chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Red Rash 4 in diameter; warm to touch; Initial information regarding an unsolicited valid non-serious case downloaded from the VAERS database received on 29-Mar-2019 from Health Authorities under reference 793203-1.  This case involves a 34 years old female patient who experienced red rash 4 in diameter and warm to touch, while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient had no current illness and past medical history or allergy. Family history were not provided.  No concomitant therapies were given.  On 04-Oct-2018, the patient received a one dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6301LA and Exp. Date 30-Jun-2019 via unknown route in right arm.  On 04-Oct-2018, the patient developed a non-serious red rash 4 in diameter (rash erythematous) and warm to touch (skin warm) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  no lab test was done.     Final diagnosis was rash erythematous and skin warm.  It was not reported if the patient received a corrective treatment.  The patient recovered from the events on an unknown date, at the time of report.  List of documents held by sender: none.
Sex: F
Vaccine: DTAPIPV, FLUN4, HEP, MMRV
Symptoms: Injection site vesicles, Rash generalised, Rash papular
Clinical narrative: Developed mild widespread papular rash that spread from days 5-12 after vaccination; Developed mild widespread papular rash that spread from days 5-12 after vaccination; Developed approx 3 vesicular lesions left arm; Initial information received on 29-Mar-2019 regarding an unsolicited valid non-serious case received from Other health professional via Health Authorities under reference 794105-1.  This case involves a 4 years old female patient who developed mild widespread papular rash that spread from days 5-12 after vaccination, and developed approx. 3 vesicular lesions left arm, while she received vaccines PROQUAD, FLUMIST QUADRIVALENT, ENGERIX-B and DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient has no past medical history. The patients concomitant medication and family history were not provided.  On 17-Dec-2018, the patient received a second dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5325BA, expiry date not provided via intramuscular route in the right arm. On 17-Dec-2018, the patient received a third dose of suspect ENGERIX-B not produced by Sanofi Pasteur lot 97Y27 via intramuscular route in the left arm. On 17-Dec-2018, the patient received a first dose of suspect FLUMIST QUADRIVALENT not produced by Sanofi Pasteur lot KL2243 via nasal route. On 17-Dec-2018, the patient received a first dose of suspect PROQUAD not produced by Sanofi Pasteur lot R017625 via subcutaneous route in the left arm.  On 20-Dec-2018, the patient developed a non-serious developed mild widespread papular rash that spread from days 5-12 after vaccination (rash papular) and (rash generalised) 3 days following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE, 3 days following the administration of ENGERIX-B, 3 days following the administration of FLUMIST QUADRIVALENT and 3 days following the administration of PROQUAD. On 20-Dec-2018, the patient developed a non-serious developed approx. 3 vesicular lesions left arm (injection site vesicles) 3 days following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE, 3 days following the administration of ENGERIX-B, 3 days following the administration of FLUMIST QUADRIVALENT and 3 days following the administration of PROQUAD. The patient had physician office visit.  (Other relevant tests included Lab data- None.)  Final diagnosis was developed mild widespread papular rash that spread from days 5-12 after vaccination, and developed approx. 3 vesicular lesions left arm.   The patient was treated with supportive care.  The patient outcome is reported as Not Recovered / Not Resolved for developed mild widespread papular rash that spread from days 5-12 after vaccination, and developed approx. 3 vesicular lesions left arm.  List of documents held by sender- none.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: Initial information regarding an unsolicited valid non-serious case downloaded from the VAERS database received on 29-Mar-2019 from Health Authorities under reference 795302-1. This case involves a 12 years old female patient who was vaccinated with a one dosage form of BOOSTRIX (Batch number: BP27L) in the left arm, GARDASIL (batch number: N010497) in the right leg and MENACTRA (Batch number: U5751AA) via intramuscular route in the left leg on 29-Oct-2018. History/Allergies: None, Current Illness: none. Concomitant medications were not reported. It was a case of actual medication error due to product storage error because the vaccines were deemed unviable due to no temperature logs being done in the Month of October 2018. It was reported as patient did not have health concerns. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: none.
