chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Fatigue, Insomnia, Pain in extremity, Somnolence
Clinical narrative: sore arm; It took the caller a long time to get to sleep; she would only sleep for 3-4 hours then she would wake up groggy and really tired; she would only sleep for 3-4 hours then she would wake up groggy and really tired; Excitability; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm right, administration date 27Mar2021 (Lot number: EN6208) at the age of 54 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Neck injury" (unspecified if ongoing), notes: from a car accident; "shoulder inury" (unspecified if ongoing), notes: from a car accident. Concomitant medication(s) included: ASPIRIN (E.C.), start date: 2019; SIMVASTATIN; NOVOLOG MIX (70/30); NYSTATIN.  The following information was reported: AGITATION (non-serious) with onset 27Mar2021, outcome "recovering", described as "Excitability"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; INSOMNIA (non-serious), outcome "unknown", described as "It took the caller a long time to get to sleep"; SOMNOLENCE (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "she would only sleep for 3-4 hours then she would wake up groggy and really tired".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: Sluggish feeling; Headache; Chills; Not feeling well / unwell; Pain in my arm; Little bit tired; Head is little bit in a fog; 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 26Mar2021 (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: SLUGGISHNESS (non-serious), outcome "unknown", described as "Sluggish feeling"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; CHILLS (non-serious), outcome "unknown", described as "Chills"; MALAISE (non-serious), outcome "unknown", described as "Not feeling well / unwell"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pain in my arm"; FATIGUE (non-serious), outcome "unknown", described as "Little bit tired"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Head is little bit in a fog". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of sluggishness, headache, chills, malaise, pain in extremity, fatigue, feeling abnormal.  Additional information: The patient took Ibuprofen as treatment of the events. The patient went to a doctor just to check the blood pressure and he was informed that he was totally fine. The patient was asking if how long does the symptoms or the adverse reactions will last.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity, Sluggishness
Clinical narrative: Sluggish feeling; Headache; Chills; Not feeling well / unwell; Pain in my arm; Little bit tired; Head is little bit in a fog; 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 26Mar2021 (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: SLUGGISHNESS (non-serious), outcome "unknown", described as "Sluggish feeling"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; CHILLS (non-serious), outcome "unknown", described as "Chills"; MALAISE (non-serious), outcome "unknown", described as "Not feeling well / unwell"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Pain in my arm"; FATIGUE (non-serious), outcome "unknown", described as "Little bit tired"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Head is little bit in a fog". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of sluggishness, headache, chills, malaise, pain in extremity, fatigue, feeling abnormal.  Additional information: The patient took Ibuprofen as treatment of the events. The patient went to a doctor just to check the blood pressure and he was informed that he was totally fine. The patient was asking if how long does the symptoms or the adverse reactions will last.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Extreme pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 24Mar2021 04:00 (Lot number: EP6955) at the age of 78 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Spinal stenosis" (unspecified if ongoing); "Smoldering multiple myeloma" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN; PREDNISONE; TRIAMTERENE HCTZ; METOPROLOL; ZOLPIDEM; OXYCODONE; LISINOPRIL; ATORVASTATIN; CALCIUM; FLUTICASONE PROPIONATE. Vaccination history included: Bnt162b2 (1st dose, lot number=EN6204), for Covid-19 immunisation. The following information was reported: PAIN (non-serious) with onset 26Mar2021, outcome "not recovered", described as "Extreme pain". Therapeutic measures were not taken as a result of pain.  Additional information: Patient was also taking unspecified vitamins as concomitant medication. It was reported that patient had been in extreme pain since Friday, when he had the Pfizer vaccine (Covid Vaccine) at 4 o' clock Wednesday and he was wondering if it would be because of the vaccine. He had never been in this kind of pain. He also stated that he was in bed and can barely move out of it. He just wanted to know if this could be due to the vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm/pain in arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Mar2021 14:30 (Lot number: EP6955) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 27Mar2021 14:30, outcome "recovered" (28Mar2021 14:30), described as "sore arm/pain in arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient had no allergies to medications, food, or other products. The patient had not received any other vaccines within 4 weeks prior vaccination. Since the vaccination the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021355806 Same reporter/drug/AE and different patient
