chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not provided. On 21-SEP-2015, the patients were vaccinated with improperly stored doses of (Merck) VARIVAX lot # K011804, expiration date: 21-AUG-2016 and lot# L016126, expiration date: 06-MAY-2017 (dose and route were not reported). No adverse effects reported and there was no Product Quality Complaints (PQC) 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 Registered Nurse refers to a unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not provided. On 21-SEP-2015, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) lot# K025766, expiration date: 08-JUN-2016 (dose and route were not reported). No adverse effects reported and there was no Product Quality Complaints (PQC) involved. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Diarrhoea, Nausea
Clinical narrative: Seen at Medical Center ER on the evening of 9/23/15 with stomach pain, nausea and diarrhea. Eval from ER was normal. Was given a prescription for ZOFRAN and CULTURELLE. Recheck visit at PCP's office on 9-24-15 was normal.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a patient of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, 0.65 ml, once, subcutaneous (strength and anatomical location were not reported). There was no concomitant medication reported. On an unknown date, the patient experienced a non blistering rash (rash), erythema (vaccination site erythema) at injection site of ZOSTAVAX vaccination (vaccination site reaction). The reporter stated that the rash was not shingles and no pustules developed. On 07-SEP-2015 (reported as "two weeks ago"), the patient contacted the pharmacy (not specified). Additionally, the reported stated that the only treatment was the pharmacy manager advised patient to "cover up the area". At the reporting time, the outcome of rash, vaccination site reaction and vaccination site erythema was reported as recovering. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: This spontaneous report was received from a female registered nurse of unknown age referring to herself. Concurrent conditions included allergy to sulfonamides, BIAXIN and AVELOX (drug hypersensitivity). The patient's pertinent medical history was not reported. On approximately JULY 2003, the patient was vaccinated with a dose of PNEUMOVAX23 (lot #, dose, frequency and route of administration were unspecified. in the left arm.  On an unspecified date in JULY 2003, her left arm became "grapefruit" size swollen (peripheral swelling), ,red (erythema) and hot to touch (skin warm). It was stated that the patient did not die, that she was not  hospitalized and that the adverse events were not life threatening. No PQC was involved. At the time of the report, it was stated that the patient recovered from erythema, peripheral swelling and skin warm within one month, by AUGUST 2003. The relatedness of PNEUMOVAX23 with the adverse events was not reported. This is  one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist technician refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 22-SEP-2015, the patient was vaccinated with an expired dose of PNEUMOVAX23 (lot # K004483, expiration date: 16-AUG-2015, 0.5 ml, intramuscularly. No adverse effects were reported and there was no Product Quality Complaints (PQC) involved. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Large local reaction at site of Varicella and KINRIX vaccines, prescribed topical triamcinolone 0.1% and oral BENADRYL for swelling and itching (5 cm diameter area of swelling bilaterally).
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L011846; expiration date 16-JUN-2017) (dose, route of administration, anatomical location and strength were not reported). There is no concomitant medication reported and no adverse effects were reported. Additional information is not expected as the reporter didn't consent new follow-up attempts. This is one of 3 reports received from the same reporter.
Age: 73.0
Sex: F
Vaccine: PNC
Symptoms: Erythema, Induration, Injection site erythema
Clinical narrative: Minimal induration to left arm at 7 o'clock in relation to inj site, macular redness to left arm extending from injection site to left axilla. Tx: TAC cream, ice, TYLENOL PRN.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported.  On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # K020181, expiration date 24-JUN-2016 and lot # L004466, expiration date 02-AUG-2016) route default as oral (dose and strength were not reported). There was no concomitant medication reported and no adverse effects were reported. Additional information is not expected as the reporter didn't consent new follow-up attempts. This is one of 3 reported received from the same reporter.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K006124; expiration date 02-FEB-2017) (dose, route of administration, anatomical location and strength were not reported). There was no concomitant medication reported and no adverse effects were reported. Additional information is not expected as the reporter didn't consent new follow-up attempts. This is one of 3 reports received from the same reporter.
