chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 28-JUL-2016, the patient was vaccinated with improperly stored dose of (wistar ra 27-3) M-M-R II lot # L029266 (dose and route of administration were not reported). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 09-JUN-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II lot # reported as M001200, therapy type was not specified (dose and route of administration were not 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: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding a 4 year old patient of unknown gender. There was no information about concurrent condition and historical medication. On 01-SEP-2016 the patient was vaccinated with expired M-M-R II, 0.5 ml, subcutaneous, lot # M001200/ expiration date-28-AUG-2016. No adverse event was reported. The outcome of event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a multiple unspecified patients of unknown ages and genders. The patients' concurrent conditions, medical histories and drug reactions/allergies were unknown. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL (Lot # K006117, expiration date 14-JAN-2017), doses and routes were not provided. There was no concomitant medication reported. The temperature / time frame was 33F for 60 hours. No data logger was involved and no previous excursions were reported. No adverse effects were reported. This is one of three cases received from the same source. Additional information has been requested.
Sex: U
Vaccine: FLU4
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT. On an unknown date, an unknown time after receiving FLULAVAL QUADRIVALENT, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not provided. The report reported that a couple of patients received the FLULAVAL QIV vaccine last year and still ended up getting the flu. No further information was available or reported regarding the event. This case was considered as suspected vaccination failure case as the laboratory confirmation and exact time to onset for influenza was not provided.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 11 year old patient of unknown gender. On 22-JAN-2016, the patient was vaccinated with the first, improperly stored dose of GARDASIL 9 (dose, anatomical location and route of administration were not provided, lot # L016429 with expiration date 09-AUG-2017). The second, improperly stored dose of the vaccine was administered on 22-APR-2016 (lot number L026602 with expiration date: 19-OCT-2017). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a nurse referring to a multiple unspecified patients of unknown ages and genders. The patients' concurrent conditions, medical histories and drug reactions/allergies were unknown. On unspecified dates, the patients were vaccinated with improperly stored doses of VAQTA (Lot # K012457, expiration date 04-JUN-2017) and (Lot #M011116, expiration date 17-JUN-2017) doses and routes were not provided. There was no concomitant medication reported. This is one of three cases received from the same source. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 5 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 26-APR-2016, the patient was vaccinated with an improperly stored dose of (Oka/Merck) PROQUAD lot # L050909, expiration date: 14-JUN-2017 (exact dose, route of administration and therapy type were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a currently 70 years old female patient with cancer referring to herself. The patient was allergic to neomycin and BENADRYL. The patient's medical history included stroke. Concomitant medication included atenolol, pantoprazole, warfarin, EFFEXOR and simvastatin (manufacturer unknown). On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date and dose were not reported; subcutaneous). On an unknown date, an unspecified time after receiving ZOSTAVAX, the patient developed shingles around her mouth. The patient didn't sought medical attention. No treatment was given for the event and no lab diagnostics studies were performed. At the reporting time, the patient didn't recover from the event. The causality was not reported. 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 physician and refers to an unspecified number of patients of unknown age and gender. There was no information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies provided. On unknown dates in 2016, the patients were vaccinated with improperly stored of PEDVAXHIB (lot # L042257 and expiration date 17-AUG-2018, lot # L051123 and expiration date 13-OCT-2018; exact doses and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that vaccines were exposed to temperature of 34.4 Fahrenheit degrees (F) for 10 minutes on 11-MAR-2016, 35.6 F for 10 minutes on 03-AUG-2016, 35.6 F for 10 minutes on 20-AUG-2016, 35.6 F for 10 minutes on 23-AUG-2016 and 35.6 F for 10 minutes on 26-AUG-2016 before administration to the patients. No previous temperature excursion was reported. No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 10-JUN-2016, the patient was vaccinated with incorrectly stored doses of M-M-R II lot # reported as M001200, therapy type was not specified (dose and route of administration were not reported). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage
Clinical narrative: Information was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 11-AUG-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L041206 (dose, route and expiration date not reported). Concomitant therapy was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 10-JUN-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II lot # reported as M001200, therapy type was not specified (dose and route of administration were not reported). This is one of several reports received from the same source. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Foetal disorder, Maternal exposure before pregnancy
Clinical narrative: This spontaneous retrospective pregnancy report was received from  a currently 28 year old female patient who was also a pharmacy technician regarding herself on an online article. Concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in December 2006, the patient was vaccinated with dose 1 of GARDASIL. On an unknown date in January 2007,the patient experienced Postural Orthostatic Tachycardia Syndrome (POTS)(MARRS# 1609USA004199). On an unknown date in February 2007, the patient received the second dose of GARDASIL. On an unknown date the patient became pregnant with her first child(MARRS# 1609USA004199). Subsequently on an unknown date the patient became pregnant with her second child. EDD and LMP was unknown. On an unknown date the patient delivered a male infant. The child was now facing many health issues(MARRS# 1609USA005978). Additional information is not expected as no contact details were provided.
