chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Impaired work ability
Clinical narrative: She is unable to work; This is a spontaneous report from a Pfizer-sponsored program. A contactable physician reported that a 79-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Strength: 0.5ml, Lot: 1391693) via an unspecified route of administration on 17Dec2019 at 0.5 ml single for immunisation. The patient medical history and concomitant medications were not reported. The patient was unable to work on an unspecified date. The outcome of event was unknown.
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: flu; lack of efficacy, gotten the flu vaccine but had still gotten the flu; Initial information received on 04-Dec-2019 regarding an unsolicited valid serious case received from a non-health care professional.  This case involves a female patient of unknown age who developed flu (influenza) and reported lack of efficacy (vaccination failure), while she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatment, past vaccination and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and other dosing details were not reported).  On an unknown date, the patient developed serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. Also this was a case of vaccination failure.  Details of laboratory data were not reported.  Final diagnosis was influenza and vaccination failure.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was not reported.  Information on the batch number was requested.; Sender's Comments: This case concerns a female patient who presented with Influenza after and despite vaccination with INFLUENZA VACCINE. The time to onset is unknown. Moreover, there is no information regarding patient's condition at time of vaccination, immune status, congenital predisposition to respiratory tract infections. Based upon the reported information, the role of the vaccine and a case of vaccination failure cannot be assessed.
Age: 24.0
Sex: F
Vaccine: FLUR4
Symptoms: Extra dose administered
Clinical narrative: ADMINISTERED FLU SHOT AGAIN BY MISTAKE , ALTHOUGH PATIENT HAD A FLU SHOT ON OCTOBER
Age: 15.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Flushing, Syncope
Clinical narrative: Patients father had pre-warned that the patient does become light headed and may faint with vaccination. Patient has severe anxiety over needles and gets light headed and faints when vaccinated. Patients father stated it happens with anything related to needles and has talked to doctors and specialists and is fine and normal. I had patient sit in her chair and the father cradled her head just incase patient did faint. I administered the vaccine and patient did get light headed and fainted. This did look like a vasovagal syncope response as she did get flush, light headed and fainted. Pt remained seated until she was back to normal and could move without incident. Pt was fine and father left with pt.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Pain in extremity, Product administered at inappropriate site
Clinical narrative: Patient was having muscle/Tendon pain at the time of the vaccine and requested to administer the vaccine at a lower site. Patient stated the pharmacist administered the vaccine too high in the bone and her arm now hurts very bad. Advised patient to follow-up with her doctor.
Age: 55.0
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient with 17cm by 11 cm erythematous, tender area at site of reaction that is tender to palpation.  States started day of vaccination and got worse day after.
Age: 70.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Amnesia, Aphasia, Blood test normal, Computerised tomogram normal, Electrocardiogram normal
Clinical narrative: feeling achey for 1 day, then complete loss of memory, speech, incoherent, hospitalized for 4 days, then slowly thought and understanmding came back. all test came back normal, ecg, cat, etc.
Age: 70.0
Sex: F
Vaccine: FLUA3, VARZOS
Symptoms: Incoherent, Magnetic resonance imaging normal, Pain, Thinking abnormal, Ultrasound scan normal
Clinical narrative: feeling achey for 1 day, then complete loss of memory, speech, incoherent, hospitalized for 4 days, then slowly thought and understanmding came back. all test came back normal, ecg, cat, etc.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling, Skin warm, Tenderness
Clinical narrative: arm swollen, tender and warm to touch
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Erythema, Pruritus, Rash
Clinical narrative: 10/29/19 Received phone call at 1515 that client received flu shot that morning and her face is red with rash and itching. no rash or redness anywhere else. Stated her legs are starting to itch but no rash, instructed her to go to PCP. Phone call made to RN regarding phone call from client, can refer to PCP or ER. Called client back and informed her to go to PCP or ER, she stated her PCP was in another city, instructed to go to ER. 10/30/19 Follow up phone call to client, she stated she felt a little woozy after shot, she stated she went to class and someone told me my face was red, she stated the redness lasted 30 minutes and was gone, She stated her breathing was fine, stated redness was from nose to eyebrows. She said her daughter was Dr, she sent her a picture and she told her to take balladry,  by the time she got home redness was gone so she did not take benadryl. She states she is fine today and no problems
