chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I was diagnosed with Covid on April 29; I was diagnosed with Covid on April 29; J&J Drug Start date 16Mar2021/ Pfizer / BioNTech Drug Start date 01Dec2021;  Drug Start date 16Mar2021/ Pfizer / BioNTech Drug Start date 01Dec2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 01Dec2021 as dose 2 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in right arm for covid-19 immunisation; Janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 16Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 01Dec2021, outcome "unknown" and all described as "J&J Drug Start date 16Mar2021/ Pfizer / BioNTech Drug Start date 01Dec2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Apr2022, outcome "not recovered" and all described as "I was diagnosed with Covid on April 29". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Apr2022) Positive, notes: diagnosed with Covid on 29Apr; (20May2022) Positive, notes: Today is day 21 and I am still testing positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was diagnosed with Covid on 29Apr. The doctor prescribed Paxlovid which patient took for 5 days. Today was day 21 and still testing positive for Covid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Rhinorrhoea, Vaccination site infection
Clinical narrative: infection; sniffles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE INFECTION (non-serious), outcome "recovered", described as "infection"; RHINORRHOEA (non-serious), outcome "unknown", described as "sniffles". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: PNC20
Symptoms: Fatigue, Magnetic resonance imaging, Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: Swollen legs and arms; Stiff neck; Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 22Feb2022 as dose number unknown, single (Batch/Lot number: unknown) for pneumococcal immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Swollen legs and arms"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "Stiff neck"; FATIGUE (non-serious), outcome "unknown", described as "Tired". The events "swollen legs and arms", "stiff neck" and "tired" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient received Prevnar 20 on 22Feb2022. Since then patinet have had multiple health issues. Started in the arm and moved through patient's whole right side. Swollen legs and arms, stiff neck, and tired. Seen 3 different doctors and now having an MRI.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: became positive on Tuesday; became positive on Tuesday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A 69-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "became positive on Tuesday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: on Tuesday.  Additional information: the patient got his booster on Sunday as he had no symptoms. He became positive on Tuesday.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure, Suspected COVID-19
Clinical narrative: your covid 19 vaccine gave me a heart failure now I only have 15 years to live; I am sitting at home with covid now; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC FAILURE (medically significant, life threatening), outcome "unknown", described as "your covid 19 vaccine gave me a heart failure now I only have 15 years to live"; SUSPECTED COVID-19 (non-serious), outcome "unknown", described as "I am sitting at home with covid now".  Clinical course: The caller stated that your covid 19 vaccine gave me a heart failure now she only had 15 years to live, she send all the reports that you want and you ignore me now. She have a medical bills she was sitting at home with covid now and you ruined my life, wanted to know what Pfizer will do about it. How can you ask people to do booster when the two vaccines gave me heart failure. (Attempted to explain that Pfizer was a manufacture of the product but the treating HCP was in the best position to determine what's best for her specific situation) When attempted to clarify, exactly what information she was looking for, caller stated I spent (dollar) 9 mailing all the information to you and now you just ignore me since Jan and I am sitting here sick, what do you mean my doctor. it's your vaccine that was ruining peoples life, you are ruining peoples life and she want to know what you are going to do about it. Who was going to pay my medical bills who was going to care for 15 years that she have left, she was a healthy person, never had covid now she only had 15 years to live. Heart failure was 35% she was down to 25%, she was a dead person walking, you have my information how come you ignore me. she was gonna to call back (then caller said something inaudible and disconnected the call).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Gait disturbance
Clinical narrative: felt pressure on their feet; couldn't walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 53-year-old female patient received BNT162b2 (COMIRNATY), on 19Aug2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT DISTURBANCE (non-serious) with onset 2021, outcome "not recovered", described as "couldn't walk"; DISCOMFORT (non-serious) with onset 2021, outcome "not recovered", described as "felt pressure on their feet".  Additional information: Reporter and her husband (male 61 years old) received their first dose on 19Aug2021, they felt pressure on their feet. She stated "like someone hit us with a baseball bat", they couldn't walk. After that they received their second dose on September, her husband 9Sep2021 and caller 10Sep2021; she stated that now we are on May but since the month of March they are still with the same symptoms. They got the injection on their left shoulder and they have lost mobility, they can't lift the arm over their head. She said "it's horrible to say but I can't shave our arm pits." They can not scratch their backs, she stated they have lost mobility and flexibility of their arm totally. At work she has dropped boxes and her husband has dropped tools. And they even feel pain when they sneeze.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s) : US-PFIZER INC-202200744593 same reporter/product/event different patient