Age: 18.0
Sex: U
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients with 18 years old. No pertinent medical history or concurrent conditions were reported. The reporter stated that, on an unknown date, the "state" (referring to the state Health Department) was giving unspecified doses of GARDASIL 9, (dose, frequency, lot # and expiration dates were not provided), to pediatric boys through age 18 years old. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Injection site pain, Mobility decreased, Pain in extremity, Pyrexia
Clinical narrative: Rt arm was aching, rt shoulder, back, lower limbs. Low grade fever 99.4 degrees F, was unable to get in and out of bathtub.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Vocational Nurse regarding an unspecified patients of unknown demographics. There was no information about pertinent medical history, drug reactions or drug allergies. On 27-JUL-2015, the patient was vaccinated with 7 doses of improperly stored PROQUAD (Merck) lot# L003221 and expiry date: 30-JUL-2016. No adverse effect was reported. The outcome of the event was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Papilloma viral infection, Smear cervix abnormal
Clinical narrative: Information has been received from a consumer referring to her 23 year old female daughter without any drug reactions/allergies. The patient's concurrent condition included blood pressure abnormal. The patient had pregnancy within the past two years (captured in case 1509USA012758). In 2009 (reported as "about 6 years ago"), the patient was vaccinated with a complete three doses series of GARDASIL (dose, frequency, route and lot number not provided). The reporter was unsure if it was a GARDASIL or GARDASIL 9 vaccination. Concomitant therapies included unspecified blood pressure medications and "DEPOCERA". The patient was diagnosed with an unspecified HPV type on 09-SEP2015 after a routine pap smear. The patient sought medical attention via clinic visit but she had not received treatment yet. She planned to go to a gynecologist for follow-up. The outcome of papilloma viral infection was reported as not recovered/not resolved at the time of reporting. This is one of two reports concerning the same patient. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to an unspecified number of unspecified patients. Since 01-JUN-2015 the patients were vaccinated with an unspecified number of improperly stored GARDASIL (lot # K005881, expiration date 14-JAN-2016) (dose and route unspecified) by an unspecified physician. No adverse reactions were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to an unspecified number of unspecified patients. Since 01-JUN-2015 the patients were vaccinated with an unspecified number of improperly stored (Merck) VARIVAX (lot # K015992, expiration date 23-SEP-2016) (dose and route unspecified) by an unspecified physician. No adverse reactions were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. On unknown dates, the patient was vaccinated with unspecified number of improperly stored (Merck) VARIVAX (dose and route not provided). Lot information of (Merck) VARIVAX was provided as lot# J014131, expiration date: 07-NOV-2015 and/or lot# K016132, expiration date: 24-SEP-2016. No adverse effects reported. This is one of several reports received fr0m the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On unspecified dates, the patients were vaccinated with improperly stored doses of (Merck) VARIVAX (lot # K011797, expiration date 21-AUG-2016, dose and route unknown). No adverse effects reported. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Injection site extravasation, Underdose
Clinical narrative: This spontaneous report was received from a healthcare professional refers to a male patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 21-SEP-2015 the patient was vaccinated into his anterolateral thigh with a dose of (Merck) VARIVAX (Lot # reported as L018000, expiration date: 19-MAY-2017), 0.5 ml, subcutaneous in the leg. Concomitant medications were not reported. It was reported that the patient moved while the (Merck) VARIVAX was being administered and some of the (Merck) VARIVAX leaked out of the plastic syringe onto his thigh. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a certified medical assistant referring to unspecified numbers of patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates these patients were vaccinated with improperly stored doses of (Merck) VARIVAX (lot # L004654, expiration date: 11-FEB-2017, strength, dose and route unknown) (incorrect product storage). There was no information about concomitant therapy. No adverse effects were reported. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Axillary mass, Erythema, Induration, Ultrasound scan
Clinical narrative: This spontaneous report was received from a physician and refers to a 65 year old female patient. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 21-SEP-2015, the patient was vaccinated with a dose of PNEUMOVAX23, in the right deltoid (dose, route, lot number and expiration date were not reported). The patient's concomitant therapies included FLONASE and IMITREX. On 22-SEP-2015, the patient sought medical attention by visiting the physician's office because she developed a "lump" (induration) and an "area of redness" on the axillary area of the right arm (erythema). On 23-SEP-2015, an unspecified ultrasound was performed., the result was not reported. It was unspecified if a treatment was given to the patient.  At the time of the report, the outcome of developed a "lump" and an "area of redness" on the axillary area of the right arm was reported as not recovered. The relatedness between the events and therapy with PNEUMOVAX23 was not reported. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Interchange of vaccine products
