chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Possible light fever; Soreness at site of administration; Mild headache; nausea; Tiredness; Sensitive teeth/gums to cold; Sensitive teeth/gums to cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Oct2021 12:15 (Lot number: EW0217) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing). Concomitant medication(s) included: ADVAIR HFA taken for asthma (ongoing). Vaccination history included: Bnt162b2 (Dose: 2, Lot number: EP6955, Administrator route: Intramuscular, Vaccine location: Left arm), administration date: 24Mar2021, when the patient was 43 years old, for COVID-19 immunization; Bnt162b2 (Dose: 1, Lot number: EL3247, Administrator route: Intramuscular, Vaccine location: Left arm), administration date: 02Mar2021, when the patient was 43 years old, for COVID-19 immunization; Flu (Other vaccine 4 weeks vaccine location: left arm), administration date: 22Sep2021.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 14Oct2021 01:00, outcome "recovering", described as "Soreness at site of administration"; HEADACHE (non-serious) with onset 13Oct2021 01:00, outcome "recovered" (Oct2021), described as "Mild headache"; NAUSEA (non-serious) with onset 13Oct2021 01:00, outcome "recovered" (Oct2021), described as "nausea"; PYREXIA (non-serious) with onset 14Oct2021 01:00, outcome "recovering", described as "Possible light fever"; FATIGUE (non-serious) with onset 13Oct2021, outcome "recovered" (Oct2021), described as "Tiredness"; GINGIVAL PAIN (non-serious), HYPERAESTHESIA TEETH (non-serious) all with onset 2021, outcome "recovering" and all described as "Sensitive teeth/gums to cold". Therapeutic measures were not taken as a result of vaccination site pain, headache, nausea, pyrexia, gingival pain, hyperaesthesia teeth.  Additional information: Patient received COMINARTY vaccine at Workplace clinic. Patient had no known allergy. other medications the patient received within 2 weeks of vaccination: Asthma inhaler. Patient received Flu vaccine within 4 weeks PRIOR. Prior to vaccination patient was not diagnosed with COVID-19 and since the vaccination, patient has not been tested for COVID-19. No Relevant Tests and Specific relevant test for thromboembolic events with thrombocytopenia were reported. The events were reported as non-serious.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Heart rate, Heart rate increased, Pyrexia
Clinical narrative: Fever; Chills; Rapid heartbeat for a number of hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administration date 25Feb2021 (Lot number: EN6198) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number:01, Lot number:EN5318, No events reported), administration date: 28Jan2021, when the patient was 59 years old, for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "Fever"; CHILLS (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "Chills"; HEART RATE INCREASED (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "Rapid heartbeat for a number of hours". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: After the second covid vaccine he had fever, chills, rapid heartbeat for a number of hours. He was told it would go away and it did. It lasted 8-10 hours.   Follow-up attempts are completed. No further information is expected..
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Inflammation
Clinical narrative: Focal cutaneous and subcutaneous inflammation; erythema; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 09Oct2021 12:00 (Lot number: FE3590) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes Type 1" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Macrolide antibiotics, reaction(s): "known allergies: Macrolide antibiotics"; Ace inhibitors, reaction(s): "known allergies: ACE inhibitors". Vaccination history included: Bnt162b2 (prev dose product=COVID 19, prev dose brand=Pfizer , prev dose brand unknown=False, prev dose lot number=EL9264, prev dose lot unknown=False, prev dose administration date=02Feb2021, prev dose dose number=1, prev dose vaccine location=Left arm), administration date: 02Feb2021, when the patient was 65 years old, for Covid immunization; Bnt162b2 (prev dose product=COVID 19, prev dose brand=Pfizer , prev dose brand unknown=False, prev dose lot number=EN6198, prev dose lot unknown=False, prev dose administration date=25Feb2021 , prev dose administration time=04:00 PM , prev dose dose number=2, Prev dose vaccine location=Left arm), administration date: 25Feb2021, when the patient was 65 years old, for Covid immunization; Duck embryo rabies vaccine, reaction(s): "known allergies: duck embryo rabies vaccine". The following information was reported: INFLAMMATION (non-serious) with onset 09Oct2021 18:00, outcome "recovering", described as "Focal cutaneous and subcutaneous inflammation"; ERYTHEMA (non-serious) with onset 09Oct2021 18:00, outcome "recovering", described as "erythema". Therapeutic measures were not taken as a result of inflammation, erythema.  