chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; patient was administered a dose of improperly stored ROTATEQ; This spontaneous report was received from a physician refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.   On 24-JUN-2020, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot # S005875, expiration date 30-NOV-2020 (exact dose was not reported), orally, for prophylaxis. The data logger registered that the vaccine was stored at the temperature below 36 (F), reported also as 34.8 (F) for 25 minutes. There was previous temperature excursion below 36 (F) which was 34.5 (F) for 1 hour and 24 minutes. No additional adverse effect was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product prescribing error
Clinical narrative: No adverse symptoms reported; Physician "intended to write an order for the patient to receive the shingles vaccine but instead wrote an order for the patient to receive V ARIV AX".; the patient inadvertently received a dose ofV ARIV AX on 6/30/2020 "instead of the shingles vaccine"; This spontaneous report was received from a medical assistance and refers to a patient of an unknown age. The patient's concomitant therapies included sterile diluent. No information regarding the patient's pertinent medical history and drug reactions or allergies was provided.  On 30-JUN-2002, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # R024023, expiration date 22-AUG-2020 (strength, dose and route of administration were not reported) for prophylaxis, instead of the shingles vaccine. The reported stated that the patient received dose of varicella virus vaccine live (oka/merck) (VARIVAX) due to an unspecified physician's error. It was reported that the physician intended to write an order for the patient to receive the shingles vaccine, but instead wrote an order for the patient to receive varicella virus vaccine live (oka/merck) (VARIVAX). No adverse symptoms were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; improperly stored dose of VARIVAX was administered to a patient; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.   On 29-JUN-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # S025912, expiration date 20-AUG-2021, 1 dosage form (route of administration not provided) for prophylaxis    Temperature: 22.3 Fahrenheit degrees (°F) ; Timeframe: 4 hours 25 minutes; previous temperature excursions: 8.6 Fahrenheit degrees (°F) for 1 hour 51 minutes. The call was made due to Digital data logger. No adverse events were reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient experienced no symptoms; an improperly stored dose of GARDASIL 9 was administered; an improperly stored dose of GARDASIL 9 was administered; This spontaneous report was received from a healthcare worker referring to a patient of unknown age and gender.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.  On 14-MAY-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), prefilled syringe, lot # R028656, expiring on 27-JUL-2021, intramuscularly, for prophylaxis (dose, and site of administration were not reported).    The administered dose of the vaccine experienced a temperature excursion of 27 degrees Fahrenheit for 3 hours, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  The patient experienced no symptoms. No product quality complaint was involve combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R028656; expirationdate: 27-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: One dose of improperly stored PROQUAD was administered to a patient on unspecified date; No adverse effects reported; This spontaneous report was received from a nurse concerning to a female patient of unknown age.No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.  On an unknown date, the patient was vaccinated with one dose of improperly stored of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), lot # S030213, expiration date of 25-MAR-2021, for prophylaxis (dosage schedule, strength, and route of administration  were not reported) (product storage error). The sterile diluent was stored properly.   The administered dose of the vaccine experienced a temperature excursion of -10.5 Celsius degrees for 2 hours and 31 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.
