chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Limb discomfort, Pain in extremity, Peripheral swelling
Clinical narrative: leg was hurting and had a hard time to get out of the chair; Tried to sit in the kitchen chair which is hard, and also had hard time walking; can hardly bend the leg and that didn't hurt when was laying in bed; goes from the groin area to the toes; A spontaneous report was received from a 83-years-old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events leg was hurting and had a hard time to get out of the chair,  tried to sit in the kitchen chair which is hard, and also had hard time walking, swelling goes from the groin area to the toes and can hardly bend the leg and that didn't hurt when was lying in bed.  The consumer's medical history was not provided.   The consumer's current condition included congestive heart failure (CHF).  No relevant concomitant medications were reported.  On 23-FEB-2021, prior to the onset of the events the consumer received second of two planned doses of mRNA-1273 (lot/batch: 012L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 20-JAN-2021, prior to the onset of the events the consumer received first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 03-MAR-2021, after the second dose the consumer experienced events leg was hurting and had a hard time to get out of the chair,  tried to sit in the kitchen chair which is hard, and also had hard time walking, swelling goes from the groin area to the toes and can hardly bend the leg and that didn't hurt when was lying in bed.   No treatment information for the events was provided.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome for the events was unknown.  The assessment was not provided for the events.; Reporter's Comments: This case concerns an 83-year-old female with PMH of CHF who had serious unexpected events of pain in extremity and gait disturbance along with nonserious unexpected limb discomfort and peripheral swelling.  Event onset occurred 9 days 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, COVID19
Symptoms: Hallucination, auditory, Hallucination, visual, Headache, Pain
Clinical narrative: VISUAL AND AUDITORY HALLUCINATION  (Audio and visual hallucinations, Hallucinations,  mixed)  BODY ACHES  (General body pain, Pain)  HEADACHES (Headache,  Headache) This spontaneous report received from the patient and concerned a female of unspecified age The patient's weight, height, and medical history were not reported .The patient received covid-19 vaccine ad.26.cov2.s  (suspension for injection, intramuscular, batch number: 1805018, and expiry: UNKNOWN) administered on 11-MAR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 11-MAR-2021, the patient experienced visual and auditory hallucination, body ache.  On 12-MAR,  the patient experienced headaches.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headaches,  and body ache, and the outcome of visual and auditory hallucination was not reported.  The reporter provided no causality assessment.  Company causality between AD26.cov2.s and visual and auditory hallucination, body ache and headache and company causality was possible.  This report was serious  (Other Medically Important Condition).
Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pain, Syncope
Clinical narrative: FAINTING (Fainting, Syncope) DIZZINESS (Dizziness, Dizziness) BODY ACHES (General body pain, Pain) NAUSEA (Nausea, Nausea) This spontaneous report received from a patient concerned a 36-year-old, unspecified sex. The patient's height, and weight were not reported. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, expiry: UNKNOWN) dose was not reported, 1 total, administered on 10-MAR-2021 17:00 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, since 0900 the patient began feeling dizzy and nauseous and fainted, patient also complained of body aches. The action taken with JNJ78436735 (Ad26.COV2.2) was not applicable. The patient recovered from fainting, nausea, and dizziness on 11-MAR-2021, and had not recovered from body aches. The reporter considered the causality between covid-19 vaccine ad26.cov2.s and fainting, nausea, dizziness and body aches as related. Company causality between covid-19 vaccine ad26.cov2.S and fainting, nausea, dizziness and body aches was possible. This report was serious (Other Medically Important Condition).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Vertigo
Clinical narrative: PASSED OUT (Passed out, Loss of consciousness) VERTIGO (Vertigo, Vertigo) MASSIVE PROBLEMS (Adverse event NOS, Adverse event This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26 .cov2 .s (suspension for injection, intramuscular, and batch number: 1802068 expiry: UNKNOWN) 0.5 ml, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, patient experienced two days of massive problems, passed out, vertigo. The action taken with covid-19 vaccine ad26 .cov .s was not applicable. The outcome of passed out, vertigo and massive problems was not reported. The reporter and company causality between covid-19 vaccine ad26 .cov .s and passed out, vertigo and massive problems was possible. The report was serious (Other Medically Important Condition).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adverse event, Loss of consciousness, Vertigo
Clinical narrative: PASSED OUT (Passed out, Loss of consciousness) VERTIGO (Vertigo, Vertigo) MASSIVE PROBLEMS (Adverse event NOS, Adverse event This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26 .cov2 .s (suspension for injection, intramuscular, and batch number: 1802068 expiry: UNKNOWN) 0.5 ml, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, patient experienced two days of massive problems, passed out, vertigo. The action taken with covid-19 vaccine ad26 .cov .s was not applicable. The outcome of passed out, vertigo and massive problems was not reported. The reporter and company causality between covid-19 vaccine ad26 .cov .s and passed out, vertigo and massive problems was possible. The report was serious (Other Medically Important Condition).
