chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray normal, Chest pain, Cold sweat, Cyanosis, Dyspnoea
Clinical narrative: My son woke up Friday morning super hot he went to school got sent home from school I gave him Tylenol when he got home he was running a fever 103. His arm all the way down from the injection site was a huge hive rash all over and is still present. He came out of his room from laying down at about 8:00 pm saying his heart was racing he was turning blue lips pale as a ghost super clammy and I put my Apple Watch on him his heart rate was 176BPM  he complained his chest was hurting and that he was having a hard time breathing. I called the advice nurse at Vancouver clinic she advised me to give him a Benadryl and Tylenol she said that she believe this was an allergic reaction to the shot & that I need to get his heart rate down she would call me back in 20 mins and if it wasn?t below 120 to call 911  when she called me back it got down to 120  he said his chest wasn?t hurting to much anymore and she told me give him one more benadryl and to watch him making sure to give him Tylenol every six- eight hours. I took him in Saturday to urgent care because he still had the hives rash the urgent care dr did ekg chest X-ray on him for his heart and scheduled a follow up with his primary this Friday. He told me that he believed it was an allergic reaction also the vaccine and to watch him
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Feeling hot, Heart rate increased, Injection site rash, Injection site urticaria
Clinical narrative: My son woke up Friday morning super hot he went to school got sent home from school I gave him Tylenol when he got home he was running a fever 103. His arm all the way down from the injection site was a huge hive rash all over and is still present. He came out of his room from laying down at about 8:00 pm saying his heart was racing he was turning blue lips pale as a ghost super clammy and I put my Apple Watch on him his heart rate was 176BPM  he complained his chest was hurting and that he was having a hard time breathing. I called the advice nurse at Vancouver clinic she advised me to give him a Benadryl and Tylenol she said that she believe this was an allergic reaction to the shot & that I need to get his heart rate down she would call me back in 20 mins and if it wasn?t below 120 to call 911  when she called me back it got down to 120  he said his chest wasn?t hurting to much anymore and she told me give him one more benadryl and to watch him making sure to give him Tylenol every six- eight hours. I took him in Saturday to urgent care because he still had the hives rash the urgent care dr did ekg chest X-ray on him for his heart and scheduled a follow up with his primary this Friday. He told me that he believed it was an allergic reaction also the vaccine and to watch him
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Pallor, Palpitations, Pyrexia, Rash, Urticaria
Clinical narrative: My son woke up Friday morning super hot he went to school got sent home from school I gave him Tylenol when he got home he was running a fever 103. His arm all the way down from the injection site was a huge hive rash all over and is still present. He came out of his room from laying down at about 8:00 pm saying his heart was racing he was turning blue lips pale as a ghost super clammy and I put my Apple Watch on him his heart rate was 176BPM  he complained his chest was hurting and that he was having a hard time breathing. I called the advice nurse at Vancouver clinic she advised me to give him a Benadryl and Tylenol she said that she believe this was an allergic reaction to the shot & that I need to get his heart rate down she would call me back in 20 mins and if it wasn?t below 120 to call 911  when she called me back it got down to 120  he said his chest wasn?t hurting to much anymore and she told me give him one more benadryl and to watch him making sure to give him Tylenol every six- eight hours. I took him in Saturday to urgent care because he still had the hives rash the urgent care dr did ekg chest X-ray on him for his heart and scheduled a follow up with his primary this Friday. He told me that he believed it was an allergic reaction also the vaccine and to watch him
