chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Oedema, Pain
Clinical narrative: Arm erythema, edema, significant pain x 1 week.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Swelling face
Clinical narrative: Patient was administered Zoster in left arm. Patient called the next day complaining of swelling of right side of her face and numbness of right arm and leg. Patient was evaluated by provider and given prednisone burst of 20 mg 3 times a day for 7 days. Patient was also given valacyclovir 1,000 mg 3 times a day for 7 days. 2 weeks later patient was evaluated again and referred to neurology due to no improvement. Still waiting an appointment.
Age: 69.0
Sex: M
Vaccine: FLUC3, PNC13
Symptoms: Arthralgia, Influenza like illness, Pain, Pyrexia, Rash
Clinical narrative: Patient stated he had a PREVNAR 13 and flu immunization on Monday. He reports on Tuesday he began to have flu-like symptoms, and a low grade fever. Patient c/o having a rash around his waist, forearms and chest. He reports his temp last night was 101.2, and today it is 99. Patient stated his joints are achy, pain 2/10. Ibuprofen 800 mg BID.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to two unspecified patient of unknown age and gender. Information on patients pertinent medical history and concurrent condition was not reported. On 22-APR-2016, two patients were vaccinated with improperly stored (Oka-Merck) PROQUAD lot # M003435, expiry 19-JUL-2017 (dose and route not reported). No adverse effects were reported. The data loggers were used. On unspecified date, the temperature was 6.5 Fahrenheit (F) for a time frame of 13 minutes and was back in range. A previous temperature excursion on unspecified date was reported to the same lot number, previously exposed to 6.7 F for 13 minutes. The total cumulative time out of range was 26 minutes. No additional information was provided. This case is one of the two reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: (L) deltoid swelling, redness, tenderness approximately 3 cm. Arm = full ROM.
Age: 46.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Nausea, Pain in extremity, Swelling
Clinical narrative: Severe arm pain, redness, swelling, nausea.
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Fatigue, Herpes zoster, Malaise, Rash
Clinical narrative: Patient reports a rash on her buttocks similar to rash she experienced when previously diagnosed with Shingles a few years ago. She also states she has experienced general malaise and fatigue since vaccine administration.
Age: 33.0
Sex: M
Vaccine: JEV1
Symptoms: Musculoskeletal pain
Clinical narrative: Patient reported sudden onset of severe pain in left shoulder where vaccine was administered. Patient still has pain in left shoulder with shoulder abduction approx. 6 weeks later.
Age: 18.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Fall, Syncope
Clinical narrative: Patient walked out to lobby and suddenly fainted, falling backwards from standing position, striking floor.
Age: 15.0
Sex: F
Vaccine: MMR
Symptoms: Anaemia, Menorrhagia
Clinical narrative: Heavy onset of period began that day. Since the final shot of GARDASIL, patient menstruates heavily every 9 to 12 days with a heavy 5 day cycle. Very small break in between periods. Patient is anemic.
Age: 17.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Movement disorder, Pain, Pain in extremity
Clinical narrative: The patient is unable to extend his left arm fully at the shoulder. When he moves the arm he experiences shooting pains down the arm.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Fall, Joint injury, Syncope, Wrist fracture, X-ray limb
Clinical narrative: Pt had fainting spell after receiving HPV #1. Fell injury to wrist and Fx.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Dry mouth, Dysphagia, Hypoaesthesia oral, Mastication disorder, Paraesthesia oral
Clinical narrative: Dry mouth, difficulty swallowing and chewing food, swollen tongue, numbness of the tongue, thick and heavy tongue feeling.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Swollen tongue, Tongue disorder
Clinical narrative: Dry mouth, difficulty swallowing and chewing food, swollen tongue, numbness of the tongue, thick and heavy tongue feeling.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Dizziness and light headed after patient go home.
Age: 1.01
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Seizure, Skin discolouration, Tremor
Clinical narrative: Child was in care of sibling, started shaking, arms turned purple.  Taken to ER and had 103 temp at the time. RPAC at ER consulted with special care physician and they determined it most likely was a seizure secondary to the MMR received 4/19/16.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Herpes zoster, Injection site reaction, Rash, Rash pruritic
Clinical narrative: Shingles rash on left thigh in dermatome of L3, initially painful and then becoming itchy. No vesicles were present, but location and nature of rash is most consistent with shingles.  Pt had received 2 doses of Varivax (11/20/08 and 1/10/12).
