chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram, Palpitations, Sleep disorder
Clinical narrative: On 5/5/21 I went to the Emergency Room because I was experiencing non stop heart palpitations with a shortness of breath.  The palpitations woke me from my sleep.  I had experienced the shortness of breath before receiving the vaccine.   However, I had never felt heart palpitations as intense and frightening as this before.  My heart was racing non stop when I was lying still in bed, for several hours and after awakening.  I then was advised to go to the ER.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, SARS-CoV-2 test positive
Clinical narrative: pt admit to hospital 3/12/22 w/ acute respiratory failure w/ hypoxia s/p positive COVID test 3/1/22. Pt had previously received 3 Pfizer doses (2/9/21. 3/2/21, 10/20/21). She was found to have a PE shortly after admit. Pt not immunocompromised, but age = 83
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jan2021 (Batch/Lot number: unknown) at the age of 49 years as dose 2, single and administration date 21Dec2020 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "calculus of kidney" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "type 2 diabetes" (unspecified if ongoing), notes: type 2 diabetes; "depression" (unspecified if ongoing); "vertigo" (unspecified if ongoing). Concomitant medication(s) included: MECLIZINE [MECLOZINE]; METFORMIN XR; MORPHINE; GABAPENTIN; OMEPRAZOLE; FLUOXETINE; OXCARBAZEPINE. Past drug history included: Hydrocodone, reaction(s): "Known allergies: hydrocodone". The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 12Mar2022, outcome "unknown", COVID-19 (medically significant) with onset 12Mar2022, outcome "recovered" (14Mar2022) and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: they had given a child the correct formulation of the Pfizer COVID-19 Vaccine as a 1st dose in Dec2021/The patient was diagnosed with COVID-19 before 21 days.; they had given a child the correct formulation of the Pfizer COVID-19 Vaccine as a 1st dose in Dec2021/The patient was diagnosed with COVID-19 before 21 days.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A child patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "they had given a child the correct formulation of the Pfizer COVID-19 Vaccine as a 1st dose in Dec2021/The patient was diagnosed with COVID-19 before 21 days.".  Clinical course: Vaccination Coordinator who was also a paramedic called in about the Pfizer COVID-19 Vaccine Dose. The patient was currently being booked for a 2nd dose of the Pfizer COVID-19 Vaccine. Caller wants to know if it's ok for the patient to take the 2nd dose and for them to take the booster dose. Caller did not have patient details available.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient tested positive for Covid despite receiving 3 vaccinations; Patient tested positive for Covid despite receiving 3 vaccinations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administration date 03Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date 08Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date 11Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Patient tested positive for Covid despite receiving 3 vaccinations". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: but anyway he had got infected with covid, as well as his 16 years old daughter and a 45 years old female.; he had got infected with covid, as well as his 16 years old daughter and a 45 years old female.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 16 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose numbre unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (primary series immunization completed, Unknown manufacturer), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "but anyway he had got infected with covid, as well as his 16 years old daughter and a 45 years old female."; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "he had got infected with covid, as well as his 16 years old daughter and a 45 years old female.". The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got his Covid 19 vaccine including the booster/but anyway he had got infected with covid, as well as his 16 years old daughter and a 45 years old female.; got his Covid 19 vaccine including the booster/but anyway he had got infected with covid, as well as his 16 years old daughter and a 45 years old female.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 45 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got his Covid 19 vaccine including the booster/but anyway he had got infected with covid, as well as his 16 years old daughter and a 45 years old female." Clinical course: The Reporter reached to provide his feedback regarding Pfizer Covid-19 Vaccine. Considered himself a vaccine believer, got his Covid 19 vaccine including the booster and followed all the indications like the use of masks, but anyway he had got infected with Covid, as well as his 16 years old daughter and a 45 years old female. Not to know the virus variant that infected him. Reported Chest issues derived his infection and also reported that many people around were also infected. In comparison with the Flu Vaccine, there should be a new Covid vaccine every year, but it's not the case.