chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Pain in extremity, Vomiting
Clinical narrative: sore arm; stomach pain; vomiting; This is a spontaneous report from a contactable consumer (patient). A 87-year-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 04Feb2021 as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included of BNT162B2 unknown dose for covid-19 immunisation. Patient stated that she had the second Pfizer Covid shot on last Thursday, 04Feb2021. Had a sore arm for 24 hours and no other symptoms except around 4:30am Sunday morning she had a horrible stomach-ache and pains, and some vomiting. It was getting better, and she has not had a temperature. Wanted to know if this could be a reaction to the shot after so many days or if many people have had this or should she be looking at another problem. Wondering about this since having a reaction after 48 hours. Did not know if this was the right number and instead of calling the doctor, she figured Pfizer would have the information about the shot. The clinical outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: there was 5 of us and none of us had reactions, only our shoulders was hurting a little but we had not fever; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 5 patients. This is 1st of 5 reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Enquired, the patient was told that, if she didn't get a reaction that means the shot was not effective and was not working, was that true. The patient stated that, there was 5 of them and none of them had reactions, only their shoulders was hurting a little, but we had not fever. The outcome of the event was unknown.  Information on lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021171051 same drug/AE, different patient.;US-PFIZER INC-2021171050 same drug/AE, different patient.;US-PFIZER INC-2021171048 same drug/AE, different patient.;US-PFIZER INC-2021171049 same drug/AE, different patient.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's wife) via Medical Information Team. A male patient (husband) of age 90 (units unspecified) received first dose of BNT162B2 (Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history included immunodeficiency (reporter would like to know if it was safe for her husband to receive the second shot of the COVID-19 vaccine if he was immunocompromised), myasthenia gravis (reporter was reporting on behalf of her immunocompromised husband with a history of myasthenia gravis). Concomitant medications were not reported. The patient experienced sore throat on an unspecified date which was not there on Saturday. Caller would like to know what would happen if her husband does not receive his second shot of the COVID-19 vaccine. 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: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Lymphadenopathy, Malaise, Nausea, Pre-existing condition improved
Clinical narrative: shortness of breath and chest pain have subsided; Dizziness; swelling underneath my armpit; not feeling well; nausea; This is a spontaneous report from a contactable consumer. This 43-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 06Feb2021 (age at the time of vaccination was 43 years) as a single dose for COVID-19 immunization. The patient's medical history included shortness of breath and chest pain. The patient's concomitant medications were not reported. On 06Feb2021, the patient experienced dizziness and it was getting better. On an unspecified date in Feb2021, the patient experienced nausea and was not feeling well. The nausea was getting better. Last night (on the day of reporting), the patient had a little bit of swelling underneath his armpit. The swelling under the arm had improved previous day night. On an unknown date, the patient underwent COVID test and shown negative results. The shortness of breath and chest pain had subsided after the patient got vaccinated. The outcome of the events was recovering.  Information about lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test
Clinical narrative: shortness of breath and chest pain have subsided; Dizziness; swelling underneath my armpit; not feeling well; nausea; This is a spontaneous report from a contactable consumer. This 43-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 06Feb2021 (age at the time of vaccination was 43 years) as a single dose for COVID-19 immunization. The patient's medical history included shortness of breath and chest pain. The patient's concomitant medications were not reported. On 06Feb2021, the patient experienced dizziness and it was getting better. On an unspecified date in Feb2021, the patient experienced nausea and was not feeling well. The nausea was getting better. Last night (on the day of reporting), the patient had a little bit of swelling underneath his armpit. The swelling under the arm had improved previous day night. On an unknown date, the patient underwent COVID test and shown negative results. The shortness of breath and chest pain had subsided after the patient got vaccinated. The outcome of the events was recovering.  