chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Angina pectoris, Chills, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: almost like a heart attack; Sharp and intense pain in the heart; Fever; Chills; Swelling of the arm; Very lethargic; Nausea; Swelling at injection site; swollen injection site that is also hot to the touch.; injection site is still tender; This case was reported by a consumer via call center representative and described the occurrence of heart attack in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On 31st October 2020, the patient received the 1st dose of Shingrix (intramuscular) and PNEUMONIA VACCINE. On 31st October 2020, less than a day after receiving Shingrix and PNEUMONIA VACCINE, the patient experienced heart attack (serious criteria GSK medically significant and other: GSK Medically Significant), cardiac pain (serious criteria GSK medically significant and other: GSK Medically Significant), fever, chills, swelling arm, lethargy, nausea, injection site swelling, injection site warmth and injection site tenderness. On an unknown date, the outcome of the heart attack, cardiac pain, fever, chills, swelling arm, lethargy, nausea, injection site swelling and injection site warmth were recovering/resolving and the outcome of the injection site tenderness was not recovered/not resolved.   It was unknown if the reporter considered the heart attack, cardiac pain, fever, chills, swelling arm, lethargy, nausea, injection site swelling, injection site warmth and injection site tenderness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and Pneumonia vaccine in the upper left arm. Within 24 hours of receiving Shingrix and Pneumonia vaccine, the patient experienced the whole list of side effects.  The patient reported experiencing 3 separate incidents of pain in the heart that was sharp and intense almost like a heart attack, fever, chills, swelling in the arm, very lethargic, nausea, swollen injection site that was also hot to the touch.  The patient stated the hot and swollen injection site lasted until Wednesday night, on 04th November 2020.  She reported symptoms have improved, but injection site was still tender; it was no longer painful like before.  The patient reported seeing a cardiologist on a regular basis, and her heart was in great shape. The reporter consented to follow up. Not all information was available. It was unknown if the reporter considered the heart attack, cardiac pain, fever, chills, swelling arm, lethargy, nausea, injection site swelling, injection site warmth and injection site tenderness to be related to Pneumonia vaccine.
Age: 65.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Lethargy, Myocardial infarction, Nausea, Peripheral swelling, Pyrexia
Clinical narrative: almost like a heart attack; Sharp and intense pain in the heart; Fever; Chills; Swelling of the arm; Very lethargic; Nausea; Swelling at injection site; swollen injection site that is also hot to the touch.; injection site is still tender; This case was reported by a consumer via call center representative and described the occurrence of heart attack in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On 31st October 2020, the patient received the 1st dose of Shingrix (intramuscular) and PNEUMONIA VACCINE. On 31st October 2020, less than a day after receiving Shingrix and PNEUMONIA VACCINE, the patient experienced heart attack (serious criteria GSK medically significant and other: GSK Medically Significant), cardiac pain (serious criteria GSK medically significant and other: GSK Medically Significant), fever, chills, swelling arm, lethargy, nausea, injection site swelling, injection site warmth and injection site tenderness. On an unknown date, the outcome of the heart attack, cardiac pain, fever, chills, swelling arm, lethargy, nausea, injection site swelling and injection site warmth were recovering/resolving and the outcome of the injection site tenderness was not recovered/not resolved.   It was unknown if the reporter considered the heart attack, cardiac pain, fever, chills, swelling arm, lethargy, nausea, injection site swelling, injection site warmth and injection site tenderness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and Pneumonia vaccine in the upper left arm. Within 24 hours of receiving Shingrix and Pneumonia vaccine, the patient experienced the whole list of side effects.  The patient reported experiencing 3 separate incidents of pain in the heart that was sharp and intense almost like a heart attack, fever, chills, swelling in the arm, very lethargic, nausea, swollen injection site that was also hot to the touch.  The patient stated the hot and swollen injection site lasted until Wednesday night, on 04th November 2020.  She reported symptoms have improved, but injection site was still tender; it was no longer painful like before.  The patient reported seeing a cardiologist on a regular basis, and her heart was in great shape. The reporter consented to follow up. Not all information was available. It was unknown if the reporter considered the heart attack, cardiac pain, fever, chills, swelling arm, lethargy, nausea, injection site swelling, injection site warmth and injection site tenderness to be related to Pneumonia vaccine.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient experienced pain during vaccine. Extremely sore arm over weekend following vaccine. Patient came in to see medical clinic on 11/11/2020 still experiencing arm pain.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Myalgia, Pyrexia, Restlessness
Clinical narrative: Chills, restlessness, muscle soreness, dizziness Slight fever 100F
Age: 60.0
Sex: M
Vaccine: FLUR4, PPV
Symptoms: Pyrexia
Clinical narrative: PATIENT REPORTED A HIGH FEVER SOON AFTER RECEIVING VACCINES. FIRST TIME HE HAS EVER GOTTEN A FLU SHOT OR PNEUMO
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Headache, Myalgia, Pain
Clinical narrative: Head ache, stomach ache, body ache, muscle ache
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: swelling, redness, and pain at injection site. vomiting, diarrhea, and fatigue
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: swelling, redness, and pain at injection site. vomiting, diarrhea, and fatigue
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site pain, Injection site pruritus, Pyrexia
Clinical narrative: For 3 days after the vaccines, patient states she had fever, and a sore, itchy right arm. Patient states she has pain at injection area. Pharmacist advised adverse effects can be expected, but if severe pain or discomfort, she should call MD. Customer calls pharmacist on 10-27-20 as her arm still hurts.
