chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient administered 3rd dose of Moderna while not meeting eligibility requirements.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, Pregnancy test negative, Ultrasound antenatal screen abnormal, Vaginal haemorrhage
Clinical narrative: First miscarriage, 06/2021 Second miscarriage, 08/2021
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient given 3rd dose of Moderna without meeting eligibility requirements.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site rash, Pyrexia, Skin warm
Clinical narrative: Fever to 102 degrees for 2 nights, headache; 5 inch rash on injection site lasting 6 days ( and counting), rash is warm to the touch.
Age: 6.0
Sex: F
Vaccine: FLUC4
Symptoms: Cardiac arrest, Presyncope
Clinical narrative: apperas to be cardiac arrest patient almost passed out and start recovering after  getting the epipen
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: Tiredness more than 2 weeks post shot and unusual grogginess. Did not have these issues at baseline prior to vaccine
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lipase increased, Pancreatitis
Clinical narrative: Idiopathic pancreatitis
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Flushing, Pain
Clinical narrative: Patient stated on 9/29/2021, she started feeling flushed and developed severe body aches. This happened in the evening. She said she took Tylenol and went to bed. She slept through the night and felt fine the next day.
Age: 24.0
Sex: F
Vaccine: UNK
Symptoms: Contusion, Fatigue, Impaired work ability
Clinical narrative: Severe bruising, extreme exhaustion and inability to work.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Human chorionic gonadotropin, Ultrasound foetal abnormal
Clinical narrative: LMP, 12/2020; Miscarriage, 08/2021
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dermatitis acneiform, Palatal swelling, Pharyngeal swelling, Rash
Clinical narrative: The client stated that approximately 30 minutes after receiving the vaccine he developed "swelling on the roof of my mouth, near the back of my throat." The client stated the swelling lasted about 1-2 hours. The client also stated that 2 hours after the vaccine he developed a rash that "looked like pimples on my arms and back." The client stated the rash lasted 1-2 weeks. The client stated the rash was not itchy. The client did not take any medications for his symptoms or for the rash. The client did follow up with a doctor in another country, who did not provide any advice regarding the 2nd COVID vaccine Pfizer. The client denied any shortness of breath after receiving the first dose of the COVID vaccine Pfizer. The client has no chronic conditions or medications. The client reports that he develops a cough when the weather is cold.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Immunodeficiency, Interchange of vaccine products
Clinical narrative: Administration error mixed series mRNA vaccine Pfizer and Moderna.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis, Ultrasound Doppler abnormal
Clinical narrative: Blood clot in lower right leg.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Left axillary lymph node swelling and tenderness
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Lymph node pain, Lymphadenopathy, Pyrexia, Skin warm
Clinical narrative: I asked the nurse when I had the shot for information and she said she didn't know. I asked my doctor today when I went to be seen what it was called and she said Flulaval Quad.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient was given a booster dose that was not eligible and outside of the guidelines
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood corticotrophin, Blood cortisol, Echocardiogram, Electrocardiogram ambulatory, Exposure during pregnancy
Clinical narrative: Received 1st dose of Pfizer vaccine on 8/12/2021.  Pt states she noted increasing tachycardia since first injection that has gotten progressively worse over time.  Pt now c/o syncope daily, is noted be orthostatic with tachycardia of 140-150bpm with simple ambulation.  Pt has been evaluated by cardiology with no significant findings as of this time.  Pt is now hospitalized on floor for further evaluation
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Laboratory test, Metabolic function test, Syncope, Tachycardia
Clinical narrative: Received 1st dose of Pfizer vaccine on 8/12/2021.  Pt states she noted increasing tachycardia since first injection that has gotten progressively worse over time.  Pt now c/o syncope daily, is noted be orthostatic with tachycardia of 140-150bpm with simple ambulation.  Pt has been evaluated by cardiology with no significant findings as of this time.  Pt is now hospitalized on floor for further evaluation
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: Administration error mixed series mRNA vaccine Pfizer and Moderna.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Electrocardiogram, Electrocardiogram ambulatory, Palpitations
Clinical narrative: heart palpitations, chest tightening and pressure beginning 08/2021  no confirmed relation to the covid vaccine.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash on both feet and lower legs 5 days post shot.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event, Wrong product administered
Clinical narrative: No adverse reactions were seen at the time of administration, but the patient received the Pfizer Covid vaccine instead of  a flu shot and had previously been fully vaccinated with the Moderna Covid vaccines back on 03/27/2021.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: Administration error mixed series mRNA vaccine Pfizer and Moderna.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Product administration error
Clinical narrative: Administration error mixed series mRNA vaccine Pfizer and Moderna.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival erythema, Gingival pain, Noninfective gingivitis, Oral lichen planus, Salivary gland mucocoele
Clinical narrative: Lichen planus oral cavity autoimmune occurrence. Gum redness, inflammation, pain. Vertical white line from tooth to gum. Symptoms occurred beginning Sep 20, 2021 (6 days after first dose of Moderna COVID vaccine).  Diagnosis by dentist  on Sep 24, 2021. Treatment: Dexamethasone elixir-swish 1 tsp. for 2 minutes, 4 times a day. Follow-up appointment Oct 1, 2021. Also mucocele inside of bottom lip (etiology unknown).