Information about lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer (Patient) via medical information team. A female patient of an unspecified age received first dose of BNT162B2 (Pfizer BioNTech COVID-19 vaccine, formulation: Solution for injection, Lot number unknown, expiration date unknown), via an unspecified route of administration on 04Feb2021 as single dose for COVID-19 immunisation. Medical history included migraine. Concomitant medications included aspirin (ACETYLSALICYLIC ACID, strength: 81 mg) at 81 mg, daily for an unspecified indication. Historical vaccine included Aimovig. Patient was taking the injection called Aimovig 70mg once a month. She had her Aimovig shot 17 days before getting the Pfizer COVID-19 vaccine and she was scheduled again for her Aimovig shot 7 days before her second dose of the pfizer COVID-19 vaccine. She was concerned whether the Aimovig shot would make the Pfizer COVID-19 vaccine less effective. Patient also mentioned that she was taking 81mg aspirin everyday but on the day she got the Pfizer COVID-19 vaccine, she skipped the aspirin. Patient was taking Sumatriptan for her headaches. Twelve hours after the first dose of the Pfizer vaccine, she had a headache and took a pill of Sumatriptan. The outcome of the event was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dyspnoea, Pyrexia
Clinical narrative: fever; felt weak when standing or walking; chills; shortness of breath; This is a spontaneous report from a contactable Consumer (Patient). A 33-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 01Feb2021 at 14:45 (33 year age at the time of vaccination) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration in Left arm on 13Jan2021 at 14:45 (33 year age at the time of vaccination) for COVID-19 immunisation. Patient had no known allergies. Patient did not receive other vaccine in four weeks. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. On 02Feb2021 at 08:30 AM, the patient experienced fever, felt weak when standing or walking, chills, shortness of breath. The AE resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for events. The outcome of event was recovered on an unspecified date in Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Injection site soreness; Swelling; Redness; Chills during period about 12-20 hours postinjection; low grade fever during period about 12-20 hours postinjection; Malaise; This is a spontaneous report from a non-contactable consumer (reported for herself). A 65-years-old elderly female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN5318) via an unspecified route of administration, administered in arm left on 28Jan2021 as Dose 2, single and received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EL3246 as Dose 1,Single for Covid-19 immunization at Hospital. Medical history included osteopenia and osteoporosis. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 has no reported allergies. On an unspecified date in Jan2021, the reporter stated that Injection site soreness, swelling, and redness, lasting a few days; chills during period about 12-20 hours postejection; low grade fever during period about 12-20 hours postejection, 38.2C at 20 hours; malaise lasting a few days. No treatment was given for the events. The patient underwent lab tests and procedures which included pyrexia: 38.2c centigrade on an unspecified date. The outcome of the events was recovered/resolved on an unspecified date in 2021.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Injection site soreness; Swelling; Redness; Chills during period about 12-20 hours postinjection; low grade fever during period about 12-20 hours postinjection; Malaise; This is a spontaneous report from a non-contactable consumer (reported for herself). A 65-years-old elderly female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN5318) via an unspecified route of administration, administered in arm left on 28Jan2021 as Dose 2, single and received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EL3246 as Dose 1,Single for Covid-19 immunization at Hospital. Medical history included osteopenia and osteoporosis. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 has no reported allergies. On an unspecified date in Jan2021, the reporter stated that Injection site soreness, swelling, and redness, lasting a few days; chills during period about 12-20 hours postejection; low grade fever during period about 12-20 hours postejection, 38.2C at 20 hours; malaise lasting a few days. No treatment was given for the events. The patient underwent lab tests and procedures which included pyrexia: 38.2c centigrade on an unspecified date. The outcome of the events was recovered/resolved on an unspecified date in 2021.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: trouble (pain) in her arm and shoulder; trouble (pain) in her arm and shoulder; This is a spontaneous report from a contactable consumer. A 79 (unspecified age unit) old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as single dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine, patient had trouble (pain) in her arm and shoulder for 4 days, caller were told that with the second dose it would be more difficult and painful. They would like to know if the second dose was a stronger vaccine. 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: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Tremor