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: My son woke up Friday morning super hot he went to school got sent home from school I gave him Tylenol when he got home he was running a fever 103. His arm all the way down from the injection site was a huge hive rash all over and is still present. He came out of his room from laying down at about 8:00 pm saying his heart was racing he was turning blue lips pale as a ghost super clammy and I put my Apple Watch on him his heart rate was 176BPM  he complained his chest was hurting and that he was having a hard time breathing. I called the advice nurse at Vancouver clinic she advised me to give him a Benadryl and Tylenol she said that she believe this was an allergic reaction to the shot & that I need to get his heart rate down she would call me back in 20 mins and if it wasn?t below 120 to call 911  when she called me back it got down to 120  he said his chest wasn?t hurting to much anymore and she told me give him one more benadryl and to watch him making sure to give him Tylenol every six- eight hours. I took him in Saturday to urgent care because he still had the hives rash the urgent care dr did ekg chest X-ray on him for his heart and scheduled a follow up with his primary this Friday. He told me that he believed it was an allergic reaction also the vaccine and to watch him
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Back pain, Exposure during pregnancy, Haemorrhage, Human chorionic gonadotropin increased
Clinical narrative: Pfizer injected to arm by nurse. They asked if I was pregnant. I indicated I wasn?t pregnant. A few weeks later I had a positive pregnancy test indicated I would have been pregnant at the time of the vaccine. High levels of HCG. On sept 6 2021 I had severe back pain, moderate bleeding , and after a confirmation from the ER doctor I had a miscarriage. Previously healthy. Unknown aetiology for miscarriage.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Pregnancy test positive
Clinical narrative: Pfizer injected to arm by nurse. They asked if I was pregnant. I indicated I wasn?t pregnant. A few weeks later I had a positive pregnancy test indicated I would have been pregnant at the time of the vaccine. High levels of HCG. On sept 6 2021 I had severe back pain, moderate bleeding , and after a confirmation from the ER doctor I had a miscarriage. Previously healthy. Unknown aetiology for miscarriage.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: UNKNOWN
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased
Clinical narrative: I received my 2nd dose of Moderna , which was still under EUA and MODERNA is the VACCINE I had injected. I have lost more than 1/2 of my range of motion in my right arm/shoulder ie: push-ups, weight lifting over head any  head range of motion,  so many range of motions are now difficult for my job due to this injection, and to the point writing is difficult as I AM A RIGHT handed dominant  I want answers as I can sue as Vaccination was not  FDA approved.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Illness, Pain, Pain in extremity
Clinical narrative: I am very sick. Fever, racing heart, hard to breathe, extremely painful arm, very weak, and pain thought body.  I feel like I have COVID again, but worse.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: I am very sick. Fever, racing heart, hard to breathe, extremely painful arm, very weak, and pain thought body.  I feel like I have COVID again, but worse.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Swollen lip.  Dr decided it was my blood pressure medicine and not the vaccine.  Said no swollen lips were being reported from the vaccine.  Prescribed prednisone which I didn?t take.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature decreased, Chills, Heart rate irregular
Clinical narrative: First shot: low energy and irregular heart beat for 3 weeks 2nd shot: Severe chills on 2nd day.  Low energy and irregular heart beat for a couple months.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Blood iron normal, Chills, Dizziness, Electrocardiogram normal
Clinical narrative: Fever, flu-like fatigue, chills, bursts of pain throughout head and body, swollen gums. These symptoms subsided within a few days. About a week afterwards symptoms of numbness, weakness  and tingling in extremities began along with bouts of dizziness and extreme fatigue. Symptoms progressively worsened for about 6 weeks and then began to improve. Fatigue is the only persistent symptom and it is improving. Emergency room doctors tested for infection and found none. They also administered  an ECG and results were normal. I was referred back to my PCP who tested for thyroid function, iron levels, diabetes and all results normal.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gingival swelling, Headache, Hypoaesthesia, Influenza like illness
Clinical narrative: Fever, flu-like fatigue, chills, bursts of pain throughout head and body, swollen gums. These symptoms subsided within a few days. About a week afterwards symptoms of numbness, weakness  and tingling in extremities began along with bouts of dizziness and extreme fatigue. Symptoms progressively worsened for about 6 weeks and then began to improve. Fatigue is the only persistent symptom and it is improving. Emergency room doctors tested for infection and found none. They also administered  an ECG and results were normal. I was referred back to my PCP who tested for thyroid function, iron levels, diabetes and all results normal.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test normal, Muscular weakness, Pain, Paraesthesia, Pyrexia
