chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: TYP
Symptoms: Giardia test negative, Salmonella test negative, Stool analysis normal, Tremor
Clinical narrative: VIVOTIF was taken on 10/14/17, 10/16/17, 10/18/17, and 10/20/17. Adverse reactions started on 10/28/17. They were an abrupt onset of lower abdominal cramps and constipation, and dizziness and shakiness right before, during and after defecation. Patient tried to alleviate constipation with laxatives. At present (1/3/18), the dizziness and shakiness have subsided, but the abdominal cramping and constipation persists.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Back pain, Blood test normal, Chest X-ray abnormal, Delirium, Dizziness postural
Clinical narrative: By 8 p.m. patient's had a fever and a very sore arm. Her fever rose to 103.8, she was delirious, tachycardic and faint on standing. By the time she was at the ER at about 2:30 a.m. on 12/27 her fever was 105, her resting heart rate was 138. Treatments: rectal acetaminophen, IV toradol and beta blocker. Outcome: fever subsided after toradol, tachycardia lessened after beta blocker
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Joint range of motion decreased, Neck pain, Pain in extremity, Pyrexia, Tachycardia
Clinical narrative: By 8 p.m. patient's had a fever and a very sore arm. Her fever rose to 103.8, she was delirious, tachycardic and faint on standing. By the time she was at the ER at about 2:30 a.m. on 12/27 her fever was 105, her resting heart rate was 138. Treatments: rectal acetaminophen, IV toradol and beta blocker. Outcome: fever subsided after toradol, tachycardia lessened after beta blocker
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Urine analysis normal
Clinical narrative: By 8 p.m. patient's had a fever and a very sore arm. Her fever rose to 103.8, she was delirious, tachycardic and faint on standing. By the time she was at the ER at about 2:30 a.m. on 12/27 her fever was 105, her resting heart rate was 138. Treatments: rectal acetaminophen, IV toradol and beta blocker. Outcome: fever subsided after toradol, tachycardia lessened after beta blocker
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Pain, Product administered at inappropriate site
Clinical narrative: Patient had severe pain the evening of the injection, and the next day he was unable to move his arm for several days. He went to the doctor's and told them that he received his injection high on the arm. He is now able to move his arm and has much less pain. The shot was administered on 12/2/17 and we were notified on 12/30/17.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Blindness, Feeling hot, Hyperhidrosis, Paraesthesia, Syncope
Clinical narrative: Fainting. Within a minute or there about of injection limbs felt like pins and needles. Patient felt very hot, lost vision, and profuse sweating. These symptoms have never been recorded during previous vaccinations.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Feeling abnormal, Headache, Influenza like illness, Nasopharyngitis
Clinical narrative: WIthin 12 hours of injection (11:00pm) felt "like a cold coming on" and felt worse through the morning. The next day, experienced extreme flu-like symptoms- achey, headache, exteme fatigue, no fever.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: WIthin 12 hours of injection (11:00pm) felt "like a cold coming on" and felt worse through the morning. The next day, experienced extreme flu-like symptoms- achey, headache, exteme fatigue, no fever.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Tendonitis
Clinical narrative: Arm pain then when she went to the doctor, she got diagnosed with tendinitis and she said the pain lasted for 2 weeks and she might go to physical therapy to come back to normal.
Age: 41.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient experienced redness, swelling and pain at injection site and sought medication treatment for injection site reaction. Symptoms resolved with ice.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: Pain at and around injection site. Began about an hour after the vaccine was administered and became gradually worse. Waiting to see if it gets better.
Age: 74.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported swelling from right deltoid to right elbow. Red and warm to the touch. Reported morning after injection.
