chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: still have the flu; Initial information received on 03-Dec-2022 regarding an unsolicited valid  non-serious social media case received from a Patient.  This case involves an unknown age and unknown gender patient who still have the flu after receiving vaccine Influenza vaccine.  It was unknown if the patient experienced any additional symptoms/events. It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a suspect Influenza vaccine produced by unknown manufacturer (strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient developed a non-serious event still have the flu (influenza) (unknown latency) following the administration of Influenza vaccine.  It was unknown if there were lab data/results available.  Action taken : Not applicable.  It was not reported if the patient received a corrective treatment for the event (still have the flu).  At time of reporting, the outcome was Unknown for the event still have the flu.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information received  on 02-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who had flu , after receiving vaccine INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date in Nov-2022, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer, with an unknown formulation and strength (lot number and expiry date: not reported)  via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event of  flu (influenza) (latency: unknown) following the administration of INFLUENZA VACCINE.  It is unknown if there were lab data/results available  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: flu; Initial information received on 02-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer.  This case involves an unknown age and unknown gender patient who experienced flu while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (formulation, strength, dose and lot number not reported) via unknown route in unknown administration site for prophylactic immunization.  On an unknown date, the patient developed a non-serious event of flu (influenza) (unknown latency) following the administration of influenza vaccine.  It was reported, No I got the flu and it sucks.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event flu.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: she has flu; Initial information received on 02-Dec-2022 regarding an unsolicited valid social media non-serious case from a consumer/non-hcp.  This case involves an unknown age female patient who has flu after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunisation).  On an unknown date the patient developed a non-serious she has flu (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown for the event she has flu.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I got my flu shot and I have the flu; Initial information received on 05-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who stated I got my flu shot and I have the flu  after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, route, dose: unknown) (lot number and expiry date: not reported) via unknown route in unknown administration site for flu  On an unknown date the patient stated I got my flu shot and I have the flu  (influenza) (unknown latency)   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Unknown for the event
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: came down with severe flu; Initial information received on 02-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves a patient of unknown demographics who while receiving vaccine INFLUENZA VACCINE, always immediately came down with severe flu.  The patient's past, medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength, route: unknown) lot number not reported via unknown route in unknown administration site for flu.  On an unknown date the patient came down with severe flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if there were lab data/results available. It was unknown if the company suspect product inappropriately used as per local Marketing authorization  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (came down with severe flu).  At time of reporting, the outcome was Unknown for the event came down with severe flu.
Sex: U
Vaccine: FLUX
Symptoms: Pulmonary embolism
Clinical narrative: 7 pulmonary embolisms from a flu shot; Initial information received on 05-Dec-2022 regarding an unsolicited valid social media serious case received  via consumer/non-hcp.  This case involves patient of unspecified demographics who experienced 7 pulmonary embolisms after receiving vaccine INFLUENZA VACCINE (flu shot).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer at (unknown: formulation, strength, dose, lot number, route in unknown administration site) for prophylactic vaccination. Information regarding batch number requested.  On an unknown date, the patient developed a serious 7 pulmonary embolisms from a flu shot (pulmonary embolism) at unknown latency following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event 7 pulmonary embolisms from a flu shot.  Seriousness Criterion: Event was assessed as medically significant.; Sender's Comments: Sanofi company comment 05-Dec-2022: This case involves patient of unspecified demographics who experienced 7 pulmonary embolisms after receiving vaccine INFLUENZA VACCINE (flu shot). The time to onset is not reported with the role of the vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, concomitants, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Influenza
Clinical narrative: sick; Initial information received on 04-Dec-2022 regarding an unsolicited valid social media non-serious case received from a patient.  This case involves an unknown age and unknown gender patient who was sick, after receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, dose, lot number and expiry date not reported) via unknown route in unknown administration site for flu (influenza).  On an unknown date, the patient developed a non-serious sick (illness) (unknown latency) following the administration of influenza vaccine.  It was reported that, The following potential adverse event has been found on a public post on the Not Today. Product Name: Product name was not provided. Since this is a public post on the Sanofi flu shot campaign we are assuming the consumer is referring to the Sanofi flu vaccine. Author/Reporter Comment: I got my shots n October & now I'm sick. Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event sick.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: just getting over the flu; Initial information received on 04-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health-care professional.  This case involves an unknown age and unknown gender patient who was just getting over the flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient developed a non-serious event of just getting over the flu (influenza) (unknown latency) following the administration of influenza vaccine.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (just getting over the flu).  At time of reporting, the outcome was Unknown for the event just getting over the flu.
