chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Peripheral swelling, Skin warm, Tenderness
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a 21-year-old female patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 12-AUG-2017, the patient was vaccinated with PNEUMOVAX 23 intramuscularly or subcutaneously in the arm (dose, lot# and expiration date were not provided). Other suspect therapies included FLUARIX, also reported as FLUVARIX in the same arm. On 13-AUG-2017 (also reported as next day), the patient had a reaction on large area of arm from the shoulder to the elbow that is red, tender, hot and swollen. The patient went to urgent care and was told that there was no infection and to treat it with cool packs. The outcome of the events was unknown. The relatedness between the event and suspect therapies was not provided. Additional information is not expected, since there was no consent for contact.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to 3 unspecified patients of unknown age. On an unknown date, the patient was vaccinated with improperly stored doses of PROQUAD rHA, lot # N012491, expiration date 17-OCT-2018, for prophylaxis. Concomitant therapies included sterile diluent (MRK). No adverse events. The vaccines were exposured to 6.2 degrees Celsius. Sender's Comments: US-009507513-1708USA008255.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of an unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX 0,65 ml for prophylaxis. On an unknown date, the patient experienced shingles primarily around her "forehead" area approximately 3 years after she was administered ZOSTAVAX. The outcome of herpes zoster was unknown. The causality assessment was not provided.
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Vision blurred
Clinical narrative: Information has been received from a 60 year old female pharmacist referring to herself. Concomitant therapies included naproxen, a whole bunch of different vitamins and COSOPT. The patient's pertinent medical history and drug reactions/allergies were reported as no. On 03-AUG-2017, the patient was vaccinated with one dose of RECOMBIVAX HB (lot # and expiration date were unknown) intramuscular for prophylaxis. On 05-AUG-2017 (reported as two days after got the shot), the patient's vision started going bad. It was all fuzzy. Her glasses were not even working. She had an appointment on Wednesday to see her doctor. No treatment was given. No lab diagnostics/studies were performed. The outcome of the events were reported as not recovered. The causality assessment was not provided. The reporter considered the events were significant disability or incapacity.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a nurse referring to unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patients received improperly stored doses of VARIVAX lot #, expiration date unknown by reporter (dose, route and frequency unknown) for prophylaxis. The temperature and time frame was reported as 6 degree Fahrenheit) (F) to 14 (F) for 1 hour. There was no previous temperature excursion and data logger was involved.; Sender's Comments: US-009507513-1708USA010747:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. In April 2017 the patient was inadvertently administered a dose of PNEUMOVAX 23 instead of PREVNAR 13 (wrong drug administered). No adverse effects reported.
Age: 1.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Diarrhoea, Lethargy, Product storage error, Pyrexia, Rash morbilliform
Clinical narrative: Information has been received from a nurse concerning a patient of unknown age and gender. The patient did not have concurrent condition, medical history or concomitant therapy. On 05-JUN-2017, the patient received improperly stored M-M-R II and VARIVAX, at an unspecified healthcare provider's office. Lot numbers and expiration dates were unknown for VARIVAX and M-M-R II and sterile diluent (manufacturer unknown) used to reconstitute the vaccines. The patient's mother received a letter, from the unspecified healthcare provider's office and was informed that the vaccines had been stored out of proper storage range and the patient should be revaccinated. 14 days after vaccination, the patient experienced a varicella-type rash that lasted two weeks. The patient also experienced measles-type rash, fever, and diarrhea and was lethargic, that lasted 10 days, in mid-July, 2017. The patient had not been revaccinated. The patient was seen by the nurse, approximately one week ago and appeared to have recovered. The causality assessment was not reported.