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: A patient received her first dose (Pfizer COVID-19 Vaccine), in Dec and before Dec, before her 2nd, before the 21 days she was diagnosed with COVID.; A patient received her first dose (Pfizer COVID-19 Vaccine), in Dec and before Dec, before her 2nd, before the 21 days she was diagnosed with COVID.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "A patient received her first dose (Pfizer COVID-19 Vaccine), in Dec and before Dec, before her 2nd, before the 21 days she was diagnosed with COVID.".  Clinical course:Dates for A patient received her first dose (Pfizer COVID-19 Vaccine), in Dec and before Dec, before her 2nd, before the 21 days she was diagnosed with COVID. When confirmed is it with Pfizer COVID-19 Vaccine: Reporter added, Yes, for the 7Apr to 11Apr. Is there a Product Complaint: Yes.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Drug ineffective, Heart rate, Suspected COVID-19
Clinical narrative: COVID twice; COVID twice; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: I had COVID twice once before the vaccine. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID twice". The patient underwent the following laboratory tests and procedures: blood pressure measurement: 120 to 130 over 80; heart rate: 79 to 81.  Clinical Course: Patient have had no health or heart problems. Heart rate is 79 to 81 BP is 120 to 130 over 80.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Laryngitis, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: AG neg 3/13 positive 3/15; rhinorrhea; laryngitis; cough; AG neg 3/13 positive 3/15; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 40 year-old male patient received bnt162b2 (BNT162B2), administration date 12Oct2021 (Lot number: FF2589) at the age of 40 years as dose 3 (booster), single, administration date 25Feb2021 (Lot number: EL3247) as dose 2, single and administration date 05Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "AG neg 3/13 positive 3/15"; RHINORRHOEA (non-serious) with onset 12Mar2022, outcome "unknown", described as "rhinorrhea"; LARYNGITIS (non-serious) with onset 12Mar2022, outcome "unknown", described as "laryngitis"; COUGH (non-serious) with onset 12Mar2022, outcome "unknown", described as "cough". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (13Mar2022) neg; (15Mar2022) positive. It was unknown if therapeutic measures were taken as a result of rhinorrhoea, laryngitis, cough. It was unknown if the patient had received any other vaccine in four weeks. It was unknown if the patient had covid prior to vaccination. No sensory involvement. Clinically stable from the onset of symptoms. Treatment with Immunoglobulin therapy at doses of 2g / kg - 77Kg (154g in total), from 22No2021 to 26Nov2021. Clinically the patient reports improvement in fine manipulation and in lower limbs. It was a chronic inflammatory demyelinating polyneuropathy vs Multifocal Motor Neuropathy vs Gillian-Barre Syndrome.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: AG neg 3/13 positive 3/15; rhinorrhea; laryngitis; cough; AG neg 3/13 positive 3/15; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 40 year-old male patient received bnt162b2 (BNT162B2), administration date 12Oct2021 (Lot number: FF2589) at the age of 40 years as dose 3 (booster), single, administration date 25Feb2021 (Lot number: EL3247) as dose 2, single and administration date 05Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "AG neg 3/13 positive 3/15"; RHINORRHOEA (non-serious) with onset 12Mar2022, outcome "unknown", described as "rhinorrhea"; LARYNGITIS (non-serious) with onset 12Mar2022, outcome "unknown", described as "laryngitis"; COUGH (non-serious) with onset 12Mar2022, outcome "unknown", described as "cough". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (13Mar2022) neg; (15Mar2022) positive. It was unknown if therapeutic measures were taken as a result of rhinorrhoea, laryngitis, cough. It was unknown if the patient had received any other vaccine in four weeks. It was unknown if the patient had covid prior to vaccination. No sensory involvement. Clinically stable from the onset of symptoms. Treatment with Immunoglobulin therapy at doses of 2g / kg - 77Kg (154g in total), from 22No2021 to 26Nov2021. Clinically the patient reports improvement in fine manipulation and in lower limbs. It was a chronic inflammatory demyelinating polyneuropathy vs Multifocal Motor Neuropathy vs Gillian-Barre Syndrome.