chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient had 1st dose of COVID-19 vaccine on 01/15/2021. Tested positive for COVID-19 on 01/24/2021 and received bamlamivimab infusion on 01/26/2021.  She was told by pharmacist to restart the COVID-19 vaccine series since the first dose would be invalid.  She returned on 04/23/2021 for second dose and on 05/14/2021 for the third dose.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Nausea, Syncope, Vomiting
Clinical narrative: Dizzy and syncope post vaccine with staring into space for 5-10 seconds. No loss of tone, shaking/clonic activity, no falls, no incontinence, immediate return to alert and oriented. States has similar episodes in past with drug intolerance. Had nausea and vomitting with delayed diarrhea s/p the episode of syncope
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose normal, Feeling hot, Headache, Heart rate decreased, Hypotension
Clinical narrative: WITHIN 2 MINUTES OF GETTING THE SECOND DOSE OF MODERNA COVID VACCINE, PATIENT FAINTED ON HIS WIFE'S ARMS. SHE PUT HIM ON NEAR BY CHAIR AND CALLED OUT TO THE PHARMACY. WE CALLED 911 RIGHT AWAY. I STOOD BY HIM. HE LOOKED PALE, DOSING OFF, I WAS ASKING HIM QUESTIONS AND HE WAS ABLE TO ANSWER FEW WORDS AND DOSE OFF AGAIN, HE FELT HOT, AND HE ASKED HIS WIFE WHAT HAPPENED AND SHE SAID HE FAINTED, AND HE REPETEADLY HAVING SAME FAINTING EPISODE WHILE SITTING, HE WAS ABLE TO DRINK WATER FROM WATER BOTTLE. I TOLD HIM TO REMOVE HIS FACE MASK FOR BETTER BREATHING. I TRIED TO CHECK HIS PULSE BUT IT WAS VERY VERY SLOW. PARAMEDICS CAME AND HE IS FEELING BETTER BY THE TIME THEY CAME. HE WAS ABLE TO COMMUNICATE ALOT BETTER WITH THEM. THEY MEASURED HIS BP AND GLUCOSE, GLUCOSE WAS 91 AND BP WAS LOW HIS FIRST TIME AROUND AND SECOND TIME WAS NORMAL BUT HAD LOW HEART RATES. HE REFUSED TO GO TO THE HOSPITAL. HE FELT LIKE HE HAD A HEADACHE AND HOT. WIFE WAS BY HIS SIDE. PARAMADICS WALKED HIM DOWN TO THEIR CAR AND ADVISED THEM TO GO TO NEAREST HOSPITAL IF NOTICE ANYTHING.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Pallor, Somnolence, Syncope
Clinical narrative: WITHIN 2 MINUTES OF GETTING THE SECOND DOSE OF MODERNA COVID VACCINE, PATIENT FAINTED ON HIS WIFE'S ARMS. SHE PUT HIM ON NEAR BY CHAIR AND CALLED OUT TO THE PHARMACY. WE CALLED 911 RIGHT AWAY. I STOOD BY HIM. HE LOOKED PALE, DOSING OFF, I WAS ASKING HIM QUESTIONS AND HE WAS ABLE TO ANSWER FEW WORDS AND DOSE OFF AGAIN, HE FELT HOT, AND HE ASKED HIS WIFE WHAT HAPPENED AND SHE SAID HE FAINTED, AND HE REPETEADLY HAVING SAME FAINTING EPISODE WHILE SITTING, HE WAS ABLE TO DRINK WATER FROM WATER BOTTLE. I TOLD HIM TO REMOVE HIS FACE MASK FOR BETTER BREATHING. I TRIED TO CHECK HIS PULSE BUT IT WAS VERY VERY SLOW. PARAMEDICS CAME AND HE IS FEELING BETTER BY THE TIME THEY CAME. HE WAS ABLE TO COMMUNICATE ALOT BETTER WITH THEM. THEY MEASURED HIS BP AND GLUCOSE, GLUCOSE WAS 91 AND BP WAS LOW HIS FIRST TIME AROUND AND SECOND TIME WAS NORMAL BUT HAD LOW HEART RATES. HE REFUSED TO GO TO THE HOSPITAL. HE FELT LIKE HE HAD A HEADACHE AND HOT. WIFE WAS BY HIS SIDE. PARAMADICS WALKED HIM DOWN TO THEIR CAR AND ADVISED THEM TO GO TO NEAREST HOSPITAL IF NOTICE ANYTHING.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Loss of personal independence in daily activities, Pain, Paraesthesia
Clinical narrative: One week after second vaccine fingers were tingly and it progressed to numbness, tingling, and pain. Went to pcp and they said they?ve had other recently vaccinated women  having same issue. Fingers and hand are numb and painful and it?s difficult to do normal activities because of this. Did not have other unusual symptoms except a little tired the day of both doses.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dyspnoea, Peripheral swelling, Pulmonary embolism, Thrombosis
Clinical narrative: Blood Cloots in legs and lungs.   Sweeling legs, couldn't breathe. Hospital and drugs.  Still continiting treatment.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan
Clinical narrative: Blood Cloots in legs and lungs.   Sweeling legs, couldn't breathe. Hospital and drugs.  Still continiting treatment.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Deafness, Ear discomfort
Clinical narrative: Pt developed R ear pressure 2 days after COVID vaccine when she woke up in the morning. Was seen at local UC and found to not have an ear infection. Discharged home. Saw her Ent on 5/12 and was found to have R hearing loss.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt was administered a third dose of the covid vaccine in error. nursing home staff presented the patient to staff as someone who needed a 'second dose'. Pt had already had a second dose (12/21/20, 1/11/21, 2/1/21). No adverse effects were reported. Error was discovered by healthcare supervisor on 5/10/21.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing
Clinical narrative: After receiving 1st dose covid vaccine patient became lightheaded and flushed. Patient has mild autism and communication is limited. Laid patient on cot. Vitals stable. Patient drank water and ate crackers and felt better. Patient discharged with Mother
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pyrexia
Clinical narrative: Joint pains. Excessive tiredness. Low grade fever.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Laboratory test normal, Pain in extremity, Ultrasound scan
Clinical narrative: (4/23/21) Symptoms included intermittent (R) lower leg pain.   After 3days, started myself on Aspirin which seemed to improve Sx somewhat.   Stopped the Aspirin.  Then learned of the link of J&J Vaccines to blood clots.  Called my primary physician (5/6/21) who suggested testing to r/o DVT.   (5/7) Venous ultrasound confirmed a DVT/ blood clot in (R) lower leg.  Was then sent directly to ER for further exam and initiation of anti-coagulation therapy.  Started on Eliquis starter pack:  Initially 10mg BID,  then 5mg BID.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccine was given too soon from her first dose.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient received vaccination although not 18 years old.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Full blood count, Hypotension, Metabolic function test, Procalcitonin
Clinical narrative: Patient presented to clinic on 5/6 with erythematous maculopapular rash on neck, chest, abdomen, legs and arms. She was afebrile at the time. No relief with OTC benadryl. Patient given IM Kenalog injection. Patient presents 5/7 with worsening rash, fatigue, low BP, and fever. Rash has same distribution. BP 88/50, and temp 37.4C upon arrival to clinic. No evidence of Stevens-Johnson syndrome. Patient was then transferred to hospital for fluids and treatment. At hospital, patient was given IV dexamethasone and benadryl with fluids. Discharged with oral prednisone. Patient came in for follow up on 5/11 feeling a lot better and rash has faded.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Rash, Rash erythematous, Rash maculo-papular, Urine analysis
Clinical narrative: Patient presented to clinic on 5/6 with erythematous maculopapular rash on neck, chest, abdomen, legs and arms. She was afebrile at the time. No relief with OTC benadryl. Patient given IM Kenalog injection. Patient presents 5/7 with worsening rash, fatigue, low BP, and fever. Rash has same distribution. BP 88/50, and temp 37.4C upon arrival to clinic. No evidence of Stevens-Johnson syndrome. Patient was then transferred to hospital for fluids and treatment. At hospital, patient was given IV dexamethasone and benadryl with fluids. Discharged with oral prednisone. Patient came in for follow up on 5/11 feeling a lot better and rash has faded.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Lip swelling, Paraesthesia, Pharyngeal swelling, Swollen tongue
Clinical narrative: Swollen throat, swollen tongue swollen lips face tingly lips face and trouble breathing
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Oropharyngeal pain
Clinical narrative: patient reported to nurse  within 5 minutes of being vaccinated that she had 'soreness and pressure' in her throat. She denied difficulty breathing with no other symptoms and Clinical Leader was notified. She was taken to the triage area for further monitoring and evaluation with CL. She maintained verbal ability during the observation period, and at no time reported difficulty breathing. No urticaria was observed; no itching or gi symptoms reported by patient during interaction. Patient was asked to lie down with her feet up which she declined, and was seated in a chair during triage. Vitals remained stable during her observation and she was encouraged to take liquids and given some water. She denied eating lunch as well, and appeared possibly anxious due to her symptoms. Clinical Leader asked her to remove her mask for optimal breathing, which appeared to lessen  anxiety in addtion to the supportive care provided. Clinic Medical Director was informed and in agreement with observation. She was observed for over an hour, at which time her symptoms continued to improve and vitals remained stable. Breanne reported feeling better and that her throat felt better with the water. She was advised to speak with her allergist (she denied any medications other than prn epi pen which she did not have with her in clinic) regarding her symptoms today as well and to bring someone with her for the next dose for support, for which she agreed.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: I woke up at 3 am the morning of the 13th with a sore arm and a swollen lymph node in my armpit.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Angiogram abnormal, Anticoagulant therapy, Deep vein thrombosis, Dyspnoea exertional
