chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Incomplete course of vaccination; chills; body aches; This case was reported by a consumer via call center representative and described the occurrence of chills in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 19th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 19th March 2019, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced chills and general body pain. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the chills and general body pain were resolved with sequelae and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the chills and general body pain to be related to Shingrix.  Additional details were received as follows: The patient stated that she received her first dose of Shingrix and that evening she experienced chills and had body aches for 36 hours.  Till the time of reporting patient has not receive the 2nd dose, which led to  incomplete course of vaccination. No additional details were available. The patient consented to follow up. This case has been linked to US2019AMR227598, reported by the same reporter.
Patient received Moderna 1st and 2nd dose (fully vaccinated as of April), tested positive for Covid 19 on 6/11.21
Patient had extreme fussiness and large blowout stools post rotavirus vaccine. She had some specks of blood in it too and was seen in the ER and a culture was taken. No fever, lots of increased sleeping, some pallor. Today mom and date note she is acting more like herself and stooling more normally and her eating has improved.
Sudden  redness on right arm from point of vax injection down to area just above elbow bend. Began on Sat. Mar 13, still some appearance on Mar 9, although seems to be disappearing.  Used ice, Benadryl to relieve redness, and OTC medication for slight itch.
experienced injection site swelling and redness; experienced injection site swelling and redness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2), administration date 05Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose of covid vaccine), for Covid-19 immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset Apr2021, outcome "unknown" and all described as "experienced injection site swelling and redness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Persistent joint pain; Body aches; Muscle pain; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of ARTHRALGIA (Persistent joint pain) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Persistent joint pain) (seriousness criterion life threatening), PAIN (Body aches), MYALGIA (Muscle pain) and FATIGUE (Fatigue). At the time of the report, ARTHRALGIA (Persistent joint pain), PAIN (Body aches), MYALGIA (Muscle pain) and FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. It was reported as persistent for medication Details and reason for taking the medicine. Under lab data/results: CT, MRI EEG, EMG, EKG were mentioned with no results being reported. Treatment information was not reported.  Company Comment: This is a Spontaneous case reported by a patient, concerning a 52-year-old female patient, with no medical history reported, who experienced the unexpected and serious (due to life-threatening) event of Arthralgia, which occurred on an unknown date related to the first dose of mRNA-1273 vaccine. Since no vaccination nor event dates were provided, temporal association and latency cannot be properly assessed. Computed tomography, magnetic resonance imaging, electroencephalogram, electromyogram and EKG were performed, with no results reported. No information about treatments received was disclosed. At the time of the report, the event had not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 35 month old female patient who experienced red area measuring 1-2 inches in diameter on arm, 3 inch diameter hard area surrounding injection site and 3 inch diameter tender area. At 35 months of age, the patient received the fourth dose on 8/9/2005. Dose regimen was 1 dose 1 time per day intramuscular. Concomitant medications were not reported. on 8/11/2005, the child developed a red (injection site erythema), hard (injection site induration), swollen (injection site swelling), tender area (injection site pain) measuring 3 inches in diameter at the injection site. She recovered by 8/15/2005. This is one of three children from the same facility who developed an injection site reaction following receipt of Prevnar lot A56117B. See MCN HQWYE949616AUG and MCN HQWYE973817AUG05.
Information has been received from a health professional concerning a 29 month old male who on 05-NOV-2004 was vaccinated subcutaneously with a 0.5 ml dose of Varivax (lot # 648302/0187P). On 03-APR-2006 the patient developed a vesicular rash and presented to the practice with the vesicular rash of about 100 itchy lesions. No other symptoms were noted. Subsequently the patient recovered. There was no product quality complaint involved. No additional information is available.
