chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging, Tendon disorder, Tendonitis
Clinical narrative: On Oct. 17, 2017, I was given a mandatory flu vaccine. The next afternoon I woke around 4pm. I had sever pain in my shoulder. Thought it would go away. It became worse that day and continued to worsen. I had no ROM of my left arm and every time I tried to use my arm I was not able to. I reported it to work comp. I was sent to physical therapy it worsened. I had an MRI. With this being said I have had no injury to my shoulder. The MRI showed acute tendonitis or tendonopathy. The pain is constant and has not let up. Workmen's comp discharged me. I have had no other treatment. I was frantic when this happened and looked up vaccine injuries. I have had every sign and symptom of this SIRVA. I am an RN so I researched all of this carefully.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Seizure
Clinical narrative: This serious initial spontaneous case, was received from other non-health professional on 11-Dec-2017, concerning a 57-year-old, adult, female patient. It was reported that, the patient had never received flu shot in the past. The patient's historical condition included: had one seizure in 2009, but was told as TIA (transient ischemic attack). The patient was allergic to thiomersal. Concomitant medications included: Atenolol, Levothyroxine, Etodolac, Ocean, Calcium plus vitamin D, Omega 3 and COQ10 for unknown indication. On an unspecified date in Jan-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: Intramuscular, anatomical location: deltoid, batch number, expiry date: not reported). On the same day, 10 minutes after receiving vaccine, patient had a seizure. One hour later, the patient had another seizure. The patient had additional episodes of seizures on unspecified dates in June and September. One week prior to this report, the patient had an episode of seizure. The patient was treated with an unspecified seizure medication. At the time of this report, the patient had not yet recovered from the event seizure.
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Initial unsolicited report received from a health-care professional on 12-Dec-2017. This case involves a female patient who was vaccinated with a 0.5 ml second dose of MENACTRA (Batch number: 45415AA, expiry date: 16-OCT-2019) intramuscularly in the right deltoid on unknown date. 0.5 ml dose of TRUMENBA once (Batch number: R45077, expiry date: 31-Jul-2018, site of administration was not reported) intramuscularly in the right deltoid on an unknown and also vaccinated with second dose of GARDASIL 9 (Batch number: U001533, expiry date: 16-Oct-2019) intramuscularly in the left deltoid on an unknown date. The patient's medical history included essential hypertension, insulin resistance and polycystic ovaries. Concomitant medications included cephalexin (Cephalexin 500 Mg) and methylprednisolone (Medrol 4mg). On 16-Sep-2017, following the vaccination, the patient had developed local reactions causing cellulitis of right arm. No Laboratory investigations was reported. Corrective treatment included Cephalexin. The outcome of the events was recovered on unspecified date at the time of reporting. List of documents held by sender: none.
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Injection site cellulitis, Local reaction
Clinical narrative: Initial unsolicited report received from a health-care professional on 12-Dec-2017. This case involves a female patient who was vaccinated with a 0.5 ml second dose of MENACTRA (Batch number: 45415AA, expiry date: 16-OCT-2019) intramuscularly in the right deltoid on unknown date. 0.5 ml dose of TRUMENBA once (Batch number: R45077, expiry date: 31-Jul-2018, site of administration was not reported) intramuscularly in the right deltoid on an unknown and also vaccinated with second dose of GARDASIL 9 (Batch number: U001533, expiry date: 16-Oct-2019) intramuscularly in the left deltoid on an unknown date. The patient's medical history included essential hypertension, insulin resistance and polycystic ovaries. Concomitant medications included cephalexin (Cephalexin 500 Mg) and methylprednisolone (Medrol 4mg). On 16-Sep-2017, following the vaccination, the patient had developed local reactions causing cellulitis of right arm. No Laboratory investigations was reported. Corrective treatment included Cephalexin. The outcome of the events was recovered on unspecified date at the time of reporting. List of documents held by sender: none.
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Injection site cellulitis
Clinical narrative: Initial unsolicited report received from a health-care professional on 12-Dec-2017. This case involves a female patient who was vaccinated with a 0.5 ml second dose of MENACTRA (Batch number: 45415AA, expiry date: 16-OCT-2019) intramuscularly in the right deltoid on unknown date. 0.5 ml dose of TRUMENBA once (Batch number: R45077, expiry date: 31-Jul-2018, site of administration was not reported) intramuscularly in the right deltoid on an unknown and also vaccinated with second dose of GARDASIL 9 (Batch number: U001533, expiry date: 16-Oct-2019) intramuscularly in the left deltoid on an unknown date. The patient's medical history included essential hypertension, insulin resistance and polycystic ovaries. Concomitant medications included cephalexin (Cephalexin 500 Mg) and methylprednisolone (Medrol 4mg). On 16-Sep-2017, following the vaccination, the patient had developed local reactions causing cellulitis of right arm. No Laboratory investigations was reported. Corrective treatment included Cephalexin. The outcome of the events was recovered on unspecified date at the time of reporting. List of documents held by sender: none.
