chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, C-reactive protein increased, Joint stiffness, Lymphocyte count increased, Musculoskeletal stiffness
Clinical narrative: High levels of pain and stiffness in joints, tendon anchorages and muscles. Initially concentrated in hips; migrating to shoulders joints, deltoids, trapezoid, front of pelvis, buttocks.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Red blood cell sedimentation rate increased, Rheumatoid factor negative, Tendon pain
Clinical narrative: High levels of pain and stiffness in joints, tendon anchorages and muscles. Initially concentrated in hips; migrating to shoulders joints, deltoids, trapezoid, front of pelvis, buttocks.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests normal, Tinnitus
Clinical narrative: None immediately after the shot. But I noticed the ringing on my left ear started gradually and it's been several weeks and even with steroids it won't go away.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram, Pallor
Clinical narrative: At 6:46 pm on 06/16/2021, 23 year old male patient was vaccinated for his first COVID vaccine by Pfizer. Within 30 seconds, while getting up, he felt dizzy and sat back down. Cool towel was provided, and head was supported. He turned extremely pale. Store PIC arrived. We helped patient lay on the floor of the clinic room. He had a pulse, 911 was called and paramedics arrived. They checked vitals and performed EKG, determined he was alright. Patient waited in waiting area for 45 minutes, was provided a Gatorade drink and glucose tablet after he was fully conscious. Then he drove home (called at 8:45pm) to check on patient, he was fine.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram thorax, Electrocardiogram, Laboratory test, Pericarditis
Clinical narrative: Pericarditis
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Alanine aminotransferase increased, Aspartate aminotransferase increased, Chest X-ray normal, Chest pain
Clinical narrative: See above. Received COVID 2 June 09 at pharmacy. Developed acute onset lower chest pain and abd. pain. Eval at emergency room showed negative troponin, CBC, EKG, CXR. Pt with elevated lipase to mid 500's and slightly bumped AST and ALT. Patient responded well to IVF with lipase decrease to 50. AST and ALT improved, but still slightly above normal. had normal AST and ALT on routine check 05/2021 (On Accutane)
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Full blood count normal, Lipase increased, Troponin normal
Clinical narrative: See above. Received COVID 2 June 09 at pharmacy. Developed acute onset lower chest pain and abd. pain. Eval at emergency room showed negative troponin, CBC, EKG, CXR. Pt with elevated lipase to mid 500's and slightly bumped AST and ALT. Patient responded well to IVF with lipase decrease to 50. AST and ALT improved, but still slightly above normal. had normal AST and ALT on routine check 05/2021 (On Accutane)
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Chest pain
Clinical narrative: 2 weeks after the shot I had a scary night where I had severe chest pain. I sat up for a few hours hoping I wasn't having a heart attack and taking water and tums. I have never had chest pain before or since. I was very concerned and wondered if it was the vaccine. I didn't have anything unusual to eat or drink. I was happy when it finally resolved that same night.  I also experienced Bell's Palsy 2 months after the vaccine. (~June 1st) I have never experienced Bell's Palsy. I am not sure if either of these events were related to the vaccine, but I have no intention of getting a yearly covid or flu vaccine now that I have Bell's Palsy. It is terrible, and I'm not taking ANY chance of getting this again even if that means I get the flu and covid yearly. I placed my trust in science, and not I am not sure I made the right choice. Although I hope my facial movement and ability to use my lips and face come back, I realize that some never recover.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bell's palsy, Blood test, Chills, Fatigue
Clinical narrative: Initial 48 hours of fever, chills, fatigue 1-2 weeks post injection, Bell's palsy on left side of face 4+ months (enduring), fatigue, joints ache (hips, wrists, elbows, shoulders)
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Initial 48 hours of fever, chills, fatigue 1-2 weeks post injection, Bell's palsy on left side of face 4+ months (enduring), fatigue, joints ache (hips, wrists, elbows, shoulders)
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received 2nd dose Moderna 3 weeks after 1st dose.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received 2nd dose Moderna 3 weeks after 1st dose.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: Patient has a knot at injection sight, with large area of swelling, redness and warmth. (Red area width is as large as a new roll of toilet paper.)
