chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: PNC13
Symptoms: Muscle tightness, Muscle twitching
Clinical narrative: This is a spontaneous report from a contactable nurse reported for her son. A 4.5-month-old male patient received the second dose of PREVNAR 13 as routine vaccination via intramuscular route in the left thigh at 0.5ml single dose on unknown date in Dec2017. Relevant medical history included heart murmur since 10Jul2017 and ongoing, the patient saw a cardiologist for this. Concomitant medications were not reported. The patient received the first dose of the same vaccine via intramuscular route in the thigh in Oct2017 at 2.5 months old for immunization. On unknown date the patient experienced some kind of facial tension or twitching that occurred within 24 hours. The facial tension or twitching lasted for 2 days and then the patient recovered. The patient currently was 8-month-old and he hasn't received the 3rd dose of PREVNAR 13 yet. The events were considered serious as medically significant. Sender's Comments: A possible causal association between administration of PREVNAR 13 and the onset of kind of facial tension or twitching cannot be excluded, assuming a apparent temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: PNC13
Symptoms: Seizure
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's brother) reported that a male patient of unspecified age and race/ethnicity received PREVNAR 13 on an unknown date, at single dose, for immunization. Medical history and concomitant medications were not reported. The patient convulsed after vaccination, on an unspecified date. Event outcome was not reported. The reporter added that the benefits were clear as were the possible side effects and thought for most people that PREVNAR 13 would be good but the reporter never went out so contact with others was limited and in the past family members have had reactions (brother convulsed etc.). No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: M
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reporting for himself of unspecified age and race/ethnicity received PREVNAR 13 on an unknown date, at single dose, for immunization. Medical history and concomitant medications were not reported. The patient ended up in the hospital because he caught pneumonia after vaccination, on an unspecified date. The reporter added that the vaccine did not work. Events outcome was not reported. No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, 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 53-year-old male patient who received SHINGRIX. On 26th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, less than a day after receiving SHINGRIX, the patient experienced fever and shivering. On 26th March 2018, the patient experienced headache and pain in arm. On an unknown date, the outcome of the fever, headache, pain in arm and shivering were unknown. The reporter considered the fever, headache, pain in arm and shivering to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's wife. In the morning the patient received the SHINGRIX on an unknown arm. When the patient came home after receiving the vaccination he reported having a headache and a sore arm. Around 12:00 midnight, the patient began to experience a fever and shivering. The reporter was unable to provided additional details and did not know in which arm the vaccine was administered.
Age: 74.0
Sex: M
Vaccine: DTAP, VARZOS
Symptoms: Hypoaesthesia, Lip blister, Lip pain, Lip swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of lip soreness in a 74-year-old male patient who received SHINGRIX. Co-suspect products included dTpa vaccine. Previously administered products included dTpa (never had a reaction with T-dap in past). On 26th March 2018, the patient received the 1st dose of SHINGRIX and dTpa vaccine. In March 2018, less than a week after receiving SHINGIRX and dTpa vaccine, the patient experienced numbness. On 26th March 2018, the patient experienced lip soreness, lip swelling and lip blister. On an unknown date, the outcome of the lip soreness, numbness, lip swelling and lip blister were not recovered/not resolved. The reporter considered the lip soreness, numbness, lip swelling and lip blister to be possibly related to SHINGRIX and dTpa vaccine. Additional details were provided as follows: The healthcare professional reported via chat that his patient received a dose of SHINGRIX morning a day before reporting. The patient then further reported that around dinner time, he noticed that his upper lip was sore and swollen. By bed time, a bleb had developed on the left-inside of my upper lip. Less than a week after vaccination, the patient had numbness. The patient thought she had a mild reaction to the vaccination. Although his lip was swollen in the morning of the reporting date, he expected this reaction to diminish over the next few days. The reporter questioned, given this reaction, should he proceed with the second shingles vaccination scheduled 2 months from now. The vaccines were giving at a pharmacy. The healthcare professional did not have lot number or expiry date. No additional information was provided.