chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.08
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from an unspecified reporter referring to an 8 week old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 23-SEP-2016 the patient was vaccinated with PEDVAXHIB (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Age: 0.33
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from an unspecified reporter referring to a 4 month old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 23-SEP-2016 the patient was vaccinated with PEDVAXHIB (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Age: 10.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from an unspecified reporter referring to a 10 year old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 23-SEP-2016 the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Age: 0.08
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from an unspecified reporter referring to a 6 week old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 23-SEP-2016 the patient was vaccinated with PEDVAXHIB (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from an unspecified reporter referring to a 14 year old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 23-SEP-2016, the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from an unspecified reporter referring to a 15 month old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 29-AUG-2016 the patient was vaccinated with PEDVAXHIB (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from an unspecified reporter referring to a 14 year old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 29-AUG-2016, the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from an unspecified reporter referring to a 13 year old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 29-AUG-2016, the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from an unspecified reporter referring to an 11 year old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 29-AUG-2016, the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Age: 10.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from an unspecified reporter referring to an 10 year old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 29-AUG-2016, the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Age: 9.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from an unspecified reporter referring to a 9 year old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 29-AUG-2016, the patient was vaccinated with GARDASIL 9 (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Age: 38.0
Sex: M
Vaccine: FLUN4
Symptoms: Influenza
Clinical narrative: A consumer report has been received. The report concerns a 39 year 3 weeks 5 days old male patient. Patient was a medimmune employee. Patient reported he got vaccination FLUMIST (intranasal) in Nov-2015 because they were giving out free FLUMIST at work. 09-Apr-2016 patient was diagnosed with Influenza strain B (Preferred Term: Influenza). Patient received vaccination through the Health and Wellness Center. FLUMIST QUADRIVALENT was continued. The outcome of the event of influenza strain B was unknown. The report was considered to be non-serious by company physician.
Age: 9.0
Sex: M
Vaccine: FLUN4
Symptoms: Dyspnoea, Joint injury, Joint swelling, Pain, Peripheral swelling
Clinical narrative: A report has been received from a Health Professional concerning a male patient, who had been receiving FLUMIST QUADRIVALENT            (INTRANASAL), 0.2 Millilitres, Unknown for INFLUENZA. FLUMIST QUADRIVALENT (INTRANASAL) started on 15-Jan-2016 for INFLUENZA.  The patient experienced ARM SWOLLEN (Preferred Term: Peripheral swelling), LEG SWOLLEN (Preferred Term: Peripheral swelling) and PAIN (Preferred Term: Pain). The outcome of the events ARM SWOLLEN, LEG SWOLLEN and PAIN was unknown. The reporter's description of the event(s) was as follows: It was reported that on July 30, 2014 the patient was seen by Dr. for an injury to the right ankle with swelling and pain. The patient also has shortness of breath with moderate physical activity. No information on medications. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN3, VARCEL
Symptoms: Anaphylactic reaction, Food allergy, Reaction to drug excipients
Clinical narrative: A spontaneous report has been received from a physician via Pfizer concerning a female patient. Physician reported that the patient experienced anaphylaxis after injections of varicella vaccine and nasal FLUMIST (intranasal) and had to be put in an ambulance. The patient later went to an allergist and was determined to be allergic to gelatin. The physician stated on of the vaccines, patient could not remember if it was varicella or FLUMIST, contained gelatin. The patient recovered from anaphylaxis on an unspecified date and the outcome of allergic to gelatin was unknown. The company physician considered anaphylaxis to be serious due to important medical event and allergic to gelatin was identified and captured by company physician as non-serious.
Sex: U
Vaccine: FLUN4
Symptoms: Rhinorrhoea
Clinical narrative: A report has been received from a Physician concerning , who had been receiving FLUMIST QUADRIVALENT (INTRANASAL), 0.2 Millilitres, Unknown. FLUMIST QUADRIVALENT (INTRANASAL) started on an unknown date. The patient experienced RUNNY NOSE. The outcome of the event of RUNNY NOSE is unknown. The report was considered to be non-serious.
