chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. It was reported that since 24-DEC-2014 the patients were administered ROTATEQ orally (dose and lot no. unspecified) which underwent supported temperature excursions. No adverse events were reported. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient gpt flu shot on 10/8/14 and patient came back to pharmacy at a later date (undetermined) to report arm pain.
Age: 60.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Bursitis, Pain in extremity
Clinical narrative: Patient was given flu shot on 10/13/14. Patient had arm pain and was treated at physician's office with a steroid injection into "bursa" b/c symptoms of bursitis.
Age: 67.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient received AFLURIA vaccine on 10/18/14 and came to pharmacy on 10/30/14 to report trouble fully moving arm and arm pain.
Age: 67.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient received AFLURIA vaccine on 10/18/14 and came to pharmacy on 10/30/14 to report trouble fully moving arm and arm pain.
Age: 78.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Gave flu shot on 10/13/14. Patient reported a few days later that she had arm pain (severe) and had trouble moving arm fully.
Age: 78.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Gave flu shot on 10/13/14. Patient reported a few days later that she had arm pain (severe) and had trouble moving arm fully.
Age: 46.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Patient having arm pain since date of injection. She has limited range of motion. Gave injection 10/14/14 reported arm pain 10/28/14 and 1/30/14 came in to report continued range of motion issues prompting this report.
Age: 69.0
Sex: F
Vaccine: TDAP
Symptoms: Extensive swelling of vaccinated limb, Pain in extremity, Skin tightness
Clinical narrative: This case was reported by a pharmacist and described the occurrence of extensive swelling of vaccinated limb in a 69-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Concurrent medical conditions included seasonal allergy. Concurrent medications included daily SINGULAIR. Subject's previous vaccinations went uncomplicated. On 11 August 2014 at 15:00, the subject received unspecified dose of BOOSTRIX (unknown route, left arm). On 17 August 2014, 6 days after vaccination with BOOSTRIX, the subject experienced severe swelling in her arm that was causing pain in that arm. The subject speculated that it may be due to the tightness of her skin caused by swelling. She noted that these events were localized to her arm. She does not experience any tingling in her hand or fingers. The reporter believed the pain was refractory to the swelling and not injection site pain. The subject's adverse events did not require medical attention. The reporter advised the subject to take BENADRYL and ADVIL and to apply ice to the swollen area. She does not know if the patient has taken any of those actions. At the time of reporting the events were worse.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Laboratory test normal, Prenatal screening test
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional (nurse) and described the occurrence of vaccine exposure during pregnancy in a 41-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline) during pregnancy. On 14 January 2014 the subject received a dose of BOOSTRIX (1 unknown dose with notation of "5-2.5-18.5" and the meaning was unclear, intramuscular, unknown site) and experienced vaccine exposure during the 3rd trimester of pregnancy. The gestational age at the time of vaccination was approximately 28 weeks. The date of last menstrual period was 26 June 2013. The estimated date of delivery was reported as 2 April 2014 per the nurse. There was no evidence of defect from prenatal testing. At the time of reporting, the pregnancy was ongoing. Follow-up information was received on 15 April 2014 via healthcare professional. The pregnancy consisted of one fetus and was not by in-vitro fertilization. The subject  was at 28 6/7 weeks gestation at the time of vaccination with BOOSTRIX. At the time of the report no other information was provided. Follow up was received from a nurse on 27 May 2014. The nurse reported that there was no in-vitro fertilization utilized in this pregnancy. The nurse also reported concurrent medications included SYNTHROID. No further details were provided at the time of reporting. Follow up was received from the nurse on 11 August 2014. The nurse confirmed the information as it was previously reported. No details regarding the outcome of the pregnancy were provided. The pregnancy was marked as lost to follow up.
