chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant via company representative refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a doses of improperly stored oral, ROTATEQ (lot# L008578, exp.date: 14-DEC-2016) (route and frequency were not reported). The temperature of the storage was 50 Fahrenheit degree for 24 hours. No adverse symptoms were reported. The outcome of the patient's event was not reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report was received from a physician via a company representative from Pfizer (MRF control # 2016076190) on 19-FEB-2016, referring to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, route and lot number were not provided). Concomitant medications were not reported. On an unknown date, the patient had severe allergic reaction to PNEUMOVAX 23. The outcome of the event was unknown and no product quality complaint was involved. The event was related to vaccination with PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 30-NOV-2015, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) (lot # K010211, expiry date 17-JAN-2016, albumin status HSA, dose, route of administration and anatomical location were not reported). No adverse symptoms were reported. The temperature excursion was due to daily vaccine counts that caused the storage unit to have temperature fluctuations because of door opening. This is one of several reports from the same reporter. Additional information is not expected as no further follow-up is required.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 03-NOV-2015, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) (lot # K010211, expiry date 17-JAN-2016, dose, route of administration and anatomical location were not reported). No adverse symptoms were reported. The temperature excursion was due to daily vaccine counts that caused the storage unit to have temperature fluctuations is because of door opening. This is one of several reports from the same reporter. Additional information is not expected as no further follow-up is required.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant via company representative refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a doses of improperly stored VAQTA (lot# L034381, exp.date: 21-DEC-2016)(strength, route and frequency were not reported). The temperature of the storage was 50 Fahrenheit degree for 24 hours. No adverse symptoms were reported. The outcome of the patient's event was not reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant via company representative refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a doses of improperly stored MMRII (lot # L012480, exp. date 10-APR-2017) (strength, route and frequency were not reported). The temperature of the storage was 50 Fahrenheit degree for 24 hours. No adverse symptoms were reported. The outcome of the patient's event was not reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from nurse practitioner regarding an unspecified patient of unknown age and gender. The medical history of patient, concurrent conditions were not reported. On 10-FEB-2016 patient was vaccinated with improperly stored VARIVAX (lot # L013827, expiry date 21-APR-2017) dosage regimen and route unknown. The nurse reported that the doses were exposed to several defrost cycles. No adverse symptoms were reported. Product quality complaint (PQC) was not filed. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Antibody test negative
Clinical narrative: This literature marketed report as received from the authors in a published article refers to 12 patients of unknown age and gender. The aim was to determine current hepatitis A (HAV) and hepatitis B (HBV) immunity rates for patients on the liver transplant list at a tertiary care center and any associations with unsuccessful vaccinations. A retrospective chart review was performed of adult patients listed for liver transplantation at a single transplant center as of June 2014. Data collected included demographics, etiology of cirrhosis, HAV/HBV immune status and vaccination history. To determine immune status, the authors looked at the presence of serological markers (HBsAg, anti-HBc, anti-HBs, IgG-anti-HAV). Statistical analysis was performed using the student t-test and the Chi-square test to detect any association between immune status and unsuccessful vaccination with patients' demographic data and etiology of cirrhosis. Results: A total of 184 patients (73 females, 111 males) were on the liver transplant list as of June 2014. Mean age was 58. Etiology varied with 35% due to hepatitis C and 18% due to alcohol. 119 (66%) patients were immune to HAV. Of this, 15 (13%) had been previously vaccinated with the remaining 104 (87%) developing immunity through prior infection. 48 (27%) patients demonstrated immunity to HBV. Of these, 17 (36%) had evidence of previously cleared infection and the remaining 31 (67%) were vaccinated with Hepatitis B Vaccine (Recombinant) (manufacturer unknown) (dose, route of administration and lot number not reported). 12 patients vaccinated for HBV either never acquired immunity or lost protective antibody over time. There was no statistically significant association between etiology of liver disease and unsuccessful vaccination for HAV (0.500) and HBV (0.517). There was no significant association between HAV immune status and age (0.898), sex (0.918) and etiology of liver disease (0.506). There was also no significant correlation between HBV immune status and age (0.071), sex (0.686) and etiology of liver disease (0.052). Conclusion: The presence of protective antibody for HAV and HBV among patients on the liver transplant waiting list was low, particularly for HBV. This is despite current AASLD recommendations for vaccination of nonimmune patients in the pre-transplant setting. We next hope to identify potential barriers to vaccination and improve immunity rates prior to transplant. The outcome of unsuccessful vaccination was unknown. Unsuccessful vaccination was considered related to Hepatitis B Vaccine (Recombinant) (manufacturer unknown). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. In approximately August 2015, the patient completed the 3 dose series of GARDASIL (exact dose, lot #, expiration date, route of administration, intervals and anatomical location were not reported). On 22-FEB-2016 (also reported as "18 after the initial 3 dose series was completed"), the patient inadvertently received 4th dose of GARDASIL (exact dose, lot #, expiration date, route of administration and anatomical location were not provided). There were no adverse effects reported. Additional information is not expected as there was no consent for follow up.
