chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: FLUA3
Symptoms: Injected limb mobility decreased, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Pt rcvd flu vaccine on 10/9/19. Pt reported this was her first ever flu vaccine. Pt noticed approximately one week after administration she noticed severe pain in left arm. She is unable to lift arm above her head. She said she is having difficulty dressing her upper body. She also reports that her pain is persistent, but not predictable. It has been approximately 4 months since the shot and her symptoms have not resolved. Pt said she saw a prescriber on January 31st. She said she saw another doctor prior to that in Oct or Nov. Pt said she saw a specialist on 2/11/2020 who prescribed her ibuprofen to help with the pain.
Age: 52.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Influenza like illness, Rash
Clinical narrative: Patient describes having flu-like symptoms after receiving both vaccines, and then developed a rash or the front and back of her torso on 2/12/20.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Patient said that after his second Shingrix shot, he started having numbness and his Dr is suspecting  Guillian-Barre Syndrome.
Age: 55.0
Sex: M
Vaccine: PNC13
Symptoms: Expired product administered
Clinical narrative: Patient given an expired Prevnar 13 vaccination
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Experienced stabbing pain starting the day of receiving vaccination. Reports pain today, almost 1 week after receiving shot. Has not tried any pain reliving options yet so I recommended using an Ice Pack and taking over the counter Tylenol for pain relief until he can see a doctor tomorrow.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Condition aggravated, Fatigue, Fibromyalgia
Clinical narrative: *Although my reactions are listed under possible side effects, when I had the first dose of the 2-dose series, in addition to having a flu shot at the same time, I had absolutely no side effects.  Therefore, I am reporting these following side effects as an adverse reaction to me.  Within 12 hours: fever, horrible headache, pain in arm around injection site (phantom pain in opposite arm).  Within 24 hours, muscle and joint pain all over, extreme tiredness, chills, skin hurt all over to the touch (one of my old fibromyalgia symptoms, but I hadn't experienced that for years);    At 36 hours, still dealing with headache, arm pain around injection site and skin red and blotchy around the site, extreme tiredness continued.  72 hours: arm still painful.  From Day 4 pain gradually subsided (I had been taking Advil on the advice of the Walgreen's pharmacist, whose advice I had sought).  Itching (the healing process, I assume) began about day 6 and continued through day 9.  I hope I haven't wasted your time, but again, I experienced no symptoms at all with the previous 1st dose in October 2019, and I thought I should report my uncommon reaction with the 2nd dose.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Myalgia, Pain of skin, Pyrexia
Clinical narrative: *Although my reactions are listed under possible side effects, when I had the first dose of the 2-dose series, in addition to having a flu shot at the same time, I had absolutely no side effects.  Therefore, I am reporting these following side effects as an adverse reaction to me.  Within 12 hours: fever, horrible headache, pain in arm around injection site (phantom pain in opposite arm).  Within 24 hours, muscle and joint pain all over, extreme tiredness, chills, skin hurt all over to the touch (one of my old fibromyalgia symptoms, but I hadn't experienced that for years);    At 36 hours, still dealing with headache, arm pain around injection site and skin red and blotchy around the site, extreme tiredness continued.  72 hours: arm still painful.  From Day 4 pain gradually subsided (I had been taking Advil on the advice of the Walgreen's pharmacist, whose advice I had sought).  Itching (the healing process, I assume) began about day 6 and continued through day 9.  I hope I haven't wasted your time, but again, I experienced no symptoms at all with the previous 1st dose in October 2019, and I thought I should report my uncommon reaction with the 2nd dose.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Fever, chills, muscle ache, headache, tiredness, lasted approximately 14 hours. Very sore at injection site, lasted 2 days. This was the 2nd shot of the shingrex series. Same symptoms were evidenced after the 1st shot, also.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, chills, muscle ache, headache, tiredness, lasted approximately 14 hours. Very sore at injection site, lasted 2 days. This was the 2nd shot of the shingrex series. Same symptoms were evidenced after the 1st shot, also.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Tremor
Clinical narrative: severe shaking and chills, headache
Age: 26.0
Sex: F
Vaccine: IPV, RAB
Symptoms: Blood calcium normal, Blood magnesium normal, C-reactive protein normal, Metabolic function test normal, Muscle contractions involuntary
Clinical narrative: Multi-focal, migratory fasciculations, mainly in limbs - small, isolated area
Age: 26.0
Sex: F
Vaccine: IPV, RAB
Symptoms: Red blood cell sedimentation rate normal
Clinical narrative: Multi-focal, migratory fasciculations, mainly in limbs - small, isolated area
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Muscle swelling, Myalgia, Myosclerosis
Clinical narrative: Mild general swelling of deltoid muscle. Mod. severe tenderness of deltoid muscle. Mod. severe induration (hardness) of muscle. Mild-mod. redness of same area, but no other skin changes. All symptoms resolved within 2 wks. with the induration  & tenderness taking the longest to decrease & resolve.
