chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Nodule, Skin warm
Clinical narrative: The patient returned to the pharmacy several days after injection was given because her arm was red and slightly warm to touch. With a small hard knot. She said it didn't hurt or itch. I advised her to use an ice pack and use BENADRYL or TYLENOL as needed. She came back the next day and the site of vaccine was improved. Only slightly red and no longer warm. No further advise given.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Allergy to vaccine, Condition aggravated, Drug hypersensitivity, Ear infection, Pyrexia
Clinical narrative: Fever as high as 103.5, tachycardia (170s), rapid breathing, mild to moderate facial swelling, extensive rash all over face and body, hives on shoulders and face. All occurred 11 days after vaccines given, and after last dose of 10 day course of amoxicillin. Ear infection also worse by then.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV, VARCEL
Symptoms: Rash generalised, Respiratory rate increased, Swelling face, Tachycardia, Urticaria
Clinical narrative: Fever as high as 103.5, tachycardia (170s), rapid breathing, mild to moderate facial swelling, extensive rash all over face and body, hives on shoulders and face. All occurred 11 days after vaccines given, and after last dose of 10 day course of amoxicillin. Ear infection also worse by then.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema
Clinical narrative: PATIENT HAS EXPERIENCED REDNESS AT THE SITE OF INJECTION. PATIENT HAS ALSO HAD SOME RED SPOT ON LEFT HAND AND ON 04-02-2019 PATIENT HAD SEEN RED SPOT ON HER LEFT PALM. PATIENT EXPERIENCING ADVERSE EFFECT EVEN AFTER ONE WEEK OF AN INJECTION.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Nasopharyngitis, Nausea, Peripheral swelling
Clinical narrative: Shakes, cold, nausea, swollen arm, redness, hot.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Tremor
Clinical narrative: Shakes, cold, nausea, swollen arm, redness, hot.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swelling, eyrthema, hot deltoid.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Around 10:30 AM, started with mild fever (less than 100F), muscle ache, similar to flu-like symptom and pain at/around injection site. In the evening, my temp reached 100.1, and continue to elevate 100.4 (17:55PM). Took Acetaminophen then temp went down to 99.7F (18:28PM), and muscle ache has gone. Also the pain at/around injection site reduced.
Age: 21.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site reaction, Urticaria
Clinical narrative: The upper left arm was very sore the day after the shot-couldn't lay on left side at night. The soreness moved down my arm to about the elbow, and after my shower on 3/8 I saw that most of the front of the arm had a raised red welt on it that felt bruised to the touch. The red patch was on the majority of the front of the arm. I did go by the pharmacy where I got the shot to talk to the Pharmacist, and he (not the person who administered the vaccine) didn't want to see my arm or really think it was alarming. I asked if I should go ahead and get the second dose, and he commented that I wouldn't be covered for shingles if I didn't...which I understand, but I'm not sure that would be safe after the reaction. The bruised feeling and red swelling lasted for about 2 weeks. I did take a photo of the arm if it would help with anything. I did speak with my Dr. and he recommends I do NOT get shot #2.
Age: 24.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Dizziness postural, Fatigue, Pain
Clinical narrative: On 04/001/2019 around 8:00 PM, he started feeling body aches and extreme fatigue. On 04/03/2019 around 9:00 AM, he started feeling dizzy when he stood up. He is still having body aches and fatigue. He is NOT having fever.
Age: 73.0
Sex: M
Vaccine: HEP
Symptoms: Cardiac failure, Chills, Peripheral coldness, Peripheral swelling, Pyrexia
Clinical narrative: On 01/16/2019, pt presented to follow-up appt with heart failure clinical pharmacy specialist reporting increased swelling in left arm after receiving Hep B vaccine which he initially thought was related to fluid retention and his heart failure. Patient received Hep B vaccine on 12/17/2018 to left and right deltoids. He reports some fevers and chills around Christmas after injection in addition to left arm swelling that began 1 week after getting the Hep B vaccination. Per pt report, right arm had swelled up but only for 1 day whereas left arm continues to swell on daily basis. He states when he wakes up his left hand and arm is normal in size and as the day goes on it begins to swell but he denies numbness or tingling. Per nursing note dated 01/16/2019, "There is +2-3 swelling to his arm especially forearm. Radial pulse +2 able to feel the pulse. Capillary refill greater than 3 seconds and slightly cool to touch."