Clinical narrative: This spontaneous prospective pregnancy report was received from a licensed practical nurse refers to a female patient of unknown age who was pregnant at the moment of this report. The patient's medical history and concurrent condition were not reported. On an unspecified dates in March 2015 and May 2015, the patient was vaccinated with the first and second dose of GARDASIL (strength, dose, anatomical location, route of administration, lot # and expiration date were not reported). On 15-SEP-2015, the patient with 7 weeks of gestation (LMP approximately 28-JUL-2015) was vaccinated with GARDASIL 9 injection, 0.5 ml, intramuscular, lot # K026246, expiration date on 28-JAN-2017 (strength and anatomical location were not reported), as the third dose in the vaccination series. At the time of the report, pregnancy outcome and the fetal outcome were unknown. This case is one of two cases from the same patient (MARRS # 1509USA012555). Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Pruritus generalised
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 38 year old nonpregnant female patient who was allergic to shellfish, sulfa and had environmental allergies. No information about her pertinent medical history or concomitant medications was provided. On an unknown date, the patient was vaccinated with the first dose in the series of RECOMBIVAX HB (dose, route of administration, lot# and expiration date were not reported). On an unspecified date the patient had an adverse reaction to the first dose of RECOMBIVAX HB, she experienced irritation at injection site. On 14-SEP-2015 (reported as "yesterday"), the patient was vaccinated with the second dose in the series of RECOMBIVAX HB (lot/batch# reported as L026037, expiration date 17-JAN-2016, intramuscularly) (dose was not reported).  On 14-SEP-2015, the patient had an adverse reaction of itching all over her body. The patient sought medical attention, she called the physician. She took BENADRYL after the second dose of RECOMBIVAX as a treatment for the itching. At the time of the report the patient was recovering from the itching all over her body. The outcome of injection site irritation after the fist dose of RECOMBIVAX HB was not reported. The relatedness between the events and RECOMBIAX HB was not reported. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Injection site irritation, Pruritus generalised
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 38 year old nonpregnant female patient who was allergic to shellfish, sulfa and had environmental allergies. No information about her pertinent medical history or concomitant medications was provided. On an unknown date, the patient was vaccinated with the first dose in the series of RECOMBIVAX HB (dose, route of administration, lot# and expiration date were not reported). On an unspecified date the patient had an adverse reaction to the first dose of RECOMBIVAX HB, she experienced irritation at injection site. On 14-SEP-2015 (reported as "yesterday"), the patient was vaccinated with the second dose in the series of RECOMBIVAX HB (lot/batch# reported as L026037, expiration date 17-JAN-2016, intramuscularly) (dose was not reported).  On 14-SEP-2015, the patient had an adverse reaction of itching all over her body. The patient sought medical attention, she called the physician. She took BENADRYL after the second dose of RECOMBIVAX as a treatment for the itching. At the time of the report the patient was recovering from the itching all over her body. The outcome of injection site irritation after the fist dose of RECOMBIVAX HB was not reported. The relatedness between the events and RECOMBIAX HB was not reported. Additional information has been requested.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Pyrexia, Serum sickness
Clinical narrative: Spouse states she took him to the ER, was feeling weak and experiencing high temperature ER diagnosed it as serum sickness from the vaccine.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Pt reported to pharmacy around 3pm on 9/24, 24hours after receiving Fluvirin influenza vaccine. Pt had hive-like rash widespread on upper torso and arms. Advised pt to begin oral diphenhydramine 50mg, if no improvement or worsening of symptoms or difficulty breathing follow up with Emergency Room or primary care provider.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: SWELLING, REDNESS AT SITE. NO PAIN OR ITCHING. PT SELF MEDICATED W/ BENADRYL, APPLIED COLD PACK TO AREA.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Blood count, Petechiae, Rash generalised
Clinical narrative: Started noticing a petechial rash all over body.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Small red mark at vaccine site. Rash started in deltoid then disappeared 24 hrs later. Second rash appeared in the front of the arm near bicep.