Clinical narrative: PULMONARY EMBOLISM in patient with no history of VTE or hypercoagulable state. Patient complaint of exertional dyspnea on exertion over past 2 weeks. She saw her PCP, D-dimer=3424, CT angiography with fairly extensive clot burden of pulmonary emboli throughout all lobes, beginning just distal to the main pulmonary arteries. Flattening of intraventricular septum is concerning for right heart strain. admitted with IV heparin for further studies. Dyspnea has significantly improved with anticoagulation and bed rest.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer, Pulmonary embolism, Ultrasound Doppler abnormal, Ventricular septal defect
Clinical narrative: PULMONARY EMBOLISM in patient with no history of VTE or hypercoagulable state. Patient complaint of exertional dyspnea on exertion over past 2 weeks. She saw her PCP, D-dimer=3424, CT angiography with fairly extensive clot burden of pulmonary emboli throughout all lobes, beginning just distal to the main pulmonary arteries. Flattening of intraventricular septum is concerning for right heart strain. admitted with IV heparin for further studies. Dyspnea has significantly improved with anticoagulation and bed rest.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling cold, Hypoaesthesia, Immediate post-injection reaction, Paraesthesia
Clinical narrative: Immediately upon receiving the first injection of the two part series, I felt coldness running down my left arm as if I was getting an IV and then tingling and numbness in my left thumb. The numbness and tingling remained for approximately 5 to 8 hours that day.  Additionally immediately upon receiving my second dose in the series on April 26, 2011 at 9:20 AM I felt both my left and right arms and hands go numb after approximately 45 minutes I felt numbness in my left cheek and upper left and lower lips. The numbness remain for approximately four hours with full resolution by eight hours later.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Pt did not have an adverse event, but there was a temperature excursion of the J &  J vaccine vial. Vaccine was taken out of fridge at 12:03pm, then 1 dose drawn up at around 12:11pm. I then accidentally left the vial out at room temperature for around 35 minutes. At this point I then put the vial back in the fridge. I asked a couple other pharmacists if okay to use and they said yes, so I drew up more doses around 3:30pm (this is an estimate). I also drew up this particular pt's dose around 5:45pm & then administered. All doses were administered within the 6 hour timeframe. Per conversation w/ manufacturer it was out at room temperature longer than what is suggested (i.e. probably around 5 minutes longer than it should have been out of fridge), so the representative at the mfr is sending this to the safety team to find out if re-vaccination may be necessary.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Seizure
Clinical narrative: Patient has history of vasovagal syncopy / seizure and told us in advance. When he was administered the vaccine, he passed out for just a short period of time and had a minor seizure (approx. 5 seconds).
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: After receiving 1st dose covid vaccine patient became lightheaded and nauseated. Laid Patient on cot. Vitals stable. Pt evaluated by Dr . Patient felt better after eating crackers and was discharged with family member
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given expired Pfizer vaccine. Vial was punctured 5/13/2021 at 8:15am, was expired 2:15pm, vaccine was given at 3:51pm.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Electrocardiogram ambulatory, Palpitations
Clinical narrative: I've gotten heart palpitations for several years. They are pretty minor, but for two days after getting the second dose of the Pfizer vaccine they got much stronger and more regular. After about a week they settled back to baseline, but I'm currently using a Holter monitor to check my heart.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Immediate post-injection reaction, Injection site erythema, Injection site inflammation
Clinical narrative: Immediately after getting 2nd dose of Moderna, the soreness and itchiness in arm was felt right away not like the 1st dose.   I had chills, aches, mild headaches and took some Tylenol to relieve symptoms. Saw little redness but after two days rash and swelling was very visible and inflamed. Third day in still have rash, soreness, swelling. Hoping this will improve very soon...
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling, Pain
Clinical narrative: Immediately after getting 2nd dose of Moderna, the soreness and itchiness in arm was felt right away not like the 1st dose.   I had chills, aches, mild headaches and took some Tylenol to relieve symptoms. Saw little redness but after two days rash and swelling was very visible and inflamed. Third day in still have rash, soreness, swelling. Hoping this will improve very soon...