Age: 73.0
Sex: M
Vaccine: HEP
Symptoms: Ultrasound scan
Clinical narrative: On 01/16/2019, pt presented to follow-up appt with heart failure clinical pharmacy specialist reporting increased swelling in left arm after receiving Hep B vaccine which he initially thought was related to fluid retention and his heart failure. Patient received Hep B vaccine on 12/17/2018 to left and right deltoids. He reports some fevers and chills around Christmas after injection in addition to left arm swelling that began 1 week after getting the Hep B vaccination. Per pt report, right arm had swelled up but only for 1 day whereas left arm continues to swell on daily basis. He states when he wakes up his left hand and arm is normal in size and as the day goes on it begins to swell but he denies numbness or tingling. Per nursing note dated 01/16/2019, "There is +2-3 swelling to his arm especially forearm. Radial pulse +2 able to feel the pulse. Capillary refill greater than 3 seconds and slightly cool to touch."
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dyspnoea, Mouth swelling, Peripheral swelling, Throat tightness
Clinical narrative: 5H after administration patient with swelling hands, feet, mouth and felt her throat closing difficulty breathing. Went to ER started nebulizer, given steroids, antihistamine.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Blister
Clinical narrative: Blisters over chest.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling/tenderness/warmth (R) deltoid.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Mobility decreased, Pain
Clinical narrative: Patient was in a lot of pain from head to toe from 2nd dose of SHINGRIX, felt really sick, couldn't get out of bed for a few days; better now but still recovering.
Age: 65.0
Sex: M
Vaccine: FLU4, TDAP, TDAP
Symptoms: Arthralgia, Chest X-ray, Chest pain, Exercise electrocardiogram, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 65-year-old male patient who received BOOSTRIX for prophylaxis. On 27th November 2018, the patient received BOOSTRIX (intramuscular). On 27th November 2018, less than a day after receiving BOOSTRIX, the patient experienced heart rate high (serious criteria hospitalization), blood pressure high (serious criteria hospitalization), chest pain (serious criteria hospitalization) and headache (serious criteria hospitalization). On an unknown date, the patient experienced muscle pain (serious criteria hospitalization) and joint pain (serious criteria hospitalization). The patient was treated with prednisone. On an unknown date, the outcome of the muscle pain, heart rate high, blood pressure high, chest pain and headache were not reported and the outcome of the joint pain was unknown.  It was unknown if the reporter considered the muscle pain, heart rate high, blood pressure high, chest pain, headache and joint pain to be related to BOOSTRIX. Additional information were reported as follows: This case was found to be duplicate of the case US2019056578. Case US2019056578 would be deleted and all the future corresponding information to the present case would be submitted to US2019052664 (case of record). The age at vaccination was not reported. The patient reported that evening after receiving the dose of BOOSTRIX he experienced high heart rate, high blood pressure, chest pain and headache and was seen in the emergency room. Since then, less than a year after receiving BOOSTRIX the patient experienced muscle and joint pain for which he received Prednisone. The patient experienced severe adverse events. The patient did not consent to follow-up. The patient did not wish to provide the date of birth.
Age: 65.0
Sex: M
Vaccine: FLU4, TDAP, TDAP
Symptoms: Heart rate increased, Hypertension, Myalgia, Scan myocardial perfusion
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 65-year-old male patient who received BOOSTRIX for prophylaxis. On 27th November 2018, the patient received BOOSTRIX (intramuscular). On 27th November 2018, less than a day after receiving BOOSTRIX, the patient experienced heart rate high (serious criteria hospitalization), blood pressure high (serious criteria hospitalization), chest pain (serious criteria hospitalization) and headache (serious criteria hospitalization). On an unknown date, the patient experienced muscle pain (serious criteria hospitalization) and joint pain (serious criteria hospitalization). The patient was treated with prednisone. On an unknown date, the outcome of the muscle pain, heart rate high, blood pressure high, chest pain and headache were not reported and the outcome of the joint pain was unknown.  It was unknown if the reporter considered the muscle pain, heart rate high, blood pressure high, chest pain, headache and joint pain to be related to BOOSTRIX. Additional information were reported as follows: This case was found to be duplicate of the case US2019056578. Case US2019056578 would be deleted and all the future corresponding information to the present case would be submitted to US2019052664 (case of record). The age at vaccination was not reported. The patient reported that evening after receiving the dose of BOOSTRIX he experienced high heart rate, high blood pressure, chest pain and headache and was seen in the emergency room. Since then, less than a year after receiving BOOSTRIX the patient experienced muscle and joint pain for which he received Prednisone. The patient experienced severe adverse events. The patient did not consent to follow-up. The patient did not wish to provide the date of birth.
