chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oxygen therapy, Pulmonary hypertension, Pyrexia
Clinical narrative: COUGH; oxygenation needs quickly escalated; SHORTNESS OF BREATH; A spontaneous report  received from a Healthcare Professional concerning, an 82-year-old male patient who received 2nd dose of the Moderna COVID-19 vaccine and experienced serious adverse events of cough, shortness of breath and hypoxia (reported as oxygenation needs quickly escalated).   The patient's medical history included hypertension and hyperlipidemia. Patient's concomitant medications were not included.   On unknown date, the patient received their 2nd dose of the two planned doses of mRNA-1273 in unknown arm (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection.   Healthcare Professional stated that Approximately 36 hours after his second vaccination, (on 14-Feb-2021), during a trip with his family, he developed mild cough and SOB that progressed to severe symptoms requiring hospitalization. Healthcare Professional stated patient oxygenation quickly escalated requiring high flow nasal cannula. Patient was initially treated as COVID and high-altitude pulmonary edema. Healthcare Professional stated COVID PCR/ respiratory PCR were negative x 3 and all infectious workup was negative. Healthcare Professional stated the care team began to treat patient with high dose steroids in case of hypersensitivity pneumonitis or eosinophilic lung disease due to vaccination. Patient required a higher level of care but was not stable for transfer home, so the decision was made to transfer patient to ICU where he is currently under the care of ICU and infectious disease specialists. Healthcare Professional stated patient echocardiogram was normal and infectious workup (including COVID and respiratory PCR and cultures) thus far remain negative. Healthcare Professional stated patient is still on high-flow nasal cannula, though skirting intubation. Healthcare Professional feels the process is likely inflammatory versus infectious. Healthcare Professional stated Autoimmune workup is pending.   Treatment included high-flow oxygen, solumedrol and empiric antibiotics.  Action taken with mRNA-1273 in response to these events was not applicable.  The outcome of these events was unknown.; 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.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Dyspnoea, Hypoxia
Clinical narrative: COUGH; oxygenation needs quickly escalated; SHORTNESS OF BREATH; A spontaneous report  received from a Healthcare Professional concerning, an 82-year-old male patient who received 2nd dose of the Moderna COVID-19 vaccine and experienced serious adverse events of cough, shortness of breath and hypoxia (reported as oxygenation needs quickly escalated).   The patient's medical history included hypertension and hyperlipidemia. Patient's concomitant medications were not included.   On unknown date, the patient received their 2nd dose of the two planned doses of mRNA-1273 in unknown arm (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection.   Healthcare Professional stated that Approximately 36 hours after his second vaccination, (on 14-Feb-2021), during a trip with his family, he developed mild cough and SOB that progressed to severe symptoms requiring hospitalization. Healthcare Professional stated patient oxygenation quickly escalated requiring high flow nasal cannula. Patient was initially treated as COVID and high-altitude pulmonary edema. Healthcare Professional stated COVID PCR/ respiratory PCR were negative x 3 and all infectious workup was negative. Healthcare Professional stated the care team began to treat patient with high dose steroids in case of hypersensitivity pneumonitis or eosinophilic lung disease due to vaccination. Patient required a higher level of care but was not stable for transfer home, so the decision was made to transfer patient to ICU where he is currently under the care of ICU and infectious disease specialists. Healthcare Professional stated patient echocardiogram was normal and infectious workup (including COVID and respiratory PCR and cultures) thus far remain negative. Healthcare Professional stated patient is still on high-flow nasal cannula, though skirting intubation. Healthcare Professional feels the process is likely inflammatory versus infectious. Healthcare Professional stated Autoimmune workup is pending.   Treatment included high-flow oxygen, solumedrol and empiric antibiotics.  Action taken with mRNA-1273 in response to these events was not applicable.  The outcome of these events was unknown.; 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: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypertension
Clinical narrative: 2/28/2021 early evening: feeling flushed /hot  but also had roaring fire in woodstove going  11pm: feeling fine, took BP and it was 195/99. retook BP 195/111  uncontrollable trembling once saw BP values  no additional symptoms  started to lower after about 1 hour  24 hours later BP was 100/68
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hot flush, Tremor
Clinical narrative: 2/28/2021 early evening: feeling flushed /hot  but also had roaring fire in woodstove going  11pm: feeling fine, took BP and it was 195/99. retook BP 195/111  uncontrollable trembling once saw BP values  no additional symptoms  started to lower after about 1 hour  24 hours later BP was 100/68
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diplopia, Lumbar puncture normal, Magnetic resonance imaging, Magnetic resonance imaging normal, Meningitis aseptic
Clinical narrative: viral meningitis; headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient (reporter's mother) of an unspecified age (Age: 81, Unit: Unknown) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 11Feb2021, patient started with headache. On 14Feb2021, patient was admitted to the hospital with possible diagnosis of viral meningitis. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vertigo, Vestibular neuronitis
Clinical narrative: viral meningitis; headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient (reporter's mother) of an unspecified age (Age: 81, Unit: Unknown) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 11Feb2021, patient started with headache. On 14Feb2021, patient was admitted to the hospital with possible diagnosis of viral meningitis. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Meningitis viral
Clinical narrative: viral meningitis; headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient (reporter's mother) of an unspecified age (Age: 81, Unit: Unknown) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 11Feb2021, patient started with headache. On 14Feb2021, patient was admitted to the hospital with possible diagnosis of viral meningitis. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood creatine phosphokinase increased, C-reactive protein increased, Condition aggravated, Dysphagia
Clinical narrative: a full exacerbation of her chronic autoimmune disease, Systemic Lupus Erythematosus/Polymyositis; a full exacerbation of her chronic autoimmune disease, Systemic Lupus Erythematosus/Polymyositis; a full exacerbation of her chronic autoimmune disease, Systemic Lupus Erythematosus/Polymyositis; This is a spontaneous report from a contactable physician reporting for a patient. A 63-year-old female patient received first dose bnt162b2 (PFIZER COVID 19 VACCINE, lot number= EM9810), intramuscular at Left arm on 09Feb2021 12:00 at single dose for COVID-19 immunisation. Medical history included Systemic Lupus Erythematosus, Polymyositis, Gastrooesophageal reflux disease (GERD) and known allergies: Penicillin. The patient was not pregnant. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior vaccination.  Concomitant medication included prednisone, mycophenolate mofetil hydrochloride (CELLCEPT), esomeprazole magnesium (NEXIUM). The patient previously took azithromycin, dexilant, heparin and experienced allergies. The patient experienced profound weakness, fever, malaise and swallowing difficulties (this was a full exacerbation of her chronic autoimmune disease, Systemic Lupus Erythematosus/ Polymyositis which had been in remission for over 3 years on medication) on 25Feb2021. The adverse events resulted in: Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The treatment of the adverse events was High Dose Corticosteroids, contemplating IVIG therapy. The patient did not test COVID post vaccination. Facility type vaccine was other. The outcome of the events was not recovered.; Sender's Comments: Based on the information available, a causal association between BNT162b2 (PFIZER COVID 19 VACCINE) and the reported 'full exacerbation of her chronic autoimmune disease, Systemic Lupus Erythematosus/ Polymyositis" cannot be excluded. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pyrexia, Red blood cell sedimentation rate increased, Systemic lupus erythematosus, White blood cell count increased