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: real sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 88-year-old female patient received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer unknown), for Covid-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "real sick".  Additional information: She states on 01Oct she got number 3 of the COVID-19 Vaccine and number 3 made her real sick but nothing like this. She states she felt like sleeping and didn't want to eat and really made her sick. She states she understand Corona from Pfizer has had bad effect. Caller states this was just something unusual and she wanted to call and tell Pfizer. Caller declines the report. Caller states she is not going to sue Pfizer or anything. She states her son got Moderna and he is vomiting when he got the Moderna. Caller declines to complete a report on her son. Caller states she doesn't want to do anything bad and she doesn't want to report her name or anything. She states how many more would have died without this. She states she had her 3rd dose of the Pfizer COVID-19 vaccine on 01Oct and wants to mention that she is almost 88 years old. She states her son is only 50 years old but was truly sick. Caller states the information was probably in the report as she did report this after her 3rd dose of the COVID-19 Vaccine in Oct. She states only one day and then this was 2 days. She states maybe with number 5 of the COVID-19 vaccine she hopes she will not have this effect. Caller states she knows this Call handler didn't make the vaccine. She states some people have died because of this and is bad. She states money needed to be payed for this. Caller states she just wanted Pfizer to know. She was told if something unusual occurred then to report the event. She states she is a natural born (withheld). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17May2022) positive, notes: Antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Extranodal marginal zone B-cell lymphoma (MALT type), Positron emission tomogram
Clinical narrative: MALToma; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 94-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown), in arm for covid-19 immunisation. No prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE: 1), for COVID-19 immunization; Bnt162b2 (DOSE: 2), for COVID-19 immunization; Bnt162b2 (DOSE: 3), for COVID-19 immunization. The following information was reported: EXTRANODAL MARGINAL ZONE B-CELL LYMPHOMA (MALT TYPE) (hospitalization) with onset Dec2021, outcome "recovered" (Feb2022), described as "MALToma". The event "maltoma" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Positron emission tomogram: clear PET scan, notes: Caller states her mother in law had the lymphoma removed and has a clear PET scan now. Therapeutic measures were taken as a result of extranodal marginal zone b-cell lymphoma (malt type). She states one went for an operation to get the lymphoma removed and the other one is undergoing chemotherapy.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body mass index, Pruritus, Urticaria, Vaccination site induration
Clinical narrative: Intolerable itchiness; Very large induration at injection site; Developed hives all over the body. Some quite large, including on the feet; mild GI upset; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 59-year-old female patient received BNT162b2 (BNT162B2), on 08Oct2021 as dose 3 (booster), single (Lot number: FC3183) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose:2), administration date: 21Jan2021, when the patient was 58-year-old, for COVID-19 immunization; BNT162b2 (Dose:1), administration date: 26Dec2020, when the patient was 58-year-old, for COVID-19 immunization. The following information was reported: URTICARIA (non-serious) with onset Oct2021, outcome "unknown", described as "Developed hives all over the body. Some quite large, including on the feet"; PRURITUS (non-serious) with onset Oct2021, outcome "unknown", described as "Intolerable itchiness"; VACCINATION SITE INDURATION (non-serious) with onset Oct2021, outcome "unknown", described as "Very large induration at injection site"; ABDOMINAL DISCOMFORT (non-serious) with onset Oct2021, outcome "unknown", described as "mild GI upset". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pruritus, vaccination site induration, urticaria, abdominal discomfort.  Additional information: At unknown time after receiving booster (either day 1 or 2) consumer (a neighbour) reported getting intolerable itchiness but she was at work and did not want to take antihistamines while working. Antihistamines were taken at some point (when at home, not sure on which day) and helped with the itch.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 03Jun2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 29Jun2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 29Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 45 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Herpes" (unspecified if ongoing), notes: Herpes. There were no concomitant medications, also reported as patient not received any other medications/products within 2 weeks of starting COVID-19 treatment. Past drug history included: Fenergan, reaction(s): "Known allergies: Fenergan", notes: Fenergan. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: 3 days in a row. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid started on 05May2022 and stopped on 10May2022. Clinical course was reported as, patient tested positive using Binax rapid antigen tests 3 days in a row. Mild symptoms returned on 19May2022 08:30. No Treatment Received for symptoms and patient not recovered from symptoms.