Sex: F
Vaccine: HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ, HPV9, MENB, MNQ
Symptoms: Cellulitis, Local reaction
Clinical narrative: Initial unsolicited report received from a health-care professional on 12-Dec-2017. This case involves a female patient who was vaccinated with a 0.5 ml second dose of MENACTRA (Batch number: 45415AA, expiry date: 16-OCT-2019) intramuscularly in the right deltoid on unknown date. 0.5 ml dose of TRUMENBA once (Batch number: R45077, expiry date: 31-Jul-2018, site of administration was not reported) intramuscularly in the right deltoid on an unknown and also vaccinated with second dose of GARDASIL 9 (Batch number: U001533, expiry date: 16-Oct-2019) intramuscularly in the left deltoid on an unknown date. The patient's medical history included essential hypertension, insulin resistance and polycystic ovaries. Concomitant medications included cephalexin (Cephalexin 500 Mg) and methylprednisolone (Medrol 4mg). On 16-Sep-2017, following the vaccination, the patient had developed local reactions causing cellulitis of right arm. No Laboratory investigations was reported. Corrective treatment included Cephalexin. The outcome of the events was recovered on unspecified date at the time of reporting. List of documents held by sender: none.
Age: 75.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Induration, Local reaction, Oedema, Pain in extremity
Clinical narrative: PATIENT REPORTED REDNESS AND SWELLING AT INJECTION SITE WHICH RADIATED TO UPPER PART OF THE BODY A FEW HOURS AFTER INJECTION. PATIENT WENT TO THE ER AND WAS GIVEN MEDICATION FOR REACTION AND WAS ABLE TO GO HOME. TODAY SHE REPORTED SWELLING AND REDNESS HAS GONE DOWN BUT SHE STILL HAS SOME PAIN.
Age: 75.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Pain, Swelling
Clinical narrative: PATIENT REPORTED REDNESS AND SWELLING AT INJECTION SITE WHICH RADIATED TO UPPER PART OF THE BODY A FEW HOURS AFTER INJECTION. PATIENT WENT TO THE ER AND WAS GIVEN MEDICATION FOR REACTION AND WAS ABLE TO GO HOME. TODAY SHE REPORTED SWELLING AND REDNESS HAS GONE DOWN BUT SHE STILL HAS SOME PAIN.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, MMR, PPV, VARCEL
Symptoms: Injection site reaction, Rash vesicular, Scab
Clinical narrative: 4 vesicular bumps on lateral right thigh, crusting over after about 1 week. Concurrent upper respiratory infection.
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling
Clinical narrative: Pt noticed the following symptoms the day after receiving vaccine: swelling/stiffness of the deltoid. Pt reported to aid station two days after receiving vaccine to be seen by provider and the following symptoms were noted: redness, swelling, induration around the site of injection as well as up the shoulder and down part of the arm. Pt was prescribed cephalexin and is to be treated for likely cellulitis vs reaction to the actual ingredients in Anthrax. Pt to return to clinic if symptoms worsen or persist.
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Musculoskeletal stiffness
Clinical narrative: Pt noticed the following symptoms the day after receiving vaccine: swelling/stiffness of the deltoid. Pt reported to aid station two days after receiving vaccine to be seen by provider and the following symptoms were noted: redness, swelling, induration around the site of injection as well as up the shoulder and down part of the arm. Pt was prescribed cephalexin and is to be treated for likely cellulitis vs reaction to the actual ingredients in Anthrax. Pt to return to clinic if symptoms worsen or persist.
Sex: U
Vaccine: HPV9, PPV, VARCEL, VARZOS
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a pharmacy technician refers to unspecified patients of unknown age and gender. On an unknown dates in 2017 (reported as from 25-OCT-2017 to 01-NOV-2017), the patients were vaccinated with an improperly stored doses of PNEUMOVAX 23, GARDASIL 9 for which was used improperly stored sterile diluent (MERCK). The improperly stored sterile diluent (MERCK) was used to reconstitute properly stored VARIVAX and ZOSTAVAX (for all vaccines dose, route of administration, lot # and expiration date were not reported). Administered doses of vaccines experienced the temperature excursion of -1°C or colder to -9. 7 degrees Celsius for 5 days. Data logger was not involved. There were no previous excursions reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not provided. On 11-DEC-2017, the patient was vaccinated with an expired dose of ROTATEQ lot # M004885, expired on 23-OCT-2017, for prophylaxis (strength, dose and route were not reported). No adverse effect was reported.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report was received from a physician refers to a female patient of unknown age. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 31-OCT-2017, the patient was vaccinated with one dose VARIVAX for prophylaxis (lot number and expiration date were not reported). Initial exposure to VARIVAX was when patient was 4 weeks pregnant. The patient became pregnant with last menstrual period (LMP) of 03-OCT-2017 and estimated delivery date (EDD) of 10-JUL-2018.  No adverse effects were reported. It was unknown if the patient was still pregnant at the time of the report.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 18-DEC-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (therapy type rHA) lot # N019253 and expiration date 20-DEC-2018 (dose, frequency and route of administration were not provided) for prophylaxis which was reconstituted with sterile diluent, lot # M036841 and expiration date 17-APR-2019. The vaccine was stored at a temperature of 6 Fahrenheit degree to 14 Fahrenheit degree, time frame of 63 minutes and previous temperature excursion of 6 degree Fahrenheit to 14 Fahrenheit for 240 minutes. Digital Data logger was involved.
