chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Breast pain, Heavy menstrual bleeding, Pain in extremity
Clinical narrative: Heavy clotted periods lasted about 4 months; pain in breasts and pain in arm/shoulder still persistent 7 months after vaccination; pain in breasts and pain in arm/shoulder still persistent 7 months after vaccination; pain in breasts and pain in arm/shoulder still persistent 7 months after vaccination; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 10:30 (Lot number: EW0173) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0158, Location of injection: Arm Right), administration date: 08Apr2021, when the patient was 39 years old, for Covid-19 immunization. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 01May2021, outcome "not recovered", described as "Heavy clotted periods lasted about 4 months"; BREAST PAIN (non-serious), PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 01May2021, outcome "not recovered" and all described as "pain in breasts and pain in arm/shoulder still persistent 7 months after vaccination". The events "heavy clotted periods lasted about 4 months", "pain in breasts and pain in arm/shoulder still persistent 7 months after vaccination", "pain in breasts and pain in arm/shoulder still persistent 7 months after vaccination" and "pain in breasts and pain in arm/shoulder still persistent 7 months after vaccination" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heavy menstrual bleeding, breast pain, pain in extremity, arthralgia.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. Patient not had covid prior to the vaccination and had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Heavy clotted periods lasted about 4 months; pain in breasts and pain in arm/shoulder still persistent 7 months after vaccination; pain in breasts and pain in arm/shoulder still persistent 7 months after vaccination; pain in breasts and pain in arm/shoulder still persistent 7 months after vaccination; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 10:30 (Lot number: EW0173) at the age of 39 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0158, Location of injection: Arm Right), administration date: 08Apr2021, when the patient was 39 years old, for Covid-19 immunization. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 01May2021, outcome "not recovered", described as "Heavy clotted periods lasted about 4 months"; BREAST PAIN (non-serious), PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 01May2021, outcome "not recovered" and all described as "pain in breasts and pain in arm/shoulder still persistent 7 months after vaccination". The events "heavy clotted periods lasted about 4 months", "pain in breasts and pain in arm/shoulder still persistent 7 months after vaccination", "pain in breasts and pain in arm/shoulder still persistent 7 months after vaccination" and "pain in breasts and pain in arm/shoulder still persistent 7 months after vaccination" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heavy menstrual bleeding, breast pain, pain in extremity, arthralgia.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. Patient not had covid prior to the vaccination and had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Lymphadenopathy
Clinical narrative: Joint aches; Headache; Lump swelling under right armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 18Nov2021 16:00 (Formulation: solution for injection, Lot number: FH8027) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Ankylosing spondylitis" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA; ATORVASTATIN; OMEPRAZOLE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EK5730, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 23Mar2021, when the patient was 55 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EJ1685, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 02Mar2021, when the patient was 55 years old, for COVID-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 19Nov2021 17:00, outcome "recovered" (Nov2021), described as "Joint aches"; HEADACHE (non-serious) with onset 19Nov2021 17:00, outcome "recovered" (Nov2021), described as "Headache"; LYMPHADENOPATHY (non-serious) with onset 19Nov2021 17:00, outcome "recovered" (Nov2021), described as "Lump swelling under right armpit". Therapeutic measures were not taken as a result of arthralgia, headache, lymphadenopathy.  Additional information: The patient had not received any other vaccine within 4 weeks. Before being vaccinated he did not have COVID and had not been tested COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain, Pyrexia
Clinical narrative: fatigue; fever; aches; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Feb2021 (Lot number: EL1283) at the age of 48 years as dose 2, single for covid-19 immunisation; influenza vaccine (FLU), intramuscular, administered in arm right, administration date 27Oct2021 (Batch/Lot number: unknown) as unk, single. Relevant medical history included: "Anxiety" (ongoing), notes: GAD; "Knee surgeries", start date: 1993 (unspecified if ongoing), notes: Knee surgeries, Onset date: 1993,1995,1999, Pertinent details: L knee all repair, L knee arthroscopy X 2; "Knee surgeries", start date: 1995 (unspecified if ongoing), notes: Knee surgeries, Onset date: 1993,1995,1999, Pertinent details: L knee all repair, L knee arthroscopy X 2; "Knee surgeries", start date: 1999 (unspecified if ongoing), notes: Knee surgeries, Onset date: 1993,1995,1999, Pertinent details: L knee all repair, L knee arthroscopy X 2; "Bunionectomy", start date: 1998 (unspecified if ongoing), notes: Onset date: 1998,1999,, Pertinent details: R and L Bunionectomy; "Bunionectomy", start date: 1999 (unspecified if ongoing), notes: Onset date: 1998,1999,, Pertinent details: R and L Bunionectomy; "Covid-19", start date: 27Dec2020 (unspecified if ongoing), notes: Stop date: Went back to work 08Jan2021, Pertinent details: Fatigue lasted @ least 3 minutes brain fog lasted until may 2021. Concomitant medication(s) included: LEXAPRO taken for anxiety, start date: 2012 (ongoing). Vaccination history included: Bnt162b2 (First dose: , Anatomical location: Left arm, Route of administration: Intramuscular, Lot number: E11284 30Apr2021), administration date: 29Jan2021, when the patient was 48 years old, for COVID-19 immunization, reaction(s): "fatigue", "fever", "aches". The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigue"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "aches". 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: Arthritis, Insomnia