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Emotional distress, Fatigue, Feeling cold, Influenza like illness
Clinical narrative: When I woke up the next day, I had flu-like symptoms without a high fever.  My body shivered and I felt cold at times, my body ached, and I was very tired.  I had a rash on the trunk of my body on the side of the injection for about 3 days, a rash that is typical for me when I have a viral infection.  The rash was not itchy or raised.  Taking 1 ibuprofen every 4 to 6 hours helped alleviate these symptoms except for the fatigue and the rash.  The the upper arm at the site of the injection was red, feverish, and swollen.  This persisted for about 3 days.  Day 2, I felt much better but still was slightly fatigues and ibuprofen was no longer needed.  On Days 3 to 5, I notice I was emotionally unsettled feeling - kind of irritable and upset feeling.  I never felt this way before to my knowledge.  After Day 5 symptoms resolved except for the site of injection redness, soreness, and fever still resolving. By Day 7 I was back to normal.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Irritability
Clinical narrative: When I woke up the next day, I had flu-like symptoms without a high fever.  My body shivered and I felt cold at times, my body ached, and I was very tired.  I had a rash on the trunk of my body on the side of the injection for about 3 days, a rash that is typical for me when I have a viral infection.  The rash was not itchy or raised.  Taking 1 ibuprofen every 4 to 6 hours helped alleviate these symptoms except for the fatigue and the rash.  The the upper arm at the site of the injection was red, feverish, and swollen.  This persisted for about 3 days.  Day 2, I felt much better but still was slightly fatigues and ibuprofen was no longer needed.  On Days 3 to 5, I notice I was emotionally unsettled feeling - kind of irritable and upset feeling.  I never felt this way before to my knowledge.  After Day 5 symptoms resolved except for the site of injection redness, soreness, and fever still resolving. By Day 7 I was back to normal.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Rash
Clinical narrative: When I woke up the next day, I had flu-like symptoms without a high fever.  My body shivered and I felt cold at times, my body ached, and I was very tired.  I had a rash on the trunk of my body on the side of the injection for about 3 days, a rash that is typical for me when I have a viral infection.  The rash was not itchy or raised.  Taking 1 ibuprofen every 4 to 6 hours helped alleviate these symptoms except for the fatigue and the rash.  The the upper arm at the site of the injection was red, feverish, and swollen.  This persisted for about 3 days.  Day 2, I felt much better but still was slightly fatigues and ibuprofen was no longer needed.  On Days 3 to 5, I notice I was emotionally unsettled feeling - kind of irritable and upset feeling.  I never felt this way before to my knowledge.  After Day 5 symptoms resolved except for the site of injection redness, soreness, and fever still resolving. By Day 7 I was back to normal.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient was not administered an improperly stored dose; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug allergies/ reaction and concomitant medications were not reported. On 26-SEP-2019, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (strength, formulation, dose/frequency, route were not reported) lot # R028528, expiry date: 04-JUN-2021 (product storage error) for prophylaxis. The vaccine was stored at a temperature of 31.6 Fahrenheit for 13 hours 35 minutes. There was no previous temperature excursion. The call was because of data logger. No adverse effect was reported. The outcome of product storage error and no adverse event was unknown.
Age: 36.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: administered a dose of GARDASIL 9 during her pregnancy; This spontaneous prospective pregnancy report was received from a 36-year-old female patient reporting on herself. The patient did not have any concomitant medications and pertinent medical history. The patient's concurrent conditions were not reported. The patient was allergic to penicillin, bupropion hydrochloride (WELLBUTRIN), dust and tree nuts. On 16-DEC-2019, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, route of administration, anatomical location, lot number and expiration date were not reported) during her pregnancy as routine vaccination (exposure during pregnancy). The patient was not aware that she was pregnant when she received her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On 23-DEC-2019, the patient had office visit  to discuss birth control options. During that visit, standard pregnancy testing (urine pregnancy test) was performed, and the patient was found to be 7 weeks and 5 days pregnant with Last Menstrual Period (LMP) of 30-OCT-2019 and Estimated Date of Delivery (EDD) of 05-AUG-2020. Initial exposure to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was at 6 weeks of pregnancy. The pregnancy outcome was outcome pending. The fetal outcome was unknown. The patient reported that she was not experiencing any symptoms so far and had not sought medical attention for her pregnancy yet. No product quality complaints were involved.
