chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of malaise in a adult patient who received SHINGRIX for prophylaxis. 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 malaise. SHINGRIX was discontinued. On an unknown date, the outcome of the malaise was unknown. It was unknown if the reporter considered the malaise to be related to SHINGRIX Additional details were provided as follows: The age at the vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The reporter had a patient who experienced malaise after receiving 1st dose of SHINGRIX, so she did not want to receive the second vaccine. The reporter wanted to know if there was any information about how effective one dose was compared to second. Vaccine was administered at a different location. No further information was provided.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse event in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter had spoken with the physician and she was told by the physican that the 2nd dose was worse than the 1st dose. The reporter stated that, the physician did not react at all after the 2nd dose. This case has been linked to the US2018GSK107501 reported by the same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 67-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date 13th July 2020) for prophylaxis. On 18th May 2018 10:30, the patient received SHINGRIX (intramuscular) .5 ml. In May 2018, less than a day after receiving SHINGRIX, the patient experienced fever, injection site pain, pain in arm and chills. The patient was treated with ibuprofen. On an unknown date, the outcome of the fever, injection site pain and chills were recovered/resolved and the outcome of the pain in arm was not recovered/not resolved. The reporter considered the fever, injection site pain and chills to be probably related to SHINGRIX. The reporter considered the pain in arm to be unlikely related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left arm. Within 24 hours, the patient developed fever, chills and soreness at the injection site. One week later, the patient reported that she had severe pain in the opposite arm she got the injection. The patient took ibuprofen and used a heating pad as treatment. On an unknown date, the patient's labs were drawn, however results were unknown.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Hypoaesthesia, Initial insomnia, Insomnia, Neuralgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of numbness in feet in a 77-year-old male patient who received SHINGRIX for prevention. Concurrent medical conditions included blood pressure, sciatica (low levels of sciatica pain for about a month now) and nerve pain. Concomitant products included evolocumab (Repatha), timolol and tafluprost (Zioptan).  On 7th June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 7th June 2018, less than a day after receiving SHINGRIX, the patient experienced numbness in feet, difficulty sleeping, nerve pain and condition aggravated. On an unknown date, the outcome of the numbness in feet was unchanged and the outcome of the difficulty sleeping was unknown and the outcome of the nerve pain and condition aggravated were recovering/resolving. It was unknown if the reporter considered the numbness in feet, difficulty sleeping, nerve pain and condition aggravated to be related to SHINGRIX. Additional details were reported as follows: The patient's concomitant medications included anticoagulant medication and blood pressure medication. At 10:00, the patient received SHINGRIX on the left arm. The patient's nerve pain became more noticeable on the last night. The patient had trouble to fall asleep last night as well. The patient also stated that, last night he experienced numbness in his right foot and calf in the lower part of his legs. His nerve pain had decreased a little and the numbness was still unchanged on the date of reporting compared to the last night. The patient denied permission to contact their physician. The patient had followed up with his healthcare provider and had scheduled for an MRI, along with an appointment with his neurologist.
