chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Pallor, Peripheral coldness, Pyrexia, Rash
Clinical narrative: From mom 101.6 fever noon. Noticed rash to both arms. Fingers are white and cold forearms are gray cream color rash. 'Big polka dots' mom states. Child was not seen for this. Spoke to the provider and mom to go to ER if further concern and mom to call and update.
Age: 64.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pyrexia
Clinical narrative: Redness pain, and increased warmth at injection site after 24 hours-fever 102 day after infection.
Age: 15.0
Sex: M
Vaccine: HEP, MMR, VARCEL
Symptoms: Incorrect route of drug administration, Product label confusion
Clinical narrative: MENACTRA dose was given sc instead of recommended route of IM. Box label reads "polysacchaide DTD " and further reads "conjugate".  Subcutaneous is the route recommended for "polysaccaride MPSV". Label was confusing. Call to manufacturer stated that a study by CDC determined that despite misadministation, persons vaccinated by the sc route were sufficiently protected and revaccination was not necessary.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Muscle twitching, Vomiting
Clinical narrative: Mother stated patient was vomiting and twitching approximately 10 hours later after receiving vaccine.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Redness, pain, and swelling from top of arm to elbow. Redness has increased but pain and swelling have decreased since onset.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Encephalitis, Muscle necrosis
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, from a contactable consumer (patient's mother). A 3 year-old male patient of unspecified ethnicity received a single dose of PREVNAR 13 via an unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced encephalitis and also nearly lost his leg when the muscle necrotized. Outcome of events was unknown. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: HPV4
Symptoms: Loss of consciousness, Syncope, Tremor
Clinical narrative: This spontaneous report was received from a pharmacist regarding an 18 year old male patient. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On 29-AUG-2016, the patient was vaccinated with GARDASIL intramuscularly (lot # K010215, expiry date 05-MAY-2017, strength, dose, vaccination site were not reported). On the same day (29-AUG-2016), after administration of GARDASIL, the patient fainted, lost consciousness and had tremors for about 30 seconds. No treatment was provided for the events however paramedics were called and evaluated the patient for release. The patient was recovered from the events on the same day (29-AUG-2016). Causality assessment was not reported. Product quality complaint (PQC) was not involved. Upon internal review, the event loss of consciousness was considered to be medically significant. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Cellulitis, Rash, White blood cell count increased
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 60 year old male patient with remission for renal cell carcinoma. There was no information about the patient's concomitant therapies, drug reactions or allergies provided. On 19-AUG-2016, the patient was vaccinated with PNEUMOVAX 23 lot # M018766 with an expiration date: 15-OCT-2017, one shot, once, intramuscularly. On 20-AUG-2016, reported also as the day after administration of PNEUMOVAX 23, the patient experienced rash and his temperature rose to "102.5 (unit of measurement unspecified). The patient sought medical attention and had to go to an unspecified hospital. The patient's white blood cell count test was 22,000 (unit of measurement unspecified) and he was diagnosed with cellulitis. He was treated with unspecified "intravenous (IV) antibiotics". It was unspecified how long the patient stayed at the hospital. The outcome of cellulitis was reported as recovered. (On an unknown date in August 2016). The relatedness between the event and PNEUMOVAX 23 was not reported. The reporter believed that event could be life threatening, if left untreated. Upon internal review cellulitis was determined to be medically significant. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Biopsy skin abnormal, Blood immunoglobulin A increased, Haematuria, Henoch-Schonlein purpura, Pancreatitis
Clinical narrative: Patient presented with vomiting, hematuria. Was admitted and diagnosed with pancreatitis, vasculitis, and HSP. Henoch-Schonlein purpura.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Ultrasound scan, Urine analysis, Vasculitis, Vomiting
Clinical narrative: Patient presented with vomiting, hematuria. Was admitted and diagnosed with pancreatitis, vasculitis, and HSP. Henoch-Schonlein purpura.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: AFLURIA vaccine given (L) deltoid. Sitting in chair against wall. Customer passed out approx. 30 sec. after giving vaccine. Passed out for approx. 10 sec and then woke back up. Did not fall out of chair. No injury noted. Customer rested for approximately 10 minutes. Grandfather assisted customer out of store. Grandfather this happens to customer with blood draws, vaccines.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Swollen, red, hot at vaccine site (redness continue all around the arm). Started day of vaccine worst days 2-3; continued x 6 days. Also took round the clock TYLENOL.