Age: 1.75
Sex: F
Vaccine: DTAP, HEPA, MMR, VARCEL
Symptoms: Injection site rash, Lacrimation increased, Pyrexia, Rash generalised
Clinical narrative: Fever, rash at injection site and all over body, with watery eyes.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Contusion, Haematochezia, Immune thrombocytopenic purpura, Immunoglobulin therapy
Clinical narrative: Patient received MMRV- PROQUAD on 07/07/2015, 9 days later started having sudden onset bruising and blood in stool, went to  ED, was diagnosed with idiopathic thrombocytopenia and given IVIG.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Induration, Pruritus
Clinical narrative: 140mmx150mm of measured induration and erythema. Patient reports itching. Afebrile.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: Sudden severe pounding headache associated with nausea & vomiting lasting 6 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Hypersomnia, Influenza like illness, Oropharyngeal pain
Clinical narrative: I started to feel like I was getting a sore throat and getting very tired.  Then I felt like I was maybe coming down with the flu or something.  I did not have a fever.  I went to bed early and slept late.  I felt better in the morning but in the afternoon I feel the tired sore again.
Age: 64.0
Sex: M
Vaccine: DTAP, VARZOS
Symptoms: Herpes zoster, Viral rash
Clinical narrative: Pt complains of rash and saw primary care prescriber and was given acyclovir for viral rash or shingles.
Sex: U
Vaccine: TDAP
Symptoms: Anaphylactic reaction
Clinical narrative: This case was reported by a pharmacist via other manufacturer and described the occurrence of anaphylactic reaction in a patient who received DTPa vaccine. On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, an unknown time after receiving DTPa vaccine, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylactic reaction was unknown. It was unknown if the reporter considered the anaphylactic reaction to be related to DTPa vaccine. Additional details were provided as follows: This case was received via Merck National Service Center. The age at vaccination was not reported. An unspecified patient experienced an anaphylactic reaction to an unspecified TDaP vaccine. No additional information was available.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. On multiple unspecified dates the patients were administered with improperly stored VARIVAX (Merck) (lot # L049534, expiration date 08-DEC-32017). The temperature excursion was -14 Celsius degree with time frame of 2 hours. There was previous temperature excursion: -11.4 Celsius degree for 5 hours. No adverse effects were reported. Additional information has been requested.
Age: 0.38
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Culture negative, Incisional drainage, Injection site abscess, Injection site erythema, Injection site reaction
Clinical narrative: Injection site following vaccination with PEDIARIX swollen and red 2/17/16 with abscess formation requiring I and D. Culture results no growth. 5/3/16 Probable seroma at injection site with PEDIARIX. Both developed about 1 month after vaccines administered.
Age: 0.38
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site swelling, Seroma
Clinical narrative: Injection site following vaccination with PEDIARIX swollen and red 2/17/16 with abscess formation requiring I and D. Culture results no growth. 5/3/16 Probable seroma at injection site with PEDIARIX. Both developed about 1 month after vaccines administered.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (medical assistant) concerning multiple unspecified patients of unknown age and gender. No concurrent condition, medical history and concomitant therapies were reported. On multiple unspecified dates, unspecified doses of VAQTA which were improperly stored under 70 F for 38 hours were administered to multiple unspecified patients. The lot # of the VAQTA included: L043029, non-valid lot# for VAQTA with expiration date reported as 17-SEP-2017; L015460 with expiration date: 20-JUL-2017 and L045713 with expiration date: 14-JAN-2017. There was no previous temperature excursion. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Gave Dtap instead of Tdap. No adverse events.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 5/3/16 evening, c/o hint of redness, itching swelling to injection site. From shoulder to elbow. Seen after 2 office calls 5/4/16. MOTRIN given Q6 hours - dosed by wt and encouraged BENADRYL by provider.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Anal incontinence, Back pain, Muscular weakness, Nuclear magnetic resonance imaging, Sensory loss
Clinical narrative: Pt received vaccine 3/11/16. Within days she developed low back pain, leg weakness, saddle anesthesia and bowel and bladder incontinence. Pt was given pain meds, had MRI done and referred to neurology.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Urinary incontinence
Clinical narrative: Pt received vaccine 3/11/16. Within days she developed low back pain, leg weakness, saddle anesthesia and bowel and bladder incontinence. Pt was given pain meds, had MRI done and referred to neurology.
