chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 48 year old female patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-Oct-2014) concerns a 48 year old male patient. On 26-Oct-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-Oct-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-Oct-2014, the patient received temperature excursioned AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. No adverse reactions were reported since administration. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 44 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Age: 49.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 49 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 26 year old female patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 42 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 46 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 30 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 31 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Age: 37.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 37 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 55 year old female patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 64 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 56 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 50 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-Oct-2014) concerns a 51 year old female patient. On 26-Oct-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-Oct-2014, the patient received temperature excursioned AFLURIA, (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: This consumer spontaneous report (initial receipt: 03-NOV-2014) concerns a female patient. On 04-OCT-2014, the patient received intramuscular AFLURIA (batch number T58706) at 0.5 ml. On 07-OCT-2014, the patient developed itchy hives all over her body. The hives completely disappeared on 15-OCT-2014. The outcome was unknown (reported as recovered for the hives). Reporter comments: The reporter assessed the event as non-serious and the Causality as probable to AFLURIA.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-Oct-2041) concerns a 27 year old male patient. On 26-Oct-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-Oct-2041, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-Oct-2041, the patient received temperature excursioned AFLURIA, (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 33 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This medically confirmed spontaneous report (initial receipt: 04-Nov-2014) concerns a female patient. On 06-Oct-2014, the patient received intramuscular AFLURIA, (batch number T59607) at 0.5 mL once on the left arm. AFLURIA was stored correctly. On 06-Oct-2014, sometime later on the same day as the vaccination, the patient noticed itching and redness at the injection site. The injection site also swelled up to the size of an orange. The patient followed up with the physician and received a corticosteroid pack. The redness and swelling completely resolved with treatment on an unknown date. The outcome was reported as recovered. Reporter comments: The reporter assessed the events as non-serious and the causality as probable in relation to AFLURIA.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 35 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-Oct-2014) concerns a 64 year old male patient. On 26-Oct-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-Oct-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-Oct-2014, the patient received temperature excursions AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-Oct-2014) concerns a 53 year old male patient. On 26-Oct-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-Oct-2014, the patient received temperature excursioned AFLURIA, (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-Oct-2014) concerns a 33 year old male patient. On 26-Oct-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-Oct-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-Oct-2014, the patient received temperature excursioned AFLURIA, (batch number: T50507) via intramuscular route at 0.5 ml. No adverse reactions were reported since administration. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-Oct-2014) concerns a 56 year old female patient. On 26-Oct-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-Oct-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-Oct-2014, the patient received temperature excursioned AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Age: 29.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-Oct-2014) concerns a 29 year old male patient. On 26-Oct-2014, AFLURIA underwent temperature excursion at 50 degrees Fahrenheit. On 27-Oct-2014, AFLURIA again had temperature exucrsion at 50 degree Fahrenheit for undetermined amount of time. On 27-Oct-2014, the patient received temperature excursioned AFLURIA, (batch number T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Incorrect product storage
Clinical narrative: This medically confirmed spontaneous report (initial receipt 28-Oct-2014) concerns a 57 year old male patient. On 26-Oct-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-Oct-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-Oct-2014, the patient received temperature excursioned AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
Age: 0.75
Sex: F
Vaccine: HEP
Symptoms: Rash generalised
Clinical narrative: Rash started on face, neck and hands then spread to her trunk and legs. This was present by 11am the day following the vaccine. Rash is not itchy. No other symptoms.
Age: 74.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Redness in left arm (upper). Difficulty elevating left upper arm soreness.
Age: 18.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Asthenia, Loss of consciousness, Pallor
Clinical narrative: Pt passed out, felt weak, turned very pale, and possibly had a seizure.
