chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: FLUA3, HEPA, PPV
Symptoms: Contusion, Feeling cold, Feeling hot, Hyperhidrosis, Mobility decreased
Clinical narrative: The evening of the day I received the vaccine, I developed severe pain and loss of mobility in my left arm. It has persisted to present and made sleeping very difficult. The first night, the pain was really extreme. I didn't even have to move the arm for it to hurt in several different places. It remains difficult to lift and use today, and I can't use the arm without pain. Something like putting a shirt on is now very difficult. The site is swollen and red (splotchy), and tender to the touch with some bruising. I don't have a fever when I check my temperature, but woke up having soaked everything with sweat. I've been sweating a lot, and feeling either hot or cold. I've taken one does of Tylenol for it, and then switched to ibuprofen (at least before bed, and sometimes when I wake up in the night, or during the day).
Age: 27.0
Sex: F
Vaccine: FLUA3, HEPA, PPV
Symptoms: Pain, Pain in extremity, Pain of skin, Rash macular, Sleep disorder
Clinical narrative: The evening of the day I received the vaccine, I developed severe pain and loss of mobility in my left arm. It has persisted to present and made sleeping very difficult. The first night, the pain was really extreme. I didn't even have to move the arm for it to hurt in several different places. It remains difficult to lift and use today, and I can't use the arm without pain. Something like putting a shirt on is now very difficult. The site is swollen and red (splotchy), and tender to the touch with some bruising. I don't have a fever when I check my temperature, but woke up having soaked everything with sweat. I've been sweating a lot, and feeling either hot or cold. I've taken one does of Tylenol for it, and then switched to ibuprofen (at least before bed, and sometimes when I wake up in the night, or during the day).
Age: 27.0
Sex: F
Vaccine: FLUA3, HEPA, PPV
Symptoms: Swelling
Clinical narrative: The evening of the day I received the vaccine, I developed severe pain and loss of mobility in my left arm. It has persisted to present and made sleeping very difficult. The first night, the pain was really extreme. I didn't even have to move the arm for it to hurt in several different places. It remains difficult to lift and use today, and I can't use the arm without pain. Something like putting a shirt on is now very difficult. The site is swollen and red (splotchy), and tender to the touch with some bruising. I don't have a fever when I check my temperature, but woke up having soaked everything with sweat. I've been sweating a lot, and feeling either hot or cold. I've taken one does of Tylenol for it, and then switched to ibuprofen (at least before bed, and sometimes when I wake up in the night, or during the day).
Age: 76.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Patient developed chills, fever (101.4), pain/aches in legs.  Patient took tylenol and aspirin and went to sleep.  Within 6 hours, symptoms had resolved.
Age: 63.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia, Somnolence
Clinical narrative: Rigors, fever, extreme fatigue and sleepy, slightly achy. Completely unable to do anything for 24 hrs and less severe symptoms for another 12 hours.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV1, UNK
Symptoms: Abdominal pain, Dyschezia, Irritability, Physical examination, Poor feeding infant
Clinical narrative: Started having abdominal pain whenever having a bowel movement, fussy at breast, rectal prolapse. Still in the middle of treatment plan with GI doctor.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV1, UNK
Symptoms: Rectal prolapse, X-ray
Clinical narrative: Started having abdominal pain whenever having a bowel movement, fussy at breast, rectal prolapse. Still in the middle of treatment plan with GI doctor.
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Cough, Fatigue, Feeling cold, Headache, Heart rate increased
Clinical narrative: Sore throat Runny and stuffy nose Fever of 101.3 for 48 hrs Chills Muscle aches Fatigue Cough Headache Sneezing Fast heart rate
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: Myalgia, Nasal congestion, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: Sore throat Runny and stuffy nose Fever of 101.3 for 48 hrs Chills Muscle aches Fatigue Cough Headache Sneezing Fast heart rate
Age: 35.0
Sex: F
Vaccine: FLUC4
Symptoms: SARS-CoV-2 test negative, Sneezing
Clinical narrative: Sore throat Runny and stuffy nose Fever of 101.3 for 48 hrs Chills Muscle aches Fatigue Cough Headache Sneezing Fast heart rate
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Scab, Skin disorder
Clinical narrative: Patient stated about 1&1/2 weeks after vaccination noticed under her arm a redness, scalding area that has a large scab. It healed on it's own without a visit to the physician. I was able to visually inspect the area and seen the remnants which looked like the area was scalded but healing. Patient stated no other symptoms from the vaccination.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness, pain around injection site
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: Patient called and reported that she had a reaction of dizziness shortly after the vaccine but after leaving my store. She took and antihistamine and had no further reactions.
