chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Immediate post-injection reaction, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Signs of cellulitis at the injection site; This spontaneous report has received from an officer manager through a company representative, regarding to a 72-year-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not provided.   On 24-SEP-2019, the patient was vaccinated with a dose pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # S013490, has been verified to be a valid lot number for pneumococcal vaccine, polyvalent (23-valent), expiration date not reported, but upon internal validation established as 06-MAR-2021 (strength, dose, route of administration and anatomical location of vaccine were not provided) for vaccination.   On 26-SEP-2019, the patient returned to the facility with signs of cellulitis at the injection site (Injection site cellulitis); however, she sought for medical atention and an unspecified physician placed the patient on antibiotic (unspecified treatment). At the reporting time, the outcome of injection site cellulitis was unknown.  The causality assessment between the injection site cellulitis and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site cellulitis
Clinical narrative: she felt pain in her arm after the injection/ the patient's arm , in which she was administered the injection, became red and swollen which radiated down to the elbow/ diagnosed with cellulitis; This spontaneous report was received from a medical assistant regarding a 72-year-old female patient. Information on medical history, concomitant medications and concurrent conditions were not reported. The patient was allergic to adhesive tapes. On 24-SEP-2019, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (dose, strength, frequency were not reported) (lot # S013490 and expiration date: 06-MAR-2021) intramuscularly for immunization. On the same day (reported as immediately after the injection), the patient noted that she felt pain in her arm. It was reported that the patient's arm, in which she was administered the injection, became red and swollen which radiated down to the elbow. On 26-SEP-2019, the patient was seen by the physician and was diagnosed with cellulitis. The patient was treated with unspecified oral antibiotic. No lab test were performed. The outcome of the event cellulitis was reported as not recovered. The causality assessment was not provided.  Upon internal review, the event diagnosed with cellulitis was determined to be medically significant.
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Immediate post-injection reaction, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: she felt pain in her arm after the injection/ the patient's arm , in which she was administered the injection, became red and swollen which radiated down to the elbow/ diagnosed with cellulitis; This spontaneous report was received from a medical assistant regarding a 72-year-old female patient. Information on medical history, concomitant medications and concurrent conditions were not reported. The patient was allergic to adhesive tapes. On 24-SEP-2019, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) (dose, strength, frequency were not reported) (lot # S013490 and expiration date: 06-MAR-2021) intramuscularly for immunization. On the same day (reported as immediately after the injection), the patient noted that she felt pain in her arm. It was reported that the patient's arm, in which she was administered the injection, became red and swollen which radiated down to the elbow. On 26-SEP-2019, the patient was seen by the physician and was diagnosed with cellulitis. The patient was treated with unspecified oral antibiotic. No lab test were performed. The outcome of the event cellulitis was reported as not recovered. The causality assessment was not provided.  Upon internal review, the event diagnosed with cellulitis was determined to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Erythematous wheal extending down to elbow; This case was reported by a physician via sales rep and described the occurrence of erythema urticarial in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced erythema urticarial. On an unknown date, the outcome of the erythema urticarial was unknown.   It was unknown if the reporter considered the erythema urticarial to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced erythematous wheal extending down to elbow.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site rash
Clinical narrative: Small rash appeared at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number 54H72, expiry date 1st October 2021) for prophylaxis.   On 16th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was recovered/resolved.   The reporter considered the injection site rash to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The pharmacist confirmed with the patient, that it was not just red but was rash at the injection site. The reporter did not know how soon after vaccination with dose of Shingrix, the patient experienced injection site rash. The healthe care professional stated that, the injection site rash resolved in 4 days. The pharmacist was transfered to medical information on whether the patient should receive the 2nd dose.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site rash, Rash
Clinical narrative: unsure if shingles rash; Rash along their torso; Rash along their torso; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th September 2019, the patient received Shingrix (intramuscular). In September 2019, less than a week after receiving Shingrix, the patient experienced shingles, rash and injection site rash. On an unknown date, the outcome of the shingles, rash and injection site rash were unknown.   It was unknown if the reporter considered the shingles, rash and injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that the patient received Shingrix and developed a rash at the injection site and along their torso (unsure if shingles rash). No details were regarding lot or expiration date, onset and duration of rash, administrator of vaccine, location of administration available at this time. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Malaise, Pain