Age: 65.0
Sex: M
Vaccine: FLU4, TDAP, TDAP
Symptoms: Arthralgia, Blood pressure increased, Chest pain, Headache, Heart rate increased
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 65-year-old male patient who received BOOSTRIX for prophylaxis. On 27th November 2018, the patient received BOOSTRIX (intramuscular). On 27th November 2018, less than a day after receiving BOOSTRIX, the patient experienced heart rate high (serious criteria hospitalization), blood pressure high (serious criteria hospitalization), chest pain (serious criteria hospitalization) and headache (serious criteria hospitalization). On an unknown date, the patient experienced muscle pain (serious criteria hospitalization) and joint pain (serious criteria hospitalization). The patient was treated with prednisone. On an unknown date, the outcome of the muscle pain, heart rate high, blood pressure high, chest pain and headache were not reported and the outcome of the joint pain was unknown.  It was unknown if the reporter considered the muscle pain, heart rate high, blood pressure high, chest pain, headache and joint pain to be related to BOOSTRIX. Additional information were reported as follows: This case was found to be duplicate of the case US2019056578. Case US2019056578 would be deleted and all the future corresponding information to the present case would be submitted to US2019052664 (case of record). The age at vaccination was not reported. The patient reported that evening after receiving the dose of BOOSTRIX he experienced high heart rate, high blood pressure, chest pain and headache and was seen in the emergency room. Since then, less than a year after receiving BOOSTRIX the patient experienced muscle and joint pain for which he received Prednisone. The patient experienced severe adverse events. The patient did not consent to follow-up. The patient did not wish to provide the date of birth.
Age: 65.0
Sex: M
Vaccine: FLU4, TDAP, TDAP
Symptoms: Hypertension, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 65-year-old male patient who received BOOSTRIX for prophylaxis. On 27th November 2018, the patient received BOOSTRIX (intramuscular). On 27th November 2018, less than a day after receiving BOOSTRIX, the patient experienced heart rate high (serious criteria hospitalization), blood pressure high (serious criteria hospitalization), chest pain (serious criteria hospitalization) and headache (serious criteria hospitalization). On an unknown date, the patient experienced muscle pain (serious criteria hospitalization) and joint pain (serious criteria hospitalization). The patient was treated with prednisone. On an unknown date, the outcome of the muscle pain, heart rate high, blood pressure high, chest pain and headache were not reported and the outcome of the joint pain was unknown.  It was unknown if the reporter considered the muscle pain, heart rate high, blood pressure high, chest pain, headache and joint pain to be related to BOOSTRIX. Additional information were reported as follows: This case was found to be duplicate of the case US2019056578. Case US2019056578 would be deleted and all the future corresponding information to the present case would be submitted to US2019052664 (case of record). The age at vaccination was not reported. The patient reported that evening after receiving the dose of BOOSTRIX he experienced high heart rate, high blood pressure, chest pain and headache and was seen in the emergency room. Since then, less than a year after receiving BOOSTRIX the patient experienced muscle and joint pain for which he received Prednisone. The patient experienced severe adverse events. The patient did not consent to follow-up. The patient did not wish to provide the date of birth.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Peripheral swelling, Rash, Rash erythematous, Rash macular
Clinical narrative: This case was reported by a consumer and described the occurrence of cellulitis in a patient who received SHINGRIX for prophylaxis. On 12th February 2019, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant), blotchy, allergic reaction and erythema. The patient was treated with cetirizine hydrochloride (Zyrtec) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the cellulitis, blotchy, allergic reaction and erythema were unknown. It was unknown if the reporter considered the cellulitis, blotchy, allergic reaction and erythema to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a pharmacy via a pharmacy claims management company. The age at vaccination was not reported. The patient was treated for an an allergic reaction or cellulitis where Benadryl and Zyrtec were prescribed. The patient complained that she was blotchy and had redness in several parts of her body from a SHINGRIX vaccine that was administered in her left arm. The patient was pursuing a claim against the manufacture.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Skin warm, Tongue coated
