chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Nurse calls to report that GARDASIL 9 was stored improperly and administered; Information has been received from a nurse regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 29-JUL-2020, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis, lot number 1637651 with expiration date in 09-JUN-2022 (dose, route of administration, strength and anatomical location were not reported).  The hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was stored at a temperature range of 50 degrees Fahrenheit (°F) for the time frame of 1 hour and 46 minutes. There was no previous temperature excursion and the call was because of a data logger.  No additional adverse events were 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: 1637651; expirationdate: 09-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2008USA000266:
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE information; unspecified patients received doses of improperly stored vaccines; This spontaneous report was received from an office manager referring to unspecified patients of unknown age and unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On unknown dates, the patients were vaccinated with unknown improperly stored doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1621931 with expiration date 26-JAN-2022 (dose detail, frequency and route of administration were not reported) and improperly stored doses of hepatitis a vaccine, inactivated (VAQTA) lot # S025993 with expiration date 17-OCT-2020 (dose detail, frequency and route of administration were not reported), both for prophylaxis (product storage error). The vaccines were stored below 36 degrees Fahrenheit (F) (29.2 F) for 2 hours and 26 minutes. The previous temperature excursion included below 36 (33.9 F) for 51 minutes. The digital data logger was involved. No adverse effect was reported.  This case was determined to be non-valid as no patient identifiers.  Follow-up information has been received from the office manager on 31-JUL-2020 via a telephone call and fax referring to a 14-year-old female patient. On 04-MAR-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  This is one of five reports received from the same reporter. 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: 1621931; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2003USA002623:
Age: 51.0
Sex: U
Vaccine: VARZOS
Symptoms: Oropharyngeal pain
Clinical narrative: possible to get a sore throat; This case was reported by a consumer via call center representative and described the occurrence of sore throat in a 51-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th July 2020, the patient received the 2nd dose of Shingrix. In July 2020, less than a day after receiving Shingrix, the patient experienced sore throat. On an unknown date, the outcome of the sore throat was unknown.   It was unknown if the reporter considered the sore throat to be related to Shingrix.  Additional case details were reported as follows: On 28th July 2020 at night, the patient received 2nd dose of Shingrix. The patient asked is it possible to get a sore throat.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Hot flush, Malaise, Pain
Clinical narrative: malaise; Body aches; hot flashes; Reactions like chills; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 61-year-old female 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, general body pain, hot flashes and chills. The action taken with Shingrix was unknown. On an unknown date, the outcome of the malaise, general body pain, hot flashes and chills were recovered/resolved.   It was unknown if the reporter considered the malaise, general body pain, hot flashes and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving 1st dose of Shingrix, the patient experianced chills, malaise, body aches, and hot flashes. The reporter was consented to follow up. For the tolerance of 2nd dose, refer linked case US2020AMR148511.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR148511:Same patient
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: nurse gave three dose of Menactra to the patient, No AE; Initial information received on 28-Jul-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case involves a 17 years old female patient who received dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] on 04-Aug-2015, 29-Oct-2019 (lot number, expiry date and other dosing details not reported) and third dose, 0.5 mL, lot number: U658BA, expiry date: 20-Apr-2021 via an intramuscular route in the right deltoid on 28-Jul-2020 for prophylactic vaccination respectively.  The patient's medical history, past medical treatment, vaccination and family history were not provided. List of concomitant: none.  It was a case of an actual medication error case due to extra dose administered.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 18.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received Tennivac which was expired two days before/no AE; Initial information was received on 29-Jul-2020 regarding an unsolicited valid non-serious case received from a other health professional.   This case involves a 18 years old male patient who was vaccinated with 0.5 ml DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] which was already expired two days ago (batch number U6021AA and expiry date 27-JUL-2020) via intramuscular route in the left deltoid for prophylactic vaccination(expired product administered).  Vaccination(s) included TENIVAC (7 years ago). Medical history, medical treatment(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO) and MENZO for Immunisation.  It was an actual medication error case due to expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: RAB