Clinical narrative: a full exacerbation of her chronic autoimmune disease, Systemic Lupus Erythematosus/Polymyositis; a full exacerbation of her chronic autoimmune disease, Systemic Lupus Erythematosus/Polymyositis; a full exacerbation of her chronic autoimmune disease, Systemic Lupus Erythematosus/Polymyositis; This is a spontaneous report from a contactable physician reporting for a patient. A 63-year-old female patient received first dose bnt162b2 (PFIZER COVID 19 VACCINE, lot number= EM9810), intramuscular at Left arm on 09Feb2021 12:00 at single dose for COVID-19 immunisation. Medical history included Systemic Lupus Erythematosus, Polymyositis, Gastrooesophageal reflux disease (GERD) and known allergies: Penicillin. The patient was not pregnant. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior vaccination.  Concomitant medication included prednisone, mycophenolate mofetil hydrochloride (CELLCEPT), esomeprazole magnesium (NEXIUM). The patient previously took azithromycin, dexilant, heparin and experienced allergies. The patient experienced profound weakness, fever, malaise and swallowing difficulties (this was a full exacerbation of her chronic autoimmune disease, Systemic Lupus Erythematosus/ Polymyositis which had been in remission for over 3 years on medication) on 25Feb2021. The adverse events resulted in: Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The treatment of the adverse events was High Dose Corticosteroids, contemplating IVIG therapy. The patient did not test COVID post vaccination. Facility type vaccine was other. The outcome of the events was not recovered.; Sender's Comments: Based on the information available, a causal association between BNT162b2 (PFIZER COVID 19 VACCINE) and the reported 'full exacerbation of her chronic autoimmune disease, Systemic Lupus Erythematosus/ Polymyositis" cannot be excluded. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Polymyositis, Systemic lupus erythematosus
Clinical narrative: a full exacerbation of her chronic autoimmune disease, Systemic Lupus Erythematosus/Polymyositis; a full exacerbation of her chronic autoimmune disease, Systemic Lupus Erythematosus/Polymyositis; a full exacerbation of her chronic autoimmune disease, Systemic Lupus Erythematosus/Polymyositis; This is a spontaneous report from a contactable physician reporting for a patient. A 63-year-old female patient received first dose bnt162b2 (PFIZER COVID 19 VACCINE, lot number= EM9810), intramuscular at Left arm on 09Feb2021 12:00 at single dose for COVID-19 immunisation. Medical history included Systemic Lupus Erythematosus, Polymyositis, Gastrooesophageal reflux disease (GERD) and known allergies: Penicillin. The patient was not pregnant. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior vaccination.  Concomitant medication included prednisone, mycophenolate mofetil hydrochloride (CELLCEPT), esomeprazole magnesium (NEXIUM). The patient previously took azithromycin, dexilant, heparin and experienced allergies. The patient experienced profound weakness, fever, malaise and swallowing difficulties (this was a full exacerbation of her chronic autoimmune disease, Systemic Lupus Erythematosus/ Polymyositis which had been in remission for over 3 years on medication) on 25Feb2021. The adverse events resulted in: Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The treatment of the adverse events was High Dose Corticosteroids, contemplating IVIG therapy. The patient did not test COVID post vaccination. Facility type vaccine was other. The outcome of the events was not recovered.; Sender's Comments: Based on the information available, a causal association between BNT162b2 (PFIZER COVID 19 VACCINE) and the reported 'full exacerbation of her chronic autoimmune disease, Systemic Lupus Erythematosus/ Polymyositis" cannot be excluded. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dysgeusia, Hypoaesthesia oral, Paraesthesia oral, Pharyngeal paraesthesia
Clinical narrative: Observed for 30 minutes post vaccination.  45 minutes post vaccination had metallic taste, tingling and numbness in lips and tongue and scratchy throat/  Contacted PCP.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dysgeusia, Hypoaesthesia oral, Paraesthesia oral, Throat irritation
Clinical narrative: Observed for 30 minutes post vaccination.  45 minutes post vaccination had metallic taste, tingling and numbness in lips and tongue and scratchy throat/  Contacted PCP.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dysgeusia, Hypoaesthesia oral, Migraine, Nasopharyngitis, Oral discomfort
Clinical narrative: Observed for 30 minutes post vaccination.  45 minutes post vaccination had metallic taste, tingling and numbness in lips and tongue and scratchy throat/  Contacted PCP.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Oropharyngeal pain, Paraesthesia oral
Clinical narrative: Observed for 30 minutes post vaccination.  45 minutes post vaccination had metallic taste, tingling and numbness in lips and tongue and scratchy throat/  Contacted PCP.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dysgeusia, Hypoaesthesia oral, Oropharyngeal pain, Paraesthesia oral, Throat irritation
