chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Paraesthesia
Clinical narrative: Immediately upon injection I felt a jolt of pain almost like I was shocked by electricity running down my arm. I knew to expect soreness and possible hardness, but as Friday evening wore on my upper left arm became completely engorged and sore. I looked like a body builder. I was barely able to move my arm. I took 2 TYLENOL and went to sleep thinking the swelling would go down. I woke up on Saturday morning and while the hardness had lessened some my arm was still extremely sore. I continued with TYLENOL and started icing my arm. When I went to change for bed on Saturday around 10 PM I noticed a large area of swelling and redness under my armpit extending halfway to my elbow. On Sunday I woke up and the pain continued to lessen, but the redness and swelling continued creeping closer to my elbow. I went to urgent care at 11 AM on Sunday where two doctors examined me to determine what was happening. As best they could tell it appeared to be an allergic reaction to the vaccine and not cellulitis. They were a bit puzzled why the underside of my arm was reacting and not the injection area. They marked my arm and told me to contact my regular physician and follow up. They prescribed prednisone, ALLEGRA, BENADRYL and an antibiotic if the redness spread. On Monday morning the redness had returned and the swelling had migrated outside the markings by the urgent care physicians. I sought help from PA. As the prednisone kicked in the swelling reduced and the redness dissipated. My arm began to bruise on Monday, 12/11/17.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Lip swelling, Pain in extremity, Pruritus, Rash
Clinical narrative: Patient states that he was fine after the shot, but his arm started hurting and he took some TYLENOL to help but it did not help and he noticed a rash (about 6 o'clock) starting on his lower abdomen. He took some Ibuprofen 800mg that he had at home, and applied some clobetasol lotion that he had at home to the rash to help with itching. Then at about 9-9:30am on 12/12 he noticed swelling of his lips and he drank some milk. He stated that the swelling went down slightly then he came to the pharmacy for assistance. I told him I could not deny it could be the vaccines but usually a reaction will start at injection site, and there was nothing there. I instructed him to see his primary care doctor. He will let us know the outcome.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Blindness unilateral, Injection site haematoma, Musculoskeletal pain, Pain in extremity
Clinical narrative: Loss of vision in left eye for several hours, large hematoma at injection site and arm/shoulder pain.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Impaired work ability, Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Arm/shoulder pain, decreased range of motion of arm, unable to perform lifting at work, multiple absences from work.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report was received from a nurse via a company representative and refers to a female patient of unknown age (the reporting immunization nurse). There was no information about the patient's concurrent conditions and concomitant therapies provided. The patient's medical history included shingles that had occurred on unspecified dates prior getting vaccination with ZOSTAVAX. On an unknown date in November 2017, reported as about 2 weeks ago, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml (one dose) (route of administration, lot# and expiry date were not reported) for shingles prevention On an unknown date in November 2017, the patient developed some redness and itchiness around the injection site on her right arm. The nurse reported that she had these symptoms persist for approximately one week and a half before she recovered from the adverse events. The patient did not sought medical attention. The outcome of injection site erythema and injection site pruritus was reported as recovered on an unknown date in November 2017. The relatedness between the events and ZOSTAVAX was not reported.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer via a Pfizer sales representative. A 20 year old female patient of an unspecified ethnicity received the first dose of TRUMENBA (batch number requested) via an unspecified route of administration on the arm on an unspecified date in 2017 at single dose as the patient was in the Group B recommendation for vaccine (immunization). The patient's medical history and concomitant medications were not reported. On an unspecified date in 2017 (reported as probably in the past 3 to 4 months), the patient received meningococcal group b rlp2086 and reported that her arm was sore and painful after the injection. The patient reported that the arm pain and soreness lasted a couple of days after the injection. The patient recovered from the events on an unspecified date in 2017. The following information on the batch number has been requested.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Injection site erythema, Injection site pain, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable physician.  A 17-year-old female patient received the second dose TRUMENBA (lot number R24748, expiration date: Jan2018), intramuscular on the left arm on 04Dec2017 16:00 at a single dose as immunization (also reported as "It was indicated for her to receive the vaccine") at the private clinic. The patient's other medical conditions, concomitant medications and investigations were reported as None. The patient received the first dose of meningococcal group b rlp2086 (lot number R24748, Exp date: Jan2018), intramuscular on the left arm on 21Oct2017 as immunization. The physician (reporter) stated that she had a patient come in to receive her second injection of the vaccine around 4pm on Monday (04Dec2017). Then on 06Dec2017, the patient came in to the office to be seen because she was having pain at the injection site and when she looked, she noticed her  left arm was red and puffy on 05Dec2017. It was mentioned that the patient had redness to the left arm, pain at injection site and puffiness on her left arm. The reporter stated that when she saw the patient in the office today around 12pm, she did not notice any puffiness but there was redness about the size of a palm about 5cm below the injection site. However, when the physician took the Band-Aid off the injection site, there was no redness at the site, the injection site was fine. The patient also reported having pain 2/10 when the physician palpated the injection site - the pain isn't bad. The physician does not believe the events were medically significant; patient does not have any fever or other symptoms. No treatment given and the physician just drew a line around the redness and informed patient to notify her if redness increases. The pain at injection site was still ongoing (not recovered) while the patient recovered from the puffiness and redness on her left arm in Dec2017. The physician commented that she see this (redness and pain) maybe one other time in 7 years and it's usually with kids, not teenagers. This wasn't something you see a lot. She always advised her patients that they may have redness, pain and things like that with the injection, but she rarely ever sees it actually happen. The physician considered the events and the suspect drug related.