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information regarding an unsolicited valid non-serious case downloaded from the VAERS database received on 29-Mar-2019 from Health Authorities under reference 795302-1. This case involves a 12 years old female patient who was vaccinated with a one dosage form of BOOSTRIX (Batch number: BP27L) in the left arm, GARDASIL (batch number: N010497) in the right leg and MENACTRA (Batch number: U5751AA) via intramuscular route in the left leg on 29-Oct-2018. History/Allergies: None, Current Illness: none. Concomitant medications were not reported. It was a case of actual medication error due to product storage error because the vaccines were deemed unviable due to no temperature logs being done in the Month of October 2018. It was reported as patient did not have health concerns. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: none.
Sex: F
Vaccine: JEV1, JEV1, JEV1
Symptoms: Foetal disorder, Injection site erythema, Injection site swelling, Maternal exposure before pregnancy, Nuclear magnetic resonance imaging
Clinical narrative: The following information was downloaded from the VAERS webpage on 25 Mar 2019. A female received her second dose of IXIARO (batch number unknown) I.M. into her right arm on an unknown date; a few weeks prior to conception of a child. She experienced injection site swelling and injection site erythema. The female had an Ultrasound and MRI investigation, but results were not provided. Outcome of events were reported as not resolved by time of report to VAERS. Case is classified overall as serious (hospitalisation) as the embryo / fetus was found to have corpus callosum agenesis. Case is linked to US-INTERCELLP-4602 (fetus with events of mid line defect and agenesis of corpus callosum).
Sex: F
Vaccine: JEV1, JEV1, JEV1
Symptoms: Ultrasound antenatal screen
Clinical narrative: The following information was downloaded from the VAERS webpage on 25 Mar 2019. A female received her second dose of IXIARO (batch number unknown) I.M. into her right arm on an unknown date; a few weeks prior to conception of a child. She experienced injection site swelling and injection site erythema. The female had an Ultrasound and MRI investigation, but results were not provided. Outcome of events were reported as not resolved by time of report to VAERS. Case is classified overall as serious (hospitalisation) as the embryo / fetus was found to have corpus callosum agenesis. Case is linked to US-INTERCELLP-4602 (fetus with events of mid line defect and agenesis of corpus callosum).
Sex: F
Vaccine: JEV1, JEV1, JEV1
Symptoms: Ultrasound scan
Clinical narrative: The following information was downloaded from the VAERS webpage on 25 Mar 2019. A female received her second dose of IXIARO (batch number unknown) I.M. into her right arm on an unknown date; a few weeks prior to conception of a child. She experienced injection site swelling and injection site erythema. The female had an Ultrasound and MRI investigation, but results were not provided. Outcome of events were reported as not resolved by time of report to VAERS. Case is classified overall as serious (hospitalisation) as the embryo / fetus was found to have corpus callosum agenesis. Case is linked to US-INTERCELLP-4602 (fetus with events of mid line defect and agenesis of corpus callosum).
Sex: U
Vaccine: JEV1, JEV1, JEV1
Symptoms: Foetal disorder, Injection site erythema, Injection site swelling, Maternal exposure before pregnancy, Nuclear magnetic resonance imaging
Clinical narrative: The following information was downloaded from the VAERS webpage on 25 Mar 2019. A female received her second dose of IXIARO (batch number unknown) I.M. into her right arm on an unknown date 'a few weeks prior to conception'. During pregnancy fetus was found to have mid line defect and agenesis of corpus callosum. Fetal MRI and antenatal ultrasound were performed on unknown dates (results not provided). Outcome of events were reported as not resolved. Case is linked to case US-INTERCELLP-4595 (mother case with events red swelling and erythema at injection site).
Sex: U
Vaccine: JEV1, JEV1, JEV1
Symptoms: Ultrasound antenatal screen
Clinical narrative: The following information was downloaded from the VAERS webpage on 25 Mar 2019. A female received her second dose of IXIARO (batch number unknown) I.M. into her right arm on an unknown date 'a few weeks prior to conception'. During pregnancy fetus was found to have mid line defect and agenesis of corpus callosum. Fetal MRI and antenatal ultrasound were performed on unknown dates (results not provided). Outcome of events were reported as not resolved. Case is linked to case US-INTERCELLP-4595 (mother case with events red swelling and erythema at injection site).
