chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Culture positive, Dysuria, Gait inability, Genital herpes
Clinical narrative: UTI and then diagnosed with HSV-1 after outbreak occurred around my genitals. I developed what I thought was just a UTI on Thursday and was prescribed the medication to treat that. For the next few days I was sore, had body aches, and chills. On Sunday I noticed the outbreak on my labia and went into Urgent Care to diagnose it. I haven't been aware of any HSV-1 in my system, but somehow I ended up getting HSV-1 all around my genitals. On Sunday i was prescribed Valacyclovir. I was in intense pain when using the restroom for both urinating and bowel movements. I went to my primary care doctor on Monday to have a second opinion and found the same answers. I missed work for two days due to the pain I was in and my inability to walk. I then had to work from home the rest of the week. My partner has been tested and does not have HSV-1 or 2.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex, Herpes simplex test positive, Impaired work ability, Pain, Urinary tract infection
Clinical narrative: UTI and then diagnosed with HSV-1 after outbreak occurred around my genitals. I developed what I thought was just a UTI on Thursday and was prescribed the medication to treat that. For the next few days I was sore, had body aches, and chills. On Sunday I noticed the outbreak on my labia and went into Urgent Care to diagnose it. I haven't been aware of any HSV-1 in my system, but somehow I ended up getting HSV-1 all around my genitals. On Sunday i was prescribed Valacyclovir. I was in intense pain when using the restroom for both urinating and bowel movements. I went to my primary care doctor on Monday to have a second opinion and found the same answers. I missed work for two days due to the pain I was in and my inability to walk. I then had to work from home the rest of the week. My partner has been tested and does not have HSV-1 or 2.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis normal
Clinical narrative: UTI and then diagnosed with HSV-1 after outbreak occurred around my genitals. I developed what I thought was just a UTI on Thursday and was prescribed the medication to treat that. For the next few days I was sore, had body aches, and chills. On Sunday I noticed the outbreak on my labia and went into Urgent Care to diagnose it. I haven't been aware of any HSV-1 in my system, but somehow I ended up getting HSV-1 all around my genitals. On Sunday i was prescribed Valacyclovir. I was in intense pain when using the restroom for both urinating and bowel movements. I went to my primary care doctor on Monday to have a second opinion and found the same answers. I missed work for two days due to the pain I was in and my inability to walk. I then had to work from home the rest of the week. My partner has been tested and does not have HSV-1 or 2.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Diarrhoea, Dizziness, Fall, Fatigue
Clinical narrative: slight sore arm and fatique after vaccine. the following evening, suddenly overcome by nausea, horrific headache, dizziness... managed to walk.. by grabbing onto furnture, 10ft to carpeted floor, collapsed, hit head  ( now have bruise/cut) .  symptoms eased enough in short tme to get to bathroom ( diahhorea) and  bed. stayed in bed for about an hour as symptoms subsided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Head injury, Headache, Nausea, Pain in extremity
Clinical narrative: slight sore arm and fatique after vaccine. the following evening, suddenly overcome by nausea, horrific headache, dizziness... managed to walk.. by grabbing onto furnture, 10ft to carpeted floor, collapsed, hit head  ( now have bruise/cut) .  symptoms eased enough in short tme to get to bathroom ( diahhorea) and  bed. stayed in bed for about an hour as symptoms subsided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphoedema, Pyrexia
Clinical narrative: Fever between 99.0-100.2 Severe lymphedema under the left arm
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Syncope
Clinical narrative: Within about a minute of receiving the vaccine, Patient stated she was feeling lightheaded. She started to lose consciousness/faint. I kept asking her if she was with me, and she would slowly and softly respond yes. Ice packs were placed on her neck and wrists and feet elevated. Patient stated that she was sweating. Within 5 minutes patient was approaching normal. Patient was kept and additional 15 minutes in the pharmacy and observed. Water was given to her at this time. Patient stated they felt fine by the time she left.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysphagia, Dyspnoea, Erythema, Fatigue
