chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, COVID-19, Exposure to SARS-CoV-2, Injection site nodule, Injection site pain
Clinical narrative: ARM PAIN, COVID INFECTION Narrative: 2/16/2021: Having right upper arm and neck pain. Throbbing pain in certain positions. No weakness or numbness in my arm. 2/18/2021: presented to ED with no redness or swelling but with palpable "pea-size" knot at the injection site, d/c with lidociane/prilocaine cream and diclofenac gel. advised to take tylenol prm. 3/17/2021: exposed to Covid from son and c/o body aches, runny nose, pain in back 3/18/2021: tested positive for covid 3/25/2021: most symptoms resolved, self-treated at home
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pain, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: ARM PAIN, COVID INFECTION Narrative: 2/16/2021: Having right upper arm and neck pain. Throbbing pain in certain positions. No weakness or numbness in my arm. 2/18/2021: presented to ED with no redness or swelling but with palpable "pea-size" knot at the injection site, d/c with lidociane/prilocaine cream and diclofenac gel. advised to take tylenol prm. 3/17/2021: exposed to Covid from son and c/o body aches, runny nose, pain in back 3/18/2021: tested positive for covid 3/25/2021: most symptoms resolved, self-treated at home
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue Narrative:
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram cerebral normal, Asthenia, Computerised tomogram head normal, Computerised tomogram neck, Dizziness
Clinical narrative: weakness Narrative:  Patient presented to outside ED with EMS secondary to concerns of stroke like symptoms within once day of COVID Moderna shot. Patient was at normal baseline day of covid vaccine then next day woke up dizzy and weak; unable to stand without support and legs felt wobbly. Had extensive workup in the ED including Head CT, CT angiogram of head/neck, MIR of brain, and echocardiogram were completed. Non-clinic Neurology was consulted and reviewed imaging; stroke and TIA were ruled out. The profound weakness and dizziness were likely secondary to COVID vaccine which patient received the day before. Patient was discharged from the ED with recommendation of physical therapy.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Echocardiogram normal, Gait disturbance, Magnetic resonance imaging head normal, Neurological symptom
Clinical narrative: weakness Narrative:  Patient presented to outside ED with EMS secondary to concerns of stroke like symptoms within once day of COVID Moderna shot. Patient was at normal baseline day of covid vaccine then next day woke up dizzy and weak; unable to stand without support and legs felt wobbly. Had extensive workup in the ED including Head CT, CT angiogram of head/neck, MIR of brain, and echocardiogram were completed. Non-clinic Neurology was consulted and reviewed imaging; stroke and TIA were ruled out. The profound weakness and dizziness were likely secondary to COVID vaccine which patient received the day before. Patient was discharged from the ED with recommendation of physical therapy.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: fever, chiills, and sweats Narrative:  Patient begin experiencing symptoms the next day following shot #1 of COVID Moderna. Symptoms report; chills, body aches, fever 101, and sweats. Did not report any therapeutic intervention or duration of symptoms rather wanted advice if should receive shot #2 based upon these symptoms.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Dyspnoea, Forced expiratory volume decreased, Forced vital capacity decreased, Pulmonary fibrosis
Clinical narrative: Dyspnea Narrative: Pt with PMH of pulmonary fibrosis. Seemed to worsen after administration of COVID vaccine Pt. required increased O2 needs. Ct showed worsening fibrosis and lung function tests showed decreased FEV1 and FVC.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary function test abnormal
Clinical narrative: Dyspnea Narrative: Pt with PMH of pulmonary fibrosis. Seemed to worsen after administration of COVID vaccine Pt. required increased O2 needs. Ct showed worsening fibrosis and lung function tests showed decreased FEV1 and FVC.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Death, Empyema, Lung disorder, Pneumonia aspiration
Clinical narrative: None reported Narrative:  A 67yo male with history of Neoplasm of Head and Neck, Pneumonia, Pyothorax, Dysphagia, OSA, Per nursing Immunization Note: received Covid - 19 vaccine on March 6, 2021 at1345 without complications, per policy/protocol and was advised to stay at the facility for 15 minutes post vaccination. He was also provided with information regarding possible side effects and how to report ADRs Unable to find any documented ADR from the vaccine. Per provider's documentation, the patient had stage IVa Oropharyngeal Squamous Cell Carcinoma and was hospitalized in February of 2021 for aspiration Pneumonia/Bacterial Pneumonia and Empyema. A CTA Chest also showed multiple nodules in the lungs and a mass like lesion in the right Pulmonary fissure with concerns for possible new pulmonary malignancy Admin officer's documentation, post communicating with Medical Examiner ,indicated the patient passed away at home on March 8, 2021
