chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a physician via a office manager and refers to a 69 years old male patient. Patient's medical history included: shoulder pain and allergy to LEVAQUIN. On 06-MAY-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # K004207, expiry date: 13-MAY-2015) intramuscularly. Concomitant therapies included acetaminophen, NORCO (indication unknown). On 08-MAY-2014 the patient seeked the medical attention, he came to the office and presented with soreness, redness, pain with extension to the armpit from the injection site. The physician diagnosed this finding as cellulitis, although it looked like "early shingles". Physician treated patient with a seven day regimen of KEFLEX. No laboratory test was performed. The outcome of the event was unknown. The relationship between the PNEUMOVAX 23 and the event was not provided. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown demographics. The patient's current conditions or medical history were not reported. On 19-MAY-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX and (Oka/Merck) PROQUAD both vaccines were given as 0.5 ml subcutaneous injection (lot numbers and expiration dates were not provided). No adverse effects reported. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a 63 years old male patient of unknown age with no medical history or drug reactions. On 20-APR-2014, the patient was vaccinated with a dose of ZOSTAVAX injection (lot # J011550, expiry date: 19-DEC-2014, dose, route unspecified) in the left arm. No concomitant therapy was reported. The pharmacy student stated that a patient experienced redness, swelling, pain and itching of his left arm in the area of the injection site after receiving ZOSTAVAX (on an unknown date in 2014). The area affected was the entire back portion of his left upper arm. It was reported, that the patient said that he felt like he had "shingles on his arm". The patient used TYLENOL and cold compresses to treat his symptoms. No diagnostic test were provided. The outcome of events was reported as recovered (on an unknown date in 2014). The relatedness between events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX Injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling and pain at LVL. PCP discussed with parent.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Decreased appetite, Ear pain, Insomnia, Irritability
Clinical narrative: Ear pain, pulling on ear, not sleeping well at night, not taking bottles well, irritability: since day vaccines given.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: VZV Ophthalmicus. Valacyclovir 1gm TID PO.
Age: 10.0
Sex: M
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Pt administered HPV injection into right arm. MAII left room and mom immediately ran out of room stating that patient was having a seizure. Pt immediately responsive when staff arrived at bedside.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Neuralgia, Pain
Clinical narrative: Approximately 6 days after immunization nerve pain, sore trunk, organs. Pain in joints. Patient reported on 5/27/14.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a current 22 year old female patient. The patient's current conditions or medical history were not reported. On an unspecified date in 2009, the patient received the first dose, on an unspecified date in 2012, received the second dose and on 31-MAR-2014 the third dose of GARDASIL injection (dose, route, lot number and expiration date not reported). No adverse effects had been observed or reported. The patient received the third dose of GARDASIL under the supervision of the physician, but the first two doses were administered at another healthcare professional's facility. The specific dates of the first two doses of GARDASIL were not available at the time of the report. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with one dose of VARIVAX (Merck) (dose, strength, lot number and expiration date were not reported) subcutaneous route. Co-suspect and concomitant therapies were not reported. The healthcare worker reports that an improperly stored VARIVAX (Merck), were administered on 05-MAY-2014. The reporter stated that the VARIVAX (Merck) was exposed to a temperature of 6.4F for 2 hours on 05-MAY-2014. No adverse effect reported. Additional information has been requested. This case is one (1) of ten (10) reports from the same reporter. (MARRS 1405USA011237, 1405USA013601, 1405USA013602, 1405USA013603, 1405USA013604, 1405USA013605, 1405USA013606, 1405USA013607, 1405USA013608 and 1405USA013609).