Age: 84.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Erythema, Fatigue, Myalgia, Nausea
Clinical narrative: Avery sore - red arm - tiredness - muscle pain - shivering - nausea
Age: 84.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: Avery sore - red arm - tiredness - muscle pain - shivering - nausea
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Hyperhidrosis, Influenza like illness
Clinical narrative: Flu-like symptoms without a high fever: fatigue, aching, and shivering.  1 ibuprofen every 4 hours helped alleviate the aching and shivering.  Shivered all night long waking me up several times and was sweaty.  The next day after the shot the symptoms remained and continued to take ibuprofen every 4 hours.  The fatigued seemed less than the first inoculation.  The site of inject was red  below the injection site and sore.  The injection site was not swollen and feverish like the first time.  On Day 2 I felt a little fatigued in the morning but I could push through it.  By late after noon on Day 2 all symptoms but the site of injection soreness was resolved.  I had very little hive-like redness on the trunk of my body that resolved by Day 3.  I felt no emotional effects from the booster.  I reported the adverse event to the pharmacist during the visit for the second injection to both the person running the cashier and the person who injected me with the booster.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Pain
Clinical narrative: Flu-like symptoms without a high fever: fatigue, aching, and shivering.  1 ibuprofen every 4 hours helped alleviate the aching and shivering.  Shivered all night long waking me up several times and was sweaty.  The next day after the shot the symptoms remained and continued to take ibuprofen every 4 hours.  The fatigued seemed less than the first inoculation.  The site of inject was red  below the injection site and sore.  The injection site was not swollen and feverish like the first time.  On Day 2 I felt a little fatigued in the morning but I could push through it.  By late after noon on Day 2 all symptoms but the site of injection soreness was resolved.  I had very little hive-like redness on the trunk of my body that resolved by Day 3.  I felt no emotional effects from the booster.  I reported the adverse event to the pharmacist during the visit for the second injection to both the person running the cashier and the person who injected me with the booster.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Cold sweat, Fatigue
Clinical narrative: Patient reported awakening the night of the injection with cold sweats and feeling very fatigued. Ran 100.3 temp for 4 hours and symptoms resolved after 24 hours
Age: 66.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient had injection site reaction on left arm.   She described having significant swelling and redness.  The swelling lasted "almost 2 weeks"  and the redness is still present but improving.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Myositis, Periarthritis
Clinical narrative: severe pain in left arm (site of injection)- same day - pain continued and seen by Dr. on 10/30/19 dx: myositis pain continued and seen by second doctor Dr. on 12/2/19 dx: adhesive capsulitis
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Feeling abnormal, Head injury, Loss of consciousness
Clinical narrative: Patient states woke up the next morning and felt, "awful".  She went to her Kitchen and ,"blacked out".  She states she passed out and hit her head.  He husband was in the next room and came to her aid.  After three days, she began to feel better.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse symptoms were reported; 1 patient was administered a dose of improperly stored recombivax; This spontaneous report has been received from a medical assistant, concerning to a patient of unknown age and gender.  The patient's concurrent conditions, medical history, past drug reactions or allergies and concomitant medications were not reported.  On 21-NOV-2019, the patient was administered a dose of improperly stored (product storage error) hepatitis b vaccine (recombinant) (RECOMBIVAX HB) injection, lot # R031052 and expiry date 03-JUN-2021, for prophylaxis (strength, dose, frequency, route, anatomical location not reported). No adverse symptoms were reported. Dose of suspect vaccine experienced the temperature excursion below 36-degree Fahrenheit (F) (31.8 F) for 15 minutes. It was reported that there was no previous temperature excursions. Data logger was involved.    This is one of the 3 reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA011753: US-009507513-1911USA011662:
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The patient received improperly stored VAQTA; Expired product administered; This spontaneous report was received from a certified medical assistant (CMA) and refers to a 2-year-old female patient. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications.  The CMA stated that on 26-NOV-2019, the patient was vaccinated with an improperly stored dose of Hepatitis A Vaccine, Inactivated (VAQTA) strength 25/0.5 (units not reported) (lot number S00952, with expiration date on 26-JUL-2020 but upon internal validation established as 05-MAY-2019) (dose, frequency, and route of administration and anatomical location were not reported) for prophylaxis.   The administered dose of the vaccine experienced a temperature excursion above 47 °F (52.09 °F) for 1.39 hours, as recorded by a data logger. The vaccine had a previous temperature excursion above 47 °F (64.83 °F) for 13.35 hours.  There was no adverse effect reported.