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia bacterial, Pulmonary mass
Clinical narrative: None reported Narrative:  A 67yo male with history of Neoplasm of Head and Neck, Pneumonia, Pyothorax, Dysphagia, OSA, Per nursing Immunization Note: received Covid - 19 vaccine on March 6, 2021 at1345 without complications, per policy/protocol and was advised to stay at the facility for 15 minutes post vaccination. He was also provided with information regarding possible side effects and how to report ADRs Unable to find any documented ADR from the vaccine. Per provider's documentation, the patient had stage IVa Oropharyngeal Squamous Cell Carcinoma and was hospitalized in February of 2021 for aspiration Pneumonia/Bacterial Pneumonia and Empyema. A CTA Chest also showed multiple nodules in the lungs and a mass like lesion in the right Pulmonary fissure with concerns for possible new pulmonary malignancy Admin officer's documentation, post communicating with Medical Examiner ,indicated the patient passed away at home on March 8, 2021
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Narrative:
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Decreased nasolabial fold, Eyelid ptosis, Facial paralysis, Movement disorder
Clinical narrative: Bell's palsy Narrative: He notes having developd s/sx concerning for Ball's palsy 5x days after the initial vaccination. This was described as paralysis of the entire left side (inability to wrinkle forehead, drooping eyelid, drooping mouth) of this face a/w nerve pain. He presented a photo that was consistent with concern for Bell's palsy including the described sx + loss of nasolabial fold. The concerns lasted for ~ 14-15 days with no residual deficits. He denied s/sx of CVA including slurred speech (some disruption from associated unilateral mouth droop), confusion, disorientation, unilateral UE or LE weakness. He denies onset of other viral illness around that time. He did not take any therapies.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Neuralgia, Speech disorder
Clinical narrative: Bell's palsy Narrative: He notes having developd s/sx concerning for Ball's palsy 5x days after the initial vaccination. This was described as paralysis of the entire left side (inability to wrinkle forehead, drooping eyelid, drooping mouth) of this face a/w nerve pain. He presented a photo that was consistent with concern for Bell's palsy including the described sx + loss of nasolabial fold. The concerns lasted for ~ 14-15 days with no residual deficits. He denied s/sx of CVA including slurred speech (some disruption from associated unilateral mouth droop), confusion, disorientation, unilateral UE or LE weakness. He denies onset of other viral illness around that time. He did not take any therapies.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Throat irritation
Clinical narrative: tickle in throat/hot brain Narrative:  LOCAL TITLE: Addendum STANDARD TITLE: ADDENDUM DATE OF NOTE: APR 05, 2021@10:32:53 ENTRY DATE: APR 05, 2021@10:32:54 AUTHOR: PROVIDER EXP COSIGNER: URGENCY: STATUS COMPLETED patient with s/e tickle in the throat not brain provided with apple juice and water drank all of the juice no additional tickle in throat at 1006am, discussed with lead who cleared for release at 1008am vvs 0950 62 pulse, 96/65 b/p and rr17 vvc 1003 67 pulse, 103/69 b/p and rr 16 02 sat 98% on room air /es/ Provider Nursing Specialty  Clinic Signed 04/05/2021 10:36 ================================================================== --- Original Document --- 04/05/21 VAERS NSG COVID VACCINE ADMINISTRATION: The patient was given the EUA fact sheet for this vaccine which list the benefits and side effects of the vaccine and which reviews the risks of the vaccine. The fact sheet was reviewed with the patient and they were given an opportunity to ask questions. The patient denied any prior severe reaction to this vaccine or its components or a severe allergic reaction such as anaphylaxis to any vaccine or to any injectable therapy. The patient gave verbal consent to receive the vaccine. Dose #2 The patient received Pfizer COVID-19 Vaccine 0.3 ml IM. MVX (Manuf); Lot#; Exp Date: PFR; ER8732; 07/31/2021 Administration Anatomic site: Left Deltoid Vaccine administered without complications. The patient was advised to remain in the facility for 15 minutes post vaccination. The patient was given a completed COVID-19 vaccination record card, a copy of the facility side effects and adverse events reporting fact sheet and instructed on how to report any adverse reactions. Vaccine administered by protocol without complications. The patient was advised to remain in the facility for 15 minutes post vaccination. /es/ Provider Nursing Coordinator Specialty  Clinic Signed: 04/05/2021 09:37
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lymph node pain, Lymphadenopathy
Clinical narrative: swollen lymph node Narrative: He developed right axillary lymphadenopathy with 1x painful/palpable enlarged LN about 5x days after the initial vaccination (right deltoid)  This persisted for ~2x days prior to resolving. During that time, he was able to complete all ADLs/IADLs and regular exercise and took ibuprofen. No other common adverse effects other than mild fatigue reported.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Diarrhoea, Hyperhidrosis, Myalgia
