chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Per patient's mother patient was noted with swelling/redness to face primarily the cheeks, skin hot to the touch and chills about 8PM 10/18/2021. Around 1:00AM 10/19/2021 they called EMS and he was taken to the hospital. On the way to the hospital he vomited once in the ambulance. Patient's temperature was 103.4 at the hospital and  was given Tylenol and Motrin. He was discharged after evaluation. Mother unaware of any other medications/treatment/diagnosis given at the hospital.
Patient was given 0.2ML of the 30MCG formula instead of 0.2ML of the 10MCG formula.
Patient passed out directly after being given the injection. She was placed on the floor to recover.  She came to fairly quickly and said she was experiencing tingling in her arms and legs. She was given a Coke and she said she was feeling better. She was sent to the Care Center because she already had a cough but no fever. She came back to the pharmacy after her visit and was given prednisone, ALLEGRA, and PROAIR due to her current illness.
ITCHING THAT BEGAN TO EARS.  RASH/ITCHING SPREAD TO BACK AND THEN FACE.  MILD SWELLING TO UPPER LIP.  DENIES SWELLING OF TONGUE; DENIES DIFFICULTY BREATHING OR SHORTNESS OF BREATH.
Pt has erythemic, pruritic papules & vesicles on anterior and posterior trunk, neck, face, & scalp.
The morning of 2 April, I woke up with a fever, chills, sweating and an excruciating headache. The symptoms persisted for approximately 10 hours. The following Monday, I woke up with sharp pains across my chest and shortness of breath. I was admitted to the hospital Emergency Room for about 7 hours and subsequently diagnosed with pericarditis. It is unknown if the pericarditis was associated to the vaccine but thought it was a good idea to document here.
Swine Flu Symptoms. High grade fever 102.00. Inability to breathe. Treated with ibuprofen fever reducer and empiric inhaler usage.  12/07/09 and 12/31/09 MR and DC summary received for 11/12/09-12/22/09.  Elective tracheostomy. Pt tolerated procedure well. Pt with pneumonia of L lung base. Pt improved and discharged home in stable condition.  12/31/09 Consult received for DOS 12/14/09. F/U visit after elective tracheostomy. Pt breathing comfortably. Wound healing well. Flexible laryngoscopy and bronchoscopy: Bronchoscopy showed: no distal obstructions and patent main stem bronchi.
A non-serious spontaneous report of "we gave expired H1N1 LAIV to a patient" was received from a registered nurse/health professional concerning a 36-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 29-Mar-2010. On 30-Mar-2010, the patient received expired H1N1, Intranasal, for unknown indication. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp. date) and PRODUCT STORAGE ERROR (Vaccine went into 2 to 8 degree Celsius thaw state on or about 20DEC2021 and was administered on 18MAR2022) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Mar-2022 at 2:16 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 18-Mar-2022 at 2:16 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp. date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2 to 8 degree Celsius thaw state on or about 20DEC2021 and was administered on 18MAR2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp. date) and PRODUCT STORAGE ERROR (Vaccine went into 2 to 8 degree Celsius thaw state on or about 20DEC2021 and was administered on 18MAR2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. This case was linked to MOD-2022-542869 (Patient Link).
Fever of 102 degrees F for about 20 hours accompanied by chills, diffuse muscle aches (especially neck and lower back), extreme fatigue. The fever broke after about 20 hours. Muscle aches and fatigue persisted an additional 24 hours or so.
After receiving the vaccine, within a few days I developed a rash on my upper thigh and leg. Within 2 weeks after the second dose, I developed severe joint pain in all my joints. I developed a rash on both legs. I also developed pins and needles sensations in hands, arms, legs. I developed numbness in my left hip, leg and foot. I developed rashes after being exposed to the sun. Its been 3 months and I still have joint pain and nerve pain. The rashes have subsided.
This spontaneous report as received from a healthcare worker refers to a 5 year old patient of unknown gender. On 29-JUL-2015, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX injection, lot # L001327, expiration date 13-JAN-2017 (dose, route and anatomical location were not reported). There were no adverse effects. This is one of the several reports received from the same reporter. Additional information has been requested.