Age: 82.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Pain
Clinical narrative: 09/21/2020 PATIENT PRESENTED WITH AN ERYTHMEA AROUND THE SITE OF INJECTION  THE ERYTHMEA COVERED A FIST SIZE AREA AROUND THE SHOT. PATIENT WAS AFEBRIL, COMPLAINED OF SOAERNESS AND PAIN. 09/25/2020, 3:30 PM TALKED TO PATIENT ON THE PHONE, SHE REPORTED THAT HER SORENESS WAS SUBSIDING. THE ERYTHMEA HAD GONE DOWN IN SIZE
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: Pt. experience swelling at arm, experience nausea, chills, and pain on arm. (left) at the night after receiving vaccination pt. received Pneumovax 23 on left arm
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: burning sensation, pain/soreness in left arm since vaccine administered
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: injection site problems with Shingrix; This case was reported by a consumer and described the occurrence of injection site reaction in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown.   It was unknown if the reporter considered the injection site reaction to be related to Shingrix.  Additional details were as follows: The age at vaccination was not applicable The reporter mentioned that she read online that after receiving dose of Shingrix, some people do experienced injection site problems. The reporter consented to follow up. This case has been linked with US2019180830 and US2019231608 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019180830:same reporter US-GLAXOSMITHKLINE-US2019231608:same reporter
Sex: F
Vaccine: FLU4, VARZOS, VARZOS, FLU4, VARZOS
Symptoms: Blister, Burning sensation, Contusion, Musculoskeletal pain, Pain
Clinical narrative: pain on front and back torso when showering; I'm actually getting shingles from the vaccine first dose; rash / started on buttocks / spread to crotch/labia; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) (batch number 57EX2, expiry date 26th March 2022) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   On 19th August 2020, the patient received the 1st dose of Shingrix (intramuscular) and Fluarix Quadrivalent 2019-2020 season. On 20th August 2020, 1 days after receiving Shingrix and Fluarix Quadrivalent 2019-2020 season, the patient experienced shingles and rash. On an unknown date, the patient experienced pain. The patient was treated with valaciclovir hydrochloride (Valacyclovir) and gabapentin. On an unknown date, the outcome of the shingles and rash were not recovered/not resolved and the outcome of the pain was unknown.   It was unknown if the reporter considered the shingles, rash and pain to be related to Shingrix and Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. On 19th August 2020, the patient received Shingrix in left deltoid and Fluarix (lot unknown) in the right arm. The patient reported a rash the next day started on buttocks and spread to crotch/labia. The patient took Valacyclovir 3 times a day for 10 days and gabapentin to treat the rash. The rash was not fully healed. The patient reported pain on front and back torso when showering. The reporter mentioned it was very helpful and compassionate with her issue. Even though the issue was not completely resolved the patient was pointed in the right direction. Since it appeared to the patient that she was a random case of actually getting shingles from the vaccine, at least after the first dose and did not knew if the patient should have a second dose or not. The patient was pointed to the direction of infectious disease doctor to look into that further. The reporter consented to follow up.
Sex: F
Vaccine: FLU4, VARZOS, VARZOS, FLU4, VARZOS
Symptoms: Rash
Clinical narrative: pain on front and back torso when showering; I'm actually getting shingles from the vaccine first dose; rash / started on buttocks / spread to crotch/labia; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) (batch number 57EX2, expiry date 26th March 2022) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   On 19th August 2020, the patient received the 1st dose of Shingrix (intramuscular) and Fluarix Quadrivalent 2019-2020 season. On 20th August 2020, 1 days after receiving Shingrix and Fluarix Quadrivalent 2019-2020 season, the patient experienced shingles and rash. On an unknown date, the patient experienced pain. The patient was treated with valaciclovir hydrochloride (Valacyclovir) and gabapentin. On an unknown date, the outcome of the shingles and rash were not recovered/not resolved and the outcome of the pain was unknown.   It was unknown if the reporter considered the shingles, rash and pain to be related to Shingrix and Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. On 19th August 2020, the patient received Shingrix in left deltoid and Fluarix (lot unknown) in the right arm. The patient reported a rash the next day started on buttocks and spread to crotch/labia. The patient took Valacyclovir 3 times a day for 10 days and gabapentin to treat the rash. The rash was not fully healed. The patient reported pain on front and back torso when showering. The reporter mentioned it was very helpful and compassionate with her issue. Even though the issue was not completely resolved the patient was pointed in the right direction. Since it appeared to the patient that she was a random case of actually getting shingles from the vaccine, at least after the first dose and did not knew if the patient should have a second dose or not. The patient was pointed to the direction of infectious disease doctor to look into that further. The reporter consented to follow up.