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Face injury, Fall, Loss of consciousness
Clinical narrative: 24 hour after the shot patient lost consciousness and collapsed on the floor and bruised his face
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Fatigue, Initial insomnia, Paraesthesia
Clinical narrative: Tinnitus- since vaccine I?ve have a constant ringing in my ears , hard to fall asleep and then have nighttime awakenings. Shortness of breath, chest pain, tingling of my left side of the face , fatigue.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Tinnitus
Clinical narrative: Tinnitus- since vaccine I?ve have a constant ringing in my ears , hard to fall asleep and then have nighttime awakenings. Shortness of breath, chest pain, tingling of my left side of the face , fatigue.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pain in extremity, Pyrexia, Throat irritation
Clinical narrative: Had nausea, fatigue, fever, sore arm, itchy throat under left ear  etc. Later buzzing sound noticed constantly, in the left ear, after May 21st. Tinnitus
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Had nausea, fatigue, fever, sore arm, itchy throat under left ear  etc. Later buzzing sound noticed constantly, in the left ear, after May 21st. Tinnitus
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling and slight pain at injection site
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Rash, Tinnitus
Clinical narrative: Severe tinnitis 06/16/2021 Inflammation and rash left upper arm next day and still continues
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain, Abdominal pain upper, Alanine aminotransferase normal, Anion gap
Clinical narrative: acute pancreatitis ; Pt awoke at 4 AM day after her COVID vaccine with abdominal pain. Pain abided some and she was able to fall back asleep.  When she woke up in the morning she had crampy pain in the epigastric abdominal area.  Pain is constant, worsened some with laying down and improved with sitting up.  She feels like she has some mild difficulty breathing when she is lying flat.  She has not been able to eat much because eating makes her feel like her stomach is going to explode.  She is barely keeping down much water due to pain. She denies any nausea or vomiting.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Aspartate aminotransferase increased, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin increased, Blood calcium
Clinical narrative: acute pancreatitis ; Pt awoke at 4 AM day after her COVID vaccine with abdominal pain. Pain abided some and she was able to fall back asleep.  When she woke up in the morning she had crampy pain in the epigastric abdominal area.  Pain is constant, worsened some with laying down and improved with sitting up.  She feels like she has some mild difficulty breathing when she is lying flat.  She has not been able to eat much because eating makes her feel like her stomach is going to explode.  She is barely keeping down much water due to pain. She denies any nausea or vomiting.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Blood chloride normal, Blood creatinine normal, Blood glucose normal, Blood osmolarity normal, Blood potassium normal
Clinical narrative: acute pancreatitis ; Pt awoke at 4 AM day after her COVID vaccine with abdominal pain. Pain abided some and she was able to fall back asleep.  When she woke up in the morning she had crampy pain in the epigastric abdominal area.  Pain is constant, worsened some with laying down and improved with sitting up.  She feels like she has some mild difficulty breathing when she is lying flat.  She has not been able to eat much because eating makes her feel like her stomach is going to explode.  She is barely keeping down much water due to pain. She denies any nausea or vomiting.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Blood sodium normal, Blood urea normal, Carbon dioxide normal, Decreased appetite, Dyspnoea
Clinical narrative: acute pancreatitis ; Pt awoke at 4 AM day after her COVID vaccine with abdominal pain. Pain abided some and she was able to fall back asleep.  When she woke up in the morning she had crampy pain in the epigastric abdominal area.  Pain is constant, worsened some with laying down and improved with sitting up.  She feels like she has some mild difficulty breathing when she is lying flat.  She has not been able to eat much because eating makes her feel like her stomach is going to explode.  She is barely keeping down much water due to pain. She denies any nausea or vomiting.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Haematocrit increased, Haemoglobin normal, Lipase increased, Platelet count normal, Pregnancy test negative
Clinical narrative: acute pancreatitis ; Pt awoke at 4 AM day after her COVID vaccine with abdominal pain. Pain abided some and she was able to fall back asleep.  When she woke up in the morning she had crampy pain in the epigastric abdominal area.  Pain is constant, worsened some with laying down and improved with sitting up.  She feels like she has some mild difficulty breathing when she is lying flat.  She has not been able to eat much because eating makes her feel like her stomach is going to explode.  She is barely keeping down much water due to pain. She denies any nausea or vomiting.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Protein total increased, Red blood cell count normal, Sleep disorder, White blood cell count normal
