chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Immunoglobulin therapy, Laboratory test, Lumbar puncture, Magnetic resonance imaging head, Magnetic resonance imaging spinal
Clinical narrative: Numbness and tingling sensation in hands and feet. Loss of strength. Pain. Difficulty walking. Diagnosed with Guillain Barre Syndrome. Recieved 5 days of Immunoglobulin therapy.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Paraesthesia
Clinical narrative: Numbness and tingling sensation in hands and feet. Loss of strength. Pain. Difficulty walking. Diagnosed with Guillain Barre Syndrome. Recieved 5 days of Immunoglobulin therapy.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Musculoskeletal stiffness, Pain, Pyrexia
Clinical narrative: I have a slight Fever, Fatigue and body aches.  Left Arm is stiff and I feel some pain (not really bad) with movement.
Age: 36.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: 2nd day got chills n fever of 102 for few days
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Feeling of body temperature change, Hot flush, Oropharyngeal pain
Clinical narrative: Got the shot last night. Starting sometime before lunch (mid morning) I?ve been having a ton of hot flashes. Been going from hot to cold really fast.  Not uncommon right before my period, but it only happens once or twice then. Probably over 30 times today.  Also sore throat and loss of taste. Maybe I just have covid? Dunno - will figure it out tomorrow.  This is ongoing.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: Patient received first dose of Pfizer COVID vaccine at one of our pharmacy off-site COVID clinics held at  University. He reported not having any previous vaccinations. However, when I went back to the hub/spoke store (the pharmacy that we run all the paperwork at from off-site clinic post-clinic), his insurance rejected the Pfizer vaccine stating "Per patient history, pt has received both doses." I did a central search for all pharmacies and found that he had gotten the Janssen vaccine 03/20/2021 that was entered at another hub/spoke pharmacy post-clinic. I immediately called the patient, the patient answered and stated that he "doesn't remember getting the J&J vaccine but maybe he actually did" and apologized. He reported no adverse effects at that time (this was around 6 hours post-vaccine administration that I made this discovery), and I plan to follow-up again to check in with him in case he has problems. I informed him that "although the CDC provides considerations for a mixed series in exceptional circumstances, this is still considered an administration error that required reporting and a mixed series is not authorized under the vaccine Emergency Use Authorization." I also informed him that it is not advised to give any additional doses.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling
Clinical narrative: Moderate joint pain and  joint swelling.  Vaccination was 7/23, joint pain began 7/28.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral
Clinical narrative: Inflammation right axillary.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Dyspnoea exertional, Electrocardiogram
Clinical narrative: Burning chest sensation, shortness of breath during brisk walk or  walking up stairs
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Hyperhidrosis, Retching, Sleep disorder
Clinical narrative: I received the shot Tuesday afternoon. Friday evening of the same week at around 7pm I was standing outside and started feeling cold on a night that wasn't terribly cold.  I started shivering uncontrollably. I jumped into bed and got under the covers in an attempt to re-warm myself.  I cold not stop shivering and eventually fell asleep. Approximately 30 minutes later I woke up and started dry heaving in the toilet. When I finished dry heaving I came out of the bathroom soaked from head to toe in sweat.  I've never had anything like this happen to me.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Sleep disorder, Vertigo, Vomiting
Clinical narrative: woke up at 1:30 AM on 7/30/2021 from a deep sleep with something I can only explain as the spins.  I had believe I had a fever because my husband gave me wet cold towels to try and cool my body and my body warmed them immediately.  I could not move or the spins would worsen, I couldn't even move my head to either side I had to keep laying down, if I tried to sit up it got worse.  After about 30 minutes I had to vomit so my husband got the trash can because I could not even attempt to get to the restroom. I began to vomit profusely. I needed something to hold me up so my husband helped me to the floor. We considered calling 911. I vomited intermittently for the next 4 hours. I could not sleep because a slight movement in my head would send me spinning. At about 5 AM I was able to slowly get to a chair in my room to try and sleep.  By 8 AM I could walk. Up until about 7 PM (on 7/30) I still felt nausea. I could only sip water or Gatorade, I have managed to eat some soup and crackers.