chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Skin warm
Clinical narrative: Received COVID-19 vaccine (Moderna) on 1/21/21. No local reaction. No immediate symptoms (hives, lip swelling, respiratory symptoms). One day later, feverish T99.5F. 1/23/21, Patient developed a painful red rash on the palmar aspect of his hands and dorsum aspect of his feet and has had this rash since (total of 5 days). He currently takes Xyzal daily. Father would like to know if patient should receive the second dose of the vaccine. Erythematous macular rash limited to hands and feet that is blanching. As time progressed, raised in some places. Looked eczematous in some places as well. Painful, stinging skin, and swollen. He has limited range of motion. Hot shower decreased discomfort, increased range of motion. Cold water also helped. Symptoms are improving. Spring 2020 - may have had COVID - had anosmia. Was not tested at the time, but did have COVID antibody testing in July which was negative. Family has reported the reaction to VAERS and is also using V-Safe.   Patient has no history of reactions to vaccines in the past nor has he had an allergic reaction to any component of the Moderna/Pfizer vaccines. He also does not have PEG/polysorbate allergy history (though he has taken Miralax in the past for constipation). Patient does have a history of anaphylaxis.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anosmia, Eczema, Mobility decreased, Pain of skin, Pallor
Clinical narrative: Received COVID-19 vaccine (Moderna) on 1/21/21. No local reaction. No immediate symptoms (hives, lip swelling, respiratory symptoms). One day later, feverish T99.5F. 1/23/21, Patient developed a painful red rash on the palmar aspect of his hands and dorsum aspect of his feet and has had this rash since (total of 5 days). He currently takes Xyzal daily. Father would like to know if patient should receive the second dose of the vaccine. Erythematous macular rash limited to hands and feet that is blanching. As time progressed, raised in some places. Looked eczematous in some places as well. Painful, stinging skin, and swollen. He has limited range of motion. Hot shower decreased discomfort, increased range of motion. Cold water also helped. Symptoms are improving. Spring 2020 - may have had COVID - had anosmia. Was not tested at the time, but did have COVID antibody testing in July which was negative. Family has reported the reaction to VAERS and is also using V-Safe.   Patient has no history of reactions to vaccines in the past nor has he had an allergic reaction to any component of the Moderna/Pfizer vaccines. He also does not have PEG/polysorbate allergy history (though he has taken Miralax in the past for constipation). Patient does have a history of anaphylaxis.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Rash, Rash erythematous, Rash macular, Rash papular
Clinical narrative: Received COVID-19 vaccine (Moderna) on 1/21/21. No local reaction. No immediate symptoms (hives, lip swelling, respiratory symptoms). One day later, feverish T99.5F. 1/23/21, Patient developed a painful red rash on the palmar aspect of his hands and dorsum aspect of his feet and has had this rash since (total of 5 days). He currently takes Xyzal daily. Father would like to know if patient should receive the second dose of the vaccine. Erythematous macular rash limited to hands and feet that is blanching. As time progressed, raised in some places. Looked eczematous in some places as well. Painful, stinging skin, and swollen. He has limited range of motion. Hot shower decreased discomfort, increased range of motion. Cold water also helped. Symptoms are improving. Spring 2020 - may have had COVID - had anosmia. Was not tested at the time, but did have COVID antibody testing in July which was negative. Family has reported the reaction to VAERS and is also using V-Safe.   Patient has no history of reactions to vaccines in the past nor has he had an allergic reaction to any component of the Moderna/Pfizer vaccines. He also does not have PEG/polysorbate allergy history (though he has taken Miralax in the past for constipation). Patient does have a history of anaphylaxis.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Skin swelling