Sex: M
Vaccine: HPV4
Symptoms: Adverse reaction, Foetal exposure during pregnancy
Clinical narrative: This spontaneous report was received from a pharmacy technician regarding her son, a 8 month old male patient on an online article. Concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in December 2006, the patient's mother was vaccinated with dose 1 of GARDASIL. On an unknown date in January 2007, the patient's mother experienced Postural Orthostatic Tachycardia Syndrome (POTS) (MARRS# 1609USA004199). On an unknown date in February 2007, the patient's mother received the second dose of GARDASIL. On an unknown date the patient's mother became pregnant with her first child (MARRS# 1609USA004199). Subsequently on an unknown date the patient's mother became pregnant with her second child (MARRS# 1609USA005960). EDD and LMP was unknown. On an unknown date the patient delivered a male infant. The child was now facing many health issues. The outcome of the health issues was unknown. Causality was not reported. Additional information is not expected as no contact details were provided.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to an unspecified number of patients of unknown age and gender. There was no information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies provided. On unknown dates in 2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L024993 and expiration date 17-OCT-2017, lot # L043214 and expiration date 30-AUG-2017; exact doses and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccines were exposed to temperature of 34.4 Fahrenheit degrees (F) for 10 minutes on 11-MAR-2016, 35.6 F for 10 minutes on 03-AUG-2016, 35.6F for 10 minutes on 20-AUG-2016, 35.6 F for 10 minutes on 23-AUG-2016 and 35.6 F for 10 minutes on 26-AUG-2016 before administration to the patients. No previous temperature excursion was reported. No adverse effects were reported. This is one of the several reports received rom the same source. Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 2 month old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 13-SEP-2016, the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23, lot # M013156, expiration date: 15-OCT-2017, (dose, route of administration and injection site were not provided). There were no concomitant medications reported. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This solicited report was received from a pharmacist and refers to a female patient of an unknown age enrolled in a Patient Support Program. The patient's concurrent conditions and concomitant medications were not reported. The patient had poison ivy prior to getting ZOSTAVAX. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, lot#, expiration date and route of administration were not reported). On an unknown date, after ZOSTAVAX administration, the patient experienced rash and also "an outbreak rash on her face". The patient was treated with unspecified steroids. The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/allergies were reported. On 29-AUG-2016, the patient was vaccinated with PROQUAD (lot # M017337, expiry date 05-OCT-2017) dose 0.5 ml, subcutaneously (strength, anatomical location and frequency were unknown). The reporter stated that on unknown dates, the patient received an unspecified number of doses of VARIVAX and M-M-R II prior to receiving a dose of PROQUAD (inappropriate schedule of drug administration). No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Administration site swelling, Administration site warmth, Injection site erythema
Clinical narrative: Site of administration reaction - elevated 1/8 inch and size of golf ball - redness- warm to touch, no other systemic symptoms. Recommended: -cool compress - BENADRYL.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Night sweats, Rash
Clinical narrative: 8-12hr post vaccine -> night sweats, 2 days post vaccine -> rash.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dyskinesia, Pallor
Clinical narrative: Pt developed pallor and jerky movements of arms and lower extremities approximately 1 min. after vaccines administration. No vomits.