Clinical narrative: late dose; Malaise; Body aches; This case was reported by a physician via sales rep and described the occurrence of malaise in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. In November 2018, immediately after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced malaise and general body pain. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the malaise and general body pain were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the malaise and general body pain to be related to Shingrix.  Additional case details were provided as follows: Soon after receiving a dose of Shingrix, the patient began to experience significant malaise and body aches and due to which she had to stay in bed for 48 hours. From the reported information, it seems that, till the time of reporting, the patient did not receive her 2nd dose, which led to an incomplete course of vaccination. All symptoms were resolved after 48 hours. The sales representative indicated that, the reporter provided this information to her during a Congress she was attending and was unable to provide any additional details. This is 1 of the 4 cases reported by the same reporter. There was a discrepancy in the reported outcomes of the events body aches and malaise. In XML, outcome was mentioned as recovered/resolved with sequel and in Argus, it was reported as recovered/resolved. However outcome of these events is captured as per Argus.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Malaise
Clinical narrative: Malaise/not feeling great; Shivers; This case was reported by a consumer via call center representative and described the occurrence of shivers in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 24th September 2019, less than a day after receiving Shingrix, the patient experienced shivers. On 25th September 2019, the patient experienced malaise. On an unknown date, the outcome of the shivers was recovered/resolved and the outcome of the malaise was not recovered/not resolved.   It was unknown if the reporter considered the shivers and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that after receiving 1st Shingrix dose in his left arm at his physician's office and experienced shivers that lasted all night long. The following day the patient was not feeling great (malaise). The patient reported that he was starting to come out of it, however it was still slightly lingering around. The reporter consented to follow up.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain in extremity
Clinical narrative: pain; swelling; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced pain in arm and injection site swelling. On an unknown date, the outcome of the pain in arm and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the pain in arm and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The medical assistant reported that the physician at her office received the first dose of Shingrix about 1 month ago. Afterwards he had pain like someone punched him in the arm and swelling at the injection site. The reporter would not provide her full name.
Sex: U
Vaccine: FLU4
Symptoms: Neurological symptom
Clinical narrative: Neurological events; This case was reported by a other health professional via sales rep and described the occurrence of neurological symptom in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number 72RS4, expiry date 30th June 2020) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced neurological symptom (serious criteria hospitalization). On an unknown date, the outcome of the neurological symptom was recovering/resolving.   It was unknown if the reporter considered the neurological symptom to be related to FluLaval Quadrivalent.  Additional details were provided as follows: The age at vaccination was not reported. The healthcare provider administered 10,000 vials of FluLaval vaccines to all employees. Three patients developed Neurological events, 1 of those 3 patients was currently in the intensive care unit (ICU). The healthcare professional (HCP) reached out to the local health department. This matter went up to leadership at the HCP. The reporter consented to follow up. This case is 1 of 3 cases reported.
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillian Barre Syndrome; This case was reported by a physician via sales rep and described the occurrence of guillain barre syndrome in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included chemotherapy, nos (Chemotherapy).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   The reporter considered the guillain barre syndrome to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced Guillian Barre Syndrome a few days after receiving the Shingrix vaccine.  The physician did not believed that the vaccine was the related to the event and planed to gave the second dose. The reporter consented for follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Malaise, Product preparation issue
Clinical narrative: tenderness at injection site/localized reaction to the injection site; warmth at injection site/localized reaction to the injection site; redness at injection site/localized reaction to the injection site; malaise; inappropriate reconstitution technique; Inappropriate dose of vaccine administered; sleepness; This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th September 2019, the patient received Shingrix. On 24th September 2019, less than a day after receiving Shingrix, the patient experienced injection site tenderness, injection site warmth, injection site erythema, malaise, sleepiness, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the injection site tenderness, injection site warmth, injection site erythema, malaise, sleepiness, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the injection site tenderness, injection site warmth, injection site erythema, malaise and sleepiness to be related to Shingrix.  