chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: 1150AM: 10 minutes post vaccine, patient with "itching" to "hairline, feet, and neck & back" without urticaria, erythema, SOB, pain, weakness, or other complaint. Temp 98.1F non-contact, BP 140/90, Pulse 86, Resp 16 1201PM: Increase in sensation of itching to neck and back to 3/10 without change in other signs and symptoms, BP 138/86. Per RN provide 25 mg PO Benadryl. Benadryl provided to patient.  1211PM: Some reduction in itching sensation 3/10. 1215PM: Continued itching sensations with expansion to upper arms at 5/10 1220PM:  RN with orders from Dr.  for up to a total of  75 mg Benadryl starting with additional 25 mg PO now. 1230PM: Itching reduced to right ear and right leg at 3/10. Much improved.  1233PM  RN with orders from Dr.  for patient to take 2 Claritin (loratadine) a day, one in the morning and one at night for the next three days. Benadryl as needed according to package instructions if needed for symptoms. 1242PM BP120/42 P 68, Temp 98.2 Resp 18. Patient reports feeling much better, slight itching to right ear at 2/10. No SOB, pain, or other discomfort 1245PM Awaiting patient?s husband to meet her in the vaccine clinic.  RN to with patient to her work area in the hospital CT area of the ED to wait for her husband to pick her up.  1252PM Patient?s husband arrived. Patient escorted to vehicle reporting comfort in managing further signs and symptoms with the orders from Dr. She will seek emergency care from EMS if shortness of breath occurs or weakness.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus, Skin warm
Clinical narrative: warm skin, tingling face, itching hands and arm
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: fine after injection unitl 1/19 then site swelling, and itching.  advised to contact PCP.  Using topical cream for itching and ice
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Fatigue, Headache, Pain
Clinical narrative: Day of injection- A couple hours passed a rash on left arm occurred another hour massive headache. i took benadryl when i got home the rash slowly started to go away. next 2 days headache with burning /pain in arm and tiredness. finally the injection site went down to almost nothing eventually headache and sleepiness went away. This morning 1/21/21 i woke up to pain in my left arm and it was swollen/red/pain and round size of an orange along with massive headache dizzy/tired.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Day of injection- A couple hours passed a rash on left arm occurred another hour massive headache. i took benadryl when i got home the rash slowly started to go away. next 2 days headache with burning /pain in arm and tiredness. finally the injection site went down to almost nothing eventually headache and sleepiness went away. This morning 1/21/21 i woke up to pain in my left arm and it was swollen/red/pain and round size of an orange along with massive headache dizzy/tired.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site hypoaesthesia, Injection site paraesthesia
Clinical narrative: Received vaccination in left deltoid, within a few minutes arm started feeling numb and tingling distal to vaccination site.  She describes it feeling like she slept on it wrong.  It is beginning to feel better with time.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Client called and c/o of pain on left side of body. She is being f/u with her doctor.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Vomiting projectile
Clinical narrative: approximately 3 hours prior to expiring the patient was experiencing forceful emesis.  later was found to have expired, patient was comfort care only.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Tongue ulceration
Clinical narrative: 12-24 hours post vaccine :Tongue Swelling and Tongue ulceration , no treatment, non-emergent.  Swelling resolved on 1/20/21.   12/21/21: Ulceration still present. No treatment.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Somnolence, Swollen tongue, Throat irritation
Clinical narrative: Patient passed out a few minutes after her vaccine.  "Patient hard to wake with verbal and mild shaking.  Provider applied ice packs to chest and face.  Patient came became more verbal and was able to speak and rink water.  Patient was observed longer by provider.   During this time the patient reported her tongue was swelling and throat felt funny.  Provider ordered we administered Diphenhydramine 25 mg IM.  EMS was called and patient was transported to area hospital.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: 4:45PM: Patient complained of nausea. Sip of water given. Patient states that it is her nerves. Pretzels and sprite given for snack. BP checked 132/103 HR-94 4:50PM BP 128/91 HR-101 No acute distress noted 5:00PM BP 125/88 HR 101 Patient resting on couch 5:13PM BP 123/83 HR 100 No acute distress 5:15PM Escorted to car with no problems noted.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dry mouth, Nasal discomfort
Clinical narrative: dry mouth Dry nose dizzy feeling of fainting
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dry mouth, Nasal dryness
Clinical narrative: dry mouth Dry nose dizzy feeling of fainting
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Catecholamine crisis, Chills, Fatigue, Heart rate increased
Clinical narrative: states received the covid vaccine - developed inc hrt rate, rigors, flushing was monitored in the vaccine clinic, and then escorted to the ED -states the ED observed until sx dec - was told she had a catacholemine response, states is feeling fatigued