Symptoms: Blood potassium increased
Clinical narrative: elevated potassium level; Initial information received on 30-Jul-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 24 year old female patient who experienced elevated potassium level (blood potassium increased), while she received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medication if any, not reported.   On 20-Jul-2020, the patient received a first dose of suspect RABIES (HDC) VACCINE [lot number and expiry date not reported] reported via an unknown route at an unknown administration site.   In Jul-2020, the patient experiences her elevated potassium level to 5.5 (blood potassium increased), 02 days following the administration of RABIES (HDC) VACCINE.  On 27-Jul-2020 she also received a second dose of suspect RABIES (HDC) VACCINE [lot number and expiry date not reported] reported via an unknown route at an unknown administration site. In Jul-2020, 2 days later her potassium level was 6.  It was reported that, doctor sent her to emergency and they tested her potassium level and it was 4.3.   Relevant laboratory test results included: Blood potassium - In July 2020:  [5.5] then [6] then [4.3]  Final diagnosis was blood potassium increased.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for blood potassium increased.  There will be no information available on the batch number for this case.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: Shivering, headache, body aches
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Injection site pain, Loss of personal independence in daily activities, Myalgia
Clinical narrative: intense, overall joint point (especially hands and jaw), lymph nodes on left side under jaw.  Overall fatigue and mild muscle pain.  Injection site pain.  Tylenol took the edge off pain, but  I was unable to perform normal tasks for a few days.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Nerve injury
Clinical narrative: Claims to have suffered nerve damage in her leg from vaccine
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Pharmacist reports patient received PNUMOVAX 23 and reported hives the next DAY; This spontaneous report was received from a pharmacist and refers to a 65-year-old female patient. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On approximately 28-JUL-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, dose number, lot #, expiration date, route of administration and anatomical location were not reported) for prophylaxis.  On the next day, on 29-JUL-2020, the patient experienced hives. The outcome of hives was unknown. The causality assessment between the event of hives and vaccination with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Product administered at inappropriate site, Pyrexia, Shoulder injury related to vaccine administration
Clinical narrative: Patient reports low grade fever and pain for a week and so went to her PCP who thought she had a reaction to the shot. Due to pain, she was referred to ortho and per the specialist, the pain was because the shot was given way high in the arm and too close to the shoulder bone. She is doing physical therapy. The injury is related to SIRVA.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient presented with redness and swelling below the vaccination site on her right arm only and swelling extended downward towards her elbow. It originally caused her pain due to the swelling, but at the time of the report, no longer was hurting. She was concerned about the swelling only at the time of the report. Patient consulted her doctor after the presentation at the pharmacy. Patient reported back that her doctor believed the swelling to be possibly due to a spider bite instead of a side effect of the vaccination. Patient was prescribed Bactrim DS with directions of 1 tablet twice daily for a 10 day treatment.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Ascites, Autopsy, Death, Decreased interest, Intestinal infarction
Clinical narrative: Per report by mother, infant stopped showing interest in eating approximately 6 hours after immunizations. Infant was pronounced deceased on March 08, 2019.   Preliminary Anatomic Findings: 1.) Ischemic bowel in distribution of superior mesenteric artery 2.) Depleted intravascular blood volume 3.) Mild ascites Cause of Death: Infarcted bowel due to mesenteric artery occlusion
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Intestinal ischaemia, Mesenteric arterial occlusion, Volume blood decreased
Clinical narrative: Per report by mother, infant stopped showing interest in eating approximately 6 hours after immunizations. Infant was pronounced deceased on March 08, 2019.   Preliminary Anatomic Findings: 1.) Ischemic bowel in distribution of superior mesenteric artery 2.) Depleted intravascular blood volume 3.) Mild ascites Cause of Death: Infarcted bowel due to mesenteric artery occlusion
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Right after I received vaccine I started feeling pain in my left arm.  Pain did not go away after 2 weeks. I waited with hope it will go away but instead it got worse.  I visited my doctor in January 2020 who recommended to take Advil or Alive to help with pain an the swollen.   I started Physical therapy sections but after 6 visits I contacted my doctor again because I was with the same pain and continued being unable to stretch out my arm.  The doctor recommended I get an MRI which attended to get it done.  I could not get it done.  During the time I was attending to get an MRI, the coronavirus pandemic started so I stopped pursuing medical help. I still have the pain and I cannot extend my arm.
