chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, MMRV, PPV, VARCEL
Symptoms: Dyspnoea, Extra dose administered, Laboratory test, Pruritus, Rash erythematous
Clinical narrative: 24 hours after applying the 5 vaccines patient had a red rash all over his body with itching and difficulty breathing. Until now it still presents only the red coloration on the skin. 11 days after the vaccine continues taking antiallergic medication. In his vaccination schedule says that he would be given 4 vaccines, but in the hospital he was given 5.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, MMRV, PPV, VARCEL
Symptoms: Rash generalised
Clinical narrative: 24 hours after applying the 5 vaccines patient had a red rash all over his body with itching and difficulty breathing. Until now it still presents only the red coloration on the skin. 11 days after the vaccine continues taking antiallergic medication. In his vaccination schedule says that he would be given 4 vaccines, but in the hospital he was given 5.
Age: 2.0
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: Patient developed urticaria and hand and foot swelling.
Age: 1.25
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting and fever.
Age: 9.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain, Nausea, Vomiting
Clinical narrative: Severe abdominal pain (writhing), nausea and vomiting hourly until we gave him zofan about 2a; we almost took him to the emergency room because the pain was so bad.
Age: 58.0
Sex: F
Vaccine: TD, VARCEL
Symptoms: Biopsy bone marrow abnormal, Electrophoresis protein abnormal, Plasma cell myeloma
Clinical narrative: Lab work indicating development of Multiple myeloma.
Age: 62.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Patient diagnosed with Guillain - Barre Syndrome.
Age: 62.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Blood test, Computerised tomogram, Coordination abnormal, Dysstasia, Gait disturbance
Clinical narrative: Patient diagnosed with Guillain - Barre Syndrome.
Age: 62.0
Sex: M
Vaccine: FLU4, FLUX
Symptoms: Influenza like illness, Muscle atrophy, Pain
Clinical narrative: Patient diagnosed with Guillain - Barre Syndrome.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Pain in jaw, Swelling, Teeth brittle, Tooth discolouration, Tooth disorder
Clinical narrative: In Sept '06 1st noticed black spots on teeth. Went to dentist for lower jaw pain and swelling around May '07 put on antibx. Off and on antibx about 6 times since. June '07 teeth started deteriorating. Currently 13 teeth are gone from deterioration.
Age: 20.0
Sex: M
Vaccine: ANTH
Symptoms: Tooth loss
Clinical narrative: In Sept '06 1st noticed black spots on teeth. Went to dentist for lower jaw pain and swelling around May '07 put on antibx. Off and on antibx about 6 times since. June '07 teeth started deteriorating. Currently 13 teeth are gone from deterioration.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, VARCEL
Symptoms: Erythema, Injection site cellulitis, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Patient seen at Emergency Rm on 2/25/17. Diagnosed with Cellulitis left arm/shoulder area near site where pt recvd PEDIARIX vaccine on 2/23/17. Treated with antibiotics-augmentin, recommended ibuprofen or Tylenol and ice/cold packs.  Pt's initial local reaction red bump reported 3 hours after injection.  Prt not reexamined on that date.  On 2/24/17 patient seen at Urgent Care, diagnosed with local reaction secondary to immunization and recommended ibuprofen or Tylenol and ice/cold pack.
Age: 3.0
Sex: M
Vaccine: DTAPHEPBIP, VARCEL
Symptoms: Swelling
Clinical narrative: Patient seen at Emergency Rm on 2/25/17. Diagnosed with Cellulitis left arm/shoulder area near site where pt recvd PEDIARIX vaccine on 2/23/17. Treated with antibiotics-augmentin, recommended ibuprofen or Tylenol and ice/cold packs.  Pt's initial local reaction red bump reported 3 hours after injection.  Prt not reexamined on that date.  On 2/24/17 patient seen at Urgent Care, diagnosed with local reaction secondary to immunization and recommended ibuprofen or Tylenol and ice/cold pack.