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: After immunization, patient fainted.  He was unconscious approximately 1 minute.   I had him remove his mask and gave him a bottle of water.  I sat with him for 10 minutes, then had his girlfriend sit with him another 15 minutes.  After that time he felt fine and they left the phamacy area.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Brain natriuretic peptide, Chest X-ray, Electrocardiogram, Full blood count, Lymphoedema
Clinical narrative: Within days bilateral lower extremity lymphedema developed & persists to this day
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Metabolic function test
Clinical narrative: Within days bilateral lower extremity lymphedema developed & persists to this day
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Chills, Dizziness, Erythema
Clinical narrative: Severe debilitating  headache left side Fatigue  Chills Fever Body aches Lower back pain Nausea Vomiting Internal pains/Organs Dizziness Swelling and redness at injection site Weakness Swelling/redness around eyes
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Severe debilitating  headache left side Fatigue  Chills Fever Body aches Lower back pain Nausea Vomiting Internal pains/Organs Dizziness Swelling and redness at injection site Weakness Swelling/redness around eyes
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Periorbital swelling, Pyrexia, Visceral pain, Vomiting
Clinical narrative: Severe debilitating  headache left side Fatigue  Chills Fever Body aches Lower back pain Nausea Vomiting Internal pains/Organs Dizziness Swelling and redness at injection site Weakness Swelling/redness around eyes
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Patient called inpatient pharmacy to report that he has been experiencing hives since receiving  the second dose of his COVID-19 vaccine on 09/20/2021. He reports that he has been experiencing hives since 09/23/2021. Told patient to seek medical attention at the nearest ED.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, Human chorionic gonadotropin, Ultrasound scan abnormal, Uterine dilation and curettage
Clinical narrative: LMP, 05/30/2021 Miscarriage, 08/2021
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Deep vein thrombosis, Illness, Influenza like illness, Pain in extremity
Clinical narrative: After the first dose I was sick as expected with a sore arm, fever, etc...  After the second dose I got really sick. I had flu like symptoms for about a week or so. Then I had issues breathing , chest pains, and my legs were really sore. I had developed new blood clots in both legs, superficial and deep vein. I did not have a heart related chest pain though. I continue to have these issues right today.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Respiration abnormal, Superficial vein thrombosis
Clinical narrative: After the first dose I was sick as expected with a sore arm, fever, etc...  After the second dose I got really sick. I had flu like symptoms for about a week or so. Then I had issues breathing , chest pains, and my legs were really sore. I had developed new blood clots in both legs, superficial and deep vein. I did not have a heart related chest pain though. I continue to have these issues right today.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Bone pain, Myalgia
Clinical narrative: All over muscle and bone aches, 102 temperature, lasted 24 hours
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site rash
Clinical narrative: pt had bruise at injection site and rash below injection site
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia
Clinical narrative: Sore/ painful ankles. Have never had this before. Both feel weak and sore.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Fall, Syncope, Vertigo
Clinical narrative: Patient fainted, fell to floor, no injuries, was surprised he was on floor.  Stated he had walking vertigo and had no drank any liquid that day. sat patient in chair gave water and he felt much much better.  Patient departed on his own after a time, said he was doing fine.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient received third dose (booster shot) for Moderna. Patient did not qualify for booster dose
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Product administration error
Clinical narrative: Administration error mixed series mRNA vaccine Pfizer and Moderna.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Irritability
Clinical narrative: 10 minutes after vaccines administered, patient developed red flare with wheel around area between where the MMRV and Influenza vaccine were administered on the left arm. The subcutaneous fluid collection seemed to be "outlined" by redness. In addition her right shoulder above the injection site for the Qudracel also became faintly red. There were no other lesions or skin findings, no respiratory symptoms, no facial swelling or vomiting. Patient did get fussy but was consolable to mom and responding appropriately to both mom and medical providers. We had the patient sit quietly for 15 minutes at which point the right shoulder redness resolved and the intensity of the redness on the left arm decreased a bit (total size of that area was approximately 4x4cm area).  We gave her benadryl and the mom also requested tylenol for pain which we gave. After this, she was discharged to home. Per mom, she looked "pale" at home and today was more tired than normal. She continues to have a small mark on her arm today (9/30/21) per mother of the child (not confirmed with photo)
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Neuralgia
