chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hiatus hernia, Inflammation, Myocardial infarction, Pyrexia, Reflux gastritis
Clinical narrative: Indigestion; Hiatal hernia; Weakness; Inflammation; Heart attack; Reflux gastritis; Headache; Fever; Sleep disturbance; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), SPIRONOLACTONE, LISINOPRIL, TICAGRELOR (BRILINTA), ATORVASTATIN and METOPROLOL SUCCINATE for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced SLEEP DISORDER (Sleep disturbance), HEADACHE (Headache) and PYREXIA (Fever). On 09-May-2021, the patient experienced REFLUX GASTRITIS (Reflux gastritis). On 19-May-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria medically significant and life threatening). On an unknown date, the patient experienced DYSPEPSIA (Indigestion), HIATUS HERNIA (Hiatal hernia), ASTHENIA (Weakness) and INFLAMMATION (Inflammation). The patient was treated with MAGNESIUM OXIDE HEAVY, SODIUM BICARBONATE (ANTACID C) at a dose of 1 dosage form; NITROGLYCERIN at a dose of 1 dosage form and Surgery (Stent insertion) for Myocardial infarction. At the time of the report, MYOCARDIAL INFARCTION (Heart attack), SLEEP DISORDER (Sleep disturbance), DYSPEPSIA (Indigestion), HIATUS HERNIA (Hiatal hernia), ASTHENIA (Weakness), INFLAMMATION (Inflammation), REFLUX GASTRITIS (Reflux gastritis), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Electrocardiogram: abnormal (abnormal) abnormal. In 2021, Endoscopy: abnormal (abnormal) abnormal.         Treatment information included proton pump inhibitor. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-108529, BE-MODERNATX, INC.-MOD-2021-108559 (E2B Linked Report). This case was linked to MOD-2021-213971 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-108529:(crosslink) BE-MODERNATX, INC.-MOD-2021-108559:(crosslink)
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Indigestion; Hiatal hernia; Weakness; Inflammation; Heart attack; Reflux gastritis; Headache; Fever; Sleep disturbance; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), SPIRONOLACTONE, LISINOPRIL, TICAGRELOR (BRILINTA), ATORVASTATIN and METOPROLOL SUCCINATE for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced SLEEP DISORDER (Sleep disturbance), HEADACHE (Headache) and PYREXIA (Fever). On 09-May-2021, the patient experienced REFLUX GASTRITIS (Reflux gastritis). On 19-May-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria medically significant and life threatening). On an unknown date, the patient experienced DYSPEPSIA (Indigestion), HIATUS HERNIA (Hiatal hernia), ASTHENIA (Weakness) and INFLAMMATION (Inflammation). The patient was treated with MAGNESIUM OXIDE HEAVY, SODIUM BICARBONATE (ANTACID C) at a dose of 1 dosage form; NITROGLYCERIN at a dose of 1 dosage form and Surgery (Stent insertion) for Myocardial infarction. At the time of the report, MYOCARDIAL INFARCTION (Heart attack), SLEEP DISORDER (Sleep disturbance), DYSPEPSIA (Indigestion), HIATUS HERNIA (Hiatal hernia), ASTHENIA (Weakness), INFLAMMATION (Inflammation), REFLUX GASTRITIS (Reflux gastritis), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Electrocardiogram: abnormal (abnormal) abnormal. In 2021, Endoscopy: abnormal (abnormal) abnormal.         Treatment information included proton pump inhibitor. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-108529, BE-MODERNATX, INC.-MOD-2021-108559 (E2B Linked Report). This case was linked to MOD-2021-213971 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-108529:(crosslink) BE-MODERNATX, INC.-MOD-2021-108559:(crosslink)
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Parkinson's disease, Sitting disability
Clinical narrative: Parkinson's disease was so severe; Couldn't walk; When sitting in the chair he couldn't even sit good inside the chair; This spontaneous case was reported by a consumer and describes the occurrence of PARKINSON'S DISEASE (Parkinson's disease was so severe) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Parkinson's disease, Depression, Memory impaired, Blood pressure fluctuation, COPD, Asthma and Heart disorder. Concomitant products included BUPROPION HYDROCHLORIDE (BUPROPION HCL XL) for Antidepressant therapy, SALBUTAMOL (PROVENTIL [SALBUTAMOL]) for Asthma, LISINOPRIL for Blood pressure management, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for COPD, ACETYLSALICYLIC ACID (BABY ASPIRIN) for Heart disorder, MEMANTINE for Memory impaired, CARBIDOPA, LEVODOPA (RYTARY) and ROPINIROLE for Parkinson's disease, TAMSULOSIN, VITAMIN D NOS and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced PARKINSON'S DISEASE (Parkinson's disease was so severe) (seriousness criterion medically significant) and GAIT DISTURBANCE (Couldn't walk). 04-Jun-2021, the patient experienced SITTING DISABILITY (When sitting in the chair he couldn't even sit good inside the chair). On 05-Jun-2021, PARKINSON'S DISEASE (Parkinson's disease was so severe), GAIT DISTURBANCE (Couldn't walk) and SITTING DISABILITY (When sitting in the chair he couldn't even sit good inside the chair) had resolved.            Concomitant product use Tamsulosin used for unspecified prostate disease.  Patient received the second Moderna vaccine dose around 3pm. No treatment medications provided by the reporter.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additionally, patient's past medical history of Parkinson's disease is a confounding factor that may play a possible contributory role. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additionally, patient's past medical history of Parkinson's disease is a confounding factor that may play a possible contributory role. Further information has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram, Electrocardiogram, Painful respiration, Palpitations