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Feeling abnormal, Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of myalgia in a 59-year-old female patient who received SHINGRIX. Concurrent medical conditions included pre-diabetes. Concomitant products included gabapentin, vitamin D, MOTRIN, Vitamin B12, Cinnamon, Cranberry Tablets, fish oil and TYLENOL. On 26th March 12:00, the patient received the 1st dose of SHINGRIX .5 ml. In March 2018, 13 hrs after receiving SHINGRIX, the patient experienced myalgia, fatigue, shivers, feeling unwell, cold, pain in arm and loss of energy. On an unknown date, the outcome of the myalgia, fatigue, shivers, feeling unwell, cold, pain in arm and loss of energy were recovering/resolving. The reporter considered the myalgia, fatigue, shivers, cold, pain in arm and loss of energy to be related to SHINGRIX. The reporter considered the feeling unwell to be unlikely related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine around 12:00 noon on 26th March, 2018 and she claims that during the night around 1:00 AM she woke up not feeling well and she felt sick with symptoms and did not feel quite right. She explained that she felt sick with symptoms and did not feel quite right. She explained that she experienced myalgia, an achy feeling, and she had to take a nap which she usually did not need to do. The patient took a TYLENOL and started to feel better. The patient had taken a MORTIN or TYLENOL three times since the vaccination and she would feel better until the medication wears off. The patient denied permission to contact their physician.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Middle insomnia, Myalgia, Nasopharyngitis, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of myalgia in a 59-year-old female patient who received SHINGRIX. Concurrent medical conditions included pre-diabetes. Concomitant products included gabapentin, vitamin D, MOTRIN, Vitamin B12, Cinnamon, Cranberry Tablets, fish oil and TYLENOL. On 26th March 12:00, the patient received the 1st dose of SHINGRIX .5 ml. In March 2018, 13 hrs after receiving SHINGRIX, the patient experienced myalgia, fatigue, shivers, feeling unwell, cold, pain in arm and loss of energy. On an unknown date, the outcome of the myalgia, fatigue, shivers, feeling unwell, cold, pain in arm and loss of energy were recovering/resolving. The reporter considered the myalgia, fatigue, shivers, cold, pain in arm and loss of energy to be related to SHINGRIX. The reporter considered the feeling unwell to be unlikely related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine around 12:00 noon on 26th March, 2018 and she claims that during the night around 1:00 AM she woke up not feeling well and she felt sick with symptoms and did not feel quite right. She explained that she felt sick with symptoms and did not feel quite right. She explained that she experienced myalgia, an achy feeling, and she had to take a nap which she usually did not need to do. The patient took a TYLENOL and started to feel better. The patient had taken a MORTIN or TYLENOL three times since the vaccination and she would feel better until the medication wears off. The patient denied permission to contact their physician.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of myalgia in a 59-year-old female patient who received SHINGRIX. Concurrent medical conditions included pre-diabetes. Concomitant products included gabapentin, vitamin D, MOTRIN, Vitamin B12, Cinnamon, Cranberry Tablets, fish oil and TYLENOL. On 26th March 12:00, the patient received the 1st dose of SHINGRIX .5 ml. In March 2018, 13 hrs after receiving SHINGRIX, the patient experienced myalgia, fatigue, shivers, feeling unwell, cold, pain in arm and loss of energy. On an unknown date, the outcome of the myalgia, fatigue, shivers, feeling unwell, cold, pain in arm and loss of energy were recovering/resolving. The reporter considered the myalgia, fatigue, shivers, cold, pain in arm and loss of energy to be related to SHINGRIX. The reporter considered the feeling unwell to be unlikely related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine around 12:00 noon on 26th March, 2018 and she claims that during the night around 1:00 AM she woke up not feeling well and she felt sick with symptoms and did not feel quite right. She explained that she felt sick with symptoms and did not feel quite right. She explained that she experienced myalgia, an achy feeling, and she had to take a nap which she usually did not need to do. The patient took a TYLENOL and started to feel better. The patient had taken a MORTIN or TYLENOL three times since the vaccination and she would feel better until the medication wears off. The patient denied permission to contact their physician.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dysgeusia, Feeling abnormal, Upper-airway cough syndrome