Clinical narrative: His arthritis was really bad due to having to temporarily stop the medication to get a Covid vaccine; Has a hard time sleeping at night; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 68 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRITIS (non-serious), outcome "unknown", described as "His arthritis was really bad due to having to temporarily stop the medication to get a Covid vaccine"; INSOMNIA (non-serious), outcome "unknown", described as "Has a hard time sleeping at night". Therapeutic measures were taken as a result of arthritis.  Additional information: Reporter reported that patient arthritis was really bad due to having to temporarily stop the medication to get a Covid vaccine and he also has a hard time sleeping at night. Patient was prescribed Xeljanz XR 11mg.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Headache, Pain in extremity
Clinical narrative: moderate arm soar; headache; pain moving into armpit; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A child female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:1, Manufacturer unknown), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "moderate arm soar"; HEADACHE (non-serious), outcome "unknown", described as "headache"; AXILLARY PAIN (non-serious), outcome "unknown", described as "pain moving into armpit".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: severe vertigo event; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The patient is the reporter's mother.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VERTIGO (non-serious), outcome "unknown", described as "severe vertigo event".  Course of the event: the patient  exactly 3 weeks after she got her shot, she was hit with severe vertigo for the first time in her life. She had never had vertigo before.  Follow-up (11Feb2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Chills, fever, body aches, headache, shivering
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Herpes zoster
Clinical narrative: 2 weeks after Pfizer booster given on 10/06/21 at local Pharmacy, developed pain in left mid back. Was minimal when I saw doctor on 10/18/21, but within a week became very severe. Went on for 6 weeks so went to pain doctor thinking it was a disc issue and scheduled epidural for next day. At epidural I was informed I had shingles lesions on my back and pain was due to shingles. Was confirmed by my back surgeon 2 weeks later. I have had both original and newer shingles vaccine. Found several journal articles indicating Pfizer can trigger latent herpes zoster virus. Articles indicate there are other cases, though not in the very high numbers. I wanted this on the record.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: Woke up 3 days later with a stiff neck. Progressively got worse. I went to urgent care and was diagnosed with stiff neck. They put me muscle relaxers. I also had to go to physical therapy. Finally resolved 2-3 months later.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time normal, Angiogram pulmonary abnormal, Blood creatine phosphokinase normal, Blood thyroid stimulating hormone normal, Brain natriuretic peptide normal
Clinical narrative: On 10-18-2021 at approximately 10pm started palpations hard heart beat. This was followed by shortness of breath, chest pain, and high heart rate. Went to the Emergency room and arrived by 12 midnight.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchial wall thickening, C-reactive protein normal, Chest X-ray normal, Chest pain, Differential white blood cell count normal
Clinical narrative: On 10-18-2021 at approximately 10pm started palpations hard heart beat. This was followed by shortness of breath, chest pain, and high heart rate. Went to the Emergency room and arrived by 12 midnight.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram normal, Electrocardiogram ambulatory normal, Electrocardiogram normal, Emphysema
Clinical narrative: On 10-18-2021 at approximately 10pm started palpations hard heart beat. This was followed by shortness of breath, chest pain, and high heart rate. Went to the Emergency room and arrived by 12 midnight.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer normal, Full blood count normal, Heart rate increased, International normalised ratio normal, Lung opacity
Clinical narrative: On 10-18-2021 at approximately 10pm started palpations hard heart beat. This was followed by shortness of breath, chest pain, and high heart rate. Went to the Emergency room and arrived by 12 midnight.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test normal, Palpitations, Prothrombin time normal, Pulmonary mass, Red blood cell sedimentation rate normal
Clinical narrative: On 10-18-2021 at approximately 10pm started palpations hard heart beat. This was followed by shortness of breath, chest pain, and high heart rate. Went to the Emergency room and arrived by 12 midnight.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroxine free normal, Tri-iodothyronine free normal, Troponin I normal, Ventricular extrasystoles
Clinical narrative: On 10-18-2021 at approximately 10pm started palpations hard heart beat. This was followed by shortness of breath, chest pain, and high heart rate. Went to the Emergency room and arrived by 12 midnight.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Urticaria
Clinical narrative: Headache and hives. I took Benadryl and the hives went away in a couple hours.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Erythema, Formication, Headache