Sex: U
Vaccine: FLUX, PNC13
Symptoms: Erythema, Limb mass, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist. This report was received via a Pfizer sales representative. A patient of unspecified age, ethnicity and gender, received PREVNAR 13, via an unspecified route of administration in the arm on an unspecified date at a single dose for routine vaccination and influenza vaccine, via an unspecified route of administration in the arm on an unspecified date at an unspecified dose for immunization. The patient's medical history and concomitant medications were not reported. For the first 4 patients during the flu season, the pharmacist coadministered the flu vaccine with pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) in the same arm with an inch apart. The patient called back and stated that it hurt. The patient couldn't move the arm, it was red and swollen and got a lump. The pharmacist thought that the events happened between Sep2017 and Nov2017 and she believed that the patient had recovered completely on an unspecified date in 2017. The pharmacist stated he changed his vaccinating procedures to one vaccine in each arm and hasn't had any problems since. The information on the batch number and expiration date has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Decreased appetite, Fatigue, Injection site pain, Malaise
Clinical narrative: This is a spontaneous report from a contactable consumer reported for him/herself. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history included pneumonia with hospitalization about three years before. Concomitant medications were not reported. The patient previously received influenza vaccine shot a couple of days before and got so sick. The patient experienced no appetite, extremely tired, and was too sick to talk on an unspecified date with outcome of unknown; the patient still have pain in the injection area with outcome of not recovered. The consumer wanted to know how long he/she was going to have these effects. The patient was blindsided with this shot, because she/he went for something else to his/her doctor and the physician just gave it to the patient who didn't even wanted.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Chills, Delirium, Nausea, Pain in extremity
Clinical narrative: Right sided pain down to legs. 102 degree fever, chills, nausea, vomiting, delirious, weak.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Right sided pain down to legs. 102 degree fever, chills, nausea, vomiting, delirious, weak.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Musculoskeletal pain, Paraesthesia
Clinical narrative: Telephone call from mother (11/30/17) reporting pain from shoulder area with tingling down to the finger tips. Improved each day until resolved on 11/30/17.
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site erythema, Injection site irritation, Injection site pruritus, Injection site warmth
Clinical narrative: Local irritation at the injection site. Redness, itchiness, warmness to the touch.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Flank pain, Musculoskeletal chest pain, Nausea, Pancreatitis
Clinical narrative: Woke up with pain under left ribs and down my left side. Pain became worse throughout the day. On day 2, still experiencing pain under the ribs on the left side and pain has now moved into my back. Nausea. I experienced pain for 2 more days.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dyspnoea, Immediate post-injection reaction
Clinical narrative: Pt reports that immediately after receiving the flu vaccine she began coughing and having difficulty breathing. She returned to the ED where the vaccine had been administered to receive treatment.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Pain
Clinical narrative: Left wrist pain began one day after vaccine placed. Has persisted, though is improving gradually. Pain occurs with wrist movement only. No swelling or redness. No hand or finger involvement. No treatment.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 10 hours after administration severe headache, chills, muscle aches, low grade fever all lasting 3 days. Injection site raised red painful swollen despite ice pack application continuously after administration; grew in size over 4 days to approximately 3"x4", extreme tenderness, red, painful.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Pyrexia
Clinical narrative: 10 hours after administration severe headache, chills, muscle aches, low grade fever all lasting 3 days. Injection site raised red painful swollen despite ice pack application continuously after administration; grew in size over 4 days to approximately 3"x4", extreme tenderness, red, painful.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Hypoaesthesia, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: High fever. Pain at the injection site. Numbness in the arm and severe pain in the arm for 3 days.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: PATIENT RECEIVED THE PNEUMOVAX 23 ON 12/08/2017 AND STARTED TO EXPERIENCE A SLIGHT FEVER THAT NIGHT. ON SATURDAY MORNING, SHE NOTICED HER ARM WAS SWOLLEN AND ITCHY. SHE DESCRIBED HER ARM LOOKING LIKE THE CARTOON CHARACTER. I CALLED THE PATIENT ON 12/11/17 TO FOLLOW UP. SHE DID NOT HAVE A FEVER AND THE SWELLING WENT DOWN BUT A LITTLE ITCHY.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Arm is swollen and puffy, extends length of arm, not painful at injection site, painful on arm,  swollen feels hot, used naproxen to treat twice, used iced, for day of and day after, and used ibuprofen .
