chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; Initial information was received on 27-Oct-2021 regarding an unsolicited valid non-serious case from a Social Media via a consumer/non-health care profession.  This case involves Adult (unknown gender) patient who had flu (influenza) after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Gave me the FLU for 4 days!"  It was unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.  At the time of reporting, outcome of the event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: I got the flu two weeks later; Initial information was received on 29-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via social media.  This case involves an unknown demographics patient who experienced flu two weeks later (influenza) after receiving vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu two weeks later (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  It was reported "Flu Shot Fridays last time I got the flu shot I got the flu two weeks later. Bull Crap."  It was not reported if the patient received a corrective treatment for the events.  At the time of reporting, the outcome of events was reported as unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Autoimmune disorder
Clinical narrative: autoimmune condition; Initial information was received on 31-Oct-2021 regarding an unsolicited valid serious case received from a consumer/non-health care professional (patient) via social media(under reference number US-SA-SAC20211103000618).  This case involves a patient of (unknown demographics) who experienced autoimmune condition (autoimmune disorder) when received vaccine INFLUENZA VACCINE.  The patient's past vaccination included INFLUENZA VACCINE with patient had the flu twice. It was really terrible. But patient got over it. Patient had many flu vaccines and they had essentially ruined life.  The patient's medical history, past medical treatment, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious autoimmune condition (autoimmune disorder) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Messing with our immune systems is causing more harm than getting the flu. Patient don't get the flu.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the event.  At the time of reporting, the outcome was unknown for the event (autoimmune disorder).  The reporter assessed the causal relationship for event (autoimmune disorder) with the INFLUENZA VACCINE as not reported.  Information on batch has been requested number for this case.; Sender's Comments: This case concerns a patient of (unknown demographics) who experienced autoimmune disorder (unknown latency) after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. The patient's past vaccination included INFLUENZA VACCINE with patient had the flu twice. There is no further information regarding patient's medical condition at the time of vaccination and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Hypersensitivity, Paralysis
Clinical narrative: paralysis; Guillain Barre syndrome (GBS) diagnosis; allergic reaction; Initial information was received on 01-Nov-2021 regarding an unsolicited valid serious case received from a consumer/non-health care professional (patient) via social media.  This case involves an unknown demographic patient who experienced paralysis, Guillain barre syndrome and allergic reaction (hypersensitivity), after receiving INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious paralysis and Guillain barre syndrome (unknown latency) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant.  On an unknown date, the patient developed non-serious allergic reaction (hypersensitivity) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the events. It was reported "Still recovering from my 2019 Fllu Vaccine. Allergic reaction, paralysis, GBS diagnosis."   At time of reporting, the outcome was recovering for the events.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns an unknown demographic patient who had paralysis, Guillain barre syndrome and hypersensitivity after receiving INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. Furthermore information regarding medical history, past medical treatment, vaccinations, concomitant medications, condition at the time of vaccination and laboratory data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.
Age: 0.5
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product preparation issue
Clinical narrative: patient was to receive the PENTACEL dose today but the patient only received the DTAP-IPV vaccine with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician, other health care professional and consumer/non-health care professional via (Reference number- 00829371) and transmitted to Sanofi on 26-Oct-2021.  This case involves a 6-month-old female patient was to receive the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] dose today but the patient only received the DTAP-IPV vaccine (product preparation issue)  Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and ROTAVIRUS VACCINE for prophylactic vaccination.   On 26-Oct-2021, the patient received third 0.5ml (total) dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot: UJ466AAA and expiry date: 21-May-2022) (Frequency = once) (Strength = standard) (dosage form: solution) via intramuscular route in the right thigh for prophylactic vaccination but the patient only received the DTAP-IPV vaccine (product preparation issue).  It was reported "Caller is want to know what to do. Caller provided with the PENTACEL reconstitution video".   This case was an actual medication error due to inappropriate reconstitution technique (latency: same day).  At the time of reporting, no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient received expired ACT-HIB in error with no reported AE; Initial information was received on 27-Oct-2021 regarding an unsolicited valid non-serious case from other health professional and physician via call center via Medical Information (MI) (Reference number- 00831144).  This case involves a 4 months old female patient (date of birth: 20-Jun-2021) who received expired HIB (PRP/T) VACCINE [ACT-HIB] in error (expired product administered).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID [DTAP], PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) [PREVNAR] and POLIO VACCINE (POLIO) for prophylactic vaccination.  On 27-Oct-2021, the patient received a second 0.5 ml dose of suspect HIB (PRP/T) VACCINE (lot number not reported and expiry date: 03-OCT-2021) via an intramuscular route in the right leg for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (same day).  It was reported "caller requesting information regarding revaccination and adverse effects to be look out for, caller declined to add email address".  At time of reporting, it was unknown whether the patient had any adverse event or not and the outcome was unknown for the reported event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on batch number for this case.