Sex: F
Vaccine: FLU4, VARZOS, VARZOS, FLU4, VARZOS
Symptoms: Genital blister, Genital rash, Musculoskeletal pain, Pain in extremity
Clinical narrative: pain on front and back torso when showering; I'm actually getting shingles from the vaccine first dose; rash / started on buttocks / spread to crotch/labia; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) (batch number 57EX2, expiry date 26th March 2022) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   On 19th August 2020, the patient received the 1st dose of Shingrix (intramuscular) and Fluarix Quadrivalent 2019-2020 season. On 20th August 2020, 1 days after receiving Shingrix and Fluarix Quadrivalent 2019-2020 season, the patient experienced shingles and rash. On an unknown date, the patient experienced pain. The patient was treated with valaciclovir hydrochloride (Valacyclovir) and gabapentin. On an unknown date, the outcome of the shingles and rash were not recovered/not resolved and the outcome of the pain was unknown.   It was unknown if the reporter considered the shingles, rash and pain to be related to Shingrix and Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. On 19th August 2020, the patient received Shingrix in left deltoid and Fluarix (lot unknown) in the right arm. The patient reported a rash the next day started on buttocks and spread to crotch/labia. The patient took Valacyclovir 3 times a day for 10 days and gabapentin to treat the rash. The rash was not fully healed. The patient reported pain on front and back torso when showering. The reporter mentioned it was very helpful and compassionate with her issue. Even though the issue was not completely resolved the patient was pointed in the right direction. Since it appeared to the patient that she was a random case of actually getting shingles from the vaccine, at least after the first dose and did not knew if the patient should have a second dose or not. The patient was pointed to the direction of infectious disease doctor to look into that further. The reporter consented to follow up.
Sex: F
Vaccine: FLU4, VARZOS, VARZOS, FLU4, VARZOS
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: pain on front and back torso when showering; I'm actually getting shingles from the vaccine first dose; rash / started on buttocks / spread to crotch/labia; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) (batch number 57EX2, expiry date 26th March 2022) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   On 19th August 2020, the patient received the 1st dose of Shingrix (intramuscular) and Fluarix Quadrivalent 2019-2020 season. On 20th August 2020, 1 days after receiving Shingrix and Fluarix Quadrivalent 2019-2020 season, the patient experienced shingles and rash. On an unknown date, the patient experienced pain. The patient was treated with valaciclovir hydrochloride (Valacyclovir) and gabapentin. On an unknown date, the outcome of the shingles and rash were not recovered/not resolved and the outcome of the pain was unknown.   It was unknown if the reporter considered the shingles, rash and pain to be related to Shingrix and Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. On 19th August 2020, the patient received Shingrix in left deltoid and Fluarix (lot unknown) in the right arm. The patient reported a rash the next day started on buttocks and spread to crotch/labia. The patient took Valacyclovir 3 times a day for 10 days and gabapentin to treat the rash. The rash was not fully healed. The patient reported pain on front and back torso when showering. The reporter mentioned it was very helpful and compassionate with her issue. Even though the issue was not completely resolved the patient was pointed in the right direction. Since it appeared to the patient that she was a random case of actually getting shingles from the vaccine, at least after the first dose and did not knew if the patient should have a second dose or not. The patient was pointed to the direction of infectious disease doctor to look into that further. The reporter consented to follow up.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Blister, Headache, Impaired work ability, Pain
Clinical narrative: Per customer, severe rashes, bumps and blisters developed a few days after his second dose of shingrix. He wen to the emergency room where hes was treated, and then followed up with his primary care provider. According to him, his doctors told him the condition was an adverse reaction to the shingrix vaccine. His primary care provider also precribed some medications to help. The patient came back to the pharmacy about two week after onset of the reaction, just to notify the pharmacist of what had happen.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Rash, Swelling
Clinical narrative: Per customer, severe rashes, bumps and blisters developed a few days after his second dose of shingrix. He wen to the emergency room where hes was treated, and then followed up with his primary care provider. According to him, his doctors told him the condition was an adverse reaction to the shingrix vaccine. His primary care provider also precribed some medications to help. The patient came back to the pharmacy about two week after onset of the reaction, just to notify the pharmacist of what had happen.