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt was administered a third dose of the covid vaccine in error. nursing home staff presented the patient to pharmacy staff as someone who needed a 'second dose'. Pt had already had a second dose (12/21/20, 1/11/21, 2/1/21). No adverse effects were reported. Error was discovered by pharmacy healthcare supervisor on 5/10/21.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Heart rate increased, Illness, Mobility decreased, Unresponsive to stimuli
Clinical narrative: Vomiting,  became unresponsive,  couldn't move off of recliner
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting,  became unresponsive,  couldn't move off of recliner
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Joint swelling, Swelling, Ultrasound Doppler
Clinical narrative: DVT blood clot in back of left calf. Swelling at foot and ankle
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Sensation of foreign body
Clinical narrative: Anxiety; lump in throat feeling. AOx3; no resp distress; able to swallow; no SOB. Pt appears anxious; VS stable (110/74; HR 100; RR 18; O2 sat 100%). Provider called to consult. Pt stable & released w/father in stable condition
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient got vaccinated at age 16 when vaccine was approved for 18plus
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Sleep disorder, Tinnitus
Clinical narrative: I developed tinnitus about three weeks after the first injection of the Moderna vaccine into my left arm. I received the second dose in my right arm on April 15. The ringing in my ears has persisted since then. The four days leading up to the sudden onset of the tinnitus were the most stressful of my life, for non-vaccine related reasons. I wonder if the extreme anxiety may have played a role in the onset of tinnitus. The volume of the ringing can vary. It sometimes appears to be mainly in the left ear, but sometimes it's in both.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Hiccups, Myalgia, Pain in extremity
Clinical narrative: Persistent hiccups for 20 mins, stopped 4 hours after. Chills started 6 hours after. Extreme muscle and joint pain started 5 hours after. Extreme arm soreness 2 hours after.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pt did not have an adverse event, but there was a temperature excursion of the J &  J vaccine vial. Vaccine was taken out of fridge at 12:03pm, then 1 dose drawn up at around 12:11pm. I then accidentally left the vial out at room temperature for around 35 minutes. At this point I then put the vial back in the fridge. I asked a couple other pharmacists if okay to use and they said yes, so I drew up more doses around 3:30pm (this is an estimate). I administered this particular dose shortly after drawing up. All doses were administered within the 6 hour timeframe. Per conversation w/ manufacturer the vial was out at room temperature longer than what is suggested (i.e. probably around 5 minutes longer than it should have been out of fridge), so the representative at the mfr is sending this to the safety team to find out if re-vaccination may be necessary.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Interchange of vaccine products, No adverse event
Clinical narrative: Appointment was scheduled through long-term care facility supervisor, who was unaware that patient had previously been vaccinated at a different facility.  Patient was given Moderna vaccine after previously completing Pfizer vaccine series.  Supervisor was contacted and reported no adverse response.
Age: 32.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Cough, Dyspnoea, Pruritus, Throat tightness
Clinical narrative: Approx 20 min after vaccine was given patient began to have a cough and itching.  This progressed to throat feeling tight and difficulty breathing.  Epinephrine 0.3 cc's was given.  O2 at 4L/NC.  Patient began to feel better within 3 min.  Squad was called and the patient was transported to the ER.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Per recovery RN notes:  05/10/2021 at 1052AM Patients  female Vaccine time: 1022AM  Symptoms: Patient stated, " I feel like a little lightheaded" Intervention: RN had patient wait an additional 15 minutes and gave her some water. After another 15 minutes patient reported she was "okay" and left the clinic at 1107.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Pain in extremity
Clinical narrative: Patient with c/o pain  in her rgiht arm, right side of upper back and right hand.  The pain started last night.  She reports not taking any meds for the pain or seeking medical attention at this time.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Flank pain, Herpes zoster, Musculoskeletal chest pain, Pain, Rash macular
Clinical narrative: Pain on side of torso of mid abdomem near lower last rib starting on Saturday, 5/8.  Felt like a side stitch similar to a long run but much more intense.  Pain steadily increased as to Monday, 5/17, in the AM went to urgent care.  They misdiagnosed and said I must have twisted wrong.  Went to primary care phisician Wednesday, 5/18, and was diagnosed with, Shingles, Herpes Zoster.  Prescribed anti-viral Valacyclovir 1000mg 3x daily, Naproxen 500Mb 2x daily and lidocaine cream as needed.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Neuralgia
Clinical narrative: Severe intermittent muscle spasm and nerve pain, ongoing for 1 month after second dose
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Skin reaction, Swelling
Clinical narrative: Developed skin reaction in the shape of a large wheel, erythema and swelling lasted 10 days.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Dry skin, Skin warm
Clinical narrative: Dizziness & clammy. No LOC; AOx4; dizziness resolved, skin warm & dry after 15 min (BP 131/67; HR 80; RR 15). Pt stable & released from vaccination site
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Epistaxis, Headache, Pain, Vaccination complication
