chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fatigue; feverish till upto 2 weeks; Shooting pain behind head; seems like a pinched nerve; Body ache; chills that doesn't seem to go away more than 1.5 weeks after the shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Jun2021 15:00 (Batch/Lot number: unknown) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High Blood pressure" (unspecified if ongoing); "Low iron" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; VITAMIN D [VITAMIN D NOS]. Vaccination history included: Bnt162b2 (product=COVID 19, Brand: Pfizer, Lot unknown: True, Lot unknown reason: Unable to locate or read the details, Administration date= 15May2021, Administration time: 03:00 PM, Dose number=1, Vaccine location= Left arm, Route of administration: Intramuscular), administration date: 15May2021, when the patient was 42 years old, for Covid-19 immunisation. The following information was reported: FATIGUE (non-serious) with onset 06Jun2021 11:00, outcome "recovered", described as "Fatigue"; PYREXIA (non-serious) with onset 06Jun2021 11:00, outcome "recovered", described as "feverish till upto 2 weeks"; HEADACHE (non-serious) with onset 06Jun2021 11:00, outcome "recovered", described as "Shooting pain behind head"; NERVE COMPRESSION (non-serious) with onset 06Jun2021 11:00, outcome "recovered", described as "seems like a pinched nerve"; PAIN (non-serious) with onset 06Jun2021 11:00, outcome "recovered", described as "Body ache"; CHILLS (non-serious) with onset 06Jun2021 11:00, outcome "recovered", described as "chills that doesn't seem to go away more than 1.5 weeks after the shot". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, pyrexia, headache, nerve compression, pain, chills.  Additional Information: Patient did not have other vaccine in four weeks. Other medications in two weeks were Amlodipine, Vitamin D. Adverse Event: Fatigue, feverish till up to 2 weeks. Shooting pain behind head, seems like a pinched nerve. Body ache, chills that doesn't seem to go away more than 1.5 weeks after the shot. Patient did not have covid prior vaccination. Patient was not tested covid post vaccination. It was not known if patient had known allergies. Prior Vaccinations (within 4 weeks) reported as none. Patient's Medical History (including any illness at time of vaccination) reported as none. Relevant Tests reported as none. The seriousness criteria were reported as not serious. Patient did not received treatment for AEs.  Follow-up attempts completed. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chest X-ray, Chest pain, Dyspnoea, Electrocardiogram
Clinical narrative: Severe chest pain and heavy breathing
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: Severe chest pain and heavy breathing
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Ear discomfort, Pruritus
Clinical narrative: 13 days after vaccine I began to have spontaneous itching which would migrate all over my body, my ears would burn, itching on my scalp, thighs, buttocks, sides, back, neck, hands would burn, usually in the evenings.  I tried different lotions with a little relief, and then on 2/5/22 began to take Zyrtec and the symptoms went away and I could sleep without being woken up with itching.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Dyspnoea exertional, Fatigue, Fibrin D dimer increased, Liver function test increased
Clinical narrative: Covid19 breakthrough.  1st vaccine received on 06/17/2021.  36 y/o PMHx HTN, HA presents to ED for dyspnea on exertion, fatigue, body aches.  Pt was initially diagnosed with Covid 19 on Jan 23rd, 2022 and symptoms improved but in the past week have returned and pt feels much worse. Pt found to have elevated D-dimer, cardiac enzymes and LFT's.  No decadron or Remdesivir at this time per MD.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocardial necrosis marker increased, Pain, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Covid19 breakthrough.  1st vaccine received on 06/17/2021.  36 y/o PMHx HTN, HA presents to ED for dyspnea on exertion, fatigue, body aches.  Pt was initially diagnosed with Covid 19 on Jan 23rd, 2022 and symptoms improved but in the past week have returned and pt feels much worse. Pt found to have elevated D-dimer, cardiac enzymes and LFT's.  No decadron or Remdesivir at this time per MD.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Severe headache, moderate to severe myalgias and fatigue for three  to four days following vaccine adminstration. Symptoms resolved after approximately five days with supportive measures (fluids, NSAIDs).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Bed rest, Exposure during pregnancy, Premature delivery, Premature rupture of membranes
Clinical narrative: I was 26 weeks and 4 days pregnant when I received the Moderna booster vaccine. Two and a half days later, I experienced a premature rupture of membranes (my water broke prematurely). I was admitted into the hospital where I remained on bed rest for 10 days. On December 8, 2021, when I reached 28 weeks and 4 days pregnant, my child was born. My original due date was February 28, 2022.  My child was born extremely prematurely weighing 2 lbs 11oz. He remains in the neonatal intensive care unit.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Myalgia
Clinical narrative: Severe shivering, muscle aches, joint pain
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction
Clinical narrative: Erectile disfunction
Age: 43.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Groin pain
Clinical narrative: None stated.
