chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Redness and inflammation at the injection site.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Erythema, Pyrexia, Skin lesion, Skin warm, Urticaria
Clinical narrative: Pt given MENACTRA vaccine IM into left deltoid 8/10/15 without difficulty. Pt developed a large erythematous, urticarial lesion around site in the next several hours with associated fever. Sx responded to BENADRYL PO, but urticarial lesion (smaller at 6 cm diameter) still erythema, warm. Present at f/u exam 24 hrs later.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to 60 patients of unknown age and gender. No information of concurrent conditions and medical history were reported. Approximately in 2015 (reported as since 23-AUG-2015 till 04-SEP-2015, today) the patients were vaccinated with improperly stored VARIVAX (Merck) (unknown strength, route and dose) lot # L016124 with expiry date of 06-MAY-2015. Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Loss of consciousness, Muscle twitching, Syncope
Clinical narrative: Child twitched and lost consciousness for a few seconds - thought to be a faint episode while seated on exam table. Pt. was monitored - given water, and a sucker. Rested. Discharged in good condition.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to 60 patients of unknown age and gender. No information of concurrent conditions and medical history were reported. Approximately in 2015 (reported as since 23-AUG-2015 til 04-SEP-2015, today) the patients were vaccinated with improperly stored (Oka-Merck) PROQUAD (unknown strength, route and dose) lot # L010143 with expiry date 24-SEP-2016. Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 3.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Injection site rash, Local reaction, Pyrexia
Clinical narrative: Rash on Lt thigh 1 wk after vaccine. Fever 2 days after vaccine. Mild local reaction x 1 wk. No intervention, self limited.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Red rash extending down length of arm from inj site, warm, red, itchy.
Age: 1.49
Sex: M
Vaccine: DTAPIPVHIB, HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash pruritic
Clinical narrative: Pruritic rash and fever T max 103 for 1 day, started 9/3/15. Received Varicella vaccination 9 days ago.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Pt. has swelling, itching, hardness at injection site. Mom gave BENADRYL, iced site, gave Ibuprofen for swelling.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Rash pruritic
Clinical narrative: Spreading pruritic rash starting 8/31/15, initially on trunk, now neck, auricular areas, axillae, and proximal extremities. Received PROQUAD 12 days prior to rash.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Lip pruritus
Clinical narrative: Swelling at injection site. Itching in lips. Began 24 hrs after injection on Sunday - patient says they have history of allergies to NSAIDS. Contact Dr on call - advised patient to take BENADRYL. Patient will follow up with primary Dr. Tuesday 9/8/15.
Age: 0.2
Sex: M
Vaccine: HEPA
Symptoms: Crying, Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of crying in a 2-month-old male patient who received HAVRIX pediatric (batch number AD9Y4, expiry date 7th October 2017). Concomitant products included medication unknown (vaccine). On 28th August 2015, the patient received the 1st dose of HAVRIX pediatric .5 ml. On 28th August 2015, several hours after receiving HAVRIX pediatric, the patient experienced crying, wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the crying, wrong vaccine administered and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the crying to be related to HAVRIX pediatric. Additional details were provided as follows: This case was previously reported to a doctor. Chief operating officer reported that a 2 months old patient inadvertently received HAVRIX instead of Hepatitis B for his vaccinations, which led to administration of wrong vaccine and inappropriate age at vaccination. The reporter was not able to provide all the specifics without the chart but noted it was given in a thigh and other vaccinations were given but names unknown. The reporter stated that a phone call was made Friday afternoon to check on the child and his mom reported that the patient was crying but he did not experience any fever or rash. At the time of reporting, the child was due for a return visit in morning at 10 AM for a follow up to the vaccination.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Erythema, Pain, Pain in extremity, Pyrexia
Clinical narrative: 12 hours of getting vaccine pt had chills, fever (102), aches. Very sore arm with redness 5 weeks.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Local reaction
Clinical narrative: "Left thigh red, swollen, hot". 3-4 cm area of swelling, induration - "local reaction".
