chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MNQ
Symptoms: Cellulitis, Extensive swelling of vaccinated limb, Injection site erythema, Injection site swelling
Clinical narrative: Cellulitis; arm swollen; Redness in the Injection site; Swelling in the Injection site; This case was reported by a other health professional via call center representative and described the occurrence of cellulitis in a 16-year-old patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA201A, expiry date 30th October 2020), (batch number AMVA206A, expiry date 13th November 2020) and (batch number AMVA323A, expiry date 31st March 2020) for prophylaxis.   On 11th August 2020, the patient received Menveo. In August 2020, less than a day after receiving Menveo, the patient experienced cellulitis (serious criteria GSK medically significant), extensive swelling of vaccinated limb, injection site erythema and injection site swelling. On an unknown date, the outcome of the cellulitis, extensive swelling of vaccinated limb, injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the cellulitis, extensive swelling of vaccinated limb, injection site erythema and injection site swelling to be related to Menveo.  Additional details were provided as follows: It was reported that, several patients had been experiencing redness and swelling in the injection site, whole arm swollen and cellulitis after receiving a dose of Menveo.  The symptoms were started within hours. The reporter was consented to follow up. The reporter did not know how many patients experienced the symptoms but agreed to follow up and look up the information.  The reporter only reported that one patient was 11 years old and other was 16 years old.  She reported 3 different lot numbers and expiration dates for the vaccines administered to different patients.  She had those details in hand because she was worried that the side effects were due to a lot issue. This was 1 of 3 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020159650:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Incomplete course of vaccination, Pyrexia, Tremor
Clinical narrative: fever; He was shivering/shaking; He was shivering/shaking; He was shivering/shaking and was cold; This case was reported by a consumer via call center representative and described the occurrence of fever in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced fever, shivering, tremor and cold. Shingrix was discontinued. On an unknown date, the outcome of the fever, shivering, tremor and cold were recovered/resolved.   The reporter considered the fever to be related to Shingrix. It was unknown if the reporter considered the shivering, tremor and cold to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the wife. The reporter would not provide an email address and did not have a personal fax number.  The patient received Shingrix about 2 years ago. The reporter would not give his exact date of birth.  The patient received Shingrix and woke up in the middle of that night with a fever.  The patient was shivering, shaking and was cold. The reporter did not know the exact temperature because it was so long ago but thinks it might had been 102-103 degrees.  The reporter stated that due to this side effect he never went back for the second shot of the series and does not plan to.  No further information was collected due to reporter reluctance and the fact that the first shot was 2 years ago. The reporter did not consent to follow up. The reporter did not want to share MD contact information. This case linked with US2020159657, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020159657:Same reporter
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: chills; fatigue; headache; body aches; fever was 99.8 the first time it presented; arm soreness; This case was reported by a consumer via call center representative and described the occurrence of chills in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2020, the patient received the 2nd dose of Shingrix. On 30th July 2020, 1 days after receiving Shingrix, the patient experienced chills, fatigue, headache, general body pain, fever and pain in arm. On an unknown date, the outcome of the chills, fatigue, headache, general body pain and fever were not recovered/not resolved and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the chills, fatigue, headache, general body pain, fever and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and chills, fatigue, headache, general body pain, fever was 99.8 the first time it presented.  The arm soreness resolved in one day.   All other symptoms were still present and come and go but had not resolved. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020159668:Same reporter
