chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent condition and concomitant medication was provided. On an unknown dates, the patients were vaccinated with the dose of improperly stored M-M- R II injection, lot # K024825, expiration date 02-DEC-2016 (dose and route of administration were not reported). No adverse effects were reported. Data logger was involved. The vaccine was exposed to a temperature of 22 Celsius (C), time frame of excursion was reported as 1104 hours total cumulative time. There was no previous excursions. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, Product label confusion
Clinical narrative: This spontaneous report was received from a registered nurse. Referring that, on an unknown date, one vial of M-M-R II (which had the lot number of L028273, expiration date 28-JUL-2017) was improperly stored in the same place in which was usually stored the sterile water diluent vials (supplied with M-M-R II) at 72F for 18 hours. However, this vial of M-M-R II was not administered to anyone. The reporter also stated that the M-M-R II vial label looks too similar to the sterile water diluent vial. There was not product quality complaint involved. Additional information is not expected, because the reporter declined to provide further information.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history or concurrent conditions were not reported. On 08-APR-2016, the patient was vaccinated with an expired dose of VARIVAX *which had the lot number of K002045, expiration date 10-FEB-2016) (strength, dose and route were not provided). Concomitant medication was not reported. It was also reported that no adverse effects were reported and there was not product quality complaint involved. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, Oropharyngeal discomfort, Oropharyngeal surgery
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information was provided regarding patient's pertinent medical history, concurrent condition and concomitant medications. No previous drug reactions or allergies were reported. On 11-AUG-2015, the patient was vaccinated with first dose of RECOMBIVAX HB injection 10 Y (dosing details were not reported) (lot # K012469 with expiry date of 14-APR-2017). The reporter stated that on an unknown date, the patient had reoccurring throat surgeries due to an unspecified throat issues for which the patient was hospitalized on multiple unspecified dates after the administration of the first dose of RECOMBIVAX HB. On 13-APR-2016, the patient received second dose of the RECOMBIVAX HB (lot # L042846 expiry date of 15-SEP-2017) which was delayed due to the surgeries (inappropriate schedule of vaccine administered). The outcome of the events was unknown. The reporter did not provide the causality assessment between the events and the suspect therapy. There was no product quality complaint involved. The events Oropharyngeal surgery and Oropharyngeal discomfort were considered serious due to hospitalization. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent condition and concomitant medication was provided. On an unknown dates, the patients were vaccinated with the doses of improperly stored VARIVAX injection, lot # K021485 with expiration date 03-NOV-2016 and lot# L024250 with expiration date 30-JUN-2017 (dose and route of administration were not provided). No adverse effects were reported. Data logger was involved. The vaccine was exposed to a temperature of 30 Celsius (C), time frame of excursion was reported as 1104 hours total cumulative time. There was no previous excursion. This is one of several reports from the same reporter. 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 healthcare professional refers to a multiple unspecified patients of unknown age and gender. No information regarding the patients' medical history, concurrent condition and concomitant medication was provided. On an unknown dates, the patients were vaccinated with the doses of improperly stored GARDASIL injection, lot # L004014 with expiration date 04-MAR-2017 and lot# L016428 with expiration date 03-JUL-2017 (dose and route of administration were not provided). No adverse effects were reported. Data logger was involved. The vaccine was exposed to a temperature of 22 Celsius (C), time frame for excursion was reported as 1104 hours total cumulative time. There was no previous excursion. This is one of several reports from the same reporter. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Feeling abnormal, Injection site erythema, Injection site pain, Nausea
Clinical narrative: Local redness/pain at injection site (L) deltoid. Since time of vaccine - patient felt "odd" heart felt racing; nausea. (2d later) had fever 101 degrees felt shaky/chills. Pt office and take BENADRYL. Heart racing.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Nervousness, Palpitations, Pyrexia
Clinical narrative: Local redness/pain at injection site (L) deltoid. Since time of vaccine - patient felt "odd" heart felt racing; nausea. (2d later) had fever 101 degrees felt shaky/chills. Pt office and take BENADRYL. Heart racing.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient spoke to pharmacist on 4/18/16 regarding her arms being sore for a long time after flu shot administered 3 years ago.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site urticaria, Local reaction
Clinical narrative: 4/6/16 - seen in the office with 2" red indurated area Lt deltoid around vaccine site. Dx local rxn. Tx: BENADRYL, compresses. 4/7/16 phone call - lower arm red and swollen too same tx. 4/18/16 - brought pictures - 2 hives around injection site. Lost weight, a bit red. Was much better prior to that. Recommended ZYRTEC, see allergist.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Vaccination site induration, Weight decreased
Clinical narrative: 4/6/16 - seen in the office with 2" red indurated area Lt deltoid around vaccine site. Dx local rxn. Tx: BENADRYL, compresses. 4/7/16 phone call - lower arm red and swollen too same tx. 4/18/16 - brought pictures - 2 hives around injection site. Lost weight, a bit red. Was much better prior to that. Recommended ZYRTEC, see allergist.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Gait disturbance, Injection site pain, Mobility decreased, Pain in extremity
Clinical narrative: The FLUZONE vaccine has cause severe pain in my left shoulder, and it goes all the way down my left leg, sometimes can't hardly walk or move my arm and leg for full use. Discussed with my doctor when I went in for check up.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Muscular weakness, Neurological examination, Presyncope, Transient ischaemic attack
Clinical narrative: Pt had swelling to the injection site- L deltoid x 7 days with weakness to L arm. Pt experienced a TIA on 4/8/16 and had a neurological work up.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA
Symptoms: Type III immune complex mediated reaction
Clinical narrative: Arthus Reaction.