Age: 52.0
Sex: M
Vaccine: FLUR4, PPV, VARZOS
Symptoms: Pain, Pyrexia, Swelling
Clinical narrative: Pt reports swelling, achiness, and low grade fever that went away after taking Tylenol.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache, Malaise
Clinical narrative: I feel almost embarrassed to submit this. I had a negative reaction, all symptoms listed on handout sheet. I was concerned as the symptoms were similar to the covid symptoms. I felt very sick, headache, upset stomach, exhaustion. It's rare for me to be sick. Here's why I'm filling out this form: I'm a small person, about 110 pounds, and I wonder if the vaccine is too strong. Isn't is the same strength as a 300 pound man would take? I had a similar reaction to the flu vaccine. I'm not reporting for anything wrong, just pointing out the strength may be too much for some and this may not be remedied but simply reporting.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Pt reported that she had chills and fever the night she got the vaccine.  She took Tylenol and the symptoms stopped by the next morning.  She reported these symptoms on 11/10/2020 the day after the vaccine was given.  All symptoms except a headache had resolved at the time of reporting.  We recommended ibuprofen for her headache.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Mobility decreased, Pain in extremity
Clinical narrative: pain in left arm, inability to lift it, and numbness in arm and hand
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; a temperature excursion for Gardasil 9; This spontaneous report was received from a nurse referring to a patient of unknown age and unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not reported.     On 19-OCT-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (1 dose, lot # 1621926 with expiration date 28-NOV-2021) via an unknown route for prophylaxis. The administered dose experienced a temperature excursion of 53 degrees Fahrenheit (F) for 24 hours. There were no previous temperature excursions. No data logger was involved. No other adverse event. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621926; expirationdate: 28-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Back pain, Chills, Fatigue
Clinical narrative: Fever / her temperature is down to 99; chills; sweating; headache; muscle aches in shoulders, neck and back; tired / still feels tired; weak / still feels / weak; arm was very sore; sore / extended to her neck; sore / extended to her / back; Nausea; This case was reported by a consumer and described the occurrence of fever in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, chills, sweating, headache, muscle pain, tiredness, weakness, pain in arm, neck pain, back pain and nausea. On an unknown date, the outcome of the fever, chills, sweating, headache, muscle pain, pain in arm, neck pain, back pain and nausea were unknown and the outcome of the tiredness and weakness were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, sweating, headache, muscle pain, tiredness, weakness, pain in arm, neck pain, back pain and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in right deltoid and fever, chills, sweating, nausea, headache, muscle aches in shoulders, neck and back, tired and weak. The patient's arm was very sore the next day and extended to her neck down her left arm to her back.  The patient just got up a while ago and temperature was down to 99 degree F but still feels tired and weak.  The reporter asked would second shot be as bad.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hyperhidrosis, Myalgia, Nausea, Neck pain
Clinical narrative: Fever / her temperature is down to 99; chills; sweating; headache; muscle aches in shoulders, neck and back; tired / still feels tired; weak / still feels / weak; arm was very sore; sore / extended to her neck; sore / extended to her / back; Nausea; This case was reported by a consumer and described the occurrence of fever in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, chills, sweating, headache, muscle pain, tiredness, weakness, pain in arm, neck pain, back pain and nausea. On an unknown date, the outcome of the fever, chills, sweating, headache, muscle pain, pain in arm, neck pain, back pain and nausea were unknown and the outcome of the tiredness and weakness were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, sweating, headache, muscle pain, tiredness, weakness, pain in arm, neck pain, back pain and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in right deltoid and fever, chills, sweating, nausea, headache, muscle aches in shoulders, neck and back, tired and weak. The patient's arm was very sore the next day and extended to her neck down her left arm to her back.  The patient just got up a while ago and temperature was down to 99 degree F but still feels tired and weak.  The reporter asked would second shot be as bad.