Additional details were reported as follows: The vaccine was given by a medical assistant at her physician's office.  she received a call from the medical assistant and was told that she was given the adjuvent before reconstituting with antigen component (powder), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  Caller reported that she experienced a localized reaction to the injection site, redness, tenderness and hot to the touch, she also felt malaise and came home that evening from work and slept for 10 hours. The medical assistant informed her that she would have to retake her Shingrix injection in three weeks. Caller inquired if she should retake her Shingrix vaccine. caller was referred to her physician regarding if she should retake her Shingrix injection in three weeks, provided GSK contact number for her physician to call Medical Information department for additional information. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: tenderness at injection site/localized reaction to the injection site; warmth at injection site/localized reaction to the injection site; redness at injection site/localized reaction to the injection site; malaise; inappropriate reconstitution technique; Inappropriate dose of vaccine administered; sleepness; This case was reported by a consumer via call center representative and described the occurrence of injection site tenderness in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th September 2019, the patient received Shingrix. On 24th September 2019, less than a day after receiving Shingrix, the patient experienced injection site tenderness, injection site warmth, injection site erythema, malaise, sleepiness, inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the injection site tenderness, injection site warmth, injection site erythema, malaise, sleepiness, inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the injection site tenderness, injection site warmth, injection site erythema, malaise and sleepiness to be related to Shingrix.  Additional details were reported as follows: The vaccine was given by a medical assistant at her physician's office.  she received a call from the medical assistant and was told that she was given the adjuvent before reconstituting with antigen component (powder), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  Caller reported that she experienced a localized reaction to the injection site, redness, tenderness and hot to the touch, she also felt malaise and came home that evening from work and slept for 10 hours. The medical assistant informed her that she would have to retake her Shingrix injection in three weeks. Caller inquired if she should retake her Shingrix vaccine. caller was referred to her physician regarding if she should retake her Shingrix injection in three weeks, provided GSK contact number for her physician to call Medical Information department for additional information. The reporter consented to follow up.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Incorrect route of product administration, Irritability, Vomiting
Clinical narrative: Inappropriate Route of Vaccination; Patient experienced fussiness; Vomit after the injection; This case was reported by a other health professional via call center representative and described the occurrence of irritability in a 2-month-old male patient who received Rota (Rotarix) (batch number KZ97P, expiry date 22nd September 2020) for prophylaxis.   On 26th September 2019, the patient received Rotarix (intramuscular). In September 2019, less than a week after receiving Rotarix, the patient experienced irritability and vomiting. On 26th September 2019, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the irritability, vomiting and inappropriate route of vaccination were unknown.   It was unknown if the reporter considered the irritability and vomiting to be related to Rotarix.  Additional details were received as follows: The vaccine was given in the right thigh on September 26, 2019. A male patient was given Rotarix via the intramuscular route, which led to inappropriate route of vaccination. The patient experienced fussiness and did vomit after the injection. The reporter consented to follow up.
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Coronary artery dilatation, Echocardiogram abnormal, Kawasaki's disease
Clinical narrative: ECHOCARDIOGRAM ABNORMAL; Coronary artery dilatation; Kawasaki's disease; Information has been downloaded from regulatory authority (US-PFIZER INC-2012090348).   This spontaneous report was received from an other health professional concerning a 12 month old male patient. His concurrent conditions included respiratory tract infection and candida nappy rash. No concomitant therapy was reported.      On 25-FEB-2011, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (bath/lot# 1510Z, 1 dosage form, intramuscular), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (batch/lot# 0811Z, 1 dosage form, subcutaneous), varicella virus vaccine live (Oka/Merck) (VARIVAX) (batch/lot# 1044Z, 1 dosage form, subcutaneous), pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) (batch/lot# E84462, 1 dosage form, intramuscular) and Hib conj vaccine (tet toxoid), diphtheria toxoid, pertussis acellular 5-component vaccine, poliovirus vaccine inactivated (MRC-5), tetanus toxoid (PENTACEL) (batch/lot# C3747AB, 1 dosage form, intramuscular) for immunisation.    On 05-MAR-2011, the patient experienced Kawasaki's disease. On 18-MAR-2011, the patient experienced coronary artery dilatation. On an unknown date, the patient experienced echocardiogram abnormal. All the events caused hospitalization. The outcome of all the events was reported as resolved.  Action taken with suspect drugs was not applicable.   The causality between the events and suspect drugs was not reported.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 3 inch raised, red, warm, itchy area located approximately 2 inches below injection site.  Symptoms showed up one day post vaccine, although itchiness resolved same day.
