chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: Headache Sore injection site
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Dizziness, Dysgeusia, Flushing, Hypoacusis
Clinical narrative: vasovagal syncopal reaction. I experienced sudden onset of feeling flushed and warmth body wide, sudden metallic taste in mouth, muffled hearing, dizziness, lightheaded, began to lose vision and consciousness, pallor noted by nurse caring for me, blood pressure recorded was 90/60. I have never experienced this type of reaction before to any vaccine or blood donation but know it can occur occasionally.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Pallor, Presyncope, Skin warm, Syncope
Clinical narrative: vasovagal syncopal reaction. I experienced sudden onset of feeling flushed and warmth body wide, sudden metallic taste in mouth, muffled hearing, dizziness, lightheaded, began to lose vision and consciousness, pallor noted by nurse caring for me, blood pressure recorded was 90/60. I have never experienced this type of reaction before to any vaccine or blood donation but know it can occur occasionally.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Pain
Clinical narrative: BODY ACHES, MIGRAINE
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Pruritus
Clinical narrative: Itching started on left wrist approximately  20 minutes after receiving vaccine and progressed to other arm, back, and legs.   Patient has no other complaints.  Initial blood pressure elevated 180-210 / 120-130.  Patient reports no history of hypertension.  Patient reports having taken Zyrtec approximately 30 minutes prior to receiving vaccine.  Benadryl offered, but declined by patient at this time.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Staff member experienced a fever of 101.7 and chills through the evening. Symptoms then resolved.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Ear congestion, Fatigue
Clinical narrative: Fatigue, ear congestion
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Headache, Myalgia, Pyrexia
Clinical narrative: On 12/23/2020 woke up with Fever 100.6 F, significant muscle aches, headache, diarrhea, and dizziness.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Cough, Dyspnoea, Pyrexia
Clinical narrative: Developed SOB, chills, fever 102.0, cough and posterior back pain with symptoms improving on 12/20/2020 in the PM. He did not seek care or report issue until now. States he feels fine now.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitic response to injection site.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Stated fever 99.5, body wide aches, fatigue
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain, Pyrexia
Clinical narrative: Took NSAID (ibuprofen) to relieve pain and reduce fever. Applied local analgesic to injection site (Methyl/M-salicylate, camphor, menthol ointment).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pruritus, Rash
Clinical narrative: rash to lower back & itching some pain @ site of injection No swelling, HA, fatigue, fever. Txt with antihistamines
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Employee developed fever of 101 initially. Was 102 by 12/22/2020 @ 3AM. Alternating Tylenol/Ibuprofen and reports improvement in symptoms.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Impaired work ability, Myalgia, Nausea
Clinical narrative: IM given 12/18/2020 at 2:40 pm , evening time 9pm claimed fever(no temperature was taken) ;; chills, myalgia, headache on and off tolerable on and off; nauseated (common symptom even in situations employee does not feel well); Took Motrin alternating with Acetaminophen at least 2 tabs a day of each. Medications alleviate symptoms but recurs again until after 48 hours Showed at work but decided to leave work to return to residence. Advised to contact primary care provider to inform provider of the signs and symptoms. Employee was advised to get Covid TEST (PCR)
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: IM given 12/18/2020 at 2:40 pm , evening time 9pm claimed fever(no temperature was taken) ;; chills, myalgia, headache on and off tolerable on and off; nauseated (common symptom even in situations employee does not feel well); Took Motrin alternating with Acetaminophen at least 2 tabs a day of each. Medications alleviate symptoms but recurs again until after 48 hours Showed at work but decided to leave work to return to residence. Advised to contact primary care provider to inform provider of the signs and symptoms. Employee was advised to get Covid TEST (PCR)
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Malaise, Musculoskeletal stiffness
Clinical narrative: 12 hours after vaccination -->generalized muscle aches and arthralgia (of major joints symmetrically painful (both knees, lateral movement of neck stiff) no joint swelling; felt chills no fever. No URI symptoms; and both thigh pain aggravated by change of position (standing from sitting to rising from chair)and even going down flight of stairs. Generalized malaise, felt sick and tired.  NO diarrhea no loss of taste. The following day (Sunday) all complaints resolved. No meds taken throughout post vaccination
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pain in extremity
