chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Adverse event, Blood test, Computerised tomogram, Nuclear magnetic resonance imaging, Off label use
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in a 41-year-old male patient who received SHINGRIX (batch number 7X3EJ, expiry date unknown) for prophylaxis. Co-suspect products included SHINGRIX (batch number 4LP5Y, expiry date unknown) for prophylaxis. The patient had a Family History of shingles (patient's cousin had shingles). Concurrent medical conditions included allergy to plants, grass allergy and allergy to animal dander. Concomitant products included Flu unspecified (Flu vaccine). On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st August 2018 02:18, the patient received the 2nd dose of SHINGRIX (intramuscular). On 1st November 2018 08:00, not applicable after receiving SHINGRIX and 92 days after receiving SHINGRIX, the patient experienced pain and adverse event. On an unknown date, the patient experienced off label use. On an unknown date, the outcome of the pain, adverse event and off label use were unknown. It was unknown if the reporter considered the pain and adverse event to be related to SHINGRIX. Additional details were provided as follows: It was reported that the patient's cousin had shingles at age of 35, so the patient dose of SHINGRIX at age of 41 years old, this led to off label use of product. In 2018, the patient had blood test, computerised tomogram scan (CT) and Nuclear magnetic resonance imaging (MRI), results were not provided. The patient experienced severe adverse events after receiving SHINGRIX. The reporter consented to follow up.
Age: 40.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in a 41-year-old male patient who received SHINGRIX (batch number 7X3EJ, expiry date unknown) for prophylaxis. Co-suspect products included SHINGRIX (batch number 4LP5Y, expiry date unknown) for prophylaxis. The patient had a Family History of shingles (patient's cousin had shingles). Concurrent medical conditions included allergy to plants, grass allergy and allergy to animal dander. Concomitant products included Flu unspecified (Flu vaccine). On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st August 2018 02:18, the patient received the 2nd dose of SHINGRIX (intramuscular). On 1st November 2018 08:00, not applicable after receiving SHINGRIX and 92 days after receiving SHINGRIX, the patient experienced pain and adverse event. On an unknown date, the patient experienced off label use. On an unknown date, the outcome of the pain, adverse event and off label use were unknown. It was unknown if the reporter considered the pain and adverse event to be related to SHINGRIX. Additional details were provided as follows: It was reported that the patient's cousin had shingles at age of 35, so the patient dose of SHINGRIX at age of 41 years old, this led to off label use of product. In 2018, the patient had blood test, computerised tomogram scan (CT) and Nuclear magnetic resonance imaging (MRI), results were not provided. The patient experienced severe adverse events after receiving SHINGRIX. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 68-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included kidney transplant. On 11th March 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 11th March 2019, less than a day after receiving SHINGRIX, the patient experienced shivering, fever and exhaustion. On an unknown date, the outcome of the shivering was recovered/resolved and the outcome of the fever was not recovered/not resolved and the outcome of the exhaustion was unknown. It was unknown if the reporter considered the shivering, fever and exhaustion to be related to SHINGRIX. Additional details were provided as follows: The patient reported that on evening of vaccination, she felt exhausted and had intense shivering for about 30 to 45 minutes and experienced fever of 99 degrees Fahrenheit. The caller reported fever was persisting on the day of reporting. The reporter gave consent to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Limb discomfort, Nausea, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 12th September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, headache, nausea, vomiting and pain in arm. On an unknown date, the outcome of the fever, headache, nausea, vomiting and pain in arm were recovered/resolved. It was unknown if the reporter considered the fever, headache, nausea, vomiting and pain in arm to be related to SHINGRIX. Additional details were reported as follows: The SHINGRIX vaccine lot number or expiry date was unknown. The caller was a patient who reported she was right around the 6 month mark for getting her second SHINGRIX. The patient stated that she experienced a low grade fever (around 100 degree Fahrenheit), headache, nausea, vomiting, and the sorest arm from any injection she had ever had. All symptoms lasted for 2 to 3 days and resolved. Lab Comments: lab test performed on an uknown date.