chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Paraesthesia oral
Clinical narrative: Patient reported a dry throat and tingling lips soon after administration.  Patient had history of anaphylaxis, and stated that these symptoms did not feel the same. Patient had no difficulty breathing nor swelling of the face. Patient was monitored for worsening of symptoms. Symptoms eventually subsided and patient returned home. Patient instructed to seek medical care if symptoms returned.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Alcohol test negative, Blood test normal, Computerised tomogram normal, Drug screen negative, Dyskinesia
Clinical narrative: Dyskinesia for about 2 hours, with involuntary head, arm, leg movements
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Electroencephalogram normal
Clinical narrative: Dyskinesia for about 2 hours, with involuntary head, arm, leg movements
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Stool analysis
Clinical narrative: Severe diarrhea for 1 1/2 months until I started budesonide
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Fatigue, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Palm-sized welt/swelling on arm at injection site with severe pain, rash on arm, swollen armpit, fever, fatigue, asthma exacerbation. The arm pain is almost as bad as labor.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pyrexia, Rash, Urticaria
Clinical narrative: Palm-sized welt/swelling on arm at injection site with severe pain, rash on arm, swollen armpit, fever, fatigue, asthma exacerbation. The arm pain is almost as bad as labor.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fall, Feeling hot
Clinical narrative: Patient received vaccine around 2:30pm. Before vaccine, pt was nervous but was unaffected by the administration. Pt was told to wait in waiting area to be observed for 15 minutes but had left 5 min later because she was feeling hot and wanted to get some air. While walking, her knees fell weak, she felt dizzy and she tumbled down to her knees. We ran over and patient was conscious and we waited and observed her further. Then we sat her down, gave her some water and restarted 15 min waiting period.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Chills, Cough, Fatigue
Clinical narrative: 4/24 - low-grade fever (99.5 F), muscle aches, headache, lasted all day + all night 4/25 - low grade fever continued (99.5 F), sweats/chills, sharp headache, fatigue, muscle aches 4/26 - low grade fever continued (99.5 F, dropped to 99.3 F in evening), sweats/chills continued, sharp headache continued, fatigue + aches continued 4/27 - low grade fever (99 F), sharp headache, chest pain when coughing, developed sinus congestion, wet cough which produced mucous (clear), slight fatigue and aches (lessened), new symptom of low humming tinnitus in left ear only (when surroundings quiet) 4/28 - fever gone for 18 hours w/o fever-reducing medication, fatigue still present, cough with phlegm still present, slight headache, slight sinus congestion, low humming tinnitus in left ear continues (when surroundings are quiet)
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Myalgia, Pain, Pyrexia
Clinical narrative: 4/24 - low-grade fever (99.5 F), muscle aches, headache, lasted all day + all night 4/25 - low grade fever continued (99.5 F), sweats/chills, sharp headache, fatigue, muscle aches 4/26 - low grade fever continued (99.5 F, dropped to 99.3 F in evening), sweats/chills continued, sharp headache continued, fatigue + aches continued 4/27 - low grade fever (99 F), sharp headache, chest pain when coughing, developed sinus congestion, wet cough which produced mucous (clear), slight fatigue and aches (lessened), new symptom of low humming tinnitus in left ear only (when surroundings quiet) 4/28 - fever gone for 18 hours w/o fever-reducing medication, fatigue still present, cough with phlegm still present, slight headache, slight sinus congestion, low humming tinnitus in left ear continues (when surroundings are quiet)
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Secretion discharge, Sinus congestion, Tinnitus
Clinical narrative: 4/24 - low-grade fever (99.5 F), muscle aches, headache, lasted all day + all night 4/25 - low grade fever continued (99.5 F), sweats/chills, sharp headache, fatigue, muscle aches 4/26 - low grade fever continued (99.5 F, dropped to 99.3 F in evening), sweats/chills continued, sharp headache continued, fatigue + aches continued 4/27 - low grade fever (99 F), sharp headache, chest pain when coughing, developed sinus congestion, wet cough which produced mucous (clear), slight fatigue and aches (lessened), new symptom of low humming tinnitus in left ear only (when surroundings quiet) 4/28 - fever gone for 18 hours w/o fever-reducing medication, fatigue still present, cough with phlegm still present, slight headache, slight sinus congestion, low humming tinnitus in left ear continues (when surroundings are quiet)
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Injection site bruising, Lymphadenopathy, Nausea, Pain
Clinical narrative: inflammatory response; severe bruising at injection site. After 2 days, neck and lymph nodes were inflamed and visually noticeable. Nauswa and aching. GI cramping.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: inflammatory response; severe bruising at injection site. After 2 days, neck and lymph nodes were inflamed and visually noticeable. Nauswa and aching. GI cramping.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Menstruation irregular, Pain, Pain in extremity