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymphadenopathy starting 7-8 days after
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Big red spot on my arm where I got the shot.  Hot to touch, very sore.  Dr.  said it was a reaction and put me on antibiotics.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Fever - lasted about 5 hours chills, fatigue, body aches - lasted about 12+ hours
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Cold sweat, Dizziness, Headache
Clinical narrative: Severe body aches, 100.5 temp, nausea, vomiting, severe headache, chills, cold sweats, dizziness,. Pain and swelling at injection site, muscle weakness in right arm.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Muscular weakness, Nausea, Pain
Clinical narrative: Severe body aches, 100.5 temp, nausea, vomiting, severe headache, chills, cold sweats, dizziness,. Pain and swelling at injection site, muscle weakness in right arm.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Severe body aches, 100.5 temp, nausea, vomiting, severe headache, chills, cold sweats, dizziness,. Pain and swelling at injection site, muscle weakness in right arm.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: 1/12/21 VACCINATION.   1/19/21 INJECTION SITE "ITCHY."   1/20/21  ITCHY,RED, RAISED, WELL DEFINED, INDURATED AREA APPROXIMATELY  3" X 1.5"  ABOUT 10 MM  FROM INJECTION SITE
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Developed diffuse urticaria 2 days after 2nd injection of vaccine; required treatment with steroids/antihistamines, gradually cleared over 5 days
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blister, Burning sensation, Chest pain, Ear pain
Clinical narrative: Pain (tingling/burning sensations) started about six hours after injection, it continued to get worse over next several days.  Pain went from ear to finger tips, including shoulder and chest.  Her personal MD thinks the vaccination triggered a shingles reaction, the patient did have a few blisters pop up on shoulder
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Pain (tingling/burning sensations) started about six hours after injection, it continued to get worse over next several days.  Pain went from ear to finger tips, including shoulder and chest.  Her personal MD thinks the vaccination triggered a shingles reaction, the patient did have a few blisters pop up on shoulder
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Chills, Erythema, Headache, Myalgia
Clinical narrative: CHILLS, FEVER 103.0, CHEST RED, HEADACHES, BONE PAIN, MUSCLE ACHES
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: CHILLS, FEVER 103.0, CHEST RED, HEADACHES, BONE PAIN, MUSCLE ACHES
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Livedo reticularis, Rash
Clinical narrative: History of peanut allergies; carries EpiPen. Noted within 3-6 minutes following vaccine, had small rash on L inner wrist; arm where received vaccine. Chest appeared bit mottled; no apparent hive. BP 140/100, HR 140, no issues with breathing. After 5-10 minutes, took 25 mg liquid Benadryl; mottling resolved, wrist with same sized rash, L injection site with bit of redness/rash. BP 108/80, pulse 87, pulse ox 99% Taken to ED by w/c for further evaluation.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Loss of consciousness, Pain in extremity
Clinical narrative: Headache and pain in arm that injection was given in then passed out
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Pain, Photophobia, Pyrexia, Tremor
Clinical narrative: low grade fever, chills, aches, sensitivity to light, shakes
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Gastrooesophageal reflux disease, Hyperhidrosis, Lymphadenopathy, Pyrexia
Clinical narrative: Used Tylenol and Motrin for fever, chills, profuse sweating, swollen lymph node in left armpit, GERD
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Fever 37.3 C and 37.6 C Muscle pain Chills Headache Pain in the left arm at the site of injection Symptoms started 12 hours after the injection. They last about 12-14 hours. I took aspirin, ibuprofen and Tylenol.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Myalgia, Nausea
Clinical narrative: Fatigue, muscle aches,  chills, fever, nausea, diarrhea for a full week and wasn't over it for two weeks.  The worst symptoms began the night following the injection.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fatigue, muscle aches,  chills, fever, nausea, diarrhea for a full week and wasn't over it for two weeks.  The worst symptoms began the night following the injection.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Systemic: Anaphylaxis-Medium; symptoms lasted 1 day
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site erythema, Injection site warmth
Clinical narrative: Injection site is pink half way down my arm and warm to the touch. No pain but discomfort.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Facial swelling
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Muscle twitching, Pyrexia
Clinical narrative: Day 1 late afternoon feverish and headache lasted approximately 2-3 hours went away without medication. Day 2 arm very sore from shoulder to elbow, was better by day 3. Day 3 around 11am left tricep started twitching only twice for about 1minute, later that night abdomen was twitching it woke me up ! lasted a couple minutes, next morning left quadricep was twitching for about 1 minute later muscle under left eye lasted off and on for a few minutes.  Finally no more twitches !!
