chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin mass
Clinical narrative: bleeding under the skin; it was green on the top part like a bruise and the darker part of blood is down by the elbow; leaking capillary; Bruising; lump that is movable in front of the deltoid.; This case was reported by a pharmacist via call center representative and described the occurrence of hemorrhage subcutaneous in a 82-year-old male patient who received Herpes zoster (Shingrix) (batch number BP57E, expiry date 7th December 2021) for prophylaxis.   Previously administered products included Shingrix. Concomitant products included warfarin sodium (Coumadin).   On 13th September 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 20th September 2019, 7 days after receiving Shingrix, the patient experienced hemorrhage subcutaneous (serious criteria GSK medically significant), injection site discoloration, capillary hemorrhage, contusion and skin mass. On an unknown date, the outcome of the hemorrhage subcutaneous and capillary hemorrhage were not recovered/not resolved and the outcome of the injection site discoloration, contusion and skin mass were unknown.   It was unknown if the reporter considered the hemorrhage subcutaneous, injection site discoloration, capillary hemorrhage, contusion and skin mass to be related to Shingrix.  Additional information was provided as follows: The case US2019172828 was found to be duplicate of case US2019172814 . Hence case US2019172828 would be deleted and all the information of this case will be added in case US2019172814 which is the case of record for this patient. The patient received Shingrix on left deltoid. The pharmacist reported that that she might have hit or nicked a capillary while administering Shingrix to a patient taking warfarin. It was leaked/bleed under the skin for some time and now it was down past the elbow. There was no blood at the injection site. It looks like it stopped. It was green on the top part like a bruise and the darker part of blood was down by the elbow. It started the following week after receiving Shingrix. He also reported a lump that is movable in front of the deltoid. The pharmacist was not sure if this was due to the Shingrix injection given its location. The reporter consented to follow up.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Injection site urticaria, Pyrexia, Swelling, Urticaria
Clinical narrative: Patient stated at 12:30 am on 9/27/19 started having fever of 102 F, swelling in her neck, and hives all over her left arm. Today she came in to tell us about the reaction. No swelling evident anymore, and hives were slowly going away. She took nyquil and tylenol.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: patient complaining of red itchy rash area at injection site and more soreness than expected
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pruritus
Clinical narrative: mild left flank erythema and itching suspect mild zoster
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chills, Headache, Myalgia, Paraesthesia
Clinical narrative: Day of vaccination 9/26: Progressive chills throughout the day, subsequent diffuse muscle aches, mild headache, congestion, weakness, finger tingling, fever >102 for several hours with shaking chills. Alternated Advil and Tylenol from approximately 18:00 until 02:00. Fever ~100 at 02:00. Low grade fever over 100 the next day 9/27, treated with Advil and Tylenol. Muscle aches improved. Temp and symptoms resolved on 9/28 upon waking.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Respiratory tract congestion, Tremor
Clinical narrative: Day of vaccination 9/26: Progressive chills throughout the day, subsequent diffuse muscle aches, mild headache, congestion, weakness, finger tingling, fever >102 for several hours with shaking chills. Alternated Advil and Tylenol from approximately 18:00 until 02:00. Fever ~100 at 02:00. Low grade fever over 100 the next day 9/27, treated with Advil and Tylenol. Muscle aches improved. Temp and symptoms resolved on 9/28 upon waking.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Product preparation issue
Clinical narrative: Pentacel was mixed with sterile diluent instead of the HIB component that it is supposed to be mixed with.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site warmth, Limb discomfort, Peripheral swelling
Clinical narrative: Patient came in stating that she had chills right after the vaccine. Her arm was red and swollen and warm to the touch.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Blood glucose normal, Cyanosis, Electrocardiogram normal, Eye movement disorder
Clinical narrative: Patient collapsed to the ground, hit her head and was unresponsive within 5 minutes of vaccine administration.  Her eyes rolled back, lips started turning blue, skin went pale and hand were cold.  Within a few minutes she came to but then passed back out.  Within 5 minutes of initial collapse she woke screaming in pain (head and stomach).  911 was called. Pharmacist monitored breathing and pulse.  Blood pressure was 112/60.  Paramedics wanted a blood glucose so pharmacist checked and it was 102.  Patients eyes rolled back into head again and it was decided to transport her to the hospital where they monitored her and performed an EKG.  Everything  was normal and patient was released around 2pm.  Parents report that she is fine now (9/30/19)