Clinical narrative: Fever, fatigue, headache, body soreness, arm severely sore, irregular menstrual bleeding.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Fever, fatigue, headache, body soreness, arm severely sore, irregular menstrual bleeding.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Medium menses started on day five after vaccine and have not subsided.  This is very unusual for me due to the fact I have an IUD, and for the last 10 years I have had  short and light menses.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Patient had no adverse event but was given the vaccine while she was under the age of 18.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tinnitus
Clinical narrative: Received the shot on Saturday and was fine until I woke up at 6am Sunday with a fever. By 8am Sunday I had ringing in both ears. It has gotten worse over the next few days. It's consistent and loud. Will be scheduling a Dr. visit although I don't think anything can be done about this. As it stands right now, I regret getting the covid vaccine.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Pyrexia
Clinical narrative: one day after the first shot i got migraine and fever (38.1), on the second day after i only had migraine
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Insomnia starting a few days after first shot. Heart rate 71 and blood pressure 130/87 at time of insomnia.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Full blood count, Metabolic function test, Palpitations
Clinical narrative: Hives, tongue swelling, shortness of breath, heart palpitations, chest pain
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Troponin, Urticaria
Clinical narrative: Hives, tongue swelling, shortness of breath, heart palpitations, chest pain
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Oropharyngeal pain, Pain
Clinical narrative: Fever, chills, body aches, nausea, fatigue, sore throat, Congestion
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: Fever, chills, body aches, nausea, fatigue, sore throat, Congestion
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Feeling cold, Pallor, Paraesthesia
Clinical narrative: Within 5 minutes post-vaccination, the patient began to feel dizzy and requested some water. He looked pallid, felt cold and clammy. I helped the patient out of his chair and onto the floor. I retrieved an instant cold pack and prepared it. When I returned to the patient 45 seconds later, he said the coolness of the ground helped. He did not feel dizzy anymore but his fingers were still tingling. I gave him the cold pack to place behind his neck and provided him a bottle of water. I had him lie prone for another 5 minutes. When I re-assessed, he was no longer feeling any negative symptoms and he no longer looked pale nor felt clammy.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain
Clinical narrative: I have a sharp pain in my left ear. I can still hear noises like usual, such as background fridge noise. But this pain is an incident condition that I did not ever experience before. It?s not a constant pain and comes in waves. My right ear feels normal. I have not sought a medical appointment yet, and am waiting to see if the pain goes away.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Painful rash at site of injection
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood magnesium normal, Brain natriuretic peptide normal, Cardiac monitoring normal, Chest X-ray normal, Chills
Clinical narrative: Vaccine was received at 11:30 am, 4/27/21.  Very minor headache started a few hours later.  Fatigue, aches and chills started around 6pm.  At 8pm, temp was normal at 97.7.  Around 11pm, while sleeping, heart rate increased to above 100, ranging from 105-140.  At 12:30am, after no decrease in heart rate, I went to ER.  After receiving 2 bags of IV fluids and multiple tests later, heart rate was down to around 105 and I was discharged at 2am.  Heart rate returned to normal (about 61 for me) around 3pm on 4/28/21
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Differential white blood cell count normal, Fatigue, Fibrin D dimer normal, Full blood count normal, Headache
Clinical narrative: Vaccine was received at 11:30 am, 4/27/21.  Very minor headache started a few hours later.  Fatigue, aches and chills started around 6pm.  At 8pm, temp was normal at 97.7.  Around 11pm, while sleeping, heart rate increased to above 100, ranging from 105-140.  At 12:30am, after no decrease in heart rate, I went to ER.  After receiving 2 bags of IV fluids and multiple tests later, heart rate was down to around 105 and I was discharged at 2am.  Heart rate returned to normal (about 61 for me) around 3pm on 4/28/21
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Metabolic function test, Pain, Sleep disorder, Troponin I normal
Clinical narrative: Vaccine was received at 11:30 am, 4/27/21.  Very minor headache started a few hours later.  Fatigue, aches and chills started around 6pm.  At 8pm, temp was normal at 97.7.  Around 11pm, while sleeping, heart rate increased to above 100, ranging from 105-140.  At 12:30am, after no decrease in heart rate, I went to ER.  After receiving 2 bags of IV fluids and multiple tests later, heart rate was down to around 105 and I was discharged at 2am.  Heart rate returned to normal (about 61 for me) around 3pm on 4/28/21