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: chills; fatigue; headache; body aches; fever was 99.8 the first time it presented; arm soreness; This case was reported by a consumer via call center representative and described the occurrence of chills in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2020, the patient received the 2nd dose of Shingrix. On 30th July 2020, 1 days after receiving Shingrix, the patient experienced chills, fatigue, headache, general body pain, fever and pain in arm. On an unknown date, the outcome of the chills, fatigue, headache, general body pain and fever were not recovered/not resolved and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the chills, fatigue, headache, general body pain, fever and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and chills, fatigue, headache, general body pain, fever was 99.8 the first time it presented.  The arm soreness resolved in one day.   All other symptoms were still present and come and go but had not resolved. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020159668:Same reporter
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Cough, Fatigue, Pain, Pain in extremity
Clinical narrative: dry cough; body aches; fatigue; fever was 98.9.; chills; arm soreness; This case was reported by a consumer via call center representative and described the occurrence of dry cough in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2020, the patient received the 2nd dose of Shingrix. On 30th July 2020, 1 days after receiving Shingrix, the patient experienced dry cough, general body pain, fatigue, fever, chills and pain in arm. On an unknown date, the outcome of the dry cough, fatigue, fever, chills and pain in arm were not recovered/not resolved and the outcome of the general body pain was recovered/resolved.   It was unknown if the reporter considered the dry cough, general body pain, fatigue, fever, chills and pain in arm to be related to Shingrix.  Additional case details were reported as follows: The reporter was the patient's wife.  On 30th July 2020 morning, the patient woke up with all symptoms.  The fever was 98.9. The arm soreness resolved in one day. All other symptoms still present at the time of reporting. The reporter consent to follow up. This case has been linked with wife case US2020159662 and US2020AMR160214, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020159662:Same reporter US-GLAXOSMITHKLINE-US2020AMR160214:Same reporter
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: dry cough; body aches; fatigue; fever was 98.9.; chills; arm soreness; This case was reported by a consumer via call center representative and described the occurrence of dry cough in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2020, the patient received the 2nd dose of Shingrix. On 30th July 2020, 1 days after receiving Shingrix, the patient experienced dry cough, general body pain, fatigue, fever, chills and pain in arm. On an unknown date, the outcome of the dry cough, fatigue, fever, chills and pain in arm were not recovered/not resolved and the outcome of the general body pain was recovered/resolved.   It was unknown if the reporter considered the dry cough, general body pain, fatigue, fever, chills and pain in arm to be related to Shingrix.  Additional case details were reported as follows: The reporter was the patient's wife.  On 30th July 2020 morning, the patient woke up with all symptoms.  The fever was 98.9. The arm soreness resolved in one day. All other symptoms still present at the time of reporting. The reporter consent to follow up. This case has been linked with wife case US2020159662 and US2020AMR160214, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020159662:Same reporter US-GLAXOSMITHKLINE-US2020AMR160214:Same reporter
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza, Oral mucosal blistering
Clinical narrative: Giant blister inside of her mouth; Flu symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of blistering of mouth in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th February 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced blistering of mouth and flu symptoms. On an unknown date, the outcome of the blistering of mouth and flu symptoms were unknown.   It was unknown if the reporter considered the blistering of mouth and flu symptoms to be related to Shingrix.  Additional details were reported as follows: The patient after receiving the first dose of Shingrix experienced flu symptoms and had a giant blister inside of her mouth. The reporter consented to follow up. No vaccines data.