Age: 10.0
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Patient received vaccine 03/29/2016 and next morning patient broke out in a mild case of hives. Patient's dad called and asked what he could do for hives. I informed him to take son to doctor.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Bacterial test negative, Diarrhoea haemorrhagic, Helicobacter test negative, Occult blood positive, Rotavirus test positive
Clinical narrative: Hemoccult positive diarrhea.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Fatigue, Muscular weakness
Clinical narrative: Severe fatigue and muscle weakness.  Caused enough concern for patient to go to Emergency Room 4/14.  ER found no known medical reason for fatigue and muscle weakness and sent patient home.  Patient returned to ER 4/17, again with no diagnosis.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Feeling abnormal, Injection site pruritus, Local swelling
Clinical narrative: The area of shot location started to itch and felt odd through my shirt. I looked at the back of my arm and discovered a four by one inch raised and red area. I rubbed hydrocortozone on the area. The next day the redness increased to my elbow (12 inches) felt very hot and the area bubbled.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: The area of shot location started to itch and felt odd through my shirt. I looked at the back of my arm and discovered a four by one inch raised and red area. I rubbed hydrocortozone on the area. The next day the redness increased to my elbow (12 inches) felt very hot and the area bubbled.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness at injection site and soreness.
Age: 11.0
Sex: M
Vaccine: RV1
Symptoms: Drug administered to patient of inappropriate age, Incorrect route of drug administration, Product preparation error
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old male patient who received ROTA (batch number A41CB504A, expiry date 5th February 2017). On 11th April 2016, the patient received ROTARIX lyophilized formulation .5 ml. On 11th April 2016, an unknown time after receiving ROTARIX lyophilized formulation, the patient experienced inappropriate age at vaccine administration and inappropriate dilution of medication. On an unknown date, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the inappropriate age at vaccine administration, inappropriate route of vaccination and inappropriate dilution of medication were unknown. Additional details were received as follows: This case was reported by a Medical Assistant. The patient inadvertently received a dose of ROTARIX lyophilized formulation at an age of 11 years which was administered intramuscularly in the left deltoid muscle that was reconstituted with Normal Saline. This led to an inappropriate age at vaccine administration, inappropriate route of vaccination and an inappropriate dilution of medication.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Allergy to chemicals, Condition aggravated, Disorientation, Disturbance in attention, Dizziness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 22-year-old female patient who received BOOSTRIX (batch number JP44F, expiry date unknown). Concurrent medical conditions included food allergy (pre-existing; worsened after the BOOSTRIX). On 9th January 2014, the patient received BOOSTRIX (intramuscular). In January 2014, 7 days after receiving BOOSTRIX, the patient experienced dizziness, headache, migraine, fatigue, palpitation, disorientation, memory deficit, mental concentration difficult, muscle pain and allergy aggravated. On an unknown date, the outcome of the dizziness, headache, migraine, fatigue, palpitation, disorientation, memory deficit, mental concentration difficult, muscle pain and allergy aggravated were recovering/resolving. The reporter considered the dizziness, headache, migraine, fatigue, palpitation, disorientation, memory deficit, mental concentration difficult, muscle pain and allergy aggravated to be related to BOOSTRIX. Additional details were received as follows: In January 2014, about 1 to 1 and half weeks after receiving BOOSTRIX, patient began experiencing dizziness, lightheadedness, fatigue, and headaches. Headaches were originally in morning and afternoon, and later spread throughout the day. Headaches then worsened into migraines. This worsening occurred about 2-3 weeks after BOOSTRIX administration. At that time, muscle pain, worsening allergies, heart palpitations, disoriented feeling, poor memory, and difficulty concentrating presented. Allergies further described as sensitivities to certain foods, chemicals, and weather. The reporter's call was transferred from the Center.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Food allergy, Headache, Memory impairment, Migraine