Bell's palsy; A spontaneous report was received from a consumer who was a 59-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed Bell's palsy (facial paralysis).   The patient's medical history was not provided.  No relevant concomitant medications were reported.   On 12 Jan 2021, approximately seven days prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 19 Jan 2021, the patient developed Bell's palsy. As per patient, there was loss of taste, his eyeball was not moving, he had facial pain and he could not raise right side of his lips. The patient stated that his symptoms were still on going at the time of report. Both his PCP and neurologist can not confirm this is not related to vaccine.  Treatment for the event included a seven-day course of Valtrex and Prednisone.   Action taken with mRNA-1273 in response to the event was not provided.  The event, Bell's palsy, was considered not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pt received third dose of shingrix vaccine (series is two). Pt completed series on 05/27/2019 and 08/15/2019 at same facility. Rph did not see record of administration prior to providing immunization. Discovered when patient presented today 4/11/23 for "second dose" and different RPh realized series had been completed in 2019. Pt reported marked nausea after 1/31/2019 dose for 1-2 days but reported no other adverse effects.
04/08/2022: client premedicated with 25 mg of Benadryl due to history of throat and tongue numbness and blood pressure drops. Clients provider is okay with her receiving 2nd booster.  Vaccine administer in special care room @1500, client lying down. 1505: client reports mild numbness to the tip of her tongue and tingling to her teeth. Client also drinking water intermittently helpful. Blood pressure check, 122/82, pulse was 62, respirations were 14. Client administered her own 25mg Benadryl at that time. Client reports Benadryl relieved side effects. Client was observed for 30 minutes without any further incident.
felt drowsy; the injection site have swollen there is no discoloration but it's stiff; the injection site have swollen as a size of large mosquito bite; small headache; foggy in head; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (foggy in head), SOMNOLENCE (felt drowsy), VACCINATION SITE INDURATION (the injection site have swollen there is no discoloration but it's stiff), VACCINATION SITE SWELLING (the injection site have swollen as a size of large mosquito bite) and HEADACHE (small headache) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced FEELING ABNORMAL (foggy in head) and HEADACHE (small headache). On 28-Apr-2021, the patient experienced SOMNOLENCE (felt drowsy), VACCINATION SITE INDURATION (the injection site have swollen there is no discoloration but it's stiff) and VACCINATION SITE SWELLING (the injection site have swollen as a size of large mosquito bite). At the time of the report, FEELING ABNORMAL (foggy in head), SOMNOLENCE (felt drowsy), VACCINATION SITE INDURATION (the injection site have swollen there is no discoloration but it's stiff), VACCINATION SITE SWELLING (the injection site have swollen as a size of large mosquito bite) and HEADACHE (small headache) outcome was unknown.            No concomitant medications were provided.  No treatment details were provided.
10/8/04: tongue swelled 10/9 swelling mouth/lips. 10/13: lip jaw right side. 10/15: upper lip jaw. 10/22: right finger 10/28: bottom lip. 11/11: eye. 11/17:lip. 11/18 tongue. 11/27:lip jaw. 11/29: left eye. Still under care
Client was received in observtion area at 14:15. client c/o dizziness, nausea, headache and chest tightness at 14:26. fluids provided and vitals initiated. Client continued to feel dizzy. Twitching on face and upper extremities noted. client reports feeling extremely weak on lower extremities. EMS was initiated by PM at 14:44 they arrived at 15:03. However clients symptoms improved except the blood pressure.  she verbalized feeling better and declined to go with the EMS to hospital. she was recommended to see her primary care provider for her increased blood pressure and in case she has difficulty breathing. client left the facility with her husband at 15:22.
Presented with weakness, 2 weeks dry cough/SOB; + covid in ED; Admitted 9/13  to medical with Covid PNA/COPD exacerbation; 9/13 zithromax, maxipime, rocephin, singulair, steroid protocol, remdesivir, zinc started; 9/14 symbicort started; 9/16 Tigecycline, merrem  started; 9/17 actemra; O2 requirements: initially on Bipap (due to High CO2), 9/15 HF NC O2; 9/16 back to Bipap and then intuabted, tx to ICU; 9/19 extubated to 5 LPM NC 9/20 out of ICU; to SNF at DC, remains on AirVo 50/60
Patient broke out in full body rash/hives 2 days after receiving her first Moderna vaccine.  Pt's husband called the pharmacy to inform us about the side effects and asked for our recommendation. Staff informed him to take patient to the hospital as it was full body reaction
Information has been received from a consumer concerning his approximately 54 year old wife with autoimmune issues, scleroderma, spinal problems, arachnoiditis, histal hernia and thimerosal allergy who "about 6 years ago" in approximately 2004 was vaccinated with a first dose of PNEUMOVAX 23 (Lot# unknown). Second 0.5 ml dose of PNEUMOVAX 23 (Lot# unknown) was given on 21-SEP-2010 in the shoulder. Concomitant therapy included estrogen therapy (unspecified), pain medication (unspecified), TOPAMAX and other unspecified medications. The consumer reported that after receiving her first dose of PNEUMOVAX 23 in approximately 2004 hie wife developed a hot, swollen 7 inch welt at the injection site, 101 degrees fever, headache, flu-like symptoms and gastrointestinal (GI) upset. The consumer stated that this reaction was less severe than the reaction that the patient experienced after the second dose of PNEUMOVAX 23. On 21-SEP-2010, the patient developed a hot, swollen, 7 inch welt at the injection site, 101 degrees fever, headache, flu-like symptoms and gastrointestinal (GI) upset. There were no laboratory tests or diagnostic studies performed. At the time of the report, the patient had not recovered. The patient did not seek medical attention. On follow up information received on 20-OCT-2010, the patient's husband added that his wife, soon after receiving PNEUMOVAX 23, experienced an exacerbation of the generalized muscle spasms due to her "degenerative spinal disease". At the time of the report, the patient continued to have residual swelling at the injection site and the outcome of the patient was not recovered. Additional information has been requested.