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Losing hair; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A female patient received bnt162b2 (COMIRNATY) (Lot number: Not Provided) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "Losing hair".  Additional information: The report was not related to a study or programme. She reported her daughter had the Pfizer Vaccine for Covid at the same time as reporter did. She thought it started in October or the first of October-year, further date details and clarification of what 'it' was that started not provided. The reporter reported her daughter was losing her hair. Reporter couldn't figure it out. Reporter's daughter took Biotin which helped with her hair.  The lot number for vaccine [BNT162B2] was not provided and will be requested during follow-up.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: indication=Treatment of COVID-19; indication=Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 14:00 (Lot number: EW0175) at the age of 66 years as dose 3 (booster), single, administered in arm left, administration date 04Mar2021 13:00 (Lot number: EN6203) as dose 2, single and administered in arm left, administration date 11Feb2021 15:00 (Lot number: EN6201) as dose 1, single for covid-19 immunisation. Relevant medical history included: "RA" (unspecified if ongoing), notes: Verbatim: RA; "Autoimmune hepatitis" (unspecified if ongoing), notes: Verbatim: Autoimmune hepatitis; "NAFL" (unspecified if ongoing), notes: verbatim: NAFL; "Depression" (unspecified if ongoing), notes: Verbatim: Depression. The patient's concomitant medications were not reported. Past drug history included: Enbrel, start date: 09Sep2013, notes: other medication in 2weeks product=Enbrel,, other medication in 2weeks brand= Accredo,, other medication in 2weeks start date=09Sep2013; Cellcept, start date: 06Dec2019, notes: other medication in 2weeks product=Cellcept,, other medication in 2weeks start date=06Dec2019; Levothryoxin, start date: Apr1995, notes: other medication in 2weeks product=Levothryoxin,, other medication in 2weeks start date=Apr1995; Pristiq, start date: May2000, notes: other medication in 2weeks product=Pristiq,, other medication in 2weeks start date=May2000. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "indication=Treatment of COVID-19". Therapeutic measures were taken as a result of suspected covid-19, Anti-viral drug (treatment start date=14Mar2022, lot number=FX2740) used for COVID 19 Treatment.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Musculoskeletal pain
Clinical narrative: pain below the shoulder blade bone; has difficulty of breathing/Shortness of Breath in Upper Chest; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) at the age of 72 years as dose 1, single and administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: She had Asthma before but this feels different. There were no concomitant medications. The following information was reported: MUSCULOSKELETAL PAIN (non-serious), outcome "unknown", described as "pain below the shoulder blade bone"; DYSPNOEA (non-serious) with onset Mar2021, outcome "not recovered", described as "has difficulty of breathing/Shortness of Breath in Upper Chest". Therapeutic measures were taken as a result of dyspnea.  Additional information: Reporter was a 72 year old female stating that she received her first dose of Pfizer BioNtech Covid vaccine on Feb2021 and second dose Mar2021. She has completed all kinds of breathing tests and heart test and was trying to find out what was happening to her. When doing Physical activity, she experiences pain below the shoulder blade bone and has difficulty of breathing and these symptoms appeared just about the same time as she received the shots. and she would like to know if this side effect has been reported? she would like to keep this information confidential. She has had Asthma before but this feels different. Reporter was stated that she was calling about the Shot, the Covid Shot; clarified the Pfizer Covid 19 Vaccine. Reporter was stated she has reported different things and they send her a survey every so often. Reporter was stated what she wanted to know was, this problem started happening after those shots, the Shortness of Breath in her upper chest, and she keeps telling her doctors that it was the shot that did it. Reporter was stated the shortness of breath in her upper chest started after her second dose. Reporter was states she was going through treatment, they think it was Asthma, but she has had that all her life, and the shortness of breath just started happening after the shots.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Hypoaesthesia, Investigation, Limb mass, SARS-CoV-2 test