Age: 61.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 61 year old female patient. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 13-DEC-2017 (reported as one week ago), the patient was vaccinated with first dose of RECOMBIVAX HB, 40 micrograms, intramuscularly for hepatitis B virus prevention (lot number and expiration date was not reported). On 19-DEC-2017, the patient was vaccinated with second dose of RECOMBIVAX HB. The patient sought medical attention by contacting pharmacist. No adverse effect were reported.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report has been received from a nurse, concerning a 83 year old female patient. The patient's concurrent condition included hypertension, thyroid disorder and high cholesterol. There was no drug allergies or reactions reported. Concomitant therapies included aspirin(manufacturer unknown), calcium (+) vitamin d , atorvastatin calcium(LIPITOR), Lisinopril and levothyroxine sodium(SYNTHROID). On 19-DEC-2017, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 intramuscularly, lot number L048680 and expiration date 10-JUN-2017 (dose and frequency were not reported) for prevention of pneumonia.  On 19-DEC-2017 (reported as shortly after receiving the vaccine), the patient experienced pain, redness and swelling at the injection site. The patient sought medical attention and did not receive any treatment for the adverse events. The outcome of pain, redness and swelling at the injection site was reported as not recovered. The causal relationship between pain, redness and swelling at the injection site and the therapy with PNEUMOVAX 23 was not assessed.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Crohn's disease
Clinical narrative: This spontaneous report has been received from a physician referring to a 18 year old male patient. The patient did not have drug reactions or allergies. Information regarding the patient's concurrent conditions and concomitant medications was not reported. The patient presented symptoms of anemia in Spring 2017. On an unspecified date in April 2017, a colonoscopy was performed (results were not reported). On 15-JUN-2017, the patient was vaccinated with the first dose of GARDASIL 9 lot # N000326, expiration date 14-OCT-2017 (strength, dose, route and anatomical location were not provided) for prophylaxis. On 22-AUG-2017, the patient received the second dose of GARDASIL 9 lot # N007931, expiration date November 2017 (strength, dose, route and anatomical location were not provided) for prophylaxis. On an unspecified date in 2017, the patient was diagnosed with Crohn's disease. The patient went to the physician's office for medical attention and he received an unspecified treatment. The outcome of Crohn's disease was reported as not resolved. The causality assessment between therapy with GARDASIL 9 and the event was not reported. Upon internal review the event of Crohn's Disease was determined to be medically significant.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Rash, Rash pruritic
Clinical narrative: Pruritic rash on face, neck, and posterior knees/thighs.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Patient returned the next day to show a Red /puffy localized area. The size was that of an orange. It was warm to the touch red and swollen in the form of a circle.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: High Dose influenza vaccine was inadvertently given to a 28 year old nurse by a staff nurse. There were no effects noted by the recipient.
Age: 47.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site induration, Injection site pruritus, Injection site reaction, Urticaria
Clinical narrative: 6 cm raised hard welt at site of injection noted day after vaccination. Welt was itchy and employee went to emergency department of her local hospital for evaluation. She reported being given oral Benedryl for treatment. Welt resolved slowly over the next several days.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to a 12 months male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 22-NOV-2017, the patient was vaccinated with an improperly stored dose of VARIVAX subcutaneous route, right arm, lot # N019133, expiration date 22-NOV-2017 (strength and dose were not reported) for prophylaxis. Other suspect therapies included M-M-R II, left arm, subcutaneous route, lot number M045390,  HEPATITIS A VIRUS VACCINE INACTIVATED, diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid(DIPHTHERIA TOXOID (+) PERTUSSIS ACELLULAR VACCINE (UNSPECIFIED) and sterile diluent (MERCK STERILE DILUENT).  No adverse effects reported.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Erythema, Mass, Sneezing, Swelling
Clinical narrative: Pt experienced a red raised lump and sneezing. She received the high dose flu vaccine and was not of age 65.
