chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: TYP
Symptoms: Vomiting
Clinical narrative: After first dose, slight abdominal cramps, and nausea. After second dose, severe nausea, slight vomiting, bad abdominal pain, diarrhea, headache, eyes feel different.
Age: 1.0
Sex: M
Vaccine: FLU4, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash pruritic
Clinical narrative: Mother presented in clinic on 2/5/18 c/o itchy bumps on pt's legs, arm, and back since 1/29/18. Mother applied Vaseline with no relief. Pt's mother reported subjective fever when bumps first appeared, pt was afebrile in clinic today. Treatment:  Benadryl.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: Patient complained that vaccine hurt when injected. She returned two days later saying her arm was extremely sore on the under side of her arm to the point she couldn't even raise it. She also had a large bruise around the injection site and it was in a strange pattern that was only bruised around the bandage (left the bandage shape out of the bruise). I called her back today and she has improved.
Sex: F
Vaccine: FLU4
Symptoms: Blood sodium decreased, Cough, Sneezing
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sodium decreased in a adult female patient who received Influenza vaccine Quadrivalent. The patient's past medical history included stroke (2 months after the double bypass) and spinal operation (in 2005 or 2006). Previously administered products included flu shot (see case: US2018GSK019042). Concurrent medical conditions included clot blood (The patient was taking medication to avoid blood clotting), esophageal acid reflux and congestive heart failure (since 2010, they tried a cauterization and it did not work so they did a double bypass). Concomitant products included carvedilol, clopidogrel bisulphate, Losartan, Digoxine, Magnesium, omeprazole, pravastatin sodium and PROAIR HFA. On an unknown date, the patient received Influenza vaccine Quadrivalent. In October 2017, several days after receiving Influenza vaccine Quadrivalent, the patient experienced sodium decreased (serious criteria hospitalization). In December 2017, the patient experienced sneezing. On an unknown date, the patient experienced cough. On an unknown date, the outcome of the sodium decreased, cough and sneezing were recovered/resolved. It was unknown if the reporter considered the sodium decreased, cough and sneezing to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. The patient's concomitant medication included multi vitamin. The patient had a flu shot a couple of days before her sodium dropped. The patient was hospitalized because of her sodium dropped. The patient experienced sneezing and coughing after the flu shot but she did not remember the flu shot name or manufacturer. This case has been linked to the US2018GSK019042, reported by the same reporter.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Patient called 1/14/18 to inform that she developed Guillain-Barre Syndrome soon after receiving flu shot on 10/9/17. She is currently still hospitalized.
Age: 11.0
Sex: M
Vaccine: HPVX
Symptoms: Asthma, Gait disturbance, Pertussis, Respiratory syncytial virus infection, Speech disorder
Clinical narrative: After patient's second set of toddler shots he began to have staring spells, he lost words and had problems walking his head also swoll up. He developed.
Age: 11.0
Sex: M
Vaccine: HPVX
Symptoms: Staring, Swelling
Clinical narrative: After patient's second set of toddler shots he began to have staring spells, he lost words and had problems walking his head also swoll up. He developed.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 18-JAN-2018, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX 19400 PFU, lot # M041086, expiration date 03-JAN-2018 (dose and route were not reported) for prophylaxis. No adverse events were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Conjunctivochalasis, Herpes zoster, Ophthalmic herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received on 01-FEB-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 20-SEP-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster with complications in the eye. On or about 20-JUN-2016, the patient was treated by a physician for the onset of an eye disorder, which was diagnosed as conjunctivochasis, which is often attributable to zoster infections in the eye. On or about 22-JUN-2016, the patient sought subsequent treatment from the same physician for ongoing and worsening symptoms of vesicular outbreaks, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed gentamycin ophthalmic solution and VALTREX for management of her persistent and painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Upon internal review, zoster infections in the eye/herpes zoster with complications in the eye was considered to be medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash vesicular
Clinical narrative: Information has been received on 01-FEB-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 21-JAN-2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 03-MAR-2016, shortly after being vaccinated, the patient was treated at a physician's office for the onset of a blistering vesicular outbreak, which was diagnosed as severe herpes zoster, or shingles. The patient has experienced persistent and uncontrolled shingles eruptions since being diagnosed, suffering from his infections for nearly one-year in duration. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Wrong drug administered