Clinical narrative: 12 hours after vaccination -->generalized muscle aches and arthralgia (of major joints symmetrically painful (both knees, lateral movement of neck stiff) no joint swelling; felt chills no fever. No URI symptoms; and both thigh pain aggravated by change of position (standing from sitting to rising from chair)and even going down flight of stairs. Generalized malaise, felt sick and tired.  NO diarrhea no loss of taste. The following day (Sunday) all complaints resolved. No meds taken throughout post vaccination
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Skin warm, Urticaria
Clinical narrative: Has allergy with prior reaction to sulfa drugs that she had the same symptoms of warmth and then developed hives. Her left upper extremity was warm to the touch when compared to her right, which was where she received her injection 20 minutes prior. Treated with motrin and benadryl 50mg po and symptoms resolved.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Hypoaesthesia, Hypoaesthesia oral, Nasal congestion
Clinical narrative: patient had left arm numbness and tingling, lips numbs, and headache at 15 minutes. Symptoms continued to increased headache, SOB, nasal congestion, nausea and vomiting, all extremities numb. face pale.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pallor, Paraesthesia, Vomiting
Clinical narrative: patient had left arm numbness and tingling, lips numbs, and headache at 15 minutes. Symptoms continued to increased headache, SOB, nasal congestion, nausea and vomiting, all extremities numb. face pale.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Employee was called 5 hours after medication administration, referring improved but still having Shortness of breath. Referred will go to the ER if symptoms continue
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Musculoskeletal stiffness, Nausea, Pain
Clinical narrative: Soreness, stiffness, fatigue, headache nausea
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Narrative: Symptoms: & Injection site pain Treatment:
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: UrticariaPruritus & URTICARIA
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: SkinRash HYDROCORTISONE
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Developed diarrhea x 10 episodes on 12/17/2020 through 7:00PM on 12/18/2020. Treated with Zofran, Pepcid, and Lactaid.
Age: 64.0
Sex: M
Vaccine: UNK, VARZOS
Symptoms: Vaccination site pain
Clinical narrative: Narrative: Per ambulatory care note on 11/6/20, pt reports receiving the second shingrix vaccine on 09/16/20 and developing pain around the vaccination site on the left arm afterward. The pain did not improve with arm exercises. No fever was reported. Symptoms: Myalgia Treatment:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Developed headache and body aches by 11:00PM following injection. Fever of 100.6 on 12/19/2020.
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Nausea, Vomiting
Clinical narrative: NauseaVomiting & NAUSEA AND VOMITING
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Phone call- already 80% improved
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain, Pyrexia
Clinical narrative: Developed a 101 fever along with body/joint aches on 12/19/2020
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Feeling abnormal, Impaired driving ability
Clinical narrative: One hour after injection I was at the store felt disoriented like I was on a strong pain pill. I felt impaired and used caution driving home from the store. That feeling lasted for 3 hours. I still feel a little foggy headed today at work.
Age: 70.0
Sex: M
Vaccine: FLU4
Symptoms: Confusional state, Fatigue, Pyrexia
Clinical narrative: Confusion, Fever & fatigue
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: developed itching within a few hours of vaccine administration. developed a rash all over body on 12/20/2020. Took Benadryl and symptoms now resolved.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache
Clinical narrative: Headache, lightheadedness, fatigue 5 to 10 min post vaccination
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: NauseaVomiting
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: NauseaVomiting
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: phone call
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspepsia, Gastrointestinal haemorrhage, Nausea, Vomiting
Clinical narrative: 12/23 patient transferred out to acute care hospital for treatment/evaluation of gi bleed. patient does have h/o PPI use that was d/c 5/2020 and no recent gerd symptoms requiring intervention >60 days. NauseaVomiting, GastricBleeding & heartburn
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Impaired work ability, Vertigo
Clinical narrative: 12 hours after receiving the vaccine on saturday afternoon experienced severe headache sunday morning. was able to work through it. subsequently developed vertigo on monday night and missed work on tuesday. very unusual for this employee. now on tuesday evening symptoms are wearing off. did not seek medical attention.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Swollen tongue, Throat tightness
