chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to three unspecified patients of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. On an unknown date, the three patients were vaccinated with improperly stored PROQUAD (Merck) (lot# L044058 and expiration date 02-MAY-2017) (dosing details unspecified). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This case is linked to case 1603USA005789 (same reporter link). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a physician via company representative regarding a female patient of unknown age. There was no information about concurrent condition and historical medication. On an unknown date the patient was vaccinated with ZOSTAVAX, 0.65 ml/one time injection, subcutaneous injection. No concomitant medication was reported. On an unknown date the patient experienced shingles. Unspecified treatment was given to the patient and she also called physician to seek medical attention. The outcome of shingles was unknown. Causality between shingles and ZOSTAVAX was unknown. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Erythema multiforme, Pruritus, Swelling, Urticaria
Clinical narrative: Erythema multiform, urticarial pruritus and swelling.
Age: 62.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cataract, Cataract operation, Heart rate increased, Hyperlipidaemia, Pyrexia
Clinical narrative: Initial information regarding this clinically sponsored solicited case was received on 07-Mar-2016 from the non-health care professional via a Patient support program Study. This case involves 62-year-old female patient who presented with heart rate was 145 beats/minute (heart rate increased), patient came down with fever that lasted one day, unknown duration after and she underwent right eye cataract removal, left eye cataract removed (cataract removal), 49 days after starting treatment with alirocumab (Praluent) and unknown duration after starting influenza vaccine. On an unknown date, patient received influenza vaccine (Dose, form, route, frequency, lot/ batch number and expiration date: unknown). On 13-Jan-2016, the patient received subcutaneous alirocumab at the dose of 150 mg every other week (Form, lot/ batch number and expiry date: unknown) via alirocumab prefilled pen for other hyperlipidemia. The patient went in for a Right eye Cataract removal on 02-Mar-2016 (Latency: 49 days after receiving alirocumab and unknown duration after receiving influenza vaccine) and on an unknown date (Latency: unknown) the patient's heart rate was 145 beats per minute (while on alirocumab). The patient was then transferred to the emergency room (ER) and admitted. Patient was discharged on 03-Mar-2016 and her heart rate was managed and within patient's normal range. On February 3 or 4th 2016, the patient had her left eye cataract removed without complication (while on alirocumab). The patient received a Flu and pneumonia shot on 03-Mar-2016 and on an unknown date (Latency: unknown) the patient experienced fever that lasted one day (while on alirocumab). No action was taken with therapy of alirocumab and unknown for influenza vaccine. Corrective treatment: Not reported. Outcome: Resolved for heart rate increased and fever. Reporter causality: Unknown. Company causality: Not associated. Seriousness Criteria: Hospitalization for heart rate was 145 beats/minute and important medical event for right eye cataract removal, left eye cataract removed.
Age: 11.0
Sex: M
Vaccine: MENB, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, pain at injection site.
Age: 0.23
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture, Chest X-ray, Eye movement disorder, Hypotonia, Metabolic function test
Clinical narrative: Mother reported fever to 102 and brief apneic episode. Not sure if true apneic never cyanotic but rolled eyes back in head and went limp. No tonic clonic movements-called EMS went to BMH where limited workup was unrevealing. Occurred within 12 hours of immunizations. Fever resolved within 48 hrs. Seemed fine and never developed other symptoms.
Age: 0.23
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Mother reported fever to 102 and brief apneic episode. Not sure if true apneic never cyanotic but rolled eyes back in head and went limp. No tonic clonic movements-called EMS went to BMH where limited workup was unrevealing. Occurred within 12 hours of immunizations. Fever resolved within 48 hrs. Seemed fine and never developed other symptoms.
