chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PNC
Symptoms: Local reaction
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age and ethnicity started to receive PREVNAR, via an unspecified route of administration from May2015 at 1 DF, single. Medical history included allergic to Sodium Benzoate and Potassium Sorbate and these were commonly used fruit preservatives from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced bad reaction (unspecified) on May2015 with outcome of unknown. The action taken in response to the event for PREVNAR was not applicable. No follow up attempts possible. No further information expected.
Sex: U
Vaccine: PNC
Symptoms: Local reaction
Clinical narrative: This is a spontaneous report from a non-contactable physician. A patient of unspecified age, ethnicity, and gender received a single dose of PREVNAR, via an unspecified route of administration on an unspecified date for immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced pronounced local reaction with an outcome of unknown. No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: DTP
Symptoms: Seizure
Clinical narrative: Initial unsolicited report received from a consumer via other company (Pfizer) (Manufacturer Report Number: 2016220448) on 21 April 2016. This case involves a female patient (age was not reported) who was vaccinated with a booster dose of (DPT Shot) (batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, post vaccination, the patient had experienced seizure. Laboratory investigations and corrective treatment was not reported. On an unspecified date, patient was recovered from the event. Upon internal review, the company decided to consider the event serious because of important medical event: seizure. List of documents held by sender: none. Sender's Comments: This is poorly documented case received from consumer where seizure is reported after receiving DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED). Manufacturer of the vaccine not provided. However, investigation results ruling out a concurrent condition and other etiologies would be helpful to further assess this case.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Entire upper arm became swollen and red.
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site mass, Myalgia, Peripheral swelling
Clinical narrative: HARD LUMP AT INJECTION SITE- LEFT DELTOID. SWELLING IN LEFT ARM AND GOING DOWN LEFT ARM. PAIN IN MUSCLE. MOTHER WILL ICE AREA AND GIVE TYLENOL OR ADVIL AS NEEDED. WILL CALL PROVIDER IF NOT IMPROVED AT THE END OF THE DAY TODAY.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Swelling, Tenderness
Clinical narrative: Slight swelling and very tender.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Angina pectoris, Chest pain, Crying, Screaming
Clinical narrative: Crying, holding chest, yelling her heart is hurting, and horrible chest pain, I gave 6ml childrens Tylenol, crying and yelling continued until 10:05PM. I had left my house and rushed her at 9:15 PM to urgent care and when I got there at 10:05 PM they had just closed the doors and she had screamed herself to sleep.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Itchy red swelling around 5x5 inches of arm treated with BENADRYL and ice. Given Abx incase of cellulitis duets spreading.
Age: 16.0
Sex: F
Vaccine: HPV2, MNQ, TDAP
Symptoms: Abdominal pain upper, Blood test normal, Chest discomfort, Electrocardiogram normal, Headache
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of chest heaviness in a 16-year-old female patient who received BOOSTRIX (batch number AH4LF, expiry date 8th July 2018). Co-suspect products included CERVARIX (batch number BF7A2, expiry date 28th May 2016) and MENVEO (batch number M15099, expiry date 30th March 2017). On 18th April 2016, the patient received BOOSTRIX, CERVARIX .5 ml and MENVEO. On 18th April 2016, several hours after receiving BOOSTRIX, CERVARIX and MENVEO, the patient experienced chest heaviness (serious criteria other: As per reporter), headache and stomach cramps. On an unknown date, the outcome of the chest heaviness, headache and stomach cramps were unknown. It was unknown if the reporter considered the chest heaviness, headache and stomach cramps to be related to BOOSTRIX and MENVEO. The reporter considered the chest heaviness, headache and stomach cramps to be related to CERVARIX. Additional details provided were as follows: The patient received all the 3 vaccines during the same day office visit. The patient complained of chest heaviness, stomach cramping and headaches, which began the evening following the administration of the vaccines. The healthcare professional reported that, the patient came back into the office on the day of reporting and further test were ran in which all vital signs (physical examination), blood work and EKG (electrocardiogram) readings were found to be normal. The reporter believed CERVARIX might have caused the series of reactions for the patient. No further information was reported regarding the event.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Arthralgia, Chills, Fatigue, Injection site swelling, Myalgia
Clinical narrative: Patient stated she could feel the vaccine going all of the way down her arm. Her mother reported to us the next morning that patient had Swelling at the injection site that went to the top of the shoulder, fatigue, muscle/joint pain, chills and nausea.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Nausea, Sensory disturbance
Clinical narrative: Patient stated she could feel the vaccine going all of the way down her arm. Her mother reported to us the next morning that patient had Swelling at the injection site that went to the top of the shoulder, fatigue, muscle/joint pain, chills and nausea.