Clinical narrative: Diagnosed with Pericarditis; Stabbing pain upon breathing, ER visit; Heart palpitations, ER visit; Shortness of breath, ER visit; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERICARDITIS (Diagnosed with Pericarditis) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Contrast media allergy. Concomitant products included FLUOXETINE for Anxiety.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced PAINFUL RESPIRATION (Stabbing pain upon breathing, ER visit), PALPITATIONS (Heart palpitations, ER visit) and DYSPNOEA (Shortness of breath, ER visit). On 02-Jun-2021, the patient experienced PERICARDITIS (Diagnosed with Pericarditis) (seriousness criterion medically significant). The patient was treated with METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) on 18-May-2021 at a dose of 1 dosage form, Prescribed twice. At the time of the report, PERICARDITIS (Diagnosed with Pericarditis), PAINFUL RESPIRATION (Stabbing pain upon breathing, ER visit), PALPITATIONS (Heart palpitations, ER visit) and DYSPNOEA (Shortness of breath, ER visit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, Electrocardiogram: normal (normal) Nothing found on test. On 14-May-2021, X-ray: normal (normal) Nothing found on test. On 02-Jun-2021, Echocardiogram: abnormal (abnormal) Revealed Pericarditis..     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Other treatment products include Narcotics, Non-Steroidal Anti-Inflammatory and Stomach Protectant medications.  Other lab test include on 14-May-2021, R/O for blood clots was done and nothing was found.  Very limited information regarding the events has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-101590 (Patient Link).; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pericarditis, X-ray
Clinical narrative: Diagnosed with Pericarditis; Stabbing pain upon breathing, ER visit; Heart palpitations, ER visit; Shortness of breath, ER visit; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERICARDITIS (Diagnosed with Pericarditis) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Contrast media allergy. Concomitant products included FLUOXETINE for Anxiety.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced PAINFUL RESPIRATION (Stabbing pain upon breathing, ER visit), PALPITATIONS (Heart palpitations, ER visit) and DYSPNOEA (Shortness of breath, ER visit). On 02-Jun-2021, the patient experienced PERICARDITIS (Diagnosed with Pericarditis) (seriousness criterion medically significant). The patient was treated with METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) on 18-May-2021 at a dose of 1 dosage form, Prescribed twice. At the time of the report, PERICARDITIS (Diagnosed with Pericarditis), PAINFUL RESPIRATION (Stabbing pain upon breathing, ER visit), PALPITATIONS (Heart palpitations, ER visit) and DYSPNOEA (Shortness of breath, ER visit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, Electrocardiogram: normal (normal) Nothing found on test. On 14-May-2021, X-ray: normal (normal) Nothing found on test. On 02-Jun-2021, Echocardiogram: abnormal (abnormal) Revealed Pericarditis..     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Other treatment products include Narcotics, Non-Steroidal Anti-Inflammatory and Stomach Protectant medications.  Other lab test include on 14-May-2021, R/O for blood clots was done and nothing was found.  Very limited information regarding the events has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-101590 (Patient Link).; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: just a sore arm; This is a Spontaneous report from a Pfizer sponsored programvia a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 03Feb2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced just a sore arm and mentioned no reaction from it on an unspecified date. Her HCP wanted her to start taking MedrolPak, a steroid, for 6 days. She wanted to know if it was okay to take it or not. She added that she had not started taking it yet. The outcome of the event was unknown.   Information on the LOT/Batch number has been requested  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Feeling abnormal, Pain