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Rash macular
Clinical narrative: Patient states she was highly anxious about receiving flu vaccine. Later red, blotchy skin. Went to ED for treatment.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Computerised tomogram abnormal, Dizziness, Fatigue, Headache, Lumbar spinal stenosis
Clinical narrative: The day of the vaccination patient felt weakness in both lower legs around 5:00 PM. Went to Hospital ER. By this time she felt tingling in her arms and legs and hands. ER had no explanation as to what was causing this. They felt there was a chance it could be the flu vaccine. They did do a CT scan of the lumbar spine and found spinal stenosis in her back according to her. She continues to feel fatigue and lightheadedness with a headache on and off.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: The day of the vaccination patient felt weakness in both lower legs around 5:00 PM. Went to Hospital ER. By this time she felt tingling in her arms and legs and hands. ER had no explanation as to what was causing this. They felt there was a chance it could be the flu vaccine. They did do a CT scan of the lumbar spine and found spinal stenosis in her back according to her. She continues to feel fatigue and lightheadedness with a headache on and off.
Age: 1.33
Sex: M
Vaccine: DTAP, FLU4
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: Moderate local reaction to Dtap / FLULAVAL administered in the R thigh on 12/18. Patient presented 7 cm area of swelling, redness, 1 1/2 day (yesterday morning) after vaccine administration. At the time of the visit (2 days after the vaccination) the erythema and swelling were decreasing. Mom has been applying cold compresses.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Dizziness, Headache, Rash, Rash erythematous
Clinical narrative: Date Received: 10/11/17, approximately 10am. Date of reaction: 10/11/17. Time of first symptom onset: 3pm, 10/11/17. Type of reaction 3pm, same date:Rash consisting of 4 red patches noticed to right forearm, not itchy. Per employee, "they are almost gone as of 4pm today" (10/12/17). 6:40pm, same day: "Shiver, headache, dizziness", gone by morning. Therapies used by person: NYQUIL and ALEVE, which seemed to help.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Rash, Wheezing
Clinical narrative: Cough, wheeze and rash.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Limb injury, Mobility decreased, Pain in extremity, Vaccination complication
Clinical narrative: Patient filed a claim for injury to shoulder due to the vaccine that was given. Patient claims that she was barely able to lift her arm up (due to it being so sore) and says it was due to the shot being given too high. She said she has required physical therapy and steroid shots to compensate for the pain and immobility.
Sex: U
Vaccine: HIBV
Symptoms: Underdose
Clinical narrative: This spontaneous report has been received from a nurse practitioner (also reported as nurse prescriber) referring to an adult patient of unknown gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date, the patient was vaccinated with a dose of pediatric LIQUID PEDVAXHIB (strength, dose, route, antomical location, lot number and expiration date were not provided) for prophylaxis. The reporter asked about when to repeat or provide another 1/2 dose or a full dose (underdose).
Sex: F
Vaccine: PPV
Symptoms: Blood iron decreased, Drug administered at inappropriate site, Hypoaesthesia, Injected limb mobility decreased, Injection site bruising
Clinical narrative: This spontaneous report as received from a consumer via Pfizer (2017505484) refers to a female patient of an unknown age. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. In 05-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 (dose, route, lot number and expiration date were not reported) for prophylaxis. Concomitant therapies included cetirizine hydrochloride(ZYRTEC). After 4 hours, the patient had worst reaction. She had not been able to lift her arm at all and bruising at the top of the deltoid muscle, the muscle right there because it was like in the joint where she got the injection and the bruising from the injection site was still there a week later but her arms had swelled up to twice the size it was and it was extremely painful but she could not even lift her shoulder, it almost made her muscle shoulder stagged down lower than her other one. She just could not do anything with her arm and since then she just get some numbness in her fingers periodically. The bruising was right where the injection was given which was actually on the very top part of her shoulder, it was not really in the middle of the deltoid where she always gotten the shot before. A week after (unknown date in October 2017), when she got her vaccine, she took blood test and they came back with low iron. All the events resolved apart from tingling and numbness. She took Aspirin when she was trying to make her arms feel better but it was done and she was taking it because of the pain. The reporter did not provide the causality for events with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23).
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: This spontaneous report as received from a consumer via Pfizer (2017505484) refers to a female patient of an unknown age. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. In 05-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 (dose, route, lot number and expiration date were not reported) for prophylaxis. Concomitant therapies included cetirizine hydrochloride(ZYRTEC). After 4 hours, the patient had worst reaction. She had not been able to lift her arm at all and bruising at the top of the deltoid muscle, the muscle right there because it was like in the joint where she got the injection and the bruising from the injection site was still there a week later but her arms had swelled up to twice the size it was and it was extremely painful but she could not even lift her shoulder, it almost made her muscle shoulder stagged down lower than her other one. She just could not do anything with her arm and since then she just get some numbness in her fingers periodically. The bruising was right where the injection was given which was actually on the very top part of her shoulder, it was not really in the middle of the deltoid where she always gotten the shot before. A week after (unknown date in October 2017), when she got her vaccine, she took blood test and they came back with low iron. All the events resolved apart from tingling and numbness. She took Aspirin when she was trying to make her arms feel better but it was done and she was taking it because of the pain. The reporter did not provide the causality for events with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23).
