chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Scab
Clinical narrative: had some of the side effects headache; had some of the side effects fever; had some of the side effects shivering; neck ache the night of the shot.; next day my stomach was upset; Slight diarrhea; I noticed a couple bumps / one of my right arm one of my left arm and one on my back below my neck; I noticed a couple bumps that itch; small blister / one was like three little blisters; I must have scratched so they were scabs; shingles; This case was reported by a consumer via call center representative and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced headache, fever, chills, neck pain, upset stomach, diarrhea, vesicular rash, itchy rash, blister, scab and shingles. On an unknown date, the outcome of the headache, fever, chills, neck pain, upset stomach, diarrhea, vesicular rash, itchy rash, blister, scab and shingles were unknown.   It was unknown if the reporter considered the headache, fever, chills, neck pain, upset stomach, diarrhea, vesicular rash, itchy rash, blister, scab and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had headache, fever, shivering and neck ache the night of the shot. The patient also had  upset stomach, diarrhea, couple bumps that itch to little on right arm and left arm and one on back and below neck, small blister scratched so they were scabs. The patient asked is it possible aving a mild chicken pox like outbreak from the shot or these just belittle shingles and asked is this contagious.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: have been sick and not able to get second dose yet; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. Shingrix was discontinued. On an unknown date, the outcome of the sickness was not recovered/not resolved.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had been sick after 1st dose of Shingrix and not able to get the second shot. The patient asked do I have any immunity.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Chills, Fatigue, Gait disturbance, Headache
Clinical narrative: fever was 100F; FATIGUE; muscle weakness is in both legs / legs are still weak / weakness in legs; headaches; walking is not right; severe chills; This case was reported by a consumer via call center representative and described the occurrence of chills in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th December 2019, the patient received the 2nd dose of Shingrix. On 26th December 2019, less than a day after receiving Shingrix, the patient experienced chills. On 27th December 2019, the patient experienced fever, fatigue, muscle weakness lower limb, headache and gait disturbance. On 28th December 2019, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the chills was recovered/resolved and the outcome of the fatigue, muscle weakness lower limb, headache and gait disturbance were not recovered/not resolved.   It was unknown if the reporter considered the chills, fever, fatigue, muscle weakness lower limb, headache and gait disturbance to be related to Shingrix.  Additional details were provided as follows: The patient experienced severe chills the evening of the vaccination.   All other symptoms presented the following day. The fever was 100 Fahrenheit and lasted one day.   The chills resolved after that one night.  The muscle weakness was in both legs and was still present.  The headaches was slight but still present.   She plays golf and tennis and her legs were still weak and her walking was not right. The patient had blood work done weeks after the vaccine and the tests did not show any issues. Follow up was received by the physician and was unable to provide vaccine details due to another pharmacy administration of vaccine to patient. Did not consent to follow-up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Pyrexia
Clinical narrative: fever was 100F; FATIGUE; muscle weakness is in both legs / legs are still weak / weakness in legs; headaches; walking is not right; severe chills; This case was reported by a consumer via call center representative and described the occurrence of chills in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th December 2019, the patient received the 2nd dose of Shingrix. On 26th December 2019, less than a day after receiving Shingrix, the patient experienced chills. On 27th December 2019, the patient experienced fever, fatigue, muscle weakness lower limb, headache and gait disturbance. On 28th December 2019, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the chills was recovered/resolved and the outcome of the fatigue, muscle weakness lower limb, headache and gait disturbance were not recovered/not resolved.   It was unknown if the reporter considered the chills, fever, fatigue, muscle weakness lower limb, headache and gait disturbance to be related to Shingrix.  Additional details were provided as follows: The patient experienced severe chills the evening of the vaccination.   All other symptoms presented the following day. The fever was 100 Fahrenheit and lasted one day.   The chills resolved after that one night.  The muscle weakness was in both legs and was still present.  The headaches was slight but still present.   She plays golf and tennis and her legs were still weak and her walking was not right. The patient had blood work done weeks after the vaccine and the tests did not show any issues. Follow up was received by the physician and was unable to provide vaccine details due to another pharmacy administration of vaccine to patient. Did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Mild rashes at injection site in shoulder\ Mild rashes in torso\  Mild rashes in arms\Mild rashes in upper legs; . This case was reported by a nurse via call center representative and described the occurrence of rash in a elderly male patient who received Herpes zoster (Shingrix) (batch number 72F23, expiry date 31st March 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced mild rashes at injection site after 1st dose of Shingrix. She also specified that the rashes went from shoulder, arms, torso and upper legs. The healthcare professional (HCP) was not sure if it was the first dose. The reporter consented to follow up. This case has been linked with the case US2020042788, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: Mild rashes at injection site; small rash on the torso; This case was reported by a nurse via call center representative and described the occurrence of injection site rash in a elderly female patient who received Herpes zoster (Shingrix) (batch number 72F23, expiry date 31st March 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site rash and rash. On an unknown date, the outcome of the injection site rash and rash were unknown.   It was unknown if the reporter considered the injection site rash and rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced mild rashes at injection site and small rash in the torso after 1st dose of Shingrix. The healthcare professional (HCP) was not sure if it was the first dose. The reporter consented to follow up. This case has been linked with the case US2020042786, reported by the same reporter.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: received the first dose of Shingrix on 10/3/2019 and that she developed an outbreak of Shingles on 12/31/2019.; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 592DX, expiry date 6th December 2021) for prophylaxis.   On 3rd October 2019, the patient received the 1st dose of Shingrix. On 31st December 2019, 89 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 reported as follows: The patient received 1st dose of Shingrix and developed an outbreak of Shingles on 31st December 2019. The patient did not receive 2nd dose at the time of reporting. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Acute leukaemia, Fatigue, Myalgia, White blood cell count decreased
