chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: Patient received a dose of improperly stored MMR-II and Varivax; No adverse event; This spontaneous case was received from and healthcare professional regarding to a patient of unknown age, gender and ethnicity. The patient's concurrent conditions, medical history, drug allergies and concomitant therapies were not reported.   On 25-FEB-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # S039316 with expiration date reported as 04-DEC-2021) 0.5 mL and improperly store varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T024285 with expiration date reported as 15-JUL-2022) 0.5 mL (route of administration and anatomical location of vaccine were not reported) for prophylaxis. The vaccine was exposed to a temperature between 5.0 °F and 8.0 °F for 8 hours and 40 minutes. A previous temperature excursion was reported. No adverse effect was reported.  Albumin status has been verified for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # S039316) to be recombinant human albumin (rHa).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2103USA003425:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: Patient received a dose of improperly stored MMR-II and Varivax; No adverse event; This spontaneous case was received from and healthcare professional regarding to a patient of unknown age, gender and ethnicity. The patient's concurrent conditions, medical history, drug allergies and concomitant therapies were not reported.   On 26-FEB-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # S039316 with expiration date reported as 04-DEC-2021) 0.5 mL and improperly store varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T024285 with expiration date reported as 15-JUL-2022) 0.5 mL (route of administration and anatomical location of vaccine were not reported) for prophylaxis. The vaccine was exposed to a temperature between 5.0 °F and 8.0 °F for 8 hours and 40 minutes. A previous temperature excursion was reported. No adverse effect was reported.  Albumin status has been verified for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (lot # S039316) to be recombinant human albumin (rHa).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2103USA003425:
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site inflammation, Injection site swelling, Injection site warmth
Clinical narrative: a kid was vaccinated with VARlVAX and had a localized reaction; The reaction was red swollen; The reaction was red swollen; hot to touch area; cellulitis at the shot location; This spontaneous report was received from an office manager referring to a 1-year-old male patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 09-MAR-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliters, subcutaneous, lot number T022314, expiration date 30-JUN-2022 for vaccine series.        On 09-MAR-2021, the patient had a localized reaction. The reaction was severe and had to be treated with antibiotics. The reaction was a red swollen, hot to touch area on the left thigh, 4 cm wide that required medical attention (injection site reaction, vaccination site cellulitis, injection site warmth, injection site inflammation and injection site erythema). Caller reported she had been doing this for 30 years and had never seen anything like it. Caller reported the reaction was coming from a specific lot number of VARlVAX, and was sure was not the diluent because it had been used to reconstitute other vaccines and no such reactions had been seen.      The outcome of injection site reaction, vaccination site cellulitis, injection site warmth, injection site inflammation and injection site erythema was reported as not recovered. The causal relationship between varicella virus vaccine live (oka/merck)(VARIVAX) and the events was not reported.; Sender's Comments:  US-009507513-2103USA006614:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, Syncope
Clinical narrative: Passed out at one time; Having COVID symptoms; Massive headache; A spontaneous report was received from a consumer concerning a 68-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced massive headache, passed out at one time/syncope and having COVID symptoms.  The patient's medical history was not reported. No relevant concomitant medications were not reported.  On 26 Feb 2021, approximately two days prior to onset of the events, the patient received their dose of mRNA-1273 (batch number: 023M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 27 Feb 2021, the patient had a massive headache. On an unknown date, the patient passed out at one time (medically significant event) and overall just having COVID symptoms. No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events massive headache, passed out at one time and having COVID symptoms was not reported.; Reporter's Comments: This case concerns a 68-year-old female who experienced serious unexpected events of syncope along with nonserious events of unexpected COVID-19 and expected headache.  Event onset occurred on Day 2 after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Blood pressure increased, Blood pressure measurement, Insomnia, Photophobia
