chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain, Pain in extremity
Clinical narrative: Severe pain in right calf that was a suspected blood clot; unable to lift arm without extreme pain; Severe pain in right calf that was a suspected blood clot; achiness; injection site pain; Injection site redness; Injection site swelling; hives; fever; This spontaneous report was received from a consumer referring to her sister-in-law who is a female patient of unknown age. Information about pertinent medical history, drug reaction/allergy and concomitant medication was unknown.       On 28-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, vaccine dosage detail, route of administration, lot# and expiration date were not reported) at her doctor's office for prophylaxis.   On an unknown date in 2020, the patient experienced injection site pain, redness and swelling; hives, achiness and fever; unable to lift arm without extreme pain for 3 days; severe pain in right calf that was a suspected blood clot. The outcome of all events was unknown. The causality between all events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.        Upon internal review, suspected blood clot was determined to be medically significant.
Sex: F
Vaccine: PPV, PPV
Symptoms: Pyrexia, Thrombosis, Urticaria
Clinical narrative: Severe pain in right calf that was a suspected blood clot; unable to lift arm without extreme pain; Severe pain in right calf that was a suspected blood clot; achiness; injection site pain; Injection site redness; Injection site swelling; hives; fever; This spontaneous report was received from a consumer referring to her sister-in-law who is a female patient of unknown age. Information about pertinent medical history, drug reaction/allergy and concomitant medication was unknown.       On 28-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, vaccine dosage detail, route of administration, lot# and expiration date were not reported) at her doctor's office for prophylaxis.   On an unknown date in 2020, the patient experienced injection site pain, redness and swelling; hives, achiness and fever; unable to lift arm without extreme pain for 3 days; severe pain in right calf that was a suspected blood clot. The outcome of all events was unknown. The causality between all events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.        Upon internal review, suspected blood clot was determined to be medically significant.
Age: 73.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Herpes zoster, Rash
Clinical narrative: First started with regular flu systems. Then had pain in left breast which was the arm I had injection in,developed a rash left shoulder and back which turned into shingles
Age: 73.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Breast pain, Herpes zoster, Influenza, Rash
Clinical narrative: First started with regular flu systems. Then had pain in left breast which was the arm I had injection in,developed a rash left shoulder and back which turned into shingles
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: After administering vaccine patient got up and walked a few feet and then fainted.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Pt experienced hives, welts at the injection area (red, sore,hot to touch--area about size of a hand), pain from elbow to shoulder, no fever (98 F).  Pt said size of redness increased over time and pain progressed to wrist to top of neck.  Pt went to urgent care the evening of 11/10/20, was given a prescription for cephalexin for 10 days and told she had cellulitis from the flu vaccination being given too low on the arm.  Pt saw PCP the next morning , 11/11/20, and will follow up with PCP after finishing course of antibiotics (she had taken 2 doses of cephalexin at the time of interview, afternoon of 11/11/20, and symptoms remained).  Pt said she had not had a problem with flu vaccines, but did have severe flu symptoms for a couple of weeks starting a few days after a flu vaccine in 11/2017.  The timing of when the symptoms appeared in relation to the 11/17 flu shot was not clear, but the pt said she was under a lot of stress at the time and may have contracted the flu.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain, Pain in extremity, Product administered at inappropriate site, Urticaria
Clinical narrative: Pt experienced hives, welts at the injection area (red, sore,hot to touch--area about size of a hand), pain from elbow to shoulder, no fever (98 F).  Pt said size of redness increased over time and pain progressed to wrist to top of neck.  Pt went to urgent care the evening of 11/10/20, was given a prescription for cephalexin for 10 days and told she had cellulitis from the flu vaccination being given too low on the arm.  Pt saw PCP the next morning , 11/11/20, and will follow up with PCP after finishing course of antibiotics (she had taken 2 doses of cephalexin at the time of interview, afternoon of 11/11/20, and symptoms remained).  Pt said she had not had a problem with flu vaccines, but did have severe flu symptoms for a couple of weeks starting a few days after a flu vaccine in 11/2017.  The timing of when the symptoms appeared in relation to the 11/17 flu shot was not clear, but the pt said she was under a lot of stress at the time and may have contracted the flu.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Laboratory test, Rash
Clinical narrative: Serum Sickness-Like Reaction:  rash starting 5days after vaccine administration at legs, starting as red bumps then spreading out in red wheals 2x3cm approx from legs to trunk, face with no respiratory compromise.  No swelling of lips, tongue, throat, no cough, no pharyngitis.  Resolved after 4d of rash.
