chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Hypotension, Pruritus, Rash, Swollen tongue, Urticaria
Clinical narrative: Patient complained of itching an hour after the Flu shot given. He progressively became hypotensive (SBP 70s), and hives with tongue swelling were noted. Patient was treated with 25mg of IV BENADRYL x 2, 20mg IV PEPCID, 125mg SOLU-MEDROL and a 1L NaCl bolus. At 1509, the rash and tongue swelling were markedly improved. Patient was at baseline the next day and was discharged on 1/23/2017 to rehab.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX (dose, route and site of administration, lot # and expiry date were not reported) for prophylaxis. No adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site reaction, Peripheral swelling
Clinical narrative: Information has been received from a female patient of unknown age, who is also a physician, via a company representative. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unknown date (reported as "approximately 2 years prior to the second dose"), the patient was vaccinated with the first dose of PNEUMOVAX23 (strength, dose, route of administration, lot# and expiration date were not reported), for prophylaxis. Subsequently, on an unknown date, the patient was hospitalized for an unspecified adverse event and during the hospitalization she was vaccinated with the second dose of PNEUMOVAX23 (strength, dose, route of administration, lot# and expiration date were not reported), for prophylaxis. The patient indicated that she was not aware that she was vaccinated with the second dose at the time. On an unknown date, the patient experienced a severe reaction at the injection site; her whole arm was swollen and red. It was reported that an unspecified treatment was given for the adverse event. At the time of reporting, the patient recovered from the reaction at the injection site. The outcome of the adverse event, which caused the hospitalization was unknown. The causality assessment between PNEUMOVAX23 and the events was not reported. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, red, itching, hot to touch, thick 3.5 inches around the injection site, redness 6.5 inches around the injection site.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient experienced pain, swelling, and redness at injection site immediately after vaccination. Visited urgent care on 1/28/2017 with possible infection at injection site.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Injection site pain
Clinical narrative: Patient reports joint soreness in the arm where injected.  Also reports joint soreness in contralateral arm and knuckles on left hand.
Age: 1.75
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse events reported.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Eyelid pain, Eyelid rash, Headache, Rash
Clinical narrative: Got ZOSTAVAX on 12/28 and around 1/17 had a really bad headache until 1/20 felt a bump on my eyelid that was really sore, 2 days later another bump popped up on the side of my eye and about 2 days later 2 or 3 more popped up in my eye brow above that eye and one on my forehead. So on 1/27the I went to my dermatologist and they had started coming to a head and the one on my eyelid looked like an ulcer.  She said it looked like an insect bite or shingles which I really believe it is shingle because now my eye and face on that side are swollen and all the bumps have scabbed over and are really red around them.  When I looked up the ZOSTAVAX drug insert I read about post vaccination Zoster rashes that occurred up to 42 days after vaccine.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Scab
Clinical narrative: Got ZOSTAVAX on 12/28 and around 1/17 had a really bad headache until 1/20 felt a bump on my eyelid that was really sore, 2 days later another bump popped up on the side of my eye and about 2 days later 2 or 3 more popped up in my eye brow above that eye and one on my forehead. So on 1/27the I went to my dermatologist and they had started coming to a head and the one on my eyelid looked like an ulcer.  She said it looked like an insect bite or shingles which I really believe it is shingle because now my eye and face on that side are swollen and all the bumps have scabbed over and are really red around them.  When I looked up the ZOSTAVAX drug insert I read about post vaccination Zoster rashes that occurred up to 42 days after vaccine.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event
Clinical narrative: No adverse events reported.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Bedridden, Bone pain, Chest pain, Erythema
Clinical narrative: Nausea, severe right sided hea ache, right arm swollen and extreme pain when touched or moved, pain down spinal cord resting in hips then knees and bone marrow of legs. Extreme fatigue. All has lasted 5 days since shot. Redness and swelling has spred down to elbow of right arm, sinuses stuffed up, chest pain from congestion.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Headache, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: Nausea, severe right sided hea ache, right arm swollen and extreme pain when touched or moved, pain down spinal cord resting in hips then knees and bone marrow of legs. Extreme fatigue. All has lasted 5 days since shot. Redness and swelling has spred down to elbow of right arm, sinuses stuffed up, chest pain from congestion.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Respiratory tract congestion, Sinus congestion, Spinal pain