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: fatigue; total body aches; brain fog; headache; swollen/painful axillary left lymph node; swollen/painful axillary left lymph node; Low-grade fever; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Oct2021 10:15 (Lot number: EW0217) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 16Feb2021, when the patient was 29 years old, for covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 26Jan2021, when the patient was 29 years old, for covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 13Oct2021 22:00, outcome "recovering", described as "Low-grade fever"; CHILLS (non-serious) with onset 13Oct2021 22:00, outcome "recovering", described as "chills"; PAIN (non-serious) with onset 14Oct2021, outcome "recovering", described as "total body aches"; FEELING ABNORMAL (non-serious) with onset 14Oct2021, outcome "recovering", described as "brain fog"; HEADACHE (non-serious) with onset 14Oct2021, outcome "recovering", described as "headache"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 14Oct2021, outcome "recovering" and all described as "swollen/painful axillary left lymph node"; FATIGUE (non-serious) with onset 15Oct2021, outcome "recovering", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, pain, feeling abnormal, headache, lymphadenopathy, lymph node pain, fatigue.  Additional Information: Facility type Vaccine: workplace clinic, If other vaccine in four weeks: No, Other medications in two weeks: Yes, if covid prior vaccination- No, if covid tested post vaccination- No, known allergies- no, other medical history- none.  Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: fatigue; total body aches; brain fog; headache; swollen/painful axillary left lymph node; swollen/painful axillary left lymph node; Low-grade fever; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Oct2021 10:15 (Lot number: EW0217) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 16Feb2021, when the patient was 29 years old, for covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 26Jan2021, when the patient was 29 years old, for covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 13Oct2021 22:00, outcome "recovering", described as "Low-grade fever"; CHILLS (non-serious) with onset 13Oct2021 22:00, outcome "recovering", described as "chills"; PAIN (non-serious) with onset 14Oct2021, outcome "recovering", described as "total body aches"; FEELING ABNORMAL (non-serious) with onset 14Oct2021, outcome "recovering", described as "brain fog"; HEADACHE (non-serious) with onset 14Oct2021, outcome "recovering", described as "headache"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 14Oct2021, outcome "recovering" and all described as "swollen/painful axillary left lymph node"; FATIGUE (non-serious) with onset 15Oct2021, outcome "recovering", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, pain, feeling abnormal, headache, lymphadenopathy, lymph node pain, fatigue.  Additional Information: Facility type Vaccine: workplace clinic, If other vaccine in four weeks: No, Other medications in two weeks: Yes, if covid prior vaccination- No, if covid tested post vaccination- No, known allergies- no, other medical history- none.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "Itching". Additional information: Patient stated she wanted to know and speak to someone about the side effect of Pfizer. When probed what side effects was she facing, Patient stated "She was talking about Itching." Product details (Lot#, expiration date, NDC#, UPC#), purchase details could not be probed over the call as patient hung up the call abruptly. Hence limited information available over the call.   Follow-up attempts have been completed and no further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Dizziness, Gait disturbance
Clinical narrative: experiencing a high fever of over 101 degrees and he is being having that from most of the day, most of today; having trouble getting out of bed; Dizzy; feels like he is going to fall over if he walks; Chills; Headache; loss of appetite; her husband was very sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 34 year-old male patient received bnt162b2 (BNT162B2), administration date 13Oct2021 (Batch/Lot number: unknown) at the age of 34 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), administration date: 2021, when the patient was 34 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 14Oct2021, outcome "unknown", described as "experiencing a high fever of over 101 degrees and he is being having that from most of the day, most of today"; MOVEMENT DISORDER (non-serious) with onset Oct2021, outcome "unknown", described as "having trouble getting out of bed"; DIZZINESS (non-serious) with onset Oct2021, outcome "unknown", described as "Dizzy"; GAIT DISTURBANCE (non-serious) with onset Oct2021, outcome "unknown", described as "feels like he is going to fall over if he walks"; CHILLS (non-serious) with onset Oct2021, outcome "unknown", described as "Chills"; HEADACHE (non-serious) with onset Oct2021, outcome "unknown", described as "Headache"; DECREASED APPETITE (non-serious) with onset Oct2021, outcome "unknown", described as "loss of appetite"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "her husband was very sick". The patient underwent the following laboratory tests and procedures: body temperature: over 101 degrees.  