Age: 12.0
Sex: M
Vaccine: PPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Pt was given a wrong vaccine.   No symptoms noted when pt left.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: Wrong imm given..should have given Quadracel
Age: 20.0
Sex: M
Vaccine: HPV4, MENB
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Rapid COVID-19: Negative. He had meningitis B vaccine and HPV vaccine yesterday -- discussed that he is likely having a reaction to one or both of these. He states his mother told him he used to have reactions to vaccines when he was younger as well. No signs of an anaphylactic or localized reaction. ER precautions reviewed at length. Advised him to rest, stay well hydrated, bland snacks/meals throughout the day, alternate ibuprofen/Tylenol per manufacturer's instructions. Notify us tomorrow of how he is feeling. If sx's persist/worsen/new sx's arise, discussed having him re-tested for COVID-19. He took today off work and may need to be off tomorrow as well. He declines needing a work note. He should be fever free for 24 hours before returning.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: tiredness; muscle aches; fever; This case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th July 2020, the patient received Shingrix. In July 2020, less than a day after receiving Shingrix, the patient experienced tiredness, muscle pain and fever. On an unknown date, the outcome of the tiredness, muscle pain and fever were not recovered/not resolved.   It was unknown if the reporter considered the tiredness, muscle pain and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as per vaccine indication. The patient had a Shingrix vaccination day before reporting in the evening and experienced muscle aches, tiredness and fever.  The patient asked how long should these symptoms last.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Insomnia, Pain, Pain in extremity
Clinical narrative: stomach pain; goosebumps.on scalp; made my.palm very very itchy.plus my ear and ankle/next day itchy; didn't sleep; sore arm; sore; no energy; This case was reported by a consumer and described the occurrence of stomach pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 8 years ago).   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced stomach pain, goose flesh, itchy skin, sleeplessness, pain in arm, pain and energy decreased. On an unknown date, the outcome of the stomach pain, goose flesh, itchy skin, sleeplessness, pain in arm, pain and energy decreased were unknown.   It was unknown if the reporter considered the stomach pain, goose flesh, itchy skin, sleeplessness, pain in arm, pain and energy decreased to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had goosebumps, very itchy in ear and ankle. The patient did not sleep because of stomach pain and sore arm. The patient had itchy, sore and no energy The patient was afraid to take another one in 2 months and should heard take another one.
Sex: U
Vaccine: VARZOS
Symptoms: Piloerection, Pruritus
Clinical narrative: stomach pain; goosebumps.on scalp; made my.palm very very itchy.plus my ear and ankle/next day itchy; didn't sleep; sore arm; sore; no energy; This case was reported by a consumer and described the occurrence of stomach pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 8 years ago).   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced stomach pain, goose flesh, itchy skin, sleeplessness, pain in arm, pain and energy decreased. On an unknown date, the outcome of the stomach pain, goose flesh, itchy skin, sleeplessness, pain in arm, pain and energy decreased were unknown.   It was unknown if the reporter considered the stomach pain, goose flesh, itchy skin, sleeplessness, pain in arm, pain and energy decreased to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had goosebumps, very itchy in ear and ankle. The patient did not sleep because of stomach pain and sore arm. The patient had itchy, sore and no energy The patient was afraid to take another one in 2 months and should heard take another one.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Blindness
Clinical narrative: that the patient was blind [could not see]./he office stating the patient went blind.; This case was reported by a physician via sales rep and described the occurrence of blind in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA68AA, expiry date unknown) for prophylaxis.   On 29th July 2020 14:30, the patient received the 2nd dose of Bexsero (intramuscular). On 29th July 2020, less than an hour after receiving Bexsero, the patient experienced blind (serious criteria GSK medically significant). On an unknown date, the outcome of the blind was unknown.   It was unknown if the reporter considered the blind to be related to Bexsero.  Additional details were provided as follows: The patient received dose of Bexsero on 29th July 2020 at approximately 14:30 and the patient's father called at approximately 15:30 to the office starting that the patient was blind. The patient was taken to the emergency room and administering physician was consulting with neurologist. The patient was not administered other medication at the time of visit.