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 12th September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, headache, nausea, vomiting and pain in arm. On an unknown date, the outcome of the fever, headache, nausea, vomiting and pain in arm were recovered/resolved. It was unknown if the reporter considered the fever, headache, nausea, vomiting and pain in arm to be related to SHINGRIX. Additional details were reported as follows: The SHINGRIX vaccine lot number or expiry date was unknown. The caller was a patient who reported she was right around the 6 month mark for getting her second SHINGRIX. The patient stated that she experienced a low grade fever (around 100 degree Fahrenheit), headache, nausea, vomiting, and the sorest arm from any injection she had ever had. All symptoms lasted for 2 to 3 days and resolved. Lab Comments: lab test performed on an uknown date.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of swelling arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced swelling arm and pain in arm. On an unknown date, the outcome of the swelling arm and pain in arm were recovered/resolved. It was unknown if the reporter considered the swelling arm and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. This case was reported by the patient's husband. The physician did not know lot number or expiration dates. The patient received SHINGRIX in her non dominant left arm and experienced significant swelling and pain in her left arm for about a week. The symptoms were most severe for the first 2 days and dissipated over a week's time.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Induration, Oral herpes, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever blister in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 8th March 2019, the patient received SHINGRIX. On 8th March 2019, 4 hrs after receiving SHINGRIX, the patient experienced pain in arm, swelling arm and induration. On 11th March 2019, the patient experienced fever blister and shivering. The patient was treated with TYLENOL. On 11th March 2019, the outcome of the shivering was recovered/resolved. On an unknown date, the outcome of the fever blister, swelling arm and induration were not recovered/not resolved and the outcome of the pain in arm was recovering/resolving. It was unknown if the reporter considered the fever blister, pain in arm, shivering, swelling arm and induration to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in the left arm. The patient said that her arm was little sore four hours after receiving the SHINGRIX. After six hours, the patient's arm was sorer and by ten hours, she had to take TYLENOL. Less than a day after receiving vaccination, the patient said her arm was swollen and hard. The patient's arm was sore but was lessening. Three days after receiving vaccination, the patient felt a fever blister started on her lip and in morning she said it was full blown. The reporter reported that around noon, she started shivering that lasted for two hours. The reporter did not give consent to follow up. The reporter would not provide any additional information.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Dizziness, Dry mouth, Dysphonia, Eyelid pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 68-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included pneumonia. Concurrent medical conditions included cervical dystonia. On 7th March 2019, the patient received the 2nd dose of SHINGRIX. On 8th March 2019, 1 days after receiving SHINGRIX, the patient experienced dizziness, sore eye, muscle pain, injection site pain, nausea, headache, fatigue, neck pain and condition aggravated. On 12th March 2019, the patient experienced hoarse voice. On 13th March 2019, the patient experienced dry mouth. On an unknown date, the outcome of the dizziness, sore eye, muscle pain, injection site pain, nausea, dry mouth, hoarse voice, headache, fatigue, neck pain and condition aggravated were not recovered/not resolved. It was unknown if the reporter considered the dizziness, sore eye, muscle pain, injection site pain, nausea, dry mouth, hoarse voice, headache, fatigue, neck pain and condition aggravated to be related to SHINGRIX. Additional details were provided as follows: The patient had a history of cervical dystonia. On 7th March 2019, the patient received SHINGRIX on left arm. The patient experienced all of the side effects the day after receiving the injection. The patient had arm pain at the injection site and also pain in the right side of her neck. The patient thought that the neck pain may be a flare up of cervical dystonia condition. The headache lasted three days and resolved, but come back. All other symptoms also resolved but re-occurred. The dizziness was the worst and that had not resolved at all. The reporter consented to follow up. Discrepancy: TTO for the events dry mouth and hoarse voice had been autocalculated as per the event onset date reported in source document, whereas narrative stated that all the events occurred the day after receiving the injection.