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from an office manager refers to a patient of unknown age and gender. Medical history was not reported. The patient was vaccinated with the first, second and third dose of GARDASIL route intramuscular, (dosage, lot numbers and expiration dates were not reported), on 24-JUN-2008, 15-DEC-2008 and 28-JAN-2009 respectively. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Nurse stated clients many had been vaccinated with improperly stored ROTATEQ (lot number not reported). No adverse effects reported. This is one of two reports from the same reporter source. Additional information is not expected.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Blood sodium decreased, Demyelination, Full blood count, Malaise
Clinical narrative: Pt had no reaction for 2 weeks. She then noticed demyeling without erythema or pain at site of injection. It has not progressed. She had generalized nausea, malaise and joint pain non specific. Screening labs at PCP - CBC and CMP - showed low sodium. Repeat lab is pending.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Metabolic function test, Nausea
Clinical narrative: Pt had no reaction for 2 weeks. She then noticed demyeling without erythema or pain at site of injection. It has not progressed. She had generalized nausea, malaise and joint pain non specific. Screening labs at PCP - CBC and CMP - showed low sodium. Repeat lab is pending.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified numbers of patients of unknown age and gender. Nurse stated clients may have been vaccinated with improperly stored GARDASIL, (lot number not reported). No adverse effects reported. This is one of two reports from the same reporter source. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Fall, Head injury, Syncope
Clinical narrative: Patient was really nervous prior to the vaccine being given. After vaccine given. Pt walked out to waiting room and fainted fell and hit her head on car seat. We advised pt to lay down, ice on head and gave some water and crackers.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site reaction, Wound
Clinical narrative: From a needle puncture a wound has grown to the size of a silver dollar. It is round in shape with what appears to be a rash around the edge. No scab forms to heal the wound. Two and 1/2 months since the initial shot.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Chills, Cough, Diarrhoea, Dyspnoea
Clinical narrative: Fever and chills following PNEUMOVAX. Redness and swelling around injection site and temperature as high as 103 with some occasional cough and shortness of breath. He felt weak when he got up and episode of sweating and blurred vision followed by diarrhea. Explained need for epinephrine if symptoms worsen advised go to Emergency Room, advised loratadine 10 mg BIG with PM hydroxyzine if needed. Continue ibuprofen.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Hyperhidrosis, Injection site erythema, Injection site swelling, Pyrexia, Vision blurred
Clinical narrative: Fever and chills following PNEUMOVAX. Redness and swelling around injection site and temperature as high as 103 with some occasional cough and shortness of breath. He felt weak when he got up and episode of sweating and blurred vision followed by diarrhea. Explained need for epinephrine if symptoms worsen advised go to Emergency Room, advised loratadine 10 mg BIG with PM hydroxyzine if needed. Continue ibuprofen.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Hypotension, Syncope
Clinical narrative: Patient has episode of vasovagal syncope approx 2 minutes after administration of HPV #1 in office. No fall or injury. Out for approx 10 seconds. Vitals stable with noted low BP.
Age: 11.0
Sex: M
Vaccine: MMR, TDAP, VARCEL
Symptoms: Feeling hot, Pruritus, Rash generalised, Swollen tongue, Vomiting
Clinical narrative: Reaction began about 2 minutes with receiving 3 vaccines. Began with itching and feeling warm. Given 25mg liquid BENADRYL and then vomited immediately. C/o tongue feeling swollen and itchy. Developed full body rash and was given EPIPEN Jr injection. Began to feel better within 10 minutes. Lungs were clear and never developed SOB. Given additional 25mg BENADRYL and started on prednisone next AM.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Localised oedema, Pain, Skin warm, Tenderness
Clinical narrative: Localized edema and erythema, approx. 3 inch diameter: reported as warm and tender to touch. Symptoms appeared the morning after the vaccine was given. Pt took BENADRYL which relieved redness and edema w/i 24 hrs. Soreness and tenderness went away 48 hrs after w/o taking pain reliever.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and redness at injection site. (4" x 4") approximate. Hot to touch.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Hypotonia, Laboratory test normal, Vomiting
Clinical narrative: Seen in ER. Child was found limp and vomiting 1 1/2 hr after dinner. Remained limp in ER for 4hrs in ER but alert at time of discharge. Referred to Neurology per dr.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Urticaria
Clinical narrative: Pt has hives on bilateral arms, neck and shoulders.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Patient developed hives/rash under skin on upper extremities and face about 2 days after vaccine hives resolved after 7 days. Pt reports being fine.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Contusion, Rash, Rash erythematous, Rash pruritic
Clinical narrative: The patient presented with a red rash on both legs and abdomen that was extremely itchy. The rash then changed to bruising with no itching. We recommended BENADRYL for itching.