Age: 49.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Injection site pain, Nausea, Pyrexia
Clinical narrative: Fever and erythema, injection site pain, nausea.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Dysstasia, Fall, Ligament sprain, Mini mental status examination normal
Clinical narrative: Beginning 1 week after vaccination, person (me) has suffered a series of momentary neuromuscular failures in limbs during moments of activity: wk 1 left knee; wk 4 left shoulder; wk 5 right shoulder; and wk 10 right knee. Loss of muscle control resulted in sprained and torn tendons in the first three instances. The week 10 right knee was a collapse - a loss of all strength - resulting in a fall with whiplash to the person and continued inability to stand erect without severe pain despite physical therapy.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Muscle contractions involuntary, Muscular weakness, Neuromyopathy, Pain, Post-traumatic neck syndrome
Clinical narrative: Beginning 1 week after vaccination, person (me) has suffered a series of momentary neuromuscular failures in limbs during moments of activity: wk 1 left knee; wk 4 left shoulder; wk 5 right shoulder; and wk 10 right knee. Loss of muscle control resulted in sprained and torn tendons in the first three instances. The week 10 right knee was a collapse - a loss of all strength - resulting in a fall with whiplash to the person and continued inability to stand erect without severe pain despite physical therapy.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Tendon rupture
Clinical narrative: Beginning 1 week after vaccination, person (me) has suffered a series of momentary neuromuscular failures in limbs during moments of activity: wk 1 left knee; wk 4 left shoulder; wk 5 right shoulder; and wk 10 right knee. Loss of muscle control resulted in sprained and torn tendons in the first three instances. The week 10 right knee was a collapse - a loss of all strength - resulting in a fall with whiplash to the person and continued inability to stand erect without severe pain despite physical therapy.
Age: 25.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: Pain in right shoulder up to her scapula.
Age: 54.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Significant (L) shoulder-arm pain with decreased range of motion.
Age: 60.0
Sex: F
Vaccine: FLUC4, PPV, VARZOS
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Pt called and reported a raised welt at injection site.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Swelling
Clinical narrative: 12/21/2017 PNEUMOVAX given-pt went to ER twice over holiday W/E for pain and swelling. Tx'd with ATB and pain med.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Pain, Sleep disorder
Clinical narrative: Flu shot for seniors 11/7/17, started throbbing within 2 hrs., started physical therapy for L. arm wk. 12/11/17 on advice of primary doctor, waking up every time I change positions; can't raise left arm w/o using R hand to help raise it up first thing in the morning; having to carry purse in R hand, hurts when I use my L arm driving; constant throbbing; this is the 7th week of this pain. Was already in PT for surgery of my back 9/22/17. Have to pay copay every time I go to PT; have been dismissed from neurosurgeon for my back 12/19/17. Have complained with my L arm from time I got the vaccine to present, to physical therapist, went to primary doctor, went to orthopedic doctor thinking might be something to do with arthritis, NOPE. Have appt. for 1/8/18 to see orthopedic doctor to check and see if it could be shoulder. Did not do this before I had flu shot and I have not done anything to make my shoulder hurt.
Sex: U
Vaccine: FLU4
Symptoms: Anaphylactic reaction
Clinical narrative: Initial unsolicited report received from a non-health care professional (sales representative) on 12-Dec-2017. This case involves a patient (age and gender was not reported) who was vaccinated with 0.5 ml single dose of FLUZONE QUADRIVALENT (Batch number, expiry date, dose in series and site of administration were not reported) via intramuscular route on an unspecified date in the last few days. Patient's ongoing illness, medical history and concomitant medications were not reported. On an unknown date, after the vaccination, patient had an anaphylactic reaction. Laboratory investigations and corrective treatment were not reported. The outcome of the event was reported as unknown. Upon internal review case was considered as serious due to important medical event anaphylactic reaction. List of documents held by sender: none. Sender's Comments: Patient experienced anaphylactic reaction after vaccination. Exact time to onset is not known. More details regarding patient's medical history, previous vaccination history, history of similar episode, 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.
