chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Loss of consciousness, Nausea, Pain in extremity
Clinical narrative: I passed out, fell to floor and was unresponsive for multiple minutes; fell to floor; Momentary feeling of nausea and lightheadedness before passing out; Momentary feeling of nausea and lightheadedness before passing out; mild sore arm; This is a spontaneous report from a contactable consumer reporting for himself. A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN6198/expiration date: not provided), via an unspecified route of administration, on 10Mar2021 at 14:00 (as a single dose in the right arm for COVID-19 IMMUNIZATION. The patient had known allergies to statins and aspirin. The patient had no other medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication (other medications taken in two weeks) were none.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Mar2021, the patient experienced a mild sore arm. On 13Mar2021 at 17:30, the patient experienced nausea and lightheadedness before passing out. The clinical course was as follows: On 10Mar2021 afternoon, the patient received the first dose of COVID-19 vaccine. No overt signs of illness or other symptoms beyond mild sore arm. On 13Mar2021, in the afternoon, the patient passed out, fell to floor and was unresponsive for multiple minutes. Momentary feeling of nausea and lightheadedness before passing out. No other signs of illness at time. Paramedics and subsequence ER visit did not find any signs of physical symptoms that would have attributed to syncope. Lightheadedness lasted for awhile and was still occurring on and off during ER visit. The adverse events resulted in a doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient did not receive any treatment for these events. The outcome of the events mild sore arm, passed out, nausea and lightheadedness was recovered on an unspecified date in Mar2021. Since the vaccination, the patient had not been tested for COVID-19.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Two blood clots in left leg; This is a spontaneous report from a contactable consumer. A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 26Feb2021 (Batch/Lot Number: EN6203) as single dose for COVID-19 immunisation. Medical history included back disorder, ATTR amyloidosis, and allergies: caffeine from an unknown date. Concomitant medication included allopurinol (ELAVIL); meloxicam; tizanidine; tafamidis (VYNDAMAX) all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269), on 05Feb2021, administration time: 06:00 PM, vaccine location: Left arm for COVID-19 immunisation. The patient experienced two blood clots in left leg on 03Mar2021 23:00. Treatment for the event includes Aspirin. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient had no COVID-19 prior vaccination. The patient was not tested for COVID-19 post vaccination. The outcome of the event was resolved on an unspecified date.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Laboratory test, Malaise, Pain, Pneumonia
Clinical narrative: The first shot made me really sick like had the flu or pneumonia or something; The first shot made me really sick like had the flu or pneumonia or something; The first shot made me really sick like had the flu or pneumonia or something; Body was aching and hurting so bad; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 25Feb2021 as single dose for COVID-19 immunization. Medical history included high blood pressure and asthma from an unknown date. Concomitant medications included amlodipine taken for high blood pressure; hydrochlorothiazide taken for high blood pressure; and salbutamol sulfate (VENTOLIN) taken for asthma. It was reported that the first shot made the patient really sick like she had the flu or pneumonia or something. She also took some over the counter extra strength Tylenol as her body was aching and hurting so bad. The patient had lab test in the past 2 weeks in 2021, she had her blood drawn. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Malaise, Muscular weakness
Clinical narrative: feeling unwell; muscle weakness; excessive tiredness; loss of appetite; fever; chills; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EP6955), via an unspecified route of administration administered in left arm at a pharmacy or drug store on 09Mar2021 10:30 AM as SINGLE DOSE for COVID-19 immunisation. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and it was unknown if COVID was tested post vaccination. Medical history included hypertension. The patient had no known allergies. Concomitant medications included acetylsalicylic acid, ascorbic acid (ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]), atorvastatin, and donepezil. On 10Mar2020 at 08:00 AM, the patient experienced feeling unwell, muscle weakness, excessive tiredness, loss of appetite, fever, and chills. The reporter considered the events as serious due to hospitalization. The events resulted in emergency room/department or urgent care. It was unknown if treatment was given for the events. The patient had not yet recovered from all events.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: feeling unwell; muscle weakness; excessive tiredness; loss of appetite; fever; chills; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EP6955), via an unspecified route of administration administered in left arm at a pharmacy or drug store on 09Mar2021 10:30 AM as SINGLE DOSE for COVID-19 immunisation. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and it was unknown if COVID was tested post vaccination. Medical history included hypertension. The patient had no known allergies. Concomitant medications included acetylsalicylic acid, ascorbic acid (ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]), atorvastatin, and donepezil. On 10Mar2020 at 08:00 AM, the patient experienced feeling unwell, muscle weakness, excessive tiredness, loss of appetite, fever, and chills. The reporter considered the events as serious due to hospitalization. The events resulted in emergency room/department or urgent care. It was unknown if treatment was given for the events. The patient had not yet recovered from all events.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration), via an unspecified route of administration on 04Mar2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 04Mar2021, the patient received the 1st dose of COVID-19 vaccine. On 08Mar2021, she started developing symptoms of Bell's palsy. On 15Mar2021, she saw an internal medicine physician and confirmed that the patient has Bell's palsy. The patient was advised not to take the second dose but also suggested contact Pfizer for further advice on the second dose. The patient will see the physician for follow-up 22Mar2021. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: cancer; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, Caller stated that she received some "bad medical news", she was diagnosed with cancer (medically significant). She did not mention when she was diagnosed. The outcome of the event was unknown. She's trying to obtain an appointment for the second dose but is unable to. Her second dose is due on the 25Mar2021.    No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema multiforme
Clinical narrative: Erythema multiforme; This is a spontaneous report from a contactable physician. A 42-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. There were no medical history and concomitant medications. The physician reported that a patient had severe erythema multiforme on 12Mar2021, severe rash after getting the vaccine and firmly believe it's a reaction to the vaccine. There is no other reason for him to have it. And one of the patient's questions is should he get the second vaccine. And physician's inclination was - no. But that's the situation physician wanted to report it and find out what the recommendation is for the second dose. When paraphrased the concern, reporter stated, specific rash called erythema multiforme. It's a very specific rash and the phrase that physician used, Erythema multiforme, it should always be recorded as that because it is a very specific kind of rash. It's not just erythema. Event improving. The physician gave patient prednisone, 50 mg per day and he got an additional dose, another kind of a steroid which is Decadron, 10 mg. The patient was not hospitalized for the event. Relatedness of drug to reaction: related.  Information about Batch/Lot number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Erythema multiforme cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Neuropathy peripheral, Paraesthesia
Clinical narrative: Felt tired for a day; Started having like pins and needles; A little bit numb in arms and in hands and fingers and in both arms; Feeling like neuropathy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on 07Mar2021 (Lot number was not reported) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated, "I was supposed to call, because I had the Pfizer vaccine last Sunday, a week ago yesterday. And I felt tired for a day like that, a little bit (unspecified date). But on Friday, a few days later, I started having like pins and needles feeling like neuropathy like a little bit numb in my arms and in my hands and my fingers and in both arms. And when I spoke to someone about, I wanted to change my second appointment, they said that I should call. I spoke to a doctor there and doctor said that I should call you guys. And that's people are tracked. I want the people's track in. I want to know if this is a typical thing, like I'm not seeing it written anywhere and I did have this reaction once through another vaccine (Unspecified vaccine). I am just checking on it because I don't know what that is with me. I'm nervous not to get the second one." The patient felt tired for a day on an unspecified date, feeling like neuropathy, started having like pins and needles, a little bit numb in arms and in hands and fingers and in both arms all on 12Mar2021. The outcome of the events was unknown. The event "feeling like neuropathy" was considered as serious (medically significant).  Information about Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Chills, Dizziness, Fatigue
Clinical narrative: Tachycardia; Hypertension; Chest discomfort; Dizziness; Chills; Weakness; Fatigue; This is a spontaneous report from a contactable healthcare professional (patient). A patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; Lot Number: EL1284), via an unspecified route of administration on 12Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced tachycardia, hypertension, chest discomfort, dizziness, chills, weakness, and fatigue within 1 hour of shot on 12Jan2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization for a day. The outcome of the events was unknown. The patient has no COVID prior vaccination. The patient was not tested for COVID post vaccination.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be completely excluded based on a temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Tachycardia