Age: 43.0
Sex: F
Vaccine: DPP, FLUX, PPV
Symptoms: Activities of daily living impaired, Dysstasia, Feeling abnormal, Muscle spasms, Nausea
Clinical narrative: Nausea, Fever, Body cramps lasted for 36 hours and then fever continued for 48 hours. No treatment other than bedrest, Tylenol.
Age: 43.0
Sex: F
Vaccine: DPP, FLUX, PPV
Symptoms: Pyrexia
Clinical narrative: Nausea, Fever, Body cramps lasted for 36 hours and then fever continued for 48 hours. No treatment other than bedrest, Tylenol.
Age: 74.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Myalgia
Clinical narrative: Pt says muscle in arm as just been achy since he's gotten the Fluzone HD. Still having that achy till this date 9/25/15.
Sex: F
Vaccine: FLUX
Symptoms: Adverse event
Clinical narrative: This spontaneous consumer report (initial receipt 14-Sep-2015) concerns a female patient. On an unspecified date, the patient received a flu vaccine (Influenza virus vaccine, manufacturer and batch number not provided). On an unspecified date following the administration of the flu shot, the patient ended up at the hospital. The outcome was unknown. Reporter's Comments: Reporter comments: The reporter stated the case was serious, as it caused hospitalisation. Sender's Comments: Company comments: Seriousness: Serious. Hospitalisation. Listedness: Unlisted. Brand of vaccine not specified. Assessment according to Assessment according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the Afluria Product Information, hospitalisation due to unspecified adverse event is unlisted. Causality: Unassessable. Insufficient information such as time to onset, event description, reason for hospitalisation, investigation treatment outcome.
Age: 56.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Diarrhoea, Pain, Swelling
Clinical narrative: Pain, swelling, diarrhea.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Nasopharyngitis, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Cold like symptoms - sore throat, runny nose, redness and warmth near injection site.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Altered state of consciousness, Heart rate increased, Muscular weakness
Clinical narrative: Muscle weakness, Rapid pulse, Feeling like passing out. Lasted several hours. Had to have help getting to bed to lie down.  This was FLUZONE HD PF 15-016 INJ.
Age: 11.0
Sex: M
Vaccine: FLU4, MNQ, TDAP
Symptoms: Erythema, Injection site induration, Peripheral swelling, Skin warm
Clinical narrative: Mom reports bilateral arms were swollen, red, warm to touch, and site was hard.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Injection site is raised, red, and warm (generally inflamed). Site is described as tender, although not more than is ordinary after a flu vaccine. Patient states that it burned when the vaccine was given, moreso than other flu vaccines. Otherwise the patient feels fine and has no other symptoms.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: Injection site is raised, red, and warm (generally inflamed). Site is described as tender, although not more than is ordinary after a flu vaccine. Patient states that it burned when the vaccine was given, moreso than other flu vaccines. Otherwise the patient feels fine and has no other symptoms.
