasal congestion, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: cough; sore throat; headache; stuffy nose; joint aches; stomach felt queasy; fever of 100.6 had to go to bed; tired; Slept until 11am; This case was reported by a consumer via interactive digital media and described the occurrence of cough in a 65-year-old patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   The patient's past medical history included influenza (had few times before vaccination). Previously administered products included Flu vaccine (received on an unknown date last year).   On 16th October 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. In October 2020, less than a week after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced sleep excessive and tiredness. On 16th October 2020, the patient experienced cough, sore throat, headache, nasal stuffiness, joint pain, feeling queasy and fever. On an unknown date, the outcome of the cough, sore throat, headache, nasal stuffiness, joint pain, feeling queasy, fever, sleep excessive and tiredness were unknown.   It was unknown if the reporter considered the cough, sore throat, headache, nasal stuffiness, joint pain, feeling queasy, fever, sleep excessive and tiredness to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were reported as follows: Patient had the flu a few times in life and until last year, never had a flu vaccine.  The patient had 1st flu vaccine last year and did not even got the sniffles. The patient received the Influenza vaccine Quadrivalent and 2 hours later, the patient had cough, sore throat, headache, stuffy nose, joint aches, stomach felt queasy, a fever of 100.6 had to go to bed. The patient was scared that I caught the rona (unspecified). Slept until 11 and was tired and that afternoon patient was mowing the lawn and trimming the hedges. Patient stated that on Sunday had clearing the trail to deer stand getting ready for this weekend's opener, who knows, next Saturday I might fall out of it and break my neck.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event, Feeling abnormal
Clinical narrative: pretty Miserable; side effect; This case was reported by a consumer via interactive digital media and described the occurrence of feeling miserable in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced feeling miserable and adverse event. On an unknown date, the outcome of the feeling miserable and adverse event were unknown.   It was unknown if the reporter considered the feeling miserable and adverse event to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had all side effects pretty miserable. The reporter asked would experience the same effects on the booster.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling hot, Pain, Rash, Rash erythematous, Rash pruritic
Clinical narrative: normal pain; rash developed that extended to my elbow; was tender; rash developed that extended to my elbow and was itchy / itchiness; rash developed that extended to my elbow and was warm / warmness; redness of the rash is slowly fading; This case was reported by a consumer via call center representative and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th October 2020, the patient received Shingrix. In October 2020, less than a week after receiving Shingrix, the patient experienced pain, rash, tenderness, itchy rash, feeling of warmth and red rash. On an unknown date, the outcome of the pain and tenderness were unknown and the outcome of the rash, itchy rash and feeling of warmth were not recovered/not resolved and the outcome of the red rash was recovering/resolving.   It was unknown if the reporter considered the pain, rash, tenderness, itchy rash, feeling of warmth and red rash to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient had a normal medical history and had not reacted to vaccines previously. After receiving Shingrix, the patient experienced the normal pain, but a rash developed that extended to the elbow and was tender, warm, and itchy. The rash and warmness were still there on the day of reporting. The redness of the rash was slowly fading, as is the warmness and itchiness. The patient feels fine, otherwise. The reporter asked had this type of reaction been reported previously and was it normal or, should the patient be concerned.
Sex: U
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: normal pain; rash developed that extended to my elbow; was tender; rash developed that extended to my elbow and was itchy / itchiness; rash developed that extended to my elbow and was warm / warmness; redness of the rash is slowly fading; This case was reported by a consumer via call center representative and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th October 2020, the patient received Shingrix. In October 2020, less than a week after receiving Shingrix, the patient experienced pain, rash, tenderness, itchy rash, feeling of warmth and red rash. On an unknown date, the outcome of the pain and tenderness were unknown and the outcome of the rash, itchy rash and feeling of warmth were not recovered/not resolved and the outcome of the red rash was recovering/resolving.   It was unknown if the reporter considered the pain, rash, tenderness, itchy rash, feeling of warmth and red rash to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient. The age at vaccination was not reported. The patient had a normal medical history and had not reacted to vaccines previously. After receiving Shingrix, the patient experienced the normal pain, but a rash developed that extended to the elbow and was tender, warm, and itchy. The rash and warmness were still there on the day of reporting. The redness of the rash was slowly fading, as is the warmness and itchiness. The patient feels fine, otherwise. The reporter asked had this type of reaction been reported previously and was it normal or, should the patient be concerned.