Age: 54.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Arthralgia, Bone pain, Oedema peripheral
Clinical narrative: 2 weeks after receiving MMR and varicella vaccine pt had bone and joint pain and lower extremity and hand edema - edema lasted for 1 week and pain for 1 1/2 weeks.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient was given a second ZOSTAVAX vaccine. Patient had one already on 9/19/14.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Swelling
Clinical narrative: Left arm rash/swelling at site of injection. Started 2 days post injection and symptoms getting worse as of 5/4/16.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a health worker referring to unspecified number of unspecified patients. On 11-MAR-2016, the vaccine of RECOMBIVAX HB had been previously excursion on -1.1 Celsius degrees for 3 hours and 45 minutes. On 12-MAR-2016, the vaccine had been previously excursion on -0.9 Celsius degrees for 10 hours and 31 minutes. On 13-MAR-2016, the vaccine had been previously excursion on -1.2 Celsius degrees for 12 hours and 4 minutes. On 14-MAR-2016, the vaccine had been previously excursion on -1.1 Celsius degrees for 12 hours and 38 minutes. On 15-MAR-2016, the vaccine had been previously excursion on -0.7 Celsius degrees for 10 hours and 54 minutes. On 16-MAR-2016, the vaccine had been previously excursion on -0.4 Celsius degrees for 4 hours and 39 minutes. On unknown dates in 2016, the patients were vaccinated with incorrectly stored RECOMBIVAX HB (dose and route were unknown, lot #: L027733, expiry date: 13-SEP-2017). No adverse events were reported. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4, MMR, MNQ, TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (R) (L) deltoid pain/hot/swelling.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema
Clinical narrative: Redness to left arm.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash pruritic, Swelling
Clinical narrative: Patient had a reaction to ZOSTAVAX vaccine. An orange size rash. The rash itches and has pain equivalent to a bee sting. It is swollen.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: Patient had a reaction to ZOSTAVAX vaccine. An orange size rash. The rash itches and has pain equivalent to a bee sting. It is swollen.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: The day after shot on 4/26 had a rash on the front of arm and down side of arm (not on injection site). Rash has gotten better but still red and itchy as of 5/4/16.
Age: 43.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Rash erythematous
Clinical narrative: Immunizations on 4/28/16. Tdap in left deltoid, MMR in right. The next day 4/29/16 developed swelling, redness and itching left deltoid. Seen 5/4/16 and swelling and redness to mid deltoid. Pain better. Scattered red spots on hands. No respiratory sx. Unable to take antihistamines so steroid cream given.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a field representative refers to a female patient of unknown age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were unspecified. On an unknown date, the patient received a late dose with the third dose of GARDASIL (1shot) via intramuscular route. Reporting physician stated that the patient received third dose later than 6 months when her treatment began. The patient required medical attention, but no treatment was provided to her. There were no mention of any symptoms apart from the late dose. Additional information has been requested.
Age: 56.0
Sex: M
Vaccine: TD
Symptoms: Diarrhoea, Erythema, Headache, Peripheral swelling, Pyrexia
Clinical narrative: Headache mild fever redness swelling in arm diarrhea started about 6:00 pm after I got home.
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-MAY-2013, the patient received the first dose of VAQTA 25/0.5 (units not provided), injection, lot # J000985, expiration date: 20-AUG-2015 (exact dose, route of administration and anatomical location were not provided). On 22-NOV-2013, the patient received her second dose of VAQTA 25/0.5 (units not provided), lot # J011712, expiration date: 21-SEP-2015 (exact dose, route of administration and anatomical location were not provided), which was several days prior to the recommended 6-month interval between doses. There was no adverse effect reported. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Pyrexia
Clinical narrative: Case number PHHY2011US114396 is an initial spontaneous report received from vaccine adverse event reporting system (VAERS reference number: 440196) website on 30 Dec 2011. This report refers to a 12-year-old male patient. The patient medical history included ZYRTEC allergy. He was vaccinated with MENVEO vaccine (batch number: M10126A) intramuscularly in to the let arm on 20 Oct 2011. This patient also received BOOSTRIX vaccine (manufacturer: GlaxoSmithKline biologics with batch number: AC52B072FA) intramuscularly in to the right arm. After one day of vaccination, the patient had fever and his body temperature was found to be 103.9 degrees on 21 Oct 2011. The patient body temperature was found to be 102.3 degrees on 22 Oct 2011 and within normal limit on 25 Oct 2011. The outcome of the events was reported as condition recovered. The causality was unknown. Upon internal review performed, according sales data, Tdap vaccine was changed to BOOSTRIX.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of drug administration, Underdose