Age: 11.0
Sex: F
Vaccine: DTAPIPVHIB, TDAP
Symptoms: Extra dose administered, Hyperaesthesia, Injection site reaction
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of skin sensitive at injection site in a 11-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline) and PENTACEL (Non-GSK). On 4 August 2014, the subject received 1st dose of BOOSTRIX (.5 ml) and received erroneously an unspecified dose of PENTACEL by mistake of human error. On 4 August 2014, less than one day after vaccination with BOOSTRIX and PENTACEL, the subject experienced increasing of sensitivity at injection site and accidental overdose. At the time of reporting, the outcome of the event was unspecified.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 59-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 25 August 2013, the subject received unspecified dose of BOOSTRIX (unknown route and arm). At an unspecified time after vaccination with BOOSTRIX, the subject experienced swelling injection site. She continues to have swelling in that arm since the vaccine was administered. At the time of reporting, the event was unresolved.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Delivery, Exposure during pregnancy, No adverse event
Clinical narrative: This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 32-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Medical history included a C-section, so it was assumed that the subject already gave birth previously. On 21 March 2014, the subject received unspecified dose of BOOSTRIX (.5 ml, unknown, left deltoid). Her last menstrual period and estimated delivery date were not provided, but the subject was 32 weeks pregnant when she received the vaccine. At the time of reporting, no adverse event was reported and the pregnancy was still ongoing. Follow-up information received on 15 April 2014 by the healthcare provider of the subject: Vaccine was given via intramuscular route. The subject's last menstrual period was in August 2013 and estimated date of delivery was on 08 May 2014. The pregnancy was a normal conception. No adverse event was reported. The case has been also reported to the regulatory agency. 03 September 2014- No further information was provided; patient lost to follow-up. Follow-up information received on 15 September 2014: On an unspecified date, after a full term pregnancy (unspecified weeks gestation), the subject gave birth to a live infant of unspecified gender.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Laboratory test normal, No adverse event, Prenatal screening test
Clinical narrative: This prospective pregnancy case was reported by a pharmacist and described the occurrence of vaccine exposure during pregnancy in a 27-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). The subject's medical history included delivery of a preterm baby, 6 year ago. The subject was not using contraception. On an unspecified date, the subject received unspecified dose of BOOSTRIX (.5 ml, intramuscular, unknown injection site). Her last menstrual period and estimated date of delivery were not provided. The subject was exposed to the vaccine during unspecified trimester. There was no evidence of a defect from prenatal testing. At the time of reporting, the subject was 33 weeks pregnant. The lot number was reported as AC528107BA from the reporter; however, based on a safety lot number review, the lot number was updated to AC52B107BA. Follow-up information received on 17 June 2014: The subject was vaccinated on 21 March 2014. The subject's last menstrual period was in August 2013 and estimated date of delivery was in May 2014. She was vaccinated when she was 33 weeks pregnant, so she was exposed to the vaccine during third trimester of pregnancy. No adverse event was reported after vaccination. 03 September 2014 - No further information was provided; patient lost to follow-up. Follow-up information received on 10 September 2014 from the pharmacist which received a follow-up form in the mail. The reporter had no further information available to add to the report.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: This case was reported by a pharmacist and described the occurrence of arm soreness at injection site in a 52-year-old female subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline). On 2 September 2014, the subject received 1st dose of BOOSTRIX (.5 ml, unknown route, right arm). On 3 September 2014, 1 day after vaccination with BOOSTRIX, the subject experienced a quarter sized swollen knot, arm soreness and redness at injection site redness and arm pain. The redness at injection site resolved after approximately 2 days. At the time of reporting pain and soreness in arm were improved. The quarter sized swollen knot had improved to dime sized swollen knot. The pharmacist considered the events were probably related to vaccination with BOOSTRIX. No further information was available. The case was closed.
Age: 4.0
Sex: F
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, Pyrexia, Wrong drug administered
Clinical narrative: This case was reported by a consumer and described the occurrence of fever in a 4-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date, the subject received erroneously an unspecified dose of BOOSTRIX (unknown route, injection site and batch number) that led to inappropriate age at vaccine administration and wrong vaccine administered. At an unspecified time after vaccination with BOOSTRIX, the subject experienced fever. The outcome of the event was unspecified.
Sex: F
Vaccine: TDAP
Symptoms: Adverse reaction
Clinical narrative: This legal claim was reported by a consumer via a pharmacist and described the occurrence of adverse reaction in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of BOOSTRIX (unknown route). On 21 July 2014, at an unspecified time after vaccination with BOOSTRIX, the subject experienced adverse reaction. At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Medical history and current conditions were not reported. On 05-FEB-2015 (also reported as today), the patient was vaccinated with an expired dose of ZOSTAVAX (subcutaneous, dose 0.65 ml, lot # 672558/1600AA, expiration date 13-JAN-2013). No adverse experience was reported. Additional information has been requested.