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: Day 1 some fatigue and headache. Day 2 Severe Fatigue, headache, dizziness, mild nausea, chills, body aches. Day 3, 102 fever. Severe chills, body pains, nausea, vomiting, diarrhea, headache. Pain and swelling in the arm but manageable. Covid test Saturday on Day 3, negative.  Day 4 same as day 3. Could not drive due to feeling faint. Day 5 & 6 nausea still medium. chills and fever still present. Tested again for covid on Tuesday (day 6) due to headaches, nausea, body aches still present. Day 7,  nausea and fatigue and chills. Day 8 woke up with huge swollen arm. it's hot, itches and very very swollen - 4" long and is painful. Medications taken on schedule Tylenol 500 mgs every 4 hrs and Advil 600 mgs every 6.  Day 8 still nauseated.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired driving ability, Nausea, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Day 1 some fatigue and headache. Day 2 Severe Fatigue, headache, dizziness, mild nausea, chills, body aches. Day 3, 102 fever. Severe chills, body pains, nausea, vomiting, diarrhea, headache. Pain and swelling in the arm but manageable. Covid test Saturday on Day 3, negative.  Day 4 same as day 3. Could not drive due to feeling faint. Day 5 & 6 nausea still medium. chills and fever still present. Tested again for covid on Tuesday (day 6) due to headaches, nausea, body aches still present. Day 7,  nausea and fatigue and chills. Day 8 woke up with huge swollen arm. it's hot, itches and very very swollen - 4" long and is painful. Medications taken on schedule Tylenol 500 mgs every 4 hrs and Advil 600 mgs every 6.  Day 8 still nauseated.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, SARS-CoV-2 test negative, Skin warm, Vomiting
Clinical narrative: Day 1 some fatigue and headache. Day 2 Severe Fatigue, headache, dizziness, mild nausea, chills, body aches. Day 3, 102 fever. Severe chills, body pains, nausea, vomiting, diarrhea, headache. Pain and swelling in the arm but manageable. Covid test Saturday on Day 3, negative.  Day 4 same as day 3. Could not drive due to feeling faint. Day 5 & 6 nausea still medium. chills and fever still present. Tested again for covid on Tuesday (day 6) due to headaches, nausea, body aches still present. Day 7,  nausea and fatigue and chills. Day 8 woke up with huge swollen arm. it's hot, itches and very very swollen - 4" long and is painful. Medications taken on schedule Tylenol 500 mgs every 4 hrs and Advil 600 mgs every 6.  Day 8 still nauseated.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling face
Clinical narrative: Patient call primary care provider on 1/20/2021 at 3:00 pm and stated that she had redden and swelling of face with itching of head, neck back, face.  Instructed to take Benadryl 50 mg. and 25 mg every 6 hours.  Patient call next morning 1/21/2021 stated much better, believes it was from new face cream she tried.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pruritus, Injection site swelling, Pain
Clinical narrative: 2nd day very sore- not unexpected. Nine days later, bruised at injection point, redness and swelling above and below bruise.  Some itching of the skin around injection point. The bruise didn?t surprise me as I bruise easily, but the redness and swelling is a new thing.  This was my first dose.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Feeling abnormal, Heart rate increased, Hypertension, Pruritus
Clinical narrative: Patient received her second COVID-19 vaccine. Rapid response called when patient returned to vaccine clinic and reported feeling "funny," itchy, and with a blotchy red rash around her neck. Heart rate noted to be 220/109, SpO2 100% on room air. Heart rate of 85. Emergency department PA notes questionable allergic reaction to the vaccine. Very mild erythema at the base of her beck. Given Benadryl, Solu-Medrrol and Pepcid. Heart rate of 183/95 trended down to 157/90 by the time of discharge.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Rash macular, SARS-CoV-2 test negative
Clinical narrative: Patient received her second COVID-19 vaccine. Rapid response called when patient returned to vaccine clinic and reported feeling "funny," itchy, and with a blotchy red rash around her neck. Heart rate noted to be 220/109, SpO2 100% on room air. Heart rate of 85. Emergency department PA notes questionable allergic reaction to the vaccine. Very mild erythema at the base of her beck. Given Benadryl, Solu-Medrrol and Pepcid. Heart rate of 183/95 trended down to 157/90 by the time of discharge.
Age: 89.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Cardiac arrest, Syncope, Unresponsive to stimuli
Clinical narrative: The patient received his vaccine in the. morning of 1/20/2021, while getting into car to go see his pulmonologist, about 2 hours after, collapsed, unresponsive with asystolic cardiac arrest.  No symptoms prior other than chronic dyspnea.  No allergic type symptoms reported by family.  Asystole with EMS, no response to ACLS, presented to ED, DOA.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Around 8pm that evening after receiving the vaccine, she started to get a headache, chills and body aches.  Throughout the night those symptoms got worse.  Had a severe headache, chills and body aches.  Compared the symptoms to having influenza.  By mid afternoon of that next day her symptoms started to fade.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: About 20 minutes after receiving vaccine I felt a very hot area in the center lower part of my chest. It radiate it out and up into my throat. It only lasted a few minutes and completely went away. About seven hours later the same thing happened but the heat was not intense as it was the first time. Nail two days later, I have a slight, very slight feeling of heat in my lower throat. I?ve never had any of these symptoms before.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Patient received the Moderna Vaccine  January 16, 2021