Age: 43.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Groin pain, SARS-CoV-2 test, Testicular swelling
Clinical narrative: None stated.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chest X-ray abnormal, Lung infiltration, Mental status changes, SARS-CoV-2 test positive
Clinical narrative: Covid-19 breakthrough. 1st vaccine received on 05/23/2021. 60 y/o PMHx Heroin abuse, Hepatitis A, Smoking, Hypothyroid, OSA, HTN, ascites with PleurX catheter presents to ED with AMS from Hospice where staff suspect Pt being provided with Heroin from family. CXR-new bilateral infiltrates, afebrile and room air Sats 97%. On ABX and no other tx indicated per ID.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: Covid-19 breakthrough. 1st vaccine received on 05/23/2021. 60 y/o PMHx Heroin abuse, Hepatitis A, Smoking, Hypothyroid, OSA, HTN, ascites with PleurX catheter presents to ED with AMS from Hospice where staff suspect Pt being provided with Heroin from family. CXR-new bilateral infiltrates, afebrile and room air Sats 97%. On ABX and no other tx indicated per ID.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injected limb mobility decreased, Injection site hypoaesthesia, Laboratory test normal, Magnetic resonance imaging normal, Paraesthesia
Clinical narrative: I started with current and numbness in my left arm every time I lowered my head. It was a current or tingling without pain; runs down the back from the torso to the feet. After a while, the left arm began to fall asleep next to the clavicle on that side. This event happened to me during the sexual act and in November of that same year it happened to me when I was filling balloons for my daughter's birthday to such an extent that I had to hold my arm to stop filling balloons
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Headache, Movement disorder, Pain
Clinical narrative: Headache, stomach upset, fever, all over body aches, sever fatigue.  Unable to get out of bed for3 days/
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache, stomach upset, fever, all over body aches, sever fatigue.  Unable to get out of bed for3 days/
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Irregular breathing, Sensory loss, Walking disability
Clinical narrative: loss of sensation in limbs; Dizziness; chills; unstability walking; uneven breath; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Jun2021 13:00 (Batch/Lot number: unknown) at the age of 20 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: SENSORY LOSS (non-serious) with onset 22Jun2021 15:30, outcome "not recovered", described as "loss of sensation in limbs"; DIZZINESS (non-serious) with onset 22Jun2021 15:30, outcome "not recovered", described as "Dizziness"; CHILLS (non-serious) with onset 22Jun2021 15:30, outcome "not recovered", described as "chills"; WALKING DISABILITY (non-serious) with onset 22Jun2021 15:30, outcome "not recovered", described as "unstability walking"; IRREGULAR BREATHING (non-serious) with onset 22Jun2021 15:30, outcome "not recovered", described as "uneven breath". Therapeutic measures were not taken as a result of sensory loss, dizziness, chills, walking disability, irregular breathing.  Additional information: Facility type vaccine was reported as pharmacy or drug Store. COVID prior vaccination was reported as no. COVID not tested post vaccination. There were no known allergies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: felt flu like; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  A 18 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 18 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Ankylosing spondylitis" (ongoing). Concomitant medication(s) included: ENBREL taken for ankylosing spondylitis. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "felt flu like".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I still have a knot on my left arm; Low grade fever; chills; felt like I had the flu; chest pains; migraine; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25May2021 10:00 (Lot number: Unknown) at the age of 57 years as dose 1, single and administered in arm left, administration date 19Jul2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing), notes: Other Medical History: Migraines; "Obesity" (unspecified if ongoing), notes: Other Medical History: Obesity; "Hypertension" (unspecified if ongoing), notes: Other Medical History: Hypertension; "Thyroid Problems" (unspecified if ongoing), notes: Other Medical History: Thyroid Problems; "Obstructive Sleep Apnea" (unspecified if ongoing), notes: Other Medical History: Obstructive Sleep Apnea; "IBS" (unspecified if ongoing), notes: Other Medical History: IBS; "Penicillin" (unspecified if ongoing), notes: Known allergy: Penicillin. Concomitant medication(s) included: METFORMIN; DOXYCYCLINE; IMITREX. Past drug history included: Tramadol, reaction(s): "Drug allergy", notes: Known allergy: Tramadol; Morphine, reaction(s): "Drug allergy", notes: Known allergy: Morphine; Cipro, reaction(s): "Drug allergy", notes: Known allergy: Cipro; Robaxin, reaction(s): "Drug allergy", notes: Known allergy: Robaxin; Norco, reaction(s): "Drug allergy", notes: Known allergy: Norco. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 25May2021 10:00, outcome "not recovered", described as "I still have a knot on my left arm"; PYREXIA (non-serious) with onset 25May2021 10:00, outcome "not recovered", described as "Low grade fever"; CHILLS (non-serious) with onset 25May2021 10:00, outcome "not recovered", described as "chills"; INFLUENZA LIKE ILLNESS (non-serious) with onset 25May2021 10:00, outcome "not recovered", described as "felt like I had the flu"; CHEST PAIN (non-serious) with onset 25May2021 10:00, outcome "not recovered", described as "chest pains"; MIGRAINE (non-serious) with onset 25May2021 10:00, outcome "not recovered", described as "migraine". Therapeutic measures were not taken as a result of peripheral swelling, pyrexia, chills, influenza like illness, chest pain, migraine.  Additional information: No other vaccine in four weeks, Other medications in two weeks: Metformin, Hydroxide, Doxycycline, Imitrex. Adverse event: Low grade fever, chills, felt like she had the flu, worse part was the chest pains and migraine and still after having the second shot she had a knot on her left arm. She had the first shot on 25May2021 and the second shot on 19Jun2021. No covid prior vaccination and no covid tested post vaccination.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Pain, SARS-CoV-2 antibody test
Clinical narrative: My arm stayed pretty warm; Some headache; Slight ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 89 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm, administration date 26Feb2021 10:00 (Lot number: EN6205) at the age of 89 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19", stop date: 14Jan2021. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE. Date:04Feb2021, Time: 10:00, Anatomical site of injection:  arm, Route of administration: Intramuscular, Batch/lot number: EM9809, Expiration Date: 30Jun2021), administration date: 04Feb2021, when the patient was 89 years old, for Covid-19 immunization, reaction(s): "arm is pretty warm and itched quite a lot", "arm is pretty warm and itched quite a lot", "knees have bothered me, my legs have bothered me quite a bit", "knees have bothered me, my legs have bothered me quite a bit", "It is hard for me to walk", "some headache and a slight ache", "some headache and a slight ache", "arm was hurt at vaccinated sites". The following information was reported: FEELING HOT (non-serious), outcome "recovered", described as "My arm stayed pretty warm"; HEADACHE (non-serious), outcome "recovered", described as "Some headache"; PAIN (non-serious), outcome "recovered", described as "Slight ache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, pain; patient was given TYLENOL.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date (at the age of 33-years-old) as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown the patient receive any other vaccines or not within four weeks prior to the vaccination. On an unknown date the patient experienced joint pain. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event joint pain was unknown at the time of this report.   No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient age and Age at vaccination was added as 33 years in pt tab and analysis tab.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Spinal pain
Clinical narrative: Pain at site of injection; Severe pain upper spine by base of skull; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Jul2021 10:15 (Lot number: EW0196) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "Sarcoidosis" (unspecified if ongoing). Concomitant medication(s) included: INSULIN. The following information was reported: INJECTION SITE PAIN (non-serious) with onset 04Jul2021 06:00, outcome "not recovered", described as "Pain at site of injection"; SPINAL PAIN (non-serious) with onset 04Jul2021 06:00, outcome "not recovered", described as "Severe pain upper spine by base of skull". Therapeutic measures were not taken as a result of injection site pain, spinal pain.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Oesophageal pain, Pain, SARS-CoV-2 test