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: Patient received first dose of Pfizer COVID vaccine at one of our Pharmacy off-site COVID clinics held at the University. He reported not having any previous vaccinations. However, when I went back to the hub/spoke store (the pharmacy that we run all the paperwork post-clinic), his insurance rejected the Pfizer vaccine stating "Per patient history, pt has received both doses." I did a central search for all Pharmacist and found that he had gotten the Janssen vaccine 03/20/2021 that was entered at another hub/spoke pharmacy post-clinic. I immediately connected him to other discrepancy patient from this clinic that we were having problems running paperwork for and discovered this patient has the same phone number as the patient I just spoke to regarding this exact same error. He is the son, and I very vividly remember giving him his vaccination because I commented on his health condition he wrote "immunocompromised / cardiac transplant recipient" saying to him "I am very surprised you haven't already gotten your COVID vaccine! You should have been first in line earlier this year." I called the patient, knowing it was his father's phone number and I would likely be speaking to him again. Pt. answered again and still stated that "doesn't remember him and his son getting the J&J vaccine but maybe they actually did" and apologized again. He reported pt. was having no adverse effects at that time (this was around 6 hours post-vaccine administration that I made this discovery), and I plan to follow-up again to check in with him in case either of them have problems. I informed him again that "although the CDC provides considerations for a mixed series in exceptional circumstances, this is still considered an administration error that required reporting and a mixed series is not authorized under the vaccine Emergency Use Authorization." I also informed him that it is not advised to give any additional doses.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Blood test, Chest pain, Computerised tomogram, Diplopia
Clinical narrative: After vaccine that night I had chest pain and fast breathing.  Didn?t feel well for a few days called my cardiologist and told me to come in.  But on the 29th of that month I started feeling dizzy light headed double vision. On the 30th it got worse and on top of those symptoms I had balance lose.  I was admitted  in hospital and stayed 2 days.    I had no balance and could not see.  They said I have vertigo. I  Never had it in my life.  It started when I took vaccine.  I was sent home with a walker and shower chair.   Could not function for weeks.   I still have dizziness and don?t feel ok my ears are killing me now.  It?s July 31st and still sick.  I meet with neurologist and he is sending me for a balance test in August along with going to see an ent.  I spend most my days in bed
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear pain, Loss of personal independence in daily activities, Magnetic resonance imaging, Malaise
Clinical narrative: After vaccine that night I had chest pain and fast breathing.  Didn?t feel well for a few days called my cardiologist and told me to come in.  But on the 29th of that month I started feeling dizzy light headed double vision. On the 30th it got worse and on top of those symptoms I had balance lose.  I was admitted  in hospital and stayed 2 days.    I had no balance and could not see.  They said I have vertigo. I  Never had it in my life.  It started when I took vaccine.  I was sent home with a walker and shower chair.   Could not function for weeks.   I still have dizziness and don?t feel ok my ears are killing me now.  It?s July 31st and still sick.  I meet with neurologist and he is sending me for a balance test in August along with going to see an ent.  I spend most my days in bed
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Respiratory rate increased, Vertigo, Visual impairment, Walking aid user
Clinical narrative: After vaccine that night I had chest pain and fast breathing.  Didn?t feel well for a few days called my cardiologist and told me to come in.  But on the 29th of that month I started feeling dizzy light headed double vision. On the 30th it got worse and on top of those symptoms I had balance lose.  I was admitted  in hospital and stayed 2 days.    I had no balance and could not see.  They said I have vertigo. I  Never had it in my life.  It started when I took vaccine.  I was sent home with a walker and shower chair.   Could not function for weeks.   I still have dizziness and don?t feel ok my ears are killing me now.  It?s July 31st and still sick.  I meet with neurologist and he is sending me for a balance test in August along with going to see an ent.  I spend most my days in bed
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea- started July 17th -  has been everyday since
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac arrest, Headache, Pulmonary thrombosis
Clinical narrative: Blood clots in the lungs cardiac arrest sever headache
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: The customer indicated that he received the J and J within the last 8 weeks. Safety and mixing of Covid-19 vaccines has not been evaluated and therefore the vaccine was inadvertently given the Pfizer vaccine post J and J vaccine
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, C-reactive protein, Carpal tunnel syndrome, Malaise, Musculoskeletal stiffness
