chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Vaginal haemorrhage
Clinical narrative: Patient is a 16yr old previously healthy female who presents with thrombocytopenia and anemia with 7days of vaginal bleeding. Patient presented to Hospital ER with a heavy menstrual period with multiple clots and a nose bleed. Patient reports that she started her menstrual period at the age of 12 and have always been irregular. The longest length of time she has gone between having periods is 3 months while the shortest time length between periods is 1 week. Her menstrual period usually lasts approximately 7days with an average of 4 heavy days. On average she will change her pad 4 times per day. Pads will be soaked through with blood and on heavy days she will double pad. During this current period her flow continues to be heavy and she has needed to change her pad approximately 6times per day. During this current period patient has also noted multiple clots with wiping during this period. On the morning of admission while blowing her nose a dime size blood clot was noted to be on the tissue. At Hospital CBC was drawn and she was noted to have a cbc significant for low platelets of 10 and hemoglobin of 9.4. Petechia and lower extremity bruises were noted. She was transferred to another ER.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site bruising, Pain in extremity
Clinical narrative: Patient states excessive soreness in her arm, esp her shoulder joint. She needs APAP q4h for pain. Also, patient and caregiver is complaining of excessive bruising at/ all around injection site.  She states her whole upper arm is bruised.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Hypersomnia, Lymph node pain, Pain
Clinical narrative: First, exhausted. Glands from elbow to ribs sore. Slept fitfully, waking ever few hours. In the morning (6am) I had a fever of 100.2. No appetite for the day. Slept ALL day. Now, 8:30 am almost 48 hours after shot, still sore on left side, and tired.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Poor quality sleep, Pyrexia
Clinical narrative: First, exhausted. Glands from elbow to ribs sore. Slept fitfully, waking ever few hours. In the morning (6am) I had a fever of 100.2. No appetite for the day. Slept ALL day. Now, 8:30 am almost 48 hours after shot, still sore on left side, and tired.
Sex: U
Vaccine: HEPA, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects were reported; the patient received improperly stored VAQTA; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 23-JUL-2020, the patient was vaccinated with a dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided) vial (upon internal validation process, the formulation was established as prefilled syringe)(lot# T008698, was established as valid, with expiration date: 04-JUN-2021) (dose, dose number, route of administration and anatomical location were not reported) for prophylaxis. The temperature to which the vaccines was exposed was 62.2 degrees of Fahrenheit and the time frame was reported as 3 hours 50 minutes. No previous temperature excursion was reported. A digital data logger was involved. No additional adverse effects were reported.   This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF);  devicelotnumber: T008698; expirationdate: 04-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2007USA009779: US-009507513-2007USA010268: US-009507513-2007USA010269:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects to the patient; dose of VAQTA was administered on 07/28/2020 and expired on 07/26/2020; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 28-JUL-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) injection, lot # S009943 was confirmed to be valid, expiration date 26-JUL-2020 (exact dose, injection site and route of administration were not provided) for prophylaxis. No adverse effects were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. Devicelotnumber: S009943; expirationdate: 26-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. No information was provided regarding medical history, concurrent conditions and concomitant medications. On or about 28-JAN-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose and route of administration were not provided) at the physician office for the long-term prevention of shingles and/or zoster-related conditions. On unspecified dates, the pt experienced shingles and was admitted to the hospital. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) inoculation, the pt suffered and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles was not recovered. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. No information was provided regarding medical history, concurrent conditions and concomitant medications. On an unknown day in 2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose and route of administration were not provided) by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On unspecified dates, the pt experienced shingles and was admitted to the hospital. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a physician for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) inoculation, the pt suffered and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles was not recovered. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st July 2020, the patient received the 1st dose of Shingrix. On 21st July 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and developed arm soreness. This case is 1 of 2 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020156646:Same reporter
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Gastric disorder, Pain in extremity
