chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU4
Symptoms: Induration
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of induration in a patient who received FLULAVAL. On 7th October 2015, the patient received FLULAVAL. On 7th October 2015, less than a day after receiving FLULAVAL, the patient experienced induration. On an unknown date, the outcome of the induration was unknown. It was unknown if the reporter considered the induration to be relataed to FLULAVAL. Additional details were received as follows: This case was previously reported to doctor. This case has been linked with cases, US2015142209, US2015142212 and US2015142208 reported by the same reporter.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient called and reported that within 24 hours of injection she had swelling and itching at site of injection. The swelling with redness and itch subsided after 4-5 days. Advised ER if needed, BENADRYL, ice for comfort.
Age: 26.0
Sex: F
Vaccine: FLUN4
Symptoms: Dyspnoea, Headache, Paraesthesia oral, Pharyngeal paraesthesia, Pulmonary pain
Clinical narrative: Tingling lips and throat, shortness of breath > 10/7. Lung pain, headache, 10/8.
Age: 39.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 39-year-old female patient who received FLUARIX quadrivalent (batch number 4A5K3, expiry date 22nd June 2016). On 24th September 2015, the patient received FLUARIX quadrivalent (intramuscular) .5 ml. On an unknown date, less than a month after receiving FLUARIX quadrivalent, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to FLUARIX quadrivalent. Additional details provided were as follows: The patient received FLUARIX quadrivalent in left arm. The patient experienced soreness in the left arm, which remained ongoing until 5th October 2015. The outcome of the reported event was unknown to the reporter.
Age: 39.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Pain in extremity, Ultrasound Doppler normal
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 39-year-old female patient who received FLUARIX quadrivalent (batch number 4A5K3, expiry date 22nd June 2016). On 24th September 2015, the patient received FLUARIX quadrivalent (intramuscular) .5 ml. On an unknown date, less than a month after receiving FLUARIX quadrivalent, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to FLUARIX quadrivalent. Additional details provided were as follows: The patient received FLUARIX quadrivalent in left arm. The patient experienced soreness in the left arm, which remained ongoing until 5th October 2015. The outcome of the reported event was unknown to the reporter.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Muscular weakness, Myalgia
Clinical narrative: Myalgia and impaired speech, red, lump at injection site, pain at site, right leg weakness.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Speech disorder
Clinical narrative: Myalgia and impaired speech, red, lump at injection site, pain at site, right leg weakness.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Dyspnoea
Clinical narrative: Skin blister. S.O.B.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Rash/hives from neck to ankles. Started an hour after injection.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Patient developed numbness on the right side of her face; The symptoms developed 24 hours after vaccination. She is being treated with prednisone.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: Given at outside pharmacy. Prolonged severe arm pain at site of injection (L deltoid).
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site oedema, Injection site pruritus
Clinical narrative: IM flu vaccine left thigh. Within 24 hours with significant erythema and edema. TX with ice, Ibuprofen. After 24 hours with pruritus at site, tx with diphenhydramine. Improved after 48 hours.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Oral pain, Oropharyngeal pain, Pharyngeal oedema, Swollen tongue
Clinical narrative: Evening of flu shot tongue throat swelling - sore throat - didn't go to urgent care or take any meds. Could breathe laying on side. Swelling decreasing in AM so didn't get checked - had sore throat and mouth up until yesterday 10/14/15 - resolved today 10/15/15.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Asthenia, Dizziness, Gait disturbance, Neurological symptom, Vision blurred
Clinical narrative: Per child's father, she vomited and began experiencing dizziness. She also experienced blurred vision and extreme weakness (had to be helped/supported while walking). Dad also reports "neurological symptoms" that lasted for about an hour. Symptoms started within 10 minutes of receiving vaccine.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Vomiting
Clinical narrative: Per child's father, she vomited and began experiencing dizziness. She also experienced blurred vision and extreme weakness (had to be helped/supported while walking). Dad also reports "neurological symptoms" that lasted for about an hour. Symptoms started within 10 minutes of receiving vaccine.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Urticaria
Clinical narrative: Pt. states she awoke at 5 am with head to toe hives. No throat or respiratory system problems. She called her physician and he told her to take BENADRYL. She also stated she had a "bad" headache, unrelieved with her normal treatment.