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: They did not mixed the HIB portion and only received the dtap-ipv with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received on 29-Oct-2021 from a consumer.  This case involved a 4 month old male patient who did not mix the hib portion and only received the dtap-ipv with no reported adverse event (product preparation error), while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) (lot number and expiry date unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event they did not mix the hib portion and only received the dtap-ipv with no reported adverse event (product preparation error) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  No relevant laboratory data was provided.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  The reporter did not report causality of events with suspects.
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired ADACEL was given with no reported adverse event; Initial information was received on 29-Oct-2021 regarding an unsolicited valid non-serious case from consumer and pharmacist via Medical Information (MI) (reference number- 00834465) and live follow-up dated 29-Oct-2021 (MI reference number- 00834904) both processed together.  This case involves a 56 years old male patient who reported expired adacel was given with no reported adverse event (expired product administered) while receiving vaccine diphtheria-2/tetanus/5 ac pertussis vaccine (Adacel).  The patient's medical history, past medical treatment, vaccination, family history and concomitant medications were not provided.  On 28-Oct-2021, the patient received at 0.5 ml dose of suspect suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (frequency: once) (batch number C5666BA and expiry date: 17-Sep-2021) via an intramuscular route in the deltoid for prophylactic vaccination.  It was of actual medication error due to expired vaccine used (latency: same day).  It was reported "Pharmacist states that yesterday, (10/28/2021), a 56 year-old patient, received an ADACEL vaccine that was later noted to have expired. No adverse effects reported, vaccine will be repeated."  At the time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  No further information reported.
Sex: M
Vaccine: DTAP, DTAPIPVHIB, HIBV, IPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: receives vaccines on delayed schedule, individually, not as combined products but like one a month with no adverse event; Initial information received on 01-Nov-2021 regarding an unsolicited valid non-serious case from consumer/ non health care professional via Health Authority (under reference: 00837153).  This case involved an unknown age male patient who experienced received vaccines on delayed schedule, individually, not as combined products but like one a month with no adverse event (inappropriate schedule of product administration) while receiving vaccines DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], IPV (VERO) [IPOL], HIB (PRP/T) VACCINE [ActHIB] and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect products DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], IPV (VERO) [IPOL], HIB (PRP/T) VACCINE [ActHIB] and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot number not reported via unknown route  On an unknown date, unknown latency after starting the suspect products, the patient developed a non-serious received vaccines on delayed schedule, individually, not as combined products but like one a month with no adverse event (inappropriate schedule of product administration).  No laboratory data reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report was submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error was in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party had contributed to or is to be held liable for the occurrence of this medication error.  There would be no information on the batch number for this case.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Headache, Injection site pain, Joint swelling
Clinical narrative: In the morning of 11/02/21, started to feel a headache and joint pains. Then noticed that my left elbow started to swell and so painful to bend. Have to take Tylenol to subside the pain and headache. The swelling gradually spreading towards my wrist. On 11/04/21, decided to have it checked with my doctor and prescribed me with Amoxicillin and Ibuprofen. Was also taken a blood sample for further lab tests. Currently (11/07/21 around 9pm), swelling still continues to spread and have now reached my wrist.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Pain, Pain in extremity
Clinical narrative: In the morning of 11/02/21, started to feel a headache and joint pains. Then noticed that my left elbow started to swell and so painful to bend. Have to take Tylenol to subside the pain and headache. The swelling gradually spreading towards my wrist. On 11/04/21, decided to have it checked with my doctor and prescribed me with Amoxicillin and Ibuprofen. Was also taken a blood sample for further lab tests. Currently (11/07/21 around 9pm), swelling still continues to spread and have now reached my wrist.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Dysarthria, Headache, Hypoaesthesia