Sex: F
Vaccine: VARZOS, FLU4
Symptoms: Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received SHINGRIX for prophylaxis. Previously administered products included influenza vaccine with an associated reaction of injection site pain (received in the past and had adverse event). 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 pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additonal details were reported as follows: The patient was sister of the reporter. The age at vaccination was not reported. The patient experienced soreness at her injection site. Limited information was provided. The rpeorter did not want to provide additional demographics.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: White blood cell count increased
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of white blood cell increased in a 76-year-old male patient who received SHINGRIX for prophylaxis.  Concurrent medical conditions included lymphocytic leukemia (chronic). On 26th April 2018, the patient received SHINGRIX. On 7th June 2018, 42 days after receiving SHINGRIX, the patient experienced white blood cell increased. On an unknown date, the outcome of the white blood cell increased was unknown. It was unknown if the reporter considered the white blood cell increased to be related to SHINGRIX. Additional details were provided as follows: The reporter himself was the patient. The patient's white blood cell count (WBC) was normal before receiving the SHINGRIX. On 7th June 2018, the patient discovered that his white blood cell count (WBC) was doubled. No additional information was provided. This case was linked with case US2018GSK108192, reported by the same reporter.  Lab Comments: On an unknown date, before receiving the SHINGRIX, white blood cell (WBC) count was normal.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Feeling abnormal, Injection site induration, Injection site mass
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included vitamin d. On 6th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 6th June 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 7th June 2018, the patient experienced energy decreased, chills, malaise, injection site lump, injection site induration and fever. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site pain and injection site lump were not recovered/not resolved and the outcome of the energy decreased and malaise were recovering/resolving and the outcome of the chills and fever were recovered/resolved and the outcome of the injection site induration was unknown. The reporter considered the injection site pain, energy decreased, chills, malaise, injection site lump, injection site induration and fever to be related to SHINGRIX. Additional information was received as follows: The patient stated that she felt pain during the injection and later that evening her arm was sore. The patient stated that in the 24 hours following the injection the pain in her left arm increased and her left arm became tender to the touch and she noticed a hard knot at the injection site. The patient stated that the day following the vaccination, she also experienced chills, fever, low energy, and general malaise. The patient stated that she took 400 mg of Ibuprofen a few times and morning of reporting day when she woke up, she felt a little better, but still feeling wiped out and with low energy. The patient had denied permission to contact their physician. The patient stated that everything went very well, with her report to GlaxoSmithKline of Adverse Event and a customer service agent was very polite and respectful and very efficient. Overall, very, very positive.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Pyrexia, Tenderness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included vitamin d. On 6th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 6th June 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 7th June 2018, the patient experienced energy decreased, chills, malaise, injection site lump, injection site induration and fever. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site pain and injection site lump were not recovered/not resolved and the outcome of the energy decreased and malaise were recovering/resolving and the outcome of the chills and fever were recovered/resolved and the outcome of the injection site induration was unknown. The reporter considered the injection site pain, energy decreased, chills, malaise, injection site lump, injection site induration and fever to be related to SHINGRIX. Additional information was received as follows: The patient stated that she felt pain during the injection and later that evening her arm was sore. The patient stated that in the 24 hours following the injection the pain in her left arm increased and her left arm became tender to the touch and she noticed a hard knot at the injection site. The patient stated that the day following the vaccination, she also experienced chills, fever, low energy, and general malaise. The patient stated that she took 400 mg of Ibuprofen a few times and morning of reporting day when she woke up, she felt a little better, but still feeling wiped out and with low energy. The patient had denied permission to contact their physician. The patient stated that everything went very well, with her report to GlaxoSmithKline of Adverse Event and a customer service agent was very polite and respectful and very efficient. Overall, very, very positive.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 76-year-old male patient who received SHINGRIX for prophylaxis. On 31st May 2018, the patient received the 1st dose of SHINGRIX. In June 2018, 7 days after receiving SHINGRIX, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved. The reporter considered the headache to be related to SHINGRIX. Additional details were provided as follows: The patient noted he did not have this issue before SHINGRIX. The patient started with a headache about a week after the vaccine and had continued to have it. The patient was referred to his physician.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received SHINGRIX (batch number T5242, expiry date 31st March 2020) for prophylaxis. On 2nd June 2018, the patient received the 2nd dose of SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) reported that that patient received the 2nd dose of SHINGRIX and had arm pain which lasted for 2 days and then resolved.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Gastric disorder, Influenza like illness, Lethargy, Pallor