Itchy - in the evening; itchy all over my whole body; and restless due to the itchiness. I was hot but didn't have a fever. About 8 pm, I had a rash all over my back. It was hives and large red inflamed area. It was itchy, too. That was the only place where I had a visible rash. I was able to reach the doctor on-call at my primary care practice that Saturday night (telemed). I sent him a picture - he said it was an allergic reaction to the vaccine ( a delayed skin reaction). He told me to take Benadryl and to go to ER if I had trouble breathing. I didn't have to go to ER as I didn't have trouble breathing. The Benadryl helped with the itching. The rash stayed there close to a week. The Benadryl did improve it and I took it for another 24 hours. On the 22nd, I went to Urgent Care  (the same phone number as my doctor) and the rash was real still really visible. They prescribed a topical ointment (steroid) and that was helpful. It was still itchy but not as bad as before I used that - it was more like a normal mosquito bite after using it. Dr. at Urgent Care said it was definitely an allergic reaction. He also prescribed an oral steroid which  I didn't take. Two months later, I had to have an MRI with contrast dye - as soon as the contrast dye went in I couldn't breathe - they had to pull me out of the machine. And then I developed the same exact rash (same size and shape, even) that I had had after the 1st vaccine. I went to my Primary Care Dr, and she also prescribed me the same topical steroid which I used. It took about a week for that rash to resolve. I wasn't as itchy as I was with the first time (after this COVID shot). They sent me to an Immunologist. With  having cancer, I've had a lot of MRI's with contrast and never had a reaction before. That doctor thought the vaccine had activated my immune system to be more reactive. Steroid and an Histamine - to premedicate with that before I take the Booster shot next week.
headache - mostly resolved; severe chills - resolved; fever - resolved; extremely sore arm; extremely sore around neck, back and shoulders; sore tight throat; period spotting before period is due
Employee states she developed a migraine the evening after receiving her 2nd COVID vaccine.   She took medication which help dull the headache.  She woke up the morning of 2/11/21 with hives on her face.  She states her face was red and her eyelids swollen.  The left eye lid more than the right.  Employee took benedryl which helped, but her left eyelid remains red and swollen.  Advised employee to contact her PCP.
Around 15 minutes after the shot, began to feel some tongue swelling.  Progressed to some throat swelling, breathing not compromised.  Pulled over and called Dr office prescribed Benadryl wh/I took upon arriving home.
No additional AE reported; HCP states she is calling to add a patient to the pregnancy registry for GARDASIL 9.Patient received GARDASIL 9 on Mar 4, 2022 while pregnant.; This prospective pregnancy spontaneous report was received from a register nurse and refers to a 14-year-old female patient. The patient's pertinent medical history, concomitant medications, past drug reactions or allergies were unknown by the reporter.  On 04-MAR-2022, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, vaccination scheme frequency and anatomical site of application were not reported; lot number T036812 that was verified to be a valid lot number for syringe formulation with an expiration date reported and established as 28-APR-2023) for prophylaxis while pregnant (exposure during pregnancy).  No additional adverse event (AE) was reported (no adverse event).
Pt stitting for 15 min observation after Moderna 1st vx to Left Deltoid. Pt started coughing and stated her throat was closing.  911 called. 0.5 ml Adrenalin given to left thigh. Proair HFA albuterol given 2 puffs orally of 90 mcg. Vitals: HR- 90, O2 stat room air- 97%, RR- 25, p- 90.  EMS arrived @ approximately 15:20 to assist pt. Demographics given to EMS. Pt departured with EMS 15:35.
Initial and follow up information has been received from a physician concerning an 8 year old white male who on 03-JAN-2008 was vaccinated with a "single dose series" of pneumococcal 23v polysaccharide vaccine (lot# 658555/0964U) IM in the left by his allergist. Information was received from an allergist and reported the history was taken from th patient's mother. The patient has a history of chronic urticaria of uncertain etiology and pressure equalization tubes "PE Tubes." The patient had the urticaria for about 14 months but has not had any urticaria since the beginning of October 2007. The mother reported that the urticaria tends to flare up when he gets the sinus infection. The patient had a runny nose for 5 days with no cough prior to vaccination. The patient went to see the allergist and was given a pneumococcal 23v polysaccharide vaccine and within minutes at 2:20 PM the patient began coughing, having difficulty breathing, his face turned red and began to swell. The patient felt dizzy, looked pale and sweaty. The patient was given epinephrine 0.3 mL IM, ranitidine 25 mg IM, BENADRYL 50 mg IM and 45 mg PO of PRELONE. The patient also had 100% oxygen provided. 9-1-1 was called and transferred the patient to a hospital ER department. All of the patient's symptoms resolved with the exception that the voice remained somewhat hoarse. The patient's systems were reviewed. The patient had no fever. The patient does have a positive skin test to dogs. He did get some swelling under his eyes with the allergic reaction. There were no complaints of chest pain during the allergic reaction. There was no cough prior to the allergic reaction, but did have coughing and difficulty breathing with the allergic reaction. The patient looked like he was gagging, but did not throw up. The patient had no diarrhea. There were no complaints of extremity pain. There were no hives. The patient complained of dizziness during the allergic reaction. On 03-JAN-2008, the patient was alert and a non toxic child. The patient also had abdominal discomfort and recovered on an unspecified date. The patient's body temperature measurement was 36.7 centigrade orally, the total heartbeat count was 96, respiratory rate measurement was 18 and blood pressure measurement was 117/7. The patient's voice is slightly hoarse. The physician reviewed the findings and he felt that the patient has had an anaphylactic reaction to the pneumococcal 23v polysaccharide. The physician had recommended overnight observation in the short stay unit in case he has a late reaction in addition to the early reaction, which is now almost completely resolved. The mother is in agreement with the plan. Additional information is not expected.