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Flank pain, Impaired work ability, Loss of personal independence in daily activities
Clinical narrative: FELT BILATERAL LUNG CONGESTION  (Lung congestion,  Pulmonary congestion)  BILATERAL SIDE PAIN  (Flank pain,  Flank pain)  VOMITING  (Vomiting,  Vomiting)  LEFT ARM PAIN  (Painful L arm,  Pain in extremity) DIFFICULTY BREATHING  (Difficulty breathing,  Dyspnoea) MISSED WORK TODAY  (Loss of personal independence in daily activities,  Loss of personal independence in daily activities)  PAIN WHEN BREATHS  (Painful respiration,  Painful respiration) FEVER OF 100 F  (Fever,  Pyrexia) FATIGUE  (Fatigue,  Fatigue) This spontaneous report received from a patient concerned a 52 year old male.  The patient's weight,  height,  and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s  (suspension for injection,  intramuscular,  batch number: 1805018,  expiry:  UNKNOWN)  dose was not reported,  administered on 10-MAR-2021  for prophylactic vaccination.  No concomitant medications were reported.  On 10-MAR-2021  (mentioned as yesterday),  the symptoms of the patient started,  and he missed work today  (loss of personal independence in daily activities)  and left arm pain  (painful  L arm)  because he was not feeling well.  The reporter advised him to contact his primary care provider,  but he said he called and they are not able to see him without an appointment also advised him to seek medical attention by going to the emergency room.  The patient agrees to go to the Emergency Room.  On 11-MAR-2021,  the patient experienced bilateral side pain  (flank pain) , vomiting,  felt bilateral lung congestion  (lung congestion),  difficulty breathing,  fever of 100 F,  fatigue,  pain when breaths  (painful respiration) . Laboratory data included:  Body temperature  (NR: not provided)  100 F.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient was recovering from fever of 100 f,  had not recovered from bilateral side pain,  left arm pain,  fatigue,  vomiting, difficulty breathing,  feels bilateral  lung congestion,  and pain when breaths,  and the outcome of missed work today was not reported.  The reporter considered the causality between Covid-19 vaccine ad26.cov2.s and event bilateral side pain,  left arm pain,  fatigue,  vomiting,  difficulty breathing,  feels bilateral lung congestion,  pain when breaths,  fever f 100 f and missed work today as possible.  Company causality between Covid-19 vaccine ad26.cov2.s  and event bilateral side pain,  left arm pain,  fatigue,  vomiting,  difficulty breathing,  feels bilateral  lung congestion,  pain when breaths,  fever of 100 f and of missed work today as possible.  This report was serious  (Other Medically Important Condition).
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity, Painful respiration, Pulmonary congestion, Pyrexia
Clinical narrative: FELT BILATERAL LUNG CONGESTION  (Lung congestion,  Pulmonary congestion)  BILATERAL SIDE PAIN  (Flank pain,  Flank pain)  VOMITING  (Vomiting,  Vomiting)  LEFT ARM PAIN  (Painful L arm,  Pain in extremity) DIFFICULTY BREATHING  (Difficulty breathing,  Dyspnoea) MISSED WORK TODAY  (Loss of personal independence in daily activities,  Loss of personal independence in daily activities)  PAIN WHEN BREATHS  (Painful respiration,  Painful respiration) FEVER OF 100 F  (Fever,  Pyrexia) FATIGUE  (Fatigue,  Fatigue) This spontaneous report received from a patient concerned a 52 year old male.  The patient's weight,  height,  and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s  (suspension for injection,  intramuscular,  batch number: 1805018,  expiry:  UNKNOWN)  dose was not reported,  administered on 10-MAR-2021  for prophylactic vaccination.  No concomitant medications were reported.  On 10-MAR-2021  (mentioned as yesterday),  the symptoms of the patient started,  and he missed work today  (loss of personal independence in daily activities)  and left arm pain  (painful  L arm)  because he was not feeling well.  The reporter advised him to contact his primary care provider,  but he said he called and they are not able to see him without an appointment also advised him to seek medical attention by going to the emergency room.  The patient agrees to go to the Emergency Room.  On 11-MAR-2021,  the patient experienced bilateral side pain  (flank pain) , vomiting,  felt bilateral lung congestion  (lung congestion),  difficulty breathing,  fever of 100 F,  fatigue,  pain when breaths  (painful respiration) . Laboratory data included:  Body temperature  (NR: not provided)  100 F.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient was recovering from fever of 100 f,  had not recovered from bilateral side pain,  left arm pain,  fatigue,  vomiting, difficulty breathing,  feels bilateral  lung congestion,  and pain when breaths,  and the outcome of missed work today was not reported.  The reporter considered the causality between Covid-19 vaccine ad26.cov2.s and event bilateral side pain,  left arm pain,  fatigue,  vomiting,  difficulty breathing,  feels bilateral lung congestion,  pain when breaths,  fever f 100 f and missed work today as possible.  Company causality between Covid-19 vaccine ad26.cov2.s  and event bilateral side pain,  left arm pain,  fatigue,  vomiting,  difficulty breathing,  feels bilateral  lung congestion,  pain when breaths,  fever of 100 f and of missed work today as possible.  This report was serious  (Other Medically Important Condition).
