chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: FLUX, HEPA, TYP, TYP
Symptoms: Dizziness, Nausea
Clinical narrative: Case Narrative: This case was found during archiving activities and has not previously been entered into the global safety database. The case was processed using procedural documents and current labeling documents. This spontaneous report was received from other healthcare professional and concerns a 20 year old female. The subject's weight, height and medical history were not reported. On 07-DEC-1998 3:30pm, the subject received VIVOTIF (capsule, hard, oral, batch 0150891B). Concomitant medications included hepatitis A vaccine and influenza vaccine. On 07-DEC-1998 9:30, the subject experienced severe dizziness and nausea. The subject was taken to the emergency room and treated at ER with intravenous fluids for three hours. Action taken with typhoid vaccine oral ty21a was unknown. The subject had recovered from severe dizziness and nausea on an unspecified date and discharged from the hospital. This report was serious (hospitalization). This case was found during archiving activities and has not previously been entered into the global safety database. The case was processed using procedural documents and current labeling documents. Additional information was received on 09-DEC-1998 partner number VIV-9836 was added to the case.
Age: 49.0
Sex: M
Vaccine: FLUC3
Symptoms: Electromyogram, Guillain-Barre syndrome, Immunoglobulin therapy, Laboratory test, Lumbar puncture
Clinical narrative: Started w/ weakness in legs and progressed to being unable to move body and limbs. Went to emergency room transferred to another hospital Sept 26-Oct 3. Transferred to a third hospital on Oct 3-Oct. 21. Readmitted to 2nd hospital Oct. 21-Nov. 5 then back to third hospital Nov. 5-Dec. 10. Lab work, IVIG, plasma exchange, EMG, Lumbar puncture, ultrasound, ADL, OT, PT.
Age: 49.0
Sex: M
Vaccine: FLUC3
Symptoms: Mobility decreased, Muscular weakness, Myalgia, Plasmapheresis, Ultrasound scan
Clinical narrative: Started w/ weakness in legs and progressed to being unable to move body and limbs. Went to emergency room transferred to another hospital Sept 26-Oct 3. Transferred to a third hospital on Oct 3-Oct. 21. Readmitted to 2nd hospital Oct. 21-Nov. 5 then back to third hospital Nov. 5-Dec. 10. Lab work, IVIG, plasma exchange, EMG, Lumbar puncture, ultrasound, ADL, OT, PT.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Angioplasty, Autoimmune disorder, Back pain, Blood test normal, Computerised tomogram
Clinical narrative: Case number PHHY2015US027734 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 557264) website on 05 Mar 2015 and with a follow-up information from the VAERS received on 25 Aug 2015. This report refers to an 11 years old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with meningococcal vaccine (manufacturer and batch number unknown, hence conservatively coded as meningococcal ACYW-135 vaccine INN) in the right arm on 03 Oct 2014. On the same day, she also received ADACEL (other manufacturer, batch number: not reported) in the right arm and GARDASIL (other manufacturer, batch number: not reported) in the left arm; all vaccines administered on 03 Oct 2014. On 10 Oct 2014, she had sustained massive headache and back ache. She was taken to emergency room. Many diagnostic tests including multiple blood tests and x-rays were done, but they did not reveal anything. One week later, she was taken to hospital with progressively worse symptoms and was hospitalized for 20 days. Magnetic Resonance Imaging (MRI) was performed and blood clot was found in the vein in head. Intracranial pressure was off the charts and she spent a full month in hospital being treated. She had multiple scans (including Computerized Tomogram (CT), sonogram) and multiple surgeries including craniotomy. She had 5 MRIs and six lumbar punctures to relieve the building spinal pressure. Angioplasty was done, but could not remove blood clot successfully. AS of 08 Dec 2014, she was still on cerebrospinal fluid medication and required ongoing lumbar puncture. Doctors diagnosed her with an unspecified autoimmune response. The outcome of the events was unknown. The events were reported as life threatening. The causality of the events was not reported. Upon follow-up it was reported that the patient received MENACTRA (other manufacturer) and not a Novartis vaccine. Hence this case will be deactivated. Follow-up information from the VAERS received on 25 Aug 2015: The patient received MENACTRA (other manufacturer) and not a Novartis vaccine. Hence this case will be deactivated.