Age: 63.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Soreness at injection site which spread to entire upper arm, intense pain upon moving arm that lasted 3 days before decreasing, fever for 3 days, continued pain upon moving arm through 9/1/2016, Advil taken for fever and pain.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site bruising, Injection site nodule, Injection site warmth
Clinical narrative: Donor noticed light purple bruise at immunization site (left bicep) Thursday 8/25/16. Then states she felt a knot Friday 8/26/16 around the site. Denies pain or tenderness. States she kept area dry & rubbed alcohol on it. No difficulty moving arm. Area slightly warm to the touch, a knot approximately 1 inch is diameter felt.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Joint range of motion decreased, Pain in extremity, Pyrexia
Clinical narrative: Sore arm, limited range of motion, fever, flu-like symptoms.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Neck pain
Clinical narrative: Pt reports 7/10 sharp pain to left side of neck behind ear when swallowing beginning approx. 15 minutes after vaccine administered. Patient states the pain has gradually improved. After 30 minutes, patient reports the sharp pains have subsided and now rates her pain at 5/10. Pt reports pain occurs only when swallowing. Pt denies any difficulty breathing, chest tightness, or cough. There is no hives, redness, or edema noted to (L) side of neck. Pt denies any chest pain, dizziness, blurred vision, or headache. Pt's vitals are stable BP 118/82, P 81, O2 98% and R 16. After 55 minutes, pt reports the pain is "a lot better." Educated pt to continue to monitor and notify PCP of persisting or worsening pain as well as any edema not resulting in increased SOB. Also educated pt to go to the ER should she experience any sudden difficulty breathing, chest pain, dizziness, hives, etc. Pt verbalizes understanding.
Age: 0.58
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Body temperature increased
Clinical narrative: Temp 100.4 -> 100.8. No site soreness or redness.
Age: 72.0
Sex: M
Vaccine: HEPA, TD, TYP, YF
Symptoms: Facial paralysis, Nasopharyngitis, Rash
Clinical narrative: Initial unsolicited report received from a physician assistant on 26-AUG-2016. This case involves a male patient (age not reported) who was vaccinated with a first dose of YELLOW FEVER VACCINE (YF) (batch number: UI293AA, expiry date: 20-Apr-2018, subcutaneously in the left deltoid), a first dose of TYPHIM VI (batch number: L1072-1, expiry date: 17-Feb-2017, intramuscularly in the right deltoid), a dose of HEP A (manufacturer: unknown) and a dose of TD (manufacturer: Mass Bio) (for HEP A and TD: batch number, dose, dose in series, route and site of administration was not reported) on 27-Jul-2016. Patient had no illness at the time of vaccination. Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as no known allergies (Unknown medical conditions). Concomitant medications were not reported. On an unspecified date, few days following the vaccination, the patient developed rash and cold. The same week patient called reporter and was diagnosed with Bells Palsy. The patient required ER/ doctor visit. Lab data and corrective treatment were not reported. The patient was recovered from event cold and rash (improved) and not recovered from event Bells Palsy. Upon medical review, the case was considered as serious due to important medical event: Bells palsy. It was reported that the family MD did not think it was related. List of documents held by sender: none.; Sender's Comments: Bell's palsy was suspected in this case, however diagnosis was not conformed. The cause of Bell's palsy is unknown. Risk factors include diabetes and a recent upper respiratory tract infection. Time to onset is unknown. Additional information on investigation results ruling out a concurrent infection and exploration of alternate etiologies, time to onset and patient's history of reaction after previous vaccinations are needed to further assess this case. However, as four vaccines were administered concomitantly, the role of each component cannot be assessed.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Pain, Rotator cuff syndrome
Clinical narrative: Sharp pain when abducting or rotation or lifting of the arm that the injection was in. Injection site still painful to touch. rotator cuff feels to be messed up.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot
Clinical narrative: Redness on triceps and biceps; warmth.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Dizziness, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of nausea in a 50-year-old female patient who received BOOSTRIX (batch number 7RJ9B, expiry date 18th November 2018). Concurrent medical conditions included latex allergy. On 19th July 2016, the patient received BOOSTRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving BOOSTRIX, the patient experienced nausea (serious criteria other: as per reporter), back pain (serious criteria other: as per reporter), dizziness (serious criteria other: as per reporter), injection site warmth (serious criteria other: as per reporter), injection site swelling (serious criteria other: as per reporter) and clot blood (serious criteria GSK medically significant and other: as per reporter). On an unknown date, the outcome of the nausea, back pain, dizziness, injection site warmth, injection site swelling and clot blood were unknown. It was unknown if the reporter considered the nausea, dizziness, injection site warmth, injection site swelling and clot blood to be related to BOOSTRIX. The reporter considered the back pain to be related to BOOSTRIX. Additional details were reported as follows: It was noted the patient had a latex allergy and was given a prefilled syringe dose. On 19th July 2016 at 13:15 hours, the patient received BOOSTRIX on the left arm. On the day of reporting the patient visited the neurologist, who believed that patient might had a clot. The neurologist offered no treatment recommendations so the patient called back to the pharmacy. As per reporter, the appointment with the neurologist was not for the reactions to the vaccine. As per reported information, the site, which had swelling and warmth as it was pushed, the patient experienced pain in back below shoulder blade. The pharmacist was not aware of when the issues exactly began or if any had resolved. The reporter denied to provide information of any treatment recommendations given or advised to the patient by any physician. The patient took other medications, but the pharmacist declined to provide. The patient approved the reporting pharmacist to provide name and number to GSK. The National Drug Code (NDC) 58160-0842-52 was also provided.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Thrombosis
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of nausea in a 50-year-old female patient who received BOOSTRIX (batch number 7RJ9B, expiry date 18th November 2018). Concurrent medical conditions included latex allergy. On 19th July 2016, the patient received BOOSTRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving BOOSTRIX, the patient experienced nausea (serious criteria other: as per reporter), back pain (serious criteria other: as per reporter), dizziness (serious criteria other: as per reporter), injection site warmth (serious criteria other: as per reporter), injection site swelling (serious criteria other: as per reporter) and clot blood (serious criteria GSK medically significant and other: as per reporter). On an unknown date, the outcome of the nausea, back pain, dizziness, injection site warmth, injection site swelling and clot blood were unknown. It was unknown if the reporter considered the nausea, dizziness, injection site warmth, injection site swelling and clot blood to be related to BOOSTRIX. The reporter considered the back pain to be related to BOOSTRIX. Additional details were reported as follows: It was noted the patient had a latex allergy and was given a prefilled syringe dose. On 19th July 2016 at 13:15 hours, the patient received BOOSTRIX on the left arm. On the day of reporting the patient visited the neurologist, who believed that patient might had a clot. The neurologist offered no treatment recommendations so the patient called back to the pharmacy. As per reporter, the appointment with the neurologist was not for the reactions to the vaccine. As per reported information, the site, which had swelling and warmth as it was pushed, the patient experienced pain in back below shoulder blade. The pharmacist was not aware of when the issues exactly began or if any had resolved. The reporter denied to provide information of any treatment recommendations given or advised to the patient by any physician. The patient took other medications, but the pharmacist declined to provide. The patient approved the reporting pharmacist to provide name and number to GSK. The National Drug Code (NDC) 58160-0842-52 was also provided.
Age: 16.0
Sex: F
Vaccine: MEN
Symptoms: Urticaria
Clinical narrative: Hives from head to lower neck.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Chapped lips, Exfoliative rash, Feeling hot, Immunoglobulin therapy, Kawasaki's disease
Clinical narrative: Felt warm and later started having fevers Tmax of 102F. Seen on 08/15/16 for persistent fevers with chapped lips, desquamative rash. Later Dx as Kawasaki disease. Admitted at medical center for 3 days with IVIG and Aspirin treatment. Normal Echo findings. Discharged home on 8/18/16.
