chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Blood pressure decreased, Body temperature decreased, Erythema, Hyperhidrosis, Peripheral swelling
Clinical narrative: High fever of 103.9 degrees occurred 10 pm on 3/28/2019, treated with ibuprofen and showered to bring down fever. Then temperature fell to 99.9 degrees at 12 am on 3/29/2019. At 3 am temperature spiked again to 103.7 degrees 3/29/2019, took two 500 mg tablets TYLENOL AND arm red and swollen 6 inches wide (looked like an arm band), with profuse sweating. At 8 am on 3/29 temperature dropped to low of 95.5 degrees. Blood pressure continued to drop during the morning and at 12 pm noon it was 86/49. Went to doctor's office at 3 pm and blood pressure taken in office was 90/52. Doctor sent for arm scan test and prescribed amoxicillin.
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Scan
Clinical narrative: High fever of 103.9 degrees occurred 10 pm on 3/28/2019, treated with ibuprofen and showered to bring down fever. Then temperature fell to 99.9 degrees at 12 am on 3/29/2019. At 3 am temperature spiked again to 103.7 degrees 3/29/2019, took two 500 mg tablets TYLENOL AND arm red and swollen 6 inches wide (looked like an arm band), with profuse sweating. At 8 am on 3/29 temperature dropped to low of 95.5 degrees. Blood pressure continued to drop during the morning and at 12 pm noon it was 86/49. Went to doctor's office at 3 pm and blood pressure taken in office was 90/52. Doctor sent for arm scan test and prescribed amoxicillin.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Impaired work ability, Nausea
Clinical narrative: Starting day after shot, patient experienced nausea, chills, and extreme fatigue to the point where she didn't go to work the next day and had to stay home. Patient recovered over the next 3-4 days without any medical assistance.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Eye irritation, Lacrimation increased, Pain
Clinical narrative: Fever, chills, aching, sore arm, frequent urinating, watery/burning eyes, sore joints.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pollakiuria, Pyrexia
Clinical narrative: Fever, chills, aching, sore arm, frequent urinating, watery/burning eyes, sore joints.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Muscular weakness, Pain, Pain in extremity, Weight bearing difficulty
Clinical narrative: Burning pain in right elbow lasting to date 03/30/2019. Pain & weakness is forearm muscles same time. Difficult to lift small objects.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient's arm was profusely red from top of shoulder down to elbow, started about 12 hours after vaccination, arm is swollen and hot to the touch. Patient said it has improved since last night. Advised he should seek treatment from a doctor; however, patient denied treatment and does not believe it is necessary.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: 2 weeks (so far) of headaches, muscle soreness, what feels like low-grade fever.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Fatigue, Hypersomnia, Musculoskeletal pain, Nasopharyngitis
Clinical narrative: Aching arm and shoulder and back by 7:00 pm the same evening. Cold. Tired. Took one ADVIL. Slept eight hours, woke Stayed a wake for an hour and then slept four hours.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Aching arm and shoulder and back by 7:00 pm the same evening. Cold. Tired. Took one ADVIL. Slept eight hours, woke Stayed a wake for an hour and then slept four hours.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Musculoskeletal pain
Clinical narrative: My left chest and my left shoulder blade have excessive pain.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Pain, Pain in extremity, Pyrexia, Somnolence
Clinical narrative: PATIENT SAID SHE GOT THE SHOT ON 3/19/19. SHE SAID IT HURT THAT AFTERNOON AND EVENING. SHE HAD FLU-LIKE SYMPTOMS, FEVER AND SLEPT THE NEXT DAY. PATIENT ARM STILL HURTS NOW AND IS GRADUALLY GETTING BETTER. WHEN PATIENT RAISES HER ARM ABOVE HER HEAD IT STILL HURTS.
Age: 49.0
Sex: F
Vaccine: HEPA
Symptoms: Lip erythema, Lip swelling, Oral discomfort, Paraesthesia, Swelling face
Clinical narrative: Hives on face, swollen face, bright red burning lips, swollen tongue, tingling feeling head to toes.
Age: 49.0
Sex: F
Vaccine: HEPA
Symptoms: Swollen tongue, Urticaria
Clinical narrative: Hives on face, swollen face, bright red burning lips, swollen tongue, tingling feeling head to toes.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia, Rash
Clinical narrative: Fever 100.5, mild abdominal rash. No treatment. Fever lasted 1.5 days. Rash not yet resolved.