Clinical narrative: Observed for 30 minutes post vaccination.  45 minutes post vaccination had metallic taste, tingling and numbness in lips and tongue and scratchy throat/  Contacted PCP.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: Error: Booster Given Too Early
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dizziness, Pharyngeal paraesthesia
Clinical narrative: I did initially feel a little light headed while waiting the 15 minutes post vaccine, but thought I was anxious. As I was driving home at 3:50 pm I suddenly started to feel tingling in my lips and my throat felt swollen and my chest tight. I was halfway home and panicked so I went home and stayed put. My throat started to relax but my chest felt tight and I was dizzy and light headed till about 9pm. My lips ended up getting a little swollen and I?m still having a burning sensation in my cheeks and chin and my lips are still itchy.  I am a nurse and my husband is a physician and we had an epi pen on hand so I didn?t feel the need to go to the hospital as I was in good care but it was terrifying.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Burning sensation, Chest discomfort, Dizziness, Lip pruritus
Clinical narrative: I did initially feel a little light headed while waiting the 15 minutes post vaccine, but thought I was anxious. As I was driving home at 3:50 pm I suddenly started to feel tingling in my lips and my throat felt swollen and my chest tight. I was halfway home and panicked so I went home and stayed put. My throat started to relax but my chest felt tight and I was dizzy and light headed till about 9pm. My lips ended up getting a little swollen and I?m still having a burning sensation in my cheeks and chin and my lips are still itchy.  I am a nurse and my husband is a physician and we had an epi pen on hand so I didn?t feel the need to go to the hospital as I was in good care but it was terrifying.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Paraesthesia oral, Pharyngeal swelling
Clinical narrative: I did initially feel a little light headed while waiting the 15 minutes post vaccine, but thought I was anxious. As I was driving home at 3:50 pm I suddenly started to feel tingling in my lips and my throat felt swollen and my chest tight. I was halfway home and panicked so I went home and stayed put. My throat started to relax but my chest felt tight and I was dizzy and light headed till about 9pm. My lips ended up getting a little swollen and I?m still having a burning sensation in my cheeks and chin and my lips are still itchy.  I am a nurse and my husband is a physician and we had an epi pen on hand so I didn?t feel the need to go to the hospital as I was in good care but it was terrifying.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Musculoskeletal chest pain, Pain
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Medium, Systemic: Headache-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Medium
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Confusional state, Dizziness, Fatigue, Headache
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Medium, Systemic: Headache-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Medium
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Lethargy, Nausea, Pain, Pyrexia
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Medium, Systemic: Headache-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Medium
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Medium, Systemic: Headache-Severe, Systemic: Nausea-Severe, Systemic: Shakiness-Medium
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Swelling face, Throat tightness
Clinical narrative: waited prescribed time and went to car but face felt tight and throat started to constrict.  I looked in mirror and saw face had swelled.  Went back into pharmacy and they called 911.  EMT took me to ambulance to check vitals and this took about 45 minutes.  They offered to take me to hospital but declined as had my husband suffering from cancer who also had shot and can't drive was waiting in the car.  We drove 1/2 mile to friends home and waited to make sure felt ok to drive back.  Drove home ok and have been feeling tired for 3 days but otherwise ok.  Pharmacy followed up next day.  Today feel a bit of pressure in the chest and have placed a call to my doctor but he has gone for weekend.  I will go to emergency room if I feel worse and will call him on Monday to report incident.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose, Blood pressure measurement, Chest discomfort, Electrocardiogram, Fatigue