Age: 29.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Itchiness, redness, swelling and warm to the touch. Redness was present in the shape of an oval. Patient applied rubbing alcohol to it; to cool injection site. No fever.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Injection site vesicles
Clinical narrative: CLIENT RECIEVED IMMUNIZATIONS 9/12/2016. AWOKE THE NEXT MORNING WITH DIME SIZED FLUID FILLED BLISTER ON RT ARM IN APPROXIMATE AREA WHERE MENACTRA WOULD HAVE BEEN GIVEN. NO FEVER NOTED BY MOM.
Age: 32.0
Sex: M
Vaccine: FLUC4
Symptoms: Blood glucose normal, Dizziness, Electrocardiogram normal, Hyperventilation
Clinical narrative: Dizziness, lightheadedness about 15 minutes following vaccination. Cold compress applied, blood pressure taken (154/92), 911 called after onset of heavy breathing. BP taken again (132/84), glucose (87). Portable EKG results unremarkable.
Age: 65.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Pyrexia
Clinical narrative: Extremely high fever.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Asthenia, Dyspnoea, Pain in extremity, Pharyngeal oedema, Swelling face
Clinical narrative: Swelling of face and throat. Weakness, pain in left arm, difficulty breathing.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Swelling from below shoulder to elbow, itchiness.
Age: 1.27
Sex: M
Vaccine: DTAP, FLU4, HIBV
Symptoms: Gait disturbance, Injection site erythema, Injection site induration, Injection site swelling, Pyrexia
Clinical narrative: On 09/07/2016 he had a fever in the morning; later in the afternoon right thigh was red at injection site, about size of tennis ball; previous shots only about size of golf ball. On 9/08/2016 entire thigh was swollen in the morning almost twice the size of other thigh; redness had spread over entire front of thigh; thigh was very firm; several hours later child was limping; gave TYLENOL and applied ice packs on and off that day and following day. 09/09/2016 thigh still hard and swollen, red patch spread to side and back of thigh; gave TYLENOL for pain and applied ice pack again. 09/11/2016 thigh redness and hardness has gone away, however thigh was still noticeable larger than other thigh.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. On 11-AUG-2016, the patient was inadvertently vaccinated with an expired dose of VARIVAX lot # K006138, expiry date: 29-APR-2016 (dose not reported). No concomitant medications were reported. There were no adverse events reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Swelling
Clinical narrative: Patient noticed swelling below flu shot site (2x3 redness and swelling).
Age: 1.0
Sex: M
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Onset of varicella disease 9/8/2016.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 06-SEP-2016, the patient was inadvertently vaccinated with M-M-R II, albumin status recombinant human albumin (rHA), subcutaneously, in the right thigh, lot # M001200, expiry date 28-AUG-2016. 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 a patient of unknown age and gender. No information regarding the patient's medical history and concurrent conditions was provided. The pharmacist reported that the unspecified patient, who was in the pharmacy at the time of reporting, would be receiving a dose of improperly stored ZOSTAVAX, lot # L037790, expiration date: 30-DEC-2016, (dose, dose number, route of administration and injection site were not provided) on 13-SEP-2016. There were no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion of 35 degrees Fahrenheit for 5 hours. No previous excursions were reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information is not expected as the reporter did not wish to be contacted.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician refers to a 71 year old male patient. The patient's medical history included allergy to penicillin. In 2013, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously (dose, site of administration, lot # and expiry date were not reported). Concomitant medications were not reported. On 29-AUG-2016, the patient developed shingles. He was treated with VALTREX, 1 gram three times daily for a week. The outcome of shingles was unknown. The patient sought medical at the physician's office. The relatedness between the event and ZOSTAVAX was not provided. This is one of two cases received from the same reporter. Additional information has been requested.