Clinical narrative: Nausea, severe right sided hea ache, right arm swollen and extreme pain when touched or moved, pain down spinal cord resting in hips then knees and bone marrow of legs. Extreme fatigue. All has lasted 5 days since shot. Redness and swelling has spred down to elbow of right arm, sinuses stuffed up, chest pain from congestion.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unknown number of patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with ZOSTAVAX, injection, subcutaneously (lot#, expiration date and dose were not reported) with diluent (lot# and expiration date were not reported) which was kept in frozen temperature conditions, less than - 15 degrees Celsius. No known side effects were reported. No previous temperature excursions were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-11701USA013576: US-009507513-1701USA013577:
Sex: U
Vaccine: HPV9
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 ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with an improperly stored doses of GARDASIL 9 lot number reported as "L040459" with an expiration date on 06-APR-2017 (Strength, dose, anatomical location and administration route were not reported) for prophylaxis. No adverse symptoms were reported.  The vaccines had a temperature excursion of -1 Celsius (C) during 95 days. No previous temperature excursions were reported and it was reported that a digital data logger was involved. No product quality complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unknown number of patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with VARIVAX, injection, subcutaneously (lot#, expiration date and dose were not reported) with diluent (lot# and expiration date were not reported) which was kept in frozen temperature conditions, less than - 15 degrees Celsius. No known side effects were reported. No previous temperature excursions were reported.  Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA013577: US-009507513-1701USA005859:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unknown number of patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with PROQUAD, injection, subcutaneously (lot#, expiration date and dose were not reported) with diluent (lot# and expiration date were not reported) which was kept in frozen temperature conditions, less than - 15 degrees Celsius. No known side effects were reported. No previous temperature excursions were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA005859: US-009507513-1701USA013576:
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Drug hypersensitivity, Product used for unknown indication, Rhinorrhoea, Urticaria
Clinical narrative: A report has been received from a consumer concerning a 6 years 6 months old female patient. Patient's concurrent diseases and relevant history was not provided. In Oct-2015, the patient received nasal FLUMIST QUADRIVALENT (intranasal) for in lieu of flu shot and in Apr-2016, patient had received unknown Penicillin for unknown indication. In Apr-2016, it was reported that reaction to penicillin broke out in hives (preferred term: urticaria) when the patient took Penicillin in Apr-2016 and that she experienced runny nose (preferred term: rhinorrhoea). Action taken with the suspect drug of Penicillin was unknown. At the time of reporting, the patient recovered from broke out in hives and the outcome of the runny nose was not recovered. Company physician assessed runny nose and broke out in hives to be non-serious.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Anal pruritus, Bacterial infection, Dysuria, Genital pain, Gynaecological examination
Clinical narrative: AT HOME; painful itching stinging sensation in started in the front of my private area, spread to the rear on private region, lasted for 2 days. On the 20th, went to Urgent care, diagnosed with dysuria, bacterial cervical infection in the cervix, vagina and anal itching. Was given nystatin cream, flagyl tablets and macrobid. On 22nd at 09:45 went to ER for all day. IV hep drip. diagnosed of vulvovaginitis. GYN exam for lichens sclerosis.  Prescribed clobetasol. Problems got worse pain level 25.
Age: 34.0
Sex: F
Vaccine: MMR
Symptoms: Lichen sclerosus, Pain, Pruritus genital, Vulvovaginal pruritus, Vulvovaginitis
Clinical narrative: AT HOME; painful itching stinging sensation in started in the front of my private area, spread to the rear on private region, lasted for 2 days. On the 20th, went to Urgent care, diagnosed with dysuria, bacterial cervical infection in the cervix, vagina and anal itching. Was given nystatin cream, flagyl tablets and macrobid. On 22nd at 09:45 went to ER for all day. IV hep drip. diagnosed of vulvovaginitis. GYN exam for lichens sclerosis.  Prescribed clobetasol. Problems got worse pain level 25.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, FLU4
Symptoms: No adverse event
Clinical narrative: No adverse events reported.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Impaired work ability, Inflammation
Clinical narrative: Inflammation, required dr visit, missed work.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site reaction, Urticaria
Clinical narrative: Kinrix given, then Proquad.  As soon as Proquad was given, He developed a large welt next to injection site. Dr. informed and Benadryl given with good effect.  Parents advised to wait in waiting room for 20 mins.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMRV
Symptoms: Injection site reaction, Rash, Rash maculo-papular