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis, Vital signs measurement
Clinical narrative: Vaccine was received at 11:30 am, 4/27/21.  Very minor headache started a few hours later.  Fatigue, aches and chills started around 6pm.  At 8pm, temp was normal at 97.7.  Around 11pm, while sleeping, heart rate increased to above 100, ranging from 105-140.  At 12:30am, after no decrease in heart rate, I went to ER.  After receiving 2 bags of IV fluids and multiple tests later, heart rate was down to around 105 and I was discharged at 2am.  Heart rate returned to normal (about 61 for me) around 3pm on 4/28/21
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: patient blacked out and passed out after receiving her first dose within the 15 min wait time. 911 was called and vitals were normal. patient refused admission to hospital
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Electrocardiogram normal, Tachycardia
Clinical narrative: 3 days after vaccine, developed tachycardia, intermittent, resting to 130bpm. No Shortness of breath or chest pain. No abnormal rhythm. Recurred day 4, 5, 6 in the mornings only. No change in diet or caffeine intake.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: wants to know if diarrhea is a side effect.; This is a spontaneous report from a contactable consumer (patient) to a Pfizer sponsored pro-gram. A female patient an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot number and expiry date unknown), via an unknown route 01Mar2021 at single dose for COVID-19 immunization. On an unspecified date, the patient had diarrhea. The patient wants to know if diarrhea is a side effect. and why it was not listed as a side effect. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site warmth, Lethargy
Clinical narrative: High fever for 3 and a half days. 102 degrees to 103.5 degrees. 1-27-21 through 1-30-21. Chills. Body aches. Lethargic. Injection site swollen, red and warm to the touch. Swollen from shoulder to elbow.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: High fever for 3 and a half days. 102 degrees to 103.5 degrees. 1-27-21 through 1-30-21. Chills. Body aches. Lethargic. Injection site swollen, red and warm to the touch. Swollen from shoulder to elbow.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: About three hours after receiving the shot I had arm pain around the injection site. About nine hours after receiving the shot I had a low grade fever, chills, a headache and body aches. These symptoms persisted for about 12 hours. I took Motrin and Tylenol and the symptoms improved.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: Injection spot is red and inflamed and very hard & hot.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Peripheral swelling
Clinical narrative: on monday i had chills for about one hour. i also have a swollen and sore arm but now (two days after vaccination) has decreased
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Patient had eyes closed and was not responsive 10 minutes after getting vaccine,. Pharmacist checked breathing and pulse which were ok. 911 was called to check out the patient. She did not go to the hospital.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Skin discolouration
Clinical narrative: Part of my left arm want purple and want num
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising
Clinical narrative: Significant bruising at injection site.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lip swelling, Paraesthesia, Paraesthesia oral, Peripheral swelling
Clinical narrative: it started about the 10 minutes after the shot.my lips started swelling up and my tongue started getting tingly on the tip. my arm got swollen and was noticeable by the wrist area on the arm the shot was given on. my neck started to swell up on that side. then my cheak started getting numb like tingly feeling. it started coming up towards my face the numbness . they just gave shot of Benadryl. never had a reaction to a vaccine
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: it started about the 10 minutes after the shot.my lips started swelling up and my tongue started getting tingly on the tip. my arm got swollen and was noticeable by the wrist area on the arm the shot was given on. my neck started to swell up on that side. then my cheak started getting numb like tingly feeling. it started coming up towards my face the numbness . they just gave shot of Benadryl. never had a reaction to a vaccine
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Magnetic resonance imaging
Clinical narrative: stroke
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Discomfort, Disorientation, Dyspnoea, Fatigue