Age: 1.25
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Vomiting
Clinical narrative: Throwing up. Approximately 12 times between 1:00 a.m. and 7:00 a.m. Then threw up again around 4:00 p.m.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain, Rash
Clinical narrative: Rash, complaint of abdominal pain.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple, unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapy were not provided. It was reported that, on unknown dates since 17-JAN-2017, the unspecified patients were vaccinated with improperly stored doses of PEDVAXHIB injection (lot# M034187 expiration date 17-MAY-2019, lot# M014925 expiration date 16-FEB-2019; strength, dose, and route were not reported) for prophylaxis. The vaccines were exposed to a temperature excursion between 46 Fahrenheit degrees and 77 Fahrenheit degrees for 2 hours 20 minutes. The call was placed because of a Digital data logger. No previous temperature excursion and no adverse experiences had been reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA009073.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. No information regarding the patient's concurrent conditions, medical history or concomitant therapies was provided. On an unknown date, the patient was vaccinated with one dose of ZOSTAVAX (dose, route of administration, lot number, expiration date were not reported) for prophylaxis, while she already had been vaccinated with ZOSTAVAX on an earlier, unspecified date. This was considered as an extra dose administered per the Prescribing Information. No adverse effects were reported. No product quality complaint was involved. Additional information is not expected, as there was no consent to contact the reporting physician.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to multiple, unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapy were not provided. It was reported that, on unknown dates since 17-JAN-2017, the unspecified patients were vaccinated with improperly stored doses of ROTATEQ  (lot# M018958 expiration date 03-MAR-2018, lot # M019707 expiration date 25-OCT-2017) for prophylaxis (strength, dose and route were not provided). The vaccines were exposed to a temperature excursion between 46 Fahrenheit degrees and 77 Fahrenheit degrees for 2 hours 20 minutes. The call was placed because of a Digital data logger. No previous temperature excursion and no adverse experiences had been reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1702USA003572:
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 22-FEB-2017, the patient was vaccinated with an expired dose of GARDASIL (lot # K006960, expiration date: 19-FEB-2017, dose and route were unknown) for prophylaxis.  No adverse effects were reported. Additional information has been requested.
Age: 35.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative and refers to a 35 years old patient of unknown gender. The patient's concomitant medications, pertinent medical history and drug reactions or allergies were not reported. On 02-MAR-2017, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously (exact dose, lot # and expiry date were not reported). No adverse effects were reported. Product quality complaint was not involved. Additional information is not expected as no consent to contact the patient's physician was given.
Age: 80.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pain in extremity
Clinical narrative: Patient reported lingering right arm pain several weeks after vaccine administration.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient stated that a week after receiving the shot,she started to develop a red raised area on her arm around the injection site.  It grew into a quarter sized area and has grown warm and has increased in size every day.  Patient got Keflex from provider and we are monitoring for cellulitis.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dyskinesia, Feeling abnormal, Slow response to stimuli
Clinical narrative: About a minute after administration of vaccine pt had non-tonic/clonic, non-rhythmic movements of arms lasting approximately 30 seconds, pt dazed, answering questions slowly, no LOC, drank some water and after about 10 minutes she was felling like herself again, 911 had been called and upon arrival pt decided not to go to ER.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning a 14 years old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 13-DEC-2016, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot # L024993, expiration date 17-OCT-2017, dose and route unspecified) for prophylaxis. The vaccines were stored at 11.6 degree centigrade for 1 hour and 50 minutes. Data logger was involved in the case. There was previous temperature excursion at 9.3 degree centigrade for 50 minutes. No adverse effect was reported. It was reported that the excursion involved a total of three lots of GARDASIL 9. Two lots (L024993 and M024261) were involved in the event "doses of GARDASIL 9 administered after 13-DEC-2016 temperature incident". This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA008047: US-009507513-1703USA002792: US-009507513-1703USA002794: US-009507513-1703USA002795: US-009507513-1703USA002796: US-009507513-1703USA002797: US-009507513-1703USA002798: US-009507513-1703USA002799: US-009507513-1612USA007442: US-009507513-1702USA010448:
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning a 12 years old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 13-DEC-2016, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot # L024993, expiration date 17-OCT-2017, dose and route unspecified) for prophylaxis. The vaccines were stored at 11.6 degree Centigrade for 1 hour and 50 minutes. Data logger was involved in the case. There was previous temperature excursion at 9.3 degree Centigrade for 50 minutes. No adverse effect was reported. It was reported that the excursion involved a total of three lots of GARDASIL 9. Two lots (L024993 and M024261) were involved in the event "doses of GARDASIL 9 administered after 13-DEC-2016 temperature incident". This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA008047: US-009507513-1703USA002792: US-009507513-1703USA002793: US-009507513-1703USA002795: US-009507513-1703USA002796: US-009507513-1703USA002797: US-009507513-1703USA002798: US-009507513-1703USA002799: US-009507513-1612USA007442: US-009507513-1702USA010448.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia, Pain in extremity
Clinical narrative: This is a spontaneous report obtained from a contactable consumer.  A 75-year-old female patient of an unspecified race and ethnicity received pneumococcal 13-val conj vac (dipht crm197 protein) on an unknown date, single dose, for immunization. Relevant medical history and concomitant medications were unknown. It was reported that the patient received two pneumococcal 13-val conj vac (dipht crm197 protein)  shots about a year apart. The patient experienced sore mainly in her bottom muscles and also her arm was sore. Consumer did not know which pneumococcal vaccine was received. Clinical outcome was unknown at time of this report.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Abdominal pain upper, Gastric dilatation, Urine analysis normal, X-ray normal
Clinical narrative: This is a spontaneous report obtained from a contactable consumer (patient). A 65 year old male patient received, on 23Feb2017, PREVNAR 13 single dose, for immunization. Relevant medical history included diabetes. Concomitant medications included insulin glargine (LANTUS) 40 IU, twice daily, from an unspecified date (ongoing), for diabetes and insulin lispro (HUMALOG) from an unspecified date before meals (ongoing), for diabetes. On 27Feb2017, the patient experienced stomach distention and stomach pain. Urine test and X-ray, performed on an unspecified date, in 2017, were normal (not able to find anything). In response to the events, the patient was treated with an unspecified muscle relaxants medications but these products did not work. Clinical outcome of the event was recovering at time of this report.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Localized pain, swelling, redness - within hours of immunization.
