chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: congestion in her head; tender and painful at the injection site; sore throat; bad cough; achy; Initial information received on 29-Dec-2020 regarding an unsolicited valid non-serious case from a consumer (patient).  This case involves a 52 years old female patient who experienced sore throat (oropharyngeal pain), bad cough (cough), was achy (pain), had congestion in her head (head discomfort) and was tender and painful at the injection site (vaccination site pain), while she received vaccine influenza quadrival a-b vaccine [Fluzone Quadrivalent].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included sodium (NA).  On 20-Oct-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (with unknown strength, formulation, dose, frequency, lot number and expiration date) via unknown route in the right arm for prophylaxis vaccination.   On 22-Oct-2020, 2 days after administration of suspect vaccine, sore throat (oropharyngeal pain), bad cough (cough), achy (pain) and stated intense for 3-4 days.  On an unknown date, (latency unknown) after administration of suspect vaccine, had congestion in her head (head discomfort) but it was less troublesome than the cough and was tender and painful at the injection site (vaccination site pain).   She has had flu vaccines before but did not knew the brand and had not done well with them and stated for many years she did not get a flu vaccine due to this but had to take care of her dad so did this year.   No laboratory data was provided.   Patient received inhalers and had 2 courses of 10 days steroids, codeine type syrup for cough and it was not reported if the patient received a corrective treatment for other events.   At the time of report, the outcome was not resolved for cough and head discomfort while unknown for other events.     There would be no information available on the batch number for this case.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: patient received 2 doses of the Fluzone Quadrivalent prefilled syringe 10 minutes apart yesterday with no specific side effects or symptoms; Initial information regarding an unsolicited valid non-serious case received from a healthcare professional on 29-Dec-2020.  This case involves a 11-year-old male patient who received 2 doses of the INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] prefilled syringe 10 minutes apart yesterday with no specific side effects or symptoms (lot UT71151A, expiration date: 30-Jun-2021) for prophylactic vaccination (extra dose administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  This was an actual medication error case due to the event extra dose administered (latency: on the same day). At the time of reporting, no adverse event was reported.  Disclaimer: this suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in directive 2001/83/ec and module VI of the good Pharmacovigilance practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available regarding batch number in this case.
Sex: U
Vaccine: HIBV, MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Menactra mistakenly for HIB with no adverse event; Initial information received on 30-Dec-2020 regarding an unsolicited valid non-serious case from an other health professional.  This case involves a 2 month old patient of unknown gender who was administered MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot: U6745AB; expiry date 21-Oct-2021) mistakenly for HAEMOPHILUS TYPE B (HIB) VACCINE [HIB] (lot and expiry date unknown) (wrong product administered) both via unknown route in unknown administration site for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported.   On 29-Dec-2020, the patient was given correct vaccine and had no reaction to the vaccine.   This was an actual medication error case due to the wrong product administered (latency: same day). At the time of reporting, no adverse event was reported.  No laboratory data was reported.  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in directive 2001/83/ec and module VI of the good Pharmacovigilance practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Patient had swollen lymph nodes under his left arm 3 days after injection was administered.  He stayed he had surgery to remove lymph nodes in June 2020.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Lymphadenopathy
Clinical narrative: Arm pain at injection site, fatigue, mild headache, swollen lymph nodes
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye pain, Flank pain, Headache, Pain
Clinical narrative: riggors, fever,, severe body aches, flank pain, headache, eyes hurt
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: riggors, fever,, severe body aches, flank pain, headache, eyes hurt
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Hyperhidrosis
Clinical narrative: Patient was anxious when arrived. After receiving the vaccine, felt light headed and revealed he has "spells" of anxiety similar to current experience.  Became diaphoretic and needed to lie down.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: itching, redness and swelling at injection sight.  Took Benadryl on 12/31.  Reappeared on 1/1, visited Er, got dexamethasone, Pepcid po and bendaryl
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Itchy around the vaccine site, stiff muscle, sore arm
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Erythema, Myalgia, Pain in extremity, Vomiting
Clinical narrative: Muscle aches, palm size red ring for 3 days, day 4 rash, Diarrhea, vomiting, arm sore 3 days.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Hypotension