Clinical narrative: acute pancreatitis ; Pt awoke at 4 AM day after her COVID vaccine with abdominal pain. Pain abided some and she was able to fall back asleep.  When she woke up in the morning she had crampy pain in the epigastric abdominal area.  Pain is constant, worsened some with laying down and improved with sitting up.  She feels like she has some mild difficulty breathing when she is lying flat.  She has not been able to eat much because eating makes her feel like her stomach is going to explode.  She is barely keeping down much water due to pain. She denies any nausea or vomiting.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: Severe violently shaking/chills and fever
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Excruciating headache and mild fever for nearly 24 hours
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Dizziness, Fibrin D dimer increased, Gait inability, Joint swelling
Clinical narrative: 30 days after the vaccine was administered started to get swelling of ankles and edema. Painful not able to walk on. Diet or exercise did not change.  Heart flutters and dizziness may times.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral, Pain
Clinical narrative: 30 days after the vaccine was administered started to get swelling of ankles and edema. Painful not able to walk on. Diet or exercise did not change.  Heart flutters and dizziness may times.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Angioedema, Asthma, Blood pressure decreased, Chapped lips
Clinical narrative: Lips went totally white and chapped, burning all around my lips began (day after shot) Burning got worse the next day around my mouth, lips got even more chapped (two days after) Ate something I've never reacted to before for dinner after dinner my entire face broke out in rash, my lips swelled up, my throat swelled, blood pressure dropped, heart raced, and I was about to faint (so lay down). Stopped reaction with two benedryl.  (three days later) - note this sort of thing has happened before after certain drugs when taken in aggregate over days (Malarone, Gabapentin)   For next 4 weeks I had a host of symptoms that were unliveable including (note: some have lasted longer) - Fainting spells, low blood pressure - Full body nerve pain and facial nerve pains that were very intense  - Dry mouth - Tachycardia at night (RAPID heart beat) - Lip angioedema usually in the morning only to be controlled with antihsitimines (still the case months later) - Massive diarrhea usually in the morning with lip angiodema   - Trouble breathing and chest pain and wheezing, one massive asthma attack  Treatment:   Antihistimines at first, but made POTS too bad so went off (helped swelling though) Steroid inhaler to help me breath  Steroids (prednisone) burst in late April/early May - moderately helpful when on the course, but made digestive issues worse and acid reflux worse, lip burning and swelling came back after i went off this  Post-Steroid burst: - Still having lip burning - Still having horrible dry mouth - Still trouble breathing and wheezing and shortness of breath - horrible digestive issues (acid reflux) - nerve pain   Treatment post steroids  - treated my MCAS  - Quercetin, Vitamin C, and NAC, eventually found compounded allegra to work without the dysautonomia side effects and now on 180mg / day has helped a lot of these symptoms - Using Cromolyn  Sodium nebulized for the breathing issues and chest pain - helping a lot for this!  With the MCAS drugs I'm improved, but I still have the following (June 16) - horrible acid reflux all day every day (doesn't matter what I eat) - Dry mouth  - I also have lip burning that is pretty constant (although swelling is down) - Moderate wheezing (but its better than before) - Moderate facial pain (but better than before) - Headaches (pretty sure it's a side effect of my meds)
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Diarrhoea, Dizziness, Dry mouth
Clinical narrative: Lips went totally white and chapped, burning all around my lips began (day after shot) Burning got worse the next day around my mouth, lips got even more chapped (two days after) Ate something I've never reacted to before for dinner after dinner my entire face broke out in rash, my lips swelled up, my throat swelled, blood pressure dropped, heart raced, and I was about to faint (so lay down). Stopped reaction with two benedryl.  (three days later) - note this sort of thing has happened before after certain drugs when taken in aggregate over days (Malarone, Gabapentin)   For next 4 weeks I had a host of symptoms that were unliveable including (note: some have lasted longer) - Fainting spells, low blood pressure - Full body nerve pain and facial nerve pains that were very intense  - Dry mouth - Tachycardia at night (RAPID heart beat) - Lip angioedema usually in the morning only to be controlled with antihsitimines (still the case months later) - Massive diarrhea usually in the morning with lip angiodema   - Trouble breathing and chest pain and wheezing, one massive asthma attack  Treatment:   Antihistimines at first, but made POTS too bad so went off (helped swelling though) Steroid inhaler to help me breath  Steroids (prednisone) burst in late April/early May - moderately helpful when on the course, but made digestive issues worse and acid reflux worse, lip burning and swelling came back after i went off this  Post-Steroid burst: - Still having lip burning - Still having horrible dry mouth - Still trouble breathing and wheezing and shortness of breath - horrible digestive issues (acid reflux) - nerve pain   Treatment post steroids  - treated my MCAS  - Quercetin, Vitamin C, and NAC, eventually found compounded allegra to work without the dysautonomia side effects and now on 180mg / day has helped a lot of these symptoms - Using Cromolyn  Sodium nebulized for the breathing issues and chest pain - helping a lot for this!  With the MCAS drugs I'm improved, but I still have the following (June 16) - horrible acid reflux all day every day (doesn't matter what I eat) - Dry mouth  - I also have lip burning that is pretty constant (although swelling is down) - Moderate wheezing (but its better than before) - Moderate facial pain (but better than before) - Headaches (pretty sure it's a side effect of my meds)