Clinical narrative: TIA with expressive aphasia; TIA with expressive aphasia; Blood pressure has been all over the place, getting as high as 160/90; Extreme light sensitivity and even closing her eyes in a dark room felt like a spot light was on her; Trouble sleeping; A Spontaneous report was received from a Consumer concerning for herself, a female patient of an unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced transient ischemic attack (TIA) with expressive aphasia/Transient ischaemic attack, transient ischemic attack (TIA) with expressive aphasia/Transient ischaemic attack/aphasia, blood pressure has been all over the place, getting as high as 160/90/blood pressure increased, extreme light sensitivity and even closing her eyes in a dark room felt like a spotlight was on her/ Photophobia and trouble sleeping/Insomnia.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 27Jan2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown) via Intramuscular route for COVID-19 infection prophylaxis. On 24Feb2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (batch number: unknown) via Intramuscular route for COVID-19 infection prophylaxis.  On 24Feb2021, 30 minutes after receiving the vaccine, patient started speaking and gibberish came out. The patient stated that she could not form words. The patient's physician diagnosed it as transient ischemic attack (TIA) with expressive aphasia. The patient had extreme light sensitivity and even closing her eyes in dark room felt like a spotlight was on her therefore, she had trouble sleeping. The patient also stated that her blood pressure had been all over the place, getting up to 160/ 90. The patient was treated with Excedrin (aspirin/paracetamol/caffeine).  The seriousness criteria for the event transient ischemic attack (TIA) with expressive aphasia was medically significant.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events, transient ischemic attack (TIA) with expressive aphasia, blood pressure has been all over the place, getting as high as 160/90, extreme light sensitivity and even closing her eyes in a dark room felt like a spotlight was on her and trouble sleeping were unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further details regarding the subject's medical history, investigations and treatment is necessary for assessment. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: TIA with expressive aphasia; TIA with expressive aphasia; Blood pressure has been all over the place, getting as high as 160/90; Extreme light sensitivity and even closing her eyes in a dark room felt like a spot light was on her; Trouble sleeping; A Spontaneous report was received from a Consumer concerning for herself, a female patient of an unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced transient ischemic attack (TIA) with expressive aphasia/Transient ischaemic attack, transient ischemic attack (TIA) with expressive aphasia/Transient ischaemic attack/aphasia, blood pressure has been all over the place, getting as high as 160/90/blood pressure increased, extreme light sensitivity and even closing her eyes in a dark room felt like a spotlight was on her/ Photophobia and trouble sleeping/Insomnia.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 27Jan2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown) via Intramuscular route for COVID-19 infection prophylaxis. On 24Feb2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (batch number: unknown) via Intramuscular route for COVID-19 infection prophylaxis.  On 24Feb2021, 30 minutes after receiving the vaccine, patient started speaking and gibberish came out. The patient stated that she could not form words. The patient's physician diagnosed it as transient ischemic attack (TIA) with expressive aphasia. The patient had extreme light sensitivity and even closing her eyes in dark room felt like a spotlight was on her therefore, she had trouble sleeping. The patient also stated that her blood pressure had been all over the place, getting up to 160/ 90. The patient was treated with Excedrin (aspirin/paracetamol/caffeine).  The seriousness criteria for the event transient ischemic attack (TIA) with expressive aphasia was medically significant.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events, transient ischemic attack (TIA) with expressive aphasia, blood pressure has been all over the place, getting as high as 160/90, extreme light sensitivity and even closing her eyes in a dark room felt like a spotlight was on her and trouble sleeping were unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further details regarding the subject's medical history, investigations and treatment is necessary for assessment. Further information has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Nephrolithiasis, Renal stone removal, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: discomfort; kidney stone pain worse and worse; kidney stone outpatient surgery with stent; warm at injection site; itching arm at injection site; red at injection site; A spontaneous report was received from a 70-year-old male consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced red at injection site, arm at injection site, itching arm at injection site, kidney stone pain worse and worse, kidney  stone outpatient surgery with stent and discomfort.  