chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: DTP
Symptoms: Erythema, Peripheral swelling, Pyrexia, Screaming
Clinical narrative: Thigh swelled; Thigh turned blood red; Temp shot up to 102; Had a blood curled scream for hours / screaming; This case was reported by a consumer via interactive digital media (facebook) and described the occurrence of swelling of legs in a female patient who received DTP (A or W not known) (DTP vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of DTP vaccine. On an unknown date, unknown after receiving DTP vaccine, the patient experienced swelling of legs, redness of legs, fever and screaming. On an unknown date, the outcome of the swelling of legs, redness of legs, fever and screaming were unknown.   It was unknown if the reporter considered the swelling of legs, redness of legs, fever and screaming to be related to DTP vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter ststed that after vaccination with DTP  vaccine, the patient's thigh swollen and turned blood red, the temperature shot up to 102 and had a blood curled scream for hours. The reporter reported that, the patient's ob doctor and rimary care said it would be too great of a risk for the patient to take it.      Lab Comments: Lab test performed on an unknown date
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: slight itching on his head, back and on right side; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was unknown.   It was unknown if the reporter considered the pruritus to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient received 1st dose and approximately 1 week developed slight itching on his head, back and on right side. This case has been linked to US2019222822, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Injection site reaction
Clinical narrative: Severe ring in the injection side; Shingles had it vaginally in the outer / Is ongoing / Has also re-activated; This case was reported by a pharmacist via other manufacturer and described the occurrence of injection site reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included genital herpes zoster.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site reaction and shingles. On an unknown date, the outcome of the injection site reaction was recovered/resolved and the outcome of the shingles was unknown.   It was unknown if the reporter considered the injection site reaction and shingles to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient had a severe ring in the injection site for several days. The patient previously had a shingles she had it vaginally. The reporter stated that the patient shingles re activated.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: fever; golf ball size swelling on her arm; arm was in pain; Headache; This case was reported by a pharmacist via patient support programs and described the occurrence of fever in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 21st November 2019, the patient received the 2nd dose of Shingrix 1 ml. On an unknown date, less than a month after receiving Shingrix, the patient experienced fever, swelling arm, pain in arm and headache. On an unknown date, the outcome of the fever, swelling arm, pain in arm and headache were recovered/resolved.   It was unknown if the reporter considered the fever, swelling arm, pain in arm and headache to be related to Shingrix.  Additional details were provided as follows: The patient had a fever for two days after the second shot,a golf ball size swelling on her arm that lasted for five days, arm was in pain for ten days and also a headache for as long as the fever lasted. The follow up consent was granted.
Sex: U
Vaccine: VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: facial numbness; This case was reported by a consumer via call center representative and described the occurrence of numbness facial in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced numbness facial. On an unknown date, the outcome of the numbness facial was unknown.   It was unknown if the reporter considered the numbness facial to be related to Shingles vaccine.  Additional details were received as follows: The age at vaccination was not reported. The patient had facial numbness after vaccination.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Influenza like illness
Clinical narrative: flu like symptoms; aches; Chills / shivering; very fatigued; stomach upset; headache; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced influenza-like symptoms, pain, chills, fatigue, upset stomach and headache. On an unknown date, the outcome of the influenza-like symptoms, pain, chills, fatigue, upset stomach and headache were unknown.   It was unknown if the reporter considered the influenza-like symptoms, pain, chills, fatigue, upset stomach and headache to be related to Shingrix.  Additional details were received as follows: The patient experienced aches, chills, shivering, very fatigued, stomach upset, headache. The patient was hoping dose 2 would be better. The patient got all the flu symptoms with the 1st vaccine and asked if the events would happen again. The patient asked if it was better to wait closer to 6 months to have the 2nd Shingrix vaccine. The patient stated that the insurance was changing and do not know if Shingrix would be covered.