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Unresponsive to stimuli, Visual impairment
Clinical narrative: Pt became non-responsive, very dizzy and vision disturbances, never passed out, sat pt on floor, 911 responded took vitals, pt was escorted home by mother.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia, Respiratory tract infection
Clinical narrative: 9-3-15 treated for infection (respiratory). 9-8-15 diagnosis pneumonia.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (dose and route of vaccination were not reported, lot # K016132 with expiration date: 24-SEP-2016, lot # L003774 with expiration date: 04-FEB-2017, lot # L007225 with expiration date: 03-MAR-2017, lot # L012036 with expiration date: 07-APR-2017, lot # reported as L018001 with expiration date: 19-MAY-2017). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, palpable lump at injection site - redness, warm to the touch. Ice/ibuprofen being used.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Erythema, itching, tenderness at injection site, started within 1-2 hours after receiving injection; spreading erythema and induration over 1 week, treated for allergic reaction and cellulitis.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Rhinitis allergic
Clinical narrative: Erythema, itching, tenderness at injection site, started within 1-2 hours after receiving injection; spreading erythema and induration over 1 week, treated for allergic reaction and cellulitis.
Sex: U
Vaccine: MMRV
Symptoms: Medication error, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a unspecified number of patients of unknown age and gender. On 27-AUG-2015, an unspecified number of patients who were all older than 12 years of age were vaccinated each with (Oka-Merck) PROQUAD (dose, route, lot# unspecified). No adverse event was reported. No product quality complaint was 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 licensed vocational nurse concerning a patient of unknown age and gender. The patient's pertinent medical history or concurrent conditions were not provided. On 25-AUG-2015 the patient was vaccinated with improperly stored doses of PROQUAD, lot # reported as: L023111, expiration date: 24-DEC-2016) (route, anatomical location and dose were not reported). Co-suspect therapies or concomitant medications were not provided. No adverse symptom was 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 licensed vocational nurse concerning a patient of unknown age and gender. The patient's pertinent medical history or concurrent conditions were not provided. On 27-AUG-2015 the patient was vaccinated with improperly stored dose of (Oka-Merck) PROQUAD, lot # reported as: L023111, expiration date: 24-DEC-2016) (route, anatomical location and dose were not reported). Co-suspect therapies or concomitant medications were not provided. No adverse symptom was 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 as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of (Oka-Merck) PROQUAD (lot# reported as L023111, expiration date 24-SEP-2016, dose and route of administration 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: 65.0
Sex: F
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Unevaluable event
Clinical narrative: None per patient. Feels fine with no sign or symptoms of adverse reactions.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 03-AUG-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (lot # L011079, expiration date 01-OCT-2016, dose, dose# and route not reported). There was no adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a physician via other manufacturer and described the occurrence of injection site swelling in a 68-year-old female patient who received Tdap vaccine (batch number 45214AA?, expiry date unknown). The patient's past medical history included Sjogren's disease, hypothyroidism, Meniere's disease and hypercholesterolemia. On 7th May 2015, the patient received Tdap (intramuscular) .5 ml. On 8th May 2015, 1 days after receiving Tdap vaccine, the patient experienced injection site swelling, injection site redness, injection site itching, injection site hives, injection site pain, injection site rash and general body pain. Tdap vaccine was discontinued. In May 2015, the outcome of the injection of the injection site pain, injection site rash and general body pain were recovered/resolved. On an unknown date, the outcome of the injection site swelling, injection site redness, injection site itching and injection site hives were unknown. The reporter considered the injection site swelling to be related to Tdap vaccine. It was unknown if the reporter considered the injection site redness, injection site itching, injection site hives, injection site pain, injection site rash and general body pain to be related to Tdap vaccine. Additional details were provided as follows: The reporter stated that, the patient's left arm was very swollen, red itchy, hives from shoulder to elbow, pain and body aches. The patient had pain and rash for 3 days. The patient was not hospitalized because of events. This case was previously reported. The reported batch number for Tdap was 45214AA, which does not exist as per sales data sheet, however no clarification could be obtained.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site urticaria, Pain
