chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Herpes zoster, Injection site erythema, Injection site infection, Injection site pain, Injection site swelling
Clinical narrative: Looks like infection [like shingles] (injection site); Where injection site was administered - arm is swollen; Where injection site was administered - arm is red; Where injection site was administered - arm is sore, hurts; [Looks like infection like] shingles; Information has been downloaded from Agency (US-BEH-2014047322).  This spontaneous report was received from a pharmacist and two consumers, concerning a 79-year-old male patient. The patient's His relevant medical history included weight loss and testosterone low as current conditions. The patient's concomitant medications included fluoxetine, fentanyl, zolpidem, methimazole and metoprolol (XL).   On 14-OCT-2014, the patient was vaccinated with influenza virus split virion 3v vaccine inactivated (AFLURIA) (formulation, vaccination scheme, route of administration, anatomical location of vaccination, lot number, and expiration date were not reported).  On 11-NOV-2014, the patient was vaccinated with varicella virus vaccine (manufacturer unknown), 0.65 milliliter (ml), administered subcutaneously as prophylaxis (formulation, anatomical location of vaccination, lot number and expiration date were not reported).  On 04-DEC-2014, the patient's arm was swollen, red and sore at the injection site (injection site swelling, injection site erythema and injection site pain). According to the pharmacist, it looked like a shingles infection (injection site infection and herpes zoster).  The outcome of injection site infection, herpes zoster, injection site pain, injection site erythema and injection site swelling was reported as not resolved.  The causal relationship between all the aforementioned events and both suspect therapies was not provided.  The events were determined to be medically significant.
Age: 63.0
Sex: F
Vaccine: PNC, UNK, VARZOS
Symptoms: Arthralgia, Depression, Headache, Joint swelling, Pain
Clinical narrative: Swollen joint; Depression; Headache; General body pain; Joint pain; This case was reported by a physician and described the occurrence of swollen joints in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included adalimumab (Humira) for rheumatoid arthritis and pneumococcal vaccine (Prevenar) for product used for unknown indication.   On an unknown date, the patient received Shingrix. On 6th July 2019, the patient started Humira (subcutaneous) 40 mg at an unknown frequency. On an unknown date, the patient started Prevenar at an unknown dose and frequency. On an unknown date, unknown after receiving Shingrix, the patient experienced swollen joints, depression, headache, general body pain and joint pain. The patient was treated with prednisone. The action taken with Humira was unknown. The action taken with Prevenar was unknown. On an unknown date, the outcome of the swollen joints, depression, general body pain and joint pain were recovered/resolved and the outcome of the headache was unknown.   It was unknown if the reporter considered the swollen joints, depression, headache, general body pain and joint pain to be related to Shingrix.  Additional details were reported as follows : The patient received shingrix and prevenar and experienced swollen joints, depression, headache, general body pain and joint pain. Less than 2 years, after receiving humira, patient experienced swollen joints, depression, headache, general body pain and joint pain. The patient had no medical history. The patient did not receive any concomitant medication. It was unknown if the reporter considered the swollen joints, depression, headache, general body pain and joint pain to be related to prevenar and humira.
