chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 24 September 2013 and on 20 March 2014 at GPV. A 03-year-old patient of unknown gender had received FLUZONE 0.25 ml instead of 0.5 ml. No adverse event was reported. The list of documents held by sender: none
Age: 1.1
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse infoinformation was received from a healthcare professional in on 25 Sep 2013. A 13 month old patient whose demographic details, medical history and concomitant medication were not reported received a 0.5 ml dose of FLUZONE on an unspecified date. (Batch number not reported). It was reported that on an unspecified date patient received incorrect does of vaccination. Laboratory investigation were not reported.  No adverse event was reported. List of documents held by sender: none
Age: 1.8
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: This case is linked with case number 2014SA041844., The case was received on 23 October 2013 at GPV. Initial misuse report received from a healthcare professional on 23 October 2013. This case is part of a cluster and it is linked to case 2014SA041844. A 20 months-old patient had received 0.5 ml dose of FLUZONE on an unspecified date. It was reported that the patient received 0.5 ml of FLUZONE instead of 0.25 ml resulting in an over dose. No adverse event was reported. Lost of documents held by sender: none
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Initial report received from healthcare professional on 21 March 2014. A 6-year-old male patient whose medical history and concomitant medication were not reported, had received intramuscular dose of FLUZONE (lot number UH900AD, expiration date was not reported) in to the deltoid right on 07 November 2013 and had cellulitis like area at injection site, injection site red, injection site itchy on 09 November 2013 and had cellulitis like area at injection site, injection site red, injection site itchy on 09 November 2013 and given ABT script. The event of cellulitis like area was reoccurred on 05 December 2013. It was also reported that on 13 January 2013, 06 February 2013, 26 February 2013, 13 March 2013. Mother reported injection site got red and itchy and resolved in 12-18 hours. The laboratory details and corrective treatment were not reported. The outcome of the event was not resolved at the time of report. List of documents held by sender: none  Follow-up information received from healthcare professional on 24 June 2014. The patient received fourth dose of FLUZONE and received previous 3 doses of influenza vaccine. The patient had no cellulitis like area at injection site. On 09 November 2013, the patient experienced golf ball size swelling and redness and injection site was itchy. The patient did not receive any other vaccinations within 4 weeks priors to vaccination and had no illness at the time of vaccination.  The patient has no known drug allergies; Ventricular Septal Defect (VSD) and patent foramen ovale were resolved on 30 September 2013. It was reported that, the patient did not experience any adverse event to prior vaccination.
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: Initial misuse report received from a healthcare professional on 13 March 2014. A patient under 3 years of age had received 0.5 ml dose of FLUZONE on an unspecified date. It was reported that the patient was given 0.5 ml of the vaccine. No adverse event ws reported. List of documents held by sender: none
Age: 5.0
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 04 March 2014. 5-year-old patient was given a dose of FLUZONE on 13 October 2013 and then again on 21 February 2014. (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Age: 1.1
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Overdose
Clinical narrative: Initial misuse report received from a healthcare professional on 14 March 2014. A 13-month-old patient had received 0.5 ml dose of FLUZONE on an unspecified date. It was reported that the patient was administered 0.5 ml of FLUZONE. No adverse event was reported. List of documents held by sender: none
Age: 2.9
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional (nurse) on 06 March 2014. A 35-months-old patient (2 years 11 months) had inadvertently administered a dose of 0.5 ml of FLUZONE instead of the 0.25 ml. No adverse event was reported. List of documents held by sender: none
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Initial report received from healthcare professional on 05 March 2014. A male patient (date of birth and age at the time of event were not reported), whose medical history was unknown and concomitant medication were not reported, had received intramuscular dose of FLUZONE , batch number: UH908AA (dose number was not reported) in left arm on 30 January 2014. It was reported that on an unspecified date, after receiving FLUZONE , the patient experienced pain at injection site while he was driving and has hands on the wheel. The corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was not recovered. Documents held by sender: none
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Initial report received from a healthcare professional on 27 February 2014. A 53-years-old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE (batch number UH897AC, dose number was unknown) intramuscularly in the left deltoid on 24 January 2014. On 26 January 2014, after three days of vaccination the patient could not lift the left arm with a shooting pain from injection site to fingers. The patient's illness at the time of vaccination was unknown and the patient does not have any pre-existing diagnosed allergies and birth defects. Corrective treatment and laboratory details were not reported. The patient was recovered on an unspecified date. Documents held by sender: none
