chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient complaint of reverse redness at the site of injection and swelling. The redness was at the upper left arm.
Age: 68.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient complaint of reverse redness at the site of injection and swelling. The redness was at the upper left arm.
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Hypoaesthesia, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: Severe pain in bilateral lower extremity as well as numbness, tingling and weakness.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Small vesicular rash on 3 of 5 left distal phalanges as well as supra-pubic region.  This developed Newest blister developed within past 1-2 days in pad between thumb and index finger.  Pt received a steroid injection in PCP's office on 7/30.
Age: 68.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site oedema, Injection site pain
Clinical narrative: Edema, erythema, pain, nodule at injection site.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Injection site reaction. Indurated and erythematous.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Antinuclear antibody, Blood test, Electromyogram, Fall, Hypoaesthesia
Clinical narrative: Tingling and numbness started in feet, which resulted in falls.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Tingling and numbness started in feet, which resulted in falls.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, MNQ, RV5
Symptoms: Drug dose omission
Clinical narrative: I ordered on paper for this 4 month old 1. Pediarix, 2. Pedvaxhib, 3. Rotateq, and 4. meningococcal conjugate Menveo, and failed to give PCV-13.
Age: 21.0
Sex: M
Vaccine: MNQ
Symptoms: Dyspnoea, Eye movement disorder, Injection site haemorrhage, Loss of consciousness
Clinical narrative: AFTER ADMINISTRATION OF IMMUNIZATION, PATIENT APPLIED PRESSURE WITH COTTONBALL TO SITE OF INJECTION WHERE THERE WAS SOME SLIGHT BLEEDING.  HE TOLD ME THAT HE "SOMETIMES GETS ANEMIC".  WITHIN A MINUTE HIS EYES ROLLED BACK IN HIS HEAD AND HE TOOK A DEEP, GASPING TYPE BREATH AND THEN PASSED OUT.  HE WAS PASSED OUT FOR LESS THAN A MINUTE WHEN HE CAME BACK TO HIS SENSES HE APPEARED OKAY AFTER DRINKING SOME WATER AND RELAXING IN PLACE FOR A WHILE.  HE THEN SAID THAT THIS HAPPENS TO HIM "ABOUT HALF THE TIME."
Age: 14.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Hives, itching, skin redness.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Brain natriuretic peptide increased, C-reactive protein increased, Chest X-ray normal
Clinical narrative: Coughing, Shortness of breath, copious white mucous, fatigue, in bed for a week, but no sore throat, and uncertain if he had a fever.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Cough, Dyspnoea, Fatigue, Metabolic function test normal, Mobility decreased
Clinical narrative: Coughing, Shortness of breath, copious white mucous, fatigue, in bed for a week, but no sore throat, and uncertain if he had a fever.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Secretion discharge
Clinical narrative: Coughing, Shortness of breath, copious white mucous, fatigue, in bed for a week, but no sore throat, and uncertain if he had a fever.
Age: 96.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Inflammation, Skin warm
Clinical narrative: Patient's arm is red, slight inflammation, and warm to the touch. Area extends from deltoid to near elbow. Did not obtain specific time of onset, but has had symptoms for 7 days. Has not received treatment, but recommended her to see physician or go to urgent care.
Age: 21.0
Sex: F
Vaccine: MMR
Symptoms: Chills, Headache, Injection site pain, Injection site rash
Clinical narrative: Pain at site, chills, headache and rash under injection site which is getting bigger.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site inflammation, Injection site scab
Clinical narrative: Patient presented to pharmacy on 8/1/16 with red, circular inflamed area approx 1.5 inches in diameter with scab at center.  Per patient injection site bled after removal of bandaid then scabbed over. No pain, no fever, not hot to touch, no swelling of mouth/tongue/throat.  No treatment sought.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Per patient arm swelled up, warm to touch, the swelling not at the inj. site but more to the inner left mid-lower arm. Patient stated that did ice it and took advil but no resolution. Advised patient to see doctor. Outlined the swelling with a sharpie and told her to make sure it does not spread. Seek care right away if gets any worse, but for sure tomorrow. Ice, ranitidine dose, and see doctor.
Age: 42.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: Patient requested M-M-R vaccine and was suppose to be VARIVAX. MD okay'd getting both vaccines.