Clinical narrative: Pain in chest area; Feels like contractions along the esophagus with pain radiating towards back and ribcage; Feels like contractions along the esophagus with pain radiating towards back and ribcage; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Apr2021 13:00 (Batch/Lot number: unknown) at the age of 37 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, single, lot number: unknown, expiration date: unknown), for Covid-19 immunisation. The following information was reported: CHEST PAIN (non-serious) with onset 10Jun2021 12:00, outcome "not recovered", described as "Pain in chest area"; OESOPHAGEAL PAIN (non-serious), PAIN (non-serious) all with onset 10Jun2021 12:00, outcome "not recovered" and all described as "Feels like contractions along the esophagus with pain radiating towards back and ribcage". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chest pain, oesophageal pain, pain.  Additional information: Report about covid vaccine: Yes. Patient occupation: None of the above. Reporter type: Patient. Lot unknown-true, lot unknown reason-Misplaced/discarded (dose number-2, dose number-1). Other vaccine same date details: other vaccine same date product-Pfizer, other vaccine same date vaccine date-24Apr2021, other vaccine same date vaccine location-Right arm. If other vaccine in four weeks: No. Other medications in two weeks: No. Adverse event: Pain in chest area (feels like contractions along the esophagus with pain radiating towards back and ribcage. Happened twice. First time was 3 weeks after 2nd dose of vaccine and lasted for around 20 min. The other time was a month later which lasted for around 2 hours. Adverse event country. AE resulted in: None of the above. If covid prior vaccination: No. If covid tested post vaccination: Yes. Covid test post vaccination: covid test type post vaccination-Nasal Swab, covid test name post vaccination-R T-PCR, covid test date-25Jun2021, covid test result-Negative. Known allergies: No.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Head discomfort, SARS-CoV-2 test, Tinnitus, Vertigo
Clinical narrative: Tinnitus in both ears; Feeling of fullness in head; ears aching; mild vertigo; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 05Feb2021 13:00 (Lot number: EL9264) at the age of 58 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 (Lot number: EL1283 at 13:00 in right arm as dose 1, single), administration date: 14Jan2021, when the patient was 58 years old, for COVID-19 immunisation, reaction(s): "Tinnitus in both ears", "brain fog", "mild nausea". The following information was reported: TINNITUS (non-serious) with onset 2021, outcome "not recovered", described as "Tinnitus in both ears"; HEAD DISCOMFORT (non-serious) with onset 2021, outcome "not recovered", described as "Feeling of fullness in head"; EAR PAIN (non-serious) with onset 2021, outcome "not recovered", described as "ears aching"; VERTIGO (non-serious) with onset 2021, outcome "not recovered", described as "mild vertigo". The events "tinnitus in both ears", "feeling of fullness in head", "ears aching" and "mild vertigo" 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 tinnitus, head discomfort, ear pain, vertigo.  Additional information: The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has been tested for COVID-19. The patient received treatment to the events which included flonase (FLUTICASONE) nasal spray.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: This is a spontaneous report received from contactable other HCP (patient). A 33-year-old female patient (not pregnant) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 33, in left arm, on Jul 6, 2021, at 18:00, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. The patient had chest pain/tightness in chest/chest discomfort; all onset Jul 7, 2021, at 12:00, with outcome of unknown. The events were evaluated at an emergency room visit. It was unknown if therapeutic measures were taken as a result. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Panic attack, SARS-CoV-2 test
Clinical narrative: started to have anxiety and some panic attacks; started to have anxiety and some panic attacks; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Plaque Psoriasis arthritis" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (dose 1, administered in the left arm, Lot number: Ek923), administration date: 14Jan2021 11:45, when the patient was 68 years old, for COVID-19 immunisation, reactions: "lose her memory", "still having some confusion". The following information was reported: ANXIETY (non-serious), PANIC ATTACK (non-serious) all with onset 2021, outcome "unknown" and all described as "started to have anxiety and some panic attacks". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of anxiety, panic attack.  Additional information: The patient has no known allergies. She was not diagnosed with COVID-19 prior to vaccination. Therapeutic measures taken included anxiety treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Fatigue, Feeling cold, Nasopharyngitis