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Patient received the Moderna Vaccine  January 16, 2021
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Ocular hyperaemia, Throat irritation
Clinical narrative: itchy throat, progressive red eyes, elevated blood pressure
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Pruritus
Clinical narrative: Vaccine recipient received vaccine on 1/8/2021. The site of injection was sore and had redness for 2-3 days. On 1/14, he reported that he developed itchiness all over his body. He reported that the site of injection was raised and looks like a bullseye and about the size of an orange. He was advised to seek follow-up with occupational health.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain, Pyrexia
Clinical narrative: First dose-sick for three days with diarrhea(8-9 trips to bathroom), body aches, fever (101.7).  Second dose- still sick with fever, body aches and diarrhea
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Computerised tomogram normal, Tremor
Clinical narrative: I have been experiencing involuntary shakes,no treatment  and I am still shaking CAT SCAN to see if it might be neurological. They did not see anything with the CAT scan
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Headache, body aches, chills, nausea, fatigue
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Dyspnoea, Eye movement disorder, Nausea
Clinical narrative: Prior to vaccination, patient denied previous reactions to vaccines or injectable products. Patient received Pfizer COVID-19 vaccine at approximately 10:55 am. Patient requested to sit down as she became faint. After sitting, patient became unresponsive with eyes rolling back in head, and gasping for breath/gurgling. Patient's head was also bobbing up and down slightly. Patient was then transferred to the floor. After moving to the floor, patient became slightly responsive but was still disoriented. 0.3 mg of epinephrine was administered into the right thigh at approximately 11:04 am. Patient's condition continued to improve, although she became nauseous with no emesis. EMS arrived at the scene and patient was monitored in the ambulance per EMS discretion but then left the scene with her husband.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Prior to vaccination, patient denied previous reactions to vaccines or injectable products. Patient received Pfizer COVID-19 vaccine at approximately 10:55 am. Patient requested to sit down as she became faint. After sitting, patient became unresponsive with eyes rolling back in head, and gasping for breath/gurgling. Patient's head was also bobbing up and down slightly. Patient was then transferred to the floor. After moving to the floor, patient became slightly responsive but was still disoriented. 0.3 mg of epinephrine was administered into the right thigh at approximately 11:04 am. Patient's condition continued to improve, although she became nauseous with no emesis. EMS arrived at the scene and patient was monitored in the ambulance per EMS discretion but then left the scene with her husband.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Hypertension, Pyrexia
Clinical narrative: FEVER 101.5, OFF BALANCE, HIGH BLOOD PRESSURE
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Feeling cold, Inflammation, Insomnia
Clinical narrative: Sore arm the first morning About 26 hours after injection I became cold. 2:00pm at 28 hours my teeth began to chatter uncontrollably.  4:00pm until 8;45pm - I had 4 tylenol during this time frame Became very achy and uncomfortable around 8:45 pm   At 1:00 am I felt inflamation on my whole left side.  My arm hurt to the shoulder to touch or move, left breast sore, left knee (artifical replacement) was sore under knee cap.  I took two extra strength tylenol for inflamation and slept for 2 hours.  Woke up in a pool fo sweat, but felt fine! Should I take the second dose?
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Pain, Pain in extremity
Clinical narrative: Sore arm the first morning About 26 hours after injection I became cold. 2:00pm at 28 hours my teeth began to chatter uncontrollably.  4:00pm until 8;45pm - I had 4 tylenol during this time frame Became very achy and uncomfortable around 8:45 pm   At 1:00 am I felt inflamation on my whole left side.  My arm hurt to the shoulder to touch or move, left breast sore, left knee (artifical replacement) was sore under knee cap.  I took two extra strength tylenol for inflamation and slept for 2 hours.  Woke up in a pool fo sweat, but felt fine! Should I take the second dose?
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pain, Neck mass
Clinical narrative: Severe Soreness in Right arm above site of injection and formed a bump.  Patient complains this occurred 2 days after receiving vaccine, and pain is unbearable between shoulder and neck with bump formation between the two points.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: Slightly less than 24 hours post my second vaccine, experienced headache, significant body aches, and fatigue. No fever. But symptoms required me to lay down/rest, and I?m healthy and active. Symptoms persisted for approximately 4-5 hours.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Pain
Clinical narrative: Severe bodyaches at 1am, migraine, chills, sweating, fatigue lasted until 9pm.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Resuscitation, Unresponsive to stimuli
Clinical narrative: 1/13/2021 12:00 PM: Patient received COVID-19 Vaccine. 1/14/2021 21:00: Nurse performed routine rounds and the patient appeared okay. 1/14/2021 22:00: CNA discovered patient unresponsive in bed, began CPR, and called 911. 1/14/2021 23:08: Pronounced deceased.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: 1/13/2021 12:00 PM: Patient received COVID-19 Vaccine. 1/14/2021 21:00: Nurse performed routine rounds and the patient appeared okay. 1/14/2021 22:00: CNA discovered patient unresponsive in bed, began CPR, and called 911. 1/14/2021 23:08: Pronounced deceased.