Clinical narrative: Narrative:  Denies bLast Wednesday, 0830, COVID vaccine at clinic.  Thursday at 1200 started w/ sxs: loss of taste or smell, total body muscle aches.  1700 felt feverish, measured temp. 104, messaged sister, told to take tylenol, did not take the tylenol and went to bed. Woke up at 1600AM the next day (Friday Am) with sheets saturated 2/ sweat & diarrhea watery/liquid x 3. Friday AM T 98.4. All sxs were resolved. Denies being around any persons unmasked, lives alone, n/vomiting, no known confirmed positive COVID contacts, rash, facial swelling/tongue swelling.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats, Pyrexia
Clinical narrative: Narrative:  Denies bLast Wednesday, 0830, COVID vaccine at clinic.  Thursday at 1200 started w/ sxs: loss of taste or smell, total body muscle aches.  1700 felt feverish, measured temp. 104, messaged sister, told to take tylenol, did not take the tylenol and went to bed. Woke up at 1600AM the next day (Friday Am) with sheets saturated 2/ sweat & diarrhea watery/liquid x 3. Friday AM T 98.4. All sxs were resolved. Denies being around any persons unmasked, lives alone, n/vomiting, no known confirmed positive COVID contacts, rash, facial swelling/tongue swelling.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: shortness of breath Narrative: Pt stated at dose #2 covid clinic he had shortness of air lasting 43 & 1/2 weeks after his dose #1 covid vaccine. At this time pt stated his respiratory function returned to baseline. Pt received his dose #2 on 4/5/2021.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: Day 2 - 3 injection sight sore and fatigue Narrative:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Auscultation, Erythema, Feeling hot, Flushing, Pruritus
Clinical narrative: flusing Narrative: She started to experience b/l UE flushing ~20 minutes post- vaccination (still in clinic waiting for husband while he was getting vaccinated). B/l UE described as hot, red, and itchy with worst affected area left forearm (vaccination in right deltoid). This lasted for a few minutes, but was already dissipating w/o intervention upon evaluation. She denied swelling, confusion/disorientation, dizziness/lightheadedness, weakness, SOB/wheezing, tachycardia/palpitations, nausea, abdominal cramping or feeling of need to vomit.  O: Gen: not in distress, answering questions appropriately, pleasant, non-toxic HEENT: PERRLA, no swelling Neck: no swelling, stridor CV: regular rate and  rhythm, normal S1/S2, no murmurs Pulm: clear to auscultation bilaterally with no wheezes/rales/rhonci Ext:moves all 4 spontaneously, no edema Skin: no lesions/swelling/hives/rashes, skin tone even over visible area of body (b/l feet, left knee, b/l UE, chest/back, face/neck), b/l UE not warm to tuch Neuro: CN III- XII grossly intact, 5/5 strength UE and LE Psych: appropriate, thoughts linear and  non-tangential A/P: Patient here for COVID vaccination, complaints of UE flushing/itchiness lasted about 2-3 minutes. No current concern for angioedema or immediate allergic reaction. By time of evaluation with provider, no s/sx of flushing or skin sx of rash/urticaria were visualized and itching had resolved.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site induration, Injection site rash, Injection site warmth
Clinical narrative: Narrative: She developed a non-pruritic rash a/w headache and fatigue after the first vaccination. The rash was described as more pink than erythematous and was localized to the anterior portion of her deltoid/axillary area of the vaccination arm (left) It started 2 days after vaccination and lasted for about 2-3 days prior to spontaneously resolving. It was described as indurated and unknown if warm to touch. There were no other reported common adverse effects other than HA and fatigue (which also resolved w/o intervention), including peeling/sloughing.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Narrative: She developed a non-pruritic rash a/w headache and fatigue after the first vaccination. The rash was described as more pink than erythematous and was localized to the anterior portion of her deltoid/axillary area of the vaccination arm (left) It started 2 days after vaccination and lasted for about 2-3 days prior to spontaneously resolving. It was described as indurated and unknown if warm to touch. There were no other reported common adverse effects other than HA and fatigue (which also resolved w/o intervention), including peeling/sloughing.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Narrative: fatigue for a day
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema
Clinical narrative: Narrative: Angioedema requiring ED evaluation following 1st dose of Pfizer-BioNTech COVID-19 vaccine.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Small intestinal obstruction
Clinical narrative: positive covid test on admission 4/4 for small bowel obstructtion Narrative: hospitalized for unrelated SBO when the asymptomatic test results were obtained