Age: 0.0
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Adenoidal hypertrophy, Adenotonsillectomy, Autism spectrum disorder, Cytogenetic analysis normal, Deafness
Clinical narrative: Patient started having Gran mal siezures consistently at 2..first one at 1 year old..placed on Tegretol till he was 5 yes old. He's had multiple neurological problems..eyes went crooked at 6 months had surgery to correct them at 2, tonsils and adenoids were enlarged taken out at 2, began having tinitus at 2, which has caused his nerve deafness and is now legally deaf. Diagnosed with Asperger Autism at about 4-5..
Age: 0.0
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Deafness neurosensory, Electroencephalogram normal, Eye movement disorder, Eye operation, Generalised tonic-clonic seizure
Clinical narrative: Patient started having Gran mal siezures consistently at 2..first one at 1 year old..placed on Tegretol till he was 5 yes old. He's had multiple neurological problems..eyes went crooked at 6 months had surgery to correct them at 2, tonsils and adenoids were enlarged taken out at 2, began having tinitus at 2, which has caused his nerve deafness and is now legally deaf. Diagnosed with Asperger Autism at about 4-5..
Age: 0.0
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Tinnitus, Tonsillar hypertrophy
Clinical narrative: Patient started having Gran mal siezures consistently at 2..first one at 1 year old..placed on Tegretol till he was 5 yes old. He's had multiple neurological problems..eyes went crooked at 6 months had surgery to correct them at 2, tonsils and adenoids were enlarged taken out at 2, began having tinitus at 2, which has caused his nerve deafness and is now legally deaf. Diagnosed with Asperger Autism at about 4-5..
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Sore upper arm at site of injection; redness at site of injection, fatigue, mild shivers, mild body aches, upset stomach.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Sore upper arm at site of injection; redness at site of injection, fatigue, mild shivers, mild body aches, upset stomach.
Age: 20.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Allergy test positive, Anaphylactic reaction, Cow's milk intolerance, Dyspepsia, Food allergy
Clinical narrative: Anaphylaxis to hazelnut following the vaccines.
Age: 20.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Gluten sensitivity, Hypovitaminosis, Rubber sensitivity
Clinical narrative: Anaphylaxis to hazelnut following the vaccines.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Injected limb mobility decreased, Malaise
Clinical narrative: About 7 hours after receiving the vaccine, began to feel ill. Vaccinated arm so sore, could not lift it. Early evening and throughout the night, muscles shivering. Ached all over, including feet muscles. Got up once during night to go to the bathroom. Very dizzy. Had to hold onto furniture for support. Due to fatigue, did not get out if bed til 3 p.m. the next day (3/30). Now at 9:30 p.m. Starting to feel more like my normal self.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: About 7 hours after receiving the vaccine, began to feel ill. Vaccinated arm so sore, could not lift it. Early evening and throughout the night, muscles shivering. Ached all over, including feet muscles. Got up once during night to go to the bathroom. Very dizzy. Had to hold onto furniture for support. Due to fatigue, did not get out if bed til 3 p.m. the next day (3/30). Now at 9:30 p.m. Starting to feel more like my normal self.
Age: 42.0
Sex: F
Vaccine: VARCEL
Symptoms: Unevaluable event
Clinical narrative: Occ health.
Age: 19.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Injection site rash
Clinical narrative: 11cm x 6cm rash on Left upper arm. MEDROL DOSE PACK, BACTRIM #30 1 PO Q 12h.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, IPV, PNC13
Symptoms: Irritability, Pruritus, Scar, Urticaria
Clinical narrative: The day after she got the shots she got hives that morning welts everywhere from head to toe and it continued on still till this day I've taken her to the doctors twice they first just gave her a steroid shot and the second time they gave her steroid medicine and zertec and Benadryl at night but this wot rash will not go away unless she continues the use of the steroids it's now leaving scars in spots where she has kept itching she has never had a reaction to anything before she's always been healthy!  I have tried everything to try n help it and it doesn't help in any way sometimes to make it worse. She has been way fussier than usual!
Age: 52.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Impaired driving ability, Somnolence
Clinical narrative: Extreme fatigue. Inability to keep my eyes open for an entire afternoon and evening. I have never experienced this kind of extreme sleep need before. I nodded off while behind the wheel of my car at the car wash, while at dinner at a noisy restaurant with my wife and son, and then twice more while driving home from the restaurant. The first time, while driving, I swerved a bit and caught myself. The second time, I swerved severely into oncoming traffic and my wife had to alert me. Both events happened during a very shot drive (less than 20 minutes).