Clinical narrative: Slight numbness in face beginning approximately two hours after injection.  Approximately three hours after injection, felt disoriented and had difficulty breathing while seated in the passenger seat of car; immediately diverted toward nearest hospital.  Five to ten minutes later, experienced an extremely elevated heart rate and a burning sensation in chest with continued difficulty breathing.  Heart rate began to decline and breathing began to normalize when approaching the emergency room, so did not seek treatment.  Waited for an hour outside emergency room before departing without treatment with no further symptoms other than fatigue and discomfort resulting from the episode.    I had a similar but milder and more immediate (~15-20 minutes after injection) reaction to a quadrivalent influenza vaccine in October 2020; other than that, I have never experienced an adverse reaction to a vaccine.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Slight numbness in face beginning approximately two hours after injection.  Approximately three hours after injection, felt disoriented and had difficulty breathing while seated in the passenger seat of car; immediately diverted toward nearest hospital.  Five to ten minutes later, experienced an extremely elevated heart rate and a burning sensation in chest with continued difficulty breathing.  Heart rate began to decline and breathing began to normalize when approaching the emergency room, so did not seek treatment.  Waited for an hour outside emergency room before departing without treatment with no further symptoms other than fatigue and discomfort resulting from the episode.    I had a similar but milder and more immediate (~15-20 minutes after injection) reaction to a quadrivalent influenza vaccine in October 2020; other than that, I have never experienced an adverse reaction to a vaccine.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Chills, Dizziness, Feeling cold, Headache, Migraine
Clinical narrative: Within 15 minutes of recieving the vaccine my son couldn't even the leave the parking lot of the pediatrician's office, he was vomiting, dizzy, nauseas, reported feeling unusually cold, had the chills, had a headache with migraine floaters and described seeing blue and white balls (all of these are listed as adverse reactions in the Merck insert for the Varicella vaccine.) Beforehand  he was fine. He had to be monitored until after the doctor's office closed and was brought back inside.  We stayed until 6:15PM.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Nausea, Vitreous floaters, Vomiting
Clinical narrative: Within 15 minutes of recieving the vaccine my son couldn't even the leave the parking lot of the pediatrician's office, he was vomiting, dizzy, nauseas, reported feeling unusually cold, had the chills, had a headache with migraine floaters and described seeing blue and white balls (all of these are listed as adverse reactions in the Merck insert for the Varicella vaccine.) Beforehand  he was fine. He had to be monitored until after the doctor's office closed and was brought back inside.  We stayed until 6:15PM.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Headache, Injection site bruising
Clinical narrative: Bruise on injection sight and my pulse has been above 90 even when resting.  Anxiety symptoms, headache, chills.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Pain, Pyrexia
Clinical narrative: Fever , body aches , upset stomach, fatigue
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Only reaction is a slightly itchy red patch the size of a quarter at the injection site, developed about a week after the injection. (The first two days had a smaller red patch at the injection site that went away.)
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: General aches; Headache; Left arm pain at injection site; Left arm pain at injection site; This is a spontaneous report from a contactable other hcp (nurse). A 58-years-old female patient (nurse) received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 2 intramuscularly administered in Deltoid Left on 20Jan2021 15:40 (Lot Number: EL8982, Expiry date: unknown) as single dose for COVID-19 immunisation. Medical history included hypersensitivity from an unknown date and unknown if ongoing, obesity from an unknown date and unknown if ongoing, diverticulum from an unknown date and unknown if ongoing, gastro oesophageal reflux disease from an unknown date and unknown if ongoing, hypersensitivity from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. There was no family history. The patient previously received first dose (Intramuscularly, LOT number: EL1284, Time: 15:40 hh:mm) of COVID vaccine and experienced Left arm sore, Muscle aches, Chills, Fever 101.2. The patient had all childhood vaccines included MMR in 1980, Tetanus booster in 26Oct2018. Concomitant medication(s) included ketotifen fumarate (KETOTIFEN FUMARATE) 1 gtt each eye QD (Once daily) rare taken for hypersensitivity from an unspecified start date from one year ago and ongoing; famotidine (PEPCID [FAMOTIDINE]) 20mg BID (two times a day) taken for gastro oesophageal reflux disease from an unspecified start date from one year ago and ongoing; pantoprazole sodium sesquihydrate (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]) 40mg QD (once daily) taken for gastro oesophageal reflux disease from an unspecified start date from one year ago and ongoing; levocetirizine dihydrochloride (XYZAL) 5mg q (Everyday) HS (At bedtime) taken for hypersensitivity from an unspecified start date from one year ago and ongoing; "SENSIMIST FLONASE" 1 puff BID (Two times a day) each taken for oesophageal reflux disease from an unspecified start date from one year ago and ongoing. On 21Jan2021 02:00, the patient experienced general aches, headache, left arm pain at injection site. Side effects occurred day after vaccine and resolved by 2nd day after vaccine. Therapeutic measures were taken with Tylenol and Ice. The outcome of the events were recovered on an unspecified date in Jan2021.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: When laying in bed, with head turned to left side, experienced vertigo with movement of head