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever / her temperature is down to 99; chills; sweating; headache; muscle aches in shoulders, neck and back; tired / still feels tired; weak / still feels / weak; arm was very sore; sore / extended to her neck; sore / extended to her / back; Nausea; This case was reported by a consumer and described the occurrence of fever in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, chills, sweating, headache, muscle pain, tiredness, weakness, pain in arm, neck pain, back pain and nausea. On an unknown date, the outcome of the fever, chills, sweating, headache, muscle pain, pain in arm, neck pain, back pain and nausea were unknown and the outcome of the tiredness and weakness were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, sweating, headache, muscle pain, tiredness, weakness, pain in arm, neck pain, back pain and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in right deltoid and fever, chills, sweating, nausea, headache, muscle aches in shoulders, neck and back, tired and weak. The patient's arm was very sore the next day and extended to her neck down her left arm to her back.  The patient just got up a while ago and temperature was down to 99 degree F but still feels tired and weak.  The reporter asked would second shot be as bad.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: What if I get a rash after receiving Shingrix; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient asked what if the patient got a rash after receiving Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Feel bad after second shingles shot?; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient felt bad after 2nd Shingrix shot.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: A very sore arm; Fever; This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm and fever. On an unknown date, the outcome of the pain in arm and fever were recovered/resolved.   It was unknown if the reporter considered the pain in arm and fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received the 1st dose of Shingrix about a year prior to the report and had a very sore arm and a fever. No other information was available. The reporter consented to follow up. For further tolerance of 2nd dose Shingrix, refer case ID US2020AMR221178.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR221178:same patient, 2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pain, Pyrexia
Clinical narrative: Injection site pain; now have more body aches; chills; 101 degree fever; This case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (received 1st dose on unknown date, refer case US2020AMR221090).   On 4th November 2020, the patient received the 2nd dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced general body pain, chills and fever. On an unknown date, the patient experienced injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the general body pain, chills, fever and injection site pain were unknown.   It was unknown if the reporter considered the general body pain, chills, fever and injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had few body aches and injection site pain and more body aches, chills and 101 degree F fever.  The reporter asked was this normal and should assume it.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR221090:same reporetr
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Vaccine positive rechallenge
Clinical narrative: A very sore arm; Fever; This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date and expereinced very sore arm and fever, refer case- US2020AMR220464).   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm and fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm and fever were unknown.   It was unknown if the reporter considered the pain in arm and fever to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced very sore arm nd fever, after receiving the 2nd dose of Shingrix. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR220464:same patient, 1st dose
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pain, Pyrexia
Clinical narrative: she does have some injection site pain; chills; fever; aches; This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of pain in extremity (received 1st dose in August 2020, refer case US2020220536). Concomitant products included INFLUENZA VACCINE (FLUBLOK).   On 4th November 2020, the patient received the 2nd dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced injection site pain, chills, fever and general body pain. On an unknown date, the outcome of the injection site pain, chills, fever and general body pain were unknown.   It was unknown if the reporter considered the injection site pain, chills, fever and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in her left arm and had some injection site pain. The patient had some aches, chills and fever.  The reporter wanted to stay anonymous. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020220536:same patient
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Blood pressure increased, Condition aggravated, Fatigue