Age: 1.52
Sex: M
Vaccine: DTAP, IPV
Symptoms: Cough, Stridor
Clinical narrative: Child woke from sleep coughing with inspiratory stridor.  Initially brought to Urgent Care, was not open and proceeded to ED.  Symptoms did improve with brought outside and initial thought was croup, although had no previous respiratory illness symptoms.  Stridor did occur again in ED.  In ED was given dexamethasone and racemic epi.  Discharged in improved condition.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swollen, red and painful around injection site, 4 in beyond injection site. Triamcinolone 1% cream prescribed topically.
Sex: F
Vaccine: HPV4
Symptoms: Nervous system disorder
Clinical narrative: This spontaneous report as received from an administrator via field employee regarding a female patient of unknown age. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. The reporter stated that "he heard that a physician gave GARDASIL (dosing details, lot#, expiry and route of administration were not reported) to her daughter and the daughter experienced neurological problems afterwards (on an unspecified date, lasting for an unspecified duration of time). The outcome of neurological problems was unknown. The reporter did not provide the causality between the neurological problems and the suspect therapy. There were no product quality complaints (PQC) involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to multiple patients of unknown age and gender. Information regarding medical history and concurrent conditions were not provided. The licensed practical nurse noted that on multiple unspecified dates, patients were vaccinated with improperly stored vaccine (temperature of 62.2 degrees F, time frame of 3.75 hours) of PNEUMOVAX 23 single dose vials, lot # L019836 with expiration date 24-MAR-2017 (dose and route were not reported). No known adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, the patients received doses of improperly stored PEDVAXHIB lot# L014428 with expiration date: 12-MAR-2018 and lot# L042258 with expiration date: 18-AUG-2018 (dose, route of administration, injection site were not reported). Administered doses of PEDVAXHIB underwent temperature excursions at 52.5 Fahrenheit degrees, for 9 hours and 10 minutes. Digital data logger was involved. Unspecified number of doses of PEDVAXHIB were also previously exposed to a high temperature of 48.9 Fahrenheit degrees for 13 hours and 40 minutes. Cumulative time out of range was 22 hours and 50 minutes. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # L016429, expiration date: August 2017, (exact doses, injection site and route of administration were not reported). There were no concomitant medications reported. It was stated that the vaccines were exposed to the temperature of 30 degrees Fahrenheit for 20 hours and to the temperature of 53 degrees Fahrenheit for 19 hours. No previous temperature excursion was reported. No adverse effects were reported. No PQC (product quality complaint) was involved. Follow-up information received on 29-MAR-2016 indicated that all telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 01-APR-2016 from the unspecified reporter concerning a patient of unknown age and gender who on 03-NOV-2015 was vaccinated with improperly stored dose of GARDASIL 9, lot number reported as L07560, expiration date: June 2017. The reporter also stated that thermometer was malfunctioning during the excursion and clarified that no COMVAX (as previously reported) only GARDASIL 9 was involved. This is one of several reports received from the same reporter. Additional information is not expected as all required information has been received. Reporters, patient details, suspect details, event details and narrative were updated.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant (M.A.) referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates, these patients were vaccinated with improperly stored ROTATEQ (lot # L035510, expiration date 13-MAY-2017, oral). GARDASIL 9 was supported in prescribing information. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored ZOSTAVAX lot # L028283 (expiry date: 28-OCT-2016) (route and site of administration not reported). Concomitant medication was not mentioned by the reporter. The vaccine was stored at 42F for a time frame of 10.5 hours and administered to the patients (incorrect product storage). Previous temperature excursion was reported to be 40F for 9 hours. It was also mentioned that the call was not a result of "data logger". No adverse effects reported. No further information was provided. Product quality complaint was not filed. Additional information has been requested. This is one of the two reports received from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX lot # L004654 (expiry date: 11-FEB-2017) (route and site of administration not reported). Concomitant medication was not mentioned by the reporter. The vaccine was stored at 42F for a time frame of 10.5 hours and administered to the patients. Previous temperature excursion was reported to be 40F for 9 hours. It was also mentioned that the call was not a result of "data logger". No adverse effects reported. No further information was provided. Product quality complaint was not filed. Additional information has been requested. This is one of the two reports received from the same reporter. d
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates the patients were vaccinated with improperly stored PNEUMOVAX 23 (therapy type: digital data logger: lot # K020215, expiry date: 15-MAY-2016). Concomitant medication was not mentioned by the reporter. The vaccines were stored at 32.4F for a time frame of 3 hours and administered to the patients. The call was a result of "data logger". No adverse effects were reported. No additional information was provided. Product quality complaint was filed. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Conjunctivitis, Dizziness, Hypotension, Inappropriate schedule of drug administration, Nausea
Clinical narrative: Information has been received from a 19 year old female patient referring to herself. There was no concurrent concomitant therapy, medical history or concomitant therapy. In July 2015, the patient was vaccinated with the first dose of GARDASIL intramuscular injection (dose and lot number unknown) for prevention of HPV. On 07-APR-2016 the patient was vaccinated with the second intramuscular dose of GARDASIL, late in the series of 3 injections. On the day after the second dose, the patient developed pink eye, low blood pressure, dizziness and nausea. The patient sought medical attention via online "teledoc" from her insurance for the pink eye and was advised to use OTC eye drops "COM A". No lab diagnostics studies were performed. On 09-APR-2016, two days after the second injection received, her blood pressure and the dizziness resolved and pink eye was getting better. The outcome of nausea was not reported. The causality between the events and GARDASIL was not provided. Additional information has been requested.
Sex: U
Vaccine: PNC
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A patient of unspecified age, ethnicity and gender received PREVNAR, via an unspecified route of administration, on an unspecified date as a single dose. Medical history and concomitant medications were not reported. The patient developed a rash and redness on the site on an unspecified date with outcome of unknown. Clinical description was reported as follows: pharmacist reported that they gave one of their patients a PREVNAR injection on 07Oct (year unspecified) and they had developed a rash and redness on the site of injection. Causality was reported as follows Pharmacist mentioned that "it was because of other injections patient got there. So, it was kind of other injection's site." So, he did not think that there was any causality related to the events for PREVNAR. Pharmacist reported that there was not a reasonable possibility this events were related to the suspect product. Follow-up (19Nov2015): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to multiple patients of unknown age. On unknown dates the patients were vaccinated with improperly stored PEDVAXHIB, lot # K002747, expiry date: 09-DEC-2016 (dose and route not provided). Digital data logger had recorded the vaccine temperature excursion of 28.4 F for 602 hours. The physician discussed temperature stability. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: PNC
Symptoms: Blood glucose increased, Injection site swelling, Weight increased
Clinical narrative: This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Nova Nordisk Inc. (manufacturer control number: 0221504). A female patient of an unspecified age and ethnicity received PREVNAR, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient stated that her sugars have been higher since receiving vaccination and that it had caused her to gain 10 pounds. On an unknown date, the patient also had injection site swelling. The clinical outcome of the events, blood glucose increased, vaccination site swelling, and weight gain, was unknown.