Clinical narrative: Tachycardia; Hypertension; Chest discomfort; Dizziness; Chills; Weakness; Fatigue; This is a spontaneous report from a contactable healthcare professional (patient). A patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; Lot Number: EL1284), via an unspecified route of administration on 12Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced tachycardia, hypertension, chest discomfort, dizziness, chills, weakness, and fatigue within 1 hour of shot on 12Jan2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization for a day. The outcome of the events was unknown. The patient has no COVID prior vaccination. The patient was not tested for COVID post vaccination.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be completely excluded based on a temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Blood pressure measurement, Dizziness, Hypertension, Somnolence
Clinical narrative: Somnolence; Dizziness; Imbalance; High blood pressure; This is a spontaneous report received from contactable consumer (patient).   A 68-year-old female patient received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. E19266) single dose, in the left arm, on 20Feb2021, for COVID-19 immunisation. Relevant medical history included penicillin allergy, aortic valve replacement and diabetes. The patient previously, on 30Jan2021, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. E105318) single dose, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not experienced Covid-19 prior vaccination. Concomitant medications were unknown. On 20Feb2021, the patient experienced somnolence, dizziness, imbalance and high blood pressure. No treatment was received. The patient did not recover from the events at time of this report. The case was assessed as non-serious. Post the vaccination, the patient has not been tested for COVID-19. Futher information has been requested.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events reported; improperly stored doses of VARlVAX that was administered; This spontaneous report as received from a nurse and an other reporter and refers to a 17-year-old female patient. No information regarding the patient's medical history and concomitant medications was provided. The patient had no illness at time of vaccination and had no pre-existing allergies, birth defects or concurrent medical conditions. There was no concomitant vaccines administered.   On 17-FEB-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, subcutaneously (SQ) in the left arm (LA) for prophylaxis (lot # S006021 was verified to be valid, expiration date reported and established as 27-FEB-2021).  It was reported that the excursion occurred on 11-FEB-2021 and lasted for 1 hour and 6 minutes, the temperature reached -6 Celsius degrees and the freezer returned to range. The excursion was notced on 19-FEB-2021. The patient did not experience any additional adverse reactions after administration of the vaccine. The vaccine was used according to the instruction and the operator was trained. The improper storage was recorded by digital data logger.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2102USA007657:
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported; PROQUAD that was administered post expiry; This spontaneous report was received from an administrator referring to a patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.     The reporter was inquiring about the potency of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rha) (PROQUAD) that was administered post expiry. The reporter informed that measles, mumps, rubella and varicella (oka-merck) virus vaccine live , rha (PROQUAD) (lot S027463 expiration date 02-MAR-2021) was given on 09-MAR-2021, at a dose of 0.5 milligram subcutaneously for prophylaxis (vaccination scheme frequency and anatomical site of vaccination were not reported). The reporter informed that measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rha (PROQUAD) was stored properly up through administration. No additional adverse events reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Bladder discomfort, Computerised tomogram, Urinary bladder haemorrhage
Clinical narrative: Discomfort and pressure felt in the bladder; Bleeding from her bladder; Passing clots; A spontaneous report  was received from a consumer concerning a female patient who received Modern's COVID-19 vaccine (mRNA-1273) and experienced discomfort and pressure felt in the bladder, passing clots, and bleeding from the bladder.  The patient's medical history is unknown. Concomitant medication includes blood pressure medication, cholesterol medication, thyroid medication and aspirin were reported.  On 11-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031L20A) for prophylaxis of COVID-19 infection.   No adverse events after the first dose were reported.   On 10-MAR-2021, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 031L20A) for prophylaxis of COVID-19 infection.  On 12-MAR-2021, the patient experienced discomfort and felt pressure in the bladder. She was also passing clots and had CAT scanning which reports as she has many clots in the bladder. She took medicine and was on observation for 48 hours, after which the clots were gone in the scanning and the bleeding stopped.  Laboratory tests included CAT scanning, which found that there were more clots in the bladder.  The treatment details were not provided.  Action taken with mRNA-1273 in response to the events was not applicable she completed both the doses.  At the time of this report, the outcome of the events were resolved on 14-MAR-2021.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Seizure, Spinal fracture