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: headache; sore right arm; This is a spontaneous report from a contactable consumer (patient self-reported) in response to non-HCP follow-up letter sent in cross reference case. A 72-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown), via an unspecified route of administration, on 22Feb2021, as single dose for COVID-19 immunisation. Patient's historical vaccine included received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264 and expiry dates: unknown), via an unspecified route of administration, on 29Jan2021 as single dose for COVID-19 immunisation. Patient concomitant medications included from 1983 she taking estrogens conjugated (PREMARIN) still ongoing. which she took due to surgery at an early age and had migraines without it, from year2000 Acetylsalicylic acid (COATED ASPIRIN) still ongoing, Lisinopril started from year2000 and still ongoing, Zinc, Vitamin D3, Ascorbic Acid (VITAMIN C) started from Mar2020 and still ongoing. Patient medical history included which was surgery at an early age. The patient took the second dose of Pfizer COVID Vaccine on 22FEB2021 which only caused headache and a sore right arm which lasted about 24 hours on unspecified date. Patient received Benadryl and Tylenol as treatment. The outcome of the event was recovered on an unknown date.  Follow-up (02Apr2021): This is a follow-up spontaneous report from a contactable consumer. This 72-year-old female consumer reported in response to non-HCP follow-up letter sent in cross reference case that included.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Muscular weakness, Myalgia
Clinical narrative: Latent onset of weakness around shoulder joint of left arm; Severely swollen lymph node on left side at juncture of neck and shoulder. Lymph node and affected muscle could be felt as a knot under the skin; Pain in lymph node and surrounding muscle; Pain in lymph node and surrounding muscle; This is a spontaneous report from a contactable consumer(patient). A 27-years-old female (Non pregnant) patient received second dose of bnt162b2 (COVID 19, Formulation: solution for injection, Lot Number: EN6203, Expiry date: unknown), via an unspecified route of administration in arm Left on 03Mar2021 at 16:15 as single dose for covid-19 immunisation. Historical vaccine included patient received first dose of bnt162b2 (COVID 19, Formulation: solution for injection, Lot number: EM9809, Expiry date: unknown), via an unspecified route of administration in arm left on 10Feb2021 at 03:45 PM was reported. The patient had no known allergies. Patient concomitant medications included desvenlafaxine (DESVENLAFAXINE) taken for an unspecified indication, start and stop date were not reported; paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. Patient medical history was not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 04Mar2021, the patient experienced severely swollen lymph node on left side at juncture of neck and shoulder. Lymph node and affected muscle could be felt as a knot under the skin, pain in lymph node and surrounding muscle, latent onset of weakness around shoulder joint of left arm on 01Apr2021. The patient didn't receive treatment for the events. The events were considered as non-serious. The outcome of the events was reported as not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: diagnosed with COVID; diagnosed with COVID; This is a spontaneous report from a contactable consumer (Patient) via Medical Information Team. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot# unknown), via an unspecified route of administration on 21Feb2021 as single dose for COVID-19 immunisation. The patient medical history and concomitants were not reported. On 10Mar2021, patient had diagnosed with COVID-19. The patient underwent lab test which included SARS-CoV-2 Test: Positive on 10Mar2021. The patient scheduled for second dose of vaccination on 14Mar2021 and was wondering if he can still get the second dose. The outcome of the events was unknown.  Information on the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis (dyspnea, stridor, drooling, tongue swelling); This is a spontaneous report from a non-contactable other Health Care Professional. A 74-year-old female patient received second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Solution for injection, lot Number: EN6204 and expiry date was not provided) and received first dose of BNT162B2: both were via an unspecified route of administration, on an unknown date, as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, during her 30 minute waiting period after the injection, the patient began to experience hoarse voice. She denied rash, difficulty breathing, difficulty swallowing, dizziness, facial swelling, lip swelling and tongue swelling. Patient complained of chest tightness (she later developed chest tightness when she was in the bay prior to epi-pen administration). Patient denies chills, fever, malaise/fatigue, facial swelling, cough, shortness of breath, wheezing, rash, hives, eczema, itching of skin and abdominal pain. The patient experienced anaphylaxis (dyspnea, stridor, drooling, tongue swelling) with early onset of presumed anaphylaxis that responded well to epi-pen. Patient sent to ED for closer observation/treatment by ambulance. Treatment was good, she started to have return of symptoms when AMR was leaving with her. The outcome of the events was reported as unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile and close temporal association, the event of Anaphylactic reaction is assessed as related to the suspect vaccine BNT162B2.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hot flush, Nausea
