chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Dyspepsia, Fatigue, Illness
Clinical narrative: deathly sick; extreme vomiting; diarrhea; stomach pain; severe indigestion; nausea; pain in his arm; very tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2), administration date 23Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "prostate cancer" (ongoing), notes: Wife, calling behalf of husband, aged 58 who is currently undergoing active treatment for advanced prostate cancer. Concomitant medication(s) included: FIRMAGON; ZYTIGA; PREDNISONE. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "pain in his arm"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "very tired"; ILLNESS (non-serious) with onset 25Feb2021, outcome "unknown", described as "deathly sick"; VOMITING (non-serious) with onset 25Feb2021, outcome "unknown", described as "extreme vomiting"; DIARRHOEA (non-serious) with onset 25Feb2021, outcome "unknown", described as "diarrhea"; ABDOMINAL PAIN UPPER (non-serious) with onset 25Feb2021, outcome "unknown", described as "stomach pain"; DYSPEPSIA (non-serious) with onset 2021, outcome "unknown", described as "severe indigestion"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea".  Additional information: The patient (Age:58, Unit: Unknown) is due tomorrow to receive the second dose, but was not going to get it. He got very very sick. The day before the vaccine the patient had his monthly injection of Firmagon, an ADT drug,  Daily, he takes Zytiga 4 pills and Prednisone 5mg daily. Initially after the vaccine, the patient had pain in his arm and was very tired. Then two days later, on Thursday he started pelvic radiation he was deathly sick. The patient experienced extreme vomiting 13 times, diarrhea and stomach pain. Then Friday, he went for radiation again and had the same symptoms. Radiologist said it was not from the radiation. Oncologist it could be the medications interacting with the vaccine. He goes daily five days a week and doesn't want to get the second dose. Over the weekend, he was a little sick but did not have radiation those days.  He had severe indigestion. The following Monday and Tuesday he had some nausea. Wednesday the radiation machine was broken so he did not receive it that day. Then on Thursday he tolerated it okay.     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Vomiting
Clinical narrative: deathly sick; extreme vomiting; diarrhea; stomach pain; severe indigestion; nausea; pain in his arm; very tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2), administration date 23Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "prostate cancer" (ongoing), notes: Wife, calling behalf of husband, aged 58 who is currently undergoing active treatment for advanced prostate cancer. Concomitant medication(s) included: FIRMAGON; ZYTIGA; PREDNISONE. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "pain in his arm"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "very tired"; ILLNESS (non-serious) with onset 25Feb2021, outcome "unknown", described as "deathly sick"; VOMITING (non-serious) with onset 25Feb2021, outcome "unknown", described as "extreme vomiting"; DIARRHOEA (non-serious) with onset 25Feb2021, outcome "unknown", described as "diarrhea"; ABDOMINAL PAIN UPPER (non-serious) with onset 25Feb2021, outcome "unknown", described as "stomach pain"; DYSPEPSIA (non-serious) with onset 2021, outcome "unknown", described as "severe indigestion"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea".  Additional information: The patient (Age:58, Unit: Unknown) is due tomorrow to receive the second dose, but was not going to get it. He got very very sick. The day before the vaccine the patient had his monthly injection of Firmagon, an ADT drug,  Daily, he takes Zytiga 4 pills and Prednisone 5mg daily. Initially after the vaccine, the patient had pain in his arm and was very tired. Then two days later, on Thursday he started pelvic radiation he was deathly sick. The patient experienced extreme vomiting 13 times, diarrhea and stomach pain. Then Friday, he went for radiation again and had the same symptoms. Radiologist said it was not from the radiation. Oncologist it could be the medications interacting with the vaccine. He goes daily five days a week and doesn't want to get the second dose. Over the weekend, he was a little sick but did not have radiation those days.  He had severe indigestion. The following Monday and Tuesday he had some nausea. Wednesday the radiation machine was broken so he did not receive it that day. Then on Thursday he tolerated it okay.     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pre-existing condition improved, Therapeutic response unexpected