Clinical narrative: temperature it was very low and it kept fluctuating today/my temperature being extremely low at times; I woke up feeling kind of cold/my hands were really cold; I had little bit of like rash on my arm; I also had little bit last night when I woke up, cold; Just felt really tired; I had little bit of fever; started to feel a little bit achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Dec2021 (Lot number: FJ8762) at the age of 38 years 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: PAIN (non-serious) with onset 30Dec2021, outcome "recovered" (01Jan2022), described as "started to feel a little bit achy"; FATIGUE (non-serious) with onset 31Dec2021, outcome "recovered" (01Jan2022), described as "Just felt really tired"; PYREXIA (non-serious) with onset 31Dec2021, outcome "recovered" (01Jan2022), described as "I had little bit of fever"; BODY TEMPERATURE DECREASED (non-serious) with onset 01Jan2022 03:00, outcome "unknown", described as "temperature it was very low and it kept fluctuating today/my temperature being extremely low at times"; FEELING COLD (non-serious) with onset 01Jan2022 03:00, outcome "unknown", described as "I woke up feeling kind of cold/my hands were really cold"; RASH (non-serious) with onset 01Jan2022, outcome "recovered" (Jan2022), described as "I had little bit of like rash on my arm"; NASOPHARYNGITIS (non-serious) with onset 01Jan2022, outcome "unknown", described as "I also had little bit last night when I woke up, cold". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, fatigue, pyrexia, body temperature decreased, feeling cold, rash, nasopharyngitis.  Additional information: Np investigation Assessment. No lab test was reported in past 2 weeks. Treatment: Patient received Aleve (treatment) and had been taken zinc, multivitamins. Facility type was reported as a clinic. No prior vaccination since 4 weeks.   No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rash
Clinical narrative: temperature it was very low and it kept fluctuating today/my temperature being extremely low at times; I woke up feeling kind of cold/my hands were really cold; I had little bit of like rash on my arm; I also had little bit last night when I woke up, cold; Just felt really tired; I had little bit of fever; started to feel a little bit achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Dec2021 (Lot number: FJ8762) at the age of 38 years 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: PAIN (non-serious) with onset 30Dec2021, outcome "recovered" (01Jan2022), described as "started to feel a little bit achy"; FATIGUE (non-serious) with onset 31Dec2021, outcome "recovered" (01Jan2022), described as "Just felt really tired"; PYREXIA (non-serious) with onset 31Dec2021, outcome "recovered" (01Jan2022), described as "I had little bit of fever"; BODY TEMPERATURE DECREASED (non-serious) with onset 01Jan2022 03:00, outcome "unknown", described as "temperature it was very low and it kept fluctuating today/my temperature being extremely low at times"; FEELING COLD (non-serious) with onset 01Jan2022 03:00, outcome "unknown", described as "I woke up feeling kind of cold/my hands were really cold"; RASH (non-serious) with onset 01Jan2022, outcome "recovered" (Jan2022), described as "I had little bit of like rash on my arm"; NASOPHARYNGITIS (non-serious) with onset 01Jan2022, outcome "unknown", described as "I also had little bit last night when I woke up, cold". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, fatigue, pyrexia, body temperature decreased, feeling cold, rash, nasopharyngitis.  Additional information: Np investigation Assessment. No lab test was reported in past 2 weeks. Treatment: Patient received Aleve (treatment) and had been taken zinc, multivitamins. Facility type was reported as a clinic. No prior vaccination since 4 weeks.   No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy
Clinical narrative: Swollen lymphnodes- arm pit and neck(three days).; Headaches; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Dec2021 08:45 (Lot number: FL3197) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "spinal stenosis" (unspecified if ongoing); "Degenerative disk dz" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing), notes: Known allergies: Latex, steroids. Concomitant medication(s) included: SINGULAIR. Past drug history included: Steroids, reaction(s): "Known allergies: steroids", notes: Known allergies: Latex, steroids. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 31Dec2021 12:00, outcome "not recovered", described as "Swollen lymphnodes- arm pit and neck(three days)."; HEADACHE (non-serious) with onset 31Dec2021 12:00, outcome "not recovered", described as "Headaches"; FATIGUE (non-serious) with onset 31Dec2021 12:00, outcome "not recovered", described as "fatigue". Therapeutic measures were not taken as a result of lymphadenopathy, headache, fatigue.  Additional information: The patient did not take any other vaccine in four weeks prior COVID -19 vaccine. The patient was not diagnosed with COVID prior vaccination and not tested with COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pain in extremity