Sex: F
Vaccine: FLUN4
Symptoms: Influenza, Pyrexia
Clinical narrative: A spontaneous report has been received from a medical rep concerning, female patient. No information regarding the relevant history, concomitant disease and concomitant drug was provided.  Medical rep stated that patient (doctor's daughter) had received FLUMIST QUADRIVALENT (intranasal) in October 2015. Agency reported patient has gotten Flu Type A (preferred term: influenza) around Christmas, and had a fever.  The outcome of the event of flu was unknown. Company physician considered the event of flu to be non-serious.
Age: 14.0
Sex: F
Vaccine: FLUN4
Symptoms: Influenza B virus test positive
Clinical narrative: A report has been received from a Health Professional vai Medical Rep. concerning a 15 year old , Female subject, who had been receiving  FLUMIST (INTRANASAL), 0.2ml, 1/2 in one nostril and the other 1/2 in the other nostril. The patient experienced TESTED POSITIVE FOR THE FLU TYPE B(Preferred Term:Influenza B virus test positive) which started on 04-Jan-2016.  The outcome of the event of TESTED POSITIVE FOR THE FLU TYPE B is unknown. The report was considered to be non-serious.
Sex: U
Vaccine: FLUN3
Symptoms: Anaphylactic reaction
Clinical narrative: A report has been received from a pharmacist via Merck, concerning a patient of unknown age and gender. No concomitant medication or relevant history was provided. On an unknown date, the patient received nasal FLUMIST (intranasal). The patient experienced anaphylactic reaction to the formaldehyde in FLUMIST. The action taken with FLUENZ and the outcome of the event of anaphylactic reaction was unknown. The company physician considered the event of anaphylactic reaction to be serious due to important medical event criterion.
Sex: U
Vaccine: FLUN4
Symptoms: Influenza
Clinical narrative: A spontaneous report has been received from a health professional via medical representative concerning a patient of unknown gender.  Patient relevant history, concurrent diseases and concomitant drugs were not provided. During the 2013-2014 season the consumer received the FLUMIST QUADRIVALENT (intranasal) vaccine and developed the flu. The outcome of the event of flu was unknown. The company physician considered the event of flu to be non-serious.
Sex: F
Vaccine: FLUN4
Symptoms: Anxiety, Loss of consciousness
Clinical narrative: A spontaneous report has been received from a consumer concerning a female patient, who had been receiving FLUMIST QUADRIVALENT         (INTRANASAL). FLUMIST QUADRIVALENT (INTRANASAL) started during Oct-2015. The patient PASSED OUT (Preferred Term: Loss of consciousness) and HAD ANXIETY (Preferred Term: Anxiety).  The outcome of the event of PASSED OUT and HAD ANXIETY was unknown. The report was considered to be non-serious.
Sex: F
Vaccine: PNC13
Symptoms: Antibody test abnormal
Clinical narrative: This is a spontaneous report obtained from a contactable pharmacist. A female patient of an unspecified age, gender and race received, on an unknown date, in Sep2015, PREVNAR 13 single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient had antibody result abnormal. It was reported that her physician ran through her titers and said that were low. Clinical outcome was unknown at time of this report.
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine
Clinical narrative: This is a spontaneous report from a contactable physician. A 58-year-old female patient of an unspecified ethnicity started to receive pneumococcal 13-val conj vac (dipht crm197 protein) at single dose for immunisation, mupirocin at an unspecified dose for an unspecified indication, both via an unspecified route of administration on an unspecified date. Medical history included drug hypersensitivity. The patient's concomitant medications were not reported. The patient experienced allergy to pneumococcal vaccine and mupirocin on an unspecified date with outcome of unknown.
Sex: U
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. This physician reported similar events for 5 patients. This is 3rd of five reports. A patient of unspecified age ethnicity and gender received TRUMENBA, via an unspecified route of administration on an unspecified date at single for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced high fever on an unspecified date with outcome of unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2016580735 as same reporter/drug/event, different patient.
Sex: U
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. This physician reported similar events for 5 patients. This is 5th of five reports. A patient of unspecified age ethnicity and gender received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced high fever on an unspecified date with outcome of unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2016580735 as same reporter/drug/event, different patient.
Sex: U
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. This physician reported similar events for 5 patients. This is 1st of five reports. A patient of unspecified age ethnicity and gender received TRUMENBA, via an unspecified route of administration on an unspecified date at single for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced high fever on an unspecified date with outcome of unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2016581035 as same reporter/drug/event, different patient. US-PFIZER INC-2016580774 as same reporter/drug/event, different patient. US-PFIZER INC-2016580585 as same reporter/drug/event, different patient. US-PFIZER INC-2016580625 as same reporter/drug/event, different patient.