Sex: M
Vaccine: TDAP
Symptoms: Fatigue, Pyrexia
Clinical narrative: Low grade fever 100.5; Fatigue; This case was reported by a physician via sales rep and described the occurrence of fever in a 56-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, 1 day after receiving Boostrix, the patient experienced fever and fatigue. On an unknown date, the outcome of the fever and fatigue were unknown.   It was unknown if the reporter considered the fever and fatigue to be related to Boostrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Boostrix and had low grade fever of 100.5 degree F and fatigue.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash 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 adult as per the vaccine indication. The patient received Shingrix and had rash.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Abdominal pain upper, Cough, Fatigue, Headache, Influenza like illness
Clinical narrative: cough; fatigue; headache; continuous stomach pain; flu like symptoms; This case was reported by a consumer via other manufacturer and described the occurrence of cough in a 61-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Influenza vaccine Quadrivalent unspecified season. On an unknown date, 2 weeks after receiving Shingles vaccine and Influenza vaccine Quadrivalent unspecified season, the patient experienced cough, fatigue, headache, stomach pain and influenza-like symptoms. The patient was treated with amoxicillin trihydrate, potassium clavulanate (Augmentin). On an unknown date, the outcome of the cough, fatigue, headache, stomach pain and influenza-like symptoms were not recovered/not resolved.   It was unknown if the reporter considered the cough, fatigue, headache, stomach pain and influenza-like symptoms to be related to Shingles vaccine and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that patient had flu like symptoms two weeks after receiving flu and shingles vaccination on the same day.  The patient had been afebrile and had tested negative for COVID19.  The patient experienced continuous stomach pain.  The patient had almost completed her antibiotic therapy but was not feeling any better.  The patient was recommended to see her provider since symptoms had not improved. The reporter consented to follow up.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Laboratory test, SARS-CoV-2 antibody test negative
Clinical narrative: cough; fatigue; headache; continuous stomach pain; flu like symptoms; This case was reported by a consumer via other manufacturer and described the occurrence of cough in a 61-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Influenza vaccine Quadrivalent unspecified season. On an unknown date, 2 weeks after receiving Shingles vaccine and Influenza vaccine Quadrivalent unspecified season, the patient experienced cough, fatigue, headache, stomach pain and influenza-like symptoms. The patient was treated with amoxicillin trihydrate, potassium clavulanate (Augmentin). On an unknown date, the outcome of the cough, fatigue, headache, stomach pain and influenza-like symptoms were not recovered/not resolved.   It was unknown if the reporter considered the cough, fatigue, headache, stomach pain and influenza-like symptoms to be related to Shingles vaccine and Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that patient had flu like symptoms two weeks after receiving flu and shingles vaccination on the same day.  The patient had been afebrile and had tested negative for COVID19.  The patient experienced continuous stomach pain.  The patient had almost completed her antibiotic therapy but was not feeling any better.  The patient was recommended to see her provider since symptoms had not improved. The reporter consented to follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Photophobia
Clinical narrative: headache/headache has resolved; light sensitivity/sensitivity to light is ongoing; This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced headache and photophobia. On an unknown date, the outcome of the headache was recovered/resolved and the outcome of the photophobia was not recovered/not resolved.   It was unknown if the reporter considered the headache and photophobia to be related to Shingrix.  Additional details were provided as follows: The patient developed a headache and light sensitivity. The headache was resolved.  The sensitivity to light was ongoing. The health care professional did not have the specific start date of the events. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever; Chills / Shivering; Headache; Muscle aches; Nausea; This case was reported by a consumer via call center representative and described the occurrence of fever in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2020, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced fever, chills, headache, muscle pain and nausea. On an unknown date, the outcome of the fever, chills, headache, muscle pain and nausea were unknown.   It was unknown if the reporter considered the fever, chills, headache, muscle pain and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.  After receiving dose of Shingrix, the patient experienced fever, chills, shivering, headache, muscle aches, and nausea. The patient was upset at me because I could not provide medical guidance on how to manage the events when referred to her HCP and abruptly hung up on me. No further adverse event details. The reporter did not consent to follow up.