Additional information: Reporter stated that her call was about her husband who was 34 years old who go the second COVID vaccine and he just got the second Pfizer COVID Vaccine last night about 24 hours ago, he was experiencing a high fever of over 101 degrees and he was being having that from most of the day, most of today. So for just probably just after under 12 hours, he was having trouble getting out of bed, he was dizzy, he felt like he was going to fall over if he walks, he was having chills and headache and loss of appetite. The reporter was wondering if he was in good health over all and if someone would have any medical advice on how to deal with this because the patient was considering going to the hospital. Probed for LOT number: Reporter stated she did not have time to talk about anything but how to deal with this right now, her husband was very sick.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Illness, Movement disorder, Pyrexia
Clinical narrative: experiencing a high fever of over 101 degrees and he is being having that from most of the day, most of today; having trouble getting out of bed; Dizzy; feels like he is going to fall over if he walks; Chills; Headache; loss of appetite; her husband was very sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 34 year-old male patient received bnt162b2 (BNT162B2), administration date 13Oct2021 (Batch/Lot number: unknown) at the age of 34 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), administration date: 2021, when the patient was 34 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 14Oct2021, outcome "unknown", described as "experiencing a high fever of over 101 degrees and he is being having that from most of the day, most of today"; MOVEMENT DISORDER (non-serious) with onset Oct2021, outcome "unknown", described as "having trouble getting out of bed"; DIZZINESS (non-serious) with onset Oct2021, outcome "unknown", described as "Dizzy"; GAIT DISTURBANCE (non-serious) with onset Oct2021, outcome "unknown", described as "feels like he is going to fall over if he walks"; CHILLS (non-serious) with onset Oct2021, outcome "unknown", described as "Chills"; HEADACHE (non-serious) with onset Oct2021, outcome "unknown", described as "Headache"; DECREASED APPETITE (non-serious) with onset Oct2021, outcome "unknown", described as "loss of appetite"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "her husband was very sick". The patient underwent the following laboratory tests and procedures: body temperature: over 101 degrees.  Additional information: Reporter stated that her call was about her husband who was 34 years old who go the second COVID vaccine and he just got the second Pfizer COVID Vaccine last night about 24 hours ago, he was experiencing a high fever of over 101 degrees and he was being having that from most of the day, most of today. So for just probably just after under 12 hours, he was having trouble getting out of bed, he was dizzy, he felt like he was going to fall over if he walks, he was having chills and headache and loss of appetite. The reporter was wondering if he was in good health over all and if someone would have any medical advice on how to deal with this because the patient was considering going to the hospital. Probed for LOT number: Reporter stated she did not have time to talk about anything but how to deal with this right now, her husband was very sick.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No additional AEs; VARIVAX administered to24 month old via IM route; This spontaneous report was received from a nurse referring to a 24-month-old patient of unknown gender. Concomitant medication, pertinent medical history and drug reactions/allergies were not reported.   On 04-FEB-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 ml intramuscularly (IM) (strength, lot #, and expiration date were not provided) for prophylaxis (incorrect route of product administration). No other information provided. No additional adverse events (AEs). The outcome of incorrect route of product administration was unknown.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event reported; The patient received an expired MMR II vaccine; This spontaneous report as received from nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drug and concomitant therapies were not reported.  On 11-FEB-2022, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # S029456, expiration date # 19-SEP-2021 (dose, lot number, frequency and dose description were not reported), for prophylaxis (expired product administered). No additional adverse event reported.