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: flu like symptoms; aches; Chills / shivering; very fatigued; stomach upset; headache; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced influenza-like symptoms, pain, chills, fatigue, upset stomach and headache. On an unknown date, the outcome of the influenza-like symptoms, pain, chills, fatigue, upset stomach and headache were unknown.   It was unknown if the reporter considered the influenza-like symptoms, pain, chills, fatigue, upset stomach and headache to be related to Shingrix.  Additional details were received as follows: The patient experienced aches, chills, shivering, very fatigued, stomach upset, headache. The patient was hoping dose 2 would be better. The patient got all the flu symptoms with the 1st vaccine and asked if the events would happen again. The patient asked if it was better to wait closer to 6 months to have the 2nd Shingrix vaccine. The patient stated that the insurance was changing and do not know if Shingrix would be covered.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: chills; myalgia; fatigue; fever; This case was reported by a nurse via sales rep and described the occurrence of chills in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd December 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In December 2019, less than a day after receiving Shingrix, the patient experienced chills, myalgia, fatigue and low grade fever. On an unknown date, the outcome of the chills, myalgia, fatigue and low grade fever were recovered/resolved.   It was unknown if the reporter considered the chills, myalgia, fatigue and low grade fever to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient had chills, myalgia, fatigue, and low grade fever after vaccination.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Influenza like illness, Lethargy, Malaise
Clinical narrative: inability to lift her arms or legs; Lethargic; Weak; Shaky; overall Malaise; Flu-like symptoms; feel tired; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (received 1st dose on 21st July 2019 and experienced events, refer case US2019220473).   On 15th November 2019, the patient received the 2nd dose of Shingrix. On 15th November 2019, less than a day after receiving Shingrix, the patient experienced tiredness. On 16th November 2019, the patient experienced influenza-like symptoms, mobility decreased, lethargy, weakness, tremor and malaise. Rechallenge with Shingrix was positive. On 18th November 2019, the outcome of the influenza-like symptoms, tiredness, mobility decreased, lethargy, weakness, tremor and malaise were resolved with sequelae.   It was unknown if the reporter considered the influenza-like symptoms, tiredness, mobility decreased, lethargy, weakness, tremor and malaise to be related to Shingrix.  Additional case details were reported as follows: The case was reported by patient's wife. On Friday, the patient received Shingrix and started to feel tired.  The next day on Saturday he was in bed all day with flu-like symptoms, including the inability to lift his arms or legs, feeling tired and lethargic, weak, shaky, and overall malaise. On Sunday, he started to feel better.  All symptoms had resolved and he went in to work. The reporter was unable to provide any additional details and her husband was not home at the time of the call. This case has been linked with the cases US2019220473 and US2019220457, reported by same reporter.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Tremor
Clinical narrative: inability to lift her arms or legs; Lethargic; Weak; Shaky; overall Malaise; Flu-like symptoms; feel tired; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (received 1st dose on 21st July 2019 and experienced events, refer case US2019220473).   On 15th November 2019, the patient received the 2nd dose of Shingrix. On 15th November 2019, less than a day after receiving Shingrix, the patient experienced tiredness. On 16th November 2019, the patient experienced influenza-like symptoms, mobility decreased, lethargy, weakness, tremor and malaise. Rechallenge with Shingrix was positive. On 18th November 2019, the outcome of the influenza-like symptoms, tiredness, mobility decreased, lethargy, weakness, tremor and malaise were resolved with sequelae.   It was unknown if the reporter considered the influenza-like symptoms, tiredness, mobility decreased, lethargy, weakness, tremor and malaise to be related to Shingrix.  Additional case details were reported as follows: The case was reported by patient's wife. On Friday, the patient received Shingrix and started to feel tired.  The next day on Saturday he was in bed all day with flu-like symptoms, including the inability to lift his arms or legs, feeling tired and lethargic, weak, shaky, and overall malaise. On Sunday, he started to feel better.  All symptoms had resolved and he went in to work. The reporter was unable to provide any additional details and her husband was not home at the time of the call. This case has been linked with the cases US2019220473 and US2019220457, reported by same reporter.