Age: 7.0
Sex: F
Vaccine: FLUN4
Symptoms: Abdominal pain, Headache
Clinical narrative: A consumer report has been received concerning a 7 year old female patient. The patient received nasal FLUENZ TETRA on 02-NOV-2015. It was reported that patient experienced headache and tummy ache on 02-NOV-2015. The patient recovered from headache and tummy ache on 03-NOV 2015. The company physician considered headache and tummy ache to be non-serious. Corrected report on 19-NOV-2015: coding of suspect drug corrected. Manufacturer corrected. Reporter details updated. Narrative updated.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Chills, Headache, Lacrimation increased, Rhinorrhoea, Sneezing
Clinical narrative: A consumer report received from MHRA concerning a 3 year old male. The patient medical history and concomitant medication were not provided. The patient had received nasal FLUENZA TETRA, 0.2 milliliters, on 20-OCT-2015. The patient experienced chills, watery eyes, sneezing, headache, and funny nose which started on 22-OCT-2015. At the time of reporting, the event of chills, water eyes, sneezing, headache and runny nose was improving. The report assessed the events chills, watery eyes, sneezing, headache and runny nose to be serious due to important medical event.
Age: 2.0
Sex: F
Vaccine: FLUN4
Symptoms: Fatigue, Malaise
Clinical narrative: A report has been received from a physician concerning a 2 year old female patient. No concomitant drugs or relevant history was provided. The patient had been receiving nasal FLUENZ TETRA started on 30-OCT-2015. Action taken was unknown. The patient recovered from the events of general feeling unwell and tired on 31-OCT-2015. The report was considered to be non-serious by the company physician.
Sex: M
Vaccine: FLUN4
Symptoms: Headache
Clinical narrative: A consumer report received concerns a male patient. No information regarding relevant history, concomitant disease and concomitant medications were provided. On 02-NOV-2015, patient received nasal FLUENZ TETRA with batch number FJ2188. On the same day, patient experienced headache. On 03-NOV-2015, patient recovered from headache. Reporter considered headache to be non-serious.
Age: 3.0
Sex: M
Vaccine: FLUN4
Symptoms: Nasopharyngitis, Rhinorrhoea
Clinical narrative: A consumer report has been received concerns a 3 year old, male patient. Patient's relevant history and concomitant disease were not reported. Patient's concomitant medications were not provided. On 26-OCT-2015, the patient received nasal FLUENZ Tetra. It was reported that the patient experienced cold and runny nose which started on 31-OCT-2015. At the time of reporting, the events of cold and runny nose were ongoing. The company physician assessed the events of cold and runny nose to be non serious.
Age: 31.0
Sex: M
Vaccine: HEPA, IPV, TYP, YF
Symptoms: Death
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of unknown cause of death in a male patient who received HAVRIX (batch number AHAVB566AN, expiry date unknown). Co-suspect products included IPOL (batch number H1354, expiry date unknown), VIVOTIF (batch number 3000128, expiry date unknown) and YF-VAX (batch number UH296AB, expiry date unknown). Concomitant products included SOMA. On 30th October 2012, the patient received HAVRIX (intramuscular), IPOL (intramuscular), VIVOTIF (oral) and YF-VAX (subcutaneous). On 31st October 2012, 1 days after receiving HAVRIX, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The patient died on 31st October 2012. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death to be related to HAVRIX. Additional details were provided as follows: The patient's age was reported as 31 (units not provided). The patient did not have any preexisting conditions or current illness. The patient had pronounced death in the bed at home.
Age: 56.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Arthritis, Discomfort, Drug administered at inappropriate site, Injection site pain, Insomnia
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for himself via a Pfizer Sponsored Program IBCC (Inbound Call Center for HCPs). A 56-year-old male patient received PREVNAR 13, via an unspecified route of administration into shoulder joint just above deltoid, on 02Dec2015 at 06:45 PM, at single dose, and fourth dose of FLUVAX, intramuscular in left deltoid, on 02Dec2015. Relevant medical history included pacemaker from 1992 and ongoing and ongoing ankylosing spondylitis (diagnosed 5-6 weeks ago). Concomitant medications were not reported. Previously the patient received 3 doses of Influenza vaccine. On 02Dec2015 at 06:45 PM PREVNAR 13 was injected into shoulder joint instead of deltoid. The patient also experienced on 04Dec2015 large lump on the side of his bicep and tendonitis, on 02Dec2015 pain (throbbing, excruciating), and on 05Dec2015 he could not sleep because of the pain, he could not lie down. The patient was hospitalized for the events large lump on the side of his bicep, pain, insomnia, tendonitis, discomfort. The patient mentioned that at time of injection it was very painful and had only gotten worse. He stated that by the third day after vaccination, the pain in his shoulder was so bad that he could not lay on his back and started having trouble sleeping. Therapeutic measures were taken as a result of the events, and included treatment with MEDROL. Six days after the injection he saw his doctor who thought it may have caused tendonitis. The patient saw shoulder specialist the day of the report (14Dec2015) who said it did not seem to be anything pertaining to tendonitis. The patient underwent lab tests and procedures which included Shoulder X-Ray (14Dec2015): clear; Shoulder Ultrasound (14Dec2015): showed little inflammation. Outcome of pain and tendonitis was not recovered. Outcome of large lump on the side of his bicep, insomnia and discomfort was recovered. Follow-up (12Feb2016): new information from the same contactable consumer included: treatment performed, outcome of the events, seriousness criteria.