Age: 3.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of inappropriate at at vaccine administration in a 3-year-old subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of KINRIX (.5 ml, unknown route, batch number and injection site) which led to a inappropriate age at vaccine administration. It should be given from 4 years old.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of wrong vaccine administered in a 11-year-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). On 20 August 2010, the subject received unspecified dose of INFANRIX (.5 ml, unknown route and injection site) instead of a dose of Tdap. No adverse event occurred. No further information was available. The case was closed.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a other health professional and described the occurrence of drug dose administration interval too short in a 2-year-old female patient who received HAVRIX (batch number C7392, expiry date 14th March 2017). On an unknown date, the patient received the 2nd dose of HAVRIX. On an unknown date, an unknown time after receiving HAVRIX, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. Additional information: the 2nd dose of HAVRIX was given 7 days too early.
Sex: U
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of wrong vaccine administered in multiple subjects of unspecified age and gender who was vaccinated with KINRIX, (GlaxoSmithKline). On an unspecified date, multiple subjects received unspecified dose of KINRIX (.5 ml, unknown route and injection site; lot number not provided) DTaP/IPV or KINRIX were given for the fourth dose of DTaP. She thinks nurses need education and come from one job to another and don't keep trakc, so they just give 5 doses of DTaP and 5 doses of IPV or the primary series and KINRIX for the 4th and 5th doses. The subjects experienced wrong vaccine administered and inapprorpriate schedule of vaccine administered. This was 1 of the 3 cases receievd from the same reporter.
Age: 0.3
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of wrong vaccine administered in a 4-month-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included DTAP, hepatitis B and IPV;GlaxoSmithKline;unknown;unknown given in July 2014. On an unspecified date, the subject received erroneously a dose of KINRIX (unknown) instead of PEDIARIX for the 2nd dose in series. Moreover, the subject was too young to receive KINRIX.
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of maladministration (asymptomatic/child too young) in a 1-day-old male subject who was vaccinated with INFANRIX, (GlaxoSmithKline). On 28 April 2014 the subject received 1st dose of INFANRIX (0.5 ml, unknown route) instead of 1st dose of ENGERIX B, which led to a maladministration (asymptomatic/child too young). No adverse event ha been reported.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event, Product quality issue
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 04-FEB-2015 the patient was vaccinated with expired dose of ZOSTAVAX (lot number: J006827 with expiry date of 14-SEP-2014) (dose, frequency and route unspecified). Concomitant medications were not reported. No adverse effects were reported. A product quality complaint was filed for current administered ZOSTAVAX due to alleged mix. The reporter stated that she administered ZOSTAVAX from a vial that had a different expiration date and lot number from the other nine vials that were present in the box. The outcome of the events was unknown. The causality of the events with ZOSTAVAX was not reported. Additional information has been requested.
Age: 22.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site hypersensitivity, Sluggishness
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of feels-sluggish in a 22-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent medical conditions included allergic to raspberries, allergy to neomycin and allergy to pine oil. On 25 April 2014 the subject received 1st dose of HAVRIX (unknown route). In April 2014, less than one week after vaccination with HAVRIX, the subject complained of feeling sluggish. The subject came back to the clinic and wondered if the event could be related to neomycin. At the time of reporting the outcome of the event was unspecified. The nurse refused to provide additional information. Follow up information received on 3 June 2014 from the nurse: On 25 April 2014 the subject received 1st dose of HAVRIX (intramuscular, unknown deltoid). On 25 April 2014, less than one day after vaccination with HAVRIX, the subject experienced feels-sluggish. The subject also experienced slight injection site sensitivity. On 29 April 2014, the event was resolved. The subject declined appointment to allergist. The healthcare professional considered the event was possibly related to vaccination with HAVRIX. The subject was advised to not receive the second dose of vaccine since he was allergic to component of vaccine. This case was reported to a regulatory agency.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: This case was reported by a other health professional and described the occurrence of expired vaccine used in a male patient who received HAVRIX (batch number AHAVB566AN, expiry date 30th May 2014. On an unknown date, the patient received HAVRIX. On an unknown date, an unknown time after receiving HAVRIX, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer and described the occurrence of adverse reaction in a 12-month-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included cow milk protein allergy. On an unspecified date the subject received 3rd dose of INFANRIX (unknown route). At an unspecified time after vaccination with INFANRIX, the subject experienced adverse reaction (unspecified). At the time of reporting the outcome of the event was unspecified. Since the vaccine INFANRIX contains Fenton medium (bovine extract) and Latham medium (derived from bovine casein) the mother was concerned about the safety of the product.
