chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: M
Vaccine: HEP, HEP
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Patient got Engerix B instead of Heplisav B. And we had to give him the correct vaccine Heplisav B after he was given the Engerix B to make sure he is fully vaccinated for medical school admission. Patient did not experience any side effects on the day of vaccination. I am going to follow up with him to make sure no side effects. Patient did not experience any adverse effects.
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Vaccine Administered outside of recommended timing. No adverse reaction to patient, no treatment indicated after provider evaluation.
Age: 15.0
Sex: F
Vaccine: HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient experienced syncopal episode due to vaccination. Patient was laid on exam bed, other Nurse and Medical Assistant and Nurse Practitioner notified immediately for assistance. Head of the bed lowered, patient's feet raised above heart level. Patient reawakened after 2 minutes.
Age: 74.0
Sex: M
Vaccine: COVID19, RSV
Symptoms: Dizziness, Influenza like illness, Pyrexia
Clinical narrative: Fever of 102 degrees. Flu-like aches. dizziness.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Spikevax was administered after Beyond use date; patient had bruise/sore arm/red circle at injection site
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: every time i receive a booster , I experience fatigue. It seems to br getting worse in that the last time  i  received the booster i experienced fatigue that is still with me today
Age: 83.0
Sex: F
Vaccine: RSV
Symptoms: Erythema
Clinical narrative: Redness that has lasted three weeks - pt. was counseled to see primary care.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Headache, Palpitations
Clinical narrative: Symptoms started Feb 1 when I awakened.  Heart pounding. Elevated blood pressure ,  elevated Bloop pressure has continued, headache
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Breast feeding, Delivery, Detoxification, Dysaesthesia
Clinical narrative: PFIZER #1 2/3/2021 PFIZER #2 11/5/2021 PATIENT VACCINATION WHILE PREGNANT THEN DEVELOPED HYPERTENSION DIFFICULT TO CONTROL DURING PREGNANCY AND LEFT PLANTAR FOOT DYSESTHESIA.  AFTER DELIVERY AND BREASTFEEDING COMPLETE HAS BEEN UNABLE TO GET PREGNANT NOW UNDERGOING IVF FOR INFERTILITY AS A CONSEQUENCE OF MRNA VACCINATION.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Exposure during pregnancy, Hypertension, Immunisation reaction, In vitro fertilisation
Clinical narrative: PFIZER #1 2/3/2021 PFIZER #2 11/5/2021 PATIENT VACCINATION WHILE PREGNANT THEN DEVELOPED HYPERTENSION DIFFICULT TO CONTROL DURING PREGNANCY AND LEFT PLANTAR FOOT DYSESTHESIA.  AFTER DELIVERY AND BREASTFEEDING COMPLETE HAS BEEN UNABLE TO GET PREGNANT NOW UNDERGOING IVF FOR INFERTILITY AS A CONSEQUENCE OF MRNA VACCINATION.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Infertility, Oocyte harvest
Clinical narrative: PFIZER #1 2/3/2021 PFIZER #2 11/5/2021 PATIENT VACCINATION WHILE PREGNANT THEN DEVELOPED HYPERTENSION DIFFICULT TO CONTROL DURING PREGNANCY AND LEFT PLANTAR FOOT DYSESTHESIA.  AFTER DELIVERY AND BREASTFEEDING COMPLETE HAS BEEN UNABLE TO GET PREGNANT NOW UNDERGOING IVF FOR INFERTILITY AS A CONSEQUENCE OF MRNA VACCINATION.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Immunoglobulin therapy, Oral blood blister, Petechiae, Platelet count decreased, Platelet transfusion
Clinical narrative: Thrombocytopenia.  Noticed petechia on legs 10/04/2023. Next day 10/05/2023  blood blisters inside mouth.  Went to emergency room. Platelets are ?2?  Admitted to hospital. Treatment was 2 units platelets, immunoglobulin, & dexamethasone.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Thrombocytopenia
Clinical narrative: Thrombocytopenia.  Noticed petechia on legs 10/04/2023. Next day 10/05/2023  blood blisters inside mouth.  Went to emergency room. Platelets are ?2?  Admitted to hospital. Treatment was 2 units platelets, immunoglobulin, & dexamethasone.
Age: 64.0
Sex: F
Vaccine: RSV
Symptoms: Injection site discolouration, Injection site swelling
Clinical narrative: Patient came to pharmacy to show her immunization administration site. She told that she got the RSV vaccine couple of weeks ago and next couple of days there was lot of swelling. She said now it has gone down. Pt didn't said she having any pain now. Upon checking there was some black patch around the area where she got the vaccine. Told patient to keep a watch for sometime and to check with a doctor if it gets worse.