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 25 September 2013. This case is invalid as no patient identifiers reported. Gave last year's FLUZONE. (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Age: 0.2
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 19 September 2013. A 02-month-old patient had received 0.25 ml dose of FLUZONE on an unspecified date. No adverse event was reported. List of documents held by sender: none
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: Initial misuse report received from a healthcare professional on 26 September 2013. The cases were received on 21 March 2014 at GPV. Child received 0.25 ml dose of FLUZONE instead of 0.5 ml. (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Age: 2.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 23 September 2013. A 02-year-old patient had received 0.5 ml of FLUZONE. It's an over dose. No adverse event was reported. List of documents held by sender: none
Age: 2.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 24 September 2013. A 02-year-old patient had received 0.5 ml FLUZONE. It's an over dose. No adverse event was reported. List of documents held by sender. none
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: The case was received on 21 March 2014 at GPV. Initial misuse report received from a healthcare professional on 16 September 2013. An adult patient had received 0.24 ml dose of FLUZONE on an unspecified date. No adverse event was reported. List of documents held by sender: none
Age: 2.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, Medication error, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 19 September 2013. The cases were received on 21 March 2014 at GPV. 2-year-10 month old patient received 0.5 ml dose of FLUZONE. (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 2.0
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 20 September 2013. The cases were received on 21 March 2014 at GPV. 2-year-old patient received 0.5 ml dose of FLUZONE. (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 26 SEPTEMBER 2013. A patient ad received 0.5 ml of FLUZONE, intradermal. It's an incorrect route of vaccine administration. No adverse event was reported. List of documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 16 September 2013. Some patients (no information was provided regarding the patients) had received a dose of FLUZONE on an unspecified date. It was reported that last week, the fridge went at 55F for 5 hrs and the patients received doses from O/E vials. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to an unspecified patient of unknown age and gender. The pharmacist reported that an unspecified patient was to start therapy with LOTEMAX for an unspecified reason one week following administration of ZOSTAVAX, subcutaneous. No additional information provided. Call ended prior to identification of adverse event. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Autonomic nervous system imbalance, Blood pressure decreased, Headache, Infectious mononucleosis, Monocyte count increased
Clinical narrative: Information has been received from a physician via a company representative refers to a 12 year old female patient with possibly depression. The patient was not pregnant. The patient received dose 1 of GARDASIL in approximately SEP-2012 (reported as sometime in the fall of 2012). It was unspecified when dose 2 was administered. Dose 3 was administered in MAY-2013. All the three doses were 0.5ml, intramuscular without lot# provided. Initially, the patient developed a prolonged case of mononucleosis which began in JAN-2013. She then developed presyncope and orthostatic hypotension. She had been seen at a medical centers and a clinic. The patient was treated with midodrine, hydration and salt tablets. She was not hospitalized. The patient also developed chronic headaches and had been prescribed TOPAMAX, NEURONTIN and LAMICTAL to treat the headaches. The patient was diagnosed with Postural Orthostatic Tachycardia Syndrome (POTS) and dysautonomia. The physician said there was no significant disability and presently the patient was able to play basketball. The physician also reported that the patient's mother searched on the internet and read that there were 6 cases of dysautonomia reported in the "Journal". Physician had no further information about these cases. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Orthostatic hypotension, Postural orthostatic tachycardia syndrome, Presyncope