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Craniotomy, Headache, Intracranial pressure increased, Lumbar puncture, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Case number PHHY2015US027734 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 557264) website on 05 Mar 2015 and with a follow-up information from the VAERS received on 25 Aug 2015. This report refers to an 11 years old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with meningococcal vaccine (manufacturer and batch number unknown, hence conservatively coded as meningococcal ACYW-135 vaccine INN) in the right arm on 03 Oct 2014. On the same day, she also received ADACEL (other manufacturer, batch number: not reported) in the right arm and GARDASIL (other manufacturer, batch number: not reported) in the left arm; all vaccines administered on 03 Oct 2014. On 10 Oct 2014, she had sustained massive headache and back ache. She was taken to emergency room. Many diagnostic tests including multiple blood tests and x-rays were done, but they did not reveal anything. One week later, she was taken to hospital with progressively worse symptoms and was hospitalized for 20 days. Magnetic Resonance Imaging (MRI) was performed and blood clot was found in the vein in head. Intracranial pressure was off the charts and she spent a full month in hospital being treated. She had multiple scans (including Computerized Tomogram (CT), sonogram) and multiple surgeries including craniotomy. She had 5 MRIs and six lumbar punctures to relieve the building spinal pressure. Angioplasty was done, but could not remove blood clot successfully. AS of 08 Dec 2014, she was still on cerebrospinal fluid medication and required ongoing lumbar puncture. Doctors diagnosed her with an unspecified autoimmune response. The outcome of the events was unknown. The events were reported as life threatening. The causality of the events was not reported. Upon follow-up it was reported that the patient received MENACTRA (other manufacturer) and not a Novartis vaccine. Hence this case will be deactivated. Follow-up information from the VAERS received on 25 Aug 2015: The patient received MENACTRA (other manufacturer) and not a Novartis vaccine. Hence this case will be deactivated.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Procedural complication, Thrombosis, Ultrasound scan, X-ray normal
Clinical narrative: Case number PHHY2015US027734 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 557264) website on 05 Mar 2015 and with a follow-up information from the VAERS received on 25 Aug 2015. This report refers to an 11 years old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with meningococcal vaccine (manufacturer and batch number unknown, hence conservatively coded as meningococcal ACYW-135 vaccine INN) in the right arm on 03 Oct 2014. On the same day, she also received ADACEL (other manufacturer, batch number: not reported) in the right arm and GARDASIL (other manufacturer, batch number: not reported) in the left arm; all vaccines administered on 03 Oct 2014. On 10 Oct 2014, she had sustained massive headache and back ache. She was taken to emergency room. Many diagnostic tests including multiple blood tests and x-rays were done, but they did not reveal anything. One week later, she was taken to hospital with progressively worse symptoms and was hospitalized for 20 days. Magnetic Resonance Imaging (MRI) was performed and blood clot was found in the vein in head. Intracranial pressure was off the charts and she spent a full month in hospital being treated. She had multiple scans (including Computerized Tomogram (CT), sonogram) and multiple surgeries including craniotomy. She had 5 MRIs and six lumbar punctures to relieve the building spinal pressure. Angioplasty was done, but could not remove blood clot successfully. AS of 08 Dec 2014, she was still on cerebrospinal fluid medication and required ongoing lumbar puncture. Doctors diagnosed her with an unspecified autoimmune response. The outcome of the events was unknown. The events were reported as life threatening. The causality of the events was not reported. Upon follow-up it was reported that the patient received MENACTRA (other manufacturer) and not a Novartis vaccine. Hence this case will be deactivated. Follow-up information from the VAERS received on 25 Aug 2015: The patient received MENACTRA (other manufacturer) and not a Novartis vaccine. Hence this case will be deactivated.
Age: 56.0
Sex: M
Vaccine: FLUX, TDAP
Symptoms: Epistaxis, Immunoglobulin therapy, Melaena, Oral disorder, Platelet transfusion
Clinical narrative: Case number PHHY2015US103600, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 559880) website on 25 Aug 2015. This report refers to a 56 year old male patient. Medical history included gastrooesophageal reflux disease, hyperlipidemia, hypertension and erectile dysfunction (on omeprazole, atorvastatin, amlodipine and VIAGRA). His father had hemochromatosis for which he was a heterozygote (previously tested). He was non-smoker and drinks alcohol rarely. Concomitant medications included omeprazole, atorvastatin, amlodipine and sildenafil. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) along with ADACEL (other manufacturer, batch number: not reported) both on 11 Nov 2014. On 27 Nov 2014, the patient experienced profound thrombocytopenia causing epistaxis, melena and painless oral lesions. This required an emergency room visit and hospitalization on the general medical floor to receive steroids, intravenous immunoglobulins and "4 platelet transfusions". Outcome of the events was not reported. Events were reported as serious (life threatening). Causality of the events was not reported.