Age: 2.0
Sex: F
Vaccine: HIBV
Symptoms: Ear swelling, Rash
Clinical narrative: Patient woke up with swollen ears and rash.
Age: 31.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: The spontaneous report as received from a medical assistant refers to a 31 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-JAN-2016, the patient was vaccinated with an improperly stored dose of M-M-R II lot # K000174, expiration date: 08-JAN-2018 (exact dose, route of administration, therapy type and anatomical location were not provided). On 25-APR-2016, the patient received again an improperly stored dose of M-M-R II lot # L007216 with expiration date: 03-MAR-2017 (exact dose, route of administration, therapy type and anatomical location were not provided). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 15-AUG-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II lot # reported as L026553, therapy type was not specified (dose and route of administration were not reported). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 30-AUG-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II lot # L026653, therapy type was not specified (dose and route of administration were not reported). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 07-JUN-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II lot # M001200, therapy type was not specified (dose and route of administration were not reported). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 27-JUL-2016, the patient was vaccinated with improperly stored M-M-R II lot # L029266 (dose and route of administration were not reported). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 30-AUG-2016, the patient was vaccinated with incorrectly stored dose (wistar ra 27-3) M-M-R II lot # L026553, therapy type was not specified (dose and route of administration were not reported). This is one of several reports received from the same source. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella zoster virus infection
Clinical narrative: This spontaneous report was received from a healthcare professional and refers to a 60 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 26-MAY-2016 at 16:05, the patient was vaccinated with a dose of ZOSTAVAX lot # L044528, expiration date was not reported, subcutaneously, in deltoid of the left upper arm (exact dose was not reported). On 27-MAY-2015 (reported as the next day), the patient broke out in varicella zoster. The patient asked the reporter if she could get shingles from the ZOSTAVAX and the reporter denied. The outcome of varicella zoster was unknown. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected as all relevant information has already been received.
Age: 44.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Rash
Clinical narrative: Fever of 100.7 on 9.11 in evening. Rash appeared on face, neck and chest on 9.12 in evening. Rash worsened on 9.13 and spread to back and arms and stomach over next two days.
Sex: F
Vaccine: TDAP
Symptoms: Incorrect route of drug administration, Injection site bruising, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Initial unsolicited misuse report received from non-healthcare professional (medical assistant) on 01 September 2016. This case is linked to case number -2016SA162934. (Same vaccine, same lot number, same reporter). This case involves female patient (age not reported) who was vaccinated with dose of Adacel (batch number: U5467AC, expiry date: 08 October 2018 and site of administration was not reported) and injection of Tubersol (batch number C4652AA, expiry date: 22 January 2017 and site of administration was not reported) both by Intradermal route on an unspecified date. The patient's Illness at time of vaccination includes none as per reporter, pre-existing physician diagnosed allergies, birth defects, medical conditions (specify): not reported and concomitant medications were not reported. On an unspecified date, patient received 0.1 milliliter of Adacel instead of Tubersol and following vaccination patient experienced redness and itching at injection site and hard bubble and bruising at the site of the administration of the Tubersol. It was a case of wrong vaccine administered. Laboratory data and corrective treatment was not reported. Outcome of events reported as unknown. List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Injection site vesicles, Wrong drug administered
Clinical narrative: Initial unsolicited misuse report received from non-healthcare professional (medical assistant) on 01 September 2016. This case is linked to case number -2016SA162934. (Same vaccine, same lot number, same reporter). This case involves female patient (age not reported) who was vaccinated with dose of Adacel (batch number: U5467AC, expiry date: 08 October 2018 and site of administration was not reported) and injection of Tubersol (batch number C4652AA, expiry date: 22 January 2017 and site of administration was not reported) both by Intradermal route on an unspecified date. The patient's Illness at time of vaccination includes none as per reporter, pre-existing physician diagnosed allergies, birth defects, medical conditions (specify): not reported and concomitant medications were not reported. On an unspecified date, patient received 0.1 milliliter of Adacel instead of Tubersol and following vaccination patient experienced redness and itching at injection site and hard bubble and bruising at the site of the administration of the Tubersol. It was a case of wrong vaccine administered. Laboratory data and corrective treatment was not reported. Outcome of events reported as unknown. List of documents held by sender: none.