Age: 73.0
Sex: F
Vaccine: FLU3, TYP
Symptoms: Pruritus, Rash, Rash erythematous, Urticaria
Clinical narrative: Four days after vaccines noted red rash with welt on left arm and trunk. Itchy. No fever, no breathing problems. Called 9-29-15 to report, seems to be getting better.
Age: 19.0
Sex: M
Vaccine: FLU3
Symptoms: Fear of injection, Hyperhidrosis, Syncope
Clinical narrative: Syncope, fainting, sweating, pt stated fear of needles, has happened in the past.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: 36 yr old was given High Dose flu vaccine reaction unknown. No treatment needed.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Mobility decreased, Musculoskeletal disorder, Musculoskeletal pain, Sleep disorder
Clinical narrative: Immediate intense pain in shoulder, sleep disruption, unable to use (R arm. Seen by NP 10/2/15 rx MEDROL dose pack MD visit 10/5 rx ZANAFLEX. MD visit 10/13 MEDROL dose pack and PT shoulder pain and loss of motion continues.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Feeling abnormal, Nausea
Clinical narrative: Vaccine administered approx. 130 pm via IM injection to (L) deltoid. Within 1 hour, patient became dizzy, very weak, and nauseous, and slightly mentally "Foggy".
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Pain in extremity, Skin warm, Swelling
Clinical narrative: Swelling started the night she had the vaccine and was worse the next morning when she woke and it was also red at the site. She did have pain in the arm, but can move it around fine. No fever. The arm is warm to touch. She is acting fine. Normal energy. Mom advised to give BENADRYL, ibuprofen, apply a cool compress and continue to observe and call if has significant increase in redness, fever, develops more pain at the site.
Age: 42.0
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Rash vesicular
Clinical narrative: Five days after receiving VARIVAX vaccine noted chicken pox type rash on trunk, arms and face.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Skin warm, Swelling
Clinical narrative: Redness, swelling, hard to touch, warm.
Age: 15.0
Sex: F
Vaccine: HPV4, VARCEL
Symptoms: Erythema, Swelling
Clinical narrative: Patient received HPV and Varicella vaccine on 10/12/15. Noticed RSQ red/swollen. Stated she received the varicella on the right arm and HPV on the left. Iced site and TYLENOL given 10/13/15.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to multiple unspecified number of patients of unknown demographics. Concurrent conditions and medical history were not reported. On unspecified dates, the doses of improperly ZOSTAVAX (dosing detail, Lot numbers and expiry dates were not reported) may have been administered to multiple unspecified number of patients. Concomitant medications were not reported. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. The patient's medical history and concurrent condition were not provided. On unspecified dates the patients were vaccinated with RECOMBIVAX HB (dosage, strength, route and lot # were not reported), which had been improperly stored. At the time of the report, no adverse effects were reported. This is one of several report from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a nurse via company representative and refers to a female patient (a registered nurse) of unknown age. There was no patient's concurrent conditions, concomitant medications and drug reactions or allergies reported. On an unknown date, the patient was vaccinated with ZOSTAVAX injection (lot#, expiration date, dose, anatomical location and route of administration were not reported). On an unknown date, the patient experienced shingles. No treatment was given and no lab diagnostics studies were performed. The patient did not seek medical attention. The relatedness between the event and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 5 newborns (numbered 213, 214, 215, 216 and 217). Background: Since June 2015, there had been 1645 times (30 minutes each time = 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time = 72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-215, there was a low temperature of 30/2F. On 22-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 3 newborns (numbered 210, 211 and 212). Background: Since June 2015, there had been 1645 times (30 minutes each time = 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time =72 hours) that temperature was 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 21-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a registered nurse via company representative referring to a 16 year old female patient. On an unknown date the patient was supposed to get a PEDVAXHIB (lot number L012838, expiration date 10-MAR-2018). No adverse effects reported. The outcome was unknown. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. Concurrent conditions and medical history were not reported. On 18-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX. Concomitant medication was not reported. Approximately on an unknown date in September 2015, within 2 to 3 days after vaccination, the patient was diagnosed with herpes zoster on one side of the face surrounding the eye with black blisters in the center of the rash (herpes zoster). Patient sought medical attention for the same (saw a physician). The outcome of herpes zoster was unknown. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. The patient's medical history and concurrent condition were not provided. On unspecified dates the patients were vaccinated with VAQTA (dosage, strength, route and lot # were not reported), which had been improperly stored. At the time of the report, no adverse effects were reported. This is one of several report from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. There was no medical history or concurrent condition reported. On unknown dates the unspecified patients were vaccinated with doses of improperly stored ZOSTAVAX (lot # K021953, expiration date 10-FEB-2016) (dosage, strength and route were not reported). There was no concomitant medication reported. No adverse effect was reported. This is one of several report from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On an unspecified date, the patient was vaccinated with an improperly stored dose of VAQTA injection (lot# K0053233, expiry date 10-FEB-2017; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. It was reported that the patient sought medical attention in the office, no treatment was given to them and no diagnostic lab studies were performed. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 4 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 26-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 2 newborns (numbered 221 and 222). Background: Since June 2015, there had been 1645 times (30 minutes each time = 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time =72 hours) that temperature was 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 24-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Exposure to toxic agent, Rash generalised
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. Concurrent conditions and medical history of the patient were not reported. On 30-SEP-2015 the patient was vaccinated with a dose of ZOSTAVAX, (lot#, expiration date, dose unspecified) subcutaneously. Other suspect and concomitant therapies were not reported. After vaccination, the patient came in contact with poison ivy. On 01-OCT-2015, the patient developed a "rash all over her body". The patient went to see a physician, but no treatment was given for event. At the time of this report, the patient had not recovered from the events. Causality was not provided. Additional information has been requested.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Needle issue, Underdose
Clinical narrative: This spontaneous report as received from a pharmacist via a poison and drug center refers to a 73 year old male patient. No information regarding the patient's medical history or concurrent conditions was provided. On 08-OCT-2015, the patient was vaccinated with a single dose of ZOSTAVAX injection (lot# reported as L0000447, expiry date 08-MAR-2016; exact dose was not reported) subcutaneously in his right arm. There were no concomitant therapies reported. During the injection of ZOSTAVAX, the needle came loose and the pharmacist was only able to administer about a half of the dose to the patient. It was unknown if the patient was going to receive another dose of ZOSTAVAX. The reporter considered the events to be non-serious. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 3 newborns (numbered 223, 224 and 225). Background: Since June 2015, there had been 1645 times (30 minutes each time = 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time =72 hours) that temperature was 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 25-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to unspecified number of patients of unknown age and gender. There was no information about patients' pertinent medical histories, concomitant medications and drug reactions or allergies provided. Since 06-OCT-2015, the patients were vaccinated with improperly stored doses of PEDVAXHIB injection (lot # K025002, expiration date 20-JUL-2017; lot # L002867, expiration date 11-NOV-2017; lot# L009649, expiration date 29-NOV-2017, dose, anatomical location and route of administration were not reported). No adverse experiences were reported. This is one of several report received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent condition, medical history or concomitant medications were not reported. On 17-SEP-2015, the patient was vaccinated with GARDASIL 9, intramuscularly in the dorsogluteal muscle (dose, frequency, lot # and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a nurse refers to a 2 year old female patient. Patient did not have any pertinent medical history. Also reported that patient was allergic to latex. On an unknown date, at the age of 12 months patient was vaccinated with first dose of VARIVAX (Merck) (dosing details were not reported) subcutaneously. On 09-SEP-2015, at 2 years of age, patient received second dose of vaccinated VARIVAX (Merck) (dosing details were not reported) (lot # L017997 with an expiry date of 19-MAY-2017) subcutaneously. On 10-SEP-2015 the patient developed a "localized rash" at the injection site. Patient did not receive any treatment for the event. The event "localized rash" was resolved within two to three days. The reporter did not provide the causality between the event and the suspect therapy. There was no product quality complaint. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 2 newborns (numbered 218, and 219). Background: Since June 2015, there had been 1645 times (30 minutes each time = 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time =72 hours) that temperature was 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 23-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unspecified dates, the patients were vaccinated with improperly stored dose of (Oka/Merck) VARIVAX injection (lot# L002214, expiry date 21-JAN-2017; dose and route of administration were not reported). A total number of 2 improperly stored doses was administered. There were no concomitant therapies reported. No adverse effects were reported. The reporter stated that the patients sought medical attention in the office, no treatment was given to them and no diagnostic lab studies were performed. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy reprot has been received from a registered nurse via a company representative referring to a pregnant female patient of unknown age. Pertinent medical history and drug reactions/allergies were not reported. On approximately 24-SEP-2015 (reproted as approximately 1 week ago), the patient was vaccinated with a dose of M-M-R II) (dose, route, lot# and expiration date were not reported) when she was 3 weeks pregnant. Concomitant drug was not reported. The patient became pregnant with estimated last menstruation period (LMP) of 03-SEP-2015 and estimated date of delivery (EDD) of 09-JUN-2016. No adverse effect was reported. Outcome of the events was unknown. Additional information has been requested.
Age: 0.69
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from a physician assistant and refers to a 10 week old female patient. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 30-OCT-1997, the patient was vaccinated with the first dose of RECOMBIVAX HB injection (lot#, expiration date, dose, anatomical location and route of administration were not reported). On 08-JAN-1998 (more than one month after the first dose), the patient was vaccinated with the second dose of RECOMBIVAX HB injection (lot#, expiration date, dose, anatomical location and route of administration were not reported). On 08-JUL-1998, the patient was vaccinated with the third dose of RECOMBIVAX HB injection (lot#, expiration date, dose, anatomical location and route of administration were not reported. On 25-SEP-2015, the patient had titers drawn for hepatitis B immunity and the titers came back as negative. No treatment was given. The outcome of the event was unknown. The relatedness between the event and RECOMIVAX HB was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant via company representative and refers to a female patient in her forties of unknown exact age. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient "in her 40's (years old)" was vaccinated with a dose of GARDASIL (dose, route of administration, lot#, expiration date and indication were not reported). Concomitant therapy was not provided. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Injection site vesicles
Clinical narrative: This spontaneous report was received from a female patient of unknown age, who is also a nurse, referring to herself via a company representative. The patient's medical history, concurrent conditions and allergies were not reported. On 08-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, frequency, route, anatomical location, lot number and expiration date were not reported. Other suspect and concomitant therapies were not reported. On 10-OCT-2015, the patient experienced injection site vesicles described as blisters at the injection site. On an unspecified date in October 2015, she was evaluated at an unspecified emergency room; she was diagnosed with cellulitis and was prescribed an unspecified antibiotic medication. The outcome of cellulitis and injection site vesicles was unknown. The relatedness between cellulitis and injection site vesicles and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Injection site cellulitis, Injection site reaction, Injection site vesicles
Clinical narrative: This spontaneous report was received from a female patient of unknown age, who is also a nurse, referring to herself via a company representative. The patient's medical history, concurrent conditions and allergies were not reported. On 08-OCT-2015, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, frequency, route, anatomical location, lot number and expiration date were not reported. Other suspect and concomitant therapies were not reported. On 10-OCT-2015, the patient experienced injection site vesicles described as blisters at the injection site. On an unspecified date in October 2015, she was evaluated at an unspecified emergency room; she was diagnosed with cellulitis and was prescribed an unspecified antibiotic medication. The outcome of cellulitis and injection site vesicles was unknown. The relatedness between cellulitis and injection site vesicles and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse midwife refers to a 17 year old female patient. No information regarding the patient's medical history or concurrent conditions was provided. The patient became pregnant with the date of last menstrual period (LMP) of approximately 31-JUL-2015 (it was reported that the patient was between 10 and 11 weeks pregnant at the time of this report) and estimated delivery date (EDD) of 06-MAY-2016 (calculated from LMP). On approximately 25-SEP-2015, reported as about 2 weeks ago, the patient was vaccinated with a dose of GARDASIL injection (lot# K023432, expiry date 18-JUN-2016; dose and route of administration were not reported). It was reported that the patient was about 8 weeks pregnant at the time of vaccination. There were no concomitant therapies reported. No adverse effect was reported. The patient did not seek medical attention and no treatment was given to her. At the time of this report, the pregnancy outcome was pending and the fetal outcome was unknown. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and allergies were not reported. On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck), lot # L015047 with expiration date 29-APR-2017, (strength, dose, frequency, route and anatomical location were not reported), which was improperly stored. Other suspect and concomitant therapies were not reported. No adverse events were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Muscular weakness
Clinical narrative: Information has been received from a pharmacist referring to a 63 years old male patient with hypertension. The patient had no drug reactions/allergies. On 06-OCT-2015 the patient was vaccinated with a dose of ZOSTAVAX, lot # L021608, expiration date 09-OCT-2016 (dose was not reported) subcutaneously. Concomitant therapies included lisinopril (manufacturer unknown). On 07-OCT-2015, the patient developed mild swelling, redness with a size of a palm and warmth at the injection site and weakness below the injection within 24 hours after vaccination. The patient visited the pharmacy on 08-OCT-2015. No treatment was given for the adverse events and no lab diagnostic studies were performed. Outcome of the events was not recovered. The causality was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 12-OCT-2015, the patient was inadvertently vaccinated with a dose of VARIVAX (Merck) (dose, route and lot # not reported) instead of ZOSTAVAX. No adverse symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse, refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored ROTATEQ oral liquid (strength, dose and lot number or batch number unspecified). No concomitant medications were reported. No symptoms were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Information has been received from a physician assistant and a health professional via company representative referring to a female patient of unknown age. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, lot number and route not provided). The patient experienced an episode of syncope immediately after receiving a dose of GARDASIL 9 in office. The patient sought medical attention in the office. The outcome of syncope was reported as recovered/resolved on an unknown date. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified amount of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unspecified dates, the patients were vaccinated with doses of improperly stored oral, ROTATEQ lot # K006805 with expiration date 24-MAR-2016, route of administration defaulted to oral (dose was not reported). No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, Interchange of vaccine products
Clinical narrative: Information has been received from a pharmacist referring to a female patient of unknown age. Concurrent conditions and medical history of the patient were not reported. On 01-OCT-2015 the patient was vaccinated with her third dose of GARDASIL 9 (lot # L027282, expiration date: 21-Sep-2017) (dose, route unspecified). The primary reporter stated that the patient started the series with GARDASIL "four or five years ago" (estimated as therapy started in 2010) for the first and second dose (Inappropriate schedule of drug administration) (Interchange of vaccine products). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a nurse, refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored RECOMBIVAX HB injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No symptoms were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse, refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored VAQTA injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No symptoms were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse, refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored VARIVAX (Merck) injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No symptoms were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site pain, Injection site paraesthesia, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 year old female patient. The patient had no pertinent medical history and no drug reactions or allergies. On 10-OCT-2015, the patient was vaccinated subcutaneously with 0.65 ml dose of ZOSTAVAX (lot number L000449 and expiration date 08-MAR-2016). There was no concomitant therapy. On 13-OCT-2015, the patient returned to the pharmacy and stated that on an unknown date in October 2015, she began to have burning, tingling, itching around the injection site. The injection site was raised and purple in color. When the patient used the ice pack on the injection site, the swelling, pain, burning, itching and purple color began to go away. However, once the ice pack was taken off, all the symptoms returned within an hour. There were no lab diagnostics studies performed. At the time of the report the patient did not recover from the events. The relatedness between the events and the ZOSTAVAX was not reported. Additional information is not expected as the reporter refused additional contact.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse, refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored PROQUAD (Merck) injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No symptoms were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site warmth, Rash papular