Age: 1.0
Sex: F
Vaccine: UNK
Symptoms: Incorrect product formulation administered, Medication error, No adverse event, Product preparation error
Clinical narrative: mixed PENTACEL with the wrong diluent and administered it to a patient with no AE; mixed PENTACEL with the wrong diluent and administered it to a patient with no AE; Initial information was received on 02-Dec-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient for whom pentacel was mixed with the wrong diluent and administered it to a patient with no adverse event after receiving 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 influenza vaccine, measles vaccine, mumps vaccine, rubella vaccine (MMR) and varicella zoster vaccine (varicella vaccine) for Immunisation.  On 01-Dec-2022, the patient received 0.25 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine (Suspension for injection) (lot: UJ662AAA, expiry date: 04-May-2023, strength: Standard, frequency: once) via intramuscular route in the right vastus lateralis for Immunization.    On 01-Dec-2022 the patient had a non-serious event mixed pentacel with the wrong diluent and administered it to a patient  with no adverse event (incorrect product formulation administered) (Product preparation error) same day following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  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 the 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.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: patient received expired ACT-HIB with no reported adverse event; Initial information received on 05-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient received expired act-hib with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-Dec-2022, the patient received a  dose of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection, (Dose number :1)Dose: 0.5 ML (millilitre) 1X and Drug Treatment Duration: ONCE lot UJ635AAB , Expiry date : 30-NOV-2022 ( strength, dose site, route: unknown, ) for Immunisation  On 01-DEC-2022 the patient received expired act-hib with no reported adverse event (expired product administered) same day following the administration of HIB (PRP/T) VACCINE.  Reportedly "Vaccine Coordinator reporting a patient received expired ACT-HIB. The caller advised the product expired on 30Nov2022 and a patient received the vaccine on 01Dec2022. Should the patient be revaccinated or was the product viable"  Action taken was not applicable..  At time of reporting, the outcome was Unknown for the event   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 the guidelines. 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: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Accidental exposure to product, Incorrect dose administered, No adverse event, Syringe issue
Clinical narrative: leaking from the syringe that ran down the patient's arm with no reported adverse event; leaking from the syringe that ran down the patient's arm with no reported adverse event; Initial information received on 05-Dec-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 54 years old female patient and reporter stated leaking from the syringe that ran down the patient's arm with no reported adverse event. (influenza quadrival a-b vaccine) [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 03-Dec-2022, the patient received 0.5 ml dose of suspect influenza quadrival a-b vaccine once with standard strength (lot UT7752KA and expiry date:30-jun-2023) via intramuscular route in the left deltoid for Immunization.  On 03-Dec-2022 there was leaking from the syringe that ran down the patient's arm with no reported adverse event (accidental exposure to product) and (incorrect dose administered) during the administration of influenza quadrival a-b vaccine.  Action taken was not applicable.  Reportedly, Pharmacist stated that she had some difficulty when administering FLUZONE QIV to a patient.  The caller noted leaking from the syringe that ran down the patient's arm. Is this considered a valid dose or does it need to be re-administered? The caller noted that it was a single dose vial and they used the needle and syringe provided with their shipment of the vaccine. The caller stated that it was not the typical syringe that they use. The needle they were provided had an orange safety mechanism. Some of the liquid leaked out between the needle and the vial during administration. The liquid appeared to leak out when the pharmacist pushed on the plunger. Approximately 20% of the vaccine ran down the patient's arm. There was no adverse reaction that the pharmacist was aware of. The patient was not upset but the patient's spouse was very upset. Should they re-administer the dose or will the dose be enough of an immune response? There was no visible damage to the syringe or the vial. This is the only one in the shipment so far that has had difficulty during administration. The caller noted that they had a problem with a different vaccine Fluad. The caller noted that once you tried to inject the Fluad, the plunger wouldn't go down.  At time of reporting, the outcome was Unknown for the events.  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 the guidelines. 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: 64.0
Sex: F
Vaccine: FLUR3
Symptoms: Pain in extremity