Clinical narrative: Received COVID-19 vaccine (Moderna) on 1/21/21. No local reaction. No immediate symptoms (hives, lip swelling, respiratory symptoms). One day later, feverish T99.5F. 1/23/21, Patient developed a painful red rash on the palmar aspect of his hands and dorsum aspect of his feet and has had this rash since (total of 5 days). He currently takes Xyzal daily. Father would like to know if patient should receive the second dose of the vaccine. Erythematous macular rash limited to hands and feet that is blanching. As time progressed, raised in some places. Looked eczematous in some places as well. Painful, stinging skin, and swollen. He has limited range of motion. Hot shower decreased discomfort, increased range of motion. Cold water also helped. Symptoms are improving. Spring 2020 - may have had COVID - had anosmia. Was not tested at the time, but did have COVID antibody testing in July which was negative. Family has reported the reaction to VAERS and is also using V-Safe.   Patient has no history of reactions to vaccines in the past nor has he had an allergic reaction to any component of the Moderna/Pfizer vaccines. He also does not have PEG/polysorbate allergy history (though he has taken Miralax in the past for constipation). Patient does have a history of anaphylaxis.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: received her first COVID-19 vaccine today at 4:40 PM.  Approximately 25 minutes after her vaccine she developed itching throughout her body.  She was first observed in her seat in the lobby for 5 min. Patient was then directed to a triage room where we observed her for another 15 minutes. She did not develop any SOB, CP, dizziness, oral itching, difficulty swallowing, fatigue or malaise.   Patient was well-appearing throughout this time.  Her lungs were clear and heart rate was regular.  She never developed hives or other rash.  She was offered Benadryl IM and declined due to the excess in drowsiness and because we only had an IM dose.  After approximately 45 minutes from time of vaccination patient departed in good condition. Her symptoms never progressed. She did state that her itching came and went, making it less likely that this was an allergic reaction. She stated that her epi-pen was at home and she lives 15 min away. I asked her to take Benadryl upon arriving home and she agreed.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Induration, Pruritus, Swelling, Urticaria
Clinical narrative: Received the vaccine on 01/16/2021. on 01/23/2021 hives and bumps on arm where the short was given on 01/24/2021. The hives and bumps went away on the 01/25/2021. After that the site was red, swollen and hot. As of 28th everything has resolved.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: Received the vaccine on 01/16/2021. on 01/23/2021 hives and bumps on arm where the short was given on 01/24/2021. The hives and bumps went away on the 01/25/2021. After that the site was red, swollen and hot. As of 28th everything has resolved.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bell's palsy, Facial paralysis, Paraesthesia
Clinical narrative: Sudden onset right sided Bell's Palsy with tinnitus upon awakening in the morning.  Proceeded to see PCP in the afternoon where I was prescribed Prednisone 60mg/day x 7 days and Valacyclovir 500mg BID x 7 days.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bell's palsy, Blood cholesterol increased, Blood immunoglobulin G normal, Blood immunoglobulin M, Lipids increased
Clinical narrative: Sudden onset right sided Bell's Palsy with tinnitus upon awakening in the morning.  Proceeded to see PCP in the afternoon where I was prescribed Prednisone 60mg/day x 7 days and Valacyclovir 500mg BID x 7 days.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Sudden onset right sided Bell's Palsy with tinnitus upon awakening in the morning.  Proceeded to see PCP in the afternoon where I was prescribed Prednisone 60mg/day x 7 days and Valacyclovir 500mg BID x 7 days.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Facial paralysis
Clinical narrative: Sudden onset right sided Bell's Palsy with tinnitus upon awakening in the morning.  Proceeded to see PCP in the afternoon where I was prescribed Prednisone 60mg/day x 7 days and Valacyclovir 500mg BID x 7 days.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysphagia, Dyspnoea, Feeling abnormal, Stridor, Swelling
Clinical narrative: Anaphylaxis reaction 45 minutes after vaccine.  Swollen tongue then trouble breathing.  I was rushed by ambulance to the emergency room.  I was treated with 2 epipens, steriods, and other treatments.  I had to stay at the hospital overnight and was treated with further breathing treatments.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swollen tongue, Wheezing
Clinical narrative: Anaphylaxis reaction 45 minutes after vaccine.  Swollen tongue then trouble breathing.  I was rushed by ambulance to the emergency room.  I was treated with 2 epipens, steriods, and other treatments.  I had to stay at the hospital overnight and was treated with further breathing treatments.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Blood test, Dyspnoea, Swollen tongue
Clinical narrative: Anaphylaxis reaction 45 minutes after vaccine.  Swollen tongue then trouble breathing.  I was rushed by ambulance to the emergency room.  I was treated with 2 epipens, steriods, and other treatments.  I had to stay at the hospital overnight and was treated with further breathing treatments.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, SARS-CoV-2 test negative