Clinical narrative: Coughing; little bit of aches in the body; feeling bad; This is a spontaneous report from a contactable consumer (patient). A 75-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL9265), via an unspecified route of administration, administered in right arm on 27Jan2021 14:00 as single dose (at the age of 75-years-old) for COVID-19 immunization. Medical history included asthma, high blood pressure, cholesterol, allergies and environmental allergies (patient is allergic to everything outside. She is allergic to the environment. She is not allergic to drugs). Concomitant medications included pravastatin, levothyroxine sodium (SYNTHROID), montelukast sodium (SINGULAIR) taken daily for allergies, fenofibrate, lisinopril taken for blood pressure, albuterol [salbutamol] and acetylsalicylic acid (BREOPRIN) both taken for asthma; for all drugs start and stop date were not reported. The patient previously took B12 shot (cyanocobalamin) in the beginning of Jan2021. She went to her doctor's office and they give it. She doesn't have NDC, lot, and expiry to provide. Dose for B12 shot is unknown. No adverse event following prior vaccinations. No additional vaccines administered on same date of the pfizer suspect. History of all previous immunization with the Pfizer vaccine considered as suspect was none. No previous medications before vaccination. Patient also reported she takes regular medications daily. She clarified that she didn't take any of her medications prior to getting the COVID vaccine. Patient was feeling fine and then it hit her on 03Feb2021 at 16:00, the patient experienced cough and little bit of aches in the body and started feeling bad. Patient reported aches are almost gone and just started coughing last night (On 03Feb2021). It was reported that yesterday (on 03Feb2021) patient went out and she started feeling bad and normally would think it was her asthma, but she wanted to make sure that she'll still get COVID after getting the shot. No emergency room and physician office visit required for adverse event. No investigation assessment. Therapeutic measures were taken as a result of cough with cough medication. The outcome of event for coughing and general body pain was recovering and for other event it was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Wife received "wonderful news, chemotherapy, responded well.  Lung Cancer.; This is a spontaneous report from a contactable other hcp.    A 60-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown single for an unspecified indication. Medical history included Guillain-Barre syndrome, Lung Cancer. The patient's concomitant medications were not reported. It was reported that, the patient experienced wife received "wonderful news, chemotherapy, responded well lung cancer on an unspecified date .The Outcome of event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: only hurt if i pressed on the exact spot the needle went in for the second dose; This is a spontaneous report from a contactable other-HCP (patient herself). A 33-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in arm on 28Jan2021 10:15 as 2nd dose, single dose for COVID-19 immunization. Patient did not receive any other vaccine in four weeks. Patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient was 33-years-old and was not pregnant at the time of vaccination. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 07Jan2021 as 1st dose, single dose for COVID-19 immunization. Patient did not had any side effects after the second dose, the injection sight barely hurt and her arm was killing her for 2 days after the first dose, but only hurt if she pressed on the exact spot the needle went in for the second dose on an unspecified date in 2021. She questioned, was it normal to have zero side effects for the second dose. She read all these people having effects with second dose, and she was perfectly fine which made her worried maybe she was injected with a bad batch of the vaccine.   Information on the lot/batch number has been requested.  Follow-up (16Apr2021): 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: F
Vaccine: COVID19
Symptoms: Fungal infection
Clinical narrative: fungal infection in the groin; This is a spontaneous report from a contactable other-HCP (healthcare professional) and contactable consumer. A 48-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical drugs included patient reported that, she missed her doses of tofacitinib citrate (XELJANZ) for approximately two months since Nov2020 due to her asthma worsened and she was on prednisone for her asthma. The patient experienced fungal infection in the groin on an unspecified date. The patient stated that she used jock itch ointment and it gets better but never really goes away for the event. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood urine present, Cystitis, Urinary tract infection
Clinical narrative: bladder infection; UTI; have blood in my urine; This is a spontaneous report from a contactable Other HCP. This Other HCP reported for a male patient (father). A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced bladder infection, uti and had blood in the urine on an unspecified date. The outcome of all events was unknown.  Follow-up (16Apr2021): 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.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Lymphadenopathy, Peripheral swelling