Age: 48.0
Sex: M
Vaccine: DTAP, IPV, MMRV, VARCEL
Symptoms: Incorrect route of product administration
Clinical narrative: 0
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: The patient's daughter called the pharmacy at 2:30 PM on 2/13/20 and said that her mom was in at 1:00 PM and received her second Shingrix vaccination. The patient had hives all over her body. The patient's daughter said that she gave her mom 50mg of benadryl and was not in distress, nor did she have any other symptoms.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Patient stated that her arm was okay initialy and a few weeks after she received the vaccination a bump started to appear (unsure when appeared). Pt stated it did not hurt but it itched and looked bad. She did not seek medical attention In January Pt stated it looked bigger/uglier, but did not hurt or itch and was to have an apt with the doctor. Pt cancelled apt for January and is not to be seen until March. Recommend pt seeks medical attention.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: minimal erythematous & swelling on (R) upper arm - Second to tdap vacc
Age: 61.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Gait disturbance, Headache, Hot flush, Injection site erythema, Injection site pain
Clinical narrative: Pt. C/O Redness, swelling & pain @ site. C/O nausea, headache, hot flashes, muscle pain in multiple sites. She called on 2/5/20 to report reaction & was seen for F/U in the office on 2/6/20. Advil or Aleve advised for pain Patient is here because she has had a drastic reaction to her Prevnar immunization. This was placed in the right arm just 2 days ago while she had a Tdap placed in the left arm. Although the with a little usual reacting to the Tdap there was a drastic reaction to the Prevnar. 4 hr after she had the Ms. a shin she began to have pain that radiated from her deltoid up in to her neck. It was tender to touch the pain continued to increase until it hit a maximum 12 hr later pain level at that time was 8/10. (Her pain at the present time is 4/10) / It kept her awake all night. Following day the pain was still present and she found it difficult to even walk. now it is about 40 hr after she had the immunization and she still is exquisitely tender to touch of the deltoid and even on the trapezius as it goes up to the occiput. She finds it difficult to move her head. As she is sitting during the visit and wants to cross her legs she needs to use her arms to help accomplish that maneuver. She notes that in addition to the pain there also was itching. The rash that she noticed was really only at the deltoid and was quite large may be 10 cm at maximum. Now it is the size of a 25 cent coin. (see photo below) she notes that she has had many immunizations before and has never had a reaction like this.
Age: 61.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site rash, Injection site swelling, Insomnia, Mobility decreased, Nausea
Clinical narrative: Pt. C/O Redness, swelling & pain @ site. C/O nausea, headache, hot flashes, muscle pain in multiple sites. She called on 2/5/20 to report reaction & was seen for F/U in the office on 2/6/20. Advil or Aleve advised for pain Patient is here because she has had a drastic reaction to her Prevnar immunization. This was placed in the right arm just 2 days ago while she had a Tdap placed in the left arm. Although the with a little usual reacting to the Tdap there was a drastic reaction to the Prevnar. 4 hr after she had the Ms. a shin she began to have pain that radiated from her deltoid up in to her neck. It was tender to touch the pain continued to increase until it hit a maximum 12 hr later pain level at that time was 8/10. (Her pain at the present time is 4/10) / It kept her awake all night. Following day the pain was still present and she found it difficult to even walk. now it is about 40 hr after she had the immunization and she still is exquisitely tender to touch of the deltoid and even on the trapezius as it goes up to the occiput. She finds it difficult to move her head. As she is sitting during the visit and wants to cross her legs she needs to use her arms to help accomplish that maneuver. She notes that in addition to the pain there also was itching. The rash that she noticed was really only at the deltoid and was quite large may be 10 cm at maximum. Now it is the size of a 25 cent coin. (see photo below) she notes that she has had many immunizations before and has never had a reaction like this.