Age: 16.0
Sex: U
Vaccine: MENB
Symptoms: Erythema, Fatigue, Injection site erythema, Injection site pain, Local reaction
Clinical narrative: generalized myalgia; fatigue; low grade temps like 100-101/Low grade fever; A pretty severe local reaction, red, very tender, swollen arms, diffuse symptoms; A pretty severe local reaction, red, very tender, swollen arms, diffuse symptoms; A pretty severe local reaction, red, very tender, swollen arms, diffuse symptoms; This is a spontaneous report from a contactable physician. This physician reported similar events for 3 patients.  This is the first of three reports.  A 16-year-old patient of unspecified gender received first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at 0.5 mL, single for immunization/routine vaccination for 16-year-old. Medical history included confirmed COVID-19 months prior and recovered. There were no concomitant medications. The patient had significant systemic  reaction to his/her first dose of meningococcal group b rlp2086. On Aug2020, the patient had generalized myalgia, fatigue, low grade fever with low grade temps like 100-101. The patient also experienced severe local reactions with pain, redness at site also described as a pretty severe local reaction, red, very tender, swollen arms, diffuse symptoms. The events were reported as medically significant. The patient recovered from the events in Aug2020.  The physician considered the events to be related to meningococcal group b rlp2086.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided the Company (Pfizer) cannot exclude that the suspect medication may have contributed to the reported events in this patient. The impact of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-2020315027 same reporter,suspect drug and adverse events in different patient;US-PFIZER INC-2020315028 same reporter,suspect drug and adverse events in different patient
Age: 16.0
Sex: U
Vaccine: MENB
Symptoms: Myalgia, Peripheral swelling, Pyrexia, SARS-CoV-2 test positive, Tenderness
Clinical narrative: generalized myalgia; fatigue; low grade temps like 100-101/Low grade fever; A pretty severe local reaction, red, very tender, swollen arms, diffuse symptoms; A pretty severe local reaction, red, very tender, swollen arms, diffuse symptoms; A pretty severe local reaction, red, very tender, swollen arms, diffuse symptoms; This is a spontaneous report from a contactable physician. This physician reported similar events for 3 patients.  This is the first of three reports.  A 16-year-old patient of unspecified gender received first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at 0.5 mL, single for immunization/routine vaccination for 16-year-old. Medical history included confirmed COVID-19 months prior and recovered. There were no concomitant medications. The patient had significant systemic  reaction to his/her first dose of meningococcal group b rlp2086. On Aug2020, the patient had generalized myalgia, fatigue, low grade fever with low grade temps like 100-101. The patient also experienced severe local reactions with pain, redness at site also described as a pretty severe local reaction, red, very tender, swollen arms, diffuse symptoms. The events were reported as medically significant. The patient recovered from the events in Aug2020.  The physician considered the events to be related to meningococcal group b rlp2086.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information provided the Company (Pfizer) cannot exclude that the suspect medication may have contributed to the reported events in this patient. The impact of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate,Linked Report(s) : US-PFIZER INC-2020315027 same reporter,suspect drug and adverse events in different patient;US-PFIZER INC-2020315028 same reporter,suspect drug and adverse events in different patient
Age: 16.0
Sex: U
Vaccine: MENB
Symptoms: Erythema, Fatigue, Injection site erythema, Injection site pain, Local reaction
Clinical narrative: severe local reactions with pain/A pretty severe local reaction, red, very tender, swollen arms, diffuse symptoms; redness at site/A pretty severe local reaction, red, very tender, swollen arms, diffuse symptoms; A pretty severe local reaction, red, very tender, swollen arms, diffuse symptoms; Low grade fever/low grade temps like 100-101; fatigue; myalgias/generalized myalgia; This is a spontaneous report from a contactable physician. This physician reported similar events for 3 patients.  This is 3rd of 3 reports.  A 16-year-old patient of unspecified gender received the first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at 0.5 mL, single for immunization/routine vaccination for 16-year-old. The patient had no medical history. There were no concomitant medications.  The patient had significant systemic reactions to his/her first dose of meningococcal group b rlp2086. The patient had generalized myalgia, fatigue, low grade fever with low grade temps like 100-101. The patient also experienced severe local reactions with pain, redness at site also described as a pretty severe local reaction, red, very tender, swollen arms, diffuse symptoms. The patient was tested at the time of the reaction and was COVID negative. These reactions all occurred in the last week (Aug2020). The physician considered the events to be serious (medically significant). The patient had recovered completely in Aug2020. The physician considered the events to be related to meningococcal group b rlp2086. The information on the batch number has been requested.; Sender's Comments: Based on the information provided the Company (Pfizer) cannot exclude that the suspect medication may have contributed to the reported events in this patient. The impact of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020315027 same reporter,suspect drug and adverse events in different patient;US-PFIZER INC-2020314784 same reporter,suspect drug and adverse events in different patient
Age: 16.0
Sex: U
Vaccine: MENB