Age: 62.0
Sex: F
Vaccine: UNK
Symptoms: Back disorder
Clinical narrative: Severe back  approximately  2 hrs after vaccine  Symptoms still here the day after, was advised at time of vaccine  if  symptoms  occur and last up to 72 hrs  in form primary care provider.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Swollen tongue
Clinical narrative: Systemic: Swelling of tongue and throat; symptoms lasted 1 day
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Peripheral swelling, Rhinorrhoea
Clinical narrative: Swelling at injection site, swelling of hands, next day runny nose
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hot flush, Pain, Tremor
Clinical narrative: Chills, shaking, hot flashes, headache body aches for 24 hours
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Feeling abnormal, Hyperhidrosis, Pain
Clinical narrative: Lasting 36 hours; Fever 103*  Rigors with Chills  Fatigue  Body aches  Sweating through multiple sets of clothing Headache  Brain fog  Loss of appetite  Took Tylenol and ibuprofen and hydrated  After ~ 36 hours feel relatively normal with occasional hot flashes
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Lasting 36 hours; Fever 103*  Rigors with Chills  Fatigue  Body aches  Sweating through multiple sets of clothing Headache  Brain fog  Loss of appetite  Took Tylenol and ibuprofen and hydrated  After ~ 36 hours feel relatively normal with occasional hot flashes
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Skin lesion
Clinical narrative: After both vaccines (12/30 and 1/18) I got itchiness on my scalp and body. Tiny lesions developed and disappeared and looked like mini blisters. Treated with Benadryl. Following-up with dermatologist on 1/26.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Paraesthesia oral, Pruritus, Throat irritation
Clinical narrative: Pt received Pfizer vaccine at 9:15 in left deltoid. At 9:30 pt complained of throat feeling itchy, and tongue feeling larger than usual and numb. Provider informed, provider assessment revealed no rash, no redness, no visible swelling of tongue, and patient reported an itch on right arm. Vitals 9:35 BP 126/70, HR 88, oxygen saturation 99% on RA, and respirations of 20/min. Vitals retaken at 9:40 BP 117/70, HR 75, oxygen saturation 98% on RA, and 20 breaths/min. Vitals retaken at 9:50 BP 115/71, HR 74, oxygen saturation 98% on RA< and 18 breaths/min. At 9:53 patient stated her throat is no longer itchy, and tongue no longer feels large.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Pain, Rash
Clinical narrative: Chills, soreness, headache, dizziness feeling passing out on day 3. Both arms rashes and warm to touch from elbow down. Left arm more rashes than right arm.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: Chills, soreness, headache, dizziness feeling passing out on day 3. Both arms rashes and warm to touch from elbow down. Left arm more rashes than right arm.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Enlarged lymph node in left axilla; started 01/09/21; painful to touch; resolving
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: 8 days after the vaccine I have itching and redness and tenderness at the sight that started out of nowhere.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Swollen tongue
Clinical narrative: had trouble breathing; toung was greatly swolen; This is a spontaneous report from a contactable consumer (patient) reported that an 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiration date: not reported), via an unspecified route of administration in the left arm on 11Jan2021 09:30 at a single dose for COVID-19 immunization. Medical history included very mild chronic obstructive pulmonary disease (COPD) from an unknown date. Concomitant medications included sertraline, temazepam, levothyroxine and pravastatin. It was reported that on 11Jan2021, the patient had injection at 9:30 am then at 6 pm, had trouble breathing and tongue was greatly swollen (reported as "toung was greatly swolen"). The patient called ambulance and went to emergency room/department or urgent care. As treatment, the patient received saline IV, banophen and prednisone. The outcome of the events was not recovered.
Age: 97.0
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Haemoptysis
Clinical narrative: Every time my mother blows her nose or coughs up phlegm there is a lot of blood; Every time my mother blows her nose or coughs up phlegm there is a lot of blood; This is a spontaneous report from a contactable consumer (patient's daughter). A 97-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 as a single dose for COVID-19 immunization, lot number: EL0142. Medical history and concomitant medications were reported as none. Patient's daughter reported severe problems with the vaccine. Every time patient blows her nose or coughs up phlegm there is a lot of blood, onset date unknown. No treatment received for the events. Outcome of the events was unknown.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Narrative:
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase normal, Aspartate aminotransferase normal, Bilirubin conjugated normal, Blood albumin normal, Blood alkaline phosphatase increased
Clinical narrative: Narrative: 1/20/21 Vomited x3 nonbilious and was found to have a fever (100.4 degrees F). Pt reports fullness, saying his belly feels hard. on exam abd distended / tympanic abdomen, decreased bowel sounds. Trafered from clinic to acute care to r/o acute abdomen. 1/19 vaccine given 1/17 - abdomen visibly rounded, patient looks uncomfortable. Patient denied pain x 3, reports feeling full. Abdomen is soft, nontender. Normoactive bowel sounds x 4 - scheduled to receive enema on 1/18. 1/16: noted to have a distended stomach, positive bowels sounds denied pain or discomfort. Ate 50% of dinner, During pm care abdomen noted to be more distended than at the start of shift. - txed with suppository Patient has BM. PMH includes dementia, hypothyroidism, dysphagia, ataxia, drug-induced tremor, schizoaffective disorder, chonic constipation, anemia, bipolar, HL