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. Concomitant therapies included sterile diluent (MERCK). On 01-FEB-2018, the patient was vaccinated with a dose of PROQUAD lot # M039447 with expiration date: 20-MAR-2018, via subcutaneous, as prophylaxis (Strength and dose were not reported) instead of the M-M-R II that was prescribed the reason provided was human error.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt. dev. "softball" sized pink/red, warm slightly tender, localized swelling of (L) lateral thigh. Temp elevation to 100 for approximately 2 days.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Syncope
Clinical narrative: Patient fainted immediately after the HPV and influenza vaccines. Patient was given juice and crackers with peanut butter and sat in the office for 20 minutes. After the patient no longer was dizzy he left the office in good condition.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Blood test, Breast pain, Burning sensation, Chills
Clinical narrative: Doctor prescribe PERCOCET - for flu - had chills/weakness/burning sensation. Went to hospital on 10/3/17 diagnosed w/pneumonia. Flu lated about 2-3 weeks. Christmas Even patient has dots underskin, noted breast area, itchy, burning, stabbing pain. On 12/20/17 Patient hospital - diagnosed w/shingles.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Haemorrhage subcutaneous, Herpes zoster, Influenza, Pneumonia, Pruritus
Clinical narrative: Doctor prescribe PERCOCET - for flu - had chills/weakness/burning sensation. Went to hospital on 10/3/17 diagnosed w/pneumonia. Flu lated about 2-3 weeks. Christmas Even patient has dots underskin, noted breast area, itchy, burning, stabbing pain. On 12/20/17 Patient hospital - diagnosed w/shingles.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chills, Diarrhoea, Hyperhidrosis, Nausea, Peripheral swelling
Clinical narrative: See attached. Chills, itching, nausea, sweats, diarrhea, bil. UE swelling.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pruritus
Clinical narrative: See attached. Chills, itching, nausea, sweats, diarrhea, bil. UE swelling.
Age: 69.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Gait disturbance, Joint stiffness
Clinical narrative: Extreme hip and knee, joints pain and stiffness. Pain 9 out of 10 difficulty walking. Could climb stairs one at a time pulling myself up. Left foot first one step at a time.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Arm was painful for day of and 2 days after injection-on Wednesday (3 days after arm went completely numb. Advised pt to f/u w/MD.
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Chest X-ray abnormal, Drug administered at inappropriate site, Laboratory test, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: January 24, 2018, Summary from Patient: 9/26/2017 flu vaccine left upper arm. Most painful vaccine that I have ever received. Pain continued 2 weeks until it got so severe I needed to see my PCP. 10/16/17. First visit with PCP. Lab work completed to help determine the problem. 10/18/17 follow up with PCP determined that I had valley fever. I had a chest X-ray, was referred to a pulmonologist and started on antifungals. 10/23/17. Pulmonologist did not believe I had valley fever. Repeated labs. Concerned about shoulder pain and recommended MRI. Later that week went to ER and they did Ultrasound to rule out DVT of my Left upper extremity. 10/30/17. Saw PCP she repeated labs and wrote a referral for MRI. 11/3/2017-MRI of left shoulder complete. 11/9/2017-Received results and had more labs ordered due to the fluid noted in the MRI referred to ortho. 11/17/17 referred to hematologist by pulmonologist. 11/17/17 saw ortho determined That the flu vaccine was given into my subscapularis joint. Recommend steroid injection but on hold until I completed hematologist appt. 12/8/17-hemagologist appt complete. 2/2018 scheduled follow-up for left shoulder with ortho for possible steroid injection. Note: The flu shot was actually given on 9/25/17 per consent form.
Age: 42.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain, Ultrasound scan normal
Clinical narrative: January 24, 2018, Summary from Patient: 9/26/2017 flu vaccine left upper arm. Most painful vaccine that I have ever received. Pain continued 2 weeks until it got so severe I needed to see my PCP. 10/16/17. First visit with PCP. Lab work completed to help determine the problem. 10/18/17 follow up with PCP determined that I had valley fever. I had a chest X-ray, was referred to a pulmonologist and started on antifungals. 10/23/17. Pulmonologist did not believe I had valley fever. Repeated labs. Concerned about shoulder pain and recommended MRI. Later that week went to ER and they did Ultrasound to rule out DVT of my Left upper extremity. 10/30/17. Saw PCP she repeated labs and wrote a referral for MRI. 11/3/2017-MRI of left shoulder complete. 11/9/2017-Received results and had more labs ordered due to the fluid noted in the MRI referred to ortho. 11/17/17 referred to hematologist by pulmonologist. 11/17/17 saw ortho determined That the flu vaccine was given into my subscapularis joint. Recommend steroid injection but on hold until I completed hematologist appt. 12/8/17-hemagologist appt complete. 2/2018 scheduled follow-up for left shoulder with ortho for possible steroid injection. Note: The flu shot was actually given on 9/25/17 per consent form.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Patient developed hives between his (R) thumb and index finger. Took 50mg of Benadryl and Sx resolved.
