chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Chest pain, Dyspnoea, Fatigue
Clinical narrative: Symptomps of myocarditis - chest pain, fatigue, abnormal heart rhythms and shortness of breath. Symptoms lasted more than two weeks and improved after I started taking 600mg ibuprofen to reduce chest pain. All symptomps have gone after 3 weeks of the vaccine shot.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Fatigue, Headache, Pain
Clinical narrative: After 2nd vaccination at 10pm on 7/1/21 patient reported a headache.  At 5am on 7/2/21 patient woke up with a fever of 100.4 temperature, headache, chills, and body aches, and feeling very tired. Later in the day her nose started to run and she felt like her chest was heavy when she took a deep breathe in. She slept all of the day. All symptoms continued throughout the day until early on 7/3/21 when the fever was gone but all the other symptoms remained mildly.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: After 2nd vaccination at 10pm on 7/1/21 patient reported a headache.  At 5am on 7/2/21 patient woke up with a fever of 100.4 temperature, headache, chills, and body aches, and feeling very tired. Later in the day her nose started to run and she felt like her chest was heavy when she took a deep breathe in. She slept all of the day. All symptoms continued throughout the day until early on 7/3/21 when the fever was gone but all the other symptoms remained mildly.
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Chest discomfort
Clinical narrative: Chest tightness
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Skin warm
Clinical narrative: Janssen COVID-19 Vaccine EUA.   Please note the chronic knee injury previously reported. A day after my shot, I experienced 48 hours of joint pain in my chronically injured knee. I ruled out outlying factors like excessive exercise, overuse, or weather events, and could only conclude the shot was affecting me.   Today, around 5 pm until writing this report at 12:30 am, my knee has been experiencing joint pain again, and again, I've ruled out all other reasons other than this potentially being  an adverse symptom of the shot.   The joint pain is mostly felt in the front of my knee, underneath my patella, and does not move to other areas. The knee is warm to the touch and not swollen like it usually would be when I experience overuse.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: Two dose of VARIVAX were administered on 05/27/2021 and expired on 05/20/2021; This spontaneous report was received from a physician concerning a patient of unknown age and gender. Information regarding the patient's concomitant therapies, current conditions, medical history and historical drug was not provided.  On 27-MAY-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX), 0.5 milliliter, lot number S015460 expiration date 20-MAY-2021 (route of administration was not provided) as prophylaxis.; Sender's Comments:  US-009507513-2106USA001319:
Age: 21.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC; A patient inadvertently received a dose of VARIVAX on 5/28/2021 that had a labeled expiry of 5/20/2021; This spontaneous report was received from a physician concerning a 21-year-old patient of unknown gender gender. Information regarding the patient's concomitant therapies, current conditions, medical history and historical drug was not provided.  On 27-MAY-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX), 0.5 milliliter, lot number S015463 expiration date 20-MAY-2021 (route of administration was not provided) as prophylaxis.  No adverse event was reported
Age: 0.08
Sex: M
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Customer reporting administration of improperly stored PEDVAX HIB and ROTATEQ; This spontaneous report was received from an office manager, concerning an approximately 7 weeks old (also reported as 5 month old) male patient. Patient had glucose-6-phosphate dehydrogenase (G6PD) deficiency and family would like to establish case with a hematologist. He presented for a physical examination concerns/questions relating the penis (illness at vaccination). The patient's concomitant medications and drug allergies were not reported.  On 06-APR-2021 (also reported as 27-APR-2021), the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (first dose, orally at the dose of 2 milliliter (ml), lot number 1687012 has been verified to be a valid lot number, expiration date reported and validated as 08-JUL-2021; strength was not provided) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (first dose, at the dose of 0.5ml, intramuscular, lot # T001206 has been verified to be a valid lot number with an expiration date reported and validated as 03-JUN-2022; strength was not provided) for prophylaxis (product storage error), however, the temperature was not reported.  It was stated that the patient did not received any treatment, it was confirmed that the operator was trained, and it was used according to the instruction leaflet. Previous temperature excursions were reported as yes, and digital data logger was involved. No adverse events were reported, nor product quality complain.   This is one of the several reports received from the same source.; Sender's Comments:  US-009507513-2106USA001370: US-009507513-2105USA001739: US-009507513-2106USA002133:
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE's; Patient was administered the 1st ROTATEQ dose after 15 weeks of age by Nurse per physician's order; This spontaneous report was received from a nurse, concerning a 4-month-old male patient. No information about the patient's concurrent conditions, drug allergies, concomitant therapies or medical history was provided.  On 14-JUN-2021, after 15 weeks of age, the patient was vaccinated by nurse per physician's order with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (lot number 1707572, and expiration date 11-MAR-2022, which were verified to be valid) for prophylaxis (vaccination scheme frequency was not reported) (product administered to patient of inappropriate age). No additional adverse event (AE).