Clinical narrative: Right upper extremity noted with papular rash with erythema extending over the entire deltoid region clear demarcation. The area is also with warmth.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Woke up next day with symptoms: Itching, redness and bumps on left leg on upper half of legs and on back of left knee. BENADRYL has relieved her symptoms.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse, refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored PNEUMOVAX23 injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No symptoms were reported. The outcome of the event was unknown. There were no product quality complaint (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: IPV, MNQ, TDAP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: No adverse events identified. Patient was given IPV that was involved in excursion on 10/01/15. 10/5/15- Vaccine temp was too cold. Vaccine was not discarded.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified amount of patients of unknown age and gender. No information about the patients pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unspecified dates, the patients were vaccinated with doses of improperly stored GARDASIL 9 lot # L011846 with expiration date 16-JUN-2017 and lot # L013429 with expiration date 21-JUL-2017 (dose and route of administration were not reported). No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse, refers to unspecified number of patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored ZOSTAVAX injection (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. No symptoms were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of 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: Information has been received from a registered nurse referring to a patient of unknown age and gender. Concurrent condition and medical history were not reported. On an unknown date the patient was vaccinated with improperly stored GARDASIL (lot # J011272, expiration date 21-APR-2016, dose and route were unknown). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 4 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 27-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Patient developed cellulitis at site of injection. Required doctors visit and antibiotics tx for 10 days.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received from a pharmacist referring to 3 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 30-SEP-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Rash on lower back and 2 sites below the belly.
Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Skin lesion
Clinical narrative: Rash on lower back and 2 sites below the belly.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. The patient's medical history and concurrent condition were not provided. On unspecified dates the patients were vaccinated with oral, ROTATEQ (dosage, strength and lot # were not reported), which had been improperly stored. At the time of the report, no adverse effects were reported. This is one of several report from the same reporter. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Muscular weakness, Pain in extremity
Clinical narrative: (R) arm pain deep aching and weakness with decreased range of motion.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Fatigue, Malaise
Clinical narrative: On 10/14/2015 approx. 6:30 PM patient came to pharmacy complaining that she got sick from PREVNAR 13. Started feeling tired and diarrhea since Sat 10/10. Diarrhea now better but still feel under weather. Denies fever, coughing or other symptoms. Feels like "got hit by a train". Referred her to her physician for further evaluation. Diarrhea better but still feel tired after 1 week.
Age: 19.0
Sex: U
Vaccine: UNK
Symptoms: Rash
Clinical narrative: Rash both arms, used BENADRYL. No other ill effects. Given at work.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Informatoion has been received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. There was no medical history or concurrent condition reported. On unknown dates the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (lot # L019126, expiry date: 27-MAY-2017; lot # L015047, expiry date: 29-APR-2017; lot # L011083, expiry date: 01-APR-2017) (dosage, strength and route were not reported). No adverse effects was reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to a 12 month old male patient. The patient's concurrent conditions, medical history and concomitant medications were not provided. On 12-OCT-2015, the patient was vaccinated with an unspecified dose of VARIVAX (Merck) lot # L013063 and expiration date 14-APR-2017 and he was also vaccinated with an unspecified dose of PROQUAD (Merck) lot# L030588 and expiration date 10-FEB-2017 as reported (route of administration and anatomical location were not provided for both vaccines). The reporter stated that the patient should had been vaccinated with M-M-R II and VARIVAX (Merck), the reporter referred that it was staff error only. No adverse events were reported. There was no product quality issue involved. This is one of two cases from the same reporter. Additional information has been requested.