Clinical narrative: Anaphylaxis reaction 45 minutes after vaccine.  Swollen tongue then trouble breathing.  I was rushed by ambulance to the emergency room.  I was treated with 2 epipens, steriods, and other treatments.  I had to stay at the hospital overnight and was treated with further breathing treatments.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dry mouth, Nausea
Clinical narrative: Patient experience nausea and sweating.  911 contacted and paramedics arrived and remained with patient until patient felt better. No ER transport required.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Nausea
Clinical narrative: Patient experience nausea and sweating.  911 contacted and paramedics arrived and remained with patient until patient felt better. No ER transport required.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Headache, Muscular weakness, Myalgia, Pyrexia
Clinical narrative: Cellulitis on the arm
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cellulitis, Chills, Headache, Muscular weakness, Myalgia
Clinical narrative: Cellulitis on the arm
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Cellulitis on the arm
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cellulitis
Clinical narrative: Cellulitis on the arm
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Pruritus
Clinical narrative: severe hives on arm of injection site and numbness in throat.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site urticaria, Pharyngeal hypoaesthesia
Clinical narrative: severe hives on arm of injection site and numbness in throat.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, Chest discomfort, Condition aggravated, Dyspnoea
Clinical narrative: 43 y/o F w/ pmhx of asthma requiring intubation x2 (most recently in 2017) c/b PE s/p AC presents with acute onset SOB s/p 2nd dose of COVID vaccine 30 minutes PTA to ED. Pt initially presented to express care and sent to ED. Pt w/ increased work of breathing. Pt c/o chest tightness. Denies fever/chills, URI sx, cough, CP, palpitations, N/V/abd pain, urinary sx, LE swelling, numb/tingling. Denies throat closure, itchiness, rash. Pt on prednisone 30mg daily for a recent asthma exacerbation that has been improving. Denis prior allergic reactions.  43yr female pmhx previous hx of pe, asthma on chronic steroids comes in with shortness of breath s/p covid vaccine. Patient on steroids for asthma exacerbation currently. Vitals show that he is tachycardic, other vitals wnl. On exam patient talking full sentences, no accessory muscle, no wheezing, saturating 100% on room air, no rash, no stridor. ddx allergic reaction, less likely asthma exacerbation vs anxiety, less likely pe.  Plan for benadryl, steroids, pepcid, labs, chest xray, covid-19, reassess.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Electrocardiogram, SARS-CoV-2 test negative, Tachycardia
Clinical narrative: 43 y/o F w/ pmhx of asthma requiring intubation x2 (most recently in 2017) c/b PE s/p AC presents with acute onset SOB s/p 2nd dose of COVID vaccine 30 minutes PTA to ED. Pt initially presented to express care and sent to ED. Pt w/ increased work of breathing. Pt c/o chest tightness. Denies fever/chills, URI sx, cough, CP, palpitations, N/V/abd pain, urinary sx, LE swelling, numb/tingling. Denies throat closure, itchiness, rash. Pt on prednisone 30mg daily for a recent asthma exacerbation that has been improving. Denis prior allergic reactions.  43yr female pmhx previous hx of pe, asthma on chronic steroids comes in with shortness of breath s/p covid vaccine. Patient on steroids for asthma exacerbation currently. Vitals show that he is tachycardic, other vitals wnl. On exam patient talking full sentences, no accessory muscle, no wheezing, saturating 100% on room air, no rash, no stridor. ddx allergic reaction, less likely asthma exacerbation vs anxiety, less likely pe.  Plan for benadryl, steroids, pepcid, labs, chest xray, covid-19, reassess.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Vision blurred
Clinical narrative: bp went way high felt faint anaphylaxis
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Blood pressure measurement, Dizziness, Hypertension
Clinical narrative: bp went way high felt faint anaphylaxis
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Blood pressure increased, Dizziness
Clinical narrative: bp went way high felt faint anaphylaxis
Age: 93.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: facility reported patient died after receiving dose, unknown cause of death at this time
Age: 90.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac failure congestive, Condition aggravated, Death, Dysarthria, Hemiparesis
Clinical narrative: per daughter pt suffered a stroke 1 hour after he was given the covid vaccination. he passed away on 01/24/2021.
Age: 90.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Neurological symptom, Transient ischaemic attack
Clinical narrative: per daughter pt suffered a stroke 1 hour after he was given the covid vaccination. he passed away on 01/24/2021.