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia, Ultrasound scan normal
Clinical narrative: Felt warm and later started having fevers Tmax of 102F. Seen on 08/15/16 for persistent fevers with chapped lips, desquamative rash. Later Dx as Kawasaki disease. Admitted at medical center for 3 days with IVIG and Aspirin treatment. Normal Echo findings. Discharged home on 8/18/16.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Abasia, Cold sweat, Disorientation, Dizziness, Hyperacusis
Clinical narrative: Faint, dizziness, disorientated, pale, clammy/sweating, sensation that the room was spinning, unable to walk, nauseated, excruciating migraine headache pain, light & sound sensitivity.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Hyperhidrosis, Migraine, Nausea, Neurological examination normal, Pallor
Clinical narrative: Faint, dizziness, disorientated, pale, clammy/sweating, sensation that the room was spinning, unable to walk, nauseated, excruciating migraine headache pain, light & sound sensitivity.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Photophobia, Syncope, Vertigo, Vestibular function test normal
Clinical narrative: Faint, dizziness, disorientated, pale, clammy/sweating, sensation that the room was spinning, unable to walk, nauseated, excruciating migraine headache pain, light & sound sensitivity.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Nausea, Pyrexia
Clinical narrative: Approximately 12 hours after receiving vaccines patient had 103 degree fever, dizziness and nausea. Symptoms had already resolved and patient was well before mother contacted me.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Eyelid oedema
Clinical narrative: Swollen lower left eyelid. Patient is a lifeguard parent agreed eye infection was possible. Advised doctor visit, mom never returned my follow-up calls.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Seconds after receiving vaccines patient had an episode of syncope. Her B/P was 98/52, she was given water and crackers. I checked her B/P 10 minutes later and it was 100/68, and the same 5 minutes later. Her color returned, she stated she felt well and she left with her grandmother and returned to school.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Pruritus, Rash erythematous
Clinical narrative: Noticed in the evening of 8/30 small red raised rash around injection site of left arm. By the morning of 8/31 she had the red raised rash to bilateral arms. Zyrtec taken without improvement. Pt complained of itchiness to both arms but it was tolerable. No rash noted on trunk, back, legs. No other symptoms noted. Pt sent to student medicine to see a provider.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Pt reported redness, swelling, burning at the site and on upper left arm surrounding the entire bicep and shoulder area. Also reported mild fever. Pt visited dr and received antibiotic.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Tingling in L hand (same side she received the vaccine) about 5 minutes after vaccine.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Rash
Clinical narrative: Pt reported to Mother she was itching and hurting. Mother observed a rash under left breast radiating to left side and back.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Arthralgia, Arthritis, Full blood count normal, Red blood cell sedimentation rate normal
Clinical narrative: Extensive arthritis and arthralgias affecting all small joints of all 4 extremities as well as major joints of all 4 extremities and numerous sites along vertebrae.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left leg 5x5 inch swelling, redness and warm to the touch.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Contusion, Dermatofibroma removal, Fatigue, Fibrous histiocytoma, Influenza
Clinical narrative: Major bruising, fever, flu symptoms that lasted for two weeks. In 2016 a tumor (dermatofibroma) was found at the injection site. It had to be removed and tested for cancer.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Injection site reaction, Pathology test, Pyrexia
Clinical narrative: Major bruising, fever, flu symptoms that lasted for two weeks. In 2016 a tumor (dermatofibroma) was found at the injection site. It had to be removed and tested for cancer.
Age: 37.0
Sex: F
Vaccine: FLUX, HEPAB
Symptoms: Hypopnoea, Urticaria
Clinical narrative: HIVES ON CHEST. SLIGHT, SHALLOW BREATHING.
Age: 73.0
Sex: F
Vaccine: PNC
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Goose egg on arm at injection site, redness, soreness followed by chills, severe muscle aches and fever between 100-101. Visited Dr. at Urgent care clinic 09/01/2016, Hydrocodon-Homatropin 5-1 .5mg/5 SYR and Azithromycin 250mg tab (6 count).  As of today, 09/01/2016, all symptoms still present except swelling of injection site has subsided.
Age: 73.0
Sex: F
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: Goose egg on arm at injection site, redness, soreness followed by chills, severe muscle aches and fever between 100-101. Visited Dr. at Urgent care clinic 09/01/2016, Hydrocodon-Homatropin 5-1 .5mg/5 SYR and Azithromycin 250mg tab (6 count).  As of today, 09/01/2016, all symptoms still present except swelling of injection site has subsided.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dyspnoea, Erythema, Rash macular, Speech disorder
Clinical narrative: Patient became red and blotchy, trouble breathing and trouble with speech.  Patient received O2.  Patient was watched in the office for 1 hour.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Peripheral swelling, Skin warm
Clinical narrative: PATIENT REPORTED SWELLING, HEAT, AND REDNESS FROM SHOULDER TO ELBOW. ON 8/31/16 SHE SAID SHE COULD BARELY LIFT ARM.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Ear infection, Fatigue, Food allergy, Headache, Infectious mononucleosis
Clinical narrative: Started with headache for several weeks. Swollen lymph nodes, chronic ear infections, mono, exhaustion, sudden food allergies, still undiagnosed.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Lymphadenopathy
Clinical narrative: Started with headache for several weeks. Swollen lymph nodes, chronic ear infections, mono, exhaustion, sudden food allergies, still undiagnosed.