Age: 1.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a nurse concerning a patient of unknown age and gender. The patient did not have concurrent condition, medical history or concomitant therapy. On 05-JUN-2017, the patient received improperly stored M-M-R II and VARIVAX, at an unspecified healthcare provider's office. Lot numbers and expiration dates were unknown for VARIVAX and M-M-R II and sterile diluent (manufacturer unknown) used to reconstitute the vaccines. The patient's mother received a letter, from the unspecified healthcare provider's office and was informed that the vaccines had been stored out of proper storage range and the patient should be revaccinated. 14 days after vaccination, the patient experienced a varicella-type rash that lasted two weeks. The patient also experienced measles-type rash, fever, and diarrhea and was lethargic, that lasted 10 days, in mid-July, 2017. The patient had not been revaccinated. The patient was seen by the nurse, approximately one week ago and appeared to have recovered. The causality assessment was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician, via a field representative, refers to a female patient of unknown age. In 2012 the patient was vaccinated with ZOSTAVAX for prophylaxis. Other suspect therapies included sterile diluent (DILUENT MRK). On an unknown date the patient experienced herpes zoster. The outcome of herpes zoster is unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 22-AUG-2017, the patient was administered an expired dose of ZOSTAVAX lot # M030139, expiration date 18-AUG-2017 (dose and frequency unknown) which was reconstituted with sterile diluent (manufacturer unknown) (lot L026395, expiration date 16-MAR-2018) subcutaneously for prophylaxis. No adverse effects reported.
Age: 0.08
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse (other health professional) and refers to a male patient of unknown age. The patient's medical history, concomitant medications, concurrent conditions and drug allergies/reactions were not reported. On 18-AUG-2017, the patient was vaccinated with unspecified dose (1DF) of RECOMBIVAX HB immunization series with (lot # N002202, expiry date:04-NOV-2019) which were improperly stored (Incorrect product storage). No adverse effects were reported. The vaccine was stored at 3.7F at worst for 7 hours. There was previous temperature excursion at 48F for 1 hour. Data logger was involved. The outcome were unknown. No product quality complaint was involved. No further information was provided. This case is cross-referenced with MARRS#1708USA010841 and  MARRS#1708USA010842(same reporter).; Sender's Comments:  US-009507513-1708USA010841: US-009507513-1708USA010842:
Sex: F
Vaccine: VARZOS
Symptoms: Adverse event, Neuralgia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with hypertension and blood cholesterol increased. On an unknown date the patient was vaccinated with ZOSTAVAX for prophylaxis. Other suspect therapies included sterile diluent(MERCK STERILE DILUENT). On an unknown date the patient experienced neuralgia and adverse event. The outcome of neuralgia was reported as not recovered/not resolved.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 22-AUG-2017 the patient was vaccinated with PNEUMOVAX 23, intramuscular for prophylaxis, lot # N013521, expiration date 23-JAN-2019.  On 22-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PNEUMOVAX 23.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician, via a company representative, refers to a 61 year old female patient. On JUL-2017 the patient was vaccinated with ZOSTAVAX for prophylaxis.    Concomitant therapies included sterile diluent(STERILE DILUENT). On JUL-2017 the patient experienced rash. The outcome of rash was reported as recovered/resolved. The causality between the suspect drug and adverse event was not provided.
Age: 53.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a pharmacist, concerning an unknown number of unspecified patients of unknown age and gender. There was no information about the patients' medical history or concurrent conditions. Concomitant therapies included sterile diluent (DILUENT MR). On an unknown date in 2017, on or after 23-JUN-2017, the patients were vaccinated with improperly stored doses of VARIVAX, lot number M025865 with expiration date 24-MAY-2018 (dosage schedule, anatomical location and route of administration were not provided) for prophylaxis, and the administered doses were exposed to a temperature higher than 6 F (Fahrenheit degrees) but lower than 17 F (Fahrenheit degrees) for 1 hour (digital data logger) with a previous temperature excursion higher than 6 F (Fahrenheit degrees) but lower than 14 F (Fahrenheit degrees) for 45 minutes. No adverse effects were reported.; Sender's Comments: US-009507513-1708USA010732:
Sex: U
Vaccine: HEPA
Symptoms: Wrong technique in product usage process
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with VAQTA for prophylaxis. On an unknown date the patient experienced wrong technique in product usage process. The outcome of wrong technique in product usage process is unknown. The reporter considered wrong technique in product usage process to be not related to VAQTA.