Clinical narrative: On 4/5/21 at 6:30 pm I had my vaccine and we waited 15 minutes at the place. When we left after 5 minutes later, I started to itch in my throat and then to cough and then my nose felt as if runny. I did not have anything, and I got red and could not pass saliva; it was difficult to breathe. I thought it was normal after the vaccine, but after my throat hurt a lot and it was painful to swallow, I realized it was not normal. I felt very tired, and I couldn't breathe.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypersensitivity, Odynophagia, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: On 4/5/21 at 6:30 pm I had my vaccine and we waited 15 minutes at the place. When we left after 5 minutes later, I started to itch in my throat and then to cough and then my nose felt as if runny. I did not have anything, and I got red and could not pass saliva; it was difficult to breathe. I thought it was normal after the vaccine, but after my throat hurt a lot and it was painful to swallow, I realized it was not normal. I felt very tired, and I couldn't breathe.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: On 4/5/21 at 6:30 pm I had my vaccine and we waited 15 minutes at the place. When we left after 5 minutes later, I started to itch in my throat and then to cough and then my nose felt as if runny. I did not have anything, and I got red and could not pass saliva; it was difficult to breathe. I thought it was normal after the vaccine, but after my throat hurt a lot and it was painful to swallow, I realized it was not normal. I felt very tired, and I couldn't breathe.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Fever, chills, tired, sore arm, cough, congestion
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion
Clinical narrative: Fever, chills, tired, sore arm, cough, congestion
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Myalgia, Urticaria
Clinical narrative: One week after injection discovered large elevated hive about 1-1/2 inches in diameter on front lower part of left upper arm.  It was pink.  The upper arm muscle got hard as it initially did after the injection and ached for 3 to 4 days.  Then all symptoms disappeared & I was fine.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Epilepsy
Clinical narrative: pt had her second dose of covid vacine. as she was sitting down to be observed, she had an epileptic seizure. pt was laid down and monitored until paramedics arrived
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest X-ray normal, Computerised tomogram head, Electrocardiogram, Heart rate increased
Clinical narrative: on April 30,2021 I woke up thinking I was having a CVA, the room was spinning and I felt nauseous .  I went to the ER at the regional Hospital.  When admitted the check my vital signs, chest  x-ray, CT brain scan . CVA negative, chest clear, heart rate elevated to 155bpm
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Vertigo
Clinical narrative: on April 30,2021 I woke up thinking I was having a CVA, the room was spinning and I felt nauseous .  I went to the ER at the regional Hospital.  When admitted the check my vital signs, chest  x-ray, CT brain scan . CVA negative, chest clear, heart rate elevated to 155bpm
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site irritation, Injection site warmth
Clinical narrative: Arm red hot and irritated  at injection site
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Decreased appetite, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Violent  shaking headache dizziness fatigue anxiety restlessness diarrhea pale bones was freezing fever loss of appetite and very very sleepy. And no this isn't a conversion disorder
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Pallor, Pyrexia, Restlessness
Clinical narrative: Violent  shaking headache dizziness fatigue anxiety restlessness diarrhea pale bones was freezing fever loss of appetite and very very sleepy. And no this isn't a conversion disorder
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Tremor
Clinical narrative: Violent  shaking headache dizziness fatigue anxiety restlessness diarrhea pale bones was freezing fever loss of appetite and very very sleepy. And no this isn't a conversion disorder
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hyperventilation, Nausea, Nervousness, Panic attack
Clinical narrative: Patient had panic attack about 10 minutes after receiving second dose of Pfizer. She said she had a hard time breathing, was asked if she felt her throat/tongue were swelling and she stated no. Patient was directed to take a seat and take deep breaths, remain calm and drink some water. After about 10 more minutes she began hyperventilating, said she felt shaky and nauseous. She requested 911 to be called. 911 was called, patient was monitored - remained conscious and seated upright throughout, but continued to breath quickly. Paramedics arrived and took her with them.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory rate increased