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Gastrooesophageal reflux disease, Laboratory test, Lip discolouration, Lip swelling
Clinical narrative: Lips went totally white and chapped, burning all around my lips began (day after shot) Burning got worse the next day around my mouth, lips got even more chapped (two days after) Ate something I've never reacted to before for dinner after dinner my entire face broke out in rash, my lips swelled up, my throat swelled, blood pressure dropped, heart raced, and I was about to faint (so lay down). Stopped reaction with two benedryl.  (three days later) - note this sort of thing has happened before after certain drugs when taken in aggregate over days (Malarone, Gabapentin)   For next 4 weeks I had a host of symptoms that were unliveable including (note: some have lasted longer) - Fainting spells, low blood pressure - Full body nerve pain and facial nerve pains that were very intense  - Dry mouth - Tachycardia at night (RAPID heart beat) - Lip angioedema usually in the morning only to be controlled with antihsitimines (still the case months later) - Massive diarrhea usually in the morning with lip angiodema   - Trouble breathing and chest pain and wheezing, one massive asthma attack  Treatment:   Antihistimines at first, but made POTS too bad so went off (helped swelling though) Steroid inhaler to help me breath  Steroids (prednisone) burst in late April/early May - moderately helpful when on the course, but made digestive issues worse and acid reflux worse, lip burning and swelling came back after i went off this  Post-Steroid burst: - Still having lip burning - Still having horrible dry mouth - Still trouble breathing and wheezing and shortness of breath - horrible digestive issues (acid reflux) - nerve pain   Treatment post steroids  - treated my MCAS  - Quercetin, Vitamin C, and NAC, eventually found compounded allegra to work without the dysautonomia side effects and now on 180mg / day has helped a lot of these symptoms - Using Cromolyn  Sodium nebulized for the breathing issues and chest pain - helping a lot for this!  With the MCAS drugs I'm improved, but I still have the following (June 16) - horrible acid reflux all day every day (doesn't matter what I eat) - Dry mouth  - I also have lip burning that is pretty constant (although swelling is down) - Moderate wheezing (but its better than before) - Moderate facial pain (but better than before) - Headaches (pretty sure it's a side effect of my meds)
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Oral discomfort, Palpitations, Pharyngeal swelling, Pulmonary function test
Clinical narrative: Lips went totally white and chapped, burning all around my lips began (day after shot) Burning got worse the next day around my mouth, lips got even more chapped (two days after) Ate something I've never reacted to before for dinner after dinner my entire face broke out in rash, my lips swelled up, my throat swelled, blood pressure dropped, heart raced, and I was about to faint (so lay down). Stopped reaction with two benedryl.  (three days later) - note this sort of thing has happened before after certain drugs when taken in aggregate over days (Malarone, Gabapentin)   For next 4 weeks I had a host of symptoms that were unliveable including (note: some have lasted longer) - Fainting spells, low blood pressure - Full body nerve pain and facial nerve pains that were very intense  - Dry mouth - Tachycardia at night (RAPID heart beat) - Lip angioedema usually in the morning only to be controlled with antihsitimines (still the case months later) - Massive diarrhea usually in the morning with lip angiodema   - Trouble breathing and chest pain and wheezing, one massive asthma attack  Treatment:   Antihistimines at first, but made POTS too bad so went off (helped swelling though) Steroid inhaler to help me breath  Steroids (prednisone) burst in late April/early May - moderately helpful when on the course, but made digestive issues worse and acid reflux worse, lip burning and swelling came back after i went off this  Post-Steroid burst: - Still having lip burning - Still having horrible dry mouth - Still trouble breathing and wheezing and shortness of breath - horrible digestive issues (acid reflux) - nerve pain   Treatment post steroids  - treated my MCAS  - Quercetin, Vitamin C, and NAC, eventually found compounded allegra to work without the dysautonomia side effects and now on 180mg / day has helped a lot of these symptoms - Using Cromolyn  Sodium nebulized for the breathing issues and chest pain - helping a lot for this!  With the MCAS drugs I'm improved, but I still have the following (June 16) - horrible acid reflux all day every day (doesn't matter what I eat) - Dry mouth  - I also have lip burning that is pretty constant (although swelling is down) - Moderate wheezing (but its better than before) - Moderate facial pain (but better than before) - Headaches (pretty sure it's a side effect of my meds)
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Syncope, Tachycardia, Vitamin D decreased, Wheezing