Clinical narrative: lymph node swelling; right ankle and foot swelling; right ankle and foot swelling; This is a spontaneous report from a contactable consumer (patient herself). A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9264), via an unspecified route of administration, administered in right upper arm on 30Jan2021 (age at vaccination: 48 years) as 2ND DOSE, SINGLE DOSE for covid-19 immunization. She says for the second dose they didn't document the expiration date, and the code was not provided for either dose on the handwritten vaccine card. The patient's medical history included breast cancer from Sep2015, lymph nodes removed from 28Oct2015, had edema which was bad and had surgery. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EK9231, expiry date: 30Apr2021) on 11Jan2021 for COVID-19 immunization. On 02Feb2021, after the second dose, the patient had lymph node swelling where she had her surgery and not the side, she had the vaccine given on; right ankle and foot swelling. She says it was her left side lymph nodes that were removed, and under her armpit her lymph node was swollen on her right side where she got her injection, she did have a big egg sized swelling. She was told that it was normal to have swelling on the site of injection, but not normal to have her lymph nodes swollen on her left side. The reporter says she noticed that her left ankle was super swollen last night, and she was retaining a ton of water, had edema which was really bad which she usually has when she flies so wears a compression stocking on the right leg. The reporter clarifies that it was her right-side ankle, her leg and foot that were swollen, her left ankle and foot was fine. She says that she did not receive treatment, elevated her feet and kept them up. She says her ankle was back to normal, and her lymph nodes are kind of going down. She clarifies that she did get a prescription of Prednisone 20mg prescribed to her by her physician, which might have helped. She says she took her first of the Prednisone 20mg last night around 06:00PM, and then took another 20mg this morning at 09:00AM. She says it was prescribed for her to take one tablet by mouth twice a day for 3 days, then one tablet by mouth for three days, so for 6 days. She says this medication was dispensed in an orange pharmacy bottle, and they did not print code/LOT/EXP on the pharmacy label. She says that both doses were injected on her right side, in her right upper arm. The patient said that the last labs she had were 6 months ago and has no recent labs. The patient reported that she received her second dose and wanted to report that she had severe side effects that she was still working through today. The outcome of all the events was resolving.   No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Itchy; large rash; hot at the upper arm; upper arm sore; This is a spontaneous report from a contactable consumer. A 81-years-old female patient received BNT162B2 (Formulation: Solution for injection; Batch/Lot Number: EL9261), dose 1 via an unspecified route of administration, administered in Arm Left on 23Jan2021 07:59 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included high blood pressure, Cardiac, Cholesterol from an unknown date and unknown if ongoing. Concomitant medication included lisinopril (LISINOPRIL) taken for hypertension; rivaroxaban (XARELTO) taken for cardiac disorder; carvedilol (CARVIDOL) taken for cardiac disorder;  ezetimibe (ZETIA) taken for blood cholesterol; rosuvastatin (ROSUVASTATIN) taken for blood cholesterol, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received the first dose of the Pfizer COVID 19 vaccine on 23Jan2021 at 07:59AM in the left arm. States she had upper sore arm a short while later in the day. Yesterday on 02Feb2021 she first noticed her arm was itching and so she took off her clothes to look and saw she had a large rash on her upper arm, 4-5 inches long, that was hot, located at the injection site and below. Adds she thought that only happens with Moderna and not Pfizer. Mentions this occurred ten days after the vaccine. She has spoken with her HCP who did not provide any advice. Mentions all these effects cleared up by the evening of 02Feb2021 except her arm is still a little sore. She is scheduled for the second dose 13Feb2021. The outcome of the event upper arm sore was recovering and the outcome of events Itchy, large rash, hot at the upper arm was recovered on 02Feb2021.  Follow-up attempts are completed. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue
Clinical narrative: fatigue; mild stomach issue; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received first dose of bnt162b2 (BNT162B2- PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration on 01Feb2021 at 09:40 (at the age of 82 year) as SINGLE DOSE for covid-19 immunisation. The patient medical history reported as none and relevant tests reported as none. Concomitant medication(s) included paracetamol (TYLENOL) taken for an unspecified indication from 01Feb2021 to 04Feb2021. Patient was not received any other vaccine prior four weeks of vaccination. Patient received second dose on 22Feb2021 at 9:40 AM (batch no: EN5318) for COVID-19 immunisation at Hospital and experienced fatigue and neck pain. In 2021 the patient experienced fatigue and mild stomach issue for 3 days. She explains that on Monday she got her first dose. Today she was talking with some and it was mentioned that she had gotten a steroids injection the Friday before the shot was given and that might not have been a good idea. Caller would like to know if we have any information regarding this. It was administered on 10Feb2021, but the lot was left blank. It was explained the steroid shot was before getting the vaccine. Therapeutic measures were not taken as a result of the events. The outcome of the events fatigue and mild stomach issue was recovered in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Renal pain