Age: 33.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness
Clinical narrative: States feeling dizzy and woozy. BP 122/80, P 80, Temp 98.4.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding an unspecified patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date since 15-FEB-2016, the patients were vaccinated with improperly stored ZOSTAVAX lot # L028286, expiration date- 28-OCT-2016 and lot # L035505, expiration date-16-DEC-2016. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. Temperature and Time frame was 20F for 11 hours and 6F for 15 hours and there was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. In approximately 2014 (reported as 1 and a half to 2 years ago), the patient was administered a dose of GARDASIL (lot#, expiration date, dose and route were unknown). In February 2016 (reported as sometime last week), the patient was vaccinated with a dose of GARDASIL 9 (route, lot#, expiration date and dose were unknown) at an unspecified physician's office (interchange of vaccine products and inappropriate schedule of drug administration). No adverse effects were reported. Additional information is not expected as the reporter didn't like to be contacted.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding an unspecified patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date since 15-FEB-2016, the patient was vaccinated with improperly stored VARIVAX (Merck) lot # L003777, expiration date- 04-FEB-2017, (incorrect product storage). No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. Temperature and Time frame was 20F for 11 hours and 6F for 15 hours and there was no previous temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a patient of unknown age and gender. There was no medical history or drug reaction/allergies reported. On an unknown date the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # L035510 with expired date 13-MAY-2017, oral, dose unknown), which was stored in 47 Fahrenheit for 14.5 hours. No concomitant therapy was reported. The reporter stated that there was no previous temperature excursion. No symptoms were reported. Additional information has been requested.
Sex: U
Vaccine: DTAPHEPBIP, HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (medical assistant) refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 15-MAR-2016 the patient was vaccinated with RECOMBIVAX HB (dose 3, lot # L025838, expiration date 14-AUG-2017, 5 microgram/0.5 ml injection, dose 5 microgram, intramuscular). On the same day, the reporter also administered PEDIARIX (dose, route and lot # not reported) to the patient. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 29-OCT-2014, the patient was vaccinated with a dose of ZOSTAVAX (dose and route of administration were not reported, lot # K003604, expiration date 20-MAR-2015). On 12-MAR-2016, the patient was vaccinated with a second dose of ZOSTAVAX (in the deltoid region of the left arm, dose and route of administration were not reported, lot #L035285, expiration date 12-FEB-2016). There was no adverse effect reported. Additional information has been requested.
Age: 0.24
Sex: F
Vaccine: IPV
Symptoms: Abnormal behaviour, Autism, Decreased eye contact, Food allergy, Multiple allergies
Clinical narrative: Not looking straight in eye, no laughter, no babbling, congested, multiple allergies, peanut allergy, autism.
Age: 0.24
Sex: F
Vaccine: IPV
Symptoms: Respiratory tract congestion
Clinical narrative: Not looking straight in eye, no laughter, no babbling, congested, multiple allergies, peanut allergy, autism.
Age: 0.49
Sex: M
Vaccine: DTAP
Symptoms: Injection site reaction, Rash papular
Clinical narrative: Patient developed a papular rash all around the injection site. Rash took several days to go away.
Age: 40.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Erythema, Neuralgia, Pain in extremity
Clinical narrative: Patient noticed increased pain sensitivity in right arm/hand on 3/16/16.  On 3/17/16 around 8am patient noticed a raised red oval area, no blisters but looks like the same shape as previous shingles.  General aches and pains in that arm/hand.  Pt had pre-existing neuropathy pain but has notices increase in that since getting the shot.
Age: 40.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Injection site erythema, Injection site pain, Injection site swelling, Neuralgia
Clinical narrative: Patient noticed increased pain sensitivity in right arm/hand on 3/16/16.  On 3/17/16 around 8am patient noticed a raised red oval area, no blisters but looks like the same shape as previous shingles.  General aches and pains in that arm/hand.  Pt had pre-existing neuropathy pain but has notices increase in that since getting the shot.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Herpes zoster, Rash, Varicella virus test positive
Clinical narrative: Rash consistent with shingles.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unspecified date, the patient was inadvertently vaccinated with VARIVAX (Merck) (route, dose, strength not reported) which was reconstituted with sterile water that did not come supplied with the shipment of the VARIVAX (Merck) (product preparation error). No adverse effects were reported. No product quality (PQC) was involved. No further information provided. 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 refers to an unspecified number of patients of unknown age and gender. There was no information about concurrent conditions, medical history or concomitant medication. On an unknown date, the patients were vaccinated with improperly stored dose of VARIVAX (Merck) (lot # L030159 and expiry date 11-AUG-2017) (dosing details unspecified). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Details of temperature excursion: Temperature: 6.7 F. Time frame: 42 Minutes. Data logger: Yes. Previous temperature excursion: No. This is one of the two 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 nurse refers to an unspecified number of patients of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. On an unknown date, the patients were vaccinated with improperly stored dose of PROQUAD (Merck) (lot# L037968 and expiry date 29-MAR-2017) (dosing details unspecified). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Details of temperature excursion: Temperature: 6.7 F, Time frame: 42 minutes, Data logger: Yes, Previous temperature excursion: No. This is one of the two reports received from the same reporter. Additional information has been requested.