Age: 72.0
Sex: M
Vaccine: FLUA4, FLUA4, TDAP
Symptoms: Dizziness, Fall, Head injury, Loss of consciousness, Suture insertion
Clinical narrative: 8/28/21 - I got up to fix breakfast after a shower. I suddenly felt nauseated and became dizzy. I apparently passed out on the kitchen floor. I hit my head, sustaining a wound. My son took me to the local ER for evaluation
Age: 72.0
Sex: M
Vaccine: FLUA4, FLUA4, TDAP
Symptoms: Blood test, Computerised tomogram, Dizziness, Head injury, Loss of consciousness
Clinical narrative: 8/28/21 - I got up to fix breakfast after a shower. I suddenly felt nauseated and became dizzy. I apparently passed out on the kitchen floor. I hit my head, sustaining a wound. My son took me to the local ER for evaluation
Age: 72.0
Sex: M
Vaccine: FLUA4, FLUA4, TDAP
Symptoms: Nausea, Wound
Clinical narrative: 8/28/21 - I got up to fix breakfast after a shower. I suddenly felt nauseated and became dizzy. I apparently passed out on the kitchen floor. I hit my head, sustaining a wound. My son took me to the local ER for evaluation
Age: 66.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Blood test normal, Chest discomfort, Cough, Fatigue, Headache
Clinical narrative: the next day she experienced flu-like symptoms,; the next day she experienced flu-like symptoms, uncontrollable trembling/shakes,; malaise; chest pain; tightness in her chest; chills; insomnia; nasal discharge; severe tiredness; severe headaches; coughing; hives on her chest, arms, and legs; fever; This spontaneous report was received from a 66-year-old female patient who reported on herself. Her pertinent medical history included undereactive thyroid, she was allergic to monosodium glutamate (MSG) and other food additives. Concomitant therapies included levothyroxine sodium (SYNTHROID). On 10-FEB-2020, she was vaccinated with the first dose of hepatitis A virus vaccine inactivated (HAVRIX) administered intramuscularly (exact dose, injection site, expiration date and lot number were not provided) as a travel precaution. It was reported, that the patient experienced the same symptoms with the vaccine as she did with hepatitis a vaccine, inactivated (VAQTA) in addition to experiencing diarrhea, vomiting, and nausea.    On 27-AUG-2020, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) injection, lot # reported as S03694, intramuscularly (exact dose reported as 1 injection, expiration date and anatomical location were not provided) for prophylaxis.     On 28-AUG-2020, reported as the next day, she experienced flu-like symptoms, uncontrollable trembling/shakes, chills, fever, nasal discharge, severe tiredness, severe headaches, malaise, insomnia, hives on her chest, arms, and legs, chest pain, tightness in her chest and coughing. The reporter stated she sought medical attention on 08-SEP-2020 for the symptoms she experienced with the vaccine. On an unknown date in September 2020, she was tested for COVID-19 and the results were negative. She started taking guaifenesin (ROBITUSSIN) and acetaminophen (COLD AND FLU RELIEF) to treat her symptoms (also reported as concomitant medication). It was reported that the patient recovered from most of the events on an unknown date in 2020. However, she was still experiencing chest pain and coughing. The reporter provided contact information for the healthcare professional (HCP) office where she received the vaccine from. However, she was unable to provide the name of the person who prescribed the vaccine.  Causality between the events and hepatitis a vaccine, inactivated (VAQTA) was not reported.