Sex: U
Vaccine: JEV1, JEV1, JEV1
Symptoms: Ultrasound scan
Clinical narrative: The following information was downloaded from the VAERS webpage on 25 Mar 2019. A female received her second dose of IXIARO (batch number unknown) I.M. into her right arm on an unknown date 'a few weeks prior to conception'. During pregnancy fetus was found to have mid line defect and agenesis of corpus callosum. Fetal MRI and antenatal ultrasound were performed on unknown dates (results not provided). Outcome of events were reported as not resolved. Case is linked to case US-INTERCELLP-4595 (mother case with events red swelling and erythema at injection site).
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Burning sensation, Headache, Musculoskeletal pain, Neck pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a 74-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (prior to getting the vaccine had several outbreaks of shingles). Previously administered products included SHINGRIX with an associated reaction of pain in extremity (For tolerance to 1st dose please refer case US2019GSK061308). Concurrent medical conditions included tremor (essential diagnosed when she was 30 years old). On an unknown date, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, 5 days after receiving SHINGRIX, the patient experienced nerve pain (serious criteria hospitalization), shingles, pain in arm, fever, mobility decreased, itchy rash, scab, burning sensation, general body pain, urinary urgency, back pain, neck pain and sweating. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the nerve pain, shingles, pain in arm, fever, mobility decreased, itchy rash, scab, burning sensation, general body pain, urinary urgency, back pain, neck pain and sweating were unknown.  It was unknown if the reporter considered the nerve pain, shingles, pain in arm, fever, mobility decreased, itchy rash, scab, burning sensation, general body pain, urinary urgency, back pain, neck pain and sweating to be related to SHINGRIX. Additional details were provided as follows: On a Thursday, approximately three weeks ago before the date of reporting, the reporter indicated that she received her SHINGRIX vaccine. Within three days of receiving the vaccine she experienced a sore arm and a fever. Five days later she could not move her body because she had nerve pain everywhere except both of her legs. Less than a week after receiving SHINGRIX, the patient had little, tiny bumps on her back with scabs that itched. When she touched them, they burnt. Because she could not move due to the pain, she could not get to the bathroom and urinated on herself more than once. Ten days after receiving the vaccine she went to the emergency room and was told she had nerve pain and was given a shot for the pain. Two to three days after going to the emergency room she went to see her physician and was told it was nerve pain and was given medications to treat shingles. The physician did not know if it was shingles. Her back and neck still hurt, making it hard for her to turn her head. Less than a month after receiving SHINGRIX, they were hurting last night before the date of reporting and she was soaked because she had sweats. The reporter consented to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Rash, Rash pruritic, Urine analysis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a 74-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (prior to getting the vaccine had several outbreaks of shingles). Previously administered products included SHINGRIX with an associated reaction of pain in extremity (For tolerance to 1st dose please refer case US2019GSK061308). Concurrent medical conditions included tremor (essential diagnosed when she was 30 years old). On an unknown date, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, 5 days after receiving SHINGRIX, the patient experienced nerve pain (serious criteria hospitalization), shingles, pain in arm, fever, mobility decreased, itchy rash, scab, burning sensation, general body pain, urinary urgency, back pain, neck pain and sweating. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the nerve pain, shingles, pain in arm, fever, mobility decreased, itchy rash, scab, burning sensation, general body pain, urinary urgency, back pain, neck pain and sweating were unknown.  It was unknown if the reporter considered the nerve pain, shingles, pain in arm, fever, mobility decreased, itchy rash, scab, burning sensation, general body pain, urinary urgency, back pain, neck pain and sweating to be related to SHINGRIX. Additional details were provided as follows: On a Thursday, approximately three weeks ago before the date of reporting, the reporter indicated that she received her SHINGRIX vaccine. Within three days of receiving the vaccine she experienced a sore arm and a fever. Five days later she could not move her body because she had nerve pain everywhere except both of her legs. Less than a week after receiving SHINGRIX, the patient had little, tiny bumps on her back with scabs that itched. When she touched them, they burnt. Because she could not move due to the pain, she could not get to the bathroom and urinated on herself more than once. Ten days after receiving the vaccine she went to the emergency room and was told she had nerve pain and was given a shot for the pain. Two to three days after going to the emergency room she went to see her physician and was told it was nerve pain and was given medications to treat shingles. The physician did not know if it was shingles. Her back and neck still hurt, making it hard for her to turn her head. Less than a month after receiving SHINGRIX, they were hurting last night before the date of reporting and she was soaked because she had sweats. The reporter consented to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Burning sensation, Herpes zoster, Hyperhidrosis, Micturition urgency