Sex: F
Vaccine: UNK
Symptoms: Pyrexia, Screaming, Tremor
Clinical narrative: Body tremors; Ear piercing screams; High fever; This case was reported by a consumer via interactive digital media and described the occurrence of tremor in a female patient who received DTP (A or W not known) (DTP (A or W not known)) for prophylaxis.   On an unknown date, the patient received the 1st dose of DTP (A or W not known). On an unknown date, unknown after receiving DTP (A or W not known), the patient experienced tremor, screaming and fever. On an unknown date, the outcome of the tremor, screaming and fever were unknown.   It was unknown if the reporter considered the tremor, screaming and fever to be related to DTP (A or W not known).  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient was 3 at the time, had no complications. The reporter reported that, the pediatrician would not administer another dose to the patient and subsequently making the patient potentially vulnerable to whooping cough. This case has been linked with case US2019AMR234293, reported by same reporter.
Sex: F
Vaccine: DTP
Symptoms: Adverse reaction
Clinical narrative: Very adverse affect; This case was reported by a consumer via interactive digital media and described the occurrence of adverse reaction in a female patient who received DTP (A or W not known) (DTP (A or W not known)) for prophylaxis.   On an unknown date, the patient received DTP (A or W not known) at an unknown dose. On an unknown date, unknown after receiving DTP (A or W not known), the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to DTP (A or W not known).  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that after vaccination, the patient had very bad adverse effects and was scary stuff. This case has been linked with case US2019AMR234290, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache, Injection site pain
Clinical narrative: headache; upset stomach; soreness at injection site/ site soreness; This case was reported by a consumer via call center representative and described the occurrence of headache in a 69-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd December 2019, the patient received Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced headache, upset stomach and injection site pain. On an unknown date, the outcome of the headache, upset stomach and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the headache, upset stomach and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 68 years or 69 years. The patient never experienced side effects to any vaccine before. The day before the reporting date, the patient received Shingrix. The patient had headache, site soreness and upset stomach. The patient asked about the duration of these side effects.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Soreness and pain at the injection site; This case was reported by a consumer and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in unknown date.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received both doses of shingrix.  The last dose was about 2-3 months ago and starting to had soreness and pain at the injection site.  The reporter asked was this common.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Hypersensitivity, Pruritus
Clinical narrative: Allergic reaction; Redness; Itchiness; This case was reported by a consumer and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th November 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix and an unknown time after starting Zyrtec, the patient experienced allergic reaction, erythema of extremities and itchy upper limbs. The patient was treated with cetirizine hydrochloride (Zyrtec). On an unknown date, the outcome of the allergic reaction, erythema of extremities and itchy upper limbs were unknown.   It was unknown if the reporter considered the allergic reaction, erythema of extremities and itchy upper limbs to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had an allergic reaction on both of my arms with redness and itchiness ever since.  The patient recommended zyrtec 10 mg. at bedtime to help with the rash and itch.  The reporter reported if not better in two weeks she would recommend a dermatologist. The reporter asked was this unusual or have others had this reaction.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Exposure via skin contact, Immediate post-injection reaction, Occupational exposure to product, Skin laceration, Wound haemorrhage
Clinical narrative: Inadvertent exposure to vaccine; Exposure via skin contact; Product Complaint; Cut her finger; some blood on the ring; This case was reported by a pharmacist via call center representative and described the occurrence of laceration of finger in a female patient who received Herpes zoster (Shingrix) (batch number 3B33N, expiry date 9th April 2022) and (batch number 2K9T2, expiry date 9th April 2022) for prophylaxis. This case was associated with a product complaint.   On 22nd November 2019, the patient received Shingrix. On 22nd November 2019, the dose was an unknown dose. On 22nd November 2019, immediately after receiving Shingrix, the patient experienced laceration of finger and wound bleeding. On an unknown date, the patient experienced inadvertent exposure to vaccine, exposure via skin contact and pharmaceutical product complaint. On an unknown date, the outcome of the laceration of finger, wound bleeding, inadvertent exposure to vaccine, exposure via skin contact and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the laceration of finger and wound bleeding to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist was preparing to reconstitute a Shingrix vaccine and when she removed the blue-green cap from the adjuvant vial and the red ring also came off and it cut her finger which led to inadvertent exposure to vaccine and exposure via skin contact. The pharmacist just cleaned the wound and put a bandage on the wound. The reporter stated that there was some blood on the ring, so that adjuvant was discarded. There was no picture of the defect and antigen vial would be discarded. Conclusions of the QA statement were received as follows: GlaxoSmithKline Biologicals considered this complaint as unsubstantiated. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Product supply issue