Sex: U
Vaccine: VARZOS
Symptoms: Oropharyngeal pain
Clinical narrative: Is it possible to get a sore throat from it.; This case was reported by a consumer via interactive digital media and described the occurrence of sore throat in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On 28th July 2020, the patient received the 2nd dose of Shingrix. In July 2020, less than a week after receiving Shingrix, the patient experienced sore throat. On an unknown date, the outcome of the sore throat was unknown.   It was unknown if the reporter considered the sore throat to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received Shingrix and asked whether it was possible to develop a sore throat from it. No other information was reported.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Flank pain, Musculoskeletal chest pain, Myalgia, Pyrexia
Clinical narrative: sharp pain in my rib cage; flank pain; fever of 100.9; chills; muscle aches; This case was reported by a consumer via call center representative and described the occurrence of rib 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 musculoskeletal chest pain (received 1st dose on 12th May 2020, refer case US2020147948).   On 13th July 2020, the patient received the 2nd dose of Shingrix. On 14th July 2020, 1 days after receiving Shingrix, the patient experienced fever. In July 2020, the patient experienced chills and muscle pain. On an unknown date, the patient experienced rib pain and flank pain. The patient was treated with paracetamol (Tylenol Extra Strength). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the rib pain, chills, muscle pain and flank pain were unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the rib pain, fever, chills, muscle pain and flank pain to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient.  The patient received Shingrix in the right arm and had this sharp pain in my rib cage inside the right flank.  The patient reported that the pain was always on the right side for both doses. The patient had a fever of 100.9 that started the next day following the injection and went up to 101.9 and it lasted 4 to 5 hours.  The patient took Tylenol Extra Strength for the fever and reported having chills and general muscle ache. The reporter consented to follow up. The patient got the injections at his pharmacy and they had this information.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020147948:same reporter
Sex: F
Vaccine: MNQ
Symptoms: Fatigue, Heart rate increased, Injection site pain, Pyrexia
Clinical narrative: She also experience fever 100.8; had anyone experience heart rate on higher side of normal; soreness at site; fatigue; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced fever, heart rate increased, injection site pain and fatigue. On an unknown date, the outcome of the fever, heart rate increased, injection site pain and fatigue were unknown.   It was unknown if the reporter considered the fever, heart rate increased, injection site pain and fatigue to be related to Menveo.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced heart rate on higher side of normal.  The patient also had fever 100.8 degree F,soreness at injection site and fatigue. No other information was reported.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Hot flush, Injection site pain, Injection site warmth
Clinical narrative: pain at the site of injection which radiates/site of injection is still warm and painful; warmth is located mid position/site of injection is still warm and painful; body aches; chills; malaise; tiredness; hot flashes; temperature as high as 101.; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of pyrexia (received 1st dose on unknown date, refer case US2020148012).   On 19th July 2020, the patient received the 2nd dose of Shingrix (intramuscular). In July 2020, less than 2 weeks after receiving Shingrix, the patient experienced injection site warmth, general body pain, chills, malaise, tiredness, hot flashes and fever. On 19th July 2020, the patient experienced injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and injection site warmth were not recovered/not resolved and the outcome of the general body pain, chills, malaise, tiredness, hot flashes and fever were unknown.   It was unknown if the reporter considered the injection site pain, injection site warmth, general body pain, chills, malaise, tiredness, hot flashes and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her left deltoid and within 6 hours she started to have pain at the site of injection which radiates.  The pain and warmth was located mid position between the elbow and shoulder around the site of the injection.  The site of injection was still warm and painful.  The patient also reported body aches, malaise, tiredness, hot flashes, chills, and temperature as high as 101. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020148012:same reporter US-GLAXOSMITHKLINE-US2020148012:Same patient
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: pain at the site of injection which radiates/site of injection is still warm and painful; warmth is located mid position/site of injection is still warm and painful; body aches; chills; malaise; tiredness; hot flashes; temperature as high as 101.; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of pyrexia (received 1st dose on unknown date, refer case US2020148012).   On 19th July 2020, the patient received the 2nd dose of Shingrix (intramuscular). In July 2020, less than 2 weeks after receiving Shingrix, the patient experienced injection site warmth, general body pain, chills, malaise, tiredness, hot flashes and fever. On 19th July 2020, the patient experienced injection site pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and injection site warmth were not recovered/not resolved and the outcome of the general body pain, chills, malaise, tiredness, hot flashes and fever were unknown.   It was unknown if the reporter considered the injection site pain, injection site warmth, general body pain, chills, malaise, tiredness, hot flashes and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her left deltoid and within 6 hours she started to have pain at the site of injection which radiates.  The pain and warmth was located mid position between the elbow and shoulder around the site of the injection.  The site of injection was still warm and painful.  The patient also reported body aches, malaise, tiredness, hot flashes, chills, and temperature as high as 101. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020148012:same reporter US-GLAXOSMITHKLINE-US2020148012:Same patient
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: i have a headache today; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2020, the patient received the 1st dose of Shingrix. On 30th July 2020, 1 days after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was unknown.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient received Shingrix the day before reporting and experienced headache on reporting date.