Clinical narrative: waited prescribed time and went to car but face felt tight and throat started to constrict.  I looked in mirror and saw face had swelled.  Went back into pharmacy and they called 911.  EMT took me to ambulance to check vitals and this took about 45 minutes.  They offered to take me to hospital but declined as had my husband suffering from cancer who also had shot and can't drive was waiting in the car.  We drove 1/2 mile to friends home and waited to make sure felt ok to drive back.  Drove home ok and have been feeling tired for 3 days but otherwise ok.  Pharmacy followed up next day.  Today feel a bit of pressure in the chest and have placed a call to my doctor but he has gone for weekend.  I will go to emergency room if I feel worse and will call him on Monday to report incident.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin tightness, Swelling face
Clinical narrative: waited prescribed time and went to car but face felt tight and throat started to constrict.  I looked in mirror and saw face had swelled.  Went back into pharmacy and they called 911.  EMT took me to ambulance to check vitals and this took about 45 minutes.  They offered to take me to hospital but declined as had my husband suffering from cancer who also had shot and can't drive was waiting in the car.  We drove 1/2 mile to friends home and waited to make sure felt ok to drive back.  Drove home ok and have been feeling tired for 3 days but otherwise ok.  Pharmacy followed up next day.  Today feel a bit of pressure in the chest and have placed a call to my doctor but he has gone for weekend.  I will go to emergency room if I feel worse and will call him on Monday to report incident.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Syncope
Clinical narrative: 3 minutes after the vaccination, I was standing up waiting to schedule my 2nd dose, then became lightheaded, a clerk immediately sat me down in a chair, then I had trouble breakthing, had neck spasms radiating to my arms, then my fingers clenched shut the my whole body, arms and legs were shaking uncontrollably. The team acted very quickly by giving me an injection of Epinephrine and Benadryl, placed me in a wheelchair then rushed to the ER, given oxygen, IV fluids, prednisone and valium to control the neck spasm as my whole body was again shaking and causing difficulty breathing, rapid breathing. Once I was stablized I was wheeled to my vehicle where I was driven home by a family member. Once I was home, 4 hours later I was still having neck spasms, also across my upper chest and tingling in my hands, this is notmal for me so it is diffiult to determine if this was still due to the vaccine and Epinephrine and Benadryl or the Moderna vaccine. This was the first time  I was ever given or used Epinephrine.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Electrocardiogram normal, Muscle spasms, Paraesthesia
Clinical narrative: 3 minutes after the vaccination, I was standing up waiting to schedule my 2nd dose, then became lightheaded, a clerk immediately sat me down in a chair, then I had trouble breakthing, had neck spasms radiating to my arms, then my fingers clenched shut the my whole body, arms and legs were shaking uncontrollably. The team acted very quickly by giving me an injection of Epinephrine and Benadryl, placed me in a wheelchair then rushed to the ER, given oxygen, IV fluids, prednisone and valium to control the neck spasm as my whole body was again shaking and causing difficulty breathing, rapid breathing. Once I was stablized I was wheeled to my vehicle where I was driven home by a family member. Once I was home, 4 hours later I was still having neck spasms, also across my upper chest and tingling in my hands, this is notmal for me so it is diffiult to determine if this was still due to the vaccine and Epinephrine and Benadryl or the Moderna vaccine. This was the first time  I was ever given or used Epinephrine.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachypnoea, Tremor
Clinical narrative: 3 minutes after the vaccination, I was standing up waiting to schedule my 2nd dose, then became lightheaded, a clerk immediately sat me down in a chair, then I had trouble breakthing, had neck spasms radiating to my arms, then my fingers clenched shut the my whole body, arms and legs were shaking uncontrollably. The team acted very quickly by giving me an injection of Epinephrine and Benadryl, placed me in a wheelchair then rushed to the ER, given oxygen, IV fluids, prednisone and valium to control the neck spasm as my whole body was again shaking and causing difficulty breathing, rapid breathing. Once I was stablized I was wheeled to my vehicle where I was driven home by a family member. Once I was home, 4 hours later I was still having neck spasms, also across my upper chest and tingling in my hands, this is notmal for me so it is diffiult to determine if this was still due to the vaccine and Epinephrine and Benadryl or the Moderna vaccine. This was the first time  I was ever given or used Epinephrine.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphonia, Paraesthesia oral, Pharyngeal swelling