Clinical narrative: Approximately one hour after receiving the vaccine, as the patient was driving home he began experiencing throat tightness and tongue swelling. Once home, they call 911 and administered 0.3 epi (had previous severe allergy to lidocaine). EMS then administered iv benadryl and an albuterol treatment. The patient was reported to go unresponsive en route and received bag and mask ventilation very briefly as well as additional 125g solumedrol and another IM epi injection. On arrival he was reported to be stable, talking, tolerating secretions, without significant complaints. He was observed in the ER for several hours without any symptoms nor objective findings to support anaphylaxis (tongue and airway normal, no wheeze, no rash). He was anxious in the ER and the treating physician wrote that he felt it may likely have been anxiety and not anaphylaxis based on their evaluation.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation
Clinical narrative: 96hrs later still feel disoriented
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Flank pain, Headache, Pain, Pyrexia, SARS-CoV-2 antibody test positive
Clinical narrative: About 12 hours after the vaccine I started to get a fever that got up to 101.2 degrees, headache, body aches and flank pain. I took Tylenol, which helped break the fever and body aches but still have a low grade fever and headache. I believe I have COVID antibodies from a previous infection back in September so think that having the antibodies already could have caused this.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Hyperhidrosis, Pallor, Somnolence
Clinical narrative: Patient became pale & diaphoretic, drowsy but responsive   2 minutes total time of episode
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Hyperhidrosis, Throat irritation
Clinical narrative: Itching in the throat and feeling sweaty
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Eye swelling, Flushing, Headache
Clinical narrative: Yesterday afternoon, she developed a loss of taste and smell. This morning around 0400, she awoke to a splitting headache. She took some Advil and tried to go back to sleep, hoping she could maybe come in to work today a little later. Around 1030 this morning, she began to have significant swelling to her face and eyes along with her skin becoming flushed. She has taken some Benadryl and been instructed to follow up with her PCP
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Yesterday afternoon, she developed a loss of taste and smell. This morning around 0400, she awoke to a splitting headache. She took some Advil and tried to go back to sleep, hoping she could maybe come in to work today a little later. Around 1030 this morning, she began to have significant swelling to her face and eyes along with her skin becoming flushed. She has taken some Benadryl and been instructed to follow up with her PCP
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Feeling abnormal, Nausea, Retching
Clinical narrative: I received the vaccine at 1:40 PM in my left arm. They had me wait 15 minutes for observation. 15 minutes later, I left feeling fine. I went back to work. Around 2:15 I started getting chills. I ignored it thinking that I was psyching myself into it thinking about the shot. But then the nausea began. I was at work and started feeling horrible. I started cramping in my stomach. I was alone at work, and then I started throwing up. It started at 3:40. I left work at 4:30 with the most body wracking chills and went to the emergency room. I was violently heaving at this point and they rushed me into a room where I received an IV drip of fluids and anti nausea medication. It wasn't until after the medication was administered that I felt better. I would say this was around 5 pm. They sent me home with an anti nausea medication. I was released to go home around 730-8 PM. I felt so much better after the medication was administered.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: I received the vaccine at 1:40 PM in my left arm. They had me wait 15 minutes for observation. 15 minutes later, I left feeling fine. I went back to work. Around 2:15 I started getting chills. I ignored it thinking that I was psyching myself into it thinking about the shot. But then the nausea began. I was at work and started feeling horrible. I started cramping in my stomach. I was alone at work, and then I started throwing up. It started at 3:40. I left work at 4:30 with the most body wracking chills and went to the emergency room. I was violently heaving at this point and they rushed me into a room where I received an IV drip of fluids and anti nausea medication. It wasn't until after the medication was administered that I felt better. I would say this was around 5 pm. They sent me home with an anti nausea medication. I was released to go home around 730-8 PM. I felt so much better after the medication was administered.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Hypertension, Paraesthesia oral, Rash, White coat hypertension
Clinical narrative: Patient reported a metallic taste on vaccine administration, after ~ 10 mins reported a tongue tingling.  The patient was escorted to the emergency department for observation.  Patient was slightly hypertensive 140's/90's which is not normal for her.  Some of this could be attributed from the "white coat effect".  The patient had no visible angioedema, just a mild rash on her trunk/upper torso/chest.  The patient was treated with 50mg PO diphenhydramine and 40mg of Famotidine.  The patient's symptoms resolved within 30 minutes of medications administered.   Patient was discharged after ~ 2 hours in the ED.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Impaired work ability, Nausea, Tachycardia