Clinical narrative: Patient had panic attack about 10 minutes after receiving second dose of Pfizer. She said she had a hard time breathing, was asked if she felt her throat/tongue were swelling and she stated no. Patient was directed to take a seat and take deep breaths, remain calm and drink some water. After about 10 more minutes she began hyperventilating, said she felt shaky and nauseous. She requested 911 to be called. 911 was called, patient was monitored - remained conscious and seated upright throughout, but continued to breath quickly. Paramedics arrived and took her with them.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Decreased appetite, Diarrhoea, Dizziness
Clinical narrative: VIolent shaking for 2 hrs, horrible headache, fever, nausea, generalized skin pain, hair follicle pain, diarrhea, cramping, abdominal pain, face rash on left side and swelling in face, dizziness, abdominal distended, kidney pain, frequent urination, loss of appetite, bones felt frozen. And no  this isn't conversion disorder.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Muscle spasms, Nausea, Pain of skin
Clinical narrative: VIolent shaking for 2 hrs, horrible headache, fever, nausea, generalized skin pain, hair follicle pain, diarrhea, cramping, abdominal pain, face rash on left side and swelling in face, dizziness, abdominal distended, kidney pain, frequent urination, loss of appetite, bones felt frozen. And no  this isn't conversion disorder.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pollakiuria, Pyrexia, Rash, Renal pain, Swelling face
Clinical narrative: VIolent shaking for 2 hrs, horrible headache, fever, nausea, generalized skin pain, hair follicle pain, diarrhea, cramping, abdominal pain, face rash on left side and swelling in face, dizziness, abdominal distended, kidney pain, frequent urination, loss of appetite, bones felt frozen. And no  this isn't conversion disorder.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: VIolent shaking for 2 hrs, horrible headache, fever, nausea, generalized skin pain, hair follicle pain, diarrhea, cramping, abdominal pain, face rash on left side and swelling in face, dizziness, abdominal distended, kidney pain, frequent urination, loss of appetite, bones felt frozen. And no  this isn't conversion disorder.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: Patient was administered the Janssen vaccine on 4/30/2021, after going to the state reporting program today on 5/1/2021 we noted that patient already has two vaccines listed as administered on 2/11/2021 and 3/11/2021 (COVID-19 mRNA, LNP-S, PF 100 mcg/0.5 mL dose). Confirmed with patient that he did not receive any COVID vaccines today. Reporting as possible duplication of COVID vaccines. No ADRs noted from patient.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Hypoaesthesia, Vertigo
Clinical narrative: Severe dizziness , numbness in right arm tightening in chest was diagnosed with vertigo prescribed meclizine 25 mg
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Flushing, Ocular hyperaemia, Syncope
Clinical narrative: Pt responded positive to allergy questions; stated she was a 30" obs for first dose.  After 26" pt stated she was extremely tired, looked up at nurse, was flushed, eyes bloodshot and appeared to faint; responded to painful stimuli, difficult to keep her awake.  Called team alert.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Limb injury
Clinical narrative: Shoulder Injury resulting immediately after the vaccine and continuing until present.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Tenderness
Clinical narrative: Bright red, sunburn-like rash. It started at neck and then moved down full front of torso the day after the 2nd dose shot. Two days after (today) it has moved to left shoulder and upper arm and low back. The rash isn?t itchy but feels warm to the touch on neck and upper arm. I haven?t done anything to treat it.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Breast tenderness, Fatigue, Increased appetite, Mood swings, Premenstrual syndrome
Clinical narrative: Increased signs of PMS, off schedule. The Nexplanon makes them mild and I don't have a period, but still get PMS-ish symptoms such as mood swings, increased arousal, sensitive breasts, increased hunger, increased tiredness. I got all of those just two days after receiving the first dose of the Moderna COVID vaccine, but they weren't due until later this month, and they were worse than usual. It's a mild thing, and has subsided, but with the J&J throwing clots on some women who are likely on birth control, I thought it was worth mentioning. Thank you for your time!
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Swelling of the arm. Swelling was a large red spot for 3 weeks. Spot hurt to touch (up to and past the 4-week mark).