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a 74-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (prior to getting the vaccine had several outbreaks of shingles). Previously administered products included SHINGRIX with an associated reaction of pain in extremity (For tolerance to 1st dose please refer case US2019GSK061308). Concurrent medical conditions included tremor (essential diagnosed when she was 30 years old). On an unknown date, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, 5 days after receiving SHINGRIX, the patient experienced nerve pain (serious criteria hospitalization), shingles, pain in arm, fever, mobility decreased, itchy rash, scab, burning sensation, general body pain, urinary urgency, back pain, neck pain and sweating. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the nerve pain, shingles, pain in arm, fever, mobility decreased, itchy rash, scab, burning sensation, general body pain, urinary urgency, back pain, neck pain and sweating were unknown.  It was unknown if the reporter considered the nerve pain, shingles, pain in arm, fever, mobility decreased, itchy rash, scab, burning sensation, general body pain, urinary urgency, back pain, neck pain and sweating to be related to SHINGRIX. Additional details were provided as follows: On a Thursday, approximately three weeks ago before the date of reporting, the reporter indicated that she received her SHINGRIX vaccine. Within three days of receiving the vaccine she experienced a sore arm and a fever. Five days later she could not move her body because she had nerve pain everywhere except both of her legs. Less than a week after receiving SHINGRIX, the patient had little, tiny bumps on her back with scabs that itched. When she touched them, they burnt. Because she could not move due to the pain, she could not get to the bathroom and urinated on herself more than once. Ten days after receiving the vaccine she went to the emergency room and was told she had nerve pain and was given a shot for the pain. Two to three days after going to the emergency room she went to see her physician and was told it was nerve pain and was given medications to treat shingles. The physician did not know if it was shingles. Her back and neck still hurt, making it hard for her to turn her head. Less than a month after receiving SHINGRIX, they were hurting last night before the date of reporting and she was soaked because she had sweats. The reporter consented to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Mobility decreased, Neck pain, Neuralgia, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a 74-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (prior to getting the vaccine had several outbreaks of shingles). Previously administered products included SHINGRIX with an associated reaction of pain in extremity (For tolerance to 1st dose please refer case US2019GSK061308). Concurrent medical conditions included tremor (essential diagnosed when she was 30 years old). On an unknown date, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, 5 days after receiving SHINGRIX, the patient experienced nerve pain (serious criteria hospitalization), shingles, pain in arm, fever, mobility decreased, itchy rash, scab, burning sensation, general body pain, urinary urgency, back pain, neck pain and sweating. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the nerve pain, shingles, pain in arm, fever, mobility decreased, itchy rash, scab, burning sensation, general body pain, urinary urgency, back pain, neck pain and sweating were unknown.  It was unknown if the reporter considered the nerve pain, shingles, pain in arm, fever, mobility decreased, itchy rash, scab, burning sensation, general body pain, urinary urgency, back pain, neck pain and sweating to be related to SHINGRIX. Additional details were provided as follows: On a Thursday, approximately three weeks ago before the date of reporting, the reporter indicated that she received her SHINGRIX vaccine. Within three days of receiving the vaccine she experienced a sore arm and a fever. Five days later she could not move her body because she had nerve pain everywhere except both of her legs. Less than a week after receiving SHINGRIX, the patient had little, tiny bumps on her back with scabs that itched. When she touched them, they burnt. Because she could not move due to the pain, she could not get to the bathroom and urinated on herself more than once. Ten days after receiving the vaccine she went to the emergency room and was told she had nerve pain and was given a shot for the pain. Two to three days after going to the emergency room she went to see her physician and was told it was nerve pain and was given medications to treat shingles. The physician did not know if it was shingles. Her back and neck still hurt, making it hard for her to turn her head. Less than a month after receiving SHINGRIX, they were hurting last night before the date of reporting and she was soaked because she had sweats. The reporter consented to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Rash pruritic, Scab, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a 74-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (prior to getting the vaccine had several outbreaks of shingles). Previously administered products included SHINGRIX with an associated reaction of pain in extremity (For tolerance to 1st dose please refer case US2019GSK061308). Concurrent medical conditions included tremor (essential diagnosed when she was 30 years old). On an unknown date, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, 5 days after receiving SHINGRIX, the patient experienced nerve pain (serious criteria hospitalization), shingles, pain in arm, fever, mobility decreased, itchy rash, scab, burning sensation, general body pain, urinary urgency, back pain, neck pain and sweating. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the nerve pain, shingles, pain in arm, fever, mobility decreased, itchy rash, scab, burning sensation, general body pain, urinary urgency, back pain, neck pain and sweating were unknown.  It was unknown if the reporter considered the nerve pain, shingles, pain in arm, fever, mobility decreased, itchy rash, scab, burning sensation, general body pain, urinary urgency, back pain, neck pain and sweating to be related to SHINGRIX. Additional details were provided as follows: On a Thursday, approximately three weeks ago before the date of reporting, the reporter indicated that she received her SHINGRIX vaccine. Within three days of receiving the vaccine she experienced a sore arm and a fever. Five days later she could not move her body because she had nerve pain everywhere except both of her legs. Less than a week after receiving SHINGRIX, the patient had little, tiny bumps on her back with scabs that itched. When she touched them, they burnt. Because she could not move due to the pain, she could not get to the bathroom and urinated on herself more than once. Ten days after receiving the vaccine she went to the emergency room and was told she had nerve pain and was given a shot for the pain. Two to three days after going to the emergency room she went to see her physician and was told it was nerve pain and was given medications to treat shingles. The physician did not know if it was shingles. Her back and neck still hurt, making it hard for her to turn her head. Less than a month after receiving SHINGRIX, they were hurting last night before the date of reporting and she was soaked because she had sweats. The reporter consented to follow up.
Age: 54.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Neck pain, Pain
Clinical narrative: The patient developed fever up to 102.4, tachycardia, and widespread upper extremity pain at the site of the reaction 10 hours after receiving the vaccination. The patient was hospitalized for the degree of fever and pain. A CT scan demonstrated enlarged and ill-defined deltoid and trapezius muscles with adjacent subcutaneous fat stranding suggestive of myositis and adjacent cellulitis.
Age: 54.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Pain in extremity, Pyrexia, Tenderness
Clinical narrative: The patient developed fever up to 102.4, tachycardia, and widespread upper extremity pain at the site of the reaction 10 hours after receiving the vaccination. The patient was hospitalized for the degree of fever and pain. A CT scan demonstrated enlarged and ill-defined deltoid and trapezius muscles with adjacent subcutaneous fat stranding suggestive of myositis and adjacent cellulitis.
Age: 54.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Blood creatine phosphokinase normal, Cellulitis, Computerised tomogram abnormal, Injection site pain, Myositis
Clinical narrative: The patient developed fever up to 102.4, tachycardia, and widespread upper extremity pain at the site of the reaction 10 hours after receiving the vaccination. The patient was hospitalized for the degree of fever and pain. A CT scan demonstrated enlarged and ill-defined deltoid and trapezius muscles with adjacent subcutaneous fat stranding suggestive of myositis and adjacent cellulitis.
Age: 54.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Pyrexia, Tachycardia, White blood cell count decreased
Clinical narrative: The patient developed fever up to 102.4, tachycardia, and widespread upper extremity pain at the site of the reaction 10 hours after receiving the vaccination. The patient was hospitalized for the degree of fever and pain. A CT scan demonstrated enlarged and ill-defined deltoid and trapezius muscles with adjacent subcutaneous fat stranding suggestive of myositis and adjacent cellulitis.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: Flu like symptons, aches and muscle pain, headache, tiredness, reddening at site of the injection, pain at site of the injection,
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: Flu like symptons, aches and muscle pain, headache, tiredness, reddening at site of the injection, pain at site of the injection,
Age: 13.0
Sex: M
Vaccine: FLU4, HEP, HPV9, MNQ, TDAP
Symptoms: Crying, Hyperhidrosis, Pallor, Tinnitus, Unresponsive to stimuli
Clinical narrative: 1435 Called to treatment room. Patient pale and unresponsive in his mom's arms. Placed on treatment table in supine position. Opened eyes and cried asking where he was. C/O ringing in ears and decreased vision. Both returned to normal within 2 minutes. BP 82/50 HR 60. No breathing difficulty. Diaphoretic. Had not eaten anything since breakfast. Given a lollipop for some sugar. 1445 BP 92/50 HR 68 Lips pink. Denies ringing in ears or visual disturbances. Denies dizziness. Laughing and joking with siblings. Assisted to sitting position on end of treatment table. 1450 Accompanied to waiting area with instructions to his mom to remain seated for 15 minutes. If symptoms return further invention including ED will be put into place. Monitored by staff while in waiting area. 1510 Denies further symptoms. Discharged to home with family.