Clinical narrative: Information has been received from a nurse practitioner concerning a 23 year old female patient. There were no pertinent medical history or drug reactions/allergies. On 16-OCT-1992, 09-DEC-1992 and 15-JUN-1993, the patient was vaccinated with the first, second and third doses of RECOMBIVAX HB, lot numbers reported as 102482 (1st dose) with expiration date June 1995, 106182 (expiration date unspecified) (2nd dose) and 1023B2 (expiration date unspecified) (3rd dose), 0.5 mL, intramuscularly, respectively (inappropriate schedules of vaccine administration). On 01-APR-2016, the patient was seen by the nurse practitioner and had titers drawn which showed her titers were low for Hepatitis B. On 04 APR-2016, the patient was seen by the nurse practitioner again and was mistakenly administered a 0.5 mL dose of RECOMBIVAX HB (lot # L025738 and expiration date 14-AUG-2017) instead of a 1.0 mL dose as indicated (underdose). The nurse practitioner stated this dose of RECOMBIVAX HB was given since the patient had "low titers". No treatment was given for the event. The outcome of the event was unknown. The reporter did not provide the causality assessment. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 21-APR-2016 at 10:20 hours, the patient was vaccinated with an expired dose of VARIVAX (Merck) injection, lot # K002917, expiry date 26-FEB-2016 (dose, route, anatomical site of injection and frequency were not reported). Concomitant therapies were not provided. No adverse effects were reported. No product quality complain (PQC) was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (medical assistant) concerning multiple unspecified patients of unknown age and gender. No concurrent condition, medical history and concomitant therapies were reported. On multiple unspecified dates, unspecified doses of VARIVAX (Merck) which were improperly stored under 8 F for 2 hours were administered to multiple unspecified patients (incorrect product storage). The lot # of the VARIVAX (Merck) included: L032396 with expiration date 26-AUG-2017 and L039093 with expiration date 06-OCT-2017. There was no previous temperature excursion. No adverse event was 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, No adverse event
Clinical narrative: Information has been received from a healthcare worker (medical assistant) concerning multiple unspecified patients of unknown age and gender. No concurrent condition, medical history and concomitant therapies were reported. On multiple unspecified dates, unspecified doses of RECOMBIVAX HB which were improperly stored under 70 F for 38 hours were administered to multiple unspecified patients (incorrect product storage). The lot # of the RECOMBIVAX HB included: L019298 with expiration date 22-JUN-2017; L045117 with expiration date 06-OCT-2018; L027733 with expiration date 13-SEP-2017; L048849 with expiration date 04-FEB-2018 and L039660 with expiration date 04-FEB-2018. There was no previous temperature excursion. No adverse event was reported. This one of several reports received from the same reporter. Additional information has been requested.
Age: 0.3
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: Initial unsolicited report received from the literature on 31 March 2016. This case is linked to 2016SA066144 (same literature and vaccine). Abstract: BACKGROUND: Quadrivalent inactivated influenza vaccines (IIV4) were first available for use during 2013-14 influenza season for individuals aged 6 months. IIV4 is designed to protect against four different flu viruses; two influenza A viruses and two influenza B viruses. METHODS: We searched the Vaccine Adverse Event Reporting System (VAERS) for reports after IIV4 and trivalent inactivated influenza vaccine (IIV3) from 7/1/2013-5/31/2015. Medical records were requested for non-manufacturer reports classified as serious (i.e. death, hospitalization, prolonged hospitalization, life-threatening illness, permanent disability). The review included automated data analysis, clinical review of all serious reports, reports of special interest, and empirical Bayesian data mining. RESULTS: VAERS received 1,838 IIV4 reports; 512 (28%) in persons aged 6 months-17 years of which 42 (8.2%) were serious reports; 1,265 (69%) in persons aged >18 years of which 84 (6.6%) were serious reports; two in children <6 months and 59 in persons of unknown age. Injection site erythema (24%), fever (14%) and injection site swelling (17%) were the most frequent adverse events among persons aged 6 months-17 years, while injection site pain (16%), pain (15%) and pain in extremity (13%) were the most frequent among persons aged 18-64 years given the vaccine alone. Among non-death serious reports, injection site reactions, constitutional symptoms, Guillain-Barre syndrome, seizures, and anaphylaxis were the most frequently reported adverse events. Data mining detected disproportional reporting for incorrect vaccine administration with no associated adverse events. Adverse events following IIV4 reported to VAERS were similar to those following IIV3. CONCLUSIONS: In our review of VAERS reports, IIV4 had a similar safety profile to IIV3. Most of the reported AEs were non-serious. Our findings are consistent with data from pre-licensure studies of IIV4. This case involves a four-month-old female patient who was vaccinated with a dose of FLUZONE QIV (batch number, expiration date, site and route of administration) on an unspecified date. The patient medical history and concomitant medications were not reported. On unspecified date, following the vaccination, the patient experienced fever and water diarrhea. Relevant laboratory test results and corrective treatments were not reported. The outcome of event was not reported. Documents held by sender: none.