Sex: M
Vaccine: UNK
Symptoms: Aphasia, Language disorder, Speech disorder
Clinical narrative: My son second set of shots cause him to have a severe reaction that lead, to a lost of words, lost of cooing sound, a language impairment and since 6 months old difficulties with speech.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest X-ray, Chest discomfort, Dyspnoea, Electrocardiogram, Eye pruritus
Clinical narrative: SOB, globus feeling, gradual tightness in chest. Itchy eyes. Denied itching or wheezing.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Full blood count, Metabolic function test, Sensation of foreign body, Troponin
Clinical narrative: SOB, globus feeling, gradual tightness in chest. Itchy eyes. Denied itching or wheezing.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Patient called and reported reaction on 2/5/18. Patient reported swelling to the size of a silver dollar and itching at the injection site. Patient did not notice the reaction until she started experiencing itching on 2/4/18. Patient took a Zyrtec D this morning as she normally does but was advised to take liquid benadryl to counteract the reaction. Patient has contacted the Dr to report the reaction since he recommended that she receive the vaccination. I also called to report the incident to the Dr but had to leave a message for nurse to return call.
Age: 69.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Back pain, Contusion, Erythema, Immediate post-injection reaction, Injected limb mobility decreased
Clinical narrative: The patient explained that as soon as it was injected it hurt. It was bad enough pain that it limited range of motion in his right arm and the pain radiated back through his right side of his upper back to his spine. Redness developed 2 days post vaccination that spread down and around his arm that was warm to the touch. He had a bruise develop the day of and still had one today after reporting this to me. It appears that a vessel was nicked when he was vaccinated.
Age: 69.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site pain, Skin warm, Vascular injury
Clinical narrative: The patient explained that as soon as it was injected it hurt. It was bad enough pain that it limited range of motion in his right arm and the pain radiated back through his right side of his upper back to his spine. Redness developed 2 days post vaccination that spread down and around his arm that was warm to the touch. He had a bruise develop the day of and still had one today after reporting this to me. It appears that a vessel was nicked when he was vaccinated.
Age: 69.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pain in extremity, Swelling
Clinical narrative: The patient explained that as soon as it was injected it hurt. It was bad enough pain that it limited range of motion in his right arm and the pain radiated back through his right side of his upper back to his spine. Redness developed 2 days post vaccination that spread down and around his arm that was warm to the touch. He had a bruise develop the day of and still had one today after reporting this to me. It appears that a vessel was nicked when he was vaccinated.
Age: 7.0
Sex: M
Vaccine: UNK
Symptoms: Culture throat, Rash, Swelling, Throat irritation
Clinical narrative: At school my son had a powder chemical substance, that I do believe to be a powdered vaccine of some kind put in his face. He broke out in a rash that cause his throat to burn, his entire upper body broke out. His head swell up on the left side.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site rash
Clinical narrative: The patient received the vaccine on 1/30/2018. She now has a rash about 2 inches x 21/2 inches around the injection site. The rash is tender to the touch. She will seek medical attention if it worsens.
Age: 72.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Two weeks after the flu shot pt was still experiencing a sore arm and pain in the joint.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Syncope
Clinical narrative: Patient experienced dizziness and fainting that resolved immediately without treatment.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort
Clinical narrative: "Chest tightness" starting 2 days after vaccine administration (1-22-18) and continuing until 1-26-18. Advised patient to consult Doctor.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 30-JAN-2018, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N017698, expiration date 09-JUN-2019 (dose and route were not reported) for prophylaxis. Concomitant therapies included Merck sterile diluent. No adverse effects. The temperature involved was 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 hour and 10 minutes. A previous temperature excursion was reported as 6 degrees Fahrenheit to 14 degrees Fahrenheit for 30 hours and 50 minutes. A data logger was involved.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable consumer received via a sales representative.  A 12-month-old patient of an unspecified 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 and concomitant medications were not reported. The patient experienced pain at the injection site that is more painful compared to other vaccines (non-serious) on an unspecified date with outcome of not recovered. The information on the batch number has been requested.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Aphasia, Asthenia, Back pain, Chest X-ray normal, Chest discomfort