Clinical narrative: She had seizure while driving home; Broken back as a result on an accident after receiving the vaccine; Previously diagnosed with seizure but it had been well controlled with medicine; A spontaneous report  was received from a consumer concerning a 69 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a seizure while driving home and a broken back as a result of an accident after receiving the vaccine.  The patient's medical history was reported as she had previously been diagnosed with a seizure disorder but it had been well controlled with medication. It had been over three to four years since she had a seizure and last time she could remember was in 2017. Concomitant medications taken by the patient were not provided.   On 19 Feb 2021, prior to the onset of the event, the patient received the first of two planned doses of mRNA-1273 (Lot number: 023N20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 19 Feb 2021, within about 30 minutes of getting the vaccine she had a seizure while driving home. This led to an vehicular accident and she had to be rushed to the hospital. Her car was totaled and she had a broken back.  Treatment activities for event was not provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, Seizure, Spinal fracture , and Condition Worsened, were unknown.; Reporter'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.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Atrial Fibrillation acted up; Hot in my injection site arm; Itching in my injection site arm; Hives in my injection site arm; Swelling in my injection site arm; Pain in my injection site arm; Red in my injection site arm; A spontaneous report was received from a consumer concerning herself, an 84-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced atrial fibrillation acted up/atrial fibrillation, hives/urticaria, pain/injection site pain, red/injection site erythema, itching/injection site pruritus, swelling/injection site swelling, hot sensation/injection site warmth.   The patient's medical history was not reported. Relevant concomitant medications were included losartan, furosemide, warfarin, thyroid, diltiazem, carvedilol, lorazepam.  On 05 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: 031L20A) intramuscularly for prophylaxis of COVID-19 infection and patient had no reactions to that vaccination.  On 05 Mar 2021, prior to the onset of event, the patient received the second of two planned doses of mRNA-1273 (Batch number: 048A21A) intramuscularly in the left arm deltoid for prophylaxis of COVID-19 infection.   On 10 Mar 2021, the patient experienced atrial fibrillation acted up which was considered medically significant and hives, pain, red, itching, swelling and hot sensation in the injection site. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the events atrial fibrillation acted up, hives, pain, red, itching, swelling and hot sensation in the injection site were unknown, at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria, Vaccination site warmth
Clinical narrative: Atrial Fibrillation acted up; Hot in my injection site arm; Itching in my injection site arm; Hives in my injection site arm; Swelling in my injection site arm; Pain in my injection site arm; Red in my injection site arm; A spontaneous report was received from a consumer concerning herself, an 84-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced atrial fibrillation acted up/atrial fibrillation, hives/urticaria, pain/injection site pain, red/injection site erythema, itching/injection site pruritus, swelling/injection site swelling, hot sensation/injection site warmth.   The patient's medical history was not reported. Relevant concomitant medications were included losartan, furosemide, warfarin, thyroid, diltiazem, carvedilol, lorazepam.  On 05 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: 031L20A) intramuscularly for prophylaxis of COVID-19 infection and patient had no reactions to that vaccination.  On 05 Mar 2021, prior to the onset of event, the patient received the second of two planned doses of mRNA-1273 (Batch number: 048A21A) intramuscularly in the left arm deltoid for prophylaxis of COVID-19 infection.   On 10 Mar 2021, the patient experienced atrial fibrillation acted up which was considered medically significant and hives, pain, red, itching, swelling and hot sensation in the injection site. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the events atrial fibrillation acted up, hives, pain, red, itching, swelling and hot sensation in the injection site were unknown, at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Angioedema, Genital swelling, Hypersensitivity, Swollen tongue