Symptoms: Myalgia, Peripheral swelling, Pyrexia, SARS-CoV-2 test negative, Tenderness
Clinical narrative: severe local reactions with pain/A pretty severe local reaction, red, very tender, swollen arms, diffuse symptoms; redness at site/A pretty severe local reaction, red, very tender, swollen arms, diffuse symptoms; A pretty severe local reaction, red, very tender, swollen arms, diffuse symptoms; Low grade fever/low grade temps like 100-101; fatigue; myalgias/generalized myalgia; This is a spontaneous report from a contactable physician. This physician reported similar events for 3 patients.  This is 3rd of 3 reports.  A 16-year-old patient of unspecified gender received the first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at 0.5 mL, single for immunization/routine vaccination for 16-year-old. The patient had no medical history. There were no concomitant medications.  The patient had significant systemic reactions to his/her first dose of meningococcal group b rlp2086. The patient had generalized myalgia, fatigue, low grade fever with low grade temps like 100-101. The patient also experienced severe local reactions with pain, redness at site also described as a pretty severe local reaction, red, very tender, swollen arms, diffuse symptoms. The patient was tested at the time of the reaction and was COVID negative. These reactions all occurred in the last week (Aug2020). The physician considered the events to be serious (medically significant). The patient had recovered completely in Aug2020. The physician considered the events to be related to meningococcal group b rlp2086. The information on the batch number has been requested.; Sender's Comments: Based on the information provided the Company (Pfizer) cannot exclude that the suspect medication may have contributed to the reported events in this patient. The impact of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020315027 same reporter,suspect drug and adverse events in different patient;US-PFIZER INC-2020314784 same reporter,suspect drug and adverse events in different patient
Age: 0.17
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: administered an expired Pentacel to patient this morning and the expiration date is 19May2018; Initial information received on 26-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 months old patient who experienced administered an expired pentacel to patient this morning and the expiration date is 19may2018, while he/she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  On an unknown date, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5339AA, expiry date- 19-May-2018 via intramuscular route in left thigh.  The patient developed a non-serious administered an expired pentacel to patient this morning and the expiration date is 19may2018 (expired product administered) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  (Other relevant tests included No lab data.) Final diagnosis was administered an expired pentacel to patient this morning and the expiration date is 19-May-2018.    It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Not Applicable for administered an expired pentacel to patient this morning and the expiration date is 19may2018.  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: 21.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: This patient received the .05 ml invalid Fluzone Quadrivalent, no AE; Fluzone Quad were administered after being exposed to 30 Farenheit, no AE; Initial information received on 11-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional  This case involves a 21 years old female patient who received the .05 ml invalid INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]( lot number not reported and expiration date: Aug-2020), after being exposed to 30 Fahrenheit via unknown route in the left deltoid as prophylactic vaccination on 08-Aug-2020.  Medical history, medical treatment(s), and family history were not provided.  No other medication or vaccinations were received on this visit.   It was an actual medication error case due to product storage error temperature too low.  It was also a case of vaccine underdose.  No adverse event reported at the time of reporting.  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.  There will be no information on the batch number for this case.
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: several episodes of nausea; dizziness; vomiting; Initial information received on 11-Aug-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 72-year-old female patient who experienced several episodes of nausea (nausea), dizziness and vomiting, while she received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  The patient's medical history, past medical treatment, past vaccination and family history were not provided. Concomitant medication were not reported.  On 11-Aug-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On 11-Aug-2019, the patient developed a non-serious several episodes of nausea (nausea) several hours following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  On an unknown date, the patient developed non-serious dizziness and vomiting (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Laboratory details were not reported.  It was not reported if the patient received any corrective treatment.  The patient recovered from nausea and the event outcome was unknown for vomiting and dizziness.  There will be no information available on batch number for this case.
Age: 34.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Loss of personal independence in daily activities, Myalgia
Clinical narrative: These symptoms occurred after both treatments with the second dose feelings just as severe as the first.   Extreme fatigue, wide spread muscle soreness especially in my back, nausea, fever, chills (can?t get warm but have a slight fever of 99.9 degrees). My symptoms are flu like and prevent me from functioning through normal activities such as walking beyond short distances and standing for short periods of time.