Clinical narrative: Information has been received from a physician via a company representative refers to a 12 year old female patient with possibly depression. The patient was not pregnant. The patient received dose 1 of GARDASIL in approximately SEP-2012 (reported as sometime in the fall of 2012). It was unspecified when dose 2 was administered. Dose 3 was administered in MAY-2013. All the three doses were 0.5ml, intramuscular without lot# provided. Initially, the patient developed a prolonged case of mononucleosis which began in JAN-2013. She then developed presyncope and orthostatic hypotension. She had been seen at a medical centers and a clinic. The patient was treated with midodrine, hydration and salt tablets. She was not hospitalized. The patient also developed chronic headaches and had been prescribed TOPAMAX, NEURONTIN and LAMICTAL to treat the headaches. The patient was diagnosed with Postural Orthostatic Tachycardia Syndrome (POTS) and dysautonomia. The physician said there was no significant disability and presently the patient was able to play basketball. The physician also reported that the patient's mother searched on the internet and read that there were 6 cases of dysautonomia reported in the "Journal". Physician had no further information about these cases. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date the patients was vaccinated with LIQUID PEDVAXHIB (strength, dose, dose number, route and lot # not reported) which was improperly stored. The temperature excursion for LIQUID PEDVAXHIB was supported with in-house stability data. It was reported that there had been two episodes of temperature excursion, after the second excursion, doses of improperly stored vaccines were administered to patients. No adverse symptoms reported. This is one of the several reports received 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 has been received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date the patients was vaccinated with GARDASIL (strength, dose, dose number, route and lot # not reported) which was improperly stored. The temperature excursion for GARDASIL was supported with in-house stability data. It was reported that there had been two episodes of temperature excursion, after the second excursion, doses of improperly stored vaccines were administered to patients. No adverse symptoms reported. This is one of the several reports received 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 health care worker refers to unspecified number of patients of unknown age and unknown gender. The unspecified patients pertinent medical history was not reported. On an unknown date the, unspecified number of patients were vaccinated with GARDASIL (dose, frequency and lot # were not reported) which were improperly stored. No adverse events were reported. No product quality complaint was reported GARDASIL. This case is linked to case # 1501USA007447 (same reporter link). Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: 48 hours after getting vaccine, patient noticed swelling, redness at site. (Vaccine given 1-6-15. Symptoms/adv. effects resolved by 1-10-15).
Age: 64.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 48 hours after getting vaccine, patient noticed swelling, redness at site. (Vaccine given 1-6-15. Symptoms/adv. effects resolved by 1-10-15).
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed nurse practitioner refers to multiple unspecified patients of unknown age and gender. On 01-OCT-2014 the patients were vaccinated with GARDASIL (dosing details unknown). The reporter stated that she had a supported temperature excursion that affected GARDASIL. Reporter stated that she presumed she had administered to multiple unspecified patients since the first excursion date, on 01-OCT-2014, but had no patient or product specific information to offer. No adverse effects were noted. Outcome of the temperature excursion of GARDASIL was unknown. No product quality complaint was involved. Telephone call follow up was received on 08-DEC-2014, the physician was not available at the time of the call. A voice message was left requesting a returned phone call. Follow up information has been received from the Nurse Practitioner on 22-DEC-2014. Lot number of GARDASIL was reported as: J014875 (invalid lot number). Vaccination date was reported as: 07-NOV-2014 (previously reported as 01-OCT-2014). Also the reporting Nurse stated that the vaccines removed from the office would be returned to the vaccine program as directed. This is one of the several cases received from the same reporter. Additional information is not expected because all follow up information required to complete the case was already received.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse concerning unspecified number of patients age and gender not provided. The nurse reported that since 25-SEP-2014 improperly stored ROTATEQ were administered to unspecified patients. No adverse effects were noted. This is one of several reports received from the same source. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Warm to touch, swelling, area of redness that extends around shoulder to armpit and 3/4 of the way down posterior upper left arm.
Age: 52.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a healthcare worker referring to a 52 years old female patient. On 13-JAN-2015, the patient was supposed to receive ZOSTAVAX, but was inadvertently administered VARIVAX (Merck), injection, 0.5 ml, (strength, route, lot number and expiry date were not reported). No adverse effects reported. No dose of ZOSTAVAX administered. Additional information is not expected since follow-up was not permitted by the reporter.
Sex: U
Vaccine: HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a 16-month-old patient of unknown gender. Information about concurrent conditions and medical history was not provided. On 23-DEC-2014 the patient was supposed to receive an unspecified flu vaccine, which was placed on a counter next to GARDASIL (strength, dose and lot# not provided). The physician inadvertently picked up and administered a dose of GARDASIL intramuscularly to the 16-month-old patient instead of the intended flu vaccine. When physician realized the error, she additionally administered the intended flu vaccine. No adverse effect reported. Additional information has been requested.