Age: 21.0
Sex: M
Vaccine: MENB
Symptoms: Axillary pain, Back pain, Body temperature increased, Fluid retention, Headache
Clinical narrative: Please note that I am not aware if this was Men B BEXSERO OR Men B TRUMENBA; On December 23rd in the evening my son started to feel nauseated with a headache and backache. I gave him 600 mg of Ibuprofen at about 1830. By 1900 his temp was 101.2 F and he was stating he couldn't feel his feet and left arm. This was a Holiday weekend, and I don't have confidence in my designated ER. I read the vaccine info sheet. I hydrated him and administered TYLENOL as I was sponging him with tepid water. His temp continued to climb to 101.8 over the next few hours. My plan was to bring him to the ER if his temp reached 102 despite the cooling measures. By about 2300 his temp began to slowly drop and he was feeling better. Over the next day he was complaining of pain under his armpit. He continued taking Ibuprofen 400 mg every 6 hours for the next several days as he continued with a temperature. The site of the injection remained red and swollen for about 3 days. His temp was normal after 4 days. On the 3rd day we noted that he had a considerable amount of fluid (presumably lymph) under his left arm. It extended from his armpit down his side approx 8 inches, and anterior posterior about 6 inches. This fluid has slowly been presumably reabsorbing, and is now just present in his armpit. This was the most distressing part for him as it was quite uncomfortable. We described it to people as if he had a Jello mold stuck on his side. As you would touch it his whole under arm would jiggle. It was quite obvious on a 6'3" 160 pound swimmer athlete. He finally felt "back to Normal" after approx. 5 days post vaccination. He had no other complaints besides the arm pain, fever, nausea, headache, back pain.
Age: 21.0
Sex: M
Vaccine: MENB
Symptoms: Hypoaesthesia, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Please note that I am not aware if this was Men B BEXSERO OR Men B TRUMENBA; On December 23rd in the evening my son started to feel nauseated with a headache and backache. I gave him 600 mg of Ibuprofen at about 1830. By 1900 his temp was 101.2 F and he was stating he couldn't feel his feet and left arm. This was a Holiday weekend, and I don't have confidence in my designated ER. I read the vaccine info sheet. I hydrated him and administered TYLENOL as I was sponging him with tepid water. His temp continued to climb to 101.8 over the next few hours. My plan was to bring him to the ER if his temp reached 102 despite the cooling measures. By about 2300 his temp began to slowly drop and he was feeling better. Over the next day he was complaining of pain under his armpit. He continued taking Ibuprofen 400 mg every 6 hours for the next several days as he continued with a temperature. The site of the injection remained red and swollen for about 3 days. His temp was normal after 4 days. On the 3rd day we noted that he had a considerable amount of fluid (presumably lymph) under his left arm. It extended from his armpit down his side approx 8 inches, and anterior posterior about 6 inches. This fluid has slowly been presumably reabsorbing, and is now just present in his armpit. This was the most distressing part for him as it was quite uncomfortable. We described it to people as if he had a Jello mold stuck on his side. As you would touch it his whole under arm would jiggle. It was quite obvious on a 6'3" 160 pound swimmer athlete. He finally felt "back to Normal" after approx. 5 days post vaccination. He had no other complaints besides the arm pain, fever, nausea, headache, back pain.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Back pain, Gait inability, Pain, Pain in extremity
Clinical narrative: The patient complained of being unable to walk. Patient's wife came to the pharmacy and two pharmacist went with her where the patient was seated on a bench. Patient said he started having sharp pain in his left lower back radiating all the way down his left leg. He said he had to sit down as the pain was excruciating. Patient said he didn't have any pain when the two pharmacists went to make sure he was doing alright and was able to walk on his own.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: The patient experienced rash all over her body and no other symptoms. Her primary doctor prescribed VALTREX 1 gram to be taken twice a day.
Age: 1.5
Sex: F
Vaccine: VARCEL
Symptoms: Chest X-ray abnormal, Pneumonia, Pyrexia
Clinical narrative: A week after the Varicella vaccine was given to my daughter, she had a high fever. After giving her over the counter MOTRIN and TYLENOL, her fever would not go down. I called the Dr and was told to take her to the ER if it would not go down. Her fever had gone as high as 104, but only went down to 102. She was taken to the Emergency Room at Hospital and was diagnosed with pneumonia. I did not know that this was a rare side effect of the vaccine until recently. I was told to report the incident.
Age: 49.0
Sex: M
Vaccine: FLU4, FLU3
Symptoms: Fatigue, Mobility decreased
Clinical narrative: Unable to move arm, fatigue.
Age: 65.0
Sex: F
Vaccine: DTP
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in a 65-year-old female patient who received DTP (A or W not known). Co-suspect produces included Flu Seasonal QIV Dresden. In December 2017, the patient received DTP (A or W not known). In November 2017, the patient received Influenza vaccine. On an unknown date, less than a month after receiving DTP (A or W not known) and less than a year after receiving Influenza vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. The reporter considered the pain to be related to DTP (A or W not known) and Influenza vaccine. Additional details were provided as follows: While discussing the difference between subcutaneous versus intramuscular vaccination, the patient mentioned had pain associated with the flu and DPT vaccinations. The patient did not know the names of the vaccines but said she did not remember having pain with previous flu shots. The patient inquired about new SHINGRIX vaccine.