Clinical narrative: as soon as he got the covid vaccine he starting feeling significantly better his resporitory issues went away and he feels a lot better; as soon as he got the covid vaccine he starting feeling significantly better his resporitory issues went away and he feels a lot better; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "respiratory issues" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), PRE-EXISTING CONDITION IMPROVED (non-serious), outcome "unknown" and all described as "as soon as he got the covid vaccine he starting feeling significantly better his resporitory issues went away and he feels a lot better".  Additional information: The patient said that he was having respiratory issues before receiving the 1st dose of the covid vaccine and said that as soon as he got the covid vaccine he starting feeling significantly better his respiratory issues went away and he feels a lot better wanted to thank Pfizer for all of their hard work and is excited to get the 2nd dose of the covid vaccine. Faxing for possible AE with respiratory issues.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: Severe chills; headache; extreme fatigue with no appetite for 3 days; extreme fatigue with no appetite for 3 days; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day 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: CHILLS (non-serious), outcome "unknown", described as "Severe chills"; HEADACHE (non-serious), outcome "unknown", described as "headache"; FATIGUE (non-serious), DECREASED APPETITE (non-serious), outcome "unknown" and all described as "extreme fatigue with no appetite for 3 days".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Influenza like illness
Clinical narrative: The patient had a couple hours of chills; felt like I was having a severe flu; 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 69 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 69 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunisation, reaction(s): "soreness at the injection site with his arm being a little bit sore that evening". The following information was reported: CHILLS (non-serious), outcome "unknown", described as "The patient had a couple hours of chills"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "felt like I was having a severe flu".  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 effective for unapproved indication
Clinical narrative: Alzheimer's dementia for several years, had shown significant improvement; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 95 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "non-Alzheimer's dementia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG EFFECTIVE FOR UNAPPROVED INDICATION (non-serious), outcome "unknown", described as "Alzheimer's dementia for several years, had shown significant improvement". Additional Information: When (Name) visited her mother in March, (Name) was alert, smiling and articulate in short sentences. She even read the aid's name tag aloud.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypokinesia
Clinical narrative: she can not move at all; has a severe headache; 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 female patient received bnt162b2 (BNT162B2), administration date 27Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Polymyalgia rheumatica" (unspecified if ongoing); "arthritis pain" (unspecified if ongoing), notes: arthritis pain. Concomitant medication(s) included: TYLENOL taken for arthralgia (ongoing); CELAXIB (ongoing). Vaccination history included: Bnt162b2 (First Dose), for Covid-19 immunization. The following information was reported: HYPOKINESIA (non-serious) with onset Mar2021, outcome "unknown", described as "she can not move at all"; HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "has a severe headache".  Additional information included: A female patient of age 71 units not provided. The patient experienced minimum side effects with first dose, caller received second dose and caller reported that she can not move at all and has a severe headache. Prior to the vaccine she takes the following medications for her condition. Concomitant medication included steroids. The patient started stopping the medication prior to getting first dose, but now after receiving second dose. The caller stated that she has to start back taking it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: I had severe dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administration date 14Mar2021 (Lot number: EP7534) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Verbatim: Diabetic; "Rheumatoid arthritis" (unspecified if ongoing), notes: Verbatim: Rheumatoid arthritis. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus. Vaccination history included: Bnt162b2 (Date of first shot: 19Feb, LOT# for first shot: EN6198), administration date: 19Feb2021, for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset Mar2021, outcome "unknown", described as "I had severe dizziness".  Additional information: The patient stated that right now she was in remission for other conditions. The patient wanted to report an allergic reaction after second dose of vaccination. Weight was reported as 326 pounds (not clarified). Severe dizziness but anyways it lasted for 3 days.   No follow up attempts are possible. No Further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Nerve compression