Clinical narrative: Nose bleeds, body aches, hair falling off of the exterior part of my lower legs, headaches.  All of the adverse events described started after the second Moderna dose, which was administered on 13 April 2021.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hunger, Nervousness, Syncope
Clinical narrative: Noted to be sitting forward with head in hands, and stated she felt "tired, like I'm going to pass out" about 5 minutes after receiving injection.  Reports feeling lightheaded and dizzy.  Denies pain, HA, SOB, dyspnea, itching, swelling of face/mouth/throat, nausea.  Has not eaten today. Was nervous about getting second dose d/t does not like needles and has been receiving weekly injections of PCN recently.   11:37:  BP /80, P 82, R 16, SpO2 97%.  No respiratory distress, swelling of face, mouth, neck.  No rash or hives.  Declines to lie down.  11:39:  Given water, juice and crackers, taking without difficulty. 11:42:  Feeling "better", dizziness resolved, still lightheaded.  States "I'm really hungry." Continuing to eat snack.   11:46:  Finished snack (8 oz juice, two pkgs graham crackers).  Reports fatigue, dizziness and lightheadedness resolved.   11:48:  Standing and walking without lightheadedeness or dizziness.  Feels well and ready to go home.  Has friend with her who can drive. 11:49: Discharged home in stable condition with routine post-vaccine instructions and instruction to eat full meal when she gets home.  Escorted to POV by RN.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Culture urine positive, Cystitis, Kidney infection, Muscle spasms
Clinical narrative: I woke up the morning of the 25th, with some lower abdomen cramping and and low back pain - lasted a few hours - and I was having contractions. I was not dilatated and labor had not progressed past early contractions. Gave me a IV of fluid - Liter; monitored babies heartbeat; They sent me home with antibiotics - for kidney or bladder infections - something along those lines that was irritating my uterus. It subsided (AE) that afternoon - I did 7 days of Macrobid.  Pregnancy history - first pregnancy; Estimated date of delivery: June 10, 2021.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Premature labour, Ultrasound scan normal
Clinical narrative: I woke up the morning of the 25th, with some lower abdomen cramping and and low back pain - lasted a few hours - and I was having contractions. I was not dilatated and labor had not progressed past early contractions. Gave me a IV of fluid - Liter; monitored babies heartbeat; They sent me home with antibiotics - for kidney or bladder infections - something along those lines that was irritating my uterus. It subsided (AE) that afternoon - I did 7 days of Macrobid.  Pregnancy history - first pregnancy; Estimated date of delivery: June 10, 2021.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: pt developed enlarged right supraclavicular lymph node 1 day after 2nd vaccine
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Mild rash at around 15 mins after getting vaccine. Took benadryl rash went away
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pallor
Clinical narrative: post vaccination patient became dizzy and pale vitals 13/66, 96, 22, 98.6, o2 98..911 called to assess patient on arrival patient was stable remained in observation for 30 minutes-mom reported that patients has a history of having extreme anxiety after any injection which causes her to get dizzy, nauseous, sweaty and at times pass out.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Pyrexia
Clinical narrative: My first shot had little side effects. Leg cramps similar to charlie horse for an hour or so, and then was fine. Second shot I did end up having a fever, which is fine and expected.  My heart rate has been consistently at 100-120 bpm still which I did not expect, though I know that infections can cause this. The vaccine clinician recommended I report any reactions like this to support ongoing data collection.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site mass, Paraesthesia
Clinical narrative: Received the Moderna COVID19 Vaccine at Walgreens on 5/7/2021 3pm. My upper right arm is tight like a raised knot at the injection site. Also, I have experienced numbness in my fingers, on and off, primarily in the arm that received injection. Numbness/Tingling sensation began Monday after injection and continues throughout the day and evening.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Patient was given expired Pfizer vaccine. The vial was punctured/mixed at 8:15 am on 05/13/2021, expired 6 hours later at 2:15pm, vaccine was given 4:02pm
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Spinal osteoarthritis, X-ray
Clinical narrative: My first COVID vaccination was on 2/19/2021. Not long after my second shot (03/19/2021), I started having some significant cervical spine pain.  While it could be a coincidence, it is possible that inflammation occurred that led to exacerbation of arthritis that I was not aware of. I had an X-ray conducted and was diagnosed with cervical spondylosis. I not had issues in the past, and the onset of noticeable pain occurred around two to three weeks post-vaccination. While not life threatening, I wanted to report this in case it is helpful in understanding the impact of the vaccine and long-term effects.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Lethargy, Nausea, Pyrexia
Clinical narrative: Lethargic, headache, slight nausea. Chills and sensitive skin. Low grade fever lasting for about 24 hours.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Sensitive skin
Clinical narrative: Lethargic, headache, slight nausea. Chills and sensitive skin. Low grade fever lasting for about 24 hours.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Lethargy, Pyrexia
Clinical narrative: Fever, chills, lethargy, loss of appetite. Lasted about 24 hours
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Epistaxis
Clinical narrative: New onset of nose bleed in left nostril causing 2 er visits, one urgent care visit and an ENT visit for cauterization
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Oligomenorrhoea
Clinical narrative: My period has been heavy and never ending, which I've NEVER experienced!