Sex: U
Vaccine: MMR, MMRV
Symptoms: Vaccination error
Clinical narrative: a child accidently received PROQUAD and MMR II; This spontaneous report was received from a registered nurse referring to a 17-month-old patient of unknown gender. The patient's historical condition, concomitant drugs and allergy to drugs were not reported.   On 15-OCT-2020, the patient was accidently vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (0.5 milliliter (ml), strength, route, lot number and expiration date were not reported) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (dose, strength, route, lot number and expiration date were not reported) (accidental overdose) for prophylaxis.
Age: 0.42
Sex: U
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 1st dose of ROTATEQ was given at 5 month and 29 days; This spontaneous report was received from a medical assistant referring to a 5 months and 29 days old patient of unknown gender. The patient's historical condition, concomitant drugs and allergy to drugs were not reported.   On 16-OCT-2020, the patient was vaccinated with the 1st dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (2 milliliter, strength, route, lot number and expiration date were not reported) for prophylaxis at 5 month and 29 days(inappropriate age at vaccine administration).
Sex: U
Vaccine: PPV
Symptoms: Product storage error, Rectal haemorrhage
Clinical narrative: Incorrect Product Storage; patient was given PNEUMOVAX 23 that was recalled; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not reported.  On 15-OCT-2020, the patient was vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) prefilled syringe (dose 0.5 ml, lot number S036495, expiration date reported and established as 13-SEP-2021, strength, route was not reported) as prophylaxis that was recalled (Recalled product administered) (Product storage error). The recall was related to improperly stored vaccines resulting in a temperature excursion. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; serialnumber: UNKNOWN; catalognumber: UNKNOWN; udinumber: UNKNOWN; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Temperature excursion; This spontaneous report was received from a licenced practical nurse and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On an unknown date in 2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 0.5 milliliter (route of administration was not reported), lot # T016147 recombinant Human Albumin (rHA) and expiration date 07-NOV-2021 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of -13.9 degree Celsius (°C) to -14.7 °C (timeframe not specified), -14°C to -10°C for 30 ; -14°C to -10°C for 15 minutes; -14°C to -10°C for 20 minutes; -14°C to -10°C for 5 minutes on (date); no previous temperature excursion were reported.  The call was made due to a digital data logger.
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; GARDASIL 9 was administered to a patient after expiry; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 03-NOV-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 # N032284 (expiration date on 22-SEP-2020) (dosage, route of administration and anatomical route of administration were unknown) for prophylaxis. It was confirmed that the involved vaccine had not undergone any temperature excursions. At the reporting time, no adverse events were mentioned.
Sex: U
Vaccine: HEP, HEPA, HEPA, HPV9, HPV9, PPV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; temperature excursion; This non-valid, spontaneous report was received from a medical assistant and refers to unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 05-NOV-2020, the patients were vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot# 1676322, expiration date 21-APR-2021, and lot# 1684149, expiration date, 25-JUN-2021, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot# 1637648, expiration date 19-JUN-2022, and lot# 1637651, expiration date was reported as 30-JUN-2022, but upon internal validation established as 09-JUN-2022, hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot# R034382, expiration date 04-JUN-2021, hepatitis a vaccine, inactivated (VAQTA) lot# S034358, expiration date 11-JAN-2021, and lot# T014835, expiration date 17-JUL-2021 and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot# S029542, expiration date 10-JUN-2021 (exact doses, site and route of administration were not reported for any); all for prophylaxis.  Administered doses of vaccines underwent a temperature excursion of 34.9 degrees Fahrenheit for 1 hour. There was no previous temperature excursion. Data logger was involved. No additional events were reported.