Age: 64.0
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a pharmacist, concerning an unknown number of unspecified patients of unknown age and gender. There was no information about the patients' medical history or concurrent conditions. Concomitant therapies included sterile diluent (DILUENT MR). On an unknown date in 2017, on or after 23-JUN-2017, the patients were vaccinated with improperly stored doses of ZOSTAVAX, lot number M041087 with expiration date 03-JAN-2018 (dosage schedule, anatomical location and route of administration were not provided) for prophylaxis, and the administered doses were exposed to a temperature higher than 6 F (Fahrenheit degrees) but lower than 17 F (Fahrenheit degrees) for 1 hour (digital data logger) with a previous temperature excursion higher than 6 F (Fahrenheit degrees) but lower than 14 F (Fahrenheit degrees) for 45 minutes. No adverse effects were reported.; Sender's Comments: US-009507513-1708USA010696:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information about concurrent conditions, concomitant therapies, drug reactions/allergies and medical history was unknown. On 14-JUL-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (dose and route unknown, lot # M039453 with expiration date at 19-DEC-2017; for prophylaxis) reconstituted with sterile diluent (STERILE DILUENT) (incorrect product storage). No adverse event was reported. The vaccine had been exposed under temperature 15 Fahrenheit (F) to 46 F for 1 hour, but did not undergo previous excursion. Data logger was used.; Sender's Comments:  US-009507513-1706USA007264:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a nurse referring to unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patients received improperly stored doses of PROQUAD lot #, expiration date unknown by reporter (dose, route and frequency unknown) for prophylaxis. The temperature and time frame was reported as 6 degree Fahrenheit (F) to 14 (F) for 1 hour. There was no previous temperature excursion and data logger was involved. Sender's Comments: US-009507513-1708USA009722.
Age: 0.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse (other health professional) and refers to a female patient of unknown age. The patient's medical history, concomitant medications, concurrent conditions and drug allergies/reactions were not reported. On 18-AUG-2017, the patient was vaccinated with unspecified dose (1DF) of RECOMBIVAX HB immunization series with (lot # N002202, expiry date:04-NOV-2019) which were improperly stored (Incorrect product storage). No adverse effects were reported. The vaccine was stored at 3.7F at worst for 7 hours. There was previous temperature excursion at 48F for 1 hour. Data logger was involved. The outcome was unknown. No product quality complaint was involved. No further information was provided. This case is cross-referenced with MARRS# 1708USA010454 and MARRS#1708USA010842 (same reporter).; Sender's Comments:  US-009507513-1708USA010454: US-009507513-1708USA010842:
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse (other health professional) and refers to a female patient of unknown age. The patient's medical history, concomitant medications, concurrent conditions and drug allergies/reactions were not reported. On 21-AUG-2017, the patient was vaccinated with unspecified doses of RECOMBIVAX HB immunization series with (lot # N002202, expiry date:04-NOV-2019) which were improperly stored (Incorrect product storage). No adverse effects were reported. The vaccine was stored at 3.7F at worst for 7 hours. There was previous temperature excursion at 48F for 1 hour. Data logger was involved. The outcome was unknown. No product quality complaint was involved. No further information was provided. This case is cross-referenced with MARRS# 1708USA010454 and  MARRS#1708USA010841 (same reporter).; Sender's Comments:  US-009507513-1708USA010841:US-009507513-1708USA010454:
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 17-AUG-2017 the patient was vaccinated with an improperly stored VAQTA lot # M031806 for prophylaxis. The vaccine was exposed to 34.6 F for 10 hours.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant concerns an unspecified amount of patients (age and gender unknown). The patients' medical histories, concurrent conditions and concomitant medication use were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot# M047660, expiration date 02-DEC-2018 or lot# M041513, expiration date 11-OCT-2018) for prophylaxis that were reconstituted with the properly stored sterile diluent. No adverse effects were reported. The vaccines were stored in the temperature of -14 degrees Celsius to -10 degrees Celsius for 5 hours 38 minutes. The vaccines also underwent an unspecified previous temperature excursion. The medical assistant also stated that she was unaware if any improperly stored doses were administered to any patients. She stated the storage unit has had multiple temperature excursions recently. She related these events to mechanical failure. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA002933:
Age: 24.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: Patient initially developed erythema at injection site which resolved now over 4 months later patient presents to clinic with tender nodule 1 x 3 cm oval at left deltoid.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: High fever, chills, achy, nausea, lasted for 3 days.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Tdap and MENVEO was given in L arm on Mon 8-21 in the afternoon. Mom brought child in on Wed 8-23 in the afternoon with L arm red, swollen and warm to touch with the area of redness 8"x12" surrounding the injection sites. Mom reports that the redness and swelling began on Tues am and progressively got worse with the area of redness spreading and the swelling becoming significant enough to bring child in for a evaluation.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Joint swelling
Clinical narrative: CUSTOMER INFORMED PHARMACY THAT HER ANKLE HAS SWOLLEN UP THE DAY AFTER THE FLU SHOT.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site infection
Clinical narrative: Infection developed at injection site beginning three days after injection.