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Incorrect route of product administration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: late due to Covid-19; lower back part of my arm above the elbow not the deltoid muscle area; administered incorrectly. It was given subcutaneous; mark at the injection / with swelling; mark at the injection site which expanded / raised / area started to spread; mark at the injection / hot; tender to the touch; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of erythema (1st dose recived in November 2019, refer case US2020AMR124245).   On 4th July 2020, the patient received the 2nd dose of Shingrix (subcutaneous). On 4th July 2020, less than an hour after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, papular rash, injection site warmth, vaccine administered at inappropriate site and intramuscular formulation administered by other route. In July 2020, the patient experienced tenderness. On an unknown date, the patient experienced social problem. On an unknown date, the outcome of the extensive swelling of vaccinated limb, papular rash, injection site warmth, tenderness, vaccine administered at inappropriate site, intramuscular formulation administered by other route and social problem were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, papular rash, injection site warmth and tenderness to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient was late for 2nd dose due to COVID, which led to social problem. The patient received injection on the back of her right arm subcutaneously, which led to vaccine administered at inappropriate site and incorrect route of vaccine administration. The patient had initial mark at the injection site which expanded to 4 by 6 inches and was very raised and hot with swelling within an hour or the injection. The area started to spread towards her elbow from higher on the arm and at the time of reporting it was fading but tender to the touch. The reporter explained that prior to the second dose injection, the pharmacist was using rubbing alcohol in her armpit on the soft part of her arm and she injected the vaccine under her skin in the back of her right arm above the elbow and not in the deltoid muscle. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR124245:same patient
Sex: F
Vaccine: VARZOS
Symptoms: Product administered at inappropriate site, Rash papular, Social problem, Tenderness
Clinical narrative: late due to Covid-19; lower back part of my arm above the elbow not the deltoid muscle area; administered incorrectly. It was given subcutaneous; mark at the injection / with swelling; mark at the injection site which expanded / raised / area started to spread; mark at the injection / hot; tender to the touch; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of erythema (1st dose recived in November 2019, refer case US2020AMR124245).   On 4th July 2020, the patient received the 2nd dose of Shingrix (subcutaneous). On 4th July 2020, less than an hour after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, papular rash, injection site warmth, vaccine administered at inappropriate site and intramuscular formulation administered by other route. In July 2020, the patient experienced tenderness. On an unknown date, the patient experienced social problem. On an unknown date, the outcome of the extensive swelling of vaccinated limb, papular rash, injection site warmth, tenderness, vaccine administered at inappropriate site, intramuscular formulation administered by other route and social problem were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, papular rash, injection site warmth and tenderness to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient was late for 2nd dose due to COVID, which led to social problem. The patient received injection on the back of her right arm subcutaneously, which led to vaccine administered at inappropriate site and incorrect route of vaccine administration. The patient had initial mark at the injection site which expanded to 4 by 6 inches and was very raised and hot with swelling within an hour or the injection. The area started to spread towards her elbow from higher on the arm and at the time of reporting it was fading but tender to the touch. The reporter explained that prior to the second dose injection, the pharmacist was using rubbing alcohol in her armpit on the soft part of her arm and she injected the vaccine under her skin in the back of her right arm above the elbow and not in the deltoid muscle. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR124245:same patient
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Chills, Discomfort, Nausea, Pruritus
Clinical narrative: red bumps on the skin; lesions, like a chicken pox/ like lesions, like having chicken pox, like a chicken pox bumps on the skin; he was uncomfortable; symtoms of low energy; fever; chills; feelings of wanting to vomit without vomiting; skin itched badly; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th July 2020, the patient received the 1st dose of Shingrix. On 5th July 2020, less than a day after receiving Shingrix, the patient experienced discomfort, energy decreased, fever and chills. In July 2020, the patient experienced nausea and pruritus. On an unknown date, the patient experienced red rash and varicella-like rash. On an unknown date, the outcome of the red rash, varicella-like rash, discomfort, energy decreased, fever, chills, nausea and pruritus were unknown.   It was unknown if the reporter considered the red rash, varicella-like rash, discomfort, energy decreased, fever, chills, nausea and pruritus to be related to Shingrix.  Additional information was provided as follows: The patient experienced being like lesions, like having chicken pox and red bumps on the skin. The patient was uncomfortable with symtoms of low energy, fever and chills, feelings of wanting to vomit without vomiting. The patient's skin itched badly. The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia, Rash erythematous, Rash vesicular