Sex: F
Vaccine: PNC13, PPV
Symptoms: Pneumonia
Clinical narrative: has had pneumonia three times; This spontaneous report was received from a patient's caregiver (also reported as received from a consumer on behalf of his mother) via Pfizer and refers to an 83-year-old female. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On an unknown date in 2008, the patient was vaccinated with her first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (formulation, dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.  On an unknown dates in 2016, 2018 and in October 2020, the patient was vaccinated with three doses of pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (formulation, dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.  On 10-FEB-2022 (reported on 11-FEB-2022 as "yesterday"), she was vaccinated with her second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (formulation, dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.  On unknown dates, the patient experienced pneumonia three times. At the time of reporting, the outcome of the event was not known.  This case was also reported as medical inquiry. The reporter wanted to know a difference between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), pneumococcal vaccine conj 13v (crm197) (PREVNAR 13), and pneumococcal vaccine conj 20v (PREVNAR 20). A pharmacist relayed that pneumococcal vaccine conj 20v (PREVNAR 20) would not allow his mother to get pneumonia and the consumer wanted to know how far apart should the vaccines be spaced if the patient was to receive pneumococcal vaccine conj 20v (PREVNAR 20) after receiving the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).  The causal relationship between the event and the suspect vaccines was not provided.  Upon internal review, the event of pneumonia three times was determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got the vax for it and then I got it/Suspected vaccination failure; I got it; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this report. The age at vaccination was not reported. The patient got the vaccine for shingles and then got them. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory test confirming shingles was unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; shingles breakouts, internal and external; feeling miserable; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (the patient had terrible chickenpox as a young adult).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and feeling miserable. On an unknown date, the outcome of the vaccination failure, shingles and feeling miserable were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient stated that, the patient had the vaccines and still get shingles internal and external. The patient stated that it was miserable and the patient wish on it no one. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: MENB
Symptoms: Full blood count, Leukaemoid reaction, Neutrophil count increased, White blood cell count increased
Clinical narrative: WBC came back 20K with ANC 16K; WBC came back 20K with ANC 16K; This case was reported by a other health professional via call center representative and described the occurrence of white blood cell increased in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included asplenia.   On an unknown date, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced white blood cell increased and absolute neutrophil count increased. On an unknown date, the outcome of the white blood cell increased was recovered/resolved and the outcome of the absolute neutrophil count increased was unknown.   It was unknown if the reporter considered the white blood cell increased and absolute neutrophil count increased to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The asplenic patient received dose of Bexsero and went for routine blood draw for other reasons.  The patient was not sick before and after immunization. The white blood count came back 20 K and absolute neutrophill count was 16 K. The Subsequent CBC a few weeks later was normal. The reporter asked if, was this just a benign demargination phenomenon or leukemoid reaction. No additional information was provided. The reporter consented to follow up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: Tired; weak; lymph node on left side is swollen; pain from lymph node to arm; pain from lymph node to arm; pain from lymph node to arm; This case was reported by a pharmacist via call center representative and described the occurrence of tiredness in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th January 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced tiredness, weakness, enlargement of lymph nodes, lymph node pain, radiating pain and pain in arm. On an unknown date, the outcome of the tiredness, weakness, enlargement of lymph nodes, lymph node pain, radiating pain and pain in arm were unknown.   It was unknown if the reporter considered the tiredness, weakness, enlargement of lymph nodes, lymph node pain, radiating pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: Pharmacist reported that the patient received her first dose of the Shingrix vaccine and since then she was tired and weak.   The patient had also reported the lymph node on her left side was swollen.   The patient was experiencing pain from the lymph  node that radiated to the back of her left arm. The reporter was inquiring if this was a normal adverse event and how long would it take to subside. The reporter provided medical advice disclaimer. No additional details were provided by the caller. The reporter did not consent to follow-up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Tired; weak; lymph node on left side is swollen; pain from lymph node to arm; pain from lymph node to arm; pain from lymph node to arm; This case was reported by a pharmacist via call center representative and described the occurrence of tiredness in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th January 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced tiredness, weakness, enlargement of lymph nodes, lymph node pain, radiating pain and pain in arm. On an unknown date, the outcome of the tiredness, weakness, enlargement of lymph nodes, lymph node pain, radiating pain and pain in arm were unknown.   It was unknown if the reporter considered the tiredness, weakness, enlargement of lymph nodes, lymph node pain, radiating pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: Pharmacist reported that the patient received her first dose of the Shingrix vaccine and since then she was tired and weak.   The patient had also reported the lymph node on her left side was swollen.   The patient was experiencing pain from the lymph  node that radiated to the back of her left arm. The reporter was inquiring if this was a normal adverse event and how long would it take to subside. The reporter provided medical advice disclaimer. No additional details were provided by the caller. The reporter did not consent to follow-up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Injection site induration, Pain in extremity
