chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 18-SEP-2010, a pharmacist at a pharmacy administered the ZOSTAVAX) to the patient (lot number, dosage and route of administration not provided). On or about 04-OCT-2016, the patient was treated by a healthcare provider at a hospital (Emergency room) for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Nasopharyngitis
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of cold in a 58-year-old female patient who received FLULAVAL Quadrivalent for prophylaxis. Co-suspect products included fluticasone propionate, ADVAIR DISKUS unknown for an unknown indication. On an unknown date, the patient received FLULAVAL Quadrivalent at an unknown dose and ADVAIR DISKUS 250/50 mg at an unknown dose and frequency. On an unknown date, 1 day after receiving FLULAVAL Quadrivalent and less than a year after starting ADVAIR DISKUS, the patient experienced cold. The patient was treated with NYQUIL. On an unknown date, the outcome of the cold was unknown. It was unknown if the reporter considered the cold to be related to FLULAVAL Quadrivalent and ADVAIR DISKUS. Additional details were provided as follows: The patient mentioned she was having cold since a week and a half. She caught it just the next day she had her flu shot. She was taking NYQUIL, which helps her breathe during night.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain and injection site rash. SHINGRIX was discontinued. On an unknown date, the outcome of the injection site pain was unknown and the outcome of the injection site rash was recovered/resolved. It was unknown if the reporter considered the injection site pain and injection site rash to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported but it could be between 50 and 64 years. The patient was called by the office to receive the 2nd dose of SHINGRIX vaccine. But the patient refused and stated that, after her 1st dose of SHINGRIX, she had pain at the injection site with a rash that went from injection site all the way to hand. The reporting nurse asked if the patient sought any medical treatment for rash. The patient said she did not and the rash lasted for 3 weeks. The reporter did not agree to follow up from GlaxoSmithKline (GSK).
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 67-year-old male patient who received SHINGRIX for prophylaxis. On 10th January 2019, the patient received the 1st dose of SHINGRIX. In January 2019, less than a day after receiving SHINGRIX, the patient experienced tiredness and injection site muscle pain. On an unknown date, the outcome of the tiredness and injection site muscle pain were unknown. It was unknown if the reporter considered the tiredness and injection site muscle pain to be related to SHINGRIX. Additional information was reported as follows: The day before the date of reporting in afternoon, the patient received SHINGRIX. After vaccination, the patient experienced mild tiredness and muscle pain or soreness at the side of the shot. The patient wanted to know whether he could take Advil.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 58-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included eczema. In October 2018, the patient received the 1st dose of SHINGRIX. 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. Additional information was reported as follows: The reporter who is a physician was reporting a case for himself. In 2018 after vaccination, the patient experienced pain at the injection site. The contact details of the physician was provided. The reporter consented to follow up. For tolerance to next dose, refer case US2019004267.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 72-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injected limb mobility decreased and pain in arm. On an unknown date, the outcome of the injected limb mobility decreased and pain in arm were recovered/resolved. It was unknown if the reporter considered the injected limb mobility decreased and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient experienced a sore arm for 2 to 3 days. She described it as being more sore than she usually felt with other vaccinations. The patient stated, it was hard to lift her arm for a few days. The reporter gave consent to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Loss of personal independence in daily activities, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 72-year-old female patient who received SHINGRIX for prophylaxis. On 30th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, pain, headache, sleepiness, activities of daily living impaired and feeling bad. On an unknown date, the outcome of the fever, pain, headache, sleepiness, activities of daily living impaired and feeling bad were recovered/resolved. It was unknown if the reporter considered the fever, pain, headache, sleepiness, activities of daily living impaired and feeling bad to be related to SHINGRIX. Additional details were received as follows: The patient reported that she was flattened for 3 weeks after vaccination with SHINGRIX. The patient stated that she had all the side effects then add 3 to 4 more. Side effects mentioned specifically were low grade fever, aches, headaches, being in bed and being prevented from doing things. The patient had to cancel several activities because she felt so bad. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 72-year-old female patient who received SHINGRIX for prophylaxis. On 30th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, pain, headache, sleepiness, activities of daily living impaired and feeling bad. On an unknown date, the outcome of the fever, pain, headache, sleepiness, activities of daily living impaired and feeling bad were recovered/resolved. It was unknown if the reporter considered the fever, pain, headache, sleepiness, activities of daily living impaired and feeling bad to be related to SHINGRIX. Additional details were received as follows: The patient reported that she was flattened for 3 weeks after vaccination with SHINGRIX. The patient stated that she had all the side effects then add 3 to 4 more. Side effects mentioned specifically were low grade fever, aches, headaches, being in bed and being prevented from doing things. The patient had to cancel several activities because she felt so bad. The reporter consented to follow up.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Injection site pain, Injection site rash, Malaise, Sensitive skin
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 58-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose recived in October 2018, refer case US2019GSK006344 for 1st dose). Concurrent medical conditions included eczema. In December 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain, injection site rash, feeling unwell, chest pain and sensitive skin. On an unknown date, the outcome of the injection site pain, injection site rash and feeling unwell were recovered/resolved and the outcome of the chest pain and sensitive skin were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, injection site rash, feeling unwell, chest pain and sensitive skin to be related to SHINGRIX. Additional information was reported as follows: The reporter who is a physician was reporting a case for himself. The patient received SHINGRIX on the left arm. After vaccination, the patient felt sick and the skin on the left side of his chest around the nipple was hypersensitive. The reporter stated that, it felt almost like shingles pain. The contact details of the physician was provided. The reporter consented to follow up.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Optic ischaemic neuropathy, Visual impairment
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of nonarteritic anterior ischemic optic neuropathy in a 51-year-old male patient who received SHINGRIX for prophylaxis. On 17th December 2018, the patient received the 1st dose of SHINGRIX. On 24th December 2018, 7 days after receiving SHINGRIX, the patient experienced nonarteritic anterior ischemic optic neuropathy (serious criteria GSK medically significant) and abnormal vision. On an unknown date, the outcome of the nonarteritic anterior ischemic optic neuropathy and abnormal vision were not recovered/not resolved. It was unknown if the reporter considered the nonarteritic anterior ischemic optic neuropathy and abnormal vision to be related to SHINGRIX. Additional details were provided as follows: On 24th December 2018, the patient developed vision issues in the left eye. The patient was diagnosed with non-arteritic anterior ischemic optic neuropathy. No other information was provided.
Sex: M
Vaccine: MENB
Symptoms: Back pain, Swelling face
Clinical narrative: This is a spontaneous report from a contactable Health Care Professional. A 19-year-old male patient received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced back pain  (non-serious) and  bump in his forehead (non-serious) on an unspecified date. The outcome of both events was unknown. Customer wanted to know if skin reactions have been reported with TRUMENBA. The information on the batch number has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: Nausea. Dizzy/ blacked out. 4 BMs within 1.5 hours (not diarrhea), stomach roiling. Horrible fatigue. Achy body. Mild headache. No fever. I took TYLENOL and that helped with some of the pain symptoms. I am starting to feel better by 5 PM today (1/17/2019). Could not go to my meeting due to feeling so crappy and dizzy.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness, Nausea, Pain
Clinical narrative: Nausea. Dizzy/ blacked out. 4 BMs within 1.5 hours (not diarrhea), stomach roiling. Horrible fatigue. Achy body. Mild headache. No fever. I took TYLENOL and that helped with some of the pain symptoms. I am starting to feel better by 5 PM today (1/17/2019). Could not go to my meeting due to feeling so crappy and dizzy.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Patient was given a vaccine that was not needed. The series was already completed. Agency had an upgrade and health maintenance had it flagged as due for 1of 3. In the actual chart, under immunizations  shows completed. I submitted a repair ticket to IT to address the issue. I explained to the patient what happened. She was good natured about it.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Bronchitis, Cyanosis, Laboratory test abnormal, Pyrexia, Skin discolouration
Clinical narrative: Arm became black and blue. Extremely achy for 5 days. Can't break a fever of 99. Pt believes the vaccine caused her to get bronchitis, which she was diagnosed with a week after getting the vaccine.