Age: 8.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a medical assistant via Poison and Drug Center and refers to a female child patient of unknown age. She had no past drug history. The patient's concurrent conditions included allergic rhinitis and asthma. On an unknown date, the patient received first dose of M-M-R II strength reported as "25 mcg neomysin/dose", 0.5 ml, subcutaneously (lot # and expiration date not reported) for her well child check. No information about the patient's concomitant medications was provided. On 23-APR-2016, the patient was vaccinated with the second dose of M-M-R II 0.5 ml, subcutaneously, lot # K005574, expiration date 17-APR-2016. No relevant tests or laboratory data was provided. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a health professional refers to a patient of unknown age and gender. There was no information about the patient's concomitant medications, allergies and pertinent medical history reported. On 19-APR-2016, the patient was inadvertently administered an expired dose of RECOMBIVAX HB lot # K003533, expiry date 07-FEB-2016 (dose, route and site of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Information has been received from a physician concerning a male patient between 11-15 years old, who was involved in a patient support program. The patient had no medical history. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose, frequency were not reported). No concomitant therapy was reported. On an unknown date sometime between 2008 to 2016, the patient fainted when he received GARDASIL. No diagnostics tests were performed. The outcome of the event was reported as recovering/resolving. The reporter considered the event to be related to GARDASIL. The patient continued to receive administration of 2nd and 3rd doses. Additional information is not expected as no consent for follow up.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a multiple unspecified patients of unknown age and gender. There was no information about the patient's pertinent medical histories, concomitant medications and drug reactions or allergies reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of (Oka-Merck) PROQUAD (lot# L039269, expiration date 05-APR-2017, dose, anatomical location and route of administration were not reported). No adverse events were reported. The temperature was 35.1 Fahrenheit with the time frame 2 hours and 48 minutes. The data logger was involved and there was no previous temperature excursion reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV4, MENB
Symptoms: Injection site erythema, Urticaria
Clinical narrative: Immunization on 4/25/16. On 4/26/16 right deltoid redness. Hives surrounding left eye, right upper forehead, right nasal bridge, in front and behind right ear. Treatment antihistamine.
Age: 36.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a certified medical assistant (C.M.A.) referring to a 36 year old patient of unknown gender. No relevant medical history or concurrent conditions were reported. On 25-APR-2016 the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (subcutaneous; lot# and expiration date were not reported) (inappropriate schedule of drug administration). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a the Medical Assistant (MA) referring to a patient of an unknown age and gender. The information regarding the patient's relevant medical history and concurrent conditions was not provided. On 19-FEB-2015, 5 unspecified patients were vaccinated with improperly stored dose of (Oka/Merck) VARIVAX lot # K005427 (expiry date: 15-APR-2016) (route, anatomical location and dosage were not reported). Information regarding the patient's concomitant medications was not provided. No adverse effect reported. The nurse reported a temperature excursion for (Oka/Merck) VARIVAX. Additionally, the reporter stated that the facility has a data logger but she was not exactly sure what the problem was that caused these excursions. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from the Medical Assistant (MA) referring to a patient of an unknown age and gender. The information regarding the patient's relevant medical history and concurrent conditions was not provided. On 19-FEB-2015, the patient was vaccinated with improperly stored dose (Oka/Merck) VARIVAX lot # K005427 (expiry date: 15-APR-2016) (start date and dosage not reported). Information regarding the patient's concomitant medications was not provided. No adverse effect reported. The nurse reported a temperature excursion for the (Oka/Merck) VARIVAX. Additionally, the reporter stated that the facility has a data logger but she was not exactly sure what the problem was that caused these excursions. This is one of several reports received from the same reporter. Additional information has been requested. Patient, product and narrative information were updated.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a multiple patients of unknown age and gender. No pertinent medical history or concomitant medications were reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored VAQTA pediatric, lot #L028666 with expiration date 04-NOV-2016 and lot #L042486 with expiration date 12-DEC-2016 (dose and route of administration not provided), and improperly stored VAQTA adult, lot #L048460 with expiration date 14-JAN-2017 and lot #M009786 with expiration date 26-MAY-2017 (dose and route of administration not provided). The vaccine products were exposed to the following conditions: temperature 0.3 degrees Celsius for 8 hours. There were no previous temperature excursion. The temperature excursion was captured via a Digital Data Logger. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 0.3
