chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Insomnia, Nasopharyngitis, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 15th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 15th January 2019, less than a day after receiving SHINGRIX, the patient experienced chills, fever, sleeplessness, cold and nauseous. On 16th January 2019, the patient experienced asthenia and pain. On an unknown date, the patient experienced sunburn-like rash and pain in arm. On an unknown date, the outcome of the chills, fever, sleeplessness, cold, nauseous, asthenia, pain, sunburn-like rash and pain in arm were recovered/resolved. It was unknown if the reporter considered the chills, fever, sleeplessness, cold, nauseous, asthenia, pain, sunburn-like rash and pain in arm to be related to SHINGRIX. Additional details were provided as follows: On 15th January 2019 at the night of the vaccine, the patient had horrible chills and fever and she could not sleep at all because she was so cold and also felt like she was going to vomit, though she did not. On 16th January 2019 the next day, she felt completely wiped out and achy. The patient's arm got really, really sore and a few days after the 1st dose, the patient's arm looked like it had a really bad sunburn. The patient gave consent to follow up. For tolerance of 2nd dose of SHINGRIX, refer linked case US2019GSK056680. Note: clarification has been raised regarding event cofirmation after each dose. For now, events are considered as per case narrative.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia, Rash erythematous
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 15th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 15th January 2019, less than a day after receiving SHINGRIX, the patient experienced chills, fever, sleeplessness, cold and nauseous. On 16th January 2019, the patient experienced asthenia and pain. On an unknown date, the patient experienced sunburn-like rash and pain in arm. On an unknown date, the outcome of the chills, fever, sleeplessness, cold, nauseous, asthenia, pain, sunburn-like rash and pain in arm were recovered/resolved. It was unknown if the reporter considered the chills, fever, sleeplessness, cold, nauseous, asthenia, pain, sunburn-like rash and pain in arm to be related to SHINGRIX. Additional details were provided as follows: On 15th January 2019 at the night of the vaccine, the patient had horrible chills and fever and she could not sleep at all because she was so cold and also felt like she was going to vomit, though she did not. On 16th January 2019 the next day, she felt completely wiped out and achy. The patient's arm got really, really sore and a few days after the 1st dose, the patient's arm looked like it had a really bad sunburn. The patient gave consent to follow up. For tolerance of 2nd dose of SHINGRIX, refer linked case US2019GSK056680. Note: clarification has been raised regarding event cofirmation after each dose. For now, events are considered as per case narrative.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of vaccination failure in a adult patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included shingles (previous shingles outbreak). On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and 30 days after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: There were no concomitant immunosuppressant medicines. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient developed shingles 1 month after getting the 2nd dose of SHINGRIX. The lab results were not confirmed.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: This is a spontaneous report from a contactable other health professional on behalf of physician. A 17-year-old female patient received the 2nd dose of TRUMENBA (Lot# S58877, Exp date Feb2019), intramuscular in deltoid left, on 21Mar2019 at 09:15 AM, at single dose, for immunisation. The patient's medical history was not reported. Concomitant medication included FLUZONE QUADRIVALENT (Lot# UJ005AE, Exp date Jun2019), intramuscular, in 2019 (within 4 weeks from TRUMENBA), for immunisation. The patient previously took the 1st dose of TRUMENBA (Lot# S58877, Exp date Feb2019, NDC 0005-0100-01), on 13Apr2018 (at 16 years old), for immunization and unspecified number of flu shots. The patient received expired TRUMENBA on 21Mar2019 at 09:15 AM.