SYncopal episode.  Passed leaving office.  Laid down on examination table for 30 minutes.  Felt better.  Driven home by mother, second episode.  Brought back to office.  Tolerated crackers and water.  Felt better, sent home.  Tired remained of the day.  Now asymptomatic.
light headedness; panic attacks; flank pain; cloudy urine; hematuria; mild anemia; This is a spontaneous report from a contactable physician. A 34-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 07Apr2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021, the patient developed light headedness, panic attacks, flank pain and cloudy urine. The event resulted in doctor or other healthcare professional office/clinic visit. On unknown date in Apr2021, the patient underwent Complete Blood Count (CBC) and the result was reported as a small amount of hematuria and mild anemia, which were new. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events light headedness, panic attacks, flank pain, cloudy urine, hematuria and mild anemia were not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
After 15 minutes from receiving the vaccine, patient complained of pruritus at her face  and  warm sensation at her upper extremeties, oral mucosa was within normal limits. Patient denied chest pain, shortness of breaths, palpitations, nor was sweating, no rash nor skin or mucosal lesions. She was calm able to talk incomplete sentences. Only remarkable previous history  of allergy to Aspirin. Patient was send to  ER and ER Physician Assessment was pruritus . She was treated at ER with Methylprednisolone and Diphenydramine  IV; symptoms resolved. Discharged home with hydroxyzine as needed for itchiness.
History of Present Illness Patient is a pleasant 44 year-old woman who presented to the ED on 11/14/21 with complaints of nausea, vomiting and worsening anxiety.  She reported that her symptoms started on 11/11/21 with cough and cold like symptoms, but then on 11/12/21 she became nauseous and started vomiting.  She had no abdominal pain.  Her glucose that evening was 400 and she continued to treat herself with her insulin pump but was having a difficult time getting her glucose to downtrend.  She added subcutaneous insulin and was finally able to get her glucose down to about 150 on 11/13/21 but since then has not been able to keep any oral intake down.  Upon arrival to the ED she presented with mild hypertension with a SBP in the 160s, otherwise vitals were stable and appropriate.  Her CBC was unremarkable.  Her CMP revealed a K of 2.8 a Cl of 97, Ca of 10.4, glucose of 210, and a BUN/creatinine of 36/1.11, respectively.  Her anion gap was 36.  A d-dimer was 570.  Her serum ketones were 3.0.  Her UDS was positive for cannabinoids.  Her UA was positive for protein at 100, neg for glucose, and 20 ketones, but was not indicative of infection.  She was negative for influenza A/B and RSV, but tested positive for COVID-19.  ABG were drawn and revealed 7.45/33/22. A CXR revealed mild atelectasis in the right base.  In the ED she was given Inapsine, a bolus of IVF, IV famotidine, and IV potassium.  She was admitted to the ICU for further evaluation and management. She was seen in the ICU this morning. Very anxious and emotional.  VSS.  No acute events noted overnight.  Had clears last NOC and did not tolerate well, increased nausea and increased anxiety.  She denies pain but admits to general malaise and body aches.  No other medical complaints this AM.  Hospital Course 1. Diabetic keto acidosis ... 3. Intractable nausea/vomiting 4. COVID-19
Patient received VZV on 3-24-08 into the right upper arm during an office visit for irritation to the right angle of her mouth.  Presented in the office 3-26-08 for a local reaction at the injection site.  The site was tender, firm to touch, with an erythematous area approximately 12 x 6 cm.  The child also presented, 3-26-08, with lesions to the right corner of her mouth, which was diagnosed as Impetigo.  Cephalexin oral susp., 250mg/5mL, 2 teaspoons po BID for 10 days was prescribed along with cool compresses to right upper arm and Tylenol.  Brother had a very similar VZV local reaction on 2-12-08.  See VAERS report # E-21343.