Clinical narrative: All symptoms started on 2/1/2018 around 2:40pm. It started with extreme weakness & fatigue.  Couldn't keep eyes open. Difficulty moving limbs. Visible muscle tremors throughout my arms and legs when I tried to move. Could not walk without help. Once I started feeling a tight chest, felt like I could not breath, I called 911. Severe body aches. Back and neck hurt. Loss of mental clarity. Difficulty finding the right words to use, would forget what I was talking about mid sentence, trouble understanding questions that were being asked. Nausea. Dizzy. Was taken to the ER via Ambulance. Muscle tremors did not stop until Sunday, 2/4/2018. Still dealing with fatigue and feeling weak as of 2/5/2018.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Dyspnoea, Electrocardiogram normal, Fatigue, Full blood count normal
Clinical narrative: All symptoms started on 2/1/2018 around 2:40pm. It started with extreme weakness & fatigue.  Couldn't keep eyes open. Difficulty moving limbs. Visible muscle tremors throughout my arms and legs when I tried to move. Could not walk without help. Once I started feeling a tight chest, felt like I could not breath, I called 911. Severe body aches. Back and neck hurt. Loss of mental clarity. Difficulty finding the right words to use, would forget what I was talking about mid sentence, trouble understanding questions that were being asked. Nausea. Dizzy. Was taken to the ER via Ambulance. Muscle tremors did not stop until Sunday, 2/4/2018. Still dealing with fatigue and feeling weak as of 2/5/2018.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Mental impairment, Mobility decreased, Nausea, Neck pain, Pain
Clinical narrative: All symptoms started on 2/1/2018 around 2:40pm. It started with extreme weakness & fatigue.  Couldn't keep eyes open. Difficulty moving limbs. Visible muscle tremors throughout my arms and legs when I tried to move. Could not walk without help. Once I started feeling a tight chest, felt like I could not breath, I called 911. Severe body aches. Back and neck hurt. Loss of mental clarity. Difficulty finding the right words to use, would forget what I was talking about mid sentence, trouble understanding questions that were being asked. Nausea. Dizzy. Was taken to the ER via Ambulance. Muscle tremors did not stop until Sunday, 2/4/2018. Still dealing with fatigue and feeling weak as of 2/5/2018.
Age: 45.0
Sex: F
Vaccine: FLUC4
Symptoms: Tremor, Urine analysis normal, Walking aid user
Clinical narrative: All symptoms started on 2/1/2018 around 2:40pm. It started with extreme weakness & fatigue.  Couldn't keep eyes open. Difficulty moving limbs. Visible muscle tremors throughout my arms and legs when I tried to move. Could not walk without help. Once I started feeling a tight chest, felt like I could not breath, I called 911. Severe body aches. Back and neck hurt. Loss of mental clarity. Difficulty finding the right words to use, would forget what I was talking about mid sentence, trouble understanding questions that were being asked. Nausea. Dizzy. Was taken to the ER via Ambulance. Muscle tremors did not stop until Sunday, 2/4/2018. Still dealing with fatigue and feeling weak as of 2/5/2018.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swollen arm around injection site, hot to the touch, red, burning.
Age: 3.0
Sex: F
Vaccine: PPV
Symptoms: Ear infection, Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Per mom, child developed fever (103.6 deg F), injection site redness, swelling, tender to touch. She phoned PCP 1-24-18 afternoon who advised to give TYLENOL or MOTRIN PO. 1-26-18 mom took child to a quick care clinic; child was found to have an ear infection and was prescribed OMNICEF by mouth. The site of injection reddened, warm, sore to touch, appeared to have cellulitis approx. 3" wide x 4.5" long area. Mom advised to give antibiotic, which would help both ear infection and cellulitis, moist compresses, TYLENOL and MOTRIN alternating for pain/fever/ or discomfort. If condition worsened or red streak developed, to notify office. When I spoke to mom Monday 1-28-18, she stated child was running around and much improved. Site improved, not growing in size.
Age: 3.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Per mom, child developed fever (103.6 deg F), injection site redness, swelling, tender to touch. She phoned PCP 1-24-18 afternoon who advised to give TYLENOL or MOTRIN PO. 1-26-18 mom took child to a quick care clinic; child was found to have an ear infection and was prescribed OMNICEF by mouth. The site of injection reddened, warm, sore to touch, appeared to have cellulitis approx. 3" wide x 4.5" long area. Mom advised to give antibiotic, which would help both ear infection and cellulitis, moist compresses, TYLENOL and MOTRIN alternating for pain/fever/ or discomfort. If condition worsened or red streak developed, to notify office. When I spoke to mom Monday 1-28-18, she stated child was running around and much improved. Site improved, not growing in size.