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Allergy test, Angiogram cerebral, Computerised tomogram head, Electromyogram, Magnetic resonance imaging head
Clinical narrative: Speech impediment  (difficulty pronouncing certain sounds)
Age: 65.0
Sex: M
Vaccine: COVID19-2
Symptoms: Speech disorder, Urine analysis
Clinical narrative: Speech impediment  (difficulty pronouncing certain sounds)
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: The patient has 2 profiles on system, one showing she has not received the Shingrix vaccine and one showing she has received the 2 dose series. The profile showing she had received them was not noticed until after the immunization was given. The patient thought it was time for her 2nd dose, but she actually received a 3rd dose.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient came to the pharmacy stating he wants a pneumonia vaccine. Prevnar-20 was prepared, but patient provided a note from his doctor to specifically get the pneumovax-23. Contacted doctor office to get confirmation that they wanted only the pneumovax-23. Was not able to reach doctor in person after multiple transfers. Pharmacist left VM for doctor and educate patient about the different pneumonia vaccines and dosing and the most updated Prevnar-20. Patient decided to have the Pneumovax-23 as his doctor recommended on his letter.  Vaccine was administered, but pharmacist checked and found out that it had expired on 08/29/2023. Patient was contacted and followed-up for any abnormal symptoms. Patient states he is feeling normal. Patient will be re-vaccinated when he feels comfortable and when he hears back from his doctor.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Computerised tomogram thorax abnormal, Dyspnoea, Electrocardiogram normal, Fibrin D dimer increased
Clinical narrative: The injection itself was painless on 2/08/24.  About 2 hours later, noticed hard lump on right arm.  At 8:30pm, noticed a very large, hard, bump/lump, raised, hot, about 2" diameter.  The next morning 2/09/24, noticed the induration and redness increased, and it was nearly 3" red circle, hot, raised, painful to touch.  That day/night 2/09/24, I had some issues with breathing and chest pressure.  I didn't do anything that night.  On 2/10/24, I woke up with a migraine and took Fioricet with Codeine.  The right arm vaccine red hot raised angry lump remained, perhaps a little smaller in diameter.  My chest continued to feel tight and deep breaths difficult.  I ended up going into the ER on 2/10/24 due to problems with breathing.  They diagnosed me with PE's and gave me Eliquis/apixaban starting on 2/10/24 for 10mg BID for one week, then down to 5mg BID until further notice from vascular medicine.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: The injection itself was painless on 2/08/24.  About 2 hours later, noticed hard lump on right arm.  At 8:30pm, noticed a very large, hard, bump/lump, raised, hot, about 2" diameter.  The next morning 2/09/24, noticed the induration and redness increased, and it was nearly 3" red circle, hot, raised, painful to touch.  That day/night 2/09/24, I had some issues with breathing and chest pressure.  I didn't do anything that night.  On 2/10/24, I woke up with a migraine and took Fioricet with Codeine.  The right arm vaccine red hot raised angry lump remained, perhaps a little smaller in diameter.  My chest continued to feel tight and deep breaths difficult.  I ended up going into the ER on 2/10/24 due to problems with breathing.  They diagnosed me with PE's and gave me Eliquis/apixaban starting on 2/10/24 for 10mg BID for one week, then down to 5mg BID until further notice from vascular medicine.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Metabolic function test normal, Migraine, Pulmonary embolism, Troponin normal
Clinical narrative: The injection itself was painless on 2/08/24.  About 2 hours later, noticed hard lump on right arm.  At 8:30pm, noticed a very large, hard, bump/lump, raised, hot, about 2" diameter.  The next morning 2/09/24, noticed the induration and redness increased, and it was nearly 3" red circle, hot, raised, painful to touch.  That day/night 2/09/24, I had some issues with breathing and chest pressure.  I didn't do anything that night.  On 2/10/24, I woke up with a migraine and took Fioricet with Codeine.  The right arm vaccine red hot raised angry lump remained, perhaps a little smaller in diameter.  My chest continued to feel tight and deep breaths difficult.  I ended up going into the ER on 2/10/24 due to problems with breathing.  They diagnosed me with PE's and gave me Eliquis/apixaban starting on 2/10/24 for 10mg BID for one week, then down to 5mg BID until further notice from vascular medicine.