Clinical narrative: severe neck pain along the side; Pinched nerve feeling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Feb2021 15:45 (Lot number: EM9809) at the age of 27 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TYLENOL. The following information was reported: NECK PAIN (non-serious) with onset Feb2021, outcome "not recovered", described as "severe neck pain along the side"; NERVE COMPRESSION (non-serious) with onset Feb2021, outcome "not recovered", described as "Pinched nerve feeling". Therapeutic measures were not taken as a result of neck pain, nerve compression.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Severe Headache; Soreness in left arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 09:00 (Lot number: EP6955) at the age of 45 years as 2nd dose, single and administered in arm left, administration date 17Mar2021 09:30 (Lot number: EP6955) as 1st dose, single for covid-19 immunisation. Relevant medical history included: "Hashimotos" (unspecified if ongoing), notes: Verbatim : hashimotos. Concomitant medication(s) included: SYNTHROID. The following information was reported: HEADACHE (non-serious) with onset 09Apr2021, outcome "recovering", described as "Severe Headache"; PAIN IN EXTREMITY (non-serious) with onset 09Apr2021, outcome "recovering", described as "Soreness in left arm". Therapeutic measures were not taken as a result of headache, pain in extremity.  No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Pain
Clinical narrative: Severe headache; Fatigue; Loss of appetite; Body ache; 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), administered in arm left, administration date 02Apr2021 (Lot number: Er8732) at the age of 34 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PANTOPRAZOLE; PRISTIQ; ZYRTEC ALLERGY; FLONASE ALLERGY RELIEF. The following information was reported: HEADACHE (non-serious) with onset 03Apr2021, outcome "recovered" (2021), described as "Severe headache"; FATIGUE (non-serious) with onset 03Apr2021, outcome "recovered" (2021), described as "Fatigue"; DECREASED APPETITE (non-serious) with onset 03Apr2021, outcome "recovered" (2021), described as "Loss of appetite"; PAIN (non-serious) with onset 03Apr2021, outcome "recovered" (2021), described as "Body ache". Therapeutic measures were not taken as a result of headache, fatigue, decreased appetite, pain.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Illness
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 22Apr2021 (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: ILLNESS (non-serious), outcome "unknown", described as "really sick"; HEADACHE (non-serious), outcome "unknown", described as "severe headache"; BACK PAIN (non-serious), outcome "unknown", described as "back pain"; FATIGUE (non-serious), outcome "unknown", described as "feeling exhaustion". Additional information: she got the 1st dose last 22Apr2021, and mentioned that she got really sick, experiencing severe headache, back pain and feeling exhaustion. She wants to ask if it will happen for the 2nd dose appointment on 17May2021 (More than 21 days). She wants to know as well if it was ok not to take the 2nd dose of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Peroneal nerve palsy, SARS-CoV-2 test
Clinical narrative: Eight days after vaccine, foot drop ("dropped foot") in right foot; bilateral numbness and tingling in hands with eight hand more severe; bilateral numbness and tingling in hands with eight hand more severe; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 09:15 (Lot number: ER8729) at the age of 50 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MIRTAZAPINE; NORTRIPTYLINE.  The following information was reported: PERONEAL NERVE PALSY (non-serious) with onset 22Apr2021, outcome "not recovered", described as "Eight days after vaccine, foot drop ("dropped foot") in right foot"; HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 17Apr2021, outcome "not recovered" and all described as "bilateral numbness and tingling in hands with eight hand more severe". The events "eight days after vaccine, foot drop ("dropped foot") in right foot", "bilateral numbness and tingling in hands with eight hand more severe" and "bilateral numbness and tingling in hands with eight hand more severe" 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 peroneal nerve palsy, hypoaesthesia, paraesthesia.