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Injection site pain, Pain, Paraesthesia, Peripheral coldness
Clinical narrative: The patient presents with unusual symptoms after her second BEXSERO shot last Tuesday. The first day of two she had pain in the arm where she got the shot and pain with raising it above her shoulder height. She also had a tingling pain up the right side of her neck. That has resolved as has the arm pain. Now she is tender to palpation over the MCP joint of the thumb of the right hand and the extensor surface of the right forearm. She gets tingling in the right hand constantly and it feels colder than the other hand. This constant tingling has been there for 4 days.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Tenderness
Clinical narrative: The patient presents with unusual symptoms after her second BEXSERO shot last Tuesday. The first day of two she had pain in the arm where she got the shot and pain with raising it above her shoulder height. She also had a tingling pain up the right side of her neck. That has resolved as has the arm pain. Now she is tender to palpation over the MCP joint of the thumb of the right hand and the extensor surface of the right forearm. She gets tingling in the right hand constantly and it feels colder than the other hand. This constant tingling has been there for 4 days.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Angiogram normal, Computerised tomogram head, Computerised tomogram head abnormal, Dyskinesia, Dysphemia
Clinical narrative: On the date of Immunization (11/07/2017) at approx. 7pm, Patient experienced acute onset of stuttering and difficulty with speaking. Patient also stated that he experienced jerking of the neck.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Electrocardiogram normal, Electroencephalogram normal, Nuclear magnetic resonance imaging normal, Speech disorder
Clinical narrative: On the date of Immunization (11/07/2017) at approx. 7pm, Patient experienced acute onset of stuttering and difficulty with speaking. Patient also stated that he experienced jerking of the neck.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Myalgia
Clinical narrative: Muscle pain.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dizziness, Malaise, Pain, Pyrexia
Clinical narrative: Extreme dizziness, malaise, low grade fever, body aches, chills, rhinorrhea. All X 2 weeks.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Rhinorrhoea
Clinical narrative: Extreme dizziness, malaise, low grade fever, body aches, chills, rhinorrhea. All X 2 weeks.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Continued pain for over 2 months since the vaccination. It is painful in my left deltoid when I raise my left arm. The pain is about an 8 on a 1-10 scale. It does not last after I put my arm down, but I cannot lift that arm without pain.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Dermatomyositis, Laboratory test, Rash
Clinical narrative: Patient said he broke out in a rash and bumps the next day. He said he came back from the doctors with his lab tests and they confirmed it is dermatomyositis. Possible reaction from the FLUARIX QUAD specifically.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Generalised erythema, Rash generalised
Clinical narrative: Father stated patient woke up from nap and had white bumps with redness around all over body. Its starting to fade away. No lip swelling or tongue swelling. No difficulty breathing. Advised to use Benadryl 3.75 ml every 6 hours as needed. Advised to take to ER if she has any difficulty breathing or wheezing.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Diarrhoea, Injection site rash, Nasopharyngitis, Pyrexia, Rash
Clinical narrative: Cold right after receiving vaccine(s), 6 days later: diarrhea and little red dots around neck and arm. 7 days later: back full in red bumps and rash throughout and on neck & legs w/ fever of over 101.1 degrees F. Took son to urgent care 12/12/17 and saw Dr. Dr. stated it was only a "viral infection."
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Rash erythematous, Viral infection, White blood cell count
Clinical narrative: Cold right after receiving vaccine(s), 6 days later: diarrhea and little red dots around neck and arm. 7 days later: back full in red bumps and rash throughout and on neck & legs w/ fever of over 101.1 degrees F. Took son to urgent care 12/12/17 and saw Dr. Dr. stated it was only a "viral infection."
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Inflammation, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Redness, inflammation, and tenderness at injection site and radiating down left arm all the way to wrist. Resolved after 3-4 days. Patient is post-transplant and was directed by oncologist to receive a 2nd PNEUMOVAX (unknown when first dose given but at least 5 years prior).
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Redness, inflammation, and tenderness at injection site and radiating down left arm all the way to wrist. Resolved after 3-4 days. Patient is post-transplant and was directed by oncologist to receive a 2nd PNEUMOVAX (unknown when first dose given but at least 5 years prior).
Age: 79.0
Sex: F
Vaccine: FLUA3
Symptoms: Contusion, Injection site bruising
Clinical narrative: PATIENT EXPERIENCED BRUISING THE FOLLOWING DAY, AT LEAST TWO INCHES BELOW THE INJECTION SITE (DELTOID MUSCLE). PATIENT DID NOT HAVE ANY PAIN. THERE WAS NO IRRITATION AT THE INJECTION SITE.