Clinical narrative: Sore arm; fatigue; feeling unwell; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. 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. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; MALAISE (non-serious), outcome "unknown", described as "feeling unwell".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever (temps reached 100.2); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 7 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administered in arm left, administration date 18Dec2021 10:30 (Batch/Lot number: unknown) at the age of 7 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Asthmatic" (unspecified if ongoing). Concomitant medication(s) included: CETIRIZINE; fluticasone propionate (FLOVENT); FLONASE [FLUTICASONE PROPIONATE]; POLYVISOL [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL PALMITATE;RIBOFLAVIN SODIUM PHOSPHATE;THIAMINE HYDROCHLORIDE] taken for vitamin supplementation. The following information was reported: PYREXIA (non-serious) with onset 18Dec2021 17:30, outcome "recovered" (Dec2021), described as "Fever (temps reached 100.2)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that the patient had a fever lasting from the day of injection through 3 consecutive days (as reported). Temps reached 100.2 but would have been higher if not controlled by ibuprofen (100 mg/5 mL) 11 mL, 6 hourly administration (orally) for 3 days. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder, Lichen planus, Oral pain, Oral pruritus
Clinical narrative: He stated that his wife received two doses of the vaccine and 2 months later she developed "Lichen planus".; itching in the mouth; Cannot eat anything; Pains in the mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) 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: LICHEN PLANUS (non-serious), outcome "unknown", described as "He stated that his wife received two doses of the vaccine and 2 months later she developed "Lichen planus"."; ORAL PRURITUS (non-serious), outcome "unknown", described as "itching in the mouth"; FEEDING DISORDER (non-serious), outcome "unknown", described as "Cannot eat anything"; ORAL PAIN (non-serious), outcome "unknown", described as "Pains in the mouth". The events "he stated that his wife received two doses of the vaccine and 2 months later she developed "lichen planus".", "itching in the mouth", "cannot eat anything" and "pains in the mouth" were evaluated at the physician office visit. Therapeutic measures were taken as a result of lichen planus, oral pruritus, feeding disorder, oral pain.  Additional information: Pfizer Covid 19 vaccine a Pfizer product, Pfizer Covid 19 vaccine manufacturer was unspecified. Dates for Pfizer Covid 19 vaccine was Unspecified. NDC number of Pfizer. Covid 19 vaccine not Provided. Reason for no lot number: of Pfizer Covid 19 vaccine not provided. Expiry Date of Pfizer Covid 19 vaccine not Provided. No Other Products. No Patient History. Investigation Assessment Not Provided. The doctor's gave medication and treatment to the patient it was not worked. The patient cannot eat anything because of itching in the mouth. Stated that she had itches and pains in the mouth. Stated it was because of the Pfizer Covid 19 vaccines.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: An excessive joint pain, that increased about 25 percent; 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 18Mar2021 (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: ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "An excessive joint pain, that increased about 25 percent".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Heart rate, Heart rate increased
Clinical narrative: After I got the shot I feel like all this like anxiety; it seems like anxiety or something; Fast heart beat; 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 04Jan2022 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANXIETY (non-serious) with onset Jan2022, outcome "unknown", described as "After I got the shot I feel like all this like anxiety; it seems like anxiety or something"; HEART RATE INCREASED (non-serious) with onset Jan2022, outcome "unknown", described as "Fast heart beat". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site swelling