Clinical narrative: 3:08pm 37yo active duty female presents with a change of voice and swelling of the throat and tingling tongue. Patient denied any difficulty breathing and was able to swallow and control secretions. Patient has had an anaphylactic reaction with pork and beef in the past. Patient states she is on numerous amounts of medication. Epinephrine was delivered via IM on right thigh at approximately 3:08pm. EMS was called at 3:10pm and arrived at 3:13pm. At 3:11pm, patient reported tongue was no longer tingly but still numb. SPO2 98%, HR110, BP 148/100. Patient was released upon stabilization.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gaze palsy, Malaise, Seizure, Unresponsive to stimuli
Clinical narrative: Systemic: Seizure-Medium
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Seizure
Clinical narrative: Systemic: Seizure-Medium
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; A nurse reported V ARlV AX was improperly stored and administered.; This spontaneous report was received from a licensed practical nurse, referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On unspecified dates, the patients were vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number T017686 which has been verified to be valid, expiration date reported and validated as 21-MAY-2022) (lot number T017682 which has been verified to be valid, expiration date reported and validated as 21-MAY-2022) (doses and frequencies were unknown by the reporter; vaccination schemes, routes of administration, and anatomical site of injection were not reported) as prophylaxis. The administered doses of the vaccine were stored on 19-JAN-2021, at a temperature of 9.1 degrees Fahrenheit (F), during a time frame of 2 hours, as recorded by a digital data logger. There were previous temperature excursions reported on 02-DEC-2020, 6 F to 14 F (11 F) during a time frame of 1 hour, and 14 F to 46 F (36F) during a time frame of 3 hours. On 14-DEC-2020, 6 F to 14 F (13.8 F) during a time frame of 6 hours, and 14 F to 46 F (15.8) during a time frame of 42 minutes. On 21-DEC-2020, 6 F to 14 F (8.8 F) during a time frame of 1 hour and 30 minutes. On 07-JAN-2021, 6 F to 14 F (9.5 F) during a time frame of 10 hours. On 18-JAN-2021, 14 F to 46 F (32.4 F) during a time frame of 5 hours 0 minutes and 0 seconds. No additional adverse events were reported in the patients.  This is a non-valid case due to the lack of patient identifiers.  Follow up information was received from the  licensed practical nurse on 28-JAN-2021 regarding a 1 year old female patient. with 2 siblings, birth weight of 5.15  lb. Her concomitant therapies included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), hepatitis a virus vaccine inactivated(HAVRIX) and pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVNAR). The patient's concurrent conditions and medical history were not provided.   Since 02-DEC-2020, the varicella virus vaccine live (oka/merck)(VARIVAX) experienced temperature excursions with a total of 29.5h.    On 12-JAN-2021, the patient was vaccinated with her first dose of this improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot# T017686, expiration date 21-MAY-2022, subcutaneously in the left thigh, for prophylaxis, on a private doctor's office/hospital with public funds.  This is one of several reports from the same reporter (US-009507513-2102USA002533,US-009507513-2102USA002536,US-009507513-2102USA002535,US-009507513-2102USA002534 and US-009507513-2102USA002537).; Sender's Comments:  US-009507513-2101USA011364:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional adverse experiences reported.; reported a vaccine excursion on PROQUAD in September 2020; the vaccine was administered to one patient; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 15-SEP-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) injection, single dose, lot number T009932 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date: 16-SEP-2021 (dose number, route of administration and anatomical location were not reported) for prophylaxis.  The reporter believed the excursion started on 10-SEP-2020, but was unsure of the full excursion details during the call. There was no previous temperature excursion. Digital Data Logger was not involved.  No additional adverse experiences were reported.