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of flu like symptoms in a 69-year-old male patient who received SHINGRIX (batch number T5242, expiry date 31st March 2020) for prophylaxis. Concurrent medical conditions included back pain. On 2nd June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 3rd June 2018, 1 days after receiving SHINGRIX, the patient experienced flu like symptoms, lethargic, fever, pallor, weight loss, gastric disorder and tiredness. On an unknown date, the outcome of the flu like symptoms, fever and pallor were recovered/resolved and the outcome of the lethargic was not recovered/not resolved and the outcome of the weight loss, gastric disorder and tiredness were unknown. The reporter considered the flu like symptoms, lethargic, fever, pallor and weight loss to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the gastric disorder and tiredness to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that the patient received SHINGRIX on left arm. The following day, the patient experienced flu like symptoms, was very pale like white as a ghost and had fever (which resolved the following day), weight loss of 1 pound, the stomach was not right and the patient was lethargic. Everything was resolved at that point except for the lethargy. The health care professional stated that the patient could not seem to shake it off from being so tired. The health care professional mentioned that, the patient was in the heat outside the day he received the vaccine. The patient was the health care professional technician at the pharmacy. The reporter and the patient work together.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Weight decreased
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of flu like symptoms in a 69-year-old male patient who received SHINGRIX (batch number T5242, expiry date 31st March 2020) for prophylaxis. Concurrent medical conditions included back pain. On 2nd June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 3rd June 2018, 1 days after receiving SHINGRIX, the patient experienced flu like symptoms, lethargic, fever, pallor, weight loss, gastric disorder and tiredness. On an unknown date, the outcome of the flu like symptoms, fever and pallor were recovered/resolved and the outcome of the lethargic was not recovered/not resolved and the outcome of the weight loss, gastric disorder and tiredness were unknown. The reporter considered the flu like symptoms, lethargic, fever, pallor and weight loss to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the gastric disorder and tiredness to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported that the patient received SHINGRIX on left arm. The following day, the patient experienced flu like symptoms, was very pale like white as a ghost and had fever (which resolved the following day), weight loss of 1 pound, the stomach was not right and the patient was lethargic. Everything was resolved at that point except for the lethargy. The health care professional stated that the patient could not seem to shake it off from being so tired. The health care professional mentioned that, the patient was in the heat outside the day he received the vaccine. The patient was the health care professional technician at the pharmacy. The reporter and the patient work together.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Injection site erythema, Injection site pain, Myalgia, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 71-year-old female patient who received SHINGRIX (batch number NX952, expiry date 6th March 2020) for prophylaxis. On 4th June 2018 13:00, the patient received the 2nd dose of SHINGRIX (intramuscular). In June 2018, less than a week after receiving SHINGRIX, the patient experienced fever, weakness, injection site pain, myalgia and injection site erythema. On an unknown date, the outcome of the fever, weakness, injection site pain, myalgia and injection site erythema were recovering/resolving. The reporter considered the fever, weakness, injection site pain, myalgia and injection site erythema to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on an unknown deltoid. The patient experienced the effects as noted at the injection site.
Age: 71.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: This case was reported by a consumer and described the occurrence of erythema in a 71-year-old patient who received SHINGRIX (batch number 32GR4, expiry date 7th April 2020) for prophylaxis.  On 31st May 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 31st May 2018, less than a day after receiving SHINGRIX, the patient experienced erythema, swelling and skin warm. On an unknown date, the outcome of the erythema, swelling and skin warm were not recovered/not resolved.  It was unknown if the reporter considered the erythema, swelling and skin warm to be related to SHINGRIX. Additional details were provided as follows: After receiving Shingrix, the patient experienced redness, swelling and heat.
Age: 50.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 50-year-old patient who received SHINGRIX for prophylaxis. 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 fever, chills, headache and general body pain. On an unknown date, the outcome of the fever, chills, headache and general body pain were recovered/resolved. It was unknown if the reporter considered the fever, chills, headache and general body pain to be related to SHINGRIX. Additional information was received as follows: This case was reported by the patient, who was a pharmacist. The patient said that SHINGRIX had been the worst immunization the patient had received as far as it related to side effects. The patient experienced fever, chills, headache and body pain, after vaccination. The patient was in excellent medical and physical condition and being a pharmacist he or she would be very reluctant to offer and administered SHINGRIX to other patient population because of the severe side effects that experienced self by the patient. Most of their population were older than 50 years and in worse physical health than the patient with underlying comorbidities. For tolerance effect after 2nd dose, please refer case US2018GSK108193.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse event in an adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter had spoken with the physician and she was told by the physician that the 2nd dose was worse than the 1st dose. The reporter stated that, the physician did not react at all after the 2nd dose. This case has been linked to the US2018102535 reported by the same reporter.