Sex: M
Vaccine: MENB
Symptoms: Groin pain, Pain in jaw
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A male patient of an unspecified age (age is either 16 or 17; unit unspecified) received TRUMENBA, via an unspecified route of administration, the first dose was in Dec2018 and the second dose was in Feb2019 at a single dose in the left arm for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the both times the patient was administered meningococcal group b rlp2086 in his left arm, he had pain in his left side from his jaw to his groin. The patient's mother was not upset about it and he will still get his third dose. Information on the lot/batch number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A patient of unspecified age and gender receive PREVNAR 13, via an unspecified route of administration from an unspecified date AT single dose for immunisation. The patient's medical history and concomitant medications were not reported. The doctor reported that he does hear about pain and fever more often after he administered PREVNAR 13. Outcome of the events was unknown. Information on the batch number has been requested.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Influenza like illness, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: This is a spontaneous report from a contactable nurses received via a Pfizer sales representative. A 66-year-old female patient started to receive PREVNAR 13, via an unspecified route of administration in the left deltoid on 14Mar2019 16:00 at 0.5 ml, single as preventive. Medical history included glaucoma open angle, high cholesterol, abnormal blood pressure, allergy to tetanus and uses blood thinner. Ongoing concomitant medication included lisinopril for blood pressure simvastatin for high cholesterol, ZOFRAN for glaucoma, hydrochlorothiazide, triamterene HCT AL for blood pressure, pravastatin for high cholesterol and ZIOPTAN for glaucoma, open angle. The patient previously took T-Dap in 2007 and experienced allergy. On 15Mar2019 (next morning after administration), the patient felt like she had the flu. The patient received the vaccine in her left deltoid and it was swollen and huge about the size of an orange at first. The patient reported that she felt like she had the flu all week. The area of swelling and redness spread to her elbow and chest wall and she still has a small hardened area at the injection sites that itches. The patient reported that her arm really hurt and took ALEVE all last weekend. The patient added that the area that was still hardened was about the size of a quarter. The redness over arm that came across chest has gone away. The patient has just a small red circle at the time of the report. The patient did not have anaphylactic reaction and did not feel well the whole weekend. The outcome of the event 'felt like she had the flu' was recovered on 17Mar2019, 'arm really hurt' recovered on 20Mar2019 and event 'did not feel well' recovered on unspecified date; all other events was recovering.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Malaise, Pain in extremity, Swelling
Clinical narrative: This is a spontaneous report from a contactable nurses received via a Pfizer sales representative. A 66-year-old female patient started to receive PREVNAR 13, via an unspecified route of administration in the left deltoid on 14Mar2019 16:00 at 0.5 ml, single as preventive. Medical history included glaucoma open angle, high cholesterol, abnormal blood pressure, allergy to tetanus and uses blood thinner. Ongoing concomitant medication included lisinopril for blood pressure simvastatin for high cholesterol, ZOFRAN for glaucoma, hydrochlorothiazide, triamterene HCT AL for blood pressure, pravastatin for high cholesterol and ZIOPTAN for glaucoma, open angle. The patient previously took T-Dap in 2007 and experienced allergy. On 15Mar2019 (next morning after administration), the patient felt like she had the flu. The patient received the vaccine in her left deltoid and it was swollen and huge about the size of an orange at first. The patient reported that she felt like she had the flu all week. The area of swelling and redness spread to her elbow and chest wall and she still has a small hardened area at the injection sites that itches. The patient reported that her arm really hurt and took ALEVE all last weekend. The patient added that the area that was still hardened was about the size of a quarter. The redness over arm that came across chest has gone away. The patient has just a small red circle at the time of the report. The patient did not have anaphylactic reaction and did not feel well the whole weekend. The outcome of the event 'felt like she had the flu' was recovered on 17Mar2019, 'arm really hurt' recovered on 20Mar2019 and event 'did not feel well' recovered on unspecified date; all other events was recovering.
Sex: F
Vaccine: PPV
Symptoms: Drug hypersensitivity, Hypersensitivity
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse reported that a 63-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (manufacturer unknown), via an unspecified route of administration on an unspecified date at single dose for immunisation, HUMALOG, via an unspecified route of administration from an unspecified date at an unknown dose and frequency for an unspecified indication. The patient medical history and patient's concomitant medications were not reported. It was reported on an unspecified date that the patient allergies: is allergic to environmental, HUMALOG, NSAIDs, Penicillins, Pneumococcal vaccine. The action taken in response to the event for insulin lispro was unknown. The outcome of the event was unknown. Information on the batch number has been requested. Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Urticaria
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A 65-year-old female patient received PREVNAR 13, (batch/lot number and expiry date were not reported), 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. On an unspecified date, the patient experienced multiple red welts on the same arm where she received pneumococcal 13-val conj vac (dipht crm197 protein). Red welts lasted for 2 weeks. The outcome of the event was recovered. The information on the batch/lot number and expiration date has been requested.
