chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: fever; body aches; headache; sharp pain in my left arm; limited in mobility to bed; This is a spontaneous report from a contactable consumer reporting for herself.  A 21-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot Number: EH9899), via an unspecified route of administration in the left arm on 18Dec2020 13:45 at single dose for covid-19 immunisation. Medical history included asthma, factor v deficiency, covid-19 and allergy to bee venom. The patient was tested positive for COVID on 10Nov2020 and was asymptomatic. Concomitant medication included benzathine benzylpenicillin (DEPO PEN). On 18Dec2020 at 23:00 (the night following the vaccine) the patient woke with a fever, body aches, headache, and a sharp pain in her left arm. She was limited in mobility to bed. these symptoms continued throughout the next day. The patient took ibuprofen but that had no effect. Diphenhydramine hydrochloride; paracetamol (TYLENOL PM) was able to reduce her fever on the second night so that she was able to sleep. Most of her symptoms started to clear up by 20Dec2020. The outcome of the events was recovering.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Mobility decreased, Pain, Pain in extremity, Pyrexia
Clinical narrative: fever; body aches; headache; sharp pain in my left arm; limited in mobility to bed; This is a spontaneous report from a contactable consumer reporting for herself.  A 21-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot Number: EH9899), via an unspecified route of administration in the left arm on 18Dec2020 13:45 at single dose for covid-19 immunisation. Medical history included asthma, factor v deficiency, covid-19 and allergy to bee venom. The patient was tested positive for COVID on 10Nov2020 and was asymptomatic. Concomitant medication included benzathine benzylpenicillin (DEPO PEN). On 18Dec2020 at 23:00 (the night following the vaccine) the patient woke with a fever, body aches, headache, and a sharp pain in her left arm. She was limited in mobility to bed. these symptoms continued throughout the next day. The patient took ibuprofen but that had no effect. Diphenhydramine hydrochloride; paracetamol (TYLENOL PM) was able to reduce her fever on the second night so that she was able to sleep. Most of her symptoms started to clear up by 20Dec2020. The outcome of the events was recovering.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: Vaccine given. Within 10 minutes, started feeling unwell. Transported down the hall to the ER. In ER, steroids, other treatments. Followed up in outpatient walk in clinic two days, then again 4 days later. Persistent rash, difficulty breathing--consistent with allergic reaction, asthma (allergic reaction more prominent at 2 days, reactive airways more prominent at 4 days)
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthma, Chest X-ray normal, Condition aggravated, Dyspnoea, Hypersensitivity
Clinical narrative: Vaccine given. Within 10 minutes, started feeling unwell. Transported down the hall to the ER. In ER, steroids, other treatments. Followed up in outpatient walk in clinic two days, then again 4 days later. Persistent rash, difficulty breathing--consistent with allergic reaction, asthma (allergic reaction more prominent at 2 days, reactive airways more prominent at 4 days)
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Malaise, Rash
Clinical narrative: Vaccine given. Within 10 minutes, started feeling unwell. Transported down the hall to the ER. In ER, steroids, other treatments. Followed up in outpatient walk in clinic two days, then again 4 days later. Persistent rash, difficulty breathing--consistent with allergic reaction, asthma (allergic reaction more prominent at 2 days, reactive airways more prominent at 4 days)
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Dyspnoea, Erythema, Feeling hot, Headache
Clinical narrative: Vaccine given. Within 10 minutes, started feeling unwell. Transported down the hall to the ER. In ER, steroids, other treatments. Followed up in outpatient walk in clinic two days, then again 4 days later. Persistent rash, difficulty breathing--consistent with allergic reaction, asthma (allergic reaction more prominent at 2 days, reactive airways more prominent at 4 days)
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Heart rate increased, Nausea, Pruritus, Rash macular
Clinical narrative: Vaccine given. Within 10 minutes, started feeling unwell. Transported down the hall to the ER. In ER, steroids, other treatments. Followed up in outpatient walk in clinic two days, then again 4 days later. Persistent rash, difficulty breathing--consistent with allergic reaction, asthma (allergic reaction more prominent at 2 days, reactive airways more prominent at 4 days)
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort, Nausea, Pruritus, Urticaria