Age: 73.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Redness appeared 1-2 hrs after administration 22 hrs after redness, heat, itchiness 2 1/2 x 1 1/2 diameter ring of inflammation.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: Patient with redness and swelling around site of injection on 7/26/16. 7/26/16 patient was noted to have rash on her chest. Patient took BENADRYL for reaction but didn't work.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema
Clinical narrative: left arm redness.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Cold sweat, Dyspnoea, Hepatic enzyme increased, Herpes virus test
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 17-year-old female patient who received MENVEO (batch number M15125, expiry date unknown). The patient's past medical history included asthma and reactive airways disease. Concurrent medical conditions included allergy. Concomitant products included DEPO PROVERA. On 7th July 2016, the patient received MENVEO. On 10th July 2016, 3 days after receiving MENVEO, the patient experienced fever and weakness. In July 2016, the patient experienced cold sweat, shortness of breath, vaginal ulceration, lymphocytes raised and elevated liver enzymes. The patient was treated with ibuprofen, acetaminophen, and albuterol. In July 2016, the outcome of the vaginal ulceration was recovered/resolved. On an unknown date, the outcome of the fever, shortness of breath and weakness were unchanged and the outcome of the cold sweat, lymphocytes raised and elevated liver enzymes were unknown. The reporter considered the fever, cold sweat, shortness of breath, vaginal ulceration, weakness, lymphocytes raised and elevated liver enzymes to be related to MENVEO. Additional details were provided as follows: This case was previously reported to a doctor. This case was reported by the patient's mother. The patient had been diagnosed with either asthma, reactive airway disease or allergies when she was about five or six years old but the reporter could not remember exactly which one. On 10th July 2016, the patient began to feel weak and developed fever of 103.2 degrees F. The fever only resolved when the patient was taking either ibuprofen or acetaminophen but returned as soon as the medication wears off. She continued to feel weak. The patient's mother reported that sometimes the fever broke and her daughter experienced a cold sweat. On 12th July 2016, the patient went to her gynecologist because she had painful vaginal sores. Her physician told her that she had Herpes, however, the test results came back as negative. The reporter also indicated that the patient experienced periods of shortness of breath. During one episode, the patient inhaled some of her dad's albuterol to help improve her breathing. On Thursday, 21st July 2016, the mother took her daughter to the emergency room. The test results showed that the patient had elevated lymphocytes and elevation in her liver function. The reporter was very concerned about what her daughter was experiencing. She did not clarify what she meant by elevation in her liver function.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Lymphocyte count increased, Pyrexia, Vaginal ulceration
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 17-year-old female patient who received MENVEO (batch number M15125, expiry date unknown). The patient's past medical history included asthma and reactive airways disease. Concurrent medical conditions included allergy. Concomitant products included DEPO PROVERA. On 7th July 2016, the patient received MENVEO. On 10th July 2016, 3 days after receiving MENVEO, the patient experienced fever and weakness. In July 2016, the patient experienced cold sweat, shortness of breath, vaginal ulceration, lymphocytes raised and elevated liver enzymes. The patient was treated with ibuprofen, acetaminophen, and albuterol. In July 2016, the outcome of the vaginal ulceration was recovered/resolved. On an unknown date, the outcome of the fever, shortness of breath and weakness were unchanged and the outcome of the cold sweat, lymphocytes raised and elevated liver enzymes were unknown. The reporter considered the fever, cold sweat, shortness of breath, vaginal ulceration, weakness, lymphocytes raised and elevated liver enzymes to be related to MENVEO. Additional details were provided as follows: This case was previously reported to a doctor. This case was reported by the patient's mother. The patient had been diagnosed with either asthma, reactive airway disease or allergies when she was about five or six years old but the reporter could not remember exactly which one. On 10th July 2016, the patient began to feel weak and developed fever of 103.2 degrees F. The fever only resolved when the patient was taking either ibuprofen or acetaminophen but returned as soon as the medication wears off. She continued to feel weak. The patient's mother reported that sometimes the fever broke and her daughter experienced a cold sweat. On 12th July 2016, the patient went to her gynecologist because she had painful vaginal sores. Her physician told her that she had Herpes, however, the test results came back as negative. The reporter also indicated that the patient experienced periods of shortness of breath. During one episode, the patient inhaled some of her dad's albuterol to help improve her breathing. On Thursday, 21st July 2016, the mother took her daughter to the emergency room. The test results showed that the patient had elevated lymphocytes and elevation in her liver function. The reporter was very concerned about what her daughter was experiencing. She did not clarify what she meant by elevation in her liver function.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness pain to left deltoid. 11 year old male patient here due to allergic reaction c/o swelling, redness, pain at the injection site, L deltoid. Afebrile. No v/d.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concurrent condition, historical condition and concomitant therapy was not provided. On 28-JUL-2016 (reported as today), the patient was vaccinated with a dose of expired ROTATEQ (lot # K022995, expired date 22-JUL-2016, oral; dose was unknown). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to an unknown number of unspecified patients of unknown age and gender. Concurrent condition, historical condition and concomitant therapy were not provided. On unknown dates starting on or after 24-JUN-2016, the patients were vaccinated with improperly stored ROTATEQ (lot # L027067, expiration date 16-APR-2017, oral; dose was unknown). The vaccines were stored under 32F for 4 hours and 30 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effect was reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MENB
Symptoms: Influenza like illness, Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of pain in arm in an unspecified number of patients who received BEXSERO. On an unknown date, the patients received BEXSERO. On an unknown date, less than a month after receiving BEXSERO, the patients experienced pain in arm, fever, mobility decreased and influenza-like symptoms. On an unknown date, the outcome of the pain in arm, fever, mobility decreased and influenza-like symptoms were unknown. It was unknown if the reporter considered the pain in arm, fever, mobility decreased and influenza-like symptoms to be related to BEXSERO. Additional details were provided as follows: The age of vaccination for patients was not reported. The reporter stated that, multiple patients experienced reactions after receiving the BEXSERO, which included really sore arm, not able to lift the arm for a couple of days, flu like symptoms and fever. The office had been noticing this trend with the vaccine. The office just started using the vaccine about a month ago and the vaccines were administered over the June to July time frame.
Sex: U
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, less than a week after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was  unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient of unknown age and gender experienced pain a the injection site for 7 days following BEXSERO administration. Minimal adverse event information was provided to the reporter.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Asthenia, Fatigue, Injected limb mobility decreased, Injection site pain, Malaise
Clinical narrative: The case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 16-year-old male patient who received BEXSERO. Previously administered products included MENACTRA (1st dose received on an unknown date and the patient did not experience any adverse event). Concomitant products included MENACTA. On 19th JULY 2016, the patient received BEXSERO. On 19th JULY 2016, less than a day after receiving BEXSERO, the patient experienced injection site pain, injected limb mobility decreased, sickness, fatigue and weakness. On 20th JULY 2016, the patient experienced general body pain and fever. The patient was treated with ADVIL. On an unknown date, the outcome of the  injection site pain, injected limb mobility decreased, sickness, fatigue, general body pain, fever and weakness were not recovered/not resolved. The reporter considered the injection site pain, injected limb mobility decreased, sickness, fatigue, general body pain, fever and weakness to be probably related to BEXSERO. Additional details were provided as follows: This case was reported by the patient's mother. The patient received BEXSERO vaccine in his left arm. The patient felt sick and not well after receiving BEXSERO vaccine. The reporter further described sick and unwell by the specific events like sore arm,  inability to lift arm, fatigue, body aches, fever and weakness. The patient also received 2nd dose of MENACTRA (non-GSK) in his right arm during same doctor visit. The patient did not experienced any reaction after vaccination with previous MENACTRA dose, therefore BEXSERO was listed as only suspect vaccine. The patient attempted to manage the events with ADVIL.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Pain, Pyrexia
Clinical narrative: The case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 16-year-old male patient who received BEXSERO. Previously administered products included MENACTRA (1st dose received on an unknown date and the patient did not experience any adverse event). Concomitant products included MENACTA. On 19th JULY 2016, the patient received BEXSERO. On 19th JULY 2016, less than a day after receiving BEXSERO, the patient experienced injection site pain, injected limb mobility decreased, sickness, fatigue and weakness. On 20th JULY 2016, the patient experienced general body pain and fever. The patient was treated with ADVIL. On an unknown date, the outcome of the  injection site pain, injected limb mobility decreased, sickness, fatigue, general body pain, fever and weakness were not recovered/not resolved. The reporter considered the injection site pain, injected limb mobility decreased, sickness, fatigue, general body pain, fever and weakness to be probably related to BEXSERO. Additional details were provided as follows: This case was reported by the patient's mother. The patient received BEXSERO vaccine in his left arm. The patient felt sick and not well after receiving BEXSERO vaccine. The reporter further described sick and unwell by the specific events like sore arm,  inability to lift arm, fatigue, body aches, fever and weakness. The patient also received 2nd dose of MENACTRA (non-GSK) in his right arm during same doctor visit. The patient did not experienced any reaction after vaccination with previous MENACTRA dose, therefore BEXSERO was listed as only suspect vaccine. The patient attempted to manage the events with ADVIL.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 18-year-old female patient who received BEXSERO. On 19th JULY 2016, the patient received BEXSERO. On 20th JULY 2015, 1 day after, receiving BEXSERO, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were unknown. It was  unknown if the reporter considered the injection site erythema and injection site warmth to be related to BEXSERO. Additional details were provided as follows: The reporter stated that, the patient experienced red, warm, large spot on arm in which the patient received BEXSERO. Minimal adverse event information was provided to the reporter.
Age: 18.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Myalgia, Nausea, Oropharyngeal pain, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of myalgia in a 18-year-old female patient who received BEXERO. Concomitant products included HAVRIX pediatric. On 19th JULY 2016, the patient received BEXSERO. On 20th JULY 2016, 1 days after receiving BEXSERO, the patient experienced myalgia, nausea, sore throat and fever. On an unknown date, the outcome of the myalgia, nausea, sore throat and fever were not recovered/not resolved. The reporter considered the myalgia, nausea, sore throat and fever to be probably related to BEXSERO. Additional details were received as follows: The age at vaccination was not reported. The patient received a dose of BEXSERO and HAVRIX in unknown arms. The reporter did not have any product information and date of birth of the patient.
Age: 0.2
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Nodule
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of nodule on extremity in a 2-month-old patients who received PEDIARIX. On an unknown date, the patients received PEDIARIX at an unknown dose. On an unknown date, an unknown time after receiving PEDIARIX, the patients experienced nodule on extremity to be related to PEDIARIX. Additional details were provided as follows: This case was previously reported to a doctor. The reporter stated that, many patients had experienced leg nodules after receiving the PEDIARIX vaccine which had lasted for a long time. The parents of the patient called to report that their babies had a know in their legs and it was not going away. The reporter felt that it was due to the PEDIARIX vaccine. The complaints appear to have occurred after the patient's 2 months check-ups. The reporter did not have any patient information at the time of the call but she was actively collecting the information to provide when she was contacted by GlaxoSmithKline. The reporter stated that, the adverse event had nothing to do with technique because several different nurses administered the product with the same results. This case was reported to the sales representative during a lunch in-service in which the physician, nurse and practice manager were all present. The Medical Science Liaison was contacted and talked with the nurse and practice manager during the meeting. On 19th July 2016, the sales representative did try to contact the GSK response centre to report the adverse event, by the GSK Response Centre was close for several hours due to technical issues. The reporter was unable to provide any further details.
Age: 0.2
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 2-month-old male patient who received KINRIX. On 25th July 2016, the patient received KINRIX. In July 2016, less than a week after receiving KINRIX, the patient experienced fever. On 25th July 2016, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the fever and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the fever to be related to KINRIX. Additional details were provided as follows: The reporter stated that the 9 weeks old patient was administered with KINRIX and experienced fever, which also led to an inappropriate age at vaccine administration.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site erythema
Clinical narrative: Local reaction at injection site. Erythema, 8cm dia. Suspect allergic trigger.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Decreased appetite, Fatigue, Musculoskeletal stiffness, Pyrexia
Clinical narrative: High fever, fatigue, neck stiffness, and decreased appetite.
Age: 13.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Blepharospasm, Syncope
Clinical narrative: Pt fainted after shot, not witnessed, was fine after 15 minutes; reported by sister; ? seizure; sister reported eyes twitching.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Headache, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Pt. noted headache PM of receiving vacc. (7/27/16). On 7-28-16 noted (R) deltoid area red, warm, itched, chills. On 7-29-16 upper half (R) arm red, warm to touch, swollen, itching. No dizziness, weakness, difficulty in breathing or swallowing noted. Severe local reaction.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Local reaction
Clinical narrative: Pt. noted headache PM of receiving vacc. (7/27/16). On 7-28-16 noted (R) deltoid area red, warm, itched, chills. On 7-29-16 upper half (R) arm red, warm to touch, swollen, itching. No dizziness, weakness, difficulty in breathing or swallowing noted. Severe local reaction.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to an unknown number of unspecified patients of unknown age and gender. Concurrent condition, historical condition and concomitant therapy were not reported. On unknown dates starting on or after 24-JUN-2016, the patients were vaccinated with improperly stored PEDVAXHIB (lot # L033690, expiration date 14-JUN-2018; dose and route were unknown). The vaccines were stored under 32F for 4 hours and 30 minutes. There was no previous temperature excursion. Data logger was involved. No adverse effect was reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a 68 year female patient referring to herself. The patient had high blood pressure and thyroid condition and was taking "blood pressure medication and thyroid medication" concomitantly. In 2009 (reported as " 7 years ago" at the time of this report), the patient was vaccinated with a dose of ZOSTAVAX (dose and route unspecified). On 11-JUL-2016 (reported as "two weeks ago" at the time of this report), they broke out with shingles. The patient sought an unspecified medical attention and treatment was given for the event. The outcome of the event was unknown. Additional information is not expected as we were not permitted to contact physician.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant, referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On unspecified time in 2009 the patient was vaccinated with a first dose of GARDASIL (site of administration, lot #, expiry date and dose were not reported). Then, on 08-JUL-2016 the patient received GARDASIL 9 as second dose (lot # L048459, expiry date 22-FEB-2018), site of administration was not reported. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of fever in a 20-year-old male patient who received BEXSERO (batch number 154101A, expiry date 1st MAY 2017). On 25th JULY 2016, the patient received BEXSERO .5 ml. In JULY 2016, less than a week after receiving BEXSERO, the patient experienced pain in arms and chills. On 25th JULY 2016, the patient experienced fever. On an unknown date, the outcome of the fever, pain in arm and chills were unknown. It was unknown if the reporter considered the fever, pain in arm and chills to be related to BEXSERO. Additional details were provided as follows: On 25th JULY 2016, at 11 AM, the patient received a dose of BEXSERO vaccine and from 5 PM, the patient started experiencing side effects like fever, arm achy and chills.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Cervix disorder
Clinical narrative: Information has been received from an unspecified office manager, who worked with a physician assistant, via a company representative, concerning a female patient of 19 years old. The patient's pertinent medical history and concurred conditions were not reported. It was reported that on unspecified dates, around the patient's age of 16 years old, she received unspecified doses of GARDASIL (lot #, dose, route and expiration date were not provided). Concomitant therapies were not reported. On an unknown date, at the patient's age 19 years old, she was diagnosed with "high grade cervical lesion" an unspecified time after receiving GARDASIL. It was also reported that the patient would need "part of her cervix removed due to the high grade cervical lesion", but it was not specified if that was scheduled yet. The outcome of high grade cervical lesion was unknown at the time of the report. There was no product quality complaint (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: Information was received on 15-JUL-2016 from an medical assistant regarding a patient (gender and age not reported) who received the first dose in the GARDASIL series as GARDASIL (lot # 1262AA, expiration 20-MAR-2013) on 21-APR-2012, the second dose of GARDASIL (lot #J006236, expiration 01-JUL-2014) on 01-JUL-2014. The third dose was inadvertently given as GARDASIL 9 (lot # L014415, expiration 30-NOV-2015) on 03-NOV-2015, and the patient was inadvertently given a fourth dose of GARDASIL 9 (lot # L024993, expiration 17-OCT-2017) on 12-JUL-2016. No adverse effects were reported. No concurrent conditions or medical history were reported. No concomitant medication was reported. No further information was provided. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Pain, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: This spontaneous report as received from a pharmacy intern refers to a 76 year old female patient. The patient's pertinent medical history included basal cell carcinoma and allergy/drug reaction to codeine. On 18-JUL-2016, she was vaccinated with PNEUMOVAX23 (lo6t # L035687, expiry date 16-FEB-2017) subcutaneous. Concomitant therapies included LIPITOR. On 19-JUL-2016, she woke up with a "red, swollen, achy and warm area" at the injection site which was "also painful". At the time of the report she did not recover from the events. The reporter did not provide the relatedness of the events with PNEUMOVAX23. Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacy intern refers to a 76 year old female patient. The patient's pertinent medical history included basal cell carcinoma and allergy/drug reaction to codeine. On 18-JUL-2016, she was vaccinated with PNEUMOVAX23 (lo6t # L035687, expiry date 16-FEB-2017) subcutaneous. Concomitant therapies included LIPITOR. On 19-JUL-2016, she woke up with a "red, swollen, achy and warm area" at the injection site which was "also painful". At the time of the report she did not recover from the events. The reporter did not provide the relatedness of the events with PNEUMOVAX23. Additional information has been requested.
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Circumstance or information capable of leading to medication error, Exposure via direct contact, Eye irrigation
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, while holding the child for vaccination with (Oka-Merck) PROQUAD injection, lot # M004893, expiration date: 26-JUL-2017, (dose was not reported), very small amount of the vaccine squirted out of needle, right before administration and got into the patient's eye. No adverse effects were reported for the mother. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter (linked with MARRS # 1608USA001261). Additional information has been requested.
Sex: F
Vaccine: MMRV, MMRV
Symptoms: Accidental exposure to product, Exposure via direct contact, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of unknown age. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown date, while holding the child for vaccination with (Oka-Merck) PROQUAD injection, lot # M004893, expiration date: 26-JUL-2017, (dose was not reported), very small amount of the vaccine squirted out of needle, right before administration and got into the patient's eye. No adverse effects were reported for the mother. No product quality complaint (PQC) was involved. This is one of two reports received from the same reporter (linked with MARRS # 1608USA001261). Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HEP, HPV4, MEN
Symptoms: Cervix carcinoma, Human papilloma virus test positive
Clinical narrative: OB Doctor diagnosed me cervical cancer and positive for HPV multiple strands including 16 and 18.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Lethargy, Pyrexia, White blood cell count increased
Clinical narrative: Fever, chills, lethargy, elevated WBC.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Arthralgia, Asthenia, Blood test normal, Chest X-ray normal, Chills
Clinical narrative: Began having diarrhea and chills same night of vaccine. Next morning having trouble breathing, coughing, trouble focusing. Dr says immune system is reacting to vaccine gave benadryl and hexadone on 7/22/2016. Issues ongoing headache, weakness, nausea, blurry vision, sweating and hot flashes chills,trouble breathing, fainting, muscle and joint pain,fatigue and trouble focusing. Almost two weeks after vaccine, had to go to emergency room on 8/1/2016 after passing out on first day back at work. Reported same symptoms to Dr at ER with onset of problems following vaccine.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Computerised tomogram normal, Cough, Diarrhoea, Dyspnoea, Electrocardiogram normal
Clinical narrative: Began having diarrhea and chills same night of vaccine. Next morning having trouble breathing, coughing, trouble focusing. Dr says immune system is reacting to vaccine gave benadryl and hexadone on 7/22/2016. Issues ongoing headache, weakness, nausea, blurry vision, sweating and hot flashes chills,trouble breathing, fainting, muscle and joint pain,fatigue and trouble focusing. Almost two weeks after vaccine, had to go to emergency room on 8/1/2016 after passing out on first day back at work. Reported same symptoms to Dr at ER with onset of problems following vaccine.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Fatigue, Headache, Hot flush, Hyperhidrosis, Loss of consciousness
Clinical narrative: Began having diarrhea and chills same night of vaccine. Next morning having trouble breathing, coughing, trouble focusing. Dr says immune system is reacting to vaccine gave benadryl and hexadone on 7/22/2016. Issues ongoing headache, weakness, nausea, blurry vision, sweating and hot flashes chills,trouble breathing, fainting, muscle and joint pain,fatigue and trouble focusing. Almost two weeks after vaccine, had to go to emergency room on 8/1/2016 after passing out on first day back at work. Reported same symptoms to Dr at ER with onset of problems following vaccine.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Myalgia, Nausea, Syncope, Vision blurred
Clinical narrative: Began having diarrhea and chills same night of vaccine. Next morning having trouble breathing, coughing, trouble focusing. Dr says immune system is reacting to vaccine gave benadryl and hexadone on 7/22/2016. Issues ongoing headache, weakness, nausea, blurry vision, sweating and hot flashes chills,trouble breathing, fainting, muscle and joint pain,fatigue and trouble focusing. Almost two weeks after vaccine, had to go to emergency room on 8/1/2016 after passing out on first day back at work. Reported same symptoms to Dr at ER with onset of problems following vaccine.
Age: 0.43
Sex: F
Vaccine: DTAPIPVHIB, HIBV, PNC13, RV1
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient at well child visit received two Hib vaccines.  Given Pentacel (instead of Pediarix) and Hib along with Prevnar and Rotarix.  No treatment or signs of adverse reaction.
Age: 60.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Pruritus, Scab, Secretion discharge, Urticaria
Clinical narrative: Large itchy red welts on back of neck at hairline. As one heals another appears. Each last 5-7 days. Serous crusts forms on skin 3 days after eruption. Treat with topical Cortaid. Not very effective.
Age: 0.47
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Patient had a fever of 100.4 for 48 hours.
Age: 6.0
Sex: F
Vaccine: HPVX
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None reported.
Age: 19.0
Sex: M
Vaccine: HEPAB, MMR, VARCEL
Symptoms: Dyspnoea, Hypersensitivity, Pharyngeal oedema, Rash
Clinical narrative: 19 YO M presenting f/u allergic reaction s/p immunizations. Pt reported SOB,throat swelling, and small bumps on body after immunizations. Pt was treated with prednisone, solumedrol, zantac, benadryl. Pt reports that sxs gradually resolved after four days. Pt denies hx of anaphylaxis or known allergies. A/E 20 min post vaccination.
Age: 4.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Redness, swelling and lump to Left thigh. mom gave ibuophen and warm compresses. seen in office on 7-29-16 continued with redness and small lump.
Age: 15.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Chills, Fatigue, Headache, Piloerection
Clinical narrative: Awoke with chills, headache, goose bumps and fever at 2:00 AM. Took Advil. Slept some after that then awoke with chills and hives. Temp of 100.6 F. Tired and no energy. Took daily Zyrtec. Next day felt better but still with 2 hives. Hives all gone by 8/1/2016. Is on daily Zyrtec for allergies.
Age: 15.0
Sex: F
Vaccine: MENB
Symptoms: Pyrexia, Urticaria
Clinical narrative: Awoke with chills, headache, goose bumps and fever at 2:00 AM. Took Advil. Slept some after that then awoke with chills and hives. Temp of 100.6 F. Tired and no energy. Took daily Zyrtec. Next day felt better but still with 2 hives. Hives all gone by 8/1/2016. Is on daily Zyrtec for allergies.
Age: 18.0
Sex: F
Vaccine: MEN
Symptoms: Dizziness
Clinical narrative: Became very dizzy.
Age: 1.02
Sex: F
Vaccine: HEPA, HIBV, MMRV, PNC13
Symptoms: Autopsy, Death, Toxicologic test
Clinical narrative: Toddler found died in her crib in the morning.
Age: 1.42
Sex: M
Vaccine: DTAP, HIBV, MMR
Symptoms: Apnoea, Cyanosis, Vomiting
Clinical narrative: This spontaneous report was received from a medical assistant, who was also the patient's mother and refers to a 17 month old male patient. The patient's concurrent conditions included asthma and drug reaction or allergy to OMNICEF. The patient's other relevant medical history was not reported. The patient's concomitant medications were unknown. On 13-JUN-2016, the patient was vaccinated with a dose of M-M-R II (route and site of administration, dose, lot number and expiration date were not reported). Other suspect therapies included unspecified hib vaccine, 3 doses administered (dates of vaccination, route and site of administration, dose, lot number and expiration date were not reported) and DTAP (administered on 13-JUN-2016, route and site of administration, dose, lot number and expiration date were not reported). On 14-JUN-2016, the patient began vomiting and was taken to an unspecified hospital. While in the hospital, he was diagnosed as having a "cyanotic episode with severe apnea". When asked if the patient was admitted to hospital, the reporter stated that he "was in the hospital for 1 day". It was unknown if any lab diagnostic studies were performed and if any treatment was given for the event. The outcome of the events was considered as recovered on an unknown date in 2016, as the reporter stated that the patient "seems to be doing fine". The relatedness between the events and the vaccination with M-M-R II, unspecified hib vaccine and DTAP was not reported. Upon internal review, severe apnea was determined to be medically significant. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 21-JUL-2016 the patient was vaccinated with improperly stored (Oka-Merck) PROQUAD (lot # L046510, expiration date 19-MAY-2017, dose and route were not reported). The vaccine had been stored under temperature of 52.3 degree Fahrenheit for 11 hours. No previous excursions. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9, MEN, PPV
Symptoms: Seizure, Syncope
Clinical narrative: Information has been received from a nurse via a company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On an unknown date the patient was vaccinated with GARDASIL 9, pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, frequency, lot #, expiration date and route were not reported for all the suspect vaccines) and meningococcal vaccine at the same time. The patient had a "mini seizure" in the exam room after receiving the vaccines and fainted outside of the office. It was reported that the patient was recovered from the adverse events at the time of reporting. The relatedness between adverse events and GARDASIL 9 and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not reported. Upon internal review, the event of seizure was considered to be medically significant. Additional information is not expected as no contact details available.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Muscular weakness
Clinical narrative: Initial solicited report received on 08 June 2016 from a consumer participating in the below-mentioned study. This case involves a 26-year-old male, who received a dose of FLUZONE Intradermal (site of administration and batch number not reported). On an unknown date after receiving a dose of FLUZONE Intradermal (site of administration and batch number not reported), the subject had severe muscle weakness. The outcome of event severe muscle weakness was not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Loss of consciousness
Clinical narrative: Initial unsolicited report received from a other-healthcare professional via other company (Pfizer) (manufacturer report number: 2016342664) on 21-JUL-2016. This case involves a 16-year-old female patient who was vaccinated with a dose of MENACTRA and a 0.5 ml dose of TRUMENBA, (for both the vaccines batch number, expiry date, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient passed out for a few seconds. Lab data and corrective treatment was not reported. On an unspecified date, the patient was recovered from event. Upon medical review, the case was considered as serious due to important medical event: passed out for a few seconds. List of documents held by sender: none. Sender's Comments: This a poorly documented case as patient passed out for few seconds following MENACTRA and TRUMENBA VACCINE. Detail medical history, past vaccination history and its tolerance are needed to further assess this case. As multiple vaccine are administered, the role each vaccine cannot be evaluated.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Hypersensitivity, Injection site induration, Injection site mass, Injection site nodule, Injection site pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of allergic reaction in a 17-year-old female patient who received BEXSERO (batch number 157501, expiry date 31st August 2017. The patient's past medical history included attention deficit/hyperactivity disorder (experienced in July 2014). Concomitant products included amfetamine aspartate + amfetamine sulfate + dexamfetamine sulfate +dexotroamphetamine saccharate (ADDERALL) and ethinyloestradiol + levonorgestrel (SEASONIQUE). On 20th July 2016, the patient received the 1st dose of BEXSERO .5 ml. In July 2016, less than a week after receiving BEXSERO, the patient experienced injection site swelling. On 20th July 2016, the patient experienced allergic reaction, injection site lump, injection sit induration, injection site pain, injection site warmth. On an unknown date, the outcome of the allergic reaction, injection site warmth and injection site swelling were unknown and the outcome of the injection site lump and injection site duration were not recovered/not resolved and the outcome of the injection site pain was recovering/resolving. The reporter considered the allergic reaction, injection site lump, injection site induration, injection site pain, injection site warmth and injection site swelling to be related to BEXSERO. Additional details were provided as follows: This case was not previously reported to anyone. The patient experienced an allergic reaction at the injection site (left deltoid) including a hard knot that was painful and sore, hot to touch and looked similar to a shoulder pad. In the night, several hours after the vaccination, the patient started to feel pain then the swelling started. At the time of reporting, pain was not as bad but hard knot was still huge.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of allergic reaction in a 17-year-old female patient who received BEXSERO (batch number 157501, expiry date 31st August 2017. The patient's past medical history included attention deficit/hyperactivity disorder (experienced in July 2014). Concomitant products included amfetamine aspartate + amfetamine sulfate + dexamfetamine sulfate +dexotroamphetamine saccharate (ADDERALL) and ethinyloestradiol + levonorgestrel (SEASONIQUE). On 20th July 2016, the patient received the 1st dose of BEXSERO .5 ml. In July 2016, less than a week after receiving BEXSERO, the patient experienced injection site swelling. On 20th July 2016, the patient experienced allergic reaction, injection site lump, injection sit induration, injection site pain, injection site warmth. On an unknown date, the outcome of the allergic reaction, injection site warmth and injection site swelling were unknown and the outcome of the injection site lump and injection site duration were not recovered/not resolved and the outcome of the injection site pain was recovering/resolving. The reporter considered the allergic reaction, injection site lump, injection site induration, injection site pain, injection site warmth and injection site swelling to be related to BEXSERO. Additional details were provided as follows: This case was not previously reported to anyone. The patient experienced an allergic reaction at the injection site (left deltoid) including a hard knot that was painful and sore, hot to touch and looked similar to a shoulder pad. In the night, several hours after the vaccination, the patient started to feel pain then the swelling started. At the time of reporting, pain was not as bad but hard knot was still huge.