Clinical narrative: Maculopapular rash on chest, abdomen, and thighs.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: VERY SORE ARM AND LARGE RED CIRCLE OF THE INSIDE OF UPPER RIGHT ARM. not IN THE AREA OF THE INJECTION.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Weakness, numbness in legs.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Eye inflammation, Mouth swelling, Ocular hyperaemia, Pharyngeal oedema, Rash
Clinical narrative: Hives developed after flu vaccine 10/5/16. Developed mild sense of swelling in the back of throat and mouth. Skin rash/hives. Erythema and inflammation of the eyes. Vomiting. Presented to ED and was admitted as inpatient for treatment.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria, Vomiting
Clinical narrative: Hives developed after flu vaccine 10/5/16. Developed mild sense of swelling in the back of throat and mouth. Skin rash/hives. Erythema and inflammation of the eyes. Vomiting. Presented to ED and was admitted as inpatient for treatment.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Confusional state, Decreased appetite, Disturbance in attention, Dizziness postural
Clinical narrative: I have been having a terrible reaction to the shot I got yesterday. I could not sleep in ANY position because the shot site was so sore today I have had shivers and my hands have been freezing and numb all day this message was sent to my PCP at 06:18 PM on 1/25/17. Fever and uncontrollable shakes seem to have disappeared and my appetite seems to be coming back. My actual arm is feeling a little better - not so sore today I have experienced cold hands and my fingers keep locking up. In addition, my eyes seem to have trouble adjusting to the bright light and focusing. My co-workers told me that my speech was not as clear as usual, but I didn't notice. I did some physical work and found that I tired quickly, taking breaks as needed. Just a slight amount of dizziness when I stand up. Some confusion and inability to focus on tasks at hand had me concerned. This message was sent to my PCP on 1/27/17 at 5:17 PM. The past two days the arm injection site is still sore and red, but not unbearable. I still have pounding in my head and can hear my heartbeat. In addition, I have ringing in both ears when it was previously just in the left ear. The sweats, fever, shakes, chills, and muscle spasms have seemed to change into a sinus infection, green phlegm, and earaches with a lot of pressure in my head currently. My hearing has been altered and my wife says that I am yelling because I can't hear.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Ear pain, Fatigue, Head discomfort, Headache, Hyperhidrosis
Clinical narrative: I have been having a terrible reaction to the shot I got yesterday. I could not sleep in ANY position because the shot site was so sore today I have had shivers and my hands have been freezing and numb all day this message was sent to my PCP at 06:18 PM on 1/25/17. Fever and uncontrollable shakes seem to have disappeared and my appetite seems to be coming back. My actual arm is feeling a little better - not so sore today I have experienced cold hands and my fingers keep locking up. In addition, my eyes seem to have trouble adjusting to the bright light and focusing. My co-workers told me that my speech was not as clear as usual, but I didn't notice. I did some physical work and found that I tired quickly, taking breaks as needed. Just a slight amount of dizziness when I stand up. Some confusion and inability to focus on tasks at hand had me concerned. This message was sent to my PCP on 1/27/17 at 5:17 PM. The past two days the arm injection site is still sore and red, but not unbearable. I still have pounding in my head and can hear my heartbeat. In addition, I have ringing in both ears when it was previously just in the left ear. The sweats, fever, shakes, chills, and muscle spasms have seemed to change into a sinus infection, green phlegm, and earaches with a lot of pressure in my head currently. My hearing has been altered and my wife says that I am yelling because I can't hear.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Hypoacusis, Hypoaesthesia, Injection site erythema, Injection site pain, Mobility decreased
Clinical narrative: I have been having a terrible reaction to the shot I got yesterday. I could not sleep in ANY position because the shot site was so sore today I have had shivers and my hands have been freezing and numb all day this message was sent to my PCP at 06:18 PM on 1/25/17. Fever and uncontrollable shakes seem to have disappeared and my appetite seems to be coming back. My actual arm is feeling a little better - not so sore today I have experienced cold hands and my fingers keep locking up. In addition, my eyes seem to have trouble adjusting to the bright light and focusing. My co-workers told me that my speech was not as clear as usual, but I didn't notice. I did some physical work and found that I tired quickly, taking breaks as needed. Just a slight amount of dizziness when I stand up. Some confusion and inability to focus on tasks at hand had me concerned. This message was sent to my PCP on 1/27/17 at 5:17 PM. The past two days the arm injection site is still sore and red, but not unbearable. I still have pounding in my head and can hear my heartbeat. In addition, I have ringing in both ears when it was previously just in the left ear. The sweats, fever, shakes, chills, and muscle spasms have seemed to change into a sinus infection, green phlegm, and earaches with a lot of pressure in my head currently. My hearing has been altered and my wife says that I am yelling because I can't hear.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Muscle spasms, Palpitations, Peripheral coldness, Photophobia, Pyrexia