The consumer's medical history included kidney stones.   No relevant concomitant medications were reported.  On 18 Feb 2021, prior to the onset of the events the consumer received the first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On an unknown date in Feb 2021, the consumer experienced red at injection site, warm at injection site and itching arm at injection site.  On an unknown date, the consumer experienced kidney stone pain worse (the consumer did mention he had been having prior kidney stone pain for several weeks before the first dose but which got  worse and worse after the first dose) and discomfort (he was referring to the pain and discomfort that comes with healing after surgery) .  On 10 Mar 2021, the consumer was scheduled a kidney stone outpatient surgery with stent (the stent was removed on 14 Mar 2021).  No treatment information for the events was provided.   Action taken with mRNA-1273 in response to the event  was unknown.  The outcome of  discomfort was unknown and for other events were recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: discomfort; kidney stone pain worse and worse; kidney stone outpatient surgery with stent; warm at injection site; itching arm at injection site; red at injection site; A spontaneous report was received from a 70-year-old male consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced red at injection site, arm at injection site, itching arm at injection site, kidney stone pain worse and worse, kidney  stone outpatient surgery with stent and discomfort.  The consumer's medical history included kidney stones.   No relevant concomitant medications were reported.  On 18 Feb 2021, prior to the onset of the events the consumer received the first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On an unknown date in Feb 2021, the consumer experienced red at injection site, warm at injection site and itching arm at injection site.  On an unknown date, the consumer experienced kidney stone pain worse (the consumer did mention he had been having prior kidney stone pain for several weeks before the first dose but which got  worse and worse after the first dose) and discomfort (he was referring to the pain and discomfort that comes with healing after surgery) .  On 10 Mar 2021, the consumer was scheduled a kidney stone outpatient surgery with stent (the stent was removed on 14 Mar 2021).  No treatment information for the events was provided.   Action taken with mRNA-1273 in response to the event  was unknown.  The outcome of  discomfort was unknown and for other events were recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dizziness, Dyspnoea, Feeling abnormal, Sluggishness
Clinical narrative: Urinary tract infection; Allergy (anaphylaxis) to levofloxacin; Hives; Difficult breathing; Felt awful; Sluggish; Light-headed; A spontaneous report was received from a consumer concerning herself, a 75-year-old female patient, who received 2 doses of Moderna's COVID-19 vaccine (mRNA-1273) and experienced allergy (anaphylaxis) to levofloxacin (anaphylactic reaction), hives (urticaria), difficult breathing (dyspnoea), felt awful (feeling abnormal), sluggish, and light-headed (dizziness).  The patient's medical history, as provided by the reporter included urinary tract infection (UTI).Medications included levofloxacin and nitrofurantoin to treat urinary tract infection.  On 19 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 010M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch Number: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 05 Mar 2021, the patient took levofloxacin 500mg to treat urinary tract infection (UTI). Soon thereafter patient had a severe allergic reaction to levofloxacin.   Treatment included Emergency Room drug-induced anaphylaxis treatment.Later Patient took nitrofurantoin for 5 days for the UTI and developed events sluggish, and light-headed hives,felt awful and difficult breathing.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the event, allergy (anaphylaxis) to levofloxacin was resolved on 05 Mar 2021. The outcome of the event, hives, difficult breathing, felt awful, sluggish, and light-headed, were unknown.; Reporter's Comments: This case concerns a 75 Y/O F who had NS unexpected urinary tract infection and serious unexpected anaphylactic reaction with NS unexpected urticaria, dyspnea, dizziness, feeling abnormal, sluggish.  Anaphylaxis on Day 18 after first dose mRNA-1273 was considered possibly related to levofloxacin for UTI. Anaphylaxis resolved. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection, Urticaria