Age: 50.0
Sex: U
Vaccine: VARZOS
Symptoms: Antibody test negative, No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a nurse referring to a 50 year old patient of unknown gender. On an unknown date, the patient was seen on a recent annual visit. Varicella titers were drawn and titers were negative. Subsequently on 08-JAN-2016 the patient was inadvertently vaccinated with ZOSTAVAX (lot # reported as K020761, expiration date 31-OCT-2016), 0.65 ml, subcutaneously instead of the first dose of VARIVAX (Merck) (wrong vaccine administered). 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 other health professional referring to a [patient of unknown age and gender. Medical history and current conditions were not reported. On 10-MAR-2016, the patient was orally vaccinated with improperly stored dose of ROTATEQ (dose, frequency and indication were not reported; lot # L037924 with expiration date: 22-JUN-2017). Concomitant therapy was not reported. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: FLUX, HEPA, HPVX, VARCEL
Symptoms: Adverse event, Incorrect product storage
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions or medical history provided. On an unknown date ranging from 15-JAN-2016 to 03-MAR-2016 (previously reported as 02-JAN-2016 to 16-MAR-2016), the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot # L018351, expiration date 11-AUG-2017, exact dose, route of administration and anatomical location were not reported). On an unknown date, the patient received also a dose of VARIVAX (Merck) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported), VAQTA (exact dose, route of administration, anatomical location, lot # and expiration date were not reported). Concomitant therapies included influenza virus vaccine (unspecified). On an unknown date following these administrations, the patient experienced an unspecified adverse event and was sent to an unspecified emergency department for an unspecified cause. The administered doses of GARDASIL 9 experienced a temperature excursion of 48.2 to maximum 57 degrees Fahrenheit ranging from 02-JAN-2016 to 29-JAN-2016 (total time 276 hours cumulative). No previous excursions were reported. The outcome of the adverse event was unknown. The relatedness between the event and suspect therapies was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Day-2 to 7: Could not lift right arm lasted for 1 week. Week 2: Soreness at injection site radiates down arm and up neck.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional referring to a patient of unknown age and gender. Medical history and current conditions were not reported. On 10-MAR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (dose, frequency and indication were not reported; lot # L027726 with expiration date: 10-MAY-2017). Concomitant therapy was not reported. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: FLU3, MMR
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Influenza vaccine given in (R) deltoid on 2/26/16. Next day, had lymph node enlargement in axilla. Went to Occupational Health and treated with warm compresses. It was tender to touch and resolved on 3/5/16 completely.
Age: 84.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report was received from a physician via company representative refers to a 84 year old female patient. Medical history and current conditions were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, frequency, indication, route of administration were not reported). Concomitant therapy was not reported. On an unknown date, the patient was diagnosed with herpes zoster on her face, near an unspecified eye and on the back of the neck and experienced a lot of pain an unspecified period of time after receiving ZOSTAVAX. The treatment was given for adverse event. The patient sought medical attention. The outcome of herpes zoster and pain was unknown. Causality assessment was not reported. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Left arm redness, swelling, itching.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Erythema, induration, and itching 14 cm x 12 cm surrounding injection site that started on 3/16/16, one day after vaccines. Treatment with OTC 1% hydrocortisone cream topically, OTC children's BENADRYL and OTC children's CLARITIN.