Clinical narrative: Lips went totally white and chapped, burning all around my lips began (day after shot) Burning got worse the next day around my mouth, lips got even more chapped (two days after) Ate something I've never reacted to before for dinner after dinner my entire face broke out in rash, my lips swelled up, my throat swelled, blood pressure dropped, heart raced, and I was about to faint (so lay down). Stopped reaction with two benedryl.  (three days later) - note this sort of thing has happened before after certain drugs when taken in aggregate over days (Malarone, Gabapentin)   For next 4 weeks I had a host of symptoms that were unliveable including (note: some have lasted longer) - Fainting spells, low blood pressure - Full body nerve pain and facial nerve pains that were very intense  - Dry mouth - Tachycardia at night (RAPID heart beat) - Lip angioedema usually in the morning only to be controlled with antihsitimines (still the case months later) - Massive diarrhea usually in the morning with lip angiodema   - Trouble breathing and chest pain and wheezing, one massive asthma attack  Treatment:   Antihistimines at first, but made POTS too bad so went off (helped swelling though) Steroid inhaler to help me breath  Steroids (prednisone) burst in late April/early May - moderately helpful when on the course, but made digestive issues worse and acid reflux worse, lip burning and swelling came back after i went off this  Post-Steroid burst: - Still having lip burning - Still having horrible dry mouth - Still trouble breathing and wheezing and shortness of breath - horrible digestive issues (acid reflux) - nerve pain   Treatment post steroids  - treated my MCAS  - Quercetin, Vitamin C, and NAC, eventually found compounded allegra to work without the dysautonomia side effects and now on 180mg / day has helped a lot of these symptoms - Using Cromolyn  Sodium nebulized for the breathing issues and chest pain - helping a lot for this!  With the MCAS drugs I'm improved, but I still have the following (June 16) - horrible acid reflux all day every day (doesn't matter what I eat) - Dry mouth  - I also have lip burning that is pretty constant (although swelling is down) - Moderate wheezing (but its better than before) - Moderate facial pain (but better than before) - Headaches (pretty sure it's a side effect of my meds)
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Back pain, Fatigue, Headache, Loss of personal independence in daily activities
Clinical narrative: Nausea roughly an hour after vaccine, then fever 100.6 one day after vaccine, extreme fatigue resulting in having difficulty caring for my children, sore arm, headache, back and neck pain that required ibuprofen to be able to move without pain. Those effects only lasted about 24 hours. Then, the next day, I awoke with a swollen lymph node in my left armpit which has been causing pain all day, if my arm is at my side, requiring ibuprofen and cold compresses to treat.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Nausea, Neck pain, Pain, Pain in extremity
Clinical narrative: Nausea roughly an hour after vaccine, then fever 100.6 one day after vaccine, extreme fatigue resulting in having difficulty caring for my children, sore arm, headache, back and neck pain that required ibuprofen to be able to move without pain. Those effects only lasted about 24 hours. Then, the next day, I awoke with a swollen lymph node in my left armpit which has been causing pain all day, if my arm is at my side, requiring ibuprofen and cold compresses to treat.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Nausea roughly an hour after vaccine, then fever 100.6 one day after vaccine, extreme fatigue resulting in having difficulty caring for my children, sore arm, headache, back and neck pain that required ibuprofen to be able to move without pain. Those effects only lasted about 24 hours. Then, the next day, I awoke with a swollen lymph node in my left armpit which has been causing pain all day, if my arm is at my side, requiring ibuprofen and cold compresses to treat.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Suspected anaphylactic reaction managed with epinephrine, solumedrol, Benadryl
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Dehydration, Dizziness, Dyspnoea, Electrocardiogram normal
Clinical narrative: Suspected anaphylactic reaction managed with epinephrine, solumedrol, Benadryl
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mucosal dryness, Nausea, Paraesthesia, Periorbital oedema, Tryptase
Clinical narrative: Suspected anaphylactic reaction managed with epinephrine, solumedrol, Benadryl
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccine positive rechallenge
Clinical narrative: Suspected anaphylactic reaction managed with epinephrine, solumedrol, Benadryl
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Pallor
Clinical narrative: 5 minutes from getting the vaccine, patient felt dizzy and looked very pale, there was remarkable pallor on the patient's face. skin looked pale.. initial blood pressure reading was 140/72. blood pressure upon discharge was recorded @ 128/82. Temp was 97.8 'C. Patient was given glucose tablets and  few seconds after, patient felt better, skin suddenly turned pinkish..  patient recovered. Patient was monitored for 30 minutes, and stable upon discharge.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Irregular breathing, Pleural effusion
Clinical narrative: Plural Effusion left lung, and Cough diagnosed by Dr. on 06/16/2021.  Both symptoms started approximately 4 days after 2nd COVID 19 vaccination on 06/07/2021.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Mobility decreased, Tension
Clinical narrative: Swelling, tension, and pain in both knees. Sudden onset. Sharp decrease  of flexibility and mobility.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Depression, Feeling abnormal, Headache, Impaired work ability