Age: 18.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Generalised erythema, Injection site erythema, Injection site swelling, Limb discomfort, Pyrexia
Clinical narrative: Sore arm & redness, fever, 1/7/17 redness spreading, swelling.
Age: 17.0
Sex: M
Vaccine: HEP, IPV, MNQ, TDAP, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth, and swelling at site.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Chest pain, Hypoaesthesia, Injection site erythema, Injection site hypoaesthesia, Injection site pain
Clinical narrative: First symptom on 3/3/17 was pain and redness at the injection area. Pain was severe, could not move arm without pain. Gave ibuprofen. 3/4/17, very tired and still in pain, gave BENADRYL. 3/5/17. Left arm was numb at injection. Took to the ER. No medication given. 3/6/17-11:00 whole arm was numb to fingers. Chest pain in a pulsing manner. Took back to the ER, no medication was given. 3/6/17 7:30, chest pain is constant, redness at injection site has reappeared. Gave an Epsom salt bath. Left arm now is hurting in addition to being numb. Left toe and then half the foot felt like electrical pulses zapping it.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: First symptom on 3/3/17 was pain and redness at the injection area. Pain was severe, could not move arm without pain. Gave ibuprofen. 3/4/17, very tired and still in pain, gave BENADRYL. 3/5/17. Left arm was numb at injection. Took to the ER. No medication given. 3/6/17-11:00 whole arm was numb to fingers. Chest pain in a pulsing manner. Took back to the ER, no medication was given. 3/6/17 7:30, chest pain is constant, redness at injection site has reappeared. Gave an Epsom salt bath. Left arm now is hurting in addition to being numb. Left toe and then half the foot felt like electrical pulses zapping it.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Right thigh bump and warm to touch, afebrile.
Age: 1.08
Sex: M
Vaccine: FLU4, HIBV, PNC13
Symptoms: Injection site erythema, Injection site reaction, Injection site vesicles, Wound
Clinical narrative: Reddened area where shot was given, blister like. Child irritated it by picking and rubbing it causing it to get deeper and larger. Size of a nickel pen wound, red x 1 week.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Soreness at site, induration, mild swelling.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Small red bump on left thigh, seen again on 1/27/17 for no improvement.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with 5 improperly stored doses of ROTATEQ (dose and frequency were not reported) (lot # M011832 and expiration date 25-JAN-2018) orally for prophylaxis. There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion between 32 degrees Fahrenheit and 36 degrees Fahrenheit for 9 hours. Data logger was involved. There were no previous excursions reported. Additional information has been requested.
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information regarding patient pertinent medical history, drug reactions, allergies, concurrent conditions and concomitant therapies was not reported. On 06-FEB-2017, the patient was vaccinated with an expired dose of M-M-R II with lot # L000458, expiration date 06-JAN-2017 (strength, dose, frequency, route of administration, and anatomical location were not provided) for prophylaxis. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Registered Nurse concerning multiple unspecified patients of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored unspecified doses of RECOMBIVAX HB intramuscular route for prophylaxis (lot number M031574 with an expiration date of 11-NOV-2018) (dosage schedule and  anatomical location were not reported). No concomitant medications were provided. There were no adverse effects reported. The doses of the vaccine experienced a temperature excursion of 32 degrees Fahrenheit (F) to 35 F (0 degrees Celsius (C) to 1 C)  for 5 minutes and 47 F to 77 F (9 C to 25 C ) for 1 minute. There was a previous temperature excursions reported as  47 F to 77 F (9 C to 25 C ) for 1 minute. The aforementioned temperatures were identified due to a data logger.  Furthermore, no product quality complaint was involved. Additional information is not expected.