Clinical narrative: I have been having a terrible reaction to the shot I got yesterday. I could not sleep in ANY position because the shot site was so sore today I have had shivers and my hands have been freezing and numb all day this message was sent to my PCP at 06:18 PM on 1/25/17. Fever and uncontrollable shakes seem to have disappeared and my appetite seems to be coming back. My actual arm is feeling a little better - not so sore today I have experienced cold hands and my fingers keep locking up. In addition, my eyes seem to have trouble adjusting to the bright light and focusing. My co-workers told me that my speech was not as clear as usual, but I didn't notice. I did some physical work and found that I tired quickly, taking breaks as needed. Just a slight amount of dizziness when I stand up. Some confusion and inability to focus on tasks at hand had me concerned. This message was sent to my PCP on 1/27/17 at 5:17 PM. The past two days the arm injection site is still sore and red, but not unbearable. I still have pounding in my head and can hear my heartbeat. In addition, I have ringing in both ears when it was previously just in the left ear. The sweats, fever, shakes, chills, and muscle spasms have seemed to change into a sinus infection, green phlegm, and earaches with a lot of pressure in my head currently. My hearing has been altered and my wife says that I am yelling because I can't hear.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Sinusitis, Sleep disorder, Speech disorder, Sputum discoloured, Tinnitus
Clinical narrative: I have been having a terrible reaction to the shot I got yesterday. I could not sleep in ANY position because the shot site was so sore today I have had shivers and my hands have been freezing and numb all day this message was sent to my PCP at 06:18 PM on 1/25/17. Fever and uncontrollable shakes seem to have disappeared and my appetite seems to be coming back. My actual arm is feeling a little better - not so sore today I have experienced cold hands and my fingers keep locking up. In addition, my eyes seem to have trouble adjusting to the bright light and focusing. My co-workers told me that my speech was not as clear as usual, but I didn't notice. I did some physical work and found that I tired quickly, taking breaks as needed. Just a slight amount of dizziness when I stand up. Some confusion and inability to focus on tasks at hand had me concerned. This message was sent to my PCP on 1/27/17 at 5:17 PM. The past two days the arm injection site is still sore and red, but not unbearable. I still have pounding in my head and can hear my heartbeat. In addition, I have ringing in both ears when it was previously just in the left ear. The sweats, fever, shakes, chills, and muscle spasms have seemed to change into a sinus infection, green phlegm, and earaches with a lot of pressure in my head currently. My hearing has been altered and my wife says that I am yelling because I can't hear.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Tremor, Vision blurred
Clinical narrative: I have been having a terrible reaction to the shot I got yesterday. I could not sleep in ANY position because the shot site was so sore today I have had shivers and my hands have been freezing and numb all day this message was sent to my PCP at 06:18 PM on 1/25/17. Fever and uncontrollable shakes seem to have disappeared and my appetite seems to be coming back. My actual arm is feeling a little better - not so sore today I have experienced cold hands and my fingers keep locking up. In addition, my eyes seem to have trouble adjusting to the bright light and focusing. My co-workers told me that my speech was not as clear as usual, but I didn't notice. I did some physical work and found that I tired quickly, taking breaks as needed. Just a slight amount of dizziness when I stand up. Some confusion and inability to focus on tasks at hand had me concerned. This message was sent to my PCP on 1/27/17 at 5:17 PM. The past two days the arm injection site is still sore and red, but not unbearable. I still have pounding in my head and can hear my heartbeat. In addition, I have ringing in both ears when it was previously just in the left ear. The sweats, fever, shakes, chills, and muscle spasms have seemed to change into a sinus infection, green phlegm, and earaches with a lot of pressure in my head currently. My hearing has been altered and my wife says that I am yelling because I can't hear.
Age: 14.0
Sex: M
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse events reported.
Age: 16.0
Sex: M
Vaccine: DTAP, MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse events reported.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: No adverse event
Clinical narrative: No adverse events reported.
Age: 59.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Induration, Local swelling, Mass, Pain
Clinical narrative: Quarter size swollen painful hard lump just below injection site. Continued to increase in size. Pain and redness on area. By next morning swollen size was 6 inches by 3 inches. At 7:00 PM 1/28/2017, upper arm from top of shoulder down to 3 inches above elbow, and 5 inches across. Hot to the touch, swelling, redness, extreme pain.