Clinical narrative: Hives in her face; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received BNT162B2 (Pfizer-Biontech covid-19 vaccine, Lot. PAA156051-EK5730) on 18Dec2020 at 10:15, at single dose, for COVID-19 immunisation. The vaccine was administered at hospital. Relevant medical history was none. Concomitant medications were unknown. On 18Dec2020, the patient experienced hives in her face. The patient was treated with diphenhydramine hydrochloride (BENADRYL). Clinical outcome of the adverse event was unknown at time of this report.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Hives in her face; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received BNT162B2 (Pfizer-Biontech covid-19 vaccine, Lot. PAA156051-EK5730) on 18Dec2020 at 10:15, at single dose, for COVID-19 immunisation. The vaccine was administered at hospital. Relevant medical history was none. Concomitant medications were unknown. On 18Dec2020, the patient experienced hives in her face. The patient was treated with diphenhydramine hydrochloride (BENADRYL). Clinical outcome of the adverse event was unknown at time of this report.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Flushing, Heart rate increased, Pruritus
Clinical narrative: Within 3 mins I started to get  flushed ,hot , sweaty, hot flashes, light headed 6 Mins later I started to itch all over  Benadryl 50mg IM
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling hot, Flushing, Hot flush, Hyperhidrosis
Clinical narrative: Within 3 mins I started to get  flushed ,hot , sweaty, hot flashes, light headed 6 Mins later I started to itch all over  Benadryl 50mg IM
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: Within 3 mins I started to get  flushed ,hot , sweaty, hot flashes, light headed 6 Mins later I started to itch all over  Benadryl 50mg IM
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Pt developed a rash on her entire upper trunk and face.  Started behind her ear on day one and by the next day had spread all over with extreme itching and discomfort.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Pruritus, Rash
Clinical narrative: Pt developed a rash on her entire upper trunk and face.  Started behind her ear on day one and by the next day had spread all over with extreme itching and discomfort.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Hyperhidrosis, Malaise, Pallor
Clinical narrative: Tightness  in throat, sob, pressure in chest, numbness in chest, Cannot take Benadryl so they gave EpiPen.  Felt better as they were taking her to the hosp and then she started to feel the pressure again. Was given a high solumedral IV and pepsidIV.  Developed anxiety. At home started to feel cold had the shakes. Body felt very heavy. Could not move her body. It was like she was drunk. Has no recollection of this. Was told by her family.  Woke up at 4am the next day feeling a lot better. Constant headache.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: Tightness  in throat, sob, pressure in chest, numbness in chest, Cannot take Benadryl so they gave EpiPen.  Felt better as they were taking her to the hosp and then she started to feel the pressure again. Was given a high solumedral IV and pepsidIV.  Developed anxiety. At home started to feel cold had the shakes. Body felt very heavy. Could not move her body. It was like she was drunk. Has no recollection of this. Was told by her family.  Woke up at 4am the next day feeling a lot better. Constant headache.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy to vaccine, Anxiety, Chest discomfort, Discomfort, Dyspnoea
Clinical narrative: Tightness  in throat, sob, pressure in chest, numbness in chest, Cannot take Benadryl so they gave EpiPen.  Felt better as they were taking her to the hosp and then she started to feel the pressure again. Was given a high solumedral IV and pepsidIV.  Developed anxiety. At home started to feel cold had the shakes. Body felt very heavy. Could not move her body. It was like she was drunk. Has no recollection of this. Was told by her family.  Woke up at 4am the next day feeling a lot better. Constant headache.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling cold, Feeling drunk, Headache, Hypoaesthesia, Movement disorder
Clinical narrative: Tightness  in throat, sob, pressure in chest, numbness in chest, Cannot take Benadryl so they gave EpiPen.  Felt better as they were taking her to the hosp and then she started to feel the pressure again. Was given a high solumedral IV and pepsidIV.  Developed anxiety. At home started to feel cold had the shakes. Body felt very heavy. Could not move her body. It was like she was drunk. Has no recollection of this. Was told by her family.  Woke up at 4am the next day feeling a lot better. Constant headache.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Tightness  in throat, sob, pressure in chest, numbness in chest, Cannot take Benadryl so they gave EpiPen.  Felt better as they were taking her to the hosp and then she started to feel the pressure again. Was given a high solumedral IV and pepsidIV.  Developed anxiety. At home started to feel cold had the shakes. Body felt very heavy. Could not move her body. It was like she was drunk. Has no recollection of this. Was told by her family.  Woke up at 4am the next day feeling a lot better. Constant headache.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Slight tingling/numbness in cheek and upper jaw, lasted for 45 minutes.  No medication taken.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear swelling, Erythema, Lip swelling