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Nausea, Neck pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 68-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included pneumonia. Concurrent medical conditions included cervical dystonia. On 7th March 2019, the patient received the 2nd dose of SHINGRIX. On 8th March 2019, 1 days after receiving SHINGRIX, the patient experienced dizziness, sore eye, muscle pain, injection site pain, nausea, headache, fatigue, neck pain and condition aggravated. On 12th March 2019, the patient experienced hoarse voice. On 13th March 2019, the patient experienced dry mouth. On an unknown date, the outcome of the dizziness, sore eye, muscle pain, injection site pain, nausea, dry mouth, hoarse voice, headache, fatigue, neck pain and condition aggravated were not recovered/not resolved. It was unknown if the reporter considered the dizziness, sore eye, muscle pain, injection site pain, nausea, dry mouth, hoarse voice, headache, fatigue, neck pain and condition aggravated to be related to SHINGRIX. Additional details were provided as follows: The patient had a history of cervical dystonia. On 7th March 2019, the patient received SHINGRIX on left arm. The patient experienced all of the side effects the day after receiving the injection. The patient had arm pain at the injection site and also pain in the right side of her neck. The patient thought that the neck pain may be a flare up of cervical dystonia condition. The headache lasted three days and resolved, but come back. All other symptoms also resolved but re-occurred. The dizziness was the worst and that had not resolved at all. The reporter consented to follow up. Discrepancy: TTO for the events dry mouth and hoarse voice had been autocalculated as per the event onset date reported in source document, whereas narrative stated that all the events occurred the day after receiving the injection.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site reaction, Injection site warmth, Limb discomfort
Clinical narrative: Patient returned to pharmacy on 03/21/19. Patient had small bruise at injection site as well as warm, red skin surrounding injection site. Patient described their arm as being sore.  Presumed injection site reaction. Confirmed with primary care provider to have patient take BENADRYL as well as to draw a circle around the inflamed area. I drew the circle and counseled patient on taking BENADRYL appropriately. Patient returned to pharmacy on 3/22/19 as a follow-up. Injection site was not as inflamed and was not warm to the touch anymore. Patient stated the BENADRYL helped (visibly improved).
Age: 48.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain upper, Blood test normal, Decreased appetite, Diarrhoea, Dizziness
Clinical narrative: First three days immediately following vaccination: Diarrhea, fever, extreme dizziness, rapid heart rate, irritability, loss of appetite, nausea, numbness of lips, headache and stomach cramps. Continuing on for the following days and still experiencing extreme dizziness, fever, irritability, headache, rapid heart rate, itching, loss of appetite.
Age: 48.0
Sex: F
Vaccine: HEPA
Symptoms: Electrocardiogram normal, Headache, Heart rate increased, Hypoaesthesia oral, Influenza virus test negative
Clinical narrative: First three days immediately following vaccination: Diarrhea, fever, extreme dizziness, rapid heart rate, irritability, loss of appetite, nausea, numbness of lips, headache and stomach cramps. Continuing on for the following days and still experiencing extreme dizziness, fever, irritability, headache, rapid heart rate, itching, loss of appetite.
Age: 48.0
Sex: F
Vaccine: HEPA
Symptoms: Irritability, Nausea, Pyrexia, Streptococcus test negative, Urine analysis normal
Clinical narrative: First three days immediately following vaccination: Diarrhea, fever, extreme dizziness, rapid heart rate, irritability, loss of appetite, nausea, numbness of lips, headache and stomach cramps. Continuing on for the following days and still experiencing extreme dizziness, fever, irritability, headache, rapid heart rate, itching, loss of appetite.
Age: 48.0
Sex: F
Vaccine: HEPA
Symptoms: Viral test negative
Clinical narrative: First three days immediately following vaccination: Diarrhea, fever, extreme dizziness, rapid heart rate, irritability, loss of appetite, nausea, numbness of lips, headache and stomach cramps. Continuing on for the following days and still experiencing extreme dizziness, fever, irritability, headache, rapid heart rate, itching, loss of appetite.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Chest X-ray normal, Chills, Differential white blood cell count, Differential white blood cell count normal
Clinical narrative: Nausea, fever, intense shivering, fainting, hyperventilating, increased blood pressure, overwhelming tired.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Full blood count normal, Hyperventilation, Laboratory test normal, Nausea
Clinical narrative: Nausea, fever, intense shivering, fainting, hyperventilating, increased blood pressure, overwhelming tired.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Syncope, Urine analysis normal
Clinical narrative: Nausea, fever, intense shivering, fainting, hyperventilating, increased blood pressure, overwhelming tired.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Localized redness, swelling, and mild itching. Cold pack given and instructed to take BENADRYL/TYLENOL if swelling and itching persists. Return to clinic if symptoms worsen or persist for longer than 3 days from today (Per MD).
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Patient presented to my office on 3/15/2019 with painful rash to right mid back and right abdomen. He had received the SHINGRIX vaccine on 3/5/19 and developed the rash beginning 3/13/19.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Hyperaesthesia, Pain
Clinical narrative: Patient presented to my office on 3/15/2019 with painful rash to right mid back and right abdomen. He had received the SHINGRIX vaccine on 3/5/19 and developed the rash beginning 3/13/19.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 67-year-old male patient who received SHINGRIX for prophylaxis. On 5th March 2019, the patient received SHINGRIX (intramuscular). On 9th March 2019, 4 days after receiving SHINGRIX, the patient experienced shingles, touch sensitivity increased and pain. On 13th March 2019, the patient experienced blister. On an unknown date, the outcome of the shingles was unknown and the outcome of the touch sensitivity increased, pain and blister were recovering/resolving. The reporter considered the shingles, touch sensitivity increased, pain and blister to be related to SHINGRIX. Additional details were provided as follows: The patient was given SHINGRIX in his left arm. About five days ago (from the reporting date), the patient's skin became sensitive to touch, even laughing hurt him. At night, when the patient got home from work, he noticed blisters on the right side of his stomach. On 14th March 2019, the blisters had spread to his back. The patient took a picture and sent it to his doctor, who said it looks like he had shingles. The emergency room visit required and the patient was going to the doctor to start on an antiviral medication. The reporter gave consent to follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Hyperaesthesia, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 67-year-old male patient who received SHINGRIX for prophylaxis. On 5th March 2019, the patient received SHINGRIX (intramuscular). On 9th March 2019, 4 days after receiving SHINGRIX, the patient experienced shingles, touch sensitivity increased and pain. On 13th March 2019, the patient experienced blister. On an unknown date, the outcome of the shingles was unknown and the outcome of the touch sensitivity increased, pain and blister were recovering/resolving. The reporter considered the shingles, touch sensitivity increased, pain and blister to be related to SHINGRIX. Additional details were provided as follows: The patient was given SHINGRIX in his left arm. About five days ago (from the reporting date), the patient's skin became sensitive to touch, even laughing hurt him. At night, when the patient got home from work, he noticed blisters on the right side of his stomach. On 14th March 2019, the blisters had spread to his back. The patient took a picture and sent it to his doctor, who said it looks like he had shingles. The emergency room visit required and the patient was going to the doctor to start on an antiviral medication. The reporter gave consent to follow up.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Hypersensitivity, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swollen where shot was, itchy, hot to the touch and half way down arm is red. Going on 3 days.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 3/22/2019 1110--Client's mom, called to report that patient had a reaction following immunizations given on Wednesday, 3/20/2019. She states that yesterday in the evening patient complained that her L arm (where DTaP was given) was itchy - she was wearing long sleeves and when mom examined it she said that her L arm had a approx 3 x 3 inch raised area of redness and swelling which was warm to touch and itchy. She described it as looking like a big hive. She states that today it isn't quite as red but it is still pink with swelling and has extended down her arm covering area from shoulder to elbow - it is still itchy but not quite as intensely and is also tender.
Age: 6.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Urticaria
Clinical narrative: 3/22/2019 1110--Client's mom, called to report that patient had a reaction following immunizations given on Wednesday, 3/20/2019. She states that yesterday in the evening patient complained that her L arm (where DTaP was given) was itchy - she was wearing long sleeves and when mom examined it she said that her L arm had a approx 3 x 3 inch raised area of redness and swelling which was warm to touch and itchy. She described it as looking like a big hive. She states that today it isn't quite as red but it is still pink with swelling and has extended down her arm covering area from shoulder to elbow - it is still itchy but not quite as intensely and is also tender.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Persistent and progressive muscular pain at right deltoid injection site for past 2 weeks. Unremarkable physical exam findings. Taking Tramadol for pain. Administered 40 mg. KENALOG injection at site of maximum pain/tenderness to palpation over right lateral deltoid 10 cm. distal to the AC joint. Seen by Dr of Ortho Clinic 03/15/2019. Given subacromial bursal pain/steroid injection. Still no relief. Using shoulder immobilizer which helps some. Still requiring tramadol for pain relief.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Headache, Hypoaesthesia, Influenza, Injection site reaction
Clinical narrative: (5) hours after injection-severe swelling of entire rt. arm turned deep dark purple from shoulder to waist-severe flu symptoms-returned to pharmacy a few days later-very ill-unable to take prescribed medications. (12) days later-severe continued side effects-dizziness-numbness of rt. arm-throbbing at injection site-sharp headaches I decided to take photographs 12 days later.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Malaise, Pain, Peripheral swelling, Skin discolouration
Clinical narrative: (5) hours after injection-severe swelling of entire rt. arm turned deep dark purple from shoulder to waist-severe flu symptoms-returned to pharmacy a few days later-very ill-unable to take prescribed medications. (12) days later-severe continued side effects-dizziness-numbness of rt. arm-throbbing at injection site-sharp headaches I decided to take photographs 12 days later.