Age: 50.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 50-year-old patient who received SHINGRIX for prophylaxis. Concomitant products included Herpes zoster SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, chills, headache and general body pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever, chills, headache and general body pain were recovered/resolved. It was unknown if the reporter considered the fever, chills, headache and general body pain to be related to SHINGRIX. Additional information was received as follows: This case was reported by the patient itself, who is a pharmacist. The patient said that SHINGRIX had been the worst immunization the patient had received as far as it related to side effects. The patient experienced fever, chills, headache and body pain, after vaccination. The patient was in excellent medical and physical condition and being a pharmacist he or she would be very reluctant to offer and administered SHINGRIX to other patient population because of the severe side effects that experienced self by the patient. Most of their population were older than 50 years and in worse physical health than the patient with underlying comorbidities. This case has been linked to the case US2018GSK102941, reported for the same patient.
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Influenza like illness
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A male patient of an unspecified age received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization; and influenza vaccine (FLU VACCINE), via an unspecified route of administration on an unspecified date at an unknown dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had flu like symptoms and ended up in the hospital after receiving pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) and the flu vaccine on an unspecified date (reported as occurred a few months ago). The outcome of the event was unknown. No follow-up attempts are possible; information about the batch number cannot be obtained.
Age: 1.0
Sex: F
Vaccine: MMRV, PNC13, VARCEL
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: Patient was administered MMRV in error. MMR, Varicella and PCV-13 ordered by physician. LPN administered PCV-13, Varicella and MMRV.
Age: 21.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Dizziness, Eye movement disorder, Fear of injection, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Client with self report of fear of needles. Received Tdap without incident. Was finishing receiving HPV when complained of burning at site and dizziness. At that time client became pallor and head dropped down, body slumped to left and eyes went back. Bil arms drew in towards her chest and legs stiffened. Client lowered from high back chair to floor and legs raised to be above clients head. Client remained unresponsive for 20-30 seconds. EMS and client's mother notified. After approx 30 sec client began kicking, swinging arms, and screaming...this lasted approx 2-3 minutes. Nurse stayed with her protecting her from harm and reassure her. After approx 3 minutes, client became alert "sorry I was yelling". Skin cont to be pallor, BP 92/56 P 66 R regular 16. EMS arrived- client signed waiver and declined service. Mother arrived and reports patient with history of fainting with lab work. Repeat BP check.. 90/54. After sitting with fan and cool drink of water for 15 minutes, client left with mother. Mother did also report client had a heart murmur as a child but has not been detected with most recent visits to PCP. Also reports client with history of low BP.
Age: 21.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Pallor, Posture abnormal, Screaming, Unresponsive to stimuli
Clinical narrative: Client with self report of fear of needles. Received Tdap without incident. Was finishing receiving HPV when complained of burning at site and dizziness. At that time client became pallor and head dropped down, body slumped to left and eyes went back. Bil arms drew in towards her chest and legs stiffened. Client lowered from high back chair to floor and legs raised to be above clients head. Client remained unresponsive for 20-30 seconds. EMS and client's mother notified. After approx 30 sec client began kicking, swinging arms, and screaming...this lasted approx 2-3 minutes. Nurse stayed with her protecting her from harm and reassure her. After approx 3 minutes, client became alert "sorry I was yelling". Skin cont to be pallor, BP 92/56 P 66 R regular 16. EMS arrived- client signed waiver and declined service. Mother arrived and reports patient with history of fainting with lab work. Repeat BP check.. 90/54. After sitting with fan and cool drink of water for 15 minutes, client left with mother. Mother did also report client had a heart murmur as a child but has not been detected with most recent visits to PCP. Also reports client with history of low BP.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Rash vesicular
Clinical narrative: Patient began having pain 24 hours after the vaccine was given and then broke out in vesicular rash along T1 dermatome line on the left. Rash progressed over several days.