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: No additional AE; A pediatric patient who was given adult VAQTA vaccine; This spontaneous report was received from a nurse prescriber and refers to a 12-month-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 05-NOV-2020, the patient received an adult hepatitis A vaccine, inactivated (VAQTA) vaccine, 1 milliliter, lot # T014590, expiration date: 15-APR-2021 (strength, frequency and route of administration were not reported) as prophylaxis. That was the first dose of the vaccine administered to the patient. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: T014590; expirationdate: 15-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: A 20 year old male patient received only one dose of GARDASIL 9 in 2019; No additional AE reported,; This spontaneous report as received from both pharmacy intern and pharmacist concerning a 20-year-old male patient. There was no information about the patient's medical history, concurrent conditions or concomitant medication. On an unspecified date in 2019,  the patient was vaccinated with only one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported). Pharmacist was aware that a three-dose series was recommended and wanted to clarify if the series needed to be restarted, as patient would like to continue. No additional adverse event reported.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: a dose of MMRII which was not supported due to a temperature excursion, was inadvertently administered to the patient; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not reported.  On 09-NOV-2020, the patient was inadvertently administered with a dose of improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)  (dose, strength, vaccination scheme, route of administration and anatomical site of vaccination were unknown, lot # S037499 has been verified as valid, expiration date 20-NOV-2021) for prophylaxis (incorrect product storage), no adverse events were reported.  The stored temperature excursion was above 8 degree Celsius (13.5 degree Celsius), time frame: 8 hour and 45 minutes, no previous temperature excursion. The temperature excursion was detected by a data logger.
Sex: U
Vaccine: HEP
Symptoms: Therapy non-responder
Clinical narrative: DId Not Seroconvert After 2 doses; Initial Report Received on 02-Oct-2020.  Follow-up Report Received on 28-Oct-2020 and 02-Nov-2020 included provision of lot numbers, age group, and titer information.  A supervisor at a blood center reported to an account manager that an adult male patient (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and did not seroconvert after two doses of HEPLISAV-B.  No medical history was reported. The reporter was unsure if the patient had any immune issues.  No concomitant medications were reported.  On 13-Jul-2020, the patient received the first dose of HEPLISAV-B.  On 20-Aug-2020, the patient received the second dose of HEPLISAV-B.  HEPLISAV-B lot numbers were 933839 and 933634. Expiration date and NDC # were not available.  A month after the last dose was administered, a titer was drawn. The reporter was not sure how the antibody levels were determined. The patient was determined to not have seroconverted after the two doses of HEPLISAV-B. The patient was determined to not have seroconverted after the two doses of HEPLISAV-B.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Therapy non-responder
Clinical narrative: Did Not Seroconvert After 2 Doses; Given Heplisav-B on 3/3/20 and 7/13/20; Initial Report Received on 02-Oct-2020.  Follow-up Report Received on 28-Oct-2020 and 02-Nov-2020 included provision of lot numbers, age group, and titer information.  A supervisor at a blood center reported to an account manager that an adult male patient (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and did not seroconvert after receiving the second dose of HEPLISAV-B outside the dosing schedule.  No medical history was reported. The reporter was unsure if the patient had any immune issues.  No concomitant medications were reported.  On 03-Mar-2020, the patient received the first dose of HEPLISAV-B.  On 13-Jul-2020, 133 days after receiving the first dose, the patient received the second dose of HEPLISAV-B outside the dosing window.   HEPLISAV-B lot numbers were 933839 and 933634. Expiration date and NDC # were not available.  A month after the last dose was administered, a titer was drawn. The reporter was not sure how the antibody levels were determined. The patient was determined to not have seroconverted after the two doses of HEPLISAV-B.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Administered Engerix-B instead of Heplisav-B for Dose 2; Initial Report Received on 27-Oct-2020  A pharmacy manager in the US (UT) reported that a 22-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for her first dose of hepatitis B immunization but was administered Engerix-B for the second dose.   No medical history was reported.   No concomitant medications were reported.  On an unspecified date, the patient received the first dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported) in Texas.   On 19-Oct-2020, more than 1 month later, the patient went to a pharmacy in Utah for her second dose. The patient did not notify that HEPLISAV-B was given for the first dose and received Engerix-B (hepatitis B vaccine) intramuscularly in the right deltoid.   At the time of report, the patient did not report any reactions to the vaccine.  No additional information was reported.   The reporter stated that the report was submitted through an internal system that reports to the Vaccine Adverse Event Reporting System (VAERS).  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Received Engerix-B as her Second Dose; Initial Report Received on 02-Nov-2020  A registered nurse reported that a 51-year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for her first dose of hepatitis B immunization and received ENGERIX-B as her second dose.   