Sex: M
Vaccine: FLUX, MENB, MNQ
Symptoms: Electrocardiogram normal, Extra dose administered, Fall, Head injury, Loss of consciousness
Clinical narrative: Initial information received on 26-Mar-2019 regarding an unsolicited valid serious case from Pfizer (Non Licensed Partner) (MFR Control No: 2019019036) via other health professional. This case involves a 16 years old male patient who fell off the exam table and split his head open on the floor, fainted and lost consciousness, while he received vaccines TRUMENBA, INFLUENZA VACCINE and MENACTRA. The patient's past vaccination(s) and family history were not provided. Notes: Patient had no history of previous adverse reactions to vaccines, fainting or seizures. Patient was well, and not sick that day. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect TRUMENBA not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient fainted and lost consciousness (syncope and loss of consciousness) about 3 minutes after administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, INFLUENZA VACCINE and TRUMENBA. These events were assessed as medically significant. It was reported that the patient fell off the exam table (fall) and split his head open on the floor (head injury). It was also a actual medication error due to extra dose administered (of MENINGOCOCCAL vaccine). It was reported that the patient received 3 vaccines at the same time (flu, MENACTRA and TRUMENBA) The patient was taken to the hospital. The EKG and scan were normal. The patient received sutures, and will follow up to the clinic. The outcome for any of the event was not reported. List of document held: none; Sender's Comments: This case concerns 16 years old male patient who experienced syncope after vaccination with MENACTRA, TRUMENBA and a  INFLUENZA VACCINE. The time to onset is not clearly defined. Patient had no provided history of previous adverse reactions to vaccines, fainting or seizures. Patient was well, and not sick that day. The EKG and scan were normal. Additional information regarding concomitant medications, lab tests excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Sex: M
Vaccine: FLUX, MENB, MNQ
Symptoms: Scan normal, Skin laceration, Suture insertion, Syncope
Clinical narrative: Initial information received on 26-Mar-2019 regarding an unsolicited valid serious case from Pfizer (Non Licensed Partner) (MFR Control No: 2019019036) via other health professional. This case involves a 16 years old male patient who fell off the exam table and split his head open on the floor, fainted and lost consciousness, while he received vaccines TRUMENBA, INFLUENZA VACCINE and MENACTRA. The patient's past vaccination(s) and family history were not provided. Notes: Patient had no history of previous adverse reactions to vaccines, fainting or seizures. Patient was well, and not sick that day. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect TRUMENBA not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient fainted and lost consciousness (syncope and loss of consciousness) about 3 minutes after administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, INFLUENZA VACCINE and TRUMENBA. These events were assessed as medically significant. It was reported that the patient fell off the exam table (fall) and split his head open on the floor (head injury). It was also a actual medication error due to extra dose administered (of MENINGOCOCCAL vaccine). It was reported that the patient received 3 vaccines at the same time (flu, MENACTRA and TRUMENBA) The patient was taken to the hospital. The EKG and scan were normal. The patient received sutures, and will follow up to the clinic. The outcome for any of the event was not reported. List of document held: none; Sender's Comments: This case concerns 16 years old male patient who experienced syncope after vaccination with MENACTRA, TRUMENBA and a  INFLUENZA VACCINE. The time to onset is not clearly defined. Patient had no provided history of previous adverse reactions to vaccines, fainting or seizures. Patient was well, and not sick that day. The EKG and scan were normal. Additional information regarding concomitant medications, lab tests excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Feeling abnormal, Hypoaesthesia, Livedo reticularis, Malaise, Nausea
Clinical narrative: Rec'd 11yo vaccines (see above) next morning C/O not feeling well "felt fuzzy" C/O nausea no vomiting remain afebrile. Played basket ball in eve outside temp 50 degrees. C/O top hands felt tingle, numb, pins and needles. Mom chked fingers mottled; white in areas gently warmed color returned. This reoccurred again at soccer practice on Thursday 3/28, unwitnessed by parents. It was cold outside at that time. No further episodes since 3/28.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Paraesthesia
Clinical narrative: Rec'd 11yo vaccines (see above) next morning C/O not feeling well "felt fuzzy" C/O nausea no vomiting remain afebrile. Played basket ball in eve outside temp 50 degrees. C/O top hands felt tingle, numb, pins and needles. Mom chked fingers mottled; white in areas gently warmed color returned. This reoccurred again at soccer practice on Thursday 3/28, unwitnessed by parents. It was cold outside at that time. No further episodes since 3/28.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation
Clinical narrative: Patient reported burning sensation in upper leg (thigh area) that started after receiving SHINGRIX and lasted 7 days, then appeared sporadically. Patient reported symptoms to Dr. who told him it did not appear to be from the shot as there are not relevant nerves in that area. Patient reported the symptoms did not interfere with activities of everyday life. The patient reported the area of sensation to be 4-5 inches in diameter.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain
Clinical narrative: Nausea, ache & pains.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Abnormal behaviour, Flank pain, Musculoskeletal stiffness
Clinical narrative: Parents state about one hour after the vaccination, patient developed stiff hands, wide open eyes, behavioral changes, and side pain. He knew who his parents were but he couldn't remember his teacher's name. This lasted about 20-30 mins and sx resolved without treatment.