Age: 3.0
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Injection site erythema
Clinical narrative: Large amount of reddened area at injection site that spread to outer aspect of thigh.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Raise, red and warm area at injection site. Site is described as tender. Patient has had flu vaccines previously, but never had this reaction. No other signs.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Redness around injection site, mild itching and feverish to touch.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Patient developed a dermatomal rash on his upper right back, neck, and shoulder. Rash is vesicular. Follow-up in clinic on 09.25.2015 confirmed the rash and exam revealed no other adverse reactions.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling hot, Productive cough, Pruritus, Sensation of foreign body, Skin warm
Clinical narrative: Itching on upper torso (front, back), neck, arms. Started in morning and continued all day and night. Continued to next day which is today 9/25/3015. On 9/25 I also have a flem lump in my throat. The itching on my front chest feels hot to the touch and also feels hot inside. I notified my primary care physician who directed me to take Benadryl and if it gets worse with breathing or throat closing to go to the ER. I took Benadryl at 12:25 pm on 9/25/2015.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and soreness below the injection site the size of a fist.  Patient choose to go to walk in clinic to have assessed by a provider.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal pain upper, Asthenia, Erythema, Induration, Malaise
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself and from a contactable other HCP. A 78-year-old female patient received PREVNAR 13 (Lot# L77777, Exp: 31Jan2017) intramuscular in right arm at 0.5 ml single on 22Jul2015 at 2:00 PM and sulfamethoxazole, trimethoprim (SMZ-TMP DS, Exp date 27Aug2015) 800-160 mg tablet at 2x/day from 22Jul2015 and ongoing for bladder infection. Relevant medical history included ongoing bladder infection on 22Jul2015. Concomitant medications were not reported. On 23Jul2015 patient woke-up at 07:00 am and experienced the following adverse events: difficulty moving, very weak, stomach ache, arm itching like crazy, arm red, arm swollen six inches wide, hurt when touch it hard, feeling very ill. The AEs required urgent care and the patient was admitted to hospital. No tests and/or treatment were required. Events difficulty moving, very weak and stomach ache recovered on 24Jul2015. Outcome of feeling very ill was unknown. Outcome of other events was not recovered. The reporter was provided with the information regarding the adverse events by the patient. The reporter considered there was a reasonable possibility that the event is related to suspect product. The reporter was not willing to be contacted again by Pfizer on the reported adverse events. Follow-up (28Jul2015): New information received from a contactable consumer includes: confirmation of the outcome for the event "Stomach ache" (recovered). Follow-up (21Sep2015): New information received from a contactable other HCP on behalf of a Physician includes: suspect data; event onset date; medical history; reporter informed regarding the adverse events; reporter event causality assessment; reporter further contactability. This case contains a Hospira co-suspect product and may have qualified for regulatory reporting for this product. This case may therefore be a duplicate report.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased, Pain, Peripheral swelling, Pruritus, Tenderness
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself and from a contactable other HCP. A 78-year-old female patient received PREVNAR 13 (Lot# L77777, Exp: 31Jan2017) intramuscular in right arm at 0.5 ml single on 22Jul2015 at 2:00 PM and sulfamethoxazole, trimethoprim (SMZ-TMP DS, Exp date 27Aug2015) 800-160 mg tablet at 2x/day from 22Jul2015 and ongoing for bladder infection. Relevant medical history included ongoing bladder infection on 22Jul2015. Concomitant medications were not reported. On 23Jul2015 patient woke-up at 07:00 am and experienced the following adverse events: difficulty moving, very weak, stomach ache, arm itching like crazy, arm red, arm swollen six inches wide, hurt when touch it hard, feeling very ill. The AEs required urgent care and the patient was admitted to hospital. No tests and/or treatment were required. Events difficulty moving, very weak and stomach ache recovered on 24Jul2015. Outcome of feeling very ill was unknown. Outcome of other events was not recovered. The reporter was provided with the information regarding the adverse events by the patient. The reporter considered there was a reasonable possibility that the event is related to suspect product. The reporter was not willing to be contacted again by Pfizer on the reported adverse events. Follow-up (28Jul2015): New information received from a contactable consumer includes: confirmation of the outcome for the event "Stomach ache" (recovered). Follow-up (21Sep2015): New information received from a contactable other HCP on behalf of a Physician includes: suspect data; event onset date; medical history; reporter informed regarding the adverse events; reporter event causality assessment; reporter further contactability. This case contains a Hospira co-suspect product and may have qualified for regulatory reporting for this product. This case may therefore be a duplicate report.
Sex: F
Vaccine: PNC13
Symptoms: Choking, Cough, Drug hypersensitivity, Dysgeusia, Pharyngeal erythema
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A female patient of unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration, on 04Jun2015, at single dose. Relevant medical history and concomitant medications were not reported. The patient experienced a lot of coughing that was making her choking, pneumonia, taste something it irritated all her throat (taste in the mouth effect), redness in the throat. The patient also mentioned that she had allergy to medicine and that she had a third set of antibiotics and nothing seemed to be helping. Somebody told her that it could be associated with the vaccination because it was a live virus and she wanted to know if it was possible. Outcome of the reported events was unknown. Follow-up (14Sep2015): New information received from the same contactable consumer (patient) includes: vaccination date updated, events updated, treatment detail.