Clinical narrative: chills; shaking; not feeling well; This is a spontaneous report received from a contactable Consumer (patient's husband).  A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318 and Expiration date was not reported), via an unspecified route of administration, in right arm, on 06Feb2021, Saturday (at the age of 78 years), as a single dose for covid-19 immunization. The patient medical history included A Fib and mitral valve replacement (caller states that his wife has had two mitral valve replacements, as she out-lived the first one). Concomitant medications included Jantoven (warfarin sodium) for a fib and mitral valve replacement. The patient had taken Covid vaccine for Covid prevention. On 07Feb2021, the next day, the patient had experienced not feeling well, chills, and shaking. Caller states that he wrapped his wife in a bunch of blankets and finally after about three hours, it subsided. Caller states that this morning, his wife got up and went to the bathroom and before she could get back to bed, she started to shake again. Caller is wondering if this is a normal side effect of the product. Caller confirmed that his wife had no other vaccines on the same day as the COVID vaccine. The outcome of the event chills was recovered on an unspecified date in 2021. The outcome of the event shaking was not recovered. The outcome of the event not feeling well was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Vomiting
Clinical narrative: vomiting and diarrhea and lack of energy, poor eating; vomiting and diarrhea and lack of energy, poor eating; vomiting and diarrhea and lack of energy, poor eating; vomiting and diarrhea and lack of energy, poor eating; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for a 86-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EL9264), dose 2 via an unspecified route of administration, administered in Arm Right on 05Feb2021 14:30  as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included pacemaker (Caller says this was put in about 5 years ago this coming May); Blood pressure high  (Caller says this was diagnosed about 35 years ago); high cholesterol (Caller says this was diagnosed about 35 years ago) and diabetes (Caller says that he had a little sugar, but everything is under control with medication. She clarifies that at one point they said he had diabetes and his A1 sugar or A1C when it was last taken was 7.1). There were no concomitant medications. Patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EL9261), first dose  via an unknown route of administration on 15Jan2021 (Batch/Lot number : EL3247) as 1ST DOSE, SINGLE for covid-19 immunisation. On 06Feb2021, the patient experienced vomiting and diarrhea and lack of energy, poor eating. The patient received treatment for diarrhoea. It was reported that Caller was calling on behalf of her 86 year old male friend. Had the second dose of the Pfizer COVID 19 vaccine on Friday, 5Feb2021. On Saturday her friend had vomiting and diarrhoea and lack of energy, poor eating. Sunday vomiting had stopped but diarrhoea continues. Took Imodium today. It was reported that consumer clarified to be the Pfizer COVID-19 vaccine, second dose. She says that he had the same shots at the same time she had them but he has had severe reactions to his. She says that they got their second dose on Friday February 5th and the next morning he had severe vomiting and diarrhoea and no energy at all. She says on Saturday the 6th he had vomiting and diarrhoea, bit on Sunday the 7th he did not vomit at all. She says he still has diarrhoea yesterday and today and he was not totally listless but he had no energy. Caller says she has been feeding him rye bread with peanut butter on it and yesterday she fed him some toast with egg on it and then a bit later vegetable soup with crackers, then later he had some popcorn. Caller says she also started him on Imodium, which he started taking today on 8Feb. Caller says she was having trouble reading the Imodium label, it was not printed. UPC: Not provided. LOT: SHF081, EXP: May2022. She says that he took his first dose so far only which was two 2mg capsules by mouth. At the time of reporting, the outcome of the events were unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Her arm was sore (clarified: on injection site); This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients (Husband and wife). This is 1st of 2 reports. A 72-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 07Feb2021 (Batch/Lot Number: EM9809) as single for covid-19 immunisation. Medical history included major lung disease. The patient's concomitant medications were not reported. The patient reported that "her arm was sore (clarified: on injection site) was that mean that vaccine was effective" on an unspecified date.The patient stated that their "doctor told, will feel cold when it goes in; should feel cold; vaccine did not feel cold, it was like getting a regular flu shot". The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021171086 Same reporter, same event, diferent patient
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19 pneumonia, Cardiac failure acute, Cardiac failure congestive, Death
Clinical narrative: Death  4/21/2021 Causes of death listed on death certificate: 1) Acute respiratory failure (onset interval 1 week)  2) COVID Pneumonia (onset interval 1 week)  Other: acute on chronic congestive heart failure
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Nucleic acid test, Polymerase chain reaction
Clinical narrative: Death  4/21/2021 Causes of death listed on death certificate: 1) Acute respiratory failure (onset interval 1 week)  2) COVID Pneumonia (onset interval 1 week)  Other: acute on chronic congestive heart failure
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pruritus
Clinical narrative: 15 minutes after receiving second dose of Pfizer COVID vaccine patient complained of headache, dizziness and itching.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Biopsy, Dermatitis, Rash