Clinical narrative: shortness of breath, hypotension, presumed anaphylaxis
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Lymphadenopathy
Clinical narrative: Swollen lymph node in left arm 1 week later  Swelling in left arm at injection site 1 week later
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Pain at site of injection
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Painful/sore joints (shoulders and elbows) for two days. Almost went for treatment after about 48 hrs, but got through a rough night and the next morning it was gone.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Local reaction, Pain, Pruritus, Skin warm
Clinical narrative: Moderate local reaction.  Swelling, redness, pain, hot to touch, itchy for 5+ days.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Moderate local reaction.  Swelling, redness, pain, hot to touch, itchy for 5+ days.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Mild swelling, pain, and itching at the injection site 8 days after injection
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: MODERNA COVID 19 VACCINE EUA PAIN TENDERNESS SWELLING/ FATIGUE, HEADACHE, MUSCLE PAIN, JOINT PAIN, CHILLS/ THEN CAME THE ALL OVER BODY RASH AND I STILL HAVE THIS
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash, Swelling, Tenderness
Clinical narrative: MODERNA COVID 19 VACCINE EUA PAIN TENDERNESS SWELLING/ FATIGUE, HEADACHE, MUSCLE PAIN, JOINT PAIN, CHILLS/ THEN CAME THE ALL OVER BODY RASH AND I STILL HAVE THIS
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Pfizer-BioNtech COVID-19 Vaccin EUA-. Severe Dizziness, light- headed.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Redness to the area after a week. resolved
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypersomnia, Pharyngeal erythema, Pharyngeal swelling
Clinical narrative: Thursday 12/29/20 : Started wheezing, I am using my nebulizer but the wheezing seems to be getting worse My throat also is swollen and red. Fatigue/sleeping a lot Headache
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Thursday 12/29/20 : Started wheezing, I am using my nebulizer but the wheezing seems to be getting worse My throat also is swollen and red. Fatigue/sleeping a lot Headache
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Very swollen lymph node in front of my left ear.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flue like symptoms but no fever.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: I am currently breastfeeding my 11 month old son. On Thursday, December 31st, 2020 (2 days after receiving my vaccine), my son developed a fever x24-36hours and diarrhea that is still on going as of today (1/4/2021). There are no known exposures for my son and his illness. I am reporting this as a possible reaction  to the Moderna COVID 19 vaccine I received that could have some how passed through the breastmilk to him.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site urticaria
Clinical narrative: About 1 week after receiving the vaccine (on 12/31/2020) I developed an itchy, raised, and red hive-like rash at the injection site. It got worse over the next day, and I put some steroid cream on it. It went away gradually and was completely resolved by 1/03/2021
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: redness and swollen to inj site, rash to hands Benadryl given for sysmptoms
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Productive cough
Clinical narrative: Arm soreness at injection site, worse than a flu shot and starting an hour after the shot and lasting approx 2 days.  Increased phelgm production for approx 24 hours following injection.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site pruritus
Clinical narrative: Moderna COVID-19 Vaccine   On day 9 after injection, began to get itching at the injection site. Now on day 10 with red area ~ 5 cm x 3 cm. Mild fatigue on day 9 as well.
Age: 26.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: Moderna COVID-19 Vaccine EUA
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood chloride increased, Blood phosphorus decreased, Blood potassium decreased, Blood thyroid stimulating hormone normal
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA - Patient witnessed another patient with syncope prior to her injection.  She was already anxious about receiving vaccination and this increased her anxiety, though she proceeded with immunization. Patient was in 15 min observation window in a chair and began to feel light-headed like she may pass out. A SWAT was called. With RN assistance, patient was lowered to the floor, with no loss of consciousness.  Patient was pale and reported anxiety, racing /pounding heart, and felt hot with facial flushing. Patient was transferred to ED and was noted to be tachycardic (120s), but dropped to 80s. She noted that this episode felt different than her prior syncopal episodes associated with anemia. Patient was observed for 5 hours and discharged to home. Patient returned to ED roughly 2.5 hours later complaining of continued dizziness and unsteady gate. Patient was pale and anxious.  Patient reported had not eaten/drank enough during her shift and received vaccine immediately post a stressful shift. Additionally, patient witnessed another patient have syncopal episode prior to her receiving her vaccine which made her anxious.  Patient was given IV fluids and had electrolytes replacement. Patient additionally received diazepam. Patient was discharged at 2358 on 12/23. Patient returned to ED on 12/24 at 0239 complaining of near syncope and lightheadedness.  Patient had tachycardia and self-reported palpitations.  Received IV fluids and observation on telemetry with no rhythm disturbance.  Patient discharged 1428 on 12/24.  On 12/29, patient returned to ED at 0326  for continued dizziness, fatigue and near syncope. Was admitted for cardiac evaluation.  Noted to have unprovoked tachycardia and was discharged with a Halter Monitor to evaluate cardiac symptoms. patient was discharged 12/31 at 1619