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Wrong drug administered
Clinical narrative: Initial unsolicited misuse report received from a non-healthcare professional (medical assistant) on 01-Sep-2016. This case is linked to 2016SA162906 (Same vaccine, same lot number, same reporter). This case involves a 2 female patient (age unknown) who was vaccinated with 0.1 ml dose of Adacel (Batch number: U5467AC, expiration date 08-Oct-2018 and site of administration was not reported) instead of Tubersol (Batch number: C4652AA, expiration date 22-Jan-2017 and site of administration was not reported) for a TB skin test intradermal on an unspecified date. It was reported that this 2 patients were brought back on another day for a subsequent visit for administration of TB skin test with Tubersol; and those 2 patients did not have any reactions after the Tubersol administration. Patient's medical history and concomitant medications were not reported. On an unspecified date post vaccination the patient developed redness and itching at the injection site. It was a case of wrong drug administered. Lab tests and corrective treatment were not reported. Outcome of event was unknown. List of documents held by sender: none.
Age: 77.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Type V hyperlipidaemia
Clinical narrative: Initial information regarding this sponsored solicited case was received from a patient via patient support program on 01-Sep-2016. This case involves an approximately 77 years old female patient who had cough all morning unknown duration after receiving therapy with influenza vaccine and Praluent. No past drugs, medical history, concurrent condition or concomitant medications were reported. On an unknown date, the patient started therapy with 75 mg/mL subcutaneous alirocumab at the dose of 75 mg every other week for mixed hyperlipidemia and on an unknown date with influenza vaccine (other therapy details, lot/batch no and expiry date: unknown). Unspecified time duration later, on an unknown date, the patient reported that she got her flu shot yesterday (date unknown) and have had a cough all morning. Action taken: no action taken with alirocumab and unknown for influenza vaccine. Corrective treatment: unknown. Outcome: not recovered. Company causality: not associated. Reporter causality: not reported for influenza vaccine and unknown for alirocumab.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chill, fever and body aches for 48 hours.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pain, Pain of skin, Pyrexia
Clinical narrative: Fever (101 degrees); Extreme aching; skin was sore to touch all over body. Headache lasting well into next day.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Pain, Pyrexia
Clinical narrative: Fever and Body aches.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 31-AUG-2016, the patient was vaccinated with incorrectly stored doses of M-M-R II lot # reported as M001200, therapy type was not specified (dose and route of administration were not reported). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: The spontaneous report as received from a healthcare professional refers to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # L023587, expiration date 26-JUN-2017 (dose, and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 05-JUL-2016, the patient was vaccinated with a dose of improperly stored (Oka/Merck) PROQUAD (lot # M010478, expiration date: 01-SEP-2017; dose and route were not provided). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Anxiety, Blood test, Cold sweat, Headache, Nausea
Clinical narrative: Neck pain, severed headaches, sudden onset headaches with blurred vision, anxiety, nausea, clamminess, low grade fever.  Currently awaiting an MRI and is under the care of a physical therapist.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Neck pain, Pyrexia, Skull X-ray, Urine analysis, Vision blurred
Clinical narrative: Neck pain, severed headaches, sudden onset headaches with blurred vision, anxiety, nausea, clamminess, low grade fever.  Currently awaiting an MRI and is under the care of a physical therapist.
Age: 2.0
Sex: M
Vaccine: FLUX
Symptoms: Fatigue, Hypersomnia, Pyrexia
Clinical narrative: Fever (101.6 axillary), fatigued, sleeping all day.
Age: 45.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Erythema, Pain, Vaccination complication
Clinical narrative: Redness, sore.