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Fatigue, Headache, Pain
Clinical narrative: Persistent headaches, shortness of breathe, body aches, fatigue, sharp chest pain
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Severe and unbearable migraine Fever, profuse sweating Teeth hurt Extreme sensitivity to light Weird taste and sensation in mouth Extreme exhaustion and weakness Chills and shivering Totally unable to function
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Photophobia, Pyrexia, Taste disorder, Toothache
Clinical narrative: Severe and unbearable migraine Fever, profuse sweating Teeth hurt Extreme sensitivity to light Weird taste and sensation in mouth Extreme exhaustion and weakness Chills and shivering Totally unable to function
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Migraine, Oropharyngeal pain, Pain
Clinical narrative: Diarrhea, blurred vision, headaches (migraine), dizzy feeling, ore throat, body aches. All have lasted for more than one week.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Diarrhea, blurred vision, headaches (migraine), dizzy feeling, ore throat, body aches. All have lasted for more than one week.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Injected limb mobility decreased
Clinical narrative: Two hours after vaccine patient had blood pressure of 160/90 and heart rate of 170. At 6:30pm patient still had blood pressure of 170/110. Urged patient again to go to urgent care. As of the next day patient said she felt dizzy after vaccine but felt better. She did not go to urgent care. However, her right arm where she received the vaccine is difficult to move.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Breath odour, Catatonia, Chills, Decreased appetite, Dyspnoea
Clinical narrative: Heavy limbs, shaking, chills, muscles "seized up", felt catatonic, fever 100.8, shooting pains in body, no appetite. Very tired, crabby, bad breath & taste , bad body odor.  This lasted several days, but headaches, sore muscles, difficulty in breathing , vertigo lasted til end of next week.  Headaches, fatigue, irritability  & bad moods, inability to exercise (I usually do) lasted went until 3rd week of March before began to taper off.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Emotional distress, Fatigue, Full blood count, Headache, Limb discomfort
Clinical narrative: Heavy limbs, shaking, chills, muscles "seized up", felt catatonic, fever 100.8, shooting pains in body, no appetite. Very tired, crabby, bad breath & taste , bad body odor.  This lasted several days, but headaches, sore muscles, difficulty in breathing , vertigo lasted til end of next week.  Headaches, fatigue, irritability  & bad moods, inability to exercise (I usually do) lasted went until 3rd week of March before began to taper off.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia, Seizure, Skin odour abnormal
Clinical narrative: Heavy limbs, shaking, chills, muscles "seized up", felt catatonic, fever 100.8, shooting pains in body, no appetite. Very tired, crabby, bad breath & taste , bad body odor.  This lasted several days, but headaches, sore muscles, difficulty in breathing , vertigo lasted til end of next week.  Headaches, fatigue, irritability  & bad moods, inability to exercise (I usually do) lasted went until 3rd week of March before began to taper off.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder, Tremor, Vertigo
Clinical narrative: Heavy limbs, shaking, chills, muscles "seized up", felt catatonic, fever 100.8, shooting pains in body, no appetite. Very tired, crabby, bad breath & taste , bad body odor.  This lasted several days, but headaches, sore muscles, difficulty in breathing , vertigo lasted til end of next week.  Headaches, fatigue, irritability  & bad moods, inability to exercise (I usually do) lasted went until 3rd week of March before began to taper off.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Heart rate increased, Syncope, Visual impairment
Clinical narrative: Experienced symptoms of syncope, dizziness, vision briefly went black, rapid heart rate, weakness
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Pulse absent
Clinical narrative: Patient lost conscience ten minutes after receiving  j&j vaccine. Patient felt dizzy/lightheaded, lost pulse, required CPR and epinephrine. Paramedics were called to the scene, requiring hospitalization.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Received first Moderna Vaccine 4/1/21. Noted generalized erythematous rash within 48 hours of first vaccine. No other symptoms.   Received 2nd Moderna Vaccine 4/30/21. At 1500 5/1/21 developed itchy generalized rash involving trunk, upper and lower extremities. No angioedema. No cough. No hives. No difficulty in breathing. No nausea or vomiting.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site induration, Injection site warmth, Urticaria
Clinical narrative: After two days of whole-body fatigue, a large red welt that is firm and hot to the touch started growing around the injection site. It is currently about the size of a baseball.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling of body temperature change, Pain, Pollakiuria
Clinical narrative: Day of tired; completely exhausted; Night of the shot awake every 2 hours had to use the bathroom (NOT USUAL) and either too hot or too cold. Following day fever of 101.0, body aches, tired, dizziness , and lightheaded.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Day of tired; completely exhausted; Night of the shot awake every 2 hours had to use the bathroom (NOT USUAL) and either too hot or too cold. Following day fever of 101.0, body aches, tired, dizziness , and lightheaded.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Hyperhidrosis