Age: 4.0
Sex: F
Vaccine: COVID19, DTAPIPV, FLU4, MMRV
Symptoms: Febrile convulsion, Influenza virus test negative, Respiratory syncytial virus test negative, SARS-CoV-2 test negative
Clinical narrative: patient presented 12 days after 4 year well child check including MMRV, DTAP-IPV, flu vaccine and covid with simple febrile seizure
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Dyspnoea, Heart rate increased, Pain in extremity
Clinical narrative: Reported Symptoms: 10038678:RESPIRATORY DEPRESSION; 10040047:SEPSIS; 10043071:TACHYCARDIA; 10084380:COVID-19 PNEUMONIA; Narrative: Patient received four Moderna COVID 19 vaccines (Feb/Mar/Aug 2021 and Apr 2022) and one Pfizer Covid 19 vaccine (Oct 2022). The patient presented to the ED on 16 June 2023 with shortness of breath, productive cough, fast heart rate, and calf pain. The patient tested positive for COVID 19 on 16 June 2023. The patient was admitted to the hospital on 16 June 2023 with respiratory failure, COVID pneumonia, sepsis, and tachycardia and was treated with remdesivir, dexamethasone, and antibiotics. The patient was discharged on 19 June 2023 in stable condition on steroid taper. Reported per EUA. Other Relevant HX: Other: sepsis, covid pneumonia
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Productive cough, Respiratory depression, SARS-CoV-2 test positive, Sepsis, Tachycardia
Clinical narrative: Reported Symptoms: 10038678:RESPIRATORY DEPRESSION; 10040047:SEPSIS; 10043071:TACHYCARDIA; 10084380:COVID-19 PNEUMONIA; Narrative: Patient received four Moderna COVID 19 vaccines (Feb/Mar/Aug 2021 and Apr 2022) and one Pfizer Covid 19 vaccine (Oct 2022). The patient presented to the ED on 16 June 2023 with shortness of breath, productive cough, fast heart rate, and calf pain. The patient tested positive for COVID 19 on 16 June 2023. The patient was admitted to the hospital on 16 June 2023 with respiratory failure, COVID pneumonia, sepsis, and tachycardia and was treated with remdesivir, dexamethasone, and antibiotics. The patient was discharged on 19 June 2023 in stable condition on steroid taper. Reported per EUA. Other Relevant HX: Other: sepsis, covid pneumonia
Age: 90.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Confusional state, Gait inability, Injection site erythema, Injection site rash
Clinical narrative: Reported Symptoms:  Narrative:  Other Relevant Hx: patient is 90 y.o. with diagnosis of mild cognitive disorder. has multiple disease states (COPD, diabetes with neuropathy) as well as diagnosis of decreased balance. Patient has received 12 vaccines for flu in the past that have be documented since 2003. No reported complaints.  Stated occurred after, so estimated time of 11/06/23 at 12pm since shot was given at 10:30 that morning. Patient didn't report until next visit on 11/20/23. Patient's wife and caregiver, greeted me at the door of their home in a retirement community. There home is clean and well kept. Patient was sitting in his living room - he was quiet, but pleasant during the visit. His wife reported that he got sick after his recent flu shot (11/6/23), didn't feel well for three days and couldn't walk during that time. She said his memory was also affected and that he wasn't able to remember the names of their grand children last week. She said he had never had a reaction to the flu shot prior to that one. Patient would answer most of my  questions, but wife would add additional pertinent information.   So rash at injection site (listed in ADE but not mentioned whether it was a rash or redness at injection site, only that it was a red patch) in the noted did address weakness and confusion but patient has comorbidities in regards to these conditions. Patient did not receive anything for treatment in regards to this reaction.  11-22-2023 wife reports pt is doing better and finally close to back to his baseline after the flu shot reaction he had.
