chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Lymphadenopathy, Menstrual disorder, Pain in extremity, Polymerase chain reaction
Clinical narrative: Lymph node under arm is still swollen; still have an aching pain under my arm; heavy periods only 2 weeks apart.; heavy periods only 2 weeks apart.; This is a spontaneous report from a contactable consumer or other non hcp. A 41-years-old non pregnancy female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, formulation: Solution for injection, Batch/lot Number: EW0186) via an unspecified route of administration in Arm Left on 15May2021 11:15 (age at vaccination: 41years old, Pregnant at Time of Vaccination: No) as single dose for covid-19 immunisation. The patient did not have known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history was not reported. Concomitant medication(s) included quetiapine (QUETIAPINE); zolpidem (ZOLPIDEM); prazosin (PRAZOSIN), all taken for an unspecified indication, start and stop date were not report-ed. Since the vaccination, the patient had been tested for COVID-19. The patient had historical vac-cine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot Number: EW0172) via an unspecified route of administration in Arm Left on 24Apr2021 03:00 PM (age at vaccination: 41years old, Pregnant at Time of Vaccination: No) as single dose for covid-19 immunisation. On 16May2021 the patient experienced lymph node under arm is still swollen, still have an aching pain under my arm, heavy periods only 2 weeks apart. Clinical course was reported as Lymph node under arm is still swollen. I still have an aching pain under my arm. My menstrual cycle is completely off, and it's been very heavy. I had two heavy periods only 2 weeks apart. The patient underwent lab tests and procedures which included polymerase chain reaction: negative on 07Jun2021. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blister, Herpes zoster, Injection site vesicles, Nerve injury
Clinical narrative: Started getting blisters across rt. upper torso- breast, and  then my back & down  right arm where I received my shot in.  Sharp pain in shoulder. Went to emergency room, was diagnosed with Shingles. I was given pain meds & antibiotics. Spots are healed but nerves & itching still occurs. Not as bad   But still is bothersome. Still take  Gabapentin now for nerve pain. & soreness. Nerve damage & pains seem permanent. I was already disabled.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pruritus
Clinical narrative: Started getting blisters across rt. upper torso- breast, and  then my back & down  right arm where I received my shot in.  Sharp pain in shoulder. Went to emergency room, was diagnosed with Shingles. I was given pain meds & antibiotics. Spots are healed but nerves & itching still occurs. Not as bad   But still is bothersome. Still take  Gabapentin now for nerve pain. & soreness. Nerve damage & pains seem permanent. I was already disabled.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Discomfort, Dysphagia, Dyspnoea
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lethargy, Pain, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 59.0
Sex: F
Vaccine: SMALL
Symptoms: Dyspepsia, Peripheral swelling
Clinical narrative: sever sweloning  hands  @ arms  legs and foot      heartburn   I was put on a  water pill  and A  heartburn  med.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Hypertension, Oral discomfort
Clinical narrative: Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: patient reported mouth and throat feel like they are burning and localized muscle pain at shoulder (trapezoid)-Medium, Systemic: Hypertension-Mild, Systemic: Shakiness-Mild
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Throat irritation, Tremor
Clinical narrative: Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: patient reported mouth and throat feel like they are burning and localized muscle pain at shoulder (trapezoid)-Medium, Systemic: Hypertension-Mild, Systemic: Shakiness-Mild
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: his neighbor was tired after the second shot; This is a spontaneous report from a contactable nurse reported for a patient (neighbor). This is report 2 of 2. This report is in regards to the caller's neighbor. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunization. It was reported that, the caller was a registered nurse called on behalf of himself in regards to the COVID vaccine. While reporting on himself, caller stated that, he had a neighbor that had the vaccine and he was tired from it. When caller was asked, whether he would provide information about his neighbor, he said his neighbor would not like it and he would prefer not to do report. The caller stated that, his neighbor was tired after the second shot. He was better after a couple of days. Stated that, he was fine after that. He got better right away. Stated that, he had no fever, chills, headache or nothing. He was just tired. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Chest X-ray, Chest discomfort, Echocardiogram, Electrocardiogram