Clinical narrative: This case was reported by a consumer and described the occurrence of cellulitis in a patient who received SHINGRIX for prophylaxis. On 12th February 2019, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant), blotchy, allergic reaction and erythema. The patient was treated with cetirizine hydrochloride (Zyrtec) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the cellulitis, blotchy, allergic reaction and erythema were unknown. It was unknown if the reporter considered the cellulitis, blotchy, allergic reaction and erythema to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a pharmacy via a pharmacy claims management company. The age at vaccination was not reported. The patient was treated for an an allergic reaction or cellulitis where Benadryl and Zyrtec were prescribed. The patient complained that she was blotchy and had redness in several parts of her body from a SHINGRIX vaccine that was administered in her left arm. The patient was pursuing a claim against the manufacture.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Erythema, Hypersensitivity, Rash macular
Clinical narrative: This case was reported by a consumer and described the occurrence of cellulitis in a patient who received SHINGRIX for prophylaxis. On 12th February 2019, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant), blotchy, allergic reaction and erythema. The patient was treated with cetirizine hydrochloride (Zyrtec) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the cellulitis, blotchy, allergic reaction and erythema were unknown. It was unknown if the reporter considered the cellulitis, blotchy, allergic reaction and erythema to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a pharmacy via a pharmacy claims management company. The age at vaccination was not reported. The patient was treated for an an allergic reaction or cellulitis where Benadryl and Zyrtec were prescribed. The patient complained that she was blotchy and had redness in several parts of her body from a SHINGRIX vaccine that was administered in her left arm. The patient was pursuing a claim against the manufacture.
Age: 18.0
Sex: F
Vaccine: FLU4, HEP, HEPA, HPV9, MENB, MMR, MNQ, VARCEL, HEP, HEPA, HPV9, MENB, MMR, MNQ, VARCEL
Symptoms: Full blood count, Metabolic function test normal, Pregnancy test negative, Rash pruritic, Rash vesicular
Clinical narrative: Client reported that the evening /night of the day she had received the vaccines she experienced itching to her arms and "her body". The next am she went to an ER and they "gave her some medicine IV for the itching and rash." She was also given RX for Prednisone and BENADRYL PO, but did not understand she needed to fill these RX- except for the IV med(s) she had not had further treatment. When seen at clinic 4-3-2019 and given physical by NP the rash was diminished from her prior complaint to be raised but not red and on her hands and small places on arms.
Age: 18.0
Sex: F
Vaccine: FLU4, HEP, HEPA, HPV9, MENB, MMR, MNQ, VARCEL, HEP, HEPA, HPV9, MENB, MMR, MNQ, VARCEL
Symptoms: Urine analysis normal, White blood cell count decreased
Clinical narrative: Client reported that the evening /night of the day she had received the vaccines she experienced itching to her arms and "her body". The next am she went to an ER and they "gave her some medicine IV for the itching and rash." She was also given RX for Prednisone and BENADRYL PO, but did not understand she needed to fill these RX- except for the IV med(s) she had not had further treatment. When seen at clinic 4-3-2019 and given physical by NP the rash was diminished from her prior complaint to be raised but not red and on her hands and small places on arms.
Age: 18.0
Sex: F
Vaccine: FLU4, HEP, HEPA, HPV9, MENB, MMR, MNQ, VARCEL, HEP, HEPA, HPV9, MENB, MMR, MNQ, VARCEL
Symptoms: Pruritus generalised, Rash
Clinical narrative: Client reported that the evening /night of the day she had received the vaccines she experienced itching to her arms and "her body". The next am she went to an ER and they "gave her some medicine IV for the itching and rash." She was also given RX for Prednisone and BENADRYL PO, but did not understand she needed to fill these RX- except for the IV med(s) she had not had further treatment. When seen at clinic 4-3-2019 and given physical by NP the rash was diminished from her prior complaint to be raised but not red and on her hands and small places on arms.