Age: 66.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Influenza like illness, Pyrexia, SARS-CoV-2 test negative, Urticaria
Clinical narrative: the next day she experienced flu-like symptoms,; the next day she experienced flu-like symptoms, uncontrollable trembling/shakes,; malaise; chest pain; tightness in her chest; chills; insomnia; nasal discharge; severe tiredness; severe headaches; coughing; hives on her chest, arms, and legs; fever; This spontaneous report was received from a 66-year-old female patient who reported on herself. Her pertinent medical history included undereactive thyroid, she was allergic to monosodium glutamate (MSG) and other food additives. Concomitant therapies included levothyroxine sodium (SYNTHROID). On 10-FEB-2020, she was vaccinated with the first dose of hepatitis A virus vaccine inactivated (HAVRIX) administered intramuscularly (exact dose, injection site, expiration date and lot number were not provided) as a travel precaution. It was reported, that the patient experienced the same symptoms with the vaccine as she did with hepatitis a vaccine, inactivated (VAQTA) in addition to experiencing diarrhea, vomiting, and nausea.    On 27-AUG-2020, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) injection, lot # reported as S03694, intramuscularly (exact dose reported as 1 injection, expiration date and anatomical location were not provided) for prophylaxis.     On 28-AUG-2020, reported as the next day, she experienced flu-like symptoms, uncontrollable trembling/shakes, chills, fever, nasal discharge, severe tiredness, severe headaches, malaise, insomnia, hives on her chest, arms, and legs, chest pain, tightness in her chest and coughing. The reporter stated she sought medical attention on 08-SEP-2020 for the symptoms she experienced with the vaccine. On an unknown date in September 2020, she was tested for COVID-19 and the results were negative. She started taking guaifenesin (ROBITUSSIN) and acetaminophen (COLD AND FLU RELIEF) to treat her symptoms (also reported as concomitant medication). It was reported that the patient recovered from most of the events on an unknown date in 2020. However, she was still experiencing chest pain and coughing. The reporter provided contact information for the healthcare professional (HCP) office where she received the vaccine from. However, she was unable to provide the name of the person who prescribed the vaccine.  Causality between the events and hepatitis a vaccine, inactivated (VAQTA) was not reported.
Age: 66.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Chest discomfort, Chest pain, Chills, Cough, Fatigue
Clinical narrative: the next day she experienced flu-like symptoms,; the next day she experienced flu-like symptoms, uncontrollable trembling/shakes,; malaise; chest pain; tightness in her chest; chills; insomnia; nasal discharge; severe tiredness; severe headaches; coughing; hives on her chest, arms, and legs; fever; This spontaneous report was received from a 66-year-old female patient who reported on herself. Her pertinent medical history included undereactive thyroid, she was allergic to monosodium glutamate (MSG) and other food additives. Concomitant therapies included levothyroxine sodium (SYNTHROID). On 10-FEB-2020, she was vaccinated with the first dose of hepatitis A virus vaccine inactivated (HAVRIX) administered intramuscularly (exact dose, injection site, expiration date and lot number were not provided) as a travel precaution. It was reported, that the patient experienced the same symptoms with the vaccine as she did with hepatitis a vaccine, inactivated (VAQTA) in addition to experiencing diarrhea, vomiting, and nausea.    On 27-AUG-2020, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) injection, lot # reported as S03694, intramuscularly (exact dose reported as 1 injection, expiration date and anatomical location were not provided) for prophylaxis.     On 28-AUG-2020, reported as the next day, she experienced flu-like symptoms, uncontrollable trembling/shakes, chills, fever, nasal discharge, severe tiredness, severe headaches, malaise, insomnia, hives on her chest, arms, and legs, chest pain, tightness in her chest and coughing. The reporter stated she sought medical attention on 08-SEP-2020 for the symptoms she experienced with the vaccine. On an unknown date in September 2020, she was tested for COVID-19 and the results were negative. She started taking guaifenesin (ROBITUSSIN) and acetaminophen (COLD AND FLU RELIEF) to treat her symptoms (also reported as concomitant medication). It was reported that the patient recovered from most of the events on an unknown date in 2020. However, she was still experiencing chest pain and coughing. The reporter provided contact information for the healthcare professional (HCP) office where she received the vaccine from. However, she was unable to provide the name of the person who prescribed the vaccine.  Causality between the events and hepatitis a vaccine, inactivated (VAQTA) was not reported.