Clinical narrative: Dizziness, nausea, hot flash. This happens every 3-4 days. I get so dizzy that I need to hold onto something. I have never had any of these symptoms before I got the vaccine including when I had COVID. I had COVID Dec 2020.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head, Tinnitus
Clinical narrative: I developed tinnitus that is ongoing.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling, pins-and-needles feeling on the bottoms of the feet.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Full blood count normal
Clinical narrative: Fever and chills first night. Then for two weeks major fatigue, dizziness, weakness. I could barely walk up stairs. Neck lymph nodes still swollrn
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pyrexia
Clinical narrative: Fever and chills first night. Then for two weeks major fatigue, dizziness, weakness. I could barely walk up stairs. Neck lymph nodes still swollrn
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: yesterday i had mild headache; This is a spontaneous report received from a contactable consumer (patient). This is second case of two cases. A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EK9231) via unspecified route of administration on 05Jan2021 (age at vaccination 63-year-old) as single dose for COVID-19 immunisation. Medical history included ongoing chronic angioedema. Concomitant medications included simvastatin started 3 years ago, losartan in Oct2020, and doxepin 50 mg once daily for chronic angioedema started 20 years ago, all are ongoing. Previously patient took first dose of BNT162B2 (Lot No. EH9899) on 14Dec2020 for COVID-19 immunization and had sore arm and mild headache. The patient experienced mild headache which was reported as yesterday she had mild headache after second dose also. The patient did not receive treatment for the events. The outcome of event was recovered on an unknown date.  No follow-up attempts are possible. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020500607 Same patient/drug, different events;US-PFIZER INC-2020500607 Same patient/drug, different events
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; tested positive; This is a spontaneous report from a contactable consumer. This consumer reporter similar events for 2 patients. This is 1st of 2 reports. A 74-year-old female (Patient) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 10-FEB-2021 at single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. On an unspecified date, however, they were exposed to COVID-19. Her partner tested positive for COVID-19 and he had very mild symptoms and she states that he had been over it for at least a week. In 2021The caller also tested positive, after her partner, and she states,it will be 10 days ago tomorrow [tested positive 9 days ago]. The caller states that she and her partner have been in quarantine since they were exposed and that their required isolation time will be finished tomorrow. She also states that her partner has an appointment at his doctor's office tomorrow. She was inquiring about receiving the second dose of the COVID-19 vaccine after testing positive for COVID-19. The caller states that they were exposed to COVID-19 along with quite a few people and everyone else was considerably younger than them. The caller and her partner symptoms were very mild and state that it felt like a bad cold and they attribute that to having had the first dose of the COVID-19 vaccine in their system. The caller would like to know if the first dose could have helped their symptoms be milder than their friends symptoms since their friends had not yet received any of the COVID-19 vaccines yet.The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021293934 Same reporter,event, product/ different patient
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore left arm; This is a spontaneous report from a contactable consumer or other non hcp. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 23Feb2021 10:00 (Batch/Lot Number: EL3247) as single dose, dose 2 via an unspecified route of administration on 16Mar2021 10:45 (Batch/Lot Number: EL3247) as single dose for covid-19 immunization. Medical history included glucose tolerance impaired. Other medical history: pre-diabetes. There were no concomitant medications. On 23Feb201, the patient experienced sore left arm . She stated she had events on each of the day she got the shots. No other vaccine in four weeks and no other medications in two weeks was given to patient. The patient was not priorly vaccinated for covid. The patient was not covid tested post vaccination. The patient had no known allergies. The outcome of the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Caller tested positive for COVID; This is a spontaneous report from a contactable pharmacist. A female patient of unspecified received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported) via unspecified route on 12Mar2021 at single dose for covid-19 immunisation. The patient was allergic to penicillin, aspartame - caused throat swelling, bee stings and was lactose intolerant and wanted to know if vaccine contains any of these allergens patient has. The patient's concomitant medications were not reported. On 17Mar2021, the patient tested positive for COVID. She had been informed that there must be a 3 month wait in between getting vaccine after being positive for COVID. The outcome of the events was unknown.  