Age: 3.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 3 year old patient. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. The patient's past vaccination included a VARIVAX (Merck) lot# L037561, expiry date: 29-SEP-2017 on an unknown date. On 14-MAR-2016, the patient was vaccinated with PROQUAD (Merck) (dosing details and route not reported) lot # L046509, expiry date: 17-MAY-2017, instead of M-M-R II. No adverse effects were reported. There were no product quality complaints (PQC) involved. Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Lymphadenopathy
Clinical narrative: This spontaneous report as received from a 53 year old male patient regarding himself. No concurrent conditions or medical history was reported. Patient had allergy to aspirin and ATIVAN. On 10-MAR-2016, the patient was vaccinated with ZOSTAVAX (dosing details, route, lot# and expiry date were not reported). There was no concomitant medication. On 10-MAR-2016, the patient experienced swollen gland, redness, and itching at the injection site. No treatment was given for the events. There was no lab tests done. The patient did not seek any medical attention. The outcome of the events was reported as not recovered/not resolved. The reporter did not provide the causality between the events and the suspect therapy. There were no product quality complaints (PQC) involved. Additional information is not expected as no contact details were provided.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67-year-old female patient. The patient had no pertinent medical history, no drug reactions and no allergies. On 03-MAR-2016, the patient was vaccinated with ZOSTAVAX subcutaneously, lot # L034724, expiration date: 09-DEC-2016 (dose was not reported). The patient had no concomitant medications. On 04-MAR-2016, the patient noticed red, warm quarter size welts around the injection site. They went away after 5 days. On 10-MAR-2016, the redness and a 2 inch welt appeared. The patient was treated with TYLENOL and BENADRYL. The outcome of the red, warm quarter size welts around the injection site was recovered on 09-MAR-2016 (reported as after 5 days). The outcome of the redness and 2 inch welt was not reported. The causality assessment between the events and ZOSTAVAX was not provided. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Aphonia, Asthenia, Chest X-ray normal, Cough, Diarrhoea
Clinical narrative: By morning was sick, it started with a cough which became productive during the day, and was thick, chunky and clear. By the end of the day had fever of 102.7 degrees. Did no have body aches but was coughing to the point that could hardly catch breath. Went to doctor who got blood work done: White cells count and live enzymes off. Doctor prescribed TAMIFLU. General health ok but by weekend had off and on nausea--no vomiting--and loose stools. Went to the ER for possible dehydration. Got some IV fluids and some medication for nausea/vomiting which was effective ER run blood work but numbers out of range earlier in the week went back to normal. Fever did break. ER prescribed anti-nausea medication when released lung xray also done and was ok. Today cough still is productive; continuous. On day 17th, don't have voice back. It is disturbing that there still is stuff on lungs. During first week was to weak to get out of bed and had headache.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Hepatic enzyme abnormal, Malaise, Nausea, Productive cough
Clinical narrative: By morning was sick, it started with a cough which became productive during the day, and was thick, chunky and clear. By the end of the day had fever of 102.7 degrees. Did no have body aches but was coughing to the point that could hardly catch breath. Went to doctor who got blood work done: White cells count and live enzymes off. Doctor prescribed TAMIFLU. General health ok but by weekend had off and on nausea--no vomiting--and loose stools. Went to the ER for possible dehydration. Got some IV fluids and some medication for nausea/vomiting which was effective ER run blood work but numbers out of range earlier in the week went back to normal. Fever did break. ER prescribed anti-nausea medication when released lung xray also done and was ok. Today cough still is productive; continuous. On day 17th, don't have voice back. It is disturbing that there still is stuff on lungs. During first week was to weak to get out of bed and had headache.
Age: 58.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, White blood cell count abnormal
Clinical narrative: By morning was sick, it started with a cough which became productive during the day, and was thick, chunky and clear. By the end of the day had fever of 102.7 degrees. Did no have body aches but was coughing to the point that could hardly catch breath. Went to doctor who got blood work done: White cells count and live enzymes off. Doctor prescribed TAMIFLU. General health ok but by weekend had off and on nausea--no vomiting--and loose stools. Went to the ER for possible dehydration. Got some IV fluids and some medication for nausea/vomiting which was effective ER run blood work but numbers out of range earlier in the week went back to normal. Fever did break. ER prescribed anti-nausea medication when released lung xray also done and was ok. Today cough still is productive; continuous. On day 17th, don't have voice back. It is disturbing that there still is stuff on lungs. During first week was to weak to get out of bed and had headache.