Age: 71.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Diarrhoea, Dizziness, Nausea, Vomiting
Clinical narrative: Dizziness, nausea, vomiting, diarrhea, primary doctor sent him to ER. Pt did not return phone calls.
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: On 1-19-17 patient could not lift her arm (area where she got the injection) on 1-20-17. Patient noticed redness on and around injection site - also it became swollen and warm.
Age: 63.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Injection site rash, Peripheral swelling
Clinical narrative: Rash at site of injection and arm swelling.
Age: 57.0
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Noticed welt 2 days after when lifted arm, itches, red. On 1/21/17 - No change in perimeter size less defined edges/border less lumpy/raised. Not feel bad. Only issue is look of it.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site hypoaesthesia, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 03/01/2017, Mild adverse reaction to vaccine component. Area was hot, swollen ET red, PT C/O itching and numbness that comes ET goes.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Vaccination complication
Clinical narrative: 03/01/2017, Mild adverse reaction to vaccine component. Area was hot, swollen ET red, PT C/O itching and numbness that comes ET goes.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Bacterial infection, Bacterial test positive, Injection site erythema, Injection site swelling
Clinical narrative: Arm is red from injection site down to elbow slightly swollen. She states it began Friday after injection. I told her to have looked at by MD immediately.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Arthritis, Joint stiffness, Lip dry, Muscle spasms
Clinical narrative: Cramps on 1/26/17. Stiff joints/inflammation (no treatment). Dry lips.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Vaccination site inflammation, Vaccination site reaction
Clinical narrative: Day after vaccination patient presented with circle red inflamed rash on area of vaccination. No fever, nor pain.
Age: 41.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis, Peripheral swelling
Clinical narrative: Arm swelling hours after shot was given. DX was cellulitis.
Age: 1.0
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Lt. arm redness with rash.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Large reddened area noted to right arm around site of injection.  Mother reported to office that the area was inflamed and warm to touch.  Mother states area was as large as "the palm of my hand".
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Malaise, Pyrexia
Clinical narrative: Intense pain to injection site, rendering the arm immobile.  Injection site and upper arm swelling to about 2 times its size.  Fever of 100. generalized malaise.
Age: 0.25
Sex: M
Vaccine: IPV
Symptoms: Catatonia
Clinical narrative: MOTHER SAID IT LOOKED LIKE I WAS DEAD FOR A SUSTAINED PERIOD OF TIME DIRECTLY AFTER GETTING SHOTS.
Age: 24.0
Sex: M
Vaccine: HEP, HPV9
Symptoms: Axillary mass, Differential white blood cell count, Full blood count, Monocyte percentage increased, Rash
Clinical narrative: 03/04/2017 itchy red rash to left elbow then spread to thighs, arms, torso, back. also c/o bilat armpit tenderness and can feel lump. states had 2 vaccines on 03/02/2017 -Hep B, HPV. denies fever/chills, st, cough. denies facial or throat swelling.
Age: 24.0
Sex: M
Vaccine: HEP, HPV9
Symptoms: Rash erythematous, Rash pruritic, Tenderness
Clinical narrative: 03/04/2017 itchy red rash to left elbow then spread to thighs, arms, torso, back. also c/o bilat armpit tenderness and can feel lump. states had 2 vaccines on 03/02/2017 -Hep B, HPV. denies fever/chills, st, cough. denies facial or throat swelling.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Blood thyroid stimulating hormone normal, Feeling abnormal, Goitre, Lymphadenopathy, Streptococcus test negative
Clinical narrative: Swelling of lymph nodes on throat. By 03/02/17, five days later lymph nodes were 1 1/2"x 1" on both sides of the neck and thyroid was slightly enlarged. Did not hurt, but felt funny according to child.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Thyroxine free normal
Clinical narrative: Swelling of lymph nodes on throat. By 03/02/17, five days later lymph nodes were 1 1/2"x 1" on both sides of the neck and thyroid was slightly enlarged. Did not hurt, but felt funny according to child.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Brachial plexus injury, Grip strength decreased, Monoplegia, Neuralgic amyotrophy, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Near total loss of use of her left arm. No ability to raise her arm, severely limited grip. Neurologist recommended prednisone and physical therapy. Also had pediatric chiro.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9, FLUX, HPV9
Symptoms: Erythema, Skin warm
Clinical narrative: T 36.5, BP 123/74. 19 cm by 19 cm area of erythema on arm that received vaccine noted on 3/2/17. Warmth of area. No trouble breathing or other swelling/redness. Prescribed cetirizine 10 mg in am, BENADRYL 25 mg in night x 4 days.