Clinical narrative: red bumps on the skin; lesions, like a chicken pox/ like lesions, like having chicken pox, like a chicken pox bumps on the skin; he was uncomfortable; symtoms of low energy; fever; chills; feelings of wanting to vomit without vomiting; skin itched badly; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th July 2020, the patient received the 1st dose of Shingrix. On 5th July 2020, less than a day after receiving Shingrix, the patient experienced discomfort, energy decreased, fever and chills. In July 2020, the patient experienced nausea and pruritus. On an unknown date, the patient experienced red rash and varicella-like rash. On an unknown date, the outcome of the red rash, varicella-like rash, discomfort, energy decreased, fever, chills, nausea and pruritus were unknown.   It was unknown if the reporter considered the red rash, varicella-like rash, discomfort, energy decreased, fever, chills, nausea and pruritus to be related to Shingrix.  Additional information was provided as follows: The patient experienced being like lesions, like having chicken pox and red bumps on the skin. The patient was uncomfortable with symtoms of low energy, fever and chills, feelings of wanting to vomit without vomiting. The patient's skin itched badly. The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Fatigue, Hyperhidrosis, Nausea, Pustule
Clinical narrative: red bumps on the skin; lesions, like a chicken pox/ like lesions, like having chicken pox, like a chicken pox bumps on the skin; he was uncomfortable; symtoms of low energy; fever; chills; feelings of wanting to vomit without vomiting; skin itched badly; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th July 2020, the patient received the 1st dose of Shingrix. On 5th July 2020, less than a day after receiving Shingrix, the patient experienced discomfort, energy decreased, fever and chills. In July 2020, the patient experienced nausea and pruritus. On an unknown date, the patient experienced red rash and varicella-like rash. On an unknown date, the outcome of the red rash, varicella-like rash, discomfort, energy decreased, fever, chills, nausea and pruritus were unknown.   It was unknown if the reporter considered the red rash, varicella-like rash, discomfort, energy decreased, fever, chills, nausea and pruritus to be related to Shingrix.  Additional information was provided as follows: The patient experienced being like lesions, like having chicken pox and red bumps on the skin. The patient was uncomfortable with symtoms of low energy, fever and chills, feelings of wanting to vomit without vomiting. The patient's skin itched badly. The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: red bumps on the skin; lesions, like a chicken pox/ like lesions, like having chicken pox, like a chicken pox bumps on the skin; he was uncomfortable; symtoms of low energy; fever; chills; feelings of wanting to vomit without vomiting; skin itched badly; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th July 2020, the patient received the 1st dose of Shingrix. On 5th July 2020, less than a day after receiving Shingrix, the patient experienced discomfort, energy decreased, fever and chills. In July 2020, the patient experienced nausea and pruritus. On an unknown date, the patient experienced red rash and varicella-like rash. On an unknown date, the outcome of the red rash, varicella-like rash, discomfort, energy decreased, fever, chills, nausea and pruritus were unknown.   It was unknown if the reporter considered the red rash, varicella-like rash, discomfort, energy decreased, fever, chills, nausea and pruritus to be related to Shingrix.  Additional information was provided as follows: The patient experienced being like lesions, like having chicken pox and red bumps on the skin. The patient was uncomfortable with symtoms of low energy, fever and chills, feelings of wanting to vomit without vomiting. The patient's skin itched badly. The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Asthenia, Chills, Cold sweat, Nausea, Pruritus
Clinical narrative: red bumps on the skin; lesions, like a chicken pox/ like lesions, like having chicken pox, like a chicken pox bumps on the skin; he was uncomfortable; symtoms of low energy; fever; chills; feelings of wanting to vomit without vomiting; skin itched badly; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th July 2020, the patient received the 1st dose of Shingrix. On 5th July 2020, less than a day after receiving Shingrix, the patient experienced discomfort, energy decreased, fever and chills. In July 2020, the patient experienced nausea and pruritus. On an unknown date, the patient experienced red rash and varicella-like rash. On an unknown date, the outcome of the red rash, varicella-like rash, discomfort, energy decreased, fever, chills, nausea and pruritus were unknown.   It was unknown if the reporter considered the red rash, varicella-like rash, discomfort, energy decreased, fever, chills, nausea and pruritus to be related to Shingrix.  Additional information was provided as follows: The patient experienced being like lesions, like having chicken pox and red bumps on the skin. The patient was uncomfortable with symtoms of low energy, fever and chills, feelings of wanting to vomit without vomiting. The patient's skin itched badly. The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia, Skin lesion