Age: 52.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue
Clinical narrative: Extreme fatigue. Inability to keep my eyes open for an entire afternoon and evening. I have never experienced this kind of extreme sleep need before. I nodded off while behind the wheel of my car at the car wash, while at dinner at a noisy restaurant with my wife and son, and then twice more while driving home from the restaurant. The first time, while driving, I swerved a bit and caught myself. The second time, I swerved severely into oncoming traffic and my wife had to alert me. Both events happened during a very shot drive (less than 20 minutes).
Age: 35.0
Sex: F
Vaccine: PPV
Symptoms: Lethargy, Pain in extremity, Pyrexia
Clinical narrative: Severe right arm pain, fever (100F), lethargy.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Myalgia, Vomiting
Clinical narrative: Received the SHINGRIX vaccine -- first dose January, second dose 3/30/19. With first dose, had fatigue, muscle aches, and mild chills/fever on day after vaccination, then large, hard, hot, painful lump at injection site for about 4 days. With second dose, about 12 hours after vaccination, experienced violent chills for about 2 hours, then vomited. Next day weak, fatigued, muscle aches.  Husband also had mild chills and fever after about twelve hours (husband had no side effects other than sore arm at injection site with first dose).
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Patient said the next day he had a low grade fever, body aches, and felt tired. Within 24 hours, symptoms resolved.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Patient called back about 4 hours after administration of vaccine to state her arm was very sore, more sore than she had imagined. Pain at injection site and radiating down to about elbow.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hyperhidrosis, Influenza like illness, Pyrexia
Clinical narrative: PATENT STATES THAT SHE HAD CHILL, SWEAT, FEVER AND FLU LIKE SYMPTOMS FOR TWO DAYS.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Heated, fevered, red and hard at the injection site. Patient's own words. also swollen.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Patient had redness on the lower arm away from the injection site that was very painful and red.  She said it seems to be getting better but almost had to go to doctor for the pain. She said she has taken ibuprofen and will apply cold compress but it seems to be getting better. She will update us in the next few days if it continues.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Pyrexia
Clinical narrative: Patient described redness below injection along with fever (101 degrees F) - s/p 24 hours; Patient described redness on trunk s/p 48 hours; Redness was not raised, warm to touch, or itchy.
Age: 64.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Inflammation, Pain, Swelling, Tenderness
Clinical narrative: Redness, swelling, pain. Hurtful to touch even if it is clothing like a sleeve. Started the night of the injection, inflamed the next day with redness and painful. The redness has come down a little bit but still painful. She is going to follow up with her PCP, she has already contacted her MD and has an appointment for Monday 4/1.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Pain in jaw
Clinical narrative: Patient states that after receiving vaccine at about 7pm, he experienced pain in all of his joints/back/and jaw starting around midnight that same day. This lasted for 3 days.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Pyrexia
Clinical narrative: Fever of 100.5 degrees, Fatigue, and joint pain.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache, Influenza like illness, Loss of personal independence in daily activities
Clinical narrative: Had same reaction to both injections: severe arm pain that limited activities, severe flu-like symptoms: headache, myalgias, extreme fatigue, nausea, dizziness, low-grade fever. The first lasted 5 days, the second one I am on day 3 and still ill.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pain in extremity, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Had same reaction to both injections: severe arm pain that limited activities, severe flu-like symptoms: headache, myalgias, extreme fatigue, nausea, dizziness, low-grade fever. The first lasted 5 days, the second one I am on day 3 and still ill.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Headache, Malaise, Nausea
Clinical narrative: Patient reported to the pharmacy at 5:00 p.m. on 3/31/2019 that she was feeling very sick, nauseous, weak, and had a headache and that she'd been feeling that way all night and all day. When asked if she felt feverish, she said yes. She said she had not been able to eat all day. I encouraged her to try to eat something and take some TYLENOL and if she didn't feel better soon she should go to the ER.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient reported to the pharmacy at 5:00 p.m. on 3/31/2019 that she was feeling very sick, nauseous, weak, and had a headache and that she'd been feeling that way all night and all day. When asked if she felt feverish, she said yes. She said she had not been able to eat all day. I encouraged her to try to eat something and take some TYLENOL and if she didn't feel better soon she should go to the ER.