Clinical narrative: Fever, flu-like fatigue, chills, bursts of pain throughout head and body, swollen gums. These symptoms subsided within a few days. About a week afterwards symptoms of numbness, weakness  and tingling in extremities began along with bouts of dizziness and extreme fatigue. Symptoms progressively worsened for about 6 weeks and then began to improve. Fatigue is the only persistent symptom and it is improving. Emergency room doctors tested for infection and found none. They also administered  an ECG and results were normal. I was referred back to my PCP who tested for thyroid function, iron levels, diabetes and all results normal.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroid function test normal
Clinical narrative: Fever, flu-like fatigue, chills, bursts of pain throughout head and body, swollen gums. These symptoms subsided within a few days. About a week afterwards symptoms of numbness, weakness  and tingling in extremities began along with bouts of dizziness and extreme fatigue. Symptoms progressively worsened for about 6 weeks and then began to improve. Fatigue is the only persistent symptom and it is improving. Emergency room doctors tested for infection and found none. They also administered  an ECG and results were normal. I was referred back to my PCP who tested for thyroid function, iron levels, diabetes and all results normal.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Thrombosis
Clinical narrative: 15 plus days of heavy vaginal bleeding 1 day after 2nd dose of Pfizer vaccine. Experiencing large blood clots and cramping throughout period. Never had a period this long with this amount of blood and clotting.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Paraesthesia oral
Clinical narrative: Tingling lips and tongue accompanied by sore throat. I took 50mg of Benadryl and adverse event reversed/stopped within a couple hours.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Nausea, Pallor
Clinical narrative: Patient presented with nausea, mild flushing, some palor and light sweating at approximately 12:30 pm. Zofran was administered. Patient with nausea, patient presents with mild flushing, some palor and light sweating at 12:30 pm. Sublingual zofran was administered. BP 117/55, HR 102, O2 99%, RR 18.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: pt reported feeling light headed and nausea bp: 81/41 upon initiation, p: 57, o2 100% took zofran 4mg
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Throat tightness
Clinical narrative: Patient reported throat feeling tight, light headed. Patient didn't eat anything this morning. 11:41 V15, 116/71, P59, o2 94, T 34.9. Patient was given water. 11:59 patient stated feeling much better.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Patient reported feeling dizzy and lightheaded. She did not take her BP meds in the morning (likely due to lack of BP medication).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Loss of consciousness, Seizure
Clinical narrative: 10:29 patient was on her way out from observation room. Patient went unconscious but was breathing. 10:32 patient had a seizure for 15 second. Placed patient on her side and called code. Medics took patient to the ER and her husband reported she has seizure history. Patient observation time was 10:27
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal loss of weight, Diarrhoea, Electrocardiogram ambulatory, Headache, Laboratory test
Clinical narrative: Near-syncope 3 days after vaccination prompted ER eval.  Subsequent onset of chronic headaches, palpitations (with confirmed PACs and PVCs on Holter), and diarrhea with unintended 20 lb weight loss.  Work-up is ongoing, but this far unrevealing for specific etiology now >3 months after vaccination.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Presyncope, Supraventricular extrasystoles, Ventricular extrasystoles
Clinical narrative: Near-syncope 3 days after vaccination prompted ER eval.  Subsequent onset of chronic headaches, palpitations (with confirmed PACs and PVCs on Holter), and diarrhea with unintended 20 lb weight loss.  Work-up is ongoing, but this far unrevealing for specific etiology now >3 months after vaccination.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cold sweat, Dizziness, Eye movement disorder, Pallor
Clinical narrative: pt felt faint, pale, clammy, and eyes rolled in back of head, major symptoms resolved in 10 minutes but continued to feel weak
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Severe  red rash itch all over my body except on face. Went to urgent care receive prescription still no change. I'm still dealing with this week's later today is 9/23/21 had last shot on 8/7/21 can send pics if need to.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia
Clinical narrative: Dizziness, lightheadedness. Patient complained of difficulty swallowing but is able to drink water and eat food now. Patient took benadryl 50mg