Clinical narrative: Sore arm, fever 99.9, vomiting, headache, chills, skin feels like it's crawling, red arm and chest hurts.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Sore arm, fever 99.9, vomiting, headache, chills, skin feels like it's crawling, red arm and chest hurts.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray normal, Chest discomfort, Chest pain, Electrocardiogram normal, Feeling hot
Clinical narrative: For the first 7 days after my Pfizer Covid-19 booster shot I endured a swelling of the lymphnodes first under my left armpit which spread to my left collarbone. I had experienced swelling of the lymphnodes exclusively in my armpit for a few days after my first two Pfizer Covid-19 shots (which were in May of 2021), so I was not too concerned for my health at this time. On the morning of January 14th, 2022, roughly 7-8 days after my booster, I woke up with chest pain, tenderness, and warmth, and with what I would describe a "weighted" feeling on my heart. This was a symptom I had never had prior in my life or after the first 2 doses, and because it was a very abnormal and laboring feeling/symptom, I scheduled a doctor's appointment for that day immediately. At this doctor's appointment, my blood pressure was found to be high (roughly 140/70), and I received a Cardiovascular EKG and Chest (2V) X-Ray, which both came out normal. I was prescribed a 375 MG dose of Naprosyn that was to be taken twice a day orally for 30 days. Under this medication, the lymphnode swelling in my collarbone was reduced and my chest pain/weight was minimal, however both were not eradicated. While at home under this medication, I would take my blood pressure once nearly every morning, and it was higher than normal for some time, but leveled out after about 1-2 weeks. With about a week left of medication, I moved back in to my college dorm to resume classes in person, where there was a lot of walking involved (roughly 15-20 min to and from each class). While these distances and walks are usually no problem for me whatsoever, I noticed that even while under my medication the swollen lymphnodes under my collarbone and chest weight was more prevalent both during and especially after my walks to and from class. Shortly after I finished my medication which was in early to mid February, the swelling of the lymphnodes and chest pain became very noticeable after these walks and would last for a few hours at a time. As of today (02/26/2022), the lymphnode swelling under my left collarbone is more or less present, some days it is constant the entire day, other days not so much. The weighted heart feeling/chest pain is less consistent than it used to be, but I still experience it intermittently and definitely more often during or after my walks to class, which I now try to limit or take breaks during (something I never feel the need to do) when I feel the sensation arising. I also have not gone to the gym since my booster, out of fear for what may happen with this condition.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Lymphadenopathy, Tenderness
Clinical narrative: For the first 7 days after my Pfizer Covid-19 booster shot I endured a swelling of the lymphnodes first under my left armpit which spread to my left collarbone. I had experienced swelling of the lymphnodes exclusively in my armpit for a few days after my first two Pfizer Covid-19 shots (which were in May of 2021), so I was not too concerned for my health at this time. On the morning of January 14th, 2022, roughly 7-8 days after my booster, I woke up with chest pain, tenderness, and warmth, and with what I would describe a "weighted" feeling on my heart. This was a symptom I had never had prior in my life or after the first 2 doses, and because it was a very abnormal and laboring feeling/symptom, I scheduled a doctor's appointment for that day immediately. At this doctor's appointment, my blood pressure was found to be high (roughly 140/70), and I received a Cardiovascular EKG and Chest (2V) X-Ray, which both came out normal. I was prescribed a 375 MG dose of Naprosyn that was to be taken twice a day orally for 30 days. Under this medication, the lymphnode swelling in my collarbone was reduced and my chest pain/weight was minimal, however both were not eradicated. While at home under this medication, I would take my blood pressure once nearly every morning, and it was higher than normal for some time, but leveled out after about 1-2 weeks. With about a week left of medication, I moved back in to my college dorm to resume classes in person, where there was a lot of walking involved (roughly 15-20 min to and from each class). While these distances and walks are usually no problem for me whatsoever, I noticed that even while under my medication the swollen lymphnodes under my collarbone and chest weight was more prevalent both during and especially after my walks to and from class. Shortly after I finished my medication which was in early to mid February, the swelling of the lymphnodes and chest pain became very noticeable after these walks and would last for a few hours at a time. As of today (02/26/2022), the lymphnode swelling under my left collarbone is more or less present, some days it is constant the entire day, other days not so much. The weighted heart feeling/chest pain is less consistent than it used to be, but I still experience it intermittently and definitely more often during or after my walks to class, which I now try to limit or take breaks during (something I never feel the need to do) when I feel the sensation arising. I also have not gone to the gym since my booster, out of fear for what may happen with this condition.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Nausea, Vomiting
Clinical narrative: Terrible migraine, Severe gripping pain on both sides of my head, Nausea, Vomiting.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, C-reactive protein, Mechanical urticaria, Scratch, Urticaria