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: FELT BILATERAL LUNG CONGESTION  (Lung congestion,  Pulmonary congestion)  BILATERAL SIDE PAIN  (Flank pain,  Flank pain)  VOMITING  (Vomiting,  Vomiting)  LEFT ARM PAIN  (Painful L arm,  Pain in extremity) DIFFICULTY BREATHING  (Difficulty breathing,  Dyspnoea) MISSED WORK TODAY  (Loss of personal independence in daily activities,  Loss of personal independence in daily activities)  PAIN WHEN BREATHS  (Painful respiration,  Painful respiration) FEVER OF 100 F  (Fever,  Pyrexia) FATIGUE  (Fatigue,  Fatigue) This spontaneous report received from a patient concerned a 52 year old male.  The patient's weight,  height,  and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s  (suspension for injection,  intramuscular,  batch number: 1805018,  expiry:  UNKNOWN)  dose was not reported,  administered on 10-MAR-2021  for prophylactic vaccination.  No concomitant medications were reported.  On 10-MAR-2021  (mentioned as yesterday),  the symptoms of the patient started,  and he missed work today  (loss of personal independence in daily activities)  and left arm pain  (painful  L arm)  because he was not feeling well.  The reporter advised him to contact his primary care provider,  but he said he called and they are not able to see him without an appointment also advised him to seek medical attention by going to the emergency room.  The patient agrees to go to the Emergency Room.  On 11-MAR-2021,  the patient experienced bilateral side pain  (flank pain) , vomiting,  felt bilateral lung congestion  (lung congestion),  difficulty breathing,  fever of 100 F,  fatigue,  pain when breaths  (painful respiration) . Laboratory data included:  Body temperature  (NR: not provided)  100 F.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient was recovering from fever of 100 f,  had not recovered from bilateral side pain,  left arm pain,  fatigue,  vomiting, difficulty breathing,  feels bilateral  lung congestion,  and pain when breaths,  and the outcome of missed work today was not reported.  The reporter considered the causality between Covid-19 vaccine ad26.cov2.s and event bilateral side pain,  left arm pain,  fatigue,  vomiting,  difficulty breathing,  feels bilateral lung congestion,  pain when breaths,  fever f 100 f and missed work today as possible.  Company causality between Covid-19 vaccine ad26.cov2.s  and event bilateral side pain,  left arm pain,  fatigue,  vomiting,  difficulty breathing,  feels bilateral  lung congestion,  pain when breaths,  fever of 100 f and of missed work today as possible.  This report was serious  (Other Medically Important Condition).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Dizziness, Dyspnoea, Hypotension
Clinical narrative: BLOOD PRESSURE TANKED TO 80/60/LOW BLOOD PRESSURE (Low blood pressure, Hypotension) OUT OF BREATH/SHORTNESS OF BREATH (Shortness of breath, Dyspnoea) LIGHT HEADED/DIZZY (Light-headed, Dizziness) BACK PAINS (Back pain, Back pain) This spontaneous report received from a patient concerned a male of unspecified age. The patient's height,  and weight were not reported. The patient's concurrent conditions included alcoholic. The patient received covid-19 vaccine ad26 .cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN)  dose was not reported,  administered on 12-MAR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported. On 13-MAR-2021, the patient had back pains and took his pain medication today. The patient had friends over and served alcohol, he took a sip of the alcohol and immediately felt light headed; winded; out of breath; dizzy. On an unspecified date in MAR-2021 his blood pressure tanked to 80/60/ low blood pressure.  It was also mentioned that the patient was still feeling out of breath. Laboratory data included: Blood pressure  (NR: not provided) Low (80/60). It was stated that the patient went to emergency room/department or urgent care for the events dizzy, low blood pressure, shortness of breath and light headed. The action taken with covid-19 vaccine ad26 .cov .s was not applicable. The patient had not recovered from out of breath/shortness of breath, light headed/dizzy,  and blood pressure tanked to 80-60-low blood pressure, and the outcome of back pains was not reported. This report was serious  (Other Medically Important Condition). Version created to amend previously reported information on 13-MAR-2021 : Upon review following information was amended: Removed the causality statement from the narrative. The emergency room (vaccine) ticked for the events light headed/dizzy, blood pressure tanked/low blood pressure and shortness of breath. Null flavor was removed from the hospital address.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Loss of consciousness, Nausea