Full body muscle spasms. Could not stop them for a good 30 minutes. Made it hard to breathe. This happened multiple times over the course of a couple hours for prolonged periods.   It was like having a shiver from being cold but 100x worse.
Took benadryl as suggested by primary provider prior to injection;  30-40 minutes after injection nausea and vomiting last about 3 hours. Soreness/aches started about 3 hours after injection lasting 2 days. Chest tightness, cough started about 3 hours after injection and are ongoing.
About 3 minutes after the vaccine was administered, patient started coughing and breaking out on his face with rash/hives, and complained of difficulty breathing. He also started to sweat on his forehead. Administered EPIPEN Jr on his right thigh through clothing. Called and ambulance and was transported to the ER.
Eczema type rash, diarrhea with blood specks, excessive spitting up, fever (Max 101.0) x24 hours, inconsolable at times, pain, itching It all started the evening after the vaccines.  Tylenol given to reduce temperature and alleviate discomfort.
This 41 yo female received her first Pfizer COVID vaccine (Lot EL1284)  on 1/7/2021.  She reports being in good health, had no illness exposures (does work in hospital with children), and had no recent travel.   She reports following her Covid vaccination, she had a sore arm at vaccine site for 4-5 days with no other issues.  On 1/31 (day24) while putting on lipstick to take a selfie to send to her friend she noticed  the right side of her lower face (lip area) felt "weird"- tingled  and the corner of her mouth would not smile symmetrically with left. Her friend commented something was off with this picture. The next day this droop worsened with loss of facial lines/wrinkles on right (nasolabial fold), had tingling/numbness to lips and corner of mouth and inability to smile on right. This prompted her husband to bring her to the ER on 2/1/2021. She denied any fever, headache, weakness to arms/legs, no SOB/CP, dysphagia or speech issues or trauma.  ER providers exam noted normal CN evaluation but documented mild right sided decrease in nasolabial fold vs left and loss of taste to anterior right tongue.  She had no involvement of eye or forehead. She was diagnosed with early Bell's Palsy and treated with oral steroids and anti-virals.  AS of 2/10/2021 with use of medications, she advised her facial weakness/droop had resolved but still has tingling.  Her smile is symmetrical at this time.   No c/o on loss of taste.  Has diagnosis of Bell's Palsy.   IHD case 9967.
Sore muscle, tender to touch; Strong metallic taste in mouth; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the arm left on 19May2021 at 14:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19May2021 at 21:00, 7 hours after vaccination, the patient experienced sore muscle which was tender to touch and strong metallic taste in mouth like had nickels on her tongue. The event was present even after almost 24 hours of vaccination. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. The clinical outcome of the events sore muscle, tender to touch and strong metallic taste in mouth was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST. The patient received FLUMIST on 06-Nov-2008. A physician from the National Center for Immunization and Respiratory Diseases Centers for Disease Control and Prevention reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril. The other half was discarded. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 24-Nov-2008 that included the following: demographic data, date of vaccination and confirmation that none of the children experienced adverse events.
Patient has hx of vasovagal response with needles. He was sitting when he got the vaccination then seconds later he started having the shakes, convulsing, slumping down and falling over but came to and felt fine. Vitals taken: All within normal limits. He got up and sat on couch to eat his lunch.
Allergic reaction, initial encounter -- vital signs stable, afebrile, O2 sat at 100% -- likely localized allergic reaction to vaccine, although cellulitis is also part of my differential -- will treat with prednisone burst for 5 days -- counseled to ice arm, take over the counter Benadryl -- if redness spreads or if patient develops fever/chills, she should start taking antibiotic prescribed for possible cellulitis -- return precautions given - prednISONE 10mg Tab; Take 3 Tabs by mouth daily for 5 days  Dispense: 15 Tab; Refill: 0 - cephalexin (KEFLEX) 500mg Cap; Take 1 Cap by mouth four times daily for 10 days  Dispense: 40 Cap; Refill: 0.