Age: 61.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Neck pain, Pain, Pruritus, Tenderness, Vaccination complication
Clinical narrative: Pt. C/O Redness, swelling & pain @ site. C/O nausea, headache, hot flashes, muscle pain in multiple sites. She called on 2/5/20 to report reaction & was seen for F/U in the office on 2/6/20. Advil or Aleve advised for pain Patient is here because she has had a drastic reaction to her Prevnar immunization. This was placed in the right arm just 2 days ago while she had a Tdap placed in the left arm. Although the with a little usual reacting to the Tdap there was a drastic reaction to the Prevnar. 4 hr after she had the Ms. a shin she began to have pain that radiated from her deltoid up in to her neck. It was tender to touch the pain continued to increase until it hit a maximum 12 hr later pain level at that time was 8/10. (Her pain at the present time is 4/10) / It kept her awake all night. Following day the pain was still present and she found it difficult to even walk. now it is about 40 hr after she had the immunization and she still is exquisitely tender to touch of the deltoid and even on the trapezius as it goes up to the occiput. She finds it difficult to move her head. As she is sitting during the visit and wants to cross her legs she needs to use her arms to help accomplish that maneuver. She notes that in addition to the pain there also was itching. The rash that she noticed was really only at the deltoid and was quite large may be 10 cm at maximum. Now it is the size of a 25 cent coin. (see photo below) she notes that she has had many immunizations before and has never had a reaction like this.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Pyrexia
Clinical narrative: Patient had 24 hour period of fever and chills a a 1 week history of redness to the arm. Sx resolved without sequelae
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Injection site erythema
Clinical narrative: Pt's left thigh had redness on injection site. Redness started a day later after vaccination.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site reaction, Skin reaction
Clinical narrative: Adverse skin reaction L thigh from varicella
Sex: M
Vaccine: VARCEL
Symptoms: CSF test normal, Foetal exposure during pregnancy, Full blood count abnormal, Hepatitis viral, Pancytopenia
Clinical narrative: term neonate present on DOL2 when mother received varicella vaccine (non-immune). mother developed itchy rash at R upper arm at vaccine site. At almost 4 weeks of age, infant developed disseminated vesiculopapular rash confirmed by PCR to be VZV. also confirmed to be Oka strain. Admitted with viral hepatitis and pancytopenia. CSF normal with VZV PCR negative. He underwent hospitalization for 5 days iv acyclovir and when no new lesions in 48 hours.  LFTs were near normal when last checked.
Sex: M
Vaccine: VARCEL
Symptoms: Polymerase chain reaction positive, Rash papular, Transaminases increased, Varicella virus test positive
Clinical narrative: term neonate present on DOL2 when mother received varicella vaccine (non-immune). mother developed itchy rash at R upper arm at vaccine site. At almost 4 weeks of age, infant developed disseminated vesiculopapular rash confirmed by PCR to be VZV. also confirmed to be Oka strain. Admitted with viral hepatitis and pancytopenia. CSF normal with VZV PCR negative. He underwent hospitalization for 5 days iv acyclovir and when no new lesions in 48 hours.  LFTs were near normal when last checked.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Cough, Fatigue, Influenza like illness, Pain
Clinical narrative: flu-like symptoms; had some sore arm; tiredness; chills; allergic reaction to the vaccine; rashes are extremely itchy; Bump on leg; some "chicken pox-like" pimples; chicken pox-like" pimples; had lumps and bumps under the skin; bumps under the skin; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 27th January 2020, 3 days after receiving Shingrix, the patient experienced pimples, vesicular rash, limb mass, swelling of legs and local swelling. On 3rd February 2020, the patient experienced itchy rash. On an unknown date, the patient experienced influenza-like symptoms, pain in arm, tiredness, chills and allergic reaction. The patient was treated with cetirizine hydrochloride (Zyrtec) and triamcinolone (Triamcinolone Topical Cream). On an unknown date, the outcome of the influenza-like symptoms, pain in arm, tiredness and chills were recovered/resolved and the outcome of the pimples, vesicular rash, limb mass, swelling of legs, itchy rash, allergic reaction and local swelling were unknown.   It was unknown if the reporter considered the influenza-like symptoms, pain in arm, tiredness, chills, pimples, vesicular rash, limb mass, swelling of legs, itchy rash, allergic reaction and local swelling to be related to Shingrix.  Additional details were received as follows: The patient had some sore arm, flu-like symptoms involving chills and tiredness which resolved in 24 hours. On 27th January 2020 the patient went to take a shower, she notices the left and right thighs, from the hips to the knees, had lumps and bumps under the skin and also there were some chicken pox like pimples on the outside. The patient stated that the lumps and bumps resolved in the thigh area and traveled down to both her calf muscles and were  in the lower calf region and the lower extremities. The lumps and bumps under skin and also rashes were extremely itchy. The dermatologist was stating that she might have had an allergic reaction to the vaccine and because of this she might not get the second dose of the Shingrix vaccine. The patient consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Urticaria, Wheezing