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood bilirubin normal, Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood glucose normal
Clinical narrative: Narrative: 1/20/21 Vomited x3 nonbilious and was found to have a fever (100.4 degrees F). Pt reports fullness, saying his belly feels hard. on exam abd distended / tympanic abdomen, decreased bowel sounds. Trafered from clinic to acute care to r/o acute abdomen. 1/19 vaccine given 1/17 - abdomen visibly rounded, patient looks uncomfortable. Patient denied pain x 3, reports feeling full. Abdomen is soft, nontender. Normoactive bowel sounds x 4 - scheduled to receive enema on 1/18. 1/16: noted to have a distended stomach, positive bowels sounds denied pain or discomfort. Ate 50% of dinner, During pm care abdomen noted to be more distended than at the start of shift. - txed with suppository Patient has BM. PMH includes dementia, hypothyroidism, dysphagia, ataxia, drug-induced tremor, schizoaffective disorder, chonic constipation, anemia, bipolar, HL
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood potassium normal, Blood sodium normal, Blood urea normal, Carbon dioxide normal, Gastric dilatation
Clinical narrative: Narrative: 1/20/21 Vomited x3 nonbilious and was found to have a fever (100.4 degrees F). Pt reports fullness, saying his belly feels hard. on exam abd distended / tympanic abdomen, decreased bowel sounds. Trafered from clinic to acute care to r/o acute abdomen. 1/19 vaccine given 1/17 - abdomen visibly rounded, patient looks uncomfortable. Patient denied pain x 3, reports feeling full. Abdomen is soft, nontender. Normoactive bowel sounds x 4 - scheduled to receive enema on 1/18. 1/16: noted to have a distended stomach, positive bowels sounds denied pain or discomfort. Ate 50% of dinner, During pm care abdomen noted to be more distended than at the start of shift. - txed with suppository Patient has BM. PMH includes dementia, hypothyroidism, dysphagia, ataxia, drug-induced tremor, schizoaffective disorder, chonic constipation, anemia, bipolar, HL
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrointestinal sounds abnormal, Glomerular filtration rate, Granulocyte count, Granulocyte percentage, Haematocrit decreased
Clinical narrative: Narrative: 1/20/21 Vomited x3 nonbilious and was found to have a fever (100.4 degrees F). Pt reports fullness, saying his belly feels hard. on exam abd distended / tympanic abdomen, decreased bowel sounds. Trafered from clinic to acute care to r/o acute abdomen. 1/19 vaccine given 1/17 - abdomen visibly rounded, patient looks uncomfortable. Patient denied pain x 3, reports feeling full. Abdomen is soft, nontender. Normoactive bowel sounds x 4 - scheduled to receive enema on 1/18. 1/16: noted to have a distended stomach, positive bowels sounds denied pain or discomfort. Ate 50% of dinner, During pm care abdomen noted to be more distended than at the start of shift. - txed with suppository Patient has BM. PMH includes dementia, hypothyroidism, dysphagia, ataxia, drug-induced tremor, schizoaffective disorder, chonic constipation, anemia, bipolar, HL
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoglobin decreased, Mean cell haemoglobin concentration normal, Mean cell haemoglobin normal, Mean cell volume normal, Platelet count normal
Clinical narrative: Narrative: 1/20/21 Vomited x3 nonbilious and was found to have a fever (100.4 degrees F). Pt reports fullness, saying his belly feels hard. on exam abd distended / tympanic abdomen, decreased bowel sounds. Trafered from clinic to acute care to r/o acute abdomen. 1/19 vaccine given 1/17 - abdomen visibly rounded, patient looks uncomfortable. Patient denied pain x 3, reports feeling full. Abdomen is soft, nontender. Normoactive bowel sounds x 4 - scheduled to receive enema on 1/18. 1/16: noted to have a distended stomach, positive bowels sounds denied pain or discomfort. Ate 50% of dinner, During pm care abdomen noted to be more distended than at the start of shift. - txed with suppository Patient has BM. PMH includes dementia, hypothyroidism, dysphagia, ataxia, drug-induced tremor, schizoaffective disorder, chonic constipation, anemia, bipolar, HL
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Protein total normal, Pyrexia, Red blood cell count decreased, Red blood cell nucleated morphology, Red cell distribution width
Clinical narrative: Narrative: 1/20/21 Vomited x3 nonbilious and was found to have a fever (100.4 degrees F). Pt reports fullness, saying his belly feels hard. on exam abd distended / tympanic abdomen, decreased bowel sounds. Trafered from clinic to acute care to r/o acute abdomen. 1/19 vaccine given 1/17 - abdomen visibly rounded, patient looks uncomfortable. Patient denied pain x 3, reports feeling full. Abdomen is soft, nontender. Normoactive bowel sounds x 4 - scheduled to receive enema on 1/18. 1/16: noted to have a distended stomach, positive bowels sounds denied pain or discomfort. Ate 50% of dinner, During pm care abdomen noted to be more distended than at the start of shift. - txed with suppository Patient has BM. PMH includes dementia, hypothyroidism, dysphagia, ataxia, drug-induced tremor, schizoaffective disorder, chonic constipation, anemia, bipolar, HL
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Vomiting, White blood cell count increased