Sex: F
Vaccine: DTAP
Symptoms: Exposure during pregnancy
Clinical narrative: This prospective pregnancy case was reported by a physician and described the occurrence of vaccine exposure during pregnancy in an unknown number of female subjects of unspecified age who were vaccinated with DTPA (with small D and P), manufacturer unspecified). On an unspecified dates the subjects received a dose of DTPa (with small D and P) (unknown details) and experienced vaccine exposure during an unknown trimester of pregnancy. The physician reported that he was administering DTPa vaccine to his pregnant subjects. Follow up was received from a nurse on 18 August 2014. The nurse was unable to identify the patient and GSK was unable to provide any patient demographics. The case has been closed as lost to follow up.
Sex: U
Vaccine: MEN, TDAP
Symptoms: Erythema, Swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling in a subject of unspecified age and gender who was vaccinated with BOOSTRIX, (GlaxoSmithKline) and meningitis vaccine and strain not specified (Meningococcal vaccine). On 13 August 2014, the subject received unspecified dose of BOOSTRIX, (.5 ml, unknown route, left arm) and unspecified dose of Meningococcal vaccine (unknown route, injection site and batch number). On 13 August 2014, less than one day after vaccination with BOOSTRIX and Meningococcal vaccine, the subject experienced pronounced swelling and erythema. At the time of reporting, the outcome of the events was unspecified. This is one of the 2 case reported by the same reporter and for the same events.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Decreased appetite, Headache, Lethargy, Nausea, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of headache in a 50-year-old male subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 24 August 2014, the subject received unspecified dose of BOOSTRIX (.5 ml, unknown route and injection site). In an unsp August 2014m at an unspecified time after vaccination with BOOSTRIX, the subject experienced headache, nausea, fever (39.1 Deg. C), lethargy and decreased appetite. On 27 August 2014, the events were resolved. The healthcare professional considered the events were possibly related to vaccination with BOOSTRIX. No further information was available. The case was closed.
Sex: U
Vaccine: DTAPIPV
Symptoms: Erythema, Swelling
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of swelling in a child subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). On 13 August 2014, the subject received unspecified dose of KINRIX (.5 ml, unknown route, batch number and injection site). On 13 August 2014, less than one day after vaccination with KINRIX, the subject experienced pronounced swelling and erythema. At the time of reporting, the outcome of the events was unspecified. This is one of the 2 case reported by the same reporter and for the same events.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown ages and genders. On an unknown date, the patients were vaccinated with incorrect storage because doses of M-M-R II (dose, route and lot # were not reported) that post supported excursion were administered to the patients. Also registered nurse mentioned that there has been no need for revaccination. No adverse effects were reported. This is one of several reports received from the same source. 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 pharmacist refers to a patient of unknown age and gender. On 04-FEB-2015, the patient was subcutaneously vaccinated with a dose of PROQUAD (Merck) (lot # K007156, expiration date 12-NOV-2015, 0.5 ml once) that was improperly stored. No adverse effects were reported. This is the one of several reports from the same reporter source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. Medical history and current conditions were not reported. On 26-JAN-2015 the patient was vaccinated with a dose of VARIVAX (Merck) (dose number, lot number and expiration date were not reported), 0.5 ml, subcutaneous, that underwent a temperature excursion. No adverse effect reported. 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 pharmacist refers to a patient of unknown age and gender. On 03-FEB-2015, the patient was subcutaneously vaccinated with a dose of PROQUAD (Merck) (lot # K007156, expiration date 12-NOV-2015, 0.5 ml once) that was improperly stored. No adverse effects were reported. This is one of several reports from the same reporter source. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, Fatigue, Headache, Nausea
Clinical narrative: This case was reported by a consumer and described the occurrence of headache in a female subject of unspecified age who was vaccinated with HAVRIX 1440 (GlaxoSmithKline). Concurrent medications included SYNTHROID and Pravastatin. On 26 February 2014 at 13:30 the subject received 1st dose of HAVRIX 1440 (1 ml, unknown, right arm) and experienced expired vaccine used. The subject reported that her pharmacy accidentally administered an expired HAVRIX vaccine. On 26 February 2014, within hours of vaccination with HAVRIX 1440, the subject experienced headache, nausea, fatigue and expired vaccine used. After the vaccination, sometime after dinner, she felt some fatigue, nausea and headache. The headache has resolved, but she is still experiencing some nausea. According to the subject immunization series was not delayed or discontinued. At the time of reporting the headache was resolved, the nausea and fatigue had improved. On 28 February 2014, the case was medical confirmed by the pharmacist who reported the subject experienced headache and nausea after receiving expired HAVRIX. HAVRIX batch and lot number were not provided. The pharmacist inquired about a replacement dose. No additional information was provided.