No medical history was reported. Allergic history included aspirin and penicillin. The patient was not pregnant.  No concomitant medications were reported.  On 26-Aug-2020, the patient received the first dose of HEPLISAV-B (Lot # 933622, expiration date 01-Aug-2021, NDC # not reported) to her left deltoid. On the same day, the patient also received a flu shot to her right deltoid.  On 30-Oct-2020, the patient received ENGERIX-B (Lot # 2573G, expiration date 28-May-2022) as her second dose (which has a 3-dose series) to her left deltoid.  This was the patient's first time receiving the hepatitis B vaccine.  At the time of report, no adverse reactions to the injections had been noted.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: got sick after the first shot; This case was reported by a consumer via interactive digital media and described the occurrence of malaise in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced malaise. On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had malaise.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: soreness at the injection site; This case was reported by a consumer and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had soreness at the injection site. The reporter asked could a heating pad be used for soreness at the injection site of a Shingrix vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Tinnitus
Clinical narrative: headache; buzzing in the head; fatigue; This case was reported by a consumer via call center representative and described the occurrence of headache in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (for tolerance of 1st dose refer case US2020221342).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache, noises in head and fatigue. On an unknown date, the outcome of the headache, noises in head and fatigue were recovered/resolved.   It was unknown if the reporter considered the headache, noises in head and fatigue to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had fatigue, buzzing in the head, and headache after receiving the 2nd dose of Shingrix and these resolved within a couple of days. The reporter did not consent to follow-up. This case is 1 of 4 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020221335:same reporter US-GLAXOSMITHKLINE-US2020221335:same reporter US-GLAXOSMITHKLINE-US2020221342:1st dose, same patient
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Injection site pain
Clinical narrative: a lot of sweating.; fever; chills, shivering; slight headache; fatigue; injection site is sore; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received in august 2020 for further tolerance refer case US2020221351).   On 5th November 2020, the patient received the 2nd dose of Shingrix. On 5th November 2020, less than a day after receiving Shingrix, the patient experienced fever, chills, headache and fatigue. On 6th November 2020, the patient experienced sweating increased. In November 2020, the patient experienced injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, fever, chills, headache, fatigue and sweating increased were unknown.   It was unknown if the reporter considered the injection site pain, fever, chills, headache, fatigue and sweating increased to be related to Shingrix.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix on right arm and experienced injection site soarness, fever, shivering, headache, fatigue and sweating a lot. The patient experienced fever, shivering, headache, fatigue less than day and sweating a lot 1 day after receiving shingrix. The reporter did not consented to follow up. No futher information was available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020221351:1st dose, same patient
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: a lot of sweating.; fever; chills, shivering; slight headache; fatigue; injection site is sore; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received in august 2020 for further tolerance refer case US2020221351).   On 5th November 2020, the patient received the 2nd dose of Shingrix. On 5th November 2020, less than a day after receiving Shingrix, the patient experienced fever, chills, headache and fatigue. On 6th November 2020, the patient experienced sweating increased. In November 2020, the patient experienced injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, fever, chills, headache, fatigue and sweating increased were unknown.   It was unknown if the reporter considered the injection site pain, fever, chills, headache, fatigue and sweating increased to be related to Shingrix.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix on right arm and experienced injection site soarness, fever, shivering, headache, fatigue and sweating a lot. The patient experienced fever, shivering, headache, fatigue less than day and sweating a lot 1 day after receiving shingrix. The reporter did not consented to follow up. No futher information was available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020221351:1st dose, same patient
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Soreness around injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix and experienced injection site soreness which was resolved in 3 days. For tolerance of 2nd dose of Shingrix, refer case US2020221389, reported by same reporter. No further information was available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020221389:for 2nd dose
Sex: U
Vaccine: FLUX
Symptoms: Asthenia