Sex: M
Vaccine: HPV4, HPV9, HPV9, UNK
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse effects reported; The patient is in the office 7/1/2020 to be administered the third dose of the HPV series, GARDASIL 9; Began HPV series, GARDASIL on 11/23/2015. The patient was administered GARDASIL 9 on 1/11/2016; This spontaneous information has been received from a registered nurse, concerning a 21-years-old male patient. The patient's pertinent medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided.    On 23-NOV-2015 the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for prophylaxis (strength, dose, frequency, lot number, expiration date, route of administration and anatomical location were not reported). On 11-JAN-2016, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, frequency, lot number, expiration date, route of administration and anatomical location were not reported) (interchange of vaccine products).  On 01-JUL-2020, the patient went to the office to receive the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot number: R024259 with expiration date 30-MAY-2021 (strength, frequency, route of administration and anatomical location were not reported) (inappropriate schedule of product administration).  No adverse effect reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R024259; expirationdate: 30-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects reported; improperly stored dose of VARIVAX was administered to a patient; This spontaneous report has been received from an office manager referring to a patient of unknown age an gender. No information has been received regarding the patient's medical history, concurrent conditions, drug and allergy history or concomitant medications.  On 25-JUN-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, frequency and route of administration was not provided) lot # S025610 and expiration date 18-AUG-2021 for prophylaxis.        The doses of varicella virus vaccine live (oka/merck)(VARIVAX) were exposed to a temperature excursion of 22.3°Fahrenheit (°F) during a time frame of 4 hours and 25 minutes, which was detected by the data logger. There was a previous temperature excursion of 8.6°F for 1 hour and 51 minutes. No adverse effects were reported.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse affects reported; An expired dose of GARDASIL 9 was administered on 7/1/2020; This spontaneous information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided.    On 01-JUL-2020, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot number N022728 with expiration date reported as 21-MAY-2020 but upon internal validation established as 31-MAY-2020, as prophylaxis (strength, frequency, route of administration and anatomical location were not reported) (expired vaccine used).  No adverse effects reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: improperly stored dose of PROQUAD was administered to a patient; no additional adverse effects reported; This spontaneous report as received from an office manager and refers to a patient of unknown age and gender. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.  On 25-JUN-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # S031705 and expiration date 06-APR-2021 for prophylaxis (dose, strength, route of administration and frequency were not reported).  On an unknown date, the vaccine had a temperature excursion of 22.3F for 4 hours and 25 minutes; previous temperature excursion was reported at 8.6F for 1 hour an 51 minutes. Digital data logger was involved.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect; Patient was administered an expired dose of VARIVAX; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent.  On 01-JUL-2020, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot# R003300 and expiration date 01-FEB-2020, for prophylaxis (strength, dose, route and frequency were not reported). No additional adverse effects reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: on 3/31/2020 a patient was administered an improperly stored dose of GARDASIL 9 (lot 9029515, expiration 7/8/2021). Temperature (0.7C). Time frame 3,048 hours.; The patient experienced no symptoms; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.      The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On 31-MAR-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), administered intramuscularly (dose and frequency were not reported) (lot number 9029515 is an invalid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), expiration date was reported as 08-JUL-2020) as prophylaxis.  The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was at 0.7 Celsius degrees for 3.048 hours (information captured by a data logger). The patient did not experience symptoms.
Sex: U
Vaccine: HPV9, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient experienced no symptoms; An improperly stored dose of GARDASIL 9 was administered to the patient; This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapies were not reported.    On 15-MAY-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscularly, lot # R028656, experitation date 27-JUL-2021 (dose was not reported) for prophylaxis. The vaccine was exposed to 27 Fahrenheit degrees for 3 hours. There was not previous temperature excursion. The call was made due to "data logger". The patient experienced no symptoms. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R028656; expirationdate: 27-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: TYP
Symptoms: Product dose omission
Clinical narrative: Missed to take last dose on scheduled day; Spontaneous report received on 21MAY2020.  A pharmacist reported that a female consumer "missed to take last dose on scheduled day" (PT: Product dose omission) following immunization with Vivotif. On 12MAY2020, the consumer started taking Vivotif. It was reported that the patient took three doses of Vivotif correctly but, missed the last dose which was scheduled on 18MAY2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer missed to take last dose of Vivotif on scheduled day (missed dose). Vivotif should be taken every other day, and the causality of product dose omission is assessed as not applicable due to the nature of the event.; Sender's Comments: A consumer missed to take last dose of Vivotif on scheduled day (missed dose). Vivotif should be taken every other day, and the causality of product dose omission is assessed as not applicable due to the nature of the event.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took Vivotif doses on every day instead of every other day; Spontaneous report received on 21MAY2020.  A pharmacy manager reported that a female consumer who "took Vivotif doses on every day instead of every other day" (PT: Inappropriate schedule of product administered). She was receiving Vivotif capsule for immunization. The consumer took the Vivotif doses every day instead of every other day. The reporter assumed that she took first dose of Vivotif on 17MAY2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took Vivotif doses on every day instead of every other day (Inappropriate schedule of product administered). The causality of the event is assessed as not applicable to Vivotif due to the nature of the event.; Sender's Comments: A consumer took Vivotif doses on every day instead of every other day (Inappropriate schedule of product administered). The causality of the event is assessed as not applicable to Vivotif due to the nature of the event.