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Throat irritation
Clinical narrative: throat itching and trouble breathing, 16 oz of water given and then pt reported feeling better
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Tongue pruritus
Clinical narrative: C/O throat and tongue, itching at 11:50. Benadryl 25 mg administered per protocol. Patient tolerated medication well with oral hydration. Education provided
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dyspepsia
Clinical narrative: epigastric burning, BP 202/104. pt took omeprazole and drank 16 oz water 20min later 226/93 code med called and transferred to ED
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Dizziness, Incoherent, Malaise
Clinical narrative: Patient reported feeling lightheaded, dizzy, and feeling "sick", Speech initially incoherent with conversation.  BP 100/49 Temp 104.3 O2: 99% HR 78
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Dizziness, Hyperhidrosis, Hypoaesthesia, Vision blurred
Clinical narrative: numbness and heaviness in back. severe dizziness, blurry vision and diaphetic, coe med called due to dizziness, pt was transferred to ED
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test abnormal, Chest pain, Echocardiogram, Electrocardiogram, Fibrin D dimer
Clinical narrative: Severe sharp on going chest pain, sharp pain when breathing the night after the vaccine. Heart beating abnormally- as heart beats fast and slows down such as a palpitation. Sharp chest pain has not subsided and it has been almost a month. No treatment has been done- solely prescription of ibprofen which at this time does not subside the chest pain. Sleeping in difficult as the chest hurts throughout the night.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate abnormal, Heart rate increased, Insomnia, Painful respiration, Palpitations
Clinical narrative: Severe sharp on going chest pain, sharp pain when breathing the night after the vaccine. Heart beating abnormally- as heart beats fast and slows down such as a palpitation. Sharp chest pain has not subsided and it has been almost a month. No treatment has been done- solely prescription of ibprofen which at this time does not subside the chest pain. Sleeping in difficult as the chest hurts throughout the night.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Severe sharp on going chest pain, sharp pain when breathing the night after the vaccine. Heart beating abnormally- as heart beats fast and slows down such as a palpitation. Sharp chest pain has not subsided and it has been almost a month. No treatment has been done- solely prescription of ibprofen which at this time does not subside the chest pain. Sleeping in difficult as the chest hurts throughout the night.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Gastrooesophageal reflux disease, Hyperhidrosis, Retching
Clinical narrative: Symptoms started about a week after second shot. Heavyness in chest ongoing but random chills and sweats and gerd symptoms that appear to becoming worse and having to sleep elavated so im not gagging at night.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: dull frontal headache 2/10, took Tylenol, vitals WNL
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Chest pain, Chills, Dizziness, Dyspnoea
Clinical narrative: Patient reported feeling dizzy, lightheadedness, short of breath BP 126/59 P 88 RR 18 Pain, fever, chills, chest pain blood glucose 191
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Patient reported feeling dizzy, lightheadedness, short of breath BP 126/59 P 88 RR 18 Pain, fever, chills, chest pain blood glucose 191
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: 1450 patient reported dizziness, responding verbally with clear speech. Denied headache, stated he has not eaten since breakfast. No tongue edema noted. Normal respiratory BP 113/51 P72 T 97.3 O2 sat 96 pt denied dysphagia. Mother, father, sister present. Oatmeal bars X2, 4 oz orange juice, 8 oz water, 1 pk  cookies consumed. remained verbally responsive, followed commands 1500 BS 95 after shock and fluids 1510 stated feeling better bp 111/56 64 p, O2 sat 97%, 1525 stated feeling much better and comfortable enough to leave. Patient exited with parents to drive him home.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Menstruation irregular, Tinnitus
Clinical narrative: Had mild to severe brain fog for the first month.  This seems to be subsiding.  Have developed persistent ringing in my ears that has become more frequent in the last four weeks.  It is more noticeable in the hours between 6:30 p.m. and 12:00 a.m.  This may be because I am too busy to notice it at work prior to 6:30 p.m. and am asleep after 12:00 a.m.  Also, my first menstrual cycle after the vaccine was highly irregular.  The next one seemed normal.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Flushing, Headache, Lymphoedema, Throat tightness