Clinical narrative: Immediately after vaccination (Noon on 9/29/21) patient stated he experienced nerve pain, different from soreness pain from previous vaccinations in the past.  The next day 9/30 he noticed the pain has increased. Patient states pain is 4 out of 10 and was concerned about the angle of which the needle entered into his arm. He will contact his primary provider tomorrow if symptoms worsen.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Colonoscopy normal, Fatigue, Stool analysis normal
Clinical narrative: Extreme fatigue; 3 - 5 times per week; occurring mid to late afternoon. Six months later, occurs 1 - 3 times per week & still occurring mid to late afternoon.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Immediate post-injection reaction, Joint range of motion decreased, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Pain and reduced mobility began immediately after vaccination and have continued for almost 7 months. Pain/discomfort is constant and interferes with sleep. Range of motion for shoulder joint is limited thus limiting common daily activities. After 5 months partial relief came with deep massage techniques, but only partial relief.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Sleep disorder
Clinical narrative: Pain and reduced mobility began immediately after vaccination and have continued for almost 7 months. Pain/discomfort is constant and interferes with sleep. Range of motion for shoulder joint is limited thus limiting common daily activities. After 5 months partial relief came with deep massage techniques, but only partial relief.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Administration error: Mixed series mRNA vaccine Pfizer and Moderna.
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: patients daughter mentioned hives and swelling on the injection site of the mother
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Ultrasound Doppler, Vaginal haemorrhage
Clinical narrative: I got the two shots in January and I?m early February I had a painful period with lots of dark red discharge, which is especially bad because I had a hysterectomy over one year prior so I shouldn?t be having periods at all with no uterine lining. I do have endometriosis and had experienced a little spotting in the year precious to the vaccine, but there was a ton right after the vaccine and it was repeated in March and April. I went to my surgeon who was confused. I went to my OBGYN and she was confused. I am now seeing another OBGYN expert to talk through my continued endometriosis issues. I have pictures of what the discharge looked like. I have heard of others having bad periods after the vaccine but none have had a hysterectomy like me, so I am writing to share my experience. I am glad I got the shot but would like to see more research be done around this issue and have it be said as a warning to others.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cough, Diarrhoea, Fatigue
Clinical narrative: Within 7 hours of shot - 102? fever, chills, shaking, nausea, diarrhea, fatigue, horrible insomnia, blinding headache. Significant illness, worse than I?ve ever felt in my life. Lasted over 24 hours straight.   Within 36 hours of shot - head congestion, deep and persistent cough, constantly sneezing, pounding headache made worse by sneezing, muscle pain and weakness. Lasted for 48 hours after onset.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Illness, Insomnia, Myalgia
Clinical narrative: Within 7 hours of shot - 102? fever, chills, shaking, nausea, diarrhea, fatigue, horrible insomnia, blinding headache. Significant illness, worse than I?ve ever felt in my life. Lasted over 24 hours straight.   Within 36 hours of shot - head congestion, deep and persistent cough, constantly sneezing, pounding headache made worse by sneezing, muscle pain and weakness. Lasted for 48 hours after onset.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Sinus congestion, Sneezing, Tremor
Clinical narrative: Within 7 hours of shot - 102? fever, chills, shaking, nausea, diarrhea, fatigue, horrible insomnia, blinding headache. Significant illness, worse than I?ve ever felt in my life. Lasted over 24 hours straight.   Within 36 hours of shot - head congestion, deep and persistent cough, constantly sneezing, pounding headache made worse by sneezing, muscle pain and weakness. Lasted for 48 hours after onset.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pruritus, Urticaria
Clinical narrative: sx started approx 7 minutes after vaccine.  C/o itching left hand spreading to bl arm and lower ext Wheal on left foot under chin, felt heart race.  Denies shortness of breath, denies chest pain, denies palpitations.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Pain, Pyrexia, Rash
Clinical narrative: Full body Rash starting at 7pm 9/30/21- small reddened and slightly raised. Covering entire skin in close proximity. (Febrile to 101.2 at 0530, full body aches/generalized malaise, headache, and slept all day.)
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash papular
Clinical narrative: Full body Rash starting at 7pm 9/30/21- small reddened and slightly raised. Covering entire skin in close proximity. (Febrile to 101.2 at 0530, full body aches/generalized malaise, headache, and slept all day.)
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Immediate post-injection reaction, Inflammation
Clinical narrative: Immediately after dose #2 on 9/26/2021,  hot, red, oval shaped rash below injection site. Morning after on 9/27/2021, systemic inflammation. Fatigue, lethargy, dizziness, severe muscle/joint aches. On 9/30, menstrual spotting starting in the am. Resumption of menstrual bleeding starting in the evening.  Last menstrual cycle ended 09/24/2021. No previous issues with irregular cycle or breakthrough bleeding.