Age: 67.0
Sex: M
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Echocardiogram normal, Impaired work ability, Nuclear magnetic resonance imaging brain normal, Ophthalmological examination normal, Vision blurred
Clinical narrative: Within 24 hours had blurred vision. Have to close one eye to be able to focus good enough to read close up work and work on the computer.
Age: 67.0
Sex: M
Vaccine: FLU4, VARZOS, VARZOS
Symptoms: Echocardiogram, Scan brain, Vision blurred
Clinical narrative: Within 24 hours had blurred vision. Have to close one eye to be able to focus good enough to read close up work and work on the computer.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Erythema, Fatigue, Injection site pain
Clinical narrative: Adverse reactions began as fatigue and joint soreness, and soreness at the injection site in the afternoon and evening. These in an of themselves would not have prompted me to file this report. By the time I went to bed, though, it had advanced to marked achiness and feeling feverish. All night I had difficulty sleeping well, culminating in chills in the middle of the night. At 4:30 I took my temperature, which read 100.6, at which point I took two ibuprofen. The rest of the night was still pretty rough but my temp was normal by morning and I've had no fever recurrence. I am, more than 48 hrs. later, still somewhat fatigued and my arm is very sore. An area bigger than a silver dollar is still quite red as well.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Pain, Pain in extremity, Pyrexia
Clinical narrative: Adverse reactions began as fatigue and joint soreness, and soreness at the injection site in the afternoon and evening. These in an of themselves would not have prompted me to file this report. By the time I went to bed, though, it had advanced to marked achiness and feeling feverish. All night I had difficulty sleeping well, culminating in chills in the middle of the night. At 4:30 I took my temperature, which read 100.6, at which point I took two ibuprofen. The rest of the night was still pretty rough but my temp was normal by morning and I've had no fever recurrence. I am, more than 48 hrs. later, still somewhat fatigued and my arm is very sore. An area bigger than a silver dollar is still quite red as well.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Fatigue, Influenza like illness, Malaise
Clinical narrative: Joint aches, especially in fingers/hands/feet; fatigue; flu-like "not feeling well", some nausea/upset stomach - about 2 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Joint aches, especially in fingers/hands/feet; fatigue; flu-like "not feeling well", some nausea/upset stomach - about 2 days.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Chromosome analysis normal, Exposure during pregnancy, Foetal heart rate abnormal
Clinical narrative: Healthy male born 2009. Srong heartbeat detected at 9 weeks. No heartbeat at 10 and 1/2 weeks after the flu shot. Estimated delivery August 15, 2015
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Confusional state, Disorientation, Dysstasia, Vision blurred
Clinical narrative: Patient stated that when she woke up on second day after shot (3/9/19), she could barely stand up due to disorientation and confusion and later in the day her vision was still blurry. Symptoms resolved over the next 2 to 3 days.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Disorientation, Dizziness, Fatigue, Feeling abnormal, Influenza like illness
Clinical narrative: Patient stated that when she woke up on second day after shot (3/9/19), she could barely stand up due to disorientation and confusion and later in the day her vision was still blurry. Symptoms resolved over the next 2 to 3 days.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Insomnia, Loss of consciousness, Mobility decreased, Restlessness, Vision blurred
Clinical narrative: Patient stated that when she woke up on second day after shot (3/9/19), she could barely stand up due to disorientation and confusion and later in the day her vision was still blurry. Symptoms resolved over the next 2 to 3 days.
Age: 63.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Swelling, redness, and pain at injection site. Low grade fever. Body aches. Fatigue.
Age: 63.0
Sex: F
Vaccine: FLU4, PPV, VARZOS
Symptoms: Pyrexia
Clinical narrative: Swelling, redness, and pain at injection site. Low grade fever. Body aches. Fatigue.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin induration, Skin warm
Clinical narrative: Skin became warm, red, indurated 3 days post injection.
Age: 64.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Reaction described as red, raised rash/swelling at the injection site.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: Received recombinant shingles vaccine and less than 2 hrs later he states he started with low grade fever and aching. Sx progressed overnight to T102/chills/soaking sweats/body aches. Left Arm was very sore at injection site. Denied redness. The next morning he felt slightly better, still run down/achy and had a headache. No cough or other flu like Sx. Denied SOB, wheezing, chest pressure.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Received recombinant shingles vaccine and less than 2 hrs later he states he started with low grade fever and aching. Sx progressed overnight to T102/chills/soaking sweats/body aches. Left Arm was very sore at injection site. Denied redness. The next morning he felt slightly better, still run down/achy and had a headache. No cough or other flu like Sx. Denied SOB, wheezing, chest pressure.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Erythema, Pain, Skin warm
Clinical narrative: Redness and warmth, pain chills. 13x10 cm LUE.