Clinical narrative: This case was reported by a physician via other manufacturer and described the occurrence of injection site swelling in a 68-year-old female patient who received Tdap vaccine (batch number 45214AA?, expiry date unknown). The patient's past medical history included Sjogren's disease, hypothyroidism, Meniere's disease and hypercholesterolemia. On 7th May 2015, the patient received Tdap (intramuscular) .5 ml. On 8th May 2015, 1 days after receiving Tdap vaccine, the patient experienced injection site swelling, injection site redness, injection site itching, injection site hives, injection site pain, injection site rash and general body pain. Tdap vaccine was discontinued. In May 2015, the outcome of the injection of the injection site pain, injection site rash and general body pain were recovered/resolved. On an unknown date, the outcome of the injection site swelling, injection site redness, injection site itching and injection site hives were unknown. The reporter considered the injection site swelling to be related to Tdap vaccine. It was unknown if the reporter considered the injection site redness, injection site itching, injection site hives, injection site pain, injection site rash and general body pain to be related to Tdap vaccine. Additional details were provided as follows: The reporter stated that, the patient's left arm was very swollen, red itchy, hives from shoulder to elbow, pain and body aches. The patient had pain and rash for 3 days. The patient was not hospitalized because of events. This case was previously reported. The reported batch number for Tdap was 45214AA, which does not exist as per sales data sheet, however no clarification could be obtained.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist regarding an approximately 73 year old female patient. Patient had none pertinent medical history and drug allergies or reactions. On 01-SEP-2015, the patient was vaccinated with ZOSTAVAX lot # L012475, expiration date- 10-JUL-2016 (dose strength and route was unknown). No concomitant medication was reported. On 02-SEP-2015, patient experienced injection site reactions that consisted of swelling, redness, and a raised bump on an unspecified arm. No treatment was given for the events and no laboratory diagnostics were performed. Patient seek medical attention. No product quality complaint (PQC) was involved. The outcome of injection site reaction that consisted of redness, and a raised bump was unknown. The outcome of injection site reaction that consisted of swelling that was reported as resolving, reporter stated that swelling had gone down a little bit. The causality between injection site reaction that consisted of swelling, redness, and a raised bump and ZOSTAVAX was unknown. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Allergy to vaccine, Injection site erythema, Pain, Pyrexia, Tenderness
Clinical narrative: This spontaneous report was received from a Certified Medical Assistant on behalf of a physician via Pfizer, referring to a 69 year old female patient with allergy to penicillin and allergy to shellfish. On 03-MAY-2011, shortly after 10:57 am, the patient was vaccinated with PNEUMOVAX 23 (strength and frequency unknown) Lot No. reported as 0930Z, exp. date: 17-JUL-2011) 0.5ml, intramuscular in the left deltoid. Concomitant medications were not described. On 03-MAY-2011, the patient experienced that her left arm was tender and painful to lift. Additionally, on approximately 05-MAY-2011 (also reported as two days after they were given it) the patient reported redness at injection site, feverish and achy all over. On an unspecified date, the patient developed allergy to PNEUMOVAX 23. The patient was not seen by the doctor, and no hospitalization was reported. There were no other vaccination within 4 weeks prior to PNEUMOVAX 23, and no illness at the time of vaccination. No relevant tests were performed. No Product Quality Issue was reported. At the time of this report, the outcome of left arm tenderness and painful to lift was recovered on 04-MAY-2015. The outcome of redness at injection site, feverish and achy all over was reported as recovered completely on an unspecified date, and the outcome of allergy to PNEUMOVAX 23 was not reported. The reporter considered the events to be related to PNEUMOVAX 23. This is one of two reports received from the same reporter (MARRS #1509USA004264). Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 03-AUG-2015 the patient was vaccinated with a dose of improperly stored (Oka-Merck) PROQUAD (lot # L011079, expiration date 01-OCT-2016, dose, dose# and route not reported). There was no adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. Concurrent conditions and medical history were not reported. On unspecified dates, in a range from 01-APR-2015 through 30-APR-2015, the patients were vaccinated with improperly stored doses of ROTATEQ (Lot# reported as K006056, expiration date, 08-MAR-2016) (Strength, dose and route were not provided). Concomitant medications were not reported. No adverse effects reported. This is one of several reports from the same source. 