Age: 82.0
Sex: U
Vaccine: PPV
Symptoms: Unevaluable event
Clinical narrative: None stated.
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Immediate post-injection reaction, Influenza like illness, Injection site pain, Lethargy
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site pain in a adolescent female patient who received BEXSERO. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, less than a day after receiving BEXSERO, the patient experienced injection site pain, lethargy, weakness and influenza-like symptoms. On an unknown date, the outcome of the injection site pain, lethargy, weakness and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the injection site pain, lethargy, weakness and influenza-like symptoms to be related to BEXSERO. Additional details were provided as follows: This case was not previously reported to anyone. This case was reported by the physician on behalf of his daughter. The age at vaccination was not reported. The patient had pain right after the injection at the site. The representative mentioned that she was not told of the injection site. The day after the injection, the patient was weak and felt like she had flu like symptoms. The doctor told to the representative that the next day the patient was fine and the doctor did not want to be contacted in any way. The patient had denied permission to contact their physician.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Within 24 hours the upper lateral left arm was swollen, painful and erythematous. The pain increased to where she could not move her arm.
Sex: U
Vaccine: MENB
Symptoms: Dizziness, Pain, Syncope
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of syncope in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced syncope, pain and dizziness. On an unknown date, the outcome of the syncope, pain and dizziness were unknown. It was unknown if the reporter considered the syncope, pain and dizziness to be related to BEXSERO. Additional details were provided as follows: The sales representative heard from the physician that she had at least two patients with the same side effects with BEXSERO. Additional details were provided as follows: The sales representative heard from the physician that she had at least two patients with the same side effects with BEXSERO. The representative did not have further details. This case had been linked with UG2017023508, reported by the same reporter. The country of occurrence and country of reporter were mistakenly entered as one country, however upon clarification it was confirmed to be another country.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site indentation, Injection site injury, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site injury in a 50-year-old female patient who received BOOSTRIX (batch number EC9A9, expiry date 22nd January 2019). Co-suspect products included KENALOG injection for drug use. On 17th January 2017, the patient received BOOSTRIX .5 ml and KENALOG Injection at an unknown dose and frequency. On 17th January 2017, several hours after receiving BOOSTRIX, the patient experienced injection site injury, injection site pain and injection site warmth. The action taken with KENALOG Injection was unknown. On an unknown date, the outcome of the injection site injury was not recovered/not resolved and the outcome of the injection site pain and injection site warmth were recovered/resolved. It was unknown if the reporter considered the injection site injury, injection site pain and injection site warmth to be related to BOOSTRIX. Additional details were provided as follows: The healthcare provider reported that the patient received BOOSTRIX in her left deltoid and experienced pain, warmth and an indentation in the arm a couple of hours after the vaccination. The patient concomitantly received KENALOG injections however, the nurse did not know the site of the KENALOG injection. The reporter did not provide the patient's date of birth or details of the person who administered the vaccine. It was unknown if the reporter considered the injection site indentation, injection site pain and injection site warmth in the arm to be related to KENALOG injection as well. The reported lot number (EC989) for BOOSTRIX did not exist and was updated to EC9A9, according to sales database.
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Cough, Eyelid oedema, Lip swelling, Urticaria
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of chronic cough in a child male patient who received KINRIX. Co-suspect products included Varicella vaccine, FLUZONE, Albuterol nebulizer solution for drug use for unknown indication. On an unknown date, the patient received KINRIX at an unknown dose, Varicella Vaccine at an unknown dose, FLUZONE at an unknown dose and Albuterol (nebulizer) at an unknown dose and frequency. On an unknown date, several minutes  after receiving KINRIX and not applicable after starting Albuterol, the patient experienced chronic cough, hives, swelling of eyelid and lip swelling. The action taken with Albuterol was unknown. On an unknown date, the outcome of the chronic cough, hives, swelling of eyelid and lip swelling were unknown. The reporter considered the chronic cough and hives to be possibly related to KINRIX. The reporter considered the swelling of eyelid and lip swelling to possibly related to Albuterol. Additional details were provided as follows: The age at vaccination was not reported. The patient received KINRIX, MMR, Varicella and FLUZONE vaccines, several minutes after receiving vaccines, the patient experienced chronic cough and hives. The healthcare professional administered Albuterol by nebulizer and after that the patient's eye lids and lips began to swell. Then ambulance was called and patient was taken to the emergency room. No further information was known about the patient's condition. The sales representative had limited information. No product lot or expiry dates were provided. The healthcare professional wanted to be contacted about these adverse events by the safety department. The reporter considered the chronic cough and hives to be possible related to MMR, Varicella and FLUZONE vaccines as well.