Age: 1.08
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Injection site erythema, Rash, Rash pustular
Clinical narrative: Redness at injection site ~2-3 cm diameter and rash on back first noted by parent 10 days after vaccination. Evaluated by MD on same day. No significant induration. Rash on back consisting of many diffuse very fine pustules with surrounding erythema, no vesicles.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood culture, Chest X-ray normal, Chills, Full blood count normal, Influenza virus test negative
Clinical narrative: Abrupt onset, about 11 hours after the vaccine, of rigors and fever to 100.4, and myalgias.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test normal, Myalgia, Pyrexia, Urine analysis, Urine analysis normal
Clinical narrative: Abrupt onset, about 11 hours after the vaccine, of rigors and fever to 100.4, and myalgias.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood culture negative, Blood urine present, Liver function test abnormal, Pain in extremity, Peripheral swelling
Clinical narrative: Soreness, swelling of arm for 2 days, developed rash on left arm on 3rd day, 4th day had pustule like rash or hives all over entire body. 5th day went to primary doc given script for Prednisone 20 mg. Has taken full course of meds and still has rash (lessened in color and intensity) and terrible itching. Script was for 9 days.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash generalised, Rash pustular, Urine analysis normal
Clinical narrative: Soreness, swelling of arm for 2 days, developed rash on left arm on 3rd day, 4th day had pustule like rash or hives all over entire body. 5th day went to primary doc given script for Prednisone 20 mg. Has taken full course of meds and still has rash (lessened in color and intensity) and terrible itching. Script was for 9 days.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Soreness, swelling of arm for 2 days, developed rash on left arm on 3rd day, 4th day had pustule like rash or hives all over entire body. 5th day went to primary doc given script for Prednisone 20 mg. Has taken full course of meds and still has rash (lessened in color and intensity) and terrible itching. Script was for 9 days.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Blister, Crying, Depressed mood, Fear
Clinical narrative: On March 6, 2019 I had the vaccine. On the same day, I had mild fever, headaches and dry lips. By March 8th I was free from those side effects. But, on March 11, I started having more side effects which were worse than the precedents: High fever (101.2), headaches, unusual fast heart rate (up to 94 bpm), low blood pressure (as low as 90/53), hard swollen lump on the shoulder, a blister full of fluid. On March 15, 2019, I went to see my doctor for fear of permanent side effects, especially my heart rate. He reassured me that none of those side effects will be permanent. Anyway, by the 18th of March, my arm got stiff. I did not call my doctor to report this unexpected debilitating and painful side effect. The dosage I had was 0.5 mL. At night it was worse. I slept in a sitting position for 3 nights. On the 4th night (March 21st) I tried to sleep in a normal (lying) position. When I woke up on the 22nd the little motion that I gained regressed. I was scared and depressed because the pain got worse on that day. So, since that time I have been sleeping again in a sitting position with a few pillows under my right arm. I think that helps prevent more damage to the arm. For a couple of days during the week of the 18th of March, I felt that my right eye was getting smaller and the site was weakening. For a few days and as of March 18, I was unable to use a fork or spoon to feed myself with my right hand until March 22. I also could not comb my hair. The arm was locked and painful. Besides tenderness to the touch, I had constant pain and shocks in the shoulder and (right) clavicle to the point of crying. I was taking TYLENOL to help me fall asleep and to minimize the fever. It was depressing. By the 23rd I gained about 1/4 motion of the arm. Today, the motion is up to a 90 degree level. Yet, it feels locked beyond that point. I have not had any type of vaccine since I was 11 years old (re: Item # 23). Had I known about all of these painful reactions to the pneumococcal vaccine, I would not have taken it.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Feeling abnormal, Headache, Heart rate increased, Hypotension, Lip dry