Age: 83.0
Sex: M
Vaccine: PNC13
Symptoms: Electrocardiogram, Injection site pain, Musculoskeletal pain, Pain in extremity
Clinical narrative: Severe pain at site of injection starting same day if injection 7/21/15. Pain has worsened and now also in opposite arm (injection in (R) deltoid, now pain (R)and (L) deltoid and scapula areas.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Malaise, Pallor, Tension, Unresponsive to stimuli
Clinical narrative: Patient stated she has history of fainting with vaccines. She ate and had something to drink today. She also had juice and candy in the office. After vaccine given, 5 minutes later she stated she felt ill, was pale, body became very tense for about 10 seconds during which time she did not answer and she drank water. She was able to move to sitting and standing. Color was improved. She felt well enough to leave office 35 minutes after vaccine. She was also examined by dr. while she was here.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Local site swelling/rash/redness approx 4 x 4".
Age: 71.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Feeling hot
Clinical narrative: Face got red 15 min after vaccine given 7/23/15. Hands, feet, private areas felt hot. Occurred day after vaccine as Nov 9:00 am.
Age: 22.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Conjunctivitis, Cough, Decreased appetite, Musculoskeletal stiffness
Clinical narrative: Fever, chills, muscle pain, no appetite, neck stiffness, cough, nasal congestion, pharyngitis, conjunctivitis.
Age: 22.0
Sex: F
Vaccine: UNK
Symptoms: Myalgia, Nasal congestion, Pharyngitis, Pyrexia
Clinical narrative: Fever, chills, muscle pain, no appetite, neck stiffness, cough, nasal congestion, pharyngitis, conjunctivitis.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: 48 hrs after Tdap and MENACTRA vaccines developed erythem, urticarial 13.5 x 11.5 cm rash over (L) deltoid (site of injections). No fever.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 14-JUL-2015, the patient was vaccinated with expired dose of MMR II lot # J0101577/0457AE and expiry date of 11-JUL-2015 (unknown strength, route and dose). Concomitant medications were not reported. No adverse effects were reported. The outcome of expired product administered was unknown. There was no product quality complaint involved. Additional information is not expected as reporter denied further contact.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Facial paresis
Clinical narrative: Facial nerve weakness, onset 1 day after immunization. Rx oral steroids, valacyclovir.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates the patients were vaccinated with doses of improperly stored VAQTA lot # K012457, expiration date 04-JUN-2017 (dose and route not reported). No adverse symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker (medical assistant) referring to an unspecified number of unknown age and gender. The patient's medical history or concurrent condition were not provided. On unknown dates the patients received improperly stored doses of GARDASIL (strength, lot#, expiration date, dose and route were unspecified). No concomitant therapy was provided. No adverse effect was reported. This is one of the several reports that received from the same source. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Varicella immunization given 7/22/15. Injection site began swelling with pain, warmth and redness on 7/24/15 at 2 AM. Pain is moderate to severe shooting down to hand. 8 cm diameter area of redness and swelling to R upper arm.
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain in extremity
Clinical narrative: Varicella immunization given 7/22/15. Injection site began swelling with pain, warmth and redness on 7/24/15 at 2 AM. Pain is moderate to severe shooting down to hand. 8 cm diameter area of redness and swelling to R upper arm.