Age: 1.25
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 15 month old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. The nurse reported that, on 15-DEC-2014, the patient was vaccinated with VARIVAX (Merck) inj that was improperly stored (0.5 ml once, subcutaneously; lot number not provided). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from certified medical assistant concerning unspecified patients of unknown age and gender. On 16-JAN-2015 the patients were vaccinated with improperly stored RECOMBIVAX HB (lot number, dose and frequency were unknown). No adverse events was reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date the patients was vaccinated with M-M-R II (strength, dose, dose number, route and lot # not reported) which was improperly stored. The temperature excursion for M-M-R II was not supported with in-house stability data. It was reported that there has been two episodes of temperature excursion, after the second excursion , doses of improperly stored vaccines were administered to patients. No adverse symptoms reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to unspecified number of patients of unknown age and unknown gender. The unspecified patients pertinent medical history was not reported. On an unknown date, the unspecified number of patients were vaccinated with PNEUMOVAX 23 (dose, frequency and lot # were not reported) which was improperly stored. No adverse events were reported. No product quality complaint was reported for PNEUMOVAX 23. This case is linked to case # 1501USA006479 (same reporter link). Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Back pain, Blood urine present, Chest discomfort, Confusional state, Cough
Clinical narrative: This spontaneous report was received from a 63 year old female patient reporting on herself. She reported that when she was 16-years-old she had a birthmark removed. The physician who removed the birthmark applied a topical product (name, manufacturer, dose and frequency unspecified) to help heal the wound. The consumer reported the site where the birthmark was removed started to "ooze a pus-like substance". The unspecified physician explained to the consumer that thimerosal was in the unspecified topical product and that the physician determined the consumer had an allergy to thimerosal. The patient's medical history included long history of bronchitis and ear infections. On 02-JAN-2015 the patient was vaccinated with PNEUMOVAX 23 lot # K009874 in the left arm (dose, route of administration and lot # were not reported). Concomitant therapies included lisinopril (manufacturer unknown) and influenza virus vaccine (unspecified). The patient reported injection site reactions and other symptoms beginning two hours after she received PNEUMOVAX 23 on 02-JAN-2015. The consumer reported she experienced chest pressure, coughing that lasted for four hours, lower back pain, blood in her urine, the arm which was injected inflamed which made it sore and "unusable for twenty-four hours", and also she experienced tingling in her left hand. The consumer also reported she woke up in the middle of the night with fever. The consumer also reported she experienced a little bruise/lump at the injection site which was about four inches in length and three inches in width. The consumer reported the little bruise/lump lasted for about a week and a half. She also experienced extreme indigestion and confusion as she had not been able to eat anything that Friday 09-JAN-2015 and Saturday 10-JAN-2015. The consumer also reported that since Sunday 11-JAN-2015, she has noticed a "frequent pressure to urinate". The patient reported she tries to drink water and immediately begins to belch. She also reported almost passed out while at work on an unspecified date in January 2015. Patient visited physician's assistant on 14-JAN-2015 and was diagnosed with a kidney stone. She received therapy for the adverse event which included: acetaminophen with codeine and tamsulosin. It was also reported that the patient had urine specimen processed which results were not reported. The outcome of the events was unknown. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Dyspepsia, Eructation, Hypophagia, Inflammation, Injection site bruising
Clinical narrative: This spontaneous report was received from a 63 year old female patient reporting on herself. She reported that when she was 16-years-old she had a birthmark removed. The physician who removed the birthmark applied a topical product (name, manufacturer, dose and frequency unspecified) to help heal the wound. The consumer reported the site where the birthmark was removed started to "ooze a pus-like substance". The unspecified physician explained to the consumer that thimerosal was in the unspecified topical product and that the physician determined the consumer had an allergy to thimerosal. The patient's medical history included long history of bronchitis and ear infections. On 02-JAN-2015 the patient was vaccinated with PNEUMOVAX 23 lot # K009874 in the left arm (dose, route of administration and lot # were not reported). Concomitant therapies included lisinopril (manufacturer unknown) and influenza virus vaccine (unspecified). The patient reported injection site reactions and other symptoms beginning two hours after she received PNEUMOVAX 23 on 02-JAN-2015. The consumer reported she experienced chest pressure, coughing that lasted for four hours, lower back pain, blood in her urine, the arm which was injected inflamed which made it sore and "unusable for twenty-four hours", and also she experienced tingling in her left hand. The consumer also reported