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Head injury, Headache, Loss of consciousness, Pallor, Peripheral coldness
Clinical narrative: Patient collapsed to the ground, hit her head and was unresponsive within 5 minutes of vaccine administration.  Her eyes rolled back, lips started turning blue, skin went pale and hand were cold.  Within a few minutes she came to but then passed back out.  Within 5 minutes of initial collapse she woke screaming in pain (head and stomach).  911 was called. Pharmacist monitored breathing and pulse.  Blood pressure was 112/60.  Paramedics wanted a blood glucose so pharmacist checked and it was 102.  Patients eyes rolled back into head again and it was decided to transport her to the hospital where they monitored her and performed an EKG.  Everything  was normal and patient was released around 2pm.  Parents report that she is fine now (9/30/19)
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Screaming, Syncope, Unresponsive to stimuli
Clinical narrative: Patient collapsed to the ground, hit her head and was unresponsive within 5 minutes of vaccine administration.  Her eyes rolled back, lips started turning blue, skin went pale and hand were cold.  Within a few minutes she came to but then passed back out.  Within 5 minutes of initial collapse she woke screaming in pain (head and stomach).  911 was called. Pharmacist monitored breathing and pulse.  Blood pressure was 112/60.  Paramedics wanted a blood glucose so pharmacist checked and it was 102.  Patients eyes rolled back into head again and it was decided to transport her to the hospital where they monitored her and performed an EKG.  Everything  was normal and patient was released around 2pm.  Parents report that she is fine now (9/30/19)
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Atrial enlargement, Cardiac stress test normal, Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: Severe chest pain onset during PT. Rated # 8 on scale 1-10. Radiation to rt arm. Center of chest described as a squeezing, hard to breath. No palpitations, diaphoresis or dizziness. Would have intermittent pain in past during PT but nothing like this.   Symptoms: CHEST PAIN, UNSPECIFIED(R079).
Age: 22.0
Sex: M
Vaccine: ANTH, SMALL, TYP
Symptoms: Echocardiogram normal, Electrocardiogram abnormal, Pain, Pain in extremity, Troponin I increased
Clinical narrative: Severe chest pain onset during PT. Rated # 8 on scale 1-10. Radiation to rt arm. Center of chest described as a squeezing, hard to breath. No palpitations, diaphoresis or dizziness. Would have intermittent pain in past during PT but nothing like this.   Symptoms: CHEST PAIN, UNSPECIFIED(R079).
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient states that on the 2nd day after receiving the vaccine she developed cellulitis around the injection site (warmth, redness, itching).  She was seen by an MD and prescribed antibiotics.  She states the symptoms are resolving.
Age: 74.0
Sex: F
Vaccine: FLUA3
Symptoms: Expired product administered
Clinical narrative: The patient was given an expired vaccine. The patient was contacted and advised to return in 2-4 weeks per recommendation of our Chief Medical Officer to get the current flu vaccine.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Deafness unilateral, Headache
Clinical narrative: I have a tremendous headache and I've lost the hearing in my left ear
Age: 76.0
Sex: F
Vaccine: FLUA3
Symptoms: Expired product administered
Clinical narrative: The patient was given an expired vaccine. The patient was contacted and advised to return in 2-4 weeks per recommendation of our Chief Medical Officer to get the current flu vaccine.
Age: 76.0
Sex: M
Vaccine: FLUA3
Symptoms: Expired product administered
Clinical narrative: The patient was given an expired vaccine. The patient was contacted and advised to return in 2-4 weeks per recommendation of our Chief Medical Officer to get the current flu vaccine.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash, Skin lesion, Varicella post vaccine
Clinical narrative: Chicken pox rash.  Parent reports it started 2 days ago with about 20 lesions, now she has at least 200.
Age: 39.0
Sex: F
Vaccine: UNK, UNK, UNK, UNK
Symptoms: Arthralgia, C-reactive protein normal, Chills, Fatigue, Musculoskeletal pain
Clinical narrative: She developed low grade fevers, chills, myalgia and fatigue in the first week following vaccination. Her fevers tapered off and she developed knee, hip and shoulder pain and stiffness that transitioned into symmetric, polyarthritis of the wrists, ankles, MTPs, MCPs and PIPs. She started Motrin OTC that has helped with the swelling of her hands and feet but she remains with pain, stiffness and difficulty typing  Symptoms: PAIN IN UNSPECIFIED JOINT(M2550), EDEMA, UNSPECIFIED(R609), FEVER, UNSPECIFIED(R509), OTHER FATIGUE(R5383), MYALGIA(M791).