Age: 13.0
Sex: M
Vaccine: FLU4, HEP, HPV9, MNQ, TDAP
Symptoms: Visual impairment
Clinical narrative: 1435 Called to treatment room. Patient pale and unresponsive in his mom's arms. Placed on treatment table in supine position. Opened eyes and cried asking where he was. C/O ringing in ears and decreased vision. Both returned to normal within 2 minutes. BP 82/50 HR 60. No breathing difficulty. Diaphoretic. Had not eaten anything since breakfast. Given a lollipop for some sugar. 1445 BP 92/50 HR 68 Lips pink. Denies ringing in ears or visual disturbances. Denies dizziness. Laughing and joking with siblings. Assisted to sitting position on end of treatment table. 1450 Accompanied to waiting area with instructions to his mom to remain seated for 15 minutes. If symptoms return further invention including ED will be put into place. Monitored by staff while in waiting area. 1510 Denies further symptoms. Discharged to home with family.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Her husband was diagnosed with shingles this morning and it was around his forehead; This spontaneous report has been received from the patient's wife, regarding to a male patient of unknown age. The patient's concurrent conditions, concomitant therapies, medical history and prevriously drug reaction or allergies were not reported.   in approximately 2014 (reported as around 5 years ago), the patient was vaccinated with one shot of zoster vaccine live (ZOSTAVAX) (lot #, expiration date, strength and anatomical location of vaccine were not reported), subcutaneously for shingles prevention. On 25-MAR-2019 (also reported as: this morning), the patient experienced shingles and it was around his forehead. At the reporting time, the patient had not recovered from the event. and had not sought medical attention for it.   The causality assessment between zoster vaccine live (ZOSTAVAX) and the event was not reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; the patient was vaccinated with an improperly stored dose of PROQUAD; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.  On 21-MAR-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant Human albumin (rHA) (PROQUAD) lot number R024015, expiration date on 19-FEB-2020 for prophylaxis (strength, dose number, anatomical location and route of administration was not reported). The sterile diluent used to reconstitute Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant Human albumin (rHA) (PROQUAD) was properly stored.  The temperatures were from 6  degrees Fahrenheit (°F) to 14°F for a timeframe of 10 hours and 35 minutes with a previous temperature excursion of 6°F to 14 °F for 9 hours and 5 minutes and from 15°F to 46°F for two hours and 30 minutes.  The temperature excursion was called because of a data logger and no adverse effects were reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA002419: US-009507513-1904USA002418:
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician concerning a female patient of unknown age. The patient's concurrent conditions and medical history, as well as concomitant medications were not reported. On 28-MAR-2019, the patient was vaccinated with GARDASIL 9 (strength, dose, anatomical site, lot # and expiration date were unknown), intramuscular for prevention of Human papillomavirus (HPV). The physician reported that the vaccine was administered before learning that the patient was pregnant. No adverse effects were reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect; expired vaccine used; This spontaneous report was received from a nurse, concerning a patient of unknown age or gender.  The patient's medical history, concurrent conditions, drug reactions or allergies were not provided.   On 29-MAR-2019, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) lot # R010368 with expiration date 25-MAR-2019, administered intramuscularly (strength, frequency, dose, and anatomical location were not provided) as prophylaxis.  No adverse effects were reported.