Clinical narrative: I felt heaviness on my chest; I felt numbness in my leg; I felt numbness in my leg and arm small bumps; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Aug2021 (Lot number: Ew0191) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Kidney reflux" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing); "Known allergies: mosquitoes (skeeter syndrome)" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CHEST DISCOMFORT (non-serious) with onset 11Aug2021, outcome "recovered", described as "I felt heaviness on my chest"; HYPOAESTHESIA (non-serious) with onset 11Aug2021, outcome "recovered", described as "I felt numbness in my leg"; LIMB MASS (non-serious) with onset 11Aug2021, outcome "recovered", described as "I felt numbness in my leg and arm small bumps". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient didn't received any other vaccine in four weeks, She delivered a baby the day before. No vaccination received prior covid vaccination. The patient went for covid test post vaccination. They let me leave right away. Within 40 min she felt heaviness on her chest. For the next week or more she felt numbness in her leg and arm small bumps.  Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Hunger, Hypoglycaemia, Increased appetite, Malaise, Nausea
Clinical narrative: Extreme increase in appetite; Extreme increase in appetite causing what seems like hypoglycemic episodes if hunger is not satisfied; 50-100% in food intake to satisfy hungrier throughout the day; Body shakes; Nausea; General unwell feeling will continue until a large meal is eaten; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 29-year-old male patient received bnt162b2 (BNT162B2), administered in right arm, administration date 21Dec2021 (Lot number: 3035BA) at the age of 29 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. The patient did not receive any concomitant medications. The following information was reported: INCREASED APPETITE (non-serious) with onset 28Dec2021, outcome "not recovered", described as "Extreme increase in appetite"; HYPOGLYCAEMIA (non-serious) with onset 28Dec2021, outcome "not recovered", described as "Extreme increase in appetite causing what seems like hypoglycemic episodes if hunger is not satisfied"; HUNGER (non-serious) with onset 28Dec2021, outcome "not recovered", described as "50-100% in food intake to satisfy hungrier throughout the day"; TREMOR (non-serious) with onset 28Dec2021, outcome "not recovered", described as "Body shakes"; NAUSEA (non-serious) with onset 28Dec2021, outcome "not recovered", described as "Nausea"; MALAISE (non-serious) with onset 28Dec2021, outcome "not recovered", described as "General unwell feeling will continue until a large meal is eaten". The events "Extreme increase in appetite", "Extreme increase in appetite causing what seems like hypoglycemic episodes if hunger is not satisfied", "50-100% in food intake to satisfy hungrier throughout the day", "Body shakes", "Nausea" and "General unwell feeling will continue until a large meal is eaten" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of increased appetite, hypoglycaemia, hunger, tremor, nausea and malaise.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had been tested for COVID-19.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tremor
Clinical narrative: Extreme increase in appetite; Extreme increase in appetite causing what seems like hypoglycemic episodes if hunger is not satisfied; 50-100% in food intake to satisfy hungrier throughout the day; Body shakes; Nausea; General unwell feeling will continue until a large meal is eaten; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.   A 29-year-old male patient received bnt162b2 (BNT162B2), administered in right arm, administration date 21Dec2021 (Lot number: 3035BA) at the age of 29 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. The patient did not receive any concomitant medications. The following information was reported: INCREASED APPETITE (non-serious) with onset 28Dec2021, outcome "not recovered", described as "Extreme increase in appetite"; HYPOGLYCAEMIA (non-serious) with onset 28Dec2021, outcome "not recovered", described as "Extreme increase in appetite causing what seems like hypoglycemic episodes if hunger is not satisfied"; HUNGER (non-serious) with onset 28Dec2021, outcome "not recovered", described as "50-100% in food intake to satisfy hungrier throughout the day"; TREMOR (non-serious) with onset 28Dec2021, outcome "not recovered", described as "Body shakes"; NAUSEA (non-serious) with onset 28Dec2021, outcome "not recovered", described as "Nausea"; MALAISE (non-serious) with onset 28Dec2021, outcome "not recovered", described as "General unwell feeling will continue until a large meal is eaten". The events "Extreme increase in appetite", "Extreme increase in appetite causing what seems like hypoglycemic episodes if hunger is not satisfied", "50-100% in food intake to satisfy hungrier throughout the day", "Body shakes", "Nausea" and "General unwell feeling will continue until a large meal is eaten" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of increased appetite, hypoglycaemia, hunger, tremor, nausea and malaise.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had been tested for COVID-19.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dysstasia, Gait disturbance, Muscular weakness, SARS-CoV-2 test