Age: 1.67
Sex: F
Vaccine: FLU4
Symptoms: Cough, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Diarrhea, vomiting, cough 2 days after flu shot and fever 3 days after flu shot
Age: 37.0
Sex: M
Vaccine: UNK
Symptoms: Discomfort, Erythema, Limb discomfort, Peripheral swelling
Clinical narrative: within hrs of vaccination with AVA began to notice arm swelling, redness and discomfort. Sought care the following day, given steroids with resolution of sx within a couple of days. Swelling did not extend past deltoid. Did have LLR with previous AVA admin between 2003-05.  Symptoms: EDEMA, UNSPECIFIED(R609), OTHER ERYTHEMATOUS CONDITIONS(L53).
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Chills, Fatigue, Gait disturbance, Headache
Clinical narrative: Woke up at 12:30 a.m. with severe chills and aches - put on socks and heavy sweatshirt and went back to bed.  When I woke at 7 a.m. I had body aches - difficult to walk,  was off-balance,  exhaustion, nauseousness, vomited immediately after taking my morning vitamins and had a headache.   I am a very active and healthy and strong person - these side effects landed me in bed all day.  Today, October 4, I'm feeling much better with a slight headache and body aches and nauseousness and feeling a bit tired.   I'm hoping I am on the mend.  I called my PCP who told me to take Tylenol and call if my condition worsened.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: Woke up at 12:30 a.m. with severe chills and aches - put on socks and heavy sweatshirt and went back to bed.  When I woke at 7 a.m. I had body aches - difficult to walk,  was off-balance,  exhaustion, nauseousness, vomited immediately after taking my morning vitamins and had a headache.   I am a very active and healthy and strong person - these side effects landed me in bed all day.  Today, October 4, I'm feeling much better with a slight headache and body aches and nauseousness and feeling a bit tired.   I'm hoping I am on the mend.  I called my PCP who told me to take Tylenol and call if my condition worsened.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse events; a patient was administered 1 dose of improperly stored VAQTA; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. There was no information about the patient's concurrent condition, concomitant medication and medically history provided.  On 09-SEP-2019, the patient was vaccinated with the first dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) lot number: S017739, expiration date: 29-AUG-2020 for prophylaxis (formulation, dose and route of administration were not reported).   The administrated dose of vaccine was exposed to the highest temperature above 47 degrees Fahrenheit / 9 degrees Celsius for 24 hours. There was no previous temperature excursion. The data logger was not involved. No adverse events were reported.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth, Neck pain, Pain in extremity, Pruritus
Clinical narrative: Injections site red, hot to touch. Itchy and pain down arm and into neck. Did ice, Benadryl and this helped. 10/04/2019 area at site reddened the size of a golf ball.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Erythema, Papule, Rash, Rash vesicular
Clinical narrative: 6 hours after vaccines he developed vesicular rash initially on bilat lower extremities w evolution to involve bilat upper extremities. vesicles superimposed on erythem papules -similar appearance to poison ivy or perhaps even varicella like. But no systemic symptoms, otherwise well
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: 3 hours after the injection, the area of the injection was very sore (I was told that this may occur); soreness (it felt like I had been punched by a professional boxer but without the bruising or swelling) lasted for 2 days (until 10/2).  I noticed a rash on the shoulder where the vaccine was injected on 10/3 (morning).  It doesn't itch and the rash is contained to the shoulder. As of 10/4, there is a slight soreness.  But, I have to press down on my should to feel any soreness.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Erythema, Malaise, Pruritus, Rash
Clinical narrative: 08-02-2019 Office visit: History of Present Illness: Rash:  The patient presents for rash.  This episode began gradually and has lasted caries.  The symptom(s) are described as moderate, unchanged and occurs daily.  The patient describes the affected area(s) as burning, itchy and red.  Associated symptoms include erythema (skin) and pruritus.  States had Tdap injection on 7/22 [given in R deltoid] and states ever since has had a rash on her arm.  Says it is hot, painful, and will not go away.  States she also felt somewhat sick for 2 days after.  Review of Systems: Integumentary:  Positive for erythema, pruritis  Assessment and Plan:  Rash.  Please take the steroids and antibiotic.  If you do not improve let us know.  (Prednisone 20 mg.  Take 2 tabs by mouth once daily for 4 days, take 1 tab daily for 3 days;  cephalexin 500 mg.  Take 1 capsule by oral route 3 times every day.  Dispense 21 capsules.)  10-03-2019 Outgoing call at 4:08 PM:  I called to follow-up on the rash on arm from a Tdap administration on 7-22.  To see that is has fully resolved and about how long it took to do that.  This is my third day/attempt to contact patient and each time a recording says mailbox is full. 10-04-2019 at 9:08 AM:  I called and mailbox is full.  All communications since the OV re: arm/rash have nothing to do about arm/rash.  I will fill out VEARS report.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Skin warm