Clinical narrative: About 3 months after the Pt had the second dose of Moderna Covid vaccine he started with extreme join pain, carpal tunnel syndrome, malaise, stiffness.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Swelling
Clinical narrative: Localized redness at injection site (Rt deltoid) measuring approx 20mm in diameter. Also noticed small raised area measuring approx. 5mm X 4mm. Mom instructed to give benadryl as soon as arrives home. Did as instructed symptoms were all resolved by 335pm.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: S/S COVID
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oxygen saturation decreased
Clinical narrative: Pt states has had to increase at home oxygen , since getting 1st dose of covid vaccine, (did get 2nd dose of covid vaccine)
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Brachial plexopathy, Electromyogram, Muscular weakness, Neuralgic amyotrophy
Clinical narrative: Left brachial plexopathy with weakness of left arm (Parsonage Turner Syndrome)
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Dry mouth, Feeling abnormal, Gait inability, Hypoaesthesia, Mouth ulceration
Clinical narrative: -With in two days mouth broke out with multiple ulcers & very dry/chalky feeling -Numbness/tingling of feet - Neuropathy. bad enough unable to walk
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Neuropathy peripheral, Paraesthesia
Clinical narrative: -With in two days mouth broke out with multiple ulcers & very dry/chalky feeling -Numbness/tingling of feet - Neuropathy. bad enough unable to walk
Age: 0.58
Sex: F
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Decreased appetite, Diarrhoea, Pyrexia, Rash
Clinical narrative: Skin rash that's spreading. The rash started on the right thigh and has been spreading to the entire body. She had a fever after getting immunizations. Her appetite has decreased. She had two watery stools after immunizations.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Left thigh upper lateral aspect developed 6 inch Erythema & mild tenderness. No induration. No Fluctuation. Fading away by 4th day.  Supportive cold soaks.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nerve conduction studies abnormal, Nerve injury
Clinical narrative: When to ER Hospital at university, Also when to sports center, saw doctor. Then saw another doctor at the hospital. Diagnotes with severe never damgge.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Myalgia, Pyrexia
Clinical narrative: Contracted breakthrough case of COVID-19.; Contracted breakthrough case of COVID-19.; Sinus congestion/pressure; Sinus congestion/pressure; Runny/stuffy nose; Runny/stuffy nose; sneezing; eye watering; loss of smell/taste; loss of smell/taste; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 25-years-old nonpregnant female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EL3247, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 25Jan2021 07:30 as DOSE 2, SINGLE for covid-19 immunization. The patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EL0142, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 04Jan2021 14:30 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient was administered Mirena IUD in the two weeks of vaccination. The patient was not tested positive prior to the vaccination. The patient did not receive any other medication with in four weeks of vaccination. On 15Jul2021 22:30, the patient experienced Contracted breakthrough case of COVID-19. The patient also presented symptoms which include sinus congestion/pressure, runny nose/stuffy nose, sneezing, eye watering and loss of smell/taste. The patient did not receive any treatment for the events. The patient had lab test for covid-19 on different dates on 15Jan2021 the result were negative, on 25Jan2021 the results were negative, on 29Jan2021 the results were negative, On 05Feb2021, the results were negative, on 12Feb2021 results were negative, On  19Feb2021 results were negative, On 01Mar2021 results were negative, On 05Mar2021 results were negative, On 12Mar2021 results were negative, On26Mar2021 results were negative, On 02Apr2021 results were negative, On 22Apr2021 results were negative, On 03May2021 results were negative, On 19Jul2021 results were positive and On 21Jul2021 results were positive.  Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Lacrimation increased, Nasal congestion