Clinical narrative: really sore injection arm; Initial information was received on 05-Dec-2022 regarding an unsolicited valid non-serious case received from a patient.  This case involves 64 years old female patient who had really sore injection arm after receiving vaccine influenza quadrivalent recombinant vaccine [Flublok].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date in 2021, the patient received a dose of suspect influenza quadrivalent recombinant vaccine (frequency: total) (form, strength, dose, lot number, expiry date: unknown) via unknown route in unknown administration site for Immunization.  On an unknown date the patient developed a non-serious event of really sore injection arm (pain in extremity) (unknown latency) following the administration of influenza quadrivalent recombinant vaccine.  Reportedly,  She says that she is due to take the FLUZONE HD QIV vaccine and wants to find out how bad the side effects are. She also stated that she had a really sore injection arm after receiving Flublock last year but she had reported it at that time.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (really sore injection arm).  At time of reporting, the outcome was Unknown for the event really sore injection arm.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Cough
Clinical narrative: Coughing, non-stop; This spontaneous case from was received on 29-Nov-2022 from Novartis (reference number: NUS2022US263847), reported by other non-healthcare professional (consumer) and concerned a 44-year-old female patient.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with influenza vaccine (brand not specified; dose, route of administration, anatomical location, and indication: not reported). The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving influenza vaccine, the patient was really coughing, non-stop and cold weather change.  The outcome of the event was not reported.  The reporter did not provide causality assessment.  Company comment: A 44-year-old patient experienced cough an unknown amount of time after receiving the suspect product influenza vaccine. The patient's medical history, concomitant drugs, and diagnostic findings were not provided. Due to lack of information and unclear temporal relationship, causality for the reported event is unassessable.; Sender's Comments: A 44-year-old patient experienced cough an unknown amount of time after receiving the suspect product influenza vaccine. The patient's medical history, concomitant drugs, and diagnostic findings were not provided. Due to lack of information and unclear temporal relationship, causality for the reported event is unassessable.
Sex: F
Vaccine: FLUX
Symptoms: Discomfort
Clinical narrative: A little discomfort; This spontaneous case was received on 30-Nov-2022 from Communications (reference number: SEQW22-06149) and concerned a female patient of unspecified age. At the time of this report, the patient was 74-year-old.  The patient's medical history and concomitant medications were not reported.   On an unspecified date, the patient was vaccinated with influenza vaccine (brand not specified; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.   On an unspecified date, an unknown amount of time after receiving influenza vaccine, the patient experienced a little discomfort.  The outcome of the event was not reported.  The reporter did not provide a causality assessment.   This case is linked to the case 202208649 (the same patient).  Company comment: A female patient was vaccinated with influenza vaccine, on an unknown date. An unknown amount of time following vaccination, patient complained of discomfort. Considering limited information provided, and unclear temporal relationship, causality of the suspect vaccine is unassessable.; Sender's Comments: A female patient was vaccinated with influenza vaccine, on an unknown date. An unknown amount of time following vaccination, patient complained of discomfort. Considering limited information provided, and unclear temporal relationship, causality of the suspect vaccine is unassessable.
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Arthritis, Musculoskeletal stiffness
Clinical narrative: Her joints are inflamed; Could not turn her neck; This spontaneous case  was received on 01-Dec-2022 via Communications (reference number: SEQW22-06192), from other non-healthcare professional and concerned a 67-year-old, female patient.  The patient's medical history and concomitant medication were not reported.  On 12-Oct-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v, dose: reported as 0.5 ml, route of administration: not reported, anatomical location: not reported) for prevention of influenza disease. The batch number reported was 346337 and expiry date: 29-Apr-2023.   On 12-Oct-2022, an unreported amount of time after receiving Fluad Quadrivalent vaccine, the patient reported not being able to turn her neck and her joints were inflamed. Treatment measures associated with events were ibuprofen, Tylenol (paracetamol), and Aspirin (acetylsalicylic acid).  On 14-Oct-2022, described as two days later, the patient recovered from the event neck stiffness. The patient reported her neck became fine, but her joints were still inflamed.   At the time of initial reporting, the patient had not recovered from the event of joint inflammation. As reported,  joints were still inflamed.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 67-year-old female patient experienced arthritis and musculoskeletal stiffness on the same day following vaccination with Fluad Quadrivalent. Causal relationship for the reported events is assessed as possibly related due to suggestive temporal relationship.; Sender's Comments: A 67-year-old female patient experienced arthritis and musculoskeletal stiffness on the same day following vaccination with Fluad Quadrivalent. Causal relationship for the reported events is assessed as possibly related due to suggestive temporal relationship.