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Palpitations, Pharyngeal swelling, SARS-CoV-2 test
Clinical narrative: dizzy; throat started to swell; Within five minutes of the immunization my heart was racing; This is a spontaneous report from a contactable healthcare professional (patient). A 44-year-old female patient received BNT162B2 (lot number and expiry date were not reported), via an unspecified route of administration, administered in right arm on 18Dec2020 09:00 (at the age of 44-year-old) at single dose for COVID-19 immunization. Medical history included dairy allergy. The patient is not pregnant at the time of vaccination. The patient's concomitant medications were not reported. No other vaccines within 4 weeks prior to the COVID vaccine nor any other medications the patient received within 2 weeks. Within five minutes of the immunization on 18Dec2020 the patient's heart was racing, she was dizzy, her throat started to swell, and she was brought to the ER where they gave her epinephrine and Benadryl. She was admitted to the hospital (Dec2020) two times within a week due to the same symptoms; continuous heart palpitations. She was still having heart palpitations. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient was hospitalized for 5 days. Since the vaccination, has the patient been tested for COVID-19. Covid test was negative on unspecified date. The outcome of the event heart was racing was not recovered and the outcome of the remaining events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events palpitations, dizziness and pharyngeal swelling occurred in a plausible temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Autopsy, Cardiac arrest, Death, Pulse absent, Respiratory arrest
Clinical narrative: The patient was found unresponsive on vitals check 20 minutes after the vaccination. Do not resuscitate/MOLST was in effect. She was pronounced dead shortly after she was found.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: The patient was found unresponsive on vitals check 20 minutes after the vaccination. Do not resuscitate/MOLST was in effect. She was pronounced dead shortly after she was found.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulse absent, Respiratory arrest
Clinical narrative: The patient was found unresponsive on vitals check 20 minutes after the vaccination. Do not resuscitate/MOLST was in effect. She was pronounced dead shortly after she was found.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Autopsy, Blood immunoglobulin E normal, Death, SARS-CoV-2 test negative, Toxicologic test normal
Clinical narrative: The patient was found unresponsive on vitals check 20 minutes after the vaccination. Do not resuscitate/MOLST was in effect. She was pronounced dead shortly after she was found.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tryptase, Unresponsive to stimuli
Clinical narrative: The patient was found unresponsive on vitals check 20 minutes after the vaccination. Do not resuscitate/MOLST was in effect. She was pronounced dead shortly after she was found.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Blood test, Computerised tomogram head normal, Hypoaesthesia, Lumbar puncture
Clinical narrative: Guillain-Barré syndrome; Tingling and numb toes and fingers, which spread to elbows and knees; Tingling and numb toes and fingers , which spread to elbows and knees; Progressed to paralysis; Problems breathing on her own; A spontaneous report was received from a consumer concerning his relative a 39-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tingling, numb toes and fingers which spread to elbows and knees, difficulty breathing  progressed to paralysis.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 23 Dec 2020, approximately three weeks prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (batch: 011J20A) intramuscularly for prophylaxis of COVID-19 infection.  On 14 Jan 2021, the patient experienced tingling, numb toes and fingers, which spread to elbows and knees and progressed to paralysis which required hospitalization and patient was diagnosed with guillain-barré syndrome.   On 25 Jan 2021, the patient was intubated with mechanical breathing because she had problems breathing on her own. patient was hospitalized for a long-term acute care hospital. Treatment for the event included patient was intubated with mechanical breathing.  The second dose of mRNA-1273 was discontinued in response to the events.  The outcome of the events, tingling, numb toes and fingers which spread to elbows and knees, progressed to paralysis, guillain-barré syndrome, was intubated with mechanical breathing and had problems breathing her own were not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Further information is requested.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: Guillain-Barré syndrome; Tingling and numb toes and fingers, which spread to elbows and knees; Tingling and numb toes and fingers , which spread to elbows and knees; Progressed to paralysis; Problems breathing on her own; A spontaneous report was received from a consumer concerning his relative a 39-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tingling, numb toes and fingers which spread to elbows and knees, difficulty breathing  progressed to paralysis.