Sex: M
Vaccine: TDAP
Symptoms: Adverse reaction
Clinical narrative: This legal claim was reported by a consumer via a pharmacist and described the occurrence of adverse reaction in a male subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of BOOSTRIX (unknown). On 19 May 2014, at an unspecified time after vaccination with BOOSTRIX, the subject experienced adverse reaction. At the time of reporting the outcome of the event was unspecified.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown demographics. On 04-FEB-2015 the patient was vaccinated with RECOMBIVAX HB (dosing regimen unspecified, lot # unknown; expiry date: 31-JAN-2015). On 04-FEB-2015 expired product administered was reported. Pharmacist reported that an expired dose of RECOMBIVAX HB, exp.31-JAN-2015, was administered today, 04-FEB-2015, to an unspecified patient. No adverse effects reported. No further information provided. The outcome of expired dose of RECOMBIVAX HB administered and no adverse effects reported was unknown. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a Healthcare worker referring to a patient of unknown age and gender. Patient's concurrent conditions, concomitant medication and medical history were not provided. On 12-JAN-2015 the patient was vaccinated with a dose of improperly stored VAQTA injection 25/0.5 (0.5 ml, lot3 was not provided) intramuscularly. No adverse events were reported after improperly stored VAQTA was administered. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional (licensed practical nurse) refers to unspecified patients of unknown demographics. Since 08-OCT-2014 these patients were administered with improperly stored PNEUMOVAX 23. All these patients experienced incorrect product storage as all of them were administered with improperly stored PNEUMOVAX 23. No adverse effects were reported. No product quality complaint (PQC) was involved. Outcome of the event, incorrect product storage was unknown. Reporter considered the event, incorrect product storage to be not related to PNEUMOVAX 23. This is one of several reports received from the same source (MARRS # 1502USA002021 and MARRS # 1502USA002816). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist via a field employee refers to a patient of unknown age (reported as "medicare age") and gender. On an unknown date the patient was vaccinated with a single dose of ZOSTAVAX (dose 0.65 ml, subcutaneous, lot# and expiration date were not reported). After the dose was given, the pharmacist looked at the patient's records and find out that the ZOSTAVAX was given previously on an unspecified date. No adverse event was reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: This case was reported by a physician and described the occurrence of hive in a 17-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). On Friday 28 March 2014, the subject received 1st dose of HAVRIX (unknown route, right arm). On Sunday 30 March 2014, 2 days after vaccination with HAVRIX, the subject experienced hive. The subject was treated with BENADRYL but the hive came back. At the time of reporting the event was unresolved.
Sex: U
Vaccine: MMR
Symptoms: Autism
Clinical narrative: This spontaneous report as received from a consumer refers to a patient of unknown age. The patient had a twin brother or sister. The patient medical history and drug reactions or allergies were not provided. 4 to 6 years ago, in approximately 2011, the patient was vaccinated with M-M-R II (route, lot # and expiration date were not provided). Concomitant medication information was not provided. Also 4 to 6 years ago, in approximately 2011, about two weeks after receiving M-M-R II, the patient became autistic and her or his other twin was fine. It was unknown if medical attention was sought for the patient. At the time of the report, the patient status was unknown. Additional information is not expected. No contact information was provided.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site swelling, Nausea, Oropharyngeal pain, Pain
Clinical narrative: Left arm pain, swelling to injection site. Body ache, fever 101 (oral), headache, itchy sore throat, nausea 2/4/15 1930 - felt worse.
Age: 20.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pyrexia, Throat irritation
Clinical narrative: Left arm pain, swelling to injection site. Body ache, fever 101 (oral), headache, itchy sore throat, nausea 2/4/15 1930 - felt worse.