Clinical narrative: here been 2 weeks so weak; This case was reported by a consumer via interactive digital media and described the occurrence of weakness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced weakness. On an unknown date, the outcome of the weakness was recovered/resolved.   It was unknown if the reporter considered the weakness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that he or she had been 2 weeks so weak never again.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th October 2019, the patient received the 2nd dose of Shingrix. On 8th October 2019, 1 days after receiving Shingrix, the patient experienced pain in arm. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had symptoms after she received the vaccine. The patient sore arm started the day after her injection.  She took Tylenol and the soreness resolved within a day.  Outcome date for sore arm was reported as 9th October 2019 however as per narrative description, the event resolved on same day of occurrence. No further details were provided. The reporter consented to follow up. This case has been linked with US2020220500 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020220500:same reporter
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre syndrome; This case was reported by a other health professional via call center representative and described the occurrence of guillain barre syndrome in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced Guillain-Barre syndrome. The reporter consented to follow-up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Altered state of consciousness, Asthenia, Dysgeusia, Fatigue, Heart rate increased
Clinical narrative: fell into a deep coma like state; thought that she had COVID and was dying; fast hear tbeat; intense fever that came on quickly and was quite high (4-5 degrees high). / fever; chemical toxic taste like iodine on steroids in her mouth / very pungent and disgusting; fatigue; unable to get up; Unable to get water; unable to think; This case was reported by a consumer via call center representative and described the occurrence of thinking reduced in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included thyroid.   On 20th August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, several hours after receiving Shingrix, the patient experienced thinking reduced (serious criteria GSK medically significant), heartbeats increased, fever, taste chemical, fatigue, mobility decreased and asthenia. On 20th August 2020, the patient experienced altered state of consciousness (serious criteria GSK medically significant) and suspected covid-19. On an unknown date, the outcome of the thinking reduced, heartbeats increased, fever and taste chemical were recovered/resolved and the outcome of the altered state of consciousness, suspected covid-19, fatigue, mobility decreased and asthenia were unknown.   It was unknown if the reporter considered the thinking reduced, altered state of consciousness, suspected covid-19, heartbeats increased, fever, taste chemical, fatigue, mobility decreased and asthenia to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the right deltoid. Several hours after vaccination,the patient thought that had COVID and was dying. The patient felt into deep coma like state and was unable to think and get water or get up. The patient experienced severe fast heart beat which was unusual because had an unusualil heart rate. The patient experienced intense fever (4 to 5 degrees high) that came quickly after vaccination. The patient reported that, after vaccination when came to home in that morning all of the sudden had a chemical toxic taste like iodine on steroids in mouth. It was very pungent and disgusting and it lasted 5 minutes. The patient stated that 5 hours later all other symptoms hit. The patient received natural steroid medication. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Mental impairment, Mobility decreased, Pyrexia, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: fell into a deep coma like state; thought that she had COVID and was dying; fast hear tbeat; intense fever that came on quickly and was quite high (4-5 degrees high). / fever; chemical toxic taste like iodine on steroids in her mouth / very pungent and disgusting; fatigue; unable to get up; Unable to get water; unable to think; This case was reported by a consumer via call center representative and described the occurrence of thinking reduced in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included thyroid.   On 20th August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, several hours after receiving Shingrix, the patient experienced thinking reduced (serious criteria GSK medically significant), heartbeats increased, fever, taste chemical, fatigue, mobility decreased and asthenia. On 20th August 2020, the patient experienced altered state of consciousness (serious criteria GSK medically significant) and suspected covid-19. On an unknown date, the outcome of the thinking reduced, heartbeats increased, fever and taste chemical were recovered/resolved and the outcome of the altered state of consciousness, suspected covid-19, fatigue, mobility decreased and asthenia were unknown.   It was unknown if the reporter considered the thinking reduced, altered state of consciousness, suspected covid-19, heartbeats increased, fever, taste chemical, fatigue, mobility decreased and asthenia to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the right deltoid. Several hours after vaccination,the patient thought that had COVID and was dying. The patient felt into deep coma like state and was unable to think and get water or get up. The patient experienced severe fast heart beat which was unusual because had an unusualil heart rate. The patient experienced intense fever (4 to 5 degrees high) that came quickly after vaccination. The patient reported that, after vaccination when came to home in that morning all of the sudden had a chemical toxic taste like iodine on steroids in mouth. It was very pungent and disgusting and it lasted 5 minutes. The patient stated that 5 hours later all other symptoms hit. The patient received natural steroid medication. The reporter consented to follow up.