Clinical narrative: flu-like symptoms; had some sore arm; tiredness; chills; allergic reaction to the vaccine; rashes are extremely itchy; Bump on leg; some "chicken pox-like" pimples; chicken pox-like" pimples; had lumps and bumps under the skin; bumps under the skin; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 27th January 2020, 3 days after receiving Shingrix, the patient experienced pimples, vesicular rash, limb mass, swelling of legs and local swelling. On 3rd February 2020, the patient experienced itchy rash. On an unknown date, the patient experienced influenza-like symptoms, pain in arm, tiredness, chills and allergic reaction. The patient was treated with cetirizine hydrochloride (Zyrtec) and triamcinolone (Triamcinolone Topical Cream). On an unknown date, the outcome of the influenza-like symptoms, pain in arm, tiredness and chills were recovered/resolved and the outcome of the pimples, vesicular rash, limb mass, swelling of legs, itchy rash, allergic reaction and local swelling were unknown.   It was unknown if the reporter considered the influenza-like symptoms, pain in arm, tiredness, chills, pimples, vesicular rash, limb mass, swelling of legs, itchy rash, allergic reaction and local swelling to be related to Shingrix.  Additional details were received as follows: The patient had some sore arm, flu-like symptoms involving chills and tiredness which resolved in 24 hours. On 27th January 2020 the patient went to take a shower, she notices the left and right thighs, from the hips to the knees, had lumps and bumps under the skin and also there were some chicken pox like pimples on the outside. The patient stated that the lumps and bumps resolved in the thigh area and traveled down to both her calf muscles and were  in the lower calf region and the lower extremities. The lumps and bumps under skin and also rashes were extremely itchy. The dermatologist was stating that she might have had an allergic reaction to the vaccine and because of this she might not get the second dose of the Shingrix vaccine. The patient consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Acne, Chills, Fatigue, Hypersensitivity, Influenza like illness
Clinical narrative: flu-like symptoms; had some sore arm; tiredness; chills; allergic reaction to the vaccine; rashes are extremely itchy; Bump on leg; some "chicken pox-like" pimples; chicken pox-like" pimples; had lumps and bumps under the skin; bumps under the skin; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 27th January 2020, 3 days after receiving Shingrix, the patient experienced pimples, vesicular rash, limb mass, swelling of legs and local swelling. On 3rd February 2020, the patient experienced itchy rash. On an unknown date, the patient experienced influenza-like symptoms, pain in arm, tiredness, chills and allergic reaction. The patient was treated with cetirizine hydrochloride (Zyrtec) and triamcinolone (Triamcinolone Topical Cream). On an unknown date, the outcome of the influenza-like symptoms, pain in arm, tiredness and chills were recovered/resolved and the outcome of the pimples, vesicular rash, limb mass, swelling of legs, itchy rash, allergic reaction and local swelling were unknown.   It was unknown if the reporter considered the influenza-like symptoms, pain in arm, tiredness, chills, pimples, vesicular rash, limb mass, swelling of legs, itchy rash, allergic reaction and local swelling to be related to Shingrix.  Additional details were received as follows: The patient had some sore arm, flu-like symptoms involving chills and tiredness which resolved in 24 hours. On 27th January 2020 the patient went to take a shower, she notices the left and right thighs, from the hips to the knees, had lumps and bumps under the skin and also there were some chicken pox like pimples on the outside. The patient stated that the lumps and bumps resolved in the thigh area and traveled down to both her calf muscles and were  in the lower calf region and the lower extremities. The lumps and bumps under skin and also rashes were extremely itchy. The dermatologist was stating that she might have had an allergic reaction to the vaccine and because of this she might not get the second dose of the Shingrix vaccine. The patient consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Limb mass, Pain in extremity, Peripheral swelling, Rash pruritic, Rash vesicular
Clinical narrative: flu-like symptoms; had some sore arm; tiredness; chills; allergic reaction to the vaccine; rashes are extremely itchy; Bump on leg; some "chicken pox-like" pimples; chicken pox-like" pimples; had lumps and bumps under the skin; bumps under the skin; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 27th January 2020, 3 days after receiving Shingrix, the patient experienced pimples, vesicular rash, limb mass, swelling of legs and local swelling. On 3rd February 2020, the patient experienced itchy rash. On an unknown date, the patient experienced influenza-like symptoms, pain in arm, tiredness, chills and allergic reaction. The patient was treated with cetirizine hydrochloride (Zyrtec) and triamcinolone (Triamcinolone Topical Cream). On an unknown date, the outcome of the influenza-like symptoms, pain in arm, tiredness and chills were recovered/resolved and the outcome of the pimples, vesicular rash, limb mass, swelling of legs, itchy rash, allergic reaction and local swelling were unknown.   