Clinical narrative: lump on the arm; documentation it says arm swelling or injection side swelling is that basically what I am looking at; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 11 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 03Jan2022 (Lot number: FK5618, Expiration Date: 31May2022) at the age of 11 years as dose 2 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Adderall for ADHD; Fluoxetine for ADHD. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN, the reporter stated "I guess it is FK5127, oh no sorry that was a first dose".), for Covid-19 immunization. The following information was reported: VACCINATION SITE MASS (non-serious) with onset Jan2022, outcome "unknown", described as "lump on the arm"; VACCINATION SITE SWELLING (non-serious) with onset Jan2022, outcome "unknown", described as "documentation it says arm swelling or injection side swelling is that basically what I am looking at".  Additional Information: The reporter stated, "My daughter just received this shot about 2 days ago and on her arm she has like a probably about a 'saw it our' sized lump on the arm and as I was reading through the documentation it says arm swelling or injection side swelling is that basically what I am looking at (Further clarification unknown). It is like a 'saw it our' size lump. It is her second shot for the COVID she did not have get something like that for the first shot. I just have to know it is second shot she getting a lump. She is 11 years old and just receiving the child dosage". When asked about Height & Weight, the reporter stated "she is probably 160, and she is 5 ft. 6 inches". No prior vaccination (4 weeks prior). No Investigation Assessment reported.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: the caller is now getting pain at the injection site where it was very bad last night; pain in her arm; 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 75 year-old female patient received bnt162b2 (BNT162B2), administration date Nov2021 (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 (Dose 1, Single, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Single, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "the caller is now getting pain at the injection site where it was very bad last night"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in her arm". Therapeutic measures were taken as a result of vaccination site pain. Additional information: She was a consumer that received the adult formulation Pfizer BioNTech Covid-19 vaccine booster back in Nov2021. She was now getting pain at the injection site where it was very bad last night and she applied Biofreeze and it helped. She mentioned to them that the pain was where she got the booster that was going towards under her arm. She would like to know why this was happening and was it normal. She called about the Pfizer COVID-19 vaccine and reported that she took the shot in Nov2021, but did not remember the day. Now she was getting pain where the shot was. The pain was very bad last night. She put Biofreeze on it and it helped. She was concerned as to why this was happening. 75 year old female consumer states she has pain in her arm from the booster shot for the Pfizer COVID vaccine 3 months later and caller wanted to know if this has been reported.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: After she came home from her second dose, she got her period immediately; 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 35 year-old female patient 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 (Manufacturer unknown), for COVID-19 immunization. The following information was reported: MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "After she came home from her second dose, she got her period immediately".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain, Pain in extremity
Clinical narrative: his arm has been sore; the pain is spreading to not just where he got the vaccination but it is starting to move from the arm to the shoulder and to the neck; the pain is spreading to not just where he got the vaccination but it is starting to move from the arm to the shoulder and to the neck; the pain is spreading to not just where he got the vaccination but it is starting to move from the arm to the shoulder and to the neck; 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 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 15Dec2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 15Dec2021, outcome "not recovered", described as "his arm has been sore"; PAIN (non-serious), ARTHRALGIA (non-serious), NECK PAIN (non-serious) all with onset Dec2021, outcome "not recovered" and all described as "the pain is spreading to not just where he got the vaccination but it is starting to move from the arm to the shoulder and to the neck".  Additional information: Clinical course: Patient states he received his vaccination on 15Dec2021, and his arm has been sore since 15Dec2021. The pain was spreading to not just where he got the vaccination, but it was starting to move from the arm to the shoulder and to the neck. He was achy and it was very painful and spreading. It was so painful it hurts to lay down in bed. Patient like to know if we have heard of this problem before. Patient like to know if he has to go to the doctor. Advised patient that Pfizer MI provides the most accurate information available, and Pfizer cannot make any treatment recommendation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.