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 licensed vocational nurse concerning a patient of unknown age and gender. The patient's pertinent medical history or concurrent conditions were not provided. On 24-AUG-2015 the patient was vaccinated with improperly stored dose of VARIVAX (Merck), lot #: K003420, expiration date: 06-MAR-2016 (route, anatomical location and dose were not reported). Co-suspect therapies or concomitant medications were not provided. No adverse symptoms 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 as received from a licensed practical nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 30-JUL-2015 the patient was vaccinated with a dose of improperly stored (Oka-Merck) PROQUAD (lot # K018144, expiration date 10-APR-2016, dose, dose# and route not reported). There was no adverse events 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 as received from a licensed practical nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 04-AUG-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (lot # K018144, expiration date 10-APR-2016, dose, dose# and route not reported). There was bi adverse events reported. This sis one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a Licensed Vocational Nurse (LVN) referring to a patient of unknown age and gender. There was no medical history or concurrent condition reported. On 18-AUG-2015 the patient was vaccinated with a dose of expired M-M-R II (lot # J006140, expiry date 17-APR-2015) (dosage, strength and route were not reported). There was no concomitant medication reported. At the time of the report, no symptoms was 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 as received from a licensed practical nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 30-JUL-2015 the patient was vaccinated with a ose of improperly stored PROQUAD (lot # K018144, expiration date 10-APR-2016, dose, dose# and route not reported). There was no adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Malaise
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL, (dose, dose number, route of administration, injection site, lot number and expiration date were not reported). It was reported that the patient felt weak and did not "feel well" (unspecified on how the patient did not feel well) an unspecified time after receiving an unspecified dose of GARDASIL. According to the reporting physician, the female patient had also developed general malaise and non specific symptoms after receiving GARDASIL on an unknown date. No treatment was given for the adverse events. No laboratory diagnostic studies were performed. The patient's mother sought medical attention for her child by calling the physician (on an unspecified date) to report the events and was told to bring her daughter in for a visit if she really concerned about her. The outcome of the events of feeling weak, not feeling well, developing general malaise and developing non specific symptom after receiving GARDASIL was unknown at the time of the report. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
Age: 25.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 25 years old patient of unkown gender. No medical history, concurrent conditions or concomitant therapies were provided. On 20-JUL-2015, the patient was vaccinated wiht an improperly stored dose of VARIVAX (Merck) lot # J012377, expiration date 03-OCT-2015 (dose, route of administration and anatomical location were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report as received from a pharmacist as a part of Market Research program refers to a female patient in her 60's. On an unknown date, the patient was vaccinated in the arm with ZOSTAVAX (dose, route and lot number were not reported). On an unknown date the patient experienced injection site reaction - large red circle on arm. The outcome of the event was reported as recovering/resolving. The reporter considered injection site reaction to be related to ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 06-AUG-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (lot # L011079, expiration date 01-OCT-2016, dose, dose# and route not reported). There was no adverse events reported. 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 a healthcare worker and refers to unspecified patients of unknown age and genders. No medical history, concurrent conditions or concomitant therapies were reported. On 17-AUG-2015, 19-AUG-2015, 24-AUG-2015 and 31-AUG-2015, the patients were vaccinated with improperly stored doses of VARIVAX lot # J012328, expiration date 02-OCT-2015 (dose, route of administration and anatomical location were not reported). No adverse experiences were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to 2 unspecified patients of unknown age and gender. On 24-AUG-2015 the patients were inadvertently vaccinated subcutaneously with doses of MMR II injection which expired on 23-AUG-2015. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. On 05-FEB-2009, the third dose of GARDASIL (lot number reported as 1129X, expiry date: 12-MAR-2011) series was administered , which was 1 week earlier than what is recommended, bu physician. No adverse reaction was reported. The outcome was unknown. No 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 pharmacist and refers to an unspecified number of patients of unknown age and gender. No medical history or current condition were reported. Starting from 12-NOV-2015, an unspecified number of patients were administered with improperly stored doses of GARDASIL (lot number-K006960, expiry date 19-FEB-2007 and lot number-K008931, expiry date-04-MAR-2017) (dose, route were not reported). No adverse event was reported. No further information was provided. This is one of two reports from the same reporter. Additional information has been requested.