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 22-year-old female patient who received BOOSTRIX (batch number JP44F, expiry date unknown). Concurrent medical conditions included food allergy (pre-existing; worsened after the BOOSTRIX). On 9th January 2014, the patient received BOOSTRIX (intramuscular). In January 2014, 7 days after receiving BOOSTRIX, the patient experienced dizziness, headache, migraine, fatigue, palpitation, disorientation, memory deficit, mental concentration difficult, muscle pain and allergy aggravated. On an unknown date, the outcome of the dizziness, headache, migraine, fatigue, palpitation, disorientation, memory deficit, mental concentration difficult, muscle pain and allergy aggravated were recovering/resolving. The reporter considered the dizziness, headache, migraine, fatigue, palpitation, disorientation, memory deficit, mental concentration difficult, muscle pain and allergy aggravated to be related to BOOSTRIX. Additional details were received as follows: In January 2014, about 1 to 1 and half weeks after receiving BOOSTRIX, patient began experiencing dizziness, lightheadedness, fatigue, and headaches. Headaches were originally in morning and afternoon, and later spread throughout the day. Headaches then worsened into migraines. This worsening occurred about 2-3 weeks after BOOSTRIX administration. At that time, muscle pain, worsening allergies, heart palpitations, disoriented feeling, poor memory, and difficulty concentrating presented. Allergies further described as sensitivities to certain foods, chemicals, and weather. The reporter's call was transferred from the Center.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Palpitations, Sensitivity to weather change
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 22-year-old female patient who received BOOSTRIX (batch number JP44F, expiry date unknown). Concurrent medical conditions included food allergy (pre-existing; worsened after the BOOSTRIX). On 9th January 2014, the patient received BOOSTRIX (intramuscular). In January 2014, 7 days after receiving BOOSTRIX, the patient experienced dizziness, headache, migraine, fatigue, palpitation, disorientation, memory deficit, mental concentration difficult, muscle pain and allergy aggravated. On an unknown date, the outcome of the dizziness, headache, migraine, fatigue, palpitation, disorientation, memory deficit, mental concentration difficult, muscle pain and allergy aggravated were recovering/resolving. The reporter considered the dizziness, headache, migraine, fatigue, palpitation, disorientation, memory deficit, mental concentration difficult, muscle pain and allergy aggravated to be related to BOOSTRIX. Additional details were received as follows: In January 2014, about 1 to 1 and half weeks after receiving BOOSTRIX, patient began experiencing dizziness, lightheadedness, fatigue, and headaches. Headaches were originally in morning and afternoon, and later spread throughout the day. Headaches then worsened into migraines. This worsening occurred about 2-3 weeks after BOOSTRIX administration. At that time, muscle pain, worsening allergies, heart palpitations, disoriented feeling, poor memory, and difficulty concentrating presented. Allergies further described as sensitivities to certain foods, chemicals, and weather. The reporter's call was transferred from the Center.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and pertinent medical history were not reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) with a lot # L030586, expiration date of 10-FEB-2017 and lot # L023111, expiration date of 24-DEC-2016, (strength, route of administration and dose were not provided). The vaccines were exposed to excursion -13.4 centigrade for 3 hours and 3 minutes, the previous temperature excursion was -13.4 centigrade for 2 hours and 21 minutes and -`3.7 centigrade for 4 hours and 26 minutes. There was no concomitant therapy reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with PROQUAD (Merck) lot no. L051098, expiration date- 17-JUN-2017. No adverse event was reported. The outcome of the event was unknown. Additional information is not expected as physician does not wants to get contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and pertinent medical history were not reported. On an unspecified dates, the patients were vaccinated with doses of improperly stored VARIVAX with lot # L037565, expiration date of 29-SEP-2017, lot # L043619, expiration date of 02-NOV-2017, lot # L038132, expiration date of 01-OCT-2017, (strength, route of administration and dose were not provided). The vaccines were exposed to excursion: -13.4 centigrade for 3 hours and 3 minutes, the previous temperature excursion was -13.4 centigrade for 2 hours and 21 minutes and -13.7 centigrade for 4 hours and 26 minutes. There was no concomitant therapy reported. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: Chest X-ray normal, Feeling cold, Laboratory test normal, Pyrexia, Tremor
Clinical narrative: 2 hrs after vaccination, developed severe chills, shakes, fever, called 911, went to ER, had IV acetaminophen and neg labs and CXR.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pt. received Tdap and MENACTRA vaccines in (R) deltoid area on 3/14/16. He awoke on 3/16/16 with a painful, red, swollen (R) deltoid are. When seen in this clinic he c/o pain and swelling at site of vaccinations.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient experienced significant swelling and pain in the right arm. Symptoms occurred approximately 2-3 hours after injection was given. Patient did not take any medication or obtained medical care.