Age: 90.0
Sex: M
Vaccine: FLU4
Symptoms: Malaise, Memory impairment
Clinical narrative: Reported Symptoms:  Narrative:  Other Relevant Hx: patient is 90 y.o. with diagnosis of mild cognitive disorder. has multiple disease states (COPD, diabetes with neuropathy) as well as diagnosis of decreased balance. Patient has received 12 vaccines for flu in the past that have be documented since 2003. No reported complaints.  Stated occurred after, so estimated time of 11/06/23 at 12pm since shot was given at 10:30 that morning. Patient didn't report until next visit on 11/20/23. Patient's wife and caregiver, greeted me at the door of their home in a retirement community. There home is clean and well kept. Patient was sitting in his living room - he was quiet, but pleasant during the visit. His wife reported that he got sick after his recent flu shot (11/6/23), didn't feel well for three days and couldn't walk during that time. She said his memory was also affected and that he wasn't able to remember the names of their grand children last week. She said he had never had a reaction to the flu shot prior to that one. Patient would answer most of my  questions, but wife would add additional pertinent information.   So rash at injection site (listed in ADE but not mentioned whether it was a rash or redness at injection site, only that it was a red patch) in the noted did address weakness and confusion but patient has comorbidities in regards to these conditions. Patient did not receive anything for treatment in regards to this reaction.  11-22-2023 wife reports pt is doing better and finally close to back to his baseline after the flu shot reaction he had.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, COVID-19, Myalgia, SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms:  10028411:MYALGIA; 10004268:COVID-19;  Narrative:  Patient received 4 doses Pfizer COVID 19 vaccine (Feb/Mar/Sep 21 and Jul 22). The patient presented to the ED on 31 July 23 with severe weakness.  The patient tested positive for COVID 19 on 31 July 23.  The patient was admitted to the hospital on 31 July with COVID 19 and monitored and treated with albuterol.  The patient was discharged in stable condition on 2 August 2023. Reported per EUA.  Other Relevant HX:  Other: covid 19
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Reported Symptoms: 10037844:RASH; Narrative: A 54 year old male who reported having recurring rash, believes it is related to covid vaccine as it occurred soon after receiving COVID-19 vaccine. Other Relevant HX: Other: RASH
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperglycaemia
Clinical narrative: Reported Symptoms: 10020639:HYPERGLYCEMIA; Narrative: Other Relevant: HX: Other: HYPERGLYCEMIA
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Seizure
Clinical narrative: Reported Symptoms:  10039906:SEIZURE;  Narrative: Per June 13, 2023, PCC attending physician's note, the patient had a history of seizure and experienced increased seizure after first dose of Covid-19 vaccine (per pt's immunization record, a Pfizer Covid - 19 vaccine administered on 02/02/2023). Thus the MD included a contraindication precaution to the Pfizer Bivalent Covid - 19 Booster per chief of Neurology's note on 3/30/2021, the patient was on Neurontin therapy for seizure Other Relevant Hx:  Other: SEIZURE
Age: 56.0
Sex: M
Vaccine: PPV
Symptoms: Dermatitis allergic, Rash
Clinical narrative: Reported Symptoms: 10011667:CUTANEOUS HYPERSENSITIVITY; 10037844:RASH; Narrative:  Other Relevant Hx:  Other:  CUTANEOUS HYPERSENSITIVITY
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure, COVID-19 pneumonia, Cough, Dyspnoea, Malaise
Clinical narrative: Reported Symptoms: 10011232:COUGHING; 10021142:HYPOXEMIA; 10035664:PNEUMONIA; 10038678:RESPIRATORY DEPRESSION; 10038695:RESPIRATORY FAILURE; Narrative: Patient received 2 Pfizer COVID 19 Vaccines (Mar/Apr 2021) and 2 Moderna COVID 19 Vaccines (Dec 21 and May 22). The patient presented to the ED on 26 June 2023 with persistent cough, shortness of breath, and malaise. The patient tested positive for COVID 19 on 26 June 2023. The patient was admitted to the hospital with COVID pneumonia and acute respiratory failure and was treated with remdesivir and dexamethasone. The patient was discharged in stable condition on 30 June 2023. Reported per EUA. Other Relevant HX: Other: covid pneumonia, respiratory failure
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Respiratory depression, SARS-CoV-2 test positive
Clinical narrative: Reported Symptoms: 10011232:COUGHING; 10021142:HYPOXEMIA; 10035664:PNEUMONIA; 10038678:RESPIRATORY DEPRESSION; 10038695:RESPIRATORY FAILURE; Narrative: Patient received 2 Pfizer COVID 19 Vaccines (Mar/Apr 2021) and 2 Moderna COVID 19 Vaccines (Dec 21 and May 22). The patient presented to the ED on 26 June 2023 with persistent cough, shortness of breath, and malaise. The patient tested positive for COVID 19 on 26 June 2023. The patient was admitted to the hospital with COVID pneumonia and acute respiratory failure and was treated with remdesivir and dexamethasone. The patient was discharged in stable condition on 30 June 2023. Reported per EUA. Other Relevant HX: Other: covid pneumonia, respiratory failure
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: Reported Symptoms: 10052538:ADVERSE DRUG REACTION NOS; Narrative: reported 2.5 years after given vaccine. no information available Other Relevant HX: Other: no information in database
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Reported Symptoms: 10024570:LIP SWELLING; Narrative: Other Relevant HX: Other: swollen lips.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fever 103.2, shaking, chills, vomiting, extreme tiredness, headache bodyaches
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor, Vomiting