Age: 78.0
Sex: M
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: Patient Reported continuous pain in upper arm since administration of vaccine (over 1 month) duration.
Sex: F
Vaccine: VARZOS
Symptoms: Grimacing, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site stinging in a female patient who received SHINGRIX. On 27th December 2017, the patient received SHINGRIX. On 27th December 2017, immediately after receiving SHINGRIX, the patient experienced injection site stinging and grimacing. On an unknown date, the outcome of the injection site stinging and grimacing were unknown. It was unknown if the reporter considered the injection site stinging and grimacing to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in left deltoid. As per the pharmacist there was more wincing of the patient when SHINGRIX was being administered. This case was linked with the case US2017201546, reported by the same reporter.
Sex: F
Vaccine: TDAP
Symptoms: Paraesthesia, Syncope, Tonic clonic movements, Visual impairment
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tonic clonic movements in a female patient who received BOOSTRIX. In August 2017, the patient received BOOSTRIX. In September 2017, less than a year after receiving BOOSTRIX, the patient experienced tonic clonic movements (serious criteria GSK medically significant), syncope, paresthesia and visual disturbance. On an unknown date, the outcome of the tonic clonic movements, syncope, paresthesia and visual disturbance were not recovered/not resolved. The reporter considered the tonic clonic movements, syncope, paresthesia and visual disturbance to be possibly related to BOOSTRIX. Additional details were provided as follows: The patient's parent reported this case. The age at vaccination was not reported. The patient's adverse events were noted in the first week of September 2017. The neurologist was conducting additional tests. The reporter did not want to provide more information.
Sex: F
Vaccine: HPV4, MENB
Symptoms: Syncope
Clinical narrative: This case was reported by a physician and described the occurrence of syncope in a female patient who received BEXSERO. Co-suspect products included GARDASIL. On 19th December 2017, the patient received BEXSERO .5 ml and GARDASIL. On 20th December 2017, 1 days after receiving BEXSERO, the patient experienced syncope. On an unknown date, the outcome of the syncope was unknown. The reporter considered the syncope to be unrelated to BEXSERO. Additional details were provided as follows: The age at the vaccination was not reported. It was reported that the patient fainted the following day of vaccination. The reporter does not think the event was related to the vaccines.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in arm in an unspecified number of patients who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain in arm, swelling arm and erythema of extremities. On an unknown date, the outcome of the pain in arm, swelling arm and erythema of extremities were unknown. It was unknown if the reporter considered the pain in arm, swelling arm and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: This case was not previously reported to anyone. The age at vaccination was not reported. The patients experienced pain in arm, redness and swelling on arm. The nurse reported that she had noticed this with other patients she had given SHINGRIX to. There were no other identifiers for these patients. This case been linked with US2017196862, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Grimacing, Immediate post-injection reaction, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site stinging in a adult female patient who received SHINGRIX. On 27th December 2017, the patient received SHINGRIX. On 27th December 2017, immediately after receiving SHINGRIX, the patient experienced injection site stinging and grimacing. On an unknown date, the outcome of the injection site stinging and grimacing were unknown. It was unknown if the reporter considered the injection site stinging and grimacing to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in left deltoid. As per the pharmacist there was more wincing of the patient when SHINGRIX was being administered. This case was linked with the case US2017201545, reported by the same reporter.
Sex: F
Vaccine: DTAPIPV
Symptoms: Bordetella test negative, Malaise, Therapeutic response decreased
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of therapeutic response decreased in a female patient who received KINRIX. On an unknown date, the patient received KINRIX at an unknown dose. In November 2017, less than a year after receiving KINRIX, the patient experienced sickness. On an unknown date, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased and sickness were unknown. It was unknown if the reporter considered the therapeutic response decreased and sickness to be related to KINRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient received KINRIX 6 months ago and pertussis levels were drawn, IgG and IgM levels were lower than expected, which led to decreased therapeutic response. No further information was provided.