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a female patient in her early 70's. Medical history and current conditions were not reported. On approximately 2014 (reported as about two years ago), the patient was vaccinated with ZOSTAVAX, (1 dose, 0.65 ml, subcutaneously). Concomitant therapy was not reported. On approximately 2014, 10 days after vaccination, the patient experienced a shingles like rash. Patient sought medical attention. The outcome of the event was unknown. Causality assessment was not reported. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Erythema multiforme, Injection site urticaria, Urticaria
Clinical narrative: Received Hep A VAQTA in left deltoid at 945 AM 3/15/16. Developed hives (all over body) 3/16/16 at 7 PM. No SOB, diff. breathing, cough or fevers. No new exposures. Rec. 50mg BENADRYL, ZANTAC x1 - hives improved but reoccurring - BENADRYL Q6 hours - seen 3/17/16 10 AM - hives (erythema multiforme) on left wrist, (R) shoulder, left deltoid and back on BENADRYL Q6 hours.
Age: 34.0
Sex: F
Vaccine: ANTH
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Information received 08MAR2016 from an Investigator. In January 2009 a 34 year old female experienced a miscarriage. A 34 year old G1P0 female received dose # 5 of BIOTHRAX vaccine (anthrax vaccine adsorbed) in December 2008 at 4+5 estimated gestational age (EGA). Subject was determined to be pregnant in December 2008, 7 days after vaccination. She reported that she had a miscarriage in January 2009 at 7+0 EGA. No other information was provided regarding other vaccinations, treatments, concurrent medical conditions or medications, medical history, or relevant laboratory/diagnostic results. Sender's Comments: The event of miscarriage is considered medically significant by the sponsor and the report has been upgraded to Serious.  In the absence of adequate medical assessment of the reported events, a causality association is deemed not assessable.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (dose, lot #, expiration date and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: TYP
Symptoms: Diarrhoea, Vomiting
Clinical narrative: 6 hours of vomiting and diarrhea 12 hours after taking oral Typhoid #2. Pt. recovered and went to work next day.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (dose, lot #, expiration date and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site vesicles, Injection site warmth, Pyrexia
Clinical narrative: Erythema, warmth and induration of left thigh starting 1 day after vaccines. < 1 cm blister on left posterior thigh. Low grade fever.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site nodule
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. There was no information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot#, expiration date, dose, anatomical location and route of administration were not reported) frequency reported. On an unknown date after vaccination, the patient developed a large knot at the injection site. The outcome of the event was reported as recovering. The patient sought medical attention and visited an office. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: FLUX, HPV9
Symptoms: Headache, Hypoaesthesia
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 17 year old female patient. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with the first dose (out of a series of three) dose of GARDASIL 9 injection (strength, site and route of administration, dose, lot number and expiration date were not reported). Concomitant therapies included influenza virus vaccine (unspecified), which was administered during the same visit. On an unknown date, after receiving GARDASIL 9, the patient experienced bad headaches and her face went numb on the same side of her body where GARDASIL 9 was injected. The patient sought medical attention as she visited an emergency room (E.R.) (no details were provided). She was also referred to a neurologist (no details were provided). It was not reported if any lab diagnostic studies were performed and if any treatment was given for the events. Product quality complaint was not involved. The outcome of the events was not reported. The relatedness between the events and GARDASIL 9 was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates ranging from 15-JAN-2016 to 03-MAR-2016 (previously reported as 02-JAN-2016 to 16-MAR-2016), the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L018351, expiration date 11-AUG-2017, exact dose, route of administration and anatomical location were not reported). The administered doses experienced a temperature excursion of 48.2 to maximum 57 degrees Fahrenheit ranging from 02-JAN-2016 to 29-JAN-2016 (total time 276 hours cumulative). No previous excursion were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist refers to a multiple unspecified female patients of unknown age. There was no information about concurrent condition, medical history or concomitant medication. Since an unknown date, "multiple unspecified patients complained of the GARDASIL injection hurting". The reporter did not know if the patient's received GARDASIL or GARDASIL 9. The outcome of event was unknown. The reporter did not provide the relatedness of the event with the suspect therapies. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abasia, Activities of daily living impaired, Bladder catheterisation, Bladder scan, Blood test