Age: 63.0
Sex: U
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2020, the patient received the 1st dose of Shingrix. On 30th July 2020, 1 days after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had headache. The reporter asked how long would headache last.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Pain, Pain in extremity, Tenderness
Clinical narrative: red area around the injection site; area is a little itchy; arm was a little sore; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th July 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 28th July 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 29th July 2020, the patient experienced injection site erythema and injection site itching. On an unknown date, the outcome of the injection site erythema and injection site itching were not recovered/not resolved and the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the injection site erythema, injection site itching and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix around noon and her arm was a little sore when she moved it or pressed down on the area.   The soreness improved but there was a red area around the injection site that was about three inches in diameter.   The area was a little itchy but not so bad that she must scratch it. The reporter did not consent to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea
Clinical narrative: Nausea; Headache; This case was reported by a other health professional via call center representative and described the occurrence of nausea in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced nausea and headache. On an unknown date, the outcome of the nausea and headache were recovered/resolved.   It was unknown if the reporter considered the nausea and headache to be related to Shingrix.  Additional details were reported as follows: The nausea and headache completely resolved within 24 hours. The reporter consented to follow up. HCP could not provide lot number or expiration date of product.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles 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 shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. No vaccines data and no patient data were provided. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and developed shingles. The reporter consented to follow up.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, IPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: inadvertently administered Ipol and Quadracel to a 6-year-old patient/ double dose of IPOL/ no AE; Initial information received on 30-Jul-2020 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a six-year-old male patient who was inadvertently administered a 0.5 mL single dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot D93B4 and expiration date: 14-Jun-2021) and POLIOMYELITIS VACCINE (INACTIVATED) [IPOL] (lot P1E170 and expiration date: 11-Sep-2020) via an unknown route at an unknown administration site for prophylactic vaccination on 30-Jul-2020.  Medical history, medical treatment, vaccination, concomitant therapy and family history were not provided.  It was an actual medication error case due to extra dose administered. It was reported that the reporter had inadvertently administered a double dose of IPV.  At the time of this report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Fall, Head injury, Loss of consciousness, Nasal injury, Neurological examination normal
Clinical narrative: Patient received 4 IM injections with no notable occurrence at the time of administration.  Approximately 10 minutes following vaccination, patient lost consciousness while seated, falling forward and striking her forehead/nose.  She did not have syncopal convulsions.  She was without consciousness for 4-5 seconds.  Upon awakening, patient was able to verbalize the events preceding the syncopal episode.  She was lucid, A and O x 3.  She had no loss of memory immediately preceding or subsequent to the syncopal event.  She had no nausea, vomiting, lethargy, visual disturbance.  Neurological exam was normal.  She was further monitored for a 10 minute time frame during which she had no change in physical exam or symptoms.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Syncope