Age: 90.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Death
Clinical narrative: per daughter pt suffered a stroke 1 hour after he was given the covid vaccination. he passed away on 01/24/2021.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose normal, Blood test normal, Cardiac monitoring, Chest X-ray normal, Electrocardiogram normal
Clinical narrative: Immediately following vaccination, the patient became dizzy, weak, and suffered a syncopal episode. Blood pressure was noted as hypotensive at 70/60. IV fluids were administered by EMS and patient was transported to the Hospital emergency department for evaluation. After lying flat and receiving IV fluids, Patient's BP improved to 136/79 per triage note. Patient was discharged from the ED with vasovagal syncope and instructed to submit VAERS report.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Loss of consciousness, Malaise
Clinical narrative: Immediately following vaccination, the patient became dizzy, weak, and suffered a syncopal episode. Blood pressure was noted as hypotensive at 70/60. IV fluids were administered by EMS and patient was transported to the Hospital emergency department for evaluation. After lying flat and receiving IV fluids, Patient's BP improved to 136/79 per triage note. Patient was discharged from the ED with vasovagal syncope and instructed to submit VAERS report.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chest X-ray, Dizziness, Electrocardiogram normal, Full blood count
Clinical narrative: Immediately following vaccination, the patient became dizzy, weak, and suffered a syncopal episode. Blood pressure was noted as hypotensive at 70/60. IV fluids were administered by EMS and patient was transported to the Hospital emergency department for evaluation. After lying flat and receiving IV fluids, Patient's BP improved to 136/79 per triage note. Patient was discharged from the ED with vasovagal syncope and instructed to submit VAERS report.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypotension, Metabolic function test, Syncope
Clinical narrative: Immediately following vaccination, the patient became dizzy, weak, and suffered a syncopal episode. Blood pressure was noted as hypotensive at 70/60. IV fluids were administered by EMS and patient was transported to the Hospital emergency department for evaluation. After lying flat and receiving IV fluids, Patient's BP improved to 136/79 per triage note. Patient was discharged from the ED with vasovagal syncope and instructed to submit VAERS report.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deafness, Loss of consciousness, Pruritus, Pulse abnormal, Unresponsive to stimuli
Clinical narrative: WIthin less than 5 minutes I went into Anaphylaxis and Respiratory Arrest, non responsive.  Was given CPR by my husband who was with me and is a nurse and called for help.  Rescue gave a shot of EPI and was still receiving CPR but airway was hard to get to because my teeth were clenched.  A few minutes after the EPI i became conscience again.  i was then transported by ambulance to the nearest hospital.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Blood test, Bruxism, Chest X-ray, Loss of consciousness
Clinical narrative: WIthin less than 5 minutes I went into Anaphylaxis and Respiratory Arrest, non responsive.  Was given CPR by my husband who was with me and is a nurse and called for help.  Rescue gave a shot of EPI and was still receiving CPR but airway was hard to get to because my teeth were clenched.  A few minutes after the EPI i became conscience again.  i was then transported by ambulance to the nearest hospital.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Respiratory arrest, Resuscitation, Unresponsive to stimuli
Clinical narrative: WIthin less than 5 minutes I went into Anaphylaxis and Respiratory Arrest, non responsive.  Was given CPR by my husband who was with me and is a nurse and called for help.  Rescue gave a shot of EPI and was still receiving CPR but airway was hard to get to because my teeth were clenched.  A few minutes after the EPI i became conscience again.  i was then transported by ambulance to the nearest hospital.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure abnormal, Dizziness, Hyperhidrosis, Syncope
Clinical narrative: During vaccine observation, patient noted slumping over in chair.  When assessed she stated she felt lightheaded and was diaphoretic.  Blood pressure obtained was BP 63/34, HR 84. EMS contacted and dispatched.  Patient experienced syncope.  1405 epinephrine with follow-up BP, 168/135; HR 60. Patient in ER later noted some hunger and had not eaten recently.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Hunger, Hyperhidrosis, Posture abnormal, Syncope
Clinical narrative: During vaccine observation, patient noted slumping over in chair.  When assessed she stated she felt lightheaded and was diaphoretic.  Blood pressure obtained was BP 63/34, HR 84. EMS contacted and dispatched.  Patient experienced syncope.  1405 epinephrine with follow-up BP, 168/135; HR 60. Patient in ER later noted some hunger and had not eaten recently.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Large red swollen/feverish ring around injection site with knot in it
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, Pyrexia, Rash