It was unknown if the reporter considered the influenza-like symptoms, pain in arm, tiredness, chills, pimples, vesicular rash, limb mass, swelling of legs, itchy rash, allergic reaction and local swelling to be related to Shingrix.  Additional details were received as follows: The patient had some sore arm, flu-like symptoms involving chills and tiredness which resolved in 24 hours. On 27th January 2020 the patient went to take a shower, she notices the left and right thighs, from the hips to the knees, had lumps and bumps under the skin and also there were some chicken pox like pimples on the outside. The patient stated that the lumps and bumps resolved in the thigh area and traveled down to both her calf muscles and were  in the lower calf region and the lower extremities. The lumps and bumps under skin and also rashes were extremely itchy. The dermatologist was stating that she might have had an allergic reaction to the vaccine and because of this she might not get the second dose of the Shingrix vaccine. The patient consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Swelling
Clinical narrative: flu-like symptoms; had some sore arm; tiredness; chills; allergic reaction to the vaccine; rashes are extremely itchy; Bump on leg; some "chicken pox-like" pimples; chicken pox-like" pimples; had lumps and bumps under the skin; bumps under the skin; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 27th January 2020, 3 days after receiving Shingrix, the patient experienced pimples, vesicular rash, limb mass, swelling of legs and local swelling. On 3rd February 2020, the patient experienced itchy rash. On an unknown date, the patient experienced influenza-like symptoms, pain in arm, tiredness, chills and allergic reaction. The patient was treated with cetirizine hydrochloride (Zyrtec) and triamcinolone (Triamcinolone Topical Cream). On an unknown date, the outcome of the influenza-like symptoms, pain in arm, tiredness and chills were recovered/resolved and the outcome of the pimples, vesicular rash, limb mass, swelling of legs, itchy rash, allergic reaction and local swelling were unknown.   It was unknown if the reporter considered the influenza-like symptoms, pain in arm, tiredness, chills, pimples, vesicular rash, limb mass, swelling of legs, itchy rash, allergic reaction and local swelling to be related to Shingrix.  Additional details were received as follows: The patient had some sore arm, flu-like symptoms involving chills and tiredness which resolved in 24 hours. On 27th January 2020 the patient went to take a shower, she notices the left and right thighs, from the hips to the knees, had lumps and bumps under the skin and also there were some chicken pox like pimples on the outside. The patient stated that the lumps and bumps resolved in the thigh area and traveled down to both her calf muscles and were  in the lower calf region and the lower extremities. The lumps and bumps under skin and also rashes were extremely itchy. The dermatologist was stating that she might have had an allergic reaction to the vaccine and because of this she might not get the second dose of the Shingrix vaccine. The patient consented to follow up.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Chills, Eye swelling, Oedema, Peripheral swelling
Clinical narrative: experienced shivering / shivers; felt cold; fever of 100.1; swelling of face; skin peeling on face; rash on neck and arm and chest /on face / rash on face with white heads; hands and feet swollen; shins sore; inside of mouth and tongue raw and sore; inside of mouth and tongue raw and sore; nerve pain in back; hoarse voice; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 30th January 2020, less than a day after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced shivering, feeling cold, fever, facial swelling, skin peeling, rash, peripheral swelling, leg pain, sore mouth, sore tongue, neuralgia and hoarse voice. The patient was treated with ibuprofen and benadryl (nos) (Benadryl). On an unknown date, the outcome of the shivering, feeling cold, fever, facial swelling, skin peeling, rash, peripheral swelling, leg pain, sore mouth, sore tongue, neuralgia and hoarse voice were recovering/resolving.   It was unknown if the reporter considered the shivering, feeling cold, fever, facial swelling, skin peeling, rash, peripheral swelling, leg pain, sore mouth, sore tongue, neuralgia and hoarse voice to be related to Shingrix.  Additional case details were reported as follows: This case was reported by nurse herself. The patient received vaccine in left arm. The patient experienced shivering, felt cold, fever of 100.1 degree F, swelling of face, rash on face with white heads and skin peeling, rash on neck and arms and chest, hands and feet swollen, shins sore, inside of mouth and tongue raw and sore, with shivers felt like nerve pain in back, hoarse voice. The issues started evening of the dose, progressed through the weekend and were now starting to improve. The patient had been seen by her physician. The reporter consented to follow up.      Lab Comments: On an unknown date lab test was performed.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Rash, Swelling face, Swelling of eyelid, Throat tightness