Sex: F
Vaccine: MMR, UNK, UNK
Symptoms: Drug hypersensitivity, Vomiting
Clinical narrative: The patient developed profuse vomiting after being vaccinated with M-M-R II and a DTAP; Her daughter was allergic to the sterile diluent; This spontaneous report was received from a Registered Nurse referring to a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 29-OCT-2003, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)(strength, route, dose, frequency, anatomical location, indication, lot # and expiration date were unknown) and diphtheria toxoid, pertussis acellular vaccine (unspecified) tetanus toxoid(manufacturer unknown)(strength, route, dose, frequency, anatomical location, indication, lot # and expiration date were unknown) that were reconstituded with sterile diluent(manufacturer unknown) due to be vaccinated.      After the vaccination, the patient developed profuse vomiting. Additionally, the the patient's mother (name unspecified) stated her daughter was allergic to the sterile diluent (manufacturer unknown by)(drug hypersensitivity).   At the time or the report, the outcome of vomiting was reported as resolved, and the outcome of drug hypersensitivity was unknown. The reporter did not mention the causality assessment between the events and therapy with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), diphtheria toxoid, pertussis acellular vaccine (unspecified) tetanus toxoid(manufacturer unknown) and  the sterile diluent(manufacturer unknown).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: dministration of one dose of an improperly stored vaccine; No adverse effects; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Information about the patient's medical history, concurrent conditions and drug reactions or allergies was not provided.      On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # R024023 with an expiration date in 22-AUG-2020), (strength, dose, route and frequency were not provided),  for prophylaxis, that underwent a temperature excursion of 17 degrees Celsius during a time frame of 50 minutes. No previous temperature excursion was reported and the digital data logger was involved. The sterile diluent used to reconstituted the improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) was properly stored. No adverse effects were reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; the patient was vaccinated with an improperly stored dose of PROQUAD; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.  On 18-MAR-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant Human albumin (rHA) (PROQUAD) lot number R024015, expiration date on 19-FEB-2020 for prophylaxis (strength, dose number, anatomical location and route of administration was not reported). The sterile diluent used to reconstitute Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant Human albumin (rHA) (PROQUAD) was properly stored.  The temperatures were from 6  degrees Fahrenheit (°F) to 14°F for a timeframe of 10 hours and 35 minutes with a previous temperature excursion of 6°F to 14 °F for 9 hours and 5 minutes and from 15°F to 46°F for two hours and 30 minutes.  The temperature excursion was called because of a data logger and no adverse effects were reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA002419: US-009507513-1903USA011545:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; the patient was vaccinated with an improperly stored dose of PROQUAD; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.  On 19-MAR-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant Human albumin (rHA) (PROQUAD) lot number R024015, expiration date on 19-FEB-2020 for prophylaxis (strength, dose number, anatomical location and route of administration was not reported). The sterile diluent used to reconstitute Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant Human albumin (rHA) (PROQUAD) was properly stored.  The temperatures were from 6  degrees Fahrenheit (°F) to 14°F for a timeframe of 10 hours and 35 minutes with a previous temperature excursion of 6°F to 14 °F for 9 hours and 5 minutes and from 15°F to 46°F for two hours and 30 minutes.  The temperature excursion was called because of a data logger and no adverse effects were reported.  This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA002418: US-009507513-1903USA011545:
Sex: F
Vaccine: HPV9
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (strength, lot #, expiry date, dose, frequency, route of administration, anatomical location were unknown) for prophylaxis. On an unknown date, also reported as soon after the vaccination, the patient experienced shingles. The outcome of herpes zoster was unknown. The reporter's causality was unknown. No product quality complaint (PQC) was associated with this report.
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This case was reported by a consumer (patient's friend) via call center representative and described the occurrence of rash zosteriform in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced rash zosteriform. On an unknown date, the outcome of the rash zosteriform was unknown. It was unknown if the reporter considered the rash zosteriform to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX last week from reporting date and at the time of reporting, the patient had rash on his side that looked like zoster. The reporter wanted to know if that rash was from SHINGRIX vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Inflammation, Pain, Synovial cyst
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of ganglion in a patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included complex regional pain syndrome (on upper extremities). On 21st March 2019, the patient received the 1st dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced ganglion, pain localized and inflammation localized. On an unknown date, the outcome of the ganglion, pain localized and inflammation localized were unknown. It was unknown if the reporter considered the ganglion, pain localized and inflammation localized to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was reported. The case was reported by the patient for themselves. The patient stated that they received the shingles vaccine 2 day ago before reporting on their thigh (unspecified) and the ganglion on the extremity the vaccine was put on was inflamed and painful. The patient wanted to know if it was normal. At the time of this report, it was unknown if the suspect vaccine was SHINGRIX or not.