Age: 56.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Laboratory test, Mass, Pain, Tendonitis, Ultrasound scan abnormal
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for himself via a Pfizer Sponsored Program IBCC (Inbound Call Center for HCPs). A 56-year-old male patient received PREVNAR 13, via an unspecified route of administration into shoulder joint just above deltoid, on 02Dec2015 at 06:45 PM, at single dose, and fourth dose of FLUVAX, intramuscular in left deltoid, on 02Dec2015. Relevant medical history included pacemaker from 1992 and ongoing and ongoing ankylosing spondylitis (diagnosed 5-6 weeks ago). Concomitant medications were not reported. Previously the patient received 3 doses of Influenza vaccine. On 02Dec2015 at 06:45 PM PREVNAR 13 was injected into shoulder joint instead of deltoid. The patient also experienced on 04Dec2015 large lump on the side of his bicep and tendonitis, on 02Dec2015 pain (throbbing, excruciating), and on 05Dec2015 he could not sleep because of the pain, he could not lie down. The patient was hospitalized for the events large lump on the side of his bicep, pain, insomnia, tendonitis, discomfort. The patient mentioned that at time of injection it was very painful and had only gotten worse. He stated that by the third day after vaccination, the pain in his shoulder was so bad that he could not lay on his back and started having trouble sleeping. Therapeutic measures were taken as a result of the events, and included treatment with MEDROL. Six days after the injection he saw his doctor who thought it may have caused tendonitis. The patient saw shoulder specialist the day of the report (14Dec2015) who said it did not seem to be anything pertaining to tendonitis. The patient underwent lab tests and procedures which included Shoulder X-Ray (14Dec2015): clear; Shoulder Ultrasound (14Dec2015): showed little inflammation. Outcome of pain and tendonitis was not recovered. Outcome of large lump on the side of his bicep, insomnia and discomfort was recovered. Follow-up (12Feb2016): new information from the same contactable consumer included: treatment performed, outcome of the events, seriousness criteria.
Age: 56.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: X-ray limb normal
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for himself via a Pfizer Sponsored Program IBCC (Inbound Call Center for HCPs). A 56-year-old male patient received PREVNAR 13, via an unspecified route of administration into shoulder joint just above deltoid, on 02Dec2015 at 06:45 PM, at single dose, and fourth dose of FLUVAX, intramuscular in left deltoid, on 02Dec2015. Relevant medical history included pacemaker from 1992 and ongoing and ongoing ankylosing spondylitis (diagnosed 5-6 weeks ago). Concomitant medications were not reported. Previously the patient received 3 doses of Influenza vaccine. On 02Dec2015 at 06:45 PM PREVNAR 13 was injected into shoulder joint instead of deltoid. The patient also experienced on 04Dec2015 large lump on the side of his bicep and tendonitis, on 02Dec2015 pain (throbbing, excruciating), and on 05Dec2015 he could not sleep because of the pain, he could not lie down. The patient was hospitalized for the events large lump on the side of his bicep, pain, insomnia, tendonitis, discomfort. The patient mentioned that at time of injection it was very painful and had only gotten worse. He stated that by the third day after vaccination, the pain in his shoulder was so bad that he could not lay on his back and started having trouble sleeping. Therapeutic measures were taken as a result of the events, and included treatment with MEDROL. Six days after the injection he saw his doctor who thought it may have caused tendonitis. The patient saw shoulder specialist the day of the report (14Dec2015) who said it did not seem to be anything pertaining to tendonitis. The patient underwent lab tests and procedures which included Shoulder X-Ray (14Dec2015): clear; Shoulder Ultrasound (14Dec2015): showed little inflammation. Outcome of pain and tendonitis was not recovered. Outcome of large lump on the side of his bicep, insomnia and discomfort was recovered. Follow-up (12Feb2016): new information from the same contactable consumer included: treatment performed, outcome of the events, seriousness criteria.
Age: 14.0
Sex: F
Vaccine: HPV9, FLU3, HEPA, HPV9
Symptoms: Dizziness, Loss of consciousness, Tremor
Clinical narrative: Syncopal episode with tonic-clonic movements.