Clinical narrative: I was falling asleep when suddenly my heart became "erratic". My heart would suddenly race and just as suddenly stop, with severe palpitations. This feeling that my heart was beating out of time, or would race, or would then be practically undetectable (I would check my pulse sometimes and it was very weak-feeling) was very scary. It kept me up most of the night, I called an ambulance who decided not to take me to the emergency room, as I thought I was having a heart attack at the time and they said I wasn't.. Severe symptoms like this continued for about 2 more days, while more subtle symptoms such as chest tightness persisted for 3 weeks to a month at least. Palpitations continue(d) to occur but less severely and more rarely. Even now, months out, occasional palpitations and chest tightness seems to occur. During the first week(s), on top of the tightness and palpitations, there were a number of other symptoms, some or many of which are hard to describe. One such symptom was that I was looking at my phone and something of thump, almost like a heartbeat, occurred but it was felt throughout my whole body. Very difficult to describe. I would "visually dissociate". Again, very difficult to describe this symptom. A sudden tightness of my neck and jaw would occur and sometimes persist for up to an hour. All of these symptoms other than the chest tightness and palpitations seem for the most part to have gone away. But there is now an anxiety-inducing awareness of my heart that I seem to bear nearly constantly.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Joint stiffness, Muscle tightness, Palpitations, Pulse abnormal, Visual impairment
Clinical narrative: I was falling asleep when suddenly my heart became "erratic". My heart would suddenly race and just as suddenly stop, with severe palpitations. This feeling that my heart was beating out of time, or would race, or would then be practically undetectable (I would check my pulse sometimes and it was very weak-feeling) was very scary. It kept me up most of the night, I called an ambulance who decided not to take me to the emergency room, as I thought I was having a heart attack at the time and they said I wasn't.. Severe symptoms like this continued for about 2 more days, while more subtle symptoms such as chest tightness persisted for 3 weeks to a month at least. Palpitations continue(d) to occur but less severely and more rarely. Even now, months out, occasional palpitations and chest tightness seems to occur. During the first week(s), on top of the tightness and palpitations, there were a number of other symptoms, some or many of which are hard to describe. One such symptom was that I was looking at my phone and something of thump, almost like a heartbeat, occurred but it was felt throughout my whole body. Very difficult to describe. I would "visually dissociate". Again, very difficult to describe this symptom. A sudden tightness of my neck and jaw would occur and sometimes persist for up to an hour. All of these symptoms other than the chest tightness and palpitations seem for the most part to have gone away. But there is now an anxiety-inducing awareness of my heart that I seem to bear nearly constantly.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Chest discomfort, Chest pain, Electrocardiogram normal
Clinical narrative: Systemic: Cardiac Disorder (diagnosed by MD)-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: pt felt like she had a heart attack, went to urgent care / ER, they did EKG but result was negative.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Systemic: Seizure-Medium
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Shoulder injury related to vaccine administration
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: Patient consulted with physician after experiencing shoulder pain following 2nd covid shot. Physician diagnosed patient with SIRVA (shoulder injury related to vaccine administration)
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufacture. initial and booster)-
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Medium
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site reaction
Clinical narrative: Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: covid arm-Medium, Additional Details: COVID-ARM.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: Pt said she have been experiencing a throbbing pain on her arm after receiving the vaccine that doesn't go away. It's has been more than 3 weeks and she is experiencing the pain and would like to be contacted.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Headache-Mild
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Pt pass out out. Was sitting down for about 8 minutes after vaccine and got up to walk and passed out. HR went to 44, bp 90/60 and 02 sat was 93. Later recovered within 30 minutes.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Neck pain, Pyrexia
Clinical narrative: Systemic: Fever-Severe, Systemic: neck and back pain; fever over 102.4-Medium, Additional Details: patient has complained of fever over 102.4 even after alternating Motrin and Tylenol around the clock.  Also moderate to severe neck and back pain
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient fainted and regained consciousness. EMS was called
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Nausea, Sleep disorder
Clinical narrative: Nauseous with severe headaches which don?t go away with pain killers. Can not sleep. I?m the headaches wake me up from my sleep. I take 1 Advil and 1 Tylenol but it doesn't go away. I also have nausea with it.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Chest pain, Confusional state, Dizziness