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Headache
Clinical narrative: Headache.
Age: 1.01
Sex: M
Vaccine: MMR, MMR, MMR
Symptoms: Diarrhoea, Measles, Pyrexia, Rash macular, Rash papular
Clinical narrative: Information has been received from a registered nurse referring to a 1 years old male patient. There was no pertinent medical history, concomitant drug or drug reaction/allergies of the patient. On 23-MAR-2016 the patient was vaccinated with 1 vial of M-M-R II (Lot # was reported as L0277432, expiration date was reported as 22-JUL-2017, dose and strength were not reported) subcutaneously. The patient had an unspecified fever and had broken out in an unspecified rash on an unspecified area of his body for 5 days in 2016 and both were getting worse. His parents sought medical attention by contacting the office after the rash had appeared and the patient was then seen in the office on 06-APR-2016 where a physician stated the rash appeared to be a measles-like rash and gave the patient the diagnosis of measles. The physician had referred the patient to be seen by an infectious disease doctor and it was unknown if the patient had gone to se this provider. No treatment was given and no lab diagnostics studies were performed. Outcome of the event and the causality were not reported. It has been confirmed that lot # L0277432 was not valid for measles, mumps, and rubella. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: MMR, MMR, MMR
Symptoms: Rhinorrhoea, Tonsillar hypertrophy
Clinical narrative: Information has been received from a registered nurse referring to a 1 years old male patient. There was no pertinent medical history, concomitant drug or drug reaction/allergies of the patient. On 23-MAR-2016 the patient was vaccinated with 1 vial of M-M-R II (Lot # was reported as L0277432, expiration date was reported as 22-JUL-2017, dose and strength were not reported) subcutaneously. The patient had an unspecified fever and had broken out in an unspecified rash on an unspecified area of his body for 5 days in 2016 and both were getting worse. His parents sought medical attention by contacting the office after the rash had appeared and the patient was then seen in the office on 06-APR-2016 where a physician stated the rash appeared to be a measles-like rash and gave the patient the diagnosis of measles. The physician had referred the patient to be seen by an infectious disease doctor and it was unknown if the patient had gone to se this provider. No treatment was given and no lab diagnostics studies were performed. Outcome of the event and the causality were not reported. It has been confirmed that lot # L0277432 was not valid for measles, mumps, and rubella. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: MMR, MMR, MMR
Symptoms: Measles post vaccine, Pyrexia, Rash, Rash morbilliform
Clinical narrative: Information has been received from a registered nurse referring to a 1 years old male patient. There was no pertinent medical history, concomitant drug or drug reaction/allergies of the patient. On 23-MAR-2016 the patient was vaccinated with 1 vial of M-M-R II (Lot # was reported as L0277432, expiration date was reported as 22-JUL-2017, dose and strength were not reported) subcutaneously. The patient had an unspecified fever and had broken out in an unspecified rash on an unspecified area of his body for 5 days in 2016 and both were getting worse. His parents sought medical attention by contacting the office after the rash had appeared and the patient was then seen in the office on 06-APR-2016 where a physician stated the rash appeared to be a measles-like rash and gave the patient the diagnosis of measles. The physician had referred the patient to be seen by an infectious disease doctor and it was unknown if the patient had gone to se this provider. No treatment was given and no lab diagnostics studies were performed. Outcome of the event and the causality were not reported. It has been confirmed that lot # L0277432 was not valid for measles, mumps, and rubella. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: MMR, MMR, MMR
Symptoms: Measles, Pyrexia, Rash
Clinical narrative: Information has been received from a registered nurse referring to a 1 years old male patient. There was no pertinent medical history, concomitant drug or drug reaction/allergies of the patient. On 23-MAR-2016 the patient was vaccinated with 1 vial of M-M-R II (Lot # was reported as L0277432, expiration date was reported as 22-JUL-2017, dose and strength were not reported) subcutaneously. The patient had an unspecified fever and had broken out in an unspecified rash on an unspecified area of his body for 5 days in 2016 and both were getting worse. His parents sought medical attention by contacting the office after the rash had appeared and the patient was then seen in the office on 06-APR-2016 where a physician stated the rash appeared to be a measles-like rash and gave the patient the diagnosis of measles. The physician had referred the patient to be seen by an infectious disease doctor and it was unknown if the patient had gone to se this provider. No treatment was given and no lab diagnostics studies were performed. Outcome of the event and the causality were not reported. It has been confirmed that lot # L0277432 was not valid for measles, mumps, and rubella. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Diarrhoea, Measles, Pyrexia, Rash macular, Rash papular