Clinical narrative: His tongue became puffy; Allergic episode after being on the elliptical bike.; Diagnosed with angioedema from a urologis; Genitals became swollen; A spontaneous report  was received from a healthcare professional concerning reporter's husband who is a male patient of unknown age, who received Moderna's COVID-19 Vaccine (mRNA-1273) experienced puffy tongue, angioedema,  genitals became swollen and allergic episode after being on the elliptical.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received his first of two planned doses of mRNA-1273 (Batch number not provided) on an unspecified date. On 05 Feb 2021, approximately 5 days prior to the onset of the symptoms, the patient received his second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection.  On 09 Feb 2021, initially patient was diagnosed with angioedema and swollen genitals from a urologist and then diagnosed with angioedema and allergic episode from a cardiologist on 23 Feb 2021. the patient was hospitalized on 15 Mar 2021 for puffy tongue.  Treatment for the event included Benadryl for angioedema from a urologist when genitals became swollen.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The events, diagnosed with angioedema and swollen glands from a urologist  were recovered on 12 Feb 2021. The outcome of the events, tongue became puffy, angioedema and allergic episode from a cardiologist, after being on the elliptical bike  were not reported.; Reporter'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.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Palpitations
Clinical narrative: Anaphylactic reactions; Within 5 minutes could not breath; Heart was racing; A spontaneous report was received from a consumer concerning a 28-yearsold female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced within five minutes could not breath/ dyspnea, heart was racing/ palpitations, and anaphylactic reaction.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 13 Feb 2021, five minutes prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch Number: 16M20A0) intramuscularly for prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced within 5 minutes could not breathe, heart was racing, and anaphylactic reaction.  The patient was seen in the emergency room for treatment. The event anaphylactic reactions was considered as Medically significant.  Treatment for the event included oxygen, prednisone, cetirizine hydrochloride, diphenhydramine and two doses of epinephrine.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.   The outcome of the events, could not breathe and heart racing, was resolved on 13 Feb 2021. The outcome of the event anaphylactic reaction was unknown.; Reporter'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.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Malaise, Pneumonia
Clinical narrative: Had pneumonia; Loss of smell; Loss of taste; received her first Moderna vaccine on 22JAN2021 and has not received second vaccine yet; Tested positive covid; Felt not right; A spontaneous report  was received from a consumer concerning herself, a 82-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced loss of smell / anosmia, loss of taste/ageusia, had pneumonia, felt not right / malaise, tested positive for Covid and received her first Moderna vaccine on 22JAN2021 and has not received second vaccine yet/product dose omission issue.  The patient's medical history, as provided by the reporter, included high blood pressure and high cholesterol. Concomitant medications reported included medications for high blood pressure and for high cholesterol.  On 22 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced loss of smell, loss of taste, and had pneumonia. The event, pneumonia, was found to be medically significant. On 03 Mar 2021, the patient was not feeling right and on 04 Mar 2021 she was tested positive for Covid-19.  Treatment details included the use of some nebulizers and quarantine.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, loss of smell, loss of taste, pneumonia, felt not right, and tested for Covid-19 was unknown and of event and has not received second vaccine yet was resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded except for the events of COVID-19 and Pneumonia.  The events of COVID-19 and Pneumonia is unlikely related to mRNA-1273 since the vaccine does not contain infectious elements capable of causing infection.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, SARS-CoV-1 test positive
Clinical narrative: Had pneumonia; Loss of smell; Loss of taste; received her first Moderna vaccine on 22JAN2021 and has not received second vaccine yet; Tested positive covid; Felt not right; A spontaneous report  was received from a consumer concerning herself, a 82-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced loss of smell / anosmia, loss of taste/ageusia, had pneumonia, felt not right / malaise, tested positive for Covid and received her first Moderna vaccine on 22JAN2021 and has not received second vaccine yet/product dose omission issue.  The patient's medical history, as provided by the reporter, included high blood pressure and high cholesterol. Concomitant medications reported included medications for high blood pressure and for high cholesterol.  On 22 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient experienced loss of smell, loss of taste, and had pneumonia. The event, pneumonia, was found to be medically significant. On 03 Mar 2021, the patient was not feeling right and on 04 Mar 2021 she was tested positive for Covid-19.  Treatment details included the use of some nebulizers and quarantine.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, loss of smell, loss of taste, pneumonia, felt not right, and tested for Covid-19 was unknown and of event and has not received second vaccine yet was resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded except for the events of COVID-19 and Pneumonia.  The events of COVID-19 and Pneumonia is unlikely related to mRNA-1273 since the vaccine does not contain infectious elements capable of causing infection.