Sex: M
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age with hypertension and drug hypersensitivity. On an unknown date in 2010, the patient was vaccinated with  ZOSTAVAX, unknown for prophylaxis. Concomitant therapies included ramipril (RAMIPRIL). On an unknown date, the patient experienced herpes zoster and inappropriate schedule of drug administration. The outcome of herpes zoster and inappropriate schedule of drug administration is unknown. The reporter considered inappropriate schedule of drug administration to be not related to ZOSTAVAX.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster
Clinical narrative: This spontaneous report as received from a nurse via a company representative and refers to a 59 year old male patient. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date in August 2017 (reported as "on an unspecified date last week"), the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). On an unknown date in August 2017 (reported as "sometime after receiving ZOSTAVAX"), the patient came down with ophthalmic shingles, diagnosed at an urgent care facility. At the time of the report, the event was ongoing. The relatedness between the event and suspect therapy was not provided. The reporting nurse considered ophthalmic shingles to be disabling. Upon internal review, the event was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to two unspecified patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date the patients were vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M044399, expiry date: 25-JUN-2018) orally for prophylaxis at a temperature of 34.5 degree farenheit for a time frame of 25 hours (incorrect product storage). There were no previous temperature excursions reported. The call was because of a data logger. No adverse effects reported. There was no product quality complaint involved.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with PROQUAD lot # M009746 for prophylaxis. Concomitant therapies included sterile diluent. On an unknown date the patient experienced expired product administered. No adverse event was reported. The outcome of expired product administered and no adverse event is unknown. The reporter considered expired product administered and no adverse event to be not related to PROQUAD. Additional information has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist. This report was received via a Pfizer sales representative. A patient of unspecified age, ethnicity and gender, received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced swelling and redness at the injection site after use of the product. The patient was ok. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Had shot on 7/31 in the AM. Woke up the next morning with a fever of 99.6 F.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Ophthalmic herpes zoster, Varicella virus test positive
Clinical narrative: On the date listed previously the patient developed ophthalmic shingles. This was confirmed with a viral culture. No long term visual effects at ths time.
Age: 22.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Swelling
Clinical narrative: 8/21/17: Vaccine administered at 7:38. 8/23/17: First report of mild cellulitis. Loratadine 10 mg daily started, mark drawn around area. 8/24/17: Swelling has spread past the demarcated line drawn yesterday.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Asthenia, Depressed level of consciousness, Feeling hot, Thirst
Clinical narrative: Child sitting in chair after receiving all 3 shots with mom at side. Child leaned to left, semi-conscious. Able to answer questions, states he was very hot and wanted a drink. Stood up to get water from faucet in room with nurse and mom at side. Child then left more weak, unable to get cup to mouth more than once. Leaned over sink, becoming too weak to stand. Was assisted to floor safely by nurse. Child returned to full consciousness after about 2 min. Allowed to rest. Got up to chair per self. Child just came from clinic following sports physical. Mom states child doesn't like shots, but has never reacted poorly. Has not eaten or drank anything yet this AM. Started football practice this week. Gave child a protein bar and pedialyte electrolyte replacement. Ate all of bar and a couple drinks of the juice. Allowed to sit for another 10 minutes. Color returned to face, stated feeling back to normal. Walked around office for 5 minutes before leaving. Mom very shaken. Reassurance provided.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Chills, Headache
Clinical narrative: Received Tdap and later that night, he developed chills, headache, bilateral elbow pain. No rash, sore throat or dyspnea.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Blood glucose normal, Bradycardia, Hypotension, Syncope
Clinical narrative: Shortly after injection patient had syncopal episode lasting approx 10 seconds. Had hypotension and bradycardia for several minutes. BP prior to vaccine 118/80, HR 74.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Induration, Local reaction, Pain, Swelling
Clinical narrative: 5.5 Inch by 4.5 inch swelling, hardness, redness, and pain. Patient vaccinated on 8/23/17 and reaction did not occur until the next day on 08/24/17. Provider states it looks to be a local reaction with or without cellulitis to right upper arm. Reaction could be local and based on increased response or a true cellulitis, so will cover with Bactrim and oral steroids.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, warm, swollen left arm. No fever. No discharge or streaking.
