chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX, PNC13
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. This pharmacist reported similar events for three patients. This is the third of three reports. A patient of unspecified age and gender received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiry date unknown), and influenza vaccine (FLU), both via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The pharmacist reported that the patient experienced side effects from receiving pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) and flu together on an unspecified date. The patient experienced flu like symptoms for 2 days. The outcome of the event was unknown.  No follow up attempts are possible, information on the lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019438281 same reporter, same product, same event, and different patient;US-PFIZER INC-2019438279 same reporter, same product, same event, and different patient
Sex: F
Vaccine: PNC13
Symptoms: Drug ineffective, Pneumonia
Clinical narrative: She developed pneumonia in left lung; Drug ineffective; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age receive pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration in 2015 at 0.5 ml, single for immunization, and pneumococcal vaccine polysacch 23v (PNEUMOVAX 23), via an unspecified route of administration in 2008 unspecified dose and frequency for immunization. The patient's medical history and concomitant medications were not reported. Patient reported that she developed pneumonia in left lung after receiving Pneumovax 23 in 2008 and Prevnar 13 in 2015. Had pneumonia in Dec2017, patient experienced drug ineffective. Outcome of the event was unknown.   Information on the batch number has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site infection, Pain in extremity
Clinical narrative: arm was very red and in alot of pain; arm was very red and in alot of pain; infection at insertion site requiring antibiotics; This is a spontaneous report from a contactable pharmacist. A 65-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13 lot number: AG8365, expiration date: 01Jun2020, NDC number: 13: 0005-197102), intramuscular in the left deltoid on 06Oct2019 at 0.5 ml, single for vaccination for pneumonia. Patient has no medical history, no investigation assessment, and no concomitant medications. The pharmacist stated that the patient got her vaccine on Sunday 06Oct2019, and came in yesterday, 08Oct2019, and talked to another pharmacist. Patient stated that her arm was very red and she was in a lot of pain on 08Oct2019. The patient came in stating that she went to the emergency room and got an infection in her arm at the insertion site and was now taking antibiotics (not specified). Outcome of the events was recovering.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: very large size redness surrounding the injection site along with swelling; very large size redness surrounding the injection site along with swelling; This is a spontaneous report from contactable physician via Pfizer Sales Representative. A 75-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date in Oct2019 at single dose for immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced very large size redness surrounding the injection site along with swelling on an unspecified date in Oct2019 with outcome of unknown. Doctor had a picture of the sight which displayed the reaction. Patient was re-seen a week after injection on 08Oct2019.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Injection site swelling, Pain, Peripheral swelling, Skin warm
Clinical narrative: Patient stated pain about 1 hour after, starting to notice a swollen circle with warmth within a few hours swelling had extended further down her right arm. woke up sunday morning and top of right arm was fully swollen and worse than night before. proceeded to hospital
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: X-ray
Clinical narrative: Patient stated pain about 1 hour after, starting to notice a swollen circle with warmth within a few hours swelling had extended further down her right arm. woke up sunday morning and top of right arm was fully swollen and worse than night before. proceeded to hospital
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: PATIENT STATED SHE HAD HIVES ALL OVER HER BODY STARTING ON 10/11/19 AFTER THE SHOT AND IT CONTINUED FOR SEVERAL DAYS.
Age: 28.0
Sex: F
Vaccine: FLUC4
Symptoms: Incorrect route of product administration, Injected limb mobility decreased, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: The flu vaccine was administered erroneously into subcutaneously tissues as evidenced by the injection site and the reaction site being low and to the right of the landmarks of the deltoid muscle.  The reaction that occurred was redness, warmth, raised area, and puritis.  No systemic symptoms were noted such as fever. The reaction began to occur about a day after the injection and the symptoms lasted for 5 days.  The peak of the reaction occurred on day 2 and 3.  At this time the doctor's office was contacted and they asked for an evaluation; however, I was not willing to pay a co-pay for a reaction caused by an erroneous flu shot administration (the office did not contact further).