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: scheduled for his second dose today but after he woke-up he is not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (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: MALAISE (non-serious) with onset 26Mar2021, outcome "unknown", described as " scheduled for his second dose today but after he woke-up he is not feeling well".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Mobility decreased, Muscle spasms, Muscular weakness, Pain in extremity, Vaccination site pain
Clinical narrative: shoulder pain at the injection site; decreased mobility in the left arm; not so much weakness as soreness/ guarding the arm because of the soreness; guarding the arm because of the soreness; Charley horses; This is a spontaneous report received from a contactable nurse from medical information team.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the arm (shoulder), administration date 09Jan2021 (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: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "shoulder pain at the injection site"; MOBILITY DECREASED (non-serious) with onset 2021, outcome "unknown", described as "decreased mobility in the left arm"; MUSCULAR WEAKNESS (non-serious) with onset 2021, outcome "unknown", described as "not so much weakness as soreness/ guarding the arm because of the soreness"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "guarding the arm because of the soreness"; MUSCLE SPASMS (non-serious) with onset 2021, outcome "unknown", described as "Charley horses".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021289893 same reporter, same suspect drug, similar events, different patient
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Mobility decreased, Muscle spasms, Pain in extremity, Vaccination site pain
Clinical narrative: decreased mobility in the left arm; shoulder pain at the injection site; weakness; arm soreness; Charlie Horses; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left deltoid, administration date 09Jan2021 (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: MOBILITY DECREASED (non-serious) with onset 2021, outcome "unknown", described as "decreased mobility in the left arm"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "shoulder pain at the injection site"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "weakness"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "arm soreness"; MUSCLE SPASMS (non-serious) with onset 2021, outcome "unknown", described as "Charlie Horses".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021289893 Same reporter, suspect drug, event; different patient
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Malaise, Vaccination site pain
Clinical narrative: tiredness, pain in the injection site, headache, feeling unwell, and flu like symptoms; tiredness, pain in the injection site, headache, feeling unwell, and flu like symptoms; tiredness, pain in the injection site, headache, feeling unwell, and flu like symptoms; tiredness, pain in the injection site, headache, feeling unwell, and flu like symptoms; tiredness, pain in the injection site, headache, feeling unwell, and flu like symptoms; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 24Mar2021 (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: FATIGUE (non-serious), VACCINATION SITE PAIN (non-serious), HEADACHE (non-serious), MALAISE (non-serious), INFLUENZA LIKE ILLNESS (non-serious) all with onset 24Mar2021, outcome "unknown" and all described as "tiredness, pain in the injection site, headache, feeling unwell, and flu like symptoms".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Oral candidiasis, SARS-CoV-1 test, Taste disorder, Tongue discomfort