Clinical narrative: PASSED OUT ONCE  (Passed out,  Loss of consciousness) COUGHING OUT  (Coughing,  Cough) CHILLS  (Chills,  Chills) NAUSEA  (Nausea,  Nausea)  FEVER  (Fever,  Pyrexia) HEADACHE  (Headache,  Headache)  This spontaneous report received from a patient concerned a female of unspecified age.  The patient's weight,  height,  and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s  (suspension for injection,  route of admin not reported,  batch number:  1805025,  expiry:  UNKNOWN) dose was not reported,  administered on 11-MAR-2021  14:00 for prophylactic vaccination.  No concomitant medications were reported.  On 11-MAR-2021,  after getting the vaccine,  the patient experienced achiness throughout the body,  coughing out,  chills,  fever, headache and nausea.  On 12-MAR-2021,  the patient also passed out once.  The action taken with covid-19 vaccine ad.26.cov2.s was not applicable.  The patient recovered from passed out once,  and fever on 12-MAR-2021,  and chills on MAR-2011,  had not recovered from headache,  and achiness throughout the body,  and the outcome of nausea and coughing out was not reported.  The reporter causality between covid-19 vaccine ad26.cov.2.s and passed out once,  coughing out,  achiness throughout the body,  chills,  nausea,  fever,  headache was possible.  The company causality between covid-19 vaccine ad26.cov2.s and passed out once,  coughing out,  achiness throughout the body,  chills,  nausea,  fever,  headache was possible.  This report was serious  (Other Medically Important Condition).
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: PASSED OUT ONCE  (Passed out,  Loss of consciousness) COUGHING OUT  (Coughing,  Cough) CHILLS  (Chills,  Chills) NAUSEA  (Nausea,  Nausea)  FEVER  (Fever,  Pyrexia) HEADACHE  (Headache,  Headache)  This spontaneous report received from a patient concerned a female of unspecified age.  The patient's weight,  height,  and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s  (suspension for injection,  route of admin not reported,  batch number:  1805025,  expiry:  UNKNOWN) dose was not reported,  administered on 11-MAR-2021  14:00 for prophylactic vaccination.  No concomitant medications were reported.  On 11-MAR-2021,  after getting the vaccine,  the patient experienced achiness throughout the body,  coughing out,  chills,  fever, headache and nausea.  On 12-MAR-2021,  the patient also passed out once.  The action taken with covid-19 vaccine ad.26.cov2.s was not applicable.  The patient recovered from passed out once,  and fever on 12-MAR-2021,  and chills on MAR-2011,  had not recovered from headache,  and achiness throughout the body,  and the outcome of nausea and coughing out was not reported.  The reporter causality between covid-19 vaccine ad26.cov.2.s and passed out once,  coughing out,  achiness throughout the body,  chills,  nausea,  fever,  headache was possible.  The company causality between covid-19 vaccine ad26.cov2.s and passed out once,  coughing out,  achiness throughout the body,  chills,  nausea,  fever,  headache was possible.  This report was serious  (Other Medically Important Condition).
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Syncope
Clinical narrative: This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received COVID-19 vaccine AD26.COV2.S (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, start therapy date was not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced fainted after getting vaccine, and flu like symptoms. The action taken with COVID-19 vaccine AD26.COV2.S was not applicable. The outcome of the flu like symptoms and fainted after getting vaccine was not reported. The reporter considered the causality between JNJ-78436735, and faint and flu like symptoms as possible. Company causality between JNJ-78436735, and faint and flu like symptoms was possible. The batch number was not reported and has been requested. This report was serious (Other Medically Important Condition). Additional information was received from consumer on 12-Mar-2021 following information was updated and incorporated into case narrative: Patient demographic details (patient initials and sex) and other identification numbers was added.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Hypertension, Rhinitis, Rhinorrhoea
Clinical narrative: This is a spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, non-smoker, abstains from alcohol, environmental allergy, allergy, and hypertension, and other pre-existing medical conditions included the patient had history of allergy shots many years ago. The patient had no allergies to foods. The patient experienced drug allergy when treated with fexofenadine hydrochloride/pseudoephedrine hydrochloride. The patient received COVID-19 vaccine AD266.COV2.S (suspension for injection, route of admin not reported, batch number: 1802070, expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 12:00 on left arm for prophylactic vaccination. Concomitant medications included pseudoephedrine hydrochloride for seasonal allergies. On 07-MAR-2021, the subject experienced spike in blood pressure. On 07-MAR-2021, the subject experienced rhinitis which went away after 30 minutes. But returned around midnight with slightly more severity. Nose running but no congestion. He was currently feeling fine. Laboratory data included: Blood pressure (NR: not provided) 170/100, 180/103. Treatment medications (dates unspecified) included: lisinopril. The action taken with COVID-19 vaccine AD26.COV2.S was not applicable. The patient recovered from spike in blood pressure, and rhinitis on MAR-2021. This report was serious (Other Medically Important Condition). Additional information was received from patient on 12-Mar-2020 following information was updated and incorporated into case narrative: Event outcome for both events, disease (allergy, environmental allergies), past reaction (ALLEGRA D allergy).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Hypoaesthesia, Pharyngeal swelling