Clinical narrative: Approximately 35 minutes after patient received the vaccine, she noted redness around her chest and neck, goin up to her face and both ears. Ears were swollen. She was transferred to the ED for evaluation, where it was noted that she had redness of her throat and chest with slight swelling of her lips. In the ED, she was given prednisone 40mg PO and famotidine 40mg PO. She was observed and discharged after ~90 minutes.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear swelling, Erythema, Lip swelling, Pharyngeal erythema
Clinical narrative: Approximately 35 minutes after patient received the vaccine, she noted redness around her chest and neck, goin up to her face and both ears. Ears were swollen. She was transferred to the ED for evaluation, where it was noted that she had redness of her throat and chest with slight swelling of her lips. In the ED, she was given prednisone 40mg PO and famotidine 40mg PO. She was observed and discharged after ~90 minutes.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Found patient sitting in chair in moderate distress, tearful, tachypneic and slightly hyperventilating. At that time, pt c/o shortness of breath and sensation of throat closing; vital signs w/ normal HR, normal BP, normal O2 sat and exam w/o rash, no lip or tongue swelling, no wheezes, no stridor, normal voice.  Given concern for possible anaphylactic reaction to COVID-19 vaccine (pt at risk given history of severe medication allergy w/ involvement of 2 organ systems) pt was empirically treated w/ epinephrine 0.3mg sq  x1, benadryl, famotadine, and solumedrol with significant improvement in symptoms.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Hyperventilation, Respiratory distress, Tachypnoea, Tearfulness
Clinical narrative: Found patient sitting in chair in moderate distress, tearful, tachypneic and slightly hyperventilating. At that time, pt c/o shortness of breath and sensation of throat closing; vital signs w/ normal HR, normal BP, normal O2 sat and exam w/o rash, no lip or tongue swelling, no wheezes, no stridor, normal voice.  Given concern for possible anaphylactic reaction to COVID-19 vaccine (pt at risk given history of severe medication allergy w/ involvement of 2 organ systems) pt was empirically treated w/ epinephrine 0.3mg sq  x1, benadryl, famotadine, and solumedrol with significant improvement in symptoms.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness
Clinical narrative: Found patient sitting in chair in moderate distress, tearful, tachypneic and slightly hyperventilating. At that time, pt c/o shortness of breath and sensation of throat closing; vital signs w/ normal HR, normal BP, normal O2 sat and exam w/o rash, no lip or tongue swelling, no wheezes, no stridor, normal voice.  Given concern for possible anaphylactic reaction to COVID-19 vaccine (pt at risk given history of severe medication allergy w/ involvement of 2 organ systems) pt was empirically treated w/ epinephrine 0.3mg sq  x1, benadryl, famotadine, and solumedrol with significant improvement in symptoms.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Nausea, Palpitations
Clinical narrative: Dizziness, nausea, vomiting. Elevated BP. Shortness of breath. Headache. Went to ER, improved with solumedrol.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness, Dyspnoea, Headache, Nausea
Clinical narrative: Dizziness, nausea, vomiting. Elevated BP. Shortness of breath. Headache. Went to ER, improved with solumedrol.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Dizziness, nausea, vomiting. Elevated BP. Shortness of breath. Headache. Went to ER, improved with solumedrol.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Tachycardia
Clinical narrative: Calling in to report itching and rash after Pfizer COVID vaccination. she received a vaccination on December 18th and started having symptoms that same day. She contacted the emergency room where she received the vaccine and they told her to take Benadryl. Since that time the itching and rash has progressed and now she is having some difficulty swallowing. No difficulty breathing or speaking.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Pruritus, Rash