Clinical narrative: the white cell count has returned to normal at 5400, but noted that the increase was in cancer cells/ acute on chronic leukemia; he was absolutely exhausted; he had muscular pain for three months; This case was reported by a consumer via call center representative and described the occurrence of acute leukemia in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chronic leukemia.   On 20th September 2019, the patient received the 1st dose of Shingrix (intramuscular). In September 2019, 9 days after receiving Shingrix, the patient experienced acute leukemia (serious criteria GSK medically significant), exhaustion and myalgia. On an unknown date, the outcome of the acute leukemia was unknown and the outcome of the exhaustion and myalgia were recovered/resolved.   It was unknown if the reporter considered the acute leukemia, exhaustion and myalgia to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose of vaccine and stated that his white cell count went from 5500 to 8100 nine days after administration of  Shingrix. The patient reported that he was absolutely exhausted and that he had muscular pain for three months. He stated that the white cell count has returned to normal at 5400, but noted that the increase was in cancer cells.  The reporter did not consent to follow up.      Lab Comments: On an unknown date White blood cell count was measured and result was reported as 5400.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza, Lethargy, Muscular weakness, Myalgia, Nausea
Clinical narrative: Body aches and pains; muscle weakness; Muscle pain; Lethargy; Shaky; Severe nausea; Super worse case of flu; This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number 5DK5E, expiry date 13th March 2022) for prophylaxis.   On 21st January 2020, the patient received the 1st dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced general body pain, muscle weakness, muscle pain, lethargy, nausea, influenza and tremor. On an unknown date, the outcome of the general body pain, muscle weakness, muscle pain, lethargy and tremor were unknown and the outcome of the nausea and influenza were recovered/resolved.   It was unknown if the reporter considered the general body pain, muscle weakness, muscle pain, lethargy, nausea, influenza and tremor to be related to Shingrix.  Additional details were reported as follows: A pharmacist reported that a the patient experienced body aches and pains, muscle weakness, muscle pain, and lethargy. She also had severe nausea the 1st week after receiving the vaccine.  The patient experienced "super worse case of flu that went on for 1st two weeks after shot" and stated she was "shaky". Consented to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Tremor
Clinical narrative: Body aches and pains; muscle weakness; Muscle pain; Lethargy; Shaky; Severe nausea; Super worse case of flu; This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number 5DK5E, expiry date 13th March 2022) for prophylaxis.   On 21st January 2020, the patient received the 1st dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced general body pain, muscle weakness, muscle pain, lethargy, nausea, influenza and tremor. On an unknown date, the outcome of the general body pain, muscle weakness, muscle pain, lethargy and tremor were unknown and the outcome of the nausea and influenza were recovered/resolved.   It was unknown if the reporter considered the general body pain, muscle weakness, muscle pain, lethargy, nausea, influenza and tremor to be related to Shingrix.  Additional details were reported as follows: A pharmacist reported that a the patient experienced body aches and pains, muscle weakness, muscle pain, and lethargy. She also had severe nausea the 1st week after receiving the vaccine.  The patient experienced "super worse case of flu that went on for 1st two weeks after shot" and stated she was "shaky". Consented to follow up.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Dizziness, Influenza like illness
Clinical narrative: Flu like symptoms; light headedness; whole body weakness; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th March 2020, the patient received the 2nd dose of Shingrix. In March 2020, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, light headedness and weakness generalized. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the light headedness and weakness generalized were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, light headedness and weakness generalized to be related to Shingrix.  Additional details were provided as follows: On 11th March 2020, about 12 to 18 hours after he received the vaccine he experienced flu like symptoms that lasted 36 hours. He also had light headedness and weakness that started about the same time, but those continue today (27th March 2020). He noted the weakness was whole body weakness. He was encouraged to speak with his physician about the continued issues.  Consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Influenza like illness
Clinical narrative: Feeling lightheaded; Flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 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 light headedness. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the light headedness was not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms and light headedness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The consumer reports having a moderate reaction following Shingrix vaccine that included flu-like symptoms for approximately 36 hours and feeling lightheaded on an ongoing basis, and that this lightheaded feeling only occurred after receiving Shingrix. No history of this before. Limited information provided. Call abruptly disconnected while consumer speaking. Caller did not provide any demographic information during briefness of the call.