Clinical narrative: Fever 103.2, shaking, chills, vomiting, extreme tiredness, headache bodyaches
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Parkinson's disease, Tremor
Clinical narrative: Trimmer in my left hand started in July 2021 and progressed with other symptoms to a Parkinson?s disease diagnosis in March 2023.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: The patient never stated anything about having any trouble breathing, having a rash, or feeling lightheaded after the vaccine was administered. She was mad that the vaccine contained an egg component because she was vegan. To the pharmacist's understanding, being vegan is a diet and lifestyle choice. The patient was asked before the vaccine was given if she had any type of rection to previous vaccines and the patient stated that she just did not feel well for a few day after the vaccine was administered. She never stated anything about being allergic to eggs, she underline the words gelatin and latex in the allergy section of the sheet. She never stated that she had previously went to an emergency room because of a vaccine or that she had any problems with breathing or feeling lightheaded after a vaccine. About an hour after the vaccine was given, she asked if the vaccine contained egg and the pharmacist stated in did have egg protein in it. She did not state that she was having trouble breathing, had any kind of rash, or feeling lightheaded or sick, she was just mad that the vaccine had egg protein in it and she was a vegan.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased, Muscular weakness, Pain
Clinical narrative: For next 3 days following the administration, patient had severe body aches and muscle weakness, patient was bed-bound at home for the following 3 days.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: Hives, Rash all over arms, legs and feet
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia, Throat irritation, Urticaria
Clinical narrative: Patient presented on 3/3/-2024 with full body hives, fever, malaise. Irritated throat, NO difficulty breathing.   MD advised treatment with benadryl and pepcid.  If worsening of throat irritation to seek medical treatment
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest pain, Chills, Electrocardiogram abnormal, Headache
Clinical narrative: 1/15/21 starting at 6:00pm:  fever, (102.5 F), stomach pains, shaking chills, chest pain.      Continuing since vaccination: headaches, chest pain, tachycardia, tachycardia during and following exercise,  chest pain,
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tachycardia, Tremor
Clinical narrative: 1/15/21 starting at 6:00pm:  fever, (102.5 F), stomach pains, shaking chills, chest pain.      Continuing since vaccination: headaches, chest pain, tachycardia, tachycardia during and following exercise,  chest pain,
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Chills, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: IMZ given 02/26/24. 02/26 fever started at night .02/27 chills and fever. 02/28 headache, upper arm started hurting, got red and itchy and developed hives and swelling surrounding the injection site. Pt reported the reaction to pharmacy on 02/29/24 1:05 pm. Pt had been taking Tylenol. Recommended that pt start taking Benedryl and notify her doctor about reaction. 3/3/24 called pt. Pt said she called her doctor. Doctor recommended Benadryl and Caladryl and also periodic arm movement . Pt reports improvement 3/3/24 but site is still a bit red and sore. She was advised by her doctor that it would take time to go away completely. Pt says she takes Benadryl at night because it makes her drowsy.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Injection site swelling, Injection site urticaria, Pyrexia
Clinical narrative: IMZ given 02/26/24. 02/26 fever started at night .02/27 chills and fever. 02/28 headache, upper arm started hurting, got red and itchy and developed hives and swelling surrounding the injection site. Pt reported the reaction to pharmacy on 02/29/24 1:05 pm. Pt had been taking Tylenol. Recommended that pt start taking Benedryl and notify her doctor about reaction. 3/3/24 called pt. Pt said she called her doctor. Doctor recommended Benadryl and Caladryl and also periodic arm movement . Pt reports improvement 3/3/24 but site is still a bit red and sore. She was advised by her doctor that it would take time to go away completely. Pt says she takes Benadryl at night because it makes her drowsy.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Arthralgia, Blood pressure increased, Brain fog, COVID-19
Clinical narrative: After a couple days of more intense headaches, those headaches lessened quite a bit, and was feeling better for approximately 1 week or so.  Then a different milder headache/fog started, and slowly got worse (especially as the day went on and I worked & was using my brain a lot more throughout the workday).  I believe in general they refer to this as "brain fog", but I relate it more to having a concussion and similar symptoms (dizzy, mild headaches, can't focus, very anxious, forgetful, sensitive to light/noise, etc).  In addition to this 'fog', I had a lot of trouble sleeping, increased hr/bp, vibration like feelings & pins/needles.  I also had a lot of pain throughout my body/muscles/joints.  I was extremely affected by this for several months & really got worse while working and concentrating.  Things got a little better but then I got Covid 19 in JAN 2022 & it made all my symptoms and new ones much worse.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Dizziness, Headache, Heart rate increased, Hyperacusis