Clinical narrative: Contracted breakthrough case of COVID-19.; Contracted breakthrough case of COVID-19.; Sinus congestion/pressure; Sinus congestion/pressure; Runny/stuffy nose; Runny/stuffy nose; sneezing; eye watering; loss of smell/taste; loss of smell/taste; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 25-years-old nonpregnant female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EL3247, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 25Jan2021 07:30 as DOSE 2, SINGLE for covid-19 immunization. The patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EL0142, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 04Jan2021 14:30 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient was administered Mirena IUD in the two weeks of vaccination. The patient was not tested positive prior to the vaccination. The patient did not receive any other medication with in four weeks of vaccination. On 15Jul2021 22:30, the patient experienced Contracted breakthrough case of COVID-19. The patient also presented symptoms which include sinus congestion/pressure, runny nose/stuffy nose, sneezing, eye watering and loss of smell/taste. The patient did not receive any treatment for the events. The patient had lab test for covid-19 on different dates on 15Jan2021 the result were negative, on 25Jan2021 the results were negative, on 29Jan2021 the results were negative, On 05Feb2021, the results were negative, on 12Feb2021 results were negative, On  19Feb2021 results were negative, On 01Mar2021 results were negative, On 05Mar2021 results were negative, On 12Mar2021 results were negative, On26Mar2021 results were negative, On 02Apr2021 results were negative, On 22Apr2021 results were negative, On 03May2021 results were negative, On 19Jul2021 results were positive and On 21Jul2021 results were positive.  Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paranasal sinus discomfort, Rhinorrhoea, SARS-CoV-2 test, Sinus congestion, Sneezing
Clinical narrative: Contracted breakthrough case of COVID-19.; Contracted breakthrough case of COVID-19.; Sinus congestion/pressure; Sinus congestion/pressure; Runny/stuffy nose; Runny/stuffy nose; sneezing; eye watering; loss of smell/taste; loss of smell/taste; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 25-years-old nonpregnant female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EL3247, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 25Jan2021 07:30 as DOSE 2, SINGLE for covid-19 immunization. The patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EL0142, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 04Jan2021 14:30 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient was administered Mirena IUD in the two weeks of vaccination. The patient was not tested positive prior to the vaccination. The patient did not receive any other medication with in four weeks of vaccination. On 15Jul2021 22:30, the patient experienced Contracted breakthrough case of COVID-19. The patient also presented symptoms which include sinus congestion/pressure, runny nose/stuffy nose, sneezing, eye watering and loss of smell/taste. The patient did not receive any treatment for the events. The patient had lab test for covid-19 on different dates on 15Jan2021 the result were negative, on 25Jan2021 the results were negative, on 29Jan2021 the results were negative, On 05Feb2021, the results were negative, on 12Feb2021 results were negative, On  19Feb2021 results were negative, On 01Mar2021 results were negative, On 05Mar2021 results were negative, On 12Mar2021 results were negative, On26Mar2021 results were negative, On 02Apr2021 results were negative, On 22Apr2021 results were negative, On 03May2021 results were negative, On 19Jul2021 results were positive and On 21Jul2021 results were positive.  Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination failure
Clinical narrative: Contracted breakthrough case of COVID-19.; Contracted breakthrough case of COVID-19.; Sinus congestion/pressure; Sinus congestion/pressure; Runny/stuffy nose; Runny/stuffy nose; sneezing; eye watering; loss of smell/taste; loss of smell/taste; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 25-years-old nonpregnant female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EL3247, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 25Jan2021 07:30 as DOSE 2, SINGLE for covid-19 immunization. The patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EL0142, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 04Jan2021 14:30 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient was administered Mirena IUD in the two weeks of vaccination. The patient was not tested positive prior to the vaccination. The patient did not receive any other medication with in four weeks of vaccination. On 15Jul2021 22:30, the patient experienced Contracted breakthrough case of COVID-19. The patient also presented symptoms which include sinus congestion/pressure, runny nose/stuffy nose, sneezing, eye watering and loss of smell/taste. The patient did not receive any treatment for the events. The patient had lab test for covid-19 on different dates on 15Jan2021 the result were negative, on 25Jan2021 the results were negative, on 29Jan2021 the results were negative, On 05Feb2021, the results were negative, on 12Feb2021 results were negative, On  19Feb2021 results were negative, On 01Mar2021 results were negative, On 05Mar2021 results were negative, On 12Mar2021 results were negative, On26Mar2021 results were negative, On 02Apr2021 results were negative, On 22Apr2021 results were negative, On 03May2021 results were negative, On 19Jul2021 results were positive and On 21Jul2021 results were positive.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations
Clinical narrative: Woke up at 2 am with racing heart for 20 minutes.; This is a spontaneous report from a Contactable consumer (patient, self-reported). A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6198 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 24Feb2021 at 11:45 AM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that on 26Feb2021 at 02:00 AM, the patient woke up at 2 am with racing heart for 20 minutes. The patient did not receive any treatment for the event. Outcome of the event was resolved on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram, Bell's palsy, Facial paralysis, Fall, Magnetic resonance imaging normal
Clinical narrative: GUILLIAN BARRE SYNDROME; This spontaneous report was received from a consumer (patient's son) and concerned a female of unspecified age, race and ethnicity. The patient's weight and height were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration unknown, batch number: Unknown) dose, anatomical location, start therapy date were not reported, administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, approximately two weeks after receiving vaccination, the patient experienced symptoms of Guillian Barre syndrome. She had been dealing with the symptoms since April, but the doctors missed it until two weeks ago. Since she went so long without being diagnosed, her insurance denied all treatment. At the time of report, she was bedridden and could not walk, or use her hands effectively; "each day she worsens".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Guillian Barre syndrome was not recovered. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report received from a consumer concerned a female, unspecified age, unknown ethnicity, who experienced symptoms of Guillain-Barre syndrome (GBS) around 2 weeks after receiving the Janssen Covid-19 vaccine. Patient was bedridden,  could not walk and could not use her hands effectively. Symptoms worsened each day. Patient's height and weight were not reported. The patient's past medical/surgical history, concurrent conditions and concomitant medications were not reported. Information is limited in this case, and the occurrence of the symptoms of GBS could represent background incidence of such events in the general population. Therefore, the relationship to the vaccination is considered unclassifiable due to insufficient information. Additional information has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Laboratory test
Clinical narrative: GUILLIAN BARRE SYNDROME; This spontaneous report was received from a consumer (patient's son) and concerned a female of unspecified age, race and ethnicity. The patient's weight and height were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration unknown, batch number: Unknown) dose, anatomical location, start therapy date were not reported, administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, approximately two weeks after receiving vaccination, the patient experienced symptoms of Guillian Barre syndrome. She had been dealing with the symptoms since April, but the doctors missed it until two weeks ago. Since she went so long without being diagnosed, her insurance denied all treatment. At the time of report, she was bedridden and could not walk, or use her hands effectively; "each day she worsens".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Guillian Barre syndrome was not recovered. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report received from a consumer concerned a female, unspecified age, unknown ethnicity, who experienced symptoms of Guillain-Barre syndrome (GBS) around 2 weeks after receiving the Janssen Covid-19 vaccine. Patient was bedridden,  could not walk and could not use her hands effectively. Symptoms worsened each day. Patient's height and weight were not reported. The patient's past medical/surgical history, concurrent conditions and concomitant medications were not reported. Information is limited in this case, and the occurrence of the symptoms of GBS could represent background incidence of such events in the general population. Therefore, the relationship to the vaccination is considered unclassifiable due to insufficient information. Additional information has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: GUILLIAN BARRE SYNDROME; This spontaneous report was received from a consumer (patient's son) and concerned a female of unspecified age, race and ethnicity. The patient's weight and height were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration unknown, batch number: Unknown) dose, anatomical location, start therapy date were not reported, administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, approximately two weeks after receiving vaccination, the patient experienced symptoms of Guillian Barre syndrome. She had been dealing with the symptoms since April, but the doctors missed it until two weeks ago. Since she went so long without being diagnosed, her insurance denied all treatment. At the time of report, she was bedridden and could not walk, or use her hands effectively; "each day she worsens".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Guillian Barre syndrome was not recovered. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report received from a consumer concerned a female, unspecified age, unknown ethnicity, who experienced symptoms of Guillain-Barre syndrome (GBS) around 2 weeks after receiving the Janssen Covid-19 vaccine. Patient was bedridden,  could not walk and could not use her hands effectively. Symptoms worsened each day. Patient's height and weight were not reported. The patient's past medical/surgical history, concurrent conditions and concomitant medications were not reported. Information is limited in this case, and the occurrence of the symptoms of GBS could represent background incidence of such events in the general population. Therefore, the relationship to the vaccination is considered unclassifiable due to insufficient information. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Neuropathy peripheral