Age: 0.58
Sex: M
Vaccine: MMRV
Symptoms: Blood test normal, Contusion, Crying, Erythema, Full blood count normal
Clinical narrative: I started to see bruising on my sons body and two days later, he woke suddenly from his nap crying that he hurt. He hurt in several places on his body that he can identify (joints). The bruising was present in different locations but continued. A scratch would turn into a bruise and things like what they call his "stork bite" turned very red. At this exact time of him waking from his nap upset, his vaccine injection site had a dime size red mark that had previously not shown up and he had a fever of 101-102 that day. This turned to him crying uncontrollably that evening to where we would hyperventilate almost as well as very lethargic. He kept complaining that he was in pain.
Age: 0.58
Sex: M
Vaccine: MMRV
Symptoms: Hyperventilation, Lethargy, Pain, Pyrexia, Scratch
Clinical narrative: I started to see bruising on my sons body and two days later, he woke suddenly from his nap crying that he hurt. He hurt in several places on his body that he can identify (joints). The bruising was present in different locations but continued. A scratch would turn into a bruise and things like what they call his "stork bite" turned very red. At this exact time of him waking from his nap upset, his vaccine injection site had a dime size red mark that had previously not shown up and he had a fever of 101-102 that day. This turned to him crying uncontrollably that evening to where we would hyperventilate almost as well as very lethargic. He kept complaining that he was in pain.
Age: 43.0
Sex: M
Vaccine: MENB
Symptoms: Arthralgia, Discomfort, Fatigue, Grip strength decreased, Headache
Clinical narrative: Neck pain, headache. My arm was painful and swollen for 16 days (iced daily for first three days). Unusual fatigue. Fevers daily, for the first 5 days fevers were about 101 degrees, now they are very mild. Night sweats. Aug. 19th I started to have difficulty holding a toothbrush, I thought I had just over-worked my hand in the studio). Aug. 22 late afternoon I started having excessive pain throughout the body but focused in joints with tingling and muscle weakness. Aug 26th and 27th the pain was so intense that I almost went to the emergency room and it felt like there was movement/pressure under my skin (cried with every movement). Around 10pm on the 27th the intense pain started to release and I had extreme tingling and itching in my hands and feet. The pressure released. Today, I feel very tired, but the intense pain is subsiding. Between the 22nd and last night, I could not touch anything without intense pain.
Age: 43.0
Sex: M
Vaccine: MENB
Symptoms: Muscular weakness, Neck pain, Night sweats, Pain, Pain in extremity
Clinical narrative: Neck pain, headache. My arm was painful and swollen for 16 days (iced daily for first three days). Unusual fatigue. Fevers daily, for the first 5 days fevers were about 101 degrees, now they are very mild. Night sweats. Aug. 19th I started to have difficulty holding a toothbrush, I thought I had just over-worked my hand in the studio). Aug. 22 late afternoon I started having excessive pain throughout the body but focused in joints with tingling and muscle weakness. Aug 26th and 27th the pain was so intense that I almost went to the emergency room and it felt like there was movement/pressure under my skin (cried with every movement). Around 10pm on the 27th the intense pain started to release and I had extreme tingling and itching in my hands and feet. The pressure released. Today, I feel very tired, but the intense pain is subsiding. Between the 22nd and last night, I could not touch anything without intense pain.
Age: 43.0
Sex: M
Vaccine: MENB
Symptoms: Paraesthesia, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Neck pain, headache. My arm was painful and swollen for 16 days (iced daily for first three days). Unusual fatigue. Fevers daily, for the first 5 days fevers were about 101 degrees, now they are very mild. Night sweats. Aug. 19th I started to have difficulty holding a toothbrush, I thought I had just over-worked my hand in the studio). Aug. 22 late afternoon I started having excessive pain throughout the body but focused in joints with tingling and muscle weakness. Aug 26th and 27th the pain was so intense that I almost went to the emergency room and it felt like there was movement/pressure under my skin (cried with every movement). Around 10pm on the 27th the intense pain started to release and I had extreme tingling and itching in my hands and feet. The pressure released. Today, I feel very tired, but the intense pain is subsiding. Between the 22nd and last night, I could not touch anything without intense pain.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient was given the wrong dose of vaccine. Patient received 0.5mL when should have received 0.25. No adverse event noted.