Age: 72.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Feeling abnormal, Feeling drunk, Gait disturbance, General physical health deterioration, Impaired driving ability
Clinical narrative: Tingle fat feeling lips. Spacey floating confused, driving felt like extremely drunk, couldn?t find words to reply to questions.  Extreme headache. Worried about stroke so paramedics came out. They did all the stroke questions and exam. Decided not enuf evidence. Called nurse friend to come by til husband home. Head cleared  better over the evening and better next day.
Age: 72.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Memory impairment, Mental disorder, Parosmia, Photophobia, Taste disorder
Clinical narrative: Tingle fat feeling lips. Spacey floating confused, driving felt like extremely drunk, couldn?t find words to reply to questions.  Extreme headache. Worried about stroke so paramedics came out. They did all the stroke questions and exam. Decided not enuf evidence. Called nurse friend to come by til husband home. Head cleared  better over the evening and better next day.
Age: 72.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Thinking abnormal, Visual impairment
Clinical narrative: Tingle fat feeling lips. Spacey floating confused, driving felt like extremely drunk, couldn?t find words to reply to questions.  Extreme headache. Worried about stroke so paramedics came out. They did all the stroke questions and exam. Decided not enuf evidence. Called nurse friend to come by til husband home. Head cleared  better over the evening and better next day.
Age: 72.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Anxiety, Aphasia, Confusional state, Feeling abnormal, Feeling drunk
Clinical narrative: Tingle fat feeling lips. Spacey floating confused, driving felt like extremely drunk, couldn?t find words to reply to questions.  Extreme headache. Worried about stroke so paramedics came out. They did all the stroke questions and exam. Decided not enuf evidence. Called nurse friend to come by til husband home. Head cleared  better over the evening and better next day.
Age: 72.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Headache, Impaired driving ability, Lip swelling, Paraesthesia oral
Clinical narrative: Tingle fat feeling lips. Spacey floating confused, driving felt like extremely drunk, couldn?t find words to reply to questions.  Extreme headache. Worried about stroke so paramedics came out. They did all the stroke questions and exam. Decided not enuf evidence. Called nurse friend to come by til husband home. Head cleared  better over the evening and better next day.
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Feeling cold, Hypoaesthesia, Lymphadenopathy, Oedema
Clinical narrative: Ongoing numb like, tingling, ache in arm/hand. Feel cold more often than before.  Swelling in axillary lymph nodes and surrounding areas. Increased edema. Increase joint pain.