Age: 45.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Discomfort, Erythema, Feeling hot, Swelling
Clinical narrative: Redness, sore.
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Cellulitis, Skin warm, Swelling
Clinical narrative: Cellulitis of the arm. Warm to the touch and doubling in size every few hours. Being treated with antibiotics.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Decreased appetite, Fatigue, Heart rate increased, Lethargy, Pyrexia
Clinical narrative: Felt like something was stuck in throat, fever, decreased appetite, tired, rapid heart rate, and lethargic.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Sensation of foreign body
Clinical narrative: Felt like something was stuck in throat, fever, decreased appetite, tired, rapid heart rate, and lethargic.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 06-JUL-2016, the patient was vaccinated with a dose of improperly stored PROQUAD (lot #M010478, expiration date: 01-SEP-2017; dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 28-JUN-2016, the patient was vaccinated with a dose of improperly stored PROQUAD (lot # M010478, expiration date: 01-SEP-2017; dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On 08-SEP-2016, the patient was inadvertently vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot # L046887, expiration date: 23-NOV-2017, dose and route of administration were not provided). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 12-SEP-2016, the patient was inadvertently vaccinated with an improperly stored dose of ROTATEQ lot # L037924, expiration date 22-JUN-2017, orally (dose was not reported). No adverse effect was reported. Product quality complaint was not involved. No additional information was available. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unspecified date, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB injection, 1 ml, lot # M023892, expiration date 15-SEP-2017 (route and site of administration were not reported). No adverse effects were reported. Product quality complaint was not involved. Temperature and time frame of incorrect storage were unspecified. Additional information has been requested.
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report was received from am office manager (other) via company representative concerning a female patient of unknown age. On an unknown date, the patient received her normal dose of (Oka/Merck) PROQUAD and then received a dose of (Oka/Merck) VARIVAX by mistake. No demographics were provided for patient, physician or reporter. Additional information is not expected as no reporter or physician contact details were provided.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 13-JUL-2016, the patient was vaccinated with a dose of improperly stored PROQUAD (lot # M010478, expiration date: 01-SEP-2017; dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 07-JUN-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II lot # reported as M001200, therapy type was not specified (dose and route of administration were not reported). This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 12-SEP-2016, the patient was vaccinated with an expired dose of ROTATEQ lot # K019372, expiration date 16-JUL-2016, orally (dose was not reported). No adverse effect was reported. Product quality complaint was not involved. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 07-JUL-2016, the patient was vaccinated with a dose of improperly stored PROQUAD (lot # M010478, expiration date: 01-SEP-2017; dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 41.0
Sex: M
Vaccine: FLUC3, PNC
Symptoms: Fall, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Lumbar puncture abnormal
Clinical narrative: Unsteady gait. Numbness in feet, legs. Falling. Shaking.
Age: 41.0
Sex: M
Vaccine: FLUC3, PNC
Symptoms: Tremor
Clinical narrative: Unsteady gait. Numbness in feet, legs. Falling. Shaking.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. Information on the concurrent conditions and medical history of the patient were not reported. On 26-AUG-2016, the patient was vaccinated with PROQUAD lot # L044056, expiry date 02-MAY-2017, and M-M-R II lot# K016154, expiry date 24-SEP-2016, both 0.5 ml, subcutaneous (overdose). No adverse effect was reported. There were no Product Quality Complaint (PQC) involved. Additional information has been requested.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Fever, site swelling, redness, tenderness and heat, nausea.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Fever, site swelling, redness, tenderness and heat, nausea.
Sex: U
Vaccine: MEN
Symptoms: Loss of consciousness
Clinical narrative: This is a spontaneous report from a non-contactable consumer. A patient (student at university) of unknown age, gender and ethnicity received TRUMENBA or BEXSERO at single dose on unknown date. The student passed out after receiving the vaccine and went to the hospital. The outcome was unknown. Pfizer is Marketing Authorization Holder of meningococcal group b rlp2086 in the reporter's country. This may be a duplicate report in situations where another Marketing Authorization Holder of meningococcal group b rlp2086 has submitted the same report to the regulatory authorities. No follow up attempts possible. No further information expected.