Clinical narrative: after about 10-15 minutes patient started to experience dizziness and feeling hot and little sweating. Sweating and feeling hot went away after 15 minutes but patient still complained about dizziness. I reached out to the patient at about 6:45pm to check on her and said she contacted the doctor and doctor advised to keep eye on her sugar since she is diabetic., the dizziness should go away in the next day. if not to call office and make appointment.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arrhythmia, Cardiac disorder, Dizziness, Feeling abnormal
Clinical narrative: Light-headed; erratic heart rate - heart rate monitored by self and fluctuated frequently between low 35 bpm to over 150 bpm; livedo reticularis on arms and legs. Photos and screen shots of heart rate documented and timestamped. I do not have a history of panic attacks and was not experiencing anxiety due to my COVID vaccine. I do not have a history of heart problems or arrhythmia prior to this incident. My normal heart rate is consistently between 52-60 bpm. and heart rate does not fluctuate erratically. I am certain my worrisome symptoms were associated with the Covid-19 vaccine from Pfizer. It appeared as though the vaccine created a cytokine-type storm in my body and my symptoms made me feel it was necessary to go to the ER.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Livedo reticularis
Clinical narrative: Light-headed; erratic heart rate - heart rate monitored by self and fluctuated frequently between low 35 bpm to over 150 bpm; livedo reticularis on arms and legs. Photos and screen shots of heart rate documented and timestamped. I do not have a history of panic attacks and was not experiencing anxiety due to my COVID vaccine. I do not have a history of heart problems or arrhythmia prior to this incident. My normal heart rate is consistently between 52-60 bpm. and heart rate does not fluctuate erratically. I am certain my worrisome symptoms were associated with the Covid-19 vaccine from Pfizer. It appeared as though the vaccine created a cytokine-type storm in my body and my symptoms made me feel it was necessary to go to the ER.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: I had all the normal symptoms to be expected with a vaccine, slight fever, headache and body pain. That's not my concerning part. My left arm is all red and swollen around the injection site: 1½-inch wide by 1-inch long and getting bigger. I have taken pictures of it (if you'd like them).
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site mass, Injection site pruritus
Clinical narrative: Moderna COVID?19 Vaccine EUA After receiving the second dose of the Moderna COVID-19 vaccine on 2/3/2021 I noticed a bump at the injection site that has not gone away as of today (5/1/2021).  At times the bump is itchy.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Pain
Clinical narrative: Chills and general achy feelings
Sex: M
Vaccine: COVID19
Symptoms: Injury
Clinical narrative: hurt himself; This is a spontaneous report from a contactable consumer (patient's wife) via a Pfizer-sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient hurt himself on an unspecified date and was treated with a tetanus shot and antibiotics (unspecified). The patient was reportedly scheduled for his second dose on 16Apr2021; the patient's wife was inquiring if this would affect the vaccine. Outcome of event was unknown.  Information about lot/batch has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Genital swelling, Headache, Peripheral swelling
Clinical narrative: Genital swelling; hand swelling; Feet swelling; Chills; Headache; This is a spontaneous report from a contactable consumer (patient, self-reported).  A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EP7533 and expiration date was not reported), via an unspecified route of administration on 30Mar2021 14:50, as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine include first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6208), via an unspecified route of administration on 09Mar2021, as single dose for COVID-19 immunization and experienced same event (chills, headache, swollen hands, feet and genital). It reported that on 31Mar2021 patient experienced chills and headaches that went away after a day. And next day on 01Apr2021 experienced Feet swelling and on 05Apr2021, hand and genital swelling. Patient mentioned that the swelling on her hands and feet went away but her genitals are still a little swollen. She mentioned that genital swelling gets a little less day by day. She will be seeing her doctor and would like to know what to tell him before getting treatment. Caller stated the first day she took Tylenol for her headache just one Tylenol and it went away. Caller stated she had all these symptoms after the first dose as well. Adverse events does not require a visit to emergency room and no physician office. No prior vaccinations within 4 weeks and no adverse event following prior vaccinations. The outcome of the event chills and headache were recovered on 01Apr2021, feet swelling was recovered on 02Apr2021 and hand swelling was recovered on 06Apr2021 and the outcome of the event genital swelling was recovering.  Follow-up (15Apr2021): This is a spontaneous report from a contactable consumer. Patient demographic, event details, corrective treatment information's were updated and Caller stated she had all these symptoms after the first dose as well.   