Clinical narrative: Extreme pain in the kidneys; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot number was not reported) via an unspecified route of administration administered in left arm on 01Feb2021 18:30 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not test covid-19 positive prior to vaccination. The patient had not been tested for covid-19 since the vaccination. Other vaccine date detail was reported as same date vaccine date 01Feb2021. The patient experienced extreme pain in the kidneys on 02Feb2021 16:30. No treatment was received for the event. Outcome of the event was reported as not recovered at this point of time.   Information on the lot/batch number has been requested.   Follow-up (16Apr2021): 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.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Headache, Hypoaesthesia, Influenza like illness
Clinical narrative: This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 66-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL92661), dose 1 via an unspecified route of administration, administered in Arm Left on 01Jan2021 17:00 as single dose for covid-19 immunisation. Medical history included mold poisoning, Known allergies: penicillin, mussels, kiwi, walnuts, potatoes, soy, mold foods balsamic vinegar. Concomitant medication included levothyroxine sodium (SYNTHROID); amphetamine aspartate, amphetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); ZINC; VITAMIN D3, fish oil (OMEGA 3 FISH OIL [FISH OIL]). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. The patient experienced numb left side of face, weak on 29Jan2021, sore arm on 30Jan2021, headache and nausea on 31Jan2021, while body aches, seasick on standing, very confused thinking on 02Feb2021, slight flu like on 03Feb2021. On 29Jan2021 patient experienced numb left side of face for 30 minutes, weak. On 30 Jan 2021 patient experienced sore arm, headache, weak. On 31 Jan 2021 patient experienced headache, nausea, weak, body aches, seasick on standing. On 01Feb2021 patient experienced all stronger symptoms of 29Jan2021. On 02Feb2021 patient experienced headache slightly lessening - same symptoms as strong and new symptom include very confused thinking and extreme nausea and seasick. On 03Feb2021 includes lessening of all symptoms still queasy and slight flu like. No treatment was given. The outcome for events was recovering. No follow up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Motion sickness, Nausea, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 66-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL92661), dose 1 via an unspecified route of administration, administered in Arm Left on 01Jan2021 17:00 as single dose for covid-19 immunisation. Medical history included mold poisoning, Known allergies: penicillin, mussels, kiwi, walnuts, potatoes, soy, mold foods balsamic vinegar. Concomitant medication included levothyroxine sodium (SYNTHROID); amphetamine aspartate, amphetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); ZINC; VITAMIN D3, fish oil (OMEGA 3 FISH OIL [FISH OIL]). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. The patient experienced numb left side of face, weak on 29Jan2021, sore arm on 30Jan2021, headache and nausea on 31Jan2021, while body aches, seasick on standing, very confused thinking on 02Feb2021, slight flu like on 03Feb2021. On 29Jan2021 patient experienced numb left side of face for 30 minutes, weak. On 30 Jan 2021 patient experienced sore arm, headache, weak. On 31 Jan 2021 patient experienced headache, nausea, weak, body aches, seasick on standing. On 01Feb2021 patient experienced all stronger symptoms of 29Jan2021. On 02Feb2021 patient experienced headache slightly lessening - same symptoms as strong and new symptom include very confused thinking and extreme nausea and seasick. On 03Feb2021 includes lessening of all symptoms still queasy and slight flu like. No treatment was given. The outcome for events was recovering. No follow up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fluid wave test, Headache, Mammogram, Pyrexia
Clinical narrative: Fever; Headache; Chills; This case has been initially considered invalid as there is no indication that the patient experienced an adverse event under the suspect product BNT162B2. Upon receipt of follow-up information on 07Jun2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer . A 73-years-old female patient received second dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via intramuscular, administered in left arm on 25Feb2021 09:40 (Batch/Lot Number: EN6200, expiration date was not reported) as single dose for COVID-19 immunization at hospital. Medical history included: covid-19 from Mar2020 (she had the virus back in Mar2020). The patient's concomitant medications were not reported. The patient previously received second dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via intramuscular, administered in right arm on 04Feb2021 09:40 (Batch/Lot Number: EL1283, expiration date was not reported) as single dose for COVID-19 immunization at hospital. On 25Feb2021, the patient experienced fever, headache and chills. The patient reported that she had a reaction to both shots but was not critically ill. The patient underwent lab tests and procedures which included: on 23Mar2020 POC Rapid Flu A+B was negative, on 03Nov2020 mammogram showed no malignancy, on 08Jul2020 sars-cov-2 antibody test was positive and showed antibodies, on 12Nov2020 sars-cov-2 antibody test was negative and on 23Mar2021 sars-cov-2 antibody test was positive. Outcome of the events was reported as recovered on 27Feb2021.