Clinical narrative: red bumps on the skin; lesions, like a chicken pox/ like lesions, like having chicken pox, like a chicken pox bumps on the skin; he was uncomfortable; symtoms of low energy; fever; chills; feelings of wanting to vomit without vomiting; skin itched badly; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th July 2020, the patient received the 1st dose of Shingrix. On 5th July 2020, less than a day after receiving Shingrix, the patient experienced discomfort, energy decreased, fever and chills. In July 2020, the patient experienced nausea and pruritus. On an unknown date, the patient experienced red rash and varicella-like rash. On an unknown date, the outcome of the red rash, varicella-like rash, discomfort, energy decreased, fever, chills, nausea and pruritus were unknown.   It was unknown if the reporter considered the red rash, varicella-like rash, discomfort, energy decreased, fever, chills, nausea and pruritus to be related to Shingrix.  Additional information was provided as follows: The patient experienced being like lesions, like having chicken pox and red bumps on the skin. The patient was uncomfortable with symtoms of low energy, fever and chills, feelings of wanting to vomit without vomiting. The patient's skin itched badly. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: several episodes of shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving 1st dose of Shingrix, the patient experienced several episodes of Shingles. The reporter consented to follow up.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature, Crying, Irritability
Clinical narrative: Tactile temp, fussiness and crying
Age: 0.75
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site rash
Clinical narrative: Rash noted at on right thigh by mother that began yesterday morning 7/16/2020
Age: 29.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered at inappropriate site
Clinical narrative: No symptoms or additional adverse effects reported; a patient received first dose in GARDASIL 9 immunization series in the gluteus; Patient Age: 29 years old/ a patient received first dose in GARDASIL 9 immunization series in the gluteus; This spontaneous report was received from a nurse prescriber referring to a 29 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 10-JUL-2020 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, route, lot # and expiration were not reported) immunization series in the gluteus for prophylaxis (product administered at inappropriate site and product administered to patient of inappropriate age).  No symptoms or additional adverse effects were reported.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: lower extremity weakness, lower extremity pain beginning the day after vaccine administration, lasting for several days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Myalgia
Clinical narrative: WEAKNESS, MUSCLE ACHES AND UPSET STOMACH
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, UNK, UNK
Symptoms: Listless, Pyrexia, Tremor
Clinical narrative: A few hours after we came home he was somewhat listless. He had a slight fever throughout the rest of the day and evening. His legs started shaking in the evening for about an hour within 5 to 10 minute increments.  He just was not himself at all.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Feeling cold, Headache, Pyrexia, Somnolence
Clinical narrative: Within 24 hours, he started a fever reaching 101.0, headache, cold, sleepy.  Looks to have lasted the day after vaccine was given. So far on 7/17/20, he is not having any symptoms except for a very light headache.   This was his first dose of the HPV vaccine
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Immediate post-injection reaction, Injected limb mobility decreased, Injection site induration, Injection site pain
Clinical narrative: On 07/14/20, 18 yo F was seen in clinic for routine general medical examination. During this visit, pt was ordered Meningococcal B, recombinant OMV vaccine IM (BEXSERO). Per documentation, 0.5 mL was injected in left deltoid at 1343 (Lot #ABXA57AA; Exp: 9/30/2021). Pt tolerated injection without incident and was discharged home. On 07/15, pt's mother called the triage line and reported that pt developed "pain of a 10 immediately after the vaccination, has some patchy redness, and an area about 2-3 inches out from the injection site that is firm, tight, and warm to touch, raised a little. Although the pt denied any fever, SOB or other symptoms, pt acknowledged working out after injection. On 07/16, pt returned to clinic. Pt reported 10/10 arm pain described as a dull ache that worsens with movement. Pt self-medicated with ibuprofen 600 mg BID-TID without improvement. Pt exam found a small vaccine puncture mark visible in mid deltoid that was neither inflamed nor raised. Pt had decreased range of motion, tenderness (soft tissue tenderness over deltoid) and swelling (mild focal soft tissue swelling and erythema over deltoid). Pt had no sign of cellulitis, soft tissue infection or compartment syndrome. Pt had severe pain that is most c/w an injection site reaction that is causing rotator cuff involvement and shoulder impingement. Pt advised "diclofenac (VOLTAREN) 1 % topical gel; Apply 2 g topically 4 (four) times daily, Supportive care. Rest and avoid aggravating activities. Ibuprofen 3-4  tabs 3 x a day with meals for 1-4 week. Ice." Pt instructed to contact MD for any worsening pain, increasing redness, swelling, etc.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Pain, Pain in extremity