Age: 39.0
Sex: F
Vaccine: UNK, UNK, UNK, UNK
Symptoms: Musculoskeletal stiffness, Myalgia, Peripheral swelling, Polyarthritis, Pyrexia
Clinical narrative: She developed low grade fevers, chills, myalgia and fatigue in the first week following vaccination. Her fevers tapered off and she developed knee, hip and shoulder pain and stiffness that transitioned into symmetric, polyarthritis of the wrists, ankles, MTPs, MCPs and PIPs. She started Motrin OTC that has helped with the swelling of her hands and feet but she remains with pain, stiffness and difficulty typing  Symptoms: PAIN IN UNSPECIFIED JOINT(M2550), EDEMA, UNSPECIFIED(R609), FEVER, UNSPECIFIED(R509), OTHER FATIGUE(R5383), MYALGIA(M791).
Age: 39.0
Sex: F
Vaccine: UNK, UNK, UNK, UNK
Symptoms: Red blood cell sedimentation rate normal, Urine analysis normal
Clinical narrative: She developed low grade fevers, chills, myalgia and fatigue in the first week following vaccination. Her fevers tapered off and she developed knee, hip and shoulder pain and stiffness that transitioned into symmetric, polyarthritis of the wrists, ankles, MTPs, MCPs and PIPs. She started Motrin OTC that has helped with the swelling of her hands and feet but she remains with pain, stiffness and difficulty typing  Symptoms: PAIN IN UNSPECIFIED JOINT(M2550), EDEMA, UNSPECIFIED(R609), FEVER, UNSPECIFIED(R509), OTHER FATIGUE(R5383), MYALGIA(M791).
Sex: M
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Diplopia, Encephalopathy, Meningitis, Rhabdomyolysis
Clinical narrative: was diagnosed with life-threatening meningitis, encephalopathy, diplopia, and suffered rhabdomyolysis and life-altering stroke, as well as permanent disabilities; was diagnosed with life-threatening meningitis, encephalopathy, diplopia, and suffered rhabdomyolysis and life-altering stroke, as well as permanent disabilities; was diagnosed with life-threatening meningitis, encephalopathy, diplopia, and suffered rhabdomyolysis and life-altering stroke, as well as permanent disabilities; was diagnosed with life-threatening meningitis, encephalopathy, diplopia, and suffered rhabdomyolysis and life-altering stroke, as well as permanent disabilities; was diagnosed with life-threatening meningitis, encephalopathy, diplopia, and suffered rhabdomyolysis and life-altering stroke, as well as permanent disabilities; Information has been received from a lawyer and the patient (pt) regarding a case in litigation involving a male patient (pt) of unknown age. No information about the pt's pertinent medical history, concomitant medications and drug reactions or allergies was provided.     On 29-SEP-2014, the pt was inoculated with a dose of zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, route, frequency, lot/batch # and expiration date were not reported).     Shortly after receiving zoster vaccine live (ZOSTAVAX), in early December 2014, the pt was diagnosed with life-threatening meningitis, encephalopathy, diplopia, and suffered rhabdomyolysis and life-altering stroke (cerebrovascular accident), as well as permanent disabilities and injuries resulting in prolonged hospitalization and acute care. After of several months of being hospitalized, the pt endured a progression of medical care including physical therapy which continued today.  As a direct and approximate result of zoster vaccine live (ZOSTAVAX), the pt suffered sustained, severe, serious, and permanent/incurable personal injuries and life-long disabilities not present prior to using zoster vaccine live (ZOSTAVAX), which were directly caused by zoster vaccine live (ZOSTAVAX). Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition and has suffered economic losses due to his inability to work, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.   The reporter considered the events to be related to zoster Vaccine Live (ZOSTAVAX).  The reporter considered all the events to be disabling, and meningitis to be life-threatening. Upon internal review, meningitis, encephalopathy, rhabdomyolysis and  stroke were considered to be medically significant events.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Experienced arm swelling which progressed from the elbow all the way up the arm; Itching; This spontaneous report was received via a company representative from a nurse practitioner who is also the mother of the patient and refers to an 11 year old female patient.  The patient's concurrent conditions, medical history, drug allergies or reactions and concomitant therapies were not reported.  On 28-AUG-2019, the patient was vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) as prophylaxis on an unspecified arm (dose, frequency, anatomical location, route of administration, lot number and expiration date were not reported).  On the same date, the patient experienced arm swelling, which progressed from the elbow all the way up the arm, and itching. The patient went to the emergency  room where she was treated with unspecified intravenous (IV) antibiotics and then was sent home. No further information was provided.  On an unspecified date, the patient recovered from the events.  The causal relationship between the events and therapy with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: An improperly stored dose of GARDASIL9 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 unknown gender. Information about pertinent medical history, drug reactions/allergies and concomitant medication was not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # N022952 with expiration date 14-JUN-2020, dose detail and route were not reported) for prophylaxis.  The vaccine experienced improperly stored and was stored below 36 Fahrenheit degrees (F) and was stored at 32.1 F for 8 hours. There was no previous temperature excursion. The call was because of a data logger involved. No adverse effects were reported.