Clinical narrative: Patient experienced immediate and severe nausea and then tachycardia ~140 bpm within 30 minutes of dose  monitored by nursing home physician assistant and sent home from work.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Facial paralysis, Fatigue, Feeling abnormal, Vision blurred
Clinical narrative: 2 hours after the vaccine felt like she was hit by a bus. Had facial droopiness. Has Migraines with the same facial droopiness.  Left eye blurred vision. Stroke like symptoms. Fatigue, weakness.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal discomfort
Clinical narrative: Acute onset nausea and abnormal throat sensation shortly after receiving  COVID vaccine.  Hemodynamically stable in ED, saturating well on RA, did receive Epi .3 mg IM for concern of throat sensation, tolerated well.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Condition aggravated, Pallor, Presyncope, Skin laceration
Clinical narrative: Patient received Covid vaccine while sitting without issue. Within minutes of receipt of the vaccine he had a vagal reaction (fell off his chair). Initial eval was notable for supine position, pale face, HR in 30's, clammy skin, small lac to L forehead (not actively bleeding). Pt was alert and oriented initially then was noted to slow  his speech/had decreased responsiveness <1 minute. He was then alert and able to answer all questions. Denies any past medical history, not on any meds, NKDA, no hx of reaction to vaccines. He denies any itching, rash, swelling, difficulty breathing/SOB/Wheezing, or GI sx. Exam remained unchanged with no objective signs of allergic reaction. His color improved as well and he reported feeling better, was able to sit up. He reports eating minimal breakfast this morning. Has a history vasaovagal reactions with blood draws. Decision made to call EMS for transfer for additional observation. EMS arrived at 1115 and transported patient to ER for observation.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Slow speech, Unresponsive to stimuli
Clinical narrative: Patient received Covid vaccine while sitting without issue. Within minutes of receipt of the vaccine he had a vagal reaction (fell off his chair). Initial eval was notable for supine position, pale face, HR in 30's, clammy skin, small lac to L forehead (not actively bleeding). Pt was alert and oriented initially then was noted to slow  his speech/had decreased responsiveness <1 minute. He was then alert and able to answer all questions. Denies any past medical history, not on any meds, NKDA, no hx of reaction to vaccines. He denies any itching, rash, swelling, difficulty breathing/SOB/Wheezing, or GI sx. Exam remained unchanged with no objective signs of allergic reaction. His color improved as well and he reported feeling better, was able to sit up. He reports eating minimal breakfast this morning. Has a history vasaovagal reactions with blood draws. Decision made to call EMS for transfer for additional observation. EMS arrived at 1115 and transported patient to ER for observation.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Hyperventilation, Rash, Throat tightness, Urticaria
Clinical narrative: Minutes after being vaccinated; patient felt flushed and arms and back and chest developed hives/rash.  Hyperventilation with throat tightness.  Healthcare worker was immediately transported to the Emergency Department and was treated  with Benadryl, Epinephrine, Solu-medrol, Pepcid and Ativan.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Dizziness, Dysstasia, Fear, Feeling abnormal
Clinical narrative: Minutes after being vaccinated; patient felt flushed and arms and back and chest developed hives/rash.  Hyperventilation with throat tightness.  Healthcare worker was immediately transported to the Emergency Department and was treated  with Benadryl, Epinephrine, Solu-medrol, Pepcid and Ativan.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperventilation, Rash, Rash macular, Respiratory rate increased, Slow speech
Clinical narrative: Minutes after being vaccinated; patient felt flushed and arms and back and chest developed hives/rash.  Hyperventilation with throat tightness.  Healthcare worker was immediately transported to the Emergency Department and was treated  with Benadryl, Epinephrine, Solu-medrol, Pepcid and Ativan.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Minutes after being vaccinated; patient felt flushed and arms and back and chest developed hives/rash.  Hyperventilation with throat tightness.  Healthcare worker was immediately transported to the Emergency Department and was treated  with Benadryl, Epinephrine, Solu-medrol, Pepcid and Ativan.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Contusion, Erythema, Injection site induration, Peripheral swelling
Clinical narrative: Left arm swelling, redness, heated/ burning, bruise, rash, low grade fever 99.4, hardened area somewhat similar to a knot on site  Took Benedryl
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Skin warm
Clinical narrative: Left arm swelling, redness, heated/ burning, bruise, rash, low grade fever 99.4, hardened area somewhat similar to a knot on site  Took Benedryl
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Right arm pain
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye
Clinical narrative: Employee calling to report a reaction after receiving a COVID-19 vaccine.    Vaccine Name -  Pfizer  Vaccine Lot # - EK5730  Vaccine Date and time  - ?12/16/2020 @ 06:15am  Is this your first or second dose? First  Date and time of symptom onset - ?  12/20/2020 @ 09:00 am  Symptoms - ?  Dry Eyes  Last day of work and shift - Yesterday 7a-7p?    Home remedies? -    eye drops, Zyrtec, flonase  Any improvement? -  no  Recommendation?  Manage per illness in the workplace policy. Told her that dry eyes is not an adverse reaction of the vaccine received. Recommend to consult her PCP about it.  Employee voiced understanding Employee of information ? yes  Employee voiced any concerns ? yes  Employee?s questions answered to employee?s satisfaction - yes
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Exposure to extreme temperature, Feeling hot, Paraesthesia
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA Patient had eaten before the vaccination, but had walked to the location of the vaccine administration, administration facility heat was on/very high, approximately 8 minutes after receiving the vaccine the patient stated that she felt hot, prickly, lightheaded and weak. She laid on the floor, remained conscious but used an ice pack on her forehead. She was able to walk to another chair located away from the heater and was observed for 30 additional minutes at which time she had a snack, drank water and was cleared to leave. Patient states that she feels okay today.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Headache, Nausea, Pyrexia
Clinical narrative: Head aches; Nausea; Fever; Metal flavor on mouth; This is spontaneous report from a contactable consumer.   A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), unknown route (site of vaccination left arm), on 16Dec2020 05:00 PM at single dose for COVID-19 immunisation. Medical history was none. Concomitant drugs were unknown. The patient experienced headache, nausea, fever, metal flavor on mouth, all at 07:30 PM on 17Dec2020. Patient was treated with acethaminophen. The action taken in response to the events for BNT162B2 was not applicable. The outcome of the events was recovered   Information about lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Headache, Nausea, Pyrexia
Clinical narrative: Nausea, severe headache, very dizzy, started 22 hours after Very flushed, fever 100.6 at 28 hours after
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Hand feels tingley for 15 minutes
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: mild pain at injection site 24 hours after receiving vaccine dose; This is a spontaneous report from a contactable via a Pfizer sales representative.  A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced mild pain at injection site 24 hours after receiving vaccine dose in Dec2020.  Patient is healthy and within weight parameters. The outcome of the event was recovered in Dec2020.    No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Sore arm, body aches, headache, and fatigue.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever 101.7F Rigors Nausea Vomiting
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Electrocardiogram normal, Fatigue, Headache
Clinical narrative: heart rate was 100BPM for 45minutes. I was immediately brought to the Emergency room because of my history of Anaphalxis twice from Sulfa drugs and IV contrast dye. My BP was 179/89 then returned to normal within 30 minutes after vaccine. I was given Pepcid and Benadryl at 5:15. I had a normal EKG and was re,eased by 6:25pm. The rest of the evening I was tires and had a metal tast in the back of my mouth. The following two mornings I woke up with a slight headache but resolved by the afternoon after taking Tylenol.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Woke up 36 hours post vaccine with Headache, nausea dizziness
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal paraesthesia, Rash
Clinical narrative: MILD RASH, TINGLING IN THRAOT
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Nausea, Tremor
Clinical narrative: Nausea, dizziness, states body feels like jelly, shaky.  No vision changes or shortness of breath.  Given oral Benadryl and oral Pepcid and discharged in stable condition after 2 hours.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Rash on face and neck, redness, itching, rash
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia
Clinical narrative: The patient received the vaccine at about 1500, did wait 15 minutes for observation, and left around 1515 with no reported complaints. At around 1535 while driving home patient started having difficulty swallowing and contacted hospital advice nurse who referred the patient to the emergency department.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Heart rate increased, Palpitations
Clinical narrative: Elevated blood pressure Elevated pulse Heart palpitations Light headedness All started within 3 hours of receiving injection
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Hypersensitivity, Pruritus, Urticaria