Age: 12.0
Sex: M
Vaccine: DTAP
Symptoms: Asthenia, Cough, Dizziness, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: High fever on and off for two weeks. Dizziness which still continues. He has had a bad cough and congestion ever since the vaccination. Lack of energy - he is unable to preform usual activities, which includes running and swim practice. He was seen by his Dr and put in antibiotics but it has not helped.
Age: 12.0
Sex: M
Vaccine: DTAP
Symptoms: Respiratory tract congestion
Clinical narrative: High fever on and off for two weeks. Dizziness which still continues. He has had a bad cough and congestion ever since the vaccination. Lack of energy - he is unable to preform usual activities, which includes running and swim practice. He was seen by his Dr and put in antibiotics but it has not helped.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Influenza like illness, Injection site pain, Pain, Pyrexia
Clinical narrative: Fever, dizzy, all over body pain, intense pain at injection site, flu-like symptoms.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass, Paraesthesia
Clinical narrative: Customer returned to pharmacy 4 days after vaccination was given. There was a small lump in the proximity where the shot was given, but no redness. Patient indicated feeling of "pins and needles" down her arm after a workout at the gym, did not indicate what day this was though. Not other affects or symptoms though.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Limb mass, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Immediate large lump and swelling in my arm, after about 2-3 hours the pain was so severe and now 2 days later I can't touch my arm and the lump is alot bigger. 24 Hours later my arm is not able to move with out pain. Level a 10+ I'm terrified to get the next dose now.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Immediate large lump and swelling in my arm, after about 2-3 hours the pain was so severe and now 2 days later I can't touch my arm and the lump is alot bigger. 24 Hours later my arm is not able to move with out pain. Level a 10+ I'm terrified to get the next dose now.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site bruising, Injection site swelling, Nausea, Vomiting
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA (VAERS number: 692220) under the Act on 17-AUG-2017. This spontaneous report was received from a physician referring to a 13 year old female patient. She had no current illnesses and no known medical history. On 24-APR-2017 at 8:00, the patient was vaccinated with GARDASIL 9 lot # M034780, intramuscular in the left arm (dose 2, expiry date were not provided). She was not taking concomitant medications. Swelling and bruising in a left deltoid began at same day as vaccination, in evening and lessened by next day. The patient was vomiting 2 times in the evening after vaccine administration. The patient also experienced nausea with no vomiting on an unknown date approximately in April 2017 (reported as "today" and also child reported she started "yesterday" after vaccine given, but vaccine actually given "2 days ago"). The final outcome of the events was unknown. Causality assessment was not provided. Additional information is not expected. Follow-up information was received from the nurse Practitioner on 02-APR-2019. The patient reportedly recovered from the events. The reporter shared that she can find 2 subsequent physicals for the patient (dates unavailable) and patient is doing well. The patient has also completed her vaccination regime and is up to date on all vaccinations.
Sex: U
Vaccine: HPV9, PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to unspecified number of patients of unknown ages and gender. Information about medical history, concurrent condition and concomitant medication was unknown. On unknown dates the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # R016638 with expiration date of 28-JAN-2020; dose, frequency and route unspecified) or GARDASIL 9 (lot# N019103 with expiration date of 03-FEB-2020 and lot# N032956 with expiration date of 13-JUL-2020, one dose, intramuscular) for prophylaxis (product storage error). No adverse effect was reported. The temperature excursion was 26.2 degree Fahrenheit with a time frame of 1 hour and 30 minutes. There was previous temperature excursion (32.1 degree Fahrenheit with a time frame of 1 hour). Data logger was involved. No product quality complaint was involved. This is a non-valid case due to lack of patients' identifier. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1904USA001644.