Sex: U
Vaccine: MMR, UNK
Symptoms: Mumps antibody test negative
Clinical narrative: Patient was administered the MMRII vaccine as a child and a low tier for mumps; This spontaneous report was received from a physician assistant referring to a child of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) for prophylaxis  (dose, route of  administration, anatomical location, lot number and expiration date were not reported) with water sterile diluent for prophylaxis  (dose, route of administration, anatomical location, lot number and expiration date were not reported). On an unknown date, after the vaccination the patient had lo titer for mumps (mumps antibody test negative).  At the time of the report, the outcome of mumps antibody test negative was unknown. The reporter did not provide causality assessment between the event and vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II).
Age: 71.0
Sex: M
Vaccine: FLUA3
Symptoms: Pain in extremity
Clinical narrative: PATIENT STATED THAT HIS ARM HURT SHORTLY AFTER RECEIVING THE VACCINE AND HAS CONTINUED TO HURT SINCE.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Magnetic resonance imaging normal, Neck pain, Scan normal
Clinical narrative: PATIENT STATES WITHIN ABOUT 4 HOURS AFTER RECEIVING THE VACCINE HE HAD FLU LIKE SYMPTOMS FOR THE ENTIRE NIGHT WITH PAIN UP THE BACK OF HIS NECK. ONLY TODAY, 12-26-2019, HAS THE PAIN RELIEVED SOME ON THE RIGHT SIDE BUT STILL HAVING SYMPTOMS ON THE LEFT.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Feeling abnormal, Headache
Clinical narrative: I woke  up with a feeling that my heart wanted to jump out of my chest. This was at 2am. I had a headache and began wondering what my BP was.. It was 190/112. In the morning I called my primary care provider. She advised me to go to the ER.. I did. Systolic pressure at that time was 181, headache persisitng. I was treated with clonidine and tylenol
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Blood glucose normal, Dizziness, Face injury, Fall, Feeling abnormal
Clinical narrative: Patient passed out within 5 minutes of receiving flu shot. He fell face down. Some shaking, possible seizure. He woke up within 30-45 sec. Stated he felt like he threw up. He was still dizzy. Then he became nauseous. Ambulance arrived. Patient could not walk out of store due to dizziness. Ambulance transported him to Hosp. Patient stated he went white last year when he received his flu shot.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness, Nausea, Tremor
Clinical narrative: Patient passed out within 5 minutes of receiving flu shot. He fell face down. Some shaking, possible seizure. He woke up within 30-45 sec. Stated he felt like he threw up. He was still dizzy. Then he became nauseous. Ambulance arrived. Patient could not walk out of store due to dizziness. Ambulance transported him to Hosp. Patient stated he went white last year when he received his flu shot.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Nausea, Pyrexia
Clinical narrative: About 6 hours after vaccine administration patient started experiencing extreme headache, joint pain, says she felt "sick to her stomach" and nauseous, and had chills along with a fever of 104 degrees. All of those symptoms lasted a full 24 hours into the next day she said by Wednesday morning 12/18 she woke up feeling that the symptoms resolved and she was returning back to normal.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Diplegia, Muscular weakness
Clinical narrative: muscle weakness-  paralysis - in arms  and  legs
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Dizziness, Ear pain, Feeling cold
Clinical narrative: muscle pain ,joint pain both ear pain ,stomach ache ,cold  hot sweats first nights ,dizzy , gout feeling in toe
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Gout, Myalgia, Night sweats
Clinical narrative: muscle pain ,joint pain both ear pain ,stomach ache ,cold  hot sweats first nights ,dizzy , gout feeling in toe
Age: 69.0
Sex: F
Vaccine: FLUA3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Upon administration, patient states that the injection site hurt and occasionally pain shot down her arm. In the first 2 weeks, she was unable to lift her arm above shoulder level. In our first post-admin conversation, we discussed injection site and I determined that the vaccine admin was not in the bursa, which was primary concern. Patient stated that things seemed to be improving, so we decided to watch and wait.      12/26- When patient lifts her arm over her head for more than 20-30 minutes, she cannot pull it down on her own, she has to use her other arm to pull it down. She saw her Dr and asked about it, and he wonders if the nerve was hit and causing these issues (per patient, the Dr's wife had a similar problem that resolved in about 6 weeks). Patient also states today that she has had some arm pain that moves around. Initially at the injection site, then at the front of her shoulder (near the joint), then the back of her shoulder (near the joint), and then again at the injection site.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Cheilitis, Oral mucosal eruption, Stomatitis
Clinical narrative: The patient came to consultation today and said she got a shingrix vaccine and this was her second dose and the first dose was fine with no issues. She said a few days after the shingrix she developed  bumps on roof of mouth and top of mouth is raw and pallet is raw. The patient also has a sore on the top of her lips. She went to the doctor and the doctor gave her a prescription for antifungal which she filled. Thanked the patient for letting us know and apologized to the patient of what happened and the patient was fine and she was not worried and she just wanted us to know. The patient also let us know she is a nurse and she knows what to look out for and she is fine.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient says her arm hurts after the vaccination. First it was the back of the left arm, that went away and now it hurts in the front of the left arm. Vaccine was given about 3 weeks ago. I advised to take Advil/APAP in the meantime.  I told her I would file a adverse report and contact manuf for more info
Age: 57.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site pain, Insomnia
Clinical narrative: Patient reported continued arm pain at site of Flublok immunization from on December 17, 2019.  Other symptoms include difficulty sleeping on that side of arm AND completing yard work, and possible putting away groceries.   She's a new patient to our pharmacy and only just got a flu shot.  She reports that she receives the flu vaccine every year, and have never gotten this reaction before.  It was difficult getting a complete medical history from her other than the sphinter of oddi dysfunction?   I recommended that she gets her arm examined ASAP by her primary care provider, Dr.   I  would follow up with her in a few weeks because the holidays may prevent her from seeing Dr..