Age: 53.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Feeling cold, Feeling hot, Hyperhidrosis, Migraine
Clinical narrative: I revieved the vaccine about 09:15 and felt fine all day other than a sore arm. At about 21:00 I started having teeth chattering rigors  and just could not get warm . At about 01:00 it stopped and a massive migraine across my forehead and the back of my head basically ear to ear. I took 650mg of tylenol and about 30 minutes later I started burning up and sweating, which continued for about 4 hours. I didn't have any upper respitatory symptoms and I didn't measure my temperature.  As of 0800 the following morning I still have the migraine.
Age: 53.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: I revieved the vaccine about 09:15 and felt fine all day other than a sore arm. At about 21:00 I started having teeth chattering rigors  and just could not get warm . At about 01:00 it stopped and a massive migraine across my forehead and the back of my head basically ear to ear. I took 650mg of tylenol and about 30 minutes later I started burning up and sweating, which continued for about 4 hours. I didn't have any upper respitatory symptoms and I didn't measure my temperature.  As of 0800 the following morning I still have the migraine.
Age: 53.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills
Clinical narrative: I revieved the vaccine about 09:15 and felt fine all day other than a sore arm. At about 21:00 I started having teeth chattering rigors  and just could not get warm . At about 01:00 it stopped and a massive migraine across my forehead and the back of my head basically ear to ear. I took 650mg of tylenol and about 30 minutes later I started burning up and sweating, which continued for about 4 hours. I didn't have any upper respitatory symptoms and I didn't measure my temperature.  As of 0800 the following morning I still have the migraine.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Swelling, Vaccine positive rechallenge
Clinical narrative: Pt received second dose of vaccine on 3/29/20 and began to notice swelling and inflammation following day and reported to ER. Adverse effect consistent frist dose reaction. MD at ER administered IV antibiotic and pt was discharged. Pt says she is feeling better and monitoring site.
Sex: U
Vaccine: MMR, UNK
Symptoms: Incorrect route of product administration
Clinical narrative: the patient was administered a dose ofMMRII by intramuscular injection on 3/27/2020; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were unknown.      On 27-MAR-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # S013539, expiration date 02-MAY-2021; strength and dose were unknown) by intramuscular injection for prophylaxis (PT: incorrect route of product administration).  Other suspect therapies included sterile diluent (STERILE DILUENT) (dose details were not provided).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction, Rash erythematous, Rash vesicular
Clinical narrative: first Shingrix injection on 11/14/2019. She received the second Shingrix injection intramuscularly in unspecified deltoid on 3/5/2020; red spot coming up" over her eyebrow; This case was reported by a consumer via call center representative and described the occurrence of vesicular rash in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (prior outbreak of shingles previously 9 years ago above her eyebrow). Previously administered products included Shingrix (1st dose received on 14th November 2019).   On 5th March 2020, the patient received the 2nd dose of Shingrix. In March 2020, immediately after receiving Shingrix, the patient experienced vesicular rash and red rash. On an unknown date, the outcome of the vesicular rash and red rash were not recovered/not resolved.   It was unknown if the reporter considered the vesicular rash and red rash to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient could be 62 years or 63 years of age. The reporter did not wish to provide her exact date of birth. The reporter was not able to locate a lot number on her paperwork from the pharmacy but did provide the pharmacy phone number, since they will have the lot number on file. Since receiving the shot of Shingrix in an unknown deltoid, the patient had noticed a red spot coming up over her eyebrow. She said she knew that it has to be shingles.  She showed it to the pharmacist where she got her Shingrix and the pharmacist said it looks like shingles. The reporter did not wish to provide her medical doctor contact information. Did not consent to follow-up.