Clinical narrative: Hand pain; Did not receive the second dose yet because of the availability; This case was reported by a consumer via call center representative and described the occurrence of pain in hand in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in hand and product supply issue. On an unknown date, the outcome of the pain in hand and product supply issue were unknown.   It was unknown if the reporter considered the pain in hand to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that she got the first dose of the Shingrix about 2 years back at a pharmacy. The patient had hand pain post vaccination. Till the time of reporting the patient did not receive the second dose because of the availability. Complete information could not be obtained as patient did not respond to questions. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Fever; Nausea; Headache; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th December 2019, the patient received the 1st dose of Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced fever, nausea and headache. On an unknown date, the outcome of the fever, nausea and headache were unknown.   It was unknown if the reporter considered the fever, nausea and headache to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported but could be between 51 or 52 years. The reporter stated that the patient received the first dose of Shingrix and experienced fever, nausea and headache. Date of birth was not provided but the reporter mentioned that he was sure that the patient was 52 years old. The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS, FLUX
Symptoms: Abdominal discomfort, Dyspnoea, Feeling hot, Hyperhidrosis, Influenza like illness
Clinical narrative: Sweating; heart palpitations; could not breath; felt really sick; severe migraine; felt hot; shaking; stomach feels like she has the flu; shoulder hurt; fells like flu; This case was reported by a consumer via call center representative and described the occurrence of sweating in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine (received a couple of years ago) and Shingrix with an associated reaction of nausea (1st dose received on an unknown date, refer case US2019225168).   On 9th December 2019, the patient received the 2nd dose of Shingrix. On 9th December 2019, less than a day after receiving Shingrix, the patient experienced sweating, palpitation, difficulty breathing, feeling unwell, migraine, feeling hot, tremor, stomach discomfort, shoulder pain and influenza-like symptoms. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the sweating, palpitation, difficulty breathing, feeling unwell, migraine, feeling hot, tremor, stomach discomfort, shoulder pain and influenza-like symptoms were unknown.   It was unknown if the reporter considered the sweating, palpitation, difficulty breathing, feeling unwell, migraine, feeling hot, tremor, stomach discomfort, shoulder pain and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient experienced during the night sweating, having heart palpitations, could not breath, and felt really sick. She also had a severe migraine, felt hot and shaking.  Her stomach feels like she had the flu, and her whole left shoulder hurts after receiving 2nd dose of Shingrix. Reporter gave permission for her physician to be contacted.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS, FLUX
Symptoms: Malaise, Migraine, Musculoskeletal pain, Palpitations, Tremor
Clinical narrative: Sweating; heart palpitations; could not breath; felt really sick; severe migraine; felt hot; shaking; stomach feels like she has the flu; shoulder hurt; fells like flu; This case was reported by a consumer via call center representative and described the occurrence of sweating in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine (received a couple of years ago) and Shingrix with an associated reaction of nausea (1st dose received on an unknown date, refer case US2019225168).   On 9th December 2019, the patient received the 2nd dose of Shingrix. On 9th December 2019, less than a day after receiving Shingrix, the patient experienced sweating, palpitation, difficulty breathing, feeling unwell, migraine, feeling hot, tremor, stomach discomfort, shoulder pain and influenza-like symptoms. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the sweating, palpitation, difficulty breathing, feeling unwell, migraine, feeling hot, tremor, stomach discomfort, shoulder pain and influenza-like symptoms were unknown.   It was unknown if the reporter considered the sweating, palpitation, difficulty breathing, feeling unwell, migraine, feeling hot, tremor, stomach discomfort, shoulder pain and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient experienced during the night sweating, having heart palpitations, could not breath, and felt really sick. She also had a severe migraine, felt hot and shaking.  Her stomach feels like she had the flu, and her whole left shoulder hurts after receiving 2nd dose of Shingrix. Reporter gave permission for her physician to be contacted.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS, FLUX