Age: 1.33
Sex: F
Vaccine: HPV9, UNK
Symptoms: Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: Information has been received from a physician assistant concerning a 16 months old female patient. Information about medical history, concurrent conditions and concomitant therapies were unknown. On 06-MAR-2019, the patient was administered GARDASIL 9 (strength, dose, route, lot # and expiration date were not reported) for prophylaxis.(product administered to patient of inappropriate age) The patent also administered along with multiple unspecified vaccination at the pediatrician office. On 07-MAR-2019, the patient was brought to physician assistant's facility and had a low grade fever. No treatment was given to the patient. No lab diagnostics/studies was performed. The outcome of low grade fever was reported as not recovered. The causality between the low grade fever and GARDASIL 9 was not provided.
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a female patient of unknown age. The medical history, concurrent condition and concomitant therapies was not provided. On an unknown date the patient received the first dose of VAQTA (lot#, expiration date, dose and route were not reported) and 3 months after she received second dose of VAQTA 50U/1.0ml, lot # R031045, expiration date 18-NOV-2019 (dose was not reported) intramuscularly both for prophylaxis (inappropriate schedule of product administration). No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On an unknown date the patient was vaccinated with improperly stored VARIVAX (lot # R022116, expiration date 02-FEB-2020; strength, dose, frequency and route were not reported) for prophylaxis (poor quality product administered and product storage error). Administered dose of vaccine experienced a temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit (also reported 18 Fahrenheit), which lasted for a time frame of 1.5 hours. There was no previous temperature excursion. A digital data logger was involved. No adverse symptoms reported.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product formulation administered, No adverse event, Product preparation issue, Product quality issue
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age. The patient's medical history, concurrent condition and concomitant medication and drug allergies were not reported. On 22-MAR-2019, the patient was vaccinated with a dose of M-M-R II "therapy type: rHA" (lot # N032427/expiration date: 16-NOV-2019) (dose, unit, frequency, anatomical location were not reported) that had not been completely reconstituted with sterile diluent (lot # N028090/expiration date: 13-FEB-2020) (dose, unit, frequency date were not reported) for prophylaxis. It was reported that the patient had no adverse effects. The outcome of the events was reported as unknown. The product quality complaint was filed.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Blister, Peripheral swelling, Rash erythematous, Rash pruritic
Clinical narrative: This spontaneous report was received from a nurse referring to a 22-year-old female patient. The patient's concurrent conditions included penicillin and erythromycin allergy, while the patient had not medical history and her concomitant medications included ORTHO TRI-CYCLEN. On 06-MAR-2019, the patient was vaccinated with GARDASIL 9 lot # 1581027 (expiration date: 03-JUN-2021) (dose and frequency not provided), intramuscular for immunization. On 07-MAR-2019, the patient developed itchy red bumps on her hands (rash popular) and her hands became swollen (peripheral swelling). Then, in the same day, one area of unspecified size and location appeared to have formed a blister. The patient did not see medical attention, no laboratory tests were performed and she did not received any treatment. The outcome for the events was reported as recovered in March 2019. The causal relationship between the events and GARDASIL 9 was not reported.
Sex: U
Vaccine: HPV9, MEN, TDAP
Symptoms: Seizure
Clinical narrative: This spontaneous report has been received from a physician via a company representative referring to unspecified number of adolescents of unknown age and gender. The patients' concomitant medications included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (unspecified TDAP) and meningococcal vaccine (unspecified). Pertinent medical history and drug reactions/allergies were unknown. On an unknown date, the patients were vaccinated with their third dose of GARDASIL 9 (dose 3; 0.5 milliliter dose and 0, 2 and 6 months; route, batch/lot# and expiration date were unknown) for prevent of human papilloma virus (HPV). On an unknown date, while in the physician's office, the patients experienced seizure. It was unknown whether treatment was given for the event or not (also reported that the patient was treated in office). It was unknown whether lab diagnostics/studies were performed or not. The outcome of the event was unknown. The event didn't resulted in death or hospitalization. The causality between the event and GARDASIL 9 was unknown. No product quality complaint (PQC) presented. Upon internal review, seizure was considered to be medically significant.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report was received from a pharmacist, referring to his daughter, a female patient of unknown age. The patient's medical history included allergy to penicillin, concurrent conditions were not disclosed. Her concomitant medications included levothyroxine. The reporter stated that the patient was vaccinated with M-M-R II for prophylaxis; when she was a child (specific date not reported), then she was vaccinated in 2009 when she was in college, and received a third dose in 2019 (also reported as "in the last 3 months") (route of administration, strength, lot # and expiration date were not provided for neither one of the 3 doses administered). Afterwards, the patient showed negative M-M-R titers (measles antibody negative, rubella antibody negative and mumps antibody test negative). It was reported that the patient did not seek medical attention due to the events, and no treatment was given. At the time of this report, the outcome of negative M-M-R titers (measles antibody negative, rubella antibody negative and mumps antibody test negative) was unknown. The causality assessment between M-M-R II and the adverse events was not provided.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was unknown. On an unknown date the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 (lot # R016638 with expiration date of 28-JAN-2020; dose, frequency and route unspecified) for prophylaxis (product storage error). No adverse effect was reported. The temperature excursion was 26.2 degree Fahrenheit with a time frame of 1 hour and 30 minutes. There was previous temperature excursion (32.1 degree Fahrenheit with a time frame of 1 hour). Data logger was involved. No product quality complaint was involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1903USA003978.