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: he had severe back ache; This is a spontaneous report received from a contactable Consumer via medical information team. A 74-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 04Apr2021 as DOSE 1, single dose for covid-19 immunisation. The patient's relevant medical history includes felt like the skin on his stomach was on fire on 01Apr2021. Concomitant medications were not reported. Vaccination history included: Herpes zoster (he had a first set of shingle shots and last fall he had another set.), for shingle. It was reported that, patient felt like the skin on his stomach was on fire on 01Apr2021. He talked to a doctor and stated that was concerned about having shingles. On 07Apr2021, the patient had experienced severe back ache. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Nail discolouration, Pain in extremity, Peripheral swelling
Clinical narrative: Nails turned black; My left arm; right middle finger from the very tip is swollen like severely swollen and sore; My left arm; right middle finger from the very tip is swollen like severely swollen and sore; 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), administration date 29Apr2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "I do not hear too well" (unspecified if ongoing), notes: Verbatim: Consumer stated, I do not hear too well. The patient's concomitant medications were not reported. The following information was reported: NAIL DISCOLOURATION (non-serious) with onset May2021, outcome "unknown", described as "Nails turned black"; PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset May2021, outcome "unknown" and all described as "My left arm; right middle finger from the very tip is swollen like severely swollen and sore".  Additional Information: When probed for the concern, Consumer stated, I got Pfizer shot last Thursday and couple of days later my left arm, couple of days later my right middle finger from the very tip is swollen like severely swollen and sore like I hit it with a hammer the nails turned black and all that.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: Severe chills; body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 08Jan2021 08:00 (Lot number: EK9231) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "mild seasonal type allergies" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose lot/batch no = EN9899, Anatomical location: Deltoid left, Date: 19Dec2020), administration date: 19Dec2020, when the patient was 49 years old, for COVID-19 IMMUNIZATION. The following information was reported: CHILLS (non-serious) with onset 08Jan2021 22:30, outcome "recovered" (2021), described as "Severe chills"; PAIN (non-serious) with onset 08Jan2021 22:30, outcome "recovered", described as "body aches". Therapeutic measures were not taken as a result of chills, pain. Additional information: The patient received the vaccine at hospital.  No follow-up attempts are possible. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Parosmia
Clinical narrative: Metal taste in his mouth; Smelling bacon; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 14 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 13May2021 21:00 (Batch/Lot number: unknown) at the age of 14 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: DEXMETHYLPHENIDATE (ongoing); SERTRALINE HYDROCHLORIDE (ongoing). The following information was reported: DYSGEUSIA (non-serious) with onset 14May2021 11:18, outcome "unknown", described as "Metal taste in his mouth"; PAROSMIA (non-serious) with onset 14May2021, outcome "not recovered", described as "Smelling bacon". It was unknown if therapeutic measures were taken as a result of parosmia.  Additional information: Reporter is calling about Pfizer covid vaccine. Reporter is calling about her son. Reporter's son is the patient. Reporter states that patient is a hypochondriac. Patient just texted reporter from school. Patient smells bacon, and has a metal taste in his mouth. Reporter thinks that this could be in patient's head. Reporter is asking if other people have experienced this .Patient smells bacon, and has a metal taste in his mouth: Patient received the vaccine late last night, about 21:00. Patient is experiencing symptoms today while at school. Patient is at lunch. Reporter states that patient would probably say that it has gotten worse. At first patient smelled bacon, and then he got a metal taste in his mouth. Reporter thinks that it is all in patients head.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Left arm severely hurts through my hand which is very weak. Left side of body from waist to calf aches as well. Pain is occasionally a "10" in the arm.; Left arm severely hurts through my hand which is very weak. Left side of body from waist to calf aches as well. Pain is occasionally a "10" in the arm.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 14:00 (Lot number: EW0158) at the age of 68 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BUSPIRONE; PAXIL [PIROXICAM]; DICYCLOMINE; VITAMINS NOS. Vaccination history included: Bnt162b2 (First dose.), administration date: 13Mar2021, for Covid-19 Immunisation. The patient had no COVID prior vaccination and no post vaccination. The following information was reported: PAIN IN EXTREMITY (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 14Apr2021 04:00, outcome "not recovered" and all described as "Left arm severely hurts through my hand which is very weak. Left side of body from waist to calf aches as well. Pain is occasionally a "10" in the arm.". Therapeutic measures were not taken as a result of pain in extremity, pain in extremity.