Clinical narrative: Metallic taste in the mouth; thought it was thrush; burning of the tongue; dulled sense of taste; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 12Mar2021 (Lot number: EN6204) at the age of 50 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DYSGEUSIA (non-serious) with onset 16Mar2021, outcome "not recovered", described as "Metallic taste in the mouth"; ORAL CANDIDIASIS (non-serious) with onset 16Mar2021, outcome "not recovered", described as "thought it was thrush"; TONGUE DISCOMFORT (non-serious) with onset 16Mar2021, outcome "recovering", described as "burning of the tongue"; TASTE DISORDER (non-serious) with onset 16Mar2021, outcome "not recovered", described as "dulled sense of taste". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dysgeusia, oral candidiasis, taste disorder. Additional information: Clinical course:  The patient had the first covid19 vaccine on 12Mar2021 and the symptoms started with a metallic taste. The patient never lost her taste and they thought it was thrush. The patient also had burning of the tongue and a dulled sense of taste. She never lost her sense of taste. The patient was treated with Nystatin as they thought it might be thrush, but there is no whiteness of the tongue. Metallic taste in the mouth and Dulled sense of taste were reported as worsened. The reporter was querying if there have been other reports about these symptoms and if these symptoms are related to the vaccine as symptoms became apparent after the first dose of the vaccine. The relatedness of drug to reaction(s)/event(s): Metallic taste in the mouth, Burning tongue, Dulled sense of taste with primary source reporter as source of assessment and Global Introspection as method of assessment was unknown. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional administered vaccines. Patient had no prior vaccinations (within 4 weeks), no Patient medical history (including any illness at time of vaccination) and no family medical history relevant to adverse events. The patient does not have SARS-CoV2 antibodies at diagnosis. The patient did not display clinical signs at rest indicative of severe systemic illness. Events did not require the initiation of new medication or other treatment or procedure.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Illness
Clinical narrative: had a temperature; she was pretty sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 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: Bnt162b2 (First Dose), for Covid-19 immunisation, reaction(s): " was fine after the first vaccination". The following information was reported: BODY TEMPERATURE INCREASED (non-serious), outcome "recovered", described as "had a temperature"; ILLNESS (non-serious), outcome "recovered", described as "she was pretty sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient had no autoimmune conditions. The day after the second dose, patient was pretty sick. She had a temperature and the classic symptoms and then was fine after.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Faecal volume increased, Feeling hot, Malaise, Nausea
Clinical narrative: Didn't eat a whole lot; It was just so hot; Couldn't keep anything down; Wasn't feeling all that great; Extreme nausea; Lot of stools; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 09:30 (Lot number: ER8730, Expiration Date: 31Jul2021) at the age of 66 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, Administration time: 09:30, Lot number: EN6205, Expiration Date: 30Jun2021), administration date: 02Mar2021, when the patient was 66 years old, for COVID-19 immunisation. The following information was reported: NAUSEA (non-serious) with onset 26Mar2021, outcome "unknown", described as "Extreme nausea"; FAECAL VOLUME INCREASED (non-serious) with onset 26Mar2021, outcome "unknown", described as "Lot of stools"; DECREASED APPETITE (non-serious) with onset 27Mar2021, outcome "unknown", described as "Didn't eat a whole lot"; FEELING HOT (non-serious) with onset 27Mar2021, outcome "unknown", described as "It was just so hot"; VOMITING (non-serious) with onset 27Mar2021, outcome "unknown", described as "Couldn't keep anything down"; MALAISE (non-serious) with onset 27Mar2021, outcome "unknown", described as "Wasn't feeling all that great".  Additional information: The patient hasn't had any gagging. The patient had no additional vaccines administered on same date of BNT162B2. The patient had not received any other vaccines within 4 weeks prior vaccination. The events did not require a visit to ER or Physician office.   No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Didn't eat a whole lot; It was just so hot; Couldn't keep anything down; Wasn't feeling all that great; Extreme nausea; Lot of stools; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 09:30 (Lot number: ER8730, Expiration Date: 31Jul2021) at the age of 66 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, Administration time: 09:30, Lot number: EN6205, Expiration Date: 30Jun2021), administration date: 02Mar2021, when the patient was 66 years old, for COVID-19 immunisation. The following information was reported: NAUSEA (non-serious) with onset 26Mar2021, outcome "unknown", described as "Extreme nausea"; FAECAL VOLUME INCREASED (non-serious) with onset 26Mar2021, outcome "unknown", described as "Lot of stools"; DECREASED APPETITE (non-serious) with onset 27Mar2021, outcome "unknown", described as "Didn't eat a whole lot"; FEELING HOT (non-serious) with onset 27Mar2021, outcome "unknown", described as "It was just so hot"; VOMITING (non-serious) with onset 27Mar2021, outcome "unknown", described as "Couldn't keep anything down"; MALAISE (non-serious) with onset 27Mar2021, outcome "unknown", described as "Wasn't feeling all that great".  