Clinical narrative: 08-02-2019 Office visit: History of Present Illness: Rash:  The patient presents for rash.  This episode began gradually and has lasted caries.  The symptom(s) are described as moderate, unchanged and occurs daily.  The patient describes the affected area(s) as burning, itchy and red.  Associated symptoms include erythema (skin) and pruritus.  States had Tdap injection on 7/22 [given in R deltoid] and states ever since has had a rash on her arm.  Says it is hot, painful, and will not go away.  States she also felt somewhat sick for 2 days after.  Review of Systems: Integumentary:  Positive for erythema, pruritis  Assessment and Plan:  Rash.  Please take the steroids and antibiotic.  If you do not improve let us know.  (Prednisone 20 mg.  Take 2 tabs by mouth once daily for 4 days, take 1 tab daily for 3 days;  cephalexin 500 mg.  Take 1 capsule by oral route 3 times every day.  Dispense 21 capsules.)  10-03-2019 Outgoing call at 4:08 PM:  I called to follow-up on the rash on arm from a Tdap administration on 7-22.  To see that is has fully resolved and about how long it took to do that.  This is my third day/attempt to contact patient and each time a recording says mailbox is full. 10-04-2019 at 9:08 AM:  I called and mailbox is full.  All communications since the OV re: arm/rash have nothing to do about arm/rash.  I will fill out VEARS report.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient preferred to receive both injections in same arm.  Administering Pharmacist failed to separate injection sites by minimum one inch (best practice recommendation).  Within 24 hours upper left arm was painful, red, hot, and very swollen.  Patient treated with acetaminophen, diphenhydramine, and ice.  Now, third day, swelling still present, heat still present, and still sore, though symptoms are slowly resolving.
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A Kinrix vaccine was given to someone under the age of 4.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Musculoskeletal pain, Myalgia
Clinical narrative: Muscle and shoulder really aches with use or sleeping on her left side.  Patient stated she felt slight soreness the day of shot but the soreness has not gone away after 2 weeks. Described as a deep muscle soreness.  No swelling, bruising or heat to touch was reported. Patient stated that there was some slight pain with administration similar to immunizations that she had in the past, nothing out of the ordinary.   Spoke with patient on october 1st and recommended making an appt. with doctor to get checked out. Recommended Ibuprofen for pain until doctor could be seen.  Spoke to patient again on 10/4/19 and she is still having the soreness.  She has made an appt. with her PCP.
Age: 1.25
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A Kinrix vaccine was given to someone under the age of 4.
Age: 0.42
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A Kinrix vaccine was given to someone under the age of 4.
Age: 5.0
Sex: F
Vaccine: IPV
Symptoms: Burning sensation, Injection site urticaria, Myalgia, Peripheral swelling, Pruritus
Clinical narrative: Arm is extremely swollen like a baseball on her shoulder. It's very red and hot to the touch. She is complaining her entire arm itches and burn. Looks like the start of hives directly on the site.  She has a fever and complaining of all her muscles hurting.
Age: 5.0
Sex: F
Vaccine: IPV
Symptoms: Pyrexia, Skin reaction, Skin warm
Clinical narrative: Arm is extremely swollen like a baseball on her shoulder. It's very red and hot to the touch. She is complaining her entire arm itches and burn. Looks like the start of hives directly on the site.  She has a fever and complaining of all her muscles hurting.
Age: 0.42
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A Kinrix vaccine was given to someone under the age of 4.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Confusional state, Headache, Myalgia, Pyrexia
Clinical narrative: High fever, rigors, headache, myalgia, confusion that came on suddenly at around 5pm, lasted until 4am the next day and then quickly resolved.  There were no symptoms or any prodrome prior to this, as I was completely in my usual state of health.