Age: 31.0
Sex: F
Vaccine: PNC13
Symptoms: Blood culture negative, Chills, Hypotension, Injection site erythema, Injection site swelling
Clinical narrative: Patient developed chills and the L arm became swollen but initially not painful. Symptoms worsened over the next 24 hrs, with fever and feeling unwell. Was evaluated at an area hospital and admitted Nov 22 - 25, 2017. Had HR in low 100s, slightly low BP and fever. Erythema and swelling of the upper L arm were described at adm. Her initial WBC was 21,000, came down to 8,500 at discharge. Plts were 170 K at adm, dropped to 141 K and were 220 K at discharge. Blood cultures were negative. She was not treated with antibiotics.
Age: 31.0
Sex: F
Vaccine: PNC13
Symptoms: Malaise, Peripheral swelling, Platelet count decreased, Pyrexia, White blood cell count increased
Clinical narrative: Patient developed chills and the L arm became swollen but initially not painful. Symptoms worsened over the next 24 hrs, with fever and feeling unwell. Was evaluated at an area hospital and admitted Nov 22 - 25, 2017. Had HR in low 100s, slightly low BP and fever. Erythema and swelling of the upper L arm were described at adm. Her initial WBC was 21,000, came down to 8,500 at discharge. Plts were 170 K at adm, dropped to 141 K and were 220 K at discharge. Blood cultures were negative. She was not treated with antibiotics.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Diarrhoea, Influenza like illness, Muscle swelling, Myalgia
Clinical narrative: Patient received PREVNAR 13 one year ago with no issues. The day after she received this vaccine her arm muscle was really sore, with a little swelling, and slightly warm around vaccine site. Doctor confirmed possible adverse reaction to vaccine. Patient also suffered from diarrhea, stomach upset, and feeling fluish shortly after vaccination. Doctor recommended for patient to take BENADRYL.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination site warmth
Clinical narrative: Patient received PREVNAR 13 one year ago with no issues. The day after she received this vaccine her arm muscle was really sore, with a little swelling, and slightly warm around vaccine site. Doctor confirmed possible adverse reaction to vaccine. Patient also suffered from diarrhea, stomach upset, and feeling fluish shortly after vaccination. Doctor recommended for patient to take BENADRYL.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Arthritis, Injection site pain, Pain, X-ray limb abnormal
Clinical narrative: Pain, achiness in upper left arm. Also, moved into shoulder causing pain w/certain movements similar to rotator cuff as well as movements behind back. Visited Dr. on November 30. Ordered x-ray and referred to therapy. Currently have first appt. to see therapist.
Age: 63.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Hard lump with redness & swelling below injection site. Lasted for a few days.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site joint pain, Injection site pain
Clinical narrative: Bruise like mark quarter-sized at site of injection that persisted over 10 days after injection. On Sunday 12/10/17 pt claimed to start having an achy pain in the whole upper arm of the injection site that worsened. Was reported today to the pharmacy @ 5:00pm. Pt claimed it aches like a "bad toothache" and the ache includes the whole upper part of the arm including joints and bruise is still apparent at injection site.
Age: 41.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Headache, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Headache, onsite reaction (arm swelling and redness) fever (38.87 C). Chills (continous, lasting 30 minutes). Treatment: 1000 mg acetaminophen bid, Ibuprofen 800 bid.
Age: 60.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Fatigue
Clinical narrative: Patient that experienced fatigue and joint pain throughout the body for 3 full days following vaccination.
Age: 25.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site vesicles
Clinical narrative: Blister at injection site.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Aggression, Agitation, Aphasia, Autonomic nervous system imbalance, Catatonia
Clinical narrative: Anti-NMDA receptor encephalitis, also known as NMDA receptor antibody encephalitis, is an acute form of brain inflammation. It is caused by an immune system attack, primarily targeting the NR1 subunit of the NMDA receptor (N-methyl D-aspartate receptor). Experienced headaches, virus like symptoms for weeks prior to disease onset. Then presented with a variety of neurologic symptoms. These symptoms include agitation, psychosis, violent behavior, seizures, bizarre movements (mostly of the lips and mouth), uncontrollable motions to the legs, tachycardia (heart rate 160-180), and dysautonomia. While hospitalized, experienced catatonic state, impaired cognition, memory deficits, and speech problems (including aphasia and mutism). Required intensive inpatient rehabilitation (OT, PT, AND SPEECH). Medications: IVIG (Immunoglobulin therapy), RITUXIMAB, PREDNISONE, CHOLECALCIFEROL, LACOSAMIDE, LORAZEPAM, MELATONIN, OMEPRAZOLE, TRIMETHOPRIM-SULFAMETHOXAZOLE. HOSPITALIZATION: Hospital ? January 27 ? March 14, another Hospital Comprehensive Inpatient Rehabilitation ? March 14 ? March 28, Hospital Outpatient Day Program ? March 29 ? April 14.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Cognitive disorder, Computerised tomogram, Dyskinesia, Electrocardiogram, Electroencephalogram