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Diarrhoea, Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Severe diarrhea and abdominal cramping. Lasted about 1.5 hours.  Sudden, unexpected start of menstrual period. Heavy blood flow.  Body aches and chills. 10+ hours
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Severe diarrhea and abdominal cramping. Lasted about 1.5 hours.  Sudden, unexpected start of menstrual period. Heavy blood flow.  Body aches and chills. 10+ hours
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Muscle spasms
Clinical narrative: Per patient report:  about once a week since my second vaccine I have had like a chill up my entire back.  Starts at bottom works up.  Tiny spasms of skin.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Headache
Clinical narrative: Headache and slight temperature
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Patient became developed COVID symptoms 5/7/21, tested 5/13/21 positive after completing vaccination
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Hypoaesthesia, Paraesthesia
Clinical narrative: arm of injection has tingling, numbness, cold
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Patient got a headache and dizziness approximately 5 minutes after the vaccine. She stated after getting her BP checked several times after her onset of symptoms, she proceeded to say she has had a history of elevated BP in March 2021 and was evaluated by NP, at vaccine site already but since she had more normal BP readings than elevated readings, she decided to not put her on BP medicine. She also had an appointment with MD 5/14/2021 because she wanted to go to another doctor but now has decided to return to see LP at clinic. I called and made her an appointment with clinic for 2:15pm same day and her boyfriend was going to take her since it was already 12:30pm and it was close by our clinic. Phone call today to patient to check on her and she said she keep her appointment at Careconnect with, NP. She stated her BP was still elevated then as well around 150/98 while she was at MD office. Patient complained of a headache off and on until 10PM last night  on 5/13/2021 but feels much better today. She stated, NP and Dr, were going to discuss the medications for her to be on and get back with her but has not restarted medicines yet. She said they had prescribed Metformin a few months ago but Dr. at office took her off Metformin so she has not been taking it for two months now. She took her BP this morning at 9am and it was still 150/98 and is waiting for them to let her know what medications they are calling in for her.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Pyrexia
Clinical narrative: brain fog, fever, headaches (migraines)
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Pt did not have an adverse event, but there was a temperature excursion of the J &  J vaccine vial. Vaccine was taken out of fridge at 12:03pm, then 1 dose drawn up at around 12:11pm. I then accidentally left the vial out at room temperature for around 35 minutes. At this point I then put the vial back in the fridge. I asked a couple other pharmacists if okay to use and they said yes, so I drew up more doses around 3:30pm (this is an estimate). I also administered this particular pt's dose shortly after. All doses were administered within the 6 hour timeframe. Per conversation w/ manufacturer the vial was out at room temperature longer than what is suggested (i.e. probably around 5 minutes longer than it should have been out of fridge), so the representative at the mfr is sending this to the safety team to find out if re-vaccination may be necessary.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: First dose of Moderna was administered to a 16 year old.  No adverse effects reported or observed.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Erythema, Pruritus, Swelling
Clinical narrative: Pt was in observation, after receiving Moderna 0.5mL IM, c/o difficulty breathing through Lt. nostril and itching to neck area. Upon assessment noted redness and swelling to neck area, no flaring of nares noted. Administered Benadrly 0.5ml IM to Lt deltoid, tolerated well. 21:00-no redness or swelling noted, no complaint of difficulty breathing voiced.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: pt received first dose of Pfizer COVID vaccine. 2-3 minutes after the shot was completed, I was alerted that someone has "passed out" in the designated waiting area. upon arriving  at the scene, I saw his mother holding him and helping him to the floor. she states he had fainted---she states he did not lose consciousness, did not fall, and did not hit his head. I called 911 and stayed with him the whole time until the rescue squad arrived. parent states pt has never had a reaction to a vaccine previously, has no health conditions, no allergies to food or drugs. upon arrival, rescue squad gathered information. a mutual decision was made between parent and rescue squad not to take patient to hospital; they walked him to the vehicle
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient got vaccinated at age 17 when approved age of vaccine was 18
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Nausea, Vomiting
Clinical narrative: Patient stated 3 days after receiving vaccine, she had nausea, vomiting and became dehydrated. She had to be admitted to the hospital overnight to receive fluids. She stated she did not change her diet. She had been drinking fluids. She does not believe symptoms were due to any food she'd eaten or food poisoning. Patient stayed overnight in the hospital. Hospital location unknown.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Polymenorrhoea
Clinical narrative: My period started 8 days early (this made it an 18 day cycle rather than my standard 26 days). I felt very hormonal leading up the the early menstruation and also with hot and cold flashes which is abnormal for me.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site induration, Injection site pain
Clinical narrative: Pain, stiffness at injection site. Fatigue (moderate)
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Angiogram abnormal, Anticoagulant therapy, Blood glucose increased, Chest discomfort