Age: 35.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Discomfort, Joint range of motion decreased, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient seen after incident. Pt reported left arm pain and reduced range of motion after vaccine. Gradually has improved. Still mild discomfort. TYLENOL helps. No overlying rash or discrete tenderness. Patient reported vaccine administered higher on her left upper arm close to superior shoulder.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Skin warm
Clinical narrative: "Redness, hot to touch within first 24 hours. Redness over 48 hours".
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Nausea, Rash, Skin warm, Swelling
Clinical narrative: Large rash, swelling, redness, warm to touch also nausea.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient had swelling /redness/ pain at injection site. Dr diagnosed her with cellulitis, she was prescribed KEFLEX for tx.
Age: 42.0
Sex: F
Vaccine: HEPA, PPV, TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient had tenderness at the injection site and redness the evening after getting IMZs.
Age: 27.0
Sex: F
Vaccine: JEV1
Symptoms: Asthenia, Chest discomfort, Dizziness, Dyspnoea, Erythema
Clinical narrative: About 6 hours after vaccine given patient noted bright red, hot face. Noticed rash on both arms (more on left arm) and stomach. Light headed, week. No temperature taken but husband thought she felt warm to touch. Morning of Thursday, March 21st woke up feeling like "elephant on my chest". She said it was harder to breath and a sore throat. Friday morning, March 22nd reported symptoms to health dept. States she feels like herself but does not want to get another Japanese Encephalitis vaccine.
Age: 27.0
Sex: F
Vaccine: JEV1
Symptoms: Feeling hot, Oropharyngeal pain, Rash, Skin warm
Clinical narrative: About 6 hours after vaccine given patient noted bright red, hot face. Noticed rash on both arms (more on left arm) and stomach. Light headed, week. No temperature taken but husband thought she felt warm to touch. Morning of Thursday, March 21st woke up feeling like "elephant on my chest". She said it was harder to breath and a sore throat. Friday morning, March 22nd reported symptoms to health dept. States she feels like herself but does not want to get another Japanese Encephalitis vaccine.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis
Clinical narrative: Cellulitis to area, treated with KEFLEX 500mg ine by mouth twice a day for 7 days, lidocaine patches 5% one patch as needed for pain #12 given.