Sex: U
Vaccine: FLU4, VARZOS
Symptoms: Injection site rash, Rash
Clinical narrative: rash on the trunk and extremities, including injection site; full body rash / rash on the trunk and extremities; This case was reported by a other health professional via call center representative and described the occurrence of injection site rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, unknown after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced injection site rash and generalized rash. On an unknown date, the outcome of the injection site rash and generalized rash were recovered/resolved.   It was unknown if the reporter considered the injection site rash and generalized rash to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the Shingrix was given concomitantly with High dose Flu vaccine a week or so ago, patient developed a full body rash including a rash on the trunk and extremities, including injection site. The healthcare professional would like guidance on the 2nd dose of Shingrix. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: pain at site of injection; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) (batch number Y7JL5, expiry date unknown) for prophylaxis.   On 1st October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 2nd October 2020, 1 days after receiving Shingrix, the patient experienced injection site pain. On 9th November 2020, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix in the left deltoid. The reporter stated that, a day after vaccination, the patient had pain at site of injection. The pain was described as significant but not high by reporter. The reporter consented to follow up.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick; Initial information was received on 05-Nov-2020 regarding an unsolicited valid non-serious social media case from the patient.  This case involves an unknown demographic patient who felt sick (malaise), while the patient received vaccine INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s), family history and concomitant therapy were not reported. The patient was allergic to egg (however not confirm at the time of reporting).   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient felt sick (malaise), (unknown latency) following the administration of INFLUENZA VACCINE.  The patient was ended up in the hospital twice after vaccination for this event.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome of the events was not reported.  There will be no information available on the batch number for this case.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Fatigue, Feeling abnormal, Nausea, Skin irritation, Skin warm
Clinical narrative: 11/12/2020 Employee states she began feeling irritation to her arm, state her fiancé felt the arm and it felt warm, reports feeling nauseated and "not feeling herself", reports feeling more tired than usual. Employee states she has not done anything to treat it up until this point. Was instructed to apply ice.
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Arthralgia
Clinical narrative: Patient is experiencing pain in her left shoulder and has been since receiving her flu shot six weeks ago. She has seen her doctor and received an ultrasound, however the pain has not resolved.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain
Clinical narrative: Received #2 part of shingles vaccine(Thurs) , Woke up Friday feeling achy and Nausea feeling. Slight headache.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Persistent soreness after 4 days.
Age: 62.0
Sex: F
Vaccine: FLUA3
Symptoms: Anxiety, Balance disorder, Chest X-ray, Computerised tomogram, Depression
Clinical narrative: rec'vd flu vax, leg muscles felt like they were sagging downwards, feeling like muscles are dragging in legs and belly area. Became depressed has anxiety. Steady trembling. Still have spongy feeling in muscles. Feeling off balance when walk. Staggering when walking. Saw doctor on 10.20.20 and again on 11.10.20 (Went to Urgent Care).