Clinical narrative: Nov. 7, 2013 she was treated for bronchitis with a Z-PAK and also given her 2nd dose of the HPV vaccine. She was running a fever when she received the vaccine. The evening of Nov. 8, 2013 she developed a rash. This rash lasted less than 24 hours. She got better from the bronchitis with the Z-PAK and then began new symptoms on Nov. 22, 2013 20:00. She ran a fever and told me she just felt awful. November 28, 2013 she was taken to urgent care. We were told both ears were bulging. She was prescribed AUGMENTIN. That evening she began having trouble urinating and it hurt her neck to look down. Nov. 29, 2013 she was taken to the ER. She was given fluids, checked for a bladder infection, and blood work was done. We were told it looked like something viral, and it should be fine for her to go on vacation. We had a flight a few hours after the ER visit. The evening of Nov. 30, 2013 she began vomiting and was so lethargic that she couldn't even walk. She was still complaining of her neck hurting and this was day 10 or 11 with a fever. Many test were run during her 11 day stay in the hospital. MRI's (brain and lumbar), x-rays, bladder scans, blood work, spinal tap, urinary catheterization, test that had to do with her vision problems. On December 5th or 6h a spinal tab was done and she was diagnosed with viral meningitis. They were never able to figure out the virus that was the cause. She was triple checked for EBV. She was also checked for CMV. She had a neurogenic bladder. The urologist that took care of her told me that I should report the HPV vaccine. At the time, things were busy around our house and time passed without me reporting the vaccine. It has been on my mind to report this vaccine for the past two years. I feel she should have never gotten this vaccine or any vaccine while sick. She was not able to return to school until January 2014.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Cytomegalovirus test, Dysuria, Epstein-Barr virus test, Feeling abnormal, Lethargy
Clinical narrative: Nov. 7, 2013 she was treated for bronchitis with a Z-PAK and also given her 2nd dose of the HPV vaccine. She was running a fever when she received the vaccine. The evening of Nov. 8, 2013 she developed a rash. This rash lasted less than 24 hours. She got better from the bronchitis with the Z-PAK and then began new symptoms on Nov. 22, 2013 20:00. She ran a fever and told me she just felt awful. November 28, 2013 she was taken to urgent care. We were told both ears were bulging. She was prescribed AUGMENTIN. That evening she began having trouble urinating and it hurt her neck to look down. Nov. 29, 2013 she was taken to the ER. She was given fluids, checked for a bladder infection, and blood work was done. We were told it looked like something viral, and it should be fine for her to go on vacation. We had a flight a few hours after the ER visit. The evening of Nov. 30, 2013 she began vomiting and was so lethargic that she couldn't even walk. She was still complaining of her neck hurting and this was day 10 or 11 with a fever. Many test were run during her 11 day stay in the hospital. MRI's (brain and lumbar), x-rays, bladder scans, blood work, spinal tap, urinary catheterization, test that had to do with her vision problems. On December 5th or 6h a spinal tab was done and she was diagnosed with viral meningitis. They were never able to figure out the virus that was the cause. She was triple checked for EBV. She was also checked for CMV. She had a neurogenic bladder. The urologist that took care of her told me that I should report the HPV vaccine. At the time, things were busy around our house and time passed without me reporting the vaccine. It has been on my mind to report this vaccine for the past two years. I feel she should have never gotten this vaccine or any vaccine while sick. She was not able to return to school until January 2014.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Lumbar puncture, Meningitis viral, Neck pain, Neurogenic bladder, Nuclear magnetic resonance imaging brain
Clinical narrative: Nov. 7, 2013 she was treated for bronchitis with a Z-PAK and also given her 2nd dose of the HPV vaccine. She was running a fever when she received the vaccine. The evening of Nov. 8, 2013 she developed a rash. This rash lasted less than 24 hours. She got better from the bronchitis with the Z-PAK and then began new symptoms on Nov. 22, 2013 20:00. She ran a fever and told me she just felt awful. November 28, 2013 she was taken to urgent care. We were told both ears were bulging. She was prescribed AUGMENTIN. That evening she began having trouble urinating and it hurt her neck to look down. Nov. 29, 2013 she was taken to the ER. She was given fluids, checked for a bladder infection, and blood work was done. We were told it looked like something viral, and it should be fine for her to go on vacation. We had a flight a few hours after the ER visit. The evening of Nov. 30, 2013 she began vomiting and was so lethargic that she couldn't even walk. She was still complaining of her neck hurting and this was day 10 or 11 with a fever. Many test were run during her 11 day stay in the hospital. MRI's (brain and lumbar), x-rays, bladder scans, blood work, spinal tap, urinary catheterization, test that had to do with her vision problems. On December 5th or 6h a spinal tab was done and she was diagnosed with viral meningitis. They were never able to figure out the virus that was the cause. She was triple checked for EBV. She was also checked for CMV. She had a neurogenic bladder. The urologist that took care of her told me that I should report the HPV vaccine. At the time, things were busy around our house and time passed without me reporting the vaccine. It has been on my mind to report this vaccine for the past two years. I feel she should have never gotten this vaccine or any vaccine while sick. She was not able to return to school until January 2014.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging spinal, Pyrexia, Rash, Tympanic membrane disorder, Visual acuity tests