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac telemetry normal, Chest X-ray normal, Computerised tomogram thorax normal, Condition aggravated, Dizziness
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA - Patient witnessed another patient with syncope prior to her injection.  She was already anxious about receiving vaccination and this increased her anxiety, though she proceeded with immunization. Patient was in 15 min observation window in a chair and began to feel light-headed like she may pass out. A SWAT was called. With RN assistance, patient was lowered to the floor, with no loss of consciousness.  Patient was pale and reported anxiety, racing /pounding heart, and felt hot with facial flushing. Patient was transferred to ED and was noted to be tachycardic (120s), but dropped to 80s. She noted that this episode felt different than her prior syncopal episodes associated with anemia. Patient was observed for 5 hours and discharged to home. Patient returned to ED roughly 2.5 hours later complaining of continued dizziness and unsteady gate. Patient was pale and anxious.  Patient reported had not eaten/drank enough during her shift and received vaccine immediately post a stressful shift. Additionally, patient witnessed another patient have syncopal episode prior to her receiving her vaccine which made her anxious.  Patient was given IV fluids and had electrolytes replacement. Patient additionally received diazepam. Patient was discharged at 2358 on 12/23. Patient returned to ED on 12/24 at 0239 complaining of near syncope and lightheadedness.  Patient had tachycardia and self-reported palpitations.  Received IV fluids and observation on telemetry with no rhythm disturbance.  Patient discharged 1428 on 12/24.  On 12/29, patient returned to ED at 0326  for continued dizziness, fatigue and near syncope. Was admitted for cardiac evaluation.  Noted to have unprovoked tachycardia and was discharged with a Halter Monitor to evaluate cardiac symptoms. patient was discharged 12/31 at 1619
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Echocardiogram normal, Ejection fraction normal, Electrocardiogram ambulatory, Fatigue, Feeling hot
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA - Patient witnessed another patient with syncope prior to her injection.  She was already anxious about receiving vaccination and this increased her anxiety, though she proceeded with immunization. Patient was in 15 min observation window in a chair and began to feel light-headed like she may pass out. A SWAT was called. With RN assistance, patient was lowered to the floor, with no loss of consciousness.  Patient was pale and reported anxiety, racing /pounding heart, and felt hot with facial flushing. Patient was transferred to ED and was noted to be tachycardic (120s), but dropped to 80s. She noted that this episode felt different than her prior syncopal episodes associated with anemia. Patient was observed for 5 hours and discharged to home. Patient returned to ED roughly 2.5 hours later complaining of continued dizziness and unsteady gate. Patient was pale and anxious.  Patient reported had not eaten/drank enough during her shift and received vaccine immediately post a stressful shift. Additionally, patient witnessed another patient have syncopal episode prior to her receiving her vaccine which made her anxious.  Patient was given IV fluids and had electrolytes replacement. Patient additionally received diazepam. Patient was discharged at 2358 on 12/23. Patient returned to ED on 12/24 at 0239 complaining of near syncope and lightheadedness.  Patient had tachycardia and self-reported palpitations.  Received IV fluids and observation on telemetry with no rhythm disturbance.  Patient discharged 1428 on 12/24.  On 12/29, patient returned to ED at 0326  for continued dizziness, fatigue and near syncope. Was admitted for cardiac evaluation.  Noted to have unprovoked tachycardia and was discharged with a Halter Monitor to evaluate cardiac symptoms. patient was discharged 12/31 at 1619
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer, Flushing, Gait disturbance, Haemoglobin decreased, Pallor
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA - Patient witnessed another patient with syncope prior to her injection.  She was already anxious about receiving vaccination and this increased her anxiety, though she proceeded with immunization. Patient was in 15 min observation window in a chair and began to feel light-headed like she may pass out. A SWAT was called. With RN assistance, patient was lowered to the floor, with no loss of consciousness.  Patient was pale and reported anxiety, racing /pounding heart, and felt hot with facial flushing. Patient was transferred to ED and was noted to be tachycardic (120s), but dropped to 80s. She noted that this episode felt different than her prior syncopal episodes associated with anemia. Patient was observed for 5 hours and discharged to home. Patient returned to ED roughly 2.5 hours later complaining of continued dizziness and unsteady gate. Patient was pale and anxious.  Patient reported had not eaten/drank enough during her shift and received vaccine immediately post a stressful shift. Additionally, patient witnessed another patient have syncopal episode prior to her receiving her vaccine which made her anxious.  Patient was given IV fluids and had electrolytes replacement. Patient additionally received diazepam. Patient was discharged at 2358 on 12/23. Patient returned to ED on 12/24 at 0239 complaining of near syncope and lightheadedness.  Patient had tachycardia and self-reported palpitations.  Received IV fluids and observation on telemetry with no rhythm disturbance.  Patient discharged 1428 on 12/24.  On 12/29, patient returned to ED at 0326  for continued dizziness, fatigue and near syncope. Was admitted for cardiac evaluation.  Noted to have unprovoked tachycardia and was discharged with a Halter Monitor to evaluate cardiac symptoms. patient was discharged 12/31 at 1619