Age: 62.0
Sex: F
Vaccine: FLUA3
Symptoms: Muscle disorder, Tremor
Clinical narrative: rec'vd flu vax, leg muscles felt like they were sagging downwards, feeling like muscles are dragging in legs and belly area. Became depressed has anxiety. Steady trembling. Still have spongy feeling in muscles. Feeling off balance when walk. Staggering when walking. Saw doctor on 10.20.20 and again on 11.10.20 (Went to Urgent Care).
Sex: F
Vaccine: DTAPIPV
Symptoms: Abdominal pain upper, Pyrexia, Urticaria
Clinical narrative: 24 hours after receiving Quadracel immunization, Patient developed hives to chest, neck, and back and stomach ache. She developed a temperature of 103 degrees F. No breathing trouble or vomiting. Mother gave Epi Pen Jr and Benadryl 1 teaspoon by mouth and took the child to the Hospital ER. In the ER Patient was given Prednisolone 15 mg orally and Acetaminophen 233 mg orally. Hives , stomach ache, and fever diminished and child stated feeling better. 1 teaspoon of Benadryl was given. Patient discharged after 2 reassessments were done by the ER doctor. Discharge medication was Orapred 15mg/5ml oral liquid, 5 ml daily for 5 days.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, X-ray
Clinical narrative: Right shoulder pain and swelling.   Ice and heat packs
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out while sitting in a chair 40 seconds after getting the flu shot
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Electroencephalogram, Laboratory test, Magnetic resonance imaging, Seizure
Clinical narrative: seizure occurred - took my husband to emergency room.  He was tested and kept overnight.  Seizure was diagnosed.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Agitation, Blood test, Computerised tomogram, Electrocardiogram, Electroencephalogram
Clinical narrative: seizure occurred - took my husband to emergency room.  He was tested and kept overnight.  Seizure was diagnosed.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Gaze palsy, Hyperhidrosis, Magnetic resonance imaging, Muscle contractions involuntary, Pallor
Clinical narrative: seizure occurred - took my husband to emergency room.  He was tested and kept overnight.  Seizure was diagnosed.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Posture abnormal, Seizure, Unresponsive to stimuli
Clinical narrative: seizure occurred - took my husband to emergency room.  He was tested and kept overnight.  Seizure was diagnosed.
Sex: U
Vaccine: PPV
Symptoms: Product storage error, Recalled product administered
Clinical narrative: patient was given PNEUMOVAX 23 that was recalled; Incorrect Product Storage; This spontaneous report was received from a medical assistant referring to a patient of unknown age and unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 15-OCT-2020, the patient was vaccinated with a recalled, improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml, lot # S036495 with expiration date 13-SEP-2021) via an unknown route for prophylaxis. No other adverse event information was given at this time. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: remained anti-HBs-nonreactive; This literature market report refers to an adult patient with unknown age and gender who was a heart transplant recipient. Information about concurrent condition and concomitant therapy was unknown.  On unknown dates, the patient received 3 doses of hepatitis b vaccine (recombinant) (manufacturer unknown) (strength, dose, frequency, route, lot# and expiration date were unknown) for prophylaxis. The patient had post-vaccination completion hepatitis B surface antibody (anti-HBs) checked and the patient remained anti-HBs-nonreactive. The outcome of the event was unknown. The reporter considered the event to be related to hepatitis b vaccine (recombinant) (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.   This is one of three reports received from the same literature.; Sender's Comments:  US-009507513-2011USA008579: US-009507513-2011USA008580:
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody positive, Incomplete course of vaccination
Clinical narrative: less than the full 3-dose series; This literature market report refers to an adult patient with unknown age and gender who was a lung transplant recipient. Information about concurrent condition and concomitant therapy was unknown.  On unknown dates, the patient received less than 3 doses of hepatitis b vaccine (recombinant) (manufacturer unknown) (strength, dose, frequency, route, lot# and expiration date were unknown) for prophylaxis (Incomplete course of vaccination). The patient had post-vaccination completion hepatitis B surface antibody (anti-HBs) checked and the patient had protective anti-HBs measured.  A copy of the published article is attached as further documentation of the patient's experience.   This is one of three reports received from the same literature.; Sender's Comments:  US-009507513-2011USA002338:Original Case : 2011USA002338