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Joint Pain-Severe, Systemic: Seizure-Medium, Additional Details: patient took tylenol every 4 hours afterwards. was completely fine after first shot and this shot she passed out twice and eyes rolled back, severe neck pain and unresponsive. following up with cardiac for EKG and further  testing.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Eye movement disorder, Injection site pain, Loss of consciousness, Neck pain, Pain
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Joint Pain-Severe, Systemic: Seizure-Medium, Additional Details: patient took tylenol every 4 hours afterwards. was completely fine after first shot and this shot she passed out twice and eyes rolled back, severe neck pain and unresponsive. following up with cardiac for EKG and further  testing.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure, Syncope, Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Joint Pain-Severe, Systemic: Seizure-Medium, Additional Details: patient took tylenol every 4 hours afterwards. was completely fine after first shot and this shot she passed out twice and eyes rolled back, severe neck pain and unresponsive. following up with cardiac for EKG and further  testing.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chest pain, Diarrhoea, Dizziness
Clinical narrative: Difficulty breathing; Dizzy; Weak; Headache; Clogged ears; Just not feeling well but not sick; Tired; Some chest pain left side; Injection site pain; Muscle pain; Joint pain; Swelling; Nausea; Diarrhea; Arm pain; Awful smell; Awful smell and taste in nose/mouth; This is a spontaneous report from a contactable Other HCP (patient). A non-pregnant 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: solution for injection; Lot Number: not reported, expiration date: not reported, Age at vaccination: 59-year-old), via an unspecified route of administration in arm left on 20Jul2021 17:00 as dose number unknown, single for COVID-19 immunization. Medical history included allergies from Pan, erythro, tetra, Prozac, and 150 foods/elements/airborne and 3x cancer survivor, complex partial seizures, vocal cords not functioning properly, migraines, broken bones, myofascial spasms, Hpylori, IBS, spondylitis, sciatica, osteoarthritis, hyperthyroidism, gerd. Concomitant medications were not reported. On 21Jul2021 06:00 AM, patient experienced difficulty breathing, dizzy, weak, headache, clogged ears, spacey, tired, some chest pain left side, injection site pain, muscle pain, joint pain, swelling, nausea, diarrhea, arm pain, just not feeling well but not sick, awful smell and taste in nose/mouth. Facility type vaccine was pharmacy or Drug Store. No other vaccine in four weeks. 11 prescriptions in two weeks were. No treatment present for adverse event. Covid was not present prior vaccination. Covid was not tested post vaccination. The outcome of events was not recovered.   The lot number for [BNT162B2], was not provided and will be requested during follow up' Vs ''information on batch/lot number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Ear discomfort, Fatigue, Feeling abnormal, Headache
Clinical narrative: Difficulty breathing; Dizzy; Weak; Headache; Clogged ears; Just not feeling well but not sick; Tired; Some chest pain left side; Injection site pain; Muscle pain; Joint pain; Swelling; Nausea; Diarrhea; Arm pain; Awful smell; Awful smell and taste in nose/mouth; This is a spontaneous report from a contactable Other HCP (patient). A non-pregnant 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: solution for injection; Lot Number: not reported, expiration date: not reported, Age at vaccination: 59-year-old), via an unspecified route of administration in arm left on 20Jul2021 17:00 as dose number unknown, single for COVID-19 immunization. Medical history included allergies from Pan, erythro, tetra, Prozac, and 150 foods/elements/airborne and 3x cancer survivor, complex partial seizures, vocal cords not functioning properly, migraines, broken bones, myofascial spasms, Hpylori, IBS, spondylitis, sciatica, osteoarthritis, hyperthyroidism, gerd. Concomitant medications were not reported. On 21Jul2021 06:00 AM, patient experienced difficulty breathing, dizzy, weak, headache, clogged ears, spacey, tired, some chest pain left side, injection site pain, muscle pain, joint pain, swelling, nausea, diarrhea, arm pain, just not feeling well but not sick, awful smell and taste in nose/mouth. Facility type vaccine was pharmacy or Drug Store. No other vaccine in four weeks. 11 prescriptions in two weeks were. No treatment present for adverse event. Covid was not present prior vaccination. Covid was not tested post vaccination. The outcome of events was not recovered.   The lot number for [BNT162B2], was not provided and will be requested during follow up' Vs ''information on batch/lot number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain in extremity, Parosmia, Swelling