Sex: F
Vaccine: HPV9
Symptoms: Hallucination
Clinical narrative: This spontaneous report was received from a physician's assistant, via company representative, referring to a 24-year-old non-pregnant female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly (strength, dose, frequency, lot# and expiration date not reported) for prophylaxis. On an unknown date, after receiving the first dose of GARDASIL 9, the patient experienced hallucinations. It was unknown if the patient received any treatment for the event. The outcome of the event was not reported. The causal relationship between GARDASIL 9 and the event was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 83-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On 11th February 2019, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 82 or 83 years old. The patient received a dose of SHINGRIX several months before the date of reporting and the pharmacist told the patient that she needed a second dose. In the interval, the patient developed shingles. The patient was diagnosed with wire shingles. The patient was due for the 2nd dose of SHINGRIX. The patient was heard that, the patient should wait a period of time before getting a second shot because of shingles. The patient wanted to know, how long was the waiting period.
Sex: M
Vaccine: VARZOS
Symptoms: Chronic myeloid leukaemia, Plasma cell myeloma
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of chronic myeloid leukemia in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced chronic myeloid leukemia (serious criteria GSK medically significant) and multiple myeloma (serious criteria GSK medically significant). On an unknown date, the outcome of the chronic myeloid leukemia and multiple myeloma were unknown. It was unknown if the reporter considered the chronic myeloid leukemia and multiple myeloma to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX, later was diagnosed with multiple myeloma and CML. The reporter was interested in safety data to make decision on 2nd dose. The reporter did not agree to follow up from GlaxoSmithKline. Clarification has been raised for diagnosed event.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Vaccine positive rechallenge
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of rash in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of rash (1st dose received on an unknown date, refer case US2019055861). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced rash. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced rash after the second dose of SHINGRIX. Rash appears to resolve and then come back. No further details were available. The reporter did not give consent to follow up. The reporter declined to provide the patient identifiers and full demographics for herself.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Incorrect route of product administration, Injection site pain, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 23rd January 2019, refer case US2019055819). On 21st March 2019 02:00, the patient received the 2nd dose of SHINGRIX (subcutaneous). On 21st March 2019, less than a day after receiving SHINGRIX, the patient experienced muscle pain, fever, fatigue, shivering and intramuscular formulation administered by other route. On 21st March 2019 08:00, the patient experienced injection site pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, muscle pain, fever, fatigue and shivering were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site pain, muscle pain, fever, fatigue and shivering to be related to SHINGRIX. Additional details were provided as follows: Six hours after receiving SHINGRIX, the patient experienced pain presented at the injection site. It was much severe than what was experienced after receiving the first dose of SHINGRIX. The patient felt like he was hit in the arm with a heavy object. Within the next 2 hours he experienced muscle aches, fever, fatigue and shivering. The fever broke the next morning. The patient received the second dose of SHINGRIX subcutaneously, which led to inappropriate route of administration. The reporter consented to follow up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 23rd January 2019, refer case US2019055819). On 21st March 2019 02:00, the patient received the 2nd dose of SHINGRIX (subcutaneous). On 21st March 2019, less than a day after receiving SHINGRIX, the patient experienced muscle pain, fever, fatigue, shivering and intramuscular formulation administered by other route. On 21st March 2019 08:00, the patient experienced injection site pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the injection site pain, muscle pain, fever, fatigue and shivering were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site pain, muscle pain, fever, fatigue and shivering to be related to SHINGRIX. Additional details were provided as follows: Six hours after receiving SHINGRIX, the patient experienced pain presented at the injection site. It was much severe than what was experienced after receiving the first dose of SHINGRIX. The patient felt like he was hit in the arm with a heavy object. Within the next 2 hours he experienced muscle aches, fever, fatigue and shivering. The fever broke the next morning. The patient received the second dose of SHINGRIX subcutaneously, which led to inappropriate route of administration. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of joint pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced joint pain. On an unknown date, the outcome of the joint pain was not reported. It was unknown if the reporter considered the joint pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient details other than gender, lot number, expiry date, date of administration or dose number of SHINGRIX were unknown. The pharmacist reported that the patient received the SHINGRIX dose at the Medical Doctor's Office (MDO) and not at their pharmacy.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 27th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a week after receiving SHINGRIX, the patient experienced pain in arm and tiredness. On an unknown date, the outcome of the pain in arm and tiredness were unknown. It was unknown if the reporter considered the pain in arm and tiredness to be related to SHINGRIX. Additional details were provided as follows: The day before reporting day, the patient received dose of SHINGRIX in the left arm. The reporter did not consent to follow up. No further details were provided.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Musculoskeletal pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shoulder pain in a 77-year-old female patient who received SHINGRIX (batch number EY93J, expiry date 13th April 2021) for prophylaxis. On 16th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shoulder pain, mobility decreased and activities of daily living impaired. The patient was treated with TYLENOL and Ice Pack (Nos). On an unknown date, the outcome of the shoulder pain, mobility decreased and activities of daily living impaired were recovered/resolved. It was unknown if the reporter considered the shoulder pain, mobility decreased and activities of daily living impaired to be related to SHINGRIX. Additional details were reported as follows: The pharmacist reported that the patient experienced shoulder pain for 5 days after injection. The pain caused the patient to be unable to lift her arm or comb her hair for 5 days. The patient reported to pharmacist that she took TYLENOL and used an ice pack for the pain. The batch number of SHINGRIX was reported as EY935, which was corrected to EY93J as per sales data sheet.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received SHINGRIX for prophylaxis. On 26th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In March 2019, less than a week after receiving SHINGRIX, the patient experienced pain in arm and swelling. On an unknown date, the outcome of the pain in arm and swelling were unknown. It was unknown if the reporter considered the pain in arm and swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on right arm at a pharmacy. The patient was referred by her physical therapist to the office since patient experienced arm pain and swelling. No further details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Somnolence
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fatigue, drowsiness, headache and muscle pain. On an unknown date, the outcome of the fatigue, drowsiness, headache and muscle pain were recovered/resolved. It was unknown if the reporter considered the fatigue, drowsiness, headache and muscle pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not provided. The event fatigue, drowsiness, headache and muscle aches lasted 36 hours. The patient feels better now.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Malaise, Nausea, Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hard to awaken in a 68-year-old male patient who received SHINGRIX for prophylaxis. On 21st March 2019, the patient received the 1st dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced feels awful and sickness. On 22nd March 2019, the patient experienced hard to awaken and nausea. On 23rd March 2019, the outcome of the hard to awaken and nausea were recovered/resolved. On an unknown date, the outcome of the feels awful and sickness were recovered/resolved. It was unknown if the reporter considered the hard to awaken, feels awful, nausea and sickness to be related to SHINGRIX. Additional details were provided as follows: The wife of the patient reported that her husband received SHINGRIX at 3:00 PM and he could not get out of bed the following day until 4:00 PM. The patient got up to use the bathroom and he drank 4 oz. of Coke and then went back to bed. Then on Friday, 1 day after receiving SHINGRIX, the patient could not wake up and he was nauseous. Friday afternoon reporter went to the pharmacy to report to them how sick he was. On Saturday 23rd March 2019, morning the patient was still feeling awful until around noon on Saturday and then all of his symptoms resolved.