Age: 37.0
Sex: M
Vaccine: HEP
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Right arm pain and swelling. Treatment included pain medications, antibiotics, antihistamines and continued therapy.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Hyperacusis, Hypoaesthesia, Limb discomfort, Menstruation irregular, Migraine
Clinical narrative: Same night as shots she spikes 104 fever. She was sensitive to light and sound. She was dry heaving. She began to have a migraine headache. She had tingling in her foot then leg and then both went numb. This was a Friday night. Clinic and urgent care were closed. I called nurses hotline. Was told to alternate TYLENOL and MOTRIN for fever. I told them she had shots that day and was told this is normal if her fever gets worse or symptoms gets worse bring her into ER and to follow up with PCM when the clinic opens on that Monday. We cold compressed and pushed fluids as much as we could. Her fever broke later the next morning. She laid in bed all day the next day and said she couldn't move her foot or leg. Sunday she was able to feel her foot and leg and Monday was able to walk. We called her PCM Monday and told her what happened after visiting immunization clinic. She recommended that we did not continue with the HPV series.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Mobility decreased, Paraesthesia, Photophobia, Pyrexia, Retching
Clinical narrative: Same night as shots she spikes 104 fever. She was sensitive to light and sound. She was dry heaving. She began to have a migraine headache. She had tingling in her foot then leg and then both went numb. This was a Friday night. Clinic and urgent care were closed. I called nurses hotline. Was told to alternate TYLENOL and MOTRIN for fever. I told them she had shots that day and was told this is normal if her fever gets worse or symptoms gets worse bring her into ER and to follow up with PCM when the clinic opens on that Monday. We cold compressed and pushed fluids as much as we could. Her fever broke later the next morning. She laid in bed all day the next day and said she couldn't move her foot or leg. Sunday she was able to feel her foot and leg and Monday was able to walk. We called her PCM Monday and told her what happened after visiting immunization clinic. She recommended that we did not continue with the HPV series.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: The day after vaccines, pt developed 12 cm redness at site of MMRV vaccine. Itchy, painfull and warm to touch. Given TYLENOL/MOTRIN and BENADRYL.
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Had febrile seizure on 3/15/19 - EMS called but pt. was not transported. Sz. lasted approximately 5 min.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Body temperature increased, Myalgia, Neck pain
Clinical narrative: Body temperature between 100 degrees - 101.5 degrees from 2/23/19 until 3/4/19. Joint and muscle pain; Headache, neck pain from 2/23/19 until 3/6/19.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles but rather caused the patient to contract a persistent strain of herpes zoster. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. As a direct and proximate result of the ZOSTAVAX, the patient's symptoms and diagnoses have resulted in physical limitations not present prior to ZOSTAVAX. Further, as a tragic consequence, the patient 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 result of ZOSTAVAX, the patient has incurred  and will continue to incur medical expenses and other economic harm. The outcome of the events was considered to be not recovered. Persistent strain of herpes zoster and vaccine did not prevent shingles was considered disabling. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 06-MAR-2019, the patient was vaccinated with improperly stored ROTATEQ (lot # R025732, expiry date: 25-MAR-2020) for prophylaxis (Product storage error). Temperature and time frame of temperature excursion was noted as from 29-JAN-2019 (12 Degree Celsius for 1 hour 21 minutes) to 26-FEB-2019 (10 Degree Celsius for 22 minutes). It was reported that there were no previous temperature excursions. Digital data logger was noted as Yes. No adverse events were reported (no adverse event). The outcome of product storage error and no adverse event was unknown. This was fourth of nine reports mentioned in the report. Sender's Comments: US-009507513-1903USA009054:Master case.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Limb discomfort, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via other manufacturer and described the occurrence of fatigue in a elderly patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced fatigue and pain in arm. On an unknown date, the outcome of the fatigue and pain in arm were recovered/resolved. It was unknown if the reporter considered the fatigue and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported for the patients. The patients were of age 65 or older than that. The pharmacist reported that, many patients had adverse reactions after receiving SHINGRIX, that was fatigue and soreness in entire arm for several days. These side effects were often prevent patients from wanting to get more than one vaccine on same day, even when eligible for both.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug interaction, Gingival bleeding