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia, Throat irritation
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A female patient of unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration, on 04Jun2015, at single dose. Relevant medical history and concomitant medications were not reported. The patient experienced a lot of coughing that was making her choking, pneumonia, taste something it irritated all her throat (taste in the mouth effect), redness in the throat. The patient also mentioned that she had allergy to medicine and that she had a third set of antibiotics and nothing seemed to be helping. Somebody told her that it could be associated with the vaccination because it was a live virus and she wanted to know if it was possible. Outcome of the reported events was unknown. Follow-up (14Sep2015): New information received from the same contactable consumer (patient) includes: vaccination date updated, events updated, treatment detail.
Sex: U
Vaccine: HPV4
Symptoms: Death
Clinical narrative: Information has been received from news article via an unspecified reporter in a website referring to 140 patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On unknown dates the patients were vaccinated with GARDASIL (strength, dose, dose#, route and lot# unknown). On unknown dates the patients died. It was unknown if autopsy was done. The cause was death was unknown. The reporter considered death to be associated with GARDASIL. This is one of several reports received from the same source. Additional information is not expected since there was no contact details provided.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Product quality issue
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of erythema in a adult patient who received FLUARIX QUADRIVALENT (batch number 5C2L4, expiry date 18th June 2016). This case was associated with a product complaint. In September 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced erythema and pharmaceutical product complaint. On an unknown date, the outcome of the erythema and pharmaceutical product complaint were unknown. The reporter considered the erythema to be probably related to FLUARIX QUADRIVALENT. Additional details provided were as follows: This case was reported by a pharmacy buyer. On 15th September 2015 or after (exact date of administration unknown), the patient received FLUARIX QUADRIVALENT on an unknown arm. The patient experienced localized redness around injection site and on arm. This is one of the five cases reported by the same reporter (see cases US2015133738, US2015133740, US2015133760 and US2015133773). The reporter was questioning about a specific lot administered to patients therefore filed related quality product complaint. At the time of reporting, any further details were not known by the reporter.
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Product quality issue
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of erythema in a adult patient who received FLUARIX QUADRIVALENT (batch number 5C2L4, expiry date 18th June 2016). This case was associated with a product complaint. In September 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .2 ml. On an unknown date, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced erythema and pharmaceuticals product complaint. On an unknown date, the outcome of the erythema and pharmaceuticals product complaint were unknown. The reporter considered the erythema to be probably related to FLUARIX QUADRIVALENT. Additional details provided were as follows: This case as reported by a pharmacy buyer. On 15th September 2015 or after (exact date of administration unknown), the patient received FLUARIX QUADRIVALENT on an unknown arm. The patient experienced localized redness around injection site and on arm. This is one of the five cases reported by the same reporter (see cases US2015133738, US2015133740, US2015133746 and US2015133773). The reporter was questioning about a specific lot administered to patients therefore filed related quality product complaint. At the time of reporting, any further details were not known by the reporter.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness on skin of right deltoid muscle. Slight swelling. Slight itching.
Age: 48.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt presents pouchs with 4 x 4 inch erythema (R) deltoid on 9/24 with some redness/warmth.
Age: 55.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and expanding erythema at site on LUE irregular in shape slight warmth to touch 3.5 x 4.0 inches.
Age: 2.0
Sex: F
Vaccine: FLUN4
Symptoms: Erythema, Urticaria
Clinical narrative: On-call physician took call from mom at 10:15pm. Within 45 min of vaccine face was red, then at night developed large hive on (L) cheek. Mom gave BENADRYL and child went to sleep. Never had any respiratory symptoms.