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of postnasal drip in a male patient who received SHINGRIX. On 26th March 2018, the patient received SHINGRIX. In March 2018, less than a week after receiving SHINGRIX, the patient experienced weird feeling and chills. On 26th March 2018, the patient experienced postnasal drip and dysgeusia. On an unknown date, the outcome of the postnasal drip, dysgeusia, weird feeling and chills were unknown. It was unknown if the reporter considered the postnasal drip, dysgeusia, weird feeling and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Almost right away after receiving SHINGRIX the patient developed a post nasal drip with a medicine taste in his mouth. The patient had also been feeling chills and felt weird.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Injection site erythema, Injection site warmth, Skin warm
Clinical narrative: This case was reported by a pharmacist via call center representative and describe the occurrence of headache in a 63-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). On 24th March 2018 10:30, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, less than a week after receiving SHINGRIX, the patient experienced headache, skin warm and erythema of extremities. On an unknown date, the outcome of the headache, skin warm and erythema of extremities were unknown. The reporter considered the headache, skin warm and erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to a physician. The reporter had a patient who received SHINGRIX in the right deltoid. On 26th March 2018, 2 days after vaccination, the patient went back to the administering pharmacy to report that she had a mild headache and a red circular area approximately 4 to 5 inches below the injection site. The red circular area approximately 4 to 5 inches below the injection site. The red circular area was at least 4 inches in diameter and it was warm to the touch. The patient indicated that the redness had moved down her arm.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 56-year-female patient who received SHINGRIX (batch number P539L, expiry date 30th January 2020). Concomitant products included ADVIL, FLONASE, IMITREX, MUCINEX, ALLEGRA, PEPCID and PEPTO BISMOL. On 20th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 20th March 2018, less than a day after receiving SHINGRIX, the patient experienced fever. On 21st March 2018, the patient experienced extensive swelling of vaccinated limb, injection site itching and injection site erythema. On an unknown date, the outcome of the extensive swelling of vaccinated limb, fever, injection site itching and injection site erythema were not recovered/not resolved. The reporter considered the extensive swelling of vaccinated limb, fever, injection site itching and injection site erythema to be almost certainly related to SHINGRIX. Additional details were reported as follows: This case was reported by a technician at the healthcare professional's (HCP) office. At 14:19 hours, the patient received SHINGRIX vaccine in right deltoid. After 1 day of vaccination with SHINGRIX, the patient experienced redness, swelling and itchiness at the injection site. The patient had not visited the office, but had called every day. The injection site reaction was 4 inches, but at the same time of reporting, it was twice as big.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Death, Dyspnoea, Sinusitis
Clinical narrative: Patient's granddaughter stated that the evening that the vaccine was received (4/3), the patient was having difficulty breathing with cough and sinus inflammation. The patient had no other symptoms the next morning (4/4), but she took a nap later in the morning and didn't wake up.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Ataxia, Cognitive disorder, Tremor
Clinical narrative: Previously I had been able to remit my ataxia and essential tremor with a ketogenic diet. After the PNEUMOVAX 23 shot, my tremor and ataxia came back despite my adherence to the diet. I also suffered cognition lapses. I have terrible preexisting cognitive problems but after the vaccine I went to wash clothes and forgot to put the clothes in the washer. This was a worsening of my cognitive state. I could not think straight.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: COPIOUS AMOUNTS OF DIARRHEA FOR 24 HOURS POST INJECTION.
Age: 11.0
Sex: F
Vaccine: FLU4, MNQ, TDAP
Symptoms: Dyspnoea, Pain, Urine analysis, Vaccination complication
Clinical narrative: Patient stated she "felt short of breath, and her entire body ached". This occurred approx. one hour after vaccines were given. Pts father called 911 and pt was taken by ambulance to the ER. A partial nebulizer treatment was given in the ambulance. No other medications were given. Pt was discharged home-diagnosis was Adverse reaction to vaccine, initial encounter.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red spot size of softball, area warm to touch near the injection site.
Age: 71.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: No adverse event, Product preparation error
Clinical narrative: N/A - SHINGRIX was mixed with sterile water instead of the provide adjuvant - No adverse event to patient.