Age: 18.0
Sex: M
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Took last dose 3 days late; Spontaneous report received on 01JUN2020.  A consumer reported that her son "took last dose 3 days late" (PT: Inappropriate schedule of product administration) while being on oral Vivotif for immunisation. He took his last dose of Vivotif three days late on 30MAY2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took last dose of vivotif three days late than the scheduled date (Inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of the event is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took last dose of vivotif three days late than the scheduled date (Inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of the event is assessed as not applicable to Vivotif.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Bedridden, Chills, Dehydration, Gait disturbance
Clinical narrative: High fever; uncontrollable shaking/unbelievable shaking; shivering; Trouble walking/trying to drink water; severe upper GI stomach cramping and sharp pains; horrible nausea; blood pressure was so low; dehydration; stomach cramping and sharp pains; my arm to be very sore; I couldn't raise my arm for 3 days; I was in the bed; This case was reported by a other health professional and described the occurrence of pain in arm in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included viral meningitis (had aseptic viral meningitis at age 47 and was hospitalized).   On 9th June 2020, the patient received the 2nd dose of Shingrix. On 12th June 2020, 3 days after receiving Shingrix, the patient experienced fever, tremor, shivering, walking difficulty, gastrointestinal cramps, nausea, low blood pressure, dehydration, stomach cramps and bedridden. In June 2020, the patient experienced pain in arm and mobility decreased. The patient was treated with ibuprofen and intravenous fluid (nos) (Intravenous Fluids). On an unknown date, the outcome of the pain in arm, mobility decreased, fever, tremor, shivering, walking difficulty, gastrointestinal cramps, nausea, low blood pressure, dehydration, stomach cramps and bedridden were unknown.   It was unknown if the reporter considered the pain in arm, mobility decreased, fever, tremor, shivering, walking difficulty, gastrointestinal cramps, nausea, low blood pressure, dehydration, stomach cramps and bedridden to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shringrex and had arm sore and it was to the point it could not raise arm for 3 days. The patient had high fevers, average 103.5 and had uncontrollable shaking and shivering so bad had trouble walking or trying to drink water from a glass. The patient had severe upper GI stomach cramping and sharp pains along with horrible nausea.  The patient was eating Ibuprofin trying to get temperature under control and for the next 6 days was in the bed, fighting high fevers Day and night and unbelievable shaking. The patient was driven to a walk in clinic where my blood pressure was so low from dehydration and had IV fluids.  The patient was also tested for Covid 19 which was negative.  The medical staff diagnosed and had severe reaction to the Shringrix shot.