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; an expired dose of VAQTA was administered to a patient. The dose of VAQTA expired on 04-JUN-2021 and was administered to the patient on 16-JUN-2021; 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, allergies, and concomitant therapies were not reported.  It was reported that on 16-JUN-2021, the patient was vaccinated with an expired unspecified dose of hepatitis a vaccine, inactivated (VAQTA) lot # T008698 with expiration date 04-JUN-2021, for prophylaxis (strength, dosage schedule, route, and anatomical location were not reported). No additional adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T008698; expirationdate: 04-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 23.0
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional adverse events reported; received a dose of Gardasil 9 on 06/01/2021 and another dose was given again a couple days later on 06/03/2021 by mistake; This spontaneous report was received from a nurse, concerning a 23-year-old patient of an unknown gender. No information about the patient's concurrent conditions, drug allergies, concomitant therapies or medical history provided.  On 01-JUN-2021, the patient was vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) prefilled syringe, and on and 03-JUN-2021, received another dose of (GARDASIL 9) prefilled syringe; both vaccine, at a dose of 0.5 milliliters (ml) as prophylaxis (lot number T025367 has been verified to be valid, expiration date reported and validated as 18-NOV-2022) (route of administration, anatomical sites of vaccination and vaccination schemes were not reporter) by mistake (inappropriate schedule of product administration). No additional adverse event 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: T025367; expirationdate: 18-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional edverse effect reported; PROQUAD underwent a temperature excursion and was administered; Information has been received from a registered nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 21-JUN-2021, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot number: U002529, expiration date: 24-JUL-2022 (dosage regimen, administration route and anatomical location were not provided) for prophylaxis. No adverse effects were reported.  The vaccine had temperature excursions of -14 (Celsius) to 10 C (-11.44 C) for 1 hour and 15 minutes. The reporter stated that a digital data logger was involved.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: she found out that she was one month pregnant; No additional AE reported.; This spontaneous prospective pregnancy report was received from a patient's husband and refers to a 35-year-old female pregnant patient. She had no pertinent medical history, concomitant therapies or drug reactions and allergies. The patient became pregnant with LMP of an unknown date in 2021.  On 19-JUN-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (exact dose, injection site, route of administration, lot # and expiration date were not reported) for prophylaxis.   On an unknown date in June 2021, after the vaccination, the patient found out that she was one month pregnant (vaccine exposure during pregnancy). The pregnancy outcome was outcome pending. No additional adverse events were reported.
Age: 28.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional adverse events; administration of an expired dose of MMR II; This spontaneous report was received from a medical assistant and refers to a 28-year-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 29-JUN-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) 0.5 ml, single dose for prophylaxis (lot # S014436 was verified to be valid, expiration date reported and established to be 09-MAY-2021). There was no previous temperature excursion reported on the product. The patient did not experience any additional adverse reactions. The outcome, action taken and the causality assessment were not provided.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AEs; expired dose of PNEUMOVAX 23 administered; This spontaneous report was received from a pharmacist and refers to a 70-year-old patient. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided.  On 29-JUN-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5 milliliter, via intramuscular route, lot # R022879, expiration date 02-AUG-2020 (injection site was not reported) for prophylaxis.         No additional adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Varivax had a temperature excursion and was administered; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 28-JUN-2021, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, once for prophylaxis (lot # T028306 was verified to be valid, expiration date reported and established to be 22-AUG-2022), (route and site of administration were not provided).  The administered dose of vaccine previously experienced a temperature excursion of 41 Fahrenheit degrees for 24 hours. There was no other previous temperature excursions. Digital Data Logger was not involved. The outcome, action taken and the causality assessment were not provided.; Sender's Comments:  US-009507513-2107USA000029: US-009507513-2107USA000236: US-009507513-2107USA000237: US-009507513-2107USA000238:
Age: 3.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no other AE occurred; the first dose of Varivax and MMR II at 3 years old and the second dose of Varivax and MMR II at 7 years old; This spontaneous report was received from a registered nurse and refers to a currently 18-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date in an approximately 2006, at 3 years old, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck)(VARIVAX), (for both: formulation, strength, dose, route of administration, lot#, expiry date were not reported), both for prophylaxis. On an unknown date in an approximately 2010, at 7 years old, the patient was vaccinated with the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and varicella virus vaccine live (oka/merck)(VARIVAX), (for both: formulation, strength, dose, route of administration, lot#, expiry date were not reported), both for prophylaxis. No other adverse event occurred.