Clinical narrative: Having severe muscle weakness; unable to steady my walk, keep balance, hold my arms or head up; unable to steady my walk, keep balance, hold my arms or head up; can't stand longer than 10 mins, comes and goes.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 18 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2022 18:00 (Lot number: KF9895) at the age of 18 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "If covid prior vaccination: Yes" (unspecified if ongoing), notes: If covid prior vaccination: Yes; "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drugs; "Known allergies: PNC" (unspecified if ongoing). Concomitant medication(s) included: PROPRANOLOL; KLONOPIN; EFFEXOR. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: KF9895, Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM), administration date: 23Feb2022, when the patient was 18 years old, for COVID-19 Immunization. The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset 16Mar2022 02:00, outcome "not recovered", described as "Having severe muscle weakness"; GAIT DISTURBANCE (non-serious), BALANCE DISORDER (non-serious) all with onset 16Mar2022 02:00, outcome "not recovered" and all described as "unable to steady my walk, keep balance, hold my arms or head up"; DYSSTASIA (non-serious) with onset 16Mar2022 02:00, outcome "not recovered", described as "can't stand longer than 10 mins, comes and goes.". The events "having severe muscle weakness", "unable to steady my walk, keep balance, hold my arms or head up", "unable to steady my walk, keep balance, hold my arms or head up" and "can't stand longer than 10 mins, comes and goes." were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of muscular weakness, gait disturbance, balance disorder, dysstasia. No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Pyrexia, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Fatigue; Fever; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Jun2021 (Batch/Lot number: unknown) at the age of 54 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) till Dec2021 at (citrate free) (1 in 1 once) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Route of administration: intramuscular), administration date: May2021, for COVID-19 immunisation. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset Feb2022, outcome "recovering", described as "Rheumatoid arthritis flare up"; FATIGUE (non-serious) with onset Jun2021, outcome "recovered" (2021), described as "Fatigue"; PYREXIA (non-serious) with onset Jun2021, outcome "recovered" (2021), described as "Fever". The action taken for adalimumab was unknown.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of fatigue, rheumatoid arthritis flare up and fever with Humira (Adalimumab) was no reasonable possibility.  Causality for Pfizer BioNTech Covid-19 Vaccine: The reporter's causality for the event fatigue and fever was probable and for rheumatoid arthritis flare up was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Rheumatoid arthritis flare up, Fatigue and Pyrexia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: severe leg cramps; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Unknown manufacturer, Primary Immunization), for COVID-19 immunization. The following information was reported: MUSCLE SPASMS (non-serious), outcome "not recovered", described as "severe leg cramps".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Illness, Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: I was really sick; coughing; wheezing; Very short on breath; administration date: 30Aug2021 dose number 2/administration date: 23Aug2021 dose number 1; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Aug2021 15:00 (Batch/Lot number: unknown) at the age of 67 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL/HCTZ. Vaccination history included: Bnt162b2 (lot unknown=True,, administration time=03:00 PM, dose number=1,, vaccine location=Left arm), administration date: 23Aug2021, when the patient was 67 years old, for COVID-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 30Aug2021, outcome "unknown", described as "administration date: 30Aug2021 dose number 2/administration date: 23Aug2021 dose number 1"; ILLNESS (non-serious) with onset 01Sep2021 12:00, outcome "not recovered", described as "I was really sick"; COUGH (non-serious) with onset 01Sep2021 12:00, outcome "not recovered", described as "coughing"; WHEEZING (non-serious) with onset 01Sep2021 12:00, outcome "not recovered", described as "wheezing"; DYSPNOEA (non-serious) with onset 01Sep2021 12:00, outcome "not recovered", described as "Very short on breath". The events "administration date: 30aug2021 dose number 2/administration date: 23aug2021 dose number 1", "i was really sick", "coughing", "wheezing" and "very short on breath" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of illness, cough, wheezing, dyspnoea.  