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: an improperly stored dose of PEDVAX was administered to the patient on an unknown date; No adverse effects; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot # N024570, expiration date: 01-MAY-2020 (strength, dose, schedule and route of administration were unknown) for prophylaxis (product storage error). The vaccine underwent temperature excursion below 36-degree Fahrenheit: 32.1 Fahrenheit for a duration of 8 hours. There was no previous temperature excursion. There was an involvement of data logger. No product quality complaints (PQC) were involved.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; the patient was inadvertently administered an expired dose of ROTATEQ; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 29-JUL-2019, the patient was inadvertently vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # R030924, expiration date reported as 11-JUN-2019, but upon lot# validation, expiration date was established as 10-JUL-2020 (dose was not provided) for prophylaxis. No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: Malaise; Body aches; Fever; This case was reported by a physician via sales rep and described the occurrence of malaise in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced malaise, general body pain and fever. On an unknown date, the outcome of the malaise, general body pain and fever were recovered/resolved.   It was unknown if the reporter considered the malaise, general body pain and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the first dose of the Shingrix vaccine and experienced malaise, body aches, and a fever of 101 degrees.  All symptoms resolved within two day. The reporter was unable to provide any additional details.  This is 1 of 4 cases reported by same reporter.      Lab Comments: the patient's body temperature was 101 degree F on an unknown date
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Pain in arm over 1 month; This case was reported by a physician via sales rep and described the occurrence of pain in arm in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patinet received Shingrix and experienced pain in arm over 1 month. The reporter was agree to follow up from the GlaxoSmithKline.
Sex: F
Vaccine: VARZOS
Symptoms: Lymph node pain
Clinical narrative: pain in lymph node under the arm; This case was reported by a consumer via call center representative and described the occurrence of lymph node pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced lymph node pain. On an unknown date, the outcome of the lymph node pain was unknown.   It was unknown if the reporter considered the lymph node pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had pain in the lymph node under the arm, after first shot of Shingrix. The reporter consented to follow up. For tolerance to the 2nd dose of Shingrix, refer case US2019171918.
Sex: F
Vaccine: MENB
Symptoms: Malaise
Clinical narrative: Malaise; This case was reported by a physician via call center representative and described the occurrence of malaise in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced malaise. On an unknown date, the outcome of the malaise was recovered/resolved.   It was unknown if the reporter considered the malaise to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The physician reported that, the patient received dose of Bexsero and experienced malaise for 4 days. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic, Scab
Clinical narrative: Rash on the lower part of both arms / located from the elbow down; Redness; Itchy rash; Crusting over; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 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, less than a year after receiving Shingrix, the patient experienced rash, red rash, itchy rash and crust. On an unknown date, the outcome of the rash, red rash, itchy rash and crust were not recovered/not resolved.   The reporter considered the rash, red rash, itchy rash and crust to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix, in the unknown arm. Soon after vaccination with dose of Shingrix, the patient experienced rash on the lower part of both arms, rash was located from the elbow down and was itchy, red and crusting over. Till the time of reporting, the patient still had rash and scheduled to get the 2nd dose. The pharmacist had limited information as she was not at the pharmacy at the time of the call.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information received were as follows: The pharmacist on the line with a patient reporting substantial arm pain following the first dose.  The patient was on the fence about getting the second dose.  The reporter consented to follow up. No other details to provide at the time of report about site of injection, lot number and expiry date.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Incomplete course of vaccination, Pyrexia
Clinical narrative: fatigue; Low grade fever; Incomplete course of vaccination; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fatigue, fever and incomplete course of vaccination. On an unknown date, the outcome of the fatigue and fever were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the fatigue and fever to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. Over 7 months ago from the date of reporting, the patient received dose of Shingrix and experienced fatigue and low grade fever for a couple of days and did not received 2nd dose yet, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling; Redness; Pain; This case was reported by a physician via call center representative and described the occurrence of injection site swelling in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site swelling, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site pain were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient had severe swelling, redness, and pain at the injection site after receiving the Shingrix. The symptoms resolved after 10 days.  The swelling was the diameter of a tennis ball. The field representative indicated that she was at a conference and was provided information from two separate contacts for three adverse events reports. This was report 2 of 3, reported by same reporter. The reporter unable to obtain additional details.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Gait inability, Impaired work ability, Pemphigoid, Vaccine positive rechallenge