Age: 66.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Headache, Influenza like illness, Insomnia, Malaise, Pyrexia
Clinical narrative: the next day she experienced flu-like symptoms,; the next day she experienced flu-like symptoms, uncontrollable trembling/shakes,; malaise; chest pain; tightness in her chest; chills; insomnia; nasal discharge; severe tiredness; severe headaches; coughing; hives on her chest, arms, and legs; fever; This spontaneous report was received from a 66-year-old female patient who reported on herself. Her pertinent medical history included undereactive thyroid, she was allergic to monosodium glutamate (MSG) and other food additives. Concomitant therapies included levothyroxine sodium (SYNTHROID). On 10-FEB-2020, she was vaccinated with the first dose of hepatitis A virus vaccine inactivated (HAVRIX) administered intramuscularly (exact dose, injection site, expiration date and lot number were not provided) as a travel precaution. It was reported, that the patient experienced the same symptoms with the vaccine as she did with hepatitis a vaccine, inactivated (VAQTA) in addition to experiencing diarrhea, vomiting, and nausea.    On 27-AUG-2020, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) injection, lot # reported as S03694, intramuscularly (exact dose reported as 1 injection, expiration date and anatomical location were not provided) for prophylaxis.     On 28-AUG-2020, reported as the next day, she experienced flu-like symptoms, uncontrollable trembling/shakes, chills, fever, nasal discharge, severe tiredness, severe headaches, malaise, insomnia, hives on her chest, arms, and legs, chest pain, tightness in her chest and coughing. The reporter stated she sought medical attention on 08-SEP-2020 for the symptoms she experienced with the vaccine. On an unknown date in September 2020, she was tested for COVID-19 and the results were negative. She started taking guaifenesin (ROBITUSSIN) and acetaminophen (COLD AND FLU RELIEF) to treat her symptoms (also reported as concomitant medication). It was reported that the patient recovered from most of the events on an unknown date in 2020. However, she was still experiencing chest pain and coughing. The reporter provided contact information for the healthcare professional (HCP) office where she received the vaccine from. However, she was unable to provide the name of the person who prescribed the vaccine.  Causality between the events and hepatitis a vaccine, inactivated (VAQTA) was not reported.
Age: 66.0
Sex: F
Vaccine: HEPA, HEPA
Symptoms: Rhinorrhoea, SARS-CoV-2 test negative, Tremor, Urticaria
Clinical narrative: the next day she experienced flu-like symptoms,; the next day she experienced flu-like symptoms, uncontrollable trembling/shakes,; malaise; chest pain; tightness in her chest; chills; insomnia; nasal discharge; severe tiredness; severe headaches; coughing; hives on her chest, arms, and legs; fever; This spontaneous report was received from a 66-year-old female patient who reported on herself. Her pertinent medical history included undereactive thyroid, she was allergic to monosodium glutamate (MSG) and other food additives. Concomitant therapies included levothyroxine sodium (SYNTHROID). On 10-FEB-2020, she was vaccinated with the first dose of hepatitis A virus vaccine inactivated (HAVRIX) administered intramuscularly (exact dose, injection site, expiration date and lot number were not provided) as a travel precaution. It was reported, that the patient experienced the same symptoms with the vaccine as she did with hepatitis a vaccine, inactivated (VAQTA) in addition to experiencing diarrhea, vomiting, and nausea.    On 27-AUG-2020, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) injection, lot # reported as S03694, intramuscularly (exact dose reported as 1 injection, expiration date and anatomical location were not provided) for prophylaxis.     On 28-AUG-2020, reported as the next day, she experienced flu-like symptoms, uncontrollable trembling/shakes, chills, fever, nasal discharge, severe tiredness, severe headaches, malaise, insomnia, hives on her chest, arms, and legs, chest pain, tightness in her chest and coughing. The reporter stated she sought medical attention on 08-SEP-2020 for the symptoms she experienced with the vaccine. On an unknown date in September 2020, she was tested for COVID-19 and the results were negative. She started taking guaifenesin (ROBITUSSIN) and acetaminophen (COLD AND FLU RELIEF) to treat her symptoms (also reported as concomitant medication). It was reported that the patient recovered from most of the events on an unknown date in 2020. However, she was still experiencing chest pain and coughing. The reporter provided contact information for the healthcare professional (HCP) office where she received the vaccine from. However, she was unable to provide the name of the person who prescribed the vaccine.  Causality between the events and hepatitis a vaccine, inactivated (VAQTA) was not reported.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pruritus, Pyrexia, Rash, Rash pruritic