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of gingival bleeding in a 61-year-old patient who received SHINGRIX for prophylaxis. Co-suspect products included Aspirin for an unknown indication. On 12th March 2019, the patient received SHINGRIX. On 13th March 2019, the patient started Aspirin at an unknown dose and frequency. On 13th March 2019, 1 days after receiving SHINGRIX, the patient experienced gingival bleeding. In March 2019, the patient experienced drug interaction. On an unknown date, the outcome of the gingival bleeding and drug interaction were unknown. It was unknown if the reporter considered the gingival bleeding to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX in the morning, and on next day the patient took some aspirin and his gums started bleeding. The patient asked, did aspirin do this when taken with the SHINGRIX. The pharmacist was not seeing aspirin specifically, as per SHINGRIX package insert reference. Therefore, it did not appear that they have studied SHINGRIX with aspirin. The patient said, the only thing he took was aspirin and he had two times of his gums bleeding. The patient had no major health problems. It had to be the interaction with the shot.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a patient who received SHINGRIX for prophylaxis. On 13th March 2019, the patient received SHINGRIX. On 14th March 2019, 1 days after receiving SHINGRIX, the patient experienced headache and general body pain. On an unknown date, the outcome of the headache and general body pain were not recovered/not resolved. It was unknown if the reporter considered the headache and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On 13th March 2019 (the day before reporting date), the patient received SHINGRIX at the local pharmacy. On 14th March 2019, the patient had headache with body aches. The patient was a teacher and was working on the reporting day. The patient asked, was it okay to take TYLENOL or ADVIL for the reported adverse event.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 76-year-old male patient who received SHINGRIX for prophylaxis. On 13th March 2019, the patient received SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced tiredness and muscle pain. The patient was treated with ibuprofen. On an unknown date, the outcome of the tiredness and muscle pain were recovered/resolved. It was unknown if the reporter considered the tiredness and muscle pain to be related to SHINGRIX. Additional case details were reported as follows: The patient had some of the side effects from the shingles shot that he got on the day before reporting. The patient could not stay on phone as he was busy, but we would follow up at another time. No additional adverse event information was given.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Myalgia, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 58-year-old male patient who received SHINGRIX for prophylaxis. On 10th September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, chills, myalgia and feeling bad. On an unknown date, the outcome of the fever, chills, myalgia and feeling bad were recovered/resolved. The reporter considered the fever, chills, myalgia and feeling bad to be related to SHINGRIX. Additional details were provided as follows: This case was reported by pharmacist for her husband. The patient experienced grade 3 fever, myalgia and shivering. The patient felt bad after receiving the 1st dose of SHINGRIX, so he did not want to have the second dose. The reporter believed that, the symptoms were related to the SHINGRIX. For tolerance of 2nd dose, refer case number US2019047194.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Aura, Diarrhoea, Erythema, Fatigue, Gastroenteritis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 81-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received on 21st August 2018). On 3rd March 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 3rd March 2019, 4 hrs after receiving SHINGRIX, the patient experienced vomiting, chills, fever, diarrhea, gastroenteritis, injection site pain, tiredness, headache, swelling arm, urinary incontinence, injected limb mobility decreased and drug dose administration interval too long. On 4th March 2019, the patient experienced hives and red face. On 13th March 2019, the patient experienced visual disturbance. On an unknown date, the outcome of the vomiting, chills, fever, injection site pain, headache and urinary incontinence were recovered/resolved and the outcome of the diarrhea, gastroenteritis, tiredness, swelling arm, hives and red face were not recovered/not resolved and the outcome of the injected limb mobility decreased, visual disturbance and drug dose administration interval too long were unknown. It was unknown if the reporter considered the vomiting, chills, fever, diarrhea, gastroenteritis, injection site pain, tiredness, headache, swelling arm, urinary incontinence, injected limb mobility decreased, hives, red face and visual disturbance to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. After receiving 2nd dose of the SHINGRIX vaccine, the patient vomited 7 times and had fever, swollen arm, pain at injection site, chills, diarrhea, uncontrolled urine, tiredness and headache. The patient had difficulty moving her arm around. Next morning (4th March 2019), the patient's left side of the face broke out hives and redness. She went to her doctor on Monday afternoon and she was diagnosed with gastroenteritis. The patient was still experiencing diarrhea, tiredness, swollen arm, redness and hives on the face. The vomiting, fever, pain at injection site, chills, uncontrolled urine and headache lasted for about 9 days. On the day of reporting, the patient experienced lightening aura in her eyes. The reporter did not consent to follow-up. This case is 1 of 3 cases reported.