she woke up in the middle of the night with fever. The consumer also reported she experienced a little bruise/lump at the injection site which was about four inches in length and three inches in width. The consumer reported the little bruise/lump lasted for about a week and a half. She also experienced extreme indigestion and confusion as she had not been able to eat anything that Friday 09-JAN-2015 and Saturday 10-JAN-2015. The consumer also reported that since Sunday 11-JAN-2015, she has noticed a "frequent pressure to urinate". The patient reported she tries to drink water and immediately begins to belch. She also reported almost passed out while at work on an unspecified date in January 2015. Patient visited physician's assistant on 14-JAN-2015 and was diagnosed with a kidney stone. She received therapy for the adverse event which included: acetaminophen with codeine and tamsulosin. It was also reported that the patient had urine specimen processed which results were not reported. The outcome of the events was unknown. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site mass, Loss of consciousness, Middle insomnia, Musculoskeletal disorder, Nephrolithiasis
Clinical narrative: This spontaneous report was received from a 63 year old female patient reporting on herself. She reported that when she was 16-years-old she had a birthmark removed. The physician who removed the birthmark applied a topical product (name, manufacturer, dose and frequency unspecified) to help heal the wound. The consumer reported the site where the birthmark was removed started to "ooze a pus-like substance". The unspecified physician explained to the consumer that thimerosal was in the unspecified topical product and that the physician determined the consumer had an allergy to thimerosal. The patient's medical history included long history of bronchitis and ear infections. On 02-JAN-2015 the patient was vaccinated with PNEUMOVAX 23 lot # K009874 in the left arm (dose, route of administration and lot # were not reported). Concomitant therapies included lisinopril (manufacturer unknown) and influenza virus vaccine (unspecified). The patient reported injection site reactions and other symptoms beginning two hours after she received PNEUMOVAX 23 on 02-JAN-2015. The consumer reported she experienced chest pressure, coughing that lasted for four hours, lower back pain, blood in her urine, the arm which was injected inflamed which made it sore and "unusable for twenty-four hours", and also she experienced tingling in her left hand. The consumer also reported she woke up in the middle of the night with fever. The consumer also reported she experienced a little bruise/lump at the injection site which was about four inches in length and three inches in width. The consumer reported the little bruise/lump lasted for about a week and a half. She also experienced extreme indigestion and confusion as she had not been able to eat anything that Friday 09-JAN-2015 and Saturday 10-JAN-2015. The consumer also reported that since Sunday 11-JAN-2015, she has noticed a "frequent pressure to urinate". The patient reported she tries to drink water and immediately begins to belch. She also reported almost passed out while at work on an unspecified date in January 2015. Patient visited physician's assistant on 14-JAN-2015 and was diagnosed with a kidney stone. She received therapy for the adverse event which included: acetaminophen with codeine and tamsulosin. It was also reported that the patient had urine specimen processed which results were not reported. The outcome of the events was unknown. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pain in extremity, Paraesthesia, Pollakiuria, Pyrexia, Urine analysis
Clinical narrative: This spontaneous report was received from a 63 year old female patient reporting on herself. She reported that when she was 16-years-old she had a birthmark removed. The physician who removed the birthmark applied a topical product (name, manufacturer, dose and frequency unspecified) to help heal the wound. The consumer reported the site where the birthmark was removed started to "ooze a pus-like substance". The unspecified physician explained to the consumer that thimerosal was in the unspecified topical product and that the physician determined the consumer had an allergy to thimerosal. The patient's medical history included long history of bronchitis and ear infections. On 02-JAN-2015 the patient was vaccinated with PNEUMOVAX 23 lot # K009874 in the left arm (dose, route of administration and lot # were not reported). Concomitant therapies included lisinopril (manufacturer unknown) and influenza virus vaccine (unspecified). The patient reported injection site reactions and other symptoms beginning two hours after she received PNEUMOVAX 23 on 02-JAN-2015. The consumer reported she experienced chest pressure, coughing that lasted for four hours, lower back pain, blood in her urine, the arm which was injected inflamed which made it sore and "unusable for twenty-four hours", and also she experienced tingling in her left hand. The consumer also reported she woke up in the middle of the night with fever. The consumer also reported she experienced a little bruise/lump at the injection site which was about four inches in length and three inches in width. The consumer reported the little bruise/lump lasted for about a week and a half. She also experienced extreme indigestion and confusion as she had not been able to eat anything that Friday 09-JAN-2015 and Saturday 10-JAN-2015. The consumer also reported that since Sunday 11-JAN-2015, she has noticed a "frequent pressure