Age: 28.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site warmth, Pain in extremity, Product administered at inappropriate site
Clinical narrative: The flu vaccine was administered erroneously into subcutaneously tissues as evidenced by the injection site and the reaction site being low and to the right of the landmarks of the deltoid muscle.  The reaction that occurred was redness, warmth, raised area, and puritis.  No systemic symptoms were noted such as fever. The reaction began to occur about a day after the injection and the symptoms lasted for 5 days.  The peak of the reaction occurred on day 2 and 3.  At this time the doctor's office was contacted and they asked for an evaluation; however, I was not willing to pay a co-pay for a reaction caused by an erroneous flu shot administration (the office did not contact further).
Age: 13.0
Sex: M
Vaccine: FLUR4, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Flublok Quad, which is indicated for ages 18 and older, was administered to a 13 year old.  No adverse effects were reported.
Age: 76.0
Sex: M
Vaccine: FLUA3
Symptoms: Injection site pain
Clinical narrative: Pain in injected area. Family physician told patient to see an Orthopedic physician.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left arm from elbow to shoulder, red, swollen, raised, hot to touch, hard to touch and very tender ?-lasting from Friday evening to Sunday morning when symptoms SLOWLY began to decrease... tenderness,  hardness and complete redness did not cease until Thursday.. almost a week after symptoms occurred
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: pt reported warmth, redness, and swelling at site of injection
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: INJECTION SITE REACTION RASH DEVELOPED. WARM TO THE TOUCH.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Dizziness, Electrocardiogram, Palpitations
Clinical narrative: Patient received her flu shot and that evening on 10/10/19 felt light headed and dizzy and had heart palpitations. Stated she went to bed that evening and the next day she felt ok and then this morning 10/15/19 she woke up with the same symptoms as on 10/10/19. Patient is currently being seen in the emergency room to be evaluated for symptoms.
Age: 2.0
Sex: M
Vaccine: DTAPIPV, HEPA
Symptoms: Wrong product administered
Clinical narrative: Patient was given instead of DTaP and Hib
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site pain, Musculoskeletal pain, Neck pain, Paraesthesia
Clinical narrative: Progressive onset of "aching" left deltoid (rated 2/10) radiating up to left side of neck/shoulder on Friday evening, October 11, 2019 approximately 7:00 p.m.  States pain persisted into Saturday, October 12, 2019 rated 2-3/10.  States pain dramatically increased from 2/10 to 10/10 on Monday, October 14, 2019 at 5:00 p.m. associated with numbness/tingling/weakness radiating down left arm.  States he took Advil 600 mg p.o. at 6:00 p.m. with some relief of symptoms.  Woke at 06:00  a.m. October 15, 2019 with severe pain from left deltoid to left elbow rated 10/10.  States he took Advil 600 mg p.o. at 06:00 a.m. and pain gradually subsided to 2/10.  Employee reported to Occupational Health at 1:15 p.m. to report adverse reaction.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Lip blister, Lip swelling, Secretion discharge
Clinical narrative: Patient reported developing blister to right lower lip with swelling blister oozed a small amount
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid swollen, red, warm to touch. Prednisone 10mg - take on tablet daily with food - taper inj dose: 6mg, 6mg, 4mg, 4mg, 2mg, 2mg, stop.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect route of product administration
Clinical narrative: Gave MCV4 subcutaneously. No treatment, notified mother immediately following injection. Contacted nurse supervisor regarding incident. No treatment. Discussed possibility of redness at injection site, contact information if mother has questions.
Age: 41.0
Sex: M
Vaccine: SMALL
Symptoms: Dermatitis contact, Injection site erythema, Injection site induration, Injection site necrosis, Injection site nodule
Clinical narrative: 41 y/o  M AD presents 11 days s/p SPX vaccine. Patient endorses L shoulder stiffness and pain, erythema, edema, and large spot where vaccine was given. On exam patient has large 2-3cm pale, ulcerated lesion w/ central necrosis. Underlying this is a indurated nodule of slightly larger circumference. Surrounding area of approximately 8cmx8cm is erythematous and warm w/ minimal induration. Larger area appears to be caused by allergic reaction to adhesive bandage.