Clinical narrative: Fever, headache, nausea and brain fog. Suppressed energy, mood and stamina. Depression. I am a cyclist and before this vaccine I was extremely healthy. After my second shot the above listed symptoms were magnified 10 fold plus muscular burning and aching. I missed 6 days of work and to this day I am suffering a huge drop in energy, mood and stamina. I feel foolish for taking this vaccine. Shame on you all.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mood altered, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever, headache, nausea and brain fog. Suppressed energy, mood and stamina. Depression. I am a cyclist and before this vaccine I was extremely healthy. After my second shot the above listed symptoms were magnified 10 fold plus muscular burning and aching. I missed 6 days of work and to this day I am suffering a huge drop in energy, mood and stamina. I feel foolish for taking this vaccine. Shame on you all.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Electrocardiogram, Palpitations, Supraventricular extrasystoles
Clinical narrative: In March I developed the worst heart palpitations I have ever had in my life. I was having a flutter every other beat with an atrial premature contraction.  I have since had to be put on isopropyl medication, magnesium beta blockers.  I have never had this problem with my heart
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Burning sensation, Headache, Pain
Clinical narrative: Full body inflammation (mostly joints) and headache during sleep, mostly when waking. Went away completely after 3 days. Movement or ice against the back of neck eased burning.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dysmenorrhoea
Clinical narrative: General menstruation symptoms (pain, bloating, cramps) 3x worse and heavier
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Oral herpes
Clinical narrative: "Cold sore" shingles outbreak in the lip, relatively large several hours after receiving vaccine second dose; "Cold sore" shingles outbreak in the lip, relatively large several hours after receiving vaccine second dose; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0170, Expiration date: unknown), via unspecified route, administered in left arm on 23Apr2021 09:00 AM (at the age of 48-year-old) as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. Patient previously received the first dose of BNT162B2 on 31Mar2021at 09:00 am (batch/Lot no: ER8734) at left arm for covid 19 immunization. The patient medical history and concomitant medications were not reported. On 23Apr2021 at 18:00, after the vaccination, the patient experienced Cold sore- shingles outbreak in the lip, relatively large several hours after receiving vaccine second dose. Prior and since vaccination patient has not been tested or diagnosed for covid-19. No other vaccines received within 4 weeks to covid vaccine. No treatment received. The outcome of the events was recovering.  No follow-up attempts possible. No further information expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Mental fatigue, Pain
Clinical narrative: mental fatigue; Pain began in the shoulder and over the days it moved to the scapula, neck and head; unusual physical fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 07Apr2021 09:00 as 1st dose, single dose (at the age of 44-years-old) for covid-19 immunization. Medical history include allergy to Aspirin (e.c.) and raw fish. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On an unspecified date in 2021, the patient had pain began in the shoulder and over the days it moved to the scapula, neck, and head, only on the left side (arm in which it was injected). Unusual physical and mental fatigue that appeared after five days and lasted a week and a half. The patient was treated with anti-inflammatory medicine. On an unspecified date in 2021, the patient was recovered from the events.  Follow-up attempts are needed; information about lot/batch number has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: I put the vaccines in our EMR (billing system). I noted the vaccine (MMR) was expired; no further AEs reported; expired dose of MMR II; This spontaneous report has been received from a nurse referring to a 4-year-old male patient. The patient's pertinent medical history, drug reactions or allergies were not reported. The patient's concomitant vaccines included: second dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) and the fifth dose of diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX).  On 13-MAY-2021, the patient was vaccinated during routine school vaccination with the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rha) (M-M-R II) 1 subcutaneous injection for prophylaxis (formulation, concentration, anatomical site of vaccination were not reported; lot number S007813 and expiration date 14-MAR-2021, which were verified as valid).   It was noted after the administration of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) that the vaccine had expired (expired product administered), (wrong technique in product usage process). The patient's response was normal, drug treatment was not required, and there were no additional adverse events to report.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported; Expired vaccine used; This spontaneous report was received from a medical assistant referring to an 8-week-old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.    On 17-MAY-2021, the patient was vaccinated with an expiration dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength was not reported; dose: 2 milliliter, lot # 1661000, expiration date was 13-MAY-2021) orally for prophylaxis. This dose was found supported by memo with no previous temperature excursions. No additional information given. No additional adverse events were reported.