Age: 68.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: In error, patient was given vaccine outside of recommended dosing schedule. No adverse events per patient and product manufacturer. TWINRIX 2nd and 3rd dose given 1 month apart instead of 5 months. Manufacturer recommended redosing 3rd vaccine in 6 months.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Nausea
Clinical narrative: The patient received her first Gardasil-9 immunization on 2/2/2016. The next day she had a little dizziness. We told her that was one of the side effects listed and was common. Her second immunization was 4/2/2016. Within 24 hours after receiving it, she experienced dizziness again plus some nausea. Her third and last immunization of Gardasil-9 was 8/21/2016. Within 24 hours, she experienced more pronounced dizziness and nausea. I told her that the symptoms were expected but not as pronounced as she described.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Mobility decreased, Myalgia
Clinical narrative: Injection site placed high on shoulder. Muscle pain, cannot lift arm above shoulder, lasting for more than 3 days. Treated with ibuprofen as needed.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: His whole upper arm almost triple in size. Swollen, red, very painful. Low grade fever. Tylenol, Ibuprofen, Ice. This was the 3rd year he reacted on flu vaccine.
Sex: M
Vaccine: MENB
Symptoms: Dyspnoea
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of shortness of breath in a adolescent male patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO .5 ml. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced shortness of breath (serious criteria other: serious as per reporter). On an unknown date, the outcome of the shortness of breath was recovered/resolved. It was unknown if the reporter considered the shortness of breath to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The dose of BEXSERO which was received by the patient was believed to be his first dose and he was then seen at the local emergency department for shortness of breath. The specifics of the emergency request (ER) visit were unknown, but the issues were resolved at the time of reporting. This case has not been reported to VAERS. All questions were asked, but limited information was provided by sales representative. This case has been linked to case US2016122906, reported by the same reporter.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Cough, Headache, Nausea, Neck pain
Clinical narrative: 9-1-16 - 6 days past flu vaccine c/o body aches, HA, nausea, cough, neck and back pain. No fever.
Age: 21.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: 9-1-16 - 6 days past flu vaccine c/o body aches, HA, nausea, cough, neck and back pain. No fever.
Age: 30.0
Sex: F
Vaccine: FLUC4
Symptoms: Pruritus, Swelling face
Clinical narrative: Patient received FLUCELVAX and started to itch with facial swelling within one hour of vaccination. Patient received prednisone 20 mg taper and diphenhydramine 25 mg (100 mg dose) with no relief. Recovery time was approx. 2 days.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Medication error
Clinical narrative: No symptoms observed while patient was present in pharmacy. Medication was still in vial after attempted administration.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Computerised tomogram abdomen abnormal, Crohn's disease, Diarrhoea
Clinical narrative: The morning following vaccine administration the patient got diarrhea.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral coldness, Sensory loss
Clinical narrative: Patient's arm became cold the following morning. Slightly lost feeling.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest X-ray normal, Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Gave PNEUMOVAX 23 IM (R) deltoid. Customer states area became red, swollen approx. 1 1/2 later (hours). Also had fever. Area became swollen, red and hot to touch. Lump formed. Went to MD office and he prescribed BENADRYL. States this did help.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Gave PNEUMOVAX 23 IM (R) deltoid. Customer states area became red, swollen approx. 1 1/2 later (hours). Also had fever. Area became swollen, red and hot to touch. Lump formed. Went to MD office and he prescribed BENADRYL. States this did help.
Age: 68.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site bruising
Clinical narrative: Unusual bruising occurred the day after the FLUAD shot was given. No pain. No side effects. Bruising down bicep muscle approx. 1 in lower than injection - About 2 inches wide. Bruising at site of injection also.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: High fever = 105.5° F. Went to an insta care.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling at injection site - treatment: prednisone 10 mg.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Conjunctivitis, Epistaxis
Clinical narrative: Epistaxis x 2 day after HPV 9.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Movement disorder, Musculoskeletal pain, Pain in extremity
Clinical narrative: After the shot, pain developed in my left shoulder and arm. I have had pain and restricted movement ever since. Treatment included prednisone, physical therapy, a cortisone shot, MRI, and exercised. This started Jan. 2016 to now Aug. 26, 2016. It is not as bad but still a significant problem.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Fatigue, Injection site swelling, Nasal congestion, Pain, Pyrexia
Clinical narrative: Fever, nasal congestion, tired and achy, slight swelling at injection site.