Age: 55.0
Sex: F
Vaccine: HEPA
Symptoms: Nausea, Pyrexia
Clinical narrative: Nausea, low grade fever 24 hrs after vaccine. Vaccine given 5/22/14.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 07-MAY-2014, the patient was vaccinated with one dose of RECOMBIVAX HB (dose, strength, lot number and expiration date were not reported) intramuscular route. Co-suspect and concomitant therapies were not reported. The healthcare worker reports that an improperly stored RECOMBIVAX HB was administered. The reporter stated that the RECOMBIVAX HB was exposed to a temperature of 34F for 30 minutes on 05-MAY-2014. No adverse effect reported. Additional information has been requested. These case is one (1) of ten (10) reports from the same reporter. (MARRS 1405USA011237, 1405USA013601, 1405USA013602, 1405USA013603, 1405USA013604, 1405USA013605, 1405USA013606, 1405USA013607, 1405USA013608 and 1405USA013609).
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 05-MAY-2014, the patient was vaccinated with one dose of RECOMBIVAX HB (dose, strength, lot number and expiration date were not reported) intramuscular route. Co-suspect and concomitant therapies were not reported. The healthcare worker reports that an improperly stored RECOMBIVAX HB was administered on 05-MAY-2014. The healthcare worker reports that the RECOMBIVAX HB was exposed to a temperature of 34F for 30 minutes on 05-MAY-2014. No adverse effect reported. Additional information has been requested. There case is one (1) of ten (10) reports from the same reporter. (MARRS 1405USA011237, 1405USA013601, 1405USA013602, 1405USA013603, 1405USA013604, 1405USA013605, 1405USA013606, 1405USA013607, 1405USA013608 and 1405USA013609).
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy technician refers to five unspecified patients of unknown age and gender. The reporter stated that on an unspecified date in May 2014, the five patients were vaccinated with an improperly stored RECOMBIVAX HB (dose 1, intramuscular, strength, anatomical location, lot # and expiration date not reported). The pharmacy technician informed that the RECOMBIVAX HB was exposed to a temperature of 55F for 1 hour on 13-MAY-2014. No adverse effects were reported. No further relevant medical information was provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to 56 patients of unknown age and gender. The company representative reported that these 56 patients who were assumed to received the M-M-R II (lot#, dose, route not reported) had mumps. Outcome of the event was unknown. This is one of several reports from the same reporter. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HEP, HIBV, OPV, TDAP
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a nurse refers to a 23 year old female patient (nurse daughter) with no drug allergies. The patient's pertinent medical history was none. Approximately in 1993 (reported as 21 years ago) the patient was vaccinated with PEDVAXHIB, RECOMBIVAX HB, poliovirus vaccine live oral (manufacturer unknown, reported as unspecified) and Tdap (manufacturer unknown, reported as unspecified). On an unknown date, the patient developed pain in both of her legs a couple of hours after receiving these vaccinations. Lab diagnostic studies performed were none. The nurse reported that she received TYLENOL after receiving vaccinations. The outcome of pain in both of her legs was reported as recovered by the next day. The causality was not reported. The patient did not sought medical attention. The nurse also reported that her grand-daughter was administered TYLENOL prior to and after receiving the unspecified Hib vaccine on an unspecified date and did not had any issues of pain or fever. This case is linked to 1405USA103470 and 1405USA013469 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 15-MAY-2014, the patient was vaccinated with one dose of RECOMBIVAX HB (dose, strength, lot number and expiration date were not reported) intramuscular route. Co-suspect and concomitant therapies were not reported. The healthcare worker reports that an improperly stored RECOMBIVAX HB was administered on 15-MAY-2014. The reporter stated that RECOMBIVAX HB was exposed to a temperature of 34F for 30 minutes on 05-MAY-2014. No adverse effect reported. Additional information has been requested. These cases is one (1) of ten (10) reports from the same reporter. (MARRS 1405USA011237, 1405USA0136601, 1405USA013602, 1405USA013603, 1405USA013604, 1405USA013605, 1405USA013606, 1405USA013607, 1405USA013508 and 1405USA013609).