Clinical narrative: On 07/14/20, 18 yo F was seen in clinic for routine general medical examination. During this visit, pt was ordered Meningococcal B, recombinant OMV vaccine IM (BEXSERO). Per documentation, 0.5 mL was injected in left deltoid at 1343 (Lot #ABXA57AA; Exp: 9/30/2021). Pt tolerated injection without incident and was discharged home. On 07/15, pt's mother called the triage line and reported that pt developed "pain of a 10 immediately after the vaccination, has some patchy redness, and an area about 2-3 inches out from the injection site that is firm, tight, and warm to touch, raised a little. Although the pt denied any fever, SOB or other symptoms, pt acknowledged working out after injection. On 07/16, pt returned to clinic. Pt reported 10/10 arm pain described as a dull ache that worsens with movement. Pt self-medicated with ibuprofen 600 mg BID-TID without improvement. Pt exam found a small vaccine puncture mark visible in mid deltoid that was neither inflamed nor raised. Pt had decreased range of motion, tenderness (soft tissue tenderness over deltoid) and swelling (mild focal soft tissue swelling and erythema over deltoid). Pt had no sign of cellulitis, soft tissue infection or compartment syndrome. Pt had severe pain that is most c/w an injection site reaction that is causing rotator cuff involvement and shoulder impingement. Pt advised "diclofenac (VOLTAREN) 1 % topical gel; Apply 2 g topically 4 (four) times daily, Supportive care. Rest and avoid aggravating activities. Ibuprofen 3-4  tabs 3 x a day with meals for 1-4 week. Ice." Pt instructed to contact MD for any worsening pain, increasing redness, swelling, etc.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Rotator cuff syndrome, Skin tightness
Clinical narrative: On 07/14/20, 18 yo F was seen in clinic for routine general medical examination. During this visit, pt was ordered Meningococcal B, recombinant OMV vaccine IM (BEXSERO). Per documentation, 0.5 mL was injected in left deltoid at 1343 (Lot #ABXA57AA; Exp: 9/30/2021). Pt tolerated injection without incident and was discharged home. On 07/15, pt's mother called the triage line and reported that pt developed "pain of a 10 immediately after the vaccination, has some patchy redness, and an area about 2-3 inches out from the injection site that is firm, tight, and warm to touch, raised a little. Although the pt denied any fever, SOB or other symptoms, pt acknowledged working out after injection. On 07/16, pt returned to clinic. Pt reported 10/10 arm pain described as a dull ache that worsens with movement. Pt self-medicated with ibuprofen 600 mg BID-TID without improvement. Pt exam found a small vaccine puncture mark visible in mid deltoid that was neither inflamed nor raised. Pt had decreased range of motion, tenderness (soft tissue tenderness over deltoid) and swelling (mild focal soft tissue swelling and erythema over deltoid). Pt had no sign of cellulitis, soft tissue infection or compartment syndrome. Pt had severe pain that is most c/w an injection site reaction that is causing rotator cuff involvement and shoulder impingement. Pt advised "diclofenac (VOLTAREN) 1 % topical gel; Apply 2 g topically 4 (four) times daily, Supportive care. Rest and avoid aggravating activities. Ibuprofen 3-4  tabs 3 x a day with meals for 1-4 week. Ice." Pt instructed to contact MD for any worsening pain, increasing redness, swelling, etc.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information; A patient received dose of improperly stored PROQUAD; This spontaneous report was received from a medical assistant, referring to patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 30-JUN-2020, a patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection (dose, vaccination scheme, route of administration and anatomical site of vaccination were not reported, lot number S022917, which has been verified to be valid, and expiration date reported and validated as 09-JAN-2021) as prophylaxis. A properly stored dose sterile diluent (MERCK STERILE DILUENT) was used to reconstitute measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). The vaccine experienced a temperature of -12.1 Celcius (C) four 45 minutes, as record by data logger. There was no previous temperature excursion. No additional adverse event were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; an improperly stored dose of VARIVAX was administered to a patient; This spontaneous report was received from an office manager, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, previous drug reactions, or allergies were not reported.  On 25-JUN-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (vaccination scheme, anatomical site of injection and route of administration were not reported; lot number S025610, which has been verified to be valid, expiration date reported and validated as 18-AUG-2021) as prophylaxis (product storage error). No additional adverse effects reported.  The vaccine experienced a temperature excursion of 22.3 degrees Fahrenheit (F) for 4 hours and 25 minutes. There was a previous temperature excursion of 8.6F for 1 hour and 51 minutes, as recorded by a data logger.