Age: 0.42
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE reported. No PQC; the vaccine was administered while out of recommended range.; This spontaneous report was received from a registered nurse referring to a 5-month-old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 15-MAY-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength was not reported; dose: 2 milliliter, lot # 1694410, expiration date was 19-DEC-2021) orally for prophylaxis. The vaccine was out of recommended temperature range (product storage error). The vaccines were stored in a temperature 89 Fahrenheit (F) with a time frame 24 hours. There was no previous temperature excursion. Data logger was involved. No additional adverse event (AE) or product quality complaint (PQC) was reported.
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; patient received a dose of VARlVAX and M-M-R II that has experienced an ongoing temperature excursion; This spontaneous report was received from a medical assistant and nurse who refers to a 12-month-old (also reported as 13-month-old) female patient. The patient had no known allergies. Information regarding pertinent medical history was not provided. The patient had 2 siblings. The patient birth weight was reported as 7 lbs and 4.2 oz. On 14-MAY-2021, the patient received following vaccines (reported as concomitant): hepatitis a vaccine (reported as HEP A), pneumococcal vaccine conj 13v (crm197)(PREVNAR 13) and diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL).  On the same date, the patient was vaccinated with improperly stored: measles (+) mumps (+) rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot # S039319, expiry date 04-DEC-2021, second dose, subcutaneously in the left vastus lateralis, for prophylaxis; and with varicella virus vaccine live (oka/merck) (VARIVAX) lot # T029535, expiry date 01-SEP-2022, second dose, subcutaneously in the right vastus lateralis, for prophylaxis (formulation, concentration, dose, frequency for both vaccines were not reported). Digital data logger was involved. The suspect vaccines underwent the temperature excursion, the highest temperature reported was 114.8 degrees of Fahrenheit (F), and the temperature during the time of administration was unknown. The temperature excursion started on 13-MAY-2021 at 09:15 and vaccines were not back in the proper range (time frame of excursion was reported as ongoing). There was no previous temperature excursion. Patient's parents were notified at vaccines excursion and they did not report any adverse events the patient experienced (no adverse event). The patient would be re-vaccinated within appropriate timeframe. No product quality complaint (PQC) was involved.
Sex: F
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: She has had reactions to other vaccines, such as the Pneumococcal vaccine.; This spontaneous report was received from a 74 year old female patient with bronchiectasis and atypical mycobacterial infection.      On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis.    On an unknown date, the patient experienced vaccine reaction (vaccination complication).  At the time of the report, the outcome of vaccination complication was unknown.        The patient did not mention the causality assessment between the event and pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown)vacciantion.; Sender's Comments:  US-009507513-2106USA003286:
Sex: U
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported.; ROTATEQ, M-M-R II and VAQTA that underwent a temperature excursion were administered.; This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not provided.   On 25-MAY-2021, the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHa) (M-M-R II) (lot # T007232, expiration date reported as 26-FEB-2022, but upon internal validation established as 27-FEB-2022) (exact dose, route of administration and anatomical location were not provided) and hepatitis A vaccine, inactivated (VAQTA) (lot # T035720, expiration date reported as 14-APR-2022, but upon internal validation established as 15-APR-2022) (exact dose, route of administration, anatomical location were not provided) for prophylaxis. The administered doses were stored in temperature above 46 Fahrenheit degrees (F) (46.8 F) for 30 minutes. No previous temperature excursion occurred. Digital data logger was involved. No additional adverse effect reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035720; expirationdate: 15-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2106USA003900: US-009507513-2106USA003899: US-009507513-2106USA003901:
Age: 33.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Contusion, Malaise, Pyrexia
Clinical narrative: she was really sick; she thinks the nurse put the bolus really close to the bone in her deltoid, she had a black bruise; high fever; Indication: to help with chronic sinus infections; This spontaneous report was received from a currently 55-year-old female patient reporting on herself. No information was provided regarding the patient's relevant medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies.  In 1999 reported as " a long time ago when the patient was 33-years-old", she was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in her deltoid unspecified side to help with chronic sinus infections (product use in unapproved indication) (dose, frequency, route of administration, vaccination scheme, lot number and expiration date were not reported). Subsequently, the patient had high fever (pyrexia), she was really sick (illness). She further stated, she thought the nurse put the bolus really close to the bone in her deltoid. So, she had a black bruise (vaccination site bruising).    The outcome of the aforementioned events was unknown.  Causality assessment was not provided by the reporter.