Clinical narrative: sick to her stomach; sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dsoe received on February or March, refer case US2020AMR161127).   On 12th August 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 12th August 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 13th August 2020, the patient experienced gastric disorder. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the gastric disorder was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and gastric disorder to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix in left arm. The patient experienced a sore arm a few hours after vaccination. One day after vaccination (on the day of reporting), the patient was better but, woke up sick to stomach.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR161127:same patient
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site reaction, Lip swelling, Local reaction, Rash vesicular
Clinical narrative: Recieved DTaP-IPV, MMRV and HepA on 8/12/20 Developed large local reaction on Right arm at site of MMRV on 8/13/20. Treated Benadryl and Prednisolone. Developed lip swelling on 8/15/20 and seen in ER, treated with Benadryl. Lip swelling resolved. Developed varicella form rash on 8/16/20
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Lymphadenopathy
Clinical narrative: Patient developed lymphadenopathy of inferior end of left superficial cervical chain approx. 2cm diameter when examined on 8/14/2020.  No treatment.  Recommended observation and RTC if symptoms worsened
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Influenza like illness, Lethargy
Clinical narrative: Within a few hours of receiving the vaccine, I felt stomach pains, had chills, was extremely tired and lethargic.  I felt like I had the flu.  These symptoms continued for about 24 hours.   I am still very tired and do not feel entirely normal 36 hours after the vaccine but I am much better than I was.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Acoustic stimulation tests abnormal, Blood test, Deafness neurosensory, Deafness unilateral, Magnetic resonance imaging brain
Clinical narrative: The 2nd shingles vaccine was given to my on 8/10/2020.   On 8/13/2020 I woke up in the morning and my right ear was dead.  I could not hear at of it at all. My doctor said to get in to see and ENT.  I called healthcare provider and went to her on 8/17/20.  She did a hearing test and looked in my ear and said she feels I have SSHL.  I did blood work and I have an MRI of the brain on 9/1/20.  The side effects that I was given did not include the rare effects that the CDC states can have pneumonia, hearing problems, blindness, brain inflamation or death.  I am scared to death I am going to have more effects.  Please get back to me about this asap.  My cell number.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Sudden hearing loss
Clinical narrative: The 2nd shingles vaccine was given to my on 8/10/2020.   On 8/13/2020 I woke up in the morning and my right ear was dead.  I could not hear at of it at all. My doctor said to get in to see and ENT.  I called healthcare provider and went to her on 8/17/20.  She did a hearing test and looked in my ear and said she feels I have SSHL.  I did blood work and I have an MRI of the brain on 9/1/20.  The side effects that I was given did not include the rare effects that the CDC states can have pneumonia, hearing problems, blindness, brain inflamation or death.  I am scared to death I am going to have more effects.  Please get back to me about this asap.  My cell number.
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Pt was given the adult dose of Hepatitis A, 1.0 ml
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Axillary pain, Chills, Fatigue, Headache
Clinical narrative: moderate to severe pain left arm and left side body muscles and joints,- 2 days duration, swelling and redness at injection site up through 3 days+ duration, chills, low grade fever, nausea, fatigue, headache, lethargy - 2 days duration.  Side effects significantly affected ability to function for 2 days. No treatment other than bed rest and sleep.  Redness, swelling and pain still present in left deltoid area and pain under left armpit when palpating lymph nodes through day 3.  Day 3 recovered from all other side effects.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lethargy, Myalgia
Clinical narrative: moderate to severe pain left arm and left side body muscles and joints,- 2 days duration, swelling and redness at injection site up through 3 days+ duration, chills, low grade fever, nausea, fatigue, headache, lethargy - 2 days duration.  Side effects significantly affected ability to function for 2 days. No treatment other than bed rest and sleep.  Redness, swelling and pain still present in left deltoid area and pain under left armpit when palpating lymph nodes through day 3.  Day 3 recovered from all other side effects.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Pyrexia
Clinical narrative: moderate to severe pain left arm and left side body muscles and joints,- 2 days duration, swelling and redness at injection site up through 3 days+ duration, chills, low grade fever, nausea, fatigue, headache, lethargy - 2 days duration.  Side effects significantly affected ability to function for 2 days. No treatment other than bed rest and sleep.  Redness, swelling and pain still present in left deltoid area and pain under left armpit when palpating lymph nodes through day 3.  Day 3 recovered from all other side effects.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Disturbance in attention, Feeling of body temperature change, Hyperhidrosis, Sensory disturbance
Clinical narrative: Patient  recieved the flushot around 3:00pm and he said 2 hours after recieving the immunization, he had strange sensations in his hands and arms, he can't focus, he is hot and cold and hot and cold and is sweating and it lasted up to 10:30pm of the same day. He reoorted the adverse reactions the next day  around 9:15am and he said he does not have any of the symptoms from yesterday but he is feeling weak does not have energy. When I followed up with the patient around 12noon, he said he is feeling much better and has a little more energy than earlier this morning.