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient under 50 years of age, of unknown gender. Medical history and concurrent conditions were not reported. On 21-MAY-2014, the patient was vaccinated with ZOSTAVAX 0.65 ml, subcutaneous, expiration date reported as 08-MAY-2014 (lot number was not reported). Secondary and concomitant therapies were not reported. The physician reported that he administered ZOSTAVAX to a patient and the patient was under 50 years old age. The ZOSTAVAX was administered on 21-MAY-2014 but it expired on 08-MAY-2014. No adverse effects reported. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 51 year old female patient with no known allergies listed. On 19-MAY-2014, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml subcutaneously in the left arm (lot # J012660, expiration date 10-JAN-2015). The patient called the pharmacist who stated that on the next day post vaccination, on 20-MAY-2014, the patient developed reddened rash at the injection site of left arm. The site was growing in circumference and was warm and painful when touched. Pharmacist stated he recommended the patient to contact her primary health care provider. No treatment was given for the event at the time of the report. The outcome of reddened rash at the injection site of left arm was reported as not recovered/not resolved. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 12-MAY-2014, the patient was vaccinated with one dose of GARDASIL (dose, strength, lot number and expiration date were not reported) intramuscular route. The healthcare worker reports that an improperly stored GARDASIL was administered on 12-MAY-2014. The healthcare worker reports that the GARDASIL, was exposed to a temperature of 34F for 30 minutes on 05-MAY-2014. No adverse effect reported. Additional information has been requested. These case is one (1) of ten (10) reports from the same reporter. (MARRS 1405USA011237, 1405USA013601, 1405USA013602, 1405USA013603, 1405USA013604, 1405USA013605, 1405USA013606, 1405USA013607, 1405USA013608 and 1405USA013609).
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker concerning to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 14-MAY-2014, the patient was vaccinated with one dose of PEDVAXHIB (dose, strength, lot number and expiration date were not reported) subcutaneous route. Co-suspect and concomitant therapies were not reported. The healthcare worker reports that an improperly stored PEDVAX, was administered on 14-MAY-2014. The reporter stated that the  PEDVAXHIB was exposed to a temperature of 34F for 30 minutes on 05-MAY-2014. No adverse effect reported. These case is one (1) of ten (10) reports from the same reporter. (MARRS 1405USA011237, 1405USA013601, 1405USA013602, 1405USA013603, 1405USA013604, 1405USA013605, 1405USA013606, 1405USA013607, 1405USA013608 and 1405USA013609). Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness, warmth at injection site.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles after ZOSTAVAX.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin, No adverse event, Pregnancy test urine
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse refers to a 16 year old female patient. On an unspecified dates, the patient was vaccinated with the first and second dose of GARDASIL (dose, route, lot number and expiration date were not reported). On an unknown date the patient was vaccinated with GARDASIL third dose, 0.5 ml, intramuscular (lot # not provided) and she was pregnant with last menstrual period (LMP) "around" 15-MAR-2014 and estimated date of delivery (EDD) of 20-DEC-2014. It was reported that the patient was also given on 14-MAY-2014 unspecified "meningococcal oligosaccharide with diphtheria conjugate (manufacturer was Novartis). There was no adverse effects reported and no PQC involved. The outcome of pregnancy was pending. Trimester of exposure, gravida, para, date of conception, foetus demographics were not provided. Urine test and Human Chorionic Gonadotropin (HCG) test for pregnancy were performed. The results were not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 21-MAY-2014 the patient was vaccinated with single dose ZOSTAVAX (lot # J000443, expiry date: 11-APR-2014) subcutaneously. The patient was vaccinated with ZOSTAVAX which was expired on 11-APR-2014 and no adverse effects were reported. The outcome of the patient was inadvertently administered ZOSTAVAX on 21-MAY-2014 that had expired on 11-APR-2014 was unknown. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. On 08-NOV-2013, 21-NOV-2013 and 10-APR-2014 the patient was vaccinated with GARDASIL (dose, route and lot # not reported) dose 1, dose 2 and dose 3 respectively. No adverse effect reported. Additional information is not expected.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of GARDASIL (strength reported as 120 microgram, dose, lot# and expiration date not reported) that was exposed to 20 F for an unspecified period of time, which was excursion that was unsupported by in-house stability data. No adverse symptoms were reported. Follow up information has been received on 24-APR-2014 from a nurse. The reporter mentioned that "30 patients or less" received improperly stored GARDASIL that was exposed to 20F for 11 days. Administration dates, lot # and expiration dates were not reported. Follow up information was received a health center manager. The patients identifiers were obtained. This report concerns one of the patients. On 14-JAN-2014, at 13:15 PM, the 27 year old female patient was vaccinated with the third dose of GARDASIL (lot # J005661) into left deltoid (dose, route not reported). The medication refrigerator was out of range on the following dates: Jan 07, temperature (Degrees Fahrenheit) 44/26; Jan 09, 36/22; Jan 11, 26/40; Jan 14, 22/26. This is one of several reports received from the same source. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of GARDASIL (strength reported as 120 microgram, dose, lot# and expiration date not reported) that was exposed to 20 F for an unspecified period of time, which was excursion that was unsupported by in-house stability data. No adverse symptoms were reported. Follow up information has been received on 24-APR-2014 from a nurse. The reporter mentioned that "30 patients or less" received improperly stored GARDASIL that was exposed to 20F for 11 days. Administration dates, lot # and expiration dates were not reported. Follow up information was received a health center manager. The patients identifiers were obtained. This report concerns one of the patients. On 30-JAN-2014, at 16:40 PM, the 26 year old female patient was vaccinated with the second dose of GARDASIL (lot # reported as J005661) into left deltoid (dose, route not reported). The medication refrigerator was out of range on the following dates: Jan 07, temperature (Degrees Fahrenheit) 44/26; Jan 09, 36/22; Jan 11, 26/40; Jan 14, 22/26; Jan 16, 26; Jan 20, 28/32; Jan 25, 22; Jan 27, 24/26; Jan 28, 20/20. This is one of several reports received from the same source. Additional information is not expected.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haemorrhage
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 79 year old female patient. Medical history reported included, high blood pressure and unspecified heart condition. The patient has not had drug reactions or allergies. On 13-MAY-2014 the patient was vaccinated with ZOSTAVAX 0.65 ml, intramuscular, lot number J013450, expiration date 24-JAN-2015. The concomitant therapies reported included COZAAR, Atenolol, PLAVIX, RESTASIS eye drops and Tretinoin cream. The reporter informed that on 13-MAY-2014, (reported as immediately) she accidentally administered ZOSTAVAX to patient, intramuscular. She stated that she monitored the patient for "30 minutes" in the pharmacy, after the ZOSTAVAX was administered intramuscular. She also stated that there was a "tiny dot" of blood at the administration site after the patient received ZOSTAVAX; she reported that the blood "went away right away". There was not laboratories performed and the patient did not received treatment for the adverse event. The patient's outcome with the event was recovered. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of GARDASIL (strength reported as 120 microgram, dose, lot# and expiration date not reported) that was exposed to 20 F for an unspecified period of time, which was excursion that was unsupported by in-house stability data. No adverse symptoms were reported. Follow up information has been received on 24-APR-2014 from a nurse. The reporter mentioned that "30 patients or less" received improperly stored GARDASIL that was exposed to 20F for 11 days. Administration dates, lot # and expiration dates were not reported. Follow up information was received a health center manager. The patients identifiers were obtained. This report concerns one of the patients. On 31-JAN-2014 (it was also reported as 13-JAN-2014), at 09:00 pm, the 25 year old female patient was vaccinated with the third dose of GARDASIL (lot # reported as J005661) into left deltoid (dose, route not reported). The medication refrigerator was out of range on the following dates: Jan 07, temperature (Degrees Fahrenheit) 44/26; Jan 09, 36/22; Jan 11, 26/40; Jan 14, 22/26; Jan 16, 26; Jan 20, 28/32; Jan 25, 22; Jan 27, 24/26; Jan 28, 20/20. This is one of several reports received from the same source. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of GARDASIL (strength reported as 120 microgram, dose, lot# and expiration date not reported) that was exposed to 20 F for an unspecified period of time, which was excursion that was unsupported by in-house stability data. No adverse symptoms were reported. Follow up information has been received on 24-APR-2014 from a nurse. The reporter mentioned that "30 patients or less" received improperly stored GARDASIL that was exposed to 20F for 11 days. Administration dates, lot # and expiration dates were not reported. Follow up information was received a health center manager. The patients identifiers were obtained. This report concerns one of the patients. On 03-FEB-2014, at 11:00, the 19 year old female patient was vaccinated with the first dose of GARDASIL (lot # reported as J005661) into right deltoid (dose, route not reported). The medication refrigerator was out of range on the following dates: Jan 07, temperature (Degrees Fahrenheit) 44/26; Jan 09, 36/22; Jan 11, 26/40; Jan 14, 22/26; Jan 16, 26; Jan 20, 28/32; Jan 25, 22; Jan 27, 24/26; Jan 28, 20/20. This is one of several reports received from the same source. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of GARDASIL (strength reported as 120 microgram, dose, lot# and expiration date not reported) that was exposed to 20 F for an unspecified period of time, which was excursion that was unsupported by in-house stability data. No adverse symptoms were reported. Follow up information has been received on 24-APR-2014 from a nurse. The reporter mentioned that "30 patients or less" received improperly stored GARDASIL that was exposed to 20F for 11 days. Administration dates, lot # and expiration dates were not reported. Follow up information was received a health center manager. The patients identifiers were obtained. This report concerns one of the patients. On 10-FEB-2014, at 09:45, the 23 year old female patient was vaccinated with the a dose of GARDASIL (lot # reported as H020845) into the right deltoid (dose, route not reported). The medication refrigerator was out of range in the following dates: Jan 07, temperature (Degrees Fahrenheit) 44/26; Jan 09, 36/22; Jan 11, 26/40; Jan 14, 22/26; Jan 16, 26; Jan 20, 28/32; Jan 25, 22: Jan 27, 24/26; Jan 28, 20/20. This is one of several reports received from the same source. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of GARDASIL (strength reported as 120 microgram, dose, lot# and expiration date not reported) that was exposed to 20 F for an unspecified period of time, which was excursion that was unsupported by in-house stability data. No adverse symptoms were reported. Follow up information has been received on 24-APR-2014 from a nurse. The reporter mentioned that "30 patients or less" received improperly stored GARDASIL that was exposed to 20F for 11 days. Administration dates, lot # and expiration dates were not reported. Follow up information was received a health center manager. The patients identifiers were obtained. This report concerns one of the patients. On 03-MAR-2014, at 13:15, the 23 year old female patient was vaccinated with the first dose of GARDASIL (lot # H020848, exp. 03-APR-2015) into right deltoid (dose, route not reported). The medication refrigerator was out of range on the following dates: Jan 07, temperature (Degrees Fahrenheit) 44/26; Jan 09, 36/22; Jan 11, 26/40; Jan 14, 22/26; Jan 16, 26; Jan 20, 28/32; Jan 25, 22; Jan 27, 24/26; Jan 28, 20/20. This is one of several reports received from the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported.On 05-MAY-2014, the patient was vaccinated with one dose of GARDASIL (dose, strength, lot number and expiration date were not reported) intramuscular route. Co-suspect and concomitant therapies were not reported. The healthcare worker reports that an improperly stored GARDASIL was administered. The healthcare worker reported that the GARDASIL, was exposed to a temperature of 34F for 30 minutes on 05-MAY-2014. No adverse effect reported. Additional information has been requested. These case is one (1) of ten (10) reports from the same reporter. (MARRS 1405USA011237, 1405USA013601, 1405USA013602, 1405USA013603, 1405USA013604, 1405USA013605, 1405USA013606, 1405USA013607, 1405USA013608 and 1405USA013609).