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 3 month old patient of unknown gender. The patients' concurrent conditions and medical history were not provided. On 23-OCT-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was 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: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a licensed practical nurse and refers to multiple patient of unknown age and gender. Information regarding medical history and concurrent conditions were not provided. The licensed practical nurse noted that on multiple unspecified dates, patients were vaccinated with improperly stored vaccine (temperature of 62.2 degrees F, time frame of 3.75 hours) of VAQTA lot # L023936 with expiration date 15-MAR-2017 (dose and route were not reported). No known adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist. This pharmacist reported for two patients with similar events. This is the first of two reports. A 81-year-old female patient started to receive PREVNAR (lot number M56442, expiration date Jun2017), intramuscular on 23Oct2015 at 1 DF, single. Medical history included coronary artery disease from an unknown date and unknown if ongoing. Concomitant medication included aspirin 81mg for cardiovascular disease prevention. The patient experienced reaction to the injection site, more red, swollen and sore/ red swollen area that extended down below the injection site on 27Oct2015 with outcome of not recovered. The action taken in response to the event for PREVNAR was not applicable. Therapeutic measures provided as cold compress. Follow-up (12Nov2015): This follow-up is submitted to amend previously reported information: reaction data coding. Follow-up (11Dec2015): Follow-up attempts completed. No further information expected.
Age: 91.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist. This pharmacist reported for two patients with similar events. This is the second of two reports. A 91-year-old male patient started to receive PREVNAR (lot number M56442, expiration date Jun2017), intramuscular from 23Oct2015 to 23Oct2015 at 1 DF, single. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced reaction to the injection site with symptoms of more red, swollen and sore/ red swollen area that extended down below the injection site on 28Oct2015 with outcome of not recovered. The action taken in response to the event for PREVNAR was not applicable. Therapeutic measure provided was cold compression. Follow-up (12Nov2015): This follow-up is submitted to amend previously reported information: reaction data coding. Follow-up (11Dec2015): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC
Symptoms: Injection site erythema
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A patient of unspecified age, ethnicity, and gender received PREVNAR, via an unspecified route of administration on an unspecified date at a single dose. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced red around the spot of the shot that was getting bigger. The clinical outcome of the event, vaccination site erythema, was unknown. No follow up attempts possible. No further information expected.
Sex: U
Vaccine: PNC
Symptoms: Hypersensitivity
Clinical narrative: This is a spontaneous report from a contactable other health professional. A patient of unspecified age, ethnicity, and gender received PREVNAR via an unspecified route of administration on an unspecified date at single dose. Relevant medical history and concomitant medications were not reported. The patient experienced allergic reaction on an unspecified date with outcome of unknown. The action taken for PREVNAR was not applicable. Follow-up (14AUG2015): Follow-up attempts completed. No further information expected.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy test positive, Food allergy, Rash erythematous, Urticaria
Clinical narrative: Arms, legs, hands & feet broke out in hives - dime to quarter size which lasted until approximately 4/8/16. Then small red dots with small white centers appeared on extremities until 4/26/16. I treated the hives with over the counter antihistamine and when they continued I went to the doctor and was given a prescription antihistamine and a steroid injection. Although this helped relieve the itching somewhat it did not keep the hives and spots from continuing. On 4/18/16 I went to a allergist to determine if it was a food allergy - he could not determine if the reaction was from the shot but the test indicated I was allergic to eggs which I have never been allergic to before and seldom eat.
Sex: U
Vaccine: PNC
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable consumer. A patient of unspecified age, ethnicity, and gender received PREVNAR via an unspecified route of administration on an unspecified date at single dose. Relevant medical history and concomitant medications were not reported. The patient experienced rash on the arm, where injection was given on an unspecified date with outcome of unknown. The action taken for PREVNAR was not applicable. Follow-up (24JUL2015): Follow-up attempts completed. No further information expected.