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Product preparation error
Clinical narrative: SHINGRIX was mixed with Sterile water instead of the provided adjuvant-No adverse event to the patient.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Back pain, Headache, Immediate post-injection reaction, Limb discomfort, Neck pain
Clinical narrative: Patient said she felt a nerve type when right after the shot. She stated the pain started in her neck and went into her head and then down her back and to her rectum and felt like it was pulling her down and her legs became very heavy.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Neuralgia, Proctalgia
Clinical narrative: Patient said she felt a nerve type when right after the shot. She stated the pain started in her neck and went into her head and then down her back and to her rectum and felt like it was pulling her down and her legs became very heavy.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Myalgia, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site erythema in a male patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site pain, myalgia and fever. On an unknown date, the outcome of the injection site erythema, injection site pain, myalgia and fever were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site pain, myalgia and fever to be related to SHINGRIX. Additional details were provided as follows: The patient experienced increased temperature. It was reported that all of the adverse events resolved within 8 hours of vaccination and the patient did not require any medical treatment. The healthcare professional provided the adverse events information to the sales representative during the visit. The sales representative was unable to document this herself so she contacted the call center to submit on her behalf.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site rash in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown. It was unknown if the reporter considered the injection site rash to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported.
Age: 1.25
Sex: M
Vaccine: MMR, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Localized area of erythema and swell induration at injection site (Lt) upper thigh. No blistering problem no lips swollen. Size = 2x3 cm.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Rash, Rash vesicular
Clinical narrative: Vesicular rash over the back - 2 weeks after vaccination.
Age: 24.0
Sex: U
Vaccine: HPV9
Symptoms: Confusional state, Dizziness, Emotional disorder
Clinical narrative: Pt given vaccine at 1020. Pt reported no S/S of dizziness or reaction 1023. Pt checking out at 1033 and was confused and emotional. Pt reported confusion, and could not answer simple questions. Laid pt down, gave water, and crackers. BP recheck and was 94/62. Physician evaluated pt and pt waited 30 additional minutes.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain, redness, swelling and warm to touch at injection site.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Chest pain, Chills, Fatigue, Injection site pain
Clinical narrative: The patient experienced severe and sudden fatigue, aching all over - especially severe from right earlobe to right elbow beginning at 7:00 PM. Continued with very hot, painful injection site, shivering, nausea, chest cavity aching throughout the night. Temperature was 99.2 when taken later in the evening. The patient put an ice pack on the injection site and took Ibuprofen 400 mg both of which seemed to help. She repeated the Ibuprofen dose later as well. The reaction ended around 7:00 AM the next day. As of 10:00 AM, she was doing much better.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Nausea, Pain
Clinical narrative: The patient experienced severe and sudden fatigue, aching all over - especially severe from right earlobe to right elbow beginning at 7:00 PM. Continued with very hot, painful injection site, shivering, nausea, chest cavity aching throughout the night. Temperature was 99.2 when taken later in the evening. The patient put an ice pack on the injection site and took Ibuprofen 400 mg both of which seemed to help. She repeated the Ibuprofen dose later as well. The reaction ended around 7:00 AM the next day. As of 10:00 AM, she was doing much better.
Age: 0.33
Sex: F
Vaccine: HIBV
Symptoms: Croup infectious, Rash erythematous, Rash generalised
Clinical narrative: A red bumpy rash from the neck down. And as of 4/4/2018 A diagnosis of Croup (after not being exposed to any sick persons).