Clinical narrative: Narrative: 1/20/21 Vomited x3 nonbilious and was found to have a fever (100.4 degrees F). Pt reports fullness, saying his belly feels hard. on exam abd distended / tympanic abdomen, decreased bowel sounds. Trafered from clinic to acute care to r/o acute abdomen. 1/19 vaccine given 1/17 - abdomen visibly rounded, patient looks uncomfortable. Patient denied pain x 3, reports feeling full. Abdomen is soft, nontender. Normoactive bowel sounds x 4 - scheduled to receive enema on 1/18. 1/16: noted to have a distended stomach, positive bowels sounds denied pain or discomfort. Ate 50% of dinner, During pm care abdomen noted to be more distended than at the start of shift. - txed with suppository Patient has BM. PMH includes dementia, hypothyroidism, dysphagia, ataxia, drug-induced tremor, schizoaffective disorder, chonic constipation, anemia, bipolar, HL
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: 4:30 am feeling very nauseas and tired  felt to tired to do even the smallest and lightest daily
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Condition aggravated, Death, Gastrointestinal haemorrhage
Clinical narrative: Narrative: Was pt previously covid positive?- Yes. Initial- 10/27/2020, 11/29/2020, 12/22/2020 Are there any predisposing factors for patient experiencing adverse drug event?- Yes, patient had multiple co-morbidities including GI bleed, hepatitis congestion due to cardiac issues, treatment for PE, NSTEMI, or antibiotics for PNA, also on concurrent medications APAP, Atorvastatin, Mirtazapine and Duloxetine. Pt with 2 doses of covid-19 vaccine, second one on 01/08/2021, 2 days pre-death Any occurrence of an ADR at time of administration? Did not specify injection site issues, per RN admin note- Vaccine "administered without complications." Did patient recover from event? Not s/p dose on 01/08/2021. First dose given on 12/21/2021, LFTS increased ~01/01/2021, peaked on 01/03/2021 and were decreasing on 01/07/2021 Was there an ADR between observation period and date of death? No Did patient recover from event? No (01/08/2021 event, died 01/10/2021) Was patient hospitalized prior to vaccination? Yes, in between inpatient and nursing home Was patient hospitalized prior to death--was hospitalization attributable to ADE? Yes re-admitted to inpatient on 12/31/2020. GI bleed Is there an alternative cause of death? Yes, as noted above. Quite a complicated case with many comorbidities/concurrent medications as noted above. Primary Diagnosis: Upper GI Bleed in the death note from 01/10/2021
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Liver function test increased, Upper gastrointestinal haemorrhage
Clinical narrative: Narrative: Was pt previously covid positive?- Yes. Initial- 10/27/2020, 11/29/2020, 12/22/2020 Are there any predisposing factors for patient experiencing adverse drug event?- Yes, patient had multiple co-morbidities including GI bleed, hepatitis congestion due to cardiac issues, treatment for PE, NSTEMI, or antibiotics for PNA, also on concurrent medications APAP, Atorvastatin, Mirtazapine and Duloxetine. Pt with 2 doses of covid-19 vaccine, second one on 01/08/2021, 2 days pre-death Any occurrence of an ADR at time of administration? Did not specify injection site issues, per RN admin note- Vaccine "administered without complications." Did patient recover from event? Not s/p dose on 01/08/2021. First dose given on 12/21/2021, LFTS increased ~01/01/2021, peaked on 01/03/2021 and were decreasing on 01/07/2021 Was there an ADR between observation period and date of death? No Did patient recover from event? No (01/08/2021 event, died 01/10/2021) Was patient hospitalized prior to vaccination? Yes, in between inpatient and nursing home Was patient hospitalized prior to death--was hospitalization attributable to ADE? Yes re-admitted to inpatient on 12/31/2020. GI bleed Is there an alternative cause of death? Yes, as noted above. Quite a complicated case with many comorbidities/concurrent medications as noted above. Primary Diagnosis: Upper GI Bleed in the death note from 01/10/2021
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Tongue dry
Clinical narrative: 0920 - Pt reported tightness in throat and dry tongue. Denied shortness of breath, difficulty breathing, or difficulty speaking. BP 149/96, HR 90, SpO2 98%. Epinephrine administered and patient transported to ED via wheelchair.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Muscular weakness, Tremor
Clinical narrative: Covid Vaccine given on 1/5. Headaches started within two hours. Fatigue and headache next two days. Followed by leg weakness in both legs and uncontrollable tremors in my entire body. I was hospitalized for 5 days. I am still having headaches and shakes all over my body with major weakness all over.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Catheterisation cardiac normal, Dehydration, International normalised ratio increased, Silent myocardial infarction, Syncope
Clinical narrative: My 81-year-old father, and my brother received the first dose of the Pfizer covid vaccine at the  Hospital  on Wednesday January 13, 2021. Within a couple of minutes of them returning home, my father collapsed. As it turns out, he'd had a silent heart attack. He is still in the medical center area Hospital this morning. A cardiologist who was filling in for my father's primary cardiologist thought maybe my father had a blockage and might have needed a stent. But when Dr. performed a cardiac catheterization,  he only found a little plaque. Medical personnel are not too sure what caused the heart attack. My was very dehydrated when he was admitted, and he has underlying health conditions including diabetes, high blood pressure, dementia and a history of blood clots. Those are just a few of his health issues. His primary cardiologist, Dr is back in town. He plans to see if my father has AFib before they release him. I believe Dr. an internist at Hospital,  said my father's INR on admitting was 1.2. My father's hematologist, Dr.,  had told us to let the person administering the vaccine know that my father is on blood thinners. I was not present when my father and brother received the vaccine, but I assume my brother passed that information on to them.