Age: 41.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site oedema, Injection site pain, Injection site pallor, Injection site reaction, Injection site ulcer
Clinical narrative: 41 y/o  M AD presents 11 days s/p SPX vaccine. Patient endorses L shoulder stiffness and pain, erythema, edema, and large spot where vaccine was given. On exam patient has large 2-3cm pale, ulcerated lesion w/ central necrosis. Underlying this is a indurated nodule of slightly larger circumference. Surrounding area of approximately 8cmx8cm is erythematous and warm w/ minimal induration. Larger area appears to be caused by allergic reaction to adhesive bandage.
Age: 41.0
Sex: M
Vaccine: SMALL
Symptoms: Injection site warmth, Musculoskeletal stiffness
Clinical narrative: 41 y/o  M AD presents 11 days s/p SPX vaccine. Patient endorses L shoulder stiffness and pain, erythema, edema, and large spot where vaccine was given. On exam patient has large 2-3cm pale, ulcerated lesion w/ central necrosis. Underlying this is a indurated nodule of slightly larger circumference. Surrounding area of approximately 8cmx8cm is erythematous and warm w/ minimal induration. Larger area appears to be caused by allergic reaction to adhesive bandage.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Cold sweat, Contusion, Dizziness
Clinical narrative: On evening of 10/12/2019 arms/hands began to shake involuntarily for about 20 minutes until slowly subsiding while experiencing cold chills and shoulder muscle aches. Next morning while in kitchen preparing breakfast , muscle aches in shoulders and back of neck and sudden light -headedness. Suddenly fainted and fell sustaining severe bruise to left hip and struck back of head on kitchen cabinet sustaining small injury. When head struck cabinet I regained conciousness and felt too weak to get up.  Cold sweat began while lying on floor.  After several minutes, I crawled to living room sofa and rested until I could get up and walk.  Vision slightly impaired for rest of day.  Next day back to normal .
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Fall, Head injury, Loss of consciousness, Myalgia, Syncope
Clinical narrative: On evening of 10/12/2019 arms/hands began to shake involuntarily for about 20 minutes until slowly subsiding while experiencing cold chills and shoulder muscle aches. Next morning while in kitchen preparing breakfast , muscle aches in shoulders and back of neck and sudden light -headedness. Suddenly fainted and fell sustaining severe bruise to left hip and struck back of head on kitchen cabinet sustaining small injury. When head struck cabinet I regained conciousness and felt too weak to get up.  Cold sweat began while lying on floor.  After several minutes, I crawled to living room sofa and rested until I could get up and walk.  Vision slightly impaired for rest of day.  Next day back to normal .
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Tremor, Visual impairment
Clinical narrative: On evening of 10/12/2019 arms/hands began to shake involuntarily for about 20 minutes until slowly subsiding while experiencing cold chills and shoulder muscle aches. Next morning while in kitchen preparing breakfast , muscle aches in shoulders and back of neck and sudden light -headedness. Suddenly fainted and fell sustaining severe bruise to left hip and struck back of head on kitchen cabinet sustaining small injury. When head struck cabinet I regained conciousness and felt too weak to get up.  Cold sweat began while lying on floor.  After several minutes, I crawled to living room sofa and rested until I could get up and walk.  Vision slightly impaired for rest of day.  Next day back to normal .
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Pain, Paraesthesia
Clinical narrative: Patient had pain upon having her injection placed, extreme soreness for the next 2 days, and then extreme pain with movement including internal and external rotation of her shoulder, abduction, flexion, extension. Some numbness and tingling in her 4 fingers not including her thumb.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: soreness and redness- red patch was at least 3 inches. Consulted with NP on site and told pt to ice and see professional if it gets worse and not better within 24 hours. will give follow up call.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Symptoms: Rash and Hives Treatment:  Prednisone / Triamcinolone / Hydroxyzine - still treating
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Low grade fever and chills, erythema extending from injection site to posterior elbow.  Skin swollen, hot and red.  Area extended to bicepts (14 cm X 10 cm).  No rash or hives.  No throat swelling or difficulty breathing.