Sex: F
Vaccine: HPV9
Symptoms: Human papilloma virus test positive, Pain, Product quality issue, Vaccination site injury, Wheelchair user
Clinical narrative: HPV "vaccine injury"/patient is in wheelchair and has chronic pain; HPV "vaccine injury". patient is in wheelchair and has chronic pain; HPV 16,11,18 (first vial tested and turn out to be positive); PQC Present: Yes/Local pediatrician sent me at the first vial so I tested & it turned out to be positive altogether 16 vials"; This spontaneous report was received from a consumer via social media referring to a 16-year-old female patient. The patient's concurrent conditions, medical history, drug reaction/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, lot/batch # and expiry date were not reported) for prophylaxis. On an unknown date, the patient had "vaccination injury" (vaccination site injury). The patient was on a wheelchair and had chronic pain (pain). It was reported that, the first vial was sent to the reporter by the local paediatrician. The reporter tested the vial and was turned to be positive with strains HPV 16, 11, 18 (Human papilloma virus test positive and product quality issue). Outcome of the events vaccination site injury, pain, human papilloma virus test positive and product quality issue was unknown. The reporter considered the events vaccination site injury and pain was related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). Causality assessment for human papilloma virus test positive and product quality issue was not reported.  The reporter considered the events vaccination site injury and pain to be disabling.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adver event; the administration of one dose of an improperly stored vaccine; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender.      The patient's pertinen medical history, drug reactions, allergies and concomitant medications were not provided.  On 16-SEP-2019, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R030924 with expiry date of 10-JUL-2020, for prophylaxis (dose and route of administration were not provided). The vaccine was exposed to a temperature of 0.24 °C during a time frame of 5 hours and 30 minutes. There was not previous temperature excursion and there was call because of a digital data logger. No adverse effects reported.
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Varicella post vaccine
Clinical narrative: 10 CHICKEN POX blisters; This spontaneous report was received from a Nurse practitioner refers to a 23 year old female patient. No information was provided regarding the patient's pertinent medical history, concomitant medication and drug reactions/allergies. On an unknown date in August 2019 (also reported as 19-AUG-2019), the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S010296, expiry date: 03-APR-2021) 1 dosage form, via subcutaneous route for prophylaxis. On 19-AUG-2019 (2 week later), the patient developed 10 chikenpox blister (varicella). No treatment received. The patient did not seek medical attention. No intervention to prevent seriousness criteria. No Cancer. No PQC involved. On an unknown date in 2019, the patient had recovered from the event and the blister have healed. Reporter's causality was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Acne, Erythema, Skin lesion
Clinical narrative: My face and particularly forehead broke out with red lesions; My face and particularly forehead broke out with red lesions; Acne outbreak; This case was reported by a nurse and described the occurrence of acne in a elderly 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 acne, skin lesion and erythema. On an unknown date, the outcome of the acne, skin lesion and erythema were unknown.   It was unknown if the reporter considered the acne, skin lesion and erythema to be related to Shingrix.  Additional details were reported as follows: The case was reported by nurse who was patient. The age at vaccination was not reported. The patient reported that the after taking first injection of Shingrix, the patient's face and particularly forehead broke out with red lesions all over the rest of face but the forehead was specially.  The patient asked if this was a very common side effect . The Alfie hydroxide face cream usually had cleared this up but now it looks like an acne outbreak.  The patient did not normally have acne the patient was really surprised that the patient's face reacted to the anti shingles shot.  The patient asked if GlaxoSmithKline could provide any more information on this events.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination, Systemic lupus erythematosus
Clinical narrative: lupus; Shingles; inappropiate schedule of vaccine; This case was reported by a physician via sales rep and described the occurrence of systemic lupus erythematosus in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, mepolizumab (Nucala) powder for solution for injection for drug use for unknown indication and prednisone for drug use for unknown indication.   On an unknown date, the patient received the 1st dose of Shingrix, the 2nd dose of Shingrix, Nucala 100 mg at an unknown frequency and prednisone at an unknown dose and frequency. On an unknown date, less than 2 years after receiving Shingrix, Nucala and prednisone and not applicable after receiving Shingrix, the patient experienced systemic lupus erythematosus (serious criteria GSK medically significant), shingles and incomplete course of vaccination. The action taken with Nucala was unknown. The action taken with prednisone was unknown. On an unknown date, the outcome of the systemic lupus erythematosus, shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the systemic lupus erythematosus and shingles to be related to Shingrix. The reporter considered the systemic lupus erythematosus and shingles to be unrelated to Nucala.  Additional information was reported as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrx but never received booster, which led to incomplete course of vaccination. The patient was on Nucala 100mg per 4 weeks for approximately 8 months. The patient experienced Shingles. The reporter told that, the patient had other comorbidities like lupus and was on frequent courses of prednisone. The reporter did not think it was related to Nucala since was in presence of other factors, but did discontinue Nucala. It was unknown if the reporter considered the systemic lupus erythematosus and shingles to be related to prednisone.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Depression