Clinical narrative: I had a persistent rash on the top of both arms, it had spread to the underside of both arms and was showing up on both ankles. Dr took two biopsies. They came up with the diagnosis of interface dermatitis.  No treatment provided, was told to let it run its course.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Fatigue; Slight muscle aches in my neck; This is a spontaneous report from a contactable consumer or other non hcp.   A 23-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, second dose on 25Jan2021 08:00 (Age at vaccination was 23-year-old) via an unspecified route of administration at arm Right as a 2nd dose, single for covid-19 immunisation. Medical history included asthma and known allergies: sulfa. Patient did not receive any other vaccine prior to four weeks. Concomitant medications included methylphenidate hydrochloride (CONCERTA); buspirone hydrochloride (BUSPAR); ethinylestradiol, etonogestrel (NUVARING); and cyanocobalamin (B12-VITAMIIN). Historical vaccine included BNT162B2 (First Dose on an unknown date and lot number and expiry date was unknown) for COVID-19 immunisation. The patient previously took Lorabid for product used for unknown indication and experienced drug hypersensitivity, keflex [cefalexin] for product used for unknown indication and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Jan2021 12:00, the patient experienced fatigue and slight muscle aches in her neck. No treatment was received due to events. The outcome of the events was recovered on an unknown date.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder, Oligomenorrhoea
Clinical narrative: The day after my vaccine I started my period. It was close to my usual cycle. It was rather light flow but for a normal duration. 23 days later began another period. It's early. I am now on day 21 of an active flow. On Day's 7-9 I experienced extremely heavy flow, soaking overnight pads in a matter of 2 hours, and experience large blood clots. On day 14 I caught medical attention at my normal primary care clinic through their walk-in services.  I was given birth control and told that at my age this was just to be expected. No lab work was performed.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Chest X-ray, Cholelithiasis, Disturbance in attention, Dysphonia
Clinical narrative: I gained about 30lbs went from 155- 185 (weight increased about 5-10lbs every 2 weeks) body muscle mass grew? shoulders, back chest, quads etc grew, do have fat but it looks like I bulked up when I haven't worked out since COVID. Prior COVID, I went to martial arts 4 times a week and went to the gym 4-5 times a week still. My awareness was not good, hand dexterity was not as high, concentrating was not easy for long, high blood pressure, pre diabetic now,  fatty liver, gallbladder stones/sludge, have high wbc count, rbc count high, high alt/ast range is 44-88-116-222, skin sensititivty, could only stay awake for 6 hours at a time.  BTold to introduce coffee to help liver/ keep taking baby aspirin/ put back on Dexilant 60mg. When working out, I go to sleep within an hour of running 1 mile,  weight lifting gets me extremely tired now, now its not as bad, can work out longer.  In may, all my allergies disappeared, now they are back but in first month I was no longer allergic to fruits. This is new and started in June, pimples on skull and ears, voice is normal now, may have grown taller, leg shins hurt when touched. Skin still very sensitive, awake longer now  but when I work out I still get tired where I have to stop, sit, or nap.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Gastrooesophageal reflux disease, Glucose tolerance impaired, Hepatic steatosis, Hypersomnia
Clinical narrative: I gained about 30lbs went from 155- 185 (weight increased about 5-10lbs every 2 weeks) body muscle mass grew? shoulders, back chest, quads etc grew, do have fat but it looks like I bulked up when I haven't worked out since COVID. Prior COVID, I went to martial arts 4 times a week and went to the gym 4-5 times a week still. My awareness was not good, hand dexterity was not as high, concentrating was not easy for long, high blood pressure, pre diabetic now,  fatty liver, gallbladder stones/sludge, have high wbc count, rbc count high, high alt/ast range is 44-88-116-222, skin sensititivty, could only stay awake for 6 hours at a time.  BTold to introduce coffee to help liver/ keep taking baby aspirin/ put back on Dexilant 60mg. When working out, I go to sleep within an hour of running 1 mile,  weight lifting gets me extremely tired now, now its not as bad, can work out longer.  In may, all my allergies disappeared, now they are back but in first month I was no longer allergic to fruits. This is new and started in June, pimples on skull and ears, voice is normal now, may have grown taller, leg shins hurt when touched. Skin still very sensitive, awake longer now  but when I work out I still get tired where I have to stop, sit, or nap.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Laboratory test, Magnetic resonance imaging head, Nausea, Neck mass