Age: 11.0
Sex: U
Vaccine: MNQ
Symptoms: Injection site rash, Injection site urticaria
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of injection site rash in a 11-year-old patient who received MENVEO (batch number M155097, expiry date unknown). On an unknown date, the patient received MENVEO. On an unknown date, an unknown time after receiving MENVEO, the patient experienced injection site rash and injection site hives. The patient was treated with ZYRTEC. On an unknown date, the outcome of the injection site rash and injection site hives were recovered/resolved. It was unknown if the reporter considered the injection site rash to be related to MENVEO. The reporter considered the injection site hives to be probably related to MENVEO. Additional details provided were as follows: The patient experienced rash and hives at the injection site following vaccination with MENVEO. The Rash or hives described as being up and down the left arm. The patient's mom administered ZYRTEC but rash or hives began resolving prior to ZYRTEC. Issues now resolved.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Site reaction. Showed up AM after PM vaccine day before. Progressed to "very painful" 48 hours later. Erythematous, raised, hot, painful approximately three inch diameter area. Advised ice pack treatments and the ingestion of non-sedating antihistamine x 3 days.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site swelling
Clinical narrative: Raised bump on inj. site.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Echocardiogram, Myocarditis
Clinical narrative: This unsolicited case was received on 05-Apr-2016 via a third party query tool search on the VAERS database, under reference number 620087. This case involves a 20-years old male patient who received the following vaccinations on 06-Jan-2016: A dose of ACAM2000 (lot number-VV04003A, manufacturer: SANOFI PASTEUR) in the unknown site via a not reported route. Patient had no history and current illness. Information regarding prior vaccination and concomitant medications were not reported. On 19-Jan-2016, 13 days post vaccination; patient had experienced chest pain and diagnosed with pericarditis-myocarditis and also experienced recurrent pain overnight. The patient required emergency visit and was hospitalized on unspecified date. Laboratory investigations included echocardiogram on 19-Jan-2016. Corrective treatment included indomethacin (1/18), Toradol and colchine. The outcome of the events was reported as recovered. List of documents held by sender: none. Sender's Comments: Myocarditis can be caused by infections, inflammatory disorders, drugs, or cardiomyopathy. Time to onset is compatible with the vaccine. Patient's concomitant medication, as well as information on the her congenital anomaly, which could have precipitated the events, complementary investigation results confirming the myocarditis and acute renal failure and ruling out inflammatory etiology, as well as confirmation of the concurrent infection with identification of the pathogen, are needed to further assess this case.