Age: 10.0
Sex: M
Vaccine: PPV
Symptoms: Anion gap, Blood calcium, Blood chloride, Blood creatinine, Blood culture
Clinical narrative: Developed fever up to 104  and  redness, pain and swelling in right arm  3 days after receiving vaccine.  Admitted to Hospital on 8/15/20 for fever and Cellulitis. Improved with IV antibiotics. Patient also developed rash from arm to back which resolved with antihistamines. Cellulitis was on right arm near injection site. Rash also developed during hospitalization. Discharged from hospital on 8/18/20.
Age: 10.0
Sex: M
Vaccine: PPV
Symptoms: Blood glucose, Blood ketone body, Blood magnesium, Blood phosphorus, Blood potassium
Clinical narrative: Developed fever up to 104  and  redness, pain and swelling in right arm  3 days after receiving vaccine.  Admitted to Hospital on 8/15/20 for fever and Cellulitis. Improved with IV antibiotics. Patient also developed rash from arm to back which resolved with antihistamines. Cellulitis was on right arm near injection site. Rash also developed during hospitalization. Discharged from hospital on 8/18/20.
Age: 10.0
Sex: M
Vaccine: PPV
Symptoms: Blood sodium, Blood urea, C-reactive protein, Calcium ionised, Carbon dioxide
Clinical narrative: Developed fever up to 104  and  redness, pain and swelling in right arm  3 days after receiving vaccine.  Admitted to Hospital on 8/15/20 for fever and Cellulitis. Improved with IV antibiotics. Patient also developed rash from arm to back which resolved with antihistamines. Cellulitis was on right arm near injection site. Rash also developed during hospitalization. Discharged from hospital on 8/18/20.
Age: 10.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Culture urine, Differential white blood cell count, Erythema, Full blood count
Clinical narrative: Developed fever up to 104  and  redness, pain and swelling in right arm  3 days after receiving vaccine.  Admitted to Hospital on 8/15/20 for fever and Cellulitis. Improved with IV antibiotics. Patient also developed rash from arm to back which resolved with antihistamines. Cellulitis was on right arm near injection site. Rash also developed during hospitalization. Discharged from hospital on 8/18/20.
Age: 10.0
Sex: M
Vaccine: PPV
Symptoms: Glycosylated haemoglobin, Injection site cellulitis, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Developed fever up to 104  and  redness, pain and swelling in right arm  3 days after receiving vaccine.  Admitted to Hospital on 8/15/20 for fever and Cellulitis. Improved with IV antibiotics. Patient also developed rash from arm to back which resolved with antihistamines. Cellulitis was on right arm near injection site. Rash also developed during hospitalization. Discharged from hospital on 8/18/20.