Sex: U
Vaccine: VARZOS
Symptoms: Gastrointestinal pain, Hypotension, Mobility decreased, Nausea, Pain in extremity
Clinical narrative: High fever; uncontrollable shaking/unbelievable shaking; shivering; Trouble walking/trying to drink water; severe upper GI stomach cramping and sharp pains; horrible nausea; blood pressure was so low; dehydration; stomach cramping and sharp pains; my arm to be very sore; I couldn't raise my arm for 3 days; I was in the bed; This case was reported by a other health professional and described the occurrence of pain in arm in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included viral meningitis (had aseptic viral meningitis at age 47 and was hospitalized).   On 9th June 2020, the patient received the 2nd dose of Shingrix. On 12th June 2020, 3 days after receiving Shingrix, the patient experienced fever, tremor, shivering, walking difficulty, gastrointestinal cramps, nausea, low blood pressure, dehydration, stomach cramps and bedridden. In June 2020, the patient experienced pain in arm and mobility decreased. The patient was treated with ibuprofen and intravenous fluid (nos) (Intravenous Fluids). On an unknown date, the outcome of the pain in arm, mobility decreased, fever, tremor, shivering, walking difficulty, gastrointestinal cramps, nausea, low blood pressure, dehydration, stomach cramps and bedridden were unknown.   It was unknown if the reporter considered the pain in arm, mobility decreased, fever, tremor, shivering, walking difficulty, gastrointestinal cramps, nausea, low blood pressure, dehydration, stomach cramps and bedridden to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shringrex and had arm sore and it was to the point it could not raise arm for 3 days. The patient had high fevers, average 103.5 and had uncontrollable shaking and shivering so bad had trouble walking or trying to drink water from a glass. The patient had severe upper GI stomach cramping and sharp pains along with horrible nausea.  The patient was eating Ibuprofin trying to get temperature under control and for the next 6 days was in the bed, fighting high fevers Day and night and unbelievable shaking. The patient was driven to a walk in clinic where my blood pressure was so low from dehydration and had IV fluids.  The patient was also tested for Covid 19 which was negative.  The medical staff diagnosed and had severe reaction to the Shringrix shot.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia, SARS-CoV-2 test negative, Tremor
Clinical narrative: High fever; uncontrollable shaking/unbelievable shaking; shivering; Trouble walking/trying to drink water; severe upper GI stomach cramping and sharp pains; horrible nausea; blood pressure was so low; dehydration; stomach cramping and sharp pains; my arm to be very sore; I couldn't raise my arm for 3 days; I was in the bed; This case was reported by a other health professional and described the occurrence of pain in arm in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included viral meningitis (had aseptic viral meningitis at age 47 and was hospitalized).   On 9th June 2020, the patient received the 2nd dose of Shingrix. On 12th June 2020, 3 days after receiving Shingrix, the patient experienced fever, tremor, shivering, walking difficulty, gastrointestinal cramps, nausea, low blood pressure, dehydration, stomach cramps and bedridden. In June 2020, the patient experienced pain in arm and mobility decreased. The patient was treated with ibuprofen and intravenous fluid (nos) (Intravenous Fluids). On an unknown date, the outcome of the pain in arm, mobility decreased, fever, tremor, shivering, walking difficulty, gastrointestinal cramps, nausea, low blood pressure, dehydration, stomach cramps and bedridden were unknown.   It was unknown if the reporter considered the pain in arm, mobility decreased, fever, tremor, shivering, walking difficulty, gastrointestinal cramps, nausea, low blood pressure, dehydration, stomach cramps and bedridden to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shringrex and had arm sore and it was to the point it could not raise arm for 3 days. The patient had high fevers, average 103.5 and had uncontrollable shaking and shivering so bad had trouble walking or trying to drink water from a glass. The patient had severe upper GI stomach cramping and sharp pains along with horrible nausea.  The patient was eating Ibuprofin trying to get temperature under control and for the next 6 days was in the bed, fighting high fevers Day and night and unbelievable shaking. The patient was driven to a walk in clinic where my blood pressure was so low from dehydration and had IV fluids.  The patient was also tested for Covid 19 which was negative.  The medical staff diagnosed and had severe reaction to the Shringrix shot.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Rheumatoid arthritis, Swelling
Clinical narrative: Rheumatoid arthritis; sore arm; painful; swollen; This case was reported by a other health professional via other manufacturer and described the occurrence of rheumatoid arthritis in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included tofacitinib citrate (Xeljanz).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rheumatoid arthritis (serious criteria GSK medically significant), pain in arm, pain and swelling. On an unknown date, the outcome of the rheumatoid arthritis, pain in arm, pain and swelling were unknown.   It was unknown if the reporter considered the rheumatoid arthritis, pain in arm, pain and swelling to be related to Shingles vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The day after receiving the vaccine the patient experienced. arm sore, painful, swollen day after injection the symptoms were improved.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Chills; Headache; Muscle aches; This case was reported by a consumer via call center representative and described the occurrence of chills in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, headache and muscle pain. On an unknown date, the outcome of the chills, headache and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the chills, headache and muscle pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient after receiving the 2nd dose of Shingrix experienced chills, headache and muscle aches. The patient asked how long do the side effects last
Sex: M
Vaccine: MENB
Symptoms: Cyanosis, Gait disturbance, Pallor
Clinical narrative: he turned really pale; e turned really blue; couldn't walk; This case was reported by a consumer via interactive digital media and described the occurrence of pallor in a male patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, 15 min after receiving Bexsero, the patient experienced pallor, cyanosis and walking difficulty. On an unknown date, the outcome of the pallor, cyanosis and walking difficulty were unknown.   It was unknown if the reporter considered the pallor, cyanosis and walking difficulty to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. The patient was received Bexsero and had severe reaction about 15 minutes after he turned really pale and blue and he could not walk.