Clinical narrative: Anti-NMDA receptor encephalitis, also known as NMDA receptor antibody encephalitis, is an acute form of brain inflammation. It is caused by an immune system attack, primarily targeting the NR1 subunit of the NMDA receptor (N-methyl D-aspartate receptor). Experienced headaches, virus like symptoms for weeks prior to disease onset. Then presented with a variety of neurologic symptoms. These symptoms include agitation, psychosis, violent behavior, seizures, bizarre movements (mostly of the lips and mouth), uncontrollable motions to the legs, tachycardia (heart rate 160-180), and dysautonomia. While hospitalized, experienced catatonic state, impaired cognition, memory deficits, and speech problems (including aphasia and mutism). Required intensive inpatient rehabilitation (OT, PT, AND SPEECH). Medications: IVIG (Immunoglobulin therapy), RITUXIMAB, PREDNISONE, CHOLECALCIFEROL, LACOSAMIDE, LORAZEPAM, MELATONIN, OMEPRAZOLE, TRIMETHOPRIM-SULFAMETHOXAZOLE. HOSPITALIZATION: Hospital ? January 27 ? March 14, another Hospital Comprehensive Inpatient Rehabilitation ? March 14 ? March 28, Hospital Outpatient Day Program ? March 29 ? April 14.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Encephalitis autoimmune, Headache, Immunoglobulin therapy, Laboratory test, Loss of control of legs
Clinical narrative: Anti-NMDA receptor encephalitis, also known as NMDA receptor antibody encephalitis, is an acute form of brain inflammation. It is caused by an immune system attack, primarily targeting the NR1 subunit of the NMDA receptor (N-methyl D-aspartate receptor). Experienced headaches, virus like symptoms for weeks prior to disease onset. Then presented with a variety of neurologic symptoms. These symptoms include agitation, psychosis, violent behavior, seizures, bizarre movements (mostly of the lips and mouth), uncontrollable motions to the legs, tachycardia (heart rate 160-180), and dysautonomia. While hospitalized, experienced catatonic state, impaired cognition, memory deficits, and speech problems (including aphasia and mutism). Required intensive inpatient rehabilitation (OT, PT, AND SPEECH). Medications: IVIG (Immunoglobulin therapy), RITUXIMAB, PREDNISONE, CHOLECALCIFEROL, LACOSAMIDE, LORAZEPAM, MELATONIN, OMEPRAZOLE, TRIMETHOPRIM-SULFAMETHOXAZOLE. HOSPITALIZATION: Hospital ? January 27 ? March 14, another Hospital Comprehensive Inpatient Rehabilitation ? March 14 ? March 28, Hospital Outpatient Day Program ? March 29 ? April 14.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Lumbar puncture, Memory impairment, Mutism, Neurological symptom, Nuclear magnetic resonance imaging
Clinical narrative: Anti-NMDA receptor encephalitis, also known as NMDA receptor antibody encephalitis, is an acute form of brain inflammation. It is caused by an immune system attack, primarily targeting the NR1 subunit of the NMDA receptor (N-methyl D-aspartate receptor). Experienced headaches, virus like symptoms for weeks prior to disease onset. Then presented with a variety of neurologic symptoms. These symptoms include agitation, psychosis, violent behavior, seizures, bizarre movements (mostly of the lips and mouth), uncontrollable motions to the legs, tachycardia (heart rate 160-180), and dysautonomia. While hospitalized, experienced catatonic state, impaired cognition, memory deficits, and speech problems (including aphasia and mutism). Required intensive inpatient rehabilitation (OT, PT, AND SPEECH). Medications: IVIG (Immunoglobulin therapy), RITUXIMAB, PREDNISONE, CHOLECALCIFEROL, LACOSAMIDE, LORAZEPAM, MELATONIN, OMEPRAZOLE, TRIMETHOPRIM-SULFAMETHOXAZOLE. HOSPITALIZATION: Hospital ? January 27 ? March 14, another Hospital Comprehensive Inpatient Rehabilitation ? March 14 ? March 28, Hospital Outpatient Day Program ? March 29 ? April 14.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Psychotic disorder, Seizure, Speech disorder, Tachycardia, Viral infection
Clinical narrative: Anti-NMDA receptor encephalitis, also known as NMDA receptor antibody encephalitis, is an acute form of brain inflammation. It is caused by an immune system attack, primarily targeting the NR1 subunit of the NMDA receptor (N-methyl D-aspartate receptor). Experienced headaches, virus like symptoms for weeks prior to disease onset. Then presented with a variety of neurologic symptoms. These symptoms include agitation, psychosis, violent behavior, seizures, bizarre movements (mostly of the lips and mouth), uncontrollable motions to the legs, tachycardia (heart rate 160-180), and dysautonomia. While hospitalized, experienced catatonic state, impaired cognition, memory deficits, and speech problems (including aphasia and mutism). Required intensive inpatient rehabilitation (OT, PT, AND SPEECH). Medications: IVIG (Immunoglobulin therapy), RITUXIMAB, PREDNISONE, CHOLECALCIFEROL, LACOSAMIDE, LORAZEPAM, MELATONIN, OMEPRAZOLE, TRIMETHOPRIM-SULFAMETHOXAZOLE. HOSPITALIZATION: Hospital ? January 27 ? March 14, another Hospital Comprehensive Inpatient Rehabilitation ? March 14 ? March 28, Hospital Outpatient Day Program ? March 29 ? April 14.