Clinical narrative: Hives on scalp initially, moving to body, hands and feet, dermatographia presenting in welts and scratches.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm at injection site; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on (02Apr2021), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 75 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Feb2021 10:00 (Lot number: EL9265) at the age of 75 years as dose 2, single for covid-19 immunisation. Family history included: "Diabetes" (ongoing), notes: more than 10 years, both parents had diabetes. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus (ongoing); LEVEMIR taken for diabetes mellitus (ongoing); JANUVIA taken for diabetes mellitus (ongoing); RAMIPRIL taken for diabetes mellitus (ongoing). Vaccination history included: Bnt162b2 (1st dose, lot EL1283, administered intramuscularly on left arm at 10:00), administration date: 14Jan2021, when the patient was 78 years old, for Covid-19 immunisation, reaction(s): "Sore arm at injection site". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 11Feb2021 10:30, outcome "recovered" (12Feb2021 04:30), described as "Sore arm at injection site". Therapeutic measures were not taken as a result of vaccination site pain.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore left arm; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on (04Jun2021), this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from a Pfizer sponsored program. The reporter is the patient.  A 73-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09Feb2021 18:00 (Lot number: EM9809) at the age of 72 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (ongoing), notes: 10 yrs ago; "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: CELEBREX taken for arthritis (ongoing); LOSARTAN taken for blood pressure increased (ongoing); AMLODIPINE BESYLATE taken for blood pressure increased (ongoing).  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Feb2021, outcome "unknown", described as "sore left arm".  Additional Information: Consumer stated, "I had my first COVID shot on the 09Feb. I am scheduled to have my second COVID shot on the 1st of March. I had a full hip replacement on the 18Feb. The Caller is asking about drug interaction with the covid vaccine he got his first shot on, 09Feb2021 and he is scheduled for his second dose next week, Monday, 01Mar2021. He took baby aspirin and he is asking if he should stop taking it until the second dose is given. He is also asking about the interaction of the COVID-19 vaccine with Oxycontin, Codeine, Tramadol, Tylenol. No prior vaccination (within 4 weeks). No relevant tests.  Follow-up (07Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness
Clinical narrative: lightheadedness; Mood is anxious (slight); This is a spontaneous report from a non-contactable other health care professional. A 42-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration on 24Mar2021 (age at vaccination of 42-year-old) as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced light-headedness on 24Mar2021 and anxious mood (slight) on an unknown date in Mar2021. It was further reported that during her 15-minute waiting period after the injection, the patient began to experience light-headedness. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. Mood was anxious (slight). The patient received treatment for the reported events as water and close monitoring. Follow-up response to treatment was excellent. Patient was discharged and was stable to go home and follow-up with. The clinical outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient information, patient tab and narrative were amended.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Vaccination site pain
Clinical narrative: Soreness at injection site; fatigue; general malaise; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247) via an unspecified route of administration on 02Mar2021 (at the age of 34-Year-old), as a single dose for COVID-19 immunisation. The medical history included allergy to penicillin and the concomitant medications within 2 weeks of vaccination included omeprazole (MANUFACTURER UNKNOWN) and famotidine (MANUFACTURER UNKNOWN). The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247) via an unspecified route of administration in left arm on 23Mar2021 (at the age of 34-Year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On an unspecified date, the patient experienced injection site pain (vaccination site pain), fatigue and general malaise. No therapeutic measures were taken for adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of injection site pain, fatigue, general malaise was recovering at the time of report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Amended Patient's initials updated as UNKNOWN since no name provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: Injection site pain; Tiredness; This is a spontaneous report received from a non-contactable non-healthcare Professional. A female patient of an unspecified age received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date, as dose number unknown, single for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient experienced injection site pain and tiredness on an unknown date. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. The clinical outcome of events injection site pain and tiredness was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previous information: Amendment of patient information as Patient's country added.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: Chills; Headache; Fatigue; Aches; This is a spontaneous report from a non-contactable consumer reported for a patient. A 33-year-old female patient of received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose (at the age of 33-years-old) for COVID-19 immunisation. The medical history of the patient and concomitant medications was not reported. On an unknown date, the patient experienced chills, headache, fatigue and aches. The clinical outcome of the events chills, headache, fatigue and aches was resolved on an unknown date.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Narrative leading sentence updated to "This is a spontaneous report from a non-contactable consumer reported for a patient." Narrative ending sentence updated to "No follow-up attempts are needed; information about lot/batch number cannot be obtained."