Sex: F
Vaccine: MENB
Symptoms: Injection site reaction
Clinical narrative: reaction keeps growing outside the sharpie line; This case was reported by a consumer via interactive digital media and described the occurrence of injection site reaction in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On 22nd June 2020, the patient received Bexsero. In June 2020, less than a week after receiving Bexsero, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown.   It was unknown if the reporter considered the injection site reaction to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Bexsero and experience reaction it was keeps growing outside the sharpe line. The reporter inquired it might need to urgent care.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Got Shingles again; This case was reported by a lawyer and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 21st January 2020, 118 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information: The initial information received via legal complaint. As per the legal complaint on 25 September 2019 the plaintiff got first shot of shingrix, on 21 January 2020, 29 January 2020 and 01 March 2020 the plaintiff got shingles again. On 18 March 2020, the plaintiff got second shot of shingrix on 16 April 2020 and 22 May 2020, got shingles again. The patient was put on medicine for 6 months and had 10 *5 they talked into shots. The patient still got 6*5 for shot plus. The reporter thinks deserve money back after both doses.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Feeling cold, Malaise
Clinical narrative: tired/wants to lay down; cold; temperature of 99.6; shivers; diarrhea; throwing up; feeling sick; ached; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd June 2020, the patient received the 1st dose of Shingrix. On 23rd June 2020, less than a day after receiving Shingrix, the patient experienced feeling unwell and pain. On 24th June 2020, the patient experienced fever, shivers, diarrhea, vomiting and cold. On 25th June 2020, the patient experienced tiredness. On an unknown date, the outcome of the feeling unwell, fever, shivers, diarrhea, vomiting and cold were recovered/resolved and the outcome of the pain and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell, pain, fever, shivers, diarrhea, vomiting, tiredness and cold to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and started feeling sick.  The patient ached all over, had a temperature of 99.6, was cold with shivers.  The patient developed diarrhea and throwing up.  The patient temperature, feeling cold, shivers, diarrhea and throwing up had all resolved.  The patient was still achy and was tired on the day of reporting, wanted to lay down. The reporter consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: tired/wants to lay down; cold; temperature of 99.6; shivers; diarrhea; throwing up; feeling sick; ached; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd June 2020, the patient received the 1st dose of Shingrix. On 23rd June 2020, less than a day after receiving Shingrix, the patient experienced feeling unwell and pain. On 24th June 2020, the patient experienced fever, shivers, diarrhea, vomiting and cold. On 25th June 2020, the patient experienced tiredness. On an unknown date, the outcome of the feeling unwell, fever, shivers, diarrhea, vomiting and cold were recovered/resolved and the outcome of the pain and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell, pain, fever, shivers, diarrhea, vomiting, tiredness and cold to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and started feeling sick.  The patient ached all over, had a temperature of 99.6, was cold with shivers.  The patient developed diarrhea and throwing up.  The patient temperature, feeling cold, shivers, diarrhea and throwing up had all resolved.  The patient was still achy and was tired on the day of reporting, wanted to lay down. The reporter consented to follow up.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, Fatigue
Clinical narrative: already had both doses of Shingrix in 2019 / 3rd dose; tired; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received a dose in 2019 in an unknown arm) and Shingrix (received a dose on 15th March 2019 in an unknown arm).   On 22nd June 2020, the patient received Shingrix (intramuscular). In June 2020, less than a week after receiving Shingrix, the patient experienced tiredness. On 22nd June 2020, the patient experienced extra dose administered. On an unknown date, the outcome of the tiredness and extra dose administered were unknown.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were provided as follows: The patient's wife reported that, her husband was at his physician's office for a pre-op appointment on Monday, 22nd June 2020 and the office suggested that he never received the second dose of Shingrix so they administered the dose.  When he arrived home, his wife informed him that, he already had both doses of Shingrix in 2019.   They contacted the physician's office and they claim that there was a 3rd dose now and that he would not be charged.   The patient's wife was concerned about him getting the extra dose because he was so tired now.   She claimed that, the patient started to get tired later in the day on Monday or Tuesday, on 23rd June 2020. The patient's wife claimed that he stated that, on the day of reporting he could go back to bed in the morning after getting up.   The patient's wife did not have information on when the patient got the 3rd dose.   The patient's most recent dose was administered in his right arm and the other two were in different arms. The reporter was consented to follow up.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash, Rash vesicular