Age: 59.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Skin warm
Clinical narrative: Quarter size swollen painful hard lump just below injection site. Continued to increase in size. Pain and redness on area. By next morning swollen size was 6 inches by 3 inches. At 7:00 PM 1/28/2017, upper arm from top of shoulder down to 3 inches above elbow, and 5 inches across. Hot to the touch, swelling, redness, extreme pain.
Age: 59.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Erythema, Injection site erythema, Injection site swelling, Swelling
Clinical narrative: Quarter size swollen painful hard lump just below injection site. Continued to increase in size. Pain and redness on area. By next morning swollen size was 6 inches by 3 inches. At 7:00 PM 1/28/2017, upper arm from top of shoulder down to 3 inches above elbow, and 5 inches across. Hot to the touch, swelling, redness, extreme pain.
Age: 21.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Cellulitis, Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Redness, lump and warmth to site.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Chills, Fatigue, Influenza like illness, Pain
Clinical narrative: Achy joints, sore, very fatigued as soon as I woke up by lunch time had a low fever/chills, felt like flu.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Pyrexia
Clinical narrative: Achy joints, sore, very fatigued as soon as I woke up by lunch time had a low fever/chills, felt like flu.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Induration, Swelling face, Vertigo
Clinical narrative: Entire Face swelled up, vertigo as well. Areas of face where Juviderm filler had been injected in Aug 2016 stayed swollen and became hard since.
Age: 56.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives/Itching in arms and neck. Still present today 01/30/2017. Taking OTC Benadryl at night. Has improved since 1/26/17.
Age: 1.08
Sex: F
Vaccine: DTAPIPVHIB, HEP, HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site rash, Rash
Clinical narrative: MOM CALLED CLINIC APPROX 6 HRS AFTER VACCINES WERE GIVEN. STATED PATIENT HAD A RASH ON LEGS, GROIN, AND STOMACH. DENIED FEVER AND STATED RASH DID NOT SEEM TO BOTHER (ITCH) PATIENT. STATED SHE WOULD F/U WITH PCP IF RASH PERSISTED.
Age: 56.0
Sex: M
Vaccine: HEPAB, RAB, RAB
Symptoms: Abdominal pain upper, Asthenia, Chest discomfort, Constipation, Cough
Clinical narrative: Loss of hand strength in both hands noticed in March & April 2015. Progression led to loss of muscle and strength control in both legs and arms, with a noticed of a slapping of feet when walking. Within the next few months, numbness and severe tingling developed in both feet and both hands. Coughing, difficulty swallowing, shortness of breath, tightness in both chest and back, stomach pains, and constipation and diarrhea variations have developed to this point.
Age: 56.0
Sex: M
Vaccine: HEPAB, RAB, RAB
Symptoms: Diarrhoea, Dysphagia, Dyspnoea, Grip strength decreased, Hypoaesthesia
Clinical narrative: Loss of hand strength in both hands noticed in March & April 2015. Progression led to loss of muscle and strength control in both legs and arms, with a noticed of a slapping of feet when walking. Within the next few months, numbness and severe tingling developed in both feet and both hands. Coughing, difficulty swallowing, shortness of breath, tightness in both chest and back, stomach pains, and constipation and diarrhea variations have developed to this point.
Age: 56.0
Sex: M
Vaccine: HEPAB, RAB, RAB
Symptoms: Loss of control of legs, Muscle tightness, Muscular weakness, Paraesthesia, Peroneal nerve palsy
Clinical narrative: Loss of hand strength in both hands noticed in March & April 2015. Progression led to loss of muscle and strength control in both legs and arms, with a noticed of a slapping of feet when walking. Within the next few months, numbness and severe tingling developed in both feet and both hands. Coughing, difficulty swallowing, shortness of breath, tightness in both chest and back, stomach pains, and constipation and diarrhea variations have developed to this point.
Age: 56.0
Sex: M
Vaccine: HEPAB, RAB, RAB
Symptoms: Autoimmune disorder, Chest discomfort, Dyspnoea, Fall, Gait disturbance
Clinical narrative: Loss of hand strength in both hands noticed in March & April 2015. Progression led to loss of muscle and strength control in both legs and arms, with a noticed of a slapping of feet when walking. Within the next few months, numbness and severe tingling developed in both feet and both hands. Coughing, difficulty swallowing, shortness of breath, tightness in both chest and back, stomach pains, and constipation and diarrhea variations have developed to this point.