Age: 34.0
Sex: M
Vaccine: FLUC4, HEPAB, TDAP
Symptoms: Dyskinesia, Feeling hot, Posture abnormal, Unresponsive to stimuli
Clinical narrative: Patient said he felt warm after the TWINRIX was injected. He claimed to feel different compared to the BOOSTRIX and FLUCELVAX. He then suddenly dazed off and not responsive even though he was still conscious. He started to have the jerking movement from his hands while his head was tilted to one said as if he was losing control. Patient slowly gain his response. Everything happened in less than 5 minutes. He was able to squeeze my hand, answer my questions, and was able to have conversation with us.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Patient reports persistent soreness and rash at the injection site.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure fluctuation, Blood pressure increased, Heart rate increased
Clinical narrative: Within 8 hrs had elevated BP & pulse rate: BP 164/97  & Pulse 112. These numbers fluctuated  over a period of 24 hrs. Contacted my family Practice Doctor within 12 hrs. and was advised if continued to report to ER. These symptoms returned to normal after 24 hrs.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Her arms swelled and was red and painful for 48 hours after the event, by 1/17/19 there was still redness but no swelling.
Age: 0.42
Sex: M
Vaccine: DTAPIPVHIB, HIBV, PNC13
Symptoms: Extra dose administered
Clinical narrative: Patient was administered 2 HIB's. Patient was called but no answer.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient had redness and her arm was swollen. She didn't say that she was in pain, nor did she realize it was swollen until she was at the doctors office and the nurse was looking and told her.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Pain, Pyrexia
Clinical narrative: Fever, Fatigue, Body aches, Painful left deltoid.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Blood glucose, Injection site erythema, Injection site pain
Clinical narrative: Patient states that the evening after the injection, she developed some soreness and redness at the injection site. The next morning she woke up and had redness and swelling from her upper elbow down to her elbow. She went to her primary care's office the next day and was prescribed prednisone, which she picked up and began taking. After taking the prednisone, the swelling and redness resolved.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Nausea, Pain, Pyrexia
Clinical narrative: Symptoms: fever, nausea, vomiting, fatigue, aches, flu-like symptoms. Time Course: 2 days.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Symptoms: fever, nausea, vomiting, fatigue, aches, flu-like symptoms. Time Course: 2 days.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, MNQ, PNC13
Symptoms: Electroencephalogram normal, Febrile convulsion
Clinical narrative: Complex febrile seizure.
Age: 11.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Pruritus, Rash, Swelling
Clinical narrative: Patient's father called me today for the first time (1/17/18) to report that she had some itching, some bumps on forearm and some swelling. He'd given her ibuprofen and BENADRYL. I said that was a good idea to continue and also maybe to ice the area. He said she didn't have any face swelling or trouble breathing. I told him to keep an eye on it, and if it got any worse to contact their primary care provider.
Age: 38.0
Sex: M
Vaccine: FLUX
Symptoms: Chiropractic, Musculoskeletal stiffness, X-ray
Clinical narrative: Flu vaccine but I don't know which. Stiff neck on same side as shot. Stayed in neck and back of my head for about 6 weeks. Had 2 urgent care visits during this time as well as an x-ray and 2 chiropractor visits. Seemed to slowly fade away the end of first week of December.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt has swelling and redness to right inner thigh.