Age: 79.0
Sex: F
Vaccine: HEPA
Symptoms: Asthenia, Influenza like illness, Injection site erythema, Pain in extremity
Clinical narrative: Localized erythema at the site of injection (after vaccination) -> then she developed arm pain and body weakness later like flu-like symptoms.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness, also swelling >5 days noted at injection site.
Age: 10.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Pyrexia, Tongue pruritus
Clinical narrative: The day after the immunization, most of patient's left bicep muscle was red, hot and itched. She had a fever of 103 degrees. The second day after the immunization her tongue also itched. Mother was told to give ibuprofen and BENADRYL. About 5 days later she was back to normal.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Immunization was given on a Monday. Patient states that approx. 24-26 hours later, noticed site was getting red and sore. By the next day, it was hard, warm and red. Dr. saw patient, documented site at 5 cm diameter redness, 3 cm in duration, cellulitis.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Headache, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Vaccine 8/24/16 930am; arm sore that night; 8/25/16 hard to raise arm and Fever 102 degree that night; took TYLENOL. Body aches, ears red, headache -tried Ibuprofen and sinus MUCINEX for HA - still has as of 8/29/16; Started itching and blotching on 8/28/16; soreness gone aches gone; Recommended TAGAMENT and BENADRYL for arm itching.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Pyrexia, Rash macular
Clinical narrative: Vaccine 8/24/16 930am; arm sore that night; 8/25/16 hard to raise arm and Fever 102 degree that night; took TYLENOL. Body aches, ears red, headache -tried Ibuprofen and sinus MUCINEX for HA - still has as of 8/29/16; Started itching and blotching on 8/28/16; soreness gone aches gone; Recommended TAGAMENT and BENADRYL for arm itching.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Pain, Pyrexia, Swelling
Clinical narrative: 8/25/16 In (R) deltoid IM Tdap - developed fever 101.7 8/27/`6 - noticed (R) swelling, pain and erythema 8/29/16.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Eye injury, Fall, Gaze palsy, Limb injury, Loss of consciousness
Clinical narrative: About 3 min after vaccines were admin. pt's eyes rolled back and pt became unconc. fell off exam table hit Rt. eye on handle of stand. Lasted about 1 min. Hurt leg.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling and warm at injection site.
Age: 16.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Cold sweat, Hypotension, Pallor
Clinical narrative: After 10 min. patient began to have cold sweats and turn pale. Low BP.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Staphylococcal infection
Clinical narrative: Pt. was seen by an infxn. disease dr and was diagnosed w/Staph infxn. at injection site.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On an unspecified dates, the patients received an improperly stored doses of GARDASIL (dose and route of administration were not provided) (lot numbers: J012438, expiration date: 5-OCT-2015; J009098, expiration date: 04-DEC-2015; J012435, expiration date: 05-OCT-2015; L001442, expiration date: 04-NOV-2016; K023435, expiration date: 05-NOV-2015; K011492, expiration date: 22-JUN-2016; K001500, expiration date: 06-NOV-2016; reported as "K004601", expiration date: 04-NOV-2016; J003727, expiration date: 07-NOV-2016; K008213, expiration date: 17-DEC-2016; reported as " K020246", expiration date: unknown, L004601 expiration date: unknown). No adverse effects were reported. No product quality complaint (PQC) was involved. Lot numbers: K004601 and K020246 are invalid lot numbers for GARDASIL. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot# 1013428, expiry date: 03-FEB-2017 (dosing details were not reported). No adverse symptoms were reported. There were no product quality complaints (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Ovarian disorder
Clinical narrative: This spontaneous report was received from a consumer, who posted an article, via a company representative, which refers to a 16 year old female patient. The patients' medical history and concurrent condition were not reported. On an unknown date the patient was vaccinated with GARDASIL (Lot number, expiration date, concentration, route of administration, dose and frequency were not reported). Information regarding concomitant medication was not provided. It was reported that on an unknown date, the patient experienced an "apparently damage to her ovaries after being administered GARDASIL" (ovarian disorder). It was also reported "about how GARDASIL is "deadly" and is supposedly causing damage to women's reproductive systems" (reproductive tract disorder). At the time of the report, the outcome of the adverse events was unknown. The causality between the adverse events and GARDASIL was not reported. Additional information is not expected.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reaction/allergies was not reported. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VAIRVAX (lot #, expiration date, dose and route were unknown). No adverse effect was reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 22-AUG-2014, the patient was vaccinated with the first dose of GARDASIL (lot # K001631 with expiration date 06-NOV-2016, dose and route were not reported). On 03-AUG-2015, the patient was vaccinated with the second dose of GARDASIL (lot # K010215 with expiration date 05-MAY-2017, dose and route were not reported) (inappropriate schedule of vaccine administered). On 09-OCT-2015, the patient was vaccinated with GARDASIL 9 reported as the "third dose"; lot # K026247 with expiration date 20-JAN-2017, dose unknown, intramuscular) (interchange of vaccine products). The outcome of the events was unknown. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot #, expiration date, dose and route were unknown). No adverse effect was reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a registered nurse referring to an unknown number of patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On unspecified dates starting on or after 21-JUL-2016, the patients were administered doses of improperly stored PROQUAD injection (lot # M004897, expiration date 26-JUL-2017, recombinant human albumin (rHA); lot# reported as L011528 which was invalid, expiration date 03-APR-2017; lot# M003436, expiration date 19-JUL-2017, recombinant human albumin (rHA) (dose and route unknown). The vaccines were exposed to 24.3 Fahrenheit degree (F) for 2 hours 50 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old female patient. The patient had no pertinent medical history, had no drug reactions or allergies and did not take any concomitant medications. On 24-AUG-2016, the patient was vaccinated with ZOSTAVAX (strength, dose, lot # and expiry date were not reported), subcutaneously in the triceps muscle. At the same time, she was also vaccinated with diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 24-AUG-2016, the patient experienced rash at injection site. There was no treatment given for the event. The outcome of the event was reported as not recovered/not resolved at the time of the report. The patient sought medical attention via contacting pharmacist. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 18-AUG-2016, the patient was inadvertently administered a dose of improperly stored ZOSTAVAX (lot# M020071, expired date 18-JUL-2017, dose unknown) subcutaneously. The vaccine was exposed under 46 Fahrenheit degree (F) for 11 hours. There was no previous temperature excursion. Digital date logger was not involved. No adverse effect was reported. Additional information has been requested.
Sex: M
Vaccine: HPVX
Symptoms: Injection site pain
Clinical narrative: Information has been received via a company representative from a male patient of twenty-five or twenty-six years old referring to himself. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On an unknown date, the patient was vaccinated with an unspecified human papilloma virus (HPV) vaccine (manufacturer unknown) (lot #, expiration date, dose and route were unknown). The patient stated that the shot really hurt. It was unknown if the patient sought medical attention, if treatment was given for the event or if lab diagnostics studies were performed. At the reporting time, the patient "looked fine". The causality of the event was not reported. Additional information is not expected as no contact information was provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were possibly vaccinated with improperly stored doses of (Oka/Merck) VARIVAX lot # M009766, expiration date 23-FEB-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced a temperature excursion of 6 degrees Fahrenheit for 48 hours. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: HPV9
Symptoms: Asthenia, Nausea, Vomiting
Clinical narrative: This spontaneous report was received from Registered Nurse (R.N.), via a company representative, referring to a male patient of unknown age. The patient was allergic to NEOSPORIN. Other relevant medical history was not reported. In approximately June 2016 (reported as 1 to 2 months ago), the patient was vaccinated with the first dose of GARDASIL 9. Dose, route, lot # and anatomical location were not reported. It was stated that later that night the patient became very weak and sick to his stomach and vomited twice. The patient's parent sought medical attention and called the physician. It was not a product quality complaint involved. At the time of reporting the patient had no recovered from events. The causality assessment between the events and the suspect therapy was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated with improperly stored doses of M-M-R II (lot number L024268 and expiration date 01-JUL-2017, albumin status therapy type, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown demographics. The patients' concurrent conditions, medical history and concomitant medications were not reported. Since 19-JUN-2016, the patients' were vaccinated with improperly stored doses of GARDASIL from lot # L040459 with expiry date of 06-AP-2017 (dose, dose number and route not reported). No adverse effects were reported. No product quality complaint was involved. This is one of the two reports received from the same reporter. Additional information has been requested.