Clinical narrative: Difficulty breathing; Dizzy; Weak; Headache; Clogged ears; Just not feeling well but not sick; Tired; Some chest pain left side; Injection site pain; Muscle pain; Joint pain; Swelling; Nausea; Diarrhea; Arm pain; Awful smell; Awful smell and taste in nose/mouth; This is a spontaneous report from a contactable Other HCP (patient). A non-pregnant 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: solution for injection; Lot Number: not reported, expiration date: not reported, Age at vaccination: 59-year-old), via an unspecified route of administration in arm left on 20Jul2021 17:00 as dose number unknown, single for COVID-19 immunization. Medical history included allergies from Pan, erythro, tetra, Prozac, and 150 foods/elements/airborne and 3x cancer survivor, complex partial seizures, vocal cords not functioning properly, migraines, broken bones, myofascial spasms, Hpylori, IBS, spondylitis, sciatica, osteoarthritis, hyperthyroidism, gerd. Concomitant medications were not reported. On 21Jul2021 06:00 AM, patient experienced difficulty breathing, dizzy, weak, headache, clogged ears, spacey, tired, some chest pain left side, injection site pain, muscle pain, joint pain, swelling, nausea, diarrhea, arm pain, just not feeling well but not sick, awful smell and taste in nose/mouth. Facility type vaccine was pharmacy or Drug Store. No other vaccine in four weeks. 11 prescriptions in two weeks were. No treatment present for adverse event. Covid was not present prior vaccination. Covid was not tested post vaccination. The outcome of events was not recovered.   The lot number for [BNT162B2], was not provided and will be requested during follow up' Vs ''information on batch/lot number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder, Vaccination site pain
Clinical narrative: Difficulty breathing; Dizzy; Weak; Headache; Clogged ears; Just not feeling well but not sick; Tired; Some chest pain left side; Injection site pain; Muscle pain; Joint pain; Swelling; Nausea; Diarrhea; Arm pain; Awful smell; Awful smell and taste in nose/mouth; This is a spontaneous report from a contactable Other HCP (patient). A non-pregnant 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: solution for injection; Lot Number: not reported, expiration date: not reported, Age at vaccination: 59-year-old), via an unspecified route of administration in arm left on 20Jul2021 17:00 as dose number unknown, single for COVID-19 immunization. Medical history included allergies from Pan, erythro, tetra, Prozac, and 150 foods/elements/airborne and 3x cancer survivor, complex partial seizures, vocal cords not functioning properly, migraines, broken bones, myofascial spasms, Hpylori, IBS, spondylitis, sciatica, osteoarthritis, hyperthyroidism, gerd. Concomitant medications were not reported. On 21Jul2021 06:00 AM, patient experienced difficulty breathing, dizzy, weak, headache, clogged ears, spacey, tired, some chest pain left side, injection site pain, muscle pain, joint pain, swelling, nausea, diarrhea, arm pain, just not feeling well but not sick, awful smell and taste in nose/mouth. Facility type vaccine was pharmacy or Drug Store. No other vaccine in four weeks. 11 prescriptions in two weeks were. No treatment present for adverse event. Covid was not present prior vaccination. Covid was not tested post vaccination. The outcome of events was not recovered.   The lot number for [BNT162B2], was not provided and will be requested during follow up' Vs ''information on batch/lot number has been requested.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Fatigue, Pain in extremity, Peripheral swelling
Clinical narrative: Very sore / swollen right arm; Very sore / swollen right arm; high fever; severe joint pain; serious shortness of breath; serious fatigue; This is a spontaneous report from a contactable consumer.   A 76-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Not reported), via an unspecified route of administration, administered in arm right on 17Jul2021 12:00 pm (age at vaccination 76 years) as dose 1, single for covid-19 immunization. The patient medical history Breast cancer, uterine cancer, COVID twice, pneumonia twice and allergies to mold and pollen. The patient known allergies included Bee / wasp stings, some shellfish and mushrooms. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The concomitant medications were not reported. The patient received other medications within 2 weeks of vaccination. On 18Jul2021, the patient had experienced Very sore / swollen right arm, high fever, severe joint pain, serious shortness of breath and serious fatigue- all were worse than when I actually had COVID the second time, when I was hospitalized and on oxygen. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. At the time of reporting, the outcome of the events were recovering.  Information about the Lot/batch number has been requested
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Very sore / swollen right arm; Very sore / swollen right arm; high fever; severe joint pain; serious shortness of breath; serious fatigue; This is a spontaneous report from a contactable consumer.   A 76-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Not reported), via an unspecified route of administration, administered in arm right on 17Jul2021 12:00 pm (age at vaccination 76 years) as dose 1, single for covid-19 immunization. The patient medical history Breast cancer, uterine cancer, COVID twice, pneumonia twice and allergies to mold and pollen. The patient known allergies included Bee / wasp stings, some shellfish and mushrooms. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The concomitant medications were not reported. The patient received other medications within 2 weeks of vaccination. On 18Jul2021, the patient had experienced Very sore / swollen right arm, high fever, severe joint pain, serious shortness of breath and serious fatigue- all were worse than when I actually had COVID the second time, when I was hospitalized and on oxygen. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. At the time of reporting, the outcome of the events were recovering.  Information about the Lot/batch number has been requested