Age: 34.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: These symptoms occurred after both treatments with the second dose feelings just as severe as the first.   Extreme fatigue, wide spread muscle soreness especially in my back, nausea, fever, chills (can?t get warm but have a slight fever of 99.9 degrees). My symptoms are flu like and prevent me from functioning through normal activities such as walking beyond short distances and standing for short periods of time.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives on buttocks
Sex: F
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse symptoms reported; the patient received a third dose of MMRII on 07/21/2020 despite receiving two doses already; This spontaneous report was received from a consumer (the patient's mother) refers to a female patient of unknown age. Information regarding her concurrent conditions, medical history, drug reactions or allergies and concomitant therapies was not provided.  On unknown dates, the patient was vaccinated with her first and second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, lot number, route of administration, anatomical location were not provided) for prophylaxis. On 21-JUL-2020, she received a third, extra dose (despite receiving two doses already) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, lot number, route of administration, anatomical location and strength were not provided) that she should not have gotten. There were no adverse symptoms reported.
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: a male adolescent experienced syncope; This spontaneous report was received from a pharmacy technician via a company representative, referring to an adolescent male patient. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On an unknown date in 2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiration date, exact dose, anatomical location, route of administration were not reported) for prophylaxis. After receiving the vaccine, he experienced syncope (the patient slumped over in chair). It was stated by the reporter that he did not need any intervention by staff. No treatment was given due to the adverse event. It was unknown if any lab diagnostics or tests were performed. The outcome of the event was reported as recovered.  Causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  Upon internal review, the event of syncope was considered to be medically significant.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injected limb mobility decreased, Loss of personal independence in daily activities, Lymphadenopathy, Pain in extremity
Clinical narrative: arm was sore; she couldn't lift it; redness; swelling /area became huge, puffy/swelled up to the size of a tennis ball; itchy; enlarged lymph node / swelled up; vertigo; could not get out of bed for two to three days; puffy; This case was reported by a consumer via call center representative and described the occurrence of pain in extremity in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (received 1st dose in January 2020 refer case the US2020156578).   On 1st July 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In July 2020, less than a day after receiving Shingrix, the patient experienced pain in extremity, injected limb mobility decreased, erythema, peripheral swelling, pruritus, enlargement of lymph nodes, vertigo, activities of daily living impaired and tissue puffing. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in extremity, injected limb mobility decreased, erythema, peripheral swelling, pruritus, enlargement of lymph nodes, vertigo and tissue puffing were recovered/resolved and the outcome of the activities of daily living impaired was unknown.   It was unknown if the reporter considered the pain in extremity, injected limb mobility decreased, erythema, peripheral swelling, pruritus, enlargement of lymph nodes, vertigo, activities of daily living impaired and tissue puffing to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. In July, the patient arm was sore within a few hours and she couldn't lift it the next day. The swelling and redness didn't develop until a few days later.  On the third days, the area became huge, puffy and itchy. An enlarged lymph node developed in the arm pit of her left arm and swelled up to the size of a tennis ball.  Four days after the shot, she had vertigo and could not get out of bed for two to three days which was how long it lasted. She did see her primary physician.  All side effects were resolved around seven days after the injection. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020156578:same reporter
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Pruritus, Swelling, Vertigo