Sex: M
Vaccine: MENB
Symptoms: Injection site swelling, Lip swelling, Pain in extremity, Paraesthesia oral
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in arm in a adolescent male patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced pain in arm, lip swelling, tingling lips and injection site swelling. BEXSERO was discontinued. On an unknown date, the outcome of the pain in arm, lip swelling, tingling lips and injection site swelling were recovered/resolved. It was unknown if the reporter considered the pain in arm, lip swelling, tingling lips and injection site swelling to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO in an unknown arm. The physician reported that the patient went to the emergency room and was discharged home and the patient will not received the 2nd dose of BEXSERO. Limited information was provided by the sales representative from the physician. This case has been linked with case US2017026063, US2017026065 and US2017026068 as reported by same reporter.
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site warmth, Rash
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of rash in a adolescent female patient who received BEXSERO. On an unknown date, the patient received BEXSERO. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced rash, injection site warmth and injection site erythema. The patient was treated with BENADRYL and ibuprofen. On an unknown date, the outcome of the rash, injection site warmth and injection site erythema were recovered/resolved. It was unknown if the reporter considered the rash, injection site warmth and injection site erythema to be related to BEXSERO. Additional details were provided as follows: At the time of reporting, the patient's age was 17 years. The patient received BEXSERO in an unknown arm. The patient experienced rash on an unknown site. Limited information was provided by the sales representative from the physician. This case has been linked with case US2017026063, US2017026064 and US2017026068 as reported by the same reporter.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Decreased appetite, Irritability, Macule, Seborrhoea
Clinical narrative: 2/27/17: Vaccines given PE nrml except for seborrhea on face and scalp 2-28-17: Red flat circular macules on chest that spread to entire trunk, legs, arms, head. Became fussy with decreased eating 3-1-17: Seen my PMD. PE as above.
Age: 40.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site bruising, Injection site injury, Injection site pain, Muscular weakness, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Developed SIRVA -(shoulder injury related to vaccine administration) with pain and weakness left shoulder MRI (3 mos post immunization) - contusion lesser tuberosity and teres minor.
Age: 40.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Asthenia, Bone marrow oedema, Drug administered at inappropriate site, Mobility decreased
Clinical narrative: Developed SIRVA -(shoulder injury related to vaccine administration) with pain and weakness left shoulder MRI (3 mos post immunization) - contusion lesser tuberosity and teres minor.
Age: 40.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Nuclear magnetic resonance imaging abnormal, Pain in extremity, X-ray
Clinical narrative: Developed SIRVA -(shoulder injury related to vaccine administration) with pain and weakness left shoulder MRI (3 mos post immunization) - contusion lesser tuberosity and teres minor.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: 65 y.o. female with redness, swelling, tenderness at or near injection site (left deltoid). Stiffness of left arm. Also an erythematous area (L) clavicle region. Reports itching.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus
Clinical narrative: 65 y.o. female with redness, swelling, tenderness at or near injection site (left deltoid). Stiffness of left arm. Also an erythematous area (L) clavicle region. Reports itching.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Pain
Clinical narrative: Injected in left deltoid - patient reports deltoid hurting when bending arm back and slightly when raise above head.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Lymphadenopathy, Pyrexia, Rash, Swelling
Clinical narrative: Rash, swelling, lymph node swelling, fever.
Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Inflammation, Rash
Clinical narrative: Rash. Patient described inflammation and possible knot or bump under skin and soreness caused by ZOSTAVAX.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Immediate post-injection reaction
Clinical narrative: Patient had allergic reaction immediately following vaccine.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Febrile convulsion, Influenza virus test negative, Respiratory syncytial virus test negative, Urine analysis normal
Clinical narrative: Pt received PENTACEL, PCV13, ROTATEQ and flu vaccine on 3-6-17. Pt had a febrile seizure later that afternoon and went to ER.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria, Vaccination site reaction
Clinical narrative: Developed welt at vaccination site.
Age: 26.0
Sex: F
Vaccine: YF
Symptoms: Diarrhoea, Gastroenteritis, Nausea, Pain, Vomiting
Clinical narrative: Patient had yellow fever vaccine Wednesday 2/22/17 at 8:40 AM, she states Thursday 2/23/17 she got body aches. She states Saturday 2/25/17 at 8 PM she got mild diarrhea and had nausea and 1 episode of vomiting. No fever. (She states she found out some other people she works with also had symptoms of stomach bug around same time she had nausea/vomiting/diarrhea). Saturday 2/25 she spoke with physician - he instructed her to drink fluids, that symptoms sounded like gastroenteritis and call if symptoms worsened. Two days 2/28/17 back to normal.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Joint range of motion decreased
Clinical narrative: Patient reports pain where flu shot administered. Patient reports decrease range of motion.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Autoimmune disorder, Bursa injury, Drug administered at inappropriate site, Mobility decreased, Pain
Clinical narrative: Pain that became more and more localized over time. Pain as movement of arm across and over head. Painful sleeping. Difficulty lifting objects.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Pain that became more and more localized over time. Pain as movement of arm across and over head. Painful sleeping. Difficulty lifting objects.