Clinical narrative: 12 year old daughter ended up in emergency room with stroke like symptoms. Severe headache followed by numbness in right hand, upper lip and slurred speech. Previously healthy with no medical issues whatsoever. Hast to follow up with a neurologist for further care.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: 12 year old daughter ended up in emergency room with stroke like symptoms. Severe headache followed by numbness in right hand, upper lip and slurred speech. Previously healthy with no medical issues whatsoever. Hast to follow up with a neurologist for further care.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acidosis, Cardiac arrest, Delirium, Endotracheal intubation, General physical health deterioration
Clinical narrative: Pt was initially admitted to the medical COVID floor where he was initiated on Dexamethasone and Remdesivir therapies. His hypoxemia continued to worsen and he required initiation of noninvasive positive pressure ventilation and was eventually transferred to the ICU on 10/28/2021 for ongoing care and management in the setting of refractory hypoxemia. His ICU course was initially complicated by delirium. His condition continued to worsen and was intubated on 10/30/2021 in the setting of impending respiratory/cardiac arrest. He began to experience increasing  hypotension as well and required initiation of vasopressors. Given the history of heart failure with reduced ejection fraction, cardiologist was consulted and Pt was additionally placed on Dobutamine. He had worsening acidemia despite optimization of ventilator settings and required initiation on renal replacement therapy on 11/02/2021. Unfortunately, he continued to decompensate and on the evening of 11/04/2021, the patient did suffer of a cardiac arrest. Unfortunately Pt did succumb to his critical illness on the evening of 11/04/2021.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypotension, Hypoxia, Illness, Intensive care, Mechanical ventilation
Clinical narrative: Pt was initially admitted to the medical COVID floor where he was initiated on Dexamethasone and Remdesivir therapies. His hypoxemia continued to worsen and he required initiation of noninvasive positive pressure ventilation and was eventually transferred to the ICU on 10/28/2021 for ongoing care and management in the setting of refractory hypoxemia. His ICU course was initially complicated by delirium. His condition continued to worsen and was intubated on 10/30/2021 in the setting of impending respiratory/cardiac arrest. He began to experience increasing  hypotension as well and required initiation of vasopressors. Given the history of heart failure with reduced ejection fraction, cardiologist was consulted and Pt was additionally placed on Dobutamine. He had worsening acidemia despite optimization of ventilator settings and required initiation on renal replacement therapy on 11/02/2021. Unfortunately, he continued to decompensate and on the evening of 11/04/2021, the patient did suffer of a cardiac arrest. Unfortunately Pt did succumb to his critical illness on the evening of 11/04/2021.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Painful large hard lump formed at injection site with large red area that was itchy. The area became very hot and peaked the following day. Area is still itchy, red, and painful today (11/7/2021)/
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth
Clinical narrative: Painful large hard lump formed at injection site with large red area that was itchy. The area became very hot and peaked the following day. Area is still itchy, red, and painful today (11/7/2021)/
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus. I have almost constant ringing/buzzing in my ears throughout the entire day now. I never had this before.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Chills, Fatigue, Pain, Swelling
Clinical narrative: 36 hours of aches and chills with exhaustion. swelling of underarm and down side of rib cage. Left breast shooting pain. Those pains lasted about 2 weeks.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Illness, SARS-CoV-2 test negative, Thrombosis
Clinical narrative: O2 level was 89-91, sent to hospital for CT scan,,checking for blood clots. Covid test negative 2 days prior to all the tests performed on 6/12/2021,several X-rays , no pneumothorax. Was ill for 1 week before going to doctor. Shortness of breath
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Feeling abnormal, Glare, Insomnia, Pain, Screaming
Clinical narrative: Zoned out and passive with blank stares, then projectile Vomiting, fussiness, loss of sleep, screaming/pain
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Vomiting projectile
Clinical narrative: Zoned out and passive with blank stares, then projectile Vomiting, fussiness, loss of sleep, screaming/pain
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Blister, Blister rupture, Chest X-ray, Computerised tomogram neck