Age: 56.0
Sex: M
Vaccine: FLUX, TDAP
Symptoms: Thrombocytopenia
Clinical narrative: Case number PHHY2015US103600, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 559880) website on 25 Aug 2015. This report refers to a 56 year old male patient. Medical history included gastrooesophageal reflux disease, hyperlipidemia, hypertension and erectile dysfunction (on omeprazole, atorvastatin, amlodipine and VIAGRA). His father had hemochromatosis for which he was a heterozygote (previously tested). He was non-smoker and drinks alcohol rarely. Concomitant medications included omeprazole, atorvastatin, amlodipine and sildenafil. The patient was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: not reported) along with ADACEL (other manufacturer, batch number: not reported) both on 11 Nov 2014. On 27 Nov 2014, the patient experienced profound thrombocytopenia causing epistaxis, melena and painless oral lesions. This required an emergency room visit and hospitalization on the general medical floor to receive steroids, intravenous immunoglobulins and "4 platelet transfusions". Outcome of the events was not reported. Events were reported as serious (life threatening). Causality of the events was not reported.
Age: 57.0
Sex: M
Vaccine: PNC13, VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 57 year old male patient with no drug reactions or allergies. The patient's pertinent medical history was not reported. On 28-JUL-2015, the patient was vaccinated with ZOSTAVAX 0.65 ml subcutaneous injection, lot # L006381, expiration date 25-MAY-2016 (site of vaccination not reported). Concomitant therapies included RAPAFLO, NORVASC, COREG, VIAGRA and simvastatin (manufacturer unknown). On 30-JUL-2015, the patient experienced injection site rash. The patient came to see the pharmacist on 07-AUG-2015. The reporter stated that on 07-AUG-2015, the patient had "small bumps that were barely visible" at the site of injection. It was also reported that the site was itchy (onset date unspecified). The patient had taken over the counter medication for symptomatic treatment; BENADRYL (dose unspecified) and topical cortisone cream. The outcome of the events was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: PNC13, VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 57 year old male patient with no drug reactions or allergies. The patient's pertinent medical history was not reported. On 28-JUL-2015, the patient was vaccinated with ZOSTAVAX 0.65 ml subcutaneous injection, lot # L006381, expiration date 25-MAY-2016 (site of vaccination not reported). Concomitant therapies included RAPAFLO, NORVASC, COREG, VIAGRA and simvastatin (manufacturer unknown). On 30-JUL-2015, the patient experienced injection site rash. The patient came to see the pharmacist on 07-AUG-2015. The reporter stated that on 07-AUG-2015, the patient had "small bumps that were barely visible" at the site of injection. It was also reported that the site was itchy (onset date unspecified). The patient had taken over the counter medication for symptomatic treatment; BENADRYL (dose unspecified) and topical cortisone cream. The outcome of the events was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Road traffic accident, Syncope
Clinical narrative: On 8/24/15 patient received his MENACTRA. Nurse observed no problems in office. He went to his car and per mom drove 7 minutes and had a syncope incident and was in a car accident. None syncope in past.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 60-year-old male patient. The patient's concurrent conditions and medical history were not reported. The patient did not have any concomitant medications or past drug history.   On 13-AUG-2015, the patient was vaccinated with a dose of expired zoster vaccine live (ZOSTAVAX) 0.65 ml, lot number K000325, expiration date 27-FEB-2015 (frequency and route were unknown) for prevention of shingles. There was no symptoms reported. It was unknown if there was any relevant lab work done. It was unknown if the patient would continue on the zoster vaccine live (ZOSTAVAX) at reporting time.   Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HPV4
Symptoms: Penile swelling, Peripheral swelling, Swelling face
Clinical narrative: Mother called 3 days later and said that her son had swelling in arm, face, and penis the day after vaccine administered. She gave him Benadryl and it went down. She did not want to bring him in to be seen.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Blindness unilateral, Hypoaesthesia, Nuclear magnetic resonance imaging normal, Paraesthesia
Clinical narrative: Numbness, tingling, loss of vision on the right side of body.  Arm parasthesia resolving as of 9-1-15.  Was seen at Hospital, MRI negative. Seeing a pediatric neurologist at Hospital 9-1-2015.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Urticaria, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Redness of skin formed on scalp Sunday AM.  Sunday afternoon the condition went to her forehead and both sides of ears. The pain increased Sunday afternoon.  Monday morning the red areas turned to welts and her arm in area of vaccination became hot to the touch and swollen.  Tuesday morning at about 9:35 patient says that she is feeling better after recieving doses of valtrex and clindamycin
Age: 0.76
Sex: M
Vaccine: HEP, HIBV, PNC13
Symptoms: Cyanosis, Eye movement disorder, Pyrexia, Seizure
Clinical narrative: My 9 month old son went in to receive his "routine" vaccines and after getting the Hib, Pneumo conjugate, and HepB shots at around 9:30 am, he ended up going into a full-blown seizure later that night (at about 1 am). It was the most terrifying thing I ever experienced, our baby's whole body convulsed, his eyes were rolled back and his lips were turning blue! It lasted for almost 2 minutes and we had no idea if he was breathing. It was the scariest thing I've ever experienced and we will never forget that trauma. We thought vaccines were supposed to keep our baby safe and here we were calling 911 in the middle of the night because our small baby was having a seizure due to a vaccination! We took an ambulance ride to the ER and they observed him for a few hours after dosing him with Tylenol and Motrin (his fever was at 103.5 AFTER forty-five minutes of administering the liquid Tylenol and Motrin). So they kept him to make sure his fever would go down and to make sure he wouldn't have another seizure. It was a horrible, scary night. We believed the pediatricians when they said that vaccines were given to help keep our baby from getting sick and here we were in the ER with a sick baby because of a vaccination, how ironic. Later that morning, we immediately called the health dept. and told them what happened and they made a note of it in his file. Needless to say, he won't be getting any more injections because I can not see my baby like that ever again. The chance is too high that he could've not come out of it, or he could've had neurological damage. It was a huge wake up call. I used to roll my eyes at anti-vaxxers until this happened to us personally. Now I realize that it's not until you see your little baby go through something so horrible and scary that you question vaccines. Once it happens personally to you and the person you love the most, nothing is worth that chance that he could be hurt or damaged from a vaccine permanently.