Age: 20.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest pain, Echocardiogram, Myocarditis, Pericarditis
Clinical narrative: This unsolicited case was received on 05-Apr-2016 via a third party query tool search on the VAERS database, under reference number 620087. This case involves a 20-years old male patient who received the following vaccinations on 06-Jan-2016: A dose of ACAM2000 (lot number-VV04003A, manufacturer: SANOFI PASTEUR) in the unknown site via a not reported route. Patient had no history and current illness. Information regarding prior vaccination and concomitant medications were not reported. On 19-Jan-2016, 13 days post vaccination; patient had experienced chest pain and diagnosed with pericarditis-myocarditis and also experienced recurrent pain overnight. The patient required emergency visit and was hospitalized on unspecified date. Laboratory investigations included echocardiogram on 19-Jan-2016. Corrective treatment included indomethacin (1/18), Toradol and colchine. The outcome of the events was reported as recovered. List of documents held by sender: none. Sender's Comments: Myocarditis can be caused by infections, inflammatory disorders, drugs, or cardiomyopathy. Time to onset is compatible with the vaccine. Patient's concomitant medication, as well as information on the her congenital anomaly, which could have precipitated the events, complementary investigation results confirming the myocarditis and acute renal failure and ruling out inflammatory etiology, as well as confirmation of the concurrent infection with identification of the pathogen, are needed to further assess this case.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site infection, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 65 year old female patient with no pertinent medical history or drug reactions/allergies. On 29-MAR-2016 the patient was vaccinated with 0.65 ml dose of ZOSTAVAX injection (lot # L039126 and expiration date 08-JAN-2017) subcutaneously. Concomitant therapies included COREG and LEXAPRO. Two days later on 31-MAR-2016, the patient returned to the pharmacy starting that on the same day (on 29-MAR-2016) after receiving ZOSTAVAX, she developed a red, hard area at the injection site that was warm to the touch. The patient sought medical attention and was given cephalexin to treat the reaction. No lab diagnostics studies were performed. The patient was seen for follow-up appointments on 01-APR-2016 and 03-APR-2016, the area was improving, but still present. The outcome of the events was reported as recovering. The causal relationship between the events and ZOSTAVAX was unknown. The reporter requested a lot check for ZOSTAVAX with lot # L039126 and expiration date 08-JAN-2017. This is one of two received from the same reporter. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Information has been received from a pharmacist concerning a 65 year old female patient with no pertinent medical history or drug reactions/allergies. On 29-MAR-2016 the patient was vaccinated with 0.65 ml dose of ZOSTAVAX injection (lot # L039126 and expiration date 08-JAN-2017) subcutaneously. Concomitant therapies included COREG and LEXAPRO. Two days later on 31-MAR-2016, the patient returned to the pharmacy starting that on the same day (on 29-MAR-2016) after receiving ZOSTAVAX, she developed a red, hard area at the injection site that was warm to the touch. The patient sought medical attention and was given cephalexin to treat the reaction. No lab diagnostics studies were performed. The patient was seen for follow-up appointments on 01-APR-2016 and 03-APR-2016, the area was improving, but still present. The outcome of the events was reported as recovering. The causal relationship between the events and ZOSTAVAX was unknown. The reporter requested a lot check for ZOSTAVAX with lot # L039126 and expiration date 08-JAN-2017. This is one of two received from the same reporter. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Chills, Pyrexia
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 62 year old male patient. The patient's medical history and concurrent conditions were not reported. On 23-MAR-2016, the patient was vaccinated with ZOSTAVAX subcutaneously, lot # L028283, expiration date 28-OCT-2016 (strength, dose, anatomical location were not provided). Approximately on 24-MAR-2016, reported as "over the next day or two after administration", the patient developed cellulitis around the injection site. The reporter stated that the patient went to an unspecified emergency room for the cellulitis on 26-MAR-2016 or on 27-MAR-2016 for treatment with unspecified intravenous antibiotics; the patient was subsequently started on an unspecified oral antibiotic as well. The pharmacist stated that the patient was never admitted to the hospital. It was reported that the patient went to the pharmacy on 28-MAR-2016 and the reporter stated his arm "was improving". It was also reported that the patient did not develop a rash. The relatedness between ZOSTAVAX and injection site cellulitis was not reported. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 62 year old male patient. The patient's medical history and concurrent conditions were not reported. On 23-MAR-2016, the patient was vaccinated with ZOSTAVAX subcutaneously, lot # L028283, expiration date 28-OCT-2016 (strength, dose, anatomical location were not provided). Approximately on 24-MAR-2016, reported as "over the next day or two after administration", the patient developed cellulitis around the injection site. The reporter stated that the patient went to an unspecified emergency room for the cellulitis on 26-MAR-2016 or on 27-MAR-2016 for treatment with unspecified intravenous antibiotics; the patient was subsequently started on an unspecified oral antibiotic as well. The pharmacist stated that the patient was never admitted to the hospital. It was reported that the patient went to the pharmacy on 28-MAR-2016 and the reporter stated his arm "was improving". It was also reported that the patient did not develop a rash. The relatedness between ZOSTAVAX and injection site cellulitis was not reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity, Peripheral swelling, Ultrasound scan normal