Age: 14.0
Sex: F
Vaccine: HPV9, FLU3, HEPA, HPV9
Symptoms: Syncope, Tonic clonic movements
Clinical narrative: Syncopal episode with tonic-clonic movements.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Coma, Computerised tomogram, Death, Electroencephalogram abnormal
Clinical narrative: 09/28/2014 c/o "BEING SICK". 10/02/2014 AT 7:00 am fell in BR. Unable to walk well even w/assistance. To ER by Ambulance. In ER, AA & O, moving all extremities. On the way to CT, she had a localized seizure involving BLE. Witnessed by myself and CT tech. Had CT< returned to ER. Had a longer T/C seizure beginning in BLE and then involving all parts of body. Head turned upward and to right. Eyes deviated upward and right but conjugate, Not responsive at this time. Lasted 1.45 minutes to 2 minutes. Given Ativan w/o change. No somulent again. Transferred to ICU. Later on during the same evening, she experienced a full T/C seizure lasting > 30 minutes. Given paralytics to get her intubated and started on Diprovan drip along with other meds. Continued with paralytics and was ventilated. She had a 24/7 EEG monitor placed which continued to show seizure wave patterns. When they let her up from her meds, she was now paralysed and comatose. Remained ventilated. After a family conference with Internal Medicine and Pulmonologist, it was decided to extubate her and allow her to die. Which she did after 45-60 minutes. These were her wishes, in her Durable Medical POA.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Endotracheal intubation, Fall, Gaze palsy, Generalised tonic-clonic seizure, Intensive care
Clinical narrative: 09/28/2014 c/o "BEING SICK". 10/02/2014 AT 7:00 am fell in BR. Unable to walk well even w/assistance. To ER by Ambulance. In ER, AA & O, moving all extremities. On the way to CT, she had a localized seizure involving BLE. Witnessed by myself and CT tech. Had CT< returned to ER. Had a longer T/C seizure beginning in BLE and then involving all parts of body. Head turned upward and to right. Eyes deviated upward and right but conjugate, Not responsive at this time. Lasted 1.45 minutes to 2 minutes. Given Ativan w/o change. No somulent again. Transferred to ICU. Later on during the same evening, she experienced a full T/C seizure lasting > 30 minutes. Given paralytics to get her intubated and started on Diprovan drip along with other meds. Continued with paralytics and was ventilated. She had a 24/7 EEG monitor placed which continued to show seizure wave patterns. When they let her up from her meds, she was now paralysed and comatose. Remained ventilated. After a family conference with Internal Medicine and Pulmonologist, it was decided to extubate her and allow her to die. Which she did after 45-60 minutes. These were her wishes, in her Durable Medical POA.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Mechanical ventilation, Paralysis, Seizure, Unresponsive to stimuli
Clinical narrative: 09/28/2014 c/o "BEING SICK". 10/02/2014 AT 7:00 am fell in BR. Unable to walk well even w/assistance. To ER by Ambulance. In ER, AA & O, moving all extremities. On the way to CT, she had a localized seizure involving BLE. Witnessed by myself and CT tech. Had CT< returned to ER. Had a longer T/C seizure beginning in BLE and then involving all parts of body. Head turned upward and to right. Eyes deviated upward and right but conjugate, Not responsive at this time. Lasted 1.45 minutes to 2 minutes. Given Ativan w/o change. No somulent again. Transferred to ICU. Later on during the same evening, she experienced a full T/C seizure lasting > 30 minutes. Given paralytics to get her intubated and started on Diprovan drip along with other meds. Continued with paralytics and was ventilated. She had a 24/7 EEG monitor placed which continued to show seizure wave patterns. When they let her up from her meds, she was now paralysed and comatose. Remained ventilated. After a family conference with Internal Medicine and Pulmonologist, it was decided to extubate her and allow her to die. Which she did after 45-60 minutes. These were her wishes, in her Durable Medical POA.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Dermatitis
Clinical narrative: Dermatitis on arm of injection.
Age: 16.0
Sex: M
Vaccine: FLUN4, HPV4, MNQ
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 1.01
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Patient broke out in hives on 11/21/15 after MMR and Varicella given on 11/18/15. Influenza PF also given on 11/18/15. (12 months).
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Feeling abnormal, Incorrect route of drug administration, Pathological doubt, Retching, Seizure
Clinical narrative: Swelling of the torso and enlarging movement of the rib bones. Intense sun tanning and shock to the skin particularly of the face and neck. Violent seizuring, dry heaving and vomiting, moral doubt in self, more skin and rib damage, more shock to the original quality of the eyes and facial features, feelings of vicious intended rape, a consequence of feeling that I have violated my faith.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Shock, Skeletal injury, Skin disorder, Swelling, Vomiting
Clinical narrative: Swelling of the torso and enlarging movement of the rib bones. Intense sun tanning and shock to the skin particularly of the face and neck. Violent seizuring, dry heaving and vomiting, moral doubt in self, more skin and rib damage, more shock to the original quality of the eyes and facial features, feelings of vicious intended rape, a consequence of feeling that I have violated my faith.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Abscess limb, C-reactive protein normal, Cellulitis, Full blood count normal, Inadequate aseptic technique in use of product
Clinical narrative: Patient states that arm was not cleaned prior to vaccination, had subsequent abscess and cellulitis formation with persistent pain despite antibiotics that radiates along entire arm.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Patient states that arm was not cleaned prior to vaccination, had subsequent abscess and cellulitis formation with persistent pain despite antibiotics that radiates along entire arm.