Clinical narrative: I gained about 30lbs went from 155- 185 (weight increased about 5-10lbs every 2 weeks) body muscle mass grew? shoulders, back chest, quads etc grew, do have fat but it looks like I bulked up when I haven't worked out since COVID. Prior COVID, I went to martial arts 4 times a week and went to the gym 4-5 times a week still. My awareness was not good, hand dexterity was not as high, concentrating was not easy for long, high blood pressure, pre diabetic now,  fatty liver, gallbladder stones/sludge, have high wbc count, rbc count high, high alt/ast range is 44-88-116-222, skin sensititivty, could only stay awake for 6 hours at a time.  BTold to introduce coffee to help liver/ keep taking baby aspirin/ put back on Dexilant 60mg. When working out, I go to sleep within an hour of running 1 mile,  weight lifting gets me extremely tired now, now its not as bad, can work out longer.  In may, all my allergies disappeared, now they are back but in first month I was no longer allergic to fruits. This is new and started in June, pimples on skull and ears, voice is normal now, may have grown taller, leg shins hurt when touched. Skin still very sensitive, awake longer now  but when I work out I still get tired where I have to stop, sit, or nap.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Red blood cell count increased, Sensitive skin, Ultrasound liver abnormal, Vomiting, Weight increased
Clinical narrative: I gained about 30lbs went from 155- 185 (weight increased about 5-10lbs every 2 weeks) body muscle mass grew? shoulders, back chest, quads etc grew, do have fat but it looks like I bulked up when I haven't worked out since COVID. Prior COVID, I went to martial arts 4 times a week and went to the gym 4-5 times a week still. My awareness was not good, hand dexterity was not as high, concentrating was not easy for long, high blood pressure, pre diabetic now,  fatty liver, gallbladder stones/sludge, have high wbc count, rbc count high, high alt/ast range is 44-88-116-222, skin sensititivty, could only stay awake for 6 hours at a time.  BTold to introduce coffee to help liver/ keep taking baby aspirin/ put back on Dexilant 60mg. When working out, I go to sleep within an hour of running 1 mile,  weight lifting gets me extremely tired now, now its not as bad, can work out longer.  In may, all my allergies disappeared, now they are back but in first month I was no longer allergic to fruits. This is new and started in June, pimples on skull and ears, voice is normal now, may have grown taller, leg shins hurt when touched. Skin still very sensitive, awake longer now  but when I work out I still get tired where I have to stop, sit, or nap.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count increased
Clinical narrative: I gained about 30lbs went from 155- 185 (weight increased about 5-10lbs every 2 weeks) body muscle mass grew? shoulders, back chest, quads etc grew, do have fat but it looks like I bulked up when I haven't worked out since COVID. Prior COVID, I went to martial arts 4 times a week and went to the gym 4-5 times a week still. My awareness was not good, hand dexterity was not as high, concentrating was not easy for long, high blood pressure, pre diabetic now,  fatty liver, gallbladder stones/sludge, have high wbc count, rbc count high, high alt/ast range is 44-88-116-222, skin sensititivty, could only stay awake for 6 hours at a time.  BTold to introduce coffee to help liver/ keep taking baby aspirin/ put back on Dexilant 60mg. When working out, I go to sleep within an hour of running 1 mile,  weight lifting gets me extremely tired now, now its not as bad, can work out longer.  In may, all my allergies disappeared, now they are back but in first month I was no longer allergic to fruits. This is new and started in June, pimples on skull and ears, voice is normal now, may have grown taller, leg shins hurt when touched. Skin still very sensitive, awake longer now  but when I work out I still get tired where I have to stop, sit, or nap.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Injection site reaction, Rash pruritic
Clinical narrative: The patient developed an itchy rash near the injection site about 4-5 inches in length and 2-3 inches in width. No other sympotoms noted at this time.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest discomfort, Chest pain, Neck pain
Clinical narrative: Intermittent chest pain, pressure, and burning x 1 week so I went to the ER  Also, bad neck pain
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Peripheral coldness, Pyrexia, Rash
Clinical narrative: Rash in forearm, fever, headache, ice cold feet
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Tachycardia
Clinical narrative: Tachycardia.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Disorientation, Loss of consciousness, Pallor
Clinical narrative: 6/25/2021   Patient was observed post Covid-19 immunization for 15 minutes .  During the observation period, he experienced an adverse reaction with the following symptoms:  loss of consciousness.   Assessment : Time of assessment 0831am. Pallor, Clammy and disoriented.   Actions taken:  Vitals sign taken  EMS called at  0831. VAERS form obtained and completed by RN. Hand off to EMS upon arrival at 856am. Patient refuses EMS transport. Water given 0835- BP- 67/44, P- 39, O2- 100 %, recheck- at 0839- BP- 105/66 , 0915- bp 012/82, P- 44, O2- 100%       Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat. EMS accessed patient, patient refuses transport. Wife with patient.     Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 6/25/2021  8:27 AM 0.3 mL 2/25/2020 Intramuscular   Manufacturer: Pfizer, Inc   Lot: ER8736   NDC: 59267-1000-2
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Condition aggravated, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Patient positive for covid-19 11/26/2020. Vaccinated 12/22/2020 and 01/12/2021 with pfizer. Patient sent to hosptial on 06/19/2021 and tested positive for covid-19 06/20/2021 with symptoms. .