Clinical narrative: 163/75, P71, O2 97%, stated "dry throat", feels like its closing. 1055 dexamethasone 4mg administered stated allergy to iodine penicillin latex remained verbally responsive 1059 c/o headache, states hypertension medication taken this AM. No dysphagia, swallowed tablet and drank water without difficulty. States lymphedema to right arm 1100. bp 176/79 p70 o2 97% 1102 dexamethasone 4 mg po administered. facial flushing noted at 1058 1103 stated feeling better its more open now transferred to Er for further evaluation
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Feeling hot, Hyperhidrosis, Menstrual disorder, Muscle spasms
Clinical narrative: Batch number on my vaccine report 1) FE9174 (26/07/21)  2) EY0581 ( 08/09/21) Major Menstrual Disruption  in my accurate 27 days menstural cycle.  No possibility of pregnancy. Had no menstrual cycle after my first injection 26 July which was due on 30th of July 2021 For 1 week, 48 hours after my second dose - extreme random heat surges predominently over legs and arms, sweating a lot at night.  difficulty regulating body temperature.  2nd missed menstural cycle due on 25th August 2021 although mild cramping had been experienced. 3rd missed menstrual cycle due on 20th September 2021.  I have no menstrual conditions and have a precise 27 days cycle. No life style change.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Temperature regulation disorder
Clinical narrative: Batch number on my vaccine report 1) FE9174 (26/07/21)  2) EY0581 ( 08/09/21) Major Menstrual Disruption  in my accurate 27 days menstural cycle.  No possibility of pregnancy. Had no menstrual cycle after my first injection 26 July which was due on 30th of July 2021 For 1 week, 48 hours after my second dose - extreme random heat surges predominently over legs and arms, sweating a lot at night.  difficulty regulating body temperature.  2nd missed menstural cycle due on 25th August 2021 although mild cramping had been experienced. 3rd missed menstrual cycle due on 20th September 2021.  I have no menstrual conditions and have a precise 27 days cycle. No life style change.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Malaise, Respiratory distress, Tongue oedema
Clinical narrative: patient stated not feeling well and did not eat. verbal resp distress tongue edema. 1335 c/o heartburn ER visit offered and accepted
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Pain, Somnolence, Tenderness
Clinical narrative: tired and sleepy with a headache sore are painful to the touch.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: Patient describes chest tightness. No pain, shortness of breath, palpitation, dizziness. Just tightness.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Injection site pain, Nausea, Pain
Clinical narrative: painful  visibly puffy knees unable to crousch (resolved fully after 4 mos) pain in right shoulder when lifting above shoulder height frequent persistent excessive sweating in addition to typicel: pain at injection site, feverish, aches, fatigue, tingling in left head & head, nausea, bain fog (resolved within 72 hours)
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia
Clinical narrative: painful  visibly puffy knees unable to crousch (resolved fully after 4 mos) pain in right shoulder when lifting above shoulder height frequent persistent excessive sweating in addition to typicel: pain at injection site, feverish, aches, fatigue, tingling in left head & head, nausea, bain fog (resolved within 72 hours)
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cardiac monitoring, Chest X-ray, Chills, Constipation
Clinical narrative: Nausea, headache, severe body aches, full body convulsions, vomiting, constipation, fever of 102, extremely cold, teeth chattering.  Hospitalized 12 hours after injection  Received fluids through IV, and two nausea meds through IV, and Tylenol  Took full week to recover to almost normal
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Nausea, headache, severe body aches, full body convulsions, vomiting, constipation, fever of 102, extremely cold, teeth chattering.  Hospitalized 12 hours after injection  Received fluids through IV, and two nausea meds through IV, and Tylenol  Took full week to recover to almost normal
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Seizure, Vomiting
Clinical narrative: Nausea, headache, severe body aches, full body convulsions, vomiting, constipation, fever of 102, extremely cold, teeth chattering.  Hospitalized 12 hours after injection  Received fluids through IV, and two nausea meds through IV, and Tylenol  Took full week to recover to almost normal
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: VERY heavy menstruation ever since vaccine. Each month, menstruation is significantly heavier than prior to being vaccinated.  Double the bleeding. Double the number of pads and tampons. EXTREMELY heavy periods for the past 6 months ever since getting vaccine.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood creatine phosphokinase, Blood magnesium, Blood test, Blood thyroid stimulating hormone