Clinical narrative: There were two adverse events.   #1 The next morning when I woke up (3/9/2021), I had two large blisters just below the nape of my neck.  When I touched them, they burst.  They were extremely painful and took several weeks to heal.  The area was painful or sensitive for several months.  #2 I don't know if this event was related or not, but VSafe called me and told me to file a VAERS report...  On March 20th, I experienced an incident where I had crackling in my throat (I could hear a sound like crumpling cellophane), I had trouble breathing.  I just couldn't catch my breath and couldn't take a deep breath.  My heart was racing.  I used an inhaler, but I didn't think it did anything at the time.  Just when things started going black, I told my husband to call an ambulance.  I sat down on the bed and the darkness receded.  I don't know if the inhaler worked or if my adrenaline kicked in...  but I felt a little better, but still had trouble breathing, so we went to the Emergency Room.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram thorax, Dyspnoea, Electrocardiogram, Loss of consciousness, Oropharyngeal discomfort
Clinical narrative: There were two adverse events.   #1 The next morning when I woke up (3/9/2021), I had two large blisters just below the nape of my neck.  When I touched them, they burst.  They were extremely painful and took several weeks to heal.  The area was painful or sensitive for several months.  #2 I don't know if this event was related or not, but VSafe called me and told me to file a VAERS report...  On March 20th, I experienced an incident where I had crackling in my throat (I could hear a sound like crumpling cellophane), I had trouble breathing.  I just couldn't catch my breath and couldn't take a deep breath.  My heart was racing.  I used an inhaler, but I didn't think it did anything at the time.  Just when things started going black, I told my husband to call an ambulance.  I sat down on the bed and the darkness receded.  I don't know if the inhaler worked or if my adrenaline kicked in...  but I felt a little better, but still had trouble breathing, so we went to the Emergency Room.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Palpitations
Clinical narrative: There were two adverse events.   #1 The next morning when I woke up (3/9/2021), I had two large blisters just below the nape of my neck.  When I touched them, they burst.  They were extremely painful and took several weeks to heal.  The area was painful or sensitive for several months.  #2 I don't know if this event was related or not, but VSafe called me and told me to file a VAERS report...  On March 20th, I experienced an incident where I had crackling in my throat (I could hear a sound like crumpling cellophane), I had trouble breathing.  I just couldn't catch my breath and couldn't take a deep breath.  My heart was racing.  I used an inhaler, but I didn't think it did anything at the time.  Just when things started going black, I told my husband to call an ambulance.  I sat down on the bed and the darkness receded.  I don't know if the inhaler worked or if my adrenaline kicked in...  but I felt a little better, but still had trouble breathing, so we went to the Emergency Room.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Tinnitus
Clinical narrative: several weeks after 2nd vaccine - noticed that tinnitus had gotten much worse than 'usual'.  its now 5 months later and it has not gotten better - it is constantly loud buzzing all day and night
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Coordination abnormal, Fine motor skill dysfunction, Headache, Hyperhidrosis
Clinical narrative: Chills, headache, fever, sweats, restless legs, lethargy, decreased muscle coordination, difficulty with fine motor skills including signing name, shaky hands, restless legs and muscle cramps
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Muscle spasms, Pyrexia, Restless legs syndrome, Tremor
Clinical narrative: Chills, headache, fever, sweats, restless legs, lethargy, decreased muscle coordination, difficulty with fine motor skills including signing name, shaky hands, restless legs and muscle cramps
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Heart rate increased, Productive cough
Clinical narrative: RAPID HEARTBEAT, EXCESSIVE PHLEGM, TROUBLE BREATHING AFTER BRIEF WALKS AND RUNS, HIGH HEARTBEAT TO WHERE CHEST HEARTS.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Blood thyroid stimulating hormone, Fibromyalgia, Full blood count, Metabolic function test
Clinical narrative: Patient experienced fibromyalgia exacerbation for almost 6 weeks. She doesn't recall ever having such a severe fibromyalgia episode. Her dose of Savella increased but she didn't start feeling better until almost 6 weeks later.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate normal, Rheumatoid factor, Thyroxine, Tri-iodothyronine, Urine analysis
Clinical narrative: Patient experienced fibromyalgia exacerbation for almost 6 weeks. She doesn't recall ever having such a severe fibromyalgia episode. Her dose of Savella increased but she didn't start feeling better until almost 6 weeks later.