Age: 6.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; one patient was administered a dose of improperly stored VARIVAX; This spontaneous report was received from a physician and refers to a 6-year-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 09-JUL-2020, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # S038701 was verified to be a valid lot number, expiration date reported and established as 01-DEC-2021 (dose, route of administration and anatomical reaction were not provided) for prophylaxis. The vaccines were reconstituted with a properly stored sterile diluent.  The administered dose of vaccine experienced a temperature excursion of 15 to 46 Fahrenheit degrees (also reported as 32.9 Fahrenheit degrees) for 5 hours. There was no previous temperature excursion. Digital Data Logger was involved.  The patient did not experience any additional adverse effects.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: patient received unspecified dose in PROQUAD immlllliz.ation series that was improperly stored; No symptoms or additional adverse effects reported; This spontaneous report was received from a nurse and refers to a patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-JUL-2020, the patient was vaccinated with dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, lot # S031704, expiration date 06-APR-2021 (strength, route of administration and dose were not reported) reconstituted in properly stored sterile diluent, for prophylaxis.  On an unknown date, the dose of the vaccine was exposed to temperature excursion at 67 Fahrenheit (F) degrees for 17 hours. There was no previous temperature excursion. The call was due to digital data logger. No symptoms or additional adverse effects reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No symptoms or additional adverse effects reported; received unspecified dose in PROQUAD that was improperly stored; This spontaneous report was received from a nurse and refers to a patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-JUL-2020, the patient was vaccinated with dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, lot # S021328, expiration date 05-JAN-2021 (strength, route of administration and dose were not reported) reconstituted in properly stored sterile diluent, for prophylaxis.  On an unknown date, the dose of the vaccine was exposed to temperature excursion at 67 Fahrenheit (F) degrees for 17 hours. There was no previous temperature excursion. The call was due to digital data logger. No symptoms or additional adverse effects reported.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect product formulation administered
Clinical narrative: Only diluent was given, when MA went to put vaccine in EMR she realized she had only given diluent and immediately gave another dose
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Pruritus, Pyrexia
Clinical narrative: -BY 11PM ON EVENING POST INJECTION - FEVER, BODY ACHES, CHILLS (SUBSIDED AFTER 2 DAYS) AND FATIGUE (ONGOING, BUT SUBSIDING) -1-2 DAYS POST INJECTION - SMALL, RAISED, BLISTERY HIVE TYPE RASH - ITCHY SPOTS ON ARMS, TRUNK, AND FACE (ONGOING 3 DAYS POST INJECTION)
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash papular, Rash vesicular
Clinical narrative: -BY 11PM ON EVENING POST INJECTION - FEVER, BODY ACHES, CHILLS (SUBSIDED AFTER 2 DAYS) AND FATIGUE (ONGOING, BUT SUBSIDING) -1-2 DAYS POST INJECTION - SMALL, RAISED, BLISTERY HIVE TYPE RASH - ITCHY SPOTS ON ARMS, TRUNK, AND FACE (ONGOING 3 DAYS POST INJECTION)
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Day 1 - Whole body muscle ache the evening vaccination was received. Vaccination site was not painful. Day 2 - 100.4 temperature in the morning, fatigue, headache, mild chills; temp went down to 99.7 during the day, then back to 100 by 8:30pm. Treatment: Tylenol and a 1+ hour nap in the morning and a 1+ hour nap in the afternoon. Day 3 - Woke feeling fine; 98.5 temperature
Age: 0.5
Sex: M
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Menveo given in error in place of Hiberix. Not off label for age, to call mother in two weeks to give the Hiberix needed.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Papule
Clinical narrative: numerous, discrete, pink to rose colored papule on all surfaces sparing palms and soles. no vesicles seen
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Ageusia, Chest X-ray, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever was noticed the evening  of the immunization. patient has been treating and controlling fever with tylenol and ibuprofen and drinking plenty of fluids and resting.  patient was seen and examined by local emergency room and also by primary  care . Both health care providers stated to patient that they suspect COVID-19 due to patient stating he has no taste with fever.  Patient has had fever on and off since evening of 7-10-20 until 7/16/20. Now his fever has passed. Patient continues to rest and drink ample fluids to stay hydrated and also is watching temperature; while awaiting COVID test results from emergency room.