Age: 10.0
Sex: M
Vaccine: PPV
Symptoms: Rash, Red blood cell sedimentation rate, Respiratory viral panel, Urine analysis
Clinical narrative: Developed fever up to 104  and  redness, pain and swelling in right arm  3 days after receiving vaccine.  Admitted to Hospital on 8/15/20 for fever and Cellulitis. Improved with IV antibiotics. Patient also developed rash from arm to back which resolved with antihistamines. Cellulitis was on right arm near injection site. Rash also developed during hospitalization. Discharged from hospital on 8/18/20.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Grip strength decreased, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: I received the shot on 8/17/20 about 4:15pm in my left shoulder. When I went to bed at 11pm, there was no significant pain in my left shoulder. When I woke up at 6am, my left shoulder was very painful. It hurt to raise my left hand above my waist, and the pain made it impossible to raise my left hand above the shoulder. I could not grasp things or pick up things. For about the next 4 hours my left arm was not usable, I did everything with my right arm. Gradually the pain abated, and I was able to get some movement out of the left arm. When I awoke the morning of 8/19/20 most of the pain was gone and my arm felt almost back to normal. I did not discuss this with the doctor because I wanted to give it some time to recover.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Myalgia, Nausea
Clinical narrative: MUSCLE PAIN FOR 48 HOURS, TENDERNESS/ SORE AT INJECTION SITE, QUEASY STOMACH, CHILLD, HEADACHE
Age: 79.0
Sex: M
Vaccine: FLU4
Symptoms: Condition aggravated, Polymyalgia rheumatica, Red blood cell sedimentation rate increased
Clinical narrative: Polymyalgia Rheumatica
Age: 11.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No know adverse reaction occurred, just wrong vaccine given
Sex: F
Vaccine: VARZOS
Symptoms: Cerebrovascular accident
Clinical narrative: right middle cerebral artery stroke; Information has been received from a lawyer, regarding a case in litigation, and refers to a female patient (pt) of unknown age. No information about the pt's medical history, concurrent conditions and concomitant therapies was provided. On or around 18-OCT-2010, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On approximately 28-OCT-2010, reported as approximately 10 days after receiving zoster vaccine live (ZOSTAVAX), the pt suffered a right middle cerebral artery stroke. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the suspect vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered to be not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The event of right middle cerebral artery stroke was considered to be disabling.  Upon internal review, the event of right middle cerebral artery stroke was determined to be medically significant.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: Administered an expired GARDASIL 9 to a patient; No adverse event; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.   On 11-AUG-2020, the patient was vaccinated with 0.5 ml of an expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis with lot # N021733 and expiration date on 01-FEB-2020 (strength, dose number, anatomical location and route of administration were not reported). No adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: N021733; expirationdate: 01-FEB-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Facial pain, Hypoaesthesia, Nausea, Paraesthesia
Clinical narrative: Nauseous; Dizzy; Tingling, numbness on my left side; Numbness on my left side; Sores on my face / Painful/Tingling Blemishes on Left side of face; Sores on my face / Painful/Tingling Blemishes on Left side of face; Sores on my face / Painful/Tingling Blemishes on Left side of face; Low grade fever; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2020, the patient received the 1st dose of Shingrix. In August 2020, 10 min after receiving Shingrix, the patient experienced nausea, dizziness, tingling, numbness, skin ulcer, skin disorder, facial pain and low grade fever. In 2020, the outcome of the nausea and dizziness were recovered/resolved and the outcome of the tingling, numbness, skin ulcer, skin disorder, facial pain and low grade fever were not recovered/not resolved.   It was unknown if the reporter considered the nausea, dizziness, tingling, numbness, skin ulcer, skin disorder, facial pain and low grade fever to be related to Shingrix.  Additional information was received as follows: The patient received the first dose of Shingrix on 6th August 2020 and about 10 minutes after injection, the patient felt nauseous and dizzy. Last few days, the patient had tingling, low grade fever, left sided numbness on the left side and was breaking out with sores on face and new onset of painful/tingling blemishes on left side of face. The patient questioned whether the patient was getting Shingles.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia, Skin disorder, Skin ulcer