Clinical narrative: Approx 5 weeks after my 2nd COVID shot I started experiencing general fatigue, which progressed to shortness of breath and irregular heart beat.  After it got worse over 5 days, I went to the emergency room.  They kept me overnight while running numerous tests.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Brain natriuretic peptide, Dyspnoea, Fatigue, Fibrin D dimer, Full blood count
Clinical narrative: Approx 5 weeks after my 2nd COVID shot I started experiencing general fatigue, which progressed to shortness of breath and irregular heart beat.  After it got worse over 5 days, I went to the emergency room.  They kept me overnight while running numerous tests.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate irregular, Low density lipoprotein, Metabolic function test, Troponin, Troponin I
Clinical narrative: Approx 5 weeks after my 2nd COVID shot I started experiencing general fatigue, which progressed to shortness of breath and irregular heart beat.  After it got worse over 5 days, I went to the emergency room.  They kept me overnight while running numerous tests.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Depression, Ear discomfort, Ear pain, Fatigue, Oropharyngeal pain
Clinical narrative: Day2: Sudden depression, severe tiredness, body aches. Day3: Ear pain, throat pain.  All the symptoms are gone except for ear pain it's still there, pain increases at night, feels like ear pressure or blockage in the right ear. I did not yet see a doctor.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Day2: Sudden depression, severe tiredness, body aches. Day3: Ear pain, throat pain.  All the symptoms are gone except for ear pain it's still there, pain increases at night, feels like ear pressure or blockage in the right ear. I did not yet see a doctor.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Peripheral swelling, Swelling face, Weight, Weight increased
Clinical narrative: Face looked extremely swollen; Thighs and arms were puffed up; Gained weight; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on unknown date in Jan2021 as dose 2, single for COVID-19 immunisation; botulinum toxin type a (BOTOX), via an unspecified route of administration from an unspecified date (Batch/Lot Number: Not Provided) to an unspecified date, at unspecified dose for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient face looked extremely swollen, thighs and arms were puffed up, gained weight on an unknown date in Jan2021. The patient underwent lab tests and procedures which included weight: gained weight on unknown date in 2021. Outcome of the events was not recovered.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AE/PQC was reported; she and her husband received a single dose of PENUMOVAX 23 approximately 6 years ago and were told they needed to receive a second dose, 5 years after receiving the first dose; This spontaneous report was received from a female patient of unknown age reporting on herself. The patient's pertinent medical history, concurrent conditions and concomitant therapies were unknown by the reporter.      In approximately August 2015 (reported as 6 years ago), the patient was vaccinated with a single dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route, lot# and the expiration date) for prophylaxis.         She would need to receive a second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 5 years after receiving the first dose (approximately in 2020). Caller confirmed she and her husband have not received a second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) yet (inappropriate schedule of product administration).   This is one of two cases reporter by the same consumer. Marrs# 2109USA004716.; Sender's Comments:  US-009507513-2109USA004716:
Sex: U
Vaccine: HPV9, UNK
Symptoms: Product storage error
Clinical narrative: No additional AEs reported; GARDASIL 9 was administered after a possible temperature excursion; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      On 02-SEP-2021, the physician received a shipment of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) that was delayed for a day during shipment. On this same date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL, lot # 1687293, expiration date on 30-APR-2023, for prophylaxis (strength, route of administration and anatomical location were not reported).   Then, the physician received an email stating that hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) should not be used as it might had encountered inappropriate temperatures during its delayed shipment; therefore, vaccine was administered after a possible temperature excursion (product storage error). The temperature and time frame was unknown and no previous temperature excursions were reported. No additional Adverse Events were reported.