Sex: U
Vaccine: FLU4
Symptoms: Vaccination complication
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of adverse reaction in a patient who received Influenza vaccine Quadrivalent unspecified season. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The nurse practitioner and a student were having a conversation about the patient in the office and the student said that the patient had an adverse reaction to a flu vaccine. No other information was available. The reporting representative did not recall the exact date that she first became aware of the event, but it was sometime last week from the date of reporting.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Flushing, Hypoaesthesia, Swelling
Clinical narrative: Only information available to reviewer: Signs and symptoms included numbness, swelling, flushing.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Gastrointestinal pain, Nausea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of gastrointestinal pain in a 71-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On 22nd December 2017, the patient received SHINGRIX. In December 2017, 1 day after receiving SHINGRIX, the patient experienced gastrointestinal pain, nausea, fatigue and dizziness. On an unknown date, the outcome of the gastrointestinal pain and nausea were recovering/resolving and the outcome of the fatigue and dizziness were unknown. It was unknown if the reporter considered the gastrointestinal pain, nausea, fatigue and dizziness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left deltoid. The healthcare professional reported that about 24 hours after receiving a dose of SHINGRIX, the patient developed gastrointestinal pain, nausea, fatigue and dizziness. The patient still has gastrointestinal pain up to six days post administration of vaccine. No further information was reported regarding the event.
Age: 19.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Arthralgia, Headache, Injection site pain, Pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 19-year-old female patient who received BEXSERO (batch number 16B501, expiry date February 2019). Concomitant products included FLULAVAL QUADRIVALENT and PROZAC. On 21st December 2017, the patient received the 2nd dose of BEXSERO .5 ml. On 21st December 2017, less than a day after receiving BEXSERO, the patient experienced injection site pain, headache, pain in hip, neck pain and general body pain. On an unknown date, the outcome of the injection site pain, headache, pain in hip, neck pain and general body pain were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, headache, pain in hip, neck pain and general body pain to be related to BEXSERO. Additional information was reported as follows: The patient received BEXSERO in the right arm and FLULAVAL QUADRIVALENT in the left arm. After vaccination, the patient experienced side effects on the BEXSERO vaccine. The patient was had severe pain on right side of body, soreness where the patient received the BEXSERO, joint pain and hip pain.
Age: 29.0
Sex: F
Vaccine: RAB, TTOX
Symptoms: Injection site haemorrhage, Laboratory test normal
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of petechia at injection site in a 29-year-old female patient who received RABAVERT. Co-suspect products included RABAVERT (batch number 643011E, expiry date 30th May 1930). Concomitant products included Tetanus. On 29th November 2017, the patient received the 1st dose of RABAVERT. On 6th December 2017, the patient received the 2nd dose of RABAVERT. In November 2017, 1 day after receiving RABAVERT and not applicable after receiving RABAVERT, the patient experienced petechia at injection site. In December 2017, the patient experienced petechia at injection site. In November 2017, the outcome of the petechia at injection site was recovered/resolved. In December 2017, the outcome of the petechia at injection site was recovered/resolved. The reporter considered the petechia at injection site to be almost certainly related to RABAVERT. The reporter considered the petechia at injection site to be almost certainly related to RABAVERT. Additional details were provided as follows: This case was reported by the physician assistant who herself was the patient. Approximately 24 hours after receiving the 2nd dose of RABAVERT, the patient noted a petechial rash over the injection site on the left deltoid and over the injection site from the first dose on the right deltoid. There was no pain or swelling associated with the rash. The rash disappeared within 24 hours of being noticed. The patient did seek medical care and reported that all laboratory values were within normal limits.
Sex: M
Vaccine: RAB
Symptoms: Asthenia, Cardiac disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of heart disorder in a adult male patient who received RABAVERT (batch number 628011A, expiry date 30th April 2020) and (batch number 627011A, expiry date 31st March 2020). On an unknown date, the patient received RABAVERT. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving RABAVERT, the patient experienced heart disorder and weakness. On an unknown date, the outcome of the heart disorder and weakness were unknown. It was unknown if the reporter considered the heart disorder and weakness to be related to RABAVERT. Additional details were provided as follows: The caller was a scientist and was not considerd a healthcare professional. The age at the vaccination was not reported. The patient reported that he received the Rabies vaccine and that he had a bad heart and was weak. It was unknown if the patient received RABIPUR vaccination for pre or post exposure prophylaxis. Attempted to clarify the timing of symptom development and when the patient received the vaccine and he refused to provide the information. The report was filed with limited information provided during the call as unable to verify demographic information or collect any further details for this report. The caller was asking for safety information about the lot numbers provided above.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Confusional state, Syncope
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fainting in a 9-year-old male patient who received FLUARIX TETRA (batch number BF7CA, expiry date 30th June 2018). On 18th November 2017, the patient received the 1st dose of FLUARIX TETRA (intramuscular) .5 ml. On 18th November 2017, less than a hour after receiving FLUARIX TETRA, the patient experienced fainting and confusion. On an unknown date, the outcome of the fainting and confusion were recovered/resolved. It was unknown if the reporter considered the fainting and confusion to be related to FLUARIX TETRA. Additional details were provided as follows: Intern reports that a male patient received a flu vaccine at a clinic off site. The age at vaccination was not reported. Within a minute or two, after receiving FLUARIX TETRA, the patient experienced fainting. Less than a day, after receiving FLUARIX TETRA, the patient awake confused per the Intern. The issues resolved and the patient departed the facility with his mother. The reported did not have information on the clinic site where the vaccination took place.