Age: 34.0
Sex: M
Vaccine: TD
Symptoms: Hypersensitivity, Muscle spasms
Clinical narrative: Patient reports that one week after the Td, he developed cramping all over his body, no rash, no difficulty breathing, was seen by an Urgent care doctor who gave him a steroid injection and told him that the combination of heat and the tetanus one week earlier, gave him an allergic reaction. I have seen him for this complaint on 6/18/18, no rash and not complaint of cramping.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Cold sweat, Diarrhoea, Dizziness, Nausea, Pyrexia
Clinical narrative: Dizziness. Nausea. Diarrhea, high fever, cold sweat and rash.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Dizziness. Nausea. Diarrhea, high fever, cold sweat and rash.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Impaired work ability, Influenza
Clinical narrative: Terrible flu symptoms, chills, headache. Unable to work for 2 days.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9
Symptoms: Blood pressure decreased, Presyncope
Clinical narrative: Near-syncope with likely vagal reponse; placed in supine position, rested, resolved over approximately one hour.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Headache, Hyperaesthesia, Nail discomfort, Pain
Clinical narrative: Woke up the next morning with a very sore right wrist, didn't notice until I drove. Thought I slept on my arm therefore assumed that's why I had pain. The next day (Thursday) it had spread, all my joints were in pain. It hurt to bend my toes, fingers, neck, back, knees and ankles. My nails felt like they were going to pop off, my body felt very sensitive. I've had a headache on and off since the day after the vaccine. I've been taking ibuprofen 800 and it helps a little bit. Change in weather affects me too, pain is widespread then there are times of random stings. Every day it gets somewhat better but I will never take this vaccine again. It's been about a week now and my body is aching just sitting up while filling out this form.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site erythema, Pain, Pruritus
Clinical narrative: About 2 or 3 days after the injection, she began to feel pain and itching. Days 4 and 5 after the injection were the worst. She has a red circle/ bruising to the area just above the left bicep even though the vaccine was given in the left deltoid.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Computerised tomogram, Injection site bruising
Clinical narrative: Pt suffered a large bruise from the injection.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Discomfort, Myalgia, Vaccination site pain
Clinical narrative: Very sore arm at site of vaccine beginning at about 6 pm after vaccine administration. The next morning the patient reports having had joint and muscle pain and discomfort all over body. Patient reports that she took extra strength acetaminophen and iced the vaccine administration area. Her symptoms lasted 2 to 3 days.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness
Clinical narrative: Patient got light-headed and needed to lay down. Was given juice and crackers.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Muscle aches, high fever, chills, nausea, headache.
Age: 70.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reported pain in arms and neck that also traveled to her legs. She reports swelling in both legs.
Age: 70.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Abdominal pain, Arthralgia, Back pain, Bone pain, Fatigue
Clinical narrative: Patient reported pain in arms and neck that also traveled to her legs. She reports swelling in both legs.
Age: 70.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Gait disturbance, Head discomfort, Insomnia, Joint stiffness, Joint swelling
Clinical narrative: Patient reported pain in arms and neck that also traveled to her legs. She reports swelling in both legs.
Age: 70.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Middle insomnia, Myalgia, Neck pain, Pain, Pain in extremity
Clinical narrative: Patient reported pain in arms and neck that also traveled to her legs. She reports swelling in both legs.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Blister, Culture wound negative, Injection site rash
Clinical narrative: Raised rash covering entire left thigh and fluid filled blisters 2-3 days after vaccine.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Erythema, induration, tenderness around site extending about 3 inches by 1 inch.
Age: 26.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: SHE HAD ARM PAIN AFTER THE SHOT FOR SEVERAL DAYS BUT THAT SUBSIDED. SHE SAID 3 DAYS AFTER THE SHOT SHE STARTED HAVING INFLAMMATION, SWELLING, WARMTH ON HER INJECTED ARM.