Clinical narrative: Information has been received from a registered nurse referring to a 1 years old female patient. There was no pertinent medical history, concomitant drug or drug reaction/allergies of the patient. On 23-MAR-2016 the patient was vaccinated with a dose of M-M-R II, (Lot# was reported as L0277432, expiration date was reported as 22-JUL-2017, dose and strength were not reported) subcutaneously. The patient had an unspecified fever and had broken out in an unspecified rash on an unspecified area of her body for 5 days in 2016 and both were getting worse. Her parents sought medical attention by contacting the office after the rash had appeared and the patient was then seen in the office on 06-APR-2016 where a physician stated the rash appeared to be a measles-like rash and gave the patient the diagnosis of measles. The physician had referred the patient to be seen by an infectious disease doctor and it was unknown if the patient had gone to see this provider. No treatment was given and no lab diagnostics studies were performed. Outcome of the event and the causality were not reported. It has been confirmed that lot# L0277432 was not valid for M-M-R II. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Rhinorrhoea, Tonsillar hypertrophy
Clinical narrative: Information has been received from a registered nurse referring to a 1 years old female patient. There was no pertinent medical history, concomitant drug or drug reaction/allergies of the patient. On 23-MAR-2016 the patient was vaccinated with a dose of M-M-R II, (Lot# was reported as L0277432, expiration date was reported as 22-JUL-2017, dose and strength were not reported) subcutaneously. The patient had an unspecified fever and had broken out in an unspecified rash on an unspecified area of her body for 5 days in 2016 and both were getting worse. Her parents sought medical attention by contacting the office after the rash had appeared and the patient was then seen in the office on 06-APR-2016 where a physician stated the rash appeared to be a measles-like rash and gave the patient the diagnosis of measles. The physician had referred the patient to be seen by an infectious disease doctor and it was unknown if the patient had gone to see this provider. No treatment was given and no lab diagnostics studies were performed. Outcome of the event and the causality were not reported. It has been confirmed that lot# L0277432 was not valid for M-M-R II. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Measles post vaccine, Pyrexia, Rash, Rash morbilliform
Clinical narrative: Information has been received from a registered nurse referring to a 1 years old female patient. There was no pertinent medical history, concomitant drug or drug reaction/allergies of the patient. On 23-MAR-2016 the patient was vaccinated with a dose of M-M-R II, (Lot# was reported as L0277432, expiration date was reported as 22-JUL-2017, dose and strength were not reported) subcutaneously. The patient had an unspecified fever and had broken out in an unspecified rash on an unspecified area of her body for 5 days in 2016 and both were getting worse. Her parents sought medical attention by contacting the office after the rash had appeared and the patient was then seen in the office on 06-APR-2016 where a physician stated the rash appeared to be a measles-like rash and gave the patient the diagnosis of measles. The physician had referred the patient to be seen by an infectious disease doctor and it was unknown if the patient had gone to see this provider. No treatment was given and no lab diagnostics studies were performed. Outcome of the event and the causality were not reported. It has been confirmed that lot# L0277432 was not valid for M-M-R II. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 1.01
Sex: F
Vaccine: MMR, MMR, MMR
Symptoms: Measles, Pyrexia, Rash