Clinical narrative: After a couple days of more intense headaches, those headaches lessened quite a bit, and was feeling better for approximately 1 week or so.  Then a different milder headache/fog started, and slowly got worse (especially as the day went on and I worked & was using my brain a lot more throughout the workday).  I believe in general they refer to this as "brain fog", but I relate it more to having a concussion and similar symptoms (dizzy, mild headaches, can't focus, very anxious, forgetful, sensitive to light/noise, etc).  In addition to this 'fog', I had a lot of trouble sleeping, increased hr/bp, vibration like feelings & pins/needles.  I also had a lot of pain throughout my body/muscles/joints.  I was extremely affected by this for several months & really got worse while working and concentrating.  Things got a little better but then I got Covid 19 in JAN 2022 & it made all my symptoms and new ones much worse.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Memory impairment, Myalgia, Pain, Paraesthesia, Photophobia
Clinical narrative: After a couple days of more intense headaches, those headaches lessened quite a bit, and was feeling better for approximately 1 week or so.  Then a different milder headache/fog started, and slowly got worse (especially as the day went on and I worked & was using my brain a lot more throughout the workday).  I believe in general they refer to this as "brain fog", but I relate it more to having a concussion and similar symptoms (dizzy, mild headaches, can't focus, very anxious, forgetful, sensitive to light/noise, etc).  In addition to this 'fog', I had a lot of trouble sleeping, increased hr/bp, vibration like feelings & pins/needles.  I also had a lot of pain throughout my body/muscles/joints.  I was extremely affected by this for several months & really got worse while working and concentrating.  Things got a little better but then I got Covid 19 in JAN 2022 & it made all my symptoms and new ones much worse.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Sensory disturbance, Sleep disorder
Clinical narrative: After a couple days of more intense headaches, those headaches lessened quite a bit, and was feeling better for approximately 1 week or so.  Then a different milder headache/fog started, and slowly got worse (especially as the day went on and I worked & was using my brain a lot more throughout the workday).  I believe in general they refer to this as "brain fog", but I relate it more to having a concussion and similar symptoms (dizzy, mild headaches, can't focus, very anxious, forgetful, sensitive to light/noise, etc).  In addition to this 'fog', I had a lot of trouble sleeping, increased hr/bp, vibration like feelings & pins/needles.  I also had a lot of pain throughout my body/muscles/joints.  I was extremely affected by this for several months & really got worse while working and concentrating.  Things got a little better but then I got Covid 19 in JAN 2022 & it made all my symptoms and new ones much worse.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Abdominal pain upper, Asthenia, Back pain, Cerebrovascular accident, Muscular weakness
Clinical narrative: on 1/29, later in day after vaccine given patient began itching  then noticed welts the next morning. She stated she took Benadryl and improved in about 2 days, but then developed back pain, swelling. On 2/2 she called pharmacy to see if symptoms could be related to vaccine...it was suggested she see or get in touch with her md...on 2/4, checked back with patient and she said back pain and swelling got worse and included stomach pain and swelling, with legs and back also giving out....she did say she felt better on 2/4 , but  she had not contacted a md as suggested but planned on reaching out to her md on Monday, 2/5......later in week she informed pharmacy she had a stroke on 2/5
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Pruritus, Swelling, Urticaria
Clinical narrative: on 1/29, later in day after vaccine given patient began itching  then noticed welts the next morning. She stated she took Benadryl and improved in about 2 days, but then developed back pain, swelling. On 2/2 she called pharmacy to see if symptoms could be related to vaccine...it was suggested she see or get in touch with her md...on 2/4, checked back with patient and she said back pain and swelling got worse and included stomach pain and swelling, with legs and back also giving out....she did say she felt better on 2/4 , but  she had not contacted a md as suggested but planned on reaching out to her md on Monday, 2/5......later in week she informed pharmacy she had a stroke on 2/5
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Muscle spasms, Myalgia
Clinical narrative: Fatigue, extreme muscle pain and spasms
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Feeling drunk
Clinical narrative: patient felt dizzy, stated he felt drunk
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood sodium decreased, Blood test, Computerised tomogram, Electrocardiogram
Clinical narrative: Trigeminal Neuralgia-Emergency room visit on 11/25/2021 due to facial swelling, numbness across face from forehead, across nose and down to chin on the right side. Low sodium, bloodwork, UA, Ct scan to rule out stroke. Started on Tegretol medication. On Dec, 22,2021 back to emergency room for atrial fibrillation and started on Eliquis. Did not have atrial fib in ER visit on 11/25/2021.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Swelling face, Trigeminal neuralgia, Urine analysis
Clinical narrative: Trigeminal Neuralgia-Emergency room visit on 11/25/2021 due to facial swelling, numbness across face from forehead, across nose and down to chin on the right side. Low sodium, bloodwork, UA, Ct scan to rule out stroke. Started on Tegretol medication. On Dec, 22,2021 back to emergency room for atrial fibrillation and started on Eliquis. Did not have atrial fib in ER visit on 11/25/2021.