Clinical narrative: Large red swollen/feverish ring around injection site with knot in it
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Large red swollen/feverish ring around injection site with knot in it
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Influenza like illness, Myalgia, Pain, Pyrexia
Clinical narrative: Aches, temperature 101.  Chills, clammy then very sweaty. Feels like he?s been beat up, exhausted. Now this afternoon temperature is normal.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Aches, temperature 101.  Chills, clammy then very sweaty. Feels like he?s been beat up, exhausted. Now this afternoon temperature is normal.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Chills, Cold sweat, Fatigue, Hyperhidrosis
Clinical narrative: Aches, temperature 101.  Chills, clammy then very sweaty. Feels like he?s been beat up, exhausted. Now this afternoon temperature is normal.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: Aches, temperature 101.  Chills, clammy then very sweaty. Feels like he?s been beat up, exhausted. Now this afternoon temperature is normal.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Paraesthesia oral, Throat irritation
Clinical narrative: pt reported tongue itch/tingling, mild sensation same in throat, no difficulty breathing,  evaluated by paramedic, given benadryl (oral, liquid) by paramedic, monitored by paramedic,  improved but not completely resolved- patient agreed to go to hospital for further eval, to be driven by husband who was in parking lot of fire co.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral, Pharyngeal paraesthesia, Throat irritation, Tongue pruritus
Clinical narrative: pt reported tongue itch/tingling, mild sensation same in throat, no difficulty breathing,  evaluated by paramedic, given benadryl (oral, liquid) by paramedic, monitored by paramedic,  improved but not completely resolved- patient agreed to go to hospital for further eval, to be driven by husband who was in parking lot of fire co.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Pruritus, Throat irritation, Throat tightness, Urticaria
Clinical narrative: Moderna COVID-19 vaccine  With in 15 mins of revieving the vaccine I got hives front the too to bottom of my back and my throat began to get itchy and it became hard to breathe. They gave me Pepcid and 2 shots of benadryl in my right arm about 15 to 20 mins apart when my symptoms wouldn't go away the gave me an epipen and called an ambulance and I was taken to hospital in to be observed longer. While at the hospital i was given 2 oral steriods to help with my reaction. I was released from the hospital at about 8:30 pm that night with prescriptions for pepcid, benadryl, prednisone, and an epipen.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Throat irritation, Urticaria
Clinical narrative: Moderna COVID-19 vaccine  With in 15 mins of revieving the vaccine I got hives front the too to bottom of my back and my throat began to get itchy and it became hard to breathe. They gave me Pepcid and 2 shots of benadryl in my right arm about 15 to 20 mins apart when my symptoms wouldn't go away the gave me an epipen and called an ambulance and I was taken to hospital in to be observed longer. While at the hospital i was given 2 oral steriods to help with my reaction. I was released from the hospital at about 8:30 pm that night with prescriptions for pepcid, benadryl, prednisone, and an epipen.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Rash, SARS-CoV-2 test negative
Clinical narrative: mild headache; mild rash; mild stomach upset; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration (left arm) on 15Jan2021 13:30 at single dose for Covid-19 immunization. The patient's medical history included asthma and allergic rhinitis; no known allergies. Concomitant medications included guaifenesin (ROBITUSSIN), levosalbutamol (LEVALBUTEROL), azelastine hcl, and unspecified vitamin (reported as "vit"). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021 (15:45), the patient experienced mild adverse events reported as headache, mild rash within approximately 8 hours after vaccination, mild stomach upset in the morning after vaccination. The patient was treated with 10 mls Benadryl and chamomile tea on 16Jan2021 "mor". The patient has been tested for COVID-19 post vaccination (unspecified date) with unknown result. The patient had been tested for Covid with Nasal Swab on 01Jan2021 (Ag) and on 07Jan2021 (PCR) both with negative result. The outcome of events was recovered on an unspecified date in Jan2021.
Sex: U
Vaccine: HEP
Symptoms: Product storage error
Clinical narrative: No additional AE details; Nurse called to report temperature excursion; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided.      On 11-DEC-2020, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB), 0.5 milliliter for prophylaxis (lot # T014835 with expiration date of 17-JUL-2021 is an invalid lot Number for hepatitis b vaccine (recombinant)(RECOMBIVAX HB). Lot # T014835 with expiration date of 17-JUL-2021 is a valid lot Number for Hepatitis A Vaccine, Inactivated(VAQTA)).       The vaccine experienced temperature below 2 degrees Celsius(C) (1.3 C) for 0 hours 24 minutes, time frame below 2°C (1.3 C) for 0 hours 24 minutes. Previous temperature excursión below 2 C (1.6C) for 24 minutes Digital data logger was involved.