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID on Thursday 05May; tested positive for COVID on Thursday 05May; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in right arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Gilbert's syndrome" (unspecified if ongoing). Concomitant medication(s) included: MIRENA, start date: 15Oct2015, also reported as other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05May2022, outcome "not recovered" and all described as "tested positive for COVID on Thursday 05May". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05May2022) Positive; (11May2022) Positive; (12May2022) Negative; (13May2022) Negative; (18May2022) Positive, notes: felt sick again and tested positive; (19May2022) Positive; (20May2022) Positive, notes: have tested positive the last three days. On Thursday(19May2022) and Friday(20May2022) felt only mild symptoms. Friday's antigen test line was almost non-visible. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid (start date: 05May2022, stop date: 10May2022). Clinical course was reported as, Patient tested positive for COVID on Thursday 05May2022 and Belgian Paxlovid that evening. She felt better but still mildly symptomatic by day 3. Patient again tested positive through Wednesday 11May2022 but negative on Thursday 12May2022 and Friday 5:13. Then on 17May2022 at 13:00 patient felt sick again and on Wednesday 18May2022 she tested positive. Patient have tested positive the last three days, though Thursday and Friday. She felt only mild symptoms. Patient expect she will test negative today (at the time of report) because Friday's antigen test line was almost non-visible. No therapeutic measures were taken as result of symptoms and patient was recovering from symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Movement disorder, Pain, Sneezing
Clinical narrative: have lost mobility; can't lift the arm over their head; even feel pain when they sneeze; even feel pain when they sneeze; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 53-year-old female patient received BNT162b2 (BNT162B2), on 10Sep2021 as dose 2, single (Batch/Lot number: unknown), in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose:1), administration date: 19Aug2021, for Covid-19 Immunization, reaction(s): "felt pressure on their feet", "couldn't walk". The following information was reported: MOBILITY DECREASED (non-serious), outcome "not recovered", described as "have lost mobility"; MOVEMENT DISORDER (non-serious), outcome "not recovered", described as "can't lift the arm over their head"; PAIN (non-serious), SNEEZING (non-serious), outcome "not recovered" and all described as "even feel pain when they sneeze".  Additional information: Caller (female 53 years old) and her husband (male 61 years old) received their first dose on 19Aug2021, they felt pressure on their feet. She stated "like someone hit us with a baseball bat", they couldn't walk. After that they received their second dose on Sep, her husband 09Sep2021 and caller 10Sep2021; she stated that now we are on May but since the month of Mar they are still with the same symptoms. They got the injection on their left shoulder and they have lost mobility, they can't lift the arm over their head. She said "it's horrible to say but I can't shave our arm pits." They can not scratch their backs, she stated they have lost mobility and flexibility of their arm totally. At work she has dropped boxes and her husband has dropped tools. And they even feel pain when they sneeze.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200744594 same reporter/product/event different patient
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Gait disturbance
Clinical narrative: felt pressure on their feet; like someone hit us with a baseball bat", they couldn't walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 19Aug2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DISCOMFORT (non-serious), outcome "not recovered", described as "felt pressure on their feet"; GAIT DISTURBANCE (non-serious), outcome "not recovered", described as "like someone hit us with a baseball bat", they couldn't walk".  Additional information: Caller stated that now they are on May but since the month of Mar they are still with the same symptoms. Question: Caller stated that the location where she and her husband received the vaccine provided phone number and stated that she was calling about the side effects that they have been experiencing and asked what should they do about it. Caller (female 53 years old) and her husband (male 61 years old) received their first dose on 19Aug2021, they felt pressure on their feet. She stated "like someone hit us with a baseball bat", they couldn't walk.  E-transmitting AE as caller disconnected the call before transfer. Caller stated that information about the shoulder side effects "is all over Google". She has already contacted her primary physician and they told her to contact Pfizer. She was very concerned because "we are just going in circles and circles, no one is doing a damn thing about it". She expressed her concerns about herself and her husband, and asked if they loose their jobs "then who is going to maintain them.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s) : US-PFIZER INC-202200743105 same reporter/product/event different patient
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Movement disorder, Pain, Sneezing