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Arthritis, Condition aggravated, Mobility decreased
Clinical narrative: Patient states she has had arthritis in her hand for years, but after she received the RSV vaccine, it significantly worsened to the point where she can barely move and use her left hand. Vaccine was administered in left arm. No problems reported with right hand.
Age: 72.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain, Product administered at inappropriate site
Clinical narrative: Pt was vaccinated on 3/1/2024 at our pharmacy on her left arm.  It appeared the injection site was far lower than her left deltoid area on the lower part of her left arm close to her elbow.  Patient experienced injection site pain (more severe than expected) and redness on the injection area.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4
Symptoms: Injection site erythema, Injection site pain, Vaccination site induration
Clinical narrative: redness, pain, and firmness at vaccine site
Age: 28.0
Sex: M
Vaccine: MNQ, TYP, UNK
Symptoms: Abdominal pain, Chills, Diarrhoea, Hyperhidrosis, Nausea
Clinical narrative: High fever, chills and sweats, body aches, nausea, vomiting, diarrhea, abdominal pain over several days. Treated with acetaminophen, ibuprofen, ondansetron.
Age: 28.0
Sex: M
Vaccine: MNQ, TYP, UNK
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: High fever, chills and sweats, body aches, nausea, vomiting, diarrhea, abdominal pain over several days. Treated with acetaminophen, ibuprofen, ondansetron.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: large red circles and hives around injection site.
Age: 43.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: Extra dose administered
Clinical narrative: Patient received a second dose of his COVID19 and Influenza vaccine. There was no noted allergic reaction or adverse outcome. Patient had received a dose of COVID19 and Influenza approximately 4 months prior.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Alcoholic, Back pain, Depression, Economic problem, Gait disturbance
Clinical narrative: TWO BACK SURGERY; ADDICTION; SUICIDE ATTEMPT; CHRONIC PAIN; This solicited report received from a patient via Agency; concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  No past medical history or concurrent conditions were reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (Dose number in series 1)(suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 01-AUG-2022 for covid-19 prophylaxis.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The patient reported that the "The Janssen Covid19 vaccine that I was poisoned with in August of 2022 cost me Two back surgeries, addiction, chronic pain, loss of kids, suicide att" (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the two back surgery, addiction, suicide attempt and chronic pain was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and two back surgery, addiction, suicide attempt, and chronic pain was not related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  Spinal operation, Dependence : The events have an unknown/unclear temporal relationship, are unlabeled, and have unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically:  NATURE OF THE EVENT . Therefore, these events are considered INCONSIETENT with vaccine administration Suicide attempt: The events have an unknown/unclear temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. Therefore, these events are considered inconsistent with vaccine  administration
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Loss of personal independence in daily activities, Pain, Peroneal nerve palsy, Quality of life decreased
Clinical narrative: TWO BACK SURGERY; ADDICTION; SUICIDE ATTEMPT; CHRONIC PAIN; This solicited report received from a patient via Agency; concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  No past medical history or concurrent conditions were reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (Dose number in series 1)(suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 01-AUG-2022 for covid-19 prophylaxis.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The patient reported that the "The Janssen Covid19 vaccine that I was poisoned with in August of 2022 cost me Two back surgeries, addiction, chronic pain, loss of kids, suicide att" (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the two back surgery, addiction, suicide attempt and chronic pain was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and two back surgery, addiction, suicide attempt, and chronic pain was not related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  Spinal operation, Dependence : The events have an unknown/unclear temporal relationship, are unlabeled, and have unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically:  NATURE OF THE EVENT . Therefore, these events are considered INCONSIETENT with vaccine administration Suicide attempt: The events have an unknown/unclear temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. Therefore, these events are considered inconsistent with vaccine  administration
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Screaming, Suicide attempt, Surgery