Clinical narrative: Urinary tract infection; Allergy (anaphylaxis) to levofloxacin; Hives; Difficult breathing; Felt awful; Sluggish; Light-headed; A spontaneous report was received from a consumer concerning herself, a 75-year-old female patient, who received 2 doses of Moderna's COVID-19 vaccine (mRNA-1273) and experienced allergy (anaphylaxis) to levofloxacin (anaphylactic reaction), hives (urticaria), difficult breathing (dyspnoea), felt awful (feeling abnormal), sluggish, and light-headed (dizziness).  The patient's medical history, as provided by the reporter included urinary tract infection (UTI).Medications included levofloxacin and nitrofurantoin to treat urinary tract infection.  On 19 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 010M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch Number: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 05 Mar 2021, the patient took levofloxacin 500mg to treat urinary tract infection (UTI). Soon thereafter patient had a severe allergic reaction to levofloxacin.   Treatment included Emergency Room drug-induced anaphylaxis treatment.Later Patient took nitrofurantoin for 5 days for the UTI and developed events sluggish, and light-headed hives,felt awful and difficult breathing.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the event, allergy (anaphylaxis) to levofloxacin was resolved on 05 Mar 2021. The outcome of the event, hives, difficult breathing, felt awful, sluggish, and light-headed, were unknown.; Reporter's Comments: This case concerns a 75 Y/O F who had NS unexpected urinary tract infection and serious unexpected anaphylactic reaction with NS unexpected urticaria, dyspnea, dizziness, feeling abnormal, sluggish.  Anaphylaxis on Day 18 after first dose mRNA-1273 was considered possibly related to levofloxacin for UTI. Anaphylaxis resolved. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Chest pain, Gait inability
Clinical narrative: Transverse Myelitis; Could not go to bathroom in spite his bladder was full; Could not get out of bed; Could not walk; Chest pain; Pain in middle back; Pain in both of arm; The blood pressure went high; Pain was intense that cannot be describe; Pain across shoulders; A spontaneous report was received from a consumer concerning a 67-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA -1273) and experienced events of chest pain, middle back pain, pain across shoulders/arthralgia, pain in both of arm/pain in extremity, pain was intense that cannot be described, the blood pressure went high/hypertension, could not get out of bed/asthenia, could not walk/gait inability, could not go to bathroom in spite his bladder was full/urinary retension and transverse myelitis.  The patient's medical history as provided by the reporter included, quadruple bypass heart surgery, partial lung removal, back problem and neck problem. No relevant concomitant medications were reported.  On 19 Jan 2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 028L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 01 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 002A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 20 Jan 2021, the patient reported that after receiving the vaccine he was taken to the hospital for chest pain, pain in middle back, pain across shoulders, pain in both of arm, pain was intense that cannot be described and the blood pressure went high. On 21 Jan 2021, in the morning, he could not get out of bed, could not walk and could not go to bathroom in spite his bladder was full for which a catheter was installed to go to bathroom and he got hospitalized for three days. The physician diagnosed him having transverse myelitis which is a side effect from vaccine.   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events is not applicable.  The outcome of the events, could not get out of bed, could not go to bathroom in spite his bladder was full were resolved on 24 Jan 2021. At the time of reporting, (16 Mar 2021), the outcome of the event, could not walk, was recovering/resolving as the patient reported he was able to walk a little and was on physiotherapy.  At the time of this report, the outcome of the events, chest pain, pain in middle back, pain across shoulders, pain in both of arm, pain was intense that cannot be described, the blood pressure went high and transverse myelitis were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension, Myelitis transverse, Pain, Pain in extremity, Urinary retention