Clinical narrative: Nov. 7, 2013 she was treated for bronchitis with a Z-PAK and also given her 2nd dose of the HPV vaccine. She was running a fever when she received the vaccine. The evening of Nov. 8, 2013 she developed a rash. This rash lasted less than 24 hours. She got better from the bronchitis with the Z-PAK and then began new symptoms on Nov. 22, 2013 20:00. She ran a fever and told me she just felt awful. November 28, 2013 she was taken to urgent care. We were told both ears were bulging. She was prescribed AUGMENTIN. That evening she began having trouble urinating and it hurt her neck to look down. Nov. 29, 2013 she was taken to the ER. She was given fluids, checked for a bladder infection, and blood work was done. We were told it looked like something viral, and it should be fine for her to go on vacation. We had a flight a few hours after the ER visit. The evening of Nov. 30, 2013 she began vomiting and was so lethargic that she couldn't even walk. She was still complaining of her neck hurting and this was day 10 or 11 with a fever. Many test were run during her 11 day stay in the hospital. MRI's (brain and lumbar), x-rays, bladder scans, blood work, spinal tap, urinary catheterization, test that had to do with her vision problems. On December 5th or 6h a spinal tab was done and she was diagnosed with viral meningitis. They were never able to figure out the virus that was the cause. She was triple checked for EBV. She was also checked for CMV. She had a neurogenic bladder. The urologist that took care of her told me that I should report the HPV vaccine. At the time, things were busy around our house and time passed without me reporting the vaccine. It has been on my mind to report this vaccine for the past two years. I feel she should have never gotten this vaccine or any vaccine while sick. She was not able to return to school until January 2014.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting, X-ray
Clinical narrative: Nov. 7, 2013 she was treated for bronchitis with a Z-PAK and also given her 2nd dose of the HPV vaccine. She was running a fever when she received the vaccine. The evening of Nov. 8, 2013 she developed a rash. This rash lasted less than 24 hours. She got better from the bronchitis with the Z-PAK and then began new symptoms on Nov. 22, 2013 20:00. She ran a fever and told me she just felt awful. November 28, 2013 she was taken to urgent care. We were told both ears were bulging. She was prescribed AUGMENTIN. That evening she began having trouble urinating and it hurt her neck to look down. Nov. 29, 2013 she was taken to the ER. She was given fluids, checked for a bladder infection, and blood work was done. We were told it looked like something viral, and it should be fine for her to go on vacation. We had a flight a few hours after the ER visit. The evening of Nov. 30, 2013 she began vomiting and was so lethargic that she couldn't even walk. She was still complaining of her neck hurting and this was day 10 or 11 with a fever. Many test were run during her 11 day stay in the hospital. MRI's (brain and lumbar), x-rays, bladder scans, blood work, spinal tap, urinary catheterization, test that had to do with her vision problems. On December 5th or 6h a spinal tab was done and she was diagnosed with viral meningitis. They were never able to figure out the virus that was the cause. She was triple checked for EBV. She was also checked for CMV. She had a neurogenic bladder. The urologist that took care of her told me that I should report the HPV vaccine. At the time, things were busy around our house and time passed without me reporting the vaccine. It has been on my mind to report this vaccine for the past two years. I feel she should have never gotten this vaccine or any vaccine while sick. She was not able to return to school until January 2014.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 59 year old male patient. the patient had no pertinent medical history, drug reactions/allergies and concomitant medications. On 09-FEB-2016, the patient was vaccinated with ZOSTAVAX (dosing details unspecified). Approximately on 15-FEB-2016 (reported as 6 days after being vaccinated with ZOSTAVAX, the patient experienced shingles. He sought medical attention by calling the pharmacist. No Product Quality Complaint (PQC) was involved. The outcome of shingles was reported as not recovered. The reporter did not provide the relatedness of the event with ZOSTAVAX. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a nurse practitioner via a company representative refers to a female patient of unknown age. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patient was vaccinated with VARIVAX (Merck) immunization series (dosing details were not reported). No concomitant medications were reported. On an unknown date the patient developed shingles when she was in fifth grade. The outcome of the event was reported as recovered/resolved. The reporter did not provide the causality assessment between the event and the suspect therapy. There was no product quality complaint reported. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PNC13, PPV, TDAP
Symptoms: Extra dose administered
Clinical narrative: Pt given PNEUMOVAX 23 and PREVNAR 13 at same visit by accident. Documented and reported in case of adverse reaction.