Clinical narrative: TWO BACK SURGERY; ADDICTION; SUICIDE ATTEMPT; CHRONIC PAIN; This solicited report received from a patient via Agency; concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  No past medical history or concurrent conditions were reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (Dose number in series 1)(suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 01-AUG-2022 for covid-19 prophylaxis.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The patient reported that the "The Janssen Covid19 vaccine that I was poisoned with in August of 2022 cost me Two back surgeries, addiction, chronic pain, loss of kids, suicide att" (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the two back surgery, addiction, suicide attempt and chronic pain was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and two back surgery, addiction, suicide attempt, and chronic pain was not related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  Spinal operation, Dependence : The events have an unknown/unclear temporal relationship, are unlabeled, and have unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically:  NATURE OF THE EVENT . Therefore, these events are considered INCONSIETENT with vaccine administration Suicide attempt: The events have an unknown/unclear temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. Therefore, these events are considered inconsistent with vaccine  administration
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dependence, Pain, Spinal operation, Suicide attempt
Clinical narrative: TWO BACK SURGERY; ADDICTION; SUICIDE ATTEMPT; CHRONIC PAIN; This solicited report received from a patient via Agency; concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  No past medical history or concurrent conditions were reported. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (Dose number in series 1)(suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 01-AUG-2022 for covid-19 prophylaxis.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The patient reported that the "The Janssen Covid19 vaccine that I was poisoned with in August of 2022 cost me Two back surgeries, addiction, chronic pain, loss of kids, suicide att" (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the two back surgery, addiction, suicide attempt and chronic pain was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and two back surgery, addiction, suicide attempt, and chronic pain was not related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  Spinal operation, Dependence : The events have an unknown/unclear temporal relationship, are unlabeled, and have unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically:  NATURE OF THE EVENT . Therefore, these events are considered INCONSIETENT with vaccine administration Suicide attempt: The events have an unknown/unclear temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. Therefore, these events are considered inconsistent with vaccine  administration
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE; patient received their first dose of ROTATEQ at age 4-months; This spontaneous report was received from a medical assistant and refers to a 4-month-old patient of unknown gender.  The patient's medical history, concurrent conditions, previous drug allergies or reactions and concomitant therapies were not reported.  On 08-FEB-2024, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), oral liquid, strength reported as "VIAL 2", (lot #X021032, expiration date: 09-MAR-2025, which is a valid lot number for rotavirus vaccine, live, oral, pentavalent (ROTATEQ)), administered for prophylaxis (route of administration was not provided) (Product administered to patient of inappropriate age). No additional adverse event was reported.
Age: 10.0
Sex: F
Vaccine: FLUN4
Symptoms: Influenza B virus test positive
Clinical narrative: PATIENT TESTED POSITIVE FOR FLUB 12 DAYS AFTER RECEIVING VACCINATION.; A spontaneous report has been received from a physician. The report concerns a female patient of Other ethnic origin (age 10 years, height 57 in, weight 102 lb).    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number TJ2944B) (expiration date 18-MAR-2024) once/single administration, via nasal route, on an unknown date.     No malfunction has been reported for FLUMIST QUADRIVALENT.    On 15-FEB-2024, the patient experienced patient tested positive for flub 12 days after receiving vaccination. (preferred term: Influenza).     The outcome of the event was unknown.    The event was considered non-serious.     Device Information:       Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: took shingles vaccine and then got shingles/suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: took shingles vaccine and then got shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-Feb-2024 This case was reported by a patient via interactive digital media. The reporter reported that his or her sibling received Shingrix vaccine and then experienced shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available. This case was linked with US2024AMR025305 reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR025305:Same reporter different patient
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the booster both of them and still got shingles/suspected Vaccination failure; still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (unknown arm) and the 1st dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: had the booster both of them and still got shingles/suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 26-FEB-2024 A friend who had the booster both of them and still got shingles. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-Feb-2024 This case was reported by consumer via interactive digital media. The reporter stated that everybody he knew who got the vaccine had shingles a few days later. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.