to urinate". The patient reported she tries to drink water and immediately begins to belch. She also reported almost passed out while at work on an unspecified date in January 2015. Patient visited physician's assistant on 14-JAN-2015 and was diagnosed with a kidney stone. She received therapy for the adverse event which included: acetaminophen with codeine and tamsulosin. It was also reported that the patient had urine specimen processed which results were not reported. The outcome of the events was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a register nurse refers to a 17 year old female patient. Medical history and concurrent conditions were not provided. In approximately December 2014, the pregnant patient was accidentally vaccinated with a dose of GARDASIL lot number K006095, expiry date 02-FEB-2017 (dose and route were not provided). There was no concomitant medication reported. On an unknown date, the patient became pregnant. The Last Menstrual Period (LMP) and Estimated Date of Delivery (EDD) was not known. The pregnancy outcome was outcome pending. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a female patient of unknown age. On an unknown date in October 2014 the patient was vaccinated with a dose of ZOSTAVAX in the left arm (dose, route and lot number were not reported). One week after the administration, the patient stated to the pharmacist that she had pain and discomfort in her right arm (onset date was not provided, estimated in 2014). The patient sought medical attention by contacting the pharmacist. The outcome of discomfort and pain in her right arm was unknown. Relatedness between the therapy and the events 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 licensed vocational nurse refers to a 66 patients of unknown age and gender. Medical history and concurrent conditions were not provided. On unspecified dates between August 2014 and October 2014, 66 patients were vaccinated with improperly stored dose of GARDASIL (dose, route, lot number and expiry date were not reported). GARDASIL was found to be unsupported excursions with in-house stability data. No adverse symptoms reported. There was no concomitant medication. The outcome of the event was unknown. This is one of several reports received from the same reporter. Follow up information was received on 07-JAN-2015 from the nurse. Nurse reported that GARDASIL was administered during temperature excursion and was out of range from 01-AUG-2014 to 18-SEP-2014. There was no product quality complaint. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Breast swelling, Breast tenderness, Erythema, Injection site erythema, Injection site pain
Clinical narrative: This spontaneous report as received from a nurse refers to a 70 year old female patient. The patient's pertinent medical history was reported as none. On 03-NOV-2014, the patient was vaccinated with PNEUMOVAX 23 (dose and route of administration were not reported, lot # K007825, exp. date: 13-JAN-2016). Concomitant therapies included PERCOCET. On an unspecified date, approximately in November 2014, the patient developed extreme tenderness, redness, and swelling after administration of PNEUMOVAX 23 which spanned from the injection site down to the patient's forearm and covered one of her breasts. The patient sought medical attention, she came back to physician office on 05-NOV-2014 because of the reactions and received ROCEPHIN injection (unspecified dose) for treatment. No laboratory tests were performed. The patient recovered from all the events on an unspecified date. The relatedness between vaccination with PNEUMOVAX 23 and the events was not reported. This case is linked to 1501USA005053 as these two cases were received from the same source. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Peripheral swelling, Tenderness
Clinical narrative: This spontaneous report as received from a nurse refers to a 70 year old female patient. The patient's pertinent medical history was reported as none. On 03-NOV-2014, the patient was vaccinated with PNEUMOVAX 23 (dose and route of administration were not reported, lot # K007825, exp. date: 13-JAN-2016). Concomitant therapies included PERCOCET. On an unspecified date, approximately in November 2014, the patient developed extreme tenderness, redness, and swelling after administration of PNEUMOVAX 23 which spanned from the injection site down to the patient's forearm and covered one of her breasts. The patient sought medical attention, she came back to physician office on 05-NOV-2014 because of the reactions and received ROCEPHIN injection (unspecified dose) for treatment. No laboratory tests were performed. The patient recovered from all the events on an unspecified date. The relatedness between vaccination with PNEUMOVAX 23 and the events was not reported. This case is linked to 1501USA005053 as these two cases were received from the same source. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient. On 12-DEC-2014 the patient was vaccinated with ZOSTAVAX lot # K015312, subcutaneous. On 14-DEC-2014, 3 days after onset of therapy the patient experienced swelling at the injection site, fever, warmth at injection site, pain at injection site and redness at injection site. The outcome of swelling at the injection site, warmth at injection site, pain at injection site and redness at injection site was reported as not recovered/not resolved. The outcome of fever was reported as recovered/resolved. The patient previously has taken lisinopril with hydrochlorothiazide and citalopram but it was unknown whether she was still taking these. Additional information has been requested.