Age: 3.0
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Cellulitis, Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: Pt received PENTACEL 7/8/15 to left thigh - 7/10/15 to ER with redness, swelling at injection site. TX allergic rxn and cellulitis.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Heart rate decreased, Pallor, Respiratory rate decreased
Clinical narrative: Vaccines administered, baby cried, good color. Shortly after baby's skin color changed from pink to pallor. Change in vitals. Heart rate 70 beats less and respirations reduced by 40 points. HR-184 to 110 RR 80-40. Took 20 mins to resolve. Good pulses, strong suck and responsive the entire time.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patient's medical history or concurrent condition were not provided. On unknown dates between 01-JUN-2015 and 15-JUL-2015, the patients received improperly stored M-M-R II 0.5 ml, (lot # J014876, expiration date 21-NOV-2015, therapy type rHA) subcutaneously. Concomitant drug was not reported. No adverse effects were reported. It was unknown whether the patients sought medical attention. This is one of several reprots received from the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Swelling
Clinical narrative: Redness and swelling 5 cm x 7 cm.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Muscle spasms
Clinical narrative: Information has been received from a Licensed Practical Nurse (L.P.N.) referring to a 67 year old female patient with asthma, hypothyroidism, hypertension, sleep apnea, insomnia and drug allergies to morphine and pravastatin. It was reported that the patient had a history of an unspecified reaction to morphine and pravastatin (manufacturers unspecified). On 22-JUL-2015 the patient was vaccinated with PNEUMOVAX 23 (0.5 ml/once, intramuscular, lot# reported as K018183, expiration date 04-MAY-2016) for vaccination. Concomitant therapies included trazodone (manufacturer unknown), methylphenidate, PROAIR (trade name reported as "PROAIR INHALER", levothyroxine (manufacturer unknown), estrogens, PREMARIN, FLEXERIL, promethazine, aspirin, oxycodone and tretinoin. On 22-JUL-2015, the patient experienced swelling at the injection site and bilateral lower leg cramps. The patient sought medical attention by calling the nurse. Ice was applied to the injection site as treatment. No lab diagnostics studies were performed. Outcome of the events was not recovered. Causality assessment was not reported. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Abscess limb, Cellulitis, Erythema, Herpes zoster, Pain
Clinical narrative: Cellulitis and abscess of upper limb. Shingles outbreak. Redness, soreness.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown date the patients were vaccinated with doses of improperly stored ROTATEQ, lot # K014826, expiration date 28-MAY-2016 (dose not reported) orally. No adverse symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist via a field employee refers to a patient of unknown age and gender. The patient's concurrent conditions and pertinent medical history were unspecified by reporter. On an unknown date, the patient was vaccinated with ZOSTAVAX vial (dose, frequency and route not reported). On the same date, the patient was vaccinated with unspecified Flu vaccination. On an unknown date, the patient experienced local itching. The pharmacist reported that the local itching lasted for 1 week. It was unspecified if the patient received any treatment or if any lab diagnostics tests were performed. The causality assessment was not provided. No product quality complaint (PQC) was reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. No concurrent or historical conditions were reported. On unknown dates, the patients were vaccinated with doses of GARDASIL (strength, dose, route, lot# and expiration date were unknown), which were improperly stored. No adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to an unspecified number of patients of unknown age and unknown gender. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients received doses of improperly stored ROTATEQ (dose, lot# and expiration date were not reported) orally. Concomitant drug was not reported. No adverse effects were reported. It was unknown whether the patients sought medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX lot # L006384, expiration date 25-FEB-2017 (dose and route not reported). No adverse symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Wrong drug administered
Clinical narrative: This spontaneous prospective pregnancy report was received from a female patient of unknown age, who was reporting on herself. No information about patient's concomitant medication, concurrent medical history, drug reactions or allergies was provided. On an unknown date approximately in 2015, an unspecified nurse mistakenly gave the patient a shot of GARDASIL (dose, administration route, lot# and expiration date not reported) instead of a Tetanus shot. No distinction was made to determine if the product given was GARDASIL or GARDASIL 9 (dose, administration route, lot# and expiration date not reported). The patient did confirm that she was 28 weeks pregnant at the time of the report with estimated Last Menstrual Period (LMP) on 26-DEC-2014, Estimated Conception Date (ECD) on 09-JAN-2014 and Estimated Delivery Date (EDD) on 02-OCT-2015. Initial exposure to GARDASIL or GARDASIL 9 was in second trimester. The pregnancy outcome was pending. The fetal outcome was unknown. Additional information has been requested.