Age: 74.0
Sex: U
Vaccine: PPV
Symptoms: Injection site bruising, Injection site swelling, Pain
Clinical narrative: Swollen from injection site to elbow also bruised. Pt. says in pain. Took Ibuprofen and or Naproxen.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Patient called and reported stiffness, and difficulty raising her arms above her shoulders.
Age: 45.0
Sex: M
Vaccine: MMR, TDAP
Symptoms: Chills, Feeling cold, Hyperhidrosis, Muscle spasms, Pyrexia
Clinical narrative: Patient had MMR and TDAP 2/24/17 at 1:40 pm. He states at 8 pm 2/24/17 he chilled and could not get warm and shivered a lot. Fever 103 at that time. Also said he had cramps in legs and hard to hold legs straight. Also had sweats. States had fever for 36 hours. Again was 103 2/24/17 8 pm. Morning of 2/25/17 fever 102.6. Evening of 2/25/17 Fever 101.5. 2/26/17 AM temp normal. 2/26/17 Back to normal in AM.
Age: 66.0
Sex: F
Vaccine: FLU4, HEPA, TDAP
Symptoms: Dry throat, Dysphagia, Lymphadenopathy, Paraesthesia, Pruritus
Clinical narrative: 2/27/17 Monday patient got Hep A, TDaP and Influenza vaccines. Approximately 30 minutes after vaccines she said face and neck itchy and tongue feels wider. Returned to office for Dr to check her. No difficulty breathing but maybe some difficulty swallowing. BP 120/60 Pulse 80 Resp 16/1:58pm. She also states feels like glands swollen and feels like pins poking lips neck and ears. Throat dry. No rash, no hives. 1:35PM BP 130/60 P88 Resp16 O2 100. Gave water to drink. BENADRYL 25mg orally at 2:05PM. Had BENEDRYL 25mg 2 more times 2/2717 after left office. 2/28/17AM Back to normal.
Age: 66.0
Sex: F
Vaccine: FLU4, HEPA, TDAP
Symptoms: Swollen tongue
Clinical narrative: 2/27/17 Monday patient got Hep A, TDaP and Influenza vaccines. Approximately 30 minutes after vaccines she said face and neck itchy and tongue feels wider. Returned to office for Dr to check her. No difficulty breathing but maybe some difficulty swallowing. BP 120/60 Pulse 80 Resp 16/1:58pm. She also states feels like glands swollen and feels like pins poking lips neck and ears. Throat dry. No rash, no hives. 1:35PM BP 130/60 P88 Resp16 O2 100. Gave water to drink. BENADRYL 25mg orally at 2:05PM. Had BENEDRYL 25mg 2 more times 2/2717 after left office. 2/28/17AM Back to normal.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Cellulitis, Injection site erythema, Injection site oedema, Injection site pain, Injection site swelling
Clinical narrative: Received PROQUAD vaccine 3/3/17; vaccine given Lt. thigh subcutaneous; redness noted after injection; redness and edema noted 3/4/17 to Lt. leg and patient seen at ER; patient in our office 3/5/17 with 7.5" x 4.5" area of redness and swelling to Lt. upper anterior thigh and area warm to touch; diagnosed with cellulitis and given Rx. Clindamycin; patient seen for follow up  at Clinic 3/6/17 with improvement but still complaining of pain to Lt. thigh.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site warmth
Clinical narrative: Received PROQUAD vaccine 3/3/17; vaccine given Lt. thigh subcutaneous; redness noted after injection; redness and edema noted 3/4/17 to Lt. leg and patient seen at ER; patient in our office 3/5/17 with 7.5" x 4.5" area of redness and swelling to Lt. upper anterior thigh and area warm to touch; diagnosed with cellulitis and given Rx. Clindamycin; patient seen for follow up  at Clinic 3/6/17 with improvement but still complaining of pain to Lt. thigh.
Age: 54.0
Sex: U
Vaccine: FLU4
Symptoms: Syringe issue
Clinical narrative: Plunger malfunctioned. No dose given on initial vaccine. Once removed from arm, plunger was able to move with increased force. Second syringe worked properly and dose administered.
Age: 67.0
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Itching, redness swelling 1 week post administration.