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Excruciating pain in the left upper arm, near the vaccination site.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives Benadryl
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymph node pain, Nausea, Pain in extremity
Clinical narrative: Pain in arm, headache, pain in lymph nodes, nausea for 48 hours after injection.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Dehydration, Dizziness, Dysstasia
Clinical narrative: Patient became extremely weak...could not stand...dizzy...pt fell...ambulance took him to the ED where he was admitted for severe dehydration. He was given IV saline and then admitted to the hospital  for 3 days and is now in a rehab nursing home unable to walk or stand with weakness and now confusion
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Gait inability, Laboratory test
Clinical narrative: Patient became extremely weak...could not stand...dizzy...pt fell...ambulance took him to the ED where he was admitted for severe dehydration. He was given IV saline and then admitted to the hospital  for 3 days and is now in a rehab nursing home unable to walk or stand with weakness and now confusion
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Infection
Clinical narrative: Breakthrough infection  with long lasting effects: taste and smell adversely affected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Dry mouth, Fatigue, Feeling abnormal
Clinical narrative: Over 102 fever, severe body, muscle, joint pain. Severe headache. Stomach pain. Dry mouth. Severe fatigue and brain fog. Barely was able to move.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Movement disorder, Myalgia, Pain, Pyrexia
Clinical narrative: Over 102 fever, severe body, muscle, joint pain. Severe headache. Stomach pain. Dry mouth. Severe fatigue and brain fog. Barely was able to move.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo positional
Clinical narrative: benign paroxysmal positional vertigo (BPPV)
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Lightheaded, dizzy, headaches
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Headache, Pain, Pain in extremity
Clinical narrative: arm pain spread to pain in same ear as injection, headache, body aches becoming severe, lasted 3 days
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Groin pain, Inflammation
Clinical narrative: Severe aching/inflammation in the hip groin area at random times during the day or night for no particular reason even after adequate resting.      This lasted for about 2-3 weeks.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dysphagia, Pyrexia, Tonsillar inflammation, Urticaria
Clinical narrative: Began having difficulty swallowing. Within the hour, tonsils were noted to be +4 by a dental hygienist. These symptoms were treated with 10mg Zyrtec and 50mg Benadryl. 6 hours later, the patient experienced fevers, chills and hives on the face, neck, and chest. Fevers (100.4-104.7 F) persisted on and off for 72 bites and hives (treated with daily Zyrtec, Benadryl, and topical triamcinolone) persisted for 8 days.
Sex: F
Vaccine: MMR
Symptoms: Erythema
Clinical narrative: she had red, more like light pink circles all over her face and lower hands. It was the weirdest thing. She thought she was having an acne breakout.; Information has been received from a currently 42 years old registered nurse via Pfizer referring to herself. She had a history of Wolff-Parkinson-White and was ablated twice. The last time was 19 years ago and she had not had any problems since then. The patient was allergic to a lot of antibiotics. She had a titer drawn in May or June 2002 and it was low and they gave her a booster.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) for prophylaxis (strength, dose, route, lot# and expiration date were not provided).   The patient had reaction to the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown). Within 24 hours, she had red, more like light pink circles all over her face and lower hands. It was the weirdest thing. She thought she was having an acne breakout. The outcome of acne was unknown. The reporter considered the acne to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(manufacturer unknown).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Arm was little sore; The first one burned a bit; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was little sore) and VACCINATION SITE PAIN (The first one burned a bit) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was little sore) and VACCINATION SITE PAIN (The first one burned a bit). At the time of the report, PAIN IN EXTREMITY (Arm was little sore) and VACCINATION SITE PAIN (The first one burned a bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported.  It was reported that, her arm was a little sore, but her reaction was not at the time the shot was given.  No Treatment medication reported.   This case was linked to MOD-2021-369400 (Patient Link).
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Discomfort, Pain, Vaccination site pain
Clinical narrative: Burning sensation in back of shoulder; Shooting pain in my shoulder and in my left arm; Shoulder pain that moves into the back of his shoulder; Pain where they gave the shot; I have been experiencing discomfort.; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation in back of shoulder), PAIN (Shooting pain in my shoulder and in my left arm), DISCOMFORT (I have been experiencing discomfort.), VACCINATION SITE PAIN (Pain where they gave the shot) and ARTHRALGIA (Shoulder pain that moves into the back of his shoulder) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011FZ1A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2021, the patient experienced DISCOMFORT (I have been experiencing discomfort.). On 23-Oct-2021, the patient experienced VACCINATION SITE PAIN (Pain where they gave the shot). On 25-Oct-2021, the patient experienced BURNING SENSATION (Burning sensation in back of shoulder), PAIN (Shooting pain in my shoulder and in my left arm) and ARTHRALGIA (Shoulder pain that moves into the back of his shoulder). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (Burning sensation in back of shoulder), PAIN (Shooting pain in my shoulder and in my left arm), DISCOMFORT (I have been experiencing discomfort.), VACCINATION SITE PAIN (Pain where they gave the shot) and ARTHRALGIA (Shoulder pain that moves into the back of his shoulder) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error, Vaccination site pain