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: Fever; Headache; Chills; This case has been initially considered invalid as there is no indication that the patient experienced an adverse event under the suspect product BNT162B2. Upon receipt of follow-up information on 07Jun2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer . A 73-years-old female patient received second dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via intramuscular, administered in left arm on 25Feb2021 09:40 (Batch/Lot Number: EN6200, expiration date was not reported) as single dose for COVID-19 immunization at hospital. Medical history included: covid-19 from Mar2020 (she had the virus back in Mar2020). The patient's concomitant medications were not reported. The patient previously received second dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via intramuscular, administered in right arm on 04Feb2021 09:40 (Batch/Lot Number: EL1283, expiration date was not reported) as single dose for COVID-19 immunization at hospital. On 25Feb2021, the patient experienced fever, headache and chills. The patient reported that she had a reaction to both shots but was not critically ill. The patient underwent lab tests and procedures which included: on 23Mar2020 POC Rapid Flu A+B was negative, on 03Nov2020 mammogram showed no malignancy, on 08Jul2020 sars-cov-2 antibody test was positive and showed antibodies, on 12Nov2020 sars-cov-2 antibody test was negative and on 23Mar2021 sars-cov-2 antibody test was positive. Outcome of the events was reported as recovered on 27Feb2021.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: headache; nausea; fatigue; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, in Arm Left on 17Feb2021 10:30 ((at age of 67 years) Batch/Lot Number: EM9809) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included estradiol/medroxyprogesterone taken for an unspecified indication, start and stop date were not reported. On 18Feb2021, patient experienced headache, nausea, fatigue. Outcome of events was recovering.    No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: Soreness in muscles; Soreness at injection site; This is a spontaneous report received from a consumer, the patient. A 39-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number; EN6208) via an unspecified route of administration in left arm on 15Mar2021 at 11:15 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. Concomitant medications were not reported. The patient did not have any allergies to food, medication or other products. The patient does not have symptoms associated with COVID-19. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient experienced soreness in muscles, not just at injection site but also in the back and thighs (muscle soreness and vaccination site pain) on 16Mar2021. The patient did not receive any treatment for the events. The clinical outcome of soreness in muscles and soreness at injection site were resolved on an unspecified date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Nasal crusting, Pain, Vaccination site pain
Clinical narrative: Body aches; Pain at injection site; Lethargy/ Need to sleep; This is a spontaneous report from a contactable consumer. A 48 year old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration on the right arm on 16Mar2021 at 08:45 as a single second dose for COVID-19 immunisation (at the age of 48 years). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number unknown), via an unspecified route of administration in the right arm on 23Feb2021 at 08:45 as a single first dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. On 24Feb2021 patient underwent lab test which included nasal swab test and result was negative. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 16Mar2021 at 13:00, the patient experienced events feverish (99-100F), body aches across entire body, pain at injection site and lethargy (Need to sleep). The patient did not receive any treatment for the events. The clinical outcome of the events body aches, pain at injection site and lethargy were recovering at the time of reporting. Since the vaccination the patient had been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Noticed swollen lymph node under left arm.; This is a spontaneous report from a contactable consumer, patient. A 57 years old non pregnant female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID 19 mRNA Vaccine; Lot number: EN6203) via unspecified route of administration in the left arm on 16Mar2021 at 9:45 am, as a single dose for COVID 19 immunisation. Medical history