Clinical narrative: DIFFICULTY BREATHING (Difficulty breathing, Dyspnoea) FACIAL NUMBNESS, SAME SIDE THAT INJECTION WAS DONE (Numbness facial, Hypoaesthesia) FELT SWOLLEN THROAT (Throat swelling, Pharyngeal swelling) FELT TIRED (Tiredness, Fatigue) This spontaneous report received from a patient concerned a 39 year old female. The patient's weight was 132 pounds, and height was approximately 63.5 inches (5'3 and half). The medical history included: no family history of disease or no allergies. The patient was not pregnant nor breastfeeding at the time of vaccination. The patient received covid-19 vaccine ad26,cov2.s (suspension for injection, route of admin not reported, batch number: 1805029) dose was not reported, administered on 07-MAR-2021 10:40 for prophylactic vaccination. The vaccination site was left arm. No concomitant medications were reported. The patient was not ill prior to receiving the COVID-19 vaccine. The patient never had a history of any similar event or adverse reaction to any other previous vaccinations in the past. The patient did not have any pre-existing acute illnesses 30 days prior to vaccinations nor was the patient hospitalized in the last 30 days. The patient never had been tested for COVID-19. The patient did not wait the full 15 minute time frame as she was instructed. One hour after vaccination while driving home with her mother on freeway, the patient began to experience some numbness on the left upper part of her head and then the numbness went down the left side of her face. The patient was having difficulty breathing and described it as if, "someone was on her chest" and lasted 5-6 minutes but the numbness still persisted and went down to her arms and legs. The patient's throat felt like it was swollen. The patient also felt "tired" a day prior to this report (captured as unspecified date in MAR-2021) and slept for a total of 14 hours and "felt better today". The patient had been afebrile since being immunized. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from difficulty breathing, had not recovered from facial numbness, same side that injection was done, and the outcome of felt tired and felt swollen throat was not reported. The reporter assessed causality for difficulty breathing and facial numbness, same side that injection as related. The reporter causality for the event of felt tired and Swollen throat was possible. Company causality between COVID-19 vaccine Ad26.COV2.S and facial numbness, same side that injection, felt tired and Swollen throat was possible. This report was serious (Other Medically Important Condition). Additional information was received from reporter on 12-MAR-2021. The following information was updated and incorporated into the case narrative: Patient's medical history updated, the non-serious event swollen throat and details concerning reported events added.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Axillary pain, Lymphadenopathy, Mammogram
Clinical narrative: SWOLLEN LEFT ARMPIT (Swelling, Swelling) PAIN IN LEFT ARMPIT (Armpit pain, Axillary pain) This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 192 pounds, and height was 161 centimeters. The patient's concurrent conditions included hypertension, diabetes mellitus, gerd, and lexapro allergy, and other pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Mammogram (NR: not provided) unknown. On 04-MAR-2021, the patient experienced swollen left armpit and pain in left armpit Patient reported that after covid vaccination in left arm she developed a swollen left armpit and pain in left armpit. Patient had to go to urgent care. The action taken with covid-19 vaccine as26.cov2.s was not applicable. The patient had not recovered from swollen left armpit, and pain in left armpit. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20210313453. Additional information was received from patient on 12/Mar/2021. The following information was updated and incorporated into the case narrative: Patient information (age, age group, weight, height) added, Patient medical history and lab details added.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Axillary pain, Mammogram, Peripheral swelling
Clinical narrative: SWOLLEN LEFT ARMPIT (Swelling, Swelling) PAIN IN LEFT ARMPIT (Armpit pain, Axillary pain) This spontaneous report received from a patient concerned a 60 year old female. The patient's weight was 192 pounds, and height was 161 centimeters. The patient's concurrent conditions included hypertension, diabetes mellitus, gerd, and lexapro allergy, and other pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Mammogram (NR: not provided) unknown. On 04-MAR-2021, the patient experienced swollen left armpit and pain in left armpit Patient reported that after covid vaccination in left arm she developed a swollen left armpit and pain in left armpit. Patient had to go to urgent care. The action taken with covid-19 vaccine as26.cov2.s was not applicable. The patient had not recovered from swollen left armpit, and pain in left armpit. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20210313453. Additional information was received from patient on 12/Mar/2021. The following information was updated and incorporated into the case narrative: Patient information (age, age group, weight, height) added, Patient medical history and lab details added.