Clinical narrative: On March 6, 2019 I had the vaccine. On the same day, I had mild fever, headaches and dry lips. By March 8th I was free from those side effects. But, on March 11, I started having more side effects which were worse than the precedents: High fever (101.2), headaches, unusual fast heart rate (up to 94 bpm), low blood pressure (as low as 90/53), hard swollen lump on the shoulder, a blister full of fluid. On March 15, 2019, I went to see my doctor for fear of permanent side effects, especially my heart rate. He reassured me that none of those side effects will be permanent. Anyway, by the 18th of March, my arm got stiff. I did not call my doctor to report this unexpected debilitating and painful side effect. The dosage I had was 0.5 mL. At night it was worse. I slept in a sitting position for 3 nights. On the 4th night (March 21st) I tried to sleep in a normal (lying) position. When I woke up on the 22nd the little motion that I gained regressed. I was scared and depressed because the pain got worse on that day. So, since that time I have been sleeping again in a sitting position with a few pillows under my right arm. I think that helps prevent more damage to the arm. For a couple of days during the week of the 18th of March, I felt that my right eye was getting smaller and the site was weakening. For a few days and as of March 18, I was unable to use a fork or spoon to feed myself with my right hand until March 22. I also could not comb my hair. The arm was locked and painful. Besides tenderness to the touch, I had constant pain and shocks in the shoulder and (right) clavicle to the point of crying. I was taking TYLENOL to help me fall asleep and to minimize the fever. It was depressing. By the 23rd I gained about 1/4 motion of the arm. Today, the motion is up to a 90 degree level. Yet, it feels locked beyond that point. I have not had any type of vaccine since I was 11 years old (re: Item # 23). Had I known about all of these painful reactions to the pneumococcal vaccine, I would not have taken it.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Loss of personal independence in daily activities, Mass, Mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: On March 6, 2019 I had the vaccine. On the same day, I had mild fever, headaches and dry lips. By March 8th I was free from those side effects. But, on March 11, I started having more side effects which were worse than the precedents: High fever (101.2), headaches, unusual fast heart rate (up to 94 bpm), low blood pressure (as low as 90/53), hard swollen lump on the shoulder, a blister full of fluid. On March 15, 2019, I went to see my doctor for fear of permanent side effects, especially my heart rate. He reassured me that none of those side effects will be permanent. Anyway, by the 18th of March, my arm got stiff. I did not call my doctor to report this unexpected debilitating and painful side effect. The dosage I had was 0.5 mL. At night it was worse. I slept in a sitting position for 3 nights. On the 4th night (March 21st) I tried to sleep in a normal (lying) position. When I woke up on the 22nd the little motion that I gained regressed. I was scared and depressed because the pain got worse on that day. So, since that time I have been sleeping again in a sitting position with a few pillows under my right arm. I think that helps prevent more damage to the arm. For a couple of days during the week of the 18th of March, I felt that my right eye was getting smaller and the site was weakening. For a few days and as of March 18, I was unable to use a fork or spoon to feed myself with my right hand until March 22. I also could not comb my hair. The arm was locked and painful. Besides tenderness to the touch, I had constant pain and shocks in the shoulder and (right) clavicle to the point of crying. I was taking TYLENOL to help me fall asleep and to minimize the fever. It was depressing. By the 23rd I gained about 1/4 motion of the arm. Today, the motion is up to a 90 degree level. Yet, it feels locked beyond that point. I have not had any type of vaccine since I was 11 years old (re: Item # 23). Had I known about all of these painful reactions to the pneumococcal vaccine, I would not have taken it.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Paraesthesia, Pyrexia, Swelling, Tenderness, Visual impairment