Clinical narrative: joint pain / elbow pain; was beat up and tired all through; he has back problems, but it made it worse; sore at the injection site; hard spot / at the injection site; blood pressure significantly went up / BP was 185/94 / had to double the dosage of his medications for blood pressure; first Shingrix Vaccine on January 2020 / 2nd Shingrix dose on October 31st, 2020; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included back pain (had back pain). Previously administered products included Shingrix (1st dose received on January 2020). Concurrent medical conditions included blood pressure high.   On 31st October 2020, the patient received Shingrix. On 31st October 2020, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the patient experienced joint pain, tiredness, back pain aggravated, injection site pain, injection site induration and increased blood pressure. The patient was treated with metoprolol, lisinopril and amlodipine. On an unknown date, the outcome of the joint pain, tiredness, back pain aggravated and increased blood pressure were recovered/resolved and the outcome of the injection site pain and injection site induration were not recovered/not resolved and the outcome of the social problem was unknown.   It was unknown if the reporter considered the joint pain, tiredness, back pain aggravated, injection site pain, injection site induration and increased blood pressure to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, after vaccination with 2nd dose of Shingrix had joint pan, elbow pain, injection site pain and injection site hardness, back pain get worse, was beat up and tired all through and Blood pressure went up. The reporter stated that, the patient received dose 2 late due to COVID 19, which led to social problem. The patient was advised by his Cardiologist to monitor his BP for 36 hours. The patient received Metoprolol, Lisinopril and Amlodipine as a treatment medication for increased blood pressure. The patient  had to double the dosage of his medications for blood pressure. The patient reported that on 31st October 2020 his blood pressure was 185/94 and he increased his Metoprolol and on 1st November 2020 he had to increase his Lisinopril.  The patient stataed that all adverse events resolved except injection site pain and injection site induration. The reporter consented to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Social problem
Clinical narrative: joint pain / elbow pain; was beat up and tired all through; he has back problems, but it made it worse; sore at the injection site; hard spot / at the injection site; blood pressure significantly went up / BP was 185/94 / had to double the dosage of his medications for blood pressure; first Shingrix Vaccine on January 2020 / 2nd Shingrix dose on October 31st, 2020; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included back pain (had back pain). Previously administered products included Shingrix (1st dose received on January 2020). Concurrent medical conditions included blood pressure high.   On 31st October 2020, the patient received Shingrix. On 31st October 2020, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the patient experienced joint pain, tiredness, back pain aggravated, injection site pain, injection site induration and increased blood pressure. The patient was treated with metoprolol, lisinopril and amlodipine. On an unknown date, the outcome of the joint pain, tiredness, back pain aggravated and increased blood pressure were recovered/resolved and the outcome of the injection site pain and injection site induration were not recovered/not resolved and the outcome of the social problem was unknown.   It was unknown if the reporter considered the joint pain, tiredness, back pain aggravated, injection site pain, injection site induration and increased blood pressure to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, after vaccination with 2nd dose of Shingrix had joint pan, elbow pain, injection site pain and injection site hardness, back pain get worse, was beat up and tired all through and Blood pressure went up. The reporter stated that, the patient received dose 2 late due to COVID 19, which led to social problem. The patient was advised by his Cardiologist to monitor his BP for 36 hours. The patient received Metoprolol, Lisinopril and Amlodipine as a treatment medication for increased blood pressure. The patient  had to double the dosage of his medications for blood pressure. The patient reported that on 31st October 2020 his blood pressure was 185/94 and he increased his Metoprolol and on 1st November 2020 he had to increase his Lisinopril.  The patient stataed that all adverse events resolved except injection site pain and injection site induration. The reporter consented to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Left side of her face began to tingle; This case was reported by a consumer via call center representative and described the occurrence of tingling in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 26th October 2020, less than a day after receiving Shingrix, the patient experienced tingling. On an unknown date, the outcome of the tingling was not recovered/not resolved.   The reporter considered the tingling to be related to Shingrix.   Additional details were provided as follows: The patient received 1st dose of Shingrix and experienced tingling on left side of face. The reporter mentioned that tingling comes and goes but had not resolved.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Chills; Headache; Nausea; Muscle aches; Low grade fever 99 degrees F; This case was reported by a consumer via call center representative and described the occurrence of chills in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included rosuvastatin calcium (Crestor) for product used for unknown indication.   