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 23 Dec 2020, approximately three weeks prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (batch: 011J20A) intramuscularly for prophylaxis of COVID-19 infection.  On 14 Jan 2021, the patient experienced tingling, numb toes and fingers, which spread to elbows and knees and progressed to paralysis which required hospitalization and patient was diagnosed with guillain-barré syndrome.   On 25 Jan 2021, the patient was intubated with mechanical breathing because she had problems breathing on her own. patient was hospitalized for a long-term acute care hospital. Treatment for the event included patient was intubated with mechanical breathing.  The second dose of mRNA-1273 was discontinued in response to the events.  The outcome of the events, tingling, numb toes and fingers which spread to elbows and knees, progressed to paralysis, guillain-barré syndrome, was intubated with mechanical breathing and had problems breathing her own were not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Further information is requested.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Condition aggravated, Exposure to SARS-CoV-2, Facial paralysis, Fatigue, Guillain-Barre syndrome
Clinical narrative: Guillain-Barré syndrome; Tingling and numb toes and fingers, which spread to elbows and knees; Tingling and numb toes and fingers , which spread to elbows and knees; Progressed to paralysis; Problems breathing on her own; A spontaneous report was received from a consumer concerning his relative a 39-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tingling, numb toes and fingers which spread to elbows and knees, difficulty breathing  progressed to paralysis.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 23 Dec 2020, approximately three weeks prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (batch: 011J20A) intramuscularly for prophylaxis of COVID-19 infection.  On 14 Jan 2021, the patient experienced tingling, numb toes and fingers, which spread to elbows and knees and progressed to paralysis which required hospitalization and patient was diagnosed with guillain-barré syndrome.   On 25 Jan 2021, the patient was intubated with mechanical breathing because she had problems breathing on her own. patient was hospitalized for a long-term acute care hospital. Treatment for the event included patient was intubated with mechanical breathing.  The second dose of mRNA-1273 was discontinued in response to the events.  The outcome of the events, tingling, numb toes and fingers which spread to elbows and knees, progressed to paralysis, guillain-barré syndrome, was intubated with mechanical breathing and had problems breathing her own were not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Further information is requested.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Hyporeflexia, Lumbar puncture abnormal, Pain, Paralysis
Clinical narrative: Guillain-Barré syndrome; Tingling and numb toes and fingers, which spread to elbows and knees; Tingling and numb toes and fingers , which spread to elbows and knees; Progressed to paralysis; Problems breathing on her own; A spontaneous report was received from a consumer concerning his relative a 39-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tingling, numb toes and fingers which spread to elbows and knees, difficulty breathing  progressed to paralysis.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 23 Dec 2020, approximately three weeks prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (batch: 011J20A) intramuscularly for prophylaxis of COVID-19 infection.  On 14 Jan 2021, the patient experienced tingling, numb toes and fingers, which spread to elbows and knees and progressed to paralysis which required hospitalization and patient was diagnosed with guillain-barré syndrome.   On 25 Jan 2021, the patient was intubated with mechanical breathing because she had problems breathing on her own. patient was hospitalized for a long-term acute care hospital. Treatment for the event included patient was intubated with mechanical breathing.  The second dose of mRNA-1273 was discontinued in response to the events.  The outcome of the events, tingling, numb toes and fingers which spread to elbows and knees, progressed to paralysis, guillain-barré syndrome, was intubated with mechanical breathing and had problems breathing her own were not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Further information is requested.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Guillain-Barré syndrome; Tingling and numb toes and fingers, which spread to elbows and knees; Tingling and numb toes and fingers , which spread to elbows and knees; Progressed to paralysis; Problems breathing on her own; A spontaneous report was received from a consumer concerning his relative a 39-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tingling, numb toes and fingers which spread to elbows and knees, difficulty breathing  progressed to paralysis.