Sex: F
Vaccine: PPV
Symptoms: Condition aggravated, Immunodeficiency common variable, Urticaria chronic
Clinical narrative: She was challenged with pneumococcal vaccine PPV23; This literature marketed information has been received from the authors in a published article title as stated below and refers to a 64-year-old female patient. Her concurrent condition included chronic spontaneous urticaria, hypertension, hyperlipidemia, rhinitis allergic, glucose tolerance impaired, gastroesophageal reflux disease, atrial fibrillation, chronic kidney disease and diverticulum. The patient's medical history included pyelonephritis, osteomyelitis, hepatitis viral test negative, rubella, scarlet fever, measles, measles, Surgical history was significant for tonsillectomy in childhood secondary to recurrent streptococcal pharyngitis, appendectomy with peritonitis at age 5 and tonsillectomy.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot #, expiration date, dose, frequency, strength, route of administration and anatomical location were not reported) for challenged.  Literature report:
Sex: U
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: rash covering their whole body; This spontaneous report as received from a physician refers to a 20-month-old patient. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  On an unknown date, the patient was vaccinated with a second hepatitis a vaccine, inactivated (VAQTA)prefilled syringe,dose:0.5 milliliter, lot # T013205, expiration date not reported, but upon internal validation established as 03-DEC-2021,intramuscularly for prophylaxis reported as hep A vaccination.    On an unknown date, the patient experienced rash covering their whole body. The patient received unspecified treatment. The outcome of rash was unknown.     The causal relationship between the aforementioned event hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T013205; expirationdate: 03-DEC-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; Sender's Comments:  US-009507513-2102USA008560:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: PROQUAD that underwent a temperature excursion was administered; No adverse event; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender.The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.    On 19-JAN-2021, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) Lot # T018274, expiration date 23-NOV-2021 for prophylaxis (dosage regimen and anatomical location were not reported). The temperature was reported to had been in between 14 °Fahrenheit (F) to 46 °F, specifically at 16.8 °F for  1 hour and 55 minutes. A previous temperature excursion was reported had taken place and temperature was reported to had been in between 5 °F to 14 °F specifically at 7.5°F for 6 hours and 53 minutes; and  between 5°F to 14°F,  specifically at 10.9 °F  for 12 hours and 46 minutes  No additional adverse effect reported and there was digital data logger involved.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event reported.; Nurse calling to report an adverse event on improperly stored administered PROQUAD; This spontaneous report was received from a registered nurse, referring to a 12-month-old patient of unknown gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.  On 25-FEB-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), administered at a dose of 0.5 milliliter (ml), as prophylaxis (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not provided; lot number T023919, which has been verified to be valid, expiration date reported and validated as 09-JAN-2022). The vaccine administered, experienced a temperature excursion of -5.2 degrees Celsius (C), for a time frame of 15 minutes as recorded by a data logger (product storage error). There was no previous temperature excursion reported. No additional adverse events were reported.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Miscarried at 6 weeks; Vaccine exposure during pregnancy; A spontaneous  report was received from a healthcare professional concerning a 32 year old female patients who received Moderna's  Covid 19 vaccine(mRNA1273) and experienced vaccine exposure during pregnancy and miscarried at 6 weeks.  The patient's medical history was not provided. Concomitant product use was not provided.    The patient received second of two planned dose of mRNA-1273  for prophylaxis of Covid 19 infection approximately 2.5 weeks before the miscarriage.  The patient experienced vaccine exposure during pregnancy and miscarried at 6 weeks, approximately 2.5 after receiving her second dose of Moderna 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 event, miscarriage spontaneous  was considered as unknown. The outcome for the event of Vaccine exposure during pregnancy was recovered/resolved.; Reporter's Comments: This case concerns a 32 year old, female subject, who experienced a spontaneous abortion and drug exposure during  pregnancy. The patient experienced vaccine exposure during pregnancy and miscarried at 6 weeks, approximately 2.5 after receiving her second dose of mRNA-1273. Very limited information has been provided at this time. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Arthritis bacterial