Age: 48.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Severe pain in arm. Could not raise arm for over a month after the vaccine was given.
Age: 48.0
Sex: F
Vaccine: FLUX, FLUX, FLUX
Symptoms: Pain in extremity
Clinical narrative: Severe pain in arm. Could not raise arm for over a month after the vaccine was given.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: No treatment. Seen at clinic on 2/19/16. Redness and warmth noted from right deltoid to shoulder area. Last seen on 2/24 and redness resolved.
Age: 12.0
Sex: M
Vaccine: FLUN3
Symptoms: Fatigue, Pyrexia, Rhinorrhoea
Clinical narrative: A report has been received from a Health Professional concerning a 12 year old, male patient who had been receiving FLUMIST (intranasal). FLUMIST (intranasal) started on an unknown date. The patient experienced fever, runny nose and tired. The patient recovered from the event of fever, runny nose and tired on an unspecified date. The report was considered to be non-serious by the company physician.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Blood test normal, Chest X-ray normal, Chest discomfort, Electrocardiogram normal, Musculoskeletal pain
Clinical narrative: After the MMR booster (I had 2 MMR vaccines as a child) my neck, jaw, and left side of my body started aching badly. Later that afternoon my chest tightened and I had a pain under my left shoulderblade. At 7pm I went to the ER because I was afraid I was having symptoms of a heart attack. They did blood tests, an EKG, and chest xray and everything came back normal. I was released at 10pm.
Age: 42.0
Sex: F
Vaccine: MMR
Symptoms: Neck pain, Pain, Pain in jaw
Clinical narrative: After the MMR booster (I had 2 MMR vaccines as a child) my neck, jaw, and left side of my body started aching badly. Later that afternoon my chest tightened and I had a pain under my left shoulderblade. At 7pm I went to the ER because I was afraid I was having symptoms of a heart attack. They did blood tests, an EKG, and chest xray and everything came back normal. I was released at 10pm.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Cervix carcinoma, Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 16 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date (reported as when she was 15 year old), the patient was vaccinated with a dose of GARDASIL 0.5 ml (lot#, exp. date and route were not reported). Subsequently, on unknown dates, she received the second and the third dose of GARDASIL 0.5 ml (lot#, exp. date and route were not reported). On an unknown date, approximately June 2015 (also reported as Summer of 2016), after the patient completed her GARDASIL series (vaccinated 3 times), the doctor found cervical cancer cells in the patient's uterus. All the cancer treatment's were provided. The outcome of the patient event was not reported. The relatedness between vaccination with GARDASIL and the patient event was not reported. The reporter considered the patient's event as cancer. Upon internal review, this adverse event was considered medically significant. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPVX, MENB, MNQ
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: L-ARM SWOLLEN, RED, AND WARM TO TOUCH.
Age: 92.0
Sex: M
Vaccine: PNC13
Symptoms: Abasia, Arthralgia, Asthenia, Blood test, Decreased appetite
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for himself and his caregiver (nonHCP). A 92 year-old male patient received PREVNAR 13, via an unspecified route of administration to right upper arm on 23Nov2015 at single dose. The patient medical history was not reported. The patient previously took pneumococcal 13 vaccine 2 years before. Concomitant medication included Baby Aspirin at 81 mg one in the morning till Dec2015. On unspecified date in 2015 the patient experienced rheumatoid arthritis, it was like he was paralyzed, couldn't walk, fever, spasms; redness and swelling of right knee / redness and swelling of right hand / redness to right knee, right hand, and right knuckles, loss of appetite; both legs were stiff, couldn't move them, drowsiness, muscle pain mostly on the right side, weakness, was in bed for 2 weeks all with outcome of unknown; and pain started in upper right hand, then down to knuckles, them to right knee, right foot, and also in his left neg, cannot grasp things with outcome of not recovered. All side effects started about 7 days post injection. Events were described as follows. Fever started about 7 days after the injection. Went up and down. Did not check it constantly. When checked, result ranged from 98-99. The highest result for the times they checked it was 99. Pain, cannot grasp things started about 7 days after the injection. Started in upper right hand, then down to knuckles, then to right knee, right foot, and also in his left leg. It was like he was paralyzed, he couldn't walk because the pain was so bad. He was in bed for 2 weeks. This got better after about four weeks, but over the past two days, has constant pain in ankles all the way to fingertips. He cannot grasp things. After the pain started, these areas got red and swollen. Over past two days, he has had a little bit of swelling to his right knuckles and wrist but they are not red. Has to keep opening and closing his hand to keep it comfortable. The patient could not open or close his hand, and was really red. For about three weeks, patient consumed just tea and water, had no appetite. Gradually began eating again. The patient underwent lab tests and procedures which included blood test with unknown results on unknown date. Therapeutic measures were taken as a result the events and included ibuprofen 200mg three times daily, started about 6-7 days post injection and taken for two weeks. Then, the third week, dose was decreased to two daily. After four weeks, patient was doing better. He saw a physician, who did not know what was wrong with him, so referred him to a rheumatologist. The rheumatologist, said he may have rheumatoid arthritis and gave him Methylprednisone 4mg, which the patient did not take. Went to hospital doctor and was told it was okay to take the prednisone