Sex: F
Vaccine: FLU3, HPV4, PPV, TDAP
Symptoms: Erythema, Peripheral swelling, Pyrexia, Type III immune complex mediated reaction
Clinical narrative: Initial information received on 12-Feb-2019 regarding an unsolicited valid serious case downloaded by Medical affairs team from the VAERS database received from Other health care professional via Health Authorities under reference 295715. This case involves a 22 years old female patient who experienced arthus reaction, 19cm red swollen area on left arm and fever greater than 101.1, while she received vaccines FLUZONE and ADACEL, PNEUMOVAX and GARDASIL. The patient's past medical history included Liver transplant, Nephrolithiasis and Pain. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included hydrocodone bitartrate, hydrocodone/acetaminophen, ROZEREM, RESTORIL; buspirone; XOPENEX HFA; ALLEGRA; promethazine; ORTHO-NOVUM; ranitidine; KEPPRA, DRYSOL; hydroxyzine and IMODIUM for Product used for unknown indication. On 26-Oct-2007, the patient received a dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine lot number not reported via unknown route in unknown administration site. On 26-Oct-2007, the patient received a dose of suspect FLUZONE lot number not reported via unknown route in unknown administration site. On 26-Oct-2007, the patient received a dose of suspect GARDASIL and PNEUMOVAX not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site. On 27-Oct-2007, the patient developed a serious arthus reaction (type III immune complex mediated reaction) 1 day following the administration of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine, FLUZONE, GARDASIL and PNEUMOVAX. This event was assessed as medically significant. On 27-Oct-2007, the patient developed a non-serious 19cm red swollen area on left arm (oedema peripheral) and fever greater than 101.1 (pyrexia) 1 day following the administration of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine, FLUZONE, GARDASIL and PNEUMOVAX. (Other relevant tests included no lab data.) Final diagnosis was fever greater than 101.1, 19cm red swollen area on left arm and arthus reaction. It was not reported if the patient received a corrective treatment. The outcome of the events was not reported. Documents held by sender: none. Sender's Comments: This case concerns 22 years old female patient who experienced Type III immune complex mediated reaction, Oedema peripheral and Pyrexia after vaccination with ADACEL and FLUZONE. The time to onset is compatible. The patient's past medical history included Liver transplant, Nephrolithiasis and Pain. Concomitant medications reported Hydrocodone/Acetaminophen, ROZEREM, RESTORIL, Buspirone, XOPENEX HFA, ALLEGRA, Promethazine, ORTHO-NOVUM, Ranitidine, KEPPRA, DRYSOL, hydroxyzine, IMODIUM. Additional information condition at the time of vaccination, lab /radiological investigation excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of individual vaccine cannot be assessed.
Sex: F
Vaccine: TDAP
Symptoms: Type III immune complex mediated reaction
Clinical narrative: Initial information received on 12-Feb-2019 regarding an unsolicited valid serious case downloaded by Medical affairs team from the VAERS database received from Other health care professional via Health Authorities under reference 296176. This case involves a 34 years old female patient who experienced arthus reaction and 3-4 cm induration lateral left arm, while she received vaccine ADACEL. The patients past medical history, concomitant medication and family history were not provided. On 31-Oct-2007, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number, expiry date not reported) via unknown route in unknown administration site. On 02-Nov-2007, the patient developed a serious arthus reaction (type iii immune complex mediated reaction) 2 days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant. On 02-Nov-2007, the patient developed a non-serious 3-4 cm  induration lateral left arm (induration) 2 days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Other relevant tests included No lab data. Final diagnosis was 3-4 cm induration lateral left arm and arthus reaction. It was not reported if the patient received a corrective treatment. The outcome of the events was not reported. List of documents held by sender- none.; Sender's Comments: This case concerns an adult patient who experienced arthus reaction and induration two day after vaccination with ADACEL. However, there is no information provided regarding patient's past history, medical condition at the time of vaccination and lab tests ruling out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Pyrexia, Type III immune complex mediated reaction
Clinical narrative: Initial information received on 12-Feb-2019 regarding an unsolicited valid serious case downloaded by Medical affairs team from the VAERS database received from Other health care professional via Health Authorities under reference 340883. This case involves a 53 years old female patient who experienced arthus reaction, myalgias and fever, while she received vaccine ADACEL. The patients past medical history included hyper feeling treated with Prozac. Concomitant medications included Synthroid 175mcg daily, Prinzide 20/12.5mg daily, Aspirin 81mg daily, Hydrocodone/acetaminophen 5/500mg as needed, Ambien 10mg as needed, acetaminophen 500mg as needed. On 24-Feb-2009, the patient received injection of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site. On 24-Feb-2009, the patient developed a serious arthus reaction (type iii immune complex mediated reaction) same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant. On 24-Feb-2009, the patient developed a non-serious myalgias (myalgia) same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On 24-Feb-2009, the patient developed a non-serious fever (pyrexia) same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Lab data was not provided. Final diagnosis was fever, myalgias and arthus reaction. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for all the events. List of documents held by sender- none.; Sender's Comments: This case concerns an adult patient who experienced arthus reaction, myalgia and fever same day after vaccination with ADACEL. The patients past medical history included hyper feeling (not clearly defined). There is no information provided regarding patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was considered as serious as per the IME list. Initial information received on 12-Feb-2019 regarding an unsolicited valid serious case downloaded by Medical affairs team from the VAERS database received from other health care professional via Health Authorities under reference 452628. This case involves a 31 years old male patient who experienced injection site erythema, injection site oedema, injection site pain, injection site swelling, injection site warmth and type III immune complex mediated reaction, while he received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site. The patient developed a serious arthus or arthus-like localized reaction around site of injection (type III immune complex mediated reaction) within 12 hours after injection of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The patient developed a non-serious injection site erythema, injection site oedema, injection site pain, injection site swelling and injection site warmth within 12 hours after injection of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. (Other relevant tests included No lab data.) Final diagnosis was injection site erythema, injection site oedema, injection site pain, injection site swelling and injection site warmth and type III immune complex mediated reaction. It was not reported if the patient received a corrective treatment. The patient outcome was not reported. List of document held by sender: none.; Sender's Comments: This case concerns 31 years old male patient who developed injection site erythema, injection site oedema, injection site pain, injection site swelling, injection site warmth and type III immune complex mediated reaction. However, patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: M
Vaccine: TDAP
Symptoms: Type III immune complex mediated reaction
Clinical narrative: This case was considered as serious as per the IME list. Initial information received on 12-Feb-2019 regarding an unsolicited valid serious case downloaded by Medical affairs team from the VAERS database received from other health care professional via Health Authorities under reference 452628. This case involves a 31 years old male patient who experienced injection site erythema, injection site oedema, injection site pain, injection site swelling, injection site warmth and type III immune complex mediated reaction, while he received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site. The patient developed a serious arthus or arthus-like localized reaction around site of injection (type III immune complex mediated reaction) within 12 hours after injection of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The patient developed a non-serious injection site erythema, injection site oedema, injection site pain, injection site swelling and injection site warmth within 12 hours after injection of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. (Other relevant tests included No lab data.) Final diagnosis was injection site erythema, injection site oedema, injection site pain, injection site swelling and injection site warmth and type III immune complex mediated reaction. It was not reported if the patient received a corrective treatment. The patient outcome was not reported. List of document held by sender: none.; Sender's Comments: This case concerns 31 years old male patient who developed injection site erythema, injection site oedema, injection site pain, injection site swelling, injection site warmth and type III immune complex mediated reaction. However, patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Fatigue, Impaired work ability, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Initial information received on 12-Feb-2019 regarding an unsolicited valid serious case received from Health Authorities under reference- 453914. This case involves a 62 years old male patient who experienced arthus reaction, loss of motion, intense pain over left shoulder extending to cervical spine with weakness, missed day of work, pain increased & started having weakness in the left arm and generalized aching & fatigue at first then neck & shoulder pain, while he received vaccine ADACEL. The patient's past, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. The patient's past medical history included NKDA (no known drug allergy). On 16-Mar-2012, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number, expiry date, dose, dose in series, route and site of administration was not reported). On 18-Mar-2012, 2 days after the vaccination the patient experienced arthus reaction (type iii immune complex mediated reaction), mobility decreased, musculoskeletal pain, neck pain, spinal pain, activities of daily living impaired (loss of personal independence in daily activities), pain, muscular weakness, asthenia and fatigue. Arthus reaction was assessed as medically significant. Lab test included physical examination. Final diagnosis was arthus reaction, mobility decreased, musculoskeletal pain, neck pain, spinal pain, activities of daily living impaired, asthenia and fatigue. It was not reported if the patient received a corrective treatment. The outcome of the events was reported as unknown for all events. List of documents held by sender: none.; Sender's Comments: A 62 years old patient experienced arthus reaction, generalized aching, fatigue at neck, shoulder pain, weakness in the left arm, pain over left shoulder extending to cervical spine with weakness and loss of motion, missed day of work after vaccination with ADACEL. Time to onset is compatible with the role of vaccine. More details regarding patient's condition at the time of vaccination, immune status, previous vaccination history, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information the role of vaccine cannot be assessed.