Clinical narrative: Breaking out in blisters / Look like chicken pox; Breaking out in blisters that itch; This case was reported by a consumer via call center representative and described the occurrence of varicella-like rash in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 14th September 2020, less than a day after receiving Shingrix, the patient experienced pruritus. On 15th September 2020, the patient experienced varicella-like rash. On 18th September 2020, the outcome of the varicella-like rash and pruritus were recovered/resolved.   The reporter considered the varicella-like rash and pruritus to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for herself. The patient received Shingrix on left arm. On Tuesday 15th September 2020, the patient started breaking out in blisters that itch and look like chickenpox. The patient stated that she continues to develop more blisters at the time of reporting and wanted to know if she was contagious.  Provided medical disclaimer and advised her to follow up with her HCP. The reporter did not consent to follow-up. Declined to provide HCP information
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash vesicular
Clinical narrative: Breaking out in blisters / Look like chicken pox; Breaking out in blisters that itch; This case was reported by a consumer via call center representative and described the occurrence of varicella-like rash in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 14th September 2020, less than a day after receiving Shingrix, the patient experienced pruritus. On 15th September 2020, the patient experienced varicella-like rash. On 18th September 2020, the outcome of the varicella-like rash and pruritus were recovered/resolved.   The reporter considered the varicella-like rash and pruritus to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for herself. The patient received Shingrix on left arm. On Tuesday 15th September 2020, the patient started breaking out in blisters that itch and look like chickenpox. The patient stated that she continues to develop more blisters at the time of reporting and wanted to know if she was contagious.  Provided medical disclaimer and advised her to follow up with her HCP. The reporter did not consent to follow-up. Declined to provide HCP information
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Pruritus, Rash vesicular
Clinical narrative: Breaking out in blisters / Look like chicken pox; Breaking out in blisters that itch; This case was reported by a consumer via call center representative and described the occurrence of varicella-like rash in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 14th September 2020, less than a day after receiving Shingrix, the patient experienced pruritus. On 15th September 2020, the patient experienced varicella-like rash. On 18th September 2020, the outcome of the varicella-like rash and pruritus were recovered/resolved.   The reporter considered the varicella-like rash and pruritus to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for herself. The patient received Shingrix on left arm. On Tuesday 15th September 2020, the patient started breaking out in blisters that itch and look like chickenpox. The patient stated that she continues to develop more blisters at the time of reporting and wanted to know if she was contagious.  Provided medical disclaimer and advised her to follow up with her HCP. The reporter did not consent to follow-up. Declined to provide HCP information
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Dizziness, Somnolence
Clinical narrative: 3 days of diarrhea, dizziness, sleepiness. (Same adverse effects as Shingles vaccine in 2018
Age: 30.0
Sex: F
Vaccine: FLUX, HPV4, HPV9
Symptoms: Discomfort, Eye swelling, Lymphadenopathy, Musculoskeletal discomfort, Pruritus
Clinical narrative: bad rash; her eyes felt swollen; felt like her throat was closing up; there was pressure in her neck and face; there was pressure in her neck and face; itchy skin; limp-nodes were swollen; some swelling; This spontaneous report was received from a consumer referring to a 40 years old female patient. The patient's drug reactions/ allergies included sulfacetamide sodium (+) sulfadiazine (+) sulfamethazine (SULFA), sulfamethoxazole (+) trimethoprim (BACKTRUM), acetaminophen (+) oxycodone hydrochloride (PERCOCET). The patient's medical history and concomitant therapy were not reported.   On an unknown date in 2010 (reported as 10 years ago), the patient received the regular quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) vaccine, all 3 shots (strength, dose, route, lot number and expiration date were not reported) for prophylaxis. On 24-JUN-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) to gain more immunity (strength, dose, route, lot number and expiration date were not reported). on an unknown date in 2020, the patient experienced some swelling.   On 27-AUG-2020, the patient was vaccinated with the second of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) to gain more immunity (strength, dose, route, lot number and expiration date were not reported). At the same time, the patient got influenza virus vaccine (unspecified) (strength, dose, route, lot number, expiration date and indication were not reported).  On 03-SEP-2020 (reported as a week after getting the second shot), the patient experienced limp-nodes were swollen and bad rash, her eyes felt swollen, she also felt like her throat was closing up and there was pressure in her neck and face and she stated she had itchy skin. The patient spoke with her primary care and went to an ear and throat doctor. The patient was given diphenhydramine (BENADRYL) and acetaminophen (TYLENOL) for the events. The outcome of the events was not recovered. The causality between the events and all the suspect therapies was not provided.