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Cerebral haemorrhage, Magnetic resonance imaging, Pain, Pain in extremity
Clinical narrative: Terrible upper arm pain. Mostly went away 2 weeks later. After 2 brain bleeds,  the pain came back in November. I had 2 mri's done in January and February. While having  both mri's, my arm filled with burning pain both times. The pain was horrible. I have had mri's many times and this has never happened. I am in physical therapy and the pain won't subside.
Age: 69.0
Sex: M
Vaccine: FLUA4
Symptoms: Extra dose administered, General symptom
Clinical narrative: Pt had signed up  and received 2 doses of fluad one month apart. The duplicate was not caught and pt was given a second dose. Pt reported mild regular symptoms and was unharmed.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: due to patient age, not eligible for vaccination with Moderna
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Photophobia, Pyrexia
Clinical narrative: Fever, chills and vomiting for 2-3 days following each vaccine. Additionally, patient experienced  waxing and waning fatigue, fever, dizziness and light sensitivity.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fever, chills and vomiting for 2-3 days following each vaccine. Additionally, patient experienced  waxing and waning fatigue, fever, dizziness and light sensitivity.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given 0.3 mL of adult Pfizer instead of pediatric dose
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Nodule, Swelling
Clinical narrative: On about 4/22/2021 at around 7PM, I took a shower. When I got out, I noticed that there was a huge, black and blue bruise above my right breast and below my clavicle. I kept an eye on it and went to the doctor to have it examined. I was told that I should just keep an eye on it, and as long as it didn't hurt, I shouldn't be alarmed. The bruise gradually faded over the following 2 weeks. On about 4/26/2021, I noticed a large, swollen nodule in the area where the clavicle articulates with the manubrium. I consulted my daughter-in-law about it, as she is studying nursing. She told me that the same thing had happened to my grandson when he was vaccinated, so we assumed that the nodule was probably caused by the vaccine. I had the nodule for about 2 weeks before it finally vanished.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was inadvertently given a booster dose of Pfizer (purple cap) too soon.  Per CDC, booster dose should be given at least 5 months after dose 2.  Patient received dose 2 on 10/9/21 and the booster was given 2/26/22.  According to the CDCs guidance on administration errors and deviations, the patient does NOT need to repeat the booster dose.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pharmacy error: The Moderna vaccine (batch/lot# 003C21A) sent on 11/24/2021 to our clinic, should have the absolute expiration date of 12/17/2021, not 12/24/2021.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pharmacy error: The Moderna vaccine with lot#003C21A that was sent out on 11/24/21 to our clinic should've the absolute expiration date of 12/17/21 and not 12/24/2021
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Pt stated she felt like she had to throw up then began feeling faint. Pt then threw up x1. Staff elevated feet, put head up, applied cool/wet towel. Temp 96.8. Pt reports not eating before taking vaccine. Offered water and food. Refused food. Drank 8oz water. Stated she felt better after throwing up. No further complaints of nausea or faintness. Able to stand and walk in own and appropriately. Mother present. Pt left with mother after observation period over.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pharmacy error: The Moderna vaccine with lot#003C21A that was sent out on 11/24/21 to our clinic should've the absolute expiration date of 12/17/21 and not 12/24/2021
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Retinal oedema, Visual impairment
Clinical narrative: Vision Issues - After receiving my Maderna Booster, I developed a condition similar to macular degeneration issue in my left eye. My eye doctor decided to treat this with an injection of Asastin in my eye. Over the next 3 months, I had an additional injection of Asastin and two injections of Eyelia. I still suffer significant vision loss as these treatments continue. Coincidently to this situation, after my second Covid-19 vaccination on 02/19/2021, my right retina became swollen and had a similar condition as I am experiencing now with my left eye. over the next 6 months, this condition was treated with injections of Asastin.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pharmacy error: The Moderna vaccine with lot#003C21A that was sent out on 11/24/21 to our clinic should've the absolute expiration date of 12/17/21 and not 12/24/2021
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Surgery
Clinical narrative: Severe abdominal pain. Surgery and removal of ga
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biliary colic