Symptoms: Vaccine positive rechallenge
Clinical narrative: Sweating; heart palpitations; could not breath; felt really sick; severe migraine; felt hot; shaking; stomach feels like she has the flu; shoulder hurt; fells like flu; This case was reported by a consumer via call center representative and described the occurrence of sweating in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine (received a couple of years ago) and Shingrix with an associated reaction of nausea (1st dose received on an unknown date, refer case US2019225168).   On 9th December 2019, the patient received the 2nd dose of Shingrix. On 9th December 2019, less than a day after receiving Shingrix, the patient experienced sweating, palpitation, difficulty breathing, feeling unwell, migraine, feeling hot, tremor, stomach discomfort, shoulder pain and influenza-like symptoms. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the sweating, palpitation, difficulty breathing, feeling unwell, migraine, feeling hot, tremor, stomach discomfort, shoulder pain and influenza-like symptoms were unknown.   It was unknown if the reporter considered the sweating, palpitation, difficulty breathing, feeling unwell, migraine, feeling hot, tremor, stomach discomfort, shoulder pain and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient experienced during the night sweating, having heart palpitations, could not breath, and felt really sick. She also had a severe migraine, felt hot and shaking.  Her stomach feels like she had the flu, and her whole left shoulder hurts after receiving 2nd dose of Shingrix. Reporter gave permission for her physician to be contacted.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS, FLUX
Symptoms: Cystitis, Feeling abnormal, Hyperhidrosis, Hyperventilation, Nausea
Clinical narrative: Sweating; heart palpitations; could not breath; felt really sick; severe migraine; felt hot; shaking; stomach feels like she has the flu; shoulder hurt; fells like flu; This case was reported by a consumer via call center representative and described the occurrence of sweating in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine (received a couple of years ago) and Shingrix with an associated reaction of nausea (1st dose received on an unknown date, refer case US2019225168).   On 9th December 2019, the patient received the 2nd dose of Shingrix. On 9th December 2019, less than a day after receiving Shingrix, the patient experienced sweating, palpitation, difficulty breathing, feeling unwell, migraine, feeling hot, tremor, stomach discomfort, shoulder pain and influenza-like symptoms. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the sweating, palpitation, difficulty breathing, feeling unwell, migraine, feeling hot, tremor, stomach discomfort, shoulder pain and influenza-like symptoms were unknown.   It was unknown if the reporter considered the sweating, palpitation, difficulty breathing, feeling unwell, migraine, feeling hot, tremor, stomach discomfort, shoulder pain and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient experienced during the night sweating, having heart palpitations, could not breath, and felt really sick. She also had a severe migraine, felt hot and shaking.  Her stomach feels like she had the flu, and her whole left shoulder hurts after receiving 2nd dose of Shingrix. Reporter gave permission for her physician to be contacted.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS, FLUX
Symptoms: Influenza like illness
Clinical narrative: Sweating; heart palpitations; could not breath; felt really sick; severe migraine; felt hot; shaking; stomach feels like she has the flu; shoulder hurt; fells like flu; This case was reported by a consumer via call center representative and described the occurrence of sweating in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu vaccine (received a couple of years ago) and Shingrix with an associated reaction of nausea (1st dose received on an unknown date, refer case US2019225168).   On 9th December 2019, the patient received the 2nd dose of Shingrix. On 9th December 2019, less than a day after receiving Shingrix, the patient experienced sweating, palpitation, difficulty breathing, feeling unwell, migraine, feeling hot, tremor, stomach discomfort, shoulder pain and influenza-like symptoms. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the sweating, palpitation, difficulty breathing, feeling unwell, migraine, feeling hot, tremor, stomach discomfort, shoulder pain and influenza-like symptoms were unknown.   It was unknown if the reporter considered the sweating, palpitation, difficulty breathing, feeling unwell, migraine, feeling hot, tremor, stomach discomfort, shoulder pain and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient experienced during the night sweating, having heart palpitations, could not breath, and felt really sick. She also had a severe migraine, felt hot and shaking.  Her stomach feels like she had the flu, and her whole left shoulder hurts after receiving 2nd dose of Shingrix. Reporter gave permission for her physician to be contacted.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise
Clinical narrative: Fluish; Felt yucky; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a female patient who received Herpes zoster (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 influenza-like symptoms and feeling unwell. On an unknown date, the outcome of the influenza-like symptoms and feeling unwell were unknown.   It was unknown if the reporter considered the influenza-like symptoms and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the patient's daughter. The patient felt fluish for a day or two after getting the vaccine. She felt yucky. The reporter statesd that her mother was private and would not want her information to be shared. The reporter consented to follow up. This case has been linked with case US2019226090, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise
Clinical narrative: Fluish; Felt yucky; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in a adult male patient who received Herpes zoster (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 influenza-like symptoms and feeling unwell. On an unknown date, the outcome of the influenza-like symptoms and feeling unwell were unknown.   It was unknown if the reporter considered the influenza-like symptoms and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the patient's wife. The patient felt fluish for a day or two after receiving the vaccine. He felt yucky. The reporter stated that her husband was private and would not want his information to be shared due to his profession. The reporter consented to follow up. This case has been linked with case US2019226091, reported by the same reporter.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Unable to dress herself; "Terrible" left arm pain; Was up all night; This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2019, the patient received the 1st dose of Shingrix. On 11th November 2019, 3 hrs after receiving Shingrix, the patient experienced pain in arm and insomnia. On an unknown date, the patient experienced activities of daily living impaired. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the insomnia and activities of daily living impaired were unknown.   It was unknown if the reporter considered the pain in arm, insomnia and activities of daily living impaired to be related to Shingrix.  Additional details were received as follows: The reporter stated that the patient developed terrible arm pain and was up all night and two days later sough medical attention for the pain. The patient stated that the pain continues at the time of reporting and patient was still seeking medical care for relief, and that she is unable to dress herself, her husband has to hook her bra for her. The reporter stated that the patient had no previous issues with her arm. The reporter consented to follow up.
Sex: F
Vaccine: UNK
Symptoms: Adverse event, Documented hypersensitivity to administered product
Clinical narrative: Documented Hypersensitivity to administered product; Didn't like outcome; This case was reported by a pharmacist via call center representative and described the occurrence of adverse event in a 58-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Concurrent medical conditions included egg allergy.   In 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. In 2019, less than a year after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced adverse event. On an unknown date, the patient experienced documented hypersensitivity to administered product. On an unknown date, the outcome of the adverse event and documented hypersensitivity to administered product were unknown.   It was unknown if the reporter considered the adverse event to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows:  The age at vaccination was not reported. The patient with egg allergy received a Influenza vaccine Quadrivalent 2019-2020 season (unknown brand) and did not like the outcome. No more details were provided to the pharmacist by the patient, and the vaccine was not given at the pharmacy so additional details were not available. This was a medication error with adverse event. Consent to follow up was provided.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site rash
Clinical narrative: rash at injection site; Wrong route of administration; This case was reported by a nurse via call center representative and described the occurrence of injection site rash in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number L9F99, expiry date 10th May 2022) for prophylaxis.   On 13th December 2019, the patient received the 1st dose of Shingrix (subcutaneous). On 13th December 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were provided as follows: The patient developed a localized rash at the injection site after receipt of her first dose of Shingrix and it was suspected that it was given subcutaneously which led to intramuscular formulation administered by other route. The follow up consent was granted.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 774SY, expiry date 2nd October 2021) for prophylaxis.   On 30th November 2019, the patient received the 1st dose of Shingrix (intramuscular). On 14th December 2019, 14 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient developed shingles across her face. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Myalgia
Clinical narrative: headache; muscle pain; joint pain; shivering; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th December 2019, the patient received the 2nd dose of Shingrix. On 30th December 2019, 1 days after receiving Shingrix, the patient experienced headache, muscle pain, joint pain and shivering. On an unknown date, the outcome of the headache, muscle pain, joint pain and shivering were unknown.   It was unknown if the reporter considered the headache, muscle pain, joint pain and shivering 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 was selected as adult as per vaccine indication. The patient had severe headache, muscle pain, joint pain, and shivering after administration of Shingrix dose.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Dyspnoea, Eye swelling, Fatigue