Additional information: The week after last shot she was really sick - coughing and wheezing. Very short on breath. Was put nebulizer treatments. Had to take at least 4 a day just to function. 7 months later she is still taking 2 - 3 each day. The patient informed that they were Unable to locate or read the lot details, No other vaccine in four weeks. Ae treatment included Nebulizer treatments, Prednisone. No COVID prior vaccination  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: I was really sick; coughing; wheezing; Very short on breath; administration date: 30Aug2021 dose number 2/administration date: 23Aug2021 dose number 1; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Aug2021 15:00 (Batch/Lot number: unknown) at the age of 67 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL/HCTZ. Vaccination history included: Bnt162b2 (lot unknown=True,, administration time=03:00 PM, dose number=1,, vaccine location=Left arm), administration date: 23Aug2021, when the patient was 67 years old, for COVID-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 30Aug2021, outcome "unknown", described as "administration date: 30Aug2021 dose number 2/administration date: 23Aug2021 dose number 1"; ILLNESS (non-serious) with onset 01Sep2021 12:00, outcome "not recovered", described as "I was really sick"; COUGH (non-serious) with onset 01Sep2021 12:00, outcome "not recovered", described as "coughing"; WHEEZING (non-serious) with onset 01Sep2021 12:00, outcome "not recovered", described as "wheezing"; DYSPNOEA (non-serious) with onset 01Sep2021 12:00, outcome "not recovered", described as "Very short on breath". The events "administration date: 30aug2021 dose number 2/administration date: 23aug2021 dose number 1", "i was really sick", "coughing", "wheezing" and "very short on breath" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of illness, cough, wheezing, dyspnoea.  Additional information: The week after last shot she was really sick - coughing and wheezing. Very short on breath. Was put nebulizer treatments. Had to take at least 4 a day just to function. 7 months later she is still taking 2 - 3 each day. The patient informed that they were Unable to locate or read the lot details, No other vaccine in four weeks. Ae treatment included Nebulizer treatments, Prednisone. No COVID prior vaccination  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, Pneumonia
Clinical narrative: COVID pneumonia; started feeling shortness of breath; 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 59 year-old female patient received bnt162b2 (COMIRNATY), administration date 09Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "autoimmune disorder" (unspecified if ongoing), notes: vaccine revealed that patient  had an autoimmune disorder.; "interstitial lung disease" (unspecified if ongoing), notes: No information on interstitial lung disease. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st), for COVID-19 immunization. The following information was reported: DYSPNOEA (hospitalization), outcome "unknown", described as "started feeling shortness of breath"; PNEUMONIA (hospitalization, medically significant), outcome "unknown", described as "COVID pneumonia". The patient was hospitalized for dyspnoea (start date: 18Mar2021, discharge date: 18Mar2021, hospitalization duration: 1 day(s)). The patient underwent the following laboratory tests and procedures: covid-19: (18Mar2021) negative. Therapeutic measures were taken as a result of pneumonia. Clinical Course: Patient was treated with antibiotics and went home, but 1 week later she came back and was hospitalized for almost 2 months.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: I have consistently gotten it every 28 days, except this month and the months of Mar and Apr (which was around the time of my first and second shot); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 03Mar2021 (Lot number: er8730) at the age of 34 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset Mar2021, outcome "unknown", described as "I have consistently gotten it every 28 days, except this month and the months of Mar and Apr (which was around the time of my first and second shot)". Additional information: No other vaccine in four weeks. Other medications in two weeks included birth control pill. Adverse event included that she got her period 2 days after shot which was one week early. She had tracked her period for the last year and has consistently gotten it every 28 days, except this month and the months of Mar and Apr (which was around the time of her first and second shot). No treatment. No covid prior vaccination and no covid tested post vaccination.