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: 2"x2" red area at imm. site No fever.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Pain, Vomiting
Clinical narrative: Headache, body aches, vomiting once.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pain in extremity, Skin warm, Swelling
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of pain localized in a adult patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain localized, local swelling, skin warm and localized erythema. On an unknown date, the outcome of the pain localized, local swelling, skin warm and localized erythema were recovered/resolved. It was unknown if the reporter considered the pain localized, local swelling, skin warm and localized erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reports severe local symptoms following the first dose of SHINGRIX (red, swollen, warm to the touch, very painful). These symptoms caused the patient to hold the arm bent, as allowing it to hang freely resulted in too much pain. The reporter did not speak with health care professional. They follow up today during regular business hours.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal distension, Herpes zoster, Musculoskeletal stiffness, Pain, Rash
Clinical narrative: This spontaneous report was received from a currently 72-year-old, female patient who was reporting on herself. The patient's concurrent conditions included breast cancer and myeloproliferative neoplasm disease. The patient did not have any known drug reactions or allergies. In approximately 2013, reported as 4 to 5 years ago, the patient was vaccinated with ZOSTAVAX for shingles (dose, route of administration, anatomical location, lot# and expiration date were not reported). However, the patient stated, that she was uncertain if the vaccine was ZOSTAVAX. Concomitant therapies included hydroxyurea, aspirin (manufacturer unknown), lansoprazole and unspecified thyroid medicine. On an unknown date, reported as now, the patient blowed up with shingles, had spots in the middle of her back, that itch as well as stiffness of the neck and swelling in the abdomen that came and went. The patient believed, that shingles hit her nervous system. Since an unknown date, the patient was taking acetaminophen for pain (onset date not reported; acetaminophen was also reported as concomitant medication). The patient did not seek medical attention and did not receive any treatment for remaining events. No laboratory test was performed. The outcome of the reported events was reported as not recovering. Causality assessment was not provided. Upon internal review, the event of shingles hitting nervous system was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: This spontaneous report was received from a currently 72-year-old, female patient who was reporting on herself. The patient's concurrent conditions included breast cancer and myeloproliferative neoplasm disease. The patient did not have any known drug reactions or allergies. In approximately 2013, reported as 4 to 5 years ago, the patient was vaccinated with ZOSTAVAX for shingles (dose, route of administration, anatomical location, lot# and expiration date were not reported). However, the patient stated, that she was uncertain if the vaccine was ZOSTAVAX. Concomitant therapies included hydroxyurea, aspirin (manufacturer unknown), lansoprazole and unspecified thyroid medicine. On an unknown date, reported as now, the patient blowed up with shingles, had spots in the middle of her back, that itch as well as stiffness of the neck and swelling in the abdomen that came and went. The patient believed, that shingles hit her nervous system. Since an unknown date, the patient was taking acetaminophen for pain (onset date not reported; acetaminophen was also reported as concomitant medication). The patient did not seek medical attention and did not receive any treatment for remaining events. No laboratory test was performed. The outcome of the reported events was reported as not recovering. Causality assessment was not provided. Upon internal review, the event of shingles hitting nervous system was determined to be medically significant.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report as received from a nurse refers to a 19 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient inadvertently received a pediatric dose of VAQTA injection, intramuscularly 25/0.5 ml (lot # N020689, expiration date 22-OCT-2018) for prophylaxis, as second dose in VAQTA immunization series. No adverse effects reported.
Sex: M
Vaccine: PNC13
Symptoms: Chest X-ray abnormal, Chest discomfort, Cough, Extra dose administered, Fatigue
Clinical narrative: This is a spontaneous report from a contactable consumer (reporting on himself) from a Pfizer-sponsored program. A 71-year-old male patient of an unspecified ethnicity received PREVNAR 13 via an unspecified route of administration at single dose in Mar2017, and via an unspecified route of administration at single dose in Mar2018, both for immunisation, pneumonia pneumococcal. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced pneumonia on lower right lobe due to infectious organism (as doctor wrote on the report) with outcome of unknown, fatigue with outcome of unknown, residual cough from the pneumonia/coughing without producing phlegm with outcome of unknown, running a temperature/fever with outcome of recovering, tightness in the chest with outcome of unknown, overall body aches with outcome of unknown. Course of events: Before pneumonia diagnosis, he was running a temperature for 2 days and tightness in the chest and coughing without producing phlegm. He had overall body aches. He ended up going to his GP. He did Xray and overall exam on 27Mar2018 and that was when came back with Pneumonia. The 1st pneumonia shot was back in 2-3 years before and then he had another shot in Mar2017. He thought it was the PREVNAR shot in 2017. He was given another one at the end of Mar2018. He believed it was the PREVNAR one. It was different from anything else he had ever had. Tightness in chest and the fatigue. He knew this could be very serious. They gave him antibiotics: azithromycin (pill form) for 5 days, TYLENOL to reduce fever, lots of liquids. He still had fatigue and residual cough from the pneumonia. They lasted a good week or so after my diagnosis. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: PNC13