Age: 92.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Grip strength decreased, Joint swelling, Mobility decreased, Muscle spasms
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for himself and his caregiver (nonHCP). A 92 year-old male patient received PREVNAR 13, via an unspecified route of administration to right upper arm on 23Nov2015 at single dose. The patient medical history was not reported. The patient previously took pneumococcal 13 vaccine 2 years before. Concomitant medication included Baby Aspirin at 81 mg one in the morning till Dec2015. On unspecified date in 2015 the patient experienced rheumatoid arthritis, it was like he was paralyzed, couldn't walk, fever, spasms; redness and swelling of right knee / redness and swelling of right hand / redness to right knee, right hand, and right knuckles, loss of appetite; both legs were stiff, couldn't move them, drowsiness, muscle pain mostly on the right side, weakness, was in bed for 2 weeks all with outcome of unknown; and pain started in upper right hand, then down to knuckles, them to right knee, right foot, and also in his left neg, cannot grasp things with outcome of not recovered. All side effects started about 7 days post injection. Events were described as follows. Fever started about 7 days after the injection. Went up and down. Did not check it constantly. When checked, result ranged from 98-99. The highest result for the times they checked it was 99. Pain, cannot grasp things started about 7 days after the injection. Started in upper right hand, then down to knuckles, then to right knee, right foot, and also in his left leg. It was like he was paralyzed, he couldn't walk because the pain was so bad. He was in bed for 2 weeks. This got better after about four weeks, but over the past two days, has constant pain in ankles all the way to fingertips. He cannot grasp things. After the pain started, these areas got red and swollen. Over past two days, he has had a little bit of swelling to his right knuckles and wrist but they are not red. Has to keep opening and closing his hand to keep it comfortable. The patient could not open or close his hand, and was really red. For about three weeks, patient consumed just tea and water, had no appetite. Gradually began eating again. The patient underwent lab tests and procedures which included blood test with unknown results on unknown date. Therapeutic measures were taken as a result the events and included ibuprofen 200mg three times daily, started about 6-7 days post injection and taken for two weeks. Then, the third week, dose was decreased to two daily. After four weeks, patient was doing better. He saw a physician, who did not know what was wrong with him, so referred him to a rheumatologist. The rheumatologist, said he may have rheumatoid arthritis and gave him Methylprednisone 4mg, which the patient did not take. Went to hospital doctor and was told it was okay to take the prednisone
Age: 92.0
Sex: M
Vaccine: PNC13
Symptoms: Musculoskeletal stiffness, Myalgia, Pain in extremity, Paralysis, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for himself and his caregiver (nonHCP). A 92 year-old male patient received PREVNAR 13, via an unspecified route of administration to right upper arm on 23Nov2015 at single dose. The patient medical history was not reported. The patient previously took pneumococcal 13 vaccine 2 years before. Concomitant medication included Baby Aspirin at 81 mg one in the morning till Dec2015. On unspecified date in 2015 the patient experienced rheumatoid arthritis, it was like he was paralyzed, couldn't walk, fever, spasms; redness and swelling of right knee / redness and swelling of right hand / redness to right knee, right hand, and right knuckles, loss of appetite; both legs were stiff, couldn't move them, drowsiness, muscle pain mostly on the right side, weakness, was in bed for 2 weeks all with outcome of unknown; and pain started in upper right hand, then down to knuckles, them to right knee, right foot, and also in his left neg, cannot grasp things with outcome of not recovered. All side effects started about 7 days post injection. Events were described as follows. Fever started about 7 days after the injection. Went up and down. Did not check it constantly. When checked, result ranged from 98-99. The highest result for the times they checked it was 99. Pain, cannot grasp things started about 7 days after the injection. Started in upper right hand, then down to knuckles, then to right knee, right foot, and also in his left leg. It was like he was paralyzed, he couldn't walk because the pain was so bad. He was in bed for 2 weeks. This got better after about four weeks, but over the past two days, has constant pain in ankles all the way to fingertips. He cannot grasp things. After the pain started, these areas got red and swollen. Over past two days, he has had a little bit of swelling to his right knuckles and wrist but they are not red. Has to keep opening and closing his hand to keep it comfortable. The patient could not open or close his hand, and was really red. For about three weeks, patient consumed just tea and water, had no appetite. Gradually began eating again. The patient underwent lab tests and procedures which included blood test with unknown results on unknown date. Therapeutic measures were taken as a result the events and included ibuprofen 200mg three times daily, started about 6-7 days post injection and taken for two weeks. Then, the third week, dose was decreased to two daily. After four weeks, patient was doing better. He saw a physician, who did not know what was wrong with him, so referred him to a rheumatologist. The rheumatologist, said he may have rheumatoid arthritis and gave him Methylprednisone 4mg, which the patient did not take. Went to hospital doctor and was told it was okay to take the prednisone