Clinical narrative: On March 6, 2019 I had the vaccine. On the same day, I had mild fever, headaches and dry lips. By March 8th I was free from those side effects. But, on March 11, I started having more side effects which were worse than the precedents: High fever (101.2), headaches, unusual fast heart rate (up to 94 bpm), low blood pressure (as low as 90/53), hard swollen lump on the shoulder, a blister full of fluid. On March 15, 2019, I went to see my doctor for fear of permanent side effects, especially my heart rate. He reassured me that none of those side effects will be permanent. Anyway, by the 18th of March, my arm got stiff. I did not call my doctor to report this unexpected debilitating and painful side effect. The dosage I had was 0.5 mL. At night it was worse. I slept in a sitting position for 3 nights. On the 4th night (March 21st) I tried to sleep in a normal (lying) position. When I woke up on the 22nd the little motion that I gained regressed. I was scared and depressed because the pain got worse on that day. So, since that time I have been sleeping again in a sitting position with a few pillows under my right arm. I think that helps prevent more damage to the arm. For a couple of days during the week of the 18th of March, I felt that my right eye was getting smaller and the site was weakening. For a few days and as of March 18, I was unable to use a fork or spoon to feed myself with my right hand until March 22. I also could not comb my hair. The arm was locked and painful. Besides tenderness to the touch, I had constant pain and shocks in the shoulder and (right) clavicle to the point of crying. I was taking TYLENOL to help me fall asleep and to minimize the fever. It was depressing. By the 23rd I gained about 1/4 motion of the arm. Today, the motion is up to a 90 degree level. Yet, it feels locked beyond that point. I have not had any type of vaccine since I was 11 years old (re: Item # 23). Had I known about all of these painful reactions to the pneumococcal vaccine, I would not have taken it.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: The patient came in to the pharmacy complaining of redness and swelling at the injection site that occurred beginning the day after the immunization was given. It was probably a few inches in diameter. They complained of no other symptoms. They were informed that they could follow up with a medical provider if the condition worsened or became bothersome.
Age: 31.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Employee received both of the above vaccines on 20 Mar 2019 to left arm. She noticed a quarter sized round red spot to back of left arm on 21 Mar 2019 at 1300. On the 22 Mar 2019, the red spot had increased to the size of a tennis ball 2x3" with redness, swelling, and induration which was warm and tender to the touch. The employee was told to come to Occupation Health immediately to be examined. Vital signs: WNL, afebrile. Employee was prescribed Cephalexin 500 mg PO four times daily for 7 days for soft tissue cellulitis infection. She was instructed to follow-up with Occupational Health 25 Mar 2019, which she did and cellulitis to left arm had improved drastically. Vital signs: WNL, afebrile.
Age: 31.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site warmth
Clinical narrative: Employee received both of the above vaccines on 20 Mar 2019 to left arm. She noticed a quarter sized round red spot to back of left arm on 21 Mar 2019 at 1300. On the 22 Mar 2019, the red spot had increased to the size of a tennis ball 2x3" with redness, swelling, and induration which was warm and tender to the touch. The employee was told to come to Occupation Health immediately to be examined. Vital signs: WNL, afebrile. Employee was prescribed Cephalexin 500 mg PO four times daily for 7 days for soft tissue cellulitis infection. She was instructed to follow-up with Occupational Health 25 Mar 2019, which she did and cellulitis to left arm had improved drastically. Vital signs: WNL, afebrile.