Age: 8.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Syncope after FLUVIRIN. Came by immediately when put on floor. Left after about 10-15 min with mother. Mother was present.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Rash, Skin warm, Swelling
Clinical narrative: Redness, swelling, warm to the touch, itching, 4 x 6 cm eruption.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased, Peripheral swelling
Clinical narrative: After receiving vaccine his arm became swollen and difficult to move being treated with ibuprofen and hydrocodone/APAP.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash generalised, Skin warm
Clinical narrative: Rash over entirety of body that feels hot. Relatively unresponsive to antihistamines.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Chills, Fatigue, Feeling hot, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 86-year-old female patient who received Influenza vaccine. On 15th September 2015, the patient received Influenza vaccine. On 15th September 2015, 2 hrs after receiving Influenza vaccine, the patient experienced shivering. On an unknown date, the patient experienced fever and tiredness. The patient was treated with ALEVE. On 15th September 2015, the outcome of the shivering was recovered/resolved. On an unknown date, the outcome of the fever was recovered/resolved and the outcome of the tiredness was not recovered/not resolved. It was unknown if the reporter considered the shivering, fever and tiredness to be related to Influenza vaccine. Additional details were provided as follows: Since many years, the patient had received flu vaccines every year and she did not experience any reaction after the vaccination. On 15th September 2015, at 4 pm, the patient received a flu vaccine. On the same day, at 6 pm, the patient started shivering and she was not able to get warm no matter how much she tried and then at 10 pm, it got resolved. The patient was fine. On 16th September 2015, Wednesday, in the evening at about 7 pm i.e. 27 hours after receiving Influenza vaccine, the patient's face started to get so hot that she felt like she was burning. Then, she took her body temperature and it was observed as 100.6 F. The patient had been indoors most of the days. The patient did not remember the last time she had temperature, usually it was 97 or lower. The patient took an ALEVE and went to bed. At the time of reporting, on 17th September 2015, less than a week after receiving the vaccine, the patient was fine but was only tired. The patient was scared to face the evening.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Diarrhoea, Feeling hot, Hyperhidrosis, Loss of consciousness, Pain
Clinical narrative: Passed out for 1 minute approximately 10 minutes after shot. Patient felt hot and sweaty. Patient threw up approximately 1 cup of vomit. Patient had diarrhea. Patient achy. Lasted approximately 12-15 hrs after vaccine. Patient had 1 incident of uncontrollable urination approximately 30 min after shot.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Urinary incontinence, Vomiting
Clinical narrative: Passed out for 1 minute approximately 10 minutes after shot. Patient felt hot and sweaty. Patient threw up approximately 1 cup of vomit. Patient had diarrhea. Patient achy. Lasted approximately 12-15 hrs after vaccine. Patient had 1 incident of uncontrollable urination approximately 30 min after shot.
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a adult female patient who received FLUARIX QUADRIVALENT (batch number 9525T, expiry date 12the June 2016). On 15th September 2015, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 15th September 2015, 2 hrs after receiving FLUARIX QUADRIVALENT, the patient experienced injection site swelling, injection site redness, injection site warmth and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site redness, injection site warmth and injection site pain were recovering/resolving. It was unknown if the reporter considered the injection site swelling, injection site redness and injection site pain to be related to FLUARIX QUADRIVALENT. The reporter considered the injection site warmth be almost certainly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient ws in the early 30s. The reported injection site of FLUARIX was left deltoid. The patient experienced swelling, pain and redness at the injection site a couple of hours after receiving a FLUARIX injection. The injection site was also warm to touch. The reported reactions were improving on the day before the time of reporting, but the reporter had not seen the patient on the day of reporting. This case was one of the five cases, reported by the same reporter (see cases US2015GSK133985, US2015GSK133986, US2015GSK133988 and US2015GSK133984).
Age: 56.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness upper arm (RT) 3" x 6", slightly swollen and warm to touch.
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site induration in a adult female patient who received FLUARIX QUADRIVALENT (batch number LM55C, expiry date 23rd June 2015). In October 2014, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced injection site induration and injection site warmth. On an unknown date, the outcome of the injection site induration and injection site warmth were recovered/resolved. It was unknown if the reporter considered the injection site induration to be related to FLUARIX QUADRIVALENT. The reporter considered the injection site warmth to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient was in her 40s, at the time of reporting. The patient experienced and induration at the injection site (deltoid) after receiving last year's FLUARIX vaccine. The injection site induration was about 14 cm which was warm to touch. The reaction resolved after 4 days from the onset. The patient would be receiving her FLUARIX vaccine this year. The reported lot number (4M7GD) corresponds to FLUARIX QIV and not to FLUARIX TIV as per the sales data sheet. Therefore, the suspect vaccine was updated to FLUARIX QIV. This case was one of the five cases, reported by the same reporter (see cases US2015GSK133984, US2015GSK133985, US2015GSK133986 and US2015GSK134910).