Age: 40.0
Sex: M
Vaccine: FLU3
Symptoms: Glycosylated haemoglobin normal, Injection site paraesthesia, Injection site warmth
Clinical narrative: Warmth noted at site and then had tingling sensation there and in L armpit coming and going. No weakness.
Sex: F
Vaccine: PNC
Symptoms: Drug hypersensitivity
Clinical narrative: This is a spontaneous report from a contactable physician received from the non-clinical-study program. A female patient of unspecified age and ethnicity received PREVNAR single dose via an unspecified route of administration on an unspecified date and started to receive RESTORIL unspecified dose and frequency via an unspecified route of administration from an unspecified date to an unspecified date for an unspecified indication. Relevant medical history and concomitant medications were not reported. The patient experienced drug allergies: RESTORIL, PREVNAR on an unspecified date with outcome of unknown. The last action taken for PREVNAR was not applicable and the last action taken for temazepam was unknown. Follow-up (27MAY2015): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC
Symptoms: Hypersensitivity
Clinical narrative: This is a spontaneous report from a non-contactable physician, case received from Merck National Service Specialist. A patient of unspecified age, ethnicity and gender started to receive PREVNAR (unknown lot# and expiration date), via an unspecified route of administration, on an unspecified date, at an dose. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient experienced unspecified allergic reaction on an unspecified date. The patient's clinical outcome was unspecified. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Injection site nodule, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer. An adult female patient of unspecified age received PREVNAR single dose via an unspecified route of administration. Relevant medical history and concomitant medications were not reported. The patient experienced unusual swelling at the site of injection and knot in her arm, swelling at the site on an unspecified date with outcome of not recovered. The consumer reported that the patient had been putting ice on the site. Follow-up (20MAY2015): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: PNC13
Symptoms: Rash, Rash erythematous
Clinical narrative: This is a spontaneous report from a contactable pharmacist from a non-clinical study program. A male patient of an unspecified age and ethnicity received a single dose of PREVNAR (Lot number: L62072), via an unspecified route of administration on 30May2015. The pharmacist provided a number 405197102; and mentioned another NDC number as 00005197102; and the UPC number as 300051971022. The patient's medical history was not reported. The pharmacist mentioned that patient was not taking any other medication. On 31May2015, the patient experienced really big red rash that went to the inside of the arm right after the shot was given. The clinical outcome for the event of really big red rash was unknown; however it lasted longer than a week. Causality was reported as the pharmacist confirmed that the patient had most likely these side effects from PREVNAR. Follow-up (22JUL2015): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Chills, Fatigue, Feeling cold, Grip strength decreased, Hypoaesthesia
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age and ethnicity started to receive PREVNAR, intramuscular from 08Jan2016 to 08Jan2016 at 1 DF, single. The patient medical history was not reported. There were no concomitant medications. The patient experienced numbness and tingling in both hands, coldness of whole body, fever, chills, fatigue and "not been able to hold anything" on an unspecified date with outcome of unknown. The action taken in response to the events for PREVNAR was not applicable. Follow-up (09MAR2016): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age and ethnicity started to receive PREVNAR, intramuscular from 08Jan2016 to 08Jan2016 at 1 DF, single. The patient medical history was not reported. There were no concomitant medications. The patient experienced numbness and tingling in both hands, coldness of whole body, fever, chills, fatigue and "not been able to hold anything" on an unspecified date with outcome of unknown. The action taken in response to the events for PREVNAR was not applicable. Follow-up (09MAR2016): Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Headache, Induration, Joint range of motion decreased, Night sweats
Clinical narrative: This is a spontaneous report from a contactable consumer. A female patient of an unspecified age and ethnicity received PREVNAR, via an unspecified route of administration on 10Nov2015, as single dose immunization. Medical history and concomitant medications were not reported. Approximately 6:00 PM on 13Nov2015, patient contacted her primary care. She reported the following events (onset in Nov2015): she experienced/was still experiencing side effects from a recent vaccination with PREVNAR on 10Nov2015. Symptoms included: extreme pain in the arm that received the injections/ significant pain in the arm and significant headache on 10Nov2015 and flesh in her arm which she received the injection became very hard to the touch (which has since subsided), rash, itching, chills and night sweats in Nov2015; had difficulty with her range of motion after the injection on an unspecified date. There was no hospitalization for the events. The patient took TYLENOL as needed for pain, no treatments were received for the other events. The outcome of the events were reported as fine now as of reporting on 02Feb2016. Follow-up (02Feb2016): New information reported from a contactable consumer includes: detailed event description, seriousness (no hospitalizations for events), treatment received (acetaminophen as needed) and outcome (fine now).