Age: 92.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia, Rheumatoid arthritis, Somnolence
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for himself and his caregiver (nonHCP). A 92 year-old male patient received PREVNAR 13, via an unspecified route of administration to right upper arm on 23Nov2015 at single dose. The patient medical history was not reported. The patient previously took pneumococcal 13 vaccine 2 years before. Concomitant medication included Baby Aspirin at 81 mg one in the morning till Dec2015. On unspecified date in 2015 the patient experienced rheumatoid arthritis, it was like he was paralyzed, couldn't walk, fever, spasms; redness and swelling of right knee / redness and swelling of right hand / redness to right knee, right hand, and right knuckles, loss of appetite; both legs were stiff, couldn't move them, drowsiness, muscle pain mostly on the right side, weakness, was in bed for 2 weeks all with outcome of unknown; and pain started in upper right hand, then down to knuckles, them to right knee, right foot, and also in his left neg, cannot grasp things with outcome of not recovered. All side effects started about 7 days post injection. Events were described as follows. Fever started about 7 days after the injection. Went up and down. Did not check it constantly. When checked, result ranged from 98-99. The highest result for the times they checked it was 99. Pain, cannot grasp things started about 7 days after the injection. Started in upper right hand, then down to knuckles, then to right knee, right foot, and also in his left leg. It was like he was paralyzed, he couldn't walk because the pain was so bad. He was in bed for 2 weeks. This got better after about four weeks, but over the past two days, has constant pain in ankles all the way to fingertips. He cannot grasp things. After the pain started, these areas got red and swollen. Over past two days, he has had a little bit of swelling to his right knuckles and wrist but they are not red. Has to keep opening and closing his hand to keep it comfortable. The patient could not open or close his hand, and was really red. For about three weeks, patient consumed just tea and water, had no appetite. Gradually began eating again. The patient underwent lab tests and procedures which included blood test with unknown results on unknown date. Therapeutic measures were taken as a result the events and included ibuprofen 200mg three times daily, started about 6-7 days post injection and taken for two weeks. Then, the third week, dose was decreased to two daily. After four weeks, patient was doing better. He saw a physician, who did not know what was wrong with him, so referred him to a rheumatologist. The rheumatologist, said he may have rheumatoid arthritis and gave him Methylprednisone 4mg, which the patient did not take. Went to hospital doctor and was told it was okay to take the prednisone
Age: 83.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Incisional drainage, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer via a Pfizer colleague(consumer is Pfizer colleague's uncle). A male patient in his early 80s received PREVNAR 13, on an unspecified date at 0.5 ml single. The patient medical history and concomitant medications. The patient experienced pain in the arm after the administration of the vaccine. Event worsened. Due to the event the patient went to emergency room and then he was hospitalized for a day or two and after he was transferred to the long term care facility (which was a part of a hospital). Patient will be getting vancomycin and ROCEPHIN for the next 3 weeks. Surgical procedure to drain his arm was done on an unknown date. Final outcome of the event was not recovered.
Age: 83.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Activities of daily living impaired, Arthritis bacterial, Aspiration joint, Asthenia, Central venous catheterisation
Clinical narrative: This is a spontaneous report from a contactable consumer via a Pfizer colleague(consumer is Pfizer colleague's uncle). A male patient in his early 80s received PREVNAR 13, on an unspecified date at 0.5 ml single. The patient medical history and concomitant medications. The patient experienced pain in the arm after the administration of the vaccine. Event worsened. Due to the event the patient went to emergency room and then he was hospitalized for a day or two and after he was transferred to the long term care facility (which was a part of a hospital). Patient will be getting vancomycin and ROCEPHIN for the next 3 weeks. Surgical procedure to drain his arm was done on an unknown date. Final outcome of the event was not recovered.
Age: 83.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Chills, Heart rate increased, Injection site pain, Malaise, Muscular weakness
Clinical narrative: This is a spontaneous report from a contactable consumer via a Pfizer colleague(consumer is Pfizer colleague's uncle). A male patient in his early 80s received PREVNAR 13, on an unspecified date at 0.5 ml single. The patient medical history and concomitant medications. The patient experienced pain in the arm after the administration of the vaccine. Event worsened. Due to the event the patient went to emergency room and then he was hospitalized for a day or two and after he was transferred to the long term care facility (which was a part of a hospital). Patient will be getting vancomycin and ROCEPHIN for the next 3 weeks. Surgical procedure to drain his arm was done on an unknown date. Final outcome of the event was not recovered.