No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: The patient received the first dose of the vaccine on 26Feb2021 and tested positive for covid on 08Mar2021.; This is a spontaneous report from a contactable pharmacist. This pharmacist reported similar events for two patients. This is 2nd of two reports. This case pertains to father case. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number Unknown), via an unspecified route of administration on 26Feb2021 as single dose for covid-19 immunization. The patients medical history and concomitant medications were not reported. The reporter stated that patient and his daughter both received the first dose of the vaccine and then they both tested positive after it. The patients 14 day quarantine is up this coming Monday and his second dose is scheduled for next Friday. The patient received the first dose of the vaccine on 26Feb2021 and tested positive for covid on 08Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 08Mar2021. The outcome of the event was reported as unknown.  No follow up attempts are possible; information on Lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021304488 Different patient, same drug/event
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test
Clinical narrative: My daughter was exposed to Corona virus the day after the vaccine; she was tested and today they called that she is positive; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (daughter) that: A unspecified age of female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration, administered on 12Mar2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 13Mar2021, the patient exposed to corona virus day after the COVID vaccine, experienced COVID symptoms and she is tested COVID-19 virus positive. Reporter stated, "My husband, myself and my daughter all received our first dose of Pfizer vaccine (unspecified vaccine) last Friday (12Mar2021), my daughter was exposed to Corona virus the day after the vaccine and she tested positive suspiciously today so her second dose is supposed to occur on 02Apr as well as my husband and I too, does she have to wait what is the protocol for that situation. On paraphrasing concern: reporter stated, "No she was exposed the next day and then she came down with symptoms on Wednesday of this week and she was tested and they called that she is positive, yes, I wanted to know if her scheduled dose that scheduled for 02Apr, if she can go or if she has to wait and how does I that affect my husband I as we live in the same house do we have to get tested before we receive our second dose? What is the protocol for that situation?" Reporter was informed about Pfizer medical information department. Reporter stated, "That's what they said when they transferred me to and I have been on hold for an hour and half, I called the main number and explained the situation and they said they had to transfer me to a medical professional. "Reporter was informed about the role of Pfizer Drug safety as here we document the experiences of our consumer with Pfizer product and permission to probe: consumer stated, "What kind of questions do you have for me? What are your questions, not right now. "Call back was done to gather further information about LOT#, however it was unsuccessful. Product details (NDC# UPC# and Treatment) and Pharmacy details could not be probed as consumer was unwilling to share further information. Hence further probing could not be done. Limited information available over the call. Product Complaint is there. Outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: felt extreme tiredness; This is a spontaneous report received from a contactable consumer (the patient) from a Pfizer-sponsored Program. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 09Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the vaccine (09Mar2021) and felt extreme tiredness (Mar2021). This day he's tired and then a moment later he's not. He asked if this was normal. He wanted to know because his second dose will be (30Mar2021) and he was planning not to have it if that's what was going happen again. The outcome of the event was unknown.     Information on Lot/Batch number has been requested.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore/achy arm.; This is a spontaneous report from a contactable consumer (patient). An 55-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE (age at vaccination was 55 years), solution for injection, lot number: EN6207 and expiry date was not provided), via an unspecified route of administration in the left arm, on 25Mar2021 at 10:00, as single dose for COVID-19 immunisation. Medical history included allergy with penicillin. Patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 25Mar2021 at 15:30, the patient had sore and achy arm. Treatment mediations were not reported. Outcome of the event recovered in Mar2021.