Clinical narrative: Patient received 4 IM injections with no notable occurrence at the time of administration.  Approximately 10 minutes following vaccination, patient lost consciousness while seated, falling forward and striking her forehead/nose.  She did not have syncopal convulsions.  She was without consciousness for 4-5 seconds.  Upon awakening, patient was able to verbalize the events preceding the syncopal episode.  She was lucid, A and O x 3.  She had no loss of memory immediately preceding or subsequent to the syncopal event.  She had no nausea, vomiting, lethargy, visual disturbance.  Neurological exam was normal.  She was further monitored for a 10 minute time frame during which she had no change in physical exam or symptoms.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Patient, was administered a meningococcal vaccine by Medical Assistant.  the patient had already received a meningococcal vaccine on 04/28/2020.  Neither Medical Assistants verified the vaccines needed through Agency.  This resulted in an unnecessary vaccine given to the patient.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Scab, Skin lesion
Clinical narrative: > 50 Pruritus lesions all over body. Appeared 8 days after vaccine. No fever. No other problems. Todays date they are starting to crust over.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Pt. spiked fever up to 104 this AM; she then had afebrile seizure. Mother arrived @ home and fever was 105.1. The gave dosage of motrin with improved oral intake and resolution of fever
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Arthralgia, Blood glucose abnormal, Fall, Lip injury, Memory impairment
Clinical narrative: 1110: Pt was sitting on table at time of shots, completely alert and oriented. After giving the Bexsero in the Left Deltoid, I turned around to discard the needle and the Pt fell to the floor. Pt not responding to me calling his name. Pt shaking. Pt began responding to me about 30 seconds later. Pt stood up and then laid down on the table, now alert and oriented again but states he does not remember falling. Dr. notified and states to check vital signs and blood sugar. Pt brother in room with him states that he has not eaten today. 1114:  BP 118/68, Pulse 100, Pulse Ox 100%, and fingerstick 112. Pt now complaining of Right knee pain and has a left upper lip abrasion from the fall. 1126: Pt sitting in chair with mom and brother. Pt eating a snack and drinking water.Pt states he feels better now. 1155: Dr. states she is just keeping an eye on him. 1243: Pt leaves with mom and brother.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: 1110: Pt was sitting on table at time of shots, completely alert and oriented. After giving the Bexsero in the Left Deltoid, I turned around to discard the needle and the Pt fell to the floor. Pt not responding to me calling his name. Pt shaking. Pt began responding to me about 30 seconds later. Pt stood up and then laid down on the table, now alert and oriented again but states he does not remember falling. Dr. notified and states to check vital signs and blood sugar. Pt brother in room with him states that he has not eaten today. 1114:  BP 118/68, Pulse 100, Pulse Ox 100%, and fingerstick 112. Pt now complaining of Right knee pain and has a left upper lip abrasion from the fall. 1126: Pt sitting in chair with mom and brother. Pt eating a snack and drinking water.Pt states he feels better now. 1155: Dr. states she is just keeping an eye on him. 1243: Pt leaves with mom and brother.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Ear discomfort, Hypoacusis, Injection site swelling, Tinnitus
Clinical narrative: DTaP shot/booster for tetanus administered in the left shoulder.  That night while I was sleeping my left ear became plugged and hard to hear out of.   My left ear remained plugged and was ringing the next day.  I took a recommended dose of Sudafed, Mucinex, and Benedril at recommended times.  The injection site was swollen (approximately 3 inches in diameter) but not red.  The next day my left ear was still ringing and it is still ringing, but the plugged feeling has subsided.