Age: 30.0
Sex: F
Vaccine: FLUX, HPV4, HPV9
Symptoms: Rash, Swelling, Throat tightness
Clinical narrative: bad rash; her eyes felt swollen; felt like her throat was closing up; there was pressure in her neck and face; there was pressure in her neck and face; itchy skin; limp-nodes were swollen; some swelling; This spontaneous report was received from a consumer referring to a 40 years old female patient. The patient's drug reactions/ allergies included sulfacetamide sodium (+) sulfadiazine (+) sulfamethazine (SULFA), sulfamethoxazole (+) trimethoprim (BACKTRUM), acetaminophen (+) oxycodone hydrochloride (PERCOCET). The patient's medical history and concomitant therapy were not reported.   On an unknown date in 2010 (reported as 10 years ago), the patient received the regular quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) vaccine, all 3 shots (strength, dose, route, lot number and expiration date were not reported) for prophylaxis. On 24-JUN-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) to gain more immunity (strength, dose, route, lot number and expiration date were not reported). on an unknown date in 2020, the patient experienced some swelling.   On 27-AUG-2020, the patient was vaccinated with the second of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) to gain more immunity (strength, dose, route, lot number and expiration date were not reported). At the same time, the patient got influenza virus vaccine (unspecified) (strength, dose, route, lot number, expiration date and indication were not reported).  On 03-SEP-2020 (reported as a week after getting the second shot), the patient experienced limp-nodes were swollen and bad rash, her eyes felt swollen, she also felt like her throat was closing up and there was pressure in her neck and face and she stated she had itchy skin. The patient spoke with her primary care and went to an ear and throat doctor. The patient was given diphenhydramine (BENADRYL) and acetaminophen (TYLENOL) for the events. The outcome of the events was not recovered. The causality between the events and all the suspect therapies was not provided.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received a vaccine that had been stored improperly during a temperature excursion; This spontaneous report was received from a medical assistant referring to a 12 months old  patient of unknown gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions/allergies were not reported.    On 07-AUG-2020, the patient received improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot #: S028919, expiration date: 16-SEP-2021) 0.5 milliliter (strength and route of administration were not provided) as prophylaxis (product storage error). The vaccine was exposed to temperature of 6 to 14 degrees Fahrenheit (8 degrees Fahrenheit) for 2 minutes and 30 seconds. No previous excursions was reported. The data logger was involved. No additional adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Eye injury, Ophthalmic herpes zoster
Clinical narrative: zoster related eyes injuries; zoster related eyes injuries; This initial spontaneous report was received from a lawyer regarding a case in litigation, referring to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and/or zoster-related conditions (strength, dose, route of administration, anatomical location, lot#, and expiration date were not reported). At the time of vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through the patient's healthcare provider that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced the patient to be vaccinated. Alternatively, in 2014, the patient's healthcare providers included but not limited to a healthcare provider, relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis that it did not carry any significant risks of adverse effects. On an unknown date, reported as subsequent to the vaccination, the patient was treated for zoster related eyes injuries. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffered 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 outcome of herpes zoster and eye injury was not recovered. The reporter considered herpes zoster and eye injury to be related to zoster vaccine live (ZOSTAVAX).
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Device malfunction, Embedded device, Needle issue
Clinical narrative: the needle detached and remained in the patient with a portion of the syringe; the needle detached and remained in the patient; poor quality device used; This spontaneous report was received from a Registered Nurse via a company representative, referring to a 12 year old male patient. The patients concurrent conditions, pertinent medical history or concomitant medications were not reported.   On 15-SEP-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) which had a lot # S026371, with expiration date on 01-APR-2022, via intramuscular in the right deltoid for vaccination.  The nurse reported that while procedure the tip of the syringe broke off inside of the needle attachment (needle issue) sometime during/after administration. When she removed the syringe after administration (syringe issue), she found that the needle detached and remained in the patient with a portion of the syringe intact inside as well (poor quality device used). There were no loose shards or missing pieces, for which she carefully inspected: this was a "clean" break.   it was not related to sudden movement by either the nurse or the patient. The patient did not require any treatment after the dose and did receive the full dose of the vaccine. The nurse disposed of the needle which was still attached to the tip of the syringe per sharps maintenance protocol, but she did keep the broken syringe for retrieval. There were a product quality complaint involved. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: S026371; expirationdate: 01-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: Yes; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 02 Device evaluation anticipated, but not yet begun; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 49.0
Sex: M
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: 49 year old male received pediatric dose VAQTA in error; 49 year old male received pediatric dose VAQTA in error; This spontaneous report was received from a 49 years old male consumer referring to himself. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     On 16-SEP-2016, the patient was vaccinated with pediatric dose of hepatitis a vaccine, inactivated (VAQTA) (1 dose, lot # T001419, expiration date 06-JAN-2021; route was not reported) for prophylaxis (underdose and product administered to patient of inappropriate age).
Age: 30.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: a 30-something years old patient received an expired dose of VAQTA; This spontaneous report was received from a nurse practitioner referring to a 30-something years old patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.        On 17-SEP-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) (1 ml, lot # S021729, expiration date 20-AUG-2020, via intramuscular route) for prophylaxis (expired product administered). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S021729; expirationdate: 20-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability