chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a patient, who had been receiving Nasal FLUMIST Quadrivalent (Intranasal), 0.2 Millilitres, Lot number: FL2117. FLUMIST Quadrivalent (Intranasal) started on an unknown date. The patient had received expired FLUMIST (medication error). The outcome of the event of expired FLUMIST (medication error) is unknown. The report was considered to be non-serious by the company physician.
Sex: M
Vaccine: FLUN4
Symptoms: Underdose
Clinical narrative: A report has been received from a Health Professional concerning a, male patient, who had been receiving FLUMIST. FLUMIST started on an unknown date. The patient was administered a partial dose of FLUMIST by a Pharmacist on December 12, 2015. The pharmacist successfully administered the first half of the dose, but the child moved away during administration of the second half of the dose. The outcome of the event of partial dose administered was unknown. The report was considered to be non-serious.
Age: 9.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a 9 year old, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 17-Feb-2016. Nurse reported that she had administered an expired FLUMIST QUADRIVALENT to a 9 year old on 17-Feb-2016. The outcome of the event of administration of expired lot is unknown. The reporter's description of the events was as follows: healthy child. The report was considered to be non-serious.
Age: 10.0
Sex: U
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a patient of unknown gender, Height: 56.0 inches; Weight: 69.0 Pounds, who had been receiving FLUMIST, 0.2 millilitres, once/single. FLUMIST was started on 05-Jan-2016. The reporter stated that FLUMIST with an expiration date of 30-Dec-2015 today 5-Jan-2016 was given to a patient. FLUMIST was continued. The outcome of the event of caller reported giving FLUMIST with an expiration date of 30-DEC-2015 today 5-JAN-2016 was unknown. The report was considered to be non-serious.
Age: 8.0
Sex: F
Vaccine: FLUN4
Symptoms: Expired product administered
Clinical narrative: A report has been received from a Health Professional concerning a, female subject, who had been receiving FLUMIST, 0.2 millilitres. FLUMIST started on 04-Jan-2016. It was reported that patient had received expired dose of FLUMIST on 04-Jan-2016 who dose was expired on 30-Dec-2015. The outcome of the event of patient received expired dose is unknown. The report was considered to be non-serious.
Sex: M
Vaccine: FLUN4
Symptoms: Dizziness, Malaise
Clinical narrative: A consumer report has been received. The report concerns a, male consumer, who had been receiving FLUMIST, 0.2 millilitres, yearly. FLUMIST started during Oct-2015. The patient experienced not feeling well and dizziness which started during Oct-2015. The patient recovered from the event of not feeling well and dizziness on an unspecified date. The report was considered to be non-serious.
Sex: M
Vaccine: FLUN4
Symptoms: Asthma
Clinical narrative: A report has been received from health professional via medical rep concerning a male patient. No information regarding relevant history and concomitant medication was provided. Reporter stated that she gave patient a dose of the FLUMIST Quadrivalent (Intranasal). After that he had an exacerbation of his asthma for about 1 week. Doctor was contemplating whether patient should get the FLUMIST vaccine again next year. Action taken with FLUMIST Quadrivalent was unknown. The outcome of exacerbation of asthma was unknown. The company physician assessed exacerbation of asthma to be non-serious.
Sex: F
Vaccine: FLUN4
Symptoms: Cerebral disorder, Disability, Epilepsy, Narcolepsy, Paralysis
Clinical narrative: A consumer report has been received from a website. The report concerns a female patient. The patient's relevant medical history or concomitant medications were not reported. The patient posted on the website that she received FLUMIST QUADRIVALENT (intranasal), four strain H1N1, 0.2 millilitres, unknown frequency in Feb-2014. After receiving the FLUMIST QUADRIVALENT, she developed a brain disorder and became narcoleptic. Indicated, when she laughed body went paralyze like epilepsy. The patient was currently on disability. She also mentioned one of the medications she took blocked her birth control, at the time of the report she was pregnant. Did not specify what other medications she has been taking. Action taken of FLUMIST QUADRIVALENT was unknown. The outcome of the events of brain disorder, when she laughs body paralyzes like epilepsy, narcolepsy and epilepsy was unknown. According to the company physician the event of brain disorder-narcolepsy added separately as brain disorder and narcolepsy and assessed as serious adverse event due to important medical event. According to the company physician the events of when she laughs body paralyzes like epilepsy and epilepsy was considered to be serious with the serious criteria of important medical event.
Sex: F
Vaccine: DTAP
Symptoms: Injection site reaction, Local reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a adult female patient who received DTPA vaccine. On an unknown date, the patient received DTPA vaccine at an unknown dose. On an unknown date, an unknown time after receiving DTPA vaccine, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown. It was unknown if the reporter considered the injection site reaction to be related to DTPA vaccine. Additional details were provided as follows: This case was reported by the patient's child. The age at vaccination was not reported. Fifteen years ago from reporting date, the patient had a local injection site reaction after receiving TDAP vaccine last time. The patient was told not to receive the vaccine again, but with 3 new babies coming they felt that she should have a pertussis immunization. The patient's doctor told her that such a vaccine was available, but their pharmacist had not been able to locate any. The reporter was asking for advise.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from Registered Nurse refers to unspecified number of patients of unknown demography. On an unknown date the patients were vaccinated with improperly stored PEDVAXHIB lot # M006709 (expiry: 12-JUN-2018). No adverse effects were reported. No product quality complaint (PQC) involved. This case is linked to cases 1608USA012662 and 1608USA012663 (same reporter link). Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Soreness (:) deltoid 8/22, then 8/24 developed redness, warmth and swelling. Redness and swelling decreased 8/25. Light headed briefly at school 8/25 - resolved. Tried BENADRYL at hs.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from Registered Nurse refers to unspecified number of patients of unknown demography. On an unknown date the patients were vaccinated with improperly stored RECOMBIVAX HB lot # M022077 (expiry: 01-MAR-2019). No adverse effects were reported. No product quality complaint (PQC) involved. This case is linked to cases 1608USA005032 and 1608USA012663 (same reporter link). Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Cellulitis
Clinical narrative: left arm cellulitis tx'd with ABX. Indicated she is much better via phone call 8/24/2016.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from Registered Nurse refers to unspecified number of patients of unknown demography. On an unknown date the patients were vaccinated with improperly stored GARDASIL 9 (lot #L038135, expiry: 27-MAY-2017) (incorrect product storage). No adverse effects were reported. No product quality complaint (PQC) involved. This case is linked to cases 1608USA005032 and 1608USA012662 (same reporter link). Additional information has been requested.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site movement impairment, Injection site pain, Injection site urticaria, Injection site warmth, Swelling
Clinical narrative: Severe soreness at injection site. Turned into a big welt. Pt had very little movement from shoulder to elbow. Site was hot to the touch. Symptoms lasted about two weeks. Swelling and hives were also a symptom.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Severe soreness at injection site. Turned into a big welt. Pt had very little movement from shoulder to elbow. Site was hot to the touch. Symptoms lasted about two weeks. Swelling and hives were also a symptom.
Sex: U
Vaccine: MNQ
Symptoms: Erythema
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of erythema in a 12-year-old patient who received MENVEO (batch number M15079, expiry date 30th April 2017). On an unknown date, the patient received MENVEO. On an unknown date, an unknown time after receiving MENVEO, the patient experienced erythema. On an unknown date, the outcome of the erythema was unknown. It was unknown if the reporter considered the erythema to be related to MENVEO. Additional details were provided as follows: The age at vaccination was not reported. The sales representative called to report the adverse event on behalf of physician. This case has been linked with US2016109244, reported by same reporter.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 17-year-old patient who received BEXSERO (batch number 151401A, expiry date 31st December 2016). Concomitant products included MENVEO. On 1st August 2016, the patient received BEXSERO. On 1st August 2016, less than a day after receiving BEXSERO, the patient experienced injection site pain (serious criteria other: serious as per reporter). On 7th August 2016, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were unchanged. It was unknown if the reporter considered the injection site pain and injection site swelling to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced soreness and bump in the arm of the BEXSERO injection and MENVEO was administered in the opposite arm. At the time of reporting, the patient visited the other healthcare professional's office for a consultation about the adverse events. The other healthcare professional agreed to have follow up with them via mail to fill out reminder of the report.
Sex: M
Vaccine: HPV4, MENB
Symptoms: Dyspnoea, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a male patient who received BEXSERO. Concurrent medical conditions included allergy to vaccine (occurred when the patient was 3 years old). Concomitant products included GARDASIL. On 9th August 2016, the patient received BEXSERO. On 10th August 2016, 1 days after receiving BEXSERO, the patient experienced injection site swelling (serious criteria other: As per reporter) and difficulty breathing. On an unknown date, the outcome of the injection site swelling and difficulty breathing were unknown. It was unknown if the reporter considered the injection site swelling and difficulty breathing to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO and GARDASIL in two separate arms. Following vaccination the arm that received BEXSERO swelled up massively and the patient had trouble breathing. The patient was taken to the emergency room (ER) where he was stabilized. The reporter did not have the vaccine lot or expiration date or any patient information other than sex. The reporter was unaware of what does in the series either the BEXSERO or GARDASIL was.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt received Tdap (L) deltoid IM on 8/23/16 and pt stayed 15 mins. and felt fine. Pt subsequently left clinic and noticed a quarter-sized reddened area to (L) deltoid on 14 August 2016. Today, pt presents with a 55 mm wide x 50 mm length reddened area, left upper arm described as sore and hot.
Age: 2.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Approximately 10 minutes after MMR vaccine given child had 2 cm area of erythema with minimal swelling around injection site. No shortness of breath or rash.
Age: 5.0
Sex: F
Vaccine: IPV, MMR
Symptoms: Petechiae
Clinical narrative: Rash after immunization. Petechiae on eyelids and neck. Observed patient for 15 minutes rash not progressed.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Injection site swelling, Pain, Pain in extremity, Tenderness
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of pain in arm in a 19-year-old female patient who received BEXSERO (batch number 149001A, expiry date 30 November 2016). On 9th AUGUST 2016, the patient received BEXSERO (intramuscular). On 9th AUGUST 2016, several hours after receiving BEXSERO, the patient experienced pain in arm, pain in elbow and tenderness. In AUGUST 2016, the patient experienced injection site swelling. The patient was treated with naproxen and steroids nos. On an unknown date, the outcome of the pain in arm, pain in elbow, tenderness and injection site swelling were unknown.  It was unknown if the reporter considered the pain in arm, pain in elbow, tenderness and injection site swelling to be related to BEXSERO. Additional details were provide as follows: This case was previously reported to a doctor. This case was reported by a licensed practical nurse. The reporter stated that, the patient experienced shooting pain up and down her left arm, whole arm tender to touch and very achy particularly around elbow after receiving BEXSERO at 10:04 am in left arm. It was also reported that, there was swelling at the injection site about the size of nickel. The patient was treated with steroids and Naproxen for pain. The reporter would not be administering second vaccination in series. The case is one of the three cases reported by the same reporter.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Rash erythematous
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of erythematous rash in a 11-year-old female patient who received BOOSTRIX (batch number 7B222, expiry date 23rd April 2017). Concurrent medical conditions included latex allergy. On 4th August 2016, the patient received BOOSTRIX .5 ml. On 9th August 2016, 5 days after receiving BOOSTRIX, the patient experienced erythematous rash. On an unknown date, the outcome of the erythematous rash was recovering/resolving. It was unknown if the reporter considered the erythematous rash to be related to BOOSTRIX. Additional details were provided as follows: The healthcare professional reported that the patient experienced a red rash on her shoulders and back. On 10th August 2016, the symptoms were subsided. The reporter stated that the patient was allergic to late but administered the single dose vial.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Labelled drug-disease interaction medication error, Rash, Swelling face, Urticaria
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of facial swelling in a 17-year-old male patient who received BEXSERO. Concurrent medical conditions included latex allergy. On 10th AUGUST 2016, the patient received the 1st dose of BEXSERO. On 10th AUGUST 2016, an unknown time after receiving BEXSERO, the patient experienced labeled drug-disease interaction medication error. In AUGUST 2016, the patient experienced facial swelling, rash and hives. The patient was treated with BENADRYL. On an unknown date, the outcome of the facial swelling, rash, hives and labeled drug-disease interaction medication error were unknown. It was unknown if the reporter considered the facial swelling, rash and hives to be related to BEXSERO. Additional details were provided as follows: The patient was having an allergy to latex and received 1st dose of BEXSERO, which led to a labeled drug-disease interaction/medication error. The patient experienced facial swelling, rash and hives on his face. The patient's mother gave him BENADRYL which took down the facial swelling and hives. No further information was provided.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain, Labelled drug-drug interaction medication error
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 16-year-old female patient who received BEXSERO (batch number 153701A, expiry date 20th APRIL 2017). Concomitant products included MENACTRA. On 8th JUNE 2016, the patient received the 1st dose of BEXSERO (intramuscular). In June 2016, less that a month after receiving BEXSERO, the patient experienced injection site pain, injected limb mobility decreased, vaccine administered at inappropriate site and labeled drug-drug interaction medication error. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were recovered/resolved and the outcome of the vaccine administered at inappropriate site and labeled drug-drug interaction medication error were unknown.  The reporter considered the injection site paint and injected limb mobility decreased to be almost certainly related to BEXSERO. Additional details were provided as follows: This case was reported by a licensed practical nurse. On 8th JUNE 2016, the patient received BEXSERO and MENACTRA in left arm, which led vaccine administered at inappropriate site and labeled drug-drug interaction medication error. The reporter stated that, the patient experienced sore arm and unable to lift arm after receiving BEXSERO at 18:30 in left arm. The patient advised the physician's office of the reported events but still received her second injection in this series on 8th AUGUST 2016. IT was reported that no events were associated with 2nd dose of vaccine. The case is one of the three cases reported by the same reporter.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: 4cm round tender erythema at injection site 48 hours after administration.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 08-AUG-2016 the patient was vaccinated with improperly stored VARIVAX (dosing details were not reported) (lot # M010480, expiry date: 03-JAN-2018). No adverse effects were reported. There was no product quality complaint involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Nausea
Clinical narrative: Patient received first dose of BEXSERO 8/23/16. Next day patient c/o mild headache, nausea. No fever or muscle weakness.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, multiple unspecified patients were vaccinated with improperly stored GARDASIL 9 lot # L011846, expiry date: 16-JUN-2017 (dosing details were not reported). It was reported that GARDASIL 9 went to a temperature of 8.4 C for 1 minute and then went to 0.6 C for 1 minute. No data logger was used. No previous temperature excursion was reported. The vaccine was back in range. No adverse effects were reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Fatigue, Feeling cold, Injection site erythema, Injection site swelling
Clinical narrative: Chills, low grade temp, excessive fatigue, redness and swelling at injection site, muscle pain.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia
Clinical narrative: Chills, low grade temp, excessive fatigue, redness and swelling at injection site, muscle pain.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Right arm swelling and redness along with itchiness. Fever on day of vaccines. Other symptoms started on 8/24/16 at 07:15. Treatment: diphenhydramine 12.5mg/5ml and hydrocortisone-aloe 1% prescribed on 8/25/16.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Dyskinesia, Laboratory test, Paraesthesia, Pyrexia, Viral infection
Clinical narrative: Since receiving DPT a month ago has had nightly tingling in both feet and all toes. Has had a febrile viral illness over last 3 days and last night had increased paresthesia associated with involuntary knee flexion-lasted 3 hours and finally stopped when fell asleep. Fine now during days.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 08-AUG-2016 the patient was vaccinated with improperly stored M-M-R II (dosing details were not reported) (lot # M004899 expiry date: 27-JAN-2018). No adverse effects were reported. There was no product quality complaint involved. This is one of the two reports from the same reporter. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: PV 13 8-19-16. Redness and swelling at site (L) delt.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant and refers to a patient of unspecified age and gender. The patient's concurrent conditions, medical history or concomitant medications were unknown. On 17-AUG-2016, the patient was inadvertently administered an expired dose of VAQTA (dose, route and anatomical location were not reported) Lot # L018498, expiration date 28-APR-2016. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug allergies and concomitant medications were not reported. On unspecified dates, the patients were administered GARDASIL (lot # K010574, expiration date: 18-APR-2017, dose, frequency and route were not reported) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site pain, Pyrexia
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of fever in a female 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 fever and injection site muscle pain. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the injection site muscle pain was  unknown. It was unknown if the reporter considered the fever and injection site muscle pain to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced fever (101 Degree F) for 3 days and extreme muscle soreness at the injection site that travelled up to her neck. No further information was provided.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from an unspecified health professional referring to a baby patient of unknown age and gender. The patient's pertinent medical history and concomitant medication were not reported. On 09-JUL-2016, the patient received two months vaccination, and was vaccinated with a dose of ROTATEQ, orally (dose and lot# were not reported). But the vaccine underwent an incorrect storage, as the hospital's fridge was off for 24 hours on 06-JUL-2016 and the maximum temperature recorded was 19 degrees Celsius. Additional information has been requested.
Sex: U
Vaccine: MENB
Symptoms: Lymphadenopathy
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of lymphadenopathy 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 lymphadenopathy. On an unknown date, the outcome of the lymphadenopathy was unknown. It was unknown if the reporter considered the lymphadenopathy to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The reported stated that the patient experienced left sided supraclavicular lymphadenopathy. The reporter refused to provide any additional information regarding this event.
Sex: U
Vaccine: MENB
Symptoms: Arthralgia, Headache, Myalgia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of arthralgia in a adult patient who received BEXSERO. On 9th August 2016, the patient received the 1st dose of BEXSERO. In August 2016, less than a week after receiving BEXSERO, the patient experienced arthralgia (serious criteria other: serious as per reporter), headache and myalgia. On an unknown date, the outcome of the arthralgia, headache and myalgia were unknown. The reporter considered the arthralgia, headache and myalgia to be almost certainly related to BEXSERO. Additional details were reported as follows: The age at vaccination was not provided. This case was previously reported to a doctor. The patient was about 16 to 18 year old. The patient received a BEXSERO vaccine at the request of the parents. A day before the reporting date, the physician received a phone call noting the patient was experiencing the noted adverse events and the appointment was scheduled for that day afternoon. The patient visited emergency room.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site redness in an 18-year-old female patient who received BEXSERO (batch number 157101A, expiry date 31st AUGUST 2017). Concomitant products included BEXSERO. On 8th AUGUST 2016, the patient received the 2nd dose of BEXSERO (intramuscular). On 10th AUGUST 2016, 2 days after receiving BEXSERO, the patient experienced injection site redness, injection site warmth, injection site pain and injection site swelling. On an unknown date, the outcome of the injection site redness, injection site warmth, injection site pain and injection site swelling were not recovered/not resolved. The reporter considered the injection site redness, injection site warmth, injection site pain and injection site swelling to be almost certainly related to BEXSERO. Additional details were provided as follows: This case was reported by a licensed practical nurse. On 6th JUNE 2016, the patient received 1st dose of BEXSERO and there were no reports of adverse events after. The patient received 2nd dose of BEXSERO at 15:59 in left arm. The case is one of the three cases reported by the same reporter.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Injection site pain
Clinical narrative: 3 weeks of pain in left Deltoid area of arm.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site swelling, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 19-year-old female patient who received BEXSERO. Concomitant products included BEXSERO. On 15th AUGUST 2016, the patient received the 2nd dose of BEXSERO .5ml. On 15th AUGUST 2016, immediately after receiving BEXSERO, the patient experienced pain in arm and injection site swelling. On an unknown date, the outcome of the pain in arm and injection site swelling were unchanged. It was unknown if the reporter considered the pain in arm to be related to BEXSERO. The reporter considered the injection site swelling to be related to BEXSERO. Additional details were provided as follows: The case was previously reported to a doctor. This case was reported by the patient's father. On 15 JUNE 2016, the patient received 1st dose of BEXSERO without experiencing any issues. On 15th AUGUST 2016, the patient received her BEXSERO booster (time unknown) on her left arm.  The patient's father stated that he had called the pediatrician's office for medical advise but had not heard back yet, sho he would call again, as the patient leaves home for school and she would  not return until break. The paperwork the patient received did not list lot number or expiration date.
Age: 19.0
Sex: U
Vaccine: MENB
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of swelling arm in a 19-year-old patient who received BEXSERO. On 19th JULY 2016, the patient received BEXSERO .5ml. On an unknown date, less than a month after receiving BEXSERO, the patient experienced swelling arm and pain in arm. On an unknown date, the outcome of the swelling arm was  unknown and the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the swelling arm and pain in arm to be related to BEXSERO. Additional details were provided as follows: The patient experienced significant arm swelling and her arm hurt for one whole week. Vaccine expiration date and lot number was not known.
Age: 11.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Incorrect dose administered
Clinical narrative: Patent was given adult dose of Hepatitis A. No symptoms or treatments.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to a 16 year old patient of unknown gender. Patients' pertinent medical history, drug reaction/allergies or concomitant information were not reported. On 08-AUG-2016, the patient was vaccinated with PROQUAD. Lot #: M007965 - Expiration Date: 15-AUG-2017 (Strength, dose and route were not provided) (drug administered to patient of inappropriate age). No adverse event was reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning multiple unspecified patients (ages and genders were not indicated). The pertinent medical history of patients and their concurrent conditions were not provided. It was reported that on an unknown date multiple unspecified patients were administered improperly stored doses of RECOMBIVAX HB lots # L033343 and L039660 with expiration dates 13-SEP-2017 and 04-FEB-2018 respectively (concentrations, dosages and therapy routes were not provided). There were no concomitant therapies reported. No adverse effects were reported. The vaccine was exposed to 88F for 735 hours and 15 minutes. There was no data logger or previous exposures. No product quality complaint (PQC) was involved. This is one of five reports from the same source (MARRS # 1608USA009575, 1608USA010369, 1608USA010371, 1608USA010372). Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On an unknown date these patients were vaccinated with improperly stored dose of GARDASIL 9 (lot # M005714, expiration date 03-OCT-2017) (strength, dosing details, anatomical location were unknown). No adverse effect was reported. No product quality complaint was involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect dose administered, Needle issue, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Vocational Nurse and refers to a patient of unspecified age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date, the patient received less than the recommended dose of the second dose in the series of GARDASIL 9 "due to leakage around the needle" of the vaccine. (dose, route and anatomical location were not reported) (lot number reported as M016193, expiration date 24-APR-2018). No adverse effects reported. No further information provided. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, drug allergies and concomitant medications were not reported. On unspecified dates, the patients were administered GARDASIL 9 (Lot# L043213, expiration date:28-AUG-2017, dose, frequency and route were not reported) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. Concurrent condition, medical history and concomitant medication were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX, (Lot # L019127, expiration date 27-MAY-2017; lot# L036830, expiration date 24-SEP-2017; lot# L029467, expiration 06-AUG-2017; lot# M002063, expiration date 12-JAN-2018) (strength, dose, route and indication were unknown). No adverse effect was reported. It was unspecified if the patients sought medical attention. This is one of three reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist regarding an unknown female (Gender was also reported as unknown) patient (age not reported) who on an unknown date received a second dose of ZOSTAVAX 0.65 ml subcutaneously (site not specified) (Lot number and expiration date not reported). On an unknown date, the patient had "bumps which she thought was a rash" and she sought medical attention reporting "she went to the emergency room where she was told she had shingles". It was reported she was given treatment (not further specified) for the adverse event. No further information was provided. No information was provided regarding when the patient received the firs dose of ZOSTAVAX. The treatment and outcome of the adverse event of shingles was not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients. The patients' concurrent condition, medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB (dose and route were unknown, lot # M001811, expiration date 04-NOV-2018). No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients. The patient's concurrent condition, medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (dose and route were unknown, lot # L032182, expiration date 25-AUG-2017). No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients. The patients' concurrent condition, medical history and concomitant medication were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose and route were unknown, lot # L018501, expiration date 22-JUN-2017; lot # L027733, expiration date 13-SEP-2017). No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, 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 therapy were not reported. On 10-AUG-2016, the patient received two doses of GARDASIL 9 injection, 0.5 ml/dose (lot# L026602, expired date and route unknown) (product use issue). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician via a company representative referring to a 73 years old patient of unknown gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, lot #, expiration date and route not reported) at a pharmacy. On 01-JUL-2016, the patient went to the physician's office and was diagnosed with a case of the shingles. The outcome of the event was unknown. The causality between ZOSTAVAX and the event was not provided. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Blood test normal, Computerised tomogram head, Depressed mood, Dyspnoea, Seizure