Sex: M
Vaccine: PNC13
Symptoms: Guillain-Barre syndrome
Clinical narrative: This is a spontaneous report from a contactable vaccine manager and from a contactable office manager reporting on behalf of a physician. A male patient of an unspecified age and ethnicity received PREVNAR 13 via an unspecified route of administration on 01Aug2016 at single dose. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced Guillain Barre syndrome on an unspecified date in 2016. The event required hospitalization since an unknown date in 2016. Event outcome was unknown at the time of report.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Cough, Pyrexia, Wheezing
Clinical narrative: Fever and cough wheeze.
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Chest X-ray, Discomfort, Herpes zoster, Pain
Clinical narrative: This spontaneous report was received from a 69 year old female patient regarding herself. The patient had no pertinent medical history and drug reactions or allergies. There were no concomitant medications. In approximately 2015 (reported as a year ago), the patient was vaccinated with ZOSTAVAX subcutaneous (dose, lot number and expiry date were not reported). In approximately June 2016 (reported as 8 weeks ago), the patient developed shingles. She stated that she did not have what was considered the normal rash and blistering that was associated with shingles, instead she had a flat rash. On the 3rd day after the pain and rash began, she sought medical attention and went to the emergency room (ER) where she underwent chest x-ray examination and white blood cell count however results of tests were not provided. She reported that the ER physician thought she was experiencing "some type of muscular problems" as she was unable to move without experiencing pain. She explained to the physician that she had a rash that went from her upper back, down and around her torso to the center of her stomach. The patient stated that ER physician confirmed that she had shingles, but no treatment was provided. She visited her primary physician the next day, who prescribed her with two month supply of LYRICA (dosage details were not reported) which helped relieve minimal pain, but she was still unable to comfortably wear clothing and was only able to do light house work. She was doing better but still experiencing a lot of discomfort. The outcome of the event was reported as recovering. The causal relationship between the event and the suspect therapy was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash, White blood cell count
Clinical narrative: This spontaneous report was received from a 69 year old female patient regarding herself. The patient had no pertinent medical history and drug reactions or allergies. There were no concomitant medications. In approximately 2015 (reported as a year ago), the patient was vaccinated with ZOSTAVAX subcutaneous (dose, lot number and expiry date were not reported). In approximately June 2016 (reported as 8 weeks ago), the patient developed shingles. She stated that she did not have what was considered the normal rash and blistering that was associated with shingles, instead she had a flat rash. On the 3rd day after the pain and rash began, she sought medical attention and went to the emergency room (ER) where she underwent chest x-ray examination and white blood cell count however results of tests were not provided. She reported that the ER physician thought she was experiencing "some type of muscular problems" as she was unable to move without experiencing pain. She explained to the physician that she had a rash that went from her upper back, down and around her torso to the center of her stomach. The patient stated that ER physician confirmed that she had shingles, but no treatment was provided. She visited her primary physician the next day, who prescribed her with two month supply of LYRICA (dosage details were not reported) which helped relieve minimal pain, but she was still unable to comfortably wear clothing and was only able to do light house work. She was doing better but still experiencing a lot of discomfort. The outcome of the event was reported as recovering. The causal relationship between the event and the suspect therapy was not reported. Additional information has been requested.
Age: 0.5
Sex: F
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a 6 month old female patient. The patient's had no relevant medical history, drug history and concomitant medications. On 15-AUG-2016 the patient was vaccinated with ROTATEQ at a dose of 2 ml, orally from lot # L029615 with 15-MAY-2017 which was exposed to temperature excursion (incorrect product storage). After receiving vaccination, no adverse effects were reported thus far. She had no relevant laboratory data. At the time of this report, it was unknown if patient would continue ROTATEQ. This is one of the several reports received from the same reporter. Additional information has been requested.