Age: 69.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Product use in unapproved indication
Clinical narrative: small patch of shingles on my injection site / shingles / from the base to half way down my neck /  doctor /confirmed it.; I have inactive TB/ On the form I filled out to get the first dose it asked if you had TB /I took the first shot; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 69-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of no adverse event (received older version of shingles shot). Concurrent medical conditions included tuberculosis (took medicine for one year). Additional patient notes included Tuberculosis.   In January 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced shingles and drug use for unapproved indication. On an unknown date, the outcome of the shingles and drug use for unapproved indication were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: This case was reported by a consumer. The patient reported that had inactive tuberculosis . The patient received (unspecified) medication for the tuberculosis for one year. The patient received first dose of shingrix in January of this year. The patient added that, on the form to get the first dose, it was asked if the patient had TB. The pharmacist could not tell the patient why it was on the form but you had to sign it before you were given the shot, which led to drug used for unapproved indication. The patient also had a small patch of shingles on the injection site and about one week later had shingles on the right side of neck from the base to half way down my neck. The patient sent a picture to his/her doctor who confirmed it. The patient was also told by the clinic that he/she could not take another TB test or would get postules over the body. So the patient was worried about taking the second dose
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered, Pain in extremity, Product preparation issue
Clinical narrative: administered only the liquid portion of the Menveo vaccine; administered only the liquid portion of the Menveo vaccine; first dose received in 14AUG 2015 and second dose received on 09 JUN 2021; that arm was sore; This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Menveo (1st dose received on 14th August 2015).   On 9th June 2021, the patient received the 2nd dose of Menveo .5 ml, Bexsero and Bexsero Pre-Filled Syringe Device. On 9th June 2021, unknown after receiving Menveo and not applicable after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate preparation of medication, inappropriate dose of vaccine administered and drug dose administration interval too long. In June 2021, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm, inappropriate preparation of medication, inappropriate dose of vaccine administered and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the pain in arm to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: The patient received Bexsero and Menveo vaccine in different arm. The patient received 2nd dose of Menveo, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter stated that the patient came in on 9th June 2021. There was a temp working in the office and she inadvertently administered only the liquid portion of the Menveo vaccine (she forgot to reconstitute), which led to inappropriate preparation of medication, inappropriate dose of vaccine administered. The patient also received a dose of Bexsero on the same day and experienced sore arm (on which she received  Bexsero vaccine). On 10th June 2021, the office realize what happened with dose of menveo, they called the patient to explain what happened. The reporter stated that on 24th June 2021, the patient would receive the correct dose of Menveo. The reporter was not aware of any side effects. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient who received the 1st dose of SHINGRIX/ in 2019 and a 2nd dose in 2021, about 1.5 years apart.; This case was reported by a pharmacist via other manufacturer and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix received in 2019).   In 2021, the patient received the 2nd dose of Shingrix. In 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that, the patient received the 2nd dose in 2021 almost 1.5 years apart later than the recommended interval, which led to lengthening of the vaccination schedule. The reporter asked should patient receive a 3rd dose.