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, IPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: inadvertently administered PENTACEL to a 15 month old patient instead of DTaP, with no reported adverse event; 4th dose of IPV too early, with no reported adverse event; Initial information was received on 17-Mar-2022 regarding an unsolicited valid non-serious case received from a health care professional via call center.  This case involves a 15 months old male patient who experienced inadvertently administered pentacel to a 15 month old patient instead of dtap, with no reported adverse event and 4th dose of ipv too early, with no reported adverse event while receiving vaccines Poliomyelitis vaccine (INACTIVATED) and 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 HIB vaccine CONJ (OMPC) (PEDVAXHIB) and Hepatitis A vaccine (HEPATITIS A) for Immunisation.  On 17-Mar-2022, the patient received 0.5 ml of suspect Diphtheria/tetanus/5 hybrid AC pertussis/ipv (MRC5)/HIB(PRP/T) vaccine (lot -UJ601AAA expiry -05-Dec-2022) via Intramuscular route in the left leg for immunisation. On an unknown date, the patient received a dose of suspect Poliomyelitis vaccine produced by unknown manufacturer (dose, lot, strength, formulation, and expiry: unknown) via unknown route in unknown administration site for immunization.   On 17-MAR-2022 the patient developed "inadvertently administered pentacel to a 15 month old patient instead of dtap, with no reported adverse event (accidental exposure to product) (latency same day) and "4th dose of ipv too early, with no reported adverse event" (inappropriate schedule of product administration) (latency; unknown) following the administration of Diphtheria/tetanus/5 hybrid AC pertussis/ipv(MRC5)/HIB(PRP/T) vaccine and Poliomyelitis vaccine.    Action taken-not applicable for both suspects  Outcome- unknown for both 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: 0.25
Sex: F
Vaccine: HIBV
Symptoms: Medication error, No adverse event, Product preparation error
Clinical narrative: added a different diluent on the vaccine itself coming from a different manufacturer and not the diluent that comes with the vaccine, with no reported adverse event; Initial information received on 17-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional via call center.  This case involves a 3 months old female patient who experienced different diluent on the vaccine itself coming from a different manufacturer and not the diluent that comes with the vaccine, 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 Diphtheria vaccine toxoid, hepatitis b vaccine RHBSAG (Yeast), Pertussis vaccine acellular 3-component, Polio vaccine Inact 3V (VERO), Tetanus vaccine toxoid (Pediarix) for Prophylactic vaccination; and Pneumococcal vaccine conj 7V (CRM197) (Prevnar) for Prophylactic vaccination.  On 16-Mar-2022, the patient received 0.5 ml dose of suspect HIB (PRP/T) Vaccine unknown formulation, (batch lot UJ522AA expiry date unknown) via intramuscular route for immunization.  On an unknown date the patient developed a non-serious event added a different diluent on the vaccine itself coming from a different manufacturer and not the diluent that comes with the vaccine, with no reported adverse event (product preparation error) (unknown latency) following the administration of 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.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Incorrect dose administered, Medication error, Needle issue
Clinical narrative: incomplete administration of QUADRACEL; Initial information received on 18-Mar-2022 regarding an unsolicited valid non-serious case received from other health professional via call center.  This case involves a 4 years old female patient who experienced incomplete administration of quadracel while receiving vaccine diphtheria-15/tetanus/5 hybrid AC PERTUSSIS/IPV (MRC5) vaccine [Quadracel].  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 Immunisation; and varicella zoster vaccine (Varicella Vaccine) for Immunisation.  On 16-Mar-2022, the patient received suspect diphtheria-15/tetanus/5 HYBRID AC PERTUSSIS/IPV (MRC5) vaccine at an unknown dose once (lot C5862BA, expiry date: 01-Apr-2023, strength, form: not reported) via intramuscular route in the left vastus lateralis for Immunisation.  On 16-MAR-2022 the patient developed a non-serious event of incomplete administration of quadracel (incorrect dose administered)(latency: same day) following the administration of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE. It was reported that she said that the needle detached from the hub during administration so they were unable to know the dose that was given.  Action taken: not applicable.  Outcome was Unknown for the event incomplete administration of quadracel.   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.