Clinical narrative: Initial unsolicited report received from a healthcare professional on 29 October 2014. A 63-year-old female patient had received first dose of ADACEL, (batch number U4655AA, expiry date 13 December 2015, route of administration not reported) in left deltoid on 29 October 2014. The patient had received a dose of HEPATITIS B VACCINE (Manufacturer Merck, batch number, dose in series, route and site of vaccination not reported) on 08 September 2014. The patient had no illness at the time of vaccination and had history of allergy to codeine and hypertension. On 29 October 2014, 12 to 24 hours after receiving the vaccine, the patient developed left leg swelling and pain. The patient was sent to emergency room and evaluated by physician. An ultrasound was performed which was negative. The patient received some treatment (unspecified). At the time of this report, the patient had not recovered. Documents held by sender: none. Follow-up information received form a physician on 22 May 2015. It was reported that physician has no additional information to provide. List of documents held by Sender: None.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Granuloma annulare
Clinical narrative: Based on additional information received on 24 August 2015, this case became medically confirmed. Initial unsolicited report received from consumer (patient's mother) on 15 May 2015. A 10-year-old female patient, whose medical history was none and concomitant medication was not reported, had received a first dose of ADACEL (batch number, expiration date, dose and site of administration were not reported) intramuscularly on 20 February 2015. The patient did not have illness at time of vaccination and any pre-existing physician diagnosed allergies, birth defects, medical conditions were denied by the reporter. She did not previously receive ADACEL vaccine. Two weeks later on an unspecified date after vaccination, the patient had experienced growths on feet which was diagnosed as granuloma annulare. It was reported that, as per physician granuloma annulare could be triggered by tetanus vaccine. The patient was evaluated by a pediatrician, podiatrist and patient would be seeing an infectious disease specialist. Laboratory investigation and corrective treatment were not reported. At the time of this report, outcome of the event was unknown. Follow-up information received from a healthcare professional on 24 August 2015. The batch number of ADACEL was updated as U4875AA and expiry date was 25 October 2016. Site of vaccine administration was left arm. The patient did not experience any other delayed reactions after the vaccination. List of documents held by sender: none.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Initial unsolicited report received from a pharmacist on 1 June 2015. A 32-year-old female patient, with no medical history and concomitant medications were not reported, had received a dose of ADACEL (batch number- U5213BA, expiry date- 12 February 2017, route of administration was not reported) in left deltoid region on 28 May 2015. Patient had no illness at the time of vaccination. On 30 May 2015, 2 days after vaccination, the patient experienced red lump with pain at the injection site. No laboratory investigations were performed. Patient was advised ice treatment and rest for the arm. Patient required ER/doctor visit. At the time of this report, patient had not recovered from the event. Documents held by sender: none. Follow-up report received from a pharmacist on 18 August 2015. It was reported that the patient had received 0.5 ml intramuscular injection of ADACEL (expiry date 2 December 2017 previously reported as 12 February 2017) in left arm. The patient experienced event on 29 May 2015, one day after vaccination.
Sex: F
Vaccine: TDAP
Symptoms: Headache, Influenza, Malaise
Clinical narrative: Initial unsolicited report received from a pharmacist on 03 June 2015. A female patient, whose medical history and concomitant medications were not reported, had received a dose of batch number, expiry date, dose, dose number, route and site of administration were not reported on an unspecified date. On an unspecified date, after vaccination, patient had experienced symptoms headache and didn't feel well for days which diagnosed as Flu. It was also reported that, patient was not pregnant during the Tdap vaccination. Laboratory investigations and corrective treatments were not reported. At the time of this report, patient had recovered. Documents held by sender: none.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Myosclerosis
Clinical narrative: Initial unsolicited report received from a pharmacist in on 18 June 2015. A 30-year-old female patient whose medical history was reported as none and concomitant medications were not reported had received a dose of ADACEL (batch number U5213BA, expiry date 2 December 2015) via intramuscular route in right deltoid on 30 May 2015. On an unknown date, after vaccination, the patient experienced soreness in her right deltoid. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the event was recovering. Documents held by sender: none. Follow up information received from a pharmacist on 3 August 2015. It was reported that, patient had unnoticeable soreness on an unspecified date. On 26 June 2015 patient had an appointment with her regular family physician (FP) at that time some muscle firmness was noted. Patient was advised to use hot and cold packs with weight lifting exercises. It was reported that, approximately ten days after appointment event soreness was resolved down from a "six". On an unspecified date, patient had recovered from above reported events. Documents held by sender: none.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Initial unsolicited report received from a nurse on 19 June 2015. A 55-year-old female patient had received a dose of ADACEL (batch number: U5214AA, expiry date, dose, dose in series were not reported) via intramuscular route in left deltoid on 10 June 2015. No illness at time of vaccination. Pre-existing physician diagnosed allergies, birth defects, medical conditions reported as diabetes type 2 and hypercholesterolemia. Concomitant medications were not reported. On 10 June 2015, after vaccination, the patient developed fever for several days as high as 105 Fahrenheit, body aches, and injection site at left deltoid was painful. Relevant diagnostic tests/laboratory data and corrective treatments were not reported. At the time of this report, the patient was recovered from all the events. Documents held by sender: none. Follow up report received from a nurse on 7 August 2015. The patient received 0.5 ml one dose of ADACEL (expiration date- 4 December 2017) on 10 June 2015. Patient concomitant medications include 20 mg Lipitor daily, 500 mg Metformin daily and 2000 IU Vitamin D daily.