Clinical narrative: 12-22 HPI  53-year-old female with a history of Addison's disease, anaphylactic reaction who presents to the ED complaining of hives and shortness of breath.  Patient reports that 3 days ago she received the COVID-19 pfizer vaccine.  She reports that since that time she has developed progressively worsening hives on her legs and arms.  Approximately 1 hour ago she began to develop shortness of breath and so she presented to the ER.  Patient reports a previous history of anaphylactic reactions multiple times.  Denies any other acute complaints at this time. MDM Patient came in with shortness of breath and hives.  Suspect allergic reaction to the COVID-19 vaccine.  Patient had already taken 50 mg of Benadryl.  She was given Solu-Medrol and EpiPen.  She reported feeling better with improvement in the pruritus.  She reports that she has had rebound reaction requiring EpiPen at 24 hours.  Given the distance that she lives from adequate medical care and the possibility for recurrent severe reactions, the patient will be hospitalized for further observation.  12-23 Female with history of asthma and addison's had anaphylaxis to covid vaccine.  Admitted over night to ensure that she did not rebound.  Received IV Dex and this am has had no reoccurrence of hives or shortness of breath.  Will discharge home on epipen, hydrocortisone prn, prednisone bid for 5 days.  Return to ER or go to PCP for worsening symptoms.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Face oedema, Peripheral swelling
Clinical narrative: Patient reported that 2 days after the injections she had bilateral arm swelling (left more than right, injection was in the right arm) and hand swelling. She had some facial edema around her eyes. No difficulty with breathing, swallowing or tongue swelling. This all occurred at home.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature increased, Erythema of eyelid, Eye pain
Clinical narrative: Prior to receiving the vaccine I was feeling well, history of asthma, seasonal and environmental allergies, and no history of significant symptoms after previous vaccinations.  Shortly after administration of the COVID-19 vaccine I began to feel nauseous which lasted in duration for approximately 3 days.  On the vaccine administration day,  several hours after administration I developed retrobulbar pain, bilateral eyelid edema, erythema of the right eyelid, this was one of the most significant symptoms that persisted for several days.  In addition, on 12/20 I experienced a several hour episode of  tinnitus and diminished auditory acuity in my right ear, this has also resolved.  From day 2 until current I have experienced decreasing myalgias and arthralgias, the most significant has been lower back midline pain which has been improving.  I developed a temperature of 99.7 Fahrenheit, with administration of acetaminophen.  Although the symptoms have improved this is certainly the most significant constellation of symptoms I have experienced after any vaccination.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Eyelid oedema, Hypoacusis, Myalgia, Nausea, Tinnitus
Clinical narrative: Prior to receiving the vaccine I was feeling well, history of asthma, seasonal and environmental allergies, and no history of significant symptoms after previous vaccinations.  Shortly after administration of the COVID-19 vaccine I began to feel nauseous which lasted in duration for approximately 3 days.  On the vaccine administration day,  several hours after administration I developed retrobulbar pain, bilateral eyelid edema, erythema of the right eyelid, this was one of the most significant symptoms that persisted for several days.  In addition, on 12/20 I experienced a several hour episode of  tinnitus and diminished auditory acuity in my right ear, this has also resolved.  From day 2 until current I have experienced decreasing myalgias and arthralgias, the most significant has been lower back midline pain which has been improving.  I developed a temperature of 99.7 Fahrenheit, with administration of acetaminophen.  Although the symptoms have improved this is certainly the most significant constellation of symptoms I have experienced after any vaccination.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Dry mouth, Headache, Pruritus, Throat tightness
Clinical narrative: Dry mouth  and itching on the back 20 minutes after receipt of vaccine.  Throat feeling blocked.  Headache.  Diphenhydramine 50 mg  PO x1 given.  Symptoms started to subside approximately 20 to 30 minutes after administration of diphenhydramine.  Blood pressure initially elevated at 178/84 but decreased to 142/82 approximately 15 minutes following administration of diphenhydramine.  Patient a little drowsy from the diphenhydramine.   Ears ringing and itching began 1 hour 15 minutes following administration of vaccine (and approximately 45 minutes following administration of diphenhydramine).    Famotidine 20 mg  PO x1 administered.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Dry mouth  and itching on the back 20 minutes after receipt of vaccine.  Throat feeling blocked.  Headache.  Diphenhydramine 50 mg  PO x1 given.  Symptoms started to subside approximately 20 to 30 minutes after administration of diphenhydramine.  Blood pressure initially elevated at 178/84 but decreased to 142/82 approximately 15 minutes following administration of diphenhydramine.  Patient a little drowsy from the diphenhydramine.   Ears ringing and itching began 1 hour 15 minutes following administration of vaccine (and approximately 45 minutes following administration of diphenhydramine).    Famotidine 20 mg  PO x1 administered.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Weird taste in mouth.