Clinical narrative: Transverse Myelitis; Could not go to bathroom in spite his bladder was full; Could not get out of bed; Could not walk; Chest pain; Pain in middle back; Pain in both of arm; The blood pressure went high; Pain was intense that cannot be describe; Pain across shoulders; A spontaneous report was received from a consumer concerning a 67-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA -1273) and experienced events of chest pain, middle back pain, pain across shoulders/arthralgia, pain in both of arm/pain in extremity, pain was intense that cannot be described, the blood pressure went high/hypertension, could not get out of bed/asthenia, could not walk/gait inability, could not go to bathroom in spite his bladder was full/urinary retension and transverse myelitis.  The patient's medical history as provided by the reporter included, quadruple bypass heart surgery, partial lung removal, back problem and neck problem. No relevant concomitant medications were reported.  On 19 Jan 2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 028L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 01 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 002A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 20 Jan 2021, the patient reported that after receiving the vaccine he was taken to the hospital for chest pain, pain in middle back, pain across shoulders, pain in both of arm, pain was intense that cannot be described and the blood pressure went high. On 21 Jan 2021, in the morning, he could not get out of bed, could not walk and could not go to bathroom in spite his bladder was full for which a catheter was installed to go to bathroom and he got hospitalized for three days. The physician diagnosed him having transverse myelitis which is a side effect from vaccine.   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events is not applicable.  The outcome of the events, could not get out of bed, could not go to bathroom in spite his bladder was full were resolved on 24 Jan 2021. At the time of reporting, (16 Mar 2021), the outcome of the event, could not walk, was recovering/resolving as the patient reported he was able to walk a little and was on physiotherapy.  At the time of this report, the outcome of the events, chest pain, pain in middle back, pain across shoulders, pain in both of arm, pain was intense that cannot be described, the blood pressure went high and transverse myelitis were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Headache, Loss of consciousness, Pain
Clinical narrative: Passed out; felt dizzy; she experiencing shaking; Massive pain in my head; really achy; Didn't feel good; A spontaneous report was received from a consumer concerning an 70 year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced achy, did not felt good, Massive pain in head, Dizzy, passed out, Shaking.  The patient's medical history and concomitant medications were not reported.  On 11 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (lot number 030A21A) via unknown route for prophylaxis of COVID-19 infection.  On 11 Mar 2021, during evening time patient did not feel good and achy, on12 Mar 2021 patient woke up and went to walk after some time she got a massive pain, felt dizzy, and passed out and shaking.   Treatment information provided was Tylenol.  Action taken with mRNA-1273 in response to the events was not applicable as.   The outcome for Ache was recovering and for other events recovered .; Reporter's Comments: This case concerns a 70 Y/O F with a serious unexpected event of loss of consciousness and NS unexpected pain, feeling abnormal, dizziness, tremor and expected headache.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Passed out; felt dizzy; she experiencing shaking; Massive pain in my head; really achy; Didn't feel good; A spontaneous report was received from a consumer concerning an 70 year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced achy, did not felt good, Massive pain in head, Dizzy, passed out, Shaking.  The patient's medical history and concomitant medications were not reported.  On 11 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (lot number 030A21A) via unknown route for prophylaxis of COVID-19 infection.  On 11 Mar 2021, during evening time patient did not feel good and achy, on12 Mar 2021 patient woke up and went to walk after some time she got a massive pain, felt dizzy, and passed out and shaking.   Treatment information provided was Tylenol.  Action taken with mRNA-1273 in response to the events was not applicable as.   The outcome for Ache was recovering and for other events recovered .; Reporter's Comments: This case concerns a 70 Y/O F with a serious unexpected event of loss of consciousness and NS unexpected pain, feeling abnormal, dizziness, tremor and expected headache.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea haemorrhagic