Age: 76.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: This spontaneous report as received from a nurse refers to a 76 year old male patient. The patient's drug allergies included allergy to morphine (patient experienced nausea and headache following administration of morphine on an unspecified date). The patient's pertinent medical history was reported as none. On 03-NOV-2014, the patient was vaccinated with PNEUMOVAX 23 (dose and route of administration were not reported, lot # K007825, exp. date: 13-JAN-2016). Concomitant therapies included PERCOCET. On an unspecified date, approximately in November 2014, the patient developed extreme tenderness, redness, and swelling after administration of PNEUMOVAX 23 which spanned from the patient's shoulder down to his elbow. The patient sought medical attention, he came back to physician's office on 05-NOV-2014 because of the reactions and received a ROCEPHIN injection (unspecified dose) for treatment. No laboratory tests were performed. The patient recovered from all the events on an unspecified date. The relatedness between vaccination with PNEUMOVAX 23 and the events was not reported. This case is linked to 1501USA005232 as these two cases were received from the same source. Additional information has been requested.
Age: 7.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a register nurse refers to a female patient of unknown age. Medical history and concurrent conditions were not provided. In 2007 also reported as approximately "7 years", the patient was vaccinated with the first dose of GARDASIL intramuscular (dose, lot number and expiry date were not reported), then voluntarily decided not to continue the series. Patient later decided to resume the series and received her second dose of GARDASIL on 05-JAN-2015 intramuscular (dose, lot number and expiry date were not reported). No adverse effect reported. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 73 year old female patient with asthma, fibromyalgia, hypertension, osteoporosis, neurogenic claudication, osteoarthritis, sulfa allergy and doxycycline allergy. The nurse reported the patient received an initial dose of PNEUMOVAX 23, (Lot # K004148, Exp date 10-MAY-2015) intramuscular on 26-DEC-2007, then was revaccinated "due to a history of asthma" on 11-SEP-2014. Concomitant therapies included metoprolol, DYAZIDE, tramadol hydrochloride, ipratropium bromide and triamcinolone. On 11-SEP-2014, the patient experienced injection site pain, redness and swelling immediately following this injection. The patient sought medical attention by office visit and was treated with BENADRYL and TYLENOL. The patient recovered on "about 12-DEC-2014." No additional information provided. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Patient has had pain and bruising at the site since vaccination.
Age: 5.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Allergy test, Anaphylactic reaction, Cough, Rash, Skin discomfort
Clinical narrative: On the way home from our office child began with a rash cough rubbing skin (child is non-verbal) parent brought child to ER. Dx anaphylaxis. Child also had allergy scratch test in am.
Age: 5.0
Sex: M
Vaccine: MMRV, MMRV
Symptoms: Anaphylactic reaction
Clinical narrative: On the way home from our office child began with a rash cough rubbing skin (child is non-verbal) parent brought child to ER. Dx anaphylaxis. Child also had allergy scratch test in am.
Age: 69.0
Sex: M
Vaccine: TDAP
Symptoms: Chest pain, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: On 12/26/14 Patient stated has had pain in arm since shot was given. On movement has pain on upper left side of chest, upper left side of back and shoulder. Plans to see MD.