Age: 1.67
Sex: M
Vaccine: FLU4
Symptoms: Asthma, Bronchitis viral, Chest X-ray abnormal, Febrile convulsion, Influenza A virus test negative
Clinical narrative: Patient seemed to be in his usual state of health on 11/5/19.  He received a flu vaccine that afternoon.  Next morning he developed a fever to 101.2.   At approx 3 am on 11/7/19 he was febrile and developed a febrile seizure that lasted less than 1 min.  It was generalized.    EMS was activated amd was taken to the ER.  He was diagnosed with a right otitis media and simple febrile seizure.
Age: 1.67
Sex: M
Vaccine: FLU4
Symptoms: Influenza B virus test, Influenza virus test negative, Lung infiltration, Otitis media, Pneumonia
Clinical narrative: Patient seemed to be in his usual state of health on 11/5/19.  He received a flu vaccine that afternoon.  Next morning he developed a fever to 101.2.   At approx 3 am on 11/7/19 he was febrile and developed a febrile seizure that lasted less than 1 min.  It was generalized.    EMS was activated amd was taken to the ER.  He was diagnosed with a right otitis media and simple febrile seizure.
Age: 1.67
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Patient seemed to be in his usual state of health on 11/5/19.  He received a flu vaccine that afternoon.  Next morning he developed a fever to 101.2.   At approx 3 am on 11/7/19 he was febrile and developed a febrile seizure that lasted less than 1 min.  It was generalized.    EMS was activated amd was taken to the ER.  He was diagnosed with a right otitis media and simple febrile seizure.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Patient called 12/26/19 to report continued throbbing pain on the immunization side, especially when laying down.  States it is difficult to put on socks in the morning and that pain is getting worse as time goes on.  She also stated concern over receiving Boostrix vaccine one month earlier on 10/10/19 and Fluzone HD on 9/19/19 and inquired if there was any correlation.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Feeling numb and tingle sensation down my arms , both legs and the left side of my face
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Injected limb mobility decreased, Insomnia, Local reaction, Pain
Clinical narrative: 3h after the vacination, patient experienced excruciating pain, that kept her awake at night. she couldn't move her left arm or raise her left arm. She also has a fever of 100.4 F. She had local reaction including redness and swelling (2*4 inches) and throbbing. she took Tylenol but it didn't help with the pain. As of 12/26, she still experiences a mild pain on her left arm
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity, Pyrexia, Swelling
Clinical narrative: 3h after the vacination, patient experienced excruciating pain, that kept her awake at night. she couldn't move her left arm or raise her left arm. She also has a fever of 100.4 F. She had local reaction including redness and swelling (2*4 inches) and throbbing. she took Tylenol but it didn't help with the pain. As of 12/26, she still experiences a mild pain on her left arm
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Rash
Clinical narrative: -developed rash (mild case) after the patient received the shot. on 12-16-19. -rash continued to get worse over the week. (rash all over the body) - patent also developed joint pain.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash, Rash pruritic
Clinical narrative: -whole left Arm, Rash, may be shingles -Painful & Itching Rash -More than 2 weeks & still not getting Better.