Clinical narrative: the left upper arm (injected side); rash on chest across the left shoulder, and back.; This case was reported by a nurse via call center representative and described the occurrence of injection site rash in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th June 2020, the patient received the 2nd dose of Shingrix. On 21st June 2020, 4 days after receiving Shingrix, the patient experienced injection site rash and varicella-like rash. On an unknown date, the outcome of the injection site rash and varicella-like rash were unknown.   It was unknown if the reporter considered the injection site rash and varicella-like rash to be related to Shingrix.  Additional information was provided as follows: The patient  developed a rash (similar appearance to chicken pox) on the left upper arm (injected side), chest, across the left shoulder and back. The reporter consented to follow up
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Nausea
Clinical narrative: Nausea; little bit of upset stomach; This case was reported by a consumer via call center representative and described the occurrence of nausea in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd June 2020, the patient received the 2nd dose of Shingrix. In June 2020, less than a week after receiving Shingrix, the patient experienced nausea and upset stomach. On an unknown date, the outcome of the nausea and upset stomach were unknown.   It was unknown if the reporter considered the nausea and upset stomach to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient expereinced nausea and a little bit of upset stomach. The reporter wanted to know how long these side effects would last. The reporter consented to follow up was not provided. Customer had to disconnect from call and did not provide additional details. Lot and expiration date unknowm. Injection site information unknown
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2020, the patient received the 1st dose of Shingrix. In June 2020, 1 week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 64 or 65 years. The patient received the first dose of Shingrix one or two weeks prior to time of reporting and that one week later, the patient had shingles. The reporter consented to follow up.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Rash all over the body; Itchy area under the knees; This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number 47D2Z, expiry date 24th April 2022) for prophylaxis.   On 23rd June 2020, the patient received the 1st dose of Shingrix. On 24th June 2020, 1 days after receiving Shingrix, the patient experienced generalized rash and itchy legs. On an unknown date, the outcome of the generalized rash and itchy legs were unknown.   It was unknown if the reporter considered the generalized rash and itchy legs to be related to Shingrix.  Additional details were provided as follows: After vaccination with Shingrix, the patient experienced rash over body from head to toes and had an itchy area under the knees. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019156556:same reporter US-GLAXOSMITHKLINE-US2019156561:same reporter US-GLAXOSMITHKLINE-US2019188923:same reporter
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Feeling abnormal, Pruritus, Pyrexia
Clinical narrative: Rash all over the body; Itchy area under the knees; This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number 47D2Z, expiry date 24th April 2022) for prophylaxis.   On 23rd June 2020, the patient received the 1st dose of Shingrix. On 24th June 2020, 1 days after receiving Shingrix, the patient experienced generalized rash and itchy legs. On an unknown date, the outcome of the generalized rash and itchy legs were unknown.   It was unknown if the reporter considered the generalized rash and itchy legs to be related to Shingrix.  Additional details were provided as follows: After vaccination with Shingrix, the patient experienced rash over body from head to toes and had an itchy area under the knees. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019156556:same reporter US-GLAXOSMITHKLINE-US2019156561:same reporter US-GLAXOSMITHKLINE-US2019188923:same reporter