Clinical narrative: Depression; This case was reported by a consumer via call center representative and described the occurrence of depression in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included escitalopram (Lexapro).   On 3rd September 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 4th September 2019, 1 days after receiving Shingrix, the patient experienced depression. On an unknown date, the outcome of the depression was unknown.   It was unknown if the reporter considered the depression to be related to Shingrix.  Additional information received were as follows: The patient stated that about 24 hours after receiving the second dose of Shingrix, she started experiencing depression, and it was still present at the reporting date. The patient had been on Lexapro before she received the Shingrix vaccine.  The repoter did not consent to follow-up. No further details were provided.  The reporter referred to healthcare professional.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discharge, Injection site erosion, Injection site erythema, Injection site scab, Injection site vesicles
Clinical narrative: The site of injection that was red; The site of injection that was warm; The site of injection that was moist; Scratching the site of injection; A worm like piece with black dot scraped off from skin / Dark brown scab at the middle of the circlet at redness; Injection site blisters; Itching; Broke out in red hives on both of her ankles, right arm and left shoulder; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 91-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th August 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 15th September 2019, 16 days after receiving Shingrix, the patient experienced injection site erythema, injection site warmth, injection site discharge, injection site abrasion, injection site scab, injection site blisters, pruritus and erythema urticarial. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site discharge, injection site abrasion, injection site scab, injection site blisters, pruritus and erythema urticarial were unknown.   It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site discharge, injection site abrasion, injection site scab, injection site blisters, pruritus and erythema urticarial to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. Last Sunday, before reporting the patient started itching and broke out in red hives on both of her ankles, right arm and left shoulder. The patient was scratching the site of injection and a worm like piece with black dot scraped off from skin.  She noticed one inch by one inch circle at the site of injection that was red, warm, and moist.  The redness had been now decreased and now there was a dark brown scab at the middle of the circlet at redness. No further details were provided. The reporter consented to follow up.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pruritus, Urticaria
Clinical narrative: The site of injection that was red; The site of injection that was warm; The site of injection that was moist; Scratching the site of injection; A worm like piece with black dot scraped off from skin / Dark brown scab at the middle of the circlet at redness; Injection site blisters; Itching; Broke out in red hives on both of her ankles, right arm and left shoulder; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 91-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th August 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 15th September 2019, 16 days after receiving Shingrix, the patient experienced injection site erythema, injection site warmth, injection site discharge, injection site abrasion, injection site scab, injection site blisters, pruritus and erythema urticarial. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site discharge, injection site abrasion, injection site scab, injection site blisters, pruritus and erythema urticarial were unknown.   It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site discharge, injection site abrasion, injection site scab, injection site blisters, pruritus and erythema urticarial to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm. Last Sunday, before reporting the patient started itching and broke out in red hives on both of her ankles, right arm and left shoulder. The patient was scratching the site of injection and a worm like piece with black dot scraped off from skin.  She noticed one inch by one inch circle at the site of injection that was red, warm, and moist.  The redness had been now decreased and now there was a dark brown scab at the middle of the circlet at redness. No further details were provided. The reporter consented to follow up.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Product administered at inappropriate site
Clinical narrative: pain / right arm pain / pain is more localized to injection site; difficult to lift his arm up; Vaccine administered at inappropriate site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th September 2019, the patient received the 2nd dose of Shingrix. On 19th September 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injected limb mobility decreased and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain, injected limb mobility decreased and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in right arm. The patient was stated the injection was given above the deltoid muscle which led to vaccine administered at inappropriate site.  The patient stated a day before reporting he started to have right arm pain and the pain was more localized to the injection site but the patient was finding it difficult to lift his arm up. The reporter consented to follow up. This case had been linked to the case US2019171934, reported by same reporter.