Clinical narrative: Injection site red; Injection site painful; Shivering; Breathing very hard; Sweating; Extremely sensitive from head to toe; Diarrhea; Eyes swollen; Tired; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th December 2019, the patient received Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site pain, shivering, difficulty breathing, sweating, sensitive skin, diarrhea, eye swelling and tiredness. On an unknown date, the outcome of the injection site erythema, shivering, difficulty breathing, sweating, sensitive skin, diarrhea and tiredness were unknown and the outcome of the injection site pain and eye swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, shivering, difficulty breathing, sweating, sensitive skin, diarrhea, eye swelling and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient received the Shingrix vaccine and was fine for the first 24 hours. Then the injection site got extremely red and painful and the patient put ice on the injection site for 30 minutes. The patient had severe shivering and was breathing very hard. The patient then went to bed for 1 hour, woke up feeling very cold, went back to bed and then started sweating for the rest of the night. The patient's body was extremely sensitive from head to toe, just by touch. The patient got diarrhea, their eyes became swollen which made him even more tired.  As of 30Dec2019,the patient was still having pain at the injection site and eyes are still a little swollen. The follow up consent was granted.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Injection site erythema, Injection site pain, Sensitive skin
Clinical narrative: Injection site red; Injection site painful; Shivering; Breathing very hard; Sweating; Extremely sensitive from head to toe; Diarrhea; Eyes swollen; Tired; This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th December 2019, the patient received Shingrix. In December 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site pain, shivering, difficulty breathing, sweating, sensitive skin, diarrhea, eye swelling and tiredness. On an unknown date, the outcome of the injection site erythema, shivering, difficulty breathing, sweating, sensitive skin, diarrhea and tiredness were unknown and the outcome of the injection site pain and eye swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, shivering, difficulty breathing, sweating, sensitive skin, diarrhea, eye swelling and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient received the Shingrix vaccine and was fine for the first 24 hours. Then the injection site got extremely red and painful and the patient put ice on the injection site for 30 minutes. The patient had severe shivering and was breathing very hard. The patient then went to bed for 1 hour, woke up feeling very cold, went back to bed and then started sweating for the rest of the night. The patient's body was extremely sensitive from head to toe, just by touch. The patient got diarrhea, their eyes became swollen which made him even more tired.  As of 30Dec2019,the patient was still having pain at the injection site and eyes are still a little swollen. The follow up consent was granted.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site warmth, Malaise
Clinical narrative: patient said site became hot and pain at injection site and made her sick
Age: 8.0
Sex: F
Vaccine: FLUC4
Symptoms: Pyrexia, Vomiting
Clinical narrative: vomiting, low fever
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient was given a second dose of the Influenza vaccine.  Had previously received a dose 10/2019
Age: 21.0
Sex: M
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Administered pediatric dose to 21 year old adult.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain
Clinical narrative: Severe chills and intense headache, nausea, body aches
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Musculoskeletal stiffness, Pain
Clinical narrative: ALL OVER ACHINESS, THROBBING IN ENTIRE HEAD, STIFF NECK
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Fibromyalgia
Clinical narrative: fibromyalgia; balance issues; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. In or around 06-MAY-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, dose #, lot #, expiration date and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), the patient suffered fibromyalgia and balance issues. As a direct and proximate result, the zoster vaccine live (ZOSTAVAX), the patient's symptoms resulted in physical limitations not present prior to using the product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries, suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury, suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events fibromyalgia and balance issues were determined to be disabling.
Age: 0.08
Sex: U
Vaccine: RV1
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: inadvertently administered the vaccine by intramuscular injection; This case was reported by a nurse via other manufacturer and described the occurrence of inappropriate route of vaccination in a 1-month-old patient who received Rota (Rotarix lyophilized formulation) (batch number AS35G, expiry date unknown) for prophylaxis.   On 18th October 2019, the patient received Rotarix lyophilized formulation (intramuscular). On 18th October 2019, unknown after receiving Rotarix lyophilized formulation, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the inappropriate route of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient was inadvertently received a dose of Rotarix by intramuscular injection, which led to inappropriate route of vaccination. The patient did not experience any symptoms. The reported batch number was updated from AF35G to AS35G, as per sales data sheet.