Sex: M
Vaccine: PPV
Symptoms: Extra dose administered
Clinical narrative: the patient's doctor has recommended another pneumonia shot, because the patient is immunocompromised due to the splenectomy.; This spontaneous report was received from a male patient of unknown age regarding himself. The patient had no drug reactions or allergies and none concomitant medications.   The patient stated that he ruptured his spleen in a softball game. Due to him rupturing his spleen in the softball game he needed to have a splenectomy performed on him "between 5 and 10 years ago". During the splenectomy the patient was admitted to a hospital for 8 days. Soon after the splenectomy the patient received 2 pneumonia shots of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), (dose, route, lot number and expiration date were not reported) in his arm (unsure which arm was). At the time of the call the patient's doctor has recommended another pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) shot, because the patient was immunocompromised due to the splenectomy (experienced product prescribing issue).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AEs reported.; Vaccine administered after expiration; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 08-SEP-2021, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot number T017385 with expiration date 01-SEP-2021 (dose, route and anatomical location were not reported) for prophylaxis (expired product administered). No other adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: improperly stored vaccines administered to patients; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 01-SEP-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T006346, expiration date 20-FEB-2022 (dose, route and frequency were not reported) for prophylaxis.  The reporter stated that the excursion occurred between 01-SEP-2021 and 09-SEP-2021; as the vaccines were stored in the freezer and got too warm and they did not realize that the freezer was "going in and out of range" (temperature of excursion and duration of excursion were not reported). Also, the reporter mentioned that the remaining vaccines were back in the recommended temperature range but she did not have information needed to evaluate at the reporting time.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA004529: US-009507513-2109USA004530: US-009507513-2109USA004531: US-009507513-2109USA004532: US-009507513-2109USA004533: US-009507513-2109USA004534: US-009507513-2109USA004535: US-009507513-2109USA004536: US-009507513-2109USA004537: US-009507513-2109USA004538: US-009507513-2109USA004539: US-009507513-2109USA004540: US-009507513-2109USA004541: US-009507513-2109USA004542: US-009507513-2109USA004543: US-009507513-2109USA004544: US-009507513-2109USA004545: US-009507513-2109USA004546: US-009507513-2109USA004547: US-009507513-2109USA004548:
Age: 37.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling, Skin discolouration
Clinical narrative: his arm was swollen up to twice it's normal size; his arm was black and purple for a week; This spontaneous report was received from a 53-year-old male patient, referring to himself. The patient's pertinent medical history included mild asthma. Drug reactions/ allergies included ASA triad. Concomitant therapies included ibuprofen (ADVIL [IBUPROFEN]). His physician wanted him to have pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) every 10 years.   On a unknown date in 2005 (also reported as 16 years ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, strength, route, lot# and expiration date were not provided) for prophylaxis and had no reaction. On an unknown date in February 2016 (also reported as 5 years ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 milliliter, strength, route, lot# and expiration date were not provided) for prophylaxis.   On the same day, the patient had a severe reaction, his arm was swollen up to twice it's normal size and black and purple for a week. Treatment was given for the events. The patient sought medical attention. Therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was discontinued. The outcome of the events was reported as recovered/resolved.        The causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AEs; less than the 6 month recommended minimum interval between doses; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. No concurrent condition, medical history, or concomitant therapy was reported.  On 21-FEB-2018, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 mL (strength and route were unknown; lot # N012954 was not valid lot number, expiration date reported as 31-AUG-2018) for prophylaxis.  On 13-AUG-2018 , the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 mL (strength and route were unknown; lot # R007388 has been verified to be a valid lot number, expiration date reported and confirm upon internal validation as 27-MAY-2019) for prophylaxis (it was less than the 6 month recommended minimum interval between doses; inappropriate schedule of product administration). No additional adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: R007388; expirationdate: 27-MAY-2019; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE reported.; the patient was initially scheduled for the 2 dose regimen and was concerned since the 2nd dose was received earlier than expected; This spontaneous report was received from a pharmacist, referring to a 12-year-old female patient. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.     On an unknown date in May 2021, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength, route, lot# and expiration date were not provided) for prophylaxis. On 03-JUL-2021, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength, route, lot# and expiration date were not provided) for prophylaxis. The patient was initially scheduled for the 2 dose regimen and was concerned since the 2nd dose was received earlier than expected (inappropriate schedule of product administration). No additional adverse event reported.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: a temperature excursion for PROQUAD; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 05-AUG-2021 the patient was vaccinated with temperature excursion measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (0.5 milliliter, 1 dose, lot # T016990, expiration date 11-NOV-2021) via subcutaneous (SQ) for prophylaxis (product storage error).       The administered dose of the vaccine experienced a temperature of 6 Fahrenheit (F) to 14°F (9.9F) for 2 hours and 11 minutes (on 14-SEP-2021) and 6°F to 14°F (6.6F) for 59 minutes (on 15-SEP-2021). There was previous temperature excursion 6°F to 14°F (7.3F) for 37 minutes (on 25-JUL-2021).