Age: 21.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Not noted until after vaccine administered that it had expired on 3/24/2019. No adverse reaction/symptoms noted. Patient was notified of expired vaccine and need to repeat dose.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pain in extremity
Clinical narrative: Patient was asymptomatic until afternoon of day 3 post injection. Noticed her arm hurt a little that day but unconcerned. Patient woke at around 1:30am on day 4 in a lot of pain from left shoulder to left elbow. The entire upper arm was bright red and hot to the touch. Patient self treated with ice packs. By afternoon on same day, patient states arm felt as it did on day 3. By day 5, when patient awoke, she was asymptomatic again.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Disturbance in attention, Dizziness, Dyspnoea
Clinical narrative: Woke up with extreme chills, whole body was trembling, extreme fatigue, dizziness, felt like heart was beating fast, shaking badly to where it seemed like I could only take short breaths, headache, nausea, still cold after layering blankets, all of my joints ached. I stayed in bed and the symptoms subsided in about 2 hours. Later that morning and throughout the day I felt extremely tired, achy, difficulty concentrating or performing daily tasks- felt "foggy". Slept on and off during the day. Slept that night and felt a little better the following day. Still aching and sluggish but better. Following day I felt better. Today is 5 days later and I finally feel normal.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Feeling cold, Headache, Heart rate increased
Clinical narrative: Woke up with extreme chills, whole body was trembling, extreme fatigue, dizziness, felt like heart was beating fast, shaking badly to where it seemed like I could only take short breaths, headache, nausea, still cold after layering blankets, all of my joints ached. I stayed in bed and the symptoms subsided in about 2 hours. Later that morning and throughout the day I felt extremely tired, achy, difficulty concentrating or performing daily tasks- felt "foggy". Slept on and off during the day. Slept that night and felt a little better the following day. Still aching and sluggish but better. Following day I felt better. Today is 5 days later and I finally feel normal.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Nausea, Pain, Sluggishness, Somnolence
Clinical narrative: Woke up with extreme chills, whole body was trembling, extreme fatigue, dizziness, felt like heart was beating fast, shaking badly to where it seemed like I could only take short breaths, headache, nausea, still cold after layering blankets, all of my joints ached. I stayed in bed and the symptoms subsided in about 2 hours. Later that morning and throughout the day I felt extremely tired, achy, difficulty concentrating or performing daily tasks- felt "foggy". Slept on and off during the day. Slept that night and felt a little better the following day. Still aching and sluggish but better. Following day I felt better. Today is 5 days later and I finally feel normal.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Woke up with extreme chills, whole body was trembling, extreme fatigue, dizziness, felt like heart was beating fast, shaking badly to where it seemed like I could only take short breaths, headache, nausea, still cold after layering blankets, all of my joints ached. I stayed in bed and the symptoms subsided in about 2 hours. Later that morning and throughout the day I felt extremely tired, achy, difficulty concentrating or performing daily tasks- felt "foggy". Slept on and off during the day. Slept that night and felt a little better the following day. Still aching and sluggish but better. Following day I felt better. Today is 5 days later and I finally feel normal.
Age: 18.0
Sex: F
Vaccine: HEP, HPV9
Symptoms: Allergy test, Blood glucose, Laboratory test, Migraine, Pain in extremity
Clinical narrative: Swelling, fever 103, migraine for extended days, sore arm for a week.
Age: 18.0
Sex: F
Vaccine: HEP, HPV9
Symptoms: Pyrexia, Swelling
Clinical narrative: Swelling, fever 103, migraine for extended days, sore arm for a week.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody positive, Rubella antibody negative, Rubulavirus test positive
Clinical narrative: This spontaneous report was received from a pharmacy technician referring to a female patient of unknown age. There was no information about patient's pertinent medical history, concomitant medications and drug reactions. On an unknown date (reported as years ago), the patient was vaccinated with M-M-R II (dose, strength, route, vaccination site, lot# and expiry date unknown) for prophylaxis. On an unknown date, the patient had unspecified titers drawn and the results were positive for Measles and Mumps, but the result for Rubella was negative (Rubella antibody negative). The outcome of the event Rubella antibody negative was unknown. Causality assessment was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: This case was found to be duplicate of the case US2019GSK030864. Case US2019052585 would be deleted and all the future corresponding information to the present case would be submitted to US2019GSK030864 (case of record).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult female patient who received SHINGRIX (batch number LL552, expiry date 8th June 2021) for prophylaxis. The patient's past medical history included shingles (the patient had shingles about one month prior to receiving SHINGRIX vaccination). On an unknown date, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: The patient's age at vaccination was not reported. The patient had shingles about one month prior to receiving SHINGRIX vaccination. After the patient had the SHINGRIX vaccination, the patient's shingles returned within 2 or 3 days.