Clinical narrative: Calling in to report itching and rash after Pfizer COVID vaccination. she received a vaccination on December 18th and started having symptoms that same day. She contacted the emergency room where she received the vaccine and they told her to take Benadryl. Since that time the itching and rash has progressed and now she is having some difficulty swallowing. No difficulty breathing or speaking.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia
Clinical narrative: started with small headache and by 10 pm she was "exhausted" and 11pm she had severe headache, chills, myalgia, nausea. Extremely ill until 30 hours after onset of symptoms. Had dull  headache the next morning.  Symptoms totally resolved 48-50 hrs after onset.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Illness, Myalgia, Nausea
Clinical narrative: started with small headache and by 10 pm she was "exhausted" and 11pm she had severe headache, chills, myalgia, nausea. Extremely ill until 30 hours after onset of symptoms. Had dull  headache the next morning.  Symptoms totally resolved 48-50 hrs after onset.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Electrocardiogram normal, Hypoaesthesia, Hypoaesthesia oral, Nausea
Clinical narrative: Staff member felt a buzzing sensation was concerned that she may be having an anaphylactic reaction. She took a Benadryl and called 911. EMTs evaluated her and determined that she was fine. No further follow-up was needed.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Tachycardia
Clinical narrative: Staff member felt a buzzing sensation was concerned that she may be having an anaphylactic reaction. She took a Benadryl and called 911. EMTs evaluated her and determined that she was fine. No further follow-up was needed.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sensory disturbance
Clinical narrative: Staff member felt a buzzing sensation was concerned that she may be having an anaphylactic reaction. She took a Benadryl and called 911. EMTs evaluated her and determined that she was fine. No further follow-up was needed.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Throat tightness, Urticaria
Clinical narrative: At 9:13am, I got my vaccine. I went to sit in the waiting area, then at 9:18, my throat began to be dry, I try to take Tylenol with some water. I could not swallow the water at all. I began sounding like I was snoring. Doctor saw me and I had hives on my chest and face. They gave me an epi pen within 10 mins of getting vaccine. I received some benadryl  and  soyum medrall and pepcide.  After that, they kept me for about 5 hours in the ER.  My vitals were taken: bp 140/90.  After released, I woke up with hives on my chest, and my face is flushed. I took my prescribed steroid this morning and a Benadryl.  **NOTE: Hospital may have reported this already**
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dry throat, Dysphagia, Dysphonia, Flushing, Pregnancy test negative
Clinical narrative: At 9:13am, I got my vaccine. I went to sit in the waiting area, then at 9:18, my throat began to be dry, I try to take Tylenol with some water. I could not swallow the water at all. I began sounding like I was snoring. Doctor saw me and I had hives on my chest and face. They gave me an epi pen within 10 mins of getting vaccine. I received some benadryl  and  soyum medrall and pepcide.  After that, they kept me for about 5 hours in the ER.  My vitals were taken: bp 140/90.  After released, I woke up with hives on my chest, and my face is flushed. I took my prescribed steroid this morning and a Benadryl.  **NOTE: Hospital may have reported this already**
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: At 9:13am, I got my vaccine. I went to sit in the waiting area, then at 9:18, my throat began to be dry, I try to take Tylenol with some water. I could not swallow the water at all. I began sounding like I was snoring. Doctor saw me and I had hives on my chest and face. They gave me an epi pen within 10 mins of getting vaccine. I received some benadryl  and  soyum medrall and pepcide.  After that, they kept me for about 5 hours in the ER.  My vitals were taken: bp 140/90.  After released, I woke up with hives on my chest, and my face is flushed. I took my prescribed steroid this morning and a Benadryl.  **NOTE: Hospital may have reported this already**
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dry throat, Dysphagia, Dyspnoea, Pharyngeal swelling, Speech disorder
Clinical narrative: At 9:13am, I got my vaccine. I went to sit in the waiting area, then at 9:18, my throat began to be dry, I try to take Tylenol with some water. I could not swallow the water at all. I began sounding like I was snoring. Doctor saw me and I had hives on my chest and face. They gave me an epi pen within 10 mins of getting vaccine. I received some benadryl  and  soyum medrall and pepcide.  After that, they kept me for about 5 hours in the ER.  My vitals were taken: bp 140/90.  After released, I woke up with hives on my chest, and my face is flushed. I took my prescribed steroid this morning and a Benadryl.  **NOTE: Hospital may have reported this already**