Age: 2.0
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Gait disturbance, Injection site pain, Pain, Pyrexia
Clinical narrative: Patient experienced pain for two days when moving legs, causing her to stop walking due to pain. Patient also experienced pain when legs were touched. Patient had a fever during those days.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Pruritus, Urticaria
Clinical narrative: Raised welt at injection site on the first injection, then the second injection had the same welt plus torso hives described as extremely itchy.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Loss of personal independence in daily activities, Nausea
Clinical narrative: Very sore arm (which I had the 1st dose) but also became warm to touch, headache and body aches, nausea, shivers, extremely tired. I, at first, thought it was just coincidence and I was coming down with the flu. I had to leave work early and then missed the next day as well. I have had little relief taking TYLENOL or ADVIL. It is now evening (1/17/19) - I feel a little better but still achy. Arm remains very sore and warm to touch - ice has helped a little bit.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Skin warm
Clinical narrative: Very sore arm (which I had the 1st dose) but also became warm to touch, headache and body aches, nausea, shivers, extremely tired. I, at first, thought it was just coincidence and I was coming down with the flu. I had to leave work early and then missed the next day as well. I have had little relief taking TYLENOL or ADVIL. It is now evening (1/17/19) - I feel a little better but still achy. Arm remains very sore and warm to touch - ice has helped a little bit.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: Injection site still red and irritated.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations, Pyrexia
Clinical narrative: Temperature of 102.0 degrees F and palpitations the palpitations and fever resolved after two days as the temperature decreased the palpitations decreased.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever, chills, nausea, total body aches, headache started 8:30 pm day of vaccine. Took TYLENOL. Still having symptoms 24 hours later.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Discomfort, Fatigue, Injection site pain, Myalgia
Clinical narrative: Sore at site of injection, chills, aching muscles, fatigue, heaviness, lasting for 6 days. FYI, this was dose #2, administered about 3 months after the first dose. Had similar reaction after first dose but did not report through VAERS. First dose reactions eased up after 5 days. Second dose reactions are taking longer to dissipate.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Blood test normal, Headache, Peripheral coldness
Clinical narrative: Joint aches, cold feet and hands, lack of energy, followed by slight fever and headache.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: Joint aches, cold feet and hands, lack of energy, followed by slight fever and headache.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Psoriasis
Clinical narrative: Patient had a severe flare up of psoriasis after getting his second dose of SHINGRIX. It developed all over both arms and legs.
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Rash, Skin warm
Clinical narrative: This spontaneous case, initially received on 13-Jun-2018 was reported by other non-health professional and concerns a female patient of unspecified age. On an unspecified date, the patient was administered with influenza vaccine, (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacture: not reported). On an unspecified date after the administration of vaccine, the patient experienced mild rash, redness and warm feeling in the arm. At the time of this report, the outcome of the events was not reported. This case is linked to 201802363 due to same patient.
Age: 1.5
Sex: M
Vaccine: DTAP, FLU4
Symptoms: Injection site rash
Clinical narrative: Left anterior thigh rash - treated with BENADRYL only - Dr office. Improved next day in office.
Age: 80.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Pt reports 7 days of itching, redness and swelling of upper arm after receiving PREVNAR 13 on 1/10/19.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site mass, Insomnia, Irritability, Rash
Clinical narrative: Received phone call from mother on 1/8/19 at 2:00PM-states patient has been extremely fussy, cranky, not sleeping since 1/7/19 at 7:00PM. No fever but extremely irritable. (R) thigh-red area the size of quarter with dark red center. Had a red rash (fine) over torso from 1/11/10-1/12/19. Redness in (R) thigh faded by 1/15/19. Mother states can still feel lump in thigh. Mother also states after 3-4 days patient was less fussy and able to sleep better.
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash erythematous
Clinical narrative: Received phone call from mother on 1/8/19 at 2:00PM-states patient has been extremely fussy, cranky, not sleeping since 1/7/19 at 7:00PM. No fever but extremely irritable. (R) thigh-red area the size of quarter with dark red center. Had a red rash (fine) over torso from 1/11/10-1/12/19. Redness in (R) thigh faded by 1/15/19. Mother states can still feel lump in thigh. Mother also states after 3-4 days patient was less fussy and able to sleep better.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: This non-serious spontaneous case, initially received on 16-Mar-2018, was reported by a 57-year-old adult male patient. On 25-Feb-2018, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 170105P, expiry date: 31-May-2018). On an unspecified date, after vaccination, the patient developed sore in arm. It was reported that, the patient had pain even after 2 weeks of vaccination. At the time of the report, the patient had not recovered from the event.
Sex: F
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional on 18-Jun-2018, concerning an adult female patient of an unspecified age. The patient's current conditions included: hypothyroid and migraine headache. The patient had no known allergies (reported as no true allergies). Concomitant medication included FIORICET and EXCEDRIN TENSION. On an unspecified date in 2015, the patient was administered FLUVIRIN Thiomersal (batch number: 1515101, dose, route of administration, anatomical location, expiry date: not reported). Seqirus Quality Assurance have confirmed that the batch number reported (1515101) was 2015 FLUVIRIN Thiomersal. On 12-Jan-2015, the patient experienced excruciating headache. At the time of this report, the outcome of the event was not reported. This case was cross linked to the case: 201802417 (same patient). Update on 17-Jul-2018: Significant case correction was performed 18-Jun-2018: Seqirus Quality Assurance have confirmed that the reported batch number (1515101) was 2015 FLUVIRIN Thiomersal. Hence, the batch number was captured on the screen of product tab. The narrative was amended accordingly.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Pt fainted after shot.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: My left arm where the shot was given. My arm swelled from the shoulder to elbow the next day, day after, from the elbow to wrist and then in 5 days all swelling was gone! No pain involved!