Age: 52.0
Sex: F
Vaccine: FLUR4, PPV, VARZOS
Symptoms: Erythema, Fatigue, Pain in extremity
Clinical narrative: 4 inch long redness area that spread about 4 inches horizontally also.  patient was also very tired and arm hurt.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Monoplegia
Clinical narrative: Left leg become paralyzed for about 12 hours
Age: 80.0
Sex: M
Vaccine: FLUA3
Symptoms: Arthralgia, Back pain, Balance disorder, Diarrhoea, Dizziness
Clinical narrative: Approximately 15 minutes after getting injection, patient felt light-headed and "not right like I needed to eat".  Felt better after eating.      t  felt off balance and had trouble standing from working on his knees,   Felt OK the next day.  Two days later felt off balaace and had trouble standing after working on his knees.Three days later started having diarrhea, that only lasted a few hours.  Four days later, "just didn't feel good".  States he "feels like he was run over by a truck, with aches and pains"  Very tired.  shoulders and neck are sore.  Has a headached, back and hips are sore.
Age: 80.0
Sex: M
Vaccine: FLUA3
Symptoms: Dysstasia, Fatigue, Feeling abnormal, Headache, Musculoskeletal pain
Clinical narrative: Approximately 15 minutes after getting injection, patient felt light-headed and "not right like I needed to eat".  Felt better after eating.      t  felt off balance and had trouble standing from working on his knees,   Felt OK the next day.  Two days later felt off balaace and had trouble standing after working on his knees.Three days later started having diarrhea, that only lasted a few hours.  Four days later, "just didn't feel good".  States he "feels like he was run over by a truck, with aches and pains"  Very tired.  shoulders and neck are sore.  Has a headached, back and hips are sore.
Age: 80.0
Sex: M
Vaccine: FLUA3
Symptoms: Neck pain, Pain
Clinical narrative: Approximately 15 minutes after getting injection, patient felt light-headed and "not right like I needed to eat".  Felt better after eating.      t  felt off balance and had trouble standing from working on his knees,   Felt OK the next day.  Two days later felt off balaace and had trouble standing after working on his knees.Three days later started having diarrhea, that only lasted a few hours.  Four days later, "just didn't feel good".  States he "feels like he was run over by a truck, with aches and pains"  Very tired.  shoulders and neck are sore.  Has a headached, back and hips are sore.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Contusion, Injection site swelling, Joint range of motion decreased, Sleep disorder, Vaccination error
Clinical narrative: Patient states that the immunizer administed the injection very hard and in the evening the area became very swollen.  He states that he has limited range of motion cannot sleep on that arm and area still feels very bruised.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site eczema, Injection site pain, Injection site swelling, Ultrasound scan normal
Clinical narrative: Deltoid swelling, tenderness, decreased ROM starting 1 mos s/p immunization in that deltoid. Also small eczematous skin lesion at site of injection present.
Age: 22.0
Sex: M
Vaccine: FLUC4
Symptoms: Needle issue
Clinical narrative: Patient came to the pharmacy to receive a flu shot.  I followed all the required criteria as per the corporate immunization protocol.  After I administered the vaccination, I noticed that the syringe used (BD Integra Syringe with Retracting BD PrecisionGlide Needle) did not have the needle attached to the syringe.  I assumed that the needle had been dislodged into his left arm.  I recommended that he be checked out via an emergency provider.  Patient was checked out and discovered that in fact the needle was NOT in his arm at all.  Apparently, the syringe must have fallen off of the syringe before the injection was initiated.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site mass, Injection site pain
Clinical narrative: DONOR RETURNS TO CENTER COMPLAINING ABOUT PAIN IN LEFT UPPER ARM WITH BRUISING AND A LUMP LESS THAN ONE INCH AFTER RECEIVING TDaP VACCINE 10/09/19. DONOR STATES THAT IT WAS BIGGER BUT HAS LESSENED.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient presented with redness and swelling on vaccinated arm below injection site. There were distinct margins for the redness and swelling in arm. Patient said that this reaction began 2 days post vaccination (on 10/11/2019) and had lasted that whole day.  It is unknown if she the reaction has gotten better or worsened.