Sex: U
Vaccine: MENB
Symptoms: Injection site pain, Pain
Clinical narrative: Pain, sore at the injection site after getting Trumenba; This is a spontaneous report from a contactable nurse via a Pfizer sales representative.  A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced pain, sore at the injection site after getting meningococcal group b rlp2086. The outcome of the event was recovered on an unspecified date.   No follow-up attempts are possible; information on the batch number cannot be obtained.
Age: 92.0
Sex: M
Vaccine: FLU3, PPV, VARZOS
Symptoms: Chills, Feeling cold, Skin burning sensation
Clinical narrative: Patient described that they started feeling extremely cold with shivers, yet their skin felt like it was burning. Stated they did not have fever, hives or trouble breathing.  Felt this way 9/27/19 and 9/28/2019
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Pt described severe rash on right arm
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Anaphylactic reaction, Cardiac monitoring normal, Computerised tomogram normal, Pharyngeal swelling
Clinical narrative: Anaphylaxis, Patient's throat closed due to swelling. Occurred 4 hours post dose, was administered epinephrine in Urgent care and transferred to hospital.
Age: 88.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Chills, Feeling cold, Skin burning sensation
Clinical narrative: Patient described that they started feeling extremely cold with shivers, yet their skin felt like it was burning. Stated they did not have fever, hives or trouble breathing.  Felt this way 9/27/19 and 9/28/2019
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness
Clinical narrative: Patient reported that she has passed out from a vaccination in the past. After administering the vaccine, patient began to sweat and feel faint. I ran to get her a candy bar and some juice. During that time, the patient's husband and another pharmacist helped her to the floor. The patient took a few sips of Powerade and ate a candy bar. After about 15 minutes, the patient was able to get back up into the chair. She remained there for another 5 minutes before she left with her husband.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Bone pain, Injection site pain, Pain
Clinical narrative: 1800 - left shoulder ache started 2200- Took Motrin 200mg preventative at bedtime 0430 (9/27/19)- extreme pain upon movement left shoulder, ache entire shoulder area, bone hurts to touch, no redness or swelling 0700- drive to work with left arm  held to body, feels like  knife stabbing into left shoulder joint. 0730: Seen in Employee health, ice applied to left shoulder, No redness or swelling present,;advised 800 mg  every 8 hours, for next day; sent home from work. 9/28/19- had extreme pain upon movement in left shoulder until 1400 - then eased up.  9/30/19 Able to work without pain- still has some bone tenderness
Age: 68.0
Sex: F
Vaccine: PPV, FLU3, FLU3, PPV
Symptoms: Chest pain, Erythema, Flushing, Hyperhidrosis, Spinal pain
Clinical narrative: patient was doing ok until she received 2 vaccines, within minutes , she was flushed red and sweating down her back and felt pain in her chest .  She started to have pain go from her head down her spinal column and reported it on a level of 10/10.   she lied down where we could take care of her, she never lost consciousness and kept her talking, her pain level went down we she left to go to the hospital to a level of 5/5.
Age: 68.0
Sex: F
Vaccine: PPV, FLU3, FLU3, PPV
Symptoms: Feeling hot, Flushing, Headache, Hyperhidrosis, Spinal pain
Clinical narrative: patient was doing ok until she received 2 vaccines, within minutes , she was flushed red and sweating down her back and felt pain in her chest .  She started to have pain go from her head down her spinal column and reported it on a level of 10/10.   she lied down where we could take care of her, she never lost consciousness and kept her talking, her pain level went down we she left to go to the hospital to a level of 5/5.
Age: 68.0
Sex: F
Vaccine: PPV, FLU3, FLU3, PPV
Symptoms: Blood pressure increased, Dyspnoea, Erythema, Flushing, Headache
Clinical narrative: patient was doing ok until she received 2 vaccines, within minutes , she was flushed red and sweating down her back and felt pain in her chest .  She started to have pain go from her head down her spinal column and reported it on a level of 10/10.   she lied down where we could take care of her, she never lost consciousness and kept her talking, her pain level went down we she left to go to the hospital to a level of 5/5.
Age: 68.0
Sex: F
Vaccine: PPV, FLU3, FLU3, PPV
Symptoms: Hyperhidrosis, Pain, Spinal pain
Clinical narrative: patient was doing ok until she received 2 vaccines, within minutes , she was flushed red and sweating down her back and felt pain in her chest .  She started to have pain go from her head down her spinal column and reported it on a level of 10/10.   she lied down where we could take care of her, she never lost consciousness and kept her talking, her pain level went down we she left to go to the hospital to a level of 5/5.