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Presyncope, Tachycardia, Troponin normal
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA - Patient witnessed another patient with syncope prior to her injection.  She was already anxious about receiving vaccination and this increased her anxiety, though she proceeded with immunization. Patient was in 15 min observation window in a chair and began to feel light-headed like she may pass out. A SWAT was called. With RN assistance, patient was lowered to the floor, with no loss of consciousness.  Patient was pale and reported anxiety, racing /pounding heart, and felt hot with facial flushing. Patient was transferred to ED and was noted to be tachycardic (120s), but dropped to 80s. She noted that this episode felt different than her prior syncopal episodes associated with anemia. Patient was observed for 5 hours and discharged to home. Patient returned to ED roughly 2.5 hours later complaining of continued dizziness and unsteady gate. Patient was pale and anxious.  Patient reported had not eaten/drank enough during her shift and received vaccine immediately post a stressful shift. Additionally, patient witnessed another patient have syncopal episode prior to her receiving her vaccine which made her anxious.  Patient was given IV fluids and had electrolytes replacement. Patient additionally received diazepam. Patient was discharged at 2358 on 12/23. Patient returned to ED on 12/24 at 0239 complaining of near syncope and lightheadedness.  Patient had tachycardia and self-reported palpitations.  Received IV fluids and observation on telemetry with no rhythm disturbance.  Patient discharged 1428 on 12/24.  On 12/29, patient returned to ED at 0326  for continued dizziness, fatigue and near syncope. Was admitted for cardiac evaluation.  Noted to have unprovoked tachycardia and was discharged with a Halter Monitor to evaluate cardiac symptoms. patient was discharged 12/31 at 1619
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vomiting
Clinical narrative: Received the injection on Wednesday afternoon. I woke up around 3am with an excruciating headache, started vomiting around 6am and continued until 7:30pm. The headache continued and as of this morning 1/4 the headache is still there and my stomach is not settled completely.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, Nausea
Clinical narrative: Patient received the vaccine and had slight chest tightness, had a slight headache and has mild nausea.   He worked the day and still has the symptoms at 1:30 pm
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Pt developed urticaria on both arms 4 hours after COVID vaccine administration. Pt received dexamethasone 10mg IM for treatment and diphenhydramine PO 25 mg. Symptoms subsequently resolved.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Urticaria
Clinical narrative: I received the Moderna COVID-19 vaccine on Tuesday, December 29th at work and on Wednesday, December 30th when I woke up my entire neck had broken out in hives. I did not have hives anywhere else or any other reaction. After taking 25 mg of Benadryl po and applying hydrocortisone cream, the hives had cleared up about 75%. I continued to use the hydrocortisone cream throughout the day, but the hives/redness had fully cleared up by Saturday, January 2nd.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen L armpit, medial, at same side of vaccine.  Resolved in 2 days with ibuprofen
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Circular redness at injection site about 2 inch in diameter.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Injection site erythema
Clinical narrative: Flu like symptoms (fever, chills, aches, fatigue, headache); redness, swelling, warmth and firmness at injection site
Sex: M
Vaccine: COVID19
Symptoms: Injection site induration, Injection site swelling, Injection site warmth, Pain, Pyrexia
Clinical narrative: Flu like symptoms (fever, chills, aches, fatigue, headache); redness, swelling, warmth and firmness at injection site
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Paraesthesia, Paraesthesia oral
Clinical narrative: Stuffy nose  tingling lips tingling face i took 50 mg of over the counter benedryl..symptoms resolved
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck pain, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Arm soreness Arm swelling Headache Right side neck pain Bumps on both cheeks (face)
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular
Clinical narrative: Arm soreness Arm swelling Headache Right side neck pain Bumps on both cheeks (face)
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Nausea
Clinical narrative: Patient experienced feeling flushed and nauseated after receiving covid vaccine injection. Declines ED evaluation. No further symptoms reported on 12/19 follow-up