Age: 31.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Hyperhidrosis, Hypersensitivity, Mobility decreased, Nausea, Peripheral swelling
Clinical narrative: A few hours after the vaccination, the patient became very nauseous and vomited. During the night she had a high fever and was sweating. He arm was very swollen and she had limited movement.
Age: 31.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pyrexia, Vomiting
Clinical narrative: A few hours after the vaccination, the patient became very nauseous and vomited. During the night she had a high fever and was sweating. He arm was very swollen and she had limited movement.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms lasting 7 days.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red hot spot around the injection site.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pruritus, Skin ulcer
Clinical narrative: Patient reports developing sores two days post-vaccination that resembled spider bites on her chest, not painful but itchy, eventually they developed into blisters.
Age: 49.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Middle insomnia, Pain, Pain in extremity
Clinical narrative: After a few hours my arm had pain. I thought it was the normal ache I usually get after the injections. After a month I felt it was more than the usual pain. It hurt more as the days went by it hurt more I am now unable to use the arm without horrible pain. Pain wakes me during the night. If I turn or move it, it hurts. It's been 7 months now and the pain is still unbearable. I have seen my doctor due to the pain. I had flu vaccine and Tdap. I get the flu vaccine yearly but this time it is unbearable and has lasted past a week. For the last 7 months I have had to take pain medicine daily to help control the pain to work and function daily. Heating pad ice pack everything that will help ease the pain.
Age: 1.25
Sex: F
Vaccine: MMRV
Symptoms: Laboratory test normal, Malaise, Pyrexia, Rash generalised, Streptococcus test negative
Clinical narrative: Rash that covered my daughters entire body started on 6/12/18. Rash lasted 2 days. Daughter experienced malaise. She also got a fever on 6/9/18 that lasted till 6/11/18.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Feeling abnormal, Gait disturbance, Injected limb mobility decreased, Nasopharyngitis
Clinical narrative: I started to run a low grade fever and feel not right on the evening I had the injection. That evening was rough. I was aching all over and feverish. Everything hurt when I woke up the next morning. I was so achy I could hardly walk. The arm I received the injection in was very sore. I could hardly move it. I was nauseous and ate very little that day. I felt better the following day. Then Sunday evening I came down with terrible congestion. It was like a head cold only no other symptoms.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pain in extremity, Pyrexia, Respiratory tract congestion
Clinical narrative: I started to run a low grade fever and feel not right on the evening I had the injection. That evening was rough. I was aching all over and feverish. Everything hurt when I woke up the next morning. I was so achy I could hardly walk. The arm I received the injection in was very sore. I could hardly move it. I was nauseous and ate very little that day. I felt better the following day. Then Sunday evening I came down with terrible congestion. It was like a head cold only no other symptoms.
Age: 42.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Blister, Cough, Feeling abnormal, Haemorrhage, Pruritus
Clinical narrative: The patient was feeling different the night after getting the vaccines. According to the patient she experienced blisters (watery and bloody blisters) the next day after getting the vaccines for 2 days. Also she experience fever, cough, hives and itching for 2 days.