Sex: U
Vaccine: COVID19
Symptoms: Insomnia, Oropharyngeal pain, Pharyngeal hypoaesthesia
Clinical narrative: Severe throat pain; throat numb drink to swallow; Lost sleeps; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20May2021 12:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 21May2021 14:00, outcome "not recovered", described as "Severe throat pain"; PHARYNGEAL HYPOAESTHESIA (non-serious) with onset 21May2021 14:00, outcome "unknown", described as "throat numb drink to swallow"; INSOMNIA (non-serious) with onset 21May2021 14:00, outcome "not recovered", described as "Lost sleeps". The events "severe throat pain", "throat numb drink to swallow" and "lost sleeps" were evaluated at the physician office visit. Therapeutic measures were taken as a result of oropharyngeal pain, pharyngeal hypoaesthesia, insomnia.  Additional information: The event severe throat pain last more than 8 days now (21May2021 - now 28May2021), lost sleeps only assisted with sleeping pill every night. Therapeutic measures were taken as a result of severe throat pain and included treatment with Tylenol and throat numb drink to swallow and lost sleeps included treatment with sleeping pill every night. Tylenol and any other medicine could not help. The patient did not have any allergies to food, medications, or other products. The patient did not receive any other medications within two weeks, prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Overdose, Vaccination site pain
Clinical narrative: overdose; Severity of deep muscle aching; was more localized at injected site and considerably less painful.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 60 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in deltoid left, administration date 02Feb2021 09:30 (Lot number: EI 9262) at the age of 60 years as dose 2, 0.5 ml single for COVID-19 immunisation. Relevant medical history included: "Med allergy compazine", start date: 1983, stop date: 1983, notes: pertinent details: Required ER Visit for IV Benadryl-Not taken since; "Med allergy bactrim DS", start date: 2005, stop date: 2005, notes: pertinent details: Biopsies confirmed fixed drug reaction; "Seasonal allergies", start date: 1990 (unspecified if ongoing), notes: pertinent details: Zytec 10mg daily OTC; "COVID-19", start date: 14Oct2020 (unspecified if ongoing); "constipation", start date: 2019 (unspecified if ongoing). Concomitant medication(s) included: cetirizine hydrochloride (ZYRTEC), taken for seasonal allergy; VITAMIN D3 CALCIUM, start date: 2019; ASA, start date: 2019; docusate sodium taken for constipation, start date: 2019. Vaccination history included: BNT162B2 (Dose: 1, Lot number: EK9231, Route: Intramuscular, Anatomical location: LB, dose: 0.5 mL), administration date: 08Jan2021, when the patient was 60 years old, for COVID-19 immunisation, reaction(s): "Deep Muscle ache", "Fever", "Chills". The following information was reported: MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "Severity of deep muscle aching"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "was more localized at injected site and considerably less painful."; OVERDOSE (non-serious) with onset 02Feb2021 09:30, outcome "unknown", described as "overdose". Therapeutic measures were not taken as a result of myalgia, vaccination site pain.  Additional Information: The reporter was also a nurse (patient). The patient had no Family medical history relevant to event. The patient did not undergo relevant tests. The patient did not receive additional vaccine administered on same date of Pfizer suspect. The patient did not receive any prior vaccinations. The Relevant medical history Med allergy Bactrim DS stop date was reported as 16Jan2005. Concomitant medication Vitamin D3 Calcium was taken for women's health and ASA was taken. The outcome of event was reported as unknown (but also reported as: time lag from stop date, if event occurred after cessation of treatment: 2nd injection the day of only). The event were reported as non-serious. The events did not require emergency or physician's office visit.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Back pain, Headache, Hyperhidrosis
Clinical narrative: back ache; sweating; headache; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 31 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 07Jan2021 17:21 (Lot number: EK9231) at the age of 31 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Iron deficiency anemia", start date: 03Sep2020 (ongoing); "CIN 2", start date: 29Sep2020 (unspecified if ongoing); "HPV +", start date: 29Sep2020 (unspecified if ongoing); "Leep procedure", start date: 07Oct2020 (unspecified if ongoing); "Irregular menstruation", start date: 01Jan2015 (ongoing); "COVID", start date: 28May2020 (unspecified if ongoing), notes: Symptomatic 01Apr2020; "COVID-19 PCR", start date: 03Oct2020 (unspecified if ongoing), notes: Not detect negative, Asymptomatic, pre-procedure; "antibody", start date: 28Sep2020 (unspecified if ongoing), notes: Result: Positive, Units: Negative; "Low vitamin D" (ongoing). Concomitant medication(s) included: VITAMIN D [VITAMIN D NOS] taken for vitamin d decreased, start date: 01Jan2006 (ongoing); FERROUS SULFATE taken for iron deficiency anaemia, start date: 23Oct2020 (ongoing); SPRINTEC taken for menstruation irregular, start date: 01Jan2016 (ongoing). Vaccination history included: Bnt162b2 (1st dose, Lot Number: EH9899, Expiration Date: 01Mar2021, Time:16:46, Route: Intramuscular, Anatomical site: Left deltoid), administration date: 17Dec2020, when the patient was 31 years old, for covid-19 immunisation, reaction(s): "left arm soreness x36h". The following information was reported: HEADACHE (non-serious) with onset 07Jan2021 22:00, outcome "recovered", described as "headache"; BACK PAIN (non-serious) with onset 08Jan2021 07:00, outcome "recovered", described as "back ache"; HYPERHIDROSIS (non-serious) with onset 08Jan2021 07:00, outcome "recovered", described as "sweating". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, back pain, hyperhidrosis.  Additional information: Patient received ibuprofen as a result of events reported. Reporter considered that BNt162b2 had a casual effect to the adverse event reported.  No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 25Jan2021 (Lot number: EL9262) at the age of 69 years as dose 1, single and administration date 20Feb2021 (Lot number: EL9267) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "Vomiting". Therapeutic measures were not taken as a result of vomiting.  Additional information: The patient was not admitted to the hospital due to the event.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Flatulence
Clinical narrative: GI Gas; bloatedness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received BNT162B2 (PFZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left, administration date 14Jan2021 08:00 (Batch/Lot number: unknown) at the age of 66 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Hypertension" (ongoing), notes: I just take medications to manage hypertension. Concomitant medication(s) included: AMLODIPINE (ongoing); IRBESARTAN (ongoing). Vaccination history included: BNT162B2 (1st dose, muscular injection, event onset: 26Dec2020 21:00 ), administration date: 24Dec2020, when the patient was 66 years old, for COVID-19 immunisation, reaction(s): "Abdominal cramps", "GI cramps", "Diarrhea", "Chills". The following information was reported: FLATULENCE (non-serious) with onset Jan2021, outcome "unknown", described as "GI Gas"; ABDOMINAL DISTENSION (non-serious) with onset Jan2021, outcome "unknown", described as "bloatedness".  Additional Information: The patient did not receive additional vaccines administered on same date of the Pfizer suspect. The patient did not undergo any relevant tests. The patient had been taking the concomitant medications for couple of years with no reaction. The patient did not use antipyretic around the dates of vaccination. The events did not result in emergency room or physician's office visit.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Fatigue, Headache, Malaise, Palpitations
Clinical narrative: Headache at the base of my skull; Face pain; Heart racing with minimal movement/heart palpitations; Fatigue; Significant increase in pre-existing tinnitus; Overall feeling of "not feeling well".; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Jun2021 09:15 (Lot number: EW0187) at the age of 45 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VIT D3; B12 [CYANOCOBALAMIN]; L-LYSINE ACETATE. Vaccination history included: Bnt162b2 (Product- COVID 19,, Brand-Pfizer,, Lot Number- EW0183,, Lot unknown- False,, Administration date- 16May2021,, Administration time-01:00 PM,, Dose number- 1, Vaccine location- Left arm), administration date: 16May2021, for covid-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 06Jun2021 11:00, outcome "not recovered", described as "Headache at the base of my skull"; FACIAL PAIN (non-serious) with onset 06Jun2021 11:00, outcome "not recovered", described as "Face pain"; PALPITATIONS (non-serious) with onset 06Jun2021 11:00, outcome "not recovered", described as "Heart racing with minimal movement/heart palpitations"; FATIGUE (non-serious) with onset 06Jun2021 11:00, outcome "not recovered", described as "Fatigue"; TINNITUS (non-serious) with onset 06Jun2021 11:00, outcome "not recovered", described as "Significant increase in pre-existing tinnitus"; MALAISE (non-serious) with onset 06Jun2021 11:00, outcome "not recovered", described as "Overall feeling of "not feeling well".".  No follow-up attempts are possible. No further information is expected.  Follow-Up (25Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Headache at the base of my skull; Face pain; Heart racing with minimal movement/heart palpitations; Fatigue; Significant increase in pre-existing tinnitus; Overall feeling of "not feeling well".; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Jun2021 09:15 (Lot number: EW0187) at the age of 45 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VIT D3; B12 [CYANOCOBALAMIN]; L-LYSINE ACETATE. Vaccination history included: Bnt162b2 (Product- COVID 19,, Brand-Pfizer,, Lot Number- EW0183,, Lot unknown- False,, Administration date- 16May2021,, Administration time-01:00 PM,, Dose number- 1, Vaccine location- Left arm), administration date: 16May2021, for covid-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 06Jun2021 11:00, outcome "not recovered", described as "Headache at the base of my skull"; FACIAL PAIN (non-serious) with onset 06Jun2021 11:00, outcome "not recovered", described as "Face pain"; PALPITATIONS (non-serious) with onset 06Jun2021 11:00, outcome "not recovered", described as "Heart racing with minimal movement/heart palpitations"; FATIGUE (non-serious) with onset 06Jun2021 11:00, outcome "not recovered", described as "Fatigue"; TINNITUS (non-serious) with onset 06Jun2021 11:00, outcome "not recovered", described as "Significant increase in pre-existing tinnitus"; MALAISE (non-serious) with onset 06Jun2021 11:00, outcome "not recovered", described as "Overall feeling of "not feeling well".".  No follow-up attempts are possible. No further information is expected.  Follow-Up (25Aug2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: FLUX