Sex: M
Vaccine: PNC13, RVX, TDAP
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a non-contactable consumer received via a Pfizer sales representative. A male patient of an unspecified age and ethnicity received PREVNAR 13, (batch/lot number and expiry date unknown) at a single dose, rotavirus vaccine at an unspecified dose, and  TDAP at an unspecified dose; all vaccines administered on 29Jan2018 for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced fever on an unspecified date. The outcome of the event was unknown. Event took place after use of product. No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Chills, Nausea
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age and ethnicity received the first dose of TRUMENBA (batch/lot and expiry date were not reported), via an unspecified route of administration on 02Aug2017 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient showed severe reaction to the shot that included severe Joint pain (9.5 out of 10), chills and nausea for several days after the shot. The outcome of the events was unknown. The patient was due for the second shot on 01Feb2018. The reported would like to know if the patient should get the shot and what was the likelihood of the patient showing the symptoms.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Laboratory test, Swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A female patient of unknown age and race/ethnicity received PREVNAR 13 (lot T35176, exp. date 31Jan2020, NDC number 0005197105) for immunization on 25Jan2018 at single dose. Relevant medical history included pain, unknown if ongoing. Concomitant medication included tramadol for pain. On 26Jan2018 the patient experienced swelling and redness at the area. The outcome of the events was not recovered. The patient received just the ice packs for the events. An unknown lab works were performed.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain
Clinical narrative: Patient received influenza vaccination while at the hospital for a gynecological surgical procedure. Had no complaints of pain at injection site or other related pain at time of injection. One week post op patient required no pain medications either narcotics or ibuprofen. 2 weeks post operatively patient begins complaining of shoulder pain. This pain has not been relieved by traditional methods and physician referred patient to a specialist as it may have nerve involvement. Patient is convinced it is related to the influenza vaccine she received and wishes for a form to be completed.
Sex: U
Vaccine: TDAP
Symptoms: Hypersensitivity, Throat tightness
Clinical narrative: Pt developed allergic rxn (tightening of throat) d/t Tdap.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Urticaria
Clinical narrative: Patient experienced flushing and hives for 90 minutes beginning 1 hour post-immunization.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site rash
Clinical narrative: Patient had a very fine rash appear between injection site and elbow (right arm). No itching, inflammation or warmth reported.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Asthenia, Blindness, Computerised tomogram, Disorientation, Headache
Clinical narrative: My son has had NUMEROUS severe migraines that include, loss of vision, hands, feet, tongue go numb and the pain in his head is instant with losing his sight. On a scale of 1-10 with 10 being the worst he is usually an 8 or 9. He also gets very disoriented. The migraines usually last at least 4 hours. They started being 3 days apart then went to two days and quickly went to one every day for a week. We have tried numerous medications along with a CAT scan and MRI and to date have nothing that has helped and found no reason while out of the blue my healthy son is basically helpless. He cannot drive, he cannot go to high school, he cannot wrestle, this has taken over his life. He has also gone to the emergency room 3 times in less than a month where I have to pay $100 each time, plus other fees.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Impaired driving ability, Loss of personal independence in daily activities, Migraine
Clinical narrative: My son has had NUMEROUS severe migraines that include, loss of vision, hands, feet, tongue go numb and the pain in his head is instant with losing his sight. On a scale of 1-10 with 10 being the worst he is usually an 8 or 9. He also gets very disoriented. The migraines usually last at least 4 hours. They started being 3 days apart then went to two days and quickly went to one every day for a week. We have tried numerous medications along with a CAT scan and MRI and to date have nothing that has helped and found no reason while out of the blue my healthy son is basically helpless. He cannot drive, he cannot go to high school, he cannot wrestle, this has taken over his life. He has also gone to the emergency room 3 times in less than a month where I have to pay $100 each time, plus other fees.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: My son has had NUMEROUS severe migraines that include, loss of vision, hands, feet, tongue go numb and the pain in his head is instant with losing his sight. On a scale of 1-10 with 10 being the worst he is usually an 8 or 9. He also gets very disoriented. The migraines usually last at least 4 hours. They started being 3 days apart then went to two days and quickly went to one every day for a week. We have tried numerous medications along with a CAT scan and MRI and to date have nothing that has helped and found no reason while out of the blue my healthy son is basically helpless. He cannot drive, he cannot go to high school, he cannot wrestle, this has taken over his life. He has also gone to the emergency room 3 times in less than a month where I have to pay $100 each time, plus other fees.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Patient complained of lingering pain at injection site today 2/5/18.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Pain in extremity, Paraesthesia
Clinical narrative: Pain, bruising, tingling down the arm.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Hypoaesthesia, Incorrect route of drug administration, Pain, Swelling
Clinical narrative: Gave vaccine subq instead of im in left arm 2/3/18. On 2/5/18 patient presented with welt, redness, swelling, pain and numbness.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Gave vaccine subq instead of im in left arm 2/3/18. On 2/5/18 patient presented with welt, redness, swelling, pain and numbness.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Eye irritation, Hypoaesthesia, Hypoaesthesia oral, Muscle twitching