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Capillary nail refill test abnormal, Dizziness, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Sars-CoV-2 vaccine (pPp treatment under Emergency Use Authorization(EUA): pfizer Received COVID-19 Vaccine at 10:45 AM.  After 10 minutes post administration, while being monitored began feeling nauseated and c/o some dizziness. Denies allergies or prior events with vaccination. A& O x3, pale, diaphoretic, weak radial pulse, cool w/ delayed cap refill. Preferred to sit with her head lowered rather than supine. VS noted and cool cloths provided. Stated she ate a little this AM, BP and pulse normally low for her and currently on menstrual cycle. Advised to stay additional 15 min. VS rechecked w/o change in symptoms. Agreed to lay supine, color improved and symptoms resolved. Declined calling MERT or 911 unless she had a change in her condition. Moved to sitting position, tolerated well asymptomatic. Stood became symptomatic, returned to sitting upright in chair. Continued dizziness, pale and nausea, A&O x3. Agreed to be seen in ER, departed in wheel chair with RN (Adult ER) to be evaluated. Time B/P Pulse Resp Position Notes 10:55 98/59 59 16 Sitting/Chair Pale, cool extremities, vertigo;  additional monitoring 11:00 89/56 66 14 Sitting/Chair Pale, vertigo- moved to supine position 11:05 98/65 60 12 Supine Symptoms improving 11:12 103/70 76 16 Sitting Symptoms resolved 11:18 Sitting Stand, symptoms returned- changed to sitting to w/c Departed Vaccine Clinic area at 11:20 A&O x3, pale, intermittent dizziness in wheel chair to Adult ER. Charge Nurse notified.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness, Pulse abnormal, Vertigo
Clinical narrative: Sars-CoV-2 vaccine (pPp treatment under Emergency Use Authorization(EUA): pfizer Received COVID-19 Vaccine at 10:45 AM.  After 10 minutes post administration, while being monitored began feeling nauseated and c/o some dizziness. Denies allergies or prior events with vaccination. A& O x3, pale, diaphoretic, weak radial pulse, cool w/ delayed cap refill. Preferred to sit with her head lowered rather than supine. VS noted and cool cloths provided. Stated she ate a little this AM, BP and pulse normally low for her and currently on menstrual cycle. Advised to stay additional 15 min. VS rechecked w/o change in symptoms. Agreed to lay supine, color improved and symptoms resolved. Declined calling MERT or 911 unless she had a change in her condition. Moved to sitting position, tolerated well asymptomatic. Stood became symptomatic, returned to sitting upright in chair. Continued dizziness, pale and nausea, A&O x3. Agreed to be seen in ER, departed in wheel chair with RN (Adult ER) to be evaluated. Time B/P Pulse Resp Position Notes 10:55 98/59 59 16 Sitting/Chair Pale, cool extremities, vertigo;  additional monitoring 11:00 89/56 66 14 Sitting/Chair Pale, vertigo- moved to supine position 11:05 98/65 60 12 Supine Symptoms improving 11:12 103/70 76 16 Sitting Symptoms resolved 11:18 Sitting Stand, symptoms returned- changed to sitting to w/c Departed Vaccine Clinic area at 11:20 A&O x3, pale, intermittent dizziness in wheel chair to Adult ER. Charge Nurse notified.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Computerised tomogram head, Electrocardiogram, Strabismus, Vision blurred
Clinical narrative: Two days after receiving vaccine she presented to an emergency department with an episode of blurry vision and outward deviation of left eye that resolved within one hour. She went to Emergency Department for evaluation.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Joint range of motion decreased, Muscle atrophy, Musculoskeletal stiffness
Clinical narrative: C/O (L) shoulder pain (superiorly, diffuse - not well localized). Exacerbated by overhead activities, worse w/movement, lateral deltoid region, top of shoulder, stiffness, weakness, shakiness of (L) hand w/use. (L) shoulder muscles w/mild atrophy diffuse. Symptoms started when vaccine was administered & no improvement since treated w/
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Physical examination, Tremor
Clinical narrative: C/O (L) shoulder pain (superiorly, diffuse - not well localized). Exacerbated by overhead activities, worse w/movement, lateral deltoid region, top of shoulder, stiffness, weakness, shakiness of (L) hand w/use. (L) shoulder muscles w/mild atrophy diffuse. Symptoms started when vaccine was administered & no improvement since treated w/
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain in extremity, Poor quality sleep
Clinical narrative: next day was very tired with a slight headache; next day was very tired with a slight headache; 12 hours after the injection I got the chills while I was in bed trying to sleep; I did not sleep well that night; 4 hours after the injection my arm was very sore; This is a spontaneous report from a contactable consumer. A 59-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 30Dec2020 09:00 at single dose at left arm for COVID-19 immunization.  Medical history included none.  There were no concomitant medications. The patient reported 4 hours after the injection/reported as 30Dec2020 14:00, my arm was very sore. On 30Dec2020 21:00, 12 hours after the injection, "I got the chills while I was in bed trying to sleep. I did not sleep well that night. The next day (31Dec2020) was very tired with a slight headache. The patient only rested all day. The next day he felt better but was slightly fatigued all day. The day after that the patient was back to being himself. His arm continued to be sore for a total of 5 days. The patient did not receive treatment for the events. The outcome of the events was recovered.   Information on the Batch/Lot number has been requested.