Age: 42.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pyrexia, Urticaria
Clinical narrative: The patient was feeling different the night after getting the vaccines. According to the patient she experienced blisters (watery and bloody blisters) the next day after getting the vaccines for 2 days. Also she experience fever, cough, hives and itching for 2 days.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise
Clinical narrative: This initial spontaneous case, was received on 21-Aug-2017 from a pharmacist and concerns a 63-year-old female patient. The patient's medical history was not reported. The patient was on unspecified concomitant medications. On 02-Feb-2017, the patient was administered with AFLURIA (TIV) (dose: 0.5 ml, batch number: WT57908, expiry date: 30-JUN-2017, route of administration, anatomical location: not reported). It was reported that, the patient had been feeling sick since Feb-2017 (reported as, from 6 months to the time of this report). The treatment medications were not reported. At the time of report, the symptoms were ongoing and the patient had not recovered from the event. The reporter stated that, the patient was hospitalized but he believed that the patient was hospitalized for some unspecified reasons. Hence, the reporter assessed the case as non-serious.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Chest discomfort, Dizziness, Flushing, Hypersensitivity, Livedo reticularis
Clinical narrative: This is a serious spontaneous case, initially received from a nurse on 30-Nov-2017, concerning a 58-year-old, adult, male patient. The patient's current conditions included allergy to tree nuts, dust, codeine, sweet potatoes, tuna, cat, dust mite and unknown fish. The patient's medical history was not reported. The patient had not taken any regular medications. The patient had recommended to take EPIPEN, BENADRYL and CLARITIN as needed or in case of emergency situations. It was reported that the patient had no reactions from prior vaccines. The patient had allergic reactions often, hence he carried BENADRYL with him. On 14-Nov-2017, the patient was administered with AFLURIA QUADRIVALENT (dose:0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 01544621A, expiry date: 30-Jun-2018). On the same day, about 5 minutes after vaccine administration, the patient experienced dizziness, itchy chest tightness and  flushing in neck and face. The patient took BENADRYL 50 mg oral. About 5 min later, patient's breathing became easier but continued flushing, reported modelling of arms and face and continued to complain of tightness in the chest but had no signs of respiratory distress. The patient took another dose of BENADRYL and hives were noticed on shoulder and upper back. It was reported that, modelling continued, the breathing was regular, but he reported as feeling tight. The patient was taken to the hospital in ambulance and admitted. He stayed 2-3 hours and was discharged from the hospital on the same day with Famotidine 40 mg for allergic type of symptoms, which was recommended to take as needed. The patient also recommended to consult a dermatologist to perform a new allergy skin test. On 21-Nov-2017, it was reported that, the patient had similar reaction again and treated himself with Benadryl. The patient once again went to hospital and prescribed with Famotidine and then discharged from hospital after a quick observation. At the time of the report, the patient was recovered from the event. Follow-up received from other health professional (nurse) on 30-Jan-2018: The nurse confirmed that patient had not taken any medications and was using EPIPEN, BENADRYL and CLARITIN as needed or in case of emergency situations. The hospitalization details,  allergic conditions (tree nuts, sweet potatoes, cat, tuna, dust mite and another unknown fish), treatment medication (Famotidine) and outcome of the event were updated. The nurse also confirmed that the patient had similar reaction again and treated himself with BENADRYL. The patient once again went to hospital and prescribed Famotidine and then discharged from hospital after a quick observation. Narrative amended accordingly.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: This is a serious spontaneous case, initially received from a nurse on 30-Nov-2017, concerning a 58-year-old, adult, male patient. The patient's current conditions included allergy to tree nuts, dust, codeine, sweet potatoes, tuna, cat, dust mite and unknown fish. The patient's medical history was not reported. The patient had not taken any regular medications. The patient had recommended to take EPIPEN, BENADRYL and CLARITIN as needed or in case of emergency situations. It was reported that the patient had no reactions from prior vaccines. The patient had allergic reactions often, hence he carried BENADRYL with him. On 14-Nov-2017, the patient was administered with AFLURIA QUADRIVALENT (dose:0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 01544621A, expiry date: 30-Jun-2018). On the same day, about 5 minutes after vaccine administration, the patient experienced dizziness, itchy chest tightness and  flushing in neck and face. The patient took BENADRYL 50 mg oral. About 5 min later, patient's breathing became easier but continued flushing, reported modelling of arms and face and continued to complain of tightness in the chest but had no signs of respiratory distress. The patient took another dose of BENADRYL and hives were noticed