Age: 59.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Headache, Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: Within 1-2 minutes after receiving Hep B vaccine and Pneumococcal-23 vaccine, patient develop red rash, swelling, warmth and itching at both right and left ante-cubital area of each arm. Rash approximately 4 in diameter. Swelling approx 2 in diameter. Itching moved down arms. Pt c/o mild left sided headache but has been having headaches recently. Pt was monitored for 45 minutes with resolution of symptoms. No medications were given to treat symptoms. Pt was discharged to home.
Age: 59.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Rash erythematous
Clinical narrative: Within 1-2 minutes after receiving Hep B vaccine and Pneumococcal-23 vaccine, patient develop red rash, swelling, warmth and itching at both right and left ante-cubital area of each arm. Rash approximately 4 in diameter. Swelling approx 2 in diameter. Itching moved down arms. Pt c/o mild left sided headache but has been having headaches recently. Pt was monitored for 45 minutes with resolution of symptoms. No medications were given to treat symptoms. Pt was discharged to home.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Circumstance or information capable of leading to medication error, Immunisation
Clinical narrative: Patients mother did not have hold of childs arms well while vaccine was being administered. Childs reached down and pulled vaccine out of his leg. Vaccine had to be re-administered.
Age: 62.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Erythema, Malaise, Pain in extremity, Peripheral swelling
Clinical narrative: Patient had influenza and pneumonia vaccine on 8/26/2015.  Woke up the next day and his right arm was painful, red, swollen and warm.  He was not feeling well and felt feverish.  He presented to an urgent care facility and was diagnosed with a cellulitis and placed on antibiotics.
Age: 62.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pyrexia, Skin warm
Clinical narrative: Patient had influenza and pneumonia vaccine on 8/26/2015.  Woke up the next day and his right arm was painful, red, swollen and warm.  He was not feeling well and felt feverish.  He presented to an urgent care facility and was diagnosed with a cellulitis and placed on antibiotics.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Pruritus
Clinical narrative: Pt reports redness @ left deltoid that spreads about 3 inches around the site. Pt notes a lump underneath the injection as well.  The erythema has spread. Pt does not note a red streak extending down her arm. Afebrile. Very prutitic for the last 2- 3 days.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Local swelling, Rash
Clinical narrative: Pt, at time of immunization had a very quick local reaction of swelling. The next day pt had an out break along side of neck.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Dyspepsia, Headache, Injection site erythema, Injection site induration
Clinical narrative: Every joint & muscle in body was hurting, bad headache, neck ache, nauseous, heartburn, right arm where Tdap was given red & hard as a rock from the top of my shoulder to just above my elbow. This lasted 5 days. I went to the ER which they wanted to test me for the flu, strep throat & pneumonia. I explained to the doctor what I thought the problem was & he seemed to brush me off. He gave me a prescription for naproxen & nausea. I iced my arm & also took ibuprofen. This last 5 days.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Nausea, Neck pain
Clinical narrative: Every joint & muscle in body was hurting, bad headache, neck ache, nauseous, heartburn, right arm where Tdap was given red & hard as a rock from the top of my shoulder to just above my elbow. This lasted 5 days. I went to the ER which they wanted to test me for the flu, strep throat & pneumonia. I explained to the doctor what I thought the problem was & he seemed to brush me off. He gave me a prescription for naproxen & nausea. I iced my arm & also took ibuprofen. This last 5 days.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Diarrhoea, Musculoskeletal stiffness, Myalgia, Nausea, Pyrexia
Clinical narrative: High fever, shaking, muscle pain and stiffness, subjective feeling of jaw locking, profuse diarrhea, nausea.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Tremor, Trismus
Clinical narrative: High fever, shaking, muscle pain and stiffness, subjective feeling of jaw locking, profuse diarrhea, nausea.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Impaired work ability, Peripheral swelling, Pyrexia
Clinical narrative: Within 12 hours of vaccination, patient had a fever of 103. Her arm was very red and swollen. She missed 2 days of work.