Age: 6.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a healthcare worker (Medical Assistant) referring to a 6 year old patient of unknown gender. The patient's pertinent medical history and drug allergies were not reported. On 27-AUG-2015 the patient was vaccinated with M-M-R  II (lot # and expiration date unknown, 0.5 ml) subcutaneously in the left thigh and at the same time administered (Oka/Merck) PROQUAD (lot #, expiration date, dose unknown) subcutaneously in the right thigh (overdose). No adverse effects reported. Additional information is not expected as the physician couldn't be contacted.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On unspecified dates since 01-AUG-2015, the patients were vaccinated with an unspecified number of improperly stored doses of GARDASIL 9 (lot number L011846 and expiration date 16-JUN-2017) (dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 03-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot# K011562, expiration date 08-APR-2017, dose and route of administration 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: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to an unspecified patients of unknown age. On 01-SEP-2015, the patients were vaccinated with doses of improperly stored VARIVAX lot # K010440, expiry date 22-JUL-2016, K011084, expiry date 08-AUG-2016 or 1004653, expiry date 11-FEB-2017 and no adverse effects were reported. The outcome of the events were unknown. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Information has been received from a pharmacist referring to a 70 year old female patient who was enrolled in a market research (titled as ZOSTAVAX HCP Competitive message testing). The patient's medical history and concurrent condition were not reported. On an unknown date of 2008, the patient was vaccinated with one single of ZOSTAVAX, subcutaneous (dose, strength, dose number and lot# were not reported). Information regarding concomitant medication was not reported. On an unspecified date of 2008 the patient experienced swelling at injection site. The outcome of the event was reported as recovered on an unknown date of 2008. The reporter considered the event to be non-serious and related to ZOSTAVAX. Additional information is not expected as the reporter refused to be contacted.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 10-AUG-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (lot # L011079, expiration date 01-OCT-2016, dose, dose# and route not reported). There was no adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to five patients of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with GARDASIL lot # L010596 with expiration date 06-APR-2017 (dose, dose number and route were not reported), which were improperly stored. No adverse effects were reported. This is one of several cases 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 as received from a licensed practical nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 10-AUG-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (lot # K018144, expiration date 10-APR-2016, dose, dose# and route not reported). There were no adverse events 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 as received from a licensed practical nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 10-AUG-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (lot # K018144, expiration date 10-APR-2016, dose, dose# and route not reported). There was no adverse events 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 as received from a licensed practical nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 07-AUG-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (lot # K018144, expiration date 10-APR-2016, dose, dose# and route not reported). There was no adverse events 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 as received from a licensed practical nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 10-AUG-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (lot # L011079, expiration date 01-OCT-2016, dose, dose# and route not reported). There was no adverse events reported. 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 a Nurse referring to an unspecified number of patients of unknown age and gender. No concurrent or historical condition was reported. On an unknown date the patients were vaccinated with an unspecified number of improperly stored (Oka/Merck) VARIVAX (lot # K020757, expiration date 31-OCT-2016 and Lot # L004649 expiration date 11-FEB-2020) (dose, route, and anatomical location were not reported). No concomitant medication was reported. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 07-AUG-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (lot # L011079, expiration date 01-OCT-2016, dose, dose# and route not reported). There was no adverse events 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, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. Concurrent conditions and medical history were not reported. On unspecified date, in a range from 01-APR-2015 through 30-APR-2015, the patients were vaccinated with improperly stored doses of VAQTA (Lot# K005958, expiration date: 09-FEB-2017) (Strength, dose and route were not provided). Concomitant medications were not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified number of patients of unknown age and gender. Concurrent conditions and medical history were not reported. On unspecified dates, in a range from 01-APR-2015 through 30-APR-2015, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # J013394, expiration date 25-AUG-2015) (Strength, dose and route were not provided). Concomitant medications were not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