Age: 88.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Hypoaesthesia, Injection site pain, Pain in extremity
Clinical narrative: Approximately 2 days after the Patient receiving the PREVNAR vaccine to his right arm's deltoid muscle, he started to have severe pain to his entire right arm and numbness to 2 of his smallest fingers of his right hand. Patient stated that it reached 10 out of 10 of pain to his right arm but he didn't seek for any doctor or nurse until I called his primary doctor on 8/22/17. He stated that his pain has not been as bad on 8/22/17 but still quiet painful and that's why I contacted his doctor. The next day (8/23/17), the primary doctor sent a script of Gabapentin 100 mg TID. The patient is doing much better in the evening of 8/24/17 and his pain seems to be in a much better control.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Vaccination site pain
Clinical narrative: Patient had pain radiating from vaccine site towards her neck and fingers. There was significant swelling, heat, and redness that spread from injection site and around her arm over the next two days. Patient came to pharmacy last night and asked if she should get it looked at by a doctor, I advised as it looked somehwhat like cellulitis. She went to urgent care 8/24/2017 and recieved and antibiotic injection and brought me a prescription for oral antibiotics and oral steroids 8/25/2017. Patient declined to take steroids but picked up antibiotics and stated that she had significant improvement in swelling, redness and heat in arm since antibiotic injection. Dr. at the urgent care diagnosed her as having cellulitis.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Patient's left upper arm (deltoid area) was mildly swollen, red, and warm to the touch. Patient also complained of itching.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Amenorrhoea, Inappropriate schedule of drug administration, Interchange of vaccine products
Clinical narrative: This spontaneous report was received from a physician via a field representative referring to a 12 year old female patient. The patient's concomitant medication, medical history and drug allergy were unknown. The patient received a dose of GARDASIL (dose, route not reported, lot# and expiration date unknown) on 07-NOV-2014, a dose of GARDASIL 9 (dose, route not reported, lot# and expiration date unknown) on 27-AUG-2015, and another dose of GARDASIL 9 (dose, route not reported, lot# and expiration date unknown) on 05-JAN-2016 for vaccination. In September 2016, the patient stopped menstruating. The patient had sought medical attention and was seen by physician. No treatment was given to the patient. Just recently (in 2017), the patient started menstruating again and recovered from the event. The causality between "stopped menstruating" and suspect vaccines was not reported.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Lymph node pain, Lymphadenopathy, Neck pain
Clinical narrative: This spontaneous report was received from a physician and a nurse and refers to a 66 year old female patient. The patient's pertinent medical history was skin cancer (2013), osteoporosis, hypercholesterolaemia and vaccination with PREVNAR 13 in 2016 (reported as last year). The patient had no drug reactions or allergies and no concomitant medications were reported. On 03-AUG-2017, the patient was vaccinated with a dose of PNEUMOVAX 23, intramuscularly for prophylaxis (exact dose, lot number and expiration date were not provided). On the same day, the patient experienced redness and tenderness at the site of the injection which traveled up her arm. On 04-AUG-2017, the patient was seen in the office and she had superclavicular lymph node enlarged (the size of a golf ball), tender and painful to the touch, also she experienced pain along the left side of her neck. The patient would be treated with paracetamol (TYLENOL), ibuprofen and cold compress, however no laboratory diagnostic studies were performed. The outcome of the events was not recovered/not resolved. The relatedness between the events and PNEUMOVAX 23 was not reported. There was no product quality complain involved in this case.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Alopecia
Clinical narrative: This spontaneous report as received from a other health professional refers to a 17 year old female patient with rubber sensitivity. On 24-APR-2016 the patient was vaccinated with GARDASIL 9 lot # L024993 dose 1, intramuscular for prophylaxis. Concomitant therapies included EPIDUO and BENZACLIN. On 24-APR-2016, 1 day after onset of therapy the patient experienced alopecia. The outcome of alopecia was reported as not recovered/not resolved. {Additional information has been requested. / Additional information is not expected.}