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional refers to a patient of unknown age and gender. Medical history and concurrent condition were not reported. On 08-MAY-2014, the patient was vaccinated with one dose of GARDASIL (dose, strength, lot number and expiration date were not reported) intramuscular route. Co-suspect and concomitant therapies were not reported. The healthcare worker reports that an improperly stored GARDASIL was administered on 08-MAY-2014. The healthcare worker reports that the GARDASIL, was exposed to a temperature of 34F for 30 minutes on 05-MAY-2014. No adverse effect reported. Additional information has been requested. These case is one (1) of ten (10) reports from the same reporter. (MARRS 1405USA011237, 1405USA013601, 1405USA013602, 1405USA013603, 1405USA013604, 1405USA013605, 1405USA013606, 1405USA013607, 1405USA013608 and 1405USA013609). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 15-MAY-2014, the patient was vaccinated with one dose of VARIVAX (Merck) (dose, strength, lot number and expiration date were not reported) subcutaneous route. Co-suspect and concomitant therapies were not reported. The healthcare worker reports than an improperly stored VARIVAX (Merck), were administered on 15-MAY-2014. The reporter stated that the VARIVAX (Merck) was exposed to a temperature of 6.4F for 2 hours on 05-MAY-2014. No adverse effect reported. These case is one (1) of ten (10) reports from the same reporter. (MARRS 1405USA011237, 1405USA013601, 1405USA013602, 1405USA013603, 1405USA013604, 1405USA013605, 1405USA013606, 1405USA013607, 1405USA013608 and 1405USA013609). Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 15-MAY-2014, the patient was vaccinated with one dose of VARIVAX (Merck) (dose, strength, lot number and expiration date were not reported) subcutaneous route. Co-suspect and concomitant therapies were not reported. The healthcare worker reports that an improperly stored VARIVAX (Merck), was administered on 15-MAY-2014. The reporter stated that the VARIVAX (Merck) was exposed to a temperature of 6.4F for 2 hours of 05-MAY-2014. No adverse effect reported. Additional information has been requested. These case is one (1) of ten (10) reports from the same reporter. (MARRS 1405USA011237, 1405USA013601, 1405USA013602, 1405USA013603, 1405USA013604, 1405USA013605, 1405USA013606, 1405USA013607, 1405USA013608 and 1405USA013609).
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Discomfort, Inflammation, Lymphadenopathy
Clinical narrative: On April 24th, 2014 received the second dose of GARDASIL vaccine at a health care facility. On April 27th, 2014 (3 days later) around 12:00 - 1:00 pm started experiencing a great discomfort in the lingual frenulum and salivary submandibular duct. I was in the beach, so was exposed to the sun as well. As the day progressed, on the right had side the gland under my chin in the neck area was swollen. Today is April 30th, 2014 and still have swollen gland. Been taking Ibuprofen 400 mg every 6-8 hours on and off, the inflammation get a little better after anti-inflammatory intake, but it hasn't disappear. Will increase the dose to Ibuprofen 800 mg every 6 hours and put ice in the inflammation area and wait 24 hours to see if any improvement will show. I have only been diagnose with Mitral Valve Prolapse (haven't had any problems) and been taking oral contraceptive LO LOESTRIN FE (28 days).
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and unknown gender. There was no information about medical history/concurrent conditions and concomitant medication. On 22-MAY-2014 the patient was inadvertently vaccinated with a dose of ZOSTAVAX (lot#, dose and route unspecified) which had expired on 24-APR-2014. No adverse effects reported. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a 63 year old female patient with no drug allergies. The patient's pertinent medical history included cholesterol, high blood pressure, osteoporosis and seasonal allergies. Approximately on 15-MAY-2014 (reported as about a week ago) the patient was vaccinated with ZOSTAVAX. Concomitant medications included unspecified cholesterol lowering medications, unspecified antihistamines, unspecified hypertension medications and unspecified osteoporosis medications. Approximately on 16-MAY-2014 (a day or so) the patient experienced unspecified herpes blisters on an unspecified location. Lab studies performed were none. The patient sought medical attention, the patient informed the physician's office on 22-MAY-2014. The outcome of unspecified herpes blister was reported as not recovered. The causality was not reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Urinary tract infection
Clinical narrative: This spontaneous report was received from a health care worker refers to an approximately 62 year old female patient (physicians mother). The patients medical history included allergy to penicillin and allergy to DEMEROL. On 19-NOV-2013 the patient was vaccinated with ZOSTAVAX 19400 PFU (lot # J007209; expiration date: 20-SEP-2014) (dose and route of administration were not reported). Concomitant therapies included amitriptyline hydrochloride (manufacturer unknown) and citalopram. On 19-NOV-2013, reported as the same day of vaccination, the patient was seen at the office for urinary tract infection and was prescribed with BACTRIM. On 20-NOV-2013, the following day, the patient experienced shingles. It was reported that the patient had sought medical attention. There was no product quality issue involved. The outcome of urinary tract infection and shingles was unknown. The causality of the event was not provided. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: DTAP, HPV4, MNQ