Clinical narrative: left/injection arm started tingling; weird sensations; increased numbness spread to all limbs; Already had peripheral neuropathy due to chemo in 2013, which mostly improved. After the vaccine, symptoms worsened and plateaued at a worsened state than before; This is a spontaneous report from a contactable consumer or other non-HCP (Patient herself).  A 34-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8733), via an unspecified route of administration, administered in Arm Left on 02Apr2021 (at the age of 34-year-old) as single dose for COVID-19 immunisation. The patient's medical history included cancer, chemo-induced peripheral neuropathy, fatigue, memory loss and known allergies to opioids. The patient already had peripheral neuropathy due to chemo in 2013, which mostly improved. The patient's concomitant medication included levonorgestrel. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination. On 02Apr2021, within less than 1hr after the first dose of the COVID vaccine, left/injection arm started tingling. Within less 12hrs tingling, other weird sensations, and increased numbness spread to all limbs. Already had peripheral neuropathy due to chemo in 2013, which mostly improved. After the vaccine, symptoms worsened and plateaued at a worsened state than before. The adverse events resulted Doctor or other healthcare professional office/clinic visit, disability or permanent damage. As a treatment the patient received the 50 mg Nortriptyline for the adverse events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information was expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Neuropathy peripheral, Paraesthesia
Clinical narrative: left/injection arm started tingling; weird sensations; increased numbness spread to all limbs; Already had peripheral neuropathy due to chemo in 2013, which mostly improved. After the vaccine, symptoms worsened and plateaued at a worsened state than before; This is a spontaneous report from a contactable consumer or other non-HCP (Patient herself).  A 34-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8733), via an unspecified route of administration, administered in Arm Left on 02Apr2021 (at the age of 34-year-old) as single dose for COVID-19 immunisation. The patient's medical history included cancer, chemo-induced peripheral neuropathy, fatigue, memory loss and known allergies to opioids. The patient already had peripheral neuropathy due to chemo in 2013, which mostly improved. The patient's concomitant medication included levonorgestrel. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination. On 02Apr2021, within less than 1hr after the first dose of the COVID vaccine, left/injection arm started tingling. Within less 12hrs tingling, other weird sensations, and increased numbness spread to all limbs. Already had peripheral neuropathy due to chemo in 2013, which mostly improved. After the vaccine, symptoms worsened and plateaued at a worsened state than before. The adverse events resulted Doctor or other healthcare professional office/clinic visit, disability or permanent damage. As a treatment the patient received the 50 mg Nortriptyline for the adverse events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information was expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Arthritis, Cold sweat, Condition aggravated, Dizziness
Clinical narrative: Arthritis inflamed; clammy; Sweating; Upset/a feeling of overall terrible; burning; growling Stomach pain; Foggy and unable to think; Foggy and unable to think; Debilitating Fatigue; Weak; Sleeping a lot; Weight loss; Migraine; Nauseous; Dizzy/lightheaded; Chronic pain much worse; Chronic pain much worse; This is a spontaneous report from a contactable consumer (patient). This 54-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 14Apr2021 at 13:45 (at the age of 54-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included common variable immunodeficiency (CVID) autoimmune disorder, chronic pain, shellfish allergy, and seafood allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine, The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included thyroid (ARMOUR THYROID), pregabalin (LYRICA), methylphenidate hydrochloride (CONCERTA), linaclotide (LINZESS), and metformin from unknown dates for unknown indications. The patient previously received doxycycline from an unknown date for an unknown indication and experienced allergy.  On 16Apr2021 at 07:00 the patient woke with a migraine, nauseous, dizzy, lightheaded, chronic pain much worse, arthritis inflamed, clammy, sweating, upset, burning, growling stomach pain, foggy and unable to think, debilitating fatigue, weak, sleeping a lot, weight loss, and a feeling of overall terrible. The patient was unable to drive, unable to leave the house or do anything but lie in bed or help to restroom. The patient received treatment from her nurse with intravenous (IV) fluids over 2 days and 2000 cc. The outcomes of  migraine, nauseous, dizzy, lightheaded, chronic pain much worse, arthritis inflamed, clammy, sweating, upset, burning, growling stomach pain, foggy and unable to think, debilitating fatigue, weak, sleeping a lot, weight loss, and a feeling of overall terrible were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspepsia, Fatigue, Hyperhidrosis, Hypersomnia, Illness