Clinical narrative: Information has been received from a registered nurse referring to a 1 years old female patient. There was no pertinent medical history, concomitant drug or drug reaction/allergies of the patient. On 23-MAR-2016 the patient was vaccinated with a dose of M-M-R II, (Lot# was reported as L0277432, expiration date was reported as 22-JUL-2017, dose and strength were not reported) subcutaneously. The patient had an unspecified fever and had broken out in an unspecified rash on an unspecified area of her body for 5 days in 2016 and both were getting worse. Her parents sought medical attention by contacting the office after the rash had appeared and the patient was then seen in the office on 06-APR-2016 where a physician stated the rash appeared to be a measles-like rash and gave the patient the diagnosis of measles. The physician had referred the patient to be seen by an infectious disease doctor and it was unknown if the patient had gone to see this provider. No treatment was given and no lab diagnostics studies were performed. Outcome of the event and the causality were not reported. It has been confirmed that lot# L0277432 was not valid for M-M-R II. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: DTAPIPV, MMRV, MMRV, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 5 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 26-JUN-2012, the patient was vaccinated with the first dose of PROQUAD (Merck) (dose, route of administration, injection site, lot# and expiration date were not provided). On 23-APR-2015, the patient was vaccinated with the second dose of PROQUAD (Merck) (dose, route of administration, injection site, lot# and expiration date were not provided). On 22-APR-2016, the patient inadvertently received an extra dose of PROQUAD (Merck) (lot # M001152, expiration date: 05-JUL-2017, dose, route of administration and injection site were not provided). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Chest X-ray normal, Chest discomfort, Chest pain
Clinical narrative: Dull substernal chest pain/tightness with SOB (difficulty taking deep breaths) with subjective fevers & chills, mild sweating, sore throat, and mild intermittent cough with clear mucus.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Chills, Dyspnoea, Echocardiogram normal, Electrocardiogram normal, Hyperhidrosis
Clinical narrative: Dull substernal chest pain/tightness with SOB (difficulty taking deep breaths) with subjective fevers & chills, mild sweating, sore throat, and mild intermittent cough with clear mucus.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Oropharyngeal pain, Productive cough, Pyrexia, Troponin I increased
Clinical narrative: Dull substernal chest pain/tightness with SOB (difficulty taking deep breaths) with subjective fevers & chills, mild sweating, sore throat, and mild intermittent cough with clear mucus.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Blood creatine phosphokinase MB normal, Chest X-ray normal, Chest discomfort, Chest pain, Chills
Clinical narrative: Dull substernal chest pain/tightness with SOB (difficulty taking deep breaths) with subjective fevers & chills, mild sweating, sore throat, and mild intermittent cough with clear mucus.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Differential white blood cell count normal, Dyspnoea, Electrocardiogram normal, Full blood count normal, Hyperhidrosis
Clinical narrative: Dull substernal chest pain/tightness with SOB (difficulty taking deep breaths) with subjective fevers & chills, mild sweating, sore throat, and mild intermittent cough with clear mucus.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Metabolic function test normal, Myocarditis, Oropharyngeal pain, Productive cough, Pyrexia
Clinical narrative: Dull substernal chest pain/tightness with SOB (difficulty taking deep breaths) with subjective fevers & chills, mild sweating, sore throat, and mild intermittent cough with clear mucus.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Troponin increased
Clinical narrative: Dull substernal chest pain/tightness with SOB (difficulty taking deep breaths) with subjective fevers & chills, mild sweating, sore throat, and mild intermittent cough with clear mucus.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Blood creatine phosphokinase MB normal, Blood creatine phosphokinase increased, Blood creatine phosphokinase normal, Chest X-ray normal, Chest discomfort
Clinical narrative: Dull substernal chest pain/tightness with SOB (difficulty taking deep breaths) with subjective fevers & chills, mild sweating, sore throat, and mild intermittent cough with clear mucus.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Chest pain, Chills, Dyspnoea, Echocardiogram normal, Electrocardiogram normal
Clinical narrative: Dull substernal chest pain/tightness with SOB (difficulty taking deep breaths) with subjective fevers & chills, mild sweating, sore throat, and mild intermittent cough with clear mucus.
Age: 20.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Hyperhidrosis, Oropharyngeal pain, Productive cough, Pyrexia, Troponin increased
Clinical narrative: Dull substernal chest pain/tightness with SOB (difficulty taking deep breaths) with subjective fevers & chills, mild sweating, sore throat, and mild intermittent cough with clear mucus.