Clinical narrative: Have lost mobility; Cant lift the arm over their head; Even feel pain when they sneeze; Even feel pain when they sneeze; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 09Sep2021 as dose 2, single (Batch/Lot number: unknown), in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose:1), administration date: 19Aug2021, for Covid-19 Immunization, reaction(s): "felt pressure on their feet", "couldn't walk". The following information was reported: MOBILITY DECREASED (non-serious), outcome "not recovered", described as "Have lost mobility"; MOVEMENT DISORDER (non-serious), outcome "not recovered", described as "Cant lift the arm over their head"; PAIN (non-serious), SNEEZING (non-serious), outcome "not recovered" and all described as "Even feel pain when they sneeze".  Additional information :Caller (female 53 years old) and her husband (male 61 years old) received their first dose on 19Aug2021, they felt pressure on their feet. She stated like someone hit us with a baseball bat, they couldnt walk. After that they received their second dose on Sep, her husband 09Sep2021 and caller 10Sep2021; she stated that now we are on May but since the month of Mar they are still with the same symptoms. They got the injection on their left shoulder and they have lost mobility, they cant lift the arm over their head. She said its horrible to say but I cant shave our arm pits.They can not scratch their backs, she stated they have lost mobility and flexibility of their arm totally. At work she has dropped boxes and her husband has dropped tools. And they even feel pain when they sneeze.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200744592 same reporter/product/event different patient
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Headache
Clinical narrative: Headache; stomach pain; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 18May2022 at 11:45 as dose 4 (booster), single (Lot number: FL3197) at the age of 56 years intramuscular, in right arm for covid-19 immunization. The patient's relevant medical history included: "seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: AZELASTINE; QNASL; PEPCID [FAMOTIDINE]. Past drug history included: Sulfa, reaction(s): "Known allergies: sulfa drugs", notes: Known allergies: sulfa drugs; Clindamycin, reaction(s): "Known allergies: clindamycin", notes: Known allergies: clindamycin. Vaccination history included: Covid-19 vaccine (Dose 1, Primary immunization series completed but unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Primary immunization series completed but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Unknown manufacturer), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 19May2022 at 06:00, outcome "recovered"; ABDOMINAL PAIN UPPER (non-serious) with onset 19May2022 at 06:00, outcome "recovered", described as "stomach pain"; FATIGUE (non-serious) with onset 19May2022 at 06:00, outcome "recovered", described as "tired". Therapeutic measures were not taken as a result of headache, abdominal pain upper, fatigue.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID, also reported as other medications/products within 2 weeks of starting COVID-19 treatment. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (2022) Positive, notes: I am now testing positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid started on 07May2022 and stopped on 12May2022. Clinical course was reported as, patient started getting COVID symptoms a week after she finished Paxlovid on 19May2022 12:00 and she was now testing positive again. Patient not recovered from symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Polymerase chain reaction
Clinical narrative: mild allergy; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 58-year-old male patient received BNT162b2 (BNT162B2), on 26Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2 , Manufacturer: Pfizer, Batch/Lot No: EL3247), administration date: 17Feb2021, when the patient was 57-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 1, Manufacturer: Pfizer, Batch/Lot No: EL3247), administration date: 27Jan2021, when the patient was 57-year-old, for COVID-19 Immunization. The following information was reported: HYPERSENSITIVITY (non-serious) with onset 15May2022, outcome "unknown", described as "mild allergy". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Facility where the most recent COVID-19 vaccine was administered was workplace clinic. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. On 16May2022, daughter exposed at school and tested positive on 17May2022 and he tested positive 18May2022 prior to vaccination. It was unknown if patient diagnosed with COVID-19. Since the vaccination, patient had been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Neck pain, Tremor, Weight decreased
Clinical narrative: neck pain; subjective weight loss; tremors; Initial information received on 16-May-2022 via healthcare professional regarding an unsolicited valid serious case issued from a literature abstract:   This case involves a 63-year-old female patient who experienced neck pain, subjective weight loss and tremors while receiving influenza vaccine (latency: unknown).  The patient's past vaccination(s) and family history were not provided. The patient had meningioma treated with gross total resection (without radiation) three years ago. At the time of report, she had ongoing Graves disease.  On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, patient was presented to the Emergency Department (ED) with two weeks of neck pain, subjective weight loss (Weight decreased), and tremors (Tremor) after receiving the influenza vaccine.  Action taken: not applicable Corrective treatment: not reported Outcome: unknown  Seriousness criteria: hospitalization Reporter causality: related Based upon the reported information, the role of a vaccine cannot be assessed.; Sender's Comments: Sanofi company comment dated 19-May-2022:  This case involves a 63-year-old female patient who experienced subjective weight loss and tremors while receiving influenza vaccine. Based upon the information the role of suspect drugs cannot be denied however the lack of information related to past drugs, latency and concomitant drugs precludes better case assessment.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: mixed the ActHib component with the dilutant for MMRV and Varicella instead of the Dtap-IPV component/ HIB portion of Pentacel was reconstituted with the MMR/Varicella diluting with no reported adverse event; Initial information received on 11-May-2022 regarding an unsolicited valid  non-serious social media case received from a other health professional.   