Sex: F
Vaccine: FLUX, PPV, VARZOS
Symptoms: Hypersensitivity, Peripheral swelling
Clinical narrative: allergic reaction to all of them; the patient's arm swelled; This spontaneous report was received from a consumer (a field employee, who also is a patient's relative) and refers to a 60-year-old female patient. She had multiple unspecified allergies. The concomitant therapies included epinephrine hydrochloride (EPIPEN). On an unknown dates, the patient was vaccinated for prophylaxis with doses of: zoster vaccine live (manufacturer unknown), pneumococcal vaccine (manufacturer unknown) and influenza virus vaccine (manufacturer unknown) (formulation, concentration, dose, route of administration, frequency, lot # and expiry date for all 3 mentioned vaccines were not reported). The reporter could not confirm if the patient had all of mentioned vaccines administered on the same day or different days and could not confirm if the vaccines were administered in the same arm or different arms. The outcome of the allergic reaction to vaccines and swelling arm was unknown. The action taken regarding all mentioned suspect therapies was not applicable. The causality assessment between the allergic reaction to vaccines and all the suspect therapies was related. The causality assessment between the swelling arm and all the suspect therapies was unknown.  This is one of the report received from the same reporter regarding the same patient.; Sender's Comments:  US-009507513-2007USA004415:
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered
Clinical narrative: No adverse effect; Was administered a third dose of PROQUAD; Information has been received from a licensed practitioner nurse concerning to an 11 year old female patient. No medical history, concurrent conditions nor concomitant medications were reported. On 14-JUL-2020, the patient was vaccinated with a third dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (Lot No. S008575, exp. date 16-SEP-2020) (route of administration not reported) for prophylaxis (extra dose administered). The vaccine was reconstituted with properly stored sterile diluent (Lot No. S002624, exp. date 05-NOV-2021).
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No other adverse effects were reported in the patient; received a dose of GARDASIL-9 in March 2020 (exact date not specified) and is currently at the pharmacy to get the second dose in the 3-dose series; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided. In March, 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) at a dose of  0.5 milliliter for prophylaxis(strength, frequency, lot # and expiration date were not provided) for prophylaxis.  It was reported that on 14-JUL-2020, the patient was at the pharmacy to get the second dose in the 3-dose series. No other adverse effects were reported in the patient.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Gait disturbance, Headache, Injection site pain, Muscular weakness
Clinical narrative: Severe Headache; Shortness of Breath; Legs Weakness; Severe Pain in Both Shoulders; Nausea; Difficulty walking; This case was reported by a consumer via call center representative and described the occurrence of headache in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shoulder pain (had history of pain in her shoulders).   On 7th July 2020, the patient received the 1st dose of Shingrix. In July 2020, 11 hrs after receiving Shingrix, the patient experienced headache, shortness of breath, lower extremities weakness of, shoulder pain, nausea and walking difficulty. On an unknown date, the outcome of the headache, shortness of breath, lower extremities weakness of, shoulder pain, nausea and walking difficulty were not recovered/not resolved.   It was unknown if the reporter considered the headache, shortness of breath, lower extremities weakness of, shoulder pain, nausea and walking difficulty to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and approximately at 1 to 2 am, she began having a severe headache, shortness of breath, legs were weak, difficulty walking, severe pain in both shoulders, and nausea.   She stated she had history of pain in her shoulders but that this pain was severe in both shoulders.   The reporter asked if GSK recommended she take Tylenol or ibuprofen. The reporter provided the caller with Medical Disclaimer and asked if she would like to have PI sent to her.   The reporter stated she would talk with her HCP and refused the PI to be sent because she the information from GSK website. The reporter consented to follow up. The reporter could provide no other contact information.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal pain, Nausea
Clinical narrative: Severe Headache; Shortness of Breath; Legs Weakness; Severe Pain in Both Shoulders; Nausea; Difficulty walking; This case was reported by a consumer via call center representative and described the occurrence of headache in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shoulder pain (had history of pain in her shoulders).   On 7th July 2020, the patient received the 1st dose of Shingrix. In July 2020, 11 hrs after receiving Shingrix, the patient experienced headache, shortness of breath, lower extremities weakness of, shoulder pain, nausea and walking difficulty. On an unknown date, the outcome of the headache, shortness of breath, lower extremities weakness of, shoulder pain, nausea and walking difficulty were not recovered/not resolved.   It was unknown if the reporter considered the headache, shortness of breath, lower extremities weakness of, shoulder pain, nausea and walking difficulty to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and approximately at 1 to 2 am, she began having a severe headache, shortness of breath, legs were weak, difficulty walking, severe pain in both shoulders, and nausea.   She stated she had history of pain in her shoulders but that this pain was severe in both shoulders.   The reporter asked if GSK recommended she take Tylenol or ibuprofen. The reporter provided the caller with Medical Disclaimer and asked if she would like to have PI sent to her.   The reporter stated she would talk with her HCP and refused the PI to be sent because she the information from GSK website. The reporter consented to follow up. The reporter could provide no other contact information.