Clinical narrative: Pt had IZ's on 8/18 - 4 days later at school pt had a seizure and fainted 3x. Went to ER and had bld wk - nl and then 2 days later saw neurologist. Seizures. Onset was 1 week ago. The problem is isolated. Additional information: Was at school; mom was told she was having a seizure and difficulty with breathing. She had fainted three times during the seizure. She was in PE waiting for roll call and then next thing she knew she woke up with people around her. No head trauma. Normal pregnancy, repeat CS, despite prior 2 children being SVD ND the first was CS. Growth and development normal. Doing very well in school. No EER hospitalizations for other reasons. Patient states she was sad that day - her brother just left for college. She was missing him. No recent illnesses; she just had her vaccinations Thursday prior to day of seizures Monday. She got the HPV and MCV vaccines with routine DT and PPD. Family History: Maternal GF had seizures after brain hemorrhage and passed away. Parent (s) or patient requiring interpreter throughout the encounter.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Pt had IZ's on 8/18 - 4 days later at school pt had a seizure and fainted 3x. Went to ER and had bld wk - nl and then 2 days later saw neurologist. Seizures. Onset was 1 week ago. The problem is isolated. Additional information: Was at school; mom was told she was having a seizure and difficulty with breathing. She had fainted three times during the seizure. She was in PE waiting for roll call and then next thing she knew she woke up with people around her. No head trauma. Normal pregnancy, repeat CS, despite prior 2 children being SVD ND the first was CS. Growth and development normal. Doing very well in school. No EER hospitalizations for other reasons. Patient states she was sad that day - her brother just left for college. She was missing him. No recent illnesses; she just had her vaccinations Thursday prior to day of seizures Monday. She got the HPV and MCV vaccines with routine DT and PPD. Family History: Maternal GF had seizures after brain hemorrhage and passed away. Parent (s) or patient requiring interpreter throughout the encounter.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, drug allergies and concomitant medications were not reported. On unspecified dates, the patients were administered PEDVAXHIB (Lot # L042258, expiration date: 18-AUG-2018, dose, frequency and route were not reported) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Chills, Headache, Muscle tightness, Photophobia, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse through a Pfizer sales representative. A 17-year-old male patient (reporter's son) received, on an unspecified date (at the same time) at 08:10 am, in the opposite arm, TRUMENBA, lot number J29203, expiry date Jun2016 on the left deltoid at 0.5 ml single and the second dose of MENACTRA, lot number JU5180AA on the right deltoid, both intramuscularly. Relevant medical history included allergy to hickory, pecan, cats, dust, mites in 2012. All allergies were mild confirmed by lab testing and the patient takes ZYRTEC at 10 mg daily. The patient previously received the first dose of MENACTRA. Concomitant medications were unknown. The patient experienced migraine headache, vomiting and muscle pain on 16May2016 at 09:30 and chills and blood pressure increased on unknown date. No admission to the hospital, treatment of physician visit was required for the events. The patient recovered from migraine headache, vomiting and muscle pain on 17May2016. The outcome of the events chills and blood pressure increased was unknown. The nurse confirmed that the patient provided to him/her information regarding the reported adverse events with the use of the vaccines. The nurse considered the Pfizer product had a causal effect to the adverse events. Follow up (13Jun2016): New information reported from a contactable nurse includes: time of vaccination, lot number, expiry date dose and anatomical location of vaccination with TRUMENBA, medical history, past vaccine history, onset date of migraine headache, vomiting and muscle pain, no admission to the hospital, treatment or physician visit was required for the events, outcome, causality assessment, nurse confirmed that the patient provided to him/her information regarding the reported adverse events with the use of the vaccines. Follow-up attempts completed. No further information expected.
Age: 17.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Vomiting
Clinical narrative: This is a spontaneous report from a contactable nurse through a Pfizer sales representative. A 17-year-old male patient (reporter's son) received, on an unspecified date (at the same time) at 08:10 am, in the opposite arm, TRUMENBA, lot number J29203, expiry date Jun2016 on the left deltoid at 0.5 ml single and the second dose of MENACTRA, lot number JU5180AA on the right deltoid, both intramuscularly. Relevant medical history included allergy to hickory, pecan, cats, dust, mites in 2012. All allergies were mild confirmed by lab testing and the patient takes ZYRTEC at 10 mg daily. The patient previously received the first dose of MENACTRA. Concomitant medications were unknown. The patient experienced migraine headache, vomiting and muscle pain on 16May2016 at 09:30 and chills and blood pressure increased on unknown date. No admission to the hospital, treatment of physician visit was required for the events. The patient recovered from migraine headache, vomiting and muscle pain on 17May2016. The outcome of the events chills and blood pressure increased was unknown. The nurse confirmed that the patient provided to him/her information regarding the reported adverse events with the use of the vaccines. The nurse considered the Pfizer product had a causal effect to the adverse events. Follow up (13Jun2016): New information reported from a contactable nurse includes: time of vaccination, lot number, expiry date dose and anatomical location of vaccination with TRUMENBA, medical history, past vaccine history, onset date of migraine headache, vomiting and muscle pain, no admission to the hospital, treatment or physician visit was required for the events, outcome, causality assessment, nurse confirmed that the patient provided to him/her information regarding the reported adverse events with the use of the vaccines. Follow-up attempts completed. No further information expected.