Additional information: The patient hasn't had any gagging. The patient had no additional vaccines administered on same date of BNT162B2. The patient had not received any other vaccines within 4 weeks prior vaccination. The events did not require a visit to ER or Physician office.   No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Goitre, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: Left thyroid gland slightly swollen about 3 days after first vaccination and continues after second shot; Hard swelling below injection site on left lateral upper arm approximately 3inches long by 1/2-inch-wide, starting 11 1/2 hours after first vaccination (with pain) It lasted about two days; Hard swelling below injection site on left lateral upper arm approximately 3inches long by 1/2-inch-wide, starting 11 1/2 hours after first vaccination (with pain) It lasted about two days; Continuous upper arms muscle pain when raise arms overhead since day after both shots , which lasted 3 weeks after 1st shot; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 10:30 (Batch/Lot number: unknown) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "sulfa antibiotics allergy" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID. The following information was reported: PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 26Mar2021 23:00, outcome "recovered" (28Mar2021 23:00) and all described as "Hard swelling below injection site on left lateral upper arm approximately 3inches long by 1/2-inch-wide, starting 11 1/2 hours after first vaccination (with pain) It lasted about two days"; MYALGIA (non-serious) with onset 26Mar2021 23:00, outcome "recovered" (Apr2021), described as "Continuous upper arms muscle pain when raise arms overhead since day after both shots , which lasted 3 weeks after 1st shot"; GOITRE (non-serious) with onset 29Mar2021, outcome "not recovered", described as "Left thyroid gland slightly swollen about 3 days after first vaccination and continues after second shot". Therapeutic measures were not taken as a result of peripheral swelling, pain in extremity, myalgia, goitre.  Additional Information: The vaccine was administered in a Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since vaccination, the patient has 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: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling cold, Malaise, X-ray limb
Clinical narrative: felt very cold; Chills; slept all day; didn't feel good; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 85 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 23Mar2021 11:00 (Lot number: ER2613) at the age of 85 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "blood pressure " (unspecified if ongoing). Concomitant medications included: AMLODIPINE BESYLATE taken for blood pressure abnormal (ongoing); HYDROCHLOROTHIAZIDE (ongoing); ROSUVASTATIN CALCIUM taken for blood cholesterol (ongoing); HYDROXYCHLOROQUINE SULFATE taken for rheumatoid arthritis, start date: 02Mar2021 (ongoing). Vaccination history included: Bnt162b2 (First dose: Pfizer COVID-19 vaccine 02Mar2021 Lot number: EN6202. Left upper arm.), administration date: 02Mar2021, for COVID-19 immunisation. The following information was reported: FEELING COLD (non-serious) with onset 28Mar2021, outcome "recovering", described as "felt very cold"; CHILLS (non-serious) with onset 28Mar2021, outcome "recovering", described as "Chills"; FATIGUE (non-serious) with onset 28Mar2021, outcome "unknown", described as "slept all day"; MALAISE (non-serious) with onset 28Mar2021, outcome "unknown", described as "didn't feel good". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Decreased appetite
Clinical narrative: Tightness in stomach; loss of appetite; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 2021 (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: ABDOMINAL PAIN UPPER (non-serious), outcome "not recovered", described as "Tightness in stomach"; DECREASED APPETITE (non-serious), outcome "not recovered", described as "loss of appetite".  Additional information: The patient received the first shot of the vaccine 3 to 4 weeks ago. The patient was asking how long the side effects are supposed to last and if he takes medication will that have an adverse effect on ways the vaccine works and vice versa.  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: Back pain, Dizziness, Pain in extremity, Vaccination site pain