Age: 1.58
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt having some redness, and slight swelling at around immunization site
Age: 50.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Paraesthesia, Pharyngeal swelling, Throat irritation
Clinical narrative: Pt. had cortisone injection (L) shoulder on 3-10-20. Pneumovax, Boostrix, Shingrix given 3-13-20. On 3-15-20 Felt scratchy throat, seemed swollen, facial tingling, Took 2 Benadryl, then napped. Sx resolved. Today 3-16-20 Had facial tingling again. Advised 2 Benadryl.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Chills, Headache, Inflammation, Injection site erythema
Clinical narrative: Patient c/o Swelling, redness, warm to touch in injection area, can't lift arm, chills, back pain, and Headache Dr. advised patient to manage with ice and Tylenol 650 mg every 8 hours, add Advil 800 every 8 hours if needed This is an inflammatory response and should be self limited.
Age: 24.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Mobility decreased
Clinical narrative: Patient c/o Swelling, redness, warm to touch in injection area, can't lift arm, chills, back pain, and Headache Dr. advised patient to manage with ice and Tylenol 650 mg every 8 hours, add Advil 800 every 8 hours if needed This is an inflammatory response and should be self limited.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information was received from a lawyer regarding a case in litigation referring to a 68 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In December 2010, the patient was vaccinated with zoster vaccine live(ZOSTAVAX)(strength, route, dosage schedule, lot number and expiration date were not reported) for prophylaxis. As a result of receipt of zoster vaccine live(ZOSTAVAX), also in December 2010, patient was caused to suffer shingles, including any and all of its sequelae. As a result of receipt of zoster vaccine live(ZOSTAVAX), patient has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).  As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information was received from a lawyer regarding a case in litigation referring to a 71 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 24-SEP-2015, the patient was vaccinated with zoster vaccine live(ZOSTAVAX)(strength, route, dosage schedule, lot number and expiration date were not reported) for prophylaxis. As a result of receipt of zoster vaccine live(ZOSTAVAX), on 09-OCT-2015, patient was caused to suffer shingles, including any and all of its sequelae. As a result of receipt of zoster vaccine live(ZOSTAVAX), patient has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).  As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information was received from a lawyer regarding a case in litigation and refers to a 60 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 04-OCT-2010, the patient was vaccinated with zoster vaccine live(ZOSTAVAX)(strength, route, dosage schedule, lot number and expiration date were not reported) for prophylaxis. As a result of receipt of zoster vaccine live(ZOSTAVAX), in November 2010, patient was caused to suffer shingles, including any and all of its sequelae. As a result of the receipt of zoster vaccine live(ZOSTAVAX), patient has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).  As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications.
Sex: F
Vaccine: PPV
Symptoms: Insomnia, Limb discomfort, Mobility decreased, Pain in extremity
Clinical narrative: arm was uncomfortable and sore; arm was uncomfortable and sore/the pain was unbearable, it felt like someone punched my arm; Indication: Covid-19; I can barely lift my arm to take off my shirt; By the time I went to bed I could barely sleep; The spot where I received it is swollen and hot to the touch; The spot where I received it is swollen and hot to the touch; This spontaneous report was received from a 47-year-old female patient reporting on herself. The patient's concurrent conditions included allergy induced asthma. Drug reactions or allergies included allergy to tetracycline. Pertinent medical history was not provided.  On 24-MAR-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) one dose, administered in the right arm (exact dose, frequency, route of administration, lot# and expiration date were not provided) as she had asthma and was nervous about getting Covid-19.   After the vaccination, her arm was uncomfortable and sore. By the time she went to bed she could barely sleep, and the pain was unbearable. It felt like someone punched arm. She could barely lift her arm to take off her shirt. The spot where she received the vaccine was swollen and hot to touch. The patient took acetaminophen (TYLENOL) to treat the events. No laboratory diagnostics or studies were performed. The patient did not seek for medical attention. The outcome of the events was reported as not recovered.  The relatedness between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Inadvertent administration of dose of ROTATEQ two weeks after the previous dose; No adverse effects reported; This spontaneous report was received from a pharmacy intern and refers to a 32 week old premature patient. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug allergies and reactions was provided.  On an unknown date, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (exact dose, dose number, lot # and expiration date was not provided) for prophylaxis. On an unknown date, reported as two weeks later, the patient was inadvertently vaccinated with another dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (exact dose, dose number, lot # and expiration date was not provided) for prophylaxis as opposed to the recommended regimen. No adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received regarding a case in litigation concerning patient of unknown age and gender. In 2010, patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not reported), as prescribed and/or administered by a healthcare provider at the medical office of a physician for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, patient was treated by a healthcare provider at the medical office for shingles. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The relatedness between the adverse event and zoster vaccine live (ZOSTAVAX) was reported as related.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site pain, Nausea, Pyrexia