Age: 15.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Immunization site warm. Swollen.
Age: 10.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Injection site pain, Injection site swelling, Peripheral swelling
Clinical narrative: Patient came in and complained at pain and swelling at injection site. Right arm was swollen. Doctor prescribed Ibuprofen and to return if symptoms worsen or fail to improve.
Age: 19.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia
Clinical narrative: This spontaneous case, reported by other non-healthcare professional (consumer) to VAERS and initially retrieved 06-Jun-2018 by Seqirus from VAERS (VAERS ID: 730224), concerns a 19-year-old, adult, female patient. The patient's historical vaccine included influenza vaccine in 2011 (at age 17) and in 2012 (at age 18), which caused severe muscle aches. On an unspecified date in 2013, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, manufacturer and trade name: not reported). On an unspecified date, after vaccination, the patient experienced severe muscle aches, which lasted more than three days. At the time of this report, the outcome of the event was not reported. The reporter assessed the event as non-serious. This case 201802207 was cross linked to case 201802205 reported by same reporter.
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This non-serious spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 16-Aug-2018 by Seqirus from VAERS (VAERS ID: 719522), concerns an adult female patient of unspecified age. On an unspecified date in 2016, the patient was administered influenza vaccine (dose, anatomical location, batch number, route of administration, expiry date, trade name, manufacturer: not reported). On an unspecified date in 2016, after vaccination, the patient developed redness and swelling at injection site. At the time of this report, the outcome of the events was not reported. This case was cross linked to case 201803418 due to same patient.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face
Clinical narrative: This spontaneous case, initially received from the other non-health care professional on 06-Dec-2017 and concerns a 29-year-old adult female patient. On unspecified date in 2013, the patient was administered with FLUVIRIN, dose: 0.5ml, route of administration: intramuscular, anatomical location: arm, batch number: 13444P (as reported), expiry date: not reported). On unspecified date in 2013 after vaccination, the patient's whole side of the face was became puffy. It was unknown to the reporter, how soon the symptom began after the vaccine. Subsequently on an unspecified date in 2013, the patient recovered from the event. The reporter assessed this case as non-serious. Follow-up for this case is not being sought as reporter information is not available. Hence the case was lost to follow-up.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous case, initially received from other non-health professional (consumer) on 29-Dec-2017, concerning a 61-year-old, adult, female patient. The patient's history included the procedure hysterectomy, nodule in the back and current condition included asthma. No concomitant medications were taken. On 29-Sep-2016, the patient was administered with FLUVIRIN (anatomical location: right arm, batch number: 1619101, expiry date: 30-Apr-2017, dose and route of administration: not reported). On an unspecified date in 2016, 1st week after receiving the vaccination (as reported), she had burnt feeling during vaccination and felt that she has had a bee sting in her arm, she was able to touch the sting area and the spot. It was reported that the patient has visited the doctor for every 3 months and no treatment was received for her symptom. She was not improved, stated that has no problems with the flu vaccine in the past. So, she needs to treat with a medical doctor or else she would contact a lawyer. At the time of this report the patient had not recovered from the event. The reporter assessed the event as non-serious and causality of the event as related to the suspect vaccine.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: This non-serious spontaneous case, initially received from a physician via pharmaceutical manufacturer Merck (reference number: 00843915) on 12-Jun-2018, concerning a female patient of an unspecified age. The patient had been allergic to morphine, nickel, formaldehyde and bee stings. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, manufacturer and trade name: not reported). On an unspecified date, after vaccination, the patient experienced allergies (unspecified). At the time of this report, the outcome of the event was not reported. The reporter considered the causality of the event as related to suspect vaccine.