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Rash all over the body; Itchy area under the knees; This case was reported by a pharmacist via call center representative and described the occurrence of generalized rash in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number 47D2Z, expiry date 24th April 2022) for prophylaxis.   On 23rd June 2020, the patient received the 1st dose of Shingrix. On 24th June 2020, 1 days after receiving Shingrix, the patient experienced generalized rash and itchy legs. On an unknown date, the outcome of the generalized rash and itchy legs were unknown.   It was unknown if the reporter considered the generalized rash and itchy legs to be related to Shingrix.  Additional details were provided as follows: After vaccination with Shingrix, the patient experienced rash over body from head to toes and had an itchy area under the knees. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2019156556:same reporter US-GLAXOSMITHKLINE-US2019156561:same reporter US-GLAXOSMITHKLINE-US2019188923:same reporter
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Woke up with Fever and chills, then developed rash that spread from head to toe.  Energy was zapped.  Parts of body very itchy. Top part of body rash cleared up in about 7 days, but still had lower rash that was under skin and not raised. Felt overall bad for the over 1 week, concerned about if 2nd shot will produce an anaphylactic reaction.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Feeling abnormal, Pruritus, Pyrexia
Clinical narrative: Woke up with Fever and chills, then developed rash that spread from head to toe.  Energy was zapped.  Parts of body very itchy. Top part of body rash cleared up in about 7 days, but still had lower rash that was under skin and not raised. Felt overall bad for the over 1 week, concerned about if 2nd shot will produce an anaphylactic reaction.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: Woke up with Fever and chills, then developed rash that spread from head to toe.  Energy was zapped.  Parts of body very itchy. Top part of body rash cleared up in about 7 days, but still had lower rash that was under skin and not raised. Felt overall bad for the over 1 week, concerned about if 2nd shot will produce an anaphylactic reaction.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: has 3 spots on her right upper thigh and back of her leg; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th June 2020, the patient received Shingrix. On 28th June 2020, 2 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was recovering/resolving.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were reported as follows: The patient had 3 spots on her right upper thigh and back of her leg. She did not visit the doctor yet. The reporter consented to follow up.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 01Jul2020, this case now contains all required information to be considered valid.  This is a spontaneous report from a Pfizer Sponsored Program Service Line. A contactable consumer (mother) reported that a 17-year-old female patient received meningococcal group b rlp2086 (Trumenba) second dose on 01Jul2017 at around 10 AM at single dose on left arm for Immunisation/Preventative. Medical history included allergic to Gelatin. Historical vaccine included meningococcal group b rlp2086 (Trumenba) first dose for immunization about a year prior to the time of report and a flu shot for immunization and experienced allergic to Gelatin. Concomitant medications were none. Consumer wants to know if gelatin is part of the ingredients list, as her daughter is allergic to gelatin. Her daughter did get fever and chills on 01Jul2020 after receiving the vaccine around 2 or 3PM. Mother reports that this was her daughter's second dose of Trumenba, she had one about a year ago and caller doesn't recall if her daughter had a reaction after that one. She states that her daughter reacted badly to a flu shot that had Gelatin in it in the past, and she just wishes it was more apparent whether the vaccines contained Gelatin or not. The outcome of the events was unknown  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: Swollen arm; This is a report obtained from a pharmacist through a Pfizer sales representative.  A patient of an unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose, on an unspecified date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced swollen arm. Clinical outcome of the adverse event was unknown at time of this report.   No follow-up attempts are needed, information about batch number cannot be obtained.
Age: 0.92
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received expired dose of IPOL vaccine/No AE; Initial information was received on 26-Jun-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 11-month-old male patient who received an expired o.5ml dose of IPV (VERO) [IPOL] [lot P1A46, expiry date: 03-May-2020] via an intramuscular route at the left thigh on 25-Jun-2020 for prophylactic vaccination.  Medical history, medical treatment, vaccination and family history were not provided.   On 25-Jun-2020, the patient received concomitant medication included HEPATITIS B VACCINE for prophylactic vaccination.  It was case of actual medication error due to expired vaccine used. The patient received expired vaccine which was expired on 03-May-2020 (expired product administered).   At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.