Sex: M
Vaccine: COVID19
Symptoms: Blood creatinine, Blood pressure measurement, Feeling cold, Pain in extremity, SARS-CoV-2 antibody test
Clinical narrative: sore arm; feeling internally cold; This is a spontaneous report from a contactable consumer. This 76- year-old male Consumer(patient) that:  A 76-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 27Jan2021 as dose 2, single and also received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 06Jan2021 as dose 1, single for COVID-19 immunization. Medical history included renal transplant from Nov2013 to an unknown date (anti-rejection drugs for kidney transplant), rheumatoid arthritis from an unknown date and unknown if ongoing (immunosuppressant drug for arthritis), blood pressure measurement from an unknown date and unknown if ongoing. Patient had,. Patient had living donor kidney transplant in NOV2013 (Donor: Son). Concomitant medications included tacrolimus (PROGRAF) taken 1mg twice daily /0.5mg daily for an unspecified indication, start and stop date were not reported; prednisone (PREDNISONE) taken 5 mg daily for an unspecified indication, start and stop date were not reported; sulfamethoxazole, trimethoprim (BACTRIM) taken 400/89 daily for an unspecified indication, start and stop date were not reported; doxazosin (DOXAZOSIN) taken 2 mg twice daily for an unspecified indication, start and stop date were not reported; irbesartan (IRBESARTAN) taken 150mg daily for an unspecified indication, start and stop date were not reported; metoprolol (METOPROLOL) taken 199mg daily for an unspecified indication, start and stop date were not reported; leflunomide (LEFLUNOMIDE) taken 20mg daily for an unspecified indication, start and stop date were not reported; rituximab (RITUXAN) infusion taken 2 time every 6 months for an unspecified indication from 06Apr2021 to an unspecified stop date (first pair and recent : 06Apr2021 and 21Apr2021, 3 months after first Pfizer dose). On Jan2021 patient had very minor reactions to both shots- sore arm and feeling internally cold, although did not have a temperature after either. The patient underwent lab tests and procedures which included blood creatinine: between 0.8 and 0.95   on unspecified date, blood creatinine: 0.87 on 20Jul2021, blood pressure measurement: unknown on unspecified date, sars-cov-2 antibody test: negative. On 17Jun2021 Covid Antibody test showed no detectable SARS-CoV-2 IgG antibodies, sars-cov-2 antibody test: negative on 07Jul2021 This was confirmed with a second test. The clinical outcome of the events was unknown.   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 have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tired after vaccine; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for a male patient that:  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: unknown), via an unspecified route of administration on an un-specified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history was not reported. There were no concomitant medications. The patient experienced tired after vaccine on an unspecified date. The outcome of event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tired, after vaccine; This is a spontaneous report from a contactable consumer (patient's daughter from a Pfizer sponsored program. A female patient (mother) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced tired, after vaccine on an unspecified date. Caller reported that her parents, were tired, after the vaccine for Covid. The outcome of event was unknown.   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-2021431971 Same reporter/diff patient
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: has a fever 100F; This is a spontaneous report received from a contactable consumer. This consumer reported for a 50-year-old female patient (reporters' friend) that: Received bnt162b2 (BNT162B2;solution for injection;Lot number was not reported), dose 1 via an unspecified route of administration on 21Jul2021 as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced has a fever 100f. The patient underwent lab tests and procedures which included body temperature: 100f Fahrenheit on an unspecified date. Outcome of the event was unknown.  Lot/batch number is not available. Follow-up attempts have been completed and no further information is expected
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Investigation, Menstruation irregular, Pregnancy test