Age: 24.0
Sex: M
Vaccine: TDAP
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Initial unsolicited report received from a Nurse on 12-Dec-2017. This case involves a male patient (age was not reported) who was vaccinated with 0.5 ml single dose of ADACEL (Batch number: U5792AA, expiry date, dose in series and site of administration were not reported) via intramuscular route on 08-Dec-2017. Patient's ongoing illness, medical history and concomitant medications were not reported and it was reported that he did not receive any other vaccines. (Also reported as no known medication allergies). On an unknown date, one day after the vaccination, the patient woke up with a rash that was under arm at armpit area, also had the rash for 4 days as of today, 12-Dec-2017, and it had spread to abdomen, arms and legs. Patient also reported that there was a pinpoint, red, papular rash that was mildly itchy. Laboratory investigations were not reported. Patient received Zyrtec and Pepcid as a corrective treatment. The patient was not recovered from the event. List of documents held by sender: none.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Abdominal pain upper, Contusion, Crying, Decreased appetite, Gastrointestinal inflammation
Clinical narrative: The day following the vaccinations, patient began experiencing stomach pains, approximately 10-12 per day. Patient would cry and double over from the pain for approximately one to two minutes with each pain. She began eating and drinking very little. She was not experiencing fever or diarrhea. She was still having wet diapers and bowel movements. On the third day following immunizations, patient was taken to the doctor due to her lethargy, stomach pains and poor appetite. The doctor suspected a virus. She was taken back to the doctor on the seventh day following her immunizations, as she was showing no signs of improvement. The doctor ordered urinalysis, blood work, and an ultrasound. That same evening, patient's feet swelled and began bruising. She was unable to put weight on them because of the pain. We took her to the emergency room, where she was admitted. While in the hospital, patient had: IV fluids, antibiotics, x-rays of both feet, further blood work and urinalysis. Patient was admitted to the hospital, 12-11-2017 and was discharged 12-13-2017. The attending physician said that she was "70, 80, 90 percent certain" that patient had been suffering from Intussusception. No explanation was given for patient's swollen feet, or for the cause of the inflamed intestine.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Hypophagia, Influenza virus test negative, Intussusception, Lethargy, Pain in extremity
Clinical narrative: The day following the vaccinations, patient began experiencing stomach pains, approximately 10-12 per day. Patient would cry and double over from the pain for approximately one to two minutes with each pain. She began eating and drinking very little. She was not experiencing fever or diarrhea. She was still having wet diapers and bowel movements. On the third day following immunizations, patient was taken to the doctor due to her lethargy, stomach pains and poor appetite. The doctor suspected a virus. She was taken back to the doctor on the seventh day following her immunizations, as she was showing no signs of improvement. The doctor ordered urinalysis, blood work, and an ultrasound. That same evening, patient's feet swelled and began bruising. She was unable to put weight on them because of the pain. We took her to the emergency room, where she was admitted. While in the hospital, patient had: IV fluids, antibiotics, x-rays of both feet, further blood work and urinalysis. Patient was admitted to the hospital, 12-11-2017 and was discharged 12-13-2017. The attending physician said that she was "70, 80, 90 percent certain" that patient had been suffering from Intussusception. No explanation was given for patient's swollen feet, or for the cause of the inflamed intestine.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Peripheral swelling, Platelet count increased, Streptococcus test negative, Ultrasound abdomen abnormal, Urine analysis normal
Clinical narrative: The day following the vaccinations, patient began experiencing stomach pains, approximately 10-12 per day. Patient would cry and double over from the pain for approximately one to two minutes with each pain. She began eating and drinking very little. She was not experiencing fever or diarrhea. She was still having wet diapers and bowel movements. On the third day following immunizations, patient was taken to the doctor due to her lethargy, stomach pains and poor appetite. The doctor suspected a virus. She was taken back to the doctor on the seventh day following her immunizations, as she was showing no signs of improvement. The doctor ordered urinalysis, blood work, and an ultrasound. That same evening, patient's feet swelled and began bruising. She was unable to put weight on them because of the pain. We took her to the emergency room, where she was admitted. While in the hospital, patient had: IV fluids, antibiotics, x-rays of both feet, further blood work and urinalysis. Patient was admitted to the hospital, 12-11-2017 and was discharged 12-13-2017. The attending physician said that she was "70, 80, 90 percent certain" that patient had been suffering from Intussusception. No explanation was given for patient's swollen feet, or for the cause of the inflamed intestine.
Age: 2.0
Sex: F
Vaccine: DTAPIPVHIB, HEPA
Symptoms: Viral infection, Weight bearing difficulty, White blood cell count increased, X-ray limb normal
Clinical narrative: The day following the vaccinations, patient began experiencing stomach pains, approximately 10-12 per day. Patient would cry and double over from the pain for approximately one to two minutes with each pain. She began eating and drinking very little. She was not experiencing fever or diarrhea. She was still having wet diapers and bowel movements. On the third day following immunizations, patient was taken to the doctor due to her lethargy, stomach pains and poor appetite. The doctor suspected a virus. She was taken back to the doctor on the seventh day following her immunizations, as she was showing no signs of improvement. The doctor ordered urinalysis, blood work, and an ultrasound. That same evening, patient's feet swelled and began bruising. She was unable to put weight on them because of the pain. We took her to the emergency room, where she was admitted. While in the hospital, patient had: IV fluids, antibiotics, x-rays of both feet, further blood work and urinalysis. Patient was admitted to the hospital, 12-11-2017 and was discharged 12-13-2017. The attending physician said that she was "70, 80, 90 percent certain" that patient had been suffering from Intussusception. No explanation was given for patient's swollen feet, or for the cause of the inflamed intestine.