Sex: U
Vaccine: COVID19
Symptoms: Injection site rash, Injection site warmth, Intermenstrual bleeding, Lethargy, Menstrual disorder
Clinical narrative: Immediately after dose #2 on 9/26/2021,  hot, red, oval shaped rash below injection site. Morning after on 9/27/2021, systemic inflammation. Fatigue, lethargy, dizziness, severe muscle/joint aches. On 9/30, menstrual spotting starting in the am. Resumption of menstrual bleeding starting in the evening.  Last menstrual cycle ended 09/24/2021. No previous issues with irregular cycle or breakthrough bleeding.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Rash erythematous
Clinical narrative: Immediately after dose #2 on 9/26/2021,  hot, red, oval shaped rash below injection site. Morning after on 9/27/2021, systemic inflammation. Fatigue, lethargy, dizziness, severe muscle/joint aches. On 9/30, menstrual spotting starting in the am. Resumption of menstrual bleeding starting in the evening.  Last menstrual cycle ended 09/24/2021. No previous issues with irregular cycle or breakthrough bleeding.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Fatigue, Headache, Vision blurred
Clinical narrative: Constant dull headache, left chest pain, shortness of breath, fatigue, and blurred vision
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: Stable rectal cancer for 1 year. before vaccination. He could examine himself and needed to insert forefinger all the way to reach the tumor prior to vaccine. It was stable like this for one year. After vaccine tumor immediately had rapid growth. Today on my exam I could feel the tumor inside anal canal.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, Haemorrhage, Human chorionic gonadotropin negative, Muscle spasms, Ultrasound antenatal screen abnormal
Clinical narrative: LMP, 04/12/2021 Miscarriage / bleeding / cramping, 06/2021
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Chills, Headache, Injection site reaction
Clinical narrative: Fever Chills Body Aches Covid arm No energy  Headaches Heavy chest
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Skin reaction
Clinical narrative: Fever Chills Body Aches Covid arm No energy  Headaches Heavy chest
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient received the third dose of Moderna prior to approval.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstruation irregular, Polymenorrhoea, Pregnancy test negative
Clinical narrative: Menstrual cycle stopped after my first dose. My first dose was august 5th my 2nd august 26. Had a normal period in July and haven?t had one since. Multiple negative pregnancy tests.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: Numb/tingly  left hand immediately after shot given.  Following day hand is achy and weak.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Administration error: Mixed series mRNA vaccine Pfizer and Moderna.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient received the third dose outside of approval guidelines.
Age: 44.0
Sex: M
Vaccine: UNK
Symptoms: Interchange of vaccine products
Clinical narrative: Client received AstraZeneca COVID vaccine, no reaction. AstraZeneca vaccine unavailable in the Janssen given as an alternative on 09/15/21.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest discomfort, Electrocardiogram, Limb discomfort, Muscular weakness
Clinical narrative: Limb weakness and heaviness spreading to chest.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus
Clinical narrative: Overt symptoms and a diagnosis of Lupus erythematosus developed in an otherwise healthy woman within 2 months of the two done vaccine
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: Administration error mixed series mRNA vaccine Pfizer and Moderna.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Nasal congestion, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Tested COVID Positive after suffering from chronic cough, nasal congestion, head congestion, mucus from nose, runny nose
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Secretion discharge, Sinus congestion
Clinical narrative: Tested COVID Positive after suffering from chronic cough, nasal congestion, head congestion, mucus from nose, runny nose
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Client received AstraZeneca COVID vaccine, no reaction. AstraZeneca vaccine unavailable in the US, Janssen given as an alternative on 09/15/21.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: This is the 2nd report I am filing.  I was put on the following medication to stop the reaction  methylprednisolone, fexofenadine and triamcinolone.  on 9/1/2021.  Today 9/302021 my symptoms have returned.  I have welts and itching on my neck, face, hairline, eyelashes, chest and in my ears.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymph node pain, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: High fever of 103.2, chills, horrible body aches, swollen and painful lymph node
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: Administration error: Mixed series mRNA vaccine Pfizer and Moderna.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: CREST syndrome, Condition aggravated, Extremity contracture, Oedema, Scleroderma
Clinical narrative: Patient had longstanding mild scleroderma. WIthin 2 days after second shot, the scleroderma "bloomed" affecting large swaths of skin with thickening and edema, and her fingers experienced contracting and rapid onset of fixed contractions. She blames vaccine totally for this sudden deterioration.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Skin hypertrophy
Clinical narrative: Patient had longstanding mild scleroderma. WIthin 2 days after second shot, the scleroderma "bloomed" affecting large swaths of skin with thickening and edema, and her fingers experienced contracting and rapid onset of fixed contractions. She blames vaccine totally for this sudden deterioration.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: Patient received an additional dose that they were not eligible for. Patient is not immunocompromised.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: Patient came in for an additional dose of Moderna and was administered a dose of Pfizer.  Vaccine mismatch.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Hypoaesthesia, Musculoskeletal stiffness