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. The patient's medical history and concurrent conditions were not reported. On 03-SEP-2015, the patient was vaccinated inadvertently with one dose of expired GARDASIL (lot # H020002, expiry date 08-AUG-2015, route was not reported). Concomitant medications were not reported. 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 nurse refers to an unspecified patients of unknown age and unknown gender. From 24-AUG-2015, improperly stored ZOSTAVAX (lot# K023623 and expiry date: 20-FEB-2015 was administered to multiple different unspecified patients on unspecified dates. No adverse effects were noted. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and unknown gender. From 24-AUG-2015, improperly stored (Oka/Merck) VARIVAX (lot# L007224 and expiry date: 03-MAR-2017 was adminsitered to multiple different unspecified patients on unspecified date. 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 as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (lot# K016129, expiration date 23-SEP-2016, dose and route of administration 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: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot# K016129, expiration date 23-SEP-2016, dose and route of administration 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: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On unspecified dates since 10-AUG-2015, the patients were vaccinated with an unspecified number of improperly stored doss of RECOMBIVAX HB (lot number J013394 and expiration date 25-AUG-2016, lot number K017721 and expiration date 27-AUG-2016, lot number K026666 and expiration date 22-OCT-2016) (dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. This is one of several reports received from the same reporter. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB Lot#K02500 and K015462 (dose was not reported). No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's pertinent medical history or concurrent conditions were not provided. On 02-SEP-2015, the patient was vaccinated with an expired dose of MMR II lot # J003004, expiration date: 14-MAR-2015) (route, anatomical location and dose were not reported). Co-suspect therapies or concomitant medications were not provided. No adverse experiences were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot# reported as L023111, expiration date 24-SEP-2016, dose and route of administration 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: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unspecified dates since 01-AUG-2015, the patients were vaccinated orally with an unspecified number of improperly stored doses of oral, ROTATEQ (lot number K011952 and expiration date 17-JUN-2016, lot number reported as L010844 and expiration date 16-NOV-2016) (dose was not reported). Concomitant therapy was not reported. No adverse effect was reported. This is one of several reports received from the same reporter. 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 medical assistant refers to unspecified number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On unknown dates, the patient were vaccinated with doses of improperly stored (ZOSTAVAX) (doses and routes were not reported) lot # L012475 expiration date 10-JUL-2016. No symptoms reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (lot# reported as L023111, expiration date 24-SEP-2016, dose and route of administration 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: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unspecified dates since 01-AUG-2015, the patients were vaccinated with an unspecified number of improperly stored doses of VAQTA (lot number K007827 and expiration date 09-DEC-2016, lot number K005323 and expiration date 10-FEB-2017, lot number L007559 and expiration date 01-JUN-2017) (dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. 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 as received from a medical assistant refers to unspecified number of patients of unknown age and gender. The patient's medical history and current conditions were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX (doses and routes were not reported) lot # K005180 expiration date 10-APR-2016, lot # K007972 expiration date 03-JUN-2016, lot # L001329 expiration date 13-JAN-2017, lot # L008272 expiration date 11-MAR-2017. No symptoms reported. This is one of several reports receive from the same reporter. Additional information is not expected as the reporter did not wish further contact.
Age: 56.0
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 56 years old patient of unknown gender. No medical history, concurrent conditions or concomitant therapies were reported. On 04-SEP-2015 (reported as "today"), the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # K010016, expiration date 05-AUG-2015, dose 0.5 ml, intramuscularly (anatomical location was not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On unspecified dates since 01-AUG-2015, the patients were vaccinated with an unspecified number of improperly stored doses of GARDASIL (lot number K005881 and expiration date 14-JAN-2017, lot number K008931 and expiration date 04-MAR-2017) (dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.