Clinical narrative: Nauseous; Dizzy; Tingling, numbness on my left side; Numbness on my left side; Sores on my face / Painful/Tingling Blemishes on Left side of face; Sores on my face / Painful/Tingling Blemishes on Left side of face; Sores on my face / Painful/Tingling Blemishes on Left side of face; Low grade fever; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2020, the patient received the 1st dose of Shingrix. In August 2020, 10 min after receiving Shingrix, the patient experienced nausea, dizziness, tingling, numbness, skin ulcer, skin disorder, facial pain and low grade fever. In 2020, the outcome of the nausea and dizziness were recovered/resolved and the outcome of the tingling, numbness, skin ulcer, skin disorder, facial pain and low grade fever were not recovered/not resolved.   It was unknown if the reporter considered the nausea, dizziness, tingling, numbness, skin ulcer, skin disorder, facial pain and low grade fever to be related to Shingrix.  Additional information was received as follows: The patient received the first dose of Shingrix on 6th August 2020 and about 10 minutes after injection, the patient felt nauseous and dizzy. Last few days, the patient had tingling, low grade fever, left sided numbness on the left side and was breaking out with sores on face and new onset of painful/tingling blemishes on left side of face. The patient questioned whether the patient was getting Shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Facial pain, Hypoaesthesia, Nausea, Paraesthesia
Clinical narrative: nausea; dizziness; low grade fever; Left sided Numbness; tingling; Painful/Tingling Blemishes on Left side of face.; Blemishes on Left side of face.; This case was reported by a consumer via interactive digital media and described the occurrence of nausea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2020, the patient received the 1st dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced nausea, dizziness, low grade fever, numbness, tingling, pain in face and skin disorder. On an unknown date, the outcome of the nausea and dizziness were recovered/resolved and the outcome of the low grade fever, numbness, tingling, pain in face and skin disorder were unknown.   It was unknown if the reporter considered the nausea, dizziness, low grade fever, numbness, tingling, pain in face and skin disorder to be related to Shingrix.  Additional information was received as follows: Age at vaccination was not reported but was captured as an adult as per vaccine indication. The patient received the dose of Shingrix on and experienced some dizziness and nausea. Last few days patient had low grade fever, left sided numbness and tingling. New onset of painful/tingling blemishes on left side of face. The patient wanted to know whether he/she had Shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia, Skin disorder
Clinical narrative: nausea; dizziness; low grade fever; Left sided Numbness; tingling; Painful/Tingling Blemishes on Left side of face.; Blemishes on Left side of face.; This case was reported by a consumer via interactive digital media and described the occurrence of nausea in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2020, the patient received the 1st dose of Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced nausea, dizziness, low grade fever, numbness, tingling, pain in face and skin disorder. On an unknown date, the outcome of the nausea and dizziness were recovered/resolved and the outcome of the low grade fever, numbness, tingling, pain in face and skin disorder were unknown.   It was unknown if the reporter considered the nausea, dizziness, low grade fever, numbness, tingling, pain in face and skin disorder to be related to Shingrix.  Additional information was received as follows: Age at vaccination was not reported but was captured as an adult as per vaccine indication. The patient received the dose of Shingrix on and experienced some dizziness and nausea. Last few days patient had low grade fever, left sided numbness and tingling. New onset of painful/tingling blemishes on left side of face. The patient wanted to know whether he/she had Shingles.
Age: 42.0
Sex: F
Vaccine: FLUR4, PPV, FLU4, PPV
Symptoms: Erythema, Mobility decreased, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: PATIENT CALLED ON 8/19 STATING THAT EARLY THAT MORNING HER ARM STARTED TO REALLY HURT AND SWELL. IT WAS VERY WARM TO THE TOUCH AND SHE WAS UNABLE TO LIFT IT ABOVE A CERTAIN LEVEL WHICH WAS OUT OF THE NORM FOR HER. SHE ALSO REPORTS A MILD FEVER. SHE HAS BEEN ALTERNATING TYLENOL AND IBUPROFEN TO RELEIVE THE PAIN AND FEVER. SHE CAME INTO STORE STATING THAT THE REDNESS AND SWELLING ARE GETTING WORSE SO SHE PURCHASED SOME BENADRYL TO TAKE AS WELL. SHE WILL SEE HER PRIMARY PHYSICIAN TOMORROW FOR FOLLOW UP.
Age: 42.0
Sex: F
Vaccine: FLUR4, PPV, FLU4, PPV
Symptoms: Skin warm
Clinical narrative: PATIENT CALLED ON 8/19 STATING THAT EARLY THAT MORNING HER ARM STARTED TO REALLY HURT AND SWELL. IT WAS VERY WARM TO THE TOUCH AND SHE WAS UNABLE TO LIFT IT ABOVE A CERTAIN LEVEL WHICH WAS OUT OF THE NORM FOR HER. SHE ALSO REPORTS A MILD FEVER. SHE HAS BEEN ALTERNATING TYLENOL AND IBUPROFEN TO RELEIVE THE PAIN AND FEVER. SHE CAME INTO STORE STATING THAT THE REDNESS AND SWELLING ARE GETTING WORSE SO SHE PURCHASED SOME BENADRYL TO TAKE AS WELL. SHE WILL SEE HER PRIMARY PHYSICIAN TOMORROW FOR FOLLOW UP.