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Inappropriate schedule of product administration, Injected limb mobility decreased, Injection site pain, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 81-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received on 21st August 2018). On 3rd March 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 3rd March 2019, 4 hrs after receiving SHINGRIX, the patient experienced vomiting, chills, fever, diarrhea, gastroenteritis, injection site pain, tiredness, headache, swelling arm, urinary incontinence, injected limb mobility decreased and drug dose administration interval too long. On 4th March 2019, the patient experienced hives and red face. On 13th March 2019, the patient experienced visual disturbance. On an unknown date, the outcome of the vomiting, chills, fever, injection site pain, headache and urinary incontinence were recovered/resolved and the outcome of the diarrhea, gastroenteritis, tiredness, swelling arm, hives and red face were not recovered/not resolved and the outcome of the injected limb mobility decreased, visual disturbance and drug dose administration interval too long were unknown. It was unknown if the reporter considered the vomiting, chills, fever, diarrhea, gastroenteritis, injection site pain, tiredness, headache, swelling arm, urinary incontinence, injected limb mobility decreased, hives, red face and visual disturbance to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. After receiving 2nd dose of the SHINGRIX vaccine, the patient vomited 7 times and had fever, swollen arm, pain at injection site, chills, diarrhea, uncontrolled urine, tiredness and headache. The patient had difficulty moving her arm around. Next morning (4th March 2019), the patient's left side of the face broke out hives and redness. She went to her doctor on Monday afternoon and she was diagnosed with gastroenteritis. The patient was still experiencing diarrhea, tiredness, swollen arm, redness and hives on the face. The vomiting, fever, pain at injection site, chills, uncontrolled urine and headache lasted for about 9 days. On the day of reporting, the patient experienced lightening aura in her eyes. The reporter did not consent to follow-up. This case is 1 of 3 cases reported.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Photopsia, Urinary incontinence, Urticaria, Visual impairment
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 81-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (1st dose received on 21st August 2018). On 3rd March 2019, the patient received the 2nd dose of SHINGRIX (intramuscular). On 3rd March 2019, 4 hrs after receiving SHINGRIX, the patient experienced vomiting, chills, fever, diarrhea, gastroenteritis, injection site pain, tiredness, headache, swelling arm, urinary incontinence, injected limb mobility decreased and drug dose administration interval too long. On 4th March 2019, the patient experienced hives and red face. On 13th March 2019, the patient experienced visual disturbance. On an unknown date, the outcome of the vomiting, chills, fever, injection site pain, headache and urinary incontinence were recovered/resolved and the outcome of the diarrhea, gastroenteritis, tiredness, swelling arm, hives and red face were not recovered/not resolved and the outcome of the injected limb mobility decreased, visual disturbance and drug dose administration interval too long were unknown. It was unknown if the reporter considered the vomiting, chills, fever, diarrhea, gastroenteritis, injection site pain, tiredness, headache, swelling arm, urinary incontinence, injected limb mobility decreased, hives, red face and visual disturbance to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for herself. After receiving 2nd dose of the SHINGRIX vaccine, the patient vomited 7 times and had fever, swollen arm, pain at injection site, chills, diarrhea, uncontrolled urine, tiredness and headache. The patient had difficulty moving her arm around. Next morning (4th March 2019), the patient's left side of the face broke out hives and redness. She went to her doctor on Monday afternoon and she was diagnosed with gastroenteritis. The patient was still experiencing diarrhea, tiredness, swollen arm, redness and hives on the face. The vomiting, fever, pain at injection site, chills, uncontrolled urine and headache lasted for about 9 days. On the day of reporting, the patient experienced lightening aura in her eyes. The reporter did not consent to follow-up. This case is 1 of 3 cases reported.
Sex: F
Vaccine: FLUX
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old female patient who received Influenza vaccine for prophylaxis. On an unknown date, the patient received Influenza vaccine. On an unknown date, less than a year after receiving Influenza vaccine, the patient experienced fever, chills and headache. On an unknown date, the outcome of the fever, chills and headache were recovered/resolved. It was unknown if the reporter considered the fever, chills and headache to be related to Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fever, chills and headache after receiving Flu vaccine. This case is linked to case US2019046212, (same patient).
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Bedridden, Gait disturbance, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling in a 69-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (did not have any side effects after the 1st dose of SHINGRIX in December 2018). On 9th March 2019, the patient received SHINGRIX. On 10th March 2019, 1 days after receiving SHINGRIX, the patient experienced swelling, tenderness, fever, arthralgia, chills, pain, walking difficulty and bedridden. On 13th March 2019, the outcome of the swelling, tenderness, fever, arthralgia, chills, pain, walking difficulty and bedridden were recovered/resolved. It was unknown if the reporter considered the swelling, tenderness, fever, arthralgia, chills, pain, walking difficulty and bedridden to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the Left deltoid. The events were lasted for 3 days.