Sex: U
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable Physician via Pfizer sales representative. This Physician reported similar event for five patients. This is the 2nd of five reports. A patient of unspecified age ethnicity and gender received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced high fever on an unspecified date with outcome of unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2016580735 as same reporter/drug/event, different patient.
Sex: U
Vaccine: MENB
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. This physician reported similar events for 5 patients. This is 4th of five reports. A patient of unspecified age ethnicity and gender received TRUMENBA, via an unspecified route of administration on an unspecified date at single for immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced high fever on an unspecified date with outcome of unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2016580735 Same reporter, same product, same events, different patients.
Age: 77.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Blood glucose, Injection site discomfort, Injection site pain, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer reported for herself. A 77-year-old female patient received PREVNAR 13 via an unspecified route of administration at 0.5ml, single at the left arm and DTAP via an unspecified route of administration at 1 DF, single at the right arm, both on 23May2016 for immunization, received at the clinic. Medical history included ongoing blood pressure high diagnosed quite a long time before. Concomitant medication included atenolol oral 25mg tablet by mouth daily for years and ongoing for blood pressure high. The patient previously took TDap for immunisation. The patient received the PREVNAR 13 vaccine back in May2016 but soon after the injection she has been having and pain at the injection site in May2016. Two to 3 days after the injection, in May2016, she started to have a sharp pain in the left arm at the injection site. The sharp pain improved but continued to have discomfort and pain at the injection site with certain movement and 2 to 3 months before discomfort affected her writing. She discussed it with her doctor, the doctor did not think that it is due to the injection but the patient thought so. The outcome of the events was not recovered. The patient had blood test every 6 month to check for blood sugar and blood pressure. Her doctor assessed the arm to see if it was her rotator cuff and did not think it is her rotator cuff but recommended therapy. She had no problem with right arm.
Age: 3.0
Sex: F
Vaccine: FLU4, HEP
Symptoms: Blood test, Joint swelling, Mechanical urticaria, Pyrexia, Rash
Clinical narrative: Initial unsolicited report received from a non-healthcare professional (Patient's parent) on 12 December 2016. This case involves a 24-months-old female patient who was vaccinated with doses of FLUZONE (batch number: U5399AA, expiry date: 30-JUN-2016, dose and dose in series were not reported) intramuscularly and HEPATITIS B VACCINE (batch number, expiry date, dose and dose in series were not reported) in an unknown site on 02 December 2016. Illness at the time of vaccination and Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as Reporter denied. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 12 December 2016, 10 days following the vaccination, the patient developed Purplish rashes, joint swelling random fevers, demographic urticaria and finally diagnosed serum sickness. The patient had previous dose of FLUZONE in 2014 and HEPATITIS B VACCINE unspecified 2-3 doses. The patient required emergency room (ER) and doctor visit on an unspecified date and was hospitalized. The patients' Laboratory investigations was reported as the patient had performed blood work and the fever was reported as 103 degree Fahrenheit. Corrective treatment was reported as unknown. The patient was discharge from the hospital on an unknown date with the hospitalization duration of one day and the outcome of event was reported as unknown. The reporter assessed the causal relationship with vaccines as related. List of documents held by sender: none. Sender's Comments: Patient had serum sickness and associated symptoms following FLUZONE AND HEPATITIS B VACCINE. Time to onset is unknown, additional information regarding patient medical history, allergic history, past vaccination history and its tolerance are needed to further assess the case. Based on available information the role of vaccine cannot be ruled, but role of each vaccine cannot be assessed.