Age: 61.0
Sex: F
Vaccine: FLUC4, PNC13, VARZOS
Symptoms: Headache, Influenza like illness, Neck pain, Peripheral swelling, Pyrexia
Clinical narrative: Swollen arm too painful to touch, head ache and neck ache, fever and flu like symptoms for a full 8 days.
Age: 61.0
Sex: F
Vaccine: FLUC4, PNC13, VARZOS
Symptoms: Tenderness
Clinical narrative: Swollen arm too painful to touch, head ache and neck ache, fever and flu like symptoms for a full 8 days.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: She said 2 months her arm is still sore and she feels a bump.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash macular, Urticaria
Clinical narrative: Patient complained of red blotches and welts on arm near reaction site
Sex: U
Vaccine: VARZOS
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: arm  hurt; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received her 1st dose of Shingrix vaccine 2-3 months ago in 2019. After receiving vaccine, the patient had her arm  hurt for 5-6 days. The reporter was requested to provide consent to follow up. For the tolerance with 2nd dose of Shingrix, refer linked case US2019226977.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Headache, Nausea, Pain
Clinical narrative: Nausea, headache, body aches that worsened as the day progressed.; Nausea, headache, body aches that worsened as the day progressed.; Nausea, headache, body aches that worsened as the day progressed.; This spontaneous report has been received from a consumer via FDA (agency# 798550) on 26-SEP-2019, referring to a 12 years old male patient. Concomitant therapies included amphetamine aspartate (+) amphetamine sulfate (+) dextroamphetamine saccharate (+) dextroamphetamine sulfate (AMPHETAMINE SALTS) 15 mg. Information about medical history and concurrent conditions was not provided. The patient did not have allergies to medications, food or other products, illness at the time of vaccination and up to one month prior or chronic or long standing health conditions.        At 15:30 of 25-JAN-2019 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose 2, in the left arm; lot #, expiration date, route and dose details were unknown) for prophylaxis.      On 27-JAN-2019 AM the patient experienced nausea, headache and body aches that worsened as the day progressed.      The outcome of the events was reported as not recovered. The causality between the events and the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.  Follow-up information has been received from the lead medical assistant on 11-DEC-2019. The medical assistant was unable to identify the patient reference in this report. Date of vaccine administration was supplied to the medical assistant so that additional information could located and provided. No additional information collected at the time of the call.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Fall, Headache, Nausea, Skin injury, Syncope
Clinical narrative: SYNCOPAL EPISODE; fell approx 3-4 feet from exam table and hit poterior scalp on floor (concrete with overlying vynyl); Concussion to head; severe headache; nausea; Information has been received from a health professional/staff via FDA (agency # 807201), referring to a 13 years old male patient. The patient had no medical history or concurrent condition. The patient's concomitant medication included loratadine (+) pseudoephedrine sulfate (RHINASE). There was no known drug allergies.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # M017983, expiration date 30-MAY-2018, dose, strength and route were unknown). On 25-MAR-2019 at 09:52, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength and expiration date were unknown, lot # was reported as R02200) intramuscularly in the right arm for prophylaxis.   On 25-MAR-2019 at 09:57, the patient had syncopal episode while attempting to stand from table after vaccination. The patient fell approximately 3-4 feet from exam table and hit posterior scalp on floor (concrete with overlying vinyl). The patient did not lose consciousness. Blood pressure (BP) at time of events was 128/84 and heart rate (HR) was reported as 70s. The patient complained of severe headache and nausea after events. Ice pack was applied and the patient referred to emergency room (ER) for further evaluation and tests. The patient denied dizziness, chest pain or shortness of breath (SOB) after events. The patient recovered from the events. The causality between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events was not provided by the reporter.  The event syncopal episode was considered as non-serious by the reporter. This case has been downgraded.  Lot number R02200 is not valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  Follow-up information has been received from a health professional on 23-DEC-2019. The patient's demographics were updated. The patient's concurrent condition included rhinitis. On 25-MAR-2019, the patient experienced concussion to head (concussion). Outcome of concussion was not reported. Causality assessment between concussion and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Concussion, Headache, Nausea, Syncope