Clinical narrative: Employee states his right eye became irritated - twitching and around nose. Initially thought it was his contact lenses and a new cleaner he started using. His face became numb from his forehead, cheek and mouth, upper teeth. He sought medical attention at local emergency department Hospital. Then went to his family physician. Vaccine was given at work Medical Department. Substitute nurse gave injection. Department under renovations. Unable to locate Vaccine consent form that has date and location vaccine was given. Will send information when record located.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Blood electrolytes, Blood lactic acid, EGFR status assay, Electrocardiogram, Full blood count
Clinical narrative: Pt. was seen by an urgent care and given Keflex. Pt. failed to improve on Keflex and was sent to the  Emergency Department. ED started IV cefazolin, then switched to IV vancomycin . Pt. was discharged on sulfamethoxazole-trimethoprim 800-160 BID
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Metabolic function test, Unevaluable event
Clinical narrative: Pt. was seen by an urgent care and given Keflex. Pt. failed to improve on Keflex and was sent to the  Emergency Department. ED started IV cefazolin, then switched to IV vancomycin . Pt. was discharged on sulfamethoxazole-trimethoprim 800-160 BID
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Asthenia, Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Pain and swelling at injection site. Pt couldn't lift arm over 90'. Very painful and weak for 3 days.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Dermatitis contact, Erythema, Rash generalised, Rash pruritic, Urticaria
Clinical narrative: Patient called pharmacy on 2/5/18 to discuss the following adverse event: Patient broke out in widespread rash on arms, legs and back/all over body on 2/3/18 at approximately 12:00AM. Patient said rash itched and appeared as red hives and she went to ER. Patient was prescribed diphenhydramine, hydrocortisone cream and prednisone tablets. Patient started this therapy and rash/hives improved some on arms but as of 2/5/18 has not improved completely on legs. Patient states rash seems to clear up but come back on legs. At the ER patient was told it was contact dermatitis but is still concerned it was event related to vaccine. Patient could not think of any other recent changes in lifestyle that could be attributed to reaction.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Fatigue, Feeling cold, Feeling hot, Headache
Clinical narrative: Terrible headache, minor fever, chills, tiredness, hot and sweaty and freezing at the same time.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Hyperhidrosis, Pyrexia
Clinical narrative: Terrible headache, minor fever, chills, tiredness, hot and sweaty and freezing at the same time.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Pain
Clinical narrative: Pain and swelling at the injection site began a couple of hours after injection, first few days so painful couldn't lift arm above 90', hurts to lay on that side or if lifts arm above head. Slowly resolving.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Decreased appetite, Erythema, Fatigue, Headache
Clinical narrative: Received vaccine about noon on 2/1/18. Onset of chills, shaking/rigors (could barely walk to BR), spiked temp at about 36 hours (12:30a, 2/3/18), diuresed 5.5# (2.5 kg) overnight, prostrate, headache, stiff neck and shoulders. Local reaction 3.5" x 2", indurated, red, very sore, "ropey." Temps: 100F @ 1a, 100.5F @ 1:45a, 101F @ 3a, 99.9F @ 3:30p, 98.2F @ 8p. Tried to stay hydrated, drank lots of water through the night. This was not the flu -- no respiratory symptoms, no sore throat, congestion or cough. Symptoms  subsided by evening, appetite returned, though "sticky" from fever and diuresis. Did not require treatment beyond rest, acetaminophen and hydration. History of previous PNEUMOVAX 23 received 11/24/1986.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Local reaction, Musculoskeletal stiffness, Pain, Polyuria
Clinical narrative: Received vaccine about noon on 2/1/18. Onset of chills, shaking/rigors (could barely walk to BR), spiked temp at about 36 hours (12:30a, 2/3/18), diuresed 5.5# (2.5 kg) overnight, prostrate, headache, stiff neck and shoulders. Local reaction 3.5" x 2", indurated, red, very sore, "ropey." Temps: 100F @ 1a, 100.5F @ 1:45a, 101F @ 3a, 99.9F @ 3:30p, 98.2F @ 8p. Tried to stay hydrated, drank lots of water through the night. This was not the flu -- no respiratory symptoms, no sore throat, congestion or cough. Symptoms  subsided by evening, appetite returned, though "sticky" from fever and diuresis. Did not require treatment beyond rest, acetaminophen and hydration. History of previous PNEUMOVAX 23 received 11/24/1986.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Tremor
Clinical narrative: Received vaccine about noon on 2/1/18. Onset of chills, shaking/rigors (could barely walk to BR), spiked temp at about 36 hours (12:30a, 2/3/18), diuresed 5.5# (2.5 kg) overnight, prostrate, headache, stiff neck and shoulders. Local reaction 3.5" x 2", indurated, red, very sore, "ropey." Temps: 100F @ 1a, 100.5F @ 1:45a, 101F @ 3a, 99.9F @ 3:30p, 98.2F @ 8p. Tried to stay hydrated, drank lots of water through the night. This was not the flu -- no respiratory symptoms, no sore throat, congestion or cough. Symptoms  subsided by evening, appetite returned, though "sticky" from fever and diuresis. Did not require treatment beyond rest, acetaminophen and hydration. History of previous PNEUMOVAX 23 received 11/24/1986.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Nausea
Clinical narrative: Injection site slight erythema, mild nausea, headache.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Injection site pruritus, Skin warm
Clinical narrative: On 2/2/18 father came because son was complaining of itchiness on left deltoid where vaccine was given. When exam patient arm notice skin red, warm to touch. Measurements W 4.5 cm and L 5 cm.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Flu shot administered by local Pharmacy. Child coming into clinic the next day with symptoms of soreness, redness and swelling of left deltoid.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Oropharyngeal pain, Rash, Respiratory tract congestion, Urticaria
Clinical narrative: Patient described that on the day of the vaccine, she developed a rash on the arm she got the vaccine and also hives on her chest. On 2/3/18, she described that the rashes have improved but she then had sore throat, congestion, and muscle aches.