Age: 41.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Hep B vaccine given on 8/3. Patient seen in office on 8/5. Patient's arm red and warm at area of injection site. Red area measures 9cm wide by 16cm long. Patient reports itching.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Cold sweat, Dizziness, Paraesthesia
Clinical narrative: approx. 5 mins after receiving vaccine, patient began complaining of weakness, lightheadedness, and right arm tingling. Patient was clammy
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Acidosis, Acute kidney injury, Alanine aminotransferase normal, Aspartate aminotransferase normal, Bacterial test negative
Clinical narrative: Severe gastroenteritis resulting in severe dehydration, hyponatremia, hypokalemia, hypochloremia, prolonged QT interval, acute kidney injury, and acidosis.  Required hospitalization for rehydration.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Blood alkaline phosphatase normal, Blood bicarbonate normal, Blood bilirubin normal, Blood chloride normal, Blood creatinine increased
Clinical narrative: Severe gastroenteritis resulting in severe dehydration, hyponatremia, hypokalemia, hypochloremia, prolonged QT interval, acute kidney injury, and acidosis.  Required hospitalization for rehydration.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Blood glucose increased, Blood potassium decreased, Blood sodium decreased, Blood urea increased, C-reactive protein increased
Clinical narrative: Severe gastroenteritis resulting in severe dehydration, hyponatremia, hypokalemia, hypochloremia, prolonged QT interval, acute kidney injury, and acidosis.  Required hospitalization for rehydration.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Clostridium test negative, Culture stool negative, Dehydration, Electrocardiogram QT prolonged, Electrolyte imbalance
Clinical narrative: Severe gastroenteritis resulting in severe dehydration, hyponatremia, hypokalemia, hypochloremia, prolonged QT interval, acute kidney injury, and acidosis.  Required hospitalization for rehydration.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Faecal calprotectin increased, Gastroenteritis, Haematocrit normal, Haemoglobin normal, Helicobacter test negative
Clinical narrative: Severe gastroenteritis resulting in severe dehydration, hyponatremia, hypokalemia, hypochloremia, prolonged QT interval, acute kidney injury, and acidosis.  Required hospitalization for rehydration.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Hypochloraemia, Hypokalaemia, Hyponatraemia, Lipase normal, Nitrite urine absent
Clinical narrative: Severe gastroenteritis resulting in severe dehydration, hyponatremia, hypokalemia, hypochloremia, prolonged QT interval, acute kidney injury, and acidosis.  Required hospitalization for rehydration.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Occult blood negative, Parasite stool test negative, Platelet count increased, Respiratory viral panel, Specific gravity urine decreased
Clinical narrative: Severe gastroenteritis resulting in severe dehydration, hyponatremia, hypokalemia, hypochloremia, prolonged QT interval, acute kidney injury, and acidosis.  Required hospitalization for rehydration.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Urine leukocyte esterase positive, White blood cell count abnormal, pH urine normal
Clinical narrative: Severe gastroenteritis resulting in severe dehydration, hyponatremia, hypokalemia, hypochloremia, prolonged QT interval, acute kidney injury, and acidosis.  Required hospitalization for rehydration.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effect reported; expired ROTATEQ was administered to a patient; This spontaneous report was received from a nurse and refers to a 2-months-old patient of unknown gender. No information regarding the concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 20-JUL-2020, the patient was vaccinated orally with expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 1 oral vaccine, lot # R033256, expiration date: 23-JUN-2020 for prevention of rotavirus.  No temperature excursion occurred. No additional adverse effect reported.
Sex: F
Vaccine: MENB
Symptoms: Erythema, Headache, Swelling
Clinical narrative: Redness; Swelling; Headache; This case was reported by a physician via sales rep and described the occurrence of erythema in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced erythema, swelling and headache. On an unknown date, the outcome of the erythema, swelling and headache were unknown.   It was unknown if the reporter considered the erythema, swelling and headache to be related to Bexsero.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced redness, swelling, and headache that persisted for a few days. The reporter did not agreed to follow up with GlaxoSmithKline
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Influenza like illness, Myalgia
Clinical narrative: symptoms like having the flu but without a fever; extreme Tiredness; Headache; muscle aches throughout entire body; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date).   On 29th July 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 30th July 2020, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms, tiredness, headache and muscle pain. On an unknown date, the outcome of the influenza-like symptoms, tiredness, headache and muscle pain were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, tiredness, headache and muscle pain to be related to Shingrix.  Additional case details were reported as follows: The patient experienced next day after vaccination headache followed by muscle aches throughout entire body and then extreme tiredness towards the end of the day.  The patient described symptoms like having the flu but without a fever. The reporter consent to follow up.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash, Pain in extremity, Rash
Clinical narrative: rash below the injection site; arm sore; This case was reported by a consumer via call center representative and described the occurrence of rash in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2020, the patient received the 1st dose of Shingrix (intramuscular). On 29th July 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 31st July 2020, the patient experienced rash. On an unknown date, the outcome of the rash was unknown and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the rash and pain in arm to be related to Shingrix.  Additional case details were reported as follows: The patient received 1st dose of Shingrix at an unspecified pharmacy.  The patient experienced 2days after vaccination injection site rash sore arm that was still continuing at the time of reporting.  The patient also reports a small rash below the injection site.