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Shingrix and Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a week after receiving Shingrix and 2 days after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix and Influenza vaccine Quadrivalent unspecified season.   Additional details were reported as follows: The age at vaccination was not administered.  The patient over 50s year age group, coadministration with Shingrix and Flu vaccine. Shingrix arm pain. Two days later flu arm pain.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccine positive rechallenge
Clinical narrative: I got both my shingles shots / I've had horrible pain in my arm / My arm hasn't been the same since; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a 50-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on unknown date,refer case US2021AMR140487).   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 pain in arm. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient himself/herself. The age at vaccination was not reported. The patient received the 2nd dose of Shingles vaccine and experienced horrible pain in arm. The reporter stated that wish he/she would have never taken the shot and stated that his/her arm was not been the same since. This case was linked with US2021AMR140487, reported by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR140487:same reporter
Age: 63.0
Sex: F
Vaccine: FLUC4, VARZOS, VARZOS
Symptoms: Condition aggravated, Genital herpes simplex, Incomplete course of vaccination
Clinical narrative: Received the 1st dose of Shingrix last fall / Should she get the 2nd dose?; confirm that it is genital Herpes; This case was reported by a pharmacist via call center representative and described the occurrence of genital herpes simplex in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number NB9D3, expiry date 16th April 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and INFLUENZA VIRUS VACCINE INACTIVATED (FLUCELVAX QUAD) for prophylaxis.   The patient's past medical history included genital herpes.   On 7th October 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 7th October 2020, the patient received FLUCELVAX QUAD. In October 2020, less than 2 weeks after receiving Shingrix, not applicable after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced genital herpes simplex. On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the genital herpes simplex and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the genital herpes simplex to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for second dose. The pharmacist reported that the patient had 1st dose of Shingrix and a dose of FLUCELVAX QUAD on same day and experienced 4 flares of genital herpes simplex. Till the time of reporting the patient did not received second dose, which led to incomplete course of vaccination.  The pharmacist inquired that if it is possible side effect of Shingrix and second dose can be administered. Health care professional states that she received a prescription for Valacyclovir on Oct 22, 2020. It was unknown if the reporter considered the herpes simplex to be related to FLUCELVAX QUAD.
Sex: M
Vaccine: VARZOS
Symptoms: Granuloma annulare, Immediate post-injection reaction, Rash, Rash papular, Rash pustular
Clinical narrative: Patient developed Granuloma Anulare after vaccination.; bumps inside the rash filled with pus.; rash on head, arms and hands / developed two weeks after the second vaccine; bump rash; This case was reported by a consumer via call center representative and described the occurrence of granuloma annulare in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced granuloma annulare, pustular rash, rash and papular rash. On an unknown date, the outcome of the granuloma annulare, pustular rash, rash and papular rash were unknown.   It was unknown if the reporter considered the granuloma annulare, pustular rash, rash and papular rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose Shingrix and developed rash on head, arms and hands( bumps inside the rash filled with pus) also was diagnosed shortly after vaccine with granuloma anulare. The reporter did not know exactly what facility vaccine was administered. she did not know what arm, when it was given and only stated rash developed two weeks after the second vaccine and  was diagnosed shortly after with Granuloma Anulare. The reporter consent to follow up.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received an expired dose of Pediarix on 23Jun2021./expired on 14Jun2021; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number D93B4, expiry date 14th June 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd June 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 23rd June 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The reporter reported that a patient received an expired dose of Pediarix on 23rd June 2021 which was already expired on 14th June 2021. No symptoms reported. The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: two doses had been given / 7Jun2018 / and 16Sep2020 /dose was given on 23Jun2021; two doses had been given / 7Jun2018 / and 16Sep2020; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number 9NH54, expiry date 14th October 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 7th June 2018).   On 23rd June 2021, the patient received the 3rd dose of Shingrix. On 16th September 2020, the patient received the 2nd dose of Shingrix. On 16th September 2020, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In June 2021, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and drug dose administration interval too long were unknown.  Additional details were provided as follows: The patient received 2nd dose late than the recommended time interval, which led to lengthening of vaccination schedule. The patient received 3rd dose of Shingrix , which led to extra dose administered. The reporter reviewed patient's vaccine history and noticed that two doses were already given.  The reporter consented to follow up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Fatigue, Headache, Herpes zoster, Oral mucosal blistering