This case involves Child and unknown gender patient who experienced mixed the acthib component with the dilutant for mmrv and varicella instead of the dtap-ipv component/ hib portion of pentacel was reconstituted with the mmr/varicella diluting with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel].     The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine unknown formulation and strength lot number not reported via unknown route in unknown administration site for prophylactic vaccinaton.  On an unknown date, the acthib component was mixed with the dilutant for mmrv and varicella instead of the dtap-ipv component/ hib portion of pentacel was reconstituted with the mmr/varicella diluting with no reported adverse event (product preparation error) (unknown latency). The HIB portion of Pentacel was reconstituted with the MMR/Varicella diluting  Action taken: Not applicable  Outcome: Unknown      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.
Sex: U
Vaccine: TD, TDAP
Symptoms: Medication error, Poor quality product administered, Product storage error
Clinical narrative: vaccine administered post excursion with no adverse event;   Initial information received on 13-May-2022 regarding an unsolicited valid non-serious case received from a other health professional.    This case involves 11 patients who experienced vaccine administered post excursion with no adverse event while receiving vaccines diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] and diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel].     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 diphtheria-2/tetanus/5 ac pertussis vaccine lot C59638AA Expiration: 18Jan2024 and a  dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult lot C5779AA Expiration: 02Oct2022  unknown formulation and strength via unknown route in unknown administration site for prophylactic vaccination.  There was some Refrigerator malfunction and power outage Max/Low Temperature reached: First excursion: (negative) -0.6 C for 277 hours and 25 minutes Second excursion: 53.1 F for 18 hours and 52 minutes Duration out of labelled range: Total 296 hours and 17 minutes. No human Error was involved.  It was administered to 11 patients post excursion (poor quality product administered) (unknown onset and latency)   Action taken: Not applicable  Outcome: Unknown     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.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: Potentially expired ACTHIB was administered today, powder expires 5/17 however the diluent expired on 5/3 with no reported adverse event; Initial information received on 17-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient who experienced potentially expired acthib was administered today, powder expires 5/17 however the diluent expired on 5/3 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.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination.  On 17-May-2022, the patient received a  dose of suspect HIB (PRP/T) VACCINE lot UJ457AA via intramuscular route in the left thigh for prophylactic vaccination.  On an unknown date the patient developed a non-serious potentially expired acthib was administered today, powder expires 5/17 however the diluent expired on 5/3 with no reported adverse event (expired product administered) (unknown latency) following the administration of HIB (PRP/T) VACCINE.  Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Potentially expired ACTHIB was administered today, powder expires 5/17 however the diluent expired on 5/3 with no reported adverse event).  At time of reporting, the outcome was Unknown for the event potentially expired acthib was administered today, powder expires 5/17 however the diluent expired on 5/3 with no reported adverse 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: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: administered the liquid component of the Pentacel to a patient without diluting the lyophilized component (with no reported adverse event); Initial information received 19-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 10 weeks old male patient who experienced administered the liquid component of the pentacel to a patient without diluting the lyophilized component (with no reported adverse event) while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis B vaccine for prophylactic vaccination, pneumococcal vaccine conj 13v (crm197) (Prevnar 13) for prophylactic vaccination and rotavirus vaccine for Prophylactic vaccination.  On 06-May-2022, the patient received a 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/IPV(MRC5)/HIB(PRP/T) vaccine (strength, formulation: unknown) (lot UJ531AAA; expiry date: 22-Jul-202) via intramuscular route in right thigh for prophylactic vaccination.  On 06-May-2022 (latency: same day) the patient experienced administered the liquid component of the pentacel to a patient without diluting the lyophilized component (with no reported adverse event) (product preparation error) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine.  Action taken; 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 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: F
Vaccine: TDAP
Symptoms: Fatigue
Clinical narrative: felt fatigued; Initial information was received on 19-May-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves female patient of unknown age who felt fatigued after receiving vaccine Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel].  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 Diphtheria-2/Tetanus/5 AC Pertussis Vaccine (formulation, strength, dose, route, batch/lot number, expiration date: unknown) in unknown administration site as prophylactic vaccination.  On an unknown date, the patient felt fatigued (fatigue) (unknown latency) following the administration of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine.  Seriousness criteria: non-serious  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (fatigue).  At time of reporting, the outcome was Unknown for the event (fatigue).