Age: 27.0
Sex: F
Vaccine: HEPAB, MMR, VARCEL
Symptoms: Asthenia, Fatigue, Lymphadenopathy, Night sweats, Pain
Clinical narrative: 12-29-14 clt never immunized as a child and received 3 immunizations on 12-18-14. Clt states 2 days after immunization experienced fatigue, achiness and weakness. On 12-23-14 clt experienced night sweats that lasted approx 4 days. On 12-28-14 clt states she broke out in rash on face, neck and trunk. Clt also reports swollen lymph nodes in (L) armpit. Referred clt to physician for evaluation. 1-13-15 clt states she was seen by a provider and dx with viral illness. Clt states sx resolved by 1-1-15. Clt received ok from provider to receive subsequent immunizations.
Age: 27.0
Sex: F
Vaccine: HEPAB, MMR, VARCEL
Symptoms: Rash, Viral infection
Clinical narrative: 12-29-14 clt never immunized as a child and received 3 immunizations on 12-18-14. Clt states 2 days after immunization experienced fatigue, achiness and weakness. On 12-23-14 clt experienced night sweats that lasted approx 4 days. On 12-28-14 clt states she broke out in rash on face, neck and trunk. Clt also reports swollen lymph nodes in (L) armpit. Referred clt to physician for evaluation. 1-13-15 clt states she was seen by a provider and dx with viral illness. Clt states sx resolved by 1-1-15. Clt received ok from provider to receive subsequent immunizations.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Hypoaesthesia
Clinical narrative: Shot given 1/28/15 (R) deltoid. Pt to clinic with c/o arm being numb 1/30/15. Has ganglion cyst wrist of same arm that she states gave similar sx with injection. No redness, induration, swelling on exam today. FROM. Nl. circulation.
Age: 2.0
Sex: F
Vaccine: HEPA, FLUX, HEPA
Symptoms: Incorrect dose administered, Injection site urticaria
Clinical narrative: This case was reported by a physician and described the occurrence of accidental overdose in a 25-month-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 13 February 2014 at 13:30 the subject received unspecified dose of HAVRIX (1 ml, unknown) and experienced accidental overdose and inappropriate age at vaccine administration. The subject accidentally received an adult dose (1.0mL) of HAVRIX. At the time of the report no other information was provided. The HAVRIX recommendation for children and adolescents is 0.5mL dose and 0.5mL booster dose administered between six to 12 months later. Follow-up information was received on 04 March 2014 via physician. Concurrent vaccination included seasonal influenza vaccine (non-gsk); non-GSK manufacturer; intramuscular; unknown given on an unspecified date; details not provided. The physician reported the subject developed hives at site of administration later that evening. 13 February 2014 and resolved without the use of medication on 14 February 2014. The physician considered the events were probably related to vaccination with HAVRIX. The physician attributed the events to erroneous administration of HAVRIX. No action was taken with HAVRIX. Children and adolescents (12 months through 18 years of age) are recommended to receive HAVRIX 0.5mL dose and 0.5mL booster dose administered anytime between six and 12 months later.