Sex: F
Vaccine: HPV4
Symptoms: Exposure via body fluid
Clinical narrative: Transmission of drug via semen; This spontaneous report was received from the patient's and refers to a female patient of unknown age. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided. On an unknown date, the patient was exposed to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) via his husband's semen(exposure via body fluid). ; Sender's Comments:  US-009507513-2101USA001097: US-009507513-2012USA013606:
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: The patient did not have any other adverse events; The patient received a dose of GARDASIL 9 on 13-JAN-2021. The dose received had an expiration date of 12-DEC-2020; This spontaneous report has been received from a an administrator, concerning a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant therapies were not reported.   On 13-JAN-2021, the patient was vaccinated with 1 dose of an expired HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) vaccine (exact dose, route of administration, anatomical location and vaccine scheme were not provided; lot number R011630 has been verified to be a valid lot number, expiration date was  reported and established on 12-JAN-20210), as prophylaxis (expired product administered). The patient did not have any other adverse events. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. device lotnumber: R011630; expirationdate: 12-DEC-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 19.0
Sex: F
Vaccine: HPV9
Symptoms: Chlamydia test, Exposure during pregnancy, Gonorrhoea, Pregnancy test positive
Clinical narrative: No additional adverse event; Caller confirmed that the consumer was found to be pregnant after the vaccine was administered; This spontaneous report was received from a nurse prescriber regarding a 19-year-old female patient. The patient's concurrent conditions, drug reactions, allergies, and concomitant therapies were not provided. Her medical history include a child birth.   On 19-JAN-2021, the patient received the second dose in the three dose series of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) intramuscular (lot number S028738 has been verified to be a valid lot number, with expiration date reported and established as 03-MAR-2022) as prophylaxis.  On the same day, after the vaccine administration, it was found that the patient was pregnant by a office positive pregnancy test performed (exposure during pregnancy).Moreover, it was confirmed that the patient last menstrual period was one month ago (19-DEC-2020). The patient's due date was reported as 25-SEP-2021, her gestion period was four weeks, the pregnancy outcome was pending, and the fetal outcome was unknown. Also, a gonorrhea and chlamydia test were performed but result the results were pending. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S028738; expirationdate: 03-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: PPV
Symptoms: Drug ineffective
Clinical narrative: Pneumovax did not work; This spontaneous report has been received from the patient's daughter, via Pfizer (Manufacturer control #2021030235), concerning a female patient of unknown age. The patient's concurrent conditions, pertinent medical history, and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot #, expiration date, dose, and route of administration were not provided) as prophylaxis. However, it was reported that it did not work (Drug ineffective). Therefore, she had to take the other one (unspecified).   The causal assessment between drug ineffective and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported.
Sex: F
Vaccine: TYP
Symptoms: Product dose omission issue
Clinical narrative: She missed to take her fourth dose of Vivotif which was due on yesterday; Spontaneous report received on 22DEC2020.  A female consumer reported that "she missed to take her fourth dose of Vivotif which was due on yesterday" (PT: Product dose omission issue). She was receiving Vivotif for immunisation. It was reported that the consumer had taken the first three doses of Vivotif as per the schedule but missed to take the fourth dose of Vivotif which was due on 21DEC2020. Action taken with Vivotif with respect to reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: It was reported that a consumer missed to take her fourth dose of Vivotif (missed dose). Vivotif dose should be taken every other day, and the causality of missed dose is not applicable to Vivotif considering the nature of the event.; Sender's Comments: It was reported that a consumer missed to take her fourth dose of Vivotif (missed dose). Vivotif dose should be taken every other day, and the causality of missed dose is not applicable to Vivotif considering the nature of the event.