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a unspecified number of patients of unknown age and gender. On unknown dates, the patient was vaccinated with improperly stored doses of PNEUMOVAX 23 lot # M026317 with expiration date 11-JAN-2018 and lot # M037533 with expiration date 17-MAY-2018. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse prescriber refers to a patient of unknown age and gender. On unknown dates, the patient received four separate doses of GARDASIL 9 (doses, route of administration, lot # and expiration date were not reported) for prophylaxis. No adverse event was reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age. On 17-AUG-2017, the patient was inadvertently vaccinated with an improperly stored dose of GARDASIL 9 lot # N000326, expiration date 14-OCT-2019) for prophylaxis. No adverse effects reported. The vaccines were exposed to a temperature of 32°F to 35°F during a time frame of 130 minutes. There was no previous temperature excursion.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to multiple unspecified patients of unknown age. On 18-AUG-2017, 20-AUG-2017 and 21-AUG-2017, the patients were vaccinated with improperly stored doses of VARIVAX for prophylaxis, which were reconstituted with properly stored sterile diluent(DILUENT MRK). No adverse events reported. The vaccines were exposed to a temperature excursion -14°C to -10°C, during a time frame of 4 hours and 30 minutes. There was no previous temperature excursion.; Sender's Comments: US-009507513-1708USA010724:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse concerning to multiple unspecified patients who on an unknown date were vaccinated with an improperly stored dose of PROQUAD (Lot No. N012491, 17-OCT-2017) (rHA). Concomitant therapies included sterile diluent. No adverse effects reported. Temperature: -9° C to 8°C. Time frame: 2 hours 13 minutes. Previous temperature excursion: No. Call made because of a "data logger". This is one of two reports from the same source. Sender's Comments: US-009507513-1708USA011112.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a registered nurse referred to multiple unspecified patients (ages and genders not reported) who on an unknown date were vaccinated with an improperly stored dosage of VARIVAX (Lot No. N007930, 08-MAR-2019) for prophylaxis. No adverse effects reported. Temperature: -9° C to 8°C Time frame: 2 hours 13 minutes Previous temperature excursion: No Call made because of a "data logger". This is one of two reports from the same reporter.; Sender's Comments: US-009507513-1708USA010608:
Sex: U
Vaccine: PNC13
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration on unspecified date at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced swelling and warm at the injection site on an unspecified date. Pharmacist applied ice pack at the injection site. The outcome of both events was recovered. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Respiration abnormal, Tremor
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 7-month-old male patient of unspecified race/ethnicity received PREVNAR 13 (Lot# S31257, Exp date Jul2018, NDC# 00051971-01), intramuscular, on 21Aug2017, at 0.5 ml single, for immunisation. Relevant medical history was not reported. Concomitant medication included ACTHIB on 21Aug2017 for immunisation. On 21Aug2017 the patient experienced erratic breathing and shaking of both arms. An ambulance was called and the patient was taken to hospital, but was not admitted. The events were recovering.
Sex: U
Vaccine: PNC13
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable Pharmacist via Pfizer sales Representative. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration on unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced soreness, redness, blue and black color at the injection site on an unspecified date. Patient applied ice pack at the injection site and patient was doing well. The outcome of the events was recovering. No follow up attempts are possible. No further information is expected.
Age: 9.0
Sex: M
Vaccine: HEPA, IPV, TDAP
Symptoms: Nausea, Pallor, Syncope
Clinical narrative: Child was sitting on Father's lab during and after immunizations when he became pale and had a brief episode of syncope. Requested that Father lie child down on cushioned bench in immunization administration room to recover. Cold pack activated and provided for child's forehead and neck. Started to gain color, but then was pale again for about 15 minutes. Child declined juice and crackers.  Provided emesis basin, as Father thought he might vomit, but he did not. Child finally got up and wanted to leave, but was still pale. Requested Father walk him out while holding his arm in case he fainted again.
Age: 1.0
Sex: M
Vaccine: DTAP, HIBV, PNC13, VARCEL
Symptoms: Injection site nodule, Injection site reaction, Rash erythematous, Rash pustular
Clinical narrative: The child developed a red raised linear pustule rash and a knot at the injection site (Left thigh) of the Varicella injection. The parent did not report any fever or sickness other than the above rash.
Age: 46.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Asthenia, Chest pain, Dysgeusia, Headache
Clinical narrative: 6PM day of - brief metal taste in mouth and pain in lower front teeth. Severe headache, weak, nervous feeling, sore right arm and swelling and hot skin at injection site. that night joints and body felt like a severe flu. Missed two days of work. Very bad headache for 2 days, no energy and continued joint pain. Fourth day headache eased off by half, arm swelling started going down, still warm to touch. Continued to ease off until day 7 when I went to ER with pain in left chest possibly unrelated.