Age: 45.0
Sex: F
Vaccine: FLUR4
Symptoms: Pain in extremity
Clinical narrative: Patient is having severe pain in the arm since administration.  It hasn't gone away now 18 days later.  Administration site shows no sign of redness or swelling, but patient reports needed Ibuprofen everyday in order to function because of the pain.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Eczema, Rash, Rash erythematous
Clinical narrative: mild red flat rash - abdomen  burny rash at areas of baseline eczema - arms, thighs Otherwise fine
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Herpes zoster, Pain
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer and the patient regarding a case in litigation involving a female patient (pt) of unknown age. There was no information about the pt's concurrent conditions, concomitant therapies or medical history provided. In or around November 2017, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles. In or around April 2018, the pt was diagnosed with shingles by her primary care physician at the hospital. The event of shingles lasted for several months causing severe pain and suffering and difficulty with weakness for which she had to undergo physical therapy. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms resulted in physical limitations not present prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. The outcome of the event of shingles was considered as not recovered.   The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).   The event of shingles was considered to be disabling.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Blood test, Diarrhoea, Rotavirus test positive
Clinical narrative: "GI FilmArray Panel" came back positive for Rota-virus; diarrhea; This spontaneous report was received from a registered nurse and refers to a 11-week-old male patient. The patient had no pertinent medical history or drug reactions and allergies. Concomitant therapies included nystatin and unspecified drug reported as "multivitamin". On 27-SEP-2019, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # R029818, expiration date 09-JUL-2020 (exact dose was not reported) for prevention of Rota-virus. On 02-OCT-2019, the patient experienced diarrhoea. On 03-OCT-2019, the patient sought medical attention and was taken to the emergency room where the gastrointestinal (GI) FilmArray Panel was performed and it came back positive for rotavirus on 04-OCT-2019. On an unknown date, unspecified blood work test was performed with unknown result. The outcome of the events was reported as recovering. There was no causality assessment provided by the reporter.  This case is linked to US-009507513-1910USA008085 due to same reporter.; Sender's Comments:  US-009507513-1910USA008085:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer and the patient regarding a case in litigation involving a female patient (pt) of unknown age. There was no information about the pt's concurrent conditions, concomitant therapies or medical history provided. In or around 15-OCT-2015, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (Herpes Zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a bad case of the shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of Zostavax, the pt sustained severe and permanent personal injuries. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event of shingles was considered as not recovered.  The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).   The event of shingles was considered to be disabling.
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Insomnia, Musculoskeletal chest pain
Clinical narrative: Trouble sleeping; Pain and swelling in his left bicep muscle and left side of this chest wall causing decreased limb mobility; Pain and swelling in his left bicep muscle and left side of his chest wall causing decreased limb mobility; Pain and swelling in his left bicep muscle and left side of his chest wall causing decreased limb mobility; Pain and swelling in his left bicep muscle and left side of this chest wall causing decreased limb mobility; Pain and swelling in his left bicep muscle and left side of this chest wall causing decreased limb mobility; Indication: Asthma; This spontaneous report was received from a pharmacist referring to a 58-year-old male patient. His concurrent conditions included asthma and drug hypersensitivity. His historical drug included penicillin. His drug reactions/allergies included allergy to penicillin. Concomitant medications included unspecified asthma medications.  On 09-OCT-2019, the patient was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prefilled syringe (lot # R009162 and expiration date: 06-JAN-2020) intramuscularly in the left arm for asthma (product use in unapproved indication). On the same day (also reported as later that night), the patient had troubled sleeping (poor quality sleep) due to pain and swelling in left bicep muscle and the left side of his chest wall causing decreased limb mobility (pain in extremity, peripheral swelling, musculoskeletal chest pain, swelling and injected limb mobility decreased). The patient sought medical attention and was prescribed Benedryl on 10-OCT-2019 with a follow-up on 11-OCT-2019 if he has not improved. No lab diagnostics/studies were performed. The outcome of poor quality sleep, injected limb mobility decreased, peripheral swelling, swelling, musculoskeletal chest pain and pain in extremity was reported as not recovered/not resolved. Outcome of product use in unapproved indication was unknown. Causality assessment of the events poor quality sleep, injected limb mobility decreased, peripheral swelling, swelling, musculoskeletal chest pain and pain in extremity were not provided. No product quality complaint (PQC) was involved.