Age: 72.0
Sex: U
Vaccine: FLU3, VARZOS
Symptoms: Rash
Clinical narrative: Mild rash upper front torsal.
Age: 66.0
Sex: F
Vaccine: FLUR3, PPV
Symptoms: Chills, Injected limb mobility decreased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: That night after receiving a flu shot in the right arm-and PREVENAR 23 in the left arm-my left arm from the almost top of the arm to my elbow was red, hot, swollen and I couldn't lift it. I had chills-didn't eat supper for two days-felt queasy.
Age: 66.0
Sex: F
Vaccine: FLUR3, PPV
Symptoms: Nausea, Skin exfoliation
Clinical narrative: That night after receiving a flu shot in the right arm-and PREVENAR 23 in the left arm-my left arm from the almost top of the arm to my elbow was red, hot, swollen and I couldn't lift it. I had chills-didn't eat supper for two days-felt queasy.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: (L) leg to vaccine site-red and swelling.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site swelling, Injection site warmth, Peripheral swelling, Pruritus
Clinical narrative: Patient states that her arm was swollen from shoulder to elbow and had rough raised bump at injection site. Area was hot to touch. Rough patches spread to several areas that were itchy. Urgent Care said it was allergic reaction.
Age: 12.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Expired product administered
Clinical narrative: Expired product administered; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. (VAERS ID 705453) on 13-DEC-2017.  This spontaneous report has been received from the agency and refers to a 12-year-old female patient. None current illness, medical history, other medications nor prior vaccinations were reported. On 25-JUL-2017 ,the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) first dose, intramuscular in the left arm (lot #, expiration date were not reported) for prophylaxis. It was reported that vaccine was drawn up and administered. Afterwards when logging vaccine was noted that dose had expired in May 2017. The outcome of expired product administered was unknown, also reported as "Recovery unknown".  Follow-up was received on 15-APR-2019.  The patient's race was given. Concomitant therapies included diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX). Information about the facility where vaccine was given and time of vaccination were updated.  Follow up information has been received from office manager and an non healthcare professional on 29-MAY-2019. The non healthcare professional stated that the event was known previously and notified patient's parent, as well and the office manager stated that she was confused about date the vaccine was administered. It was clarified that dose was administered in 2017 and by a healthcare professional. The office manager reported that she would consult with healthcare professional and return call if any more details become available.
Age: 12.0
Sex: F
Vaccine: HPV9, HPV9, HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired product administered; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. (VAERS ID 705453) on 13-DEC-2017.  This spontaneous report has been received from the agency and refers to a 12-year-old female patient. None current illness, medical history, other medications nor prior vaccinations were reported. On 25-JUL-2017 ,the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) first dose, intramuscular in the left arm (lot #, expiration date were not reported) for prophylaxis. It was reported that vaccine was drawn up and administered. Afterwards when logging vaccine was noted that dose had expired in May 2017. The outcome of expired product administered was unknown, also reported as "Recovery unknown".  Follow-up was received on 15-APR-2019.  The patient's race was given. Concomitant therapies included diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX). Information about the facility where vaccine was given and time of vaccination were updated.  Follow up information has been received from office manager and an non healthcare professional on 29-MAY-2019. The non healthcare professional stated that the event was known previously and notified patient's parent, as well and the office manager stated that she was confused about date the vaccine was administered. It was clarified that dose was administered in 2017 and by a healthcare professional. The office manager reported that she would consult with healthcare professional and return call if any more details become available.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pruritus
Clinical narrative: Initial unsolicited report received from consumer on 17 Nov 2017. This was an invalid case as no specific event was reported. This case is linked with 2017SA234154 and 2017SA233336 (Same reporter). This case involves female patient (Age not reported) who was vaccinated with dose of FLUZONE QUADRIVALENT (batch number, expiry date, route and site of administration were not reported) on 25 Sep 2017. The patient's medical history and concomitant medication were not reported. On an unspecified date, post vaccination patient had had an adverse reaction. Laboratory investigation and corrective treatment were not reported. She was still dealing with some adverse effects from the vaccine, although she did say it has somewhat improved. List of documents held by sender: none. Follow up report received from consumer on 17-Nov-2017. Patient's age was reported as 80-year-old. Patient had received influenza vaccines in the past with no adverse reaction. It was reported that patient was vaccinated with 0.5 ml dose via intramuscular route once on 25-Sep-2017 for immunization. It was reported that on an unknown date, the day after vaccination, she developed redness, swelling, and pruritus around the site of the injection extending down to the elbow. The redness and itching extended to her chest. She applied over-the-counter hydrocortisone cream to the affected areas for 5-6 days. This helped with the redness and itching and she stopped the topical medication. On October 5th, redness and pruritus reappeared, now on both arms and her chest. The itching was intense and she tried a number of over-the-counter topical agents but she did not restart hydrocortisone cream. She states that the pruritus is about 85% better at this time but it is still present on the right arm and shoulder. Outcome of the pruritus was recovering. List of documents held by sender: none.