Age: 55.0
Sex: F
Vaccine: TTOX
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Pain
Clinical narrative: I have been experiencing pain and loss of mobility because of pain. It has become worse as weeks have passed. I went to the doctor and was put on prednisone for seven days and meloxicam. The steroid did not help. I am not able to use my right arm to perform most daily tasks, such as scrubbing, carrying anything very heavy, reaching up or reaching around. I believe this is a brachial plexus injury. I am trying to get into my PCP for further treatment/referral to a neurologist.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Pain, Rash, Skin warm, Swelling
Clinical narrative: Patient awoke the following morning after the vaccine with swelling, soreness, and a warm rash. Patient stated that following day his symptoms started to improve and are improving.
Age: 33.0
Sex: M
Vaccine: VARCEL
Symptoms: Headache, Musculoskeletal stiffness, Pyrexia, Rash, Varicella post vaccine
Clinical narrative: 18 days after vaccine patient developed vaccine induced chicken pox including rash, fever, headaaches and neckstiffness. No clinically improving.
Age: 22.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Student present to Urgent care with a c/o pain, swelling redness to Pneumococcal site on left Deltoid along with an elevated temperature of 102.6. Student Treated by Doctor on duty, Given TYLENOL 1000mg @ 3:30 PM and Ibuprofen 200 MG at 4:PM. Student was advised to continue taking TYLENOL 325 mg  tabs  2  every 4 hours as needed and Ibuprofen 600mg every 6 hours as needed for pain Ice pack to injection site. Student instructed to return to student health service if any new or worsen symptoms in one day. Flu vaccine given Left upper deltoid Pneumococcal vaccine given Left lower deltoid.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test normal, Bone scan normal, Loss of personal independence in daily activities, Mobility decreased, Myalgia
Clinical narrative: Approximately around the end of September 2017, she realized that she could not pick things up off the floor or extend her arms, or reach behind to scratch her back. It keeps getting progressively worse. Cannot comb her hair or kneel down on the floor. Cannot turn ceiling fan lights off or put covers over herself. Cant shake hands. Core muscle like her shoulders and upper arms and neck as well as girdle area are painful. Extremely painful. "I Cannot move". Abosultely the worst in the morning and she cannot get out of bed. She needs to swing herself out of bed and get herself up with her elbows. As the day goes by, it gets better, but by the end of the night her muscles feel so bad again. "Its the worst thing that has ever happened to me."
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Urine analysis normal
Clinical narrative: Approximately around the end of September 2017, she realized that she could not pick things up off the floor or extend her arms, or reach behind to scratch her back. It keeps getting progressively worse. Cannot comb her hair or kneel down on the floor. Cannot turn ceiling fan lights off or put covers over herself. Cant shake hands. Core muscle like her shoulders and upper arms and neck as well as girdle area are painful. Extremely painful. "I Cannot move". Abosultely the worst in the morning and she cannot get out of bed. She needs to swing herself out of bed and get herself up with her elbows. As the day goes by, it gets better, but by the end of the night her muscles feel so bad again. "Its the worst thing that has ever happened to me."
Age: 23.0
Sex: M
Vaccine: MENB
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient presented to the pharmacy on 2/2/18 with raised erythema at the injection site. It had first appeared the previous day & had grown in size to approximately 3.5in in diameter. The patient reported injection site pain on 1/30 (vaccination given) and 1/31, but denied any pain on 2/2. The patient had marked the margins of the erythema the previous night with a marker, the affected region had grown by ~1 inch in diameter since then. I recommended the patient see a provider at student health, as I suspected it was cellulitis.