Clinical narrative: Severe abdominal pain. Surgery and removal of ga
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient age 17 at time of the second dose.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pharmacy error: The Moderna vaccine with lot#003C21A that was sent out on 11/24/21 to our clinic should've the absolute expiration date of 12/17/21 and not 12/24/2021
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head, Paraesthesia
Clinical narrative: Constant tingling of both arms and hands occurred the day after I received the Covid-19 Janssen Vaccine. Cerebral hemispheres which (per read) most likely represents vasospastic phenomena of migraines vs. small vessel ischemic changes in a patient with appropriate CV risk factors.  As well there is partially empty sella, which is a benign finding, but is occationally reported to be associated with headaches.  Given no structural abnormalities to explain patient's symptoms, temporal relation to his vaccination, and newer reports associated with the J and J vaccine (though patient does not have, but isolated sensory dysfunction) there is possibility that patient's symptoms are a vaccine side effect.  Discussed the importance of documenting his symptoms in VAERS so that further investigation can be done.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pharmacy error: The Moderna vaccine (batch/lot# 003C21A) sent on 11/24/2021 to our clinic, should have the absolute expiration date of 12/17/2021, not 12/24/2021.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: International normalised ratio increased
Clinical narrative: My INR went up to 8 without any other changes. INR stayed stable with the second and third dose. My desired range is between 3 and 3.5.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pharmacy error: The Moderna vaccine with lot#003C21A that was sent out on 11/24/21 to our clinic should've the absolute expiration date of 12/17/21 and not 12/24/2021
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: pt admit to hospital w/ incidental covid s/p 2 doses of Moderna 8/4/21 & 9/1/21
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, COVID-19, SARS-CoV-2 test positive
Clinical narrative: anaphylaxis following vaccine in 5/5/21, POA states pharmacy reported, otherwise (+) covid home test on 1/26, (+) COVID PCR test on 2/22/21
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pharmacy error: The Moderna vaccine (batch/lot# 003C21A) sent on 11/24/2021 to our clinic, should have the absolute expiration date of 12/17/2021, not 12/24/2021.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Decreased appetite, Dizziness, Dyspepsia
Clinical narrative: Body aches and cramps, headache, fever, chills, sweats, dizziness, loss of appetite, unable to eat, brain fog, extreme fatigue.   I was dysfunctional for 4 days and had to stay in bed.  The fatigue continued for 3 months.,  My chronic migraines, digestive problems, insomnia, and light sensitivity all got worse.  My migraines became twice as frequent and I had to double my dose of migraine pain medication for each migraine event.  I am still recovering.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeding disorder, Feeling abnormal, Headache, Hyperhidrosis
Clinical narrative: Body aches and cramps, headache, fever, chills, sweats, dizziness, loss of appetite, unable to eat, brain fog, extreme fatigue.   I was dysfunctional for 4 days and had to stay in bed.  The fatigue continued for 3 months.,  My chronic migraines, digestive problems, insomnia, and light sensitivity all got worse.  My migraines became twice as frequent and I had to double my dose of migraine pain medication for each migraine event.  I am still recovering.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Migraine, Muscle spasms, Pain, Photophobia
Clinical narrative: Body aches and cramps, headache, fever, chills, sweats, dizziness, loss of appetite, unable to eat, brain fog, extreme fatigue.   I was dysfunctional for 4 days and had to stay in bed.  The fatigue continued for 3 months.,  My chronic migraines, digestive problems, insomnia, and light sensitivity all got worse.  My migraines became twice as frequent and I had to double my dose of migraine pain medication for each migraine event.  I am still recovering.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Body aches and cramps, headache, fever, chills, sweats, dizziness, loss of appetite, unable to eat, brain fog, extreme fatigue.   I was dysfunctional for 4 days and had to stay in bed.  The fatigue continued for 3 months.,  My chronic migraines, digestive problems, insomnia, and light sensitivity all got worse.  My migraines became twice as frequent and I had to double my dose of migraine pain medication for each migraine event.  I am still recovering.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Pharmacy error: The Moderna vaccine with lot#003C21A that was sent out on 11/24/21 to our clinic should've the absolute expiration date of 12/17/21 and not 12/24/2021
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein increased, Echocardiogram abnormal, Pericardial effusion, Pericarditis, Red blood cell sedimentation rate increased