Age: 65.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Neck pain
Clinical narrative: Associate received Pfizer covid vaccine  (lot EJ1685 Exp 03/2021) and 27 minutes later complained of shoulder/back pain traveling down her arm.  She was transported via wheelchair to ED triage for further assessment.  No cardiac issues identified; she was monitored in ED ~2hrs and symptoms almost completely resolved per ED note.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Chills, fever, fatigue, muscle pain
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Neck pain, Pain in extremity
Clinical narrative: Onset about 1 hour after injection with mild left deltoid pain. Then over course of 3 hours developed left arm pain, frontal headache, and posterior neck pain. No rash.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache
Clinical narrative: Progress Notes APRN (Nurse Practitioner) ? ? Nurse Practitioner Cosign Needed Expand All Collapse All    COVID VACCINE CLINIC 12/22/2020    Date:  12/22/2020                                                                                              Subjective Patient is a 23 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination.    She denied any history of previous adverse reactions to vaccines.   She was given the Pfizer vaccination in the left deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience Headache and felling warm.  She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis.       Review of Systems  Neurological: Positive for headaches.  All other systems reviewed and are negative.        Objective    Vitals Vitals:   12/22/20 1554 12/22/20 1623 BP: 132/73 121/73 BP Location: Right arm Right arm Patient Position: Sitting Sitting Pulse: 94 85 Temp: (!) 96.7 °F (35.9 °C)   SpO2: 99% 99%     Physical Exam Vitals signs reviewed.  HENT:     Head: Normocephalic.     Nose: Nose normal.     Mouth/Throat:     Mouth: Mucous membranes are moist.  Eyes:     Pupils: Pupils are equal, round, and reactive to light.  Neck:     Musculoskeletal: Normal range of motion.  Cardiovascular:     Rate and Rhythm: Normal rate.     Pulses: Normal pulses.  Pulmonary:     Effort: Pulmonary effort is normal.  Musculoskeletal: Normal range of motion.  Skin:    General: Skin is warm.     Capillary Refill: Capillary refill takes less than 2 seconds.  Neurological:     General: No focal deficit present.     Mental Status: She is alert and oriented to person, place, and time.  Psychiatric:        Mood and Affect: Mood normal.         Assessment/Plan  Treatment included: no therapy. Follow up response to treatment: no side effects. Patient discharge: Stable to go home and follow up with PCP.     Pt was told to take Tylenol for HA.  Continue to monitor symptoms.       APRN Electronically Signed 12/22/2020 4:27 PM
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: About 1 hr after started to have muscle pain/soreness.  Still sore ~40 hrs out.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: Employee received vaccine, stayed 15 minutes and left ?. came back within 5-10 minutes c/o throat tightness and difficulty breathing
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site paraesthesia, Injection site warmth, Lymph node pain, Lymphadenopathy, Pain in extremity
Clinical narrative: Warmth and tingling that started in the injection site (right deltoid) that ran down the arm and to the hand a couple minutes after injection. Warmth and tingling in moderate intensity lasted about 20 minutes and decreased with increased arm movement but lasted the first 24 hours with mild aches in the same arm. An enlarged and painful lymph node occurred in the armpit of the same arm two days later and lasted (although decreasingly) for at least the next 5 days.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Skin warm
Clinical narrative: Warmth and tingling that started in the injection site (right deltoid) that ran down the arm and to the hand a couple minutes after injection. Warmth and tingling in moderate intensity lasted about 20 minutes and decreased with increased arm movement but lasted the first 24 hours with mild aches in the same arm. An enlarged and painful lymph node occurred in the armpit of the same arm two days later and lasted (although decreasingly) for at least the next 5 days.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain
Clinical narrative: Injection site soreness
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, SARS-CoV-2 test negative
Clinical narrative: Injection site soreness
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Dyspnoea, Fatigue, Nasal congestion
Clinical narrative: sore throat, lower back pain, fatigue, 101.8 fever, stuffy nose, joint pain, difficulty breathing
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: sore throat, lower back pain, fatigue, 101.8 fever, stuffy nose, joint pain, difficulty breathing
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia
Clinical narrative: Fatigue, Headache, Muscle Aches and Joint Pain.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Throat irritation
Clinical narrative: Patient received covid 19 vaccine. She began to experience itching throat and swollen tongue. She was sent to the Emergency Department. She received IV Benadryl 50 mg, IV famotidine 20 mg and 125 mg IV solu-medrol. Around 930, patient stated that symptoms had resolved, except for tongue being slightly swollen. Patient was admitted to the observation unit of the hospital.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Nausea, Palpitations, Tachypnoea
Clinical narrative: Patient complained of anxiety, palpitations, and tachypnea.   Patient was laid supine, VS monitored, reassurance, fluids, and snack. Went home after feeling better. Stated some mild nausea the day after.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dysphagia, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: Employee received vaccine, within 10minutes, c/o of weakness, dizziness, shaking.... no complaints of Shortness of breath or tightness... refused to receive any additional treatment.  Continued monitoring for another 2 hours, no additional symptoms, then developed numbness and tingling around mouth and trouble swallowing....  sent to ER.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Employee received vaccine, within 10minutes, c/o of weakness, dizziness, shaking.... no complaints of Shortness of breath or tightness... refused to receive any additional treatment.  Continued monitoring for another 2 hours, no additional symptoms, then developed numbness and tingling around mouth and trouble swallowing....  sent to ER.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA  numbness in left arm and hand post injection