Age: 20.0
Sex: M
Vaccine: VARCEL
Symptoms: Diarrhoea, Headache, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever, serious headache, diarrhea, sore throat for 3 full days.  Treating with Tylenol and Aleve and cold compresses to keep fever down.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Patient had an itchy rash about 4 inches in diameter. Instructed to take Benadryl and use topical steroid (triamcinolone is what he had at home.)
Age: 0.27
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Apnoea, Blood culture negative, Bradycardia, Chest X-ray normal, Full blood count normal
Clinical narrative: Patient had an apneic episode with bradycardia at home. Was observed overnight in hospital and was fine. Ex 26 week preemie with chronic lung disease on oxygen.
Age: 17.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Activities of daily living impaired, Asthenia, Feeling abnormal, Nausea, Syncope
Clinical narrative: Patient was very nervous before vaccine, stayed in exam room for 20 minutes with cold compress, no syncope noted however mom said he felt horrible the entire day could not practice with marching band just layed down on the field, said he was weak, faint nauseated, felt better at 1130 pm that same evening.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Cough, Lacrimation increased, Nasal congestion
Clinical narrative: Nasal congestion day of administration, watery eyes the following day, mild cough 8/26/2015.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Since vaccination, patient has reported redness and pain and swelling (2x2") at the injection site. She states it has gotten worse since receiving the injection.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Headache, Myalgia, Pyrexia
Clinical narrative: Patient reported muscle and joint pain, fever and headache within 12 hours of receiving this vaccine.
Age: 3.0
Sex: F
Vaccine: PPV
Symptoms: Abscess drainage, Injection site abscess, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: Red raised area at injection site, no treatment.  On 08/07/2015 at 12:45PM patient had a 3 1/2 cm raised red area, warm to touch and painful, no fever as patient was taking Ibuprofin for pain.  Abscess was drained with fair amount of exudate and tested positive for MRSA.
Age: 3.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Staphylococcal infection, Staphylococcus test positive
Clinical narrative: Red raised area at injection site, no treatment.  On 08/07/2015 at 12:45PM patient had a 3 1/2 cm raised red area, warm to touch and painful, no fever as patient was taking Ibuprofin for pain.  Abscess was drained with fair amount of exudate and tested positive for MRSA.
Age: 21.0
Sex: F
Vaccine: DTAP, HPV4
Symptoms: Erythema
Clinical narrative: Since I got the HPV and tetanus shot I've had red circle spots appear on my right leg.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Abdominal pain upper, Asthenia, Syncope
Clinical narrative: Fainting, Stomach ache, and weakness. Ice packs back of neck and forehead.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Dizziness, Dyspnoea, Photopsia, Retching
Clinical narrative: SHARP PAIN IN MY STOMACH, FLASHING LIGHTS, DIFFICULTY BREATHING, GAGGING, AND VERY FAINT FEELING.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Patient was diagnosed with precancerous HPV. Colposcopy ordered
Age: 20.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Skin infection
Clinical narrative: Patient had redness, tenderness, and swelling at the Pneumovax injection site. Patient went to PCP and the doctor's office sent her to the ER. ER physician diagnosed patient with a skin infection due to the vaccination. Patient was not allergic to the vaccine.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Significant swelling, erythema the site.
Age: 22.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Injection site rash, Rash
Clinical narrative: Fine rash to both shoulders, worse in deltoid area of injection site, few fine rashy areas on chest, not itchy, not painful, not burning.  No additional symptoms.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Ear pain, Eye discharge, Headache, Injection site erythema
Clinical narrative: Pain and redness around injection site (2 inch diameter red circle).  Sore throat, nasal congestion, sinus pain, headache, inner ear pain, body aches, fever, coughing, sneezing.  I am still experiencing all of these symptoms (except for the problems around the site injection) 4 days later.  I also developed discharge and redness in my left eye.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Nasal congestion, Ocular hyperaemia, Oropharyngeal pain, Pain
Clinical narrative: Pain and redness around injection site (2 inch diameter red circle).  Sore throat, nasal congestion, sinus pain, headache, inner ear pain, body aches, fever, coughing, sneezing.  I am still experiencing all of these symptoms (except for the problems around the site injection) 4 days later.  I also developed discharge and redness in my left eye.