Age: 47.0
Sex: U
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Rash on neck began 2 days after injection.
Age: 4.0
Sex: M
Vaccine: TYP
Symptoms: Decreased appetite, Laboratory test normal, Pyrexia
Clinical narrative: 2/1/17 Father called and states patient received Typhoid vaccine 1/12/17 in Am. Since Friday night 1/13/17 he has been having a fever off and on. Treating with TYLENOL but still issue. 2/1/17 Am also Father states has not felt like eating sold food starting a few days after had Typhoid injection. Went to Urgent Care, but they could not find a reason for fever and symptoms. Fevers 99-100. 2/1/17 5 Pm has gone 7 hours with no fever now so father thinks better. Would usually have normal temp during day and then fever in evening or night. 2/3/17 Back to normal.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Rash, Urticaria
Clinical narrative: 10 cm area of erythema at injection site right deltoid; urticarial lesions on face, -started evening of vaccination
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site joint movement impairment, Injection site pain
Clinical narrative: Patient presents with left shoulder pain that has lasted for three weeks. It began after receiving her flu shot. The pain has lessened over time but some remains and she reports limits her range of motion. The patient's relieved with ALEVE OTC. She has not yet seen a doctor. She reports a previous shoulder injury in the same shoulder.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Pt complained of soreness in right arm, swelling and redness from site of injection to elbow.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Influenza, Mobility decreased, Peripheral swelling, Pyrexia
Clinical narrative: 24 hr Flu described by pt. 102 fever swollen arm and pt could not lift arm.
Age: 28.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Injection site pain
Clinical narrative: Pain at site of inj for >3 wks. Pt got both vaccines in same arm (> 1 inch apart).
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Cough, Malaise, Pyrexia, Viral upper respiratory tract infection
Clinical narrative: Pt blames flu shot ruined his health and he is always sick now. Brought in not from MD's office saying he experiences fevers, cough, chills after receiving flu shot. According to consent form he said he had a cold 2 wks ago and feels fine at the time.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site
Clinical narrative: Patient comes to the pharmacy to report that the injection on 10/28 was too high (went into the bursa). Patient ended up needing physical therapy for a couple months.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: The next day a raised red spot the size of a quarter at the injection site. By Sunday the back of her arm was pink and still had the red spot. On Monday she went to see her doctor to verify it wasn't cellulitis. Dr told her to use ice and take BENADRYL - just a bad reaction.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: 4 hrs after shot - severe pain radiating cold chills and fever and headache. Next morning - more continuation of symptoms took ADVIL 48hr feeling better.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site bruising, Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: 2/22/17 Left leg had dime size redness with a lump. 2/23/17 redness to left leg increased to baseball size c/o leg itching. She was prescribed clindamycin. 2/24/17 center of leg looked bruised and is dark red. C/O left leg itching. Dr. recommended ZYRTEC. 3/7/17 Mom reports apple size bruised area, no redness, no lump.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Skin warm, Urticaria
Clinical narrative: Patient's arm became warm with hives/rash.
Age: 1.0
Sex: M
Vaccine: MMRV, PNC13
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration
Clinical narrative: Left thigh with immediate site reaction with 4 inch by 1 1/2 inch erythematous area with 2 inch induration: No respiratory symptoms. Given BENADRYL checked back in 20 mins. No induration erythema 2 inches by 2 inches, no pain.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Nausea, Syncope, Vomiting
Clinical narrative: Faint, sick to stomach, lightheaded, nausea, vomit.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 8 days after injection. Had redness/tenderness and warmth in the area of injection site. Pt saw her MD and was given antibiotics.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Swelling face
Clinical narrative: Pt call pharmacy at approximately 850 pm stating his "face is swelling"-instructed pt to go to emergency room for possible anaphylaxis.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Skin warm
Clinical narrative: Induration and warmth surrounding arm no fever, no chills. Prescribed prednisone at this time.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: Redness/itching/pain.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Influenza, Joint effusion, Joint swelling, Peripheral swelling
Clinical narrative: F/U symptoms Red, hot, swelling on shoulder area, next day the back on bicep was very sore to touch, swelling above elbow. Next day elbow swollen, red, hot. The next day below elbow water on elbow, trip to doctor for anti-bacterial meds.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Skin warm, Swelling, Tenderness
Clinical narrative: F/U symptoms Red, hot, swelling on shoulder area, next day the back on bicep was very sore to touch, swelling above elbow. Next day elbow swollen, red, hot. The next day below elbow water on elbow, trip to doctor for anti-bacterial meds.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: (L) arm where MENACTRA was given was warm to touch red itchy and painful area about the size of grapefruit.