Sex: M
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: Trouble sleeping; Pain and swelling in his left bicep muscle and left side of this chest wall causing decreased limb mobility; Pain and swelling in his left bicep muscle and left side of his chest wall causing decreased limb mobility; Pain and swelling in his left bicep muscle and left side of his chest wall causing decreased limb mobility; Pain and swelling in his left bicep muscle and left side of this chest wall causing decreased limb mobility; Pain and swelling in his left bicep muscle and left side of this chest wall causing decreased limb mobility; Indication: Asthma; This spontaneous report was received from a pharmacist referring to a 58-year-old male patient. His concurrent conditions included asthma and drug hypersensitivity. His historical drug included penicillin. His drug reactions/allergies included allergy to penicillin. Concomitant medications included unspecified asthma medications.  On 09-OCT-2019, the patient was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prefilled syringe (lot # R009162 and expiration date: 06-JAN-2020) intramuscularly in the left arm for asthma (product use in unapproved indication). On the same day (also reported as later that night), the patient had troubled sleeping (poor quality sleep) due to pain and swelling in left bicep muscle and the left side of his chest wall causing decreased limb mobility (pain in extremity, peripheral swelling, musculoskeletal chest pain, swelling and injected limb mobility decreased). The patient sought medical attention and was prescribed Benedryl on 10-OCT-2019 with a follow-up on 11-OCT-2019 if he has not improved. No lab diagnostics/studies were performed. The outcome of poor quality sleep, injected limb mobility decreased, peripheral swelling, swelling, musculoskeletal chest pain and pain in extremity was reported as not recovered/not resolved. Outcome of product use in unapproved indication was unknown. Causality assessment of the events poor quality sleep, injected limb mobility decreased, peripheral swelling, swelling, musculoskeletal chest pain and pain in extremity were not provided. No product quality complaint (PQC) was involved.
Sex: F
Vaccine: PPV
Symptoms: Malaise, Pain, Pain in extremity
Clinical narrative: arm pain especially when lifting her arm; malaise; This spontaneous report was received from a pharmacist via company representative regarding to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medications were not reported. The pharmacist described that on an unspecified date in 2017,(also reported as 2 years ago) he had two patients with the same reaction to vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, dose, route, lot # and expiry date were not reported) for prophylaxis. The reporter stated that on an unspecified date in 2017, the female patient had arm pain especially when lifting her arm (pain in extremity) and malaise which were resolved on an unspecified date in 2017 (also reported as with one week of the date of the administration). It was reported the pharmacist has not seen her since she recovered from her symptoms. The patient has no cancer, product quality issue and over dose.  The causality assessment between events and product was not provided.  This is one of several reports received from the same reporter.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Was not certain if it was cellulitis on left arm; Local reaction where the injection site stung/injection site burn; Red things on arm; swollen; First dose of Shingrix in her left arm subcutaneous; This case was reported by a physician via call center representative and described the occurrence of injection site cellulitis in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) and levothyroxine sodium (Synthroid).   On 5th October 2019, the patient received the 1st dose of Shingrix (subcutaneous). On 5th October 2019, less than a day after receiving Shingrix and an unknown time after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site cellulitis, injection site stinging, injection site erythema, injection site swelling and intramuscular formulation administered by other route. The patient was treated with sulfamethoxazole + trimethoprim (Bactrim). On an unknown date, the outcome of the injection site cellulitis, injection site stinging, injection site erythema and injection site swelling were recovering/resolving and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site cellulitis, injection site stinging, injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient also received the Fluarix Quad 2019 -2020 in her right arm on the same date. The orthopedic Surgeon reported that his wife received Shingrix in her left arm subcutaneously rather than intramuscular in error at her pharmacy. The patient experienced a local reaction where the injection site stung and burned after receiving the Shingrix vaccine. She also had large red things on her arm that kept getting larger and were painful, red and swollen and were well defined in the arm area where she received the injection. The physician was not certain if it was cellulitis on her left arm but he was treating it with Bactrim and things were now resolving. The reporter consented to follow up. This case has been linked with US2019183586, same reporter.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Local reaction