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dizziness, Irritability
Clinical narrative: Chest pain, dizziness, pain in lungs, tiredness
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray normal, Chest pain, Dizziness, Electrocardiogram normal, Fatigue
Clinical narrative: Chest pain, dizziness, pain in lungs, tiredness
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary pain, Troponin normal
Clinical narrative: Chest pain, dizziness, pain in lungs, tiredness
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysstasia, Muscular weakness, Paraesthesia
Clinical narrative: Patient developed bilateral lower extremity numbness and tingling, as well as weakness that resolved after several hours of observation in the Emergency Department. It is highly likely that the response may have been in part related to anxiety.  After several hours of observation the patient had return of motor strength and was able to discharge. She continued to have paresthesia that was improving at time of discharge.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Burning sensation, Coagulation test, Dyspnoea, Dysstasia
Clinical narrative: Patient developed bilateral lower extremity numbness and tingling, as well as weakness that resolved after several hours of observation in the Emergency Department. It is highly likely that the response may have been in part related to anxiety.  After several hours of observation the patient had return of motor strength and was able to discharge. She continued to have paresthesia that was improving at time of discharge.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling hot, Full blood count, Hypoaesthesia, Immediate post-injection reaction, Limb discomfort
Clinical narrative: Patient developed bilateral lower extremity numbness and tingling, as well as weakness that resolved after several hours of observation in the Emergency Department. It is highly likely that the response may have been in part related to anxiety.  After several hours of observation the patient had return of motor strength and was able to discharge. She continued to have paresthesia that was improving at time of discharge.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Metabolic function test, Pain in extremity, Palpitations, Paraesthesia
Clinical narrative: Patient developed bilateral lower extremity numbness and tingling, as well as weakness that resolved after several hours of observation in the Emergency Department. It is highly likely that the response may have been in part related to anxiety.  After several hours of observation the patient had return of motor strength and was able to discharge. She continued to have paresthesia that was improving at time of discharge.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Hypoaesthesia, Muscular weakness, Paraesthesia
Clinical narrative: Patient developed bilateral lower extremity numbness and tingling, as well as weakness that resolved after several hours of observation in the Emergency Department. It is highly likely that the response may have been in part related to anxiety.  After several hours of observation the patient had return of motor strength and was able to discharge. She continued to have paresthesia that was improving at time of discharge.
Age: 39.0
Sex: F
Vaccine: VARCEL
Symptoms: Colitis ulcerative, Laboratory test normal
Clinical narrative: No additional AE; patient vaccinated wilh VARlVAX on 30 -NOV-2020 while on oral Prednisone; This spontaneous report was received from a registered nurse and refers to a 39-year-old female patient. Her concomitant medications included prednisone. The patient had a medical history of ulcerative colitis. There was no information about the patient's concurrent conditions provided.  She was supposed to start therapy with adalimumab (HUMIRA) (reported as HUMERA), a titer was drawn which revealed that she was negative, so on 30-NOV-2020, she was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) first dose (dose, route of administration, anatomical location, lot # and expiration date were not reported), for prophylaxis, while on therapy with prednisone. No adverse event was reported.
Age: 23.0
Sex: U
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: No additional adverse events reported; a 23 years old patient received a dose of PROQUAD instead of VARIVAX and MMRII as recomended per his age.; This spontaneous report was received from a nurse referring to a 23 year old patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On 09-DEC-2020, the patient received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 ml,  lot # S030213, expiration date on 25-MAR-2021, for prophylaxis (strength, route of administration and anatomical location were unknown); instead of varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) as recommended per his age. No additional adverse events were reported.