Age: 16.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Unknown EDC, pt had previous negative pregnancy test 9 days prior. Pt presented to clinic. Miscommunication occurred between clinic and lab. Patient received varicella vaccine then after leaving the clinic a positive pregnancy test was called to clinic staff. Patient also received: Gardasil, Hep B, Influenza, IPV, Meningococcal, MMR, TDaP on this day.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Eye pruritus, Pain, Swelling face
Clinical narrative: Swelling in left side of face (eyes, nose, left cheek area); itching of eye at beginning of reaction significant pain. Treatment: KEFLEX, acyclovir, ibuprofen, ice pack, fexofenadine. Outcome: after 3 days the symptoms went away - don't know if it was from the medications or just on their own.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Angiogram retina, Ophthalmological examination abnormal, Vision blurred, Visual field defect, Visual field tests abnormal
Clinical narrative: Started with visual disturbance in left eye 1 week after vaccine. Prism like effect in left visual field and blurriness. Seen by ER, then by my OD which referred me to neuro ophthalmology which ruled out neurological cause, then sent to Ophthalmology. IVP dye test reveals a dark spot in left eye which Dr. characterized as a virus in the left eye. Right eye not affected. No illnesses prior to vaccine or after with the only exception being the left eye. Still on this date of report still having the same visual disturbance that has not gotten any better.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Visual impairment
Clinical narrative: Started with visual disturbance in left eye 1 week after vaccine. Prism like effect in left visual field and blurriness. Seen by ER, then by my OD which referred me to neuro ophthalmology which ruled out neurological cause, then sent to Ophthalmology. IVP dye test reveals a dark spot in left eye which Dr. characterized as a virus in the left eye. Right eye not affected. No illnesses prior to vaccine or after with the only exception being the left eye. Still on this date of report still having the same visual disturbance that has not gotten any better.
Age: 0.92
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Mother stated patient developed hives along her collarbone. Mother stated "it was a line of hives along her collarbone and then one bigger hive." Mother stated child did not seemed bothered by the hives. Mother did give a dose of BENADRYL (dosage was given by her pediatrician). Mother stated in the morning the hives were gone.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Patient with right upper arm redness, starting night of vaccine administration day, patient seen on 12/22/17 with almost complete resolution of possible cellulitis without taking antibiotic prescribed.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain
Clinical narrative: Pain from the shoulder down.
Age: 22.0
Sex: F
Vaccine: FLUC4
Symptoms: Discomfort, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Pt complained of painful vaccination. Days later, discomfort persisted. Despite taking Aleve for pain/stiffness, discomfort persisted. A month and several days later, was still painful and stiff. Patient feels vaccination was a little too high in her deltoid.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Ear pain, Fatigue, Headache, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: Severe headache, ear pain both worse on the L side. Ringing in my ears, fatigue, low grade fever, sinusitis, tonsillitis on L side. My L ear pain has been awful, and ringing in ears. Both of these symptoms are worse when lying down. I've missed several days of work. I'm worried about my left ear pain, ringing in ears and left sided headache.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Sinusitis, Tinnitus, Tonsillitis
Clinical narrative: Severe headache, ear pain both worse on the L side. Ringing in my ears, fatigue, low grade fever, sinusitis, tonsillitis on L side. My L ear pain has been awful, and ringing in ears. Both of these symptoms are worse when lying down. I've missed several days of work. I'm worried about my left ear pain, ringing in ears and left sided headache.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse events have been reported. The patient was erroneously given this vaccine. He had a dose of this vaccine on 4/20/2017, so was not due to receive another dose.
Age: 64.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Blood glucose normal, Chest discomfort, Dizziness, Electrocardiogram
Clinical narrative: 12/08/17 at 4 pm: Approximately 5 minutes after receiving vaccine patient was sitting in chair, then complaint of feeling dizziness, nausea, stomach pain. She was assisted to lie flat on exam table. Patient became lethargic, hypotensive, and complained of chest tightness. EMS called and evaluated patient. Patient sent to emergency room with EMS.
Age: 64.0
Sex: F
Vaccine: HEP
Symptoms: Hypotension, Lethargy, Nausea
Clinical narrative: 12/08/17 at 4 pm: Approximately 5 minutes after receiving vaccine patient was sitting in chair, then complaint of feeling dizziness, nausea, stomach pain. She was assisted to lie flat on exam table. Patient became lethargic, hypotensive, and complained of chest tightness. EMS called and evaluated patient. Patient sent to emergency room with EMS.