Sex: U
Vaccine: COVID19
Symptoms: Hypotension, Loss of consciousness
Clinical narrative: LOSS OF CONSCIOUSNESS (Loss of consciousness, Loss of consciousness)  HYPOTENSIVE (Hypotensive, Hypotension) This spontaneous report received from a physician concerned a multiple patients of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced loss of consciousness. On 11-MAR-2021, the subject experienced hypotensive.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patients was recovering from loss of consciousness, and hypotensive.  Reporter considered causality between covid-19 vaccine ad26.cov2.s and  loss of consciousness,  and hypotensive as possible.  Company causality between  covid-19 vaccine ad26.cov2.s and  loss of consciousness, and hypotensive considered as possible.  This report was serious (Other Medically Important Condition).
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Proquad that underwent a temperature excursion was administered; Information has been received from the registered medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not provided.   On 22-MAR-2021, the patient received a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD), 1 dosage form, lot # S030205, expiration date on 25-MAR-2021, that underwent a temperature excursion. The vaccine was stored on -15 degrees Celsius to -10 degrees Celsius (-11.53 degrees Celsius) for 10 hours. The call was because a data logger. According to the reporter, it was unable to clarify if symptoms were experienced by the patient.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Chills, Dizziness, Feeling hot, Flushing
Clinical narrative: Around 60 seconds after the shot was administered  i felt sporadic burning going down my left arm, then started feeling dizzy and felt like I was burning from the inside out, then as I was sitting, I  felt the room spinning and I passed out. The nurse then administered the 2 doses of epinephrine and I came out of it. Afterwards I wasn't able to swallow for at least a few minutes.  Then the ambulance showed up took my vitals and administered a shot of 50 mg of benadryl.  I started feeling better on my way to the hospital.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor, Vision blurred
Clinical narrative: Around 60 seconds after the shot was administered  i felt sporadic burning going down my left arm, then started feeling dizzy and felt like I was burning from the inside out, then as I was sitting, I  felt the room spinning and I passed out. The nurse then administered the 2 doses of epinephrine and I came out of it. Afterwards I wasn't able to swallow for at least a few minutes.  Then the ambulance showed up took my vitals and administered a shot of 50 mg of benadryl.  I started feeling better on my way to the hospital.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Dizziness, Dysphagia, Loss of consciousness, Vertigo
Clinical narrative: Around 60 seconds after the shot was administered  i felt sporadic burning going down my left arm, then started feeling dizzy and felt like I was burning from the inside out, then as I was sitting, I  felt the room spinning and I passed out. The nurse then administered the 2 doses of epinephrine and I came out of it. Afterwards I wasn't able to swallow for at least a few minutes.  Then the ambulance showed up took my vitals and administered a shot of 50 mg of benadryl.  I started feeling better on my way to the hospital.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Lip swelling
Clinical narrative: Swelling of lips, outer eye, took 25 mg Benadryl. BPs 140/90 (pulse 64); 122/70 (pulse 65).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pyrexia, Vomiting
Clinical narrative: Dizzy feeling. The next day had a low-grade fever and vomiting.
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Breast tenderness, Chest pain, Heart rate increased
Clinical narrative: High heart rate, slight chest pain, tender breast
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Impaired work ability, Injection site erythema, Injection site pain
Clinical narrative: 2/26 First dose of Pfizer Covid vaccine: Within 15 minutes -tingly and achy from injection site to wrist and fingers. Extremely sore at site. I was very, very tired by 4PM. 2/27: site is very red, round, raised. I am extremely tired and achey. This persists all day. 2/28 Severe headache and nausea. Site is extremely sensitive (cannot tolerate touch), still red and about double in size. Cannot do daily activities, but can still tolerate food and water. I feel very unwell. 3/1 Headache and nausea persist. I have to take a sick day; I cannot work. By the evening I'm feeling less nauseous. 3/2 By evening I am much improved - only slightly nauseous, but the aches return. 3/3 Runny nose emerges with significant congestion. (The app is about to time out. -- I have more to add. I also had a strong reaction to the second injection on 3/21/2021.)
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site paraesthesia, Injection site swelling, Loss of personal independence in daily activities, Malaise, Nausea
Clinical narrative: 2/26 First dose of Pfizer Covid vaccine: Within 15 minutes -tingly and achy from injection site to wrist and fingers. Extremely sore at site. I was very, very tired by 4PM. 2/27: site is very red, round, raised. I am extremely tired and achey. This persists all day. 2/28 Severe headache and nausea. Site is extremely sensitive (cannot tolerate touch), still red and about double in size. Cannot do daily activities, but can still tolerate food and water. I feel very unwell. 3/1 Headache and nausea persist. I have to take a sick day; I cannot work. By the evening I'm feeling less nauseous. 3/2 By evening I am much improved - only slightly nauseous, but the aches return. 3/3 Runny nose emerges with significant congestion. (The app is about to time out. -- I have more to add. I also had a strong reaction to the second injection on 3/21/2021.)