No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: aches; slight fever; This is a spontaneous report from a non-contactable consumer (patient's father).   A 25-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on an unknown date as single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. It was reported that the patient was out with friends had dinner. The patient received his first dose of the Pfizer covid vaccine Monday morning and got a call Monday night one of his friends tested positive. The patient got shot Monday and had a slight fever, aches, and woke up this morning and is fine. It was reported that they were concerned if he needs to get a test or anything. The outcome of the events was recovering/resolving.  No follow-up attempts were possible. Information about lot/batch number cannot be obtained.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: he had an allergic reaction to the vaccine; This is a spontaneous report received from medical information team. A contactable consumer (patient) reported that a 57-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: ER8732) via an unspecified route of administration in left arm (at the age of 58-year-old) on 24Mar2021 at 13:30 at single dose for COVID-19 immunisation. Medical history included diabetes, diagnosed about four years ago, he believes; blood pressure diagnosed about the same time, about 4 years ago; cholesterol levels were diagnosed about 15 years ago, probably more than that, all ongoing. Concomitant medications included ongoing metformin orally at 500 mg once a day for diabetes; ongoing lisinopril orally at 5 mg once a day for blood pressure; ongoing gemfibrozil orally at 600 mg twice a day for high cholesterol. The patient previously received acetylsalicylic acid (ASPIRIN) in 1994 and that's the last time he took it and was allergic to it. He took it once. The first time he took it, he got a very severe allergic reaction, his whole face was swollen. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. After he took the first dose of the vaccine, he developed swelling to the left side of face near to his lips that night, and it was gone the next morning. He just had a little swelling on his lips up into the face. He got vaccine on 24Mar2021 at 13:30, the swelling, he got that at 00:00 on 25Mar2021 at night and the next morning, he still saw it and by noon it was gone. The 2nd dose was supposedly on 14Apr2021 but no available schedule so he booked today (15Apr2021). When he went to get the second dose of the vaccine, there refused to vaccinate him because they said he had an allergic reaction to the vaccine. Nurses and the doctors at the facility refused to give him the 2nd dose, instead advised him to report it to Pfizer. He already talked to his primary care physician and said that he can take at his own risk. A visit to Emergency Room or Physician Office was not required. The outcome of event was recovered on 25Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Malaise, Pain in extremity, Pyrexia
Clinical narrative: Fever; Chills; Malaise; Fatigue; Arm Pain; This is a spontaneous report from a contactable consumer or other non hcp. A 50-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EW0161, expiration date not reported) via unspecified route of administration in Arm Left on 14Apr2021 10:30 (age at vaccination 50-years-old) as single dose for covid-19 immunisation. Facility where most recent COVID-19 vaccine was administered was other. Medical history included chronic diverticulitis, drug hypersensitivity to penicillin, augmentin, erythromycin and lactose intolerance. Concomitant medications in two weeks included loratadine, pseudoephedrine sulfate (CLARITIN-D) taken for hypersensitivity from an unknown date. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 24Mar2021 at 09:00 AM, (at the age of 50-years-old) as a single dose for COVID-19 immunization. Patient did not have or was diagnosed for COVID prior to vaccination. Patient was not tested for COVID post vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Apr2021 20:30 the patient experienced fever, chills, malaise, fatigue and arm pain. The patient received acetaminophen as treatment for the adverse events. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: developed high fever; Chills; Headache; This is a spontaneous report from a contactable consumer via Medical information team. A female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Unknown), via an unspecified route of administration on 14Apr2021 as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Daughter, calling on behalf of mother reported that the patient received her first dose on 14Apr2021 (yesterday) and now developed high fever, chills and headache on an unspecified date in Apr2021. She wanted to know whether she can take any medicine and was waiting for doctor to call her back. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Blood 1,25-dihydroxycholecalciferol decreased, Blood sodium, Fatigue, Headache
Clinical narrative: feeling run down/Fatigue; Headache; This is a spontaneous report by a contactable consumer (patient's daughter). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, on an unknown date as a single dose for COVID-19 immunisation. The patient medical history included diabetic, feeling run down, fatigued and weak. The concomitant medication included vitamin C, Zinc and B12. The patient had undergone laboratory tests which include vitamin D levels were 9.5 and sodium level was low. On an unknown date, the patient experienced headache and fatigue/ feeling run down. It was reported that reporter wanted to know if patient would be allowed to have a vitamin B12 shot without interfering with the vaccine. On 04Apr2021, the patient was also had second dose of the Pfizer Covid-19 vaccine and wants to know how much time after she may present side effects. It was reported that patient was in hospital for the event feeling run down on an unknown date. The reporter also wants to know how long the symptoms of a headache and fatigue last. The outcome of the events was unknown.     No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Rash, Rash erythematous, Rash macular