Age: 83.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Pain in extremity, Pyrexia, Shoulder operation
Clinical narrative: This is a spontaneous report from a contactable consumer via a Pfizer colleague(consumer is Pfizer colleague's uncle). A male patient in his early 80s received PREVNAR 13, on an unspecified date at 0.5 ml single. The patient medical history and concomitant medications. The patient experienced pain in the arm after the administration of the vaccine. Event worsened. Due to the event the patient went to emergency room and then he was hospitalized for a day or two and after he was transferred to the long term care facility (which was a part of a hospital). Patient will be getting vancomycin and ROCEPHIN for the next 3 weeks. Surgical procedure to drain his arm was done on an unknown date. Final outcome of the event was not recovered.
Age: 90.0
Sex: M
Vaccine: TDAP
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of other bacterial vaccines, init encntr on 2016-02-10.
Age: 11.0
Sex: F
Vaccine: FLUN4, MNQ, UNK
Symptoms: Pyrexia
Clinical narrative: Postvaccination fever on 2015-10-28.
Age: 0.57
Sex: M
Vaccine: PER, RV1
Symptoms: Vaccination complication
Clinical narrative: Advrs effect of pertuss vaccine, inc combin w pertuss, subs on 2016-01-12.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth, Malaise, Oropharyngeal blistering
Clinical narrative: Patient called clinic on 01/15/2016:  Pt experiencing swelling and warmth at Tdap injection site; immunization given on 1/11/16. Denies fever, itching, drainage at site. Complains of blisters in throat and general malaise. Advised cool compresses at site, Tylenol for comfort. No appointments available today; advised patient to go to walk-in clinic if symptoms increase or new symptoms develop. Pt verbalized understanding. Initial call taken by RN, January 15, 2016 6:07 PM. Patient called clinic on 01/18/2016: Pt called in regards to recent TDAP Whooping Cough. States she immediately got sick from said inj, and developed blisters in throat. Discussed symptoms with pharmacist and was informed there is latex in shot, which she is mostly certain she has an allergy to. Pt wanted to inform her provider and all other providers so as to make note for any future pts that might be susceptible to said reaction. Initial call taken January 18, 2016 12:38 PM. Added to allergies. Please be advised. Noted. Take Benadryl for a day orteo if still with sore throat (hopeflly not allergic to Benadryl). LATEX and TDAP added to allergies already MD, January 24, 2016 7:54 PM. Follow-up by CMA, January 18, 2016 3:21 PM. Spoke with pt. to be sure she got prior message, she stated she takes antihistamine 3xday and believes that helped with this reaction.  Per our Izzy Coordinator, she does not think our brand of izzy has Latex in it.  I spoke with the CDC and they confirmed there may be latex in the syringe cap but not in the vial itself. I spoke with pt. again and she stated she has never been tested for latex allergy, is allergic to tapes, and again said she got blisters on her throat.  I told her I would let her PCP know and we may test her at next OV.  Pt. verb. understanding. Action Taken: Provider Notified. Follow-up by RN, January 27, 2016 4:39 PM. Will consider referral to ALLERGOLOGIST. Electronically signed by MD on 01/27/2016 at 6:03 PM.
Age: 68.0
Sex: F
Vaccine: HEP, PNC13
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site swelling, Muscle spasms
Clinical narrative: Pt received PCV 13 on R deltoid on 2/17/16, and started 2/17/16 9 pm, had fever, dizziness and nausea, temp went as high as 105F (41 degree Celsius), and had to keep taking Tylenol to keep fever down, temp tends to spike higher at night. Here to seek urgent care. R deltoid area of arm is mild reddened and swelling, tender to touch. Pt also c/o right arm and right leg spasm since PCV 13 was injected. Currently rating R arm pain at 8/10. Afebile now at 98.7 F.
Age: 68.0
Sex: F
Vaccine: HEP, PNC13
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: Pt received PCV 13 on R deltoid on 2/17/16, and started 2/17/16 9 pm, had fever, dizziness and nausea, temp went as high as 105F (41 degree Celsius), and had to keep taking Tylenol to keep fever down, temp tends to spike higher at night. Here to seek urgent care. R deltoid area of arm is mild reddened and swelling, tender to touch. Pt also c/o right arm and right leg spasm since PCV 13 was injected. Currently rating R arm pain at 8/10. Afebile now at 98.7 F.
Age: 23.0
Sex: M
Vaccine: ADEN_4_7, FLUN4, HEPA, MNQ, TDAP
Symptoms: Dizziness, Hypotension, Presyncope, Thirst, Visual impairment
Clinical narrative: Pt had all of his immunizations done on 1/29. On 1/30 in the morning he woke up with symptoms of pre-syncope (saw black, felt lightheaded). He also felt excessively thirsty even after drinking 7 canteens over 24 hours. He also had some hypotension during examination. He was given acetaminophen.