Clinical narrative: Diarrhea/streaks of blood in feces; A spontaneous report was received from a consumer concerning for himself, a 47-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event Diarrhea/streaks of blood in feces/ Diarrhoea haemorrhagic.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 12Mar2021, prior to the onset of the event, the patient received his planned dose of mRNA-1273 (lot/batch 027A21A), intramuscularly, for prophylaxis of COVID-19 infection.  On 15Mar2021, the patient experienced diarrhea and streaks of blood in feces.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, Diarrhea/streaks of blood in feces was considered as unknown at the time of the report.; Reporter's Comments: Based on the current limited available information provided at this time and lack of temporal association between the use of the product and the start date of the event, Diarrhea Hemorrhagic, the event was assessed as possibly Related to study drug.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Reynold's syndrome, Swelling
Clinical narrative: Reynaud's disease; Swollen toes; Numb toes; A spontaneous report was received from a consumer concerning herself, a 40-year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  swollen toes, numb toes and diagnosed with Reynaud's disease.  The patient's medical history was not provided. Concomitant medication use was not provided by reporter.   ON 30-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number 028L20A) for COVID-19 infection prophylaxis.   On 01-FEB-2021, the day after the dose of the Moderna vaccine, the patient experienced swollen toes, numb toes and was diagnosed with Reynaud's disease.  Treatment details included blood pressure medication.   Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, swollen toes, numb toes and diagnosed with Reynaud's disease was considered to be not resolved at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: chills; fatigue; headache; 102 fever; The initial case was missing the following minimum criteria: This case has been considered invalid as unspecified adverse event. Upon receipt of follow-up information on 02Mar2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient (also age at vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), the second dose via an unspecified route of administration, administered in Arm Left on 06Feb2021 1:30 PM (Batch/Lot Number: CL1964) as SINGLE DOSE for covid-19 immunization. Medical history included chronic respiratory disorder (Fumes/vapour), Chronic rhinosinusitis (Sinus surgery) from 07Jan2021, Observance sleep apnea from 16Sep2019 (CPAP machine), and Sinus condition for years from unspecified date; all unknown if ongoing. For the sinus condition for years a surgery was needed and was recommended between 1st & 2nd vaccine shots (on 04Feb2021) and the surgery were planned prior to taking the vaccine. The types of surgery recommended were septoplasty, functional endoscopic and turbinectomy. The patient also had family history which includes Heart diseases and High blood pressure from unknown date and unknown if ongoing. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at 52-years-old at the time of vaccination Lot: EL3247 administered in Arm Left on 16Jan2021-1:30 PM for Covid 19- immunization and experienced GERD on 17Jan2021 (Pertinent Details: Endoscopy). Concomitant medication included cefuroxime axetil (CEFUROXIME AXETIL ZHIJUN, 500mg tab) taken for an unspecified indication from 08Feb2021 to 16Feb2021; oxycodone hydrochloride, paracetamol (OXYCODONE AND ACETAMINOPHEN, 5-325) taken for an unspecified indication from 05Feb2021 to 05Feb2021 (also reported as (Only one tab). The patient experienced 102 Fever, chill (reported onset from last dose was 7 minutes), fatigue, Headache on 06Feb2021. The patient was not admitted hospital due to the events.  The outcome of the events was recovered on 07Feb2021. No Treatment were received.   Information about lot/batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Maternal exposure during pregnancy, Night sweats
Clinical narrative: Super painful arm; night sweats; headache/intermittent headaches; super achy; chills; pregnant; fatigue; This is a spontaneous report from a contactable female nurse. A 31-year-old female pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number:  EL3247), via an unspecified route of administration, administered in left arm on 19Jan2021 13:00 (at the age of 31-years-old) as single dose for COVID-19 immunisation. The patient medical history included seasonal allergies, acid reflux, headaches, IBS. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient concomitant medication included pantoprazole sodium sesquihydrate (PROTONIX), minerals nos, vitamins nos (PRENATAL VITAMINS), cetirizine hydrochloride (ZYRTEC) and allergy shot. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EH9899) via an unspecified route of administration, administered in arm left on 29Dec2020 13:00 (at the age of 31-years-old) as single dose for COVID-19 immunisation and experienced headache, night sweats, achy, exposure during pregnancy and chills.  