Age: 3.0
Sex: F
Vaccine: FLU4, HEP
Symptoms: Serum sickness, Skin discolouration
Clinical narrative: Initial unsolicited report received from a non-healthcare professional (Patient's parent) on 12 December 2016. This case involves a 24-months-old female patient who was vaccinated with doses of FLUZONE (batch number: U5399AA, expiry date: 30-JUN-2016, dose and dose in series were not reported) intramuscularly and HEPATITIS B VACCINE (batch number, expiry date, dose and dose in series were not reported) in an unknown site on 02 December 2016. Illness at the time of vaccination and Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as Reporter denied. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 12 December 2016, 10 days following the vaccination, the patient developed Purplish rashes, joint swelling random fevers, demographic urticaria and finally diagnosed serum sickness. The patient had previous dose of FLUZONE in 2014 and HEPATITIS B VACCINE unspecified 2-3 doses. The patient required emergency room (ER) and doctor visit on an unspecified date and was hospitalized. The patients' Laboratory investigations was reported as the patient had performed blood work and the fever was reported as 103 degree Fahrenheit. Corrective treatment was reported as unknown. The patient was discharge from the hospital on an unknown date with the hospitalization duration of one day and the outcome of event was reported as unknown. The reporter assessed the causal relationship with vaccines as related. List of documents held by sender: none. Sender's Comments: Patient had serum sickness and associated symptoms following FLUZONE AND HEPATITIS B VACCINE. Time to onset is unknown, additional information regarding patient medical history, allergic history, past vaccination history and its tolerance are needed to further assess the case. Based on available information the role of vaccine cannot be ruled, but role of each vaccine cannot be assessed.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test normal, Choking sensation, Dry throat, Dysgeusia, Endoscopy normal
Clinical narrative: Initial unsolicited case received from consumer (patient herself) on 12 Dec 2016. This case involves a 39 year old female patient who was vaccinated with a dose of ADACEL (Batch number, expiry date and dose was not reported) administered intramuscularly in left deltoid on 09 Oct 2015. The patient illness at the time of vaccination was reported as scrapped knees and wound care, and Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as NKA (no known allergies) and any other vaccinations within four weeks of vaccination was not reported. The patient concomitant medications was not reported. On 09 Oct 2015, four minutes after the vaccination the patient developed metallic taste in mouth/taste continues/taste has been constant since vaccine, and on an unknown date reported as states taste continues and throat is so dry, like I'm going to choke (choking sensation and dry throat). On an unknown date the patient was seen by ENT, rheumatologist, other family doctor, dentist, and allergist for tests. The patient lab tests include endoscopy and blood work, stated all normal. The patient corrective treatment was not reported. The outcome of the events was reported as not recovered. List of documents held by sender: none.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site vesicles
Clinical narrative: Cluster of four vesicle at vaccine administration site.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Immediate post-injection reaction, Pallor, Tremor, Vision blurred
Clinical narrative: Pt stated he was very anxious about getting vaccination.  Immediately after the administration of the Hepatitis A vaccine he stated his vision was getting blurry and his color became pallor.  Pt was sitting and lowered his head for a few minutes on instruction.  He remained conscious and then raised his head up. His hands were shaky. Pt was given some water to drink and then some cola to drink.  He stated he felt better and remained seated for about 20 minutes.  His father was with him and was going to drive him home.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown demographics. The patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. On multiple unspecified dates these patients were vaccinated with improperly stored doses of GARDASIL 9, (lot# M023169 and expiry date 13-JUN-2018) for prophylaxis (strength, dosing details, route and  anatomical location were unknown). No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Follow up information was received on 20-DEC-2016. All telephone attempts to obtain follow-up information have been unsuccessful. A request was made for patients' identifiers and dates of vaccination. Additional information has been requested.; Sender's Comments: US-009507513-1610USA013965: US-009507513-1610USA013571: MERCK 1610USA013964:Mfr number.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported.  On an unknown date, the patient was were vaccinated with improperly stored GARDASIL lot # K008931, expiry date: 04-MAR-2017 (dosing details, route of administration were not reported) for prophylaxis. It was reported that, the vaccines were exposed to a temperature 30.9F for a time frame of 16 hours and 14 minutes. No previous temperature excursion was reported. There were no product quality complaints (PQC) involved. Data digital logger was involved. Follow up information has been received from the medical assistant on 21-DEC-2016 who stated that, she would fax the information with the letter. This is one of two reports from the same reporter. Additional information has been requested. Reporter address and narrative were updated.; Sender's Comments:  US-009507513-1610USA016261:, MERCK 1610USA014314:Mfr number.