Age: 33.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Malaise, Pyrexia, Vaccination site bruising
Clinical narrative: she was really sick; she thinks the nurse put the bolus really close to the bone in her deltoid, she had a black bruise; high fever; Indication: to help with chronic sinus infections; This spontaneous report was received from a currently 55-year-old female patient reporting on herself. No information was provided regarding the patient's relevant medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies.  In 1999 reported as " a long time ago when the patient was 33-years-old", she was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in her deltoid unspecified side to help with chronic sinus infections (product use in unapproved indication) (dose, frequency, route of administration, vaccination scheme, lot number and expiration date were not reported). Subsequently, the patient had high fever (pyrexia), she was really sick (illness). She further stated, she thought the nurse put the bolus really close to the bone in her deltoid. So, she had a black bruise (vaccination site bruising).    The outcome of the aforementioned events was unknown.  Causality assessment was not provided by the reporter.
Age: 0.25
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: No adverse event, Product preparation error
Clinical narrative: no adverse event; Drug use in unapproved age group; This spontaneous report was received from a nurse, concerning a 3-month-old male patient. No information was provided regarding the patient's pertinent medical history, concomitant medications and previous drug reactions or allergies.  On 27-MAY-2021, the patient was vaccinated with 1 dose of the following vaccines: hepatitis a vaccine, inactivated (VAQTA) 25U/0.5ml pre-filled syringe (lot number T035720, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 15-APR-2022), varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number T032930, which was verified to be a valid lot number, expiration date reported as 28-SEP-2022 but upon internal validation established as 08-SEP-2022) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant Human albumin) (M-M-R II) (lot number T006165, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 19-FEB-2022) (frequencies, routes of administration, anatomical locations and vaccination schemes were not reported). All the vaccines were administered as prophylaxis. The vaccines were reconstituted with sterile diluent (lot number T022570, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 08-FEB-2023) (product use issue). No additional adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035720; expirationdate: 15-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sex: U
Vaccine: VARZOS
Symptoms: Skin disorder
Clinical narrative: Dermatological Issues; Information has been received from a lawyer and a currently 68 years old patient of unknown gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 19-APR-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date were unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequently (date not reported), the patient was treated by a provider for dermatological Issues. The patient claimed following damages as a result of zoster vaccine live (ZOSTAVAX): injury to themselves and economic losses. The outcome of the event was unknown. The causality between the event and zoster vaccine live (ZOSTAVAX) was related.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Wrong product administered
Clinical narrative: No reported side effects; accidently gave PROQUAD and VARlVAX instead of MMR-II and VARlVAX; accidently gave PROQUAD and VARlVAX instead of MMR-II and VARlVAX; This spontaneous report was received from a licensed practical nurse and refers to a 1-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 27-MAY-2021, the patient was accidently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) 1 dose, 0.5 milliliter, lot # T030479, expiration date 07-MAR-2022 (injection site and route of administration were not reported) and varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose, 0.5 milliliter (injection site, route of administration, lot # and expiration date were not reported), both for prophylaxis instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and vaccine live (oka/merck)(VARIVAX).  It was not discovered until vaccine reconciliation on 28-MAY-2021 (reported as "today"). There was no reported side effects. The nurse confirmed this was not a product confusion or product quality complaint, it was a medication error as she was new to pediatric office.