Symptoms: Laboratory test abnormal, Pain, Pneumonia, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (reporting on himself) from a Pfizer-sponsored program. A 71-year-old male patient of an unspecified ethnicity received PREVNAR 13 via an unspecified route of administration at single dose in Mar2017, and via an unspecified route of administration at single dose in Mar2018, both for immunisation, pneumonia pneumococcal. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced pneumonia on lower right lobe due to infectious organism (as doctor wrote on the report) with outcome of unknown, fatigue with outcome of unknown, residual cough from the pneumonia/coughing without producing phlegm with outcome of unknown, running a temperature/fever with outcome of recovering, tightness in the chest with outcome of unknown, overall body aches with outcome of unknown. Course of events: Before pneumonia diagnosis, he was running a temperature for 2 days and tightness in the chest and coughing without producing phlegm. He had overall body aches. He ended up going to his GP. He did Xray and overall exam on 27Mar2018 and that was when came back with Pneumonia. The 1st pneumonia shot was back in 2-3 years before and then he had another shot in Mar2017. He thought it was the PREVNAR shot in 2017. He was given another one at the end of Mar2018. He believed it was the PREVNAR one. It was different from anything else he had ever had. Tightness in chest and the fatigue. He knew this could be very serious. They gave him antibiotics: azithromycin (pill form) for 5 days, TYLENOL to reduce fever, lots of liquids. He still had fatigue and residual cough from the pneumonia. They lasted a good week or so after my diagnosis. No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site pain, Pyrexia, Tunnel vision, Vision blurred
Clinical narrative: Pt called office to report possible reaction following Immunization. Pt came in for evaluation by provider, complaining of "severe" pain at injection site. Reported chills/fever, tunnel vision, difficulty focusing vision. Pt advised that symptoms likely caused by robust response to PNEUMOVAX. Pt symptoms had improved by time of office visit. Pt was advised to call with any recurring symptoms.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, itching upper part of left arm surrounding site of Tdap, MENVEO injections. Firmness and warmth noticed by mother on 4/3/18 evening. Mother gave ZYRTEC 4/4/18. Dr prescribed BACTRIM oral antibiotics. Dr advised BENADRYL, cool compresses, ibuprofen. Patient still currently taking BACTRIM. 4 days post injections, still with redness and swelling.
Age: 11.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Blood glucose normal, Dyskinesia, Eye movement disorder, Headache, Joint hyperextension
Clinical narrative: Patient had just had a blood draw before immunizations were administered (Tdap, was given first patient tolerated IM well and then HPV was administered 45 seconds later) 30 seconds after HPV administration patient turned pale, and his eyes rolled up and he began to become rigid and to hyperextend back and neck. Patient lost consciousness for about 45 seconds and had erratic arm movements. Patient regained consciousness after being laid on the floor and O2 was administered. Patient complained of headache and was sleepy and did not remember his last name or age. Vital signs where always stable. Paramedics arrived and patient was transported to Hospital for evaluation and treatment.
Age: 11.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Loss of consciousness, Memory impairment, Muscle rigidity, Pallor, Somnolence
Clinical narrative: Patient had just had a blood draw before immunizations were administered (Tdap, was given first patient tolerated IM well and then HPV was administered 45 seconds later) 30 seconds after HPV administration patient turned pale, and his eyes rolled up and he began to become rigid and to hyperextend back and neck. Patient lost consciousness for about 45 seconds and had erratic arm movements. Patient regained consciousness after being laid on the floor and O2 was administered. Patient complained of headache and was sleepy and did not remember his last name or age. Vital signs where always stable. Paramedics arrived and patient was transported to Hospital for evaluation and treatment.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Fatigue, Paraesthesia, Skin warm, Swelling
Clinical narrative: Red, swollen, hot to touch. Felt tingling down her arm and very tired.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Headache, Injection site induration, Injection site pain, Injection site reaction
Clinical narrative: Patient called to report feeling ill since vaccine administration. Complains of fever, swelling/redness/pain in left arm. Reports a large welt at the sign of injection. Also complains of headache. Pt advised to be seen by provider at our office for evaluation. Pt presents complaining of fever, nausea. Has large area of hot, tender induration at injection site. Advised to monitor area, take ADVIL, supportive care. Advised to call if redness spreads, or symptoms worsen.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Malaise, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: Patient called to report feeling ill since vaccine administration. Complains of fever, swelling/redness/pain in left arm. Reports a large welt at the sign of injection. Also complains of headache. Pt advised to be seen by provider at our office for evaluation. Pt presents complaining of fever, nausea. Has large area of hot, tender induration at injection site. Advised to monitor area, take ADVIL, supportive care. Advised to call if redness spreads, or symptoms worsen.