Clinical narrative: arm was sore; she couldn't lift it; redness; swelling /area became huge, puffy/swelled up to the size of a tennis ball; itchy; enlarged lymph node / swelled up; vertigo; could not get out of bed for two to three days; puffy; This case was reported by a consumer via call center representative and described the occurrence of pain in extremity in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (received 1st dose in January 2020 refer case the US2020156578).   On 1st July 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In July 2020, less than a day after receiving Shingrix, the patient experienced pain in extremity, injected limb mobility decreased, erythema, peripheral swelling, pruritus, enlargement of lymph nodes, vertigo, activities of daily living impaired and tissue puffing. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in extremity, injected limb mobility decreased, erythema, peripheral swelling, pruritus, enlargement of lymph nodes, vertigo and tissue puffing were recovered/resolved and the outcome of the activities of daily living impaired was unknown.   It was unknown if the reporter considered the pain in extremity, injected limb mobility decreased, erythema, peripheral swelling, pruritus, enlargement of lymph nodes, vertigo, activities of daily living impaired and tissue puffing to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. In July, the patient arm was sore within a few hours and she couldn't lift it the next day. The swelling and redness didn't develop until a few days later.  On the third days, the area became huge, puffy and itchy. An enlarged lymph node developed in the arm pit of her left arm and swelled up to the size of a tennis ball.  Four days after the shot, she had vertigo and could not get out of bed for two to three days which was how long it lasted. She did see her primary physician.  All side effects were resolved around seven days after the injection. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020156578:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Deafness unilateral
Clinical narrative: lost hearing in right ear; This case was reported by a other health professional via other manufacturer and described the occurrence of hearing loss in a female patient who received Herpes zoster (Shingrix) (batch number LD3NH, expiry date 11th December 2021) for prophylaxis.   On 23rd July 2020, the patient received Shingrix (intramuscular) .5 ml. On 27th July 2020, 4 days after receiving Shingrix, the patient experienced hearing loss (serious criteria GSK medically significant). On an unknown date, the outcome of the hearing loss was not recovered/not resolved.   It was unknown if the reporter considered the hearing loss to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported as patient lost hearing in her right ear 4 days after receiving the Shingrix Vaccine.  The reporter consented to follow up. The case has been linked with case US2020159610, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020159610:same reporter
Sex: M
Vaccine: MENB
Symptoms: Decreased appetite, Diarrhoea, Erythema, Fatigue, Injection site erythema
Clinical narrative: Redness in the area distal to injection where it looks like a cellulitis like rash; Reaction at the vaccination site, red; reaction at the vaccination site, red, sore; reaction at the vaccination site, red, sore, hard; lethargy; loss of appetite / appetite loss; Loose bowel movements; redness in the area distal to injection; fatigue; This case was reported by a physician via call center representative and described the occurrence of cellulitis in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   In August 2020, the patient received Bexsero. In August 2020, less than 2 weeks after receiving Bexsero, the patient experienced cellulitis (serious criteria GSK medically significant), injection site erythema, injection site pain, injection site induration, lethargy, appetite lost, loose bowel, erythema and fatigue. On an unknown date, the outcome of the cellulitis, erythema and fatigue were unknown and the outcome of the injection site erythema and loose bowel were recovering/resolving and the outcome of the injection site pain, injection site induration, lethargy and appetite lost were recovered/resolved.   It was unknown if the reporter considered the cellulitis, injection site erythema, injection site pain, injection site induration, lethargy, appetite lost, loose bowel, erythema and fatigue to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Bexsero, the patient had a reaction at the vaccination site, red, sore, hard. Then developed lethargy, loss of appetite, loose bowel movement. After 3 days, the symptoms started to improve.   But at the time of reporting, there was redness in the area distal to injection where it looked like a cellulitis like rash. Upon follow up with Medical Information, it was reported that, at the time of reporting, the patient had what looked like cellulitis around the vaccination site, although not on it directly.  The patient's pediatrician did not know what it was but did not think it was cellulitis.  The patient's parent was a retired doctor and according to them, it did look like cellulitis. It was one week later.  The patient had initial reactions of pain, induration, lethargy, and appetite loss for several days. That disappeared at the time of reporting. The patient did not experienced pain. No further details were provided. The reporter did not consent to follow up.