Clinical narrative: experienced shivering / shivers; felt cold; fever of 100.1; swelling of face; skin peeling on face; rash on neck and arm and chest /on face / rash on face with white heads; hands and feet swollen; shins sore; inside of mouth and tongue raw and sore; inside of mouth and tongue raw and sore; nerve pain in back; hoarse voice; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 30th January 2020, less than a day after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced shivering, feeling cold, fever, facial swelling, skin peeling, rash, peripheral swelling, leg pain, sore mouth, sore tongue, neuralgia and hoarse voice. The patient was treated with ibuprofen and benadryl (nos) (Benadryl). On an unknown date, the outcome of the shivering, feeling cold, fever, facial swelling, skin peeling, rash, peripheral swelling, leg pain, sore mouth, sore tongue, neuralgia and hoarse voice were recovering/resolving.   It was unknown if the reporter considered the shivering, feeling cold, fever, facial swelling, skin peeling, rash, peripheral swelling, leg pain, sore mouth, sore tongue, neuralgia and hoarse voice to be related to Shingrix.  Additional case details were reported as follows: This case was reported by nurse herself. The patient received vaccine in left arm. The patient experienced shivering, felt cold, fever of 100.1 degree F, swelling of face, rash on face with white heads and skin peeling, rash on neck and arms and chest, hands and feet swollen, shins sore, inside of mouth and tongue raw and sore, with shivers felt like nerve pain in back, hoarse voice. The issues started evening of the dose, progressed through the weekend and were now starting to improve. The patient had been seen by her physician. The reporter consented to follow up.      Lab Comments: On an unknown date lab test was performed.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Dysphonia, Feeling cold, Glossodynia, Neuralgia
Clinical narrative: experienced shivering / shivers; felt cold; fever of 100.1; swelling of face; skin peeling on face; rash on neck and arm and chest /on face / rash on face with white heads; hands and feet swollen; shins sore; inside of mouth and tongue raw and sore; inside of mouth and tongue raw and sore; nerve pain in back; hoarse voice; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 30th January 2020, less than a day after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced shivering, feeling cold, fever, facial swelling, skin peeling, rash, peripheral swelling, leg pain, sore mouth, sore tongue, neuralgia and hoarse voice. The patient was treated with ibuprofen and benadryl (nos) (Benadryl). On an unknown date, the outcome of the shivering, feeling cold, fever, facial swelling, skin peeling, rash, peripheral swelling, leg pain, sore mouth, sore tongue, neuralgia and hoarse voice were recovering/resolving.   It was unknown if the reporter considered the shivering, feeling cold, fever, facial swelling, skin peeling, rash, peripheral swelling, leg pain, sore mouth, sore tongue, neuralgia and hoarse voice to be related to Shingrix.  Additional case details were reported as follows: This case was reported by nurse herself. The patient received vaccine in left arm. The patient experienced shivering, felt cold, fever of 100.1 degree F, swelling of face, rash on face with white heads and skin peeling, rash on neck and arms and chest, hands and feet swollen, shins sore, inside of mouth and tongue raw and sore, with shivers felt like nerve pain in back, hoarse voice. The issues started evening of the dose, progressed through the weekend and were now starting to improve. The patient had been seen by her physician. The reporter consented to follow up.      Lab Comments: On an unknown date lab test was performed.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oral pain, Pain in extremity, Peripheral swelling, Pyrexia, Rash
Clinical narrative: experienced shivering / shivers; felt cold; fever of 100.1; swelling of face; skin peeling on face; rash on neck and arm and chest /on face / rash on face with white heads; hands and feet swollen; shins sore; inside of mouth and tongue raw and sore; inside of mouth and tongue raw and sore; nerve pain in back; hoarse voice; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 30th January 2020, less than a day after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced shivering, feeling cold, fever, facial swelling, skin peeling, rash, peripheral swelling, leg pain, sore mouth, sore tongue, neuralgia and hoarse voice. The patient was treated with ibuprofen and benadryl (nos) (Benadryl). On an unknown date, the outcome of the shivering, feeling cold, fever, facial swelling, skin peeling, rash, peripheral swelling, leg pain, sore mouth, sore tongue, neuralgia and hoarse voice were recovering/resolving.   It was unknown if the reporter considered the shivering, feeling cold, fever, facial swelling, skin peeling, rash, peripheral swelling, leg pain, sore mouth, sore tongue, neuralgia and hoarse voice to be related to Shingrix.  Additional case details were reported as follows: This case was reported by nurse herself. The patient received vaccine in left arm. The patient experienced shivering, felt cold, fever of 100.1 degree F, swelling of face, rash on face with white heads and skin peeling, rash on neck and arms and chest, hands and feet swollen, shins sore, inside of mouth and tongue raw and sore, with shivers felt like nerve pain in back, hoarse voice. The issues started evening of the dose, progressed through the weekend and were now starting to improve. The patient had been seen by her physician. The reporter consented to follow up.      Lab Comments: On an unknown date lab test was performed.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin exfoliation, Swelling face