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Malaise, Myalgia
Clinical narrative: Patient reported muscle aches, chills, fatigue, malaise for 2 days after vaccine
Age: 68.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Blood test normal, Loss of consciousness, Urine analysis normal
Clinical narrative: Passed out next morning, went to ER, received 2 units of fluids, released with heart monitor for 48 hrs
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Headache, Hyperhidrosis, Pain
Clinical narrative: HEADACHE, EXCESSIVE CHILLS, EXCESSIVE SWEATING, FEVER, BODYACHES, STOMACHACHE
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: HEADACHE, EXCESSIVE CHILLS, EXCESSIVE SWEATING, FEVER, BODYACHES, STOMACHACHE
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: The customer administered MMRRII intramuscularly instead of subcutaneously; No other AE; This spontaneous report has been received from a pharmacist concerning a patient of unknown age and gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.      On 04-DEC-2020, the patient was vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) formulation not reported but defaulted to subcutaneous injection, Lot # S036662, expiration date not reported but upon internal validation established as 14-NOV-2021 for prophylaxis. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was administered intramuscularly instead of subcutaneously.  No other adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Autoimmune disorder, Autoimmune hepatitis, Balance disorder, Cardiac disorder, Myocardial infarction
Clinical narrative: autoimmune hepatitis liver disease / development of autoimmune diseases; myocardial infarction / cardiac issues; pruritus / lesions across her body; vertigo / balance issues; This spontaneous report as received from a lawyer referring to a patient of unknown age and gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On 08-JAN-2015, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, route, dosage schedule, lot number and expiration date were not reported). On an unknown date, shortly after receiving zoster vaccine live(ZOSTAVAX) vaccine. Plaintiff suffered various health issues, including, but not limited to, lesions across her body, cardiac issues, vision problems, balance issues, and the development of autoimmune diseases. Specifically, Plaintiff was diagnosed with pruritus, myocardial infarction, vertigo, and autoimmune hepatitis liver disease. These injuries were caused by zoster vaccine live(ZOSTAVAX).  As a direct and proximate result, the plaintiff s symptoms have resulted in physical limitations not present before. Plaintiff also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Plaintiff sustained serious, progressive, severe and permanent personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment.   Upon internal review, the events were considered disabling; and myocardial infarction and autoimmune hepatitis were considered medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus, Skin lesion, Vertigo, Visual impairment
Clinical narrative: autoimmune hepatitis liver disease / development of autoimmune diseases; myocardial infarction / cardiac issues; pruritus / lesions across her body; vertigo / balance issues; This spontaneous report as received from a lawyer referring to a patient of unknown age and gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On 08-JAN-2015, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, route, dosage schedule, lot number and expiration date were not reported). On an unknown date, shortly after receiving zoster vaccine live(ZOSTAVAX) vaccine. Plaintiff suffered various health issues, including, but not limited to, lesions across her body, cardiac issues, vision problems, balance issues, and the development of autoimmune diseases. Specifically, Plaintiff was diagnosed with pruritus, myocardial infarction, vertigo, and autoimmune hepatitis liver disease. These injuries were caused by zoster vaccine live(ZOSTAVAX).  As a direct and proximate result, the plaintiff s symptoms have resulted in physical limitations not present before. Plaintiff also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Plaintiff sustained serious, progressive, severe and permanent personal injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment.   Upon internal review, the events were considered disabling; and myocardial infarction and autoimmune hepatitis were considered medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation, concerning a male patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided.   In or about September 2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) at a pharmacy, for routine health maintenance and for its intended purpose: the prevention of shingles (dose, route of administration, anatomical location, lot number and expiration date were not reported).   In or around April 2018, the pt presented to the physician, with a painful rash on his right leg, which was diagnosed as shingles. The shingles outbreak lasted approximately three months, causing severe pain and suffering. Symptoms resulted in physical limitations not present prior to vaccination and the pt experienced mental and emotional distress due to resulting physical limitations and seriousness of the condition. The pt suffered severe, serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Moreover, the pt had incurred and would continue to incur medical expenses and other economic harm.   The outcome of the event was considered to be not resolved. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the event of shingles was considered to be disabling.