Age: 66.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Urticaria, Pruritus.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Per mom once patient was home the area were she received Dtap on thigh had red raised area the size of a golf ball, with even larger redness around that, it lasted several days before clearing up. Per patients mother this is the 3rd reaction for Dtap containing vaccine, each time the reaction gets larger and larger.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Erythema and edema in left arm.
Age: 33.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Rash
Clinical narrative: Skin rash.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral swelling
Clinical narrative: Arm swelling.
Age: 49.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Mobility decreased
Clinical narrative: Unable to move arm, fatigue
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Bradycardia, Confusional state, Respiratory depression
Clinical narrative: Confusion, Anaphylaxis, RespDepression and Bradycardia.
Age: 43.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Erythema, Infection, Injection site swelling, Pain in extremity
Clinical narrative: Information has been received from a 43 year old, non-pregnant female with no known drug allergies and a history of "chickenpox 3 times." On 28-NOV-2017, the patient was vaccinated with ZOSTAVAX 0.65 ml once (lot number and expiration date not provided) via unspecified injection, to prevent shingles. The patient stated that she got the vaccine before age 50 because she is "at high risk for shingles." Concomitant therapies included: fesoterodine fumarate (TOVIAZ), levothyroxine sodium (UNITHROID), gabapentin, potassium citrate, polyethylene glycol, and phentermine. Later on that day (28-NOV-2017), the patient's arm "swelled up, and as the night went on it started to hurt really bad. Then it started itching and the swelling grew." The next day (29-NOV-2017), the patient's arm was "hurting, burning and hot to the touch. It started turning red and was running down her arm." The events got worse and on 02-DEC-2017, the patient went to an urgent care facility for her injection site reaction. Unspecified treatment was reported to have been given. The outcome of the events was reported as recovering. Follow-up information was received on 15-DEC-2017 from the 43 year old female patient with an unspecified thyroid condition and unspecified bladder condition. Additional concomitant medication of dimethicone (POLYSILANE) noted. On the evening of 28-NOV-2017, the patient's arm began swelling up at the injection site. The patient described the arm as "hot to touch." On 29-NOV-2017, the patient reported that the infected area doubled in size, became more painful, and started to itch. The patient took an unknown dosage of ibuprofen (MOTRIN). On 01-DEC-2017, the infected site grew "two inches bigger." The patient applied ice to the site. On 02-DEC-2017, the patient went to the urgent care facility and was prescribed an unknown steroid and an unknown antibiotic. It is reported that the pain and itch are gone, but the infected area is still red and purple. Additional information is not expected.
Age: 43.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling, Pruritus, Skin discolouration, Skin warm
Clinical narrative: Information has been received from a 43 year old, non-pregnant female with no known drug allergies and a history of "chickenpox 3 times." On 28-NOV-2017, the patient was vaccinated with ZOSTAVAX 0.65 ml once (lot number and expiration date not provided) via unspecified injection, to prevent shingles. The patient stated that she got the vaccine before age 50 because she is "at high risk for shingles." Concomitant therapies included: fesoterodine fumarate (TOVIAZ), levothyroxine sodium (UNITHROID), gabapentin, potassium citrate, polyethylene glycol, and phentermine. Later on that day (28-NOV-2017), the patient's arm "swelled up, and as the night went on it started to hurt really bad. Then it started itching and the swelling grew." The next day (29-NOV-2017), the patient's arm was "hurting, burning and hot to the touch. It started turning red and was running down her arm." The events got worse and on 02-DEC-2017, the patient went to an urgent care facility for her injection site reaction. Unspecified treatment was reported to have been given. The outcome of the events was reported as recovering. Follow-up information was received on 15-DEC-2017 from the 43 year old female patient with an unspecified thyroid condition and unspecified bladder condition. Additional concomitant medication of dimethicone (POLYSILANE) noted. On the evening of 28-NOV-2017, the patient's arm began swelling up at the injection site. The patient described the arm as "hot to touch." On 29-NOV-2017, the patient reported that the infected area doubled in size, became more painful, and started to itch. The patient took an unknown dosage of ibuprofen (MOTRIN). On 01-DEC-2017, the infected site grew "two inches bigger." The patient applied ice to the site. On 02-DEC-2017, the patient went to the urgent care facility and was prescribed an unknown steroid and an unknown antibiotic. It is reported that the pain and itch are gone, but the infected area is still red and purple. Additional information is not expected.