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Initial unsolicited report received from a pharmacist on 08 April 2016. This case involves a female patient (age not reported) who was vaccinated with a dose of TDAP (dose, dose in series, batch number, route and site of administration were not reported) on an unspecified date (about year ago). Patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient developed high fever. Patient's lab data and corrective treatment were not reported. On an unspecified date, patient had recovered. List of documents held by sender: none.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker concerning an unspecified patient of unknown age and gender. No concurrent condition, medical history and concomitant therapies were reported. On 15-APR-2016, the patient was inadvertently administered an expire dose of PROQUAD (Merck) (dosage not provided, subcutaneous, lot # K014800 with expire date of 12-MAR-2016). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a physician concerning an older than 32 weeks old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with a dose of ROTATEQ (strength, frequency and route unknown, lot # L027070 and expiration date 30-APR-2017) (inappropriate schedule of drug administration). This was outside of the recommended dosing schedule. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates starting on or after 22-APR-2016, the patients were administered an unspecified number of improperly stored doses of GARDASIL (lot # L020162, expiration date 23-JUL-2017) (dose and route of administration were not reported). The administered doses experienced a temperature excursion of 32 F for 2 hours and 8 minutes. No previous excursions were reported. The temperature excursions were detected by a data logger. No adverse effect were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Blood test, Dizziness, Hypoaesthesia, Muscle spasms
Clinical narrative: Blurry vision 4/25. (All) joint pain. Dizziness. Numbness and tingling both arms. Muscle cramps (fingers to shoulders - both arms).
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Paraesthesia, Vision blurred
Clinical narrative: Blurry vision 4/25. (All) joint pain. Dizziness. Numbness and tingling both arms. Muscle cramps (fingers to shoulders - both arms).
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to unspecified number of unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates starting on or after 22-APR-2016, the patients were administered an unspecified number of improperly stored doses of VAQTA (lot # K023019, expiration date 28-APR-2017) (dose and route of administration were not reported). The administered doses experienced a temperature excursion of 32 F for 2 hours and 8 minutes. No previous excursions were reported. The temperature excursions were detected by a data logger. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a licensed vocational nurse concerning a patient of unknown age and gender. No concurrent condition, medical history and concomitant therapies were reported. On 02-NOV-2015 the patient was administered the first dose of GARDASIL 9 (Lot# L016428 with expire date of 30-JUL-2017), the second dose (Lot# L020015 with expire date of 16-AUG-2017) on 01-FEB-2016, and the third dose (Lot# L043213 with expire date of 28-AUG-2017) on 20-APR-2016 all intramuscularly (inappropriate schedule of drug administration). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician via employee refers to unspecified patients of unknown age and gender. The patients' medical history included splenectomy. The patients' concurrent conditions and concomitant medications were not reported. On an unknown date, patients were vaccinated with PNEUMOVAX 23 (dose, route and site of administration, lot # and expiry date were not reported). The physician was administered the vaccine every 10 years to patients who had splenectomy. No adverse symptoms were reported. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: PPV
Symptoms: Erythema multiforme, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Erythema multiforme and erythema, edema, pain at injection site.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Erythema multiforme, Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Erythema multiforme and erythema, edema, pain at injection site.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 29-MAR-2016, the patient was vaccinated with VAQTA intramuscularly, (lot number, expiry date, dose and anatomical site of injection were not reported); and then, he/she received another dose on 01-MAY-2016. Concomitant therapies were not provided. No adverse effects were reported. No product quality complain (PQC) was involved. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 74 year old male patient. No medical history and concurrent conditions were reported. On 17-MAR-2016 the patient was vaccinated with ZOSTAVAX (lot # L015416, expiry date August 2016) subcutaneously (dosing regimen and frequency unknown). No concomitant medications were reported. On an unknown date in 2016 (also reported as now) the patient was scheduled to begin therapy with Prednisone (manufacturer unknown) (circumstance or information capable of leading to medication error) at 40 mg per day as prescribed by his physician for an unknown condition (adverse event) (details unspecified), it was reported that the condition began on an unspecified date approximately in 2016. It was reported that the patient sought medical attention and was seen by an unspecified physician. The pharmacist also reported that the patient has not yet started Prednisone (manufacturer unknown) therapy. The action taken with therapy with ZOSTAVAX was unknown. The outcome of the event was reported as not recovered. The relatedness of the events to the therapy with ZOSTAVAX was unknown. There was no product quality complaint reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Oral mucosal eruption, Pericarditis, Pneumonia
Clinical narrative: This spontaneous report as received from a physician refers to a 60 year old female patient. Pertinent medical history was not reported. In approximately November 2014 (reported as "about a year and a half ago"), the patient was vaccinated with ZOSTAVAX (strength, dose, route and lot # not reported). No concomitant therapy reported. On an unknown date the patient developed pericarditis, pneumonia and persistent asthenia with an oral rash. The patient sought unspecified medical attention. Varicella-Zoster virus (VZV) kit was offered to the patient by the physician and declined because "lesions" had subsided. The patient had not recovered from pericarditis, pneumonia and persistent asthenia. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: States he received the pneumonia injection, and the site has swollen about the size of a softball. Pain at injection site. Ibuprofen 200 mg qid.