Clinical narrative: Hospitalized after vaccination with acute submassive PE.  ASSESSMENT / PLAN: Patient is a 53-year-old male in no significant past medical history who presented with complaints of progressively worsening shortness of breath, chest pressure and was found to have acute submassive pulmonary embolism for which he underwent successful mechanical thrombectomy per Interventional Radiology.  Subsequent bilateral lower extremity DVT ultrasound demonstrated acute DVTs in the left popliteal, posterior tibial, peroneal veins. DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute pulmonary embolism, unspecified pulmonary embolism type, unspecified whether acute cor pulmonale present (HCC) [I26.99] HOSPITAL COURSE: The patient is a 53-year-old male in no significant past medical history who is admitted for Acute Saddle Pulmonary Embolism. In the ED, the patient was tachycardic, tachypenic requiring 2 L of O2. CT angiogram thorax showed saddle embolus with extensive bilateral pulmonary emboli and evidence for right heart failure. He was immediately started on IV Heparin. PERT Team was activated and the patient underwent a successful mechanical thrombectomy with IR. Dopplers of the lower extremity showed Left lower popliteal, posterior tibial and peroneal DVTs. After 24 hours of hemodynamically stable vitals, the patient was transition to Eliquis.  The patient stay was complicated with elevated blood glucose along with Hba1c of 9.7. Endocrinology was consulted and started the patient with Lantus and LDC. The patient will be discharged with diabetic regimen and followed up with PCP/outpatient Endocrine.    The patient was stable, AOx4, without complications and discharged safely to his home with his wife.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Dyspnoea, Glycosylated haemoglobin increased, Pulmonary embolism, Right ventricular failure
Clinical narrative: Hospitalized after vaccination with acute submassive PE.  ASSESSMENT / PLAN: Patient is a 53-year-old male in no significant past medical history who presented with complaints of progressively worsening shortness of breath, chest pressure and was found to have acute submassive pulmonary embolism for which he underwent successful mechanical thrombectomy per Interventional Radiology.  Subsequent bilateral lower extremity DVT ultrasound demonstrated acute DVTs in the left popliteal, posterior tibial, peroneal veins. DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute pulmonary embolism, unspecified pulmonary embolism type, unspecified whether acute cor pulmonale present (HCC) [I26.99] HOSPITAL COURSE: The patient is a 53-year-old male in no significant past medical history who is admitted for Acute Saddle Pulmonary Embolism. In the ED, the patient was tachycardic, tachypenic requiring 2 L of O2. CT angiogram thorax showed saddle embolus with extensive bilateral pulmonary emboli and evidence for right heart failure. He was immediately started on IV Heparin. PERT Team was activated and the patient underwent a successful mechanical thrombectomy with IR. Dopplers of the lower extremity showed Left lower popliteal, posterior tibial and peroneal DVTs. After 24 hours of hemodynamically stable vitals, the patient was transition to Eliquis.  The patient stay was complicated with elevated blood glucose along with Hba1c of 9.7. Endocrinology was consulted and started the patient with Lantus and LDC. The patient will be discharged with diabetic regimen and followed up with PCP/outpatient Endocrine.    The patient was stable, AOx4, without complications and discharged safely to his home with his wife.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Tachycardia, Tachypnoea, Thrombectomy, Ultrasound scan abnormal
Clinical narrative: Hospitalized after vaccination with acute submassive PE.  ASSESSMENT / PLAN: Patient is a 53-year-old male in no significant past medical history who presented with complaints of progressively worsening shortness of breath, chest pressure and was found to have acute submassive pulmonary embolism for which he underwent successful mechanical thrombectomy per Interventional Radiology.  Subsequent bilateral lower extremity DVT ultrasound demonstrated acute DVTs in the left popliteal, posterior tibial, peroneal veins. DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute pulmonary embolism, unspecified pulmonary embolism type, unspecified whether acute cor pulmonale present (HCC) [I26.99] HOSPITAL COURSE: The patient is a 53-year-old male in no significant past medical history who is admitted for Acute Saddle Pulmonary Embolism. In the ED, the patient was tachycardic, tachypenic requiring 2 L of O2. CT angiogram thorax showed saddle embolus with extensive bilateral pulmonary emboli and evidence for right heart failure. He was immediately started on IV Heparin. PERT Team was activated and the patient underwent a successful mechanical thrombectomy with IR. Dopplers of the lower extremity showed Left lower popliteal, posterior tibial and peroneal DVTs. After 24 hours of hemodynamically stable vitals, the patient was transition to Eliquis.  The patient stay was complicated with elevated blood glucose along with Hba1c of 9.7. Endocrinology was consulted and started the patient with Lantus and LDC. The patient will be discharged with diabetic regimen and followed up with PCP/outpatient Endocrine.    The patient was stable, AOx4, without complications and discharged safely to his home with his wife.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dry skin, Erythema, Pruritus, Skin exfoliation, Tachycardia
Clinical narrative: In 48 hours after the first injection Facial itching especially both jaw areas and forehead, scaly forehead and very rough skin like sandpaper on the jaw areas.  Slight improvement after 2 1/2 weeks. After second injection while waiting the 15 minutes had tachycardia for approximately 5 minutes of 125.   Within 48 hours after this injection the itching reoccured and now basically my whole face had extreme itiching, redness, very dry and scaly skin.  Tried Benadryl cream and oral Benadryl with no relief. Saw Dr on my PCP on 05/13/21 and prescribed Prednisone and Prednisone Cream.  Now 2 days later getting relief from the itching.  3 more days of Prednisone to take
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: In 48 hours after the first injection Facial itching especially both jaw areas and forehead, scaly forehead and very rough skin like sandpaper on the jaw areas.  Slight improvement after 2 1/2 weeks. After second injection while waiting the 15 minutes had tachycardia for approximately 5 minutes of 125.   Within 48 hours after this injection the itching reoccured and now basically my whole face had extreme itiching, redness, very dry and scaly skin.  Tried Benadryl cream and oral Benadryl with no relief. Saw Dr on my PCP on 05/13/21 and prescribed Prednisone and Prednisone Cream.  Now 2 days later getting relief from the itching.  3 more days of Prednisone to take
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ear for past 10 days.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye disorder, Fall, Feeling cold, Feeling hot