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Immediate post-injection reaction
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of cough in a 70-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, immediately after receiving SHINGRIX, the patient experienced cough. On an unknown date, the outcome of the cough was unknown. It was unknown if the reporter considered the cough to be related to SHINGRIX. Additional details were provided as follows: The patient started coughing soon after the vaccination with SHINGRIX and kept coughing for 10-15 minutes. The reporter made the patient stayed until she stopped coughing. The patient coughed later the day, but could not remember if it was that night or not. The follow up would be requested.
Age: 61.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Headache, Insomnia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of generalized joint pain in a 61-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included PNEUMOCOCCAL VACCINE (PCV-13 PNEUMOCOCCAL VACCINE) for prophylaxis. On 6th February 2018, the patient received the 1st dose of SHINGRIX and the 1st dose of PCV-13 PNEUMOCOCCAL VACCINE. In February 2019, less than a week after receiving Shingrix, the patient experienced generalized joint pain, headache, chills, fatigue, nausea and difficulty sleeping. The patient was treated with ibuprofen. On an unknown date, the outcome of the generalized joint pain, headache, chills, fatigue, nausea and difficulty sleeping were unknown. It was unknown if the reporter considered the generalized joint pain, headache, chills, fatigue, nausea and difficulty sleeping to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the Nurse Practitioner. The patient received two vaccinations PCV-13 and a dose of SHINGRIX. On 7th February 2019, the patient walked in and complained on generalized joint pain, headache, chills, fatigue, and nausea, and trouble sleeping. The patient stated she had taken ibuprofen for symptoms.  No noticeable local adverse events. The nurse reviewed side effects of both vaccines with patient. The reporter agreed to be followed up.
Age: 61.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Nausea
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of generalized joint pain in a 61-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included PNEUMOCOCCAL VACCINE (PCV-13 PNEUMOCOCCAL VACCINE) for prophylaxis. On 6th February 2018, the patient received the 1st dose of SHINGRIX and the 1st dose of PCV-13 PNEUMOCOCCAL VACCINE. In February 2019, less than a week after receiving Shingrix, the patient experienced generalized joint pain, headache, chills, fatigue, nausea and difficulty sleeping. The patient was treated with ibuprofen. On an unknown date, the outcome of the generalized joint pain, headache, chills, fatigue, nausea and difficulty sleeping were unknown. It was unknown if the reporter considered the generalized joint pain, headache, chills, fatigue, nausea and difficulty sleeping to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the Nurse Practitioner. The patient received two vaccinations PCV-13 and a dose of SHINGRIX. On 7th February 2019, the patient walked in and complained on generalized joint pain, headache, chills, fatigue, and nausea, and trouble sleeping. The patient stated she had taken ibuprofen for symptoms.  No noticeable local adverse events. The nurse reviewed side effects of both vaccines with patient. The reporter agreed to be followed up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Hepatic enzyme increased
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of elevated liver enzymes in a 78-year-old female patient who received SHINGRIX for prophylaxis. In January 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced elevated liver enzymes. On an unknown date, the outcome of the elevated liver enzymes was not recovered/not resolved. It was unknown if the reporter considered the elevated liver enzymes to be related to SHINGRIX. Additional details were reported as follows: The patient received the vaccine in the 1st or 2nd week of January 2018. She had routine blood work done prior to the vaccine and levels were normal. The patient had more blood work done after getting the vaccine and her liver enzymes were elevated. The reporter consented to follow-up. Lab Comments: Lab test performed on an unknown date, prior and after vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 88-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced pain in arm, feeling unwell, fever and pain. On an unknown date, the outcome of the pain in arm, feeling unwell, fever and pain were recovered/resolved. It was unknown if the reporter considered the pain in arm, feeling unwell, fever and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 87 or 88 years. The batch number and expiry date was unknown. The patient received vaccine in unknown deltoid. The patient's arm felt really sore after vaccination and she felt pretty crappy for a couple days. She might have had a bit of a fever, was achy, and did not generally felt well. She felt very crummy. The patient did not mention exactly when they started, she just kept mentioning the next day. The patient did not report exactly when they resolved.