It was reported that patient experienced 12 hours post injection that was on 20Jan2021 at 13:00, super painful arm, night sweats, headache, super achy and chills and the 2nd night post that was on an unknown date in Jan2021, continued with night sweats and fatigue and intermittent headaches with achiness. The patient last menstrual period was on 19Dec2020. The patient was 4 Weeks pregnant at the onset of the event. The patient was due to deliver on 25Sep2021. The patient did not receive any treatment for the events super painful arm, night sweats, headache, super achy, fatigue and chills. The events were reported as non-serious. The outcome of the events painful arm, night sweats, headache, super achy, fatigue and chills were recovered on an unknown date Jan2021 while for other event pregnant was unknown.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: Super painful arm; night sweats; headache/intermittent headaches; super achy; chills; pregnant; fatigue; This is a spontaneous report from a contactable female nurse. A 31-year-old female pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number:  EL3247), via an unspecified route of administration, administered in left arm on 19Jan2021 13:00 (at the age of 31-years-old) as single dose for COVID-19 immunisation. The patient medical history included seasonal allergies, acid reflux, headaches, IBS. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient concomitant medication included pantoprazole sodium sesquihydrate (PROTONIX), minerals nos, vitamins nos (PRENATAL VITAMINS), cetirizine hydrochloride (ZYRTEC) and allergy shot. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EH9899) via an unspecified route of administration, administered in arm left on 29Dec2020 13:00 (at the age of 31-years-old) as single dose for COVID-19 immunisation and experienced headache, night sweats, achy, exposure during pregnancy and chills.  It was reported that patient experienced 12 hours post injection that was on 20Jan2021 at 13:00, super painful arm, night sweats, headache, super achy and chills and the 2nd night post that was on an unknown date in Jan2021, continued with night sweats and fatigue and intermittent headaches with achiness. The patient last menstrual period was on 19Dec2020. The patient was 4 Weeks pregnant at the onset of the event. The patient was due to deliver on 25Sep2021. The patient did not receive any treatment for the events super painful arm, night sweats, headache, super achy, fatigue and chills. The events were reported as non-serious. The outcome of the events painful arm, night sweats, headache, super achy, fatigue and chills were recovered on an unknown date Jan2021 while for other event pregnant was unknown.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, SARS-CoV-2 test
Clinical narrative: very dizzy when he got up; This is a spontaneous report from a contactable consumer, the patient, reporting for himself. A 71-years-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: PP12OR EL9267), via an unspecified route of administration in left arm on 24Feb2021 at 12:00 PM (at the age of 71-years-old) as a single dose for COVID-19 immunization. Medical history was none. The patient had no allergies to medications, food, or other products. Concomitant medications included lisinopril (LISINOPRIL) and finasteride (PROPECIA); both were taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162b2 (Batch/Lot Number: PP920 EL9263), via an unspecified route of administration in left arm on 03Feb2021 at 12:00 PM (at the age of 71-years-old) as a single dose for COVID-19 immunization and was fine. The patient did not receive any other vaccines within four weeks prior to BNT162b2. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 via a Curative DC on 26Feb2021 with negative result. The patient was fine for day after second dose of vaccine, but on the second and third morning from 26Feb2021 at 6:00 AM, the patient was very dizzy when he got up. It was moderated later in the day, but it was still slight (it's currently third morning). The patient did not receive treatment for the event. The outcome of event, very dizzy when he got up, was not recovered.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: slight numbness in the left side of the face; This is a spontaneous report from a contactable consumer or other non hcp. A 30-year-old male patient received bnt162b2 (BNT162B2, solution for injection, Lot #; EL9266), dose 1 via an unspecified route of administration, administered in Arm Left on 26Feb2021 09:30 as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol (NYQUIL) taken for an unspecified indication, start and stop date were not reported; omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported. The patient previously took naldecon [carbinoxamine maleate;paracetamol;phenylephrine hydrochloride] and experienced drug hypersensitivity. On 26Feb2021 11:15, the patient experienced slight numbness in the left side of the face. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Dizziness, Headache, SARS-CoV-2 test