Symptoms: Erythema, Injection site pain, Lymphadenopathy, Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 11 year old male patient. None of pertinent medical history and drug reactions/allergies reported. On 20-MAY-2014 the patient was vaccinated with a dose of GARDASIL lot # J011960, Exp date 08-JUN-2015, intramuscularly (dose unspecified). The patient was vaccinated with diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and MENACTRA during the same visit on 20-MAY-2014 (dose and route unspecified). On 20-APR-2014 the patient reported that the injection stung. On 20-MAY-2014 the patient experienced redness and swelling in his lymph nodes in the axilla region of the arm in which he received GARDASIL. On 22-MAY-2014, the patient's arm is hurting so that he cannot move it and he was going to be examined by physician on the same day, the healthcare worker recommended that ice be applied to the patient's arm of discomfort, and no other treatment had been given at the time of this report. No laboratory tests were performed. The outcome of events were reported as not recovered/not resolved. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 years old female patient. On 15-MAY-2014 the patient was vaccinated intramuscularly instead of subcutaneously with a dose of ZOSTAVAX (injection in the left arm, dose 0.65 ml, lot# and expiration date not reported). The pharmacist reported that the patient was vaccinated with ZOSTAVAX at another health care provider facility. On approximately 15-MAY-2014, the patient experienced redness, warmth and tenderness at the injection site of left arm. There was no treatment given for the events. The outcome of the events was not recovered. The patient sought medical attention by speaking to pharmacist (in May 2014, exact date not reported). The relatedness between the events and ZOSTAVAX was not reported. Additional information is not expected.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with a dose of GARDASIL (strength reported as 120 microgram, dose, lot# and expiration date not reported) that was exposed to 20 F for an unspecified period of time, which was excursion that was unsupported by in-house stability data. No adverse symptoms were reported. Follow up information has been received on 24-APR-2014 from a nurse. The reporter mentioned that "30 patients or less" received improperly stored GARDASIL that was exposed to 20F for 11 days. Administration dates, lot # and expiration dates were not reported. Follow up information was received a health center manager. The patients identifiers were obtained. This report concerns one of the patients. On 07-FEB-2014, at 13:20, the 24 year old female patient was vaccinated with the third dose of GARDASIL (lot # H020848, exp. 03-APR-2015) into left deltoid (dose, route not reported). The medication refrigerator was out of range on the following dates: Jan 07, temperature (Degrees Fahrenheit) 44/26; Jan 09, 36/22; Jan 11, 26/40; Jan 14, 22/26; Jan 16, 26; Jan 20, 28/32; Jan 25, 22; Jan 27, 24/26; Jan 28, 20/20. This is one of several reports received from the same source. Additional information is not expected.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Arm red to elbow and warm to touch.
Age: 71.0
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Injection site reaction, Pain, Rash, Urticaria
Clinical narrative: After one week, localized site reaction. Generalized hives, skin eruptions with pain over most of the body and back.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (L) arm, raised, swollen, red approximately 4" diameter by injection site.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Skin swelling
Clinical narrative: Localized superficial swelling of the skin. No treatment. Symptomatic care was recommended.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Rash at site of MMR and Varicella vaccines with itching - outer left thigh.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever and rash covering back and abdomen. Fever began 5-9-14 (vaccines administered 5-6-14) rash appeared 5-14-14. Encouraged to notify PCP and ask about antihistamine dosage/use. TYLENOL and MOTRIN discussed.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: ZOSTAVAX administered on 5/1/14, reported to the pharmacy on 5/9/14 that she had shingles, has seen a doctor to receive treatment with gabapentin, valacyclovir, NORCO and lidocaine patches.
Age: 39.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site induration, Pain in extremity
Clinical narrative: Knot at site of injection. Pain in pinky and ring finger on hand of the same arm the vaccinations were given.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Telephone call from mom. Pt. was fine all day. Received GARDASIL #3 at 1 pm and started vomiting 1/2 h after vaccine every 1 h. Vomited last 10 am 5/21/14. Stared with diarrhea.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown demographics. The patient's current conditions or medical history were not reported. On 19-MAY-2014, the patient was vaccinated with an expired dose of ROTATEQ vial 2 ml oral (lot number and expiration date were not reported). No adverse effects reported. Additional information has been requested.