Age: 42.0
Sex: F
Vaccine: FLUR4, PPV, FLU4, PPV
Symptoms: Anger, Chills, Confusional state, Erythema, Inflammation
Clinical narrative: PATIENT CALLED ON 8/19 STATING THAT EARLY THAT MORNING HER ARM STARTED TO REALLY HURT AND SWELL. IT WAS VERY WARM TO THE TOUCH AND SHE WAS UNABLE TO LIFT IT ABOVE A CERTAIN LEVEL WHICH WAS OUT OF THE NORM FOR HER. SHE ALSO REPORTS A MILD FEVER. SHE HAS BEEN ALTERNATING TYLENOL AND IBUPROFEN TO RELEIVE THE PAIN AND FEVER. SHE CAME INTO STORE STATING THAT THE REDNESS AND SWELLING ARE GETTING WORSE SO SHE PURCHASED SOME BENADRYL TO TAKE AS WELL. SHE WILL SEE HER PRIMARY PHYSICIAN TOMORROW FOR FOLLOW UP.
Age: 42.0
Sex: F
Vaccine: FLUR4, PPV, FLU4, PPV
Symptoms: Nausea, Peripheral swelling, Pyrexia, Skin warm, Swelling
Clinical narrative: PATIENT CALLED ON 8/19 STATING THAT EARLY THAT MORNING HER ARM STARTED TO REALLY HURT AND SWELL. IT WAS VERY WARM TO THE TOUCH AND SHE WAS UNABLE TO LIFT IT ABOVE A CERTAIN LEVEL WHICH WAS OUT OF THE NORM FOR HER. SHE ALSO REPORTS A MILD FEVER. SHE HAS BEEN ALTERNATING TYLENOL AND IBUPROFEN TO RELEIVE THE PAIN AND FEVER. SHE CAME INTO STORE STATING THAT THE REDNESS AND SWELLING ARE GETTING WORSE SO SHE PURCHASED SOME BENADRYL TO TAKE AS WELL. SHE WILL SEE HER PRIMARY PHYSICIAN TOMORROW FOR FOLLOW UP.
Age: 42.0
Sex: F
Vaccine: FLUR4, PPV, FLU4, PPV
Symptoms: Tremor
Clinical narrative: PATIENT CALLED ON 8/19 STATING THAT EARLY THAT MORNING HER ARM STARTED TO REALLY HURT AND SWELL. IT WAS VERY WARM TO THE TOUCH AND SHE WAS UNABLE TO LIFT IT ABOVE A CERTAIN LEVEL WHICH WAS OUT OF THE NORM FOR HER. SHE ALSO REPORTS A MILD FEVER. SHE HAS BEEN ALTERNATING TYLENOL AND IBUPROFEN TO RELEIVE THE PAIN AND FEVER. SHE CAME INTO STORE STATING THAT THE REDNESS AND SWELLING ARE GETTING WORSE SO SHE PURCHASED SOME BENADRYL TO TAKE AS WELL. SHE WILL SEE HER PRIMARY PHYSICIAN TOMORROW FOR FOLLOW UP.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Rash
Clinical narrative: Patient reported full body itching  and rashes all over his body hours after receiving the vaccine.  He said he took some Benadryl and after about 2 hours the rashes and itching reduced.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: SWELLING THROUGHOUT INJECTION SITE DELTOID AND LOWER ARM PER PATIENT; PATIENT SAID IT APPEARED TO LOOK LIKE VASCULITIS
Age: 1.92
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema
Clinical narrative: Area of redness approx 1/2 inch from injection site. Size approx 2.5 in in diameter. No other s/sx of reaction. No fever, N/V/D. Child eating/drinking normally. Triage recommended Tylenol and mindful watching.  Parent brought child in 8/19/20 to reassure no adverse SE, vital WNL
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Had a shingles rash on her back.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Ear pruritus, Injection site erythema, Urticaria
Clinical narrative: ear itching, whole body hives, redness in right thigh. this was treated with OTC Benadryl. this was within 3 hours of vaccination. mother called with information.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Feeling cold, Immediate post-injection reaction, Injection site pain, Nausea
Clinical narrative: Immediately at time of injection, felt arm soreness to be expected, but came home worked out, and then felt nausea and tired.  Took Tylenol last night at 7 pm, this am at 2 am and then again at 12:30 pm. At midnight, could not sleep well, felt cold, body aches, restless , feverish, left shoulder really sore. Today , woke at noon today, did not sleep well last night at all, ate bananas, and vomited at 1:30 pm, Feeling better now, 234 pm,
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Pain, Pain in extremity, Poor quality sleep, Pyrexia, Restlessness
Clinical narrative: Immediately at time of injection, felt arm soreness to be expected, but came home worked out, and then felt nausea and tired.  Took Tylenol last night at 7 pm, this am at 2 am and then again at 12:30 pm. At midnight, could not sleep well, felt cold, body aches, restless , feverish, left shoulder really sore. Today , woke at noon today, did not sleep well last night at all, ate bananas, and vomited at 1:30 pm, Feeling better now, 234 pm,
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: Immediately at time of injection, felt arm soreness to be expected, but came home worked out, and then felt nausea and tired.  Took Tylenol last night at 7 pm, this am at 2 am and then again at 12:30 pm. At midnight, could not sleep well, felt cold, body aches, restless , feverish, left shoulder really sore. Today , woke at noon today, did not sleep well last night at all, ate bananas, and vomited at 1:30 pm, Feeling better now, 234 pm,