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site induration in a adult female patient who received FLUARIX QUADRIVALENT (batch number LM55C, expiry date 23rd June 2015). In October 2014, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced injection site induration and injection site warmth. On an unknown date, the outcome of the injection site induration and injection site warmth were recovered/resolved. It was unknown if the reporter considered the injection site induration to be related to FLUARIX QUADRIVALENT. The reporter considered the injection site warmth to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient was in her 40s, at the time of reporting. The patient experienced an induration at the injection site (deltoid) after receiving last year's FLUARIX vaccine. The injection site induration was about 14 cm which was warm to touch. The reaction resolved after 4 days from the onset. The patient would be receiving her FLUARIX vaccine this year. The reported lot number (4M7GD) corresponds to FLUARIX QIV and not to FLUARIX TIV as per the sales data sheet. Therefore, the suspect vaccine was updated to FLUARIX QIV. This case was one of the five cases, reported by the same reporter (see cases US2015GSK133984, US2015GSK133985, US2015GSK133988 and US2015GSK134910).
Age: 4.0
Sex: F
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Erythema, Inflammation, Skin warm, Urticaria
Clinical narrative: Left upper arm with 4 in x 3 in area of slight erythema and warmth, no tenderness. Likely large weal inflammatory reading.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Diarrhoea, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Extreme swelling, redness, itching, burning, pain at injection site=five days. Extreme diarrhea, vomiting and weakness or sick feeling for 5-6 days.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Malaise, Vomiting
Clinical narrative: Extreme swelling, redness, itching, burning, pain at injection site=five days. Extreme diarrhea, vomiting and weakness or sick feeling for 5-6 days.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 2 x 5 area around injection red and hot.
Age: 13.0
Sex: F
Vaccine: FLUN4, HEP, HPV4, MNQ, VARCEL
Symptoms: Computerised tomogram head, Full blood count, Metabolic function test, Syncope
Clinical narrative: Pt had a syncopal episode about 7-8 min after the vaccine was administered.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Neuralgia
Clinical narrative: Extreme flare of neurological pain in my right arm and hand.  This is a level of pain I have never experienced before, which leads me to believe it may have been triggered by the flu vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Depression
Clinical narrative: This spontaneous report was received from an unspecified female patient of unknown age. No concurrent condition or medical history was reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose and route of administration not provided). No concomitant therapy was reported. The patient reported that she felt depressed since vaccination. The outcome of the event was reported as not recovered. The causality assessment was not reported. No product quality issue was involved. Additional information is not expected, no healthcare professional contact details were provided.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Injection site erythema, Injection site oedema, Local reaction
Clinical narrative: Left upper arm local allergic rxn w/ redness and edema approximately 5-6 cm diam. where flu shot given yesterday.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Chills, Condition aggravated, Dysstasia, Parkinson's disease
Clinical narrative: Rapid onset chills, shakes (severe). Progressed to inability to stand or walk. Became incontinent of urine. Pt has Parkinson's; this caused transient severe symptoms. Much improved 12 hrs later.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Tremor, Urinary incontinence
Clinical narrative: Rapid onset chills, shakes (severe). Progressed to inability to stand or walk. Became incontinent of urine. Pt has Parkinson's; this caused transient severe symptoms. Much improved 12 hrs later.
Age: 89.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Cardiac function test normal, Cheilitis, Pyrexia, Vomiting
Clinical narrative: Stomach pain & vomiting 8 hrs after injection, sores on lips, fever.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Loss of consciousness, Syncope
Clinical narrative: Patient felt dizzy. When moves to a private room, she collapsed while two staff members supported her. She land on her back and regained consciousness. EMS was called and evaluated here. She was walked out to her car.