Age: 46.0
Sex: M
Vaccine: ANTH
Symptoms: Impaired work ability, Influenza like illness, Injection site swelling, Injection site warmth, Nervousness
Clinical narrative: 6PM day of - brief metal taste in mouth and pain in lower front teeth. Severe headache, weak, nervous feeling, sore right arm and swelling and hot skin at injection site. that night joints and body felt like a severe flu. Missed two days of work. Very bad headache for 2 days, no energy and continued joint pain. Fourth day headache eased off by half, arm swelling started going down, still warm to touch. Continued to ease off until day 7 when I went to ER with pain in left chest possibly unrelated.
Age: 46.0
Sex: M
Vaccine: ANTH
Symptoms: Pain in extremity, Toothache
Clinical narrative: 6PM day of - brief metal taste in mouth and pain in lower front teeth. Severe headache, weak, nervous feeling, sore right arm and swelling and hot skin at injection site. that night joints and body felt like a severe flu. Missed two days of work. Very bad headache for 2 days, no energy and continued joint pain. Fourth day headache eased off by half, arm swelling started going down, still warm to touch. Continued to ease off until day 7 when I went to ER with pain in left chest possibly unrelated.
Age: 30.0
Sex: F
Vaccine: DTAP
Symptoms: Chills, Decreased appetite, Injection site pain, Pain, Peripheral coldness
Clinical narrative: Soreness in left arm at injection site. Fever from 5 pm progressing in temperature to 101.6 at 9 pm the following night which broke at 12:30 am on 08/25/2017. Loss of appetite. Body aches, chills until morning of 08/25/2017. Trouble regulating temperature- very cold extremities still present 2 days later.
Age: 30.0
Sex: F
Vaccine: DTAP
Symptoms: Pyrexia, Temperature regulation disorder
Clinical narrative: Soreness in left arm at injection site. Fever from 5 pm progressing in temperature to 101.6 at 9 pm the following night which broke at 12:30 am on 08/25/2017. Loss of appetite. Body aches, chills until morning of 08/25/2017. Trouble regulating temperature- very cold extremities still present 2 days later.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: LEFT DELTOID WITH PAIN, PRURITUS AND SWELLING FOR 1 TO 2 DAYS FOLLOWING VACCINE ADMINISTRATION. PRESCRIBED IBUPROFEN AND BENADRYL.
Age: 1.0
Sex: U
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a 13 year old patient. On 30-MAY-2008 the patient was vaccinated with VARIVAX lot # 1861U dose 2, subcutaneous in the right arm for prophylaxis. Other suspect therapies included M-M-R II, diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and poliovirus vaccine inactivated (unspecified). On 19-JUN-2017, 9 years 21 days after onset of therapy the patient experienced herpes zoster. The outcome of herpes zoster was reported as recovered/resolved. Lot number 1861U has been verified to be a valid lot number for VARIVAX. "Lot number 0238X has been verified to be a valid lot number for M-M-R II. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 15-JUN-2017 the patient was vaccinated with GARDASIL 9 lot # M014929, expiration date 27-MAY-2017, for prophylaxis. On 15-JUN-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. The outcome of expired product administered and no adverse event is unknown. The reporter considered expired product administered and no adverse event to be not related to GARDASIL 9.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Medical assistant referring to a patient of unknown age.  On 14-AUG-2017, the patient was vaccinated with an improperly stored dose of VAQTA dose 1, lot # N003194, expiration date 28-OCT-2017, for prophylaxis. No adverse event reported.  The vaccines were exposed at a temperature of 33.6 °F, during a time frame of 21 hours 40 minutes. There was no previous temperature excursion.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer and a consumer regarding a male patient (age not specified). The patient's medical history, concomitant medications and concurrent conditions were not provided. On or about 03-JUL-2007 the patient was administered ZOSTAVAX, 1 DF, as recommended for routine adult health maintenance and the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster.  On or about 21-MAY-2016, the patient was treated by a physician in the emergency department for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed acetaminophen and oxycodone (PERCOCET), tramadol, and acyclovir for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Dyspnoea, Eye irritation, Headache, Injection site erythema, Injection site induration
Clinical narrative: Adverse event - Hot at injection site, extreme swelling, extreme redness, itching, blistering, hardening at injection site underneath in the lymph nodes in the arm pit. Headaches, irritable, irritation in eyes. No fever or elevation in heart rate. Some respiratory difficulty requiring the use of the rescue inhaler and a neutralizing treatment at the Urgent Care facility. However, there was not swelling in the throat area.