I started developing facial paralysis about a week after receiving the vaccine. I have no previous health issues. I still can't move the right side of my face. My right eye doesn't shut all the way now so I have a chronically dry eye on the right.
3RD DOSE MODERNA COVID VACCINE GIVEN 11/23/21, #939905; 4TH DOSE MODERNA COVID VACCINE GIVEN 4/19/22, #065K21A; pt had a positive COVID test on 8/8/22 in the facility; she passed away in the facility on 8/30/22
Hardening of area; two red patches; tichy; appeared to harder further after massage of arm
Information has been received from a nurse concerning a 20 year old female with no drug allergies and no pertinent medical history who in 2006-2007 had possibly received the entire series of GARDASIL (LOT# not reported). the patient started having headaches in the winter of 2008. The MRI or computed axial tomography of the brain was performed on an unspecified date showing chiari malformations. Unspecified eye studies and a computed axial tomography of brain (CT scan) were also performed with no reported results. The patient had an office and emergency room visit. The patient continues to have persistent headaches. Follow-up information has been received via a telephone call from the nurse concerning the 20 year old female patient. The patient received GARDASIL while away at college several years ago. The nurse reported that the patient experienced chronic headaches for more than 6 months. The nurse also reported that the patient's first MRI was performed in January 2008 and was diagnosed with mild chiari malformations and the rest of the MRI was normal. On 02-AUG-2008 the patient went to the emergency room for headache and dizziness. The patient was admitted. They ruled out meningitides and performed another MRI where they concluded there was no change in the scan. The patient was discharged on 03-AUG-2008 with  mild chiari malformations; the patient was under the care of a neurologist and was treated with unspecified medications. The patient was hospitalized. The patient's mother was questioning the relationship between her daughter's chronic headaches and her GARDASIL series; the office did not believe the headache was related to GARDASIL. Additional information is not expected.
This 48-year-old patient inadvertently received a pediatric dose of Pfizer (10 mcg/0.2 mL) which is approved for ages 5-11.  Patient was observed for the recommended 15 minutes with no adverse reactions.  This was the patient's third dose; the first 2 doses were with the Pfizer (purple cap), for ages 12+.
11/13th at 11pm she received a flu shot then at 2pm she noticed that her arm was really sore, and swollen from the scapula area to below her elbow on left extremity. She states her arm was a dark red. MD stated to put cold packs on arm.
Breakthrough case admission after 3 vaccines Moderna 2/25/21 lot# 010A21A;  Moderna 3/25/21 lot# 030A21A;  Moderna 12/8/21 Lot# 060H21A
Severe headache from about day 3 after vaccine.  Felt like a vice across back of head. On March 19 headache with with vomiting.  Went to emergency room on March 20 on advice of primary care doctor. Diagnosed with a migraine. Given  fluids, Toradol, Compazine and potassium. Headache was preceded by visual disturbance. Relief for 3 days. Fever on April 4. Migraine again on April 17. Also, developed tinnitus in left ear around week 2 after vaccine.  Still have tinnitus. Have had vertigo off and on. Last episode was May 2.
Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On 11-MAR-2016 the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot # L011537, expiration date 03-JUL-2016, dose, dose# and route unknown). No adverse effect reported. Additional information has been requested.
Patient developed symptoms including cough, fever, new loss of taste or smell, fatigue, body aches, headache, sore throat, and runny nose on 08/01.  He tested positive for COVID on 8/4/2020
8/31/04: 18x12cm area of cellulitis on left thigh, treated with warm compresses and Keflex.
menstrual cycle started. I'm currently breastfeeding and have not had one in 2 years.
hives; This case was reported by a physician via call center representative and described the occurrence of hives in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th April 2019, the patient received the 1st dose of Shingrix. On 5th May 2019, 9 days after receiving Shingrix, the patient experienced hives. The patient was treated with antihistamine (Antihistamines). On an unknown date, the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were provided as follows: The health care professional stated that the patient received Shingrix and developed hives, that are reported as ongoing and are only suppressed by taking antihistamines. The reporter consented to follow up.