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 which had lot # M003659 with expiry: 20-SEP-2017, for prophylaxis (dosing details not reported).  No adverse effects reported. The vaccine with above lot number was exposed to a temperature excursion of 72.1 degree Fahrenheit for 1 hour 42 minutes, and it had no previous temperature excursion. It was detected by data logger. No further information provided. As of 12-DEC-2016, a return call was received from the nurse. The reporter was unable to provide any patient identifiers or dates of vaccination. This is one of three reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1610USA014251:,MERCK 1610USA014627:Mfr number.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant regarding 10 unspecified patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported.  On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 lot # L023230, expiry date: 28-JUL-2017 (dosing details, route of administration were not reported) for prophylaxis. It was reported that the vaccines were exposed to a temperature 30.9F during a time frame of 16 hours and 14 minutes. No previous temperature excursion was reported. There were no product quality complaints (PQC) involved. Data digital logger was involved.  Follow up information has been received from the medical assistant on 21-DEC-2016 who stated that, she would fax the information with the letter.  This is one of two reports from the same reporter. Additional information has been requested. Reporter address and narrative were updated.; Sender's Comments:  US-009507513-10USA014314:, MERCK 1610USA016261:Mfr number.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse refers to unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of  GARDASIL 9 (lot# M030380 and expiry date 01-FEB-2019) intramuscularly for prophylaxis. No adverse effects were reported. The vaccine was exposed temperature excursion of 32.7 Fahrenheit for 2 hours and 15 minutes and 33.1 Fahrenheit for 4 hours. No previous temperature excursion were reported. Data digital logger was involved. No product quality complaint (PQC) was filed. Further details were not provided. A call was placed to the licensed practical nurse on 21-DEC-2016 that requested patient identifiers and date of vaccination.  All telephone attempts to obtain follow-up information have been unsuccessful. This case is one of three reports received from the same reporter. Additional information has been requested. Narrative updated. ; Sender's Comments: US-009507513-1611USA002941: US-009507513-1611USA002946:,MERCK 1611USA002299:Mfr number.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a a Licensed Practical Nurse (LPN) referring to an unspecified number of patients of unknown age and gender.  The patient's concurrent conditions, medical history drug reactions, allergies and concomitant medications were not reported. It was reported that the patients were vaccinated with improperly stored dose of GARDASIL 9 (lot # L036301, expiration date 20-DEC-2017) administered on 08-DEC-2016, and GARDASIL 9 (lot # L040054, expiration date 26-DEC-2018) administered on  09-dec-2016 (strength, dose and route of administration were not reported) for prophylaxis. It was reported that the temperature excursion was for 30 minutes at 8.4°degrees C, according to the data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA008769.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, concurrent conditions and medical history reported. On an unknown date in May 2016, the patient was vaccinated with the first dose of ZOSTAVAX (dose, route of administration, lot#, expiry date and site of administration were not reported). On 04-DEC-2016, the patient was inadvertently administered a second dose of ZOSTAVAX. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant, referring to an unspecified number of patient of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients received improperly stored VAQTA injection (lot # M017982, expiration date 13-SEP-2017; dose and route unknown) for prophylaxis. No adverse effect was reported. The vaccines were stored under temperature -0.24 Celsius degree (C) for 193.5 hours. There was no previous temperature excursion. Digital data logger was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # L039268 with expiry date 05-APR-2017, lot # M029599 with expiry date 10-DEC-2017 (dosing details unspecified) for prophylaxis. No adverse effects were reported. Product quality complaint (PQC) was not involved. No further information was available.  Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 17-JUN-2016 the patient was vaccinated with an improperly stored dose of PROQUAD (incorrect product storage) (lot # L030587, expiry date 10-FEB-2017) (dosing regimen and frequency unknown) for an unknown indication. No concomtiant medications were reported. It was reported that the PROQUAD was stored at a temperature of 4 degrees centigrade between 06-OCT-2015 to 09-AUG-2016. It was reported that there was no previous temperature excursion. No adverse effects were reported. The action taken with the therapy with PROQUAD was unknown. The outcome of the events was unknown. There was no product quality complaint reported. This report was not because of a data logger. This is one of the many reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1612USA011226: US-009507513-1612USA011227:US-009507513-1612USA005074.