Age: 2.0
Sex: F
Vaccine: HEPA, FLUX, HEPA
Symptoms: Injection site urticaria
Clinical narrative: This case was reported by a physician and described the occurrence of accidental overdose in a 25-month-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 13 February 2014 at 13:30 the subject received unspecified dose of HAVRIX (1 ml, unknown) and experienced accidental overdose and inappropriate age at vaccine administration. The subject accidentally received an adult dose (1.0mL) of HAVRIX. At the time of the report no other information was provided. The HAVRIX recommendation for children and adolescents is 0.5mL dose and 0.5mL booster dose administered between six to 12 months later. Follow-up information was received on 04 March 2014 via physician. Concurrent vaccination included seasonal influenza vaccine (non-gsk); non-GSK manufacturer; intramuscular; unknown given on an unspecified date; details not provided. The physician reported the subject developed hives at site of administration later that evening. 13 February 2014 and resolved without the use of medication on 14 February 2014. The physician considered the events were probably related to vaccination with HAVRIX. The physician attributed the events to erroneous administration of HAVRIX. No action was taken with HAVRIX. Children and adolescents (12 months through 18 years of age) are recommended to receive HAVRIX 0.5mL dose and 0.5mL booster dose administered anytime between six and 12 months later.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Aldolase normal, Antinuclear antibody negative, C-reactive protein increased, Muscular weakness, Pain in extremity
Clinical narrative: Approx. 5 days after receiving ZOSTAVAX vaccine, I developed the abrupt onset of progressive pain and weakness involving my entire arms and legs bilaterally that ultimately became significantly incapacitating. I saw a rheumatologist approx. 7 wks. after the onset. He dxed. polymyalgia rheumatica, and started me on a long-term course of prednisone, which I am still taking, and will be for at least 6 mos.-1 yr. My sxs. completely abated within 48 hrs. of starting prednisone. Dr. did not believe my condition was caused by or related to the vaccine.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Polymyalgia rheumatica, Red blood cell sedimentation rate increased, Rheumatoid factor negative
Clinical narrative: Approx. 5 days after receiving ZOSTAVAX vaccine, I developed the abrupt onset of progressive pain and weakness involving my entire arms and legs bilaterally that ultimately became significantly incapacitating. I saw a rheumatologist approx. 7 wks. after the onset. He dxed. polymyalgia rheumatica, and started me on a long-term course of prednisone, which I am still taking, and will be for at least 6 mos.-1 yr. My sxs. completely abated within 48 hrs. of starting prednisone. Dr. did not believe my condition was caused by or related to the vaccine.
Age: 45.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: This case was reported by a pharmacist and described the occurrence of expired vaccine used in a 45-year-old male subject who was vaccinated with HAVRIX adult (GlaxoSmithKline). On an unspecified date, the subject received erroneously an expired vaccine dose of HAVRIX adult (unknown route and injection site).
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Atrial fibrillation, Blood pressure increased, Decreased appetite, Diarrhoea, Dizziness
Clinical narrative: Headache, chilly feeling, mild diarrhea, AF, severe dizziness, shortness of breath, loss of appetite, fast pulse, elevation of BP. Started on 1st day, better by 5th.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Feeling cold, Headache, Heart rate increased, Leukopenia
Clinical narrative: Headache, chilly feeling, mild diarrhea, AF, severe dizziness, shortness of breath, loss of appetite, fast pulse, elevation of BP. Started on 1st day, better by 5th.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Platelet count decreased
Clinical narrative: Headache, chilly feeling, mild diarrhea, AF, severe dizziness, shortness of breath, loss of appetite, fast pulse, elevation of BP. Started on 1st day, better by 5th.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Dizziness, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: Chills, severe headache, body aches. Upon waking next morning, feeling faint and sweaty. Ran temperature in evening of next day - up to 101.4 degrees. Tenderness at injection site. Note: injection given on empty stomach due to blood being drawn for routine analysis.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Pain
Clinical narrative: Chills, severe headache, body aches. Upon waking next morning, feeling faint and sweaty. Ran temperature in evening of next day - up to 101.4 degrees. Tenderness at injection site. Note: injection given on empty stomach due to blood being drawn for routine analysis.
Age: 12.0
Sex: M
Vaccine: HEPA
Symptoms: Injection site rash
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site rash in a 12-year-old male subject who was vaccinated with HAVRIX, (GlaxoSmithKline). The subject's medical history included contact dermatitis. On 14 January 2014 the subject received a dose of HAVRIX (unknown details, unknown arm). On the evening of 14 January 2014, within hours of vaccination with HAVRIX, the subject experienced injection site rash. The pharmacist reproted that the rash was from "his shoulder to his elbow and it looks like a mosquito bite rash." It was unknown if the vaccination series was discontinued at the time of reporting. At the time of reporting the event was improved. Per the pharmacist, the rash was "diminishing" and the rash was "now very light" at the time of reporting. The pharmacist considered the event was unrelated to vaccination with HAVRIX.
Age: 28.0
Sex: F
Vaccine: MMR, MNQ, VARCEL
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: Patient received varicella vaccine. Did not know she was pregnant. Also received MMR.
Age: 12.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Pyrexia
Clinical narrative: Pt received HPV immun and fever spiked to 104 degrees at night with no other symptoms.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. Medical history and current conditions were not reported. On 23-JAN-2015 the patient was vaccinated with a dose of VARIVAX (Merck) (dose number, lot number and expiration date were not reproted), 0.5 ml, subcutaneous, that underwent a temperature excursion. No adverse effect reported. Additional information has been requested. Thiss is one (1) of two (2) reports from the same source.