Patient presented 7/29/05 with right arm swollen and red.  Doctor prescribed an antibiotic.  Child was acting fine.
Information has been received regarding a case in litigation concerning an approximately 8 week old male child who in or about May 1992, through and including August 1996, was injected with vaccinations containing high levels of mercury contained in the preservative thimerosal. It is alleged that as a result of these vaccinations the pt sustained severe and permanent personal injuries, including being diagnosed with autism and other neurological disorders as well as other severe and permanent health consequences. In addition it is alleged that the pt sustained further neurologica insult and exacerbation of his neurological disorder as a result of innoculation with MMR II. Upon internal review, the pt's severe autism, severe and permanent personal injury, general physical health deterioration, and neurological disorder were considered to be other medical events. No further info is available.
4 hours after vaccine, my left arm began hurting alot. 6 hours after vaccine, my whole body ached, and I could tell something was wrong.  12 hours after vaccine, I woke up shivering uncontrollably and covered in sweat. Throbbing headache and could barely move left arm. 30 hours after vaccine (now), cold sweats have stopped, though I still feel extremely sore, tired, and have a headache.
Information has been received from a physician concerning a 36 month old male patient with a history of gastrointestinal problems, absent left kidney and ureteropelvic junction obstruction who on 30-MAR-2007 was vaccinated with first dose of Varivax (Lot # 654756/1335F). Concomitant therapy included amoxicillin for an unspecified infection. On 30-MAR-2007, immediately after vaccination, the patient experienced "allergic/anaphylactic type of reaction". The patient was treated with epinephrine and Benadryl and then went to the emergency department of a local hospital. He was at the emergency department for 6 hours and was not admitted as an in-patient. The patient was prescribed prednisone. A product quality complaint was not involved. Allergic/anaphylactic type of reaction was considered to be an other important medical event by the reporter. Additional information has been requested. Additional information has been received from the physician's office supervisor who stated that patient had no fever, upper rspiratory infection or cough at the time of vaccination. on 30-MAR-2007 10 minutes after vaccination the patient went back to the car with his mother. In car the patient told his mother that the was not feeling well and he was pale. The patient was brought back into the office and he fainted in the exam room. The patient was vomiting, coughing and wheezing. The patient was given albuterol nebulizer, 0.5 ml. Three to 5 minutes later patient felt little better, but was still pale and lethargic with a flushed rash. The patient was no longer vomiting, his chest was clear and he had no rib retraction. The patient was given epinephrine 0.14 ml IM and BENADRYL 15 mg IM. Oxygen 5L was also started. The patient's vital signs were temperature 98.9 degree. O2 saturation 98% heart rate 80, respiration 25. After 5 more minutes the patient was more alert but still tired. After another 15 minutes the patient was again very sleepy, and the was taken to ER. On arrival he was alert and tired. The patient had a chest computed tomography angiography (CTA) and "CVRRR" (result not reproted). The skin flush and rash improved. The patient was diagnosed as having an anaphylactic reaction to vaccine. The patient recovered on same day. No further information is expected.
a large redness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (a large redness on the injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal and Colitis.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (a large redness on the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (a large redness on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications included blood pressure medications and colitis medication
Headache; Neck was hot; Legs began hurting; Chills; Injection site arm is swollen; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Neck was hot), PAIN IN EXTREMITY (Legs began hurting), CHILLS (Chills), VACCINATION SITE SWELLING (Injection site arm is swollen) and HEADACHE (Headache) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 18-Dec-2020.    On 10-Jan-2021 at 11:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced FEELING HOT (Neck was hot), PAIN IN EXTREMITY (Legs began hurting), CHILLS (Chills) and VACCINATION SITE SWELLING (Injection site arm is swollen). On 11-Jan-2021, the patient experienced HEADACHE (Headache). On 10-Jan-2021, FEELING HOT (Neck was hot) and CHILLS (Chills) had resolved. At the time of the report, PAIN IN EXTREMITY (Legs began hurting), VACCINATION SITE SWELLING (Injection site arm is swollen) and HEADACHE (Headache) outcome was unknown.        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 product use was not provided by the reporter. Treatment included Tylenol.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Palpitations started about 90 minutes after the shot. Averaged about one palpitation per hour for 8 hours. Did not notice any overnight or in the 3 hours after waking.