Age: 56.0
Sex: M
Vaccine: HEPAB, RAB, RAB
Symptoms: Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Mobility decreased, Movement disorder
Clinical narrative: Loss of hand strength in both hands noticed in March & April 2015. Progression led to loss of muscle and strength control in both legs and arms, with a noticed of a slapping of feet when walking. Within the next few months, numbness and severe tingling developed in both feet and both hands. Coughing, difficulty swallowing, shortness of breath, tightness in both chest and back, stomach pains, and constipation and diarrhea variations have developed to this point.
Age: 56.0
Sex: M
Vaccine: HEPAB, RAB, RAB
Symptoms: Paraesthesia, Peroneal nerve palsy
Clinical narrative: Loss of hand strength in both hands noticed in March & April 2015. Progression led to loss of muscle and strength control in both legs and arms, with a noticed of a slapping of feet when walking. Within the next few months, numbness and severe tingling developed in both feet and both hands. Coughing, difficulty swallowing, shortness of breath, tightness in both chest and back, stomach pains, and constipation and diarrhea variations have developed to this point.
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 15 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 08-NOV-2016, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB (dose and route not reported) from lot # M025194 with expiry date 22-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all follow up information has been received; Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140:
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 15 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 31-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019, for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all follow up information has been received. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 15 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 01-NOV-2016, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB (dose and route not reported) from lot # M025194, expiry date: 22-MAR-2019, for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all follow up information has been received; Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140:
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 15 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 01-NOV-2016, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019, for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all follow up information has been received; Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140:
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information was received on 11-JAN-2017 from a registered nurse via a company representative regarding a male patient.  Medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that the patient received his first dose of GARDASIL intramuscular in 2014, and he received his second dose of GARDASIL intramuscular in 2015 (considered inappropriate schedule of vaccine administration). Action taken was not applicable and the outcome was unknown. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Autoimmune disorder, Disability, Malaise, Myofascitis
Clinical narrative: This spontaneous report was received from a social media by a physician (who is the father) refers to female patient (who is the daughter) of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL. The consumer stated that the patient went from a varsity lacrosse player to chronically ill, steroid dependent with autoimmune myofascitis (disability) after taking the GARDASIL. The outcome of the event was unknown. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: This spontaneous report was received from a social media via physician refers to atleast 32 female patients of unknown age. There was no information on concomitant medication, medical history and concurrent condition. On an unknown date, the patients were vaccinated with GARDASI) dose 0.5ml, intramuscular (lot # not reported). On an unknown date, the patients died. It was reported that it was unclear whether the death were related to the vaccine, and patients death after the shot did not mean the shots were necessary to blame. Upon internal review, the event of death was determined to be medically significant. This case has been linked with the MARRS case no. 1701USA010389. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer, who reported for herself. A 65-year-old female patient received the first dose of PREVNAR 13 , on 16Jan2017 at 8:30-9:30 am, at 0.5 ml single in arm, to not get pneumonia (immunization).  Medical history included right hip replacement on 13Jan2015, rheumatoid arthritis, blood pressure and arthritis. Concomitant medication included vitamin B12 taken for about a half a year and ongoing, tocilizumab (ACTEMRA) from Feb2016 and ongoing for rheumatoid arthritis , atenolol for blood pressure since years and ongoing , hydrochlorothiazide/ lisinopril for blood pressure since years, diclofenac sodium for arthritis from fall of 2016 and ongoing  and  cefalexin (CEPHALEXIN) due to  hip replacement from Jan2015 and ongoing.  The patient previously took methotrexate ,leflunomide, allopurinol and mometasone furoate (ASMANEX) and experienced drug hypersensitivity and shortness breath. The shortness of breath was during use of the products and once stopped , it went away completely. In late 2015 she received adalimumab (HUMIRA) every 2 weeks or twice a month (she only took 3 shots ) and experienced forgetfulness and shortness of breath. A couple years before the report (date unspecified) she took ciprofloxacin and had difficulty swallowing and shortness of breath. She had also  allergy to monosodium glutamate (MSG).In Jan2017, after vaccination,  the patient experienced headache and shortness of breath. Headache was mild and pressure. She took diphenhydramine hydrochloride (BENADRYL) off and on because she is allergic to MSG, but symptoms came back. Her rheumatologist suggested switching to loratadine (CLARITIN) and she took it last night.  The final outcome of the events was not recovered.