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 22-JUN-2016 the patient was vaccinated with an improperly stored dose of PROQUAD (incorrect product storage) (lot # L030587, expiry date 10-FEB-2017) (dosing regimen and frequency unknown) for an unknown indication. No concomtiant medications were reported. It was reported that the PROQUAD was stored at a temperature of 4 degrees centigrade between 06-OCT-2015 to 09-AUG-2016. It was reported that there was no previous temperature excursion. On 22-JUL-2016 the patient was vaccinated with second dose of improperly stored dose of PROQUAD (incorrect product storage) (Inappropriate schedule of drug administration) (lot # L030587, expiry date 10-FEB-2017) (dosing regimen and frequency unknown) for an unknown indication. No adverse effects were reported. The action taken with the therapy with PROQUAD was unknown. The outcome of the events was unknown. There was no product quality complaint reported. This report was not because of a data logger. This is one of the many reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1612USA011225:US-009507513-1612USA011227:US-009507513-1612USA005074.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 09-AUG-2016 the patient was vaccinated with an improperly stored dose of PROQUAD (incorrect product storage) (lot # L030587, expiry date 10-FEB-2017) (dosing regimen and frequency unknown) for an unknown indication. No concomtiant medications were reported. It was reported that the PROQUAD was stored at a temperature of 4 degrees centigrade between 06-OCT-2015 to 09-AUG-2016. It was reported that there was no previous temperature excursion. No adverse effects were reported. The action taken with the therapy with PROQUAD was unknown. The outcome of the events was unknown. There was no product quality complaint reported. This report was not because of a data logger.  This is one of the many reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1612USA005074: US-009507513-1612USA011225: US-009507513-1612USA011226.
Sex: U
Vaccine: PNC13
Symptoms: Injection site cellulitis
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A patient of unspecified age and gender received a single dose of  PREVNAR 13, on an unknown date for immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in Sep (unspecified year), the patient developed a severe site reaction resulting in cellulitis, needing antibiotic treatment. The outcome of the event was unknown. Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. In particular, the following relevant information is not available: date of vaccination and onset date of the event. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 25.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Discomfort, Injection site pain, Muscle contractions involuntary, Muscular weakness, Pain in extremity
Clinical narrative: On 9/26/16 Patient stated that after having his TDap injection in his left deltoid and his MENACTRA injection in his right deltoid, he developed pain in the right deltoid at the injection site.Patient is right hand dominant. He states 2-3 days after the vaccines he developed weakness and muscle contractions in both arms right greater than left. 10/14/16 He sought treated 18 days after receiving the injections. His complaint was that his pain started in the right deltoid and then migrated to his right forearm.He was also was feeling pressure in his right forearm and right hand. Patient was not really complaining about his left because he stated he doesn't use his left hand often. Patient stated that he uses the computer 2-3 hours a day . Patient had not tried any pain relief medication. He also complained of some tingling in his right 5 digits. The doctor treated him with Naproxen, one tablet twice a day.10/17/2016 he followed up with the doctor at which time he was improving. He then returned 11/18/2016 and was seen by the same doctor. He was diagnosed with a ganglion cyst on his right wrist.
Age: 25.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Paraesthesia, Synovial cyst
Clinical narrative: On 9/26/16 Patient stated that after having his TDap injection in his left deltoid and his MENACTRA injection in his right deltoid, he developed pain in the right deltoid at the injection site.Patient is right hand dominant. He states 2-3 days after the vaccines he developed weakness and muscle contractions in both arms right greater than left. 10/14/16 He sought treated 18 days after receiving the injections. His complaint was that his pain started in the right deltoid and then migrated to his right forearm.He was also was feeling pressure in his right forearm and right hand. Patient was not really complaining about his left because he stated he doesn't use his left hand often. Patient stated that he uses the computer 2-3 hours a day . Patient had not tried any pain relief medication. He also complained of some tingling in his right 5 digits. The doctor treated him with Naproxen, one tablet twice a day.10/17/2016 he followed up with the doctor at which time he was improving. He then returned 11/18/2016 and was seen by the same doctor. He was diagnosed with a ganglion cyst on his right wrist.
Age: 35.0
Sex: M
Vaccine: HEP
Symptoms: Injection site induration, Injection site nodule, Pruritus
Clinical narrative: Individual noticed hard knot approximately 1/2" in diameter at site of injection and localized itching beginning on date noted above. Knot is still present and localized itching is intermittent.