Sex: U
Vaccine: HEPA, UNK
Symptoms: Expired product administered
Clinical narrative: expired dose administered; This spontaneous report as received from a physician, concerning a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 09-DEC-2020, the patient was vaccinated with an expired dose of  hepatitis a vaccine, inactivated (VAQTA) lot # S031918 with expiration date on 05-NOV-2020 (strength, dose, route of administration and frequency were not reported) for prophylaxis. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S031918; expirationdate: 05-NOV-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: Caller stated an expired VARIVAX was administered to a female patient today.; This spontaneous report was received from a licensed practical nurse, referring to an infant (also reported as "patient age: around 12-months old") female patient. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 16-DEC-2020, the patient was vaccinated with one expired dose (expired product administered) of varicella virus vaccine live (oka/merck) (VARIVAX) vials, as prophylaxis (strength, vaccination scheme, anatomical site of vaccination and route of administration were not provided; lot number R033660 which has been verified to be valid, expiration date reported and validated as 20-NOV-2020). The vaccine administered did not experience previous temperature excursion.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received Gardasil 9 several years ago and is now back at the pharmacy to complete the series; This spontaneous report was received from a pharmacist and refers to a 21-year-old patient of unknown gender. The patient's concurrent condition, medical history, concomitant medications, drugs reactions or allergies were not provided.  On unspecified date (reported as several years ago), the patient was vaccinated with the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 ml, (route of administration, lot # and expiration date were not provided) for prophylaxis. On 18-DEC-2020, the patient went back to complete the series and was vaccinated with another dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml (route of administration, lot # and expiration date were not provided) for prophylaxis. The outcome of inappropriate schedule of product administration is unknown.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: a dose of GARDASIL 9 was administered during a temperature excursion; No additional adverse events reported; This spontaneous report was received from a medical assistant and refers to a 14-year-old patient of unknown gender. No information regarding the patients' pertinent medical histories, concurrent conditions, concomitant therapies, drug reactions or allergies was provided.  On 11-NOV-2020, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 mL (lot #S008153 was considered valid, expiration date reported and validated as 20-NOV-2021; dose number, route of administration and anatomical injection site were not reported) for prophylaxis. It was reported that on that date, the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was exposed to a temperature excursion of 48.8 Fahrenheit (F) degrees and 32.7 F degrees for 47 hours and 15 minutes. No Digital Data logger was reported. No additionally adverse events (AE)/ product quality complains (PQC) reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S008153; expirationdate: 20-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: No; reasonfornoneval: 02 Device evaluation anticipated, but not yet begun; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AE; The patient stated he went to his doctor today to get the second shot and they have told him that they don't accept his insurance and they did not administer the second dose.; The patient stated he went to his doctor today to get the second shot and they have told him that they don't accept his insurance and they did not administer the second dose.; This spontaneous was received from a consumer referring to himself as a male patient of unknown age. The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not provided by reporter.  On 18-NOV-2020, the patient was vaccinated with the first dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) (strength, route of administration and anatomical injection site were not provided; dose, frequency, lot number, and expiration date were reported as unknown) as prophylaxis.  On 18-DEC-2020 (also reported as today), the patient went to his doctor to get the second shot and they told him that they do not accept his insurance and they did not administer the second dose (inappropriate schedule of product administration and circumstance or information capable of leading to medication error). The consumer has been unable to find another provider that has the Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) vaccine in his area. No additional adverse event reported. At the reporting time the outcome of inappropriate schedule of product administration, and circumstance or information capable of leading to medication error was unknown.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Headache, Pain, Pyrexia
Clinical narrative: Fever 100.4° F , headache; body aches , trouble focusing