Age: 43.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Insomnia, Pain, Pain in extremity, Peripheral swelling, Skin reaction
Clinical narrative: Information has been received from a 43 year old, non-pregnant female with no known drug allergies and a history of "chickenpox 3 times." On 28-NOV-2017, the patient was vaccinated with ZOSTAVAX 0.65 ml once (lot number and expiration date not provided) via unspecified injection, to prevent shingles. The patient stated that she got the vaccine before age 50 because she is "at high risk for shingles." Concomitant therapies included: fesoterodine fumarate (TOVIAZ), levothyroxine sodium (UNITHROID), gabapentin, potassium citrate, polyethylene glycol, and phentermine. Later on that day (28-NOV-2017), the patient's arm "swelled up, and as the night went on it started to hurt really bad. Then it started itching and the swelling grew." The next day (29-NOV-2017), the patient's arm was "hurting, burning and hot to the touch. It started turning red and was running down her arm." The events got worse and on 02-DEC-2017, the patient went to an urgent care facility for her injection site reaction. Unspecified treatment was reported to have been given. The outcome of the events was reported as recovering. Follow-up information was received on 15-DEC-2017 from the 43 year old female patient with an unspecified thyroid condition and unspecified bladder condition. Additional concomitant medication of dimethicone (POLYSILANE) noted. On the evening of 28-NOV-2017, the patient's arm began swelling up at the injection site. The patient described the arm as "hot to touch." On 29-NOV-2017, the patient reported that the infected area doubled in size, became more painful, and started to itch. The patient took an unknown dosage of ibuprofen (MOTRIN). On 01-DEC-2017, the infected site grew "two inches bigger." The patient applied ice to the site. On 02-DEC-2017, the patient went to the urgent care facility and was prescribed an unknown steroid and an unknown antibiotic. It is reported that the pain and itch are gone, but the infected area is still red and purple. Additional information is not expected.
Age: 43.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin warm
Clinical narrative: Information has been received from a 43 year old, non-pregnant female with no known drug allergies and a history of "chickenpox 3 times." On 28-NOV-2017, the patient was vaccinated with ZOSTAVAX 0.65 ml once (lot number and expiration date not provided) via unspecified injection, to prevent shingles. The patient stated that she got the vaccine before age 50 because she is "at high risk for shingles." Concomitant therapies included: fesoterodine fumarate (TOVIAZ), levothyroxine sodium (UNITHROID), gabapentin, potassium citrate, polyethylene glycol, and phentermine. Later on that day (28-NOV-2017), the patient's arm "swelled up, and as the night went on it started to hurt really bad. Then it started itching and the swelling grew." The next day (29-NOV-2017), the patient's arm was "hurting, burning and hot to the touch. It started turning red and was running down her arm." The events got worse and on 02-DEC-2017, the patient went to an urgent care facility for her injection site reaction. Unspecified treatment was reported to have been given. The outcome of the events was reported as recovering. Follow-up information was received on 15-DEC-2017 from the 43 year old female patient with an unspecified thyroid condition and unspecified bladder condition. Additional concomitant medication of dimethicone (POLYSILANE) noted. On the evening of 28-NOV-2017, the patient's arm began swelling up at the injection site. The patient described the arm as "hot to touch." On 29-NOV-2017, the patient reported that the infected area doubled in size, became more painful, and started to itch. The patient took an unknown dosage of ibuprofen (MOTRIN). On 01-DEC-2017, the infected site grew "two inches bigger." The patient applied ice to the site. On 02-DEC-2017, the patient went to the urgent care facility and was prescribed an unknown steroid and an unknown antibiotic. It is reported that the pain and itch are gone, but the infected area is still red and purple. Additional information is not expected.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: This spontaneous report was received from a nurse and refers to a female patient of unknown age. The patient's pertinent medical history included cured hepatitis C. The patient did not have any drug reactions or allergies. No information regarding concomitant medications was provided. On 19-DEC-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N010105; expiry date 15-NOV-2017 (dose and route of administration were not provided). On an unknown date in December 2017 (reported as shortly after receiving the vaccination), the patient developed a cellulitis-like reaction. The patient sought medical attention by calling the office. No antibiotics or other treatment were given. No lab diagnostics or studies were performed. The outcome of the event was reported as recovered on an unknown date in December 2017 (reported as: up to week after receiving the injection"). The causality assessment was not provided. The reporter requested a lot check for the PNEUMOVAX 23. Upon internal review, the event of the cellulitis-like reaction not under control was considered medically significant. Sender's Comments: US-009507513-1712USA014308: US-009507513-1801USA000917.