Clinical narrative: Patient complained a 36 hours after the first dose of Moderna she felt stiff on left arm and leg, her fingers and toes clinched involuntary, her Left fingers were numb as well.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: The patient got Moderna as her first dose and was given Pfizer as the second dose. The patient did not have an adverse reaction to our knowledge at this time.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: I had a local injection site reaction with swelling and redness for 2 weeks. I started having pain with physical limitations when pushing/pulling movements with arm. The pain is not in shoulder but deep in arm at injection site. If I use my arm to push or pull in up, down, forward, backward motions I have pain that restricts further action.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: I had a local injection site reaction with swelling and redness for 2 weeks. I started having pain with physical limitations when pushing/pulling movements with arm. The pain is not in shoulder but deep in arm at injection site. If I use my arm to push or pull in up, down, forward, backward motions I have pain that restricts further action.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: Dizziness and spinning suddenly while lying in bed.   Woke up to feeling off severe dizziness.    Mildly nauseous as well.  Persisted as light headedness and mild dizziness through the day.   Blood pressure routinely checked and normal.   HR normal.   No fever.   No recent head trauma.  Never had this before.   No new or different foods in prior days.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram head, Computerised tomogram normal, Electroencephalogram normal, Laboratory test normal, Seizure
Clinical narrative: 2 weeks after the first Vaccine the patient had a seizure, then 7 days after the second vaccine the patient had another seizure. The patient has never had a history of seizures. now being worked at at the Hospital and has not had any issues since
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Muscle spasms, Nausea
Clinical narrative: Headache, fever, chills, body ache, cramping, diehreah, nausea from 9-21-21 and ongoing as of 9-30-21
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Headache, fever, chills, body ache, cramping, diehreah, nausea from 9-21-21 and ongoing as of 9-30-21
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: Administration error mixed series mRNA vaccine Pfizer and Moderna.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Pruritus, Skin reaction, Swelling
Clinical narrative: Large red, raised area. Itchy. Arm numb. Very painful.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Oral mucosal blistering
Clinical narrative: Blisters on inside of mouth. White blisters on inner lining of lips and jaws. No course of treatment was taken. Blisters were of varying sizes. Lasted around 72 hours before beginning to go away. Went away completely and with no lingering problems.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Carotid artery dissection, Cerebrovascular accident, Headache, Thrombosis
Clinical narrative: Stroke, right coratid artery dissection within 3 months, blood clot in neck artery, headaches
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Mental status changes, Pyrexia
Clinical narrative: Fever:  38.5 C, responsive to Acetaminophen 1g IVPB, and 1g ceftriaxone IV  down to 37.1 C, 90 minutes after administration Patient reported altered mental status, unable to remember how she arrived to ER
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, Emotional distress, Human chorionic gonadotropin positive, Ultrasound uterus abnormal, Uterine dilation and curettage
Clinical narrative: LMP, 02/26/2021 -- > EDD 12/03/2021 Patient stated vaginal discharge, 06/02/2021 Miscarriage @ 13 + 5  D & C, 06/28/2021
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaginal discharge, Vaginal haemorrhage
Clinical narrative: LMP, 02/26/2021 -- > EDD 12/03/2021 Patient stated vaginal discharge, 06/02/2021 Miscarriage @ 13 + 5  D & C, 06/28/2021
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chest pain, Chills, Headache, Hyperhidrosis
Clinical narrative: Injection site hurt so much I couldn't lift my arm over my head, chest burned, muscles ached, sore throat and headache, elevated temperature of 99° when checked, chilling followed by sweating all night long in my sleep. Symptoms began appearing around noon the day after my vaccine and dissipated overnight while I slept.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Injection site pain, Myalgia, Oropharyngeal pain
Clinical narrative: Injection site hurt so much I couldn't lift my arm over my head, chest burned, muscles ached, sore throat and headache, elevated temperature of 99° when checked, chilling followed by sweating all night long in my sleep. Symptoms began appearing around noon the day after my vaccine and dissipated overnight while I slept.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Extra dose administered, Lymph node pain, Lymphadenopathy
Clinical narrative: First two days after vaccine - muscle aches and joint paint throughout body; these symptoms subsided by day 3  First 3 days after vaccine - pain and swelling in the lymph nodes under armpit near vaccine. Pain and swelling still present.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: First two days after vaccine - muscle aches and joint paint throughout body; these symptoms subsided by day 3  First 3 days after vaccine - pain and swelling in the lymph nodes under armpit near vaccine. Pain and swelling still present.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test negative
Clinical narrative: I have not developed any antibodies 6months after taking the Pfizer vaccine. Am I protected, should I try another vaccine?