Sex: F
Vaccine: TYP
Symptoms: Inappropriate schedule of product administration, Product dose omission issue
Clinical narrative: Completed the course of Vivotif in an inappropriate schedule as she took the second dose of vivotif on day 5; Spontaneous report received on 26DEC2020.  A 43-year-old adult female consumer reported that she "missed her second dose of Vivotif" (PT: Product dose omission issue). She was receiving Vivotif (lot number: 3003330 and expiry date: DEC2020) for immunisation for typhoid. On 22DEC2020, she took her first dose of Vivotif. On 26DEC2020, she reported that she missed to take her second dose of Vivotif. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer missed her second dose of Vivotif (missed dose) on the scheduled date. Further details of the event is limited. Vivotif doses should be taken every other day. Considering the nature of the event, the causality of missed dose is not applicable to Vivotif.  Follow up information was received on 05JAN2021. Previously reported event was updated.  It was reported that the consumer "Completed the course of Vivotif in an inappropriate schedule as she took the second dose of vivotif on day 5" (PT: Inappropriate schedule of product administration). On 26DEC2020, she took her second dose of Vivotif and took her third and fourth dose of Vivotif on 28DEC2020 and 30DEC2020 respectively. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: It was reported that a consumer completed the course of Vivotif in an inappropriate schedule as she took the second dose of vivotif on day 5 (Inappropriate schedule of product administration). This consumer missed her second dose of Vivotif on the scheduled date and took it on day 5 instead of day 3, and then completed the remaining course. Vivotif doses should be taken every other day, and considering the nature of the event, the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif. ; Sender's Comments: It was reported that a consumer completed the course of Vivotif in an inappropriate schedule as she took the second dose of vivotif on day 5 (Inappropriate schedule of product administration). This consumer missed her second dose of Vivotif on the scheduled date and took it on day 5 instead of day 3, and then completed the remaining course. Vivotif doses should be taken every other day, and considering the nature of the event, the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif.
Sex: F
Vaccine: TYP
Symptoms: Expired product administered
Clinical narrative: Realized that the dose of Vivotif that she took yesterday had expired back in November; Spontaneous report received on 29DEC2020.  A 31-year-old female pharmacist "realized that the dose of Vivotif that she took yesterday had expired back in November" (PT: Expired product administered). She was receiving Vivotif (expiry date: NOV2020) for immunisation. On 28DEC2020, she took her first dose of Vivotif. Later, she realized that the dose of Vivotif she took had been expired back in NOV2020. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took first dose of Vivotif and the next day, she realized it was expired about a month ago (expired product administered). Further details of the event is limited. Considering the nature of the event, the causality of expired product administered is not applicable to Vivotif.; Sender's Comments: A consumer took first dose of Vivotif and the next day, she realized it was expired about a month ago (expired product administered). Further details of the event is limited. Considering the nature of the event, the causality of expired product administered is not applicable to Vivotif.
Sex: M
Vaccine: MEN
Symptoms: Illness, Language disorder
Clinical narrative: made my son sick; regress in language; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced sickness and language disorder. On an unknown date, the outcome of the sickness and language disorder were unknown.   It was unknown if the reporter considered the sickness and language disorder to be related to Meningococcal B vaccine.  Additional information was provided as follows: The case was reported by patient's parent. The age at vaccination was not reported. The reporter stated that this vaccine made patient sick and regress in language for months, definitely not good for the brain.
Sex: F
Vaccine: MEN
Symptoms: Body temperature increased, Gait disturbance, Mobility decreased, Pain
Clinical narrative: was in severe pain; spiked a high temp; Could not walk or raise her arms; Could not walk; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced pain, high temperature, mobility decreased and unable to walk. Meningococcal B vaccine was discontinued. On an unknown date, the outcome of the pain, high temperature, mobility decreased and unable to walk were recovered/resolved.   It was unknown if the reporter considered the pain, high temperature, mobility decreased and unable to walk to be related to Meningococcal B vaccine.  Additional details were provided as follows: The reporter was patient's mother. The age at vaccination was not reported. The patient was vaccinated with Meningitis B vaccine and experienced severe side effects. The patient had a high temperature, severe pain, and could not walk or raise her arms for 4 days. The reporter stated the pediatrician did not seem surprised and he cancelled the second shot. No further information was provided.