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Mobility decreased
Clinical narrative: This spontaneous report was received from a nurse and refers to a female patient of unknown age. The patient's pertinent medical history included hypertension. The patient did not have any drug reactions or allergies. No information regarding concomitant medications was provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 lot # N010105; expiry date 15-NOV-2017 (dose and route of administration were not provided). On an unknown date, the patient developed pain and swelling in the arm where the vaccination was given and "couldn't lift her arms". The patient sought medical attention by calling the office. No antibiotics or other treatment were given. No lab diagnosics or studies were performed. The outcome of the event was reported as recovered (on an unknown date reported as: "up to a week after receiving the injcection). The causality assessment was not provided. The reporter requested a lot check for the PNEUMOVAX 23.; Sender's Comments: US-009507513-1801USA000916: US-009507513-1712USA014308:
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: Moderate swelling, redness, and erythema (local reaction).
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Nodule, Pain, Tenderness
Clinical narrative: Patient came by on 1/3/18 and stated that her arm was still tender and felt like it sometimes had a knot in it since her flu vaccine on 9/26/2017. She said it sometimes hurt to raise her arm. I asked if she had seen a doctor regarding the problem. She said she had not seen a doctor, but uses the Clinic. I recommended that she have it examined.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. The reporter informed that on 01-DEC-2017, the patient was inadvertently administered a dose of expired ROTATEQ orally, for prophylaxis, lot# M007311 and expiration date 30-NOV-2017 (strength, dose and frequency were not reported). No adverse effects were reported.
Sex: F
Vaccine: MMR
Symptoms: Measles antibody negative, Mumps antibody test negative, Rubella antibody negative
Clinical narrative: This spontaneous report as received from a medical assistant referring to a 22 year old female patient. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. It was unknown if the patient was previously vaccinated with M-M-R II. On 20-NOV-2017, the patient was vaccinated with a dose of M-M-R II, 1 dose, lot # reported as N029919 with expiration date 13-JUN-2018, for prophylaxis (route of administration was not provided). Concomitant therapies included sterile diluent (STERILE DILUENT). On an unspecified date in 2017, the patient had "negative bloodwork for immunity" to all three components of M-M-R II. At the time of reporting the outcome of measles antibody negative, rubella antibody negative and mumps antibody test negative was unknown. The causality assessment between the events and M-M-R II was not provided. Lot number N029919 is an invalid lot number for  M-M-R II.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an office manager referring to a 4 month old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 30-NOV-2017, the patient was administered a dose of improperly stored ROTATEQ lot # M044397, expired on 20-JUN-2018 or lot # N003984, expired on 19-NOV-2018 (the specific lot number administered was unknown by reporter), orally, for prophylaxis (strength was not reported). The vaccine was stored at or above a temperature of 32°F up to 35°F (35.4°F) for 45 minutes. No previous temperature excursions neither adverse effects were reported. The call was because of a data logger.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician referring to a 70 year old male patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unspecified date in 2012, reported as about 5 years ago the patient was vaccinated with ZOSTAVAX for prophylaxis (dose, route of administration, lot number and expiration date were not reported). It was reported that the patient presented to the physician over the weekend with shingles. The reporter stated that the patient was prescribed a course of anti-virals on an unspecified date. At the time of the report, the outcome of shingles was unknown. Additionally, the reporter did not provide causality assessment between the event and vaccination with ZOSTAVAX.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from an Administrator referring to a 6 month old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 28-NOV-2017, the patient was vaccinated with an improperly stored dose of ROTATEQ per oral (dose, dose number, frequency and anatomical location were unknown) the lot #s reported were N003984 with expiration date 19-NOV-2018 and M044397 with 20-JUN-2018, the lot number administered to the patient was unknown for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 32 F up to 35 F (35.4F) degrees Fahrenheit for 45 minutes. There was Digital Data logger involved. There were no previous excursions reported. It was reported that this case was 2 of 7.