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Eyelids pruritus, Intensive care, Paraesthesia oral, Pruritus
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA - Patient with history of anaphylaxis requiring intubation to benzonatate.  Patient answered "no" to questionnaire about allergic reactions prior to vaccination.  11 minutes after vaccination, patient reported tingling of lips and swelling of face. Developed hoarseness. SWAT was called and patient given benadryl and taken to ED (1055). Patient received steroids and H1/H2 blockers in addition to epinephrine.  Patient brought to ICU for monitoring.  Patient continued on therapy and was discharged 1/2 at 1113. Patient returned to ED on 1/3 at 1558  with macular papular rash on leg, chest and back with itching on eyelids and face.  No respiratory involvement. Patient given benadryl and predinisone and discharged from ED at 2016.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash maculo-papular, Swelling face
Clinical narrative: Pfizer-BioNTech COVID-19 Vaccine EUA - Patient with history of anaphylaxis requiring intubation to benzonatate.  Patient answered "no" to questionnaire about allergic reactions prior to vaccination.  11 minutes after vaccination, patient reported tingling of lips and swelling of face. Developed hoarseness. SWAT was called and patient given benadryl and taken to ED (1055). Patient received steroids and H1/H2 blockers in addition to epinephrine.  Patient brought to ICU for monitoring.  Patient continued on therapy and was discharged 1/2 at 1113. Patient returned to ED on 1/3 at 1558  with macular papular rash on leg, chest and back with itching on eyelids and face.  No respiratory involvement. Patient given benadryl and predinisone and discharged from ED at 2016.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Generalized body aches that evening, same day as injection. Woke up the next morning, 12/31/2020 with a headache, fever of 100.2, and fatigue
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Patient had chills and a fever that started on 12/30/2020 @ 12:00am.  The highest fever recorded was 100.6.  He took Tylenol on 12/30/2020 @ 6:00am.  His symptoms resolved on 12/30/2020 at 8:30pm.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Anterior cervical lymphadenopathy on the ipsilateral side of the vaccination. It seemed to begin on the third day but was most pronounced and painful on the fourth day.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Increasing redness and itchiness, swelling, and discomfort at injection site on R arm, delayed response not present at time of injection, symptoms began 12/27/20 and gradually worsened since then, no improving. Tried Benadryl and cold compresses, as well as Tyelnol.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Pain, Pruritus, Rash
Clinical narrative: Body aches, stomach cramping, rash on abdomen, arms.  Start of period early (last period 12/22). Itchy all over
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Patient developed muscle twitching, fatigue, dizziness and headache minutes after vaccine was given. Day after vaccine given, patient developed small red area around injection site that also had swelling and was warm to touch. No fever or other complication.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site warmth, Muscle twitching
Clinical narrative: Patient developed muscle twitching, fatigue, dizziness and headache minutes after vaccine was given. Day after vaccine given, patient developed small red area around injection site that also had swelling and was warm to touch. No fever or other complication.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain
Clinical narrative: Patient developed muscle twitching, fatigue, dizziness and headache minutes after vaccine was given. Day after vaccine given, patient developed small red area around injection site that also had swelling and was warm to touch. No fever or other complication.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Migraine, Nausea, Swelling face, Urticaria
Clinical narrative: Hives and facial swelling.  Swelling within the ears.  Migrain.  Nausea.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Severe joint pain, especially in hips, knees and hands lasting approximately 72 hours after first onset of symptoms. Treatment Tylenol/NSAIDs. Resolved on its own.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Syringe issue
Clinical narrative: Upon injection, vaccine leaked out of syringe at hub site. Stopped injection after noticing after ~0.1mL expelled. Syringe removed, needle noticeably noted to have a curve and retracted into the syringe partially engaged safety.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Hyperhidrosis, Malaise
Clinical narrative: I received the COVID vaccine on Monday Dec. 21, 2020 at 14:30.  By 17:00 I was not feeling well.  I was tired, had a headache, muscle aches, nausea and a fever of 101 F.   The headache, low grade fever and significant malaise continued through Tues Dec 22 and Wed Dec 23.   On Thursday morning Dec 24 at 2:30 AM, I woke from sleep with the urge to use the bathroom.   I suddenly felt light-headed and dizzy and had a diaphoresis that soaked my hair and PJs.   Fortunately my husband who is a nurse anesthetist helped me through the episode safely and was able to get me back to bed.   I am not sure if that event was related to the vaccine or if I happened to be a little dehydrated and had a vaso-vagal event.  I did not take any medications because I was allowing my body to have a natural response to the vaccine.