Sex: M
Vaccine: COVID19
Symptoms: Cerebral disorder
Clinical narrative: Brain disorder; A spontaneous report  was received from a consumer concerning a unknown age of, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced ended up in hospital, had brain surgery.  The patient's medical history, as provided by the reporter, included brain surgery. Concomitant medications were not reported.  On unknown date, prior to the onset of the events, the patient received their dose of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the unknown site for prophylaxis of COVID-19 infection.   On unknown date, the patient experienced a brain disorder, ended up in hospital, and had brain surgery. Treatment for the event included brain surgery.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the reported event was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.Further information has been requested.; Sender's Comments:  MOD21-056185:Patient case
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Musculoskeletal pain
Clinical narrative: Severe aches on the buttocks; Cramps 2 days after the second shot; A spontaneous report  was received on 18 Mar 2021 from a consumer concerning, a 71-year old, female patient, who received Moderna's COVID-19 vaccine and experienced severe aches on the buttocks/ musculoskeletal pain and Cramps 2 days after the second shot/ muscle spasms.  The patient's medical history was not provided.  Concomitant product use was not provided.  On 10 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Batch number: 010M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 10 Mar 2021, approximately 2 days prior to the onset of the symptoms, the patient received the second of two planned doses of mRNA-1273 (Batch number: 031M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 12 Mar 2021, the patient experiencing severe aches on the buttocks and cramps 2 days after the second shot. Patient reports being hospitalized for 3 months.  Treatment information provided included iv fluids and pain killers   Action taken with mRNA-1273 in response to the event was not applicable.   The outcome of events, severe aches on the buttocks and cramps, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder
Clinical narrative: first dose caused flareup from my autoimmune disease; A spontaneous report was received from a consumer concerning a female patient, who received Moderna' s COVID-19 vaccine (mRNA-1273) and experienced first dose caused flareup from my autoimmune disease  As provided by the reporter ,The patient does not have medical history.  On 23 FEB 2021,the patient received her first  planned dose of mRNA-1273 intramuscularly in arm for prophylaxis of COVID-19 infection.   On 23 FEB 2021, after receiving mRNA-1273, the patient experienced first dose caused flareup from my autoimmune disease  23Mar2021. This patient reports having an autoimmune disease. She is calling because she believes the first dose of the vaccine caused an autoimmune disease flare up. Concerned because she believes she might still be having a flare up by the time its due for her second dose next week. Wants to know if she should postpone her appointment until the flareup is gone and is there a limit for how long it is able to be from the first dose.  Action taken with mRNA-1273 in response to the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: allergic anaphylaxis; A spontaneous report was received from a consumer, concerning herself a 77 years old female patient, who received Moderna's COVID-19 vaccine and experienced allergic anaphylaxis reaction in which the throat is swollen and could not eat and drink liquids.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 08 MAR 2021 prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 030A21A) via Intramuscular route for COVID-19 infection prophylaxis.  On unknown date, she experienced allergic anaphylactic reactions which the throat was swollen and could not eat and drink liquids. She took Benadryl (diphenhydramine) as the treatment.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event was considered to be unknown at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis
Clinical narrative: Acute Bronchitis; A spontaneous report  was received from a consumer concerning a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events acute bronchitis.  The patient's medical history included thyroid and cholesterol. Concomitant medications reported were Thyroid medication, Cholesterol medication, Prednisone for drug use for unknown indication.  On 22 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 029L20A) via unknown route for prophylaxis of COVID-19 infection. On 19 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 013M20A) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) acute bronchitis.  Treatment details included Prednisone.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), acute bronchitis was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest X-ray, Computerised tomogram, Magnetic resonance imaging head, Transient ischaemic attack