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Within a few minutes (maybe 5 minutes?), the patient returned to the pharmacy after she threw up in her mask. Technician, gave her a bottled water, new mask, and plastic bag. She asked him if this was a normal reaction. He told her he was unsure. The vaccinating pharmacist was on the phone at the time of this event, but had verified with patient before administering the vaccine that it was preservative free. Patient also told rph that she was trying to get pregnant since she marked "yes" in the box "are you pregnant or is there a chance you could become pregnant in the next month?"
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site reaction, Peau d'orange
Clinical narrative: Cellulite at the injection site; This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced cellulite at the injection site on an unspecified date with outcome of unknown.   No follow-up attempts are needed. No further information is expected. Information about lot/batch number cannot be obtained.; Sender's Comments: A possible causal association between administration of PREVNAR 13 and the onset of cellulite at the injection site/vaccination site cellulitis cannot be excluded, considering the plausible temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Product supply issue
Clinical narrative: didn't feel well; the vaccine was out of stock; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (Refer linked case US2020156565 for 1st dose.).   On 3rd August 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced feeling unwell and product supply issue. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the feeling unwell was recovered/resolved and the outcome of the product supply issue was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingrix.  Additional details were reported as follows: The patient received 2nd dose of Shingrix because the vaccine was out of stock which led to product supply issue and patient didn't feel well for 24 hours, after the 24 hours period, she felt fine. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020156568:same reporter US-GLAXOSMITHKLINE-US2020156565:same patient
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes ophthalmic, Herpes zoster
Clinical narrative: shingles on my face and eye; shingles on my face and eye; This case was reported by a consumer via call center representative and described the occurrence of herpes ophthalmic in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number J3M5J, expiry date 6th February 2022) for prophylaxis.   In August 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In August 2020, couple of days after receiving Shingrix, the patient experienced herpes ophthalmic (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the herpes ophthalmic and shingles were unknown.   It was unknown if the reporter considered the herpes ophthalmic and shingles to be related to Shingrix.  Additional information was received as follows: The patient received the fisrt dose of Shingrix last week on left deltoid, but within a couple days he had shingles on his face and eye.
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix was given to a patient less than 4 years of age; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a child patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, unknown after receiving Kinrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The reporter reported that Kinrix was given to a patient less than 4 years of age which led to inappropriate age at vaccine administration. The follow up consent was not granted. This was a medication error without harm.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: Very significant swelling and inflammation at the injection site (shoulder).  So concerning the next day, that we took him back to the doctor so they could look at.  The swelling took many days before it went away.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Very painful at injection site for a month. pain disappeared.  Came back after a month and lasted for a couple of weeks. Disappeared and has returned again as of 8-18-20
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Injected limb mobility decreased, Pain in extremity, Somnolence
Clinical narrative: Patient called pharmacy at 6 pm on 8/18/20 to report that she had extreme arm soreness related to vaccine that she states inhibited her from lifting her arm. At this time she was counseled to take OTC pain relief and ice vaccination site. She was instructed to call doctor or pharmacy if pain worsened. Followed up with patient today 8/19/20. She states that after talking on 8/18/20 that pain continued to  worsen and inhibited her from sleeping well due to being uncomfortable. She states that she has taken tylenol and ibuprofen periodically throughout today and feels that it is continuing to improve. She states that she is able to move arm more than previous day but is still restricted due to the pain. She stated that she has not called doctor yet.