Age: 43.0
Sex: F
Vaccine: FLUR4
Symptoms: Antinuclear antibody negative, Blood creatinine increased, Blood urea increased, Glomerular filtration rate decreased, HIV test negative
Clinical narrative: Chronic condition at this time.
Age: 43.0
Sex: F
Vaccine: FLUR4
Symptoms: Hepatitis viral test negative, IgA nephropathy, Renal impairment, Tubulointerstitial nephritis
Clinical narrative: Chronic condition at this time.
Age: 27.0
Sex: F
Vaccine: FLU4, HEP, TDAP, VARCEL
Symptoms: Dizziness
Clinical narrative: After receiving the IMZs the patient got to the bench and was lightheaded and dizzy. She had to lay down and we called 911. EMS checked her over and she had some water and felt better after resting for about 10 minutes.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Nausea, Pallor, Vomiting
Clinical narrative: Approximately 3 minutes after vaccine administered patient reported dizziness, lightheadedness, nausea. Vomited x1, felt better x 2 minutes then reported she felt dizzy and lightheaded again. Vomited x 2. Patient appeared pale. O2 99%, HR 71, BP 85/30. Alert and oriented. Speaking clearly. 911 called, taken to hospital by EMS.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Blood test normal, Body temperature, Chest X-ray, Cold sweat
Clinical narrative: Severe  deep pain around injection area shooting up neck and down right side. Sweaty, clammy, excruciating pain reaching out and up my neck caused nausea and no sleep. This pain continued but radiated throughout my body over the course of the next 2 months. I felt like I had aged from 65 to 85 over night. I took ibuprofen. My joints  ie, hands, shoulders and hips plus feet were achy. This continued. My immune system compromised. I had 3 bouts of sleep coughs and general tending to get a cold, but not. Finally a cold sore, temperature, went to Primary doctor. Next went to Urgent Care. Now on  methylphenidate. My body is not so achy, but back to normal. I have cold like symptoms now.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Cough, Hyperhidrosis, Immunodeficiency, Injection site pain, Insomnia
Clinical narrative: Severe  deep pain around injection area shooting up neck and down right side. Sweaty, clammy, excruciating pain reaching out and up my neck caused nausea and no sleep. This pain continued but radiated throughout my body over the course of the next 2 months. I felt like I had aged from 65 to 85 over night. I took ibuprofen. My joints  ie, hands, shoulders and hips plus feet were achy. This continued. My immune system compromised. I had 3 bouts of sleep coughs and general tending to get a cold, but not. Finally a cold sore, temperature, went to Primary doctor. Next went to Urgent Care. Now on  methylphenidate. My body is not so achy, but back to normal. I have cold like symptoms now.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Nasopharyngitis, Nausea, Neck pain, Oral herpes, Pain
Clinical narrative: Severe  deep pain around injection area shooting up neck and down right side. Sweaty, clammy, excruciating pain reaching out and up my neck caused nausea and no sleep. This pain continued but radiated throughout my body over the course of the next 2 months. I felt like I had aged from 65 to 85 over night. I took ibuprofen. My joints  ie, hands, shoulders and hips plus feet were achy. This continued. My immune system compromised. I had 3 bouts of sleep coughs and general tending to get a cold, but not. Finally a cold sore, temperature, went to Primary doctor. Next went to Urgent Care. Now on  methylphenidate. My body is not so achy, but back to normal. I have cold like symptoms now.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: The site of administration hurts and has a knot 2 months after the shot was given.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Joint stiffness
Clinical narrative: Pt came into the clinic with swelling, redness, and skin tightness to the left shoulder. Pt also stated that he the area of the vaccine felt itchy. Patient was given medications by the Provider and told to follow back up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient stated  she had a reaction to the SHINGRIX vaccine in which she experienced fever, headache, nausea and chills. She had an injection site reaction and her upper arm became red and hot to the touch. Patient stated it was just a little bit itchy. Her symptoms lasted around 48 hours. She has never had a reaction to a vaccine in the past. She noted that these were all reactions listed that may happen but wanted to report the reaction she experienced because it was out of the ordinary for her since she has never had any reaction to other vaccines in the past.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Patient stated  she had a reaction to the SHINGRIX vaccine in which she experienced fever, headache, nausea and chills. She had an injection site reaction and her upper arm became red and hot to the touch. Patient stated it was just a little bit itchy. Her symptoms lasted around 48 hours. She has never had a reaction to a vaccine in the past. She noted that these were all reactions listed that may happen but wanted to report the reaction she experienced because it was out of the ordinary for her since she has never had any reaction to other vaccines in the past.