Clinical narrative: Arthritis inflamed; clammy; Sweating; Upset/a feeling of overall terrible; burning; growling Stomach pain; Foggy and unable to think; Foggy and unable to think; Debilitating Fatigue; Weak; Sleeping a lot; Weight loss; Migraine; Nauseous; Dizzy/lightheaded; Chronic pain much worse; Chronic pain much worse; This is a spontaneous report from a contactable consumer (patient). This 54-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 14Apr2021 at 13:45 (at the age of 54-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included common variable immunodeficiency (CVID) autoimmune disorder, chronic pain, shellfish allergy, and seafood allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine, The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included thyroid (ARMOUR THYROID), pregabalin (LYRICA), methylphenidate hydrochloride (CONCERTA), linaclotide (LINZESS), and metformin from unknown dates for unknown indications. The patient previously received doxycycline from an unknown date for an unknown indication and experienced allergy.  On 16Apr2021 at 07:00 the patient woke with a migraine, nauseous, dizzy, lightheaded, chronic pain much worse, arthritis inflamed, clammy, sweating, upset, burning, growling stomach pain, foggy and unable to think, debilitating fatigue, weak, sleeping a lot, weight loss, and a feeling of overall terrible. The patient was unable to drive, unable to leave the house or do anything but lie in bed or help to restroom. The patient received treatment from her nurse with intravenous (IV) fluids over 2 days and 2000 cc. The outcomes of  migraine, nauseous, dizzy, lightheaded, chronic pain much worse, arthritis inflamed, clammy, sweating, upset, burning, growling stomach pain, foggy and unable to think, debilitating fatigue, weak, sleeping a lot, weight loss, and a feeling of overall terrible were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Migraine, Nausea, Pain
Clinical narrative: Arthritis inflamed; clammy; Sweating; Upset/a feeling of overall terrible; burning; growling Stomach pain; Foggy and unable to think; Foggy and unable to think; Debilitating Fatigue; Weak; Sleeping a lot; Weight loss; Migraine; Nauseous; Dizzy/lightheaded; Chronic pain much worse; Chronic pain much worse; This is a spontaneous report from a contactable consumer (patient). This 54-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 14Apr2021 at 13:45 (at the age of 54-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included common variable immunodeficiency (CVID) autoimmune disorder, chronic pain, shellfish allergy, and seafood allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine, The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included thyroid (ARMOUR THYROID), pregabalin (LYRICA), methylphenidate hydrochloride (CONCERTA), linaclotide (LINZESS), and metformin from unknown dates for unknown indications. The patient previously received doxycycline from an unknown date for an unknown indication and experienced allergy.  On 16Apr2021 at 07:00 the patient woke with a migraine, nauseous, dizzy, lightheaded, chronic pain much worse, arthritis inflamed, clammy, sweating, upset, burning, growling stomach pain, foggy and unable to think, debilitating fatigue, weak, sleeping a lot, weight loss, and a feeling of overall terrible. The patient was unable to drive, unable to leave the house or do anything but lie in bed or help to restroom. The patient received treatment from her nurse with intravenous (IV) fluids over 2 days and 2000 cc. The outcomes of  migraine, nauseous, dizzy, lightheaded, chronic pain much worse, arthritis inflamed, clammy, sweating, upset, burning, growling stomach pain, foggy and unable to think, debilitating fatigue, weak, sleeping a lot, weight loss, and a feeling of overall terrible were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Arthritis, Asthenia, Burning sensation, Cold sweat