Sex: U
Vaccine: TDAP
Symptoms: Death neonatal, Foetal exposure during pregnancy, Intraventricular haemorrhage, Mechanical ventilation, Sepsis
Clinical narrative: Initial unsolicited literature report received from a physician ion 16 June 2015. This case is linked to 2015SA092506, 2015SA092507, 2015SA092508, 2015SA092509, 2015SA092510, 2015SA092511, 2015SA092512, 2015SA089479, 2015SA092723, 2015SA092724, 2015SA092725 (same vaccine). Abstracts: OBJECTIVE: To evaluate pregnancy outcomes of women who received Tdap vaccination at or after 32 weeks of gestation. Outcomes from consecutive pregnancies during which the mother received Tdap were also analyzed. METHODS: In a retrospective cohort study at a single institution, we compared pregnancy outcomes between those who accepted or declined Tdap at 32 weeks of gestation. Additionally, women who received Tdap vaccination in this and a prior pregnancy in the past 5 years were compared with multiparous women who only received Tdap in this pregnancy. RESULTS: Since 2013, 7,378 women who were offered the Tdap vaccine antenatally delivered at our institution: 7,152 accepted (97 percentage). There was no difference in stillbirths, major malformations, chorioamnionitis, 5-minute Apgar score, or cord blood pH. Neonatal complications including ventilation requirement, sepsis, intraventricular hemorrhage, and neonatal death were also similar. However, preterm birth rates at 36 weeks of gestation or less (6 percentage compared with 12 percentage, P less than 0.001), incidence of small for gestational age (10 percentage compared with 15 percentage, P equal to 03), and length of neonatal hospitalization (3.9 compared with 4.7 days, P less than 001) were all significantly increased in the unvaccinated cohort. No difference in neonatal outcomes was noted between women who were administered at least two Tdap vaccines in the past 5 years (n equal to 1,229) and those who received only a single dose (n equal to 4,159). CONCLUSION: No adverse pregnancy outcomes were identified in association with antepartum Tdap vaccination. This remained true in women receiving more than one Tdap vaccine in a 5-year timeframe. This may be the result of a type II error. A 7,378 number of female patients out of which (97 percentage) patients received Tdap vaccine and 226 (3 percentage) patients declined Tdap vaccine. A 7,152 number of female patients, whose medical history and concomitant medication were not reported had received a dose of TDAP (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. As Tdap vaccine was exposure in utero, thus 12 (0.2 percentage) neonate patients had developed 5 minute Apgar less than 4. Laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was unknown. Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Blood pH decreased, Foetal exposure during pregnancy
Clinical narrative: Initial unsolicited literature report received from a physician on 16 June 2015. This case is linked to 2015SA092506, 2015SA092507, 2015SA092508, 2015SA092509, 2015SA092510, 2015SA092511, 2015SA092512, 2015SA089479, 2015SA092722, 2015SA092724, 2015SA092725 (same vaccine). Abstracts: OBJECTIVE: To evaluate pregnancy outcomes of women who received Tdap vaccination at or after 32 weeks of gestation. Outcomes from consecutive pregnancies during which the mother received Tdap were also analyzed. METHODS: In a retrospective cohort study at a single institution, we compared pregnancy outcomes between those who accepted or declined Tdap at 32 weeks of gestation. Additionally, women who received Tdap vaccination in this and a prior pregnancy in the past 5 years were compared with multiparous women who only received Tdap in this pregnancy. RESULTS: Since 2013, 7,378 women who were offered the Tdap vaccine antenatally delivered at our institution: 7,152 accepted (97 percentage). There was no difference in stillbirths, major malformations, chorioamnionitis, 5-minute Apgar score, or cord blood pH. Neonatal complications including ventilation requirement, sepsis, intraventricular hemorrhage, and neonatal death were also similar. However, preterm birth rates at 36 weeks of gestation or less (6 percentage compared with 12 percentage, P less than 0.001), incidence of small