Clinical narrative: Was not certain if it was cellulitis on left arm; Local reaction where the injection site stung/injection site burn; Red things on arm; swollen; First dose of Shingrix in her left arm subcutaneous; This case was reported by a physician via call center representative and described the occurrence of injection site cellulitis in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) and levothyroxine sodium (Synthroid).   On 5th October 2019, the patient received the 1st dose of Shingrix (subcutaneous). On 5th October 2019, less than a day after receiving Shingrix and an unknown time after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site cellulitis, injection site stinging, injection site erythema, injection site swelling and intramuscular formulation administered by other route. The patient was treated with sulfamethoxazole + trimethoprim (Bactrim). On an unknown date, the outcome of the injection site cellulitis, injection site stinging, injection site erythema and injection site swelling were recovering/resolving and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site cellulitis, injection site stinging, injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient also received the Fluarix Quad 2019 -2020 in her right arm on the same date. The orthopedic Surgeon reported that his wife received Shingrix in her left arm subcutaneously rather than intramuscular in error at her pharmacy. The patient experienced a local reaction where the injection site stung and burned after receiving the Shingrix vaccine. She also had large red things on her arm that kept getting larger and were painful, red and swollen and were well defined in the arm area where she received the injection. The physician was not certain if it was cellulitis on her left arm but he was treating it with Bactrim and things were now resolving. The reporter consented to follow up. This case has been linked with US2019183586, same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This case was reported by a consumer and described the occurrence of flu like symptoms in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced flu like symptoms. On an unknown date, the outcome of the flu like symptoms was unknown.   It was unknown if the reporter considered the flu like symptoms to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The pharmacist reported that some patients got mild flu like symptoms after receiving Shingrix. This case has been linked with US2019AMR184960, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Cough, Malaise, Pain, Pneumonia
Clinical narrative: Pneumonia; ill; deep body aches; cough; This case was reported by a consumer and described the occurrence of pneumonia in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included pneumonia shot (received second shot a year before the reporting date).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced pneumonia (serious criteria GSK medically significant), unwell, general body pain and cough. On an unknown date, the outcome of the pneumonia, unwell, general body pain and cough were recovering/resolving.   It was unknown if the reporter considered the pneumonia, unwell, general body pain and cough to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient did have the second pneumonia shot last year. The patient reported a side effect to first Shingles shot.  It was reported that the night after shot the patient was ill with deep body aches and a cough. The pharmacist said some get mild flu like symptoms. The next day, the patient had deep coughs and the patient diagnosed with full blown Pneumonia. The patient never had pneumonia not even a cold or flu or last 3 years and there was no reason for me to have pneumonia. The patient asked if GSK had other reports like this. After 2 weeks, the patient finally getting better. The patient was afraid to get the second shot. The case has been linked to the case US2019AMR184953, reported by the same reporter.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Wasn't certain if it was cellulitis on his left arm; Local reaction where the injection site stung/injection site burning; swollen; Large red things on arm; First dose of Shingrix in his left arm subcutaneous; This case was reported by a physician via call center representative and described the occurrence of injection site cellulitis in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypertension. Concomitant products included Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season).   On 5th October 2019, the patient received the 1st dose of Shingrix (subcutaneous). On 5th October 2019, less than a day after receiving Shingrix and an unknown time after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site cellulitis, injection site stinging, injection site swelling, injection site erythema and intramuscular formulation administered by other route. The patient was treated with sulfamethoxazole + trimethoprim (Bactrim). On an unknown date, the outcome of the injection site cellulitis, injection site stinging, injection site swelling and injection site erythema were recovering/resolving and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site cellulitis, injection site stinging, injection site swelling and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient also received the Fluarix Quad 2019 -2020 in his right arm on the same date. The orthopedic Surgeon reported that he received Shingrix in her left arm subcutaneously rather than intramuscular in error at her pharmacy. The patient experienced a local reaction where the injection site stung and burned after receiving the Shingrix vaccine. He also had large red things on her arm that kept getting larger and were painful, red and swollen and were well defined in the arm area where he received the injection. The physician was not certain if it was cellulitis on his left arm but he was treating it with Bactrim and things were now resolving. The reporter consented to follow up. This case has been linked with US2019183591, same reporter.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Chemotherapy, Herpes zoster, Laboratory test abnormal, Neoplasm malignant, Radiotherapy