Age: 53.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Urticaria
Clinical narrative: Patient called to report feeling ill since vaccine administration. Complains of fever, swelling/redness/pain in left arm. Reports a large welt at the sign of injection. Also complains of headache. Pt advised to be seen by provider at our office for evaluation. Pt presents complaining of fever, nausea. Has large area of hot, tender induration at injection site. Advised to monitor area, take ADVIL, supportive care. Advised to call if redness spreads, or symptoms worsen.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site streaking
Clinical narrative: Received PCV-13 vaccine as part of routine vaccination. On 3/25/18 patient began with pain at the site of the injection and redness. By 3/27/18 patient came into PCP office for assessment of arm with increased redness, swelling, induration, streaking of redness several inches down arm from where injection site was. She was treated with KEFLEX for suspected cellulitis secondary to injection. On 3/31/18 patient presented to emergency department with worsening cellulitis extending from site that was assessed at visit in PCP office. Admission was warranted, patient was treated with ANCEF and Vancomycin intravenously for 2 days with resolution of cellulitis. Discharged home with oral antibiotics. Check in with patient on 4/6/18 and verbalization of complete resolvement of infection.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling
Clinical narrative: Received PCV-13 vaccine as part of routine vaccination. On 3/25/18 patient began with pain at the site of the injection and redness. By 3/27/18 patient came into PCP office for assessment of arm with increased redness, swelling, induration, streaking of redness several inches down arm from where injection site was. She was treated with KEFLEX for suspected cellulitis secondary to injection. On 3/31/18 patient presented to emergency department with worsening cellulitis extending from site that was assessed at visit in PCP office. Admission was warranted, patient was treated with ANCEF and Vancomycin intravenously for 2 days with resolution of cellulitis. Discharged home with oral antibiotics. Check in with patient on 4/6/18 and verbalization of complete resolvement of infection.
Age: 2.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Gait inability, Paralysis
Clinical narrative: During a 3/26/2018 well visit, parents described that after the "2y well shots" patient had a few hours of "acting like she was paralyzed and couldn't walk". This resolved the following morning. This occurred during the evening following shots. When I questioned if she was sore and refused to bear weight the parents reiterated "that she acted like she was paralyzed and couldn't walk." Medical treatment was not subsequently sought because of the complete resolution the following morning. There is no further documentation in her chart pertaining to the event until the 3/26/2018 visit. Patient is currently developing normally and is healthy. Parents however refuse further vaccines.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Cardiac disorder, Death
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of heart disease, unspecified in a 62-year-old male patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020). The patient's past medical history included hypertension and diabetes. On 27th March 2018 11:30, the patient received SHINGRIX. On 27th March 2018 18:00, 6 hrs 30 min after receiving SHINGRIX, the patient experienced heart disease, unspecified (serious criteria death). On 27th March 2018 18:00, the outcome of the heart disease, unspecified was fatal. The patient died on 27th March 2018. The reported cause of death was heart disease, unspecified. It was unknown if the reporter considered the heart disease, unspecified to be related to SHINGRIX. Additional details were provided as follows: At 6 pm, the patient passed away. The healthcare professional explained that the coroner reported that the patient passed away due to heart issues etc. The pharmacist was sure that the patient also passed away due to heart issues. The pharmacist called into medical information to confirm that other patients had not passed away due to the SHINGRIX vaccine.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Flushing, Headache, Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of muscle pain in a 76-year-old male patient who received SHINGRIX (batch number P539L, expiry date 30th January 2020). Concomitant products Albuterol, amlodipine, Aspirin, Atorvastatin, valsartan, hydrochlorothiazide, Metoprolol, mometasone and SPIRIVA. On 27th March 2018 09:00, the patient received SHINGRIX .5 ml. On 27th March 2018, several hours after receiving SHINGRIX, the patient experienced muscle pain, body temperature increased, flushing and headache. On an unknown date, the outcome of the muscle pain, body temperature increased, flushing and headache were recovering/resolving. The reporter considered the muscle pain, body temperature increased, flushing and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right deltoid. The patient's wife called the registered pharmacist and reported that her husband experienced the symptoms night before reporting date. The vaccine was administered at the patient's doctor's office.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Headache, Injection site mass, Nausea, Pain in extremity