Age: 45.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Sinus headache, Sneezing
Clinical narrative: Pain and redness around injection site (2 inch diameter red circle).  Sore throat, nasal congestion, sinus pain, headache, inner ear pain, body aches, fever, coughing, sneezing.  I am still experiencing all of these symptoms (except for the problems around the site injection) 4 days later.  I also developed discharge and redness in my left eye.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Injection site reaction, Rash erythematous, Skin neoplasm excision
Clinical narrative: Red rash developed at injection site following injection and grew in size. Earlier this year, rash never went away and biopsy conducted and found to be basal cell carcinoma in situ.
Age: 48.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site mass
Clinical narrative: Lump in bicep and redness radiating down injection arm.
Age: 19.0
Sex: F
Vaccine: HPV2
Symptoms: Activities of daily living impaired, Antinuclear antibody, Arthralgia, Blood potassium increased, Crying
Clinical narrative: Walking down stairs with suitcase knees were in pain, leg was in pain, hands were in pain. My health has gone down since then. In June my blood work which had been normal on my yearly visits came back off to the point the Dr retested thinking it was a mix up at the lab. My sed rate was 50 and my potassium was over a 10 the Dr called me to take the test again. It came back normal. I was referred to a auto immunity Dr but the tests came back negative. I have been slowing going down. My sed rate got up to 97. My knees hand wrists are in constant pain. I am falling down a lot. I have had many tests and they still cannot find a reason. I have a 3.5 average in college and cannot walk the campus as I did last year. I have missed classes in the first two weeks of my 2nd year due to the pain. Up until the time I had this HPV vaccine I was fine. Now I am so much pain I am in tears daily.
Age: 19.0
Sex: F
Vaccine: HPV2
Symptoms: Echocardiogram, Fall, Full blood count, Gait disturbance, Laboratory test
Clinical narrative: Walking down stairs with suitcase knees were in pain, leg was in pain, hands were in pain. My health has gone down since then. In June my blood work which had been normal on my yearly visits came back off to the point the Dr retested thinking it was a mix up at the lab. My sed rate was 50 and my potassium was over a 10 the Dr called me to take the test again. It came back normal. I was referred to a auto immunity Dr but the tests came back negative. I have been slowing going down. My sed rate got up to 97. My knees hand wrists are in constant pain. I am falling down a lot. I have had many tests and they still cannot find a reason. I have a 3.5 average in college and cannot walk the campus as I did last year. I have missed classes in the first two weeks of my 2nd year due to the pain. Up until the time I had this HPV vaccine I was fine. Now I am so much pain I am in tears daily.
Age: 19.0
Sex: F
Vaccine: HPV2
Symptoms: Pain in extremity, Red blood cell sedimentation rate increased, Rheumatoid factor, X-ray with contrast upper gastrointestinal tract
Clinical narrative: Walking down stairs with suitcase knees were in pain, leg was in pain, hands were in pain. My health has gone down since then. In June my blood work which had been normal on my yearly visits came back off to the point the Dr retested thinking it was a mix up at the lab. My sed rate was 50 and my potassium was over a 10 the Dr called me to take the test again. It came back normal. I was referred to a auto immunity Dr but the tests came back negative. I have been slowing going down. My sed rate got up to 97. My knees hand wrists are in constant pain. I am falling down a lot. I have had many tests and they still cannot find a reason. I have a 3.5 average in college and cannot walk the campus as I did last year. I have missed classes in the first two weeks of my 2nd year due to the pain. Up until the time I had this HPV vaccine I was fine. Now I am so much pain I am in tears daily.
Sex: U
Vaccine: MENB
Symptoms: Colitis ulcerative, Haematochezia
Clinical narrative: Case number PHEH2015US016860, is an initial spontaneous report from a physician received on 25 Aug 2015. This report refers to a patient of unknown demographics. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with first dose of BEXSERO (batch number: not reported) on 27 Jul 2015. On 03 Aug 2015, the patient experienced ulcerative colitis and bloody stools. Final outcome, seriousness and causality were not reported. Seriousness of the event colitis ulcerative was upgraded based on Novartis Important Medical Events list.
Age: 87.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Sore arm and swelling of hand.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Computerised tomogram normal, Fall, Head injury, Syncope
Clinical narrative: After receiving the flu vaccine and GARDASIL vaccine, patient had a syncopal episode and fell and hit her head on the floor. The episode lasted around 5-10 seconds. Patient was sent to the ER after recovering well.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose normal, Bundle branch block, Dizziness, Electrocardiogram abnormal, Hyperhidrosis
Clinical narrative: Gave shot, immediately felt dizzy, sweating, nausea. Called paramedics. Paramedics found bundle branch block on EKG and took her to ER.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Nausea
Clinical narrative: Gave shot, immediately felt dizzy, sweating, nausea. Called paramedics. Paramedics found bundle branch block on EKG and took her to ER.