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Ongoing numb like, tingling, ache in arm/hand. Feel cold more often than before.  Swelling in axillary lymph nodes and surrounding areas. Increased edema. Increase joint pain.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: COVID-19, Fatigue, Influenza, Influenza virus test positive, Pyrexia
Clinical narrative: Tested positive for  COVID-19 after several short trips with symptoms as follows:  Congestion  Fatigue (severe) Fever
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Tested positive for  COVID-19 after several short trips with symptoms as follows:  Congestion  Fatigue (severe) Fever
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: COVID-19, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID-19 with following symptoms: Congestion (severe)
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Shoulder injury related to vaccine administration, X-ray limb abnormal
Clinical narrative: Instant pain at injection site which is ongoing to the present date. Diagnosed with SIRVA and prescribed steroids and PT. Ongoing follow up appointments.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Pain
Clinical narrative: weak.tired and chill ,whole body sore
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Cough, Headache, Pain
Clinical narrative: Deep cough lungs hurt coughed up green colored flem and really bad headache the chills body ached
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Productive cough, Pulmonary pain, Sputum discoloured
Clinical narrative: Deep cough lungs hurt coughed up green colored flem and really bad headache the chills body ached
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Vaccination failure
Clinical narrative: Gave me the vaccine and I got them/ Suspected vaccination failure; Got them under my breasts; Terrible burning, cant wear bra; This case was reported by a consumer via interactive digital media and described the occurrence of 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), shingles and burning sensation. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and burning sensation to be related to Shingles vaccine.     Additional Information: GSK receipt date: 02-DEC-2022 Reporter's comment:  This case was reported by a consumer via interactive digital media. The patient reported that she had with them under her breasts for 2 months and she could not wear bra. A terrible burning and they gave her the vaccine and she got them. The patient said If she was known, she did not put it on, but it was optional. They gave her the vaccine for that disgusting thing of shingles and now patient had 2 months that they did not go away with anything and she had some terrible burning. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not possible, as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2 years ago, 2nd not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 29-NOV-2022 Reporter's comment: The reporter stated that 2 years prior to the reporting, the patient's wife, brother, nephew, niece and patient himself, received only 1 single dose of Shingrix. The patient never informed that Shingrix was given as 2 doses series and never received a second Shingrix dose. It was stated they all received the shot in the arm. Additional supportive information: Till the time of reporting the patient did not received 2nd dose of Shingrix which led to incomplete course of vaccination. The reporter consented to follow up. This case is 1 out of 5 cases reported by the same reporter and this case is for the reporter's niece.; Sender's Comments:  US-GSK-US2022AMR179085:Same reporter US-GSK-US2022178660:Same reporter US-GSK-US2022AMR179086:Same reporter US-GSK-US2022AMR179084:Same reporter
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Bexsero instead of  meningococcal Conjugate; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old female patient who received Men B NVS (Bexsero) (batch number 59M3M, expiry date 28th February 2023) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th October 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 12th October 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 29-NOV-2022 Reporter's comment:  The reporter reported that the patient was given Bexsero vaccination instead of a meningococcal conjugate.  Intended vaccine was meningococcal conjugate. The reporter consented to follow up. Additional supportive information:  The patient received Bexsero vaccine instead of a meningococcal conjugate, which led to wrong vaccine administered.
Age: 21.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal discomfort, Injection site inflammation, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Low grade fever; Upset stomach; Vomited; Swelling at the injection site; Injection site is itchy; Injection site is inflamed; This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 21-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included paracetamol (Tylenol).   On 15th November 2022, the patient received Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On 15th November 2022, several hours after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced injection site swelling, injection site itching and injection site inflammation. In November 2022, the patient experienced low grade fever, upset stomach and vomiting. In November 2022, the outcome of the low grade fever, upset stomach and vomiting were recovered/resolved. On an unknown date, the outcome of the injection site swelling, injection site itching and injection site inflammation were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site itching, injection site inflammation, low grade fever, upset stomach and vomiting to be related to Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra 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 Information: GSK Receipt Date: 29-NOV-2022 Reporter's Comments: The medical assistant reported that the patient received a dose of Fluarix Quadrivalent into left deltoid and hours later the patient experienced swelling at the injection site and reported it was itchy and inflamed. The reporter also reported that less than 2 weeks, the patient experienced a low grade fever, upset stomach and vomited. The concomitant drug included Benadryl. The reporter did not consent to follow up. No HCP consent provided. Additional Supportive Information: Concomitant medication Benadryl was only retained in narrative, as the ingredient was "NOS" which leads to report failure.