Age: 68.0
Sex: F
Vaccine: PPV, FLU3, FLU3, PPV
Symptoms: Chest pain, Erythema, Flushing, Hyperhidrosis, Spinal pain
Clinical narrative: patient experienced flushing with sweating and very warm all over. she had pain she rated at 10 out of 10 going from her head down her spine that was pulsating .  she never lost consciousness and was able to described the pain and how she was dealing with her pain.   when she was transported her pain level was at a 5 out of 10
Age: 68.0
Sex: F
Vaccine: PPV, FLU3, FLU3, PPV
Symptoms: Feeling hot, Flushing, Headache, Hyperhidrosis, Spinal pain
Clinical narrative: patient experienced flushing with sweating and very warm all over. she had pain she rated at 10 out of 10 going from her head down her spine that was pulsating .  she never lost consciousness and was able to described the pain and how she was dealing with her pain.   when she was transported her pain level was at a 5 out of 10
Age: 68.0
Sex: F
Vaccine: PPV, FLU3, FLU3, PPV
Symptoms: Blood pressure increased, Dyspnoea, Erythema, Flushing, Headache
Clinical narrative: patient experienced flushing with sweating and very warm all over. she had pain she rated at 10 out of 10 going from her head down her spine that was pulsating .  she never lost consciousness and was able to described the pain and how she was dealing with her pain.   when she was transported her pain level was at a 5 out of 10
Age: 68.0
Sex: F
Vaccine: PPV, FLU3, FLU3, PPV
Symptoms: Hyperhidrosis, Pain, Spinal pain
Clinical narrative: patient experienced flushing with sweating and very warm all over. she had pain she rated at 10 out of 10 going from her head down her spine that was pulsating .  she never lost consciousness and was able to described the pain and how she was dealing with her pain.   when she was transported her pain level was at a 5 out of 10
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: injection site red  swollen and hot to touch  approx. 4 x 4 inches .  patient c/o it was "itchy"  but no other complaints
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Localised infection
Clinical narrative: Rash at injection site, pharmacist recommended taking 50mg Benadryl and wait a couple hours to see if it helps then go to urgent care if not. 2 days later, on 9/30/2019, pt reported in the morning that the rash went down to her elbow, and she had to go to urgent care and was diagnosed with arm infection.
Age: 70.0
Sex: M
Vaccine: FLUA3, VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient wanted to get 2 vaccines on the same arm on 8/19.  He was due for 2nd Shingrix vaccine and also was due for an annual flu shot.  The two injection sites were separated by about 1 inch apart.  The patient came to the pharmacy complaining of sore arm that has been lasting for longer than 2 weeks.  Per patient, he cannot lift his right arm freely due to severe pain.  Morning seems to be worse than the evening.  We are suspecting that getting 2 vaccines on the same arm probably burdened his immunity.  The patient has never had unusual reactions to any vaccines.  The patient has been taking Tylenol for pain with a minimal pain relief.  The patient would seek medical help soon, but her wife is sick, so he will wait until her wife gets better first.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Myalgia, Pain
Clinical narrative: Sharp pain in deltoid when he reaches up and around. Instructed to ice deltoid and apply aspercream with lidocaine 2-3 times daily as needed.
Age: 86.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Limb mass
Clinical narrative: Lump that developed in the same arm below the injection sites within 24 hours of receiving. The injections were given more than an inch apart. Patient did not want the shots to be given in separate arms.
Age: 72.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Body temperature increased, Chills, Fatigue, Feeling cold, Pain
Clinical narrative: On the same day that I received the injections, in the afternoon, around 3 p.m., started to get very cold,  started shivering and my teeth were chattering.  I assumed it was from the air conditioning.  Later at dinner, around 5:30, in a different location, I two cups of hot tea to try and warm myself, with no luck.  After returning home I went to bed around 9 pm, still feeling extremely cold and shivering.  I slept poorly.  I felt very achy.  I awoke around 5 a.m. feeling very hot.  My husband took my temperature and it was 101.8 degrees.  He gave me two extra strength acetaminophen, which helped bring my fever down and relieved some of my aches.  However, all day that day (Sunday, Sept. 29, 2019) I was extremely tired and fatigued and the aches returned, but not the fever.  Today, Monday, Sept. 30, 2019, I have no fever or aches, but am extremely fatigued.