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site swelling, Pruritus
Clinical narrative: Initial unsolicited report received from consumer on 17 Nov 2017. This was an invalid case as no specific event was reported. This case is linked with 2017SA234154 and 2017SA233336 (Same reporter). This case involves female patient (Age not reported) who was vaccinated with dose of FLUZONE QUADRIVALENT (batch number, expiry date, route and site of administration were not reported) on 25 Sep 2017. The patient's medical history and concomitant medication were not reported. On an unspecified date, post vaccination patient had had an adverse reaction. Laboratory investigation and corrective treatment were not reported. She was still dealing with some adverse effects from the vaccine, although she did say it has somewhat improved. List of documents held by sender: none. Follow up report received from consumer on 17-Nov-2017. Patient's age was reported as 80-year-old. Patient had received influenza vaccines in the past with no adverse reaction. It was reported that patient was vaccinated with 0.5 ml dose via intramuscular route once on 25-Sep-2017 for immunization. It was reported that on an unknown date, the day after vaccination, she developed redness, swelling, and pruritus around the site of the injection extending down to the elbow. The redness and itching extended to her chest. She applied over-the-counter hydrocortisone cream to the affected areas for 5-6 days. This helped with the redness and itching and she stopped the topical medication. On October 5th, redness and pruritus reappeared, now on both arms and her chest. The itching was intense and she tried a number of over-the-counter topical agents but she did not restart hydrocortisone cream. She states that the pruritus is about 85% better at this time but it is still present on the right arm and shoulder. Outcome of the pruritus was recovering. List of documents held by sender: none.
Age: 46.0
Sex: F
Vaccine: FLU4, FLU4, FLUX
Symptoms: Pain in extremity
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 01-Dec-2017. This case involves a 46-year-old female patient who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date, dose, dose in series and route of administration were not reported) administered in high up on shoulder on 19-Sep-2017. The patient medical history and concomitant medication was not reported. On 20-Sep-2017, one day following the vaccination, the patient experienced shoulder pain. It was reported as after 3 weeks of shoulder pain patient saw physician on an unknown date and treated with prednisone for 30 days and pain was improved while on Prednisone, and when patient finished Prednisone, she again experienced shoulder pain. On 06-Nov-2017, patient returned to physician again and received another round of Prednisone for 3 more weeks and shoulder pain improved, but returned when she stopped taking prednisone. It was also a case of actual medication error due to wrong injection technique (Vaccine was administered high up on shoulder). Relevant lab tests and other corrective treatment was not reported. As of 01-Dec-2017, the patient was not recovered from the event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. List of documents held by sender: none.
Age: 46.0
Sex: F
Vaccine: FLU4, FLU4, FLUX
Symptoms: Drug administered at inappropriate site, Musculoskeletal pain, Wrong technique in product usage process
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 01-Dec-2017. This case involves a 46-year-old female patient who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date, dose, dose in series and route of administration were not reported) administered in high up on shoulder on 19-Sep-2017. The patient medical history and concomitant medication was not reported. On 20-Sep-2017, one day following the vaccination, the patient experienced shoulder pain. It was reported as after 3 weeks of shoulder pain patient saw physician on an unknown date and treated with prednisone for 30 days and pain was improved while on Prednisone, and when patient finished Prednisone, she again experienced shoulder pain. On 06-Nov-2017, patient returned to physician again and received another round of Prednisone for 3 more weeks and shoulder pain improved, but returned when she stopped taking prednisone. It was also a case of actual medication error due to wrong injection technique (Vaccine was administered high up on shoulder). Relevant lab tests and other corrective treatment was not reported. As of 01-Dec-2017, the patient was not recovered from the event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. List of documents held by sender: none.
Age: 47.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain, Ultrasound scan
Clinical narrative: ARM CONTINUES TO HURT.