Clinical narrative: soreness at the injection site; fever; headache; nausea; felt like she had the flu for 2 days; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (for tolerance to the 1st dose refer case US2020029075).   In November 2019, 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, influenza-like symptoms, fever, headache and nausea. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, fever, headache and nausea were resolved with sequelae and the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the injection site pain, influenza-like symptoms, fever, headache and nausea to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix and felt like she had the flu for 2 days, fever, headache, nausea, soreness at the injection site and was in bed for 10 straight hours.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: soreness at the injection site; fever; headache; nausea; felt like she had the flu for 2 days; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (for tolerance to the 1st dose refer case US2020029075).   In November 2019, 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, influenza-like symptoms, fever, headache and nausea. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, fever, headache and nausea were resolved with sequelae and the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the injection site pain, influenza-like symptoms, fever, headache and nausea to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix and felt like she had the flu for 2 days, fever, headache, nausea, soreness at the injection site and was in bed for 10 straight hours.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: rash in the injection site several days after receiving SHINGRIX; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 5 days after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced injection site rash after vaccination. The patient would like no know how to proceed with 2nd dose.
Sex: U
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: 2nd shot yesterday-now fever; 2nd shot yesterday-now body aches /sore; nausea; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, general body pain and nausea. On an unknown date, the outcome of the fever, general body pain and nausea were unknown.   It was unknown if the reporter considered the fever, general body pain and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccinae indication. The reporter stated that, after vaccination had fever, general body pain and nausea. For the tolerence of 2nd dose refer case US2020AMR047393, reported by same reporter for the same patient.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: If the person giving me the shot, pushed the medicine in slowly instead at lightening speed, would my sore arm feel better?; This case was reported by a consumer and described the occurrence of pain in arm in a 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 pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient itself. The age at vaccination was not reported. The patient received shingrix vaccine and experienced sore arm. The patient wanted to know if the person who gave the vaccine shot, pushed the medicine in slowly instead at lightening speed, would the sore arm  would have been feel better. No other information was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash; This case was reported by a other health professional via interactive digital media and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter stated that the patient experienced rash after vaccination.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Light rash on her neck/itching; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 88-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 9th March 2020, the patient received Shingles vaccine. On 20th March 2020, 11 days after receiving Shingles vaccine, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was unknown.   It was unknown if the reporter considered the itchy rash to be related to Shingles vaccine.  Additional case details were reported as follows: The case was reported by patient's child. The reporter stated that the patient experienced itching and a light rash on her neck. The reporter asked could this be a side effect of the cabinet.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia, Mobility decreased, Muscular weakness, Tremor
Clinical narrative: pain at the shot site / cannot sleep at night because of the intense pain at the site; Sleeplessness; Cannot raise by hand than 45 degrees from the resting position; Hand has become weak and shakes uncontrollably; Hand has become weak and shakes uncontrollably; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th October 2019, the patient received the 2nd dose of Shingrix. On 14th October 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, sleeplessness, mobility decreased, hands weakness of and tremor of hands. On an unknown date, the outcome of the injection site pain, sleeplessness, mobility decreased, hands weakness of and tremor of hands were unknown.   It was unknown if the reporter considered the injection site pain, sleeplessness, mobility decreased, hands weakness of and tremor of hands to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had pain at the shot site and cannot sleep at night because of the intense pain at the site. The patient cannot raise hand more than 45 degrees from the resting position. The patient hand had become weak and shakes uncontrollably. The patient asked if one of the side effects of the shot and can it be cured by some anti-dote treatment to the shot.