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Erythema, Tenderness
Clinical narrative: Local erythema with tenderness. No induration.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, VARCEL
Symptoms: Dizziness
Clinical narrative: Patient was administered vaccine at 4:12 pm patient felt dizzy. No treatment needed.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Immediate post-injection reaction, Injection site urticaria
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 2 year old patient of unknown gender. On an unknown date, the patient was vaccinated with the first dose of VARIVAX (Merck) (dose, route, anatomical location, lot # and expiration date were not reported). On an unknown date, the patient experienced hives at the injection site immediately while the reporting physician was still administering the patient's first dose of VARIVAX (Merck). The physician reported that the patient had similar reactions to PREVNAR 13 and DTaP vaccines as well on unspecified dates. The outcome of the event was unknown. The relatedness between the event and the vaccination with VARIVAX (Merck) was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to 25 unspecified patients of unknown demographics. On an unknown date the patient was vaccinated with VARIVAX (Merck) (dosing regimen unspecified). No concomitant medications reported. On an unknown date the medical assistant reported that 25 unspecified patients received a dose of VARIVAX (Merck) that was stored improperly. No adverse effects reported. The outcome of the medication error: unspecified patient received a dose of VARIVAX (Merck) that was used improperly and no adverse effects reported is unknown. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Red, warm, painful left upper arm.
Age: 17.0
Sex: F
Vaccine: MMR
Symptoms: Autism
Clinical narrative: This spontaneous report was received from a consumer who was the mother of a 17 year old female patient. No medical history and concomitant medications were reported. Approximately in 1998 (reported as around 12 months of age), the patient was vaccinated with M-M-R II (Strength, dose, route, lot # were not provided). Other suspect therapies included DTAP (brand, dose, manufacturer not specified). The reporter stated that she believed her daughter's diagnosis of "autism" not long after the administration of the M-M-R II and DTAP was the result of the "cocktail" of vaccinations given concomitantly. Patient sought medical attention through office visits. The patient's status was, she was diagnosed as "Autistic". No further symptoms were provided. No product quality complaint was involved. The outcome of "autism" was unknown. Causality assessment was not provided. 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 certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. It was reported that since 24-DEC-2014 the patients were administered GARDASIL intramuscularly (dose and lot no. unspecified) which underwent supported temperature excursions. No adverse events were reported. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site infection
Clinical narrative: Infection at injection site. Received IV antibiotics.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional (licensed practical nurse) refers to unspecified patients of unknown demographics. Since 08-OCT-2014 these patients were administered with improperly stored RECOMBIVAX HB. All these patients experienced incorrect product storage as all of them were administered with improperly stored RECOMBIVAX HB. No adverse effects were reported. No product quality complaint (PQC) was involved. Outcome of the event, incorrect product storage was unknown. Reporter considered the event, incorrect product storage to be not related to RECOMBIVAX HB. This is one of several reports received from the same source (MARRS # 1502USA002815 and MARRS #1502USA002021). Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Head discomfort, Pallor, Syncope
Clinical narrative: Pale, lightheaded, pt states "pressure in her head" and syncope after HPV #3. Dose 1 and 2 pt felt lightheaded and appeared pale, felt fine after 20 minutes.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a healthcare professional (nurse) via sales representative and described the occurrence of swelling injection site in a 12-month-old male subject who was vaccinated with HAVRIX pediatric (GlaxoSmithKline). Concurrent vaccination included MMR (non-gsk); non-GSK manufacturer;unknown left thigh given on 24 January 2014; varicella virus vaccine; manufacturer unspecified;unknown;right thigh given on 24 January 2014. On 24 January 2014 the subject received 1st dose of HAVRIX pediatric (unknown details, right thigh). On 2 February 2014, 9 days after vaccination with HAVRIX pediatric, the subject experienced swelling injection site and injection site redness. Per the nurse, the subject experienced swelling at the injection site that was "non-tender and about 4 centimeters (40 millimeters) in diameter." The subject sought medical attention at the emergency room on 2 February 2014 and the physician's office on 3 and 4 February 2014. The nurse considered that "it was possible" that the events were "a reaction to the aluminum in the vaccine." At the time of reporting the outcome of the events were was unspecified. The healthcare professional considered the events were possibly related to vaccination with HAVRIX pediatric.