included mild asthma, only have one half of thyroid on unknown date. Patient previously received first dose of BNT162B2 (PFIZER BIONTECH COVID 19 mRNA Vaccvine; Lot number: EL3247), (age at vaccination was 57 years old) via unspecified route of administration in the left arm on 23FEB2021 at 9:00 am, as a single dose for COVID-19 immunisation. Patient was found to be allergic to honey. Concomitant medications reported were Synthroid tabs 50 mcg (UNKNOWN MANUFACTURE); QVAR RediHaler 80 mcg (UNKNOWN MANUFACTURE) for unknown indication from unknown date. Unknown, prior to vaccination the patient was not diagnosed with COVID 19. On 17Mar2021 10:00 am the patient experienced swollen lymph nodes. Since the vaccination, the patient had not been tested for COVID 19. The patient did not receive treatment for the reported events. The clinical outcome for swollen lymph nodes was recovering. No follow up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever of 100.5; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203), via an unspecified route of administration in the left arm on 16Mar2021 at 14:00, as a single dose for COVID-19 immunisation. The patient's 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 did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247), via an unspecified route of administration in the left arm on 23Feb2021 at 11:30 as a single dose for COVID-19 immunisation. On 17Mar2021 at 17:30, the patient experienced fever of 100.5 (units unspecified). The patient didn't receive any treatment for fever. The clinical outcome of the event fever was recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Pain in extremity, Paraesthesia oral, Vertigo
Clinical narrative: Dizzy; Veritgo; Warmth; Tingly tongue; Very sore arm; This is a spontaneous report received from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6203) via an unspecified route of administration in the right arm on 17Mar2021 at 10:30 hours (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included IBD (Inflammatory bowel disease). The patient was known allergic to penicillin.Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included multi vitamins (MANUFACTURER UNKNOWN), Vitamin C (MANUFACTURER UNKNOWN), juleber (MANUFACTURER UNKNOWN), immodium (MANUFACTURER UNKNOWN), tyle (MANUFACTURER UNKNOWN) within 2 weeks of vaccination and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021, the patient experienced warmth at 05:30 hours, then tingling tongue and very sore arm. Next morning at 05:30 hours,the patient felt dizzy and vertigo. The patient did not receive any treatment for the adverse events. The clinical outcome of the events warmth, tingling tongue, very sore arm dizzy and vertigo was not resolved at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Hyperhidrosis, Pain in extremity
Clinical narrative: Headache; diarrhea; chills; sweating; sore arm; This is a spontaneous report from a contactable consumer, the patient. A 27-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot/batch no: unknown), via an unspecified route of administration, in his left arm on 17Mar2021 (at the age of 27-years-old) for COVID-19 immunisation. The patient had no medical history and had no known allergies. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine and was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The concomitant medications included cephalexin (MANUFACTURER UNKNOWN) for an unknown indication. On 18Mar2021 at 03:15 am, the patient experienced headache, diarrhea, chills, sweating and sore arm. No therapeutic measures were taken for these events. The clinical outcome of the events headache, diarrhea, chills, sweating and sore arm was unknown at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Night sweats, Pain, Pyrexia
Clinical narrative: Pain radiating to my back; Night sweats; Severely swollen Lymph Nodes with pain radiating to my back.; Severe chills; probably fever; This is a spontaneous report from a contactable patient. A 51-year-old non- pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: UNKNOWN), via an unspecified route of administration on left arm on an unknown date in Mar2021 at 12:30 (at the age of 51-years-old), as single dose for COVID-19 immunisation. Medical history included high cholesterol and anxiety started on an unknown date. The patient's known allergy to sulfa meds and hazel nuts. Concomitant medications included Montelukast Sodium (SINGULAIR), Sertraline (ZOLOFT), Levothyroxine (MANUFACTURER UNKNOWN), Lovastatin (MANUFACTURER UNKNOWN); all for unknown indication, from unknown dates and unknown if ongoing. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient did not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. On 17Mar2021 at 10:00, the patient experienced severely swollen lymph nodes with pain radiating to the back. The patient also experienced severe chills and night sweats (probably a fever but didn't take temp). The patient did not receive any treatments for the events. The clinical outcome of the events severely swollen lymph nodes with pain radiating to the back, severe chills, night sweats, probably fever was recovering at the time of reporting.   Information about lot number cannot be obtained. No further information is expected.