Age: 47.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Ultrasound scan
Clinical narrative: ARM CONTINUES TO HURT.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Chills, Impaired work ability, Insomnia, Malaise, Pain in extremity
Clinical narrative: This spontaneous report was received from a registered nurse who referred to a 72 year old male patient. The patient had no pertinent medical history and drug reactions or allergies. On 24-OCT-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscular injection, lot # N014946, expiration date 01-FEB-2019 as "preventative". Concomitantly the patient was vaccinated with an unspecified influenza virus vaccine (manufacturer unknown) on the same date. The nurse reported that "8 hours later, patient had fever, chills, sleeplessness, and sore arm at injection site. Symptoms resolved by the next morning (on 25-OCT-2017) without treatment, and arm soreness persisted for 3 to 4 days, and resolved without treatment" on approximately 28-OCT-2017. The patient did not have any lab diagnostics or studies performed. The patient did not seek medical attention. The relatedness between the event and vaccine, PNEUMOVAX 23 was not reported.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a registered nurse who referred to a 72 year old male patient. The patient had no pertinent medical history and drug reactions or allergies. On 24-OCT-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscular injection, lot # N014946, expiration date 01-FEB-2019 as "preventative". Concomitantly the patient was vaccinated with an unspecified influenza virus vaccine (manufacturer unknown) on the same date. The nurse reported that "8 hours later, patient had fever, chills, sleeplessness, and sore arm at injection site. Symptoms resolved by the next morning (on 25-OCT-2017) without treatment, and arm soreness persisted for 3 to 4 days, and resolved without treatment" on approximately 28-OCT-2017. The patient did not have any lab diagnostics or studies performed. The patient did not seek medical attention. The relatedness between the event and vaccine, PNEUMOVAX 23 was not reported.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV, PPV
Symptoms: Chills, Injection site pain, Insomnia, Pyrexia
Clinical narrative: This spontaneous report was received from a registered nurse who referred to a 72 year old male patient. The patient had no pertinent medical history and drug reactions or allergies. On 24-OCT-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 intramuscular injection, lot # N014946, expiration date 01-FEB-2019 as "preventative". Concomitantly the patient was vaccinated with an unspecified influenza virus vaccine (manufacturer unknown) on the same date. The nurse reported that "8 hours later, patient had fever, chills, sleeplessness, and sore arm at injection site. Symptoms resolved by the next morning (on 25-OCT-2017) without treatment, and arm soreness persisted for 3 to 4 days, and resolved without treatment" on approximately 28-OCT-2017. The patient did not have any lab diagnostics or studies performed. The patient did not seek medical attention. The relatedness between the event and vaccine, PNEUMOVAX 23 was not reported.
Age: 42.0
Sex: F
Vaccine: IPV, MMR, TD, IPV, MMR, TD
Symptoms: Administration site swelling, Asthenia, Hypoaesthesia, Injection site erythema, Lethargy
Clinical narrative: Initial unsolicited report received from a healthcare professional on 23-Oct-2017. This case involves a 42-year-old female patient who was vaccinated with a dose of TUBERCULIN PPD(M) 5 TU (TUBERSOL) (Batch number: C5036A), IPV (VERO) (POLIO VACCINE) (Batch number: N1F931M) in left deltoid, MEASLES, MUMPS AND RUBELLA VACCINE (M-M-R) (Batch number: M029229) in hip (Expiration date: not reported) (dose, dose in series and route of administration, site of administration were not reported for all) and suspension of injection of DIPHTHERIA/TETANUS ADSORBED TOXOIDS (TETANUS AND DIPHTHERIA TOXOIDS ADSORBED) (Batch number: A098A1, Expiration date: not reported) with 0.5 ml intradermal in right deltoid on 03-May-2017 at 2:00 PM. The patient's medical history were not reported and had taken Synthroid (thyroid medication) as routine medication on 03-May-2017. On 06-May-2017, three days post-vaccination, the patient experienced redness that got increasingly bigger and swelling around the site of administration (right deltoid), shooting pain down the right hand, numbness, tingling, weakness, neck pain and stiffness, and she felt both sore and lethargic. The patient visited the doctor's office 1-month post-administration. Laboratory data were not reported and no treatment was reported. It was reported that patient's recovery status is unknown. List of documents held by sender: none.
Age: 42.0
Sex: F
Vaccine: IPV, MMR, TD, IPV, MMR, TD
Symptoms: Musculoskeletal stiffness, Neck pain, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Initial unsolicited report received from a healthcare professional on 23-Oct-2017. This case involves a 42-year-old female patient who was vaccinated with a dose of TUBERCULIN PPD(M) 5 TU (TUBERSOL) (Batch number: C5036A), IPV (VERO) (POLIO VACCINE) (Batch number: N1F931M) in left deltoid, MEASLES, MUMPS AND RUBELLA VACCINE (M-M-R) (Batch number: M029229) in hip (Expiration date: not reported) (dose, dose in series and route of administration, site of administration were not reported for all) and suspension of injection of DIPHTHERIA/TETANUS ADSORBED TOXOIDS (TETANUS AND DIPHTHERIA TOXOIDS ADSORBED) (Batch number: A098A1, Expiration date: not reported) with 0.5 ml intradermal in right deltoid on 03-May-2017 at 2:00 PM. The patient's medical history were not reported and had taken Synthroid (thyroid medication) as routine medication on 03-May-2017. On 06-May-2017, three days post-vaccination, the patient experienced redness that got increasingly bigger and swelling around the site of administration (right deltoid), shooting pain down the right hand, numbness, tingling, weakness, neck pain and stiffness, and she felt both sore and lethargic. The patient visited the doctor's office 1-month post-administration. Laboratory data were not reported and no treatment was reported. It was reported that patient's recovery status is unknown. List of documents held by sender: none.