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test, Therapeutic response unexpected
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pre-existing condition improved in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included breast cancer stage iv (stage 4 lobular breast cancer). On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, 8 days after receiving SHINGRIX, the patient experienced pre-existing condition improved and unexpected therapeutic effect. On an unknown date, the outcome of the pre-existing condition improved and unexpected therapeutic effect were unknown. It was unknown if the reporter considered the pre-existing condition improved and unexpected therapeutic effect to be related to SHINGRIX. Additional details were provided as follows: The patient experienced circulating tumor cell (CTC) count decreased to zero 8 days after receiving SHINGRIX. Prior test results had been consistent (2, 2, 3, 3 and 4). The reporter was oncology nurse reported that a patient with stage 4 lobular breast cancer who recently had a CTC (Circulating Tumor Cell) count of zero after nearly 8 months of elevated (and persistently rising CTC counts (starting in Sept 2018 values obtained every 6 to 8 weeks, on capecitabine, were 2, 2, 3, 3, 4.) The very unexpected result of zero was from a lab specimen obtained 8 days after the first dose of the SHINGRIX vaccine. The reporter asked that the vaccine's stimulation of the CD4 T cells be involved with either a false suppression of circulating tumor cells, adversely affect the test process or be an actual reduction of live CTCs Or was it more likely that this was a coincidence.
Sex: U
Vaccine: IPV
Symptoms: Incorrect route of product administration, Injection site erythema, Underdose
Clinical narrative: Based on information received on 28-MAR-2019, the report previously considered as non-valid became valid: the patient identifier reported. Initial information received on 12-Mar-2019 regarding an unsolicited non-valid non-serious case received from a physician. This case involves a 55 years old patient who experienced local skin erythema at injection site, while he/she received vaccine IPOL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 12-Mar-2019, the patient received a 0.1 mL dose of suspect IPV (VERO) lot number N1V451M via subdermal route in unknown administration site. On an unknown date, the patient developed a non-serious local skin erythema at injection site (vaccination site erythema) following the administration of IPV (VERO). It was a case of actual medication error due to Inappropriate route of vaccination and vaccine underdose. Final diagnosis was local skin erythema at injection site. It was not reported if the patient received a corrective treatment. The outcome of the event not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Follow-up information was received on 28-MAR-2019 and additional information was received on same date 28-MAR-2019 from a physician. Based on information received, the report previously considered as non-valid became valid: the patient identifier reported. Patient demographics, date of vaccination, dose, lot number and event updated in field and narrative. Documents held by the sender: none.
Sex: U
Vaccine: IPV
Symptoms: Liquid product physical issue, No adverse event, Poor quality product administered
Clinical narrative: Initial information received on 22-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient of unknown demographics who received a 0.5ml second dose of IPOL, lot N1K921M, expiry date- 14-Nov-2019 via intramuscular route in the left thigh on 22-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to poor quality vaccine administered. Black speck the size of a pen mark on a piece of paper floating in the vial and the vial was opened 06-Mar-2019. It was also a case of Particle present in liquid product. No adverse event reported. Global PTC Number- 100004070. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Follow-up information was received on 25-MAR-2019 from a nurse. Global PTC Number updated. List of documents held by sender: none.
Sex: U
Vaccine: MNQ, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 26-Mar-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 13 years old patient who received a first dose of MENACTRA lot U5848AA, expiration date: 11-Mar-2019 via unknown route in the right deltoid on 22-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included was ADACEL on 22-Mar-2019. It was an actual medication error due to expired vaccine used. A 13 year old patient received a expired MENACTRA vaccine. No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Expired product administered
Clinical narrative: Initial information received on 26-Mar-2019 regarding an unsolicited valid non-serious case received from an other health care professional. This case involves a 15 months old male patient who received a 0.5 ml fourth dose of vaccine DAPTACEL lot C5171AA, expiration date: 23-Mar-2019 via unknown route in the right thigh on 26-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HIB VACCINE. It was an actual medication error due to expired vaccine used. A 15 month old male patient received a three days expired dose of DAPTACEL. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.