Clinical narrative: Itchy skin/itchiness; Blotchy rash on her body; Skin was splotchy different areas; Had sort of an allergic reaction to the vaccine; Red rash; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of unknown age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) via unknown route of administration on 14Apr2021 at single dose for COVID-19 immunisation. The patient's medical history was allergies included egg allergy and seasonal allergy. There were no breathing problems. Concomitant medications were not reported. It was reported that patient received her first dose of the Pfizer-Biontech Covid19 vaccine, yesterday, and developed itchiness and a "blotchy" rash on her body about 1 hour afterward on 14Apr2021. She took an antihistamine and had some relief. she was treated with an antihistamine. she also mentioned that she found it interesting that the rash was not at the injection site. 30 minutes after the vaccine, skin was splotchy different areas, itchy skin. antihistamine 1 hour after that. had some relief. Some residual itchiness. Patient had red rash that occurred more immediate. Patient also had sort of an allergic reaction to the vaccine and all on 14Apr2021. The outcome of all the events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Pyrexia
Clinical narrative: Mild fever (101.0 F); This is a spontaneous report from a contactable consumer (patient). A 62-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, (Batch/Lot Number: EP6955),via an unspecified route of administration, administered in left arm on 13Apr2021 at 11:00 AM as SINGLE DOSE for covid-19 immunization. Patient was 62 years old at the time of vaccination. Patient medical history and concomitant medications were not reported. The patient was not allergic to medications, food, or other products. The patient received first dose of bnt162b2 via an unspecified route of administration, administered in left arm on 23Mar2021 at 12:00 PM (Batch/Lot Number: EP6955) as single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination patient has not been tested for COVID-19. On 14Apr2021 at 19:00 PM, the patient experienced mild fever (101.0 F). In Apr2021, the event was recovered.  Followup#01(20Apr2021): No new information received.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Erythema, Mass
Clinical narrative: knot under her skin; a lump in her chest and that spot is red; a lump in her chest and that spot is red; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID mRNA VACCINE, solution for injection, Lot Number: EW0162, Expiry Date: Unknown), via an unspecified route of administration, administered in arm Left on 14Apr2021 at 13: 00 (at the age of 63-year-old) as single dose for covid-19 immunization. The patient medical history included COVID (a year ago she had got COVID), and she had no allergic reaction, the patient's concomitant medications were not reported. Patient stated that when it came out a year ago, she had got COVID so that is why she took the vaccine this year. She took her first dose of the Pfizer Covid-19 vaccine yesterday and about 4 to 5 hours later she noticed a knot under her skin on her chest with a red area and at 18: 00 to 19: 00 when she was at work, she got a reaction which was a lump in her chest and that spot was red. She probed if the lump was still there, and she stated that she went to bed with it and she woke up with it that's why she was called. She wanted to know what it was. Patient stated that her second dose is scheduled for 08May2021. On an unspecified date, 5 hours later of vaccination, the patient experienced knot under her skin, a lump in her chest and that spot is red, a lump in her chest and that spot is red. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dizziness, Feeling abnormal, Malaise, Off label use
Clinical narrative: Methylprednisolone  for a sprained rotator cuff; lightheaded and dizzy/ light headedness and  dizziness; did not feel well; Feel like I am sort of out of it; This is a spontaneous report from a non-contactable consumer from a Jubilant Cadista pharmaceuticals.     A female patient received the second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation; methylprednisolone 4 mg tablet (Batch/Lot Number: 2DL0026P; Expiration Date: 30Sep2022), oral from 26Mar2021  to Mar2021 "Per the card in the pack" and then from Mar2021 and ongoing, at Dose lowered "per the instructions"for Sprained rotator cuff.  Medical history included Sprained rotator cuff, High blood pressure, and High cholesterol.  The patient's concomitant medications included an unspecified blood pressure medication and an unspecified cholesterol medication. The patient previously took the first dose of BNT162B2 on an unspecified date in 2021 for COVID-19 immunisation. In Mar2021, after starting the products, the patient was lightheaded and dizzy, she did not feel well, and felt like she was "sort of out of it". She was trying to observe Holy Week and not eat much; she should have been fasting, but she needed to take Methylprednisolone with food. She thought that when she took Methylprednisolone with food, she did better and felt better. It had really worked to help her shoulder, but she thought that she had "a lot in her system now" with both the Covid vaccine  and Methylprednisolone, and it was "just a bit for her system" because all she took was a blood pressure and a cholesterol  medication. On an unspecified date in Mar2021, the patient reduced her dosage of Methylprednisolone "per the instructions". As of 29-Mar-2021, the patient continued treatment with Methylprednisolone, and her light headedness and  dizziness, not feeling well, feeling sort of out of it, were ongoing.  