Age: 43.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Rash, hives, fever 100.3 tx OTC medications.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, Extra dose administered, Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a physician refers to a 20 year old female patient with no pertinent medical history or drug reactions/allergies. On 23-JAN-1994, 21-FEB-1994, and 27-JUL-1994, the patient was respectively vaccinated with the first, the second and the third dose of RECOMBIVAX HB, (dose, route, lot # and expiration date not reported). There was no concomitant medication. On 21-JUL-2014, the result of "hepatitis B titer" was "less than 5 (units not provided)". As a treatment for the "low titer", on that same date, the patient may had been administered an expired dose (fourth dose) of RECOMBIVAX HB, (possibly from lot # 1572AA and expiration date 26-MAY-2014). At the time of the report, the outcome of the events was unknown. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients. On an unknown date the patients received doses of improperly stored VARIVAX (Merck) (strength, dose, route and lot# not provided). Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Cold sweat, Dizziness, Nausea, Paraesthesia, Paraesthesia oral
Clinical narrative: This spontaneous report as received from a licensed vocational nurse (LVN) refers to a 30-years-old non-pregnant female patient who was a new employee (healthcare worker) of reporter's facility. The nurse reported that the patient had no pertinent medical history and no drug reactions or allergies. On unspecified dates, the patient was vaccinated with doses of M-M-R II (number of doses, frequency, route of administration, indication and lot numbers were not provided). On an unknown date, patient's mumps titers were measured and assessed as "low". On 13-JAN-2015, the patient was vaccinated with pre-employment booster of M-M-R II (dose: 0.5 ml, frequency was not reported, subcutaneously in the left arm, lot # K004948, expiration date: 04-APR-2016) due to having "low mumps titers". No concomitant medication was reported. On 13-JAN-2015, almost immediately after administration of M-M-R II, the patient began to feel symptoms of lightheadedness and nausea. She also reported tingling in the fingers of her left hand, as well as tingling in her lips. The patient's skin became clammy, and the nurse recorded her heart rate to be 120 beats per minute (reference ranges were not provided). Her blood pressure at that time was also 108/54 (units and reference ranges were not provided). The patient rested, and when her heart rate was reassessed after an unspecified period of time, also reported as "a few minutes", her heart rate was recorded to be 86 beats per minute. At the time of that report, the patient was still in the nurse's care under observation. Though the patient reported "feeling better", the nurse was considering asking her to go to the emergency room for further evaluation. The patient was sitting upright and speaking during this report. No product quality complaint (PQC) was involved. The outcome of the events was reported as recovering. The relatedness between the events and M-M-R II was not assessed by the reporter. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: MMR
Symptoms: Viral titre decreased
Clinical narrative: This spontaneous report as received from a licensed vocational nurse (LVN) refers to a 30-years-old non-pregnant female patient who was a new employee (healthcare worker) of reporter's facility. The nurse reported that the patient had no pertinent medical history and no drug reactions or allergies. On unspecified dates, the patient was vaccinated with doses of M-M-R II (number of doses, frequency, route of administration, indication and lot numbers were not provided). On an unknown date, patient's mumps titers were measured and assessed as "low". On 13-JAN-2015, the patient was vaccinated with pre-employment booster of M-M-R II (dose: 0.5 ml, frequency was not reported, subcutaneously in the left arm, lot # K004948, expiration date: 04-APR-2016) due to having "low mumps titers". No concomitant medication was reported. On 13-JAN-2015, almost immediately after administration of M-M-R II, the patient began to feel symptoms of lightheadedness and nausea. She also reported tingling in the fingers of her left hand, as well as tingling in her lips. The patient's skin became clammy, and the nurse recorded her heart rate to be 120 beats per minute (reference ranges were not provided). Her blood pressure at that time was also 108/54 (units and reference ranges were not provided). The patient rested, and when her heart rate was reassessed after an unspecified period of time, also reported as "a few minutes", her heart rate was recorded to be 86 beats per minute. At the time of that report, the patient was still in the nurse's care under observation. Though the patient reported "feeling better", the nurse was considering asking her to go to the emergency room for further evaluation. The patient was sitting upright and speaking during this report. No product quality complaint (PQC) was involved. The outcome of the events was reported as recovering. The relatedness between the events and M-M-R II was not assessed by the reporter. Additional information has been requested.