chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dose_number=3; Extreme soreness at injection site; Extreme lethargy approximately 24 hour later; Severe migraine; Noticeable tinnitus; Hunger without ability to actually eat food without feeling sick; Hunger without ability to actually eat food without feeling sick; Overall body aches and soreness; feeling like I have the Flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Nov2021 14:00 (Batch/Lot number: unknown) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Autism" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "GAD" (unspecified if ongoing); "Major Depression type" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "known_allergies Penicillin" (unspecified if ongoing). Concomitant medication(s) included: DIAZEPAM; LISDEXAMFETAMINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8731, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 29Apr2021, when the patient was 31 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0185, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 07Apr2021, when the patient was 31 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 20Nov2021 10:00, outcome "recovering", described as "Extreme soreness at injection site"; LETHARGY (non-serious) with onset 20Nov2021 10:00, outcome "recovered", described as "Extreme lethargy approximately 24 hour later"; MIGRAINE (non-serious) with onset 20Nov2021 10:00, outcome "recovered", described as "Severe migraine"; TINNITUS (non-serious) with onset 20Nov2021 10:00, outcome "recovered", described as "Noticeable tinnitus"; HUNGER (non-serious), EATING DISORDER (non-serious) all with onset 20Nov2021 10:00, outcome "recovered" and all described as "Hunger without ability to actually eat food without feeling sick"; PAIN (non-serious) with onset 20Nov2021 10:00, outcome "recovered", described as "Overall body aches and soreness"; INFLUENZA LIKE ILLNESS (non-serious) with onset 20Nov2021 10:00, outcome "recovered", described as "feeling like I have the Flu"; IMMUNISATION (non-serious), outcome "unknown", described as "dose_number=3". Therapeutic measures were not taken as a result of vaccination site pain, lethargy, migraine, tinnitus, hunger, eating disorder, pain, influenza like illness.  Additional Information:  Facility where the most recent COVID-19 vaccine was administered was at Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Hospitalization was not Prolonged. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Very sick /pretty sick; Tired; Congestion; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Very sick /pretty sick), FATIGUE (Tired) and NASAL CONGESTION (Congestion) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 008B21-2A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Lung congestion (Chronic lung congestion for 7 years) and Cough (pretty much every day.). Concomitant products included PREDNISONE for Inflammation localised.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Very sick /pretty sick), FATIGUE (Tired) and NASAL CONGESTION (Congestion). At the time of the report, ILLNESS (Very sick /pretty sick), FATIGUE (Tired) and NASAL CONGESTION (Congestion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other concomitant medications were  Blood pressure medications 3 and blood thinner, unspecified.  Treatment medications were  typical decongestant medicine, unspecified.
This form is being submitted as patient and parent stated he was 12 but in fact his DOB states he is under the age of 12, not realized until after the injection was given
Within 15 minutes after receiving DTaP, MMR, and varicella virus vaccines, he developed a pruritic eruption and breathing difficulty. He presented to the ED with a diffuse urticarial rash on his face and trunk. He was given epinephrine 0.1 mg/kg IM, diphenhydramine PO, and prednisolone PO. He spit up the oral medications and was given diphenhydramine IV and methylprednisolone IV. He was discharged on prednisolone and diphenhydramine.
I had a partial loss of vision in the upper half of my right eye. It lasted for 10 seconds before it started to dissipate on it's own. It gradually started to clear up. On May 15th, I went to my eye Doctor. He explained I should go to the emergency room to be checked for possibility of stroke. I went to ER at 5:00PM that same day and sent me home with a heart monitor. I haven't had any reoccurrence since. Omaurosis Fugax is what I was diagnosed with. I was put on 325 mg of Aspirin per day since the event.
Wheezing on 10/01/08 @ 9 pm Hives on 10/02/08  Site edema, and hot to touch on 10/02/08.  Self administered benadryl and cortisone cream
Could not sleep on at bedtime. Next day better but still tender. On 8/26 hot to touch and red circle golf ball size at injection site.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient contacted pharmacy 4/7/21 at 8pm to seek advice on a rash that has covered his entire upper torso.