Clinical narrative: experienced shivering / shivers; felt cold; fever of 100.1; swelling of face; skin peeling on face; rash on neck and arm and chest /on face / rash on face with white heads; hands and feet swollen; shins sore; inside of mouth and tongue raw and sore; inside of mouth and tongue raw and sore; nerve pain in back; hoarse voice; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th January 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 30th January 2020, less than a day after receiving Shingrix and an unknown time after starting ibuprofen, the patient experienced shivering, feeling cold, fever, facial swelling, skin peeling, rash, peripheral swelling, leg pain, sore mouth, sore tongue, neuralgia and hoarse voice. The patient was treated with ibuprofen and benadryl (nos) (Benadryl). On an unknown date, the outcome of the shivering, feeling cold, fever, facial swelling, skin peeling, rash, peripheral swelling, leg pain, sore mouth, sore tongue, neuralgia and hoarse voice were recovering/resolving.   It was unknown if the reporter considered the shivering, feeling cold, fever, facial swelling, skin peeling, rash, peripheral swelling, leg pain, sore mouth, sore tongue, neuralgia and hoarse voice to be related to Shingrix.  Additional case details were reported as follows: This case was reported by nurse herself. The patient received vaccine in left arm. The patient experienced shivering, felt cold, fever of 100.1 degree F, swelling of face, rash on face with white heads and skin peeling, rash on neck and arms and chest, hands and feet swollen, shins sore, inside of mouth and tongue raw and sore, with shivers felt like nerve pain in back, hoarse voice. The issues started evening of the dose, progressed through the weekend and were now starting to improve. The patient had been seen by her physician. The reporter consented to follow up.      Lab Comments: On an unknown date lab test was performed.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site 3" X 4" starting in the evening of immunizations. No fever or pain. Seen in office on 02/11/2020. Improved by 02/13/2020.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events; a patient was inadvertently administered an expired VAQTA vaccine; This spontaneous report was received from a medical assistant referring to a 27 years old patient of unknown gender. The patient's concomitant medication, historical condition and current condition were unknown.  On 16-JAN-2020, the patient was inadvertently administered an expired hepatitis a vaccine, inactivated (VAQTA) (lot # R031045; expiration date 18-NOV-2019; dose, strength, frequency, route, unknown) for prophylaxis (expired product administered).         No additional adverse events reported. The outcome of the events was unknown.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; Product storage error; This spontaneous report was received from a physician refers unspecified number of patients on unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.   On an unspecified date, the patients were vaccinated with improperly stored doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot number 1621926, expiration date 28-NOV-2021, lot number R025729, expiration date 18-JUN-2021; Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number S006052, expiration date 07-DEC-2020, lot number S004400 expiration date 14-NOV-2020, lot number 1660951, expiration date 11-NOV-2020, lot number R025733 expiration date 30-MAR-2020; varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number R024023, expiration date 22-AUG-2020, lot number S012037 expiration date 17-APR-2020, and lot number S021927 expiration date 15-JUL-2021 (dose and route of administration were not reported). The sterile diluent that was used to reconstitute the varicella virus vaccine live (Oka/Merck) (VARIVAX) was properly stored. There was no adverse effects reported. Administered doses of vaccines HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) experienced the temperature excursion of above 9 degrees Celsius (°C) for 99hours and 45 minutes. Also, for varicella virus vaccine live (Oka/Merck) (VARIVAX) experienced the temperature excursion of -14°C to-10°C (-14 °C) for 122 hours and 45 minutes, and -9°C to 8°C (1.2 °C) for 129 hours and 45 minutes. No data logger was involved. There were no previous excursions reported.   This case is considered to be non-valid due the lack of patient identifiers.  Follow up information was received from the reporting physician on 13-FEB-2020. The patient was male. On 28-JAN-2020, the patient was vaccinated with  HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9).  The physician reported that the patient received only  HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9).  This case was previously classified as Non valid due to lack of patient identifiers, however up on follow up information the case was confirmed to be a valid case as patient identifier was reported.  This is one of the several reports from the same reporter.; Sender's Comments:  US-009507513-2002USA001552:
Sex: M
Vaccine: VARCEL
Symptoms: Rash vesicular, Skin lesion, Varicella post vaccine, Varicella virus test positive