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: I received the COVID vaccine on Monday Dec. 21, 2020 at 14:30.  By 17:00 I was not feeling well.  I was tired, had a headache, muscle aches, nausea and a fever of 101 F.   The headache, low grade fever and significant malaise continued through Tues Dec 22 and Wed Dec 23.   On Thursday morning Dec 24 at 2:30 AM, I woke from sleep with the urge to use the bathroom.   I suddenly felt light-headed and dizzy and had a diaphoresis that soaked my hair and PJs.   Fortunately my husband who is a nurse anesthetist helped me through the episode safely and was able to get me back to bed.   I am not sure if that event was related to the vaccine or if I happened to be a little dehydrated and had a vaso-vagal event.  I did not take any medications because I was allowing my body to have a natural response to the vaccine.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vertigo
Clinical narrative: Woke up with a case a vertigo that lasted 30-45 minutes, Headache that lasted around 6 hours that same day
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Pruritus
Clinical narrative: 2 Red Area-, itching, burning-the size of a golf ball, the other the size of a quarter- Located at the front of my neck  I had vaccine on 12/30/20  at 1:30 pm, and woke up on 01/01/21 at 7am with the red areas.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Palpitations
Clinical narrative: I felt like I was having palpitations, and my blood pressure shot up to 169/119.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: About 6 hours after receiving dose, experienced aching in both arms that extended down into both hands - hands was resolved by next morning. Achiness in both arms remained x 48 hours
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Dyspnoea, Flushing, Nausea, Pyrexia
Clinical narrative: * TESTED POSTIVE FOR COVID ANTIBODIES 06/2020 - 'STILL HAVE RESIDUAL COUGH' 12/21/2020 - VACCINATION 12/22/2020 9:30 WERE AT WORK; FELT SUPER FLUSHED, SOB, COULDN'T FOCUS, FELT FEVERISH, FELT NAUSEOUS.  OCCUPATIONAL HEALTH REFERRED TO URGENT CARE; DR STATED 'NOT TYPICAL RESPONSE'; COVID TEST; NEGATIVE
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: * TESTED POSTIVE FOR COVID ANTIBODIES 06/2020 - 'STILL HAVE RESIDUAL COUGH' 12/21/2020 - VACCINATION 12/22/2020 9:30 WERE AT WORK; FELT SUPER FLUSHED, SOB, COULDN'T FOCUS, FELT FEVERISH, FELT NAUSEOUS.  OCCUPATIONAL HEALTH REFERRED TO URGENT CARE; DR STATED 'NOT TYPICAL RESPONSE'; COVID TEST; NEGATIVE
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, SARS-CoV-2 test positive
Clinical narrative: 12/26/20 started to experience covid -19 symptoms.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: patient developed fatigue approximately 24 hours after immunization that lasted for about 24 hours. Patient also had soreness at injection site 24 hours after that lasted 24 hours.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Eye irritation, Fatigue, Flushing, Headache
Clinical narrative: first 24 hours: nausea, left arm pain and heaviness 1/2/2021 until present: body aches, very strong headache, sore throat, very tired, coughing with pain, flushed, feel as if my eyes are on fire.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Nausea, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: first 24 hours: nausea, left arm pain and heaviness 1/2/2021 until present: body aches, very strong headache, sore throat, very tired, coughing with pain, flushed, feel as if my eyes are on fire.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: 6 days after injection, left supraclavicular lymph node swelling and tenderness and axillary tenderness and swelling
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Computerised tomogram head, Computerised tomogram normal, Facial paralysis, Hypoaesthesia oral
Clinical narrative: 52 year old female received the Pfizer vaccine on 30 Dec 2020. Noticed a slight left sided facial droop as left lower lip numbess on 31 Dec 2020, which has become more pronounced over the past 2 days. She states she spoke to the nurse hotline right before speaking to me who told her to go to the ED (she was on her way). Denies any extremity weakness, numbness, HA or dizziness. No pain to face or ear. Speech clear on the phone. No recent illness or history of Bell's palsy. NKDA or any prior adverse reactions to immunizations.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Insomnia
Clinical narrative: Client called clinic on 12/30/2020 in the am requesting us to call in prescription pain medication due to having severe arm pain at the injection site. He stated he had not slept any for the last two nights. Encouraged client to see his PMD if he was in the kind of pain that required a Rx pain medication. Encouraged client to ice down his arm for pain.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis exfoliative generalised, Hypersensitivity, Pruritus, Rash
Clinical narrative: Patinet is a 37 y.o. female ER nurse who received her Covid vaccine just prior to arrival.  While being observed at the vaccine site, she developed itching and a rash.  She was brought down to the ER for evaluation.  Mainly she is itchy all over.  She notes a rash across her chest.  But she has no cough shortness of breath wheezing.  There is no problem swallowing there is no facial swelling.  She does not have a history of anaphylaxis, or medication allergies. Review of Systems  Constitutional: Negative for chills, diaphoresis and fever.  HENT: Negative for congestion, trouble swallowing and voice change.   Eyes: Negative for redness and itching.  Respiratory: Negative for cough, shortness of breath, wheezing and stridor.   Musculoskeletal: Negative for myalgias.  Skin: Positive for rash.       Pruritus  Allergic/Immunologic: Negative for environmental allergies, food allergies and immunocompromised state.  Neurological: Negative for headaches.   01/04/2021- Speaking with the patient she states noticed "hives" accross chest, right lower extremity, and left upper extremity.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Suppressed lactation