Sex: M
Vaccine: TDAP
Symptoms: Muscular weakness, Musculoskeletal pain, Neck pain, Pain, Spinal pain
Clinical narrative: Initial information received on 12-Feb-2019 regarding an unsolicited valid serious case received from Health Authorities under reference- 453914. This case involves a 62 years old male patient who experienced arthus reaction, loss of motion, intense pain over left shoulder extending to cervical spine with weakness, missed day of work, pain increased & started having weakness in the left arm and generalized aching & fatigue at first then neck & shoulder pain, while he received vaccine ADACEL. The patient's past, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. The patient's past medical history included NKDA (no known drug allergy). On 16-Mar-2012, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number, expiry date, dose, dose in series, route and site of administration was not reported). On 18-Mar-2012, 2 days after the vaccination the patient experienced arthus reaction (type iii immune complex mediated reaction), mobility decreased, musculoskeletal pain, neck pain, spinal pain, activities of daily living impaired (loss of personal independence in daily activities), pain, muscular weakness, asthenia and fatigue. Arthus reaction was assessed as medically significant. Lab test included physical examination. Final diagnosis was arthus reaction, mobility decreased, musculoskeletal pain, neck pain, spinal pain, activities of daily living impaired, asthenia and fatigue. It was not reported if the patient received a corrective treatment. The outcome of the events was reported as unknown for all events. List of documents held by sender: none.; Sender's Comments: A 62 years old patient experienced arthus reaction, generalized aching, fatigue at neck, shoulder pain, weakness in the left arm, pain over left shoulder extending to cervical spine with weakness and loss of motion, missed day of work after vaccination with ADACEL. Time to onset is compatible with the role of vaccine. More details regarding patient's condition at the time of vaccination, immune status, previous vaccination history, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information the role of vaccine cannot be assessed.
Sex: M
Vaccine: TDAP
Symptoms: Type III immune complex mediated reaction
Clinical narrative: Initial information received on 12-Feb-2019 regarding an unsolicited valid serious case received from Health Authorities under reference- 453914. This case involves a 62 years old male patient who experienced arthus reaction, loss of motion, intense pain over left shoulder extending to cervical spine with weakness, missed day of work, pain increased & started having weakness in the left arm and generalized aching & fatigue at first then neck & shoulder pain, while he received vaccine ADACEL. The patient's past, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. The patient's past medical history included NKDA (no known drug allergy). On 16-Mar-2012, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number, expiry date, dose, dose in series, route and site of administration was not reported). On 18-Mar-2012, 2 days after the vaccination the patient experienced arthus reaction (type iii immune complex mediated reaction), mobility decreased, musculoskeletal pain, neck pain, spinal pain, activities of daily living impaired (loss of personal independence in daily activities), pain, muscular weakness, asthenia and fatigue. Arthus reaction was assessed as medically significant. Lab test included physical examination. Final diagnosis was arthus reaction, mobility decreased, musculoskeletal pain, neck pain, spinal pain, activities of daily living impaired, asthenia and fatigue. It was not reported if the patient received a corrective treatment. The outcome of the events was reported as unknown for all events. List of documents held by sender: none.; Sender's Comments: A 62 years old patient experienced arthus reaction, generalized aching, fatigue at neck, shoulder pain, weakness in the left arm, pain over left shoulder extending to cervical spine with weakness and loss of motion, missed day of work after vaccination with ADACEL. Time to onset is compatible with the role of vaccine. More details regarding patient's condition at the time of vaccination, immune status, previous vaccination history, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information the role of vaccine cannot be assessed.