Clinical narrative: Cancer; Shingles; Rash; This case was reported by a pharmacist via call center representative and described the occurrence of cancer in a 78-year-old male patient who received Herpes zoster (Shingrix) (batch number 9349T, expiry date 7th March 2021) for prophylaxis.   On 27th August 2018, the patient received the 2nd dose of Shingrix. In September 2019, 7 days after receiving Shingrix, the patient experienced cancer (serious criteria GSK medically significant), shingles and rash. The patient was treated with chemotherapy, nos (Chemotherapy) and non-drug therapy (Radiation). On an unknown date, the outcome of the cancer was not recovered/not resolved and the outcome of the shingles and rash were recovered/resolved.   It was unknown if the reporter considered the cancer, shingles and rash to be related to Shingrix.  Additional details were provided as follows: About 1 week after vaccination, the patient developed a rash on his ankle. He went to healthcare professional (HCP) and was diagnosed with shingles. Concerned that he had developed shingles, his HCP ran additional testing and based on those tests he was diagnosed with cancer. The HCP started chemotherapy and radiation about 1 to 2 months after the shingles. At the time of report, the patient was still undergoing treatment for the cancer.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Cancer; Shingles; Rash; This case was reported by a pharmacist via call center representative and described the occurrence of cancer in a 78-year-old male patient who received Herpes zoster (Shingrix) (batch number 9349T, expiry date 7th March 2021) for prophylaxis.   On 27th August 2018, the patient received the 2nd dose of Shingrix. In September 2019, 7 days after receiving Shingrix, the patient experienced cancer (serious criteria GSK medically significant), shingles and rash. The patient was treated with chemotherapy, nos (Chemotherapy) and non-drug therapy (Radiation). On an unknown date, the outcome of the cancer was not recovered/not resolved and the outcome of the shingles and rash were recovered/resolved.   It was unknown if the reporter considered the cancer, shingles and rash to be related to Shingrix.  Additional details were provided as follows: About 1 week after vaccination, the patient developed a rash on his ankle. He went to healthcare professional (HCP) and was diagnosed with shingles. Concerned that he had developed shingles, his HCP ran additional testing and based on those tests he was diagnosed with cancer. The HCP started chemotherapy and radiation about 1 to 2 months after the shingles. At the time of report, the patient was still undergoing treatment for the cancer.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Red dot rash on the front and back of torso; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, 1 day after receiving Shingrix, the patient experienced red rash. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the red rash was unknown.   It was unknown if the reporter considered the red rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that she noticed red dot rash next morning on the front and back of her torso. It ranges from butline down to top of thighs. The patient spoke to her doctor and was advised to take Benadryl. She took Benadryl on the day before reporting. The reporter did not consent to follow-up. No further details were provided.
Sex: F
Vaccine: HEP
Symptoms: Seizure
Clinical narrative: seizure; This case was reported by a pharmacist via call center representative and described the occurrence of seizure in a 1-month-old female patient who received HBV (Engerix B) (batch number HN5BE, expiry date unknown) for prophylaxis.   On 8th October 2019, the patient received Engerix B 10 µg. On 8th October 2019, less than a day after receiving Engerix B, the patient experienced seizure (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the seizure was not recovered/not resolved.   It was unknown if the reporter considered the seizure to be related to Engerix B.  Additional details were provided as follows: The age at vaccination was not reported. Shortly after getting the vaccine, they were putting her in the care to go home, the patient started having a seizure. The patient was taken to the emergency room (ER) and later admitted to the hospital. On 10th October 2019, she was on anti-seizure medication in the hospital, but was still experiencing seizures. She did not have any seizures prior to getting Engerix-B. The Engerix B batch number was reported as HN5B3, however based on a batch number review, the batch number was corrected to HN5BE.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: pink 4 inch area at injection site; warm to touch at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 84-year-old female patient who received Herpes zoster (Shingrix) (batch number LD3NH, expiry date 11th December 2021) for prophylaxis.   On 7th October 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient developed a 4-inch area around the injection site on her right arm that was pink and warm to the touch.   There was discrepancy in the outcome of the event, in the source document it was reported as recovering/ resolving and in the database it was reported as not recovered/ not resolved.