on shoulder and upper back. It was reported that, modelling continued, the breathing was regular, but he reported as feeling tight. The patient was taken to the hospital in ambulance and admitted. He stayed 2-3 hours and was discharged from the hospital on the same day with Famotidine 40 mg for allergic type of symptoms, which was recommended to take as needed. The patient also recommended to consult a dermatologist to perform a new allergy skin test. On 21-Nov-2017, it was reported that, the patient had similar reaction again and treated himself with Benadryl. The patient once again went to hospital and prescribed with Famotidine and then discharged from hospital after a quick observation. At the time of the report, the patient was recovered from the event. Follow-up received from other health professional (nurse) on 30-Jan-2018: The nurse confirmed that patient had not taken any medications and was using EPIPEN, BENADRYL and CLARITIN as needed or in case of emergency situations. The hospitalization details,  allergic conditions (tree nuts, sweet potatoes, cat, tuna, dust mite and another unknown fish), treatment medication (Famotidine) and outcome of the event were updated. The nurse also confirmed that the patient had similar reaction again and treated himself with BENADRYL. The patient once again went to hospital and prescribed Famotidine and then discharged from hospital after a quick observation. Narrative amended accordingly.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Cough, Dyspnoea, Swelling face, Throat tightness
Clinical narrative: This initial spontaneous case, was received on 23-Oct-2017 by other health professional (nurse) and concerns a 53-year-old-adult female patient. The patient had no known allergy to any component of the vaccine (no egg allergy) and history of any drug allergies was not reported. On 18-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 01144611A, expiry date: not reported). On 18-Oct-2017, 2.5 hours after administration of vaccine, the patient had breathing problems, cough, felt like throat was closing and facial swelling. The patient had idiopathic anaphylaxis. The patient was treated with 2 doses of epinephrine and then 3rd dose was administered in hospital. On the same day, the patient recovered from the events. It was reported that, the patient had no inpatient hospitalization. The reporter assessed the events as serious (medically significant). Non-significant follow up received on 08-Nov-2017: The reporter confirmed the event stop date as 18-Oct-2017. It was reported that, the patient did not have an inpatient hospitalization. The narrative was amended accordingly. Follow-up received from nurse on 27-Nov-2017: Added patient's medical history, symptoms of the event idiopathic anaphylaxis, as breathing problems, cough, felt like throat was closing and facial swelling. Narrative was amended accordingly.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Blood pressure increased, Hypertension, Pallor, Throat irritation, Vasoconstriction
Clinical narrative: This serious spontaneous case, was initially received on 05-Oct-2017, reported by other-health professional, and concerns a 61-year-old, adult, female patient. The patient was allergic to shellfish, sulfa, latex, antibiotics, and aminoglycosides. The patient's concomitant medications included: BENADRYL and URSO. On 05-Oct-2017, the patient received AFLURIA QUADRIVALENT for the first time (dose: 0.5ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: XF31007, expiry date: 30-Jun-2018). On 05-Oct-2017, 3 minutes after administration of the suspect vaccine, the patient turned pale which was noticed by the nurse (nurse who administered the vaccine and the nurse who identified the symptoms was not the same) and asked whether she was okay. The patient felt her throat itchy, not fully anaphylactic. The patient became hypertensive (170/110), normally her blood pressure was low. The patient was taken to the emergency department and treated with BENADRYL (25 mg, q4h, IV (intravenous)) and PEPCID which helped to lower her blood pressure. She was also treated with ZANTAC and she felt like she was vasoconstricted. She was sent home with oral BENADRYL, which worked to treat the event. On an unspecified date, the patient recovered from the events. Follow-up received on 17-Oct-2017: Route of administration was updated to intramuscular. Dose and frequency of treatment medication BENADRYL was updated to 25 mg, q4h. ZANTAC was added as treatment medication. Outcome of the events was updated to recovered from recovering and narrative was amended accordingly. Non-significant case correction received 05-Oct-2017: Batch number (XF31007) was captured on the screen and narrative was amended accordingly.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Hyperhidrosis, Injection site pain, Nausea
Clinical narrative: I received the 2nd SHINGRIX shot yesterday 6/4/2018. I have severe pain in the muscle where the shot was administered. Over night I started with an upset stomach and chills and sweats. I felt like I was going the throw up. It became more severe early in the morning lasting for approximately 10 hours. My stomach has remained uncomfortable but I don't feel like I have to throw up as the 12 - 14 hour after the onset of symptoms.
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 67 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event and reporter's comment. Amended narrative accordingly.