Clinical narrative: dizzy; lower back pain; pain at the injection site; She also had pain in her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Mar2021 12:00 (Lot number: ER8727) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (ongoing), notes: for 20-30 years . Concomitant medication(s) included: FELODIPINE taken for hypertension (ongoing). The following information was reported: DIZZINESS (non-serious) with onset 28Mar2021, outcome "recovering", described as "dizzy"; BACK PAIN (non-serious) with onset 27Mar2021, outcome "recovering", described as "lower back pain"; VACCINATION SITE PAIN (non-serious) with onset 27Mar2021, outcome "recovering", described as "pain at the injection site"; PAIN IN EXTREMITY (non-serious) with onset 27Mar2021, outcome "recovering", described as "She also had pain in her arm". Additional information: Patient was vaccinated at a senior center. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) and had no vaccines administered on same date with the Pfizer vaccine considered as suspect. The patient had no prior vaccinations within 4 weeks.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Sinus disorder
Clinical narrative: a little bit of a low grade cold; sinus drip; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (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: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "a little bit of a low grade cold"; SINUS DISORDER (non-serious), outcome "not recovered", described as "sinus drip". Additional information: Patient have not experienced a fever. Event sinus drip thing was going on. Reporter stated these symptoms have nothing to do with the COVID vaccine as they had received it 3 weeks ago and the symptoms were from a day or two ago when they were out in the wind. Patient was due for second dose on Wednesday, 31Mar2021. Reporter was querying if the events pose any problems in getting the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the information currently available, the reported 'cold' and 'sinus drip' are likely intercurrent medical conditions and are unrelated to suspect product bnt162b2. Case will be reassessed if additional information is received.,Linked Report(s) : US-PFIZER INC-2021355750 Same reporter and drug; similar event; different patient.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm/pain in arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 32 year-old male patient received bnt162b2 (BNT162B2), administration date 27Mar2021 (Batch/Lot number: unknown) at the age of 32 years 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 27Mar2021, outcome "recovered" (Mar2021), described as "sore arm/pain in arm". Therapeutic measures were not taken as a result of pain in extremity. Additional information: The event lasted about a whole 24 hours.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021355594 Same reporter, drug and event; different patient.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection soreness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Dec2020 (Lot number: EK9231) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Common variable immune deficiency" (unspecified if ongoing); "Known allergies: SULFA" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Injection soreness".  Additional information: Patient took unspecified medications within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Painful respiration
Clinical narrative: very sharp pain in back where lungs might be; She felt it when she breathed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Mar2021 (Lot number: EP6955) at the age of 22 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BACK PAIN (non-serious) with onset 28Mar2021, outcome "not recovered", described as "very sharp pain in back where lungs might be"; PAINFUL RESPIRATION (non-serious) with onset 28Mar2021, outcome "not recovered", described as "She felt it when she breathed". Therapeutic measures were not taken as a result of back pain, painful respiration. Additional information: Clinical course: The patient got her first shot Saturday at noon. Last night, 28Mar2021, she started getting very sharp pain in her back where lungs might be. She thought it might go away over night, but now it was very sharp pain in her back where her lungs were. She felt it when she breathed. The patient was querying if this was a side effect, and if other people have reported that or was this a muscle issue that has nothing to do with shot. The patient had no additional vaccines administered on same date of the Pfizer suspect, no prior vaccinations (within 4 weeks), no adverse events following prior vaccinations and no family medical history relevant to adverse events.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Lymphadenopathy, Pain