Age: 21.0
Sex: F
Vaccine: UNK
Symptoms: Vomiting
Clinical narrative: Low grade fever; Upset stomach; Vomited; Swelling at the injection site; Injection site is itchy; Injection site is inflamed; This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 21-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included paracetamol (Tylenol).   On 15th November 2022, the patient received Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On 15th November 2022, several hours after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced injection site swelling, injection site itching and injection site inflammation. In November 2022, the patient experienced low grade fever, upset stomach and vomiting. In November 2022, the outcome of the low grade fever, upset stomach and vomiting were recovered/resolved. On an unknown date, the outcome of the injection site swelling, injection site itching and injection site inflammation were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site itching, injection site inflammation, low grade fever, upset stomach and vomiting to be related to Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra 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 Information: GSK Receipt Date: 29-NOV-2022 Reporter's Comments: The medical assistant reported that the patient received a dose of Fluarix Quadrivalent into left deltoid and hours later the patient experienced swelling at the injection site and reported it was itchy and inflamed. The reporter also reported that less than 2 weeks, the patient experienced a low grade fever, upset stomach and vomited. The concomitant drug included Benadryl. The reporter did not consent to follow up. No HCP consent provided. Additional Supportive Information: Concomitant medication Benadryl was only retained in narrative, as the ingredient was "NOS" which leads to report failure.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Death
Clinical narrative: DEATH; HEART PROBLEMS; This spontaneous report received from a consumer via a company representative concerned a male of an unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was perfectly healthy before vaccination. 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, 01 total was administered for covid-19 prophylaxis. 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, after vaccination the patient experienced heart problems in two weeks.  On an unspecified date, the patient died from an unknown cause of death. It was unknown if an autopsy was performed or not. The reporter states "My friend had the shot, went from perfectly health to having a serious heart problems in two weeks. He just passed and his death certificate lists contributing factors as unknown". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on an unspecified date, and the outcome of heart problems was not reported. This report was serious (Death). This case, from the same reporter is linked to 20221209280.; Sender's Comments: V0-20221211945-Death . Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Arterial bypass operation, Physical examination
Clinical narrative: HAD THREE ARTERY BYPASS IN TWO WEEKS; This spontaneous report received from a patient (health care professional (registered nurse)) via a company representative via social media concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: For years, the patient had not been sick. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose not reported, 1 total administered (dose 1) on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  The patient had annual physical and all was well. On an unspecified date the patient had three artery bypass in two weeks. Reporter stated " Johnson & Johnson way too much writing. I had checked all the companies as husband was insisting I take vaccine. I chose j&j as seeing made felt the best as know most doctors very smart ( I'm an RN). Oh well. Had just had annual physical. All was well. Had not been sick in years. In two weeks had three artery bypass ". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of had three artery bypass in two weeks was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20221212440 - had three artery bypass in two weeks. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Illness
Clinical narrative: SICK; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a consumer via a company representative via social media concerned an adult female of an unspecified age, race and ethnicity. Initial information was processed along with the additional information received on 06-DEC-2022.  The patient's weight, height, and medical history were not reported.  The patient previously received two doses of covid-19 vaccine (unspecified manufacturer) (Dose number in series 1) (form of admin, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, administered for covid-19 prophylaxis.  It was unknown whether patients had any adverse event following vaccination with covid-19 vaccine (unspecified manufacturer) (Dose number in series 1). The patient received third dose of covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total, administered for covid-19 prophylaxis, which was associated with revaccination with different covid-19 vaccine (Dose number in series 2). 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 was sick (Dose number in series 2). It was reported that "My entire fam has had1,2,3x's- that's extended fam- on my side adult niece- all jabbed- All sick now". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sick and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious. This report was associated with a product quality complaint. The suspected product quality complaint has been confirmed to be voided (there was no product quality issue described in the information reported as there was insufficient information to determine vaccination failure. There was no timeline for date of vaccination to contracting covid and no confirmatory test reported) based on the PQC evaluation/investigation performed. This case, from the same reporter is linked to 20221210446, 20221210598, 20221210961, 20221211116, 20221212903 and 20221210980.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Influenza like illness, SARS-CoV-2 test
Clinical narrative: covid 19; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 055F22B) for COVID-19 prophylaxis.     Question:Was there parental vaccine exposure?Answer:No.  Previously administered products included for Product used for unknown indication: Pfizer (Dose 2) and Pfizer (Dose 1). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 03-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Dec-2022, the patient experienced COVID-19 (covid 19) and INFLUENZA LIKE ILLNESS (flu like symptoms). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever, at an unspecified dose and frequency. At the time of the report, COVID-19 (covid 19) and INFLUENZA LIKE ILLNESS (flu like symptoms) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Dec-2022, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Patient had flu like symptoms including fever, headache, coughing, body aches, and chills. Patient had been taking over the counter Coricidin HBP liquid.