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). Previously administered products included ZOSTAVAX (received in 2014). On 22nd March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). .5 ml. On 22nd March 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm, injection site lump, nausea, appetite absent, headache and fever. On 26th March 2018, the outcome of the nausea, appetite absent, headache and fever were recovered/resolved. On an unknown date, the outcome of the pain in arm and injection site lump were recovering/resolving. It was unknown if the reporter considered the pain in arm, injection site lump, nausea, appetite absent, headache and fever to be related to SHINGRIX. Additional details were provided as follows: The patient was only on maintenance medications and did not have anything in their medical history that was pertinent to this case. The patient was administered SHINGRIX in the left arm in the morning and later that day after lunch, they presented with all the symptoms. Everything resolved by 26th March 2018 except for the arm soreness (felt like there was a knot in the arm where the patient got the vaccine). The patient's body temperature was recorded as 103 F. It was getting better but had not fully resolved till the time of reporting. The health care professional was certain it was due to the vaccine because the patient was a pharmacist as well. The patient stayed in bed for the whole weekend that this happened.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). Previously administered products included ZOSTAVAX (received in 2014). On 22nd March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). .5 ml. On 22nd March 2018, several hours after receiving SHINGRIX, the patient experienced pain in arm, injection site lump, nausea, appetite absent, headache and fever. On 26th March 2018, the outcome of the nausea, appetite absent, headache and fever were recovered/resolved. On an unknown date, the outcome of the pain in arm and injection site lump were recovering/resolving. It was unknown if the reporter considered the pain in arm, injection site lump, nausea, appetite absent, headache and fever to be related to SHINGRIX. Additional details were provided as follows: The patient was only on maintenance medications and did not have anything in their medical history that was pertinent to this case. The patient was administered SHINGRIX in the left arm in the morning and later that day after lunch, they presented with all the symptoms. Everything resolved by 26th March 2018 except for the arm soreness (felt like there was a knot in the arm where the patient got the vaccine). The patient's body temperature was recorded as 103 F. It was getting better but had not fully resolved till the time of reporting. The health care professional was certain it was due to the vaccine because the patient was a pharmacist as well. The patient stayed in bed for the whole weekend that this happened.
Sex: U
Vaccine: HEPA, MENB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a patient who received BEXSERO. Co-suspect products included HAVRIX. In March 2018, the patient received BEXSERO (intramuscular) and HAVRIX (intramuscular). In March 2018, less than a month after receiving BEXSERO and HAVRIX, the patient experienced injection site erythema, injection site swelling, labeled drug-drug interaction medication error and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site erythema, injection site swelling, labeled drug-drug interaction medication error and vaccine administered at inappropriate site were unknown. The reporter considered the injection site erythema and injection site swelling to be unlikely related to BEXSERO. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to HAVRIX. Additional details were provided as follows: The patient was given BEXSERO and HAVRIX in the same arm at the same time, which led to labeled drug-drug interaction medication error and vaccine administered at inappropriate site. The patient developed arm redness and swelling around the injection sites. The health care professional had called on behalf of the doctor. The health care professional did not have any vaccine or patient information. Vaccines were given some time last week before the date of reporting. The health care professional was not sure when reaction started or if they had resolved but did not believe these reactions were from the vaccines.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Feeling cold, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fever in a 57-year-old female patient who received SHINGRIX. On 27th March 2018, the patient received SHINGRIX. On 27th March 2018, less than a day after receiving SHINGRIX, the patient experienced fever, upset stomach and pain in arm. On an unknown date, the outcome of the fever was recovering/resolving and the outcome of the upset stomach and pain in arm were unknown. It was unknown if the reporter considered the fever, upset stomach and pain in arm to be related to SHINGRIX. Additional information was reported as follows: The case was reported by registered nurse (RN) who was patient. The age at vaccination was not reported but it could be 56 or 57 years. On 27th March 2018 at night, the patient experienced fever with stomach upset and a little arm pain. She stated that she did not check to see what her temperature was, but knew she had a fever since she could not get warm no matter how many clothes she put on. She woke up on 28th March with a fever, but by 6:30pm it was better.