Clinical narrative: Arthritis inflamed; clammy; Sweating; Upset/a feeling of overall terrible; burning; growling Stomach pain; Foggy and unable to think; Foggy and unable to think; Debilitating Fatigue; Weak; Sleeping a lot; Weight loss; Migraine; Nauseous; Dizzy/lightheaded; Chronic pain much worse; Chronic pain much worse; This is a spontaneous report from a contactable consumer (patient). This 54-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 14Apr2021 at 13:45 (at the age of 54-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included common variable immunodeficiency (CVID) autoimmune disorder, chronic pain, shellfish allergy, and seafood allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine, The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included thyroid (ARMOUR THYROID), pregabalin (LYRICA), methylphenidate hydrochloride (CONCERTA), linaclotide (LINZESS), and metformin from unknown dates for unknown indications. The patient previously received doxycycline from an unknown date for an unknown indication and experienced allergy.  On 16Apr2021 at 07:00 the patient woke with a migraine, nauseous, dizzy, lightheaded, chronic pain much worse, arthritis inflamed, clammy, sweating, upset, burning, growling stomach pain, foggy and unable to think, debilitating fatigue, weak, sleeping a lot, weight loss, and a feeling of overall terrible. The patient was unable to drive, unable to leave the house or do anything but lie in bed or help to restroom. The patient received treatment from her nurse with intravenous (IV) fluids over 2 days and 2000 cc. The outcomes of  migraine, nauseous, dizzy, lightheaded, chronic pain much worse, arthritis inflamed, clammy, sweating, upset, burning, growling stomach pain, foggy and unable to think, debilitating fatigue, weak, sleeping a lot, weight loss, and a feeling of overall terrible were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Dizziness, Fatigue, Feeling abnormal, Hyperhidrosis
Clinical narrative: Arthritis inflamed; clammy; Sweating; Upset/a feeling of overall terrible; burning; growling Stomach pain; Foggy and unable to think; Foggy and unable to think; Debilitating Fatigue; Weak; Sleeping a lot; Weight loss; Migraine; Nauseous; Dizzy/lightheaded; Chronic pain much worse; Chronic pain much worse; This is a spontaneous report from a contactable consumer (patient). This 54-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 14Apr2021 at 13:45 (at the age of 54-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included common variable immunodeficiency (CVID) autoimmune disorder, chronic pain, shellfish allergy, and seafood allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine, The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included thyroid (ARMOUR THYROID), pregabalin (LYRICA), methylphenidate hydrochloride (CONCERTA), linaclotide (LINZESS), and metformin from unknown dates for unknown indications. The patient previously received doxycycline from an unknown date for an unknown indication and experienced allergy.  On 16Apr2021 at 07:00 the patient woke with a migraine, nauseous, dizzy, lightheaded, chronic pain much worse, arthritis inflamed, clammy, sweating, upset, burning, growling stomach pain, foggy and unable to think, debilitating fatigue, weak, sleeping a lot, weight loss, and a feeling of overall terrible. The patient was unable to drive, unable to leave the house or do anything but lie in bed or help to restroom. The patient received treatment from her nurse with intravenous (IV) fluids over 2 days and 2000 cc. The outcomes of  migraine, nauseous, dizzy, lightheaded, chronic pain much worse, arthritis inflamed, clammy, sweating, upset, burning, growling stomach pain, foggy and unable to think, debilitating fatigue, weak, sleeping a lot, weight loss, and a feeling of overall terrible were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersomnia, Malaise, Migraine, Nausea, Pain
Clinical narrative: Arthritis inflamed; clammy; Sweating; Upset/a feeling of overall terrible; burning; growling Stomach pain; Foggy and unable to think; Foggy and unable to think; Debilitating Fatigue; Weak; Sleeping a lot; Weight loss; Migraine; Nauseous; Dizzy/lightheaded; Chronic pain much worse; Chronic pain much worse; This is a spontaneous report from a contactable consumer (patient). This 54-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 14Apr2021 at 13:45 (at the age of 54-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included common variable immunodeficiency (CVID) autoimmune disorder, chronic pain, shellfish allergy, and seafood allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine, The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included thyroid (ARMOUR THYROID), pregabalin (LYRICA), methylphenidate hydrochloride (CONCERTA), linaclotide (LINZESS), and metformin from unknown dates for unknown indications. The patient previously received doxycycline from an unknown date for an unknown indication and experienced allergy.  On 16Apr2021 at 07:00 the patient woke with a migraine, nauseous, dizzy, lightheaded, chronic pain much worse, arthritis inflamed, clammy, sweating, upset, burning, growling stomach pain, foggy and unable to think, debilitating fatigue, weak, sleeping a lot, weight loss, and a feeling of overall terrible. The patient was unable to drive, unable to leave the house or do anything but lie in bed or help to restroom. The patient received treatment from her nurse with intravenous (IV) fluids over 2 days and 2000 cc. The outcomes of  migraine, nauseous, dizzy, lightheaded, chronic pain much worse, arthritis inflamed, clammy, sweating, upset, burning, growling stomach pain, foggy and unable to think, debilitating fatigue, weak, sleeping a lot, weight loss, and a feeling of overall terrible were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.