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 23 Dec 2020, approximately three weeks prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (batch: 011J20A) intramuscularly for prophylaxis of COVID-19 infection.  On 14 Jan 2021, the patient experienced tingling, numb toes and fingers, which spread to elbows and knees and progressed to paralysis which required hospitalization and patient was diagnosed with guillain-barré syndrome.   On 25 Jan 2021, the patient was intubated with mechanical breathing because she had problems breathing on her own. patient was hospitalized for a long-term acute care hospital. Treatment for the event included patient was intubated with mechanical breathing.  The second dose of mRNA-1273 was discontinued in response to the events.  The outcome of the events, tingling, numb toes and fingers which spread to elbows and knees, progressed to paralysis, guillain-barré syndrome, was intubated with mechanical breathing and had problems breathing her own were not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Further information is requested.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barré syndrome; Tingling and numb toes and fingers, which spread to elbows and knees; Tingling and numb toes and fingers , which spread to elbows and knees; Progressed to paralysis; Problems breathing on her own; A spontaneous report was received from a consumer concerning his relative a 39-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tingling, numb toes and fingers which spread to elbows and knees, difficulty breathing  progressed to paralysis.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 23 Dec 2020, approximately three weeks prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (batch: 011J20A) intramuscularly for prophylaxis of COVID-19 infection.  On 14 Jan 2021, the patient experienced tingling, numb toes and fingers, which spread to elbows and knees and progressed to paralysis which required hospitalization and patient was diagnosed with guillain-barré syndrome.   On 25 Jan 2021, the patient was intubated with mechanical breathing because she had problems breathing on her own. patient was hospitalized for a long-term acute care hospital. Treatment for the event included patient was intubated with mechanical breathing.  The second dose of mRNA-1273 was discontinued in response to the events.  The outcome of the events, tingling, numb toes and fingers which spread to elbows and knees, progressed to paralysis, guillain-barré syndrome, was intubated with mechanical breathing and had problems breathing her own were not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Further information is requested.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia, Paralysis
Clinical narrative: Guillain-Barré syndrome; Tingling and numb toes and fingers, which spread to elbows and knees; Tingling and numb toes and fingers , which spread to elbows and knees; Progressed to paralysis; Problems breathing on her own; A spontaneous report was received from a consumer concerning his relative a 39-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tingling, numb toes and fingers which spread to elbows and knees, difficulty breathing  progressed to paralysis.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 23 Dec 2020, approximately three weeks prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (batch: 011J20A) intramuscularly for prophylaxis of COVID-19 infection.  On 14 Jan 2021, the patient experienced tingling, numb toes and fingers, which spread to elbows and knees and progressed to paralysis which required hospitalization and patient was diagnosed with guillain-barré syndrome.   On 25 Jan 2021, the patient was intubated with mechanical breathing because she had problems breathing on her own. patient was hospitalized for a long-term acute care hospital. Treatment for the event included patient was intubated with mechanical breathing.  The second dose of mRNA-1273 was discontinued in response to the events.  The outcome of the events, tingling, numb toes and fingers which spread to elbows and knees, progressed to paralysis, guillain-barré syndrome, was intubated with mechanical breathing and had problems breathing her own were not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Further information is requested.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Corneal reflex decreased, Ear pain, Facial pain, Facial paralysis
Clinical narrative: After the first Dose I exp tingling on right side of my face. I woke up next day exp headache and fatigue realized right eye lid wasn't closing same time as left eyelid. I went to walk in clinic next morning confirmed Bell's Palsy started Prednisone. I do have a genetic blood clotting disorder for 18 years.Since the vaccine on 3/31 I woke up with pain in my foot on lower right leg applied ice and took Tylenol. I scheduled a doppler at the Imaging center on 2/7 confirmed blood clots and prescribed Xarelto.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hordeolum, Hypoaesthesia oral