Sex: M
Vaccine: MENB
Symptoms: Injection site induration, Injection site pain, Injection site rash, Lethargy
Clinical narrative: Redness in the area distal to injection where it looks like a cellulitis like rash; Reaction at the vaccination site, red; reaction at the vaccination site, red, sore; reaction at the vaccination site, red, sore, hard; lethargy; loss of appetite / appetite loss; Loose bowel movements; redness in the area distal to injection; fatigue; This case was reported by a physician via call center representative and described the occurrence of cellulitis in a 18-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   In August 2020, the patient received Bexsero. In August 2020, less than 2 weeks after receiving Bexsero, the patient experienced cellulitis (serious criteria GSK medically significant), injection site erythema, injection site pain, injection site induration, lethargy, appetite lost, loose bowel, erythema and fatigue. On an unknown date, the outcome of the cellulitis, erythema and fatigue were unknown and the outcome of the injection site erythema and loose bowel were recovering/resolving and the outcome of the injection site pain, injection site induration, lethargy and appetite lost were recovered/resolved.   It was unknown if the reporter considered the cellulitis, injection site erythema, injection site pain, injection site induration, lethargy, appetite lost, loose bowel, erythema and fatigue to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Bexsero, the patient had a reaction at the vaccination site, red, sore, hard. Then developed lethargy, loss of appetite, loose bowel movement. After 3 days, the symptoms started to improve.   But at the time of reporting, there was redness in the area distal to injection where it looked like a cellulitis like rash. Upon follow up with Medical Information, it was reported that, at the time of reporting, the patient had what looked like cellulitis around the vaccination site, although not on it directly.  The patient's pediatrician did not know what it was but did not think it was cellulitis.  The patient's parent was a retired doctor and according to them, it did look like cellulitis. It was one week later.  The patient had initial reactions of pain, induration, lethargy, and appetite loss for several days. That disappeared at the time of reporting. The patient did not experienced pain. No further details were provided. The reporter did not consent to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Immunisation, Syringe issue
Clinical narrative: upon correct technique to administer Shingrix in pt's left arm the syringe BD integra 3ml 25 gauge 1 inch, was placed in pt's left deltoid  and vaccine leaked out of syringe while syringe still in pt's arm, leaving no vaccine administered to pt at that encounter, pt was revaccinated that same day as per immunize.org recommendation in right arm with no issue to report
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dyspnoea, Syncope, Throat tightness
Clinical narrative: Patient got dyspnea after received the vaccine at 11:00. Had syncopal symptoms with admin of vaccine then dyspnea/ throat tightness on the ride home.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: MOM STATES LATER IN THE DAY ON 8/17/2020 SHE TOOK OFF THE BANDAID TO THE INJECTION SITE AND IT WAS RED AND SWOLLEN, SHE STATES SHE DREW A LINE AROUND IT WITH A PEN AND THEN THE NEXT DAY THE INDURATION HAS GROWN SO THAT IS WHEN SHE TOOK HIM TO THE URGENT CARE. SHE STATES IT IS RED, RAISED, HAS A RASH DOWN THE LE AND IS HOT TO THE TOUCH. MOTHER STATES CHILD WAS PRESCRIBED AND ANTIBIOTIC FROM THE URGENT CARE THAT STARTS WITH A "C" AND ARE TO GIVE 8ML PO BID.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Staring, Unresponsive to stimuli
Clinical narrative: Client received a Tdap, IPV, MMRV, MCV4, and HPV9.  Immediately receiving the HPV9 the client drew his hands up toward his face staring with no response to stimuli for approximately 10 to 15 seconds. Then he responded saying, "what just happened?"  He was alert and drank some cold water.  After he gained his composure he was assisted by the nurse to the waiting room for observation.  After approximately 20 minutes he was accompanied by his Mother to his car.  Instructions were given for them to take the elevator down walking close to Mother, and if he began to feel faint to sit or lay down until the feeling passed.