Age: 24.0
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Exposure during pregnancy, Wrong drug administered
Clinical narrative: Wrong vaccination given. DTaP given instead of Tdap. Pt is pregnant.
Age: 18.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Allergy test, Dizziness, Ear pain, Flushing, Throat irritation
Clinical narrative: After receiving her flu vaccine, she stood up and felt lightheaded. She then felt flushed, had right ear pain and throat discomfort. She went to ED she was treated with BENADRYL and prednisone.
Age: 18.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dysphagia, Erythema
Clinical narrative: After receiving her flu vaccine, she stood up and felt lightheaded. She then felt flushed, had right ear pain and throat discomfort. She went to ED she was treated with BENADRYL and prednisone.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Hypoaesthesia, Paraesthesia
Clinical narrative: Tingling down spine, arms and legs. Hands and feet numb and chest heaviness. These symptoms present 8 hours. Told pt to call 911 or go to ER.
Age: 65.0
Sex: F
Vaccine: FLU4, TDAP, VARZOS
Symptoms: Injection site rash
Clinical narrative: Developed pussy rash on site where ZOSTAVAX was injected.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Pruritus
Clinical narrative: Redness from mid delt to elbow after 4 days. Itching 4 days after.
Age: 35.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Fever, redness and tenderness to injection site.
Age: 26.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema multiforme
Clinical narrative: Erythema Multiforme. Ibuprofen 600 mg QID.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site urticaria
Clinical narrative: Immediate hive like erythema at injection site. Lungs clear. BENADRYL given in office.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Hypersensitivity, Rash generalised, Skin warm
Clinical narrative: Generalized rash 12 h post vacc. Phone contact - BENADRYL advised. Seen 8/31. Patient words: Last dose of BENADRYL was on Saturday. Spoke to doc on call Saturday and was instructed to give him BENADRYL. He seems fine today. And, actually, the rash did not seem to bother him when it was present. He did complain about being 'warm' and would hold his elbows. The patient is a 2 year, 1 month old male who presents with vaccine allergy. Prior to the reaction the patient received DTaP vaccine and hepatitis A vaccine. Initial presentation was 2 day(s) ago. Presentation included rash (from neck down, improving..painful joints that were warm to the touch).
Age: 0.5
Sex: M
Vaccine: DTAP, HIBV, IPV, RV5
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Both thighs are red, swollen and tender to touch - reaction was located above area where vaccines were given.
Age: 11.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient had reaction to Tdap (ADACEL) vaccine given 8/26/15. Hot to touch and red. Dr treated w/ antibiotics.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site reaction, Injection site swelling, Malaise, Pain
Clinical narrative: Patient received PREVNAR 13 injection on 8/22/15; patient states woke up on 8/23/15 not feeling well; said had body aches; Left arm swollen near injection site. Small bruise next to injection site. Patient states stayed in bed most of the day. Two days later, a red rash appeared over a 3-4 inch area below the injection site. Arm painful to the touch. Six days post injection a small red spot 1cm in diameter appeared in the middle of the rash area.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Rash erythematous, Tenderness
Clinical narrative: Patient received PREVNAR 13 injection on 8/22/15; patient states woke up on 8/23/15 not feeling well; said had body aches; Left arm swollen near injection site. Small bruise next to injection site. Patient states stayed in bed most of the day. Two days later, a red rash appeared over a 3-4 inch area below the injection site. Arm painful to the touch. Six days post injection a small red spot 1cm in diameter appeared in the middle of the rash area.
Age: 1.57
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Malaise, Pain, Swelling, Tenderness
Clinical narrative: Swelling; redness; tender to touch; general pain/malaise.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Erythema, Tenderness
Clinical narrative: Shot 3 d ago. Redness appeared next day. Tender. Just increasing in size then left thigh.
Age: 28.0
Sex: M
Vaccine: MMR
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister
Clinical narrative: Pt called 5 days after receiving vaccine. Reported 2 lg blisters on non-vaccine arm (right). She said they are spread out on arm and are appx the size of a half-dollar piece. Asked pt to f/u with MD/PCP.
Age: 14.0
Sex: M
Vaccine: PPV
Symptoms: Headache, Injection site erythema, Injection site reaction, Injection site swelling, Neck pain
Clinical narrative: Seen on 8/26/15 at office for c/o fever, body aches and local reaction Lt arm at injection site. 8/27/15 seen this AM c/o H/A, neck pain and swollen and red at injection site. WBC at 15,000. Doxycycline prescribed.