Age: 85.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Tremor
Clinical narrative: PREVNAR vaccine given in left arm, night of vaccination patient had "shakes", the following day patient's left arm red and tender at site, around six inches around site, also hot to touch.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to an unspecified number of patients of unspecified age and gender. No medical history and concurrent conditions were reported. Since 09-JUN-2015 (exact dates unspecified), the patients received doses of improperly stored PNEUMOVAX23 (lot number, dose, frequency, route and site of administration was not reported). No adverse effects were reported. The outcome of the events was unknown. No product quality complaint (PQC) was filed. No further information was provided. This is one of the 4 reports of the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On 02-JUL-2015, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # J011339, expiration date 13-DEC-2014) (route of administration and dose were not reported). No adverse effects reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site discomfort, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 7/17/15 10:30AM Pt called call center reporting upper left arm pain, with redness, hard to move arm, body aches. Declined appt of ER visit. Declines phone appt with PCP. Dr. (allergist) called pt at 11:14AM. Pt denies fever, but has swelling and discomfort at site. Instructed to take acetaminophen 1000 mg PO. 7/17/15 12:21PM Pt has less pain and plans to resume normal activities per Dr. follow up phone call.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Pain
Clinical narrative: 7/17/15 10:30AM Pt called call center reporting upper left arm pain, with redness, hard to move arm, body aches. Declined appt of ER visit. Declines phone appt with PCP. Dr. (allergist) called pt at 11:14AM. Pt denies fever, but has swelling and discomfort at site. Instructed to take acetaminophen 1000 mg PO. 7/17/15 12:21PM Pt has less pain and plans to resume normal activities per Dr. follow up phone call.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Lymphadenopathy, Rash
Clinical narrative: This spontaneous report was received from a nurse and refers to a currently 17 years old female patient. No medical history and concurrent conditions were reported. The patient had no drug reactions or allergies. Approximately in May 2015 (reported as "two months ago"), the patient was vaccinated with a dose of GARDASIL (lot #, expiration date, dose, route of administration and anatomical location were not reported). Concomitant therapies included LOESTRIN. Approximately in May 2015, the patient experienced rash on her face and swelling of lymph nodes in her neck. No treatment was given and no lab diagnostic studies were performed. The patient sought medical attention, the patient's mother called the office. The outcome of the events was recovered on an unknown date in May 2015 (reported as "within 4 unspecified days after GARDASIL was administered). The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Pertinent medical history and concomitant medications were not reported. On 25-JUN-2015, the patient was vaccinated with improperly stored VAQTA (lot # reported as 1004743 with expiration date 25-JUN-2016, dose and route not reported). No adverse symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Injection site irritation, Injection site pruritus
Clinical narrative: (L) thigh localized inflammation/irritation. No temp or leg pain. Mild itching - resolved with BENADRYL. Small area of erythema persisting.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Food allergy, Rash, Urticaria
Clinical narrative: Grandmother called to report child developing rash starting on Rt Arm the afternoon of 7/22/2015. Described rash looking like hives, spreading to left arm and back. No fever. No itching. Did have smoothie with mixed berries earlier in day.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Dizziness, Nausea, Oxygen saturation normal
Clinical narrative: Patient felt dizzy and nauseous after vaccines were administered for a brief time.
Age: 17.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema
Clinical narrative: 6.5cm x 7.5cm - area reddened.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Immediate post-injection reaction
Clinical narrative: Immediate frontal headache.
Age: 5.0
Sex: M
Vaccine: HEP, IPV
Symptoms: Dyskinesia, Excessive eye blinking, Tic
Clinical narrative: Patient developed motor tics about 8 hrs after giving first dose of hepatitis B and polio. Opening/closing of mouth, eye blinking. Symptoms have continued for the last 5 days.
Age: 51.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Fatigue, Influenza like illness, Myalgia, Nasal congestion, Palpitations
Clinical narrative: Received pneumonia and shingles 7/14/15-developed flu like symptoms hours later, seen in ER next am left without provider seeing due to wait. Now presents with fatigue, myalgias (improving). Racing heart and nasal congestion resolved.