Clinical narrative: After the first Dose I exp tingling on right side of my face. I woke up next day exp headache and fatigue realized right eye lid wasn't closing same time as left eyelid. I went to walk in clinic next morning confirmed Bell's Palsy started Prednisone. I do have a genetic blood clotting disorder for 18 years.Since the vaccine on 3/31 I woke up with pain in my foot on lower right leg applied ice and took Tylenol. I scheduled a doppler at the Imaging center on 2/7 confirmed blood clots and prescribed Xarelto.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Eyelid function disorder, Fatigue, Headache, Pain in extremity
Clinical narrative: After the first Dose I exp tingling on right side of my face. I woke up next day exp headache and fatigue realized right eye lid wasn't closing same time as left eyelid. I went to walk in clinic next morning confirmed Bell's Palsy started Prednisone. I do have a genetic blood clotting disorder for 18 years.Since the vaccine on 3/31 I woke up with pain in my foot on lower right leg applied ice and took Tylenol. I scheduled a doppler at the Imaging center on 2/7 confirmed blood clots and prescribed Xarelto.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Thrombosis, Ultrasound Doppler
Clinical narrative: After the first Dose I exp tingling on right side of my face. I woke up next day exp headache and fatigue realized right eye lid wasn't closing same time as left eyelid. I went to walk in clinic next morning confirmed Bell's Palsy started Prednisone. I do have a genetic blood clotting disorder for 18 years.Since the vaccine on 3/31 I woke up with pain in my foot on lower right leg applied ice and took Tylenol. I scheduled a doppler at the Imaging center on 2/7 confirmed blood clots and prescribed Xarelto.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, Condition aggravated, Pain of skin, Skin swelling, Sleep disorder
Clinical narrative: left lymph node swollen; This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified age received the second dose of BNT162B2 (TRADE NAME UNSPECIFIED; lot number unknown) via an unspecified route of administration on an unspecified date, reported as in Jan (2021) or Feb (2021), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number unknown) on an unspecified date for COVID-19 immunisation. The patient reported that she received her second dose of the COVID vaccine and was well over the two-week mark and she believed her shot was effective in preventing her and her husband from getting COVID at home as her daughter and her boyfriend recently tested positive for COVID. The patient reported that her left lymph node was still swollen, and her second dose was in Feb (2021) or even Jan (2021). The clinical outcome of left lymph node swollen was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy
Clinical narrative: left lymph node swollen; This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified age received the second dose of BNT162B2 (TRADE NAME UNSPECIFIED; lot number unknown) via an unspecified route of administration on an unspecified date, reported as in Jan (2021) or Feb (2021), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number unknown) on an unspecified date for COVID-19 immunisation. The patient reported that she received her second dose of the COVID vaccine and was well over the two-week mark and she believed her shot was effective in preventing her and her husband from getting COVID at home as her daughter and her boyfriend recently tested positive for COVID. The patient reported that her left lymph node was still swollen, and her second dose was in Feb (2021) or even Jan (2021). The clinical outcome of left lymph node swollen was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oral disorder, Oral herpes
Clinical narrative: I have a lip cyst/lesion; two cold sores inside my upper lip - one almost directly behind the outer lesion, one on the other side of my mouth; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 at 11:15 (Batch/Lot number and Expiry date: unknown) as single dose for COVID-19 immunisation. Medical history included allergies, asthma, dysthymia, fibromyalgia. History of known allergies include penicillin and amoxicillin. Concomitant medication(s) included duloxetine hydrochloride (CYMBALTA); lisinopril; atorvastatin (LIPITOR [ATORVASTATIN]) and atorvastatin taken for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 29Jan2021 at 14:15, the patient experienced I have a lip cyst/lesion and two cold sores inside my upper lip - one almost directly behind the outer lesion, one on the other side of my mouth. The patient don't know if this was a side effect or just a coincidence. He don't have a history of cold sores and herpes. Therapeutic measures were not received as a result of events. The outcome of the events were not recovered.  Information on lot/batch has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip disorder, Oral herpes