On 26th October 2020, the patient received the 1st dose of Shingrix (intramuscular) and Crestor at an unknown dose and frequency. On 27th October 2020, 1 days after receiving Shingrix and Crestor, the patient experienced chills, headache, nausea, muscle pain and low grade fever. On an unknown date, the outcome of the chills, headache, nausea, muscle pain and low grade fever were not recovered/not resolved.   It was unknown if the reporter considered the chills, headache, nausea, muscle pain and low grade fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and rosuvastatin generic Crestor and experience chills, headache, nausea, muscle aches, and low grade fever of 99 degrees F and these symptoms improved after 3 to 4 days, but still persist at this time. The reporter consented to follow up and did not had any additional details for this AE.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site pain, Muscular weakness, Neuralgia
Clinical narrative: Weakness in right hand; Numbness in right hand; Pain in the right arm in the brachial plexus; This case was reported by a physician via call center representative and described the occurrence of hands weakness of in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix. In October 2020, 11 days after receiving Shingrix, the patient experienced hands weakness of, numbness in hand and neuralgia. On an unknown date, the outcome of the hands weakness of, numbness in hand and neuralgia were not recovered/not resolved.   It was unknown if the reporter considered the hands weakness of, numbness in hand and neuralgia to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix vaccine 3 weeks ago in the right arm. Caller reported 10 days ago, the patient reported weakness, numbness in the right hand and pain in the right arm in the brachial plexus. This was still ongoing currently. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity, Rash pruritic
Clinical narrative: Rash / That is itchy; Arm was sore; red around injection site; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 2nd dose of Shingrix (intramuscular). In October 2020, 1 week after receiving Shingrix, the patient experienced itchy rash, pain in arm and injection site erythema. On an unknown date, the outcome of the itchy rash and pain in arm were not recovered/not resolved and the outcome of the injection site erythema was recovered/resolved.   It was unknown if the reporter considered the itchy rash, pain in arm and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 2nd dose of Shingrix 2 weeks ago.  The Patient reported the day after receiving the vaccine her arm was sore and red around the injection site and this lasted for about a week and then resolved. The patient reported that a week ago she developed a rash around the waistline that is itchy and still currently ongoing and spreading around the waist. Patient reported she has been using Cortisone 10 twice a day for the rash.
Age: 31.0
Sex: M
Vaccine: FLUN4
Symptoms: Fall, Loss of consciousness, Skin abrasion
Clinical narrative: Patient received the vaccination and then got up from the chair to walk approximately 7 feet in front of him to sit in the waiting room area as recommended after vaccinations. Approximately 1-2 minutes after sitting back down in the waiting area, patient then fell from a sitting position onto the floor. Emergency personnel was immediately contacted. Patient was passed out for approximately one minute, but was able to respond verbally after being spoken to repeatedly and after rubbing of the back and tapping of the shoulder. Patient was then able to get up from a lying position after approximately 3 minutes of laying down. He sustained multiple abrasions to the forehead which we then iced while he sat down and attempted to clean. The patient was given some water and multiple ice packs. Emergency personnel was on scene approximately 10 minutes after and evaluated the patient, who they then cleared to return home.
Age: 59.0
Sex: F
Vaccine: FLUR4
Symptoms: Myalgia
Clinical narrative: pt reports sore muscles after having a severe arm reaction on 10/23
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Candidate had came in for MMR vaccine, he complained of pain to  right arm where the TDAP vaccine was injected. RN ,was asked to assess the injection site. There was no redness noted on the right arm, slightly warm on the injection site compared to the right lower arm,  the injection site was still visible correct site which  was in the deltoid area, denies any tingling or numbness , with full range of motion of the right arm, complained of localized pain to right arm, denies any shooting pain to the right arm, fingers. He was adviced to keep taking Ibuprofen, apply alternate warm and cold compress. Follow up again Monday 10/26/2020 .
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Woke up a few days after having received vaccine, and abduction of right (injected) arm was greatly reduced from the night before. There was also severe pain at the site of injection. Abduction decreasing steadily until date of report. Size of right arm decreasing steadily in comparison to left arm. This condition was absent just prior to being given the vaccine.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Inflammation, Tenderness
Clinical narrative: Redness/tenderness/inflammation.