Age: 65.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Injection site pruritus, Injection site swelling, Injection site vesicles, Injection site warmth, Irritability
Clinical narrative: Adverse event - Hot at injection site, extreme swelling, extreme redness, itching, blistering, hardening at injection site underneath in the lymph nodes in the arm pit. Headaches, irritable, irritation in eyes. No fever or elevation in heart rate. Some respiratory difficulty requiring the use of the rescue inhaler and a neutralizing treatment at the Urgent Care facility. However, there was not swelling in the throat area.
Age: 65.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Lymphadenopathy
Clinical narrative: Adverse event - Hot at injection site, extreme swelling, extreme redness, itching, blistering, hardening at injection site underneath in the lymph nodes in the arm pit. Headaches, irritable, irritation in eyes. No fever or elevation in heart rate. Some respiratory difficulty requiring the use of the rescue inhaler and a neutralizing treatment at the Urgent Care facility. However, there was not swelling in the throat area.
Age: 65.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Decreased appetite, Dyspnoea, Fatigue, Headache, Wheezing
Clinical narrative: Adverse event - Hot at injection site, extreme swelling, extreme redness, itching, blistering, hardening at injection site underneath in the lymph nodes in the arm pit. Headaches, irritable, irritation in eyes. No fever or elevation in heart rate. Some respiratory difficulty requiring the use of the rescue inhaler and a neutralizing treatment at the Urgent Care facility. However, there was not swelling in the throat area.
Age: 65.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Dyspnoea, Eye irritation, Headache, Injection site erythema, Injection site induration
Clinical narrative: Episode onset: 7 days ago after being given PREVNAR 13 vaccine. The problem occurs constantly. The problem has been gradually improving. Associated symptoms include anorexia, fatigue and headaches. Pertinent negatives include no fever, nausea or vomiting. Associated symptoms comments: Wheezing and SOB. Nothing aggravates the symptoms. Treatments tried: Albuterol MDI. The treatment provided significant relief.
Age: 65.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Injection site pruritus, Injection site swelling, Injection site vesicles, Injection site warmth, Irritability
Clinical narrative: Episode onset: 7 days ago after being given PREVNAR 13 vaccine. The problem occurs constantly. The problem has been gradually improving. Associated symptoms include anorexia, fatigue and headaches. Pertinent negatives include no fever, nausea or vomiting. Associated symptoms comments: Wheezing and SOB. Nothing aggravates the symptoms. Treatments tried: Albuterol MDI. The treatment provided significant relief.
Age: 65.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Lymphadenopathy
Clinical narrative: Episode onset: 7 days ago after being given PREVNAR 13 vaccine. The problem occurs constantly. The problem has been gradually improving. Associated symptoms include anorexia, fatigue and headaches. Pertinent negatives include no fever, nausea or vomiting. Associated symptoms comments: Wheezing and SOB. Nothing aggravates the symptoms. Treatments tried: Albuterol MDI. The treatment provided significant relief.
Age: 65.0
Sex: M
Vaccine: PNC13, PNC13
Symptoms: Decreased appetite, Dyspnoea, Fatigue, Headache, Wheezing
Clinical narrative: Episode onset: 7 days ago after being given PREVNAR 13 vaccine. The problem occurs constantly. The problem has been gradually improving. Associated symptoms include anorexia, fatigue and headaches. Pertinent negatives include no fever, nausea or vomiting. Associated symptoms comments: Wheezing and SOB. Nothing aggravates the symptoms. Treatments tried: Albuterol MDI. The treatment provided significant relief.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Anaphylactic reaction, Chest pain, Oxygen saturation decreased, Toothache, Wheezing
Clinical narrative: Wheezing, low SpO2, teeth pain, chest pain, anaphylaxis.
Age: 15.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Confusional state, Headache, Hypoaesthesia, Mental status changes, Speech disorder
Clinical narrative: Severe headaches started, vomiting, one sided numbness of body, inability to speak, confusion, and altered mental status.