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 28-DEC-2017, the patient was vaccinated with an expired dose of ZOSTAVAX lot # M039452 and expiration date 19-DEC-2017 (dose, frequency and route of administration were not provided) for prophylaxis. The reporter stated that the vaccine of ZOSTAVAX did not have any temperature excursions prior to administration. No adverse symptoms reported.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse, and refers to an 18 week female patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications. On 02-NOV-2017, the patient inadvertently received first dose of ROTATEQ orally for prophylaxis lot number M044399 (dose and expiration date were not reported). There was not product quality complain or adverse effect involved.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly store dose of GARDASIL 9 lot number N020352 and expiration date of 10-APR-2020, 1 injection, intramuscularly for prophylaxis (dose was not reported). No adverse effects were reported. The vaccine was exposed to a temperature excursion of  47°F to 77°F with a time frame of 5 hours. There was no previous temperature excursion. A "data logger" was involved. There was not product quality complaint involved.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain, Feeling abnormal, Injection site pain, Musculoskeletal pain
Clinical narrative: Initial unsolicited report received from a pharmacist on 27-Oct-2017. This case involves 87-year-old male patient who was vaccinated with dose of FLUZONE HD 0.5 ml via intra muscular route, (batch number: UI883AB, expiry date: unknown, dose in series and site of administration were not reported) in the left deltoid on 25-Oct-2017. Patient's medical history and concomitant medications were not reported. Stated patient did not receive any other vaccines that day. Stated that patient had no known allergies. On 25-Oct-2017, same day following the vaccination, patient experienced severe pain from shoulder to shoulder and extending down the back. Stated patient reported he also felt funny. Lab data and corrective treatment were unknown. The event outcome was recovered at the time of reporting. List of documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Swelling, Tenderness
Clinical narrative: Initial unsolicited report received from a nurse on 01 November 2017. This case involves a 65-year-old female patient female patient who was vaccinated with an FLUZONE HIGH DOSE (dose volume, dose in series, batch number, expiry date, route of administration was not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed reaction of redness, swelling, tenderness. The patient's laboratory data and corrective treatment were not reported. At the time of report the patient was recovering from the events (Patient's symptoms improved 3 week after injection). Follow up information received from a nurse on 19-Dec-2017. This case involve 66-year-old female patient who was vaccinated with 0.5 ml FLUZONE HIGH DOSE (batch number: UI835AA, expiry date: 27 Mar 2018) via intramuscular route in left deltoid on 26 Sep 2017. Any other vaccinations within 4 week prior to date was unknown. On 12 Oct 2017, 16 days post vaccination, the patient had events i.e. topical reaction of redness, swelling, tenderness and decreased size of induration. It was reported that, the patient did not report incident until 12 Oct 2017. Also reported that, patient was advised to apply ice to injection site. On 17 Oct 2017, improvement was noted with decreased size of induration (recovering). List of documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Syncope, Vertigo
Clinical narrative: Initial unsolicited report received from a pharmacist on 03-Nov-2017. This case involves a male patient (age reported as more than 65 year), who was vaccinated with a dose of FLUZONE HIGH-DOSE (batch number, expiry date, dose, dose in series, route and site of administration was not reported) on an unknown date. Patient's medication history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced the worst vertigo and almost to the point of syncope. Lab data and corrective treatment were not reported. Event outcome was not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Autoimmune disorder, Crohn's disease, Iritis, Paraesthesia
Clinical narrative: Initial unsolicited report received from consumer on 20-Dec-2017. This case involve patient (age and gender was not reported) who was vaccinated with dose of FLUZONE HD (batch number, expiry date, route and site of administration were not reported) on an unspecified date in Nov 2015. The patient's medical history and concomitant medication were not reported. On an unspecified date in Jan 2016, few weeks post vaccination patient had noticed tingling in feet. Patient was diagnosed with several autoimmune disease Iritis and Crohn's). It was patient's belief that the amount of antigen provided by high dose of FLUZONE jolted patients compromised immune system into high gear resulting in production of anti-mag antibodies. As a result of having anti-mag patients life was extremely disrupted, physical and mental state was deteriorating. Laboratory investigation and corrective treatment were not reported. Outcome of events was not reported. List of documents held by sender: none.