Age: 47.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Significant pain in left upper arm (at injection site) and inability to lift any object with her left arm. These symptoms began within 1-2 hours after the vaccine and lasted for about 10 days.   Regarding upcoming Item 22 - Patient reported receiving influenza vaccine on 9/14/2020, but this was not administered by our office so we do not have any details regarding the vaccine brand, admin site, or lot information.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Pain in extremity
Clinical narrative: Felt feverish ~4-5 hours after injection, but had walked over 3 miles at 3.4 mph in sun,  wind and 75 degree day and did not contribute it to Shingrix.  Started shivering around 6:00 p.m. but also commonly occurs after a good walk as my body continues to kick off heat.   Took temp around 8:00 p.m. and was 100.1, then took 400mg ibuprofen. At 11:00 p.m. temp was 99.7.   On 11/10/202, temp remained from 100.1 to 99.7  throughout the day with continual doses of ibuprofen.   Arm was sore, slightly swollen and warm. Had headache, tiredness and felt lousy.  Temp at 11:00 p.m. was down to 97.7 about 7 hours after the last ibuprofen.  11/11/20220 no fever. Arm red at injection site, swollen, and warm
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: Felt feverish ~4-5 hours after injection, but had walked over 3 miles at 3.4 mph in sun,  wind and 75 degree day and did not contribute it to Shingrix.  Started shivering around 6:00 p.m. but also commonly occurs after a good walk as my body continues to kick off heat.   Took temp around 8:00 p.m. and was 100.1, then took 400mg ibuprofen. At 11:00 p.m. temp was 99.7.   On 11/10/202, temp remained from 100.1 to 99.7  throughout the day with continual doses of ibuprofen.   Arm was sore, slightly swollen and warm. Had headache, tiredness and felt lousy.  Temp at 11:00 p.m. was down to 97.7 about 7 hours after the last ibuprofen.  11/11/20220 no fever. Arm red at injection site, swollen, and warm
Age: 53.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Meralgia paraesthetica, Ulnar nerve injury, X-ray
Clinical narrative: Meralgia paresthetica and ulnar nerve damage
Age: 64.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site bruising, Injection site haemorrhage, Injection site induration, Injection site pain
Clinical narrative: Patient has three bruised/blood filled areas at and surrounding the area of injection. She noticed this within 24 hours after vaccine administration. There is a knot at the injection site along with pain. She does not take blood thinners or aspirin so she normally does not bruise or bleed easily with injections in the past.
Age: 68.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Chest X-ray, Chills, Electrocardiogram, Headache, Hypovolaemia
Clinical narrative: Headache, body aches, chills, low grade fever, nausea, vomiting, pain and arm swelling at site of pneumonia injection ER and overnight stay, 10/29-10/30  Follow up visit to Dr. office onNov 2, 2020
Age: 68.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Injection site pain, Injection site swelling, Nausea, Pain, Pyrexia
Clinical narrative: Headache, body aches, chills, low grade fever, nausea, vomiting, pain and arm swelling at site of pneumonia injection ER and overnight stay, 10/29-10/30  Follow up visit to Dr. office onNov 2, 2020
Age: 68.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Syncope, Vomiting
Clinical narrative: Headache, body aches, chills, low grade fever, nausea, vomiting, pain and arm swelling at site of pneumonia injection ER and overnight stay, 10/29-10/30  Follow up visit to Dr. office onNov 2, 2020
Age: 38.0
Sex: F
Vaccine: FLUR4
Symptoms: Blood pressure increased, Paraesthesia, Pharyngeal paraesthesia, Swollen tongue
Clinical narrative: Patient received FluBlok vaccine at 11:49 am. She noticed tongue swelling approximately 25 minutes after receiving the vaccine. She waited at least 15 minutes in the pharmacy waiting area before leaving and noticed the tongue swelling as she was driving back to her office. EMS was called 54 minutes after she received the vaccine. EMS took her to a local ED where she was treated and released. The swelling in her tongue and tingling in her throat continued for several hours after arriving home on the evening of vaccination but subsided by this (next) morning. Her primary symptoms were tongue swelling, and "tingling" sensation in back of throat and right cheek, and elevated BP was noted upon assessment while waiting for EMS to arrive.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Peripheral swelling, Swelling
Clinical narrative: Swelling of lips, torso, hands and legs.  Employee sent to hospital and instructed to take Zyrtec or Allegra once a day for symptom relief.  May us OTC hydrocortisone cream as needed.  Instructed to return to hospital if symptoms do not improve. 11/11/2020 EHN emailed employee to follow up.
Age: 72.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Injection site pain, Pain, X-ray
Clinical narrative: Experiencing pain in the top of left arm. Next day pain radiated down to wrist. A couple of days later that subsided. Pain is ongoing in arm and shoulder. Prescribed Lidocaine by physician.