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: fever; chills; headache; injection site pain /sore arm; injection site swelling; muscle weakness; tiredness /extremely tired; This case was reported by a consumer via call center representative and described the occurrence of fever in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced fever, chills, headache, injection site pain, injection site swelling, muscle weakness and tiredness. On an unknown date, the outcome of the fever, chills, headache, injection site pain, injection site swelling, muscle weakness and tiredness were recovered/resolved.   It was unknown if the reporter considered the fever, chills, headache, injection site pain, injection site swelling, muscle weakness and tiredness to be related to Shingrix.  Additional case details were reported as follows: The patient experienced fever, chills, headache, injection site pain, injection site swelling, muscle weakness and tiredness after vaccination. The patient consented to follow up.   Follow up information was received from the consumer on 20th February 2020: The patient reported that received the 2nd dose and experienced events, refer case US2020AMR044175.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Pyrexia
Clinical narrative: fever; chills; headache; injection site pain /sore arm; injection site swelling; muscle weakness; tiredness /extremely tired; This case was reported by a consumer via call center representative and described the occurrence of fever in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced fever, chills, headache, injection site pain, injection site swelling, muscle weakness and tiredness. On an unknown date, the outcome of the fever, chills, headache, injection site pain, injection site swelling, muscle weakness and tiredness were recovered/resolved.   It was unknown if the reporter considered the fever, chills, headache, injection site pain, injection site swelling, muscle weakness and tiredness to be related to Shingrix.  Additional case details were reported as follows: The patient experienced fever, chills, headache, injection site pain, injection site swelling, muscle weakness and tiredness after vaccination. The patient consented to follow up.   Follow up information was received from the consumer on 20th February 2020: The patient reported that received the 2nd dose and experienced events, refer case US2020AMR044175.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Headache, Influenza like illness
Clinical narrative: experienced fatigue / she is still a little tired today; experienced shivering; experienced fever; experienced flu like symptoms; experienced headache; experienced dizziness; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th March 2020, the patient received the 2nd dose of Shingrix (intramuscular). In March 2020, less than a week after receiving Shingrix, the patient experienced shivering, fever, influenza-like symptoms, headache, dizziness and fatigue. On an unknown date, the outcome of the shivering, fever, influenza-like symptoms, headache and dizziness were recovered/resolved and the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the shivering, fever, influenza-like symptoms, headache, dizziness and fatigue to be related to Shingrix.  Additional case details were reported as follows: The patient received second dose of Shingrix and experienced shivering, fever, flu like syndrome, headache, dizziness and fatigue. The patient consented to follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: experienced fatigue / she is still a little tired today; experienced shivering; experienced fever; experienced flu like symptoms; experienced headache; experienced dizziness; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th March 2020, the patient received the 2nd dose of Shingrix (intramuscular). In March 2020, less than a week after receiving Shingrix, the patient experienced shivering, fever, influenza-like symptoms, headache, dizziness and fatigue. On an unknown date, the outcome of the shivering, fever, influenza-like symptoms, headache and dizziness were recovered/resolved and the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the shivering, fever, influenza-like symptoms, headache, dizziness and fatigue to be related to Shingrix.  Additional case details were reported as follows: The patient received second dose of Shingrix and experienced shivering, fever, flu like syndrome, headache, dizziness and fatigue. The patient consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Nodule
Clinical narrative: painful nodule distal to the site of the injection; This case was reported by a physician via call center representative and described the occurrence of painful nodule in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced painful nodule. On an unknown date, the outcome of the painful nodule was recovered/resolved.   It was unknown if the reporter considered the painful nodule to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter stated that the patient had a painful nodule distal to the site of the injection in the wrist for 1 month , after receiving the 2nd dose of Shingrix. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Nausea
Clinical narrative: headache; nausea; mild flu-like symptoms; shivering; This case was reported by a consumer via call center representative and described the occurrence of headache in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknonw date 3 months before day of reporting).   On 9th March 2020 10:00, the patient received the 2nd dose of Shingrix (intramuscular). On 9th March 2020, less than a day after receiving Shingrix, the patient experienced headache, nausea, influenza-like symptoms and shivering. On an unknown date, the outcome of the headache, nausea, influenza-like symptoms and shivering were recovering/resolving.   It was unknown if the reporter considered the headache, nausea, influenza-like symptoms and shivering to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix at 10 AM the day before reporting and experienced headache, nausea, influenza-like symptoms and shivering in the middle of the night.   The patient never had a response like this from a vaccine before.  Till the time of reporting she was still experiencing some mild flu-like symptoms. The reporter consented to follow up.