Symptoms: Influenza, Pneumonia
Clinical narrative: turned into double pneumonia; flu; Initial information was received on 09-Oct-2021 regarding an unsolicited valid serious case received from a consumer/non-health care professional (patient's husband) via social media.  This case is linked to case 2021SA338747 (same reporter).  This case involves an unknown age female patient who had flu (influenza) and it turned into double pneumonia (pneumonia) while receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  The patient's past vaccination(s) included influenza vaccine shot every year for prophylactic vaccination.  Past medical treatment(s) concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date were not provided) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date the patient had serious flu (influenza) and it turned into double pneumonia (pneumonia) (unknown latency) following the administration of INFLUENZA VACCINE. These both events were assessed as medically significant.  The reporter never bothered to get one. He made it to 55 and never had the flu. He worked in public transportation and he was not able to wash his hands often not being near water while working. He said its not a bad idea to get one. His whole family gets a flu shot every year. They were not always as lucky as he was.  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was unknown for events.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns an unknown age female patient who had influenza and pneumonia after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset is unknown. The patient's past vaccination(s) included influenza vaccine shot every year. Additional information regarding patient's past medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Feeling abnormal
Clinical narrative: This case involves an unknown age and gender patient who experienced feeling bad (feeling abnormal) for days after receiving INFLUENZA VACCINE. It was unknown if the patient had any medical history, concomitant disease or risk factor. Past medical treatment(s), vaccination(s) concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed a non-serious made me feel bad for days (feeling abnormal) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "I am undecided whether I get my flu shot first or the booster". It was unknown if the patient experienced any additional symptoms/events. It was unknown if there were lab data/results available. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was unknown for the event. There will be no information available on the batch number for this case.
Sex: M
Vaccine: YF
Symptoms: Vaccination site reaction
Clinical narrative: This case involves Adult male patient who experienced vaccination to which he had a reaction (vaccination site reaction), after receiving vaccine YELLOW FEVER VACCINE. The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. No other concomitant vaccines were not provided. On an unknown date, the patient received a dose of suspect YELLOW FEVER VACCINE produced by unknown manufacturer (lot number and expiry date was not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a non-serious vaccination to which he had a reaction (vaccination site reaction) (unknown latency) following the administration of YELLOW FEVER VACCINE. It was unknown if the patient experienced any additional symptoms/events. Details of laboratory data and results were not reported. It was not reported if the patient received any corrective treatment for the event. At time of reporting, outcome of the event was unknown. There will be no information available on batch number for this case.
Sex: U
Vaccine: MENB, MNQ
Symptoms: Chills, Headache, Nausea, Vomiting
Clinical narrative: This case involves patient (unknown age and gender) who had extreme headache (headache), nausea, shivering (chills) and vomiting, after receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA). It was unknown if the patient had any medical history, concomitant disease or risk factor. Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and dose of suspect TRUMENBA not produced by Sanofi Pasteur (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed non-serious extreme headache (headache), nausea, shivering (chills) and vomiting, within one hour following the administration of vaccines. It was unknown if the patient experienced any additional symptoms/events. It was unknown if there were lab data/results available. The patient went to the emergency room (ER) and was administered ONDANSETRON (Zofran ) and IBUPROFEN as a corrective treatment.  The patient recovered from the reported events. There will be no information available on the batch number for this case.