Clinical narrative: I have a lip cyst/lesion; two cold sores inside my upper lip - one almost directly behind the outer lesion, one on the other side of my mouth; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 at 11:15 (Batch/Lot number and Expiry date: unknown) as single dose for COVID-19 immunisation. Medical history included allergies, asthma, dysthymia, fibromyalgia. History of known allergies include penicillin and amoxicillin. Concomitant medication(s) included duloxetine hydrochloride (CYMBALTA); lisinopril; atorvastatin (LIPITOR [ATORVASTATIN]) and atorvastatin taken for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 29Jan2021 at 14:15, the patient experienced I have a lip cyst/lesion and two cold sores inside my upper lip - one almost directly behind the outer lesion, one on the other side of my mouth. The patient don't know if this was a side effect or just a coincidence. He don't have a history of cold sores and herpes. Therapeutic measures were not received as a result of events. The outcome of the events were not recovered.  Information on lot/batch has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal discomfort, Swelling face
Clinical narrative: Within 45 secs to 2 mins of receiving the Pfizer vaccine #1,  patient (myself)  experienced tingling in Lt, eye then swelling in Lt. eye lids, lt. cheek, lt. corner mouth which progressed. This was witnessed by the team giving vaccine and later on by EMT on the scene. Post feeling dizzy along with swelling the EMT person had me leave my car & placed me on litter in ambulance waiting in parking lot.  Within 5 -6 mins. of the shot, I then felt severe HA, and swelling in my throat. EMT immediately started IV - gave IV Benadryl, then gave 1 shot of Epinephrine. Called EMT which took me via ambulance to hospital. There EM MD assess then gave me Solumedrol IV push & admitted me to ED OBS formally. Felt better but then few hours later all symptoms returned along with severe pain in hand with red palms & cyanotic finger tips. ED MD treated me again with higher dose of Benadryl & add Prilosec for potentiation of Benadryl and observed me. Felt better after several more hours.  Was discharged on 50 mg Prednisone  X 5 days & prescription for Epinephrine pen. Followed up w/PCP couple days later.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cyanosis, Dizziness, Epinephrine, Eye swelling, Headache
Clinical narrative: Within 45 secs to 2 mins of receiving the Pfizer vaccine #1,  patient (myself)  experienced tingling in Lt, eye then swelling in Lt. eye lids, lt. cheek, lt. corner mouth which progressed. This was witnessed by the team giving vaccine and later on by EMT on the scene. Post feeling dizzy along with swelling the EMT person had me leave my car & placed me on litter in ambulance waiting in parking lot.  Within 5 -6 mins. of the shot, I then felt severe HA, and swelling in my throat. EMT immediately started IV - gave IV Benadryl, then gave 1 shot of Epinephrine. Called EMT which took me via ambulance to hospital. There EM MD assess then gave me Solumedrol IV push & admitted me to ED OBS formally. Felt better but then few hours later all symptoms returned along with severe pain in hand with red palms & cyanotic finger tips. ED MD treated me again with higher dose of Benadryl & add Prilosec for potentiation of Benadryl and observed me. Felt better after several more hours.  Was discharged on 50 mg Prednisone  X 5 days & prescription for Epinephrine pen. Followed up w/PCP couple days later.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Palmar erythema, Paraesthesia, Pharyngeal swelling, Swelling face
Clinical narrative: Within 45 secs to 2 mins of receiving the Pfizer vaccine #1,  patient (myself)  experienced tingling in Lt, eye then swelling in Lt. eye lids, lt. cheek, lt. corner mouth which progressed. This was witnessed by the team giving vaccine and later on by EMT on the scene. Post feeling dizzy along with swelling the EMT person had me leave my car & placed me on litter in ambulance waiting in parking lot.  Within 5 -6 mins. of the shot, I then felt severe HA, and swelling in my throat. EMT immediately started IV - gave IV Benadryl, then gave 1 shot of Epinephrine. Called EMT which took me via ambulance to hospital. There EM MD assess then gave me Solumedrol IV push & admitted me to ED OBS formally. Felt better but then few hours later all symptoms returned along with severe pain in hand with red palms & cyanotic finger tips. ED MD treated me again with higher dose of Benadryl & add Prilosec for potentiation of Benadryl and observed me. Felt better after several more hours.  Was discharged on 50 mg Prednisone  X 5 days & prescription for Epinephrine pen. Followed up w/PCP couple days later.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Feeling abnormal, Hypertension, Lip swelling, Pharyngeal swelling
Clinical narrative: patient presented to the emergency dept with lip swelling and throat fullness after receiving the vaccine.  symptoms occurred about 15min after receiving the vaccine.  IM diphenhydramine given and symptoms resolved within 15min.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia
Clinical narrative: patient presented to the emergency dept with lip swelling and throat fullness after receiving the vaccine.  symptoms occurred about 15min after receiving the vaccine.  IM diphenhydramine given and symptoms resolved within 15min.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Throat tightness
Clinical narrative: patient presented to the emergency dept with lip swelling and throat fullness after receiving the vaccine.  symptoms occurred about 15min after receiving the vaccine.  IM diphenhydramine given and symptoms resolved within 15min.