Age: 72.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Poor quality sleep
Clinical narrative: On the same day that I received the injections, in the afternoon, around 3 p.m., started to get very cold,  started shivering and my teeth were chattering.  I assumed it was from the air conditioning.  Later at dinner, around 5:30, in a different location, I two cups of hot tea to try and warm myself, with no luck.  After returning home I went to bed around 9 pm, still feeling extremely cold and shivering.  I slept poorly.  I felt very achy.  I awoke around 5 a.m. feeling very hot.  My husband took my temperature and it was 101.8 degrees.  He gave me two extra strength acetaminophen, which helped bring my fever down and relieved some of my aches.  However, all day that day (Sunday, Sept. 29, 2019) I was extremely tired and fatigued and the aches returned, but not the fever.  Today, Monday, Sept. 30, 2019, I have no fever or aches, but am extremely fatigued.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Pruritus, Urticaria
Clinical narrative: Arm became itchy and had hives. Mom gave Benadryl. Hives did not return. Vaccines were given in the same arm so unsure of which vaccine the reaction was from.
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal discomfort, Arthralgia, Asthenia, Dizziness, Fatigue
Clinical narrative: Joints ache, exhaustion, dizziness, headache, sore-throat, upset-stomach, soreness at injection site and weakness.
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Headache, Injection site pain, Oropharyngeal pain
Clinical narrative: Joints ache, exhaustion, dizziness, headache, sore-throat, upset-stomach, soreness at injection site and weakness.
Age: 4.0
Sex: F
Vaccine: FLU4, MMRV
Symptoms: Urticaria
Clinical narrative: hives to left side of face and right arm- both vaccines given in right arm
Age: 26.0
Sex: F
Vaccine: FLUR4
Symptoms: Injury associated with device
Clinical narrative: Needle Stick after giving vaccination
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Vomiting
Clinical narrative: Patient suffered from lightheaded episode, dizziness, and little vomiting  few minutes after the injection.   After checking patient's blood pressure, providing hydration and being check by first res ponders , she was OK and drove back home.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site warmth
Clinical narrative: Pt. stated that vaccination site was warm to the touch, red and itchy. Was wondering if it was an allergic reaction. Told pt. to follow up with MD.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Hyperaesthesia, Injection site pain, Paraesthesia
Clinical narrative: 27 days since the shot, and it feels as though I have had a severe case of shingles without the blisters/rash.  Arm on fire traveling on the radial nerve.  Skin so sensitive, at times i could not have anything touch on my arm or left shoulder.  This was WAAAYYY beyond site soreness which I expected.  I am still having pain, electric shocks down my arm.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Migraine, Pain, Sinus congestion, Sinus headache, Sinus pain
Clinical narrative: Severe migraine/sinus headache, left sinus tenderness & congestion, body aches
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash pustular
Clinical narrative: patient developed a red hot rash that took up the majority of her left upper arm. once that resolved, she developed white pustules in several areas over her body that intensely itched for several weeks. she went to see her doctor who prescribed her a topical to relieve the itching and told her not to receive the 2nd dose of series. symptoms resolved by time of discussion with pharmacist, though her skin is scarred where the pustules were.
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event, Vaccination failure
Clinical narrative: Suffered damages as they paid for a product that was not effective for its stated purpose.; Suffered damages as they paid for a product that was not effective for its stated purpose.; Information has been received from a lawyer and the patient (pt) regarding a case in litigation involving a female patient (pt) of unknown age. No information about the pt's pertinent medical history, concomitant medications and drug reactions or allergies was provided.     On or about 23-OCT-2017, the pt received vaccination with a dose of zoster vaccine live (ZOSTAVAX) for the long-term prevention of herpes zoster (or shingles) (strength, route, frequency, lot/batch # and expiration date were not reported).  On an unknown date, the pt suffered damages as it was paid for a product that was not effective (vaccination failure) for its stated purpose; she suffered actual damages, including economic damages, physical pain and suffering and/or other damages (adverse event). The outcome of vaccination failure, adverse event and pain was nor provided.  The reporter considered vaccination failure, and an the unspecified adverse event to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: shipment was delayed, breaking cold chain regulations, No AE; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 44 years old female patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and reported that shipment was delayed, breaking cold chain regulations (product storage error).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 23-Sep-2019, the patient received a dose of suspect 0.5 ml INFLUENZA QUADRIVAL A-B VACCINE lot UJ223AA and expiry date: 30-Jun-2020 via unknown route in the left deltoid.  It was a case of actual medication error due to incorrect product storage.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.