for gestational age (10 percentage compared with 15 percentage, P equal to 03), and length of neonatal hospitalization (3.9 compared with 4.7 days, P less than 001) were all significantly increased in the unvaccinated cohort. No difference in neonatal outcomes was noted between women who were administered at least two Tdap vaccines in the past 5 years (n equal to 1,229) and those who received only a single dose (n equal to 4,159). CONCLUSION: No adverse pregnancy outcomes were identified in association with antepartum Tdap vaccination. This remained true in women receiving more than one Tdap vaccine in a 5-year timeframe. This may be the result of a type II error. A 7,378 number of female patients out of which (97 percentage) patients received Tdap vaccine and 226 (3 percentage) patients declined Tdap vaccine. A 7,152 number of female patients, whose medical history and concomitant medication were not reported had received a dose of TDAP (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. As Tdap vaccine was exposure in utero, thus 50 (0.7 percentage) neonate patients had blood pH 7.0 or less. Laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was unknown. Documents held by sender: none.
Sex: U
Vaccine: TDAP
Symptoms: Death, Foetal exposure during pregnancy
Clinical narrative: Initial unsolicited literature report received from a physician on 16 June 2015. This case is linked to 2015SA092506, 2015SA092507, 2015SA092508, 2015SA092509, 2015SA092510, 2015SA092511, 2015SA092512, 2015SA089479, 2015SA092722, 2015SA092723, 2015SA092725 (same vaccine). Abstracts: OBJECTIVE: To evaluate pregnancy outcomes of women who received Tdap vaccination at or after 32 weeks of gestation. Outcomes from consecutive pregnancies during which the mother received Tdap were also analyzed. METHODS: In a retrospective cohort study at a single institution, we compared pregnancy outcomes between those who accepted or declined Tdap at 32 weeks of gestation. Additionally, women who received Tdap vaccination in this and a prior pregnancy in the past 5 years were compared with multiparous women who only received Tdap in this pregnancy. RESULTS: Since 2013, 7,378 women who were offered the Tdap vaccine antenatally delivered at our institution: 7,152 accepted (97 percentage). There was no difference in stillbirths, major malformations, chorioamnionitis, 5-minute Apgar score, or cord blood pH. Neonatal complications including ventilation requirement, sepsis, intraventricular hemorrhage, and neonatal death were also similar. However, preterm birth rates at 36 weeks of gestation or less (6 percentage compared with 12 percentage, P less than 0.001), incidence of small for gestational age (10 percentage compared with 15 percentage, P equal to 03), and length of neonatal hospitalization (3.9 compared with 4.7 days, P less than 001) were all significantly increased in the unvaccinated cohort. No difference in neonatal outcomes was noted between women who were administered at least two Tdap vaccines in the past 5 years (n equal to 1,229) and those who received only a single dose (n equal to 4,159). CONCLUSION: No adverse pregnancy outcomes were identified in association with antepartum Tdap vaccination. This remained true in women receiving more than one Tdap vaccine in a 5-year timeframe. This may be the result of a type II error. A 7,378 number of female patients out of which (97 percentage) patients received Tdap vaccine and 226 (3 percentage) patients declined Tdap vaccine. A 7,152 number of female patients, whose medical history and concomitant medication were not reported had received a dose of TDAP (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. As Tdap vaccine was exposure in utero, out of total 2,093 number of neonate patients out of which 206 (3 percentage) patients birth weight was observed less than the third percentile, 364 (5 percentage) patients birth weight was observed less than the fifth percentile, 714 (10 percentage) patients birth weight was observed less than tenth percentile and 809 (11 percentage) patients birth weight was observed greater than the ninetieth percentile. Laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was unknown. Documents held by sender: none.