Age: 24.0
Sex: F
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Pediatric dose given-pt. needed adult dose.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Exposure during pregnancy, Hypertension, Type 2 diabetes mellitus
Clinical narrative: Chills, rigors (no fever). Comorbidity: Pregnancy, HTN, DM type 2(insulin) H/O preeclampsia.
Sex: F
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Case number PHEH2016US024151, is an initial spontaneous report received from a pharmacist on 16 Sep 2016. This report refers to a 24 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUAD 2016/2017 (batch number: 165803) at a dose of 0.5 ml intramuscularly on 16 Sep 2016, when she was at the age of 24 years old. No adverse event was reported following this administration error (inappropriate age at vaccine administration).
Age: 97.0
Sex: F
Vaccine: FLUX
Symptoms: Nasopharyngitis, Oropharyngeal pain, Throat tightness
Clinical narrative: Case number# PHEH2016US007409, is a report initially received from a consumer through phone via a Patient Oriented Program: POP20150640 on 22 Mar 2016. This report refers to a 97 year old female patient. Medical history and concomitant medication were not reported. The patient received ENTRESTO 49/51 mg for the treatment of heart failure from an unknown start date at a dose of 100 mg BID (oral). The patient also received Influenza Vaccine (flu shot) last Friday on 04 NOV 2016 and on 06 Nov 2016, the patient experienced symptoms of sore throat (oropharyngeal pain). On an unknown date, the patient also experienced tightness in her throat right below her chin area (throat tightness) and cold (nasopharyngitis). The outcome of the events oropharyngeal pain, throat tightness and nasopharyngitis was unknown. The seriousness and casualty of the events oropharyngeal pain and nasopharyngitis were not reported. Follow up case initially received from a consumer through phone via a Patient Oriented Program: POP20150640 on 07 Nov 2016: Added patient details, added concentration and frequency of the suspect drug and added two new events (sore throat and throat tightness) and amended narrative. Following an internal review done on 14 Nov 2016, for the date received on 07 Nov 2016, a significant case correction was performed: Coded Influenza virus vaccine as co suspect and updated narrative accordingly.
Sex: M
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2016US024428, is an initial spontaneous report received from a pharmacist on 20 Sep 2016. This report refers to a 33 years old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUAD (batch number: 165803) at a dose of 0.5 ml intramuscularly on 19 Sep 2016, when he was at the age of 33 years old. The pharmacist did not realize until after administration that the labeling was for person 65 years and older. No adverse event was reported following this administration error (drug administered to patient of inappropriate age).
Age: 74.0
Sex: M
Vaccine: FLUA3
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: Case PHEH2106US025144 is a spontaneous report initially received from a pharmacist on 27 Sep 2016. This report refers to 74 year old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with single dose of FLUAD (batch number: 165902, expiry: not reported) on 27 Sep 2016. On the same day, it was reported that, when the pharmacist administered the vaccine, part of vaccine leaked out of pre filled syringe and patient only received the partial dose. No adverse event was reported following this medication error (underdose). Non significant information received from a pharmacist on 27 Se[ 2016: Updated reporter information.
Sex: U
Vaccine: FLUA3
Symptoms: No adverse event, Syringe issue, Underdose
Clinical narrative: Case PHEH2016US025479, is an initial spontaneous report received from a pharmacist on 30 Sep 2016. This is also a quality complaint report (QA reference number: 1017148). This report refers to a patient of an unknown age and gender. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUAD (batch number: 165902, expiry date: 30 Apr 2017) on 27 Sep 2016. The pharmacist stated that, she administered FLUAD to a patient and during the administration of the product, she noticed that part of the vaccine leaked out from between the needle and syringe. Patient did not receive a full dose. Also the patient (reported as customer) did not think the needle was tight. No  adverse event was reported following this maladministration (underdose and syringe issue).
Age: 62.0
Sex: M
Vaccine: FLUA3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Case number PHEH2016US025981 is a spontaneous report initially received from a healthcare professional on 05 Oct 2016. This report refers to a 62 year old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with single dose of FLUAD (batch number: 165803) at the age of 60 years (patient under age 65) at a dose of 0.5 ml intramuscularly on 28 Sep 2016. No adverse event was reported following this medication error (inappropriate age at vaccine administration). Non significant information received from a healthcare professional on 05 Oct 2016: Updated reporter information.