Sex: F
Vaccine: PPV
Symptoms: Adverse reaction
Clinical narrative: weird reaction to pneumonia vaccine; This is a spontaneous report from a contactable consumer, reporting for herself. A 59-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), via an unspecified route of administration on an unspecified date at a single dose for immunization. Medical history included ongoing hypothyroidism. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient experienced weird reaction to pneumonia vaccine on an unspecified date six years ago. The clinical outcome of the event, weird reaction to pneumonia vaccine, was unknown.  Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) 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 pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Herpes ophthalmic
Clinical narrative: Herpes keratitas in left eye, treated with valacyclovir 3 times per day for 7 days, Lotamax Ophthalmic Gel Drops 2 times per day for 14 days
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate increased, Injection site discolouration, Injection site swelling, Lymphadenopathy
Clinical narrative: On 4/23/2021 (day after vaccine left arm became very sore, I was extremely tired-exhausted, began about 8:30AM. Later that evening  around 7:00 PM, my heart started to beat faster then suddenly slowed down and then skipped a beat, but this didn't last a couple  minutes. 10 pm noticed my left upper arm was swelling in a large area.  It was swollen and was very painful.    4/24/21 My upper left arm was very swollen and had purple colored spots around the swollen area.  I also noticed that my lymph glands under my left arm were swollen.  The swelling on upper arm started to go down on 4/25/21, but lymph gland under left arm was still swollen for several days.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: On 4/23/2021 (day after vaccine left arm became very sore, I was extremely tired-exhausted, began about 8:30AM. Later that evening  around 7:00 PM, my heart started to beat faster then suddenly slowed down and then skipped a beat, but this didn't last a couple  minutes. 10 pm noticed my left upper arm was swelling in a large area.  It was swollen and was very painful.    4/24/21 My upper left arm was very swollen and had purple colored spots around the swollen area.  I also noticed that my lymph glands under my left arm were swollen.  The swelling on upper arm started to go down on 4/25/21, but lymph gland under left arm was still swollen for several days.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Cheilitis, Eyelid rash, Injection site erythema, Injection site pruritus, Lip swelling
Clinical narrative: A week after the vaccine, I developed "covid arm" (a red, itchy circular patch at the injection site). Then almost week after that, I developed swelling on my lips, a raised, red, itchy rash around my lips, on my chip/neck, and on my right eyelid. The eyelid also swelled slightly. I visited my doctor and was given a steroid injection and a prescription for prednisone. I was also instructed to take Benadryl at night and pepsid and claritin during the days to counteract the reaction.  Of note: I received a Botox injection in my forehead on Feb. 22nd, 2021.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic, Swelling of eyelid
Clinical narrative: A week after the vaccine, I developed "covid arm" (a red, itchy circular patch at the injection site). Then almost week after that, I developed swelling on my lips, a raised, red, itchy rash around my lips, on my chip/neck, and on my right eyelid. The eyelid also swelled slightly. I visited my doctor and was given a steroid injection and a prescription for prednisone. I was also instructed to take Benadryl at night and pepsid and claritin during the days to counteract the reaction.  Of note: I received a Botox injection in my forehead on Feb. 22nd, 2021.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Headache, Pyrexia
Clinical narrative: Fever, headache, depression
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Headache, Induration, Oropharyngeal pain
Clinical narrative: The day after the shot, my arm was sore like the first shot but not bad. I did have a 101.8 fever, sore throat, runny nose, headaches all day on and off, extreme fatigue. The following day (today; April 28, 2021) the symptoms all went away except my arm started itching and was very hot and hard to the touch. I looked in the mirror and it was bright red and a big red circle had appeared. As the day has gone on, it has gotten larger and hurts so bad and is so itchy and my arm is swollen in the entire circle. It is now as big as my fist.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Pyrexia, Rhinorrhoea
Clinical narrative: The day after the shot, my arm was sore like the first shot but not bad. I did have a 101.8 fever, sore throat, runny nose, headaches all day on and off, extreme fatigue. The following day (today; April 28, 2021) the symptoms all went away except my arm started itching and was very hot and hard to the touch. I looked in the mirror and it was bright red and a big red circle had appeared. As the day has gone on, it has gotten larger and hurts so bad and is so itchy and my arm is swollen in the entire circle. It is now as big as my fist.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: The day after the shot, my arm was sore like the first shot but not bad. I did have a 101.8 fever, sore throat, runny nose, headaches all day on and off, extreme fatigue. The following day (today; April 28, 2021) the symptoms all went away except my arm started itching and was very hot and hard to the touch. I looked in the mirror and it was bright red and a big red circle had appeared. As the day has gone on, it has gotten larger and hurts so bad and is so itchy and my arm is swollen in the entire circle. It is now as big as my fist.