Clinical narrative: I am breastfeeding-Milk supply significantly decreased (<50% of typical) day of vaccine. Milk supply still decreased 5 days later,
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Patient developed fatigue approximately 24 hours after immunization that lasted a couple days.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Swollen tongue
Clinical narrative: Approx 25 min after injection I became dizzy and my HR went to the 130?s, at around 30 min post injection my tongue started to swell
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Left arm warm, red, sore, swelling noted
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pruritus, Urticaria
Clinical narrative: dizziness, itching/small hives on forearm (not at injection site) , 30 minutes after vaccine given.   Vitals monitored, were normal, sent home and advised to take Benadryl.  More hives on upper lip/chin appeared 36 hours after vaccine given.   Patient was at home, self-treated with benadryl, zyrtec, famotidine and ice pack applied to area.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Neck pain, Pain in extremity
Clinical narrative: Significant neck and upper back pain as soon as 1 hour post vaccine lasting until at least 24 hours - tylenol and heat/ice (no change) chills without fever overnight the night of - no treatment soreness in arm 1 hr post to up to its worst at 24 hours later when I could not abduct >90 degrees for 24 more hours
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: I got moderna COVID19 vaccine on 12/26/2020. Day 1-3 local pain and swelling, no redness. All resolved after day 3-4. Very tired all week post vaccine,.  Day 5-6 noticed ipsilateral axillary lymph node swelling.  On day 7 post vaccine I got a localized area of itching swelling and redness as if I had been bitten by a few mosquitoes at injection site that was new. Milder on day 8, less itchy and swollen, but still red and a little raised.  Mild shortness of breath.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Lymphadenopathy
Clinical narrative: I got moderna COVID19 vaccine on 12/26/2020. Day 1-3 local pain and swelling, no redness. All resolved after day 3-4. Very tired all week post vaccine,.  Day 5-6 noticed ipsilateral axillary lymph node swelling.  On day 7 post vaccine I got a localized area of itching swelling and redness as if I had been bitten by a few mosquitoes at injection site that was new. Milder on day 8, less itchy and swollen, but still red and a little raised.  Mild shortness of breath.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Disorientation, Dyspnoea, Hallucination
Clinical narrative: Really bad headache first 3 days Horrible Chills still ongoing Disoriented and almost like hallucinations Most interesting randomly talking to himself.  I mean like a full conversation with someone that isn?t there.  He also sometimes feels like when holding something he doesn?t see it or feel it and drops it or vice versa ?.. thinks holding something and isn?t Balance is off Shortness of breath  No fever thank goodness and taste and smell are normal
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Really bad headache first 3 days Horrible Chills still ongoing Disoriented and almost like hallucinations Most interesting randomly talking to himself.  I mean like a full conversation with someone that isn?t there.  He also sometimes feels like when holding something he doesn?t see it or feel it and drops it or vice versa ?.. thinks holding something and isn?t Balance is off Shortness of breath  No fever thank goodness and taste and smell are normal
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Erythema, Heart rate increased, Vertigo
Clinical narrative: After got vaccinated, I walked out of the clinic to monitoring area approximately 15 walking steps, I felt a little off balance but I was able to make to the chair and sat down.  Few seconds later, my heart beat increased faster and faster, my neck turned red.  I called for help, they gave me some apple juice to drink and talked to me.  About 5 minutes later, my heart beat went back to normal rate and my redness turned back to normal skin color.  I only had a little vertigo symptom but I was able to manage myself.  About 2 hours later, symptoms disappeared and I was back to my normal health
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Chills, Cough, Malaise
Clinical narrative: 12/31/20 - cough, sneezing, weakness.  Felt ill all weekend. 1/3/21 - called Employee Health with low-grade fever, chills, nausea, weakness and elevated blood pressure 165/104, which had come down by the afternoon to 155/95
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, SARS-CoV-2 test negative, Sneezing
Clinical narrative: 12/31/20 - cough, sneezing, weakness.  Felt ill all weekend. 1/3/21 - called Employee Health with low-grade fever, chills, nausea, weakness and elevated blood pressure 165/104, which had come down by the afternoon to 155/95
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Developed Tachycardia approximately 40 minutes post vaccine
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: patient developed fatigue day after vaccination that lasted about 1 day.