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling
Clinical narrative: Swollen joints,  extreme arthritis pain in finger joints, wrists, and elbow.  The increasing pain in joints includes more joints each week.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abnormal uterine bleeding, Abortion spontaneous, Exposure during pregnancy, Human chorionic gonadotropin, Ultrasound scan
Clinical narrative: LMP, 03/06/2021 Miscarriage, 06/2021 Prolonged bleeding since Sep 2021
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous
Clinical narrative: I am a female healthcare worker who is reporting a miscarriage at approx. 6 weeks + 4 days; for data acquisition of a female who became pregnant within 6 months of receiving an mRNA vaccine with which there is limited data surrounding pregnancy and birth defects. I am otherwise healthy with 1 previous pregnancy and 1 healthy full term child born pre-pandemic in 2019.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, Human chorionic gonadotropin negative, Injury, Maternal exposure before pregnancy, Thrombosis
Clinical narrative: Miscarriage, 06/2021 (-) FHT
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound scan normal
Clinical narrative: Miscarriage, 06/2021 (-) FHT
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Feeling abnormal, Impaired work ability, Mental impairment
Clinical narrative: I have severe brain fog. I have struggled to get my thoughts together to make sentences. I try to write work emails and can't think straight enough to comply one. Its hard to explain it just seems like a blur over my brain and I'm just confuy.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Not sure why, but since August 24th I have been dizzy.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Chest pain, Headache, Joint swelling
Clinical narrative: PT CAME BACK ON 9/30/21 FOR HER SECOND SHOT REVEALED THAT SHE HAD SEVERE SYMPTOM THE NIGHT OF 8/20/21. PT HAD HEADACHE 4-5 TIMES A WEEK; ROOM SPINNING ON AND OFF THAT NIGHT; SWELLING OF THE ANKLES; LEG PAIN; HEAVY LEGS; FEVER AT NIGHT 3 TIMES A WEEK,;WEAKNESS; BACK PAIN; AND CHEST PAIN AT TIMES. PT DID NOT REPORT THESE SYMPTOMS UNTIL TODAY. TODAY, PT SAID SHE STILL HAS ANKLE SWELLING, FEVER, BACK PAIN. ADVISED PT TO TAKE TYLENOL OR MOTRIN. PT DID NOT SEE ANY DOCTOR REGARDING THESE EFFECTS.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, Pyrexia, Vertigo
Clinical narrative: PT CAME BACK ON 9/30/21 FOR HER SECOND SHOT REVEALED THAT SHE HAD SEVERE SYMPTOM THE NIGHT OF 8/20/21. PT HAD HEADACHE 4-5 TIMES A WEEK; ROOM SPINNING ON AND OFF THAT NIGHT; SWELLING OF THE ANKLES; LEG PAIN; HEAVY LEGS; FEVER AT NIGHT 3 TIMES A WEEK,;WEAKNESS; BACK PAIN; AND CHEST PAIN AT TIMES. PT DID NOT REPORT THESE SYMPTOMS UNTIL TODAY. TODAY, PT SAID SHE STILL HAS ANKLE SWELLING, FEVER, BACK PAIN. ADVISED PT TO TAKE TYLENOL OR MOTRIN. PT DID NOT SEE ANY DOCTOR REGARDING THESE EFFECTS.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Nausea
Clinical narrative: second vaccine: Severe dizziness, nausea, gastro upset  first vaccine: muscle weakness, dizziness, nausea
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac flutter, Chest pain, Diarrhoea, Dyspnoea, Fatigue
Clinical narrative: Vaccination #1:  headache, nausea, severe pain in arm, fatigue, body/muscle aches, flutter in chest (created shortness of breath), diarrhea.  These symptoms began approximated 20-30 minutes after injection and lasted for four days. Vaccination #2:  pain in arm, headache and severe flutter in chest (causing shortness of breath) began about two hours after injection.  When I laid down in bed, the /flutter/shortness of breath got worse.  Body/muscle aches, fatigue, and diarrhea began in the morning after injection and lasted for days.  Then the pains in the chest began and the shortness of breath/flutter in chest continued and did not subside until 9/17/2021.  I developed insomnia and low libido  since receiving second vaccination.. My first good night of rest was 9/26/20.  Still experiencing low libido from vaccination
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Insomnia, Libido decreased, Myalgia, Nausea
Clinical narrative: Vaccination #1:  headache, nausea, severe pain in arm, fatigue, body/muscle aches, flutter in chest (created shortness of breath), diarrhea.  These symptoms began approximated 20-30 minutes after injection and lasted for four days. Vaccination #2:  pain in arm, headache and severe flutter in chest (causing shortness of breath) began about two hours after injection.  When I laid down in bed, the /flutter/shortness of breath got worse.  Body/muscle aches, fatigue, and diarrhea began in the morning after injection and lasted for days.  Then the pains in the chest began and the shortness of breath/flutter in chest continued and did not subside until 9/17/2021.  I developed insomnia and low libido  since receiving second vaccination.. My first good night of rest was 9/26/20.  Still experiencing low libido from vaccination