Age: 14.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Seen on 8/26/15 at office for c/o fever, body aches and local reaction Lt arm at injection site. 8/27/15 seen this AM c/o H/A, neck pain and swollen and red at injection site. WBC at 15,000. Doxycycline prescribed.
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Rash
Clinical narrative: Skin rash. BENADRYL 12.5 mg/5 ml given.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea
Clinical narrative: Prolonged diarrhea starting 2 days after vaccination, 10-12 times daily. Watery and mucousy lasting about 6 weeks. Not reported to MD until 8/24/15 after resolution.
Age: 0.7
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 7 months 22 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. ON an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313 exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. All telephone attempts to obtain follow-up information had been unsuccessful. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored ZOSTAVAX (dose, frequency and route not reported). The Lot number ZOSTAVAX was reported as L03218, expiry 30-APR-2016 and L012478, 10-JUL-2016. No adverse event was reported at the time of this report. This case is one of the several reports from the same reporter. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Headache, swollen red (R) upper arm "hard and red" per mother, MENVEO was on right. Left arm was BOOSTRIX and smaller red area not as swollen.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. ON 27-AUG-2015, the patient was vaccinated with an expired dose of RECOMBIVAX HB (lot number reported as 1205AA and expiration date 01-APR-2014) (dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site warmth, Pruritus
Clinical narrative: Arm was hot, red and hard where shot was given, also redness on back, also itching. Redness still on arm only.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Lymphadenopathy, Pyrexia
Clinical narrative: Information has been received from a nurse practitioner via a field representative referring to a 21 year old female patient. The patient's pertinent medical history and drug reactions/allergies were not reported. On 28-JUL-2015 the patient was vaccinated with her first dose of GARDASIL 9 lot # K026246 (dose, route, and expiration date were not reported). Information regarding concomitant medication was not reported. On 29-JUL-2015 or 30-JUL-2015, a day or two after the patient received her first dose of GARDASIL 9, she got a high fever of 103 Fahrenheit, swollen lymph nodes, and general fatigue. The patient sought medical attention via phone call. On 14-AUG-2015, the patient came in to see the nurse practitioner. No lab diagnostics studies were performed. The patient was completely recovered on an unspecified date of 2015. The causality was not reported. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Erythema, Paraesthesia, Swelling
Clinical narrative: Vaccinated on 8/19/15. Parent reports redness, swelling on same day. On 8/24/15, walking into clinic, redness spreading down arm patient reporting tingling.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Dizziness, Headache, Pain in extremity, Pallor
Clinical narrative: Diffuse tremors, dizziness, weakness, pallor. Injection 11:30am, onset symptoms 8pm 8/25/15. 8/26/15 AM weak, headache and very painful arm.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Tremor
Clinical narrative: Diffuse tremors, dizziness, weakness, pallor. Injection 11:30am, onset symptoms 8pm 8/25/15. 8/26/15 AM weak, headache and very painful arm.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient came in 8/22/15 Red swelling on upper arm wasn't' hot to touch. Told her to ice down overnight. Patient came in Sunday 8/23, swelling and redness went down.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Patient came in 8/22/15 Red swelling on upper arm wasn't' hot to touch. Told her to ice down overnight. Patient came in Sunday 8/23, swelling and redness went down.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: Red rash around site within 24 hours of vaccination; tender and spreading. Yesterday area brighter and warm to touch. Not sure if AE's resulted from vaccine or way it was administered. Went to ER on 8/31 for possible cellulitis. Doctor did not do testing just observation and circled area around site to continue monitoring. Doctor prescribed KEFLEX (7 days) antibiotic and started yesterday. Today vax site looks about the same - no improvements yet.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Large swollen site.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Generalized urticaria 12 hours post vaccine.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The concurrent condition, medical history and concomitant medication was not reported. On an unknown date in August 2014, the patient received the first dose of the series of GARDASIL intramuscularly (lot details unavailable). On 28-AUG-2015, the patient received the second dose of GARDASIL 9 (Lot: L019286, Expiry: 14-SEP-2017), 0.5 ml, intramuscular. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 0.7
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an 8 months 14 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. All telephone attempts to obtain follow-up information had been unsuccessful. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event, Syringe issue
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a patient of an unknown age and gender. On an unknown date, the patient was vaccinated with GARDASIL 9 prefilled syringe, intramuscular (strength, dose, dose number and frequency were not reported). It was reported, that prefilled syringe "leaked from opposite side during injection" by physician. No adverse effects reported. The reporter stated, that injection was completed using another GARDASIL 9 prefilled syringe. Additional information has been requested.