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, Rhinorrhoea
Clinical narrative: 2/26 First dose of Pfizer Covid vaccine: Within 15 minutes -tingly and achy from injection site to wrist and fingers. Extremely sore at site. I was very, very tired by 4PM. 2/27: site is very red, round, raised. I am extremely tired and achey. This persists all day. 2/28 Severe headache and nausea. Site is extremely sensitive (cannot tolerate touch), still red and about double in size. Cannot do daily activities, but can still tolerate food and water. I feel very unwell. 3/1 Headache and nausea persist. I have to take a sick day; I cannot work. By the evening I'm feeling less nauseous. 3/2 By evening I am much improved - only slightly nauseous, but the aches return. 3/3 Runny nose emerges with significant congestion. (The app is about to time out. -- I have more to add. I also had a strong reaction to the second injection on 3/21/2021.)
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Injection site discolouration, Injection site haemorrhage, Injection site pain, Injection site swelling
Clinical narrative: Once injection given, felt like Electric shock immediately afterwards, bleed a little, area swelled, painful and turned a purple /black.  The next day my neck, shoulder and area where injected swelled and painful. Muscles aches all over.  After about 3-4 days leg muscles stopped hurting but muscles in left arm continue to be bothersome, from my shoulder down to my thumb muscle spasms throughout the day. To this day 3/29/21 I continue to have muscle spasms from my shoulder down my left arm.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain, Swelling
Clinical narrative: Once injection given, felt like Electric shock immediately afterwards, bleed a little, area swelled, painful and turned a purple /black.  The next day my neck, shoulder and area where injected swelled and painful. Muscles aches all over.  After about 3-4 days leg muscles stopped hurting but muscles in left arm continue to be bothersome, from my shoulder down to my thumb muscle spasms throughout the day. To this day 3/29/21 I continue to have muscle spasms from my shoulder down my left arm.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hot flush, Malaise, Nausea
Clinical narrative: Nausea, dizzy at times, headache, hot flashes, just in general not feeling well.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site reaction, Rash macular, Skin warm
Clinical narrative: 8 days after dose 1 of the Moderna vaccine, I developed a red, hot, spot about 6 inches in diameter around the injection site.  It was a delayed onset.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Rash, Rash erythematous, Rash vesicular
Clinical narrative: Within 5 hours, my arm swelled up. It turned bright red, with a rash, by evening, I had lesions with clear fluid on top of the rash. It has now been 48 hours, and I still have a swollen arm and red rash covering my bicep and triceps. I have had about 8-12 lesions that have popped.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Underage person received vaccine - no adverse event
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Extreme Injection site swelling, pain, redness, hot, body aches, chills, headache, neck ache.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Neck pain, Pain
Clinical narrative: Extreme Injection site swelling, pain, redness, hot, body aches, chills, headache, neck ache.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Dyspnoea, Hypertension, Paraesthesia, Rash
Clinical narrative: Patient developed rash, signs of stress breathing, tingling arm and legs, dry throat, high blood pressure after 3 mins of 1st moderna vaccine administration. - 911 was called and ambulance arrived within 10 mins of call - patient was assessed and observed for 30 mins by emt, symptoms improved and patient chose to return home for further observation from home.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Acute hepatic failure, Acute kidney injury, Blood test, Chills
Clinical narrative: Pain in upper abdomen, nausea, feeling unwell, fatigued, chills, headache. Layer developed dissented stomach and fluid retention in legs and feet. Hospitalized 3/24/21. Acute liver failure, and acute renal failure.  Possible  Rhabdomyolysis.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Fluid retention, Gastric dilatation, Headache, Malaise
Clinical narrative: Pain in upper abdomen, nausea, feeling unwell, fatigued, chills, headache. Layer developed dissented stomach and fluid retention in legs and feet. Hospitalized 3/24/21. Acute liver failure, and acute renal failure.  Possible  Rhabdomyolysis.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Ultrasound abdomen abnormal
Clinical narrative: Pain in upper abdomen, nausea, feeling unwell, fatigued, chills, headache. Layer developed dissented stomach and fluid retention in legs and feet. Hospitalized 3/24/21. Acute liver failure, and acute renal failure.  Possible  Rhabdomyolysis.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood creatine phosphokinase, Blood creatinine, Liver function test increased, Rhabdomyolysis
Clinical narrative: Pain in upper abdomen, nausea, feeling unwell, fatigued, chills, headache. Layer developed dissented stomach and fluid retention in legs and feet. Hospitalized 3/24/21. Acute liver failure, and acute renal failure.  Possible  Rhabdomyolysis.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus - Spiked ringing in both ears.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Nausea, Tremor, Vomiting