Clinical narrative: SYNCOPAL EPISODE; fell approx 3-4 feet from exam table and hit poterior scalp on floor (concrete with overlying vynyl); Concussion to head; severe headache; nausea; Information has been received from a health professional/staff via FDA (agency # 807201), referring to a 13 years old male patient. The patient had no medical history or concurrent condition. The patient's concomitant medication included loratadine (+) pseudoephedrine sulfate (RHINASE). There was no known drug allergies.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # M017983, expiration date 30-MAY-2018, dose, strength and route were unknown). On 25-MAR-2019 at 09:52, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength and expiration date were unknown, lot # was reported as R02200) intramuscularly in the right arm for prophylaxis.   On 25-MAR-2019 at 09:57, the patient had syncopal episode while attempting to stand from table after vaccination. The patient fell approximately 3-4 feet from exam table and hit posterior scalp on floor (concrete with overlying vinyl). The patient did not lose consciousness. Blood pressure (BP) at time of events was 128/84 and heart rate (HR) was reported as 70s. The patient complained of severe headache and nausea after events. Ice pack was applied and the patient referred to emergency room (ER) for further evaluation and tests. The patient denied dizziness, chest pain or shortness of breath (SOB) after events. The patient recovered from the events. The causality between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events was not provided by the reporter.  The event syncopal episode was considered as non-serious by the reporter. This case has been downgraded.  Lot number R02200 is not valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  Follow-up information has been received from a health professional on 23-DEC-2019. The patient's demographics were updated. The patient's concurrent condition included rhinitis. On 25-MAR-2019, the patient experienced concussion to head (concussion). Outcome of concussion was not reported. Causality assessment between concussion and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Heart rate increased
Clinical narrative: rapid heart rate became apparent after arriving home and resting at about 2 pm, four hours after vaccination. My resting heart rate is typically around 70 bpm. My bpm during this period of time was around 105 bpm. Walking across the room took it to around 120. My bp was normal during this time. This continued until approximately 10 pm, a duration of about 4 hours.  I rested, performed some deep breathing exercises, and pushed fluids
Age: 52.0
Sex: F
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Patient stated that she developed hives during the night after receiving the vaccine.  No breathing problems, no other stated symptoms.
Sex: M
Vaccine: MMR, UNK
Symptoms: Exposure via eye contact, No adverse event, Occupational exposure to product
Clinical narrative: No additional adverse effects reported. No additional AE information provided.; a physician got reconstituted MMRII in his eye; Information has been received from an office manager referring to a male patient of unknown age who was a physician himself. The patient's medical history, concurrent conditions and concomitant medications were not provided.      On 27-NOV-2019, the patient got reconsitituted measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, strength, route, lot # and expiration were unknown) for prophylaxis with sterile diluent (route, frequency, dose, strength, lot # and expiration were unknown) in his eye (occupational exposure to product). No additional adverse event (AE) information provided. The outcome of the events were unknown.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No other adverse effects; patient received one dose each of PROQUAD and VARIVAX/ both vaccines administered on the same day; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not provided.   On 04-DEC-2019, the patient was vaccinated with one dose each of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (dose number and route were unknown; Lot # S021325, expiration date 05-JAN-2021) and varicella virus vaccine live (oka/merck) (VARIVAX) (dose number and route were unknown; Lot # S002392, expiration date 23-JAN-2021) for prophylaxis (inappropriate schedule of product administration). No other adverse effects were reported in the patient.
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: a male patient was administered properly stored M-M-R II which had expired.; The patient's pre-employment titers done on 11-NOV-2019 were low for measles.; This spontaneous report has been received from a medical assistant referring to a 44 years old male patient. The patient had pertinent medical history included post-traumatic stress disorder. Concomitant therapy included fluoxetine. There were no drug reactions or allergies reported.   On unknown dates (reported when the patient was a child), the patient had received two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot #, expiration date, frequency, route and dose details were unknown) for prophylaxis. The patient's pre-employment titers done on 11-NOV-2019 were low for measles.        On 13-DEC-2019, the patient was vaccinated with the first dose in the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) vaccination series (lot # N032750, expiration date: 20-NOV-2019, subcutaneously in the left arm) which had expired for prophylaxis (expired product administered). The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was reconstituted with properly stored sterile diluent (lot # N028745, expiration date 15-MAR-2020). No additional adverse effect reported.  The outcome of the pre-employment titers low for measles was recovering. The causality between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No known adverse effects; received a dose of PROQUAD and a dose of VARIVAX; This spontaneous report was received from a licensed practical nurse referring to a child patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On 14-DEC-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S013712 with expiration date on 01-NOV-2020; and varicella virus vaccine live (oka/merck) (VARIVAX) lot # S004862 with expiration date on 18-FEB-2021. Both vaccines were administered for prophylaxis, however, for both vaccines the dosage schedule, route of administration and anatomical location were not reported (vaccination error). No adverse event was reported.  This is one of two cases received from the same source.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Full blood count, Injection site cellulitis, Injection site erythema, Laboratory test, Sepsis