Age: 67.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Abdominal pain upper, Diarrhoea, Injection site erythema, Injection site urticaria
Clinical narrative: Red welt at injection site - cold compress, ibuprofen. Diarrhea, stomach cramping - IMMODIUM. Symptoms started 2-3 days after injection.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Red rash, hot to the touch, started next morning around 8 am. Treated w/advised to take ibuprofen and cold packs.
Age: 19.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Facial paralysis
Clinical narrative: This spontaneous report was received from a Registered Nurse concerning a 16 year old female patient. The patient's concurrent conditions and medical history were reported as none. On 30-JUL-2014, the patient was vaccinated with GARDASIL (lot # J013324, exp.: 12-FEB-2016) (dose, route and anatomical location were not provided). Then, on 03-MAR-2016, the patient was vaccinated with GARDASIL 9 (lot # L027282, exp.: 21-SEP-2015) (dose, route and anatomical location were not provided). Concomitant medications were not reported. On 09-MAR-2016, the patient went to a emergency department and was diagnosed with Bell's Palsy (with nerve paralysis). CYCLOVIR and prednisone were given for treatment. No laboratory tests were performed. At the reporting time, the outcome of Bell's Palsy was reported as not recovered. The relatedness between the event and suspect therapy was not provided. Lot # J013324 has been verified to be a valid lot number for GARDASIL. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC13, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: None. Report filed b/c patient inadvertently given both PROQUAD and VARIVAX (double varicella vaccine). Pt did not develop vaccine induced dz.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician refers to multiple patients of unknown age and gender. Concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses (temperature excursion: 28-OCT-2015 to 13.17 F and 11-SEP-2015 to 13.13 F, time frame: worst case 10 minutes each occasion) of PROQUAD with lot/batch # L019996, expiry date 02-DEC-2016 and lot/batch # L033962, expiry date 28-FEB-2017 (dose, dose number, vaccination site and route of administration not provided). There was no previous temperature excursion. Concomitant therapies were not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of the several reports from same reporter link. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: 3/14/16 - Received MMRV. 3/15/16 - Mom noted red, hot to touch, tender to touch, hard area approximately 4-5" long and 2.5" wide on upper (L) arm. MOTRIN and ALLEGTA given. 3/17/16 - Examined in office oval area 4 x 3" light pink in color non tender, not indurated, hot.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Cyanosis, Dyspnoea, Loss of consciousness, Skin warm
Clinical narrative: Father stated via telephone that child lost consciousness, was warm, lips blue, difficulty breathing, went to ER.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Decreased appetite, Dehydration, Diarrhoea, Dizziness, Feeling abnormal
Clinical narrative: Later at night throwing up, quite dizzy, had diarrhea. Was dehydrated and had no appetite. Felt so bad that went to ER twice, on 1/23 and 2/28, but should have gone 3 times. On ER got IV and anti-nausea meds. Followed up with doct after ER visits and got pill for vomiting/dizziness but made it worse. Today still vomiting; diarrhea subsided 2 weeks ago. Allergist recommended flu vaccine.