Clinical narrative: Period was 4 days shorter in may, 6 days late in June, lasted 7 days and then continued to spot days after, July 12 days late, and period finally came. It  is light, no cramps hardly.. took several ho; Period was 4 days shorter in may, 6 days late in June, lasted 7 days and then continued to spot days after, July 12 days late, and period finally came. It  is light, no cramps hardly.. took several ho; This is a spontaneous report from a contactable consumer or other non hcp. A 36-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number: UNKNOWN), via unspecified route of administration, administered in Arm Left on 14May2021 15:00 (age at vaccination: 36-years-old), as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received first dose of of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number: UNKNOWN), via unspecified route of administration, administered in Arm Left on 15Apr2021 15:00 (age at vaccination: 36-years-old), as dose 1, single for covid-19 immunisation. It was reported that the patient's period was 4 days shorter in May2021, 6 days late in Jun2021, lasted 7 days and then continued to spot days after. In Jul2021, it was 12 days late, and period finally came. It was light, no cramps hardly. These events required physician office Visit  The patient took several hormone and pregnancy tests, and everything came back fine. The patient reported that her period was just missing which made her think that she was V pregnant (sic) and was not. The doctor suggested that it was an immune reaction to the vaccine. The outcome of events was not recovered.  Information on the Lot/batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Lipoma, Rash, Surgery
Clinical narrative: guess what same thing happened to her mom, big bumps on her arm and her mother ended up having surgery to cut the lipoma out; guess what same thing happened to her mom, big bumps on her arm and her mother ended up having surgery to cut the lipoma out; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), dose unknown via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for immunisation. The patient's medical history and concomitant medications was not reported. The patient experienced guess what same thing happened to her mom, big bumps on her arm and her mother ended up having surgery to cut the lipoma out, Therapeutic measures were taken as a result of guess what same thing happened to her mom, big bumps on her arm and her mother ended up having surgery to cut the lipoma out. The outcome of the events was unknown  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nodule
Clinical narrative: nodule; This is a spontaneous report from a contactable physician. A 44-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date Apr2021 as a single dose for COVID-19 immunization. The patient had received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unknown date Mar2021 as a single dose for COVID-19 immunization and experienced Hard spiderweb, Nodules. The patient medical history and concomitant medications were not reported. The patient took 7 months post Sculptra Aesthetic injection to temples, jawlines, cheeks, and chin. On an unknown date, the patient experienced hard spiderweb, nodule. The outcome of the event was unknown.  Information about the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Rash, Vomiting
Clinical narrative: She got really sick and started throwing up; She got really sick and started throwing up; Rash; This is a spontaneous report from a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on 24Jul2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 24Jul2021, the patient got a rash right away and then, patient got really sick and started throwing up. The outcome of events was unknown.  Information on lot/ batch number has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: throbbing and pain in left arm; This is a spontaneous report from a contactable consumer. This consumer re-ported for 79-Year-old female patient (friend) received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on an unspecified date (age at vaccination: 79 years), as unknown, single dose for COVID-19 immunization. The patient's medical history included ongoing diabetes. Concomitant medications were not reported. The patient experienced throbbing and pain in left arm on an unspecified date which she got her COVID 19 vaccine in. The patient thought she was still having arm pain because she has diabetes and with diabetic patient's it takes things longer to heal. She thought that was why her arm still hurts like she just got the vaccine. The caller was pretty sure the patient got the vaccines in her left arm because she was right-handed. Outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling
Clinical narrative: woke up with her eye a little bit swollen was reported as worsened/swelling of left eye; This is a spontaneous report from a contactable consumer or other non hcp (patient's mother). A 17-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration, administered in Arm Left on 15Jul2021 at 15:03 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization (at the age of 17-years-old). Medical history included had tonsils out (maybe a month ago) on an unknown date outside of that no other health issues. There were no concomitant medications. It was reported that patient received a first dose of vaccine 10 days ago and on 26Jul2021 woke up with her eye a little bit swollen was reported as worsened and had swelling of left eye. The reporter further mentioned that eye was a bit swollen, it was a little more puffy since yesterday, it's worsened, but it was not like its huge. She was hesitant about taking the vaccine so she wanted to call to make sure. The reporter also stated that she did a little research and saw that there's a potential for eye swelling and she just wanted to find out if they needed to see a doctor about it, put a little ice on it and or give some Benadryl. The patient was not recovered from the event.   Information on lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: hurting; headache; This is a spontaneous report from a contactable consumer or other non hcp.   