Age: 73.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Injection site pain, Injection site reaction, Sensation of foreign body
Clinical narrative: This is a spontaneous report from a contactable pharmacist.  A 73-year-old male patient of an unspecified ethnicity received PREVNAR 13 , lot number N16515 , expiration date 01Oct2017 NDC number 0005197102, intramuscular in Upper arm on 23Sep2016 at 0.5 ml, single for immunisation.  Medical history included blood pressure abnormal from an unknown date and unknown if ongoing.  Concomitant vaccine included influenza vaccine (AFLURIA).  The patient previously took varicella zoster vaccine, and influenza vaccine (FLU VACCINE).  The patient experienced has mild pain at the site of injection and felt as though something was where injected from Dec2016 with outcome of not recovered.
Age: 13.0
Sex: M
Vaccine: HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Dyskinesia, Hyperhidrosis, Hypotonia, Immediate post-injection reaction, Skin warm
Clinical narrative: Immediately after receiving his fifth vaccine shot in a row, patient became limp and was placed lying flat. He momentarily threw his arms up. He regained a drowsy consciousness in 5 seconds, was warm and diaphoretic with HR of 80. Patient or his father would not allow a BP or OX reading. He remained lying for 30 minutes then was able to walk well.
Age: 13.0
Sex: M
Vaccine: HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Somnolence
Clinical narrative: Immediately after receiving his fifth vaccine shot in a row, patient became limp and was placed lying flat. He momentarily threw his arms up. He regained a drowsy consciousness in 5 seconds, was warm and diaphoretic with HR of 80. Patient or his father would not allow a BP or OX reading. He remained lying for 30 minutes then was able to walk well.
Age: 12.0
Sex: F
Vaccine: FLU4, HEP, HEPA, HPV9, IPV, MMR, TDAP, VARCEL, FLU4, HEP, HEPA, HPV9, IPV, MMR, TDAP, VARCEL
Symptoms: Eye swelling, Macule, Ocular hyperaemia, Papule, Pyrexia
Clinical narrative: Child arrived from another country 3 weeks before arriving to clinic for school entry vaccines. Family are refugees with no obtainable vaccine records. Vaccines were given on 01/09/2017. A rash started to the upper chest on 01/16/2017. The rash progressed to the upper back, and two lesions on the face (right forehead and medial right eyebrow regions) over the next two days. Student was seen in the clinic on 01/18/2017 for stomach rash and history of fever. There were approximately 10 lesions on the upper chest and 10 lesions on the upper back. The lesions appeared as small macules, papules, and scabbed lesions. There were no fluid filled vesicles noted. The student was restricted from school entrance for 7 days. Epidemiology (County)was contacted and provided the timeline symptoms, history etc. They concurred and the child remained in isolation at home. The mother appeared to the clinic without the child on 01/20/2017 stating that there was swelling and redness around the right eye. The mother was instructed to take the child to the ER at Medical Center (two blocks away from clinic) for R/O periorbital cellulitis. The mother returned to the school on 01/24/2017 with an ER note confirming the Varicella diagnosis and asking to be checked prior to school entrance by clinic NP. There was one lesion on the left that was not fully scabbed and the child was restricted 24 hours more for school entry. The child was evaluated on 01/25/2017 and all lesions were scabbed. The child had approximately 40-50 scabbed lesion to chest, abdomen, back both arms, and legs without sequelae.
Age: 12.0
Sex: F
Vaccine: FLU4, HEP, HEPA, HPV9, IPV, MMR, TDAP, VARCEL, FLU4, HEP, HEPA, HPV9, IPV, MMR, TDAP, VARCEL
Symptoms: Rash, Scab, Skin lesion, Varicella post vaccine
Clinical narrative: Child arrived from another country 3 weeks before arriving to clinic for school entry vaccines. Family are refugees with no obtainable vaccine records. Vaccines were given on 01/09/2017. A rash started to the upper chest on 01/16/2017. The rash progressed to the upper back, and two lesions on the face (right forehead and medial right eyebrow regions) over the next two days. Student was seen in the clinic on 01/18/2017 for stomach rash and history of fever. There were approximately 10 lesions on the upper chest and 10 lesions on the upper back. The lesions appeared as small macules, papules, and scabbed lesions. There were no fluid filled vesicles noted. The student was restricted from school entrance for 7 days. Epidemiology (County)was contacted and provided the timeline symptoms, history etc. They concurred and the child remained in isolation at home. The mother appeared to the clinic without the child on 01/20/2017 stating that there was swelling and redness around the right eye. The mother was instructed to take the child to the ER at Medical Center (two blocks away from clinic) for R/O periorbital cellulitis. The mother returned to the school on 01/24/2017 with an ER note confirming the Varicella diagnosis and asking to be checked prior to school entrance by clinic NP. There was one lesion on the left that was not fully scabbed and the child was restricted 24 hours more for school entry. The child was evaluated on 01/25/2017 and all lesions were scabbed. The child had approximately 40-50 scabbed lesion to chest, abdomen, back both arms, and legs without sequelae.