Clinical narrative: Swollen Lymph nodes on left arm; Hot flashes; Achey; This is a spontaneous report received from a contactable reporter(s) (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 22Mar2021 13:15 (Lot number: EN6205) at the age of 57 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "PCOS" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Asa, reaction(s): "allergies", notes: Known allergies: ASA. Vaccination history included: Bnt162b2 (DOSE  1, Lot number: EN6207, Arm left, Time: 13:30), administration date: 01Mar2021, when the patient was 57 years old, for COVID-19 immunisation, reaction(s): "Headache". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 23Mar2021 11:00, outcome "not recovered", described as "Swollen Lymph nodes on left arm"; HOT FLUSH (non-serious) with onset 23Mar2021 11:00, outcome "recovering", described as "Hot flashes"; PAIN (non-serious) with onset 23Mar2021 11:00, outcome "recovering", described as "Achey". Therapeutic measures were not taken as a result of lymphadenopathy, hot flush, pain.  Additional information: No other vaccine in four weeks. No covid prior to vaccination. Not covid tested post vaccination. Headache 1st shot lasting 3 days. Second shot- swollen lymph nodes on left arm (injection site) onset: day 2 ongoing, hot flashes, and achey.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021359401 Same reporter/patient/vaccine, different dose/event
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 84 year-old male patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) at the age of 84 years 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: FATIGUE (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "Fatigue". Therapeutic measures were not taken as a result of fatigue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Peripheral swelling
Clinical narrative: Arm is swelling; Knot that came up on top of wrist; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 12:00 (Lot number: EN6205, Expiration Date: 30Mar2021) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COPD" (ongoing); "B carrier of hepatitis" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "A fib" (unspecified if ongoing); "Congestive heart failure" (unspecified if ongoing); "Blockage" (unspecified if ongoing); "Blood thinner" (unspecified if ongoing). Concomitant medication(s) included: SYMBICORT taken for chronic obstructive pulmonary disease (ongoing); ELIQUIS taken for atrial fibrillation, cardiac failure congestive, anticoagulant therapy, start date: Oct2019 (ongoing); SOTALOL taken for atrioventricular block (ongoing); CLOPIDOGREL (ongoing); ATORVASTATIN taken for blood cholesterol abnormal (ongoing); POTASSIUM (ongoing); MAGNESIUM OXIDE (ongoing). Past drug history included: Aspirin, reaction(s): "Allergy"; Codeine, reaction(s): "Allergy"; Sulfur, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (1st dose, Lot number: EN620C, Expiry date: 06Mar2021), administration date: 02Mar2021, when the patient was 72 years old, for COVID-19 immunisation. The following information was reported: NODULE (non-serious) with onset 29Mar2021, outcome "not recovered", described as "Knot that came up on top of wrist"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Arm is swelling".  Additional information: The patient had no additional vaccines administered on same date of BNT162B2. The patient had not received any other vaccines within 4 weeks prior vaccination. The events did not require a visit to ER or Physician office.   No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Euphoric mood, Malaise
Clinical narrative: after my first vaccine, I had a feeling of "euphoria" SUPER HUMAN and was able to complete very difficult  moves in the gym, which I was never able to complete for the past 6 years; I am still not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 54-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Mar2021 16:45 (Lot number: EL3248) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Uterine Cancer" (unspecified if ongoing); "Bipolar 2" (unspecified if ongoing). Concomitant medication(s) included: OXYCARBAMAZEPINA; ALPRAZOLAM; QUETIAPINE; LORAZEPAM; AMPHETAMINE; VITAMINS D3; BIOTIN.The following information was reported: EUPHORIC MOOD (non-serious) with onset 24Mar2021, outcome "unknown", described as "after my first vaccine, I had a feeling of "euphoria" SUPER HUMAN and was able to complete very difficult  moves in the gym, which I was never able to complete for the past 6 years"; MALAISE (non-serious) with onset 2021, outcome "not recovered", described as "I am still not feeling well". Therapeutic measures were not taken as a result of malaise and EUPHORIC MOOD.Additional Information: After her first vaccine, she had a feeling of euphoria SUPERHUMAN and was able to complete very difficult  moves in the gym, which she was never able to complete for the past 6 years. This first vaccine event was not reported because it was a positive event and not an adverse event, but now she wondered if there is a connection between my reactions to both vaccines. Possibly an interaction with one of her concomitant medications. List of any other medications the patient received within 2 weeks of vaccination: Oxycarbaxepine, Alprazolam, Quetiapine, Lorazepam. Further prescriptions Amphetamine, Vitamins D3 and Biotin. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. It was reported that Awareness 1st dose of vaccine was on 03 March 2021 (Please note this was not reported at the time because the event was considered a positive effect) Only after the 2nd dose, was there potentially a connection between the two events. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: he was so feeling poorly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received COVID-19 Vaccine - Manufacturer Unknown, (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: FEELING ABNORMAL (non-serious), outcome "unknown", described as "he was so feeling poorly".  Additional Information: The reporter did not know which vaccine the patient got. Because of the event, the patient took a couple days off of work.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Photopsia, Vitreous floaters
Clinical narrative: white flashing, like white lights in both eyes like a field of fireworks; vision was also like it had a floater or two, black or white; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Mar2021 13:00 (Lot number: EP7534) at the age of 66 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PHOTOPSIA (non-serious) with onset 25Mar2021 13:05, outcome "recovered" (25Mar2021 13:06), described as "white flashing, like white lights in both eyes like a field of fireworks"; VITREOUS FLOATERS (non-serious) with onset 25Mar2021 13:05, outcome "recovered" (25Mar2021 13:06), described as "vision was also like it had a floater or two, black or white". Additional information: Clinical course: Patient got the shot on Thursday and she was talking to the person administering the shot then got up and sat down in the waiting area and she stated that as soon as she sat down, she started seeing white flashing, like white lights in both eyes like a field of fireworks. It lasted a whole minute to a minute and a half. Patient's vision was also like it had a floater or two, black or white, and had one flash occasionally. It was reported that patient panicked and thought she was having a detached retina or something. Patient didn't know if she could see through the white lights but that they went away after a minute or two. Patient wanted to know if anyone else has had this and was afraid that if she gets the second shot that it will happen again. Patient was reported to be an excessively healthy person and stated that she's not getting the COVID shot because she has a fear of getting COVID. The patient had no history of all previous immunizations with the Pfizer vaccine considered as suspect, no additional vaccines administered on same date of the Pfizer suspect, prior vaccinations within 4 weeks and no adverse events following prior vaccinations and no relevant tests. Patient stated that she doesn't get flu shots, she doesn't want to put all that garbage in her body, she was healthy.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Lymphadenopathy, Pain
Clinical narrative: Headache; Lymph swollen; Excess sweating; She could not put her pants on after first dose because she was just sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Jan2021 12:00 (Lot number: EL0142) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "stress" (unspecified if ongoing); "sulfa" (unspecified if ongoing), notes: Intolerant to certain medications. Anything related to Sulfa, Codeine, Penicillin, Dilaudid; "Penicillin" (unspecified if ongoing), notes: Intolerant to certain medications. Anything related to Sulfa, Codeine, Penicillin, Dilaudid. The patient took concomitant medications. Past drug history included: Codeine, reaction(s): "Intolerant to certain medications", notes: Intolerant to certain medications. Anything related to Sulfa, Codeine, Penicillin, Dilaudid; Dilaudid, reaction(s): "Intolerant to certain medications", notes: Intolerant to certain medications. Anything related to Sulfa, Codeine, Penicillin, Dilaudid. Vaccination history included: Hpv vaccine, for Immunisation; Flu vaccine, for Immunisation, reaction(s): "headache ", "felt ill". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 09Jan2021 08:00, outcome "not recovered", described as "Lymph swollen"; HYPERHIDROSIS (non-serious) with onset 09Jan2021 08:00, outcome "not recovered", described as "Excess sweating  "; HEADACHE (non-serious) with onset 09Jan2021 18:00, outcome "recovering", described as "Headache "; PAIN (non-serious) with onset 09Jan2021, outcome "recovering", described as "She could not put her pants on after first dose because she was just sore".  Additional information: Patient reported she is on birth control. Soreness started around 18:00 -19:00. Events did not result to emergency room and physician office visit  No follow-up attempts are possible. No further information is expected.