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Immunoglobulin therapy, Myocarditis, Otitis externa
Clinical narrative: myocarditis requiring hospitalization and IVIG treatment otitis externa
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Impaired work ability, Injected limb mobility decreased
Clinical narrative: Severe body aches, chills, major headache, hard time lifting right arm due to tightness and pain, fatigue and nausea. These symptoms lasted for 48 hours. Took ibuprofen every 4 to 6 hours and slept on and off for 20 hours. Ended up having to take time off work.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Nausea, Pain, Pain in extremity
Clinical narrative: Severe body aches, chills, major headache, hard time lifting right arm due to tightness and pain, fatigue and nausea. These symptoms lasted for 48 hours. Took ibuprofen every 4 to 6 hours and slept on and off for 20 hours. Ended up having to take time off work.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Inmate was a new intake into this facility. Inmate was offered the Janssen vaccine and he consented to receive. Inmate received the vaccine. Upon entering the information into the medical record, a documented history of Janssen vaccine was given on 4/27/21. Inmate did not require a second dose, but was not truthful on intake as to having previously received a vaccine. No adverse side effects reported as of the time of submitting this report.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Chest pain, Eye swelling, Feeding disorder
Clinical narrative: Got the shot at 3pm could not sleep until 6am, was throwing up and had a fever of 102.0, oxygen was 91. Having swollen eyes, the sweats, red eyes, headache, not being able to eat, joint pain. Full body rash, 68 hours after the shot had chest pain, ringing in ears. Couldn't get out of bed for 4 days. Goes for blood work July 12th to see what is going on cause it's been over a  month and is not back to normal yet.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Insomnia, Ocular hyperaemia, Pyrexia
Clinical narrative: Got the shot at 3pm could not sleep until 6am, was throwing up and had a fever of 102.0, oxygen was 91. Having swollen eyes, the sweats, red eyes, headache, not being able to eat, joint pain. Full body rash, 68 hours after the shot had chest pain, ringing in ears. Couldn't get out of bed for 4 days. Goes for blood work July 12th to see what is going on cause it's been over a  month and is not back to normal yet.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Tinnitus, Vomiting
Clinical narrative: Got the shot at 3pm could not sleep until 6am, was throwing up and had a fever of 102.0, oxygen was 91. Having swollen eyes, the sweats, red eyes, headache, not being able to eat, joint pain. Full body rash, 68 hours after the shot had chest pain, ringing in ears. Couldn't get out of bed for 4 days. Goes for blood work July 12th to see what is going on cause it's been over a  month and is not back to normal yet.