Patient was here last 10/1/18 and had both high-dose flu shot and PNEUMOVAX in the same arm (right). The next day, patient states that she noted the area of injection to be red, swollen and painful. Denies any fever. Today, the redness is still present but as big and it has gone down in terms of swelling as well. She also states that yesterday, she felt that her muscles in her arm, chest and back were painful and was worse when she lies down. Denies any wheezing, denies any fever.
Patient reports she received vaccine at 10:10 a.m. in the morning.  At about 1237 at night she woke up feeling throat swelling and increased wheezing.  She took 50 milligrams of Benadryl and got up and walked around.  She reports that her symptoms resolved after about 30 minutes and she went back to bed without any difficulty.  She has had a previous history of anaphylactic reaction to atenolol and chlorthalidone, which do not appear to have a cross reaction to the vaccine.  She is wondering if she should cancel her 2nd vaccine appointment and is concerned that she may not have full immunity with only 1 vaccine dose. Dr. recommends that she not receive the 2nd dose of COVID-19 vaccine.
Autism Spectrum Disorder. 5/23/06 Received medical records from PCP which reveal pt had URI & OM week prior to vax.  Day of vax, continued URI sys but resolved OM.  PMH: mult recurrent bouts of URI w/bronchitis, exudative tonsillitis, bilateral OM, wheezing, nasal congestion, difficulty breathing/eating/drinking, & atopic dermatitis.  Delayed speech noted at 2yo check up.  Eval at Easter Seals 2004 revealed developmental & motor delays & started on OT.  Slow progress & dx w/autism 2/2006.  Continues in PT/OT/ST & special ed class/ss 3/30/2010 Autism spectrum disorder.
Developed itchy, red eye at approx 5:30 PM on 10/23/03 which continued on 10/24/03. On 10/25/03 developed hives. On 10/26/03 developed impaired speech and difficulty swallowing. Went to hospital and was started on Prednisone. Saw dermatologist after that who increased Prednisone dosage. 11/3/03 pt recovered, no symptoms.
Information has been received from a nurse practitioner, via a company representative, concerning a 15 year old female patient, who on 01-FEB-2007 was vaccinated with the first dose of Gardasil (Lot # 655503/0012U). There was no concomitant medication. On 02-FEB-2007, within 24 hours after the vaccination, the patient developed a rash on the arm and trunk. On approximately 04-FEB-2007 ("48 hours later") the patient's rash spread to the legs. The nurse practitioner stated that the rash "lasted 2 weeks with no fever or itching," and confirmed that the patient had recovered from the rash. The patient sought unspecified medical attention. Additional information has been requested.
Got sick, Flu like symptoms; Fever 101.4 F; Chills; General body pain; Sore throat; Headache; Metalic taste in mouth; Cough; Runny nose; This case was reported by a consumer via other manufacturer and described the occurrence of influenza-like symptoms in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE HIGH-DOSE QUADRIVALENT INFLUENZA VACCINE) for prophylaxis and COVID-19 VACCINE MRNA (MRNA 1273) (COVID-19 VACCINE MODERNA) for prophylaxis.   On an unknown date, the patient received Shingrix. On 1st September 2021, the patient received FLUZONE HIGH-DOSE QUADRIVALENT INFLUENZA VACCINE .7 ml. In September 2021, the patient received COVID-19 VACCINE MODERNA. On an unknown date, unknown after receiving Shingrix and an unknown time after receiving COVID-19 VACCINE MODERNA, the patient experienced influenza-like symptoms, fever, chills, general body pain, sore throat, headache, taste metallic, cough and runny nose. On an unknown date, the outcome of the influenza-like symptoms, sore throat and headache were unknown and the outcome of the fever, chills, general body pain, taste metallic, cough and runny nose were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, fever, chills, general body pain, sore throat, headache, taste metallic, cough and runny nose to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's medical history, past medical treatment, vaccination, concomitant medications and family history were not provided. On 1st September 2021, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. On an unknown date, patient received Shingrix. The patient got sick with flu like symptoms, metallic taste in his mouth,  body aches, chills, 