Age: 59.0
Sex: M
Vaccine: FLUC4
Symptoms: Chest pain, Cough, Decreased appetite, Diarrhoea, Hallucination
Clinical narrative: Hallucinations, diarrhea, chest pain, cough, night sweats, appetite loss.
Age: 59.0
Sex: M
Vaccine: FLUC4
Symptoms: Night sweats
Clinical narrative: Hallucinations, diarrhea, chest pain, cough, night sweats, appetite loss.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus, Swelling
Clinical narrative: Patient had pain, redness, swelling and itching. pain was only on night 1 and is resolved. At day 7 she has only itching per pt.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Back pain, Chills, Pyrexia, Retching
Clinical narrative: Wife called me today stating her husband had started getting chills this afternoon, dry heaving, a fever, and pain near his spine at the bottom of his back. She stated he did not have soreness of the injection site or redness. Wife then stated patient had cancer previously and is in remission. I suggested the patient get in to see the doctor immediately. Although these symptoms may be a result of a vaccination, they could also be the result of other illnesses that need to be evaluated by a physician.  Have not heard result or outcome at this time. Wife was taking patient to get evaluated.
Age: 18.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Back pain, Dizziness, Eye pain, Eye swelling, Fatigue
Clinical narrative: Pain in both eyes when he moved them with sensitivity to light and swelling, dizziness, head would hurt if he moved it quickly, pain in his lower back, fatigue, malaise, sore throat.
Age: 18.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Headache, Malaise, Oropharyngeal pain, Pain, Photophobia
Clinical narrative: Pain in both eyes when he moved them with sensitivity to light and swelling, dizziness, head would hurt if he moved it quickly, pain in his lower back, fatigue, malaise, sore throat.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Bone pain, Chills, Dyskinesia, Erythema, Induration
Clinical narrative: On 1-25-18 arm sore by end of day, on 1-26-18 arm pain continued to increase as day went on. Arm swelling to elbow and turning red, then very red & hot. Bone in Lt. arm and muscle hurt. Even posterior ribs hurt by evening. Very painful to move fingers on left hand. At 10 PM had fever of 100.2 and chills. Legs were starting to jerk and cramps in my feet. 1-27-18 Deltoid area to elbow very swollen, red and firm. Increased pain on movement. Pain decreased over next few days, red tissue lasted about 5 days and pain when I would lift my left arm up. Took photo's.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Muscle spasms, Musculoskeletal chest pain, Myalgia, Pain, Pain in extremity
Clinical narrative: On 1-25-18 arm sore by end of day, on 1-26-18 arm pain continued to increase as day went on. Arm swelling to elbow and turning red, then very red & hot. Bone in Lt. arm and muscle hurt. Even posterior ribs hurt by evening. Very painful to move fingers on left hand. At 10 PM had fever of 100.2 and chills. Legs were starting to jerk and cramps in my feet. 1-27-18 Deltoid area to elbow very swollen, red and firm. Increased pain on movement. Pain decreased over next few days, red tissue lasted about 5 days and pain when I would lift my left arm up. Took photo's.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: On 1-25-18 arm sore by end of day, on 1-26-18 arm pain continued to increase as day went on. Arm swelling to elbow and turning red, then very red & hot. Bone in Lt. arm and muscle hurt. Even posterior ribs hurt by evening. Very painful to move fingers on left hand. At 10 PM had fever of 100.2 and chills. Legs were starting to jerk and cramps in my feet. 1-27-18 Deltoid area to elbow very swollen, red and firm. Increased pain on movement. Pain decreased over next few days, red tissue lasted about 5 days and pain when I would lift my left arm up. Took photo's.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Inflammation, Injection site pain, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Donor complained of pain radiating from left to right of shoulder back to shoulder blade after given tetanus immunization. She stated shot was placed between deltoid/shoulder bone area. This has caused pain with inflammation along with restricted ROM of shoulder. Sees PCP for treatment and taking meloxicam for inflammation. Will start physical therapy 2/7/18. Shot was given on 1/6/18 and this event was reported to medical staff on 2/4/18.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Burning sensation, Chills, Erythema, Injection site induration, Injection site mass
Clinical narrative: She said on Saturday, 2/3/18, that her arm became hot and feverish with a hard lump at the injection site. Then her arm began to itch. However, when she woke up on Sunday morning, her face was also red and swollen with a burning sensation. In addition, she was having lots of chills. She went on to say that most of the above has subsided after taking benadryl. In addition she said today, Monday, 2/5/18, she was only experiencing some soreness and tenderness on the back side of her arm. The patient stated she was taking benadryl to help combat the reaction, and she was feeling much better since the swelling had subsided.