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional adverse events reported.; a dose of GARDASIL 9 was administered during a temperature excursion; temperature 48.4F and 32.7F; This spontaneous report was received from a certified medical assistant and refers to 12-year-old patient of an unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 04-DEC-2020, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 ml, lot # S008153, expiration date 20-NOV-2021 (route of administration and anatomical location were not reported) for prophylaxis. The vaccine was administered during a temperature excursion, before the stability was known. Administered dose of the vaccine was stored in temperature of 48.4 degrees Fahrenheit (F) for 15 minutes and in temperature of 32.7 F for 47 hours. No previous temperature excursion occurred. Digital data logger was not involved.   No adverse events were reported. 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: S008153; expirationdate: 20-NOV-2021; 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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Vaccine at 10 am 12/18/2020 That same day:  Feet numbness at 10:45 am - resolved at 4 pm L hand numbness around 11 am - quickly resolved lower face numbness around 11 am - intermittent throughout the day  all symptoms resolved by evening/overnight 12/19/2020 mild facial numbness about 4-5 hours during the day  fully resolved by 12/19/2020 evening, without any further symptom recurrence at any site
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: After the second shot her arm hurt; The company had a shortage and I could not get my second; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 3 years before the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm and product supply issue. On an unknown date, the outcome of the pain in arm and product supply issue were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for herself. The patient reported that the company had a shortage and she could not get her 2nd dose, which led to product supply issue. Three months before the date of reporting, the patient received the 2nd dose of Shingrix in right arm. The patient asked was that sufficient or do she need a booster. After receiving 2nd dose of Shingrix, the patient's arm hurt.  The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020230677:Same reporter - FU1 deleted
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Nausea, SARS-CoV-2 test negative
Clinical narrative: 48hr following dose 1: mild nausea, dizziness, foggy brain.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling on left hand and left arm. Lasted a few hours. Started in fingers of left hand, progressing up to left arm.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Respiratory tract oedema, Stridor, Urticaria, Wheezing
Clinical narrative: Anaphylaxis reaction with hives, stridor/airway edema, wheezing
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Hyperhidrosis
Clinical narrative: Anaphylaxis reaction with hives, stridor/airway edema, wheezing
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Respiratory tract oedema, Stridor, Urticaria, Wheezing
Clinical narrative: Vaccine given at 1615.  By 1630 became symptomatic shortness of breath, diaphoretic, labored breathing.  Teammate seated,  given 25mg Benadryl, symptoms worsened, Epi pen administered, and taken by wheelchair to ED.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Hyperhidrosis
Clinical narrative: Vaccine given at 1615.  By 1630 became symptomatic shortness of breath, diaphoretic, labored breathing.  Teammate seated,  given 25mg Benadryl, symptoms worsened, Epi pen administered, and taken by wheelchair to ED.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: sore arm; fever; chills; body aches; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm, fever, chills and general body pain. On an unknown date, the outcome of the pain in arm, fever, chills and general body pain were recovered/resolved.   It was unknown if the reporter considered the pain in arm, fever, chills and general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 76 or 77 year. The patient received 1st dose of shingrix and experienced arm soreess, body aches, fever and chills. The reporter did not consent to follow up. For tolerance of 2nd dose, refer case US2020AMR237450.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR237450:same reporter
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Pfizer-BioNTech Covid-19 Vaccine EUA Nausea, vomiting, body aches, fever 100.6
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Rash, Swollen tongue
Clinical narrative: developed swelling of tongue; dyspnea; skin rash; This is a spontaneous report from a non-contactable consumer.   A 35-year-old male patient received BNT162B2, via an unspecified route of administration on an unspecified date in 2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. This is a call from CDC this morning regarding a new case, the patient was administered vaccine and developed swelling of tongue, dyspnea, skin rash on an unspecified date in 2020, then treated with dexamethasone, diphenhydramine hydrochloride (BENADRYL), via intramuscular (IM) epinephrine in emergency room (ER). The outcome of events was unknown. She will alert him each time there is a report of severe hypersensitivity for his awareness. Further, the CDC is in the process of appointing a contact who will be able to meet with us regularly on this topic. Their conversation was amicable and demonstrated a willingness to work closely with us as we navigate the issue of hypersensitivity.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: The reported information is limited. Based on the temporal relationship and the description of the events, swelling of tongue, dyspnea, skin rash, there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: extreme arm soreness, fever of 101.4, chills, body ache
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Rash papular
Clinical narrative: erythematous papular rash scattered throughout abdomen, torso, neck with areas Onset of symptoms noticed 6hrs from vaccine, rash has continued to spread 4 days from time of vaccination sparing most of the extremities.