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Pruritus, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer. A female patient of an unspecified age and ethnicity received PREVNAR, via an unspecified route of administration on 10Nov2015, as single dose immunization. Medical history and concomitant medications were not reported. Approximately 6:00 PM on 13Nov2015, patient contacted her primary care. She reported the following events (onset in Nov2015): she experienced/was still experiencing side effects from a recent vaccination with PREVNAR on 10Nov2015. Symptoms included: extreme pain in the arm that received the injections/ significant pain in the arm and significant headache on 10Nov2015 and flesh in her arm which she received the injection became very hard to the touch (which has since subsided), rash, itching, chills and night sweats in Nov2015; had difficulty with her range of motion after the injection on an unspecified date. There was no hospitalization for the events. The patient took TYLENOL as needed for pain, no treatments were received for the other events. The outcome of the events were reported as fine now as of reporting on 02Feb2016. Follow-up (02Feb2016): New information reported from a contactable consumer includes: detailed event description, seriousness (no hospitalizations for events), treatment received (acetaminophen as needed) and outcome (fine now).
Age: 3.0
Sex: F
Vaccine: FLU3, HEPA, HIBV, PNC
Symptoms: Abdominal discomfort, Vomiting
Clinical narrative: This is a spontaneous report from a consumer (patient's parent) and follow-up from a contactable physician. A 3-year-old female patient of an unspecified ethnicity received PREVNAR (Lot Number: C60102), Hib vaccine (Lot Number: L006546), HAVRIX (Lot Number: F4KRS), and FLUZONE (Lot Number: U4978AB; Expiration Date: 30Jun2015) all intramuscular on 22Oct 2015 at single doses. Medical history included bronchiolitis on 21Dec2012, which required hospitalization for 24 hours. Concomitant medications were not reported. The patient previously received PREVNAR on 02Nov2012 (Lot Number: 918175) and 19Jul2013 (Lot Number: G47423): PEDIARIX on 02Nov2012 (Lot Number: AC21B408CA; Expiration Date: 23Jan2015), 11Jan2013 (Lot Number: AC210357BB; Expiration Date: 17May2014), and 19Apr2013; DTAP DT on 02Sep2015 (Lot Number: C9S96); Rotavirus vaccine on 02Nov2012 (Lot Number: A41FB288A) and 11Jan2013 (Lot Number: A41FB305A); MMR on 21Mar2014 (Lot Number: J004210); Varicella vaccine on 02Sep2015 (Lot Number: L004654); Hib vaccine on 11Jan2013 (Lot Number: H0103038) and 19Apr2013 (Lot Number: H020881); HAVRIX on 13Sep2013 (Lot Number: 2YA5A; Expiration Date: 22Nov2015); and FLUZONE on 17Oct2014 (Lot Number: U4794CA; Expiration Date: 30Jun2014). On 24Oct 2015, the patient experienced upset stomach and vomiting with outcome of recovered. The physician stated that the events were non serious and that the causal effect between the events and PREVNAR was unknown. Follow-up (20Nov2015): New information received from a contactable physician includes: medical history, past vaccine history, seriousness (non-serious), and causality (unknown).