Clinical narrative: pounding headache; sore throat; felt feverish; feel achy; fatigued; diagnosed her with shingles; blisters around her mouth and face on the RIGHT side; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (severe case of Chickenpox at age 14 years). Previously administered products included Shingrix (received Shingrix on an unknown date).   On 18th June 2021 02:00, the patient received the 2nd dose of Shingrix (intramuscular). In June 2021, 4 hrs after receiving Shingrix, the patient experienced shingles and blister. On 18th June 2021, the patient experienced pain and fatigue. On 19th June 2021, the patient experienced headache, sore throat and fever. On an unknown date, the outcome of the shingles, pain, fatigue, headache, sore throat, fever and blister were not recovered/not resolved.   It was unknown if the reporter considered the shingles, pain, fatigue, headache, sore throat, fever and blister to be related to Shingrix.  Additional details provided as follows: The patient received her Shingrix vaccine and after 4 hours patient experienced pain and fatigue.On the next day she experienced pounding headache and sore throat.On that evening the patient reported that she felt feverish. On 20 June 2021,the patient reported that she experienced blisters around her mouth and face on the right side. The patient reported that she went to Health care professional on 23rd june and diagnosed with shingles. The patient reported her Health care professional did not want her to take any steroids or antiviral medications to not disturb the Shingrix vaccine. The patient reported that she will go back to the HCP next week for a follow-up.Her Health care professional is hoping for a spontaneous recovery due to the Shingrix vaccine. The patient reported that at the time of reporting none of the symptoms have resolved completely. The patient reported a severe case of Chickenpox at age 14, but never had shingle before now.  Patient did not gave permission to contact Health care professional. Did not consented to followup.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: pounding headache; sore throat; felt feverish; feel achy; fatigued; diagnosed her with shingles; blisters around her mouth and face on the RIGHT side; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (severe case of Chickenpox at age 14 years). Previously administered products included Shingrix (received Shingrix on an unknown date).   On 18th June 2021 02:00, the patient received the 2nd dose of Shingrix (intramuscular). In June 2021, 4 hrs after receiving Shingrix, the patient experienced shingles and blister. On 18th June 2021, the patient experienced pain and fatigue. On 19th June 2021, the patient experienced headache, sore throat and fever. On an unknown date, the outcome of the shingles, pain, fatigue, headache, sore throat, fever and blister were not recovered/not resolved.   It was unknown if the reporter considered the shingles, pain, fatigue, headache, sore throat, fever and blister to be related to Shingrix.  Additional details provided as follows: The patient received her Shingrix vaccine and after 4 hours patient experienced pain and fatigue.On the next day she experienced pounding headache and sore throat.On that evening the patient reported that she felt feverish. On 20 June 2021,the patient reported that she experienced blisters around her mouth and face on the right side. The patient reported that she went to Health care professional on 23rd june and diagnosed with shingles. The patient reported her Health care professional did not want her to take any steroids or antiviral medications to not disturb the Shingrix vaccine. The patient reported that she will go back to the HCP next week for a follow-up.Her Health care professional is hoping for a spontaneous recovery due to the Shingrix vaccine. The patient reported that at the time of reporting none of the symptoms have resolved completely. The patient reported a severe case of Chickenpox at age 14, but never had shingle before now.  Patient did not gave permission to contact Health care professional. Did not consented to followup.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Decreased appetite, Fatigue, Inappropriate schedule of product administration, Rash
Clinical narrative: has a rash on his left leg starting (6/23/21); had fatigue/ Tired; appetite loss; dose number two given 6/21/21, 8 months after first dose; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 21st June 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 21st June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 22nd June 2021, the patient experienced fatigue and appetite lost. On 23rd June 2021, the patient experienced rash. On an unknown date, the outcome of the fatigue and appetite lost were recovered/resolved and the outcome of the rash was not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the fatigue, appetite lost and rash to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The reporter stated that, after vaccination with 2nd dose of Shingrix, had fatigue and appetite loss and rash on his left leg. 1 day after vaccination with Shingrix, the patient experienced fatigue, appetite lost. 2 days after vaccination, the patient experienced rash. The patient received 2nd dose 8 months after first dose, which led to lengthening of vaccination schedule. The reporter did not consent to follow up.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Cold sweat, Dizziness, Headache, Pain in extremity
Clinical narrative: Headache; Cold sweats; Sore arm; lightheaded; This case was reported by a consumer via call center representative and described the occurrence of headache in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd June 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. In June 2021, less than a week after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced headache, cold sweat, pain in arm and light headedness. On an unknown date, the outcome of the headache, cold sweat, pain in arm and light headedness were unknown.   It was unknown if the reporter considered the headache, cold sweat, pain in arm and light headedness to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The case was reported by patient's parent. Lot and expiration date was not provided. The patient experienced sore arm, headache, cold sweats and was lightheaded. Not all information was provided.  No consent was provided.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site urticaria