Clinical narrative: Tremulous, nausea, vomiting x 2. Flushing/sweating. BP 111/52 (pulse 66).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Neuralgia, Pain in extremity
Clinical narrative: bilateral wrist and hand pain -like nerve pain for about 3 weeks then both ring fingers have had nerve pain ever since.  a few times underside of toes has burned sometimes aches inner ankle bone Today the nerve pain is my right index finger and knuckle. I had NONE of these things until after dose 2 of the pfizer vaccine
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Bach ache, headache
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Headache, Myalgia
Clinical narrative: Chills, Temp. 36.4, Headache, Sore Arm and muscles, Arthritic joints, Low Back Pain, Ringing in ears
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Polyarthritis, Tinnitus
Clinical narrative: Chills, Temp. 36.4, Headache, Sore Arm and muscles, Arthritic joints, Low Back Pain, Ringing in ears
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling of body temperature change, Pain, Pyrexia
Clinical narrative: Vaccination at 4:10 PM on Friday. Chills started suddenly  at 2:45 PM on Saturday, 22-1/2 after shot. Then fever, body aches, severe shivering, hot then cold until about midnight. Symptoms less severe after that until around 4:30 PM on Sunday, a period of about 26 hours. Exhaustion Sunday evening through present time which is 12:30 AM on Tuesday, with only occasional chills.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Pain in extremity, Pyrexia
Clinical narrative: 1. sore left arm - started after 10 hrs; lasted 2 days 2. fever (37.4 C), started after 12 hrs; lasted 8 hrs 3. enlarged and painful lymph nodes in armpit, started after 4 days, ongoing  No treatments administered for any symptom.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Dizziness, Vertigo
Clinical narrative: Severe vertigo that kept me bedridden for two days after vaccine, with symptoms of severe dizziness that lasted on and off for three weeks
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, X-ray limb
Clinical narrative: I had a telehealth appointment with the patient 3/29/21. She tells me she had right shoulder and arm pain after her first dose. Received second dose in left arm without issues. She continues to have shoulder pain and is unclear if this is related to vaccine or not.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Headache, dizziness, given PO fluids. BPs 120/83 (pulse 86), 128/85 (final, pulse 77).
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site rash, Injection site reaction, Rash macular
Clinical narrative: I received a rash at the injection site within a couple hours after receiving the first dose of the Moderna COVID-19 vaccine. The rash worsened after my second dose 4 weeks later. It has now been almost 8 weeks since the rash appeared, and it still has not gone away. It looks like small red and yellow bumps covering my upper arm. There is no soreness or itchiness associated with the bumps, but they do seem to improve but then return.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Chills, Pyrexia
Clinical narrative: sore shoulder starting 7 hrs after injection. Woke up to 102 F fever and chills at 2 am.  Symptoms slowly dropped away to just balance issues as of morning of 03/29.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeding disorder, Nasopharyngitis, Neck pain, Pain in jaw
Clinical narrative: Jaw very painful and sore, swollen badly, can't eat, very painful, side of neck and throat swollen painful and hurts badly, fever, cold chills.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Swelling face, Throat tightness
Clinical narrative: Jaw very painful and sore, swollen badly, can't eat, very painful, side of neck and throat swollen painful and hurts badly, fever, cold chills.
Age: 97.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Gait disturbance, Loss of personal independence in daily activities
Clinical narrative: Moderna COVID-19 Vaccine EUA - lost ability to walk, feed self - this from someone with Alzheimer's disease and who was frail and an extreme fall risk. However, the severe downturn exactly one week after the shot made us wonder if it caused this significant decline.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Itching and reddened oval area around injection site, beginning 7 days after vaccination.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Feeling cold, Headache
Clinical narrative: On March 27, 2021, at about 12pm I started with chills, feeling very cold and I slight headache. I checked my temperature at about 2pm and it read 102.7. I took two ibuprofen tablets of 200mg. I slept for about three hours, woke up for about three hours and then went to sleep at night. When I woke up at about 7am the next day I felt better. I still had a slight head ache but after about 2hrs it went away.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Blood test abnormal, Chest X-ray normal, Dizziness, Exercise electrocardiogram abnormal
Clinical narrative: Within minutes of vaccine felt lightheaded.  Vitals were checked.  My HR was in 140's and bp 137/92 (which is pretty high for me).  I was observed for 45minutes and vitals didn't stablize.  Became more lightheaded, developed palpitations, nausea, and abdominal pain.