Age: 63.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Tremor
Clinical narrative: Tremor in (R) arm, weakness in entire body over time. Noticed symptoms of tremor in one week but went away, came back worsened over time, permanent lost 4 mo's. ER visit inconclusive. Seeing neurologist 7/23/15.
Age: 15.0
Sex: F
Vaccine: HPV4, HPVX
Symptoms: Fall, Lip injury, Swelling face, Syncope, Tooth fracture
Clinical narrative: Fainting episode after HPV vaccine given, fall on the floor had bump on forehead/superficial cut inner lip/chipped tooth.
Age: 15.0
Sex: F
Vaccine: HPV4, HPVX
Symptoms: Dizziness, Facial bones fracture, Fall, Feeding disorder, Fluid intake reduced
Clinical narrative: Fainting episode after HPV vaccine given, fall on the floor had bump on forehead/superficial cut inner lip/chipped tooth.
Age: 15.0
Sex: F
Vaccine: HPV4, HPVX
Symptoms: Headache, Lip injury, Mouth haemorrhage, Photopsia, Rhinoplasty
Clinical narrative: Fainting episode after HPV vaccine given, fall on the floor had bump on forehead/superficial cut inner lip/chipped tooth.
Age: 15.0
Sex: F
Vaccine: HPV4, HPVX
Symptoms: Sensitivity of teeth, Swelling face, Syncope, Tooth fracture
Clinical narrative: Fainting episode after HPV vaccine given, fall on the floor had bump on forehead/superficial cut inner lip/chipped tooth.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Localized redness, slight swelling, warm to touch.
Age: 13.0
Sex: F
Vaccine: DTAP, MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse reaction.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse (R.N.) concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, unspecified patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, route, Lot No. and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a Medical Assistant via a company representative, concerning a female patient of unknown age. The patient's concurrent conditions and pertinent medical history were not reported. On 14-JUL-2015, the patient received late second dose of GARDASIL (lot #, exp. date, strength and dose were not provided). It was unspecified when the patient received her first dose of GARDASIL, however, it was confirmed that interval between first and second dose administered had definitely been longer than 2 months. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. The pharmacist reported that on 12-JUL-2015, the patient was vaccinated with one improperly stored dose of PNEUMOVAX 23 (lot number, expiration date was not reported, dose and route were not reported). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. The pharmacist reported that on 12-JUL-2015, the patient was vaccinated with one improperly stored dose of PNEUMOVAX23 (lot number, expiration date was not reported, dose and route were not reported). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Patient's medical history and concurrent conditions were not reported. On 29-MAY-2015, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX lot number K021487 (dose and route were not reported) and a dose of improperly stored MMR II lot number reported as 014833 (dose and route were not reported). Concomitant medications were not reported. No adverse effects were reported. Lot number 014833 is not valid lot number for MMR II. This is the one of the several reports from the same reporter source. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV4, MEN
Symptoms: Eye injury, Fall, Loss of consciousness, Suture insertion
Clinical narrative: This spontaneous report as received from a physician via a company representative on 21-JUL-2015 refers to a 17 year old male patient. The patient's medical history and concurrent conditions were unspecified. On an unknown date in July 2015 (reported as last week) the patient was vaccinated with the first dose of GARDASIL (Strength, dose and lot number not reported) intramuscularly. The concomitant medication included unspecified Hepatitis A vaccine (manufacturer unknown) and unspecified Meningococcal vaccine. The physician reported that the patient passed out (syncope) and fell within 15 minutes of administration of GARDASIL and required stitches in the eye area. The event occurred within the physician's office. It was unspecified, if any lab test/diagnostic studies was performed. On an unspecified date of July 2015, the patient recovered from the events. Causality assessment for the event was not provided by the reporter. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial and follow up information has been received from a medical assistant referring to a patient of unknown age and gender. On 28-APR-2015, the patient was vaccinated with a dose of ROTATEQ oral, lot # K011663, (expiration date, dose and site of administrations were not reported) that was exposed to temperatures outside of the recommended range during 40 hours. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information is not expected as all the follow ups requested to complete the case were received.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician an office manager refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On 05-JUN-2015 the patient was vaccinated with an improperly stored dose of MMR II lot # K014833, expiration date 14-SEP-2016 (dose, dose number, route and anatomical locations were unspecified). Concomitant therapies were not reported. On 24-JUN-2015, the patient was revaccinated with an unspecified lot of MMR II. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician and office manager refers to a 4 year old patient of unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On 09-JUN-2015 the patient was vaccinated with an improperly stored dose of MMR II lot # K014833, expiration date 14-sEP-2016, for prophylaxis (dose, dose number, route and anatomical location were unspecified). No adverse effects reported. Concomitant therapies were not reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Incorrect route of drug administration
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 64 year old female patient. The patient was allergic (also reported unspecified reaction) to Penicillin. On 10-JUL-2015, the patient was inadvertently vaccinated with ZOSTAVAX (lot # K021953 and expiration date 10-FEB-2016) intramuscular. Concomitant therapies included fluoxetine, metformin, metoprolol, LANTUS, LIPITOR, levothyroxine and HUMALOG. On 10-JUL-2015, the patient felt burn. When patient felt burn, the pharmacist realized it was administered by the wrong route. Pharmacist reported she removed the needle and administered it subcutaneously. Action taken was not applicable. The outcome of events was reported as recovered/resolved. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Pruritus
Clinical narrative: Patient c/o itchy.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date the patients were vaccinated with improperly  stored doses of VARIVAX (Merck) or PROQUAD (Merck), lot # K016425, expiration date 26-MAR-2016; lot # L009209, expiration date 17-SEP-2016; or, lot # L004005, expiration date 05-AUG-2016 (dose, dose number, route and anatomical location were unspecified). No adverse effects reported. Concomitant therapies were not reported. Lot numbers reported are valid only for PROQUAD (Merck). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to an unspecified number of patients of unspecified age and gender. No medical history and concurrent conditions were reported. Since 09-JUN-2015 (exact dates unspecified), the patients received doses of improperly stored GARDASIL (lot number, dose, frequency, route and site of administration was not reported). No adverse effects were reported. The outcome of the events was unknown. No product quality complaint (PQC) was filed. No further information was provided. This is one of the 4 reports of the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to an unspecified number of patients of unspecified age and gender. No medical history and concurrent conditions were reported. Since 09-JUN-2015 (exact dates unspecified), the patients received doses of improperly stored, oral, ROTATEQ suspension 2 (lot number, dose, frequency, route and site of administration was not reported). No adverse effects were reported. The outcome of the events was unknown. No product quality complaint (PQC) was filed. No further information was provided. This is one of the 4 reports of the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. Pertinent medical history and concomitant medications were not reported. On 30-JUN-2015, the patient was vaccinated with improperly stored VAQTA (lot # K010579 with expiration date 12-FEB-2017, dose and route not reported). No adverse symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Dysphagia, Erythema, Hypersensitivity, Pruritus, Rash
Clinical narrative: Allergic reaction after vaccination approximately 1 hour after receiving-developed difficulty swallowing, rash, itching. This 13 yrs old male presents to ER via walk-in with complaints of Allergic Reaction. The patient presents with difficulty swallowing, itching, rash, redness of skin. Onset: The symptoms/episode began/occurred suddenly, 1 hour(s) ago, after getting 4 injections at Dr's office: HPV, Tdap, meningococcal, Hep A vaccines. Associated signs and symptoms: Pertinent positives: hives, swelling, Pertinent negatives: chest pain, dysphagia, shortness of breath. Possible causes: At home the patient or guardian has treated the symptoms with nothing. Severity of symptoms: At their worst the symptoms were moderate in the emergency department the symptoms are unchanged. The EMS care prior to arrival includes: none. The patient has not experienced similar symptoms in the past. The patient has been recently seen by a physician. Dr., earlier today.