Sex: F
Vaccine: COVID19
Symptoms: Haemodynamic test normal, Throat irritation, Tongue pruritus
Clinical narrative: itchy throat; itchy throat/back of the tongue reaction; This is a spontaneous report from a contactable physician. This physician reported similar events for two patients. This is the first report.  A female patient of an unspecified age (reported as 50, unit unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not provided), via an unspecified route of administration on 17Dec2020 22:00 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced itchy throat/back of the tongue reaction. No rash, then they gave her epi 10, ED (emergency department) doctor assessed for 2 hours. No evidence of tongue swelling, hemodynamics was normal. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the close temporal relationship and the description of the events, itchy throat/ tongue reaction there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020500303 Same reporter, product, and event, different patient
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Hypoaesthesia, Pain in extremity
Clinical narrative: Extreme arm pain alternating with numbness and tingling, joint pain in shoulder, elbow, and wrist, chills, low grade fever (100.5), fatigue
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: Extreme arm pain alternating with numbness and tingling, joint pain in shoulder, elbow, and wrist, chills, low grade fever (100.5), fatigue
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pfizer-BoiTech COVID-19 Vaccine   Immediate burning at injection site following dose. (Similar to the sensation of receiving contrast for a CT scan) which I found odd. Injection site pain continued over night, swelling and site redness to follow and A 1.5 inch welt appeared  approx 24hrs after receiving vaccine. Pain is localized to the injection site only . Treatment includes rest and Tylenol with little effect. Continuing to monitor for any further developments or additional side effects.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Urticaria
Clinical narrative: Pfizer-BoiTech COVID-19 Vaccine   Immediate burning at injection site following dose. (Similar to the sensation of receiving contrast for a CT scan) which I found odd. Injection site pain continued over night, swelling and site redness to follow and A 1.5 inch welt appeared  approx 24hrs after receiving vaccine. Pain is localized to the injection site only . Treatment includes rest and Tylenol with little effect. Continuing to monitor for any further developments or additional side effects.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Peripheral swelling
Clinical narrative: Swollen hands; dizzy; This is a spontaneous report from a contactable nurse. A 38-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK5730), intramuscularly in the left arm, on 17Dec2020 at 14:00 (at the age of 38-years-old) at a single dose for COVID-19 immunization. Medical history included non-ongoing COVID-19 (previous well recovered from COVID-19 months earlier) from 2020 to an unspecified date. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. It was unknown whether the patient received other vaccines within four weeks prior to vaccination or other medications within two weeks of vaccination. The patient experienced swollen hands and dizzy on 17Dec2020 at 15:00. The events resulted in emergency room/department or urgent care visit. Therapeutic measures were taken as a result of the events, which included cetirizine hydrochloride (MANUFACTURER UNKNOWN) and monitoring. The clinical outcome of swollen hands and dizzy was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Feeling hot, Flushing, Hyperhidrosis, Nausea
Clinical narrative: 40 minutes later, I became flushed, hot, sweaty and clammy and tachycardic along with a syncope episode. Nausea came after, and only treatment was fluids. This episode happened after discharge around 9:45pm and then returned to the hospital for the same course of action.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Tachycardia
Clinical narrative: 40 minutes later, I became flushed, hot, sweaty and clammy and tachycardic along with a syncope episode. Nausea came after, and only treatment was fluids. This episode happened after discharge around 9:45pm and then returned to the hospital for the same course of action.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Musculoskeletal discomfort, Neck pain, Pain
Clinical narrative: Slight intermittent headache, neck and shoulder soreness, left arm soreness.  Right hip and thigh pain when getting up from the chair about 3 times over the course of a few hours.   Stabbing left heel pain x1 in the middle of the night.  The next morning (12/22/2020) my right thigh was just slightly sore.  Later in the day I had slight right hip discomfort again but it went away quickly.   About 30 hours after the injection I had right knee discomfort lasting a few hours.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Slight intermittent headache, neck and shoulder soreness, left arm soreness.  Right hip and thigh pain when getting up from the chair about 3 times over the course of a few hours.   Stabbing left heel pain x1 in the middle of the night.  The next morning (12/22/2020) my right thigh was just slightly sore.  Later in the day I had slight right hip discomfort again but it went away quickly.   About 30 hours after the injection I had right knee discomfort lasting a few hours.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Pain, Pain in extremity
Clinical narrative: Next day after vaccine was given, I had whole body aches and low grade temp of 100.8.  Off and on chills.  It felt like I had covid all over again  (I tested positive end of October).  Very sore L arm.