Sex: F
Vaccine: TDAP
Symptoms: Obsessive-compulsive disorder
Clinical narrative: severe OCD; This case was reported by a consumer via call center representative and described the occurrence of obsessive-compulsive disorder in a female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   The patient's past medical history included seizure. Previously administered products included TD vaccine (had TD vaccine ). Concurrent medical conditions included immunocompromised.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced obsessive-compulsive disorder. On an unknown date, the outcome of the obsessive-compulsive disorder was unknown.   It was unknown if the reporter considered the obsessive-compulsive disorder to be related to Tdap Vaccine.  Additional details were provided as follows: The case was reported by the mother of the patient. The age at vaccination was not reported. The reporter reported her daughter had benign seizures as a baby resulting in postponing pertussis vaccine.  The reporter reported her daughter never had a pertussis vaccine and has not had a seizure since being a baby.  The patient only had TD vaccine although a physician suggested she did not receive vaccines due to her daughter potentially having a compromised immune system.  The patient had a TDaP vaccine thought to be Boostrix, but mother was uncertain and developed severe OCD. The reporter declined to provide daughter's PII due to her privacy reasons. Limited information available.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Rash
Clinical narrative: Rash to Left Arm; injection site pain; This case was reported by a consumer via call center representative and described the occurrence of rash in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in January 2020).   On 2nd July 2020, the patient received the 2nd dose of Shingrix. In July 2020, 48 hrs after receiving Shingrix, the patient experienced rash and injection site pain. On an unknown date, the outcome of the rash and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the rash and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had a rash on her left arm and pain at the injection site.   The reporter wanted to know if she could give chicken pox or shingles vaccine to her 4 month old grandchildren.   The reporter provided caller with the information found in Content and from Shingrix PI and provided the caller with the Medical Disclaimer to talk with her HCP.   The caller was offered Shingrix PI and this information was emailed to her. The reporter consented to follow up. No other contact information provided per caller.
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Vaccination site erythema, Vaccination site inflammation, Vaccination site pain
Clinical narrative: injection site is red and painful; injection site is red; injection site is red and painful; Initial information received on 14-Jul-2020 regarding an unsolicited valid non-serious case received from a consumer/non-hcp via the Pharmaceuticals company.  This case involves a female patient (age not reported) who experienced injection site is red and painful (vaccination site inflammation, vaccination site erythema and vaccination site pain), while she received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  Medical history, medical treatment, vaccination, concomitant therapy and family history were not provided.  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number and expiry date were not reported) via an unknown route in the right arm for prophylactic vaccination.  On an unknown date, the patient developed a non-serious injection site is red and painful (vaccination site inflammation, vaccination site erythema and vaccination site pain) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Details of laboratory data was not reported.  Final diagnosis was vaccination site inflammation.  It was not reported if the patient received any corrective treatment.  At the time of this report, event outcome was not reported.  There will be no information available on the lot number for this case.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Condition aggravated, Injection site pain, Injection site swelling, Tic
Clinical narrative: Pain and Swelling, at injection site.   Increased severity and  frequency  of head , neck, and facial neurological ticks
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; patient received unspecified dose in VARIVAX immuniz.ation series that was improperly stored; This spontaneous report was received from a nurse and refers to a 4 years old patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided.     On 09-JUL-2020, the patient was vaccinated with unspecified improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S038178 with expiration date of 26-NOV-2021 for prophylaxis. No symptoms or additional adverse effects reported. The vaccine experienced temperature of excursión of 67 degrees Fahrenheit for 17 hours. There were not previous excursion, Digital data logger was involved.
Age: 40.0
Sex: F
Vaccine: TD
Symptoms: Allergy to vaccine, Eye pain, Headache, Hypersensitivity, Injection site inflammation
Clinical narrative: Injection site inflammation and swelling 7/16 woke up with fever of 101.0 High fever, body aches, nausea, throwing up every hour on the hour    10:15 am Fever was 99.7 - Dr thinks it was an allergic reaction to the tetanus . she had had a reaction once before ? nausea and threw up but nothing like this. Dr called in Zofran for her. - 705pm 101 ? no matter what she takes will not go down ? super achy  7/17 7am today, woke up drenched in sweat last night, temp down to 99. Woke today with killer headache, eyes hurt, temp back up to 101.6