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Sleep disorder
Clinical narrative: Vaccination #1:  headache, nausea, severe pain in arm, fatigue, body/muscle aches, flutter in chest (created shortness of breath), diarrhea.  These symptoms began approximated 20-30 minutes after injection and lasted for four days. Vaccination #2:  pain in arm, headache and severe flutter in chest (causing shortness of breath) began about two hours after injection.  When I laid down in bed, the /flutter/shortness of breath got worse.  Body/muscle aches, fatigue, and diarrhea began in the morning after injection and lasted for days.  Then the pains in the chest began and the shortness of breath/flutter in chest continued and did not subside until 9/17/2021.  I developed insomnia and low libido  since receiving second vaccination.. My first good night of rest was 9/26/20.  Still experiencing low libido from vaccination
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, Haemorrhage, Human chorionic gonadotropin, Ultrasound foetal abnormal
Clinical narrative: Miscarriage / heavy bleeding, 07/2021
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Nerve injury, Paraesthesia, Peripheral swelling
Clinical narrative: I reduced the Pfizer Covid vaccination at pharmacy on 08/28/2021 I woke up the next day with a tingling, heavy arm. I figured it was from the vaccination site so I rubbed my arm for a couple days. Stretched, and lift weights to help move the flow of the medication. It has been exactly 1x month and I am still experiencing circulation issues from the elbow down , and my hand is constantly tingling. Sensation . The upper part of my arm were the injection was given feels like I am carrying a 10lbs weight on it constantly. I did try to report this to my primary care doctor but the response was not receptive.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site discomfort, Limb discomfort, Paraesthesia, Peripheral vascular disorder
Clinical narrative: I reduced the Pfizer Covid vaccination at pharmacy on 08/28/2021 I woke up the next day with a tingling, heavy arm. I figured it was from the vaccination site so I rubbed my arm for a couple days. Stretched, and lift weights to help move the flow of the medication. It has been exactly 1x month and I am still experiencing circulation issues from the elbow down , and my hand is constantly tingling. Sensation . The upper part of my arm were the injection was given feels like I am carrying a 10lbs weight on it constantly. I did try to report this to my primary care doctor but the response was not receptive.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: Abrupt onset of Severe Hypertension
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Neck pain, Rash, Vomiting
Clinical narrative: 1 Day after shot , pt complained of stiff neck  and  neck  pain. 2  Day  after ,  pt  had  vomited. 3 Day after,  Rash  all  over  body. 4 Day after ,  man  took pt to ER to be examined.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium decreased, Cerebrovascular accident, Glomerular filtration rate decreased, Hepatic enzyme, Renal impairment
Clinical narrative: Stroke
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Urticaria
Clinical narrative: Flu Vaccine x 2 weeks ago at a pharmacy 9/28/2021 #3 Pfizer (booster due to high risk child at home. yesterday c/o (L) sore arm + took Tylenol. last night c/o pin prick rash - developed hives @ torso/back + shoulders. No fever no SOB etc. advised antihistamine + follow-up
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm swelling, heat, erythema itching and pain. Seen in Urgent Care, treated with OTC Zyrtec, Hydrocortisone, Ibuprofen, ice + elevation.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Diarrhoea, Dizziness postural, Dysstasia
Clinical narrative: 9/11/21 Injection at 11AM 9/12/21 3A.M. severe vomiting, diarrhea, unable to move ARM mental confusion - extreme weakness could not stand due to weak/dizzy - extreme fatigue  9/13/21 diarrhea - fatigue - weakness - dizzy persist - mental confusion 9/14/21 Fatigue - weakness - dizzy persist 9/15/21 Weakness + Fatigue persist 9/16/21 symptoms resolved
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Joint range of motion decreased, Vomiting
Clinical narrative: 9/11/21 Injection at 11AM 9/12/21 3A.M. severe vomiting, diarrhea, unable to move ARM mental confusion - extreme weakness could not stand due to weak/dizzy - extreme fatigue  9/13/21 diarrhea - fatigue - weakness - dizzy persist - mental confusion 9/14/21 Fatigue - weakness - dizzy persist 9/15/21 Weakness + Fatigue persist 9/16/21 symptoms resolved
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Facial pain, Pain, Paraesthesia
Clinical narrative: Patient states arm tingling, redness shooting pain up to side side of left  face.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Pt recieved 2 doses of Pfizer + then a third shot of Moderna by mistake