Sex: F
Vaccine: FLUX
Symptoms: Cough, Lower respiratory tract congestion, Pain, Upper respiratory tract congestion
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 02-Aug-2018 by Seqirus from VAERS (VAERS ID: 744961), concerning a 21-year-old, adult, female patient. The patient's historical condition included allergic rhinitis. The patient's vaccination history included unspecified influenza vaccinations and 2 weeks later, experienced fever body aches, upper and lower respiratory tract congestion, and cough persisting for several weeks thereafter (in 2009). The patient experienced reproducible likely non-immunoglobulin E (non-IgE) medicated reactions (reproducible with subsequent vaccinations of approximately same severity) after influenza vaccination in 2010 also. The patient was allergic to sulphonamide drug (reported as sulpha drugs). The patient had no current illness. On an unspecified date in 2011, the patient was administered INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date in 2011, two weeks after vaccination, the patient experienced reproducible likely non-IgE medicated reactions (reproducible with subsequent vaccinations of approximately same severity) like fever (101-104-degree), body ache, upper and lower respiratory tract congestion, and cough persisting for several weeks. The patient did not decline yearly vaccinations as she worked as a registered nurse in a hospital. The outcome of the events was not reported. The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy
Clinical narrative: This non-serious spontaneous case, initially received from a pharmacist on 24-Jan-2018, concerns a female pregnant patient of an unspecified age. On an unspecified date, the pregnant patient was administered with FLUVIRIN (dose, route of administration, anatomical location, batch number and expiry date: not reported) (explicitly coded as vaccine exposure during pregnancy).
Sex: F
Vaccine: FLU3
Symptoms: Headache, Malaise
Clinical narrative: This is spontaneous case, reported by other non-healthcare professional, initially received on 04-Feb-2018, concerns an unspecified age of female patient. On an unspecified date, the patient was administered with FLUVIRIN (route of administration: intramuscular, dose: unknown, anatomical site, manufacturer name, trade name, batch number and expiry date: not reported). On unspecified date, after 2 weeks of vaccination, the patient had headache and she got sick after eating. At this time of the report, the outcome was not reported. The reporter assessed this case as non-serious.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous case, initially received on 02-Feb-2018, was reported by a pharmacist and concerns a 53-year-old, adult female patient. The patient had no medical history and concomitant medications. On 31-Jan-2018, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 179905P, expiry date: 31-Mar-2018). On an unspecified date in 2018, the patient developed itching and redness at the injection site about the size of a pin point. The patient used ice at the site of the injection as treatment. At the time of this report, the outcome of the events was not reported. The reporter assessed the case as non-serious. Non-significant follow-up received from the pharmacist on 14-Feb-2018: No additional information was available, hence no changes were made in narrative.
Sex: F
Vaccine: FLUX
Symptoms: Lower respiratory tract congestion, Pain, Pyrexia, Upper respiratory tract congestion
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 02-Aug-2018 by Seqirus from VAERS (VAERS ID: 744961), concerning a 19-year-old, adult female patient. The patient's historical condition included allergic rhinitis and the patient was allergic to sulpha drugs (since an unspecified date). On an unspecified date in 2009, the patient was administered influenza vaccine, (dose: unknown, route of administration, anatomical site, trade name, manufacturer, batch number and expiry date: not reported). On an unspecified date in 2009, 2 weeks after vaccination [as reported], the patient developed fever at a temperature between 101 to 104, body aches, upper and lower respiratory congestion, and cough which persisted for several weeks. The patient described these events as likely non-IgE mediated reactions to Influenza vaccination. At the time of the report, the outcome of the events was not reported. The reporter assessed the case as non-serious. This case was linked to 201803106 due to same patient and reporter.
Sex: M
Vaccine: FLU3
Symptoms: Cough, Headache, Hypersensitivity, Influenza like illness, Nasal discharge discolouration
Clinical narrative: This non-serious spontaneous case, initially received on 14-Feb-2018, was reported by other non-health professional and concerns a patient of unspecified age and gender. On 09-Feb-2018, the patient was administered with FLUVRIN (batch number: 1721501, expiry date: 30-Jun-2018, dose, route of administration, anatomical location: not reported). On the same day, around 10 pm, the patient developed flu-like and allergy symptoms. The patient had intense headache, throat soreness and swelling, runny nose (clear fluid) and body ache. On 10-Feb-2018, the patient had cough and on 11-Feb-2018, nasal fluid turned from clear to yellow. On 12-Feb-2018, the patient visited a physician and was prescribed with ZITHROMAX. the outcome of the events was not reported. Follow-up report received from other non-health care professional on 27-Mar-2018: No response was received. Hence the case is lost to follow-up.