Clinical narrative: developed hives around injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site hives in a female patient who received Herpes zoster (Shingrix) (batch number KB97C, expiry date 13th November 2022) for prophylaxis.   Concurrent medical conditions included latex allergy.   On 22nd June 2021, the patient received the 1st dose of Shingrix. In June 2021, less than 2 weeks after receiving Shingrix, the patient experienced injection site hives. The action taken with Shingrix was unknown. On an unknown date, the outcome of the injection site hives was unknown.   It was unknown if the reporter considered the injection site hives to be related to Shingrix.  Additional details were provided are as follows: The patient received 1st dose of Shingrix and developed hives around injection site. The reporter was looking for information about giving only one dose of Shingrix and latex content, as the patient was allergic to latex. The reporter consented to follow up via email or by Fax.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza, Vomiting
Clinical narrative: flu symptom; vomiting; This case was reported by a pharmacist via call center representative and described the occurrence of flu symptoms in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced flu symptoms and vomiting. On an unknown date, the outcome of the flu symptoms and vomiting were unknown.   It was unknown if the reporter considered the flu symptoms and vomiting to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The pharmacist reported that, the female patient had vomiting and flu symptom after receiving the 2nd dose of Shingirx vaccine. No patient's identifiers was provided. No LOT number and expiration date was provided. No vaccination date and date of when the symptoms was appear or end was provided The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: shot #1 on 17-Nov-2020 but has not yet received Shingrix shot #2.; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose of Shingrix received on 17th November 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional details were reported as follows: The reporter was wife of the patient. The age at the vaccination was not applicable for this report. Till now patient didn't receive his second dose which led to incomplete course of vaccination. The reporter reported husband was not there to give consent however wife indicated that she does not think her husband would mind that she gave GlaxoSmithKline his doctor's contact information. Consented to follow up. This case is linked to the case US2021000076, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021000076:Same reporter
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Neck pain, Neuralgia, Pain in extremity
Clinical narrative: BLURRED VISION; NECK PAIN; JAW PAIN; NERVE PAIN; ARM PAIN; SHOULDER PAIN; HEADACHES; This spontaneous report received from a consumer concerned a 62 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 30-APR-2021, the subject experienced blurred vision. On 30-APR-2021, the subject experienced neck pain. On 30-APR-2021, the subject experienced jaw pain. On 30-APR-2021, the subject experienced nerve pain. On 30-APR-2021, the subject experienced arm pain. On 30-APR-2021, the subject experienced shoulder pain. On 30-APR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm pain, headaches, nerve pain, neck pain, shoulder pain, jaw pain, and blurred vision. This report was non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in jaw, Vision blurred
Clinical narrative: BLURRED VISION; NECK PAIN; JAW PAIN; NERVE PAIN; ARM PAIN; SHOULDER PAIN; HEADACHES; This spontaneous report received from a consumer concerned a 62 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported .The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 30-APR-2021, the subject experienced blurred vision. On 30-APR-2021, the subject experienced neck pain. On 30-APR-2021, the subject experienced jaw pain. On 30-APR-2021, the subject experienced nerve pain. On 30-APR-2021, the subject experienced arm pain. On 30-APR-2021, the subject experienced shoulder pain. On 30-APR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm pain, headaches, nerve pain, neck pain, shoulder pain, jaw pain, and blurred vision. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Arthralgia, Musculoskeletal stiffness, Pain in extremity, Pruritus
Clinical narrative: LOWER BACK STIFFNESS; ITCHY; LEFT FOOT PAIN; LEFT ANKLE PAIN KNEE PAIN AND JOINT PAIN; This spontaneous report received from a patient concerned a 48 year old female. The patient's weight was 200 pounds, and height was 65 inches. The patient's concurrent conditions included crohn's disease, alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no drug drug abuse or illicit drug use. The patient's mother had history of blood clots due to cancer and chemo. The patient experienced burning in mouth, redness face, stomach pain and tenderness when treated with clarithromycin, clindamycin, metronidazole for drug used for unknown indication, and itchy rash when treated with oxycodone for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: 09-JUL-2021) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. Concomitant medications included paracetamol for drug used for unknown indication, and mesalazine. On 01-APR-2021, the subject experienced left foot pain. On 01-APR-2021, the subject experienced left ankle pain knee pain and joint pain. Treatment medications included: ibuprofen. On 02-APR-2021, the subject experienced itchy. Laboratory data included: Antibody test (NR: not provided) negative. On 20-APR-2021, Laboratory data included: Antibody test (NR: not provided) negative. On MAY-2021, Laboratory data included: Ultrasound Doppler (NR: not provided) Negative for veinous thrombosis blood clots. On 03-MAY-2021, Laboratory data included: Antibody test (NR: not provided) negative. On 17-MAY-2021, the subject experienced lower back stiffness. On 20-MAY-2021, Laboratory data included: Antibody test (NR: not provided) negative. On 09-JUN-2021, treatment medications included: famotidine/ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itchy on 03-APR-2021, and had not recovered from left foot pain, lower back stiffness, and left ankle pain knee pain and joint pain. This report was non-serious. This case, from the same reporter is linked to 20210664067.