Sex: F
Vaccine: TDAP
Symptoms: Type III immune complex mediated reaction
Clinical narrative: Initial information received on 12-Feb-2019 regarding an unsolicited valid serious case downloaded by Medical affairs team from the VAERS database received from other health care professional via Health Authorities under reference 587650. This case involves a 41 years old female patient who experienced Arthus Reaction L shoulder, while she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 26-Jul-2015, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious Arthus Reaction L shoulder (Type III Immune Complex Mediated Reaction) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant. Other relevant tests not reported. Final diagnosis was Type III Immune Complex Mediated Reaction. It was not reported if the patient received a corrective treatment. The patient outcome was not reported for Type III Immune Complex Mediated Reaction. List of documents held by sender: none.; Sender's Comments: This case concerns a 41 years old female patient who developed Type III Immune Complex Mediated Reaction after vaccination with ADACEL. The time to onset unknown. However, there is no information regarding patient's medical condition at time of vaccination. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: F
Vaccine: TDAP
Symptoms: Type III immune complex mediated reaction
Clinical narrative: Initial information received on 12-Feb-2019 regarding an unsolicited valid serious case downloaded by Regulatory Authority from the VAERS database received from other health care professional via Health Authorities under reference 679510. This case involves a 24 years old female patient who experienced developed an Arthus-type reaction in her right arm, while she received vaccine ADACEL. The patient's past medical treatment included NAPROSYN. The patient's past medical history, vaccination(s) and family history were not provided. On 07-Nov-2016, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site. On 10-Nov-2016, the patient developed a serious Arthus-type reaction in her right arm (Type III immune complex mediated reaction) 3 days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant. Other relevant tests not reported. Final diagnosis was Type III Immune Complex Mediated Reaction. It was not reported if the patient received a corrective treatment. The event outcome was not reported for Type III Immune Complex Mediated Reaction. List of documents held by sender: none. Sender's Comments: This case concerns a 24 years old female patient who developed Type III Immune Complex Mediated Reaction three days after vaccination with ADACEL. The time to onset was compatible. However, there is no information regarding patient's medical condition at time of vaccination. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Rash, Rash erythematous, Type III immune complex mediated reaction
Clinical narrative: Based on additional information received on 12-Feb-2019, this case initially considered as non-serious was upgraded to serious as per IME list. Seriousness criteria: medically significant (IME list). Initial information received on 12-Feb-2019 regarding an unsolicited valid serious case downloaded by Regulatory Authority from the VAERS database received from other health care professional via Health Authorities under reference 744119. This case involves a 11 years old female patient who experienced arthus reaction and red rash on both arms, while she received vaccines MENACTRA and ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-Apr-2018, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number not reported) via unknown route in unknown administration site. On 09-Apr-2018, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (lot number not reported) via unknown route in unknown administration site. On 10-Apr-2018, one day following the administration of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE the patient developed a non-serious red rash on both arms (TDAP measured 14 by 10 cm and MENACTRA measured 4 by 3) red rash on both arms and Arthus reaction. (Other relevant tests included No lab data). Final diagnosis was rash, rash erythematous and Type III immune complex mediated reaction. The patient received Antihistamines and steroid creams was received as corrective treatment. The patient outcome was not reported. Addendum: 04-Apr-2019. The seriousness criteria was updated and a suspect ADACEL added. List of document held by sender: None. Sender's Comments: This case concerns a young patient who presented with rash and Arthus reaction after vaccination. The time to onset is compatible. There is, however, no information regarding patient's condition at time of vaccination and lab tests do not rule out alternate etiologies, particularly infectious. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 67.0
Sex: F
Vaccine: PPV, PPV
Symptoms: C-reactive protein, Cellulitis, Full blood count, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 67 years old female patient. The patient did not have any drug reactions or allergies. Information about pertinent medical history included hyperlipidemia and the concomitant therapy included atorvastatin. On an unknown date in 2018, the patient was vaccinated with PREVNAR. On 20-MAR-2019, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # R033343 with expiration date 03-AUG-2020, intramuscularly in the left deltoid for prophylaxis (reported as received PREVNAR 2018 and she was 67 years old). On the same date, the patient stated her left arm was hot, red, and swollen to the elbow. On 21-MAR-2019, the patient went to an unspecified urgent care and received treatment with ANCEF 2 grams via intravenous (IV), made a complete blood count and the C-reactive protein test with result of 45.5. On the same date, the patient was discharged to home with oral BACTRIM. The patient was made intervention to prevent serious criteria. The reporter requested a lot check and the request was time sensitive. The outcome of events and the causality assessments between events and PNEUMOVAX 23 were not reported. The reporter considered all the events to be medically significant.