Age: 43.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site rash, Injection site swelling, Malaise, Pyrexia
Clinical narrative: Fever, Malaise, Injection site swelling/rash, fatigue.
Age: 51.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Feeling hot
Clinical narrative: Joint aches, high temp, dizziness, vomiting, arm soreness and throbbing, headache, sneezing, chills  and hot spells, fatigue
Age: 51.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Headache, Pain, Pain in extremity, Pyrexia, Sneezing
Clinical narrative: Joint aches, high temp, dizziness, vomiting, arm soreness and throbbing, headache, sneezing, chills  and hot spells, fatigue
Age: 51.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Vomiting
Clinical narrative: Joint aches, high temp, dizziness, vomiting, arm soreness and throbbing, headache, sneezing, chills  and hot spells, fatigue
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling
Clinical narrative: Swelling of entire anterior left thigh muscle.  Able to walk.  No pain.  No fever.
Age: 66.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: Patient stated she developed Guillain-Barre - required rehab to recover
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site vesicles
Clinical narrative: 10 days after vaccine, patient erupted with small amount of  vesicular lesions at site of injection
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: Erythema extending from the site of the injection, developing 2 days after the injection was given.  Felt to be consistent with a cellulitis and treated with antibiotics.
Sex: F
Vaccine: HEP
Symptoms: Death
Clinical narrative: Patient died with no known cause less than 24 hours after her vaccination.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Burning sensation, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Sore arm,  redness, swelling, burning sensation, painful
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Injection site erythema, Injection site irritation, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, swelling and itching at injection site. Also experiencing body aches and fatigue. Recommended topical hydrocortisone on irritated site on day 2, and Tylenol for body aches. Outcome unknown.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Redness, swelling and itching at injection site. Also experiencing body aches and fatigue. Recommended topical hydrocortisone on irritated site on day 2, and Tylenol for body aches. Outcome unknown.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Pyrexia, Vaccination complication
Clinical narrative: Fever, chills, and fatigue the night of the shot. Patient most likely just reacted to the shot itself
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Decreased appetite, Dizziness, Erythema
Clinical narrative: About 5pm on 8/17/20, I noticed my left ankle was very itchy and red. After, I went to be the same day, I woke up shivering, cold and feverish. The next day, 8/18/20, my stomach hurt, very bad headache, very tired/fatigued, nausea, loss of appetite, dizziness. This lasted the entire day on 8/18/20. I was not able to eat anything, just drink water and a little bit of juice. Today, is much better, but still have a slight headache. I took ibuprofen both days, but not sure it helped.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling cold, Headache, Nausea, Pruritus
Clinical narrative: About 5pm on 8/17/20, I noticed my left ankle was very itchy and red. After, I went to be the same day, I woke up shivering, cold and feverish. The next day, 8/18/20, my stomach hurt, very bad headache, very tired/fatigued, nausea, loss of appetite, dizziness. This lasted the entire day on 8/18/20. I was not able to eat anything, just drink water and a little bit of juice. Today, is much better, but still have a slight headache. I took ibuprofen both days, but not sure it helped.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: About 5pm on 8/17/20, I noticed my left ankle was very itchy and red. After, I went to be the same day, I woke up shivering, cold and feverish. The next day, 8/18/20, my stomach hurt, very bad headache, very tired/fatigued, nausea, loss of appetite, dizziness. This lasted the entire day on 8/18/20. I was not able to eat anything, just drink water and a little bit of juice. Today, is much better, but still have a slight headache. I took ibuprofen both days, but not sure it helped.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Malaise, Myalgia, Nausea
Clinical narrative: Muscle pain in arm, shivering, stomach pain and nausea, all over malaise....
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Muscle pain in arm, shivering, stomach pain and nausea, all over malaise....
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Tremor
Clinical narrative: Fatigue, shaking chills, headache, muscle ache