Sex: U
Vaccine: FLU4, MENB
Symptoms: Exposure during pregnancy, Foetal heart rate decreased
Clinical narrative: low fetal heart tones; Fetal exposure during pregnancy; This prospective pregnancy case was reported by a nurse and described the occurrence of fetal heartbeat absent in a patient exposed to Men B NVS (Bexsero) (batch number ABXA14AB, expiry date 30th March 2021) in utero. The mother received the product for prophylaxis.   Co-suspect product exposures included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe, Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 4MA5A, expiry date 30th June 2020), ceftriaxone (batch number JR6214, expiry date 28th February 2022) and azithromycin.   The parent's medical history included Had medical history of attention deficite hyperactivity disorder in 2011 and obesity in 2017.   On 11th February 2020, the 18-year-old mother received Bexsero .5 ml, Bexsero Pre-Filled Syringe Device and FluLaval Tetra 2019-2020 season (intramuscular) .5 ml. On 20th February 2020, the mother started ceftriaxone (intramuscular) 250 mg at an unknown frequency and azithromycin (oral) 1 g at an unknown frequency. The mother's last menstrual period was on 16th October 2019 and estimated date of delivery was 22nd July 2020. The patient was exposed to Bexsero at week 15 of gestation. The action taken with ceftriaxone was unknown. The action taken with azithromycin was unknown. The patient was diagnosed with fetal heartbeat absent and fetal exposure during pregnancy. On an unknown date, the outcome of the fetal heartbeat absent and fetal exposure during pregnancy were unknown.   It was unknown if the reporter considered the fetal heartbeat absent to be related to Bexsero, Bexsero Pre-Filled Syringe Device and FluLaval Tetra 2019-2020 season.     See case US2020AMR026586 for details regarding the mother case. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient's parent received Bexsero, Flulav tetra 2019-2020 season), ceftriaxone and azithromycin during pregnancy which led to fetal exposure during pregnancy. The patient's parent visited emergency room due to decreased fetal heart tones.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: injection site was red; injection site / very hot to the touch; This case was reported by a consumer and described the occurrence of injection site erythema in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th December 2020, the patient received the 1st dose of Shingrix. In December 2020, less than a week after receiving Shingrix, the patient experienced injection site erythema and injection site warmth. The patient was treated with non-drug therapy (Ice Pack (No Medication)) and analgesic, nos (Analgesics). On an unknown date, the outcome of the injection site erythema and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: After receiving Shingrix and last night the patient's injection site was red and very hot to the touch. The patient used an ice pack for comfort.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: developed shingles a couple of days later; This case was reported by a other health professional and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. Couple of days after receiving Shingrix, the patient developed shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: took the bandaid off / red; took the bandaid off / swollen; took the bandaid off / hot; Hurt when touched; This case was reported by a consumer and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site warmth and injection site tenderness. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site warmth were recovered/resolved and the outcome of the injection site tenderness was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth and injection site tenderness to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. The next day after receiving Shingrix, the patient took the band aid off and it was red and swollen and amp, hot the exact length and width of the band aid. The patient stated that, it lasted a little over a week spreading out and lighter than the original area. The patient reported that, it hurt when touched but it did not inconvenience him/her in any way. The patient was concerned about his/her next injection due in May and asking if he/she should still receive the 2nd injection.  The patent went back to showed it to pharmacist after about a week and a couple of days after receiving Shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Skin warm, Swelling
Clinical narrative: took the bandaid off / red; took the bandaid off / swollen; took the bandaid off / hot; Hurt when touched; This case was reported by a consumer and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling, injection site warmth and injection site tenderness. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site warmth were recovered/resolved and the outcome of the injection site tenderness was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth and injection site tenderness to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. The next day after receiving Shingrix, the patient took the band aid off and it was red and swollen and amp, hot the exact length and width of the band aid. The patient stated that, it lasted a little over a week spreading out and lighter than the original area. The patient reported that, it hurt when touched but it did not inconvenience him/her in any way. The patient was concerned about his/her next injection due in May and asking if he/she should still receive the 2nd injection.  The patent went back to showed it to pharmacist after about a week and a couple of days after receiving Shingrix.
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: Arms were so sore; This case was reported by a consumer and described the occurrence of pain in arm in a adult female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, 1 day after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   The reporter considered the pain in arm to be possibly related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Age at vaccination was not reported. The patient reported that the patient rolled over the morning after receiving vaccine, the patient's arm was sore. This is 1 of 4 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR252430:same reporter US-GLAXOSMITHKLINE-US2020AMR252429:same reporter US-GLAXOSMITHKLINE-US2020AMR252428:same reporter