Clinical narrative: Pericarditis, Admitted to the Hospital, NSAID and Colchicine
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pharmacy error: The Moderna vaccine with lot#003C21A that was sent out on 11/24/21 to our clinic should've the absolute expiration date of 12/17/21 and not 12/24/2021
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Seizure
Clinical narrative: Pt rc'd J&J vaccine @1111 and instantly felt faint. EMR was called. Pt preceded to seize , nurses stabilize pt until pt was done seizing. Seizure lasted 45 seconds. Post seizure pt awake and alerted. Orientedx3. EMR advised pt to go to the ER but pt refused. Pt stated that she felt fine after observing her for 30 mins.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Myocarditis
Clinical narrative: Myocarditis - still a problem today, one year later
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Anger, Personality change
Clinical narrative: Has been acting deranged and very angry/having a deranged behavior and angry after getting the shot; Has been acting deranged/ having a deranged behavior; noticed a change in her attitude; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 90 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Manic depression" (unspecified if ongoing), notes: manic depression/manic depressive. The patient's concomitant medications were not reported. The following information was reported: ANGER (non-serious), outcome "unknown", described as "Has been acting deranged and very angry/having a deranged behavior and angry after getting the shot"; ABNORMAL BEHAVIOUR (non-serious), outcome "unknown", described as "Has been acting deranged/ having a deranged behavior"; PERSONALITY CHANGE (non-serious), outcome "unknown", described as "noticed a change in her attitude".  Additional information: Reporter stated she was calling regarding her step-mother who has a history of manic depression/manic depressive. After getting the COVID vaccine she has been acting deranged, she is a very angry person and has not stopped. She stated she wants us to do a study to see how this vaccine effects people, especially people who are older. Her step mother is in her 80s. She has manic depression and we need to know these details. She has been having a deranged behavior and angry after getting the shot. She will be calling the CDC next. She wants us to take a closer look at manic people. Her step mom normally has a good attitude, but since she got the shot she has been acting deranged and really angry which is not her. She is normally a loving, dancing person. The family has all noticed a change in her attitude. She just wants to do more research and find out who the vaccine is good for and not good for. She stated it is unknown apparently how long these events will last for the patient.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Facial paralysis, Feeling abnormal, Headache, Pain in extremity
Clinical narrative: facial paralysis; Sore arm; dull headache; dizzy; ringing in the ear; felt like I would black out; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 16Apr2021 (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: FACIAL PARALYSIS (medically significant) with onset May2021, outcome "unknown", described as "facial paralysis"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Sore arm"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "dull headache"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizzy"; TINNITUS (non-serious) with onset 2021, outcome "unknown", described as "ringing in the ear"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "felt like I would black out". Caller states she received the first shot on 16Apr2021 and has complains of the following side effects: "Sore arm, dull headache, dizzy, ringing in the ear, felt like I would black out." It was reported that Onset of facial paralysis was Day 37 after Dose 1 (participant did not receive Dose 2).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: facial paralysis; Sore arm; dull headache; dizzy; ringing in the ear; felt like I would black out; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 16Apr2021 (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: FACIAL PARALYSIS (medically significant) with onset May2021, outcome "unknown", described as "facial paralysis"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Sore arm"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "dull headache"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizzy"; TINNITUS (non-serious) with onset 2021, outcome "unknown", described as "ringing in the ear"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "felt like I would black out". Caller states she received the first shot on 16Apr2021 and has complains of the following side effects: "Sore arm, dull headache, dizzy, ringing in the ear, felt like I would black out." It was reported that Onset of facial paralysis was Day 37 after Dose 1 (participant did not receive Dose 2).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.