Sex: F
Vaccine: VARZOS
Symptoms: Type IV hypersensitivity reaction
Clinical narrative: violent, delayed reaction; This case was reported by a consumer via other manufacturer and described the occurrence of delayed type hypersensitivity in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included allergy, bee sting hypersensitivity and allergy. Previously administered products included Epipen.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 12 hrs after receiving Shingles vaccine, the patient experienced delayed type hypersensitivity (serious criteria hospitalization). On an unknown date, the outcome of the delayed type hypersensitivity was unknown.   It was unknown if the reporter considered the delayed type hypersensitivity to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had allergies to preservatives,any drug that ends in "caine" (lidocaine, prilocaine etc),bee stings, and tar. Patient carried Epipen and had a hesitation to receiving the Covid 19 vaccine It was reported that patient received the 1st dose of Shingrix and 12 hrs after the vaccination patient had a violent, delayed reaction and patient was sent to the hospital.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Decreased appetite, Dizziness, Fall, Fatigue
Clinical narrative: legs and feet hurt; multiple falls; decreased appetite; also nausea; body ache; gait problem; extreme fatigue; shaky feet; dizziness; joint pain; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose of shingrix on an unknown date).   On 14th November 2020, the patient received the 2nd dose of Shingrix. In November 2020, 1 week after receiving Shingrix, the patient experienced fatigue, tremor limb, dizziness, joint pain, general body pain, gait disorder and nausea. On an unknown date, the patient experienced leg pain, fall and decreased appetite. On an unknown date, the outcome of the fatigue, tremor limb, dizziness, joint pain, leg pain, general body pain, gait disorder, fall, nausea and decreased appetite were unknown.   It was unknown if the reporter considered the fatigue, tremor limb, dizziness, joint pain, leg pain, general body pain, gait disorder, fall, nausea and decreased appetite to be related to Shingrix.  Additional details were provided as follows: The case was reported by the daughter for her mother. About a week after receiving dose of Shingrix, patient experienced extreme fatigue, shaky feet, dizziness, joint pain, body aches, leg pain, multiple falls, nausea and gait disorder and decreased appetite. The patient consented to follow up.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Nausea, Pain, Pain in extremity, Tremor
Clinical narrative: legs and feet hurt; multiple falls; decreased appetite; also nausea; body ache; gait problem; extreme fatigue; shaky feet; dizziness; joint pain; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose of shingrix on an unknown date).   On 14th November 2020, the patient received the 2nd dose of Shingrix. In November 2020, 1 week after receiving Shingrix, the patient experienced fatigue, tremor limb, dizziness, joint pain, general body pain, gait disorder and nausea. On an unknown date, the patient experienced leg pain, fall and decreased appetite. On an unknown date, the outcome of the fatigue, tremor limb, dizziness, joint pain, leg pain, general body pain, gait disorder, fall, nausea and decreased appetite were unknown.   It was unknown if the reporter considered the fatigue, tremor limb, dizziness, joint pain, leg pain, general body pain, gait disorder, fall, nausea and decreased appetite to be related to Shingrix.  Additional details were provided as follows: The case was reported by the daughter for her mother. About a week after receiving dose of Shingrix, patient experienced extreme fatigue, shaky feet, dizziness, joint pain, body aches, leg pain, multiple falls, nausea and gait disorder and decreased appetite. The patient consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles rash; Shingles rash; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th December 2020, the patient received Shingrix. On 18th December 2020, 2 days after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient was pharmacist, received shingrix on wednesday and got shingles rash on friday before date of reporting. The patient stated that it was not listed as a side effect but she had shingles. The reporter did not consent to follow up.