Age: 18.0
Sex: M
Vaccine: HEP, MMR, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: After receiving vaccinations and bicillin shot. Patient was  instructed to sit for 15 mins. During that time patient was noted to have hives and urticaria. Patient was then sent to medical assessment for further evaluation where he was given Benadryl and Epinephrine and EMS was called to transfer the patient to the ED.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Decreased appetite, Dizziness, Fatigue, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Fever up to 104.8, stiff neck, tired, appetite down, dizzy
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Respiratory viral panel, SARS-CoV-2 test negative, Viral test negative
Clinical narrative: Fever up to 104.8, stiff neck, tired, appetite down, dizzy
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Scab, Urticaria
Clinical narrative: Patient called and said that a few days after receiving the vaccine she developed a rash to her right elbow area and right knee area.  She said that some of  the rash bumps are scabbed over ( as patient says they were open due to intense itching) and some were 'welt like' in appearance.  She tried OTC medication such as hydrocortisone cream and Benadryl, which did not help.  Dr. sent in hydroxyzine to the pharmacy to help with the itching.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Nausea
Clinical narrative: I experienced fever, chills, weakness, fatigue, nausea, light-headedness and aches.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: I experienced fever, chills, weakness, fatigue, nausea, light-headedness and aches.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Amylase, Anaemia, Blood uric acid, Contusion, Epistaxis
Clinical narrative: Patient is a 16yr old previously healthy female who presents with thrombocytopenia and anemia with 7days of vaginal bleeding. Patient presented to Hospital ER with a heavy menstrual period with multiple clots and a nose bleed. Patient reports that she started her menstrual period at the age of 12 and have always been irregular. The longest length of time she has gone between having periods is 3 months while the shortest time length between periods is 1 week. Her menstrual period usually lasts approximately 7days with an average of 4 heavy days. On average she will change her pad 4 times per day. Pads will be soaked through with blood and on heavy days she will double pad. During this current period her flow continues to be heavy and she has needed to change her pad approximately 6times per day. During this current period patient has also noted multiple clots with wiping during this period. On the morning of admission while blowing her nose a dime size blood clot was noted to be on the tissue. At Hospital CBC was drawn and she was noted to have a cbc significant for low platelets of 10 and hemoglobin of 9.4. Petechia and lower extremity bruises were noted. She was transferred to another ER.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Full blood count, Haemoglobin decreased, Human chorionic gonadotropin, Lipase, Menorrhagia
Clinical narrative: Patient is a 16yr old previously healthy female who presents with thrombocytopenia and anemia with 7days of vaginal bleeding. Patient presented to Hospital ER with a heavy menstrual period with multiple clots and a nose bleed. Patient reports that she started her menstrual period at the age of 12 and have always been irregular. The longest length of time she has gone between having periods is 3 months while the shortest time length between periods is 1 week. Her menstrual period usually lasts approximately 7days with an average of 4 heavy days. On average she will change her pad 4 times per day. Pads will be soaked through with blood and on heavy days she will double pad. During this current period her flow continues to be heavy and she has needed to change her pad approximately 6times per day. During this current period patient has also noted multiple clots with wiping during this period. On the morning of admission while blowing her nose a dime size blood clot was noted to be on the tissue. At Hospital CBC was drawn and she was noted to have a cbc significant for low platelets of 10 and hemoglobin of 9.4. Petechia and lower extremity bruises were noted. She was transferred to another ER.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Petechiae, Platelet count decreased, Thrombocytopenia, Thrombosis, Urine analysis
Clinical narrative: Patient is a 16yr old previously healthy female who presents with thrombocytopenia and anemia with 7days of vaginal bleeding. Patient presented to Hospital ER with a heavy menstrual period with multiple clots and a nose bleed. Patient reports that she started her menstrual period at the age of 12 and have always been irregular. The longest length of time she has gone between having periods is 3 months while the shortest time length between periods is 1 week. Her menstrual period usually lasts approximately 7days with an average of 4 heavy days. On average she will change her pad 4 times per day. Pads will be soaked through with blood and on heavy days she will double pad. During this current period her flow continues to be heavy and she has needed to change her pad approximately 6times per day. During this current period patient has also noted multiple clots with wiping during this period. On the morning of admission while blowing her nose a dime size blood clot was noted to be on the tissue. At Hospital CBC was drawn and she was noted to have a cbc significant for low platelets of 10 and hemoglobin of 9.4. Petechia and lower extremity bruises were noted. She was transferred to another ER.