Sex: M
Vaccine: FLU3
Symptoms: Oropharyngeal pain, Pain, Pharyngeal oedema, Rhinorrhoea
Clinical narrative: This non-serious spontaneous case, initially received on 14-Feb-2018, was reported by other non-health professional and concerns a patient of unspecified age and gender. On 09-Feb-2018, the patient was administered with FLUVRIN (batch number: 1721501, expiry date: 30-Jun-2018, dose, route of administration, anatomical location: not reported). On the same day, around 10 pm, the patient developed flu-like and allergy symptoms. The patient had intense headache, throat soreness and swelling, runny nose (clear fluid) and body ache. On 10-Feb-2018, the patient had cough and on 11-Feb-2018, nasal fluid turned from clear to yellow. On 12-Feb-2018, the patient visited a physician and was prescribed with ZITHROMAX. the outcome of the events was not reported. Follow-up report received from other non-health care professional on 27-Mar-2018: No response was received. Hence the case is lost to follow-up.
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This non-serious spontaneous case, initially received on 30-Mar-2018, reported by other health professional and concerns a female patient of unspecified age. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, manufacture and trade name: not reported). On an unspecified date, after the administration of vaccine, the patient experienced erythema, swelling and warmth at the site of injection. The outcome of the events was not reported.
Age: 0.92
Sex: M
Vaccine: FLUX, HEPA, MMR, VARCEL
Symptoms: Diarrhoea
Clinical narrative: This spontaneous case, reported by other healthcare professional and initially received on 06-Jun-2018, concerns a 11-month old infant, male patient. The patient had no medical history and concomitant medications were not reported. However, it was reported that, the patient eats eggs and does not have any reaction. On 30-Oct-2017, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported). The patient also received non-company suspect Hepatitis A vaccine (dose, route of administration, anatomical location, batch number were not reported), Varicella zoster vaccine (dose, route of administration, anatomical location, batch number were not reported) and Measles vaccine, mumps vaccine, rubella vaccine (dose, route of administration, anatomical location, batch number: not reported). On the same day, within two hours after vaccination, the patient experienced diarrhoea which lasted for a week. The outcome of the event (diarrhoea) was not reported. Update 22-Jul-2018: Case correction was performed 06-Jun-2018: The causality of the event 'diarrhoea' was corrected from related to unassessable. The case comment was amended accordingly.
Sex: F
Vaccine: FLUX
Symptoms: Cough, Lower respiratory tract congestion, Pain, Pyrexia, Upper respiratory tract congestion
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 02-Aug-2018 by Seqirus from VAERS (VAERS ID: 744961), concerns an adult female patient of unspecified age. The patient took unspecified influenza vaccine (2009) and 2 weeks later experienced fever (temperature between 101 to 104), body aches, upper and lower respiratory tract congestion, and cough which persisted for several weeks. The patient development reproducible, likely non-IgE mediated reactions (approximately same severity) to influenza vaccinations received in 2010 and 2011. The patient's historical condition included allergic rhinitis and the patient was allergic to sulpha drugs (since an unspecified date). On an unspecified date in 2013, the patient was administered influenza vaccine (dose, route of administration, anatomical site, trade name, manufacturer, batch number and expiry date: not reported). On an unspecified date in 2013, 2 weeks after vaccination [as reported], the patient experienced fever with a temperature between 101-104, body aches, upper and lower respiratory tract congestion, and cough which persisted for several weeks. The patient works as a registered nurse (RN), hence did not decline yearly vaccinations until recently. At the time of this report, the outcome of the events was not reported. This case was linked to the case 201803106 due to the same patient and reporter. Update on 29-Aug-2018: Non-significant case correction was performed with IRD 02-Aug-2018: Onset latency of 2 weeks were added in all the events tab.