Sex: M
Vaccine: PNC
Symptoms: Injection site haemorrhage, Injection site mass, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist. An 83-year-old male patient of unspecified ethnicity received PREVNAR via an unspecified route of administration on an unspecified date at single dose for immunization. Relevant medical history and concomitant medications were not reported. The patient experienced "on administration he got a big lump that swelled up and it started bleeding right away" on 28Sep2015 with outcome of unknown. The action taken for PREVNAR 7 was not applicable. The pharmacist mentioned that the patient did not have any redness or warmth, no skin reaction, no rash or anything, no fever, no upset stomach. The pharmacist mentioned that the patient was already gone and he was doing fine, but she wanted to know how common that reaction was. Follow-up (27NOV2015): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: PNC
Symptoms: Contusion
Clinical narrative: This is a spontaneous report from a contactable consumer. A female patient of an unspecified age and ethnicity received PREVNAR, via an unspecified route of administration, on an unspecified date, as a single dose and methotrexate via an unspecified route of administration, on an unspecified date, at an unspecified dose, for an unspecified indication. Medical history and concomitant medications were not reported. The patient experienced PREVNAR bruising on an unspecified date with outcome of unknown. The action taken with methotrexate was unknown. Follow-up (20NOV2015): Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: PNC
Symptoms: Pruritus, Rhinitis allergic
Clinical narrative: This is a spontaneous report from a physician. A female patient of an unspecified age started to received PREVNAR (Lot number L77780, expiration date 01Jan2017), via an unspecified route of administration from an unspecified date on 11Aug2015 at 1 DF, single. The patient medical history was not reported. The patient concomitant medications were not reported. The patient experienced allergic reaction to PREVNAR and pruritus on an unspecified date with outcome of unknown. The action taken in response to the event for PREVNAR was not applicable. Follow-up (08Oct2015): This follow-up report is being submitted to amend previously reported information: event coded to allergy to vaccine. Follow0up (30Oct2015): Follow-up attempts completed. No further information expected. Follow-up (25Jan2016): New information received from a contactable physician includes: product data and reaction date (new event added: pruritus. Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: PNC
Symptoms: Allergy to vaccine, Asthenia
Clinical narrative: This is a spontaneous report from a contactable physician. A male patient of an unspecified age and ethnicity received a single dose of PREVNAR, via an unspecified route of administration on an unspecified date. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced an allergy to the vaccine and weakness with outcome of unknown. The action taken in response to the events for PREVNAR was not applicable. Follow-up (13Nov2015): Follow-up attempts completed. No further information expected.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Pt received PREVNAR 13 on 4-25-16. She returned to the office with a large red and swollen area on her upper left arm just below the injection site. Pt treated with BENADRYL 25 mg q 6 hrs and KEFLEX 500 mg BID.
Age: 0.21
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Erythema, Immediate post-injection reaction, Inflammation, Swelling
Clinical narrative: PEDIARIX administered to right thigh. Swelling developed immediately. Mild erythema area soft to palpation. Ice applied. Inflammation stopped, redness receded.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Erythema at injection site, painful firm, raised.
Age: 0.36
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker referring to a 4 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 15-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site warmth, Pyrexia
Clinical narrative: Lump on right thigh area was red and warm to touch. Mother did mention a fever with it. No associated wheezing, fever was resolved by time of appt. and feeling well no treatment done.
Age: 1.51
Sex: M
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Injection site induration
Clinical narrative: 2.5 x 1.5 inch induration on the right thigh - Hep A site. 2.0 x 1.5 inch induration on the left thigh - PREVNAR site. No sign of cellulitis/no exudate/does not fluctuate.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a multiple patients of unknown age and gender. No pertinent medical history or concomitant medications were reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored RECOMBIVAX HB pediatric formulation, lot # L040458 with expiration date 04-FEB-2018 and lot # L033343 with expiration date 13-SEP-2017 (dose and route of administration not provided), and improperly stored RECOMBIVAX HB adult formulation, lot # L042846 with expiration date 15-SEP-2017 and lot # L014419 with expiration date 15-APR-2017 (dose and route of administration not provided). The vaccine products were exposed to the following conditions: temperature 0.3 degrees Celsius for 8 hours. There was no previous temperature excursions. The temperature excursion was captured via a Digital Data Logger. This is one of several report from the same reporter. Additional information has been requested.
Age: 40.0
Sex: F
Vaccine: RAB
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient stated shoulder that received immunization was red and sore.