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: improperly stored vaccines administered to patients; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 01-SEP-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T006346, expiration date 20-FEB-2022 (dose, route and frequency were not reported) for prophylaxis.  The reporter stated that the excursion occurred between 01-SEP-2021 and 09-SEP-2021; as the vaccines were stored in the freezer and got too warm and they did not realize that the freezer was "going in and out of range" (temperature of excursion and duration of excursion were not reported). Also, the reporter mentioned that the remaining vaccines were back in the recommended temperature range but she did not have information needed to evaluate at the reporting time.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA002915:Original Case : 2109USA002915
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: improperly stored vaccines administered to patients; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 02-SEP-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX)  lot # T006346, expiration date 20-FEB-2022 (dose, route and frequency were not reported) for prophylaxis.  The reporter stated that the excursion occurred between 01-SEP-2021 and 09-SEP-2021; as the vaccines were stored in the freezer and got too warm and they did not realize that the freezer was "going in and out of range" (temperature of excursion and duration of excursion were not reported). Also, the reporter mentioned that the remaining vaccines were back in the recommended temperature range but she did not have information needed to evaluate at the reporting time.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA002915:Original Case : 2109USA002915
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: improperly stored vaccines administered to patients; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 07-SEP-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX)  lot # T006346, expiration date 20-FEB-2022 (dose, route and frequency were not reported) for prophylaxis.  The reporter stated that the excursion occurred between 01-SEP-2021 and 09-SEP-2021; as the vaccines were stored in the freezer and got too warm and they did not realize that the freezer was "going in and out of range" (temperature of excursion and duration of excursion were not reported). Also, the reporter mentioned that the remaining vaccines were back in the recommended temperature range but she did not have information needed to evaluate at the reporting time.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA002915:Original Case : 2109USA002915
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: improperly stored vaccines administered to patients; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 08-SEP-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX)  lot # T006346, expiration date 20-FEB-2022 (dose, route and frequency were not reported) for prophylaxis.  The reporter stated that the excursion occurred between 01-SEP-2021 and 09-SEP-2021; as the vaccines were stored in the freezer and got too warm and they did not realize that the freezer was "going in and out of range" (temperature of excursion and duration of excursion were not reported). Also, the reporter mentioned that the remaining vaccines were back in the recommended temperature range but she did not have information needed to evaluate at the reporting time.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA002915:Original Case : 2109USA002915
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: improperly stored vaccines administered to patients; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 09-SEP-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX)  lot # T006346, expiration date 20-FEB-2022 (dose, route and frequency were not reported) for prophylaxis.  The reporter stated that the excursion occurred between 01-SEP-2021 and 09-SEP-2021; as the vaccines were stored in the freezer and got too warm and they did not realize that the freezer was "going in and out of range" (temperature of excursion and duration of excursion were not reported). Also, the reporter mentioned that the remaining vaccines were back in the recommended temperature range but she did not have information needed to evaluate at the reporting time.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA002915:Original Case : 2109USA002915
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: improperly stored vaccines administered to patients; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 01-SEP-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T032149, expiration date 20-MAR-2022, (dose, route and frequency were not reported) for prophylaxis.   The reporter stated that the excursion occurred between 01-SEP-2021 and 09-SEP-2021; as the vaccines were stored in the freezer and got too warm and they did not realize that the freezer was "going in and out of range" (temperature of excursion and duration of excursion were not reported). Also, the reporter mentioned that the remaining vaccines were back in the recommended temperature range but she did not have information needed to evaluate at the reporting time.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA002915:Original Case : 2109USA002915
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: improperly stored vaccines administered to patients; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 02-SEP-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T032149, expiration date 20-MAR-2022, (dose, route and frequency were not reported) for prophylaxis.   The reporter stated that the excursion occurred between 01-SEP-2021 and 09-SEP-2021; as the vaccines were stored in the freezer and got too warm and they did not realize that the freezer was "going in and out of range" (temperature of excursion and duration of excursion were not reported). Also, the reporter mentioned that the remaining vaccines were back in the recommended temperature range but she did not have information needed to evaluate at the reporting time.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA002915:Original Case : 2109USA002915