Clinical narrative: for Cellulitis right upper arm with sepsis secondary to the cellulitis; for Cellulitis right upper arm with sepsis secondary to the cellulitis; severe yeast infection of the genitals and groin area related to the antibiotic therapy; Indication: asthma; white blood cell count over 30,000 during her hospital stay; redness of the right upper arm; This spontaneous report was received from a physician assistant and refers to a 30-year-old female patient. The patient's pertinent medical history included asthma. Her concomitant therapies included unspecified asthma medication. The patient did not have any drug reactions or allergies.  On 25-NOV-2019 the patient was vaccinated with a first dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection, intramuscularly in her right upper arm (lot # S018140 has been verified to be a valid lot number, expiration date 02-MAR-2021; exact dose was not reported) for asthma (unapproved indication).  On an unknown date in November 2019, the patient developed a cellulitis of right upper arm with sepsis secondary to the cellulitis and was admitted to the hospital because of the events on 27-NOV-2019. The patient was given unspecified antibiotics, which did not improve her condition and subsequently she was put on therapy with vancomycin (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported). On an unknown date in November 2019 (reported as during hospital stay), the patient's white blood cell count was over 30000 (units not provided). Additionally, the reporter informed that the patient had unspecified hospital lab work and complete blood count performed, however the results were not provided.  On 29-NOV-2019, while on therapy with vancomycin, the patient was discharged from the hospital. On 02-DEC-2019, the patient was seen by the physician assistant for a hospital follow up visit with residual redness of the right upper arm.  Subsequently, the patient developed a severe yeast infection of the genitals and groin area related to the antibiotic therapy and was seen by a physician on 11-DEC-2019.  The outcome of the events was reported as recovering as the patient was not fully recovered at the time of the report.  The causality assessment between the events and the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not provided.  The reporter considered the event infection (yeast infection) to be very serious (medically significant), as it could have become life threatening. Upon internal review, the events cellulitis of upper arm and sepsis secondary to the cellulitis were determined to be medically significant.
Age: 30.0
Sex: F
Vaccine: PPV
Symptoms: Vulvovaginal mycotic infection, White blood cell count increased
Clinical narrative: for Cellulitis right upper arm with sepsis secondary to the cellulitis; for Cellulitis right upper arm with sepsis secondary to the cellulitis; severe yeast infection of the genitals and groin area related to the antibiotic therapy; Indication: asthma; white blood cell count over 30,000 during her hospital stay; redness of the right upper arm; This spontaneous report was received from a physician assistant and refers to a 30-year-old female patient. The patient's pertinent medical history included asthma. Her concomitant therapies included unspecified asthma medication. The patient did not have any drug reactions or allergies.  On 25-NOV-2019 the patient was vaccinated with a first dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection, intramuscularly in her right upper arm (lot # S018140 has been verified to be a valid lot number, expiration date 02-MAR-2021; exact dose was not reported) for asthma (unapproved indication).  On an unknown date in November 2019, the patient developed a cellulitis of right upper arm with sepsis secondary to the cellulitis and was admitted to the hospital because of the events on 27-NOV-2019. The patient was given unspecified antibiotics, which did not improve her condition and subsequently she was put on therapy with vancomycin (formulation, strength, dose, frequency, route of administration, lot # and expiration date were not reported). On an unknown date in November 2019 (reported as during hospital stay), the patient's white blood cell count was over 30000 (units not provided). Additionally, the reporter informed that the patient had unspecified hospital lab work and complete blood count performed, however the results were not provided.  On 29-NOV-2019, while on therapy with vancomycin, the patient was discharged from the hospital. On 02-DEC-2019, the patient was seen by the physician assistant for a hospital follow up visit with residual redness of the right upper arm.  Subsequently, the patient developed a severe yeast infection of the genitals and groin area related to the antibiotic therapy and was seen by a physician on 11-DEC-2019.  The outcome of the events was reported as recovering as the patient was not fully recovered at the time of the report.  The causality assessment between the events and the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not provided.  The reporter considered the event infection (yeast infection) to be very serious (medically significant), as it could have become life threatening. Upon internal review, the events cellulitis of upper arm and sepsis secondary to the cellulitis were determined to be medically significant.