The action taken in response to the events for methylprednisolone was Dose Reduced. The outcome of the events was not resolved.  Pfizer is a marketing authorization holder of [methylprednisolone] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [methylprednisolone] has submitted the same report to the regulatory authorities.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain, Pyrexia
Clinical narrative: Patient experienced body aches, light headed, headache, fever; Patient experienced body aches, light headed, headache, fever,; Patient experienced body aches, light headed, headache, fever,; Patient experienced body aches, light headed, headache, fever,; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced body aches, lightheaded, headache, fever, all on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Fatigue, Heart rate increased, Illness
Clinical narrative: Very fast blood flowing, the heart beat for the whole time; Fatigue; feel sick and is still sick; Weakness; but feels very feverish all the time.; soreness in her arm; I had a swollen arm that was painful for 4 days; This is a Spontaneous report from a contactable consumer (patient) and Other HCP.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 27Mar2021 as SINGLE DOSE for covid-19 immunisation.  Medical history included neutropenia.     The patient's concomitant medications were not reported.  She was administered the first dose of Pfizer-BioNTech COVID-19 Vaccine on 27Mar2021. She is supposed to schedule her second dose of Pfizer-BioNTech COVID-19 Vaccine for this weekend. She reported having very swellingness of her arm, her arm hurt for 3-4 days on 28Mar2021. But this last weekend she has gotten to feel sick and is still sick, very weak in Apr2021. She does not have a high fever, has no fever, but feels very feverish all the time in Apr2021. She gets these kind of symptoms, these kind of flu-like symptoms all the time because she has neutropenia where she has very, very low white blood cells, so she gets sick very frequently. She had fatigue, very fast blood flowing, the heart beat for the whole time.  The patient underwent lab tests and procedures which included covid-19: pending on 12Apr2021. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Very fast blood flowing, the heart beat for the whole time; Fatigue; feel sick and is still sick; Weakness; but feels very feverish all the time.; soreness in her arm; I had a swollen arm that was painful for 4 days; This is a Spontaneous report from a contactable consumer (patient) and Other HCP.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 27Mar2021 as SINGLE DOSE for covid-19 immunisation.  Medical history included neutropenia.     The patient's concomitant medications were not reported.  She was administered the first dose of Pfizer-BioNTech COVID-19 Vaccine on 27Mar2021. She is supposed to schedule her second dose of Pfizer-BioNTech COVID-19 Vaccine for this weekend. She reported having very swellingness of her arm, her arm hurt for 3-4 days on 28Mar2021. But this last weekend she has gotten to feel sick and is still sick, very weak in Apr2021. She does not have a high fever, has no fever, but feels very feverish all the time in Apr2021. She gets these kind of symptoms, these kind of flu-like symptoms all the time because she has neutropenia where she has very, very low white blood cells, so she gets sick very frequently. She had fatigue, very fast blood flowing, the heart beat for the whole time.  The patient underwent lab tests and procedures which included covid-19: pending on 12Apr2021. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Hyperacusis, Tinnitus
Clinical narrative: listening to a slow ceiling fan motor whooshing and constantly hears it in both ears; began experiencing hearing loss, noise disappeared suddenly in both ears; very deadening sound in both ears; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8733), via intramuscular route of administration on 01Apr2021 at 09:30 (at the age of 70 years) at a single dose in the left arm for COVID-19 immunization. Medical history included blood clot in leg almost 10 years ago. Concomitant medications included rivaroxaban (XARELTO, strength: 20 mg) taken for blood clot in leg and other unspecified medications. The patient previously took silodosin (RAPAFLO) a number of years ago for urination and he broke out in hives. Patient had no family medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had first shot done on 01Apr2021 at 09:30. On the evening of 13Apr2021 at 19:30, he kind of got a very deadening sound in both ears and then began experiencing hearing loss, noise disappeared suddenly in both ears. He woke up the next day (14Apr2021 at 05:00) with what he described as listening to a slow ceiling fan motor whooshing and constantly hears it in both ears. He called his doctor because he thought it may disappear but his doctor instructed him to see an ear and throat doctor about this (for clarification). He called to report the events and to know if it's safe to get the second dose of the vaccine. The outcome of the events was not recovered.