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Discomfort, Incorrect route of product administration, Pain, Swelling, Tenderness
Clinical narrative: *administration route note: was admin IM per lab tech personnel, according to pt specialist advised from ultrasound result that vaccine was actually subcutaneous with incorrect admin Pt had onset of localized pain, swelling, tenderness 16 days after vaccine was administered, worsened x3 days and then improving, last followup was minimal discomfort/tenderness, no swelling/rash at that time was 5 weeks since immunization
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; Information has been received regarding a case in litigation, concerning a patient (pt) of unknown age and gender. The pt's medical history, concurrent conditions and concomitant medications were not reported.   On an unspecified date in 2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a pharmacist at a family pharmacy, for the long-term prevention of shingles and/or zoster related conditions (dose, route of administration, anatomical location, lot number and expiration date were not reported).   Subsequently, on an unspecified date, the pt was treated by a healthcare provider at a medical office for shingles. As a direct and proximate result of the use of zoster vaccine live (ZOSTAVAX), the pt had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles was not resolved. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: No additional adverse events reported; she found out she was 6 weeks pregnant so pregnant when received GARDASIL 9; This spontaneous prospective pregnancy report was received from a 38-year-old female patient referring to herself. The patient had no pertinent medical history. Her drug reactions/allergies and concomitant medications were not reported. The patient's concurrent conditions included multigravida.    On 22-OCT-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) initial dose, as routine vaccination (route of administration, anatomical location, lot # and expiration date were not reported).      On 05-NOV-2020, she went to the physician office and a pregnancy tests was performed which was positive. It was found that the patient was 6 weeks of pregnancy. The patient's last menstrual  period was calculated to be 24-SEP-2020 and the estimated date of delivery was calculated as 21-JUL-2021. The pregnancy outcome was pending and the fetal outcome unknown. No additional adverse events were reported.
Age: 41.0
Sex: F
Vaccine: FLUX, IPV, MMR, UNK, UNK
Symptoms: Exposure during pregnancy
Clinical narrative: the patient received MMR II while pregnant; 41 year old patient received MMR II while pregnant; the patient experienced no symptoms; This spontaneous prospective pregnancy report was received from a registered nurse referring to a 41 year old female patient. The patient's pertinent medical history was not reported. Concomitant therapies included calcium supplement, iron (unspecified), minerals (unspecified), vitamins (unspecified) (prenatal vitamins), and psyllium husk (METAMUCIL).  On 20-AUG-2020, while pregnant, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot# S031483 (expiration date: 07-OCT-2021); poliovirus vaccine inactivated lot# R1B251M; and diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid lot# 374LB, all of them for prophylaxis.  Then, on 17-SEP-2020, the patient received the following vaccines: measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II); diphtheria toxoid, tetanus toxoid; poliovirus vaccine inactivated; and influenza virus vaccine (unspecified), all of them for prophylaxis (additional dosage regimen information was not reported).  The patient's last menstrual period date was 17-AUG-2020. Additionally, it was reported that on 29-OCT-202, the patient underwent an ultrasound that showed her to be 10 weeks pregnant at that time. The estimated date of delivery would be 24-MAY-2021.The pregnancy outcome was outcome pending.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Soreness on her right arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th January 2020, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that after receiving the 1st dose of Shingrix she experienced soreness on her right arm that resolved after a couple of days.  The reporter consented to follow up. For tolerance to 2nd dose refer linked case US2020217491, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020217491:Same patient
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Injection site bruising, Injection site rash, Injection site reaction, Injection site swelling
Clinical narrative: swelling in the injection site; 2 large areas with rash and 1 smaller area with rash; area with a bruise; herpetic looking blisters; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 47XJ3, expiry date 29th April 2022) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 24th August 2020, refer case US2020219722).   On 3rd November 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 3rd November 2020, less than a day after receiving Shingrix, the patient experienced injection site swelling, rash, contusion and rash herpetiform. On an unknown date, the outcome of the injection site swelling, rash, contusion and rash herpetiform were unknown.   It was unknown if the reporter considered the injection site swelling, rash, contusion and rash herpetiform to be related to Shingrix.  Additional details were reported as follows: The patient received the 2nd dose of Shingrix in the right deltoid. The patient experienced swelling in the injection site, 2 large areas with rash and 1 smaller area with rash, area with a bruise and herpetic looking blisters. The pharmacist said that he believed the symptoms started on the afternoon of 3rd November 2020.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020219722:same patient (1st dose)