Clinical narrative: broke out in Shingles; injection site was hard; arm was sore; had water filled blisters; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 333te, expiry date 15th April 2023) for prophylaxis.   On 23rd November 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 23rd November 2021, several hours after receiving Shingrix, the patient experienced injection site induration and pain in arm. On 27th November 2021, the patient experienced shingles and blister. On an unknown date, the outcome of the shingles, injection site induration, pain in arm and blister were recovered/resolved.   It was unknown if the reporter considered the shingles, injection site induration, pain in arm and blister to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The patient got her first Shingrix vaccine and few hours after the vaccine, her arm was sore and the injection site was hard and this lasted for a few days.   The patient also broke out in Shingles about 2 inches below the site of her injection.   The patient had water filled blisters on that covered about a 3.5 inch radius.   These blisters lasted about a week and she did not had any symptoms since then.   The patient spoke per content and referred to health care professional(HCP) for direction about getting her second vaccine. The patient was very satisfied with her conversation with the representative on the day of reporting. This was a follow up to a shingles outbreak that patient had when she got the first shingles vaccine.  The patient felt that representative was not sympathetic at all, when she called first time to report the shingles outbreak and thus she was very upset.  And the reason she called back was because it was at the suggestion of my physician.  So this representative was much more sympathetic and had a lot of information, the other representative, when she called, which was some time after 23rd November 2021, basically told her to  just call physician and patient asked if they need any information about who she was and they replied no. The reporter did not consent to follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: CANNOT WALK LONG ACROSS THE YARD WITHOUT GETTING OUT OF BREATH; This spontaneous report received from a consumer via a company representative through social media concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: patient was in great health. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced cannot walk long across the yard without getting out of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of cannot walk long across the yard without getting out of breath was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism, Thrombocytopenia, Thrombosis
Clinical narrative: THROMBOCYTOPENIA; THROMBOSIS; BILATERAL PULMONARY EMBOLISM; This solicited report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced thrombocytopenia, thrombosis, and bilateral pulmonary embolism. Treatment medications (dates unspecified) included: enoxaparin sodium, and rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the thrombocytopenia, thrombosis and bilateral pulmonary embolism was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and thrombocytopenia as related. The reporter did not provide a causality assessment between covid-19 vaccine ad26.cov2.s, and thrombosis, and bilateral pulmonary embolism. Company causality between covid-19 vaccine ad26.cov2.s thrombocytopenia, thrombosis, and bilateral pulmonary embolism was related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220232473-Covid-19 vaccine ad26.cov2.s-Thrombocytopenia, thrombosis, and bilateral pulmonary embolism . This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SERIOUSLY ILL; This spontaneous report received from a consumer via social media via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number were not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced seriously ill. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of seriously ill was not reported. This report was non-serious. This case, from the same reporter is linked to 20220236894.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous report received from a patient concerned an adult male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for ankylosing spondylitis. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient was recovering from covid-19. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: one of their vaccines was used to give two booster doses accidently from vials that were expired past their beyond use date of 12FEB2022.; one of their vaccines was used to give two booster doses accidently from vials that were expired past their beyond use date of 12FEB2022.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (one of their vaccines was used to give two booster doses accidently from vials that were expired past their beyond use date of 12FEB2022.) and PRODUCT STORAGE ERROR (one of their vaccines was used to give two booster doses accidently from vials that were expired past their beyond use date of 12FEB2022.) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (one of their vaccines was used to give two booster doses accidently from vials that were expired past their beyond use date of 12FEB2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (one of their vaccines was used to give two booster doses accidently from vials that were expired past their beyond use date of 12FEB2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (one of their vaccines was used to give two booster doses accidently from vials that were expired past their beyond use date of 12FEB2022.) and PRODUCT STORAGE ERROR (one of their vaccines was used to give two booster doses accidently from vials that were expired past their beyond use date of 12FEB2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that vials were initially stored in refrigerator on 13Jan2022 6:00 AM and last date to use was 12Feb2022. 2 booster doses were given from one vial.  No concomitant medications were reported.   This case was linked to MOD-2022-483927 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Feb-2022: Follow-up received contains no new information.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lethargy, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: lethargy; Fever; chills; Swollen lymph node at left armpit still apparent.; achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Oct2021 13:00 (Lot number: FF8839) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Seizure disorder" (unspecified if ongoing). Concomitant medication(s) included: LAMOTRIGINE; ZONISAMIDE; FISH OIL. Vaccination history included: Bnt162b2 (previous dose product=COVID 19,, lot number=EL3247,, administrator route=Intramuscular,, administration date=14Jan2021,, dose number=1,, vaccine location=Left arm), administration date: 14Jan2021, when the patient was 33 years old, for Covid-19 immunization; Bnt162b2 (previous dose product=COVID 19,, lot number=EL3247,, Administrator route=Intramuscular,, Administration date=04Feb2021, Dose number=2,, vaccine location=Left arm), administration date: 04Feb2021, when the patient was 33 years old, for Covid-19 immunization.  The following information was reported: LETHARGY (non-serious) with onset 14Oct2021 02:00, outcome "recovering", described as "lethargy"; PYREXIA (non-serious) with onset 14Oct2021 02:00, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 14Oct2021 02:00, outcome "recovering", described as "chills"; LYMPHADENOPATHY (non-serious) with onset 14Oct2021 02:00, outcome "recovering", described as "Swollen lymph node at left armpit still apparent."; PAIN (non-serious) with onset 14Oct2021 02:00, outcome "recovering", described as "achy". Therapeutic measures were not taken as a result of lethargy, pyrexia, chills, lymphadenopathy, pain.  Additional information: The facility type vaccine was reported as workplace clinic. Patient had not received any other vaccine in four weeks. Other medications in two weeks included Lamotrigine, Zonisamide, Multivitamin, Fish Oil. Adverse event fever, chills, achy, lethargy for the first 24 hrs. swollen lymph node at left armpit still apparent. The patient was recovering from the events without treatment. The patient had no covid prior vaccination. The patient had not covid tested post vaccination. The patient had no known allergies.  Follow-up attempts are completed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Heart rate, Heart rate increased, Pain
Clinical narrative: difficulty breathing; Rapid heart rate; chest tightness; pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 17Sep2021 (Lot number: EW0196) at the age of 23 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing), notes: if covid prior vaccination Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (First dose single, solution for injection, lot number=EW0167, vaccine location=Right arm), administration date: 27Aug2021, when the patient was 23 years old, for Covid-19 immunization. The following information was reported: DYSPNOEA (non-serious) with onset 18Sep2021, outcome "recovered" (2021), described as "difficulty breathing"; HEART RATE INCREASED (non-serious) with onset 18Sep2021, outcome "recovered" (2021), described as "Rapid heart rate"; CHEST DISCOMFORT (non-serious) with onset 18Sep2021, outcome "recovered" (2021), described as "chest tightness"; PAIN (non-serious) with onset 18Sep2021, outcome "recovered" (2021), described as "pain". The events "difficulty breathing", "rapid heart rate", "chest tightness" and "pain" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dyspnoea, heart rate increased, chest discomfort, pain.  Additional Information: Facility type vaccine physician's office/urgent care. The patient has no reported allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Lethargy, Pollakiuria, Pyrexia, Tremor
Clinical narrative: Lethargic; Low grade fever on at least three occasions; Tremors; Loss of appetite; frequent urination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 67-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Oct2021 11:00 (Lot number: FE3590) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Gastritis" (unspecified if ongoing). Concomitant medication(s) included: FLU, administration date 15Sep2021. Past drug history included: Nsaids, reaction(s): "known allergies: NSAIDS". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6204, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 18Mar2021, when the patient was 67 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6204, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 25Feb2021, when the patient was 67 years old, for Covid-19 immunization. The following information was reported: LETHARGY (non-serious) with onset 13Oct2021 23:00, outcome "recovering", described as "Lethargic"; PYREXIA (non-serious) with onset 13Oct2021 23:00, outcome "recovering", described as "Low grade fever on at least three occasions"; TREMOR (non-serious) with onset 13Oct2021 23:00, outcome "recovering", described as "Tremors"; DECREASED APPETITE (non-serious) with onset 13Oct2021 23:00, outcome "recovering", described as "Loss of appetite"; POLLAKIURIA (non-serious) with onset 13Oct2021 23:00, outcome "recovering", described as "frequent urination". Therapeutic measures were not taken as a result of lethargy, pyrexia, tremor, decreased appetite, pollakiuria.  Additional information: Covid prior vaccination and covid tested post vaccination was reported as NO.  No follow-up attempts are possible. No further information is expected.