Clinical narrative: the patient was seen in the office and the lesions appear to be caused by chicken pox; On an unspecified date last week a patient was administered an initial dose of VARIVAX and on an unspecified date since the administration he began experiencing lesions on an unspecified location on his body; This spontaneous report has been received from a physician via company representative, concerning a male patient around 4-years old. Information about the patient's past drug and medical history, as well as concomitant therapies and allergies were not reported.  On an unknown day in January 2020 (reported as last week), the patient was vaccinated with an initial dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, 1 dosage form (concentration, frequency, administration route, anatomical location, lot number, and expiration date were not reported) as prophylaxis (reported as varicella prevention).  On an unknown date in 2020 (since the administration), the patient began experiencing lesions on an unspecified location on his body. He was seen in the physician's office on 03-FEB-2020 and the lesions appear to be caused by chicken pox (rash vesicular, skin lesion). Laboratory test was ordered to confirm if the lesions were caused by chicken pox.   The causality assessment between varicella virus vaccine live (Oka/Merck) (VARIVAX) and the occurred event was not reported.
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: severe pain in the arm where the patient received the injection; "red spot" at the site of injection; unable to move that arm; This spontaneous report as received from a pharmacist refers to a 68 year old male patient. The patient's concurrent conditions and medical history were not reported. The patient did not have any allergies. Concomitant therapies included atorvastatin, donepezil, meloxicam, icosapent ethyl (VASCEPA), meclizine, olmesartan medoxomil and pantoprazole.    On 04-FEB-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) intramuscular injection (lot # S024808 and expiration date: 02-JUN-2021; dose and frequency not reported) as prophylaxis.     Later on the same day, the patient developed severe pain in the arm where he received the injection (injection site pain) and he developed a "red spot" at the site of the injection (injection site erythema). Due to the severe pain, the patient was unable to move that arm (injected limb mobility decreased). The patient went to see a physician and received acetaminophen (TYLENOL) as treatment. The outcome of the events was reported as not recovered.   The reporter considered the events injection site pain, injected limb mobility decreased and injection site erythema to be serious due to disability.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer, regarding a case in litigation, concerning a female patient of an unspecified age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2012, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (strength, dosage regimen, route, lot number and expiration date were not reported) for the long-term prevention of shingles and/or zoster related conditions. On an unspecified date, subsequent to patient's inoculation, he experienced shingles and was treated by a health care provider due to the event. As a direct and proximate result use of the vaccine live (ZOSTAVAX) vaccine, the patient's had and would continue to 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 would continue to suffer such losses and damages in the future. At the time of the report, the patient had not recovered from the event. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received from a lawyer concerning a female patient of unknown age. The patient's medical history, concurrent conditions or concomitant medications were not reported. On or about 23-OCT-2012, the patient was vaccinated as prescribed with zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles and/or zoster-related conditions (dose, strength, route of administration and lot number were not reported). On an unspecified date, the patient developed shingles and was treated in an hospital. According to reporter, as a direct and proximate result of the use of zoster vaccine live (ZOSTAVAX) the patient had 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.  At the reporting time, the patient had not recovered from the event shingles. The reporter considered the event shingles to be related to zoster vaccine live (ZOSTAVAX).
Age: 24.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional adverse events; patient was in office to receive 3rd dose of HPV series after received 2nd dose of GARDASIL 9 more than a year ago; This spontaneous report has been received from a pharmacist, concerning an adult patient of unknown age and gender.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On an unknown date (reported as when the patient was 24-year-old), the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, anatomical location, lot number and expiration date not reported) as prophylaxis.   On unknown date (reported as two month), the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, anatomical location, lot number and expiration date not reported) as prophylaxis.   Then on 12-FEB-2020 (reported as "today"), more than a year ago after received 2nd dose of vaccine, the patient came to the office to receive the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (inappropriate schedule of product administration).