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Erythema, Pyrexia, Urticaria
Clinical narrative: Shortness of breath; Redness all over his body; Hives; Fever; This spontaneous case from the United States was received on 17-May-2022 from other healthcare professional via Agency(reference number: SEQW22-01439) and concerned a 24-year-old, male patient. At the time of this report, the patient was 36-year-old.  The patient's relevant medical history and concomitant medications were not reported.  On an unspecified date in Oct-2009, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact split 4v; route of administration, anatomical location and dose: not reported) for influenza prevention. The batch number was not reported.   On an unspecified date in 2009, shortly after receiving Afluria Quadrivalent, the patient experienced shortness of breath, redness all over his body, hives and fever.    As reported, the patient had hives with his COVID vaccine, he was in the air force and was exempt from flu vaccines.  The outcome of all events was not reported.  The reporter did not provide causality assessment.  Company comment: A 24-year-old male patient experienced dyspnea, erythema, urticaria and pyrexia, shortly after receiving Afluria Quadrivalent vaccine. Information regarding medical history and concomitant medications was not provided. Reportedly, the patient had hives with COVID vaccine, also. Considering plausible temporal relationship causality is assessed as possibly related. Agency criteria for anaphylaxis could not be assessed due to insufficient information provided.; Sender's Comments: A 24-year-old male patient experienced dyspnea, erythema, urticaria and pyrexia, shortly after receiving Afluria Quadrivalent vaccine. Information regarding medical history and concomitant medications was not provided. Reportedly, the patient had hives with COVID vaccine, also. Considering plausible temporal relationship causality is assessed as possibly related. Agency criteria for anaphylaxis could not be assessed due to insufficient information provided.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Dermatitis contact, Ear pruritus, Pruritus, Skin burning sensation
Clinical narrative: I never had a problem or adverse reaction to using hair dye until after receiving my Covid 19 booster shot.  After receiving the third shot (booster) I dyed my hair as I normally do about one a month and had a severe reaction.   Burning, blistering and severe itching of my scalp, ears, forehead, face and neck occurred and this lasted for weeks.  Subsequent,  I tried a professional grade weaker hair dye and the same severe reactions occurred.   This never happened until after I received the booster shot.  I believe it is directly attributable to the booster and now question what other adverse reactions might occur in the future due to this shot.  I no longer consider the Covid vaccine to be safe for continued use because of this documented reaction and the great likelihood of future unknown negative reactions
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Pain
Clinical narrative: Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Lethargy, Pain
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Exhaustion / Lethargy-Severe
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypotension, Nausea
Clinical narrative: Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Additional Details: Approximately 5-10 minutes after IM adminstration of Pfizer vaccine, patient was complaining of nausea, lightheadedness, feeling of "passing out". Patient's blood pressure was 98/67 with HR 62.  I called 911 and immediately gave patient about 8 -10 ounces of water, which she sipped slowly over 10-15 minutes.  Rechecked her blood pressure, which was 102/69 until rescue arrived.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose decreased, Cold sweat, Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient stated that he feels lightheadedness and upon touch, he feels clampy. Advised him to lie down (his mom holding him), and then checked his blood pressure. His blood pressure is on a lower side 89/60 with pulse around 46.  He ate breakfast (cereal and banana) at 8am and the vaccine was given at 12:00pm. His blood sugar might be low (but cannot confirm since we do not have the authority to do blood sugar check).  I gave the patient some Pedialyte which has electrolytes and sugar.