Sex: F
Vaccine: COVID19
Symptoms: Pharyngitis streptococcal
Clinical narrative: She was diagnosed with strep throat; This is a spontaneous report from a contactable Other Health Professional (Patient herself). A female patient of an unspecified age received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 22Jan2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the reporter stated that she was diagnosed with strep throat today and her due for the next dose this Friday. The patient was asked that can she still get the second dose scheduled on Friday. Therapeutic measures were taken as a result of event with clindamycin and a steroid. The outcome of the event was unknown.  Information on Lot/Batch has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles appeared after 4 weeks and have remained for five weeks now.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Patient fully vaccinated, developed loss of taste and smell. Tested positive for COVID-19
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiomyopathy acute, Full blood count, Metabolic function test
Clinical narrative: Acute cardiomyopathy that required hospitalization and subsequent follow up
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Visual impairment
Clinical narrative: Pt complains of eye swelling and altered vision. States she has been seeing black spots in her vision and has some swelling around her right eye. Refrained from giving second shot due to these effects
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Laboratory test, Lethargy, Measles antibody positive, Mumps antibody test negative, Ocular hyperaemia
Clinical narrative: Ten days after receiving vaccine, patient developed high fever of 103. Second day developed rash on face and neck that spread to rest of body by day three. Severe lethargy persisted for six days. Rash lasted seven days and fever lashed four and a half days. Also had runny nose and redness in the eyes.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Pyrexia, Rash, Rhinorrhoea, Rubella antibody positive, Varicella virus test negative
Clinical narrative: Ten days after receiving vaccine, patient developed high fever of 103. Second day developed rash on face and neck that spread to rest of body by day three. Severe lethargy persisted for six days. Rash lasted seven days and fever lashed four and a half days. Also had runny nose and redness in the eyes.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Cardioversion, Heart rate irregular, Laboratory test, Palpitations
Clinical narrative: I had a 2nd dose on 3/23. On 4/9, I had irregular rhythm associated with atrial fibrillation. This lasted until I was cardioverted on 4/23. I had a change in rhythm again after that and I had to be cardioverted a second time. On 6/8, in the evening, I palpated an irregular pulse associated with atrial fibrillation. This continued until I was cardioverted in the afternoon of 6/14. Since then I have not experienced an irregular pulse. I am scheduled a follow up on 8/5 with my cardiologist. I have had 2 ablations in the hopes they would give a cure, but they have not.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Chronic obstructive pulmonary disease, Condition aggravated, Death, Nucleic acid test
Clinical narrative: Death   4/30/2021 Causes of death listed on death certificate: 1) Covid Pneumonia  2) Chronic obstructive pulmonary disease, unspecified  Other: none
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Polymerase chain reaction
Clinical narrative: Death   4/30/2021 Causes of death listed on death certificate: 1) Covid Pneumonia  2) Chronic obstructive pulmonary disease, unspecified  Other: none
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthma, Condition aggravated, Pyrexia
Clinical narrative: mild fever, asthma flare-ups
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthma, Autopsy
Clinical narrative: mild fever, asthma flare-ups
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: PT TESTED POSITIVE FOR COVID 19 AFTER BEING FULLY VACCINATED.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Tremor
Clinical narrative: I have uncontrollable shakes and I have been diagnosed with borderline Parkinson's disease.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Fatigue, Magnetic resonance imaging
Clinical narrative: Tiredness; Feeling so weak; Does not have much of an appetite to eat anything; This is a spontaneous report from a contactable consumer (patient). A 87-years-old female patient received first dose of BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EK4176) 0.3ml, via an unspecified route of administration, administered in Arm Right on 20Jan2021 (at the age of 87-year-old) as single dose for covid-19 immunisation. Medical history included ongoing hypertension. Concomitant medications included apixaban (ELIQUIS) taken for anticoagulant therapy from an unspecified start date and ongoing; metoprolol succinate (TOPROL XL) taken for hypertension from an unspecified start date and ongoing; amlodipine besylate taken for hypertension from an unspecified start date and ongoing; olmesartan medoxomil taken for hypertension from an unspecified start date and ongoing. Patient had no problems before with her medications. On an unknown date in 2021, the patient experienced feeling so weak, does not have much of an appetite to eat anything. She noticed on Monday it was getting worse, then she had another attack of it today. It suddenly comes on and all of a sudden she is so weak. Its like she can not balance herself out. On 01Feb2021, patient experienced tiredness. The patient underwent lab tests and procedures which included magnetic resonance imaging: cyst on her right kidney on Mar2020. MRI was done prior to the vaccine, she had been having issues with pain on her right side so they did an MRI. They told her she has a cyst on her right kidney. She has not taken any kind of medications for that. They want to do another MRI before doing anything. She asks, what should she do about the second dose. Patient was supposed to get the next dose on 09Feb2021. She does not really want to take it if it will do her like this. The outcome of the events so weak, does not have much of an appetite to eat anything were not recovered and the outcome of the event tiredness was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: She got her vaccine, she had an area approximately about 5" x 4" across on her arm, quite raised, very very red, it hurt, painful and itchy.  It lasted for a week to 10 days up to 2 weeks at the site of the injection.  I experienced achiness, malaise for several days afterwards, and kind of continued for about 3 weeks before it settled down.   She treated it with Tylenol, bed rest and Motrin.  She had gone to her PCP with the first vaccine which I will describe later.   She used to be very active and she now cannot walk trails, and still has the feeling of malaise 4 months post vaccine.  She feels she is still having some inflammatory ongoing process in her muscles, joints and has had three short courses of steroids over the last couple of months, and is now in physical therapy and going to be seen by an Orthopedist again to see what may be going on.    She is a retired nurse and feels that now she has a permanent condition based on having the vaccine, and does not know if she would have a booster if it was offered, and her quality of life has changed and is "no way to live".