Clinical narrative: dizziness; vertigo; mild headache; mild diarrhea; no appetite; This is a spontaneous report from a contactable consumer (patient). A 67-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number Unknown) via an unspecified route of administration, administered in left arm on 30Jan2021 at 09:00 (at the age of 67 years old) as a single dose, for COVID-19 immunization. The patient also received dose 2 of BNT162b2 (Lot number Unknown) via an unspecified route of administration, administered in left arm on 20Feb2021 at 09:00 (at the age of 67 years old) as a single dose. The patient was administered dose 2 of BNT162b2 at a Doctor's office/urgent care. Medical history included hernia from an unspecified date (Hernia surgery 22Feb2021). The patient did not have any known allergies to medications, food, or other products. The patient did not experience COVID-19 prior to vaccination. Concomitant medications received within 2 weeks of vaccination included levothyroxine and rosuvastatin. The patient did not receive any other vaccines within four weeks prior to vaccination. On 19Feb2021, six days after vaccination (as reported), the patient woke up with dizziness, vertigo, mild headache and mild diarrhea. These continued throughout the day with no appetite. The vertigo was better if the patient sat still. The patient woke up on day 2 to vertigo again but easing. The events did not result in hospitalization/prolongation of hospitalization. The patient had a negative COVID-19 test (nasal swab) on 19Feb2021. The patient did not receive treatment for the events. The clinical outcome of the events dizziness, mild headache, mild diarrhea and no appetite was not recovered. The clinical outcome of the event vertigo was recovering.   The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 mRNA VACCINE, were not provided and will be requested during follow up.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: dizziness; vertigo; mild headache; mild diarrhea; no appetite; This is a spontaneous report from a contactable consumer (patient). A 67-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number Unknown) via an unspecified route of administration, administered in left arm on 30Jan2021 at 09:00 (at the age of 67 years old) as a single dose, for COVID-19 immunization. The patient also received dose 2 of BNT162b2 (Lot number Unknown) via an unspecified route of administration, administered in left arm on 20Feb2021 at 09:00 (at the age of 67 years old) as a single dose. The patient was administered dose 2 of BNT162b2 at a Doctor's office/urgent care. Medical history included hernia from an unspecified date (Hernia surgery 22Feb2021). The patient did not have any known allergies to medications, food, or other products. The patient did not experience COVID-19 prior to vaccination. Concomitant medications received within 2 weeks of vaccination included levothyroxine and rosuvastatin. The patient did not receive any other vaccines within four weeks prior to vaccination. On 19Feb2021, six days after vaccination (as reported), the patient woke up with dizziness, vertigo, mild headache and mild diarrhea. These continued throughout the day with no appetite. The vertigo was better if the patient sat still. The patient woke up on day 2 to vertigo again but easing. The events did not result in hospitalization/prolongation of hospitalization. The patient had a negative COVID-19 test (nasal swab) on 19Feb2021. The patient did not receive treatment for the events. The clinical outcome of the events dizziness, mild headache, mild diarrhea and no appetite was not recovered. The clinical outcome of the event vertigo was recovering.   The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 mRNA VACCINE, were not provided and will be requested during follow up.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Feeling cold, Headache
Clinical narrative: swollen lymph nodes around my neck; diarrhea; severe headache; chills; fever near 102; muscle aches; profuse sweating; felt freezing cold; inability to sleep; This is a spontaneous report from a contactable other hcp, the patient.   A 22-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration, administered in the left arm on 25Feb2021 at 10:00 (at the age of 22-years-old) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient has no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously received the first dose of BNT162b2 on 04Feb2021 at 10:00 (Lot Number: UNKNOWN; at age of 22-years-old) via an unspecified route of administration in the left arm for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 25Feb2021 at 16:30, the patient experienced in order, diarrhea, severe headache, chills, fever near 102, muscle aches, profuse sweating although felt freezing cold, inability to sleep. The headache has lasted 3 days now as well as swollen lymph nodes around his neck. The patient did not receive any treatment for the events. The patient was recovering from the events, swollen lymph nodes around his neck, diarrhea, severe headache, chills, fever near 102, muscle aches, profuse sweating, felt freezing cold, and inability to sleep.   No follow-up attempts are possible; information about lot/batch number cannot be obtained