Clinical narrative: Her arm is sore; Shook it vigorously; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Her arm is sore) and PRODUCT PREPARATION ERROR (Shook it vigorously) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced PRODUCT PREPARATION ERROR (Shook it vigorously). On an unknown date, the patient experienced VACCINATION SITE PAIN (Her arm is sore). On 27-Oct-2021, PRODUCT PREPARATION ERROR (Shook it vigorously) had resolved. At the time of the report, VACCINATION SITE PAIN (Her arm is sore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  No treatment medications were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia
Clinical narrative: slept a lot; been tired for several months; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (slept a lot) and FATIGUE (been tired for several months) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (takes medications for severe allergies) and Lung disorder (takes Albuterol to help the lungs). Concomitant products included ALBUTEROL [SALBUTAMOL] for Lung disease.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced HYPERSOMNIA (slept a lot) and FATIGUE (been tired for several months). At the time of the report, HYPERSOMNIA (slept a lot) and FATIGUE (been tired for several months) outcome was unknown.            Patient reported that everybody the patient knew got tired from the Covid-19 vaccines and one friend received the Moderna Covid-19 vaccine.  No treatment medications were reported.  Company comment-This case concerns a 67 year-old, female patient with concomitant use of salbutamol, who experienced the non serious unexpected AESI event of hypersomnia. The event occurred at an unknown date after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable, as the event was reported exclusively after the second dose. The use of concomitant medication salbutamol, negative rechallenge remain a confounder. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.   This case was linked to MOD-2021-368011 (Patient Link).; Sender's Comments: This case concerns a 67 year-old, female patient with concomitant use of salbutamol, who experienced the non serious unexpected AESI event of hypersomnia. The event occurred at an unknown date after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable, as the event was reported exclusively after the second dose. The use of concomitant medication salbutamol, negative rechallenge remain a confounder. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: a knot in her shoulder area on top of the cephalic vein under her collar bone surgically removed / It was a lymph node /had other lymph nodes in her arm near her elbow that were enlarged but not removed; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (a knot in her shoulder area on top of the cephalic vein under her collar bone surgically removed / It was a lymph node /had other lymph nodes in her arm near her elbow that were enlarged but not removed) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included Systemic lupus erythematosus.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced LYMPHADENOPATHY (a knot in her shoulder area on top of the cephalic vein under her collar bone surgically removed / It was a lymph node /had other lymph nodes in her arm near her elbow that were enlarged but not removed). At the time of the report, LYMPHADENOPATHY (a knot in her shoulder area on top of the cephalic vein under her collar bone surgically removed / It was a lymph node /had other lymph nodes in her arm near her elbow that were enlarged but not removed) had resolved.      No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-368139 (Patient Link).
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Insomnia, Myalgia, Pain in extremity
Clinical narrative: Could not sleep last night after booster shot; Has no energy at all after booster shot; Aches all over after booster shot; Sore right arm during the night after booster shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore right arm during the night after booster shot), INSOMNIA (Could not sleep last night after booster shot), ASTHENIA (Has no energy at all after booster shot) and MYALGIA (Aches all over after booster shot) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A, 025J20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore right arm during the night after booster shot). On 29-Oct-2021, the patient experienced INSOMNIA (Could not sleep last night after booster shot), ASTHENIA (Has no energy at all after booster shot) and MYALGIA (Aches all over after booster shot). At the time of the report, PAIN IN EXTREMITY (Sore right arm during the night after booster shot), INSOMNIA (Could not sleep last night after booster shot), ASTHENIA (Has no energy at all after booster shot) and MYALGIA (Aches all over after booster shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment information was not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: got swelling in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (got swelling in the arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 028L20A and 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Hypertension.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (got swelling in the arm). At the time of the report, PERIPHERAL SWELLING (got swelling in the arm) outcome was unknown.            Concomitant medications include unspecified diabetic and hypertensive medications. Treatment includes: application of alcohol.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Sleepy for one day after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy for one day after receiving the vaccine) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced SOMNOLENCE (Sleepy for one day after receiving the vaccine). In September 2021, SOMNOLENCE (Sleepy for one day after receiving the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The  concomitant medications on use were not provided. No treatment information was provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Rash pruritic
Clinical narrative: Whole arm rash itching like crazy; Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Whole arm rash itching like crazy), PYREXIA (Fever) and FATIGUE (Fatigue) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Whole arm rash itching like crazy), PYREXIA (Fever) and FATIGUE (Fatigue). At the time of the report, RASH PRURITIC (Whole arm rash itching like crazy), PYREXIA (Fever) and FATIGUE (Fatigue) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant information was not provided.   Treatment information included a cream for the rash.   This case was linked to MOD-2021-368777, MOD-2021-368799 (Patient Link).