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site urticaria, Loss of personal independence in daily activities, Malaise, Mobility decreased, Myositis
Clinical narrative: She got her vaccine, she had an area approximately about 5" x 4" across on her arm, quite raised, very very red, it hurt, painful and itchy.  It lasted for a week to 10 days up to 2 weeks at the site of the injection.  I experienced achiness, malaise for several days afterwards, and kind of continued for about 3 weeks before it settled down.   She treated it with Tylenol, bed rest and Motrin.  She had gone to her PCP with the first vaccine which I will describe later.   She used to be very active and she now cannot walk trails, and still has the feeling of malaise 4 months post vaccine.  She feels she is still having some inflammatory ongoing process in her muscles, joints and has had three short courses of steroids over the last couple of months, and is now in physical therapy and going to be seen by an Orthopedist again to see what may be going on.    She is a retired nurse and feels that now she has a permanent condition based on having the vaccine, and does not know if she would have a booster if it was offered, and her quality of life has changed and is "no way to live".
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: She got her vaccine, she had an area approximately about 5" x 4" across on her arm, quite raised, very very red, it hurt, painful and itchy.  It lasted for a week to 10 days up to 2 weeks at the site of the injection.  I experienced achiness, malaise for several days afterwards, and kind of continued for about 3 weeks before it settled down.   She treated it with Tylenol, bed rest and Motrin.  She had gone to her PCP with the first vaccine which I will describe later.   She used to be very active and she now cannot walk trails, and still has the feeling of malaise 4 months post vaccine.  She feels she is still having some inflammatory ongoing process in her muscles, joints and has had three short courses of steroids over the last couple of months, and is now in physical therapy and going to be seen by an Orthopedist again to see what may be going on.    She is a retired nurse and feels that now she has a permanent condition based on having the vaccine, and does not know if she would have a booster if it was offered, and her quality of life has changed and is "no way to live".
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lacrimation increased, Oropharyngeal pain, Pain, Sleep disorder
Clinical narrative: I experienced a weird taste in my mouth shortly after the shot and the day was fine I just felt kind of drained and that night is when it started I was puking my eyes were watering my throat hurt and I couldn?t hardly sleep the next day I?ve experienced a lot of body aches
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Taste disorder, Vomiting
Clinical narrative: I experienced a weird taste in my mouth shortly after the shot and the day was fine I just felt kind of drained and that night is when it started I was puking my eyes were watering my throat hurt and I couldn?t hardly sleep the next day I?ve experienced a lot of body aches
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Myalgia, Nausea, Pain, SARS-CoV-2 test negative
Clinical narrative: Muscle pain and nausea began in the morning. Around 12pm sharp shooting pains in both legs began (temperature was 99 degrees F). At 3 pm temperature temperature was 103 degrees F.  Fever persisted for 4 days between 99 and 101. Leg pains subsided within the first day. Slight nausea and slight elevated persisted until day 6 and then subsided.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: PT TESTED POSITIVE FOR COVID 19 AFTER BEING FULLY VACCINATED.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Sudden death
Clinical narrative: On Saturday, 2/27/21, a little over 24 hours after receiving vaccine, sudden death occurred.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy breast, Blood test, Bone scan, Breast cancer, Breast mass
Clinical narrative: Found a lump in my left breast. Went to doctor and found it was cancer. I was in remission for 15 years before that date.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Mammogram, Ultrasound scan
Clinical narrative: Found a lump in my left breast. Went to doctor and found it was cancer. I was in remission for 15 years before that date.