Clinical narrative: mini stroke; still weak; A spontaneous report (United States) was received from a consumer concerning an 80 years old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event mini stroke/transient ischaemic attack and still weak/asthenia.  The patient's medical history was not provided. The concomitant medications on use were also not provided.  On 26 Feb 2021, approximately 17 days prior to the onset of the events, the patient received their first of two planned doses of mRNA (Batch number: 011A21A) through unknown route of administration for prophylaxis of COVID-19 infection.  On 15 Mar 2021, patient experienced mini stroke. The patient was hospitalized on the same day till 17 Mar 2021.It was serious event which required hospitalization.  Laboratory tests performed included ultrasounds, cat scan of the brain, MRI of brain, ultrasound of arteries, and chest x-ray. The findings of lab tests were not provided. The patient was given acetylsalicylic acid and an injection in the belly to prevent blood clots.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events was unknown; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: mini stroke; still weak; A spontaneous report (United States) was received from a consumer concerning an 80 years old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event mini stroke/transient ischaemic attack and still weak/asthenia.  The patient's medical history was not provided. The concomitant medications on use were also not provided.  On 26 Feb 2021, approximately 17 days prior to the onset of the events, the patient received their first of two planned doses of mRNA (Batch number: 011A21A) through unknown route of administration for prophylaxis of COVID-19 infection.  On 15 Mar 2021, patient experienced mini stroke. The patient was hospitalized on the same day till 17 Mar 2021.It was serious event which required hospitalization.  Laboratory tests performed included ultrasounds, cat scan of the brain, MRI of brain, ultrasound of arteries, and chest x-ray. The findings of lab tests were not provided. The patient was given acetylsalicylic acid and an injection in the belly to prevent blood clots.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events was unknown; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Sore shoulder; This is a spontaneous report from a contactable consumer (patient) received via medical information team. A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL1283), via an unspecified route of administration on 12Jan2021 (at an age of 73-years-old) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. She got her first dose on 12Jan2021 at the center (City name withheld) and scheduled to come back for her second dose 4 weeks after receiving her first dose. The appointment for 4 weeks out was already made for 09Feb2021, states she did not know who to call to change it. Upon follow up on 08Feb2021, patient reported that when she originally scheduled her appt. online, she was told that she would get moderna and follow up appt. in 4 weeks. When she ended up getting Pfizer, she tried to change her appt. to 3 weeks, but she was not able to. She called the county and was told it would be ok to have it at 4 weeks per their epidemiologist. She had no side effects other than a sore shoulder that night. Patient was not admitted to the hospital due to the event. No treatment was received for the event. The outcome of the event sore shoulder was unknown.  Upon Follow-up (08Feb2021): New information received from a contactable consumer. This consumer reported in response to Non-HCP letter sent which included: patient details (age group: adult, weight: 123 lb, height: 5 feet, 2 inches), new event (sore shoulder), treatment and clinical information.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: received her 1st dose on 20Jan2021 and her 2nd dose yesterday 26Jan2021; soreness in the injection site; This is a spontaneous report from a contactable pharmacist. A 79-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; lot number and expiry date: unknown) via an unspecified route of administration, on 26Jan2021 at a single dose, for COVID -19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2, on 20Jan2021, for COVID -19 immunization. The patient accidentally received her 2nd dose of the Pfizer Covid vaccine earlier than the recommended interval. She received her first dose on 20Jan2021 and her 2nd dose yesterday, 26Jan2021. She has no other symptoms other than soreness in the injection site on an unspecified date in Jan2021. Outcome of the event soreness in the injection site was unknown.  Information about lot/batch number has been requested.