A 13-years-old female patient received BNT162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, Lot No, NDC number, Expiry date was not reported), via an unspecified route of administration on 26Jul2021 as 2nddose, single for covid-19 immunisation. Historical vaccine was A 13-years-old female patient received BNT162b2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, Lot No, NDC number, Expiry date was not reported), via an unspecified route of administration on unspecified date as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced hurting, headache on Jul2021. Upon follow-up on 27Jul2021 is a follow-up spontaneous report from a contactable consumer. This consumer reported for a patient characteristic (age at time of onset of reaction was 13 years female), reaction reported by primary source was headache, Drug information (Pfizer Covid 19 Vaccine, Lot number was unknown, action taken with drug was unknown). Narrative case summary and further information. Patient is not a reporter, reporter type is consumer or other non-health professional, specify Consumer or other non-health professional is mother. Dates for headache is unspecified. Yes, it is a Pfizer Covid 19 Vaccine a Pfizer product. Pfizer Covid 19 Vaccine manufacturer was unspecified, Dates for Pfizer Covid 19 Vaccine Start and Stop were unspecified. NDC number and Expiry date of Pfizer Covid 19 Vaccine was not reported. Reason for no lot number of Pfizer Covid 19 Vaccine was patient was unwilling to complete the report. Other products details not provided. Patient history was not provided, investigation assessment was not provided. Outcome of the events was unknown.    Follow-up (27Jul2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported for a patient characteristic (age at time of onset of reaction was 13 years female), reaction reported by primary source was headache, Drug information (Pfizer Covid 19 Vaccine, Lot number was unknown, action taken with drug was unknown). Narrative case summary and further information. Patient is not a reporter, reporter type is consumer or other non-health professional, specify Consumer or other non-health professional is mother. Dates for headache is unspecified. Yes, it is a Pfizer Covid 19 Vaccine a Pfizer product. Pfizer Covid 19 Vaccine manufacturer was unspecified, Dates for Pfizer Covid 19 Vaccine Start and Stop were unspecified. NDC number and Expiry date of Pfizer Covid 19 Vaccine was not reported. Reason for no lot number of Pfizer Covid 19 Vaccine was patient was unwilling to complete the report. Other products details not provided. Patient history was not provided, investigation assessment was not provided.  Information about batch/lot number has been requested.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Headache, Hypersensitivity, Hypoaesthesia, Pain
Clinical narrative: fever; headache; could not walk due to the pain and swelling; swollen and non-responsive left leg; could not walk due to the pain and swelling; could not walk due to the pain and swelling; left leg was unresponsive and numb; severe allergic reaction; This is a spontaneous report from a contactable consumer reported for a 33-year-old male (patient). A 33-year-old male patient received second dose of bnt162b2 (Pfizer-biotech COVID-19 vaccine, Solution for injection, Batch/lot number: Unknown, Expiry date: Unknown), via an unspecified route in left arm on 16Jul2021 (age at vaccination: 33-year-old) as a single dose for covid-19 immunization. The patient was a perfectly healthy person and has no medical conditions. No pre-existing condition was reported before getting the bnt162b2 Vaccine. The patient concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer-biotech COVID-19 vaccine, Solution for injection) on 25Jun2021, as a single dose for covid-19 immunization. On 25Jul2021, patient was taken to the ER (from last Sunday afternoon, 25Jul2021, to almost midnight) due to swollen and numb, non-responsive left leg. He could not walk due to the pain and swelling and wanted to know if this is something that has been previously reported before. Patient also experienced a fever, headache and other issues after receiving the second dose Pfizer Covid 19 Vaccine and was taken to the emergency room on 25Jul2021. The patient was discharged from the emergency room close to midnight and was taken to the emergency room mid-afternoon. On 16Jul2021, patient had severe allergic reaction. Reporter wanted to know how long AEs usually last after receiving a dose of the Pfizer BioNTech covid-19 Vaccine. The patient was perfectly healthy person and normal person and now the patient can't walk. The patient can't touch the ground with his foot. How is the patient going to work? What is causing this? What is going to happen now? How long will it take the patient to recover from this? Reporter is mostly concerned about his leg that is unresponsive and numb and the patient can't walk. No information was reported on treatment recommendation for AE. The clinical outcome of numb, non-responsive left leg was ongoing, the leg was also extremely painful, it has not improved and was persisting; could not walk on foot because it was swollen and in a lot of pain was not improved; fever, severe allergic reaction, headache was unknown.  Follow-up attempts are completed. No further information is expected.