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous case, initially received from other health professional on 13-Jun-2018, concerns an adult female patient of an unspecified age. The patient's current illness included: tennis elbow, hypertension and migraine (since unspecified dates). The patient was allergic to penicillin and tomatoes. Concomitant medications included: Propanol, Topiramate and Meloxicam. On an unspecified date, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date (reported as 2 years ago), the patient experienced redness, slight swelling and was slightly warm to touch at the injection site. At the time of this report, the outcome of the events was not reported. The reporter assessed this case as non-serious. This case was linked to case 201802391 (same patient).
Age: 24.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Lower respiratory tract congestion, Pain, Pyrexia, Upper respiratory tract congestion
Clinical narrative: This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 02-Aug-2018 by Seqirus from VAERS (VAERS ID: 744961), concerning a 24-year-old, adult, female patient. The patient's vaccination history included unspecified influenza vaccines in the past (on an unspecified date in 2009, 2010, 2011 and 2013). It was reported that, 2 weeks after vaccination every year, the patient developed non-immunoglobulin E [IgE] mediated reactions with same severity which included fever with a temperature 101-104, body aches, upper and lower respiratory tract congestion, and cough which persisted for several weeks. The patient's medical history included allergic rhinitis and had no known current illness. The patient was allergic to sulpha drugs (since an unspecified date). On an unspecified date in 2014, the patient was administered influenza vaccine (dose: unknown, route of administration, anatomical site, trade name, manufacturer, batch number and expiry date: not reported). On an unspecified date in 2014, 2 weeks after vaccination [as reported], the patient experienced fever with a temperature 101-104, body aches, upper and lower respiratory tract congestion, and cough which persisted for several weeks. The outcome of the events was not reported. The reporter assessed this case as non-serious. This case was linked to the case 201803106 due to the same patient and reporter.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: This non-serious spontaneous case, initially received from other non-health professional (consumer) via Merck on 24-Jul-2018, concerning a female patient of unspecified age. The patient's current condition included diabetes (since an unspecified date) and cholesterol (since last few years). The patient was allergic to doxycycline, metformin, oestrogen and REGLAN. The concomitant medications included ZETIA for cholesterol, glimepiride, SYNTHROID. On an unspecified date, the patient was administered influenza virus (dose, route of administration, anatomical location, batch number, expiry date, manufacturer and trade name: not reported). On an unspecified date, after vaccination, the patient developed allergy. At the time of this report, the outcome of the event was not reported.
Sex: M
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: This initial spontaneous case was received from other non-healthcare professional on 16-Aug-2018, concerns a male patient of unspecified age. On 14-Oct-2017, the patient was administered influenza vaccine (dose, route of administration, anatomical location, batch number, manufacture, trade name and expiry date: not reported). On an unspecified date in Oct-2017, after vaccination, the patient experienced pain, which lasted for 2 days. The patient had recovered from the event. The reporter assessed the case as non-serious. This case was linked to case number 201803259 due to same reporter.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous case, initially received from the other non-health professional (consumer) on 22-Oct-2018, concerns a 61-year-old, adult female patient. The patient's historical vaccine included influenza vaccine which she received every year for the past 40 years. The patient had been allergic to gelatine and beef which could cause hives or anaphylaxis. On an unspecified date in 2017, the patient was administered influenza vaccine (dose, route of administration: intramuscular, anatomical location: deltoid, batch number and expiry date, trade name, manufacturer: not reported). On the same day, few hours after vaccination, the patient experienced very large and swollen area down past her elbow which lasted for few days. At the time of report, the patient had recovered from the event. The reporter assessed this case as non-serious.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: This non-serious spontaneous case, initially received from other non-healthcare professional (consumer) via pharmaceutical manufacturer Novartis (PVI-US-2018-001621) on 13-Jun-2018, concerning a female patient of body weight 189 pounds and height of 65 inches. The patient's current conditions included vitamin D deficiency, anemia, depression, migraines and hypothyroidism (since unspecified dates). The patient had been allergic to AMOXIL, tramadol and BENADRYL. On an unspecified date, the patient was administered with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, manufacturer and trade name: not reported). On an unspecified date, after vaccination, the patient experienced allergies (unspecified). At the time of this report, the outcome of the event was not reported. The reporter considered the causality of the event as related to suspect vaccine.