Age: 12.0
Sex: F
Vaccine: FLU4, HEP, HEPA, HPV9, IPV, MMR, TDAP, VARCEL, FLU4, HEP, HEPA, HPV9, IPV, MMR, TDAP, VARCEL
Symptoms: Erythema of eyelid, Eyelid oedema, Macule, Papule, Pyrexia
Clinical narrative: Child arrived from another country 3 weeks before arriving to clinic for school entry vaccines. Family are refugees with no obtainable vaccine records. Vaccines were given on 01/09/2017. A rash started to the upper chest on 01/16/2017. The rash progressed to the upper back, and two lesions on the face (right forehead and medial right eyebrow regions) over the next two days. Student was seen in the clinic on 01/18/2017 for stomach rash and history of fever. There were approximately 10 lesions on the upper chest and 10 lesions on the upper back. The lesions appeared as small macules, papules, and scabbed lesions. There were no fluid filled vesicles noted. The student was restricted from school entrance for 7 days. Epidemiology (County)was contacted and provided the timeline symptoms, history etc. They concurred and the child remained in isolation at home. The mother appeared to the clinic without the child on 01/20/2017 stating that there was swelling and redness around the right eye. The mother was instructed to take the child to the ER at Medical Center (two blocks away from clinic) for R/O periorbital cellulitis. The mother returned to the school on 01/24/2017 with an ER note confirming the Varicella diagnosis and asking to be checked prior to school entrance by clinic NP. There was one lesion on the left that was not fully scabbed and the child was restricted 24 hours more for school entry. The child was evaluated on 01/25/2017 and all lesions were scabbed. The child had approximately 40-50 scabbed lesion to chest, abdomen, back both arms, and legs without sequelae.
Age: 12.0
Sex: F
Vaccine: FLU4, HEP, HEPA, HPV9, IPV, MMR, TDAP, VARCEL, FLU4, HEP, HEPA, HPV9, IPV, MMR, TDAP, VARCEL
Symptoms: Rash, Scab, Skin lesion
Clinical narrative: Child arrived from another country 3 weeks before arriving to clinic for school entry vaccines. Family are refugees with no obtainable vaccine records. Vaccines were given on 01/09/2017. A rash started to the upper chest on 01/16/2017. The rash progressed to the upper back, and two lesions on the face (right forehead and medial right eyebrow regions) over the next two days. Student was seen in the clinic on 01/18/2017 for stomach rash and history of fever. There were approximately 10 lesions on the upper chest and 10 lesions on the upper back. The lesions appeared as small macules, papules, and scabbed lesions. There were no fluid filled vesicles noted. The student was restricted from school entrance for 7 days. Epidemiology (County)was contacted and provided the timeline symptoms, history etc. They concurred and the child remained in isolation at home. The mother appeared to the clinic without the child on 01/20/2017 stating that there was swelling and redness around the right eye. The mother was instructed to take the child to the ER at Medical Center (two blocks away from clinic) for R/O periorbital cellulitis. The mother returned to the school on 01/24/2017 with an ER note confirming the Varicella diagnosis and asking to be checked prior to school entrance by clinic NP. There was one lesion on the left that was not fully scabbed and the child was restricted 24 hours more for school entry. The child was evaluated on 01/25/2017 and all lesions were scabbed. The child had approximately 40-50 scabbed lesion to chest, abdomen, back both arms, and legs without sequelae.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Musculoskeletal pain, Nuclear magnetic resonance imaging normal, X-ray normal
Clinical narrative: Patient reported lingering shoulder pain after flu shot in Nov. Went to ortho and he said she had bursitis. Pain continued despite several steroid shots. X-ray and MRI were unremarkable per pt.
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Musculoskeletal pain, Neck pain, Pain, Pain in extremity
Clinical narrative: I woke up the morning of the 12th with a knot of soreness in the left upper arm at the site of my tetanus vaccination. Since then I have developed extreme soreness in my arm, shoulder blade, and neck. I have reduced range of motion in my left arm. I have intermittent burning pain radiating up my arm to my neck. NSAIDs, Tylenol, warming pads, and sore muscle creams do not adequately dampen the pain. The pain is so intense and that it often keeps me up at night. I will have to have a follow up appointment as the pain seems to be intensifying.