Clinical narrative: septic right knee; A spontaneous  VAERS report was received from a reporter ( healthcare professional)  concerning a 76 year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced serious event septic right knee (PT-Arthritis bacterial).  The patient's medical history was not provided. The patient received first dose of vaccine (Lot number:039K20A) on 30-Dec-2021. The relevant concomitant medications were also not provided.  On 26-Jan-2021 , prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 019K20A) through intramuscular route of administration in the right arm for prophylaxis of COVID-19 infection.  On 17-Feb-2021, the patient experienced septic right knee and was admitted to the hospital and treatment was provided ( treatment details are not provided).   Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event was not provided.; Reporter's Comments: This is a case of a 73-year-old male subject with limited hx and experienced septic right knee 23 days after receiving second dose of vaccine. Very limited information regarding these events have been provided at this time. However, based on the onset date and cause of infection due to bacterial organism, the event is unlikely related to the vaccine.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Oxygen saturation, Pneumonia, Polymerase chain reaction
Clinical narrative: double pneumonia; A spontaneous report was received from a healthcare professional concerning a 71-year-old, male patient who received a Moderna's COVID-19 vaccine (mRNA-1273) second dose.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included lisinopril, terazosin, clopidogrel, atorvastatin.  On 13-Feb-2021 prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  Caregiver reported on spouse's symptoms following dose 2 of vaccine. On 13-Feb-2021, after second dose of vaccine, patient experienced slight fever of 99.2 Fahrenheit, joint pain, and typical cold symptoms. On 14-Feb-2021, patient felt fatigues and slight fever. On 15-Feb-2021, patient felt not right. On 17-Feb-2021, early morning, fever was 99.8 Fahrenheit, and he sounded like has fluid overload. Called ambulance because patient felt like he could not breathe. At hospital oxygen saturation was 67%. Polymerase chain reaction COVID-19 test  was negative. Patient got admitted to intensive care unit. No treatment information was provided.  The patient received both scheduled dose of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events, double pneumonia, felt like he couldn't breathe, feeling not right, fever, typical cold symptoms, joint pain, and fatigue were considered 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 event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: Severe Abdominal pain; A spontaneous report, was received from a consumer, concerning a female patient of unknown age, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced severe abdominal pain (abdominal pain).  The patient's medical history was not provided. Concomitant medication was not reported.    On 12 Feb 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown), intramuscular for the prophylaxis of COVID-19 infection.  On 13 Feb 2021, the patient experienced severe abdominal pain and visited emergency room (ER) and stayed there for 7 hours. On 18 Feb 2021, the patient was re-hospitalized and stayed for 25 hours. No treatment information was provided.  Action taken with second dose of mRNA-1273 in response to the event was not provided.  The outcome of the event, severe abdominal pain, was not 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: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; A spontaneous report was received from a consumer concerning an 82-year-old, female patient who received  Moderna's  Covid-19 vaccine (mRNA1273) and developed Bell's palsy and experienced pain and burning in eyes and a severe headache. . The patient's medical history includes heart disease. Products known to have been used by the patient, within two weeks prior to the event, included clopidogrel bisulfate.  The patient received first of two planned dose of mRNA-1273 (Batch Number 041L20A) intramuscularly on 14-JAN-2021 for prophylaxis of Covid-19 infection.  On 18-FEB-2021, it was reported that the patient had eye pain and some symptoms of Bell's Palsy. On 19-FEB-2021, the symptoms worsened and so on 20-FEB-2021, the patient was taken to urgent care where she was diagnosed with Bell's palsy. The left side of the patient's face, according to her husband, was drooping and she was having trouble eating and drinking. The patient also had a severe headache.   Treatment for the event included prednisone. Patient was also wearing a patch to help prevent pain.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, Bell's palsy  was considered unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Facial paralysis, Herpes zoster, Rash
Clinical narrative: Shingles; Pain behind ear; Rash; Slight dropping in face on the side of vaccination; A spontaneous report was received from consumer concerning a 63 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events- Drooping of Face, Pain Behind Ear, Rash and Shingles.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 13 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 030MZ0A) intramuscularly for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient noticed that she was experiencing slight dropping in her face on the side of the vaccination. The next day, on 17 Feb 2021, the patient began experiencing some pain behind her ear and a small rash on the same side. She was diagnosed with shingles on 22Feb2021.  Treatment information provided include Allergy Pills, Tylenol, Prednisone, Anti-Bacterial medications.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the event- Drooping of Face, Pain Behind Ear, Rash and Shingles was unknown.; Reporter's Comments: Based on the information provided and a temporal association between the reported events and the administration of mRNA-1273 vaccine, a causal relationship cannot be excluded.