Clinical narrative: Patient had a reaction immediately after the JJ vaccine. Patient passed out for 10-15seconds, her body stiffened up, she felt hot and then cold and started sweating excessively. Patients eyes closed briefly and then opened. Patient then became conscious and was unware what had happened.  Patient is not on any medication and had not eaten all morning. After administering the vaccine a small amount of blood came out. I gave her a cotton ball to apply on the area and to hold. After 20-30 seconds she said she felt faint and hot all of a sudden. Her body then went limp and her eyes began to close. Her body then stiffened up for a few seconds. After shouting her name a few times she regained consciousness and was able to talk. she didn't realize what had happened. Her body was fine again but she had urinated during the episode.  Upon speaking to the patient I learnt that she was nervous about the vaccination and she had felt dizzy in the past when giving blood. I observed the patient over the next 45 minutes. Her speech was fine, she was still a little light headed. She was in her seat for 40 minutes, then I asked her to stand and to move a little to see how she was. She was able to walk a bit but then sat down as she still felt light headed. She than sipped on water and continued talking and seemed to get some energy back.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Injection site haemorrhage, Loss of consciousness, Musculoskeletal stiffness, Urinary incontinence
Clinical narrative: Patient had a reaction immediately after the JJ vaccine. Patient passed out for 10-15seconds, her body stiffened up, she felt hot and then cold and started sweating excessively. Patients eyes closed briefly and then opened. Patient then became conscious and was unware what had happened.  Patient is not on any medication and had not eaten all morning. After administering the vaccine a small amount of blood came out. I gave her a cotton ball to apply on the area and to hold. After 20-30 seconds she said she felt faint and hot all of a sudden. Her body then went limp and her eyes began to close. Her body then stiffened up for a few seconds. After shouting her name a few times she regained consciousness and was able to talk. she didn't realize what had happened. Her body was fine again but she had urinated during the episode.  Upon speaking to the patient I learnt that she was nervous about the vaccination and she had felt dizzy in the past when giving blood. I observed the patient over the next 45 minutes. Her speech was fine, she was still a little light headed. She was in her seat for 40 minutes, then I asked her to stand and to move a little to see how she was. She was able to walk a bit but then sat down as she still felt light headed. She than sipped on water and continued talking and seemed to get some energy back.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: PATIENT'S THROAT BEGAN TO ITCH, IMMEDIATELY GAVE PATIENT BENADRYL SYRUP 10 ML BY MOUTH AT 1046AM . BY 1055 PATIENT SYMPTOMS RESOLVED. INSTRUCTED PATIENT TO CALL IMMEDIATELY IF ANY OTHER ISSUES CAME UP AND GO TO ER
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein increased, Oropharyngeal pain, Rash, Rash erythematous, Red blood cell sedimentation rate increased
Clinical narrative: Patient received this Pfizer vaccination outside of this clinic, tolerated first dose with no issues, however 3 days after receiving second dose he had the onset of diffuse erythematous rash covering his legs and arms, he also noted a mild sore throat, but no respiratory distress. he did not immediately seek medical attention but reported symptoms to a doctor friend, who advised benadry, and to seek medical attention. He began taking benadryl 50mg q8 hours and symptoms gradually improved, he later sought care through our clinic and was seen 3 weeks after onset of symptoms. He has been taking Benadryl regularly 50mg every 8 hours which has been effective in controlling symptoms but when he misses dose he experiences recurrence of rash.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Tryptase increased
Clinical narrative: Patient received this Pfizer vaccination outside of this clinic, tolerated first dose with no issues, however 3 days after receiving second dose he had the onset of diffuse erythematous rash covering his legs and arms, he also noted a mild sore throat, but no respiratory distress. he did not immediately seek medical attention but reported symptoms to a doctor friend, who advised benadry, and to seek medical attention. He began taking benadryl 50mg q8 hours and symptoms gradually improved, he later sought care through our clinic and was seen 3 weeks after onset of symptoms. He has been taking Benadryl regularly 50mg every 8 hours which has been effective in controlling symptoms but when he misses dose he experiences recurrence of rash.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Petechiae
Clinical narrative: 12-13 Petechiae on left forearm onset 12 days after second Moderna dose. 1 on right eyelid onset day 13. Blood work showed normal platelets. No other symptoms. Petechiae began fading 1 day after onset. Eyelid petechiae still present.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Sleep disorder
Clinical narrative: After first injection, I received daily and weekly surveys.  This time I didn't, this is the reason I'm filling out this form.  This time, about 3 hours after the Moderna injection #2, I started having body aches and general malaise.  The first night I ached so badly, it woke me up.  My fingers and even my butt cheeks were aching.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Joint stiffness, Urticaria
Clinical narrative: first day joint stiffnes.  On second day until today I have had hives and flushness to the face.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Pulmonary embolism
Clinical narrative: was diagnosed with pulmonary emboli 4/26/21
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous, Skin warm
Clinical narrative: localized red rash the size of a fist. warm to the touch and is painful
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Breast pain, Fatigue, Herpes zoster
Clinical narrative: Immediate fatigue worsen daily... pain in left breast. left arm pit back left shoulder blade for several days then the shingles blisters appeared saw emergency dr on may 1st 2021. Were told this shingles outbreak is directly from the vaccine. Told can have second covid19 vaccine in few weeks but primary care dr said not safe to have second covid19 vaccine because it could be more serious effects next time. What should this patient do regarding second dose?