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaemia, Angiogram normal, Dyspnoea, Fibrin D dimer increased, Haematocrit decreased
Clinical narrative: anemia, elevated d-dimer-done and work up shortness of breath symptoms which started a few months ago heavy menstrual bleeding post vaccine
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haemoglobin decreased, Heavy menstrual bleeding
Clinical narrative: anemia, elevated d-dimer-done and work up shortness of breath symptoms which started a few months ago heavy menstrual bleeding post vaccine
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: -gave expired dose -expired -2:10 pm -given-3:05 pm
Sex: M
Vaccine: COVID19
Symptoms: Face oedema, Skin reaction, Skin warm, Urticaria
Clinical narrative: Pt reported severe skin reaction on face 9-24-21 Pt described edema,whelps, skin was hot to the touch e] use for COVID-19 under Emergency Use Authorization (EUA): pt received Moderna Lot # 046c21a
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Asthenia, Chills, Hyperhidrosis
Clinical narrative: Phizer covid vaccine sn FA7484 9/8/21. symptoms began on 9/16/21. Intermintant fever and chill with and without profuse sweating (most began on 9/20 - 9/23), loss of energy (9/17- current), sore muscles (9/19- current), sore joints (919-current) with swelling. Joint problems are still continuing. GI upset on 9/19
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Myalgia, Pyrexia
Clinical narrative: Phizer covid vaccine sn FA7484 9/8/21. symptoms began on 9/16/21. Intermintant fever and chill with and without profuse sweating (most began on 9/20 - 9/23), loss of energy (9/17- current), sore muscles (9/19- current), sore joints (919-current) with swelling. Joint problems are still continuing. GI upset on 9/19
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Hypotension, Pruritus, Stridor, Throat tightness
Clinical narrative: delayed anaphylaxis; This is a spontaneous report from a contactable other-HCP (patient) reported for herself. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Brand= Pfizer), dose 2 intramuscularly, administered in arm right on 21Jan2021 (lot number: EJ1686) (30-year-old at vaccination) as single dose for COVID-19 immunisation. The patient was not pregnant. Facility type vaccine was hospital. Medical history included allergy induced asthma, known allergies: keflex, pine, amoxicillin, methyl methacrylate, adhesives, monocryl sutures, triclosan, tramadol. Historical vaccination included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Brand= Pfizer), dose 1 intramuscularly in left arm on 27Dec2021 (lot number: EL1284) (30-year-old at vaccination) for COVID-19 immunization. No COVID prior vaccination. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient experienced delayed anaphylaxis (hospitalization, life threatening) on 21Jan2021 16:15 with outcome of recovered in 2021. The patient was hospitalized for delayed anaphylaxis for 1 days. Delayed anaphylaxis requiring 4 epipens to be given and then started on an epinephrine drip for over 12 hours. AE resulted in: Emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). No COVID tested post vaccination.; Sender's Comments: A causal association between administration of BNT162B2 and the onset of anaphylaxis cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cough, Dyspnoea, Eye swelling, Hypotension, Laboratory test
Clinical narrative: delayed anaphylaxis; This is a spontaneous report from a contactable other-HCP (patient) reported for herself. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Brand= Pfizer), dose 2 intramuscularly, administered in arm right on 21Jan2021 (lot number: EJ1686) (30-year-old at vaccination) as single dose for COVID-19 immunisation. The patient was not pregnant. Facility type vaccine was hospital. Medical history included allergy induced asthma, known allergies: keflex, pine, amoxicillin, methyl methacrylate, adhesives, monocryl sutures, triclosan, tramadol. Historical vaccination included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Brand= Pfizer), dose 1 intramuscularly in left arm on 27Dec2021 (lot number: EL1284) (30-year-old at vaccination) for COVID-19 immunization. No COVID prior vaccination. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient experienced delayed anaphylaxis (hospitalization, life threatening) on 21Jan2021 16:15 with outcome of recovered in 2021. The patient was hospitalized for delayed anaphylaxis for 1 days. Delayed anaphylaxis requiring 4 epipens to be given and then started on an epinephrine drip for over 12 hours. AE resulted in: Emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). No COVID tested post vaccination.; Sender's Comments: A causal association between administration of BNT162B2 and the onset of anaphylaxis cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product.