Clinical narrative: Bullous Pemphigoid generalized all over the body; Can't walk; very debilitating; This case was reported by a physician via sales rep and described the occurrence of bullous pemphigoid in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pemphigoid (1st dose received on an unknown date, for tolerance refer case US2019AMR176390).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced bullous pemphigoid (serious criteria GSK medically significant), unable to walk and debility. The patient was treated with dapsone and steroids nos (Steroids). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the bullous pemphigoid, unable to walk and debility were not recovered/not resolved.   It was unknown if the reporter considered the bullous pemphigoid, unable to walk and debility to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient again developed bullous pemphigoid condition after receiving the 2nd dose of Shingrix.  The reporter stated that, the condition had been very debilitating for the patient and he could not walk and had to miss work as a result. The patient was treated with high doses of steroids and was now taking Dapsone. Emergency visit was required. The reporter consented to follow up and provided address for further contact. The reporter did not provide any additional information.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Lethargy, Mydriasis, Vision blurred, Visual impairment
Clinical narrative: Eyes dilated, vision fuzzy around edges of object, perception off.  Feel very lethargic,
Age: 13.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Abdominal pain, Diarrhoea, Nausea, Vomiting
Clinical narrative: PATIENT WAITED APPORIATE AMOUNT OF TIME BEFORE LEAVING THE OFFICE. WENT HOME AS ALL OKAY, PATIENT WENT TO BED AND AROUND 9:00 PM PATIENT STARTED WITH ABDONIMAL PAIN, NAUSEA, VOMITTING AND DIARRHEA
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Deafness unilateral, Hypoacusis, Magnetic resonance imaging
Clinical narrative: After taking the shingles vaccine I suffered a 50% hearing loss in my right ear. My ENT prescribed # shots of steroids in my ear as well as oral medicine [steroids] I also have been involved with HBOT therapy at my own expense
Age: 66.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Mobility decreased
Clinical narrative: The gentleman reported that his arm felt "locked up" the evening after receiving the shot for which he went to the doctor.
Age: 56.0
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Immediate post-injection reaction
Clinical narrative: Arm soreness began immediately after injection.  Started chilling in middle of night.  By morning, still chilling, very weak and nauseous. Headache started very early morning and wouldn't go away, despite Tylenol  (8am), Ibuprofen (noon) or aspirin (3pm).  Temp in early morning was 100.   Chills lessened during day, but every time I tried to sit up, headache and nausea worsened.  Threw up fluids in early morning and at noon.  By 5pm, was able to get a little fluid and plain bread to stay down.  Headaches and fatigue on Sunday and , although lessened, that continues today (Monday).  For whatever it's worth, I reacted to first vaccine 3 months ago, with chills, aches and fatigue, but not all the rest.  Also, got bette
Age: 56.0
Sex: U
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: Arm soreness began immediately after injection.  Started chilling in middle of night.  By morning, still chilling, very weak and nauseous. Headache started very early morning and wouldn't go away, despite Tylenol  (8am), Ibuprofen (noon) or aspirin (3pm).  Temp in early morning was 100.   Chills lessened during day, but every time I tried to sit up, headache and nausea worsened.  Threw up fluids in early morning and at noon.  By 5pm, was able to get a little fluid and plain bread to stay down.  Headaches and fatigue on Sunday and , although lessened, that continues today (Monday).  For whatever it's worth, I reacted to first vaccine 3 months ago, with chills, aches and fatigue, but not all the rest.  Also, got bette
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Eye pruritus, Eye swelling, Urticaria
Clinical narrative: pt experienced eye itching and swelling about 20min after vaccination and within an hour had hives to body - was taken to the ER and received steroids and Benadryl .
Age: 69.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Erythema, Induration, Peripheral swelling, Pruritus
Clinical narrative: pt reports  "vaccine reaction."  Veteran received influenza vaccine in left deltoid in clinic on 10/2/19. States left arm is "hard as a rock, swollen, itchy. Happened within 15 minutes of shot. Red 5" from top to  bottom. Have chills & fever" - received Shingrex vaccination same date, right deltoid. Reports "about the size of an egg, firm,  doesn't itch"
Age: 69.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: pt reports  "vaccine reaction."  Veteran received influenza vaccine in left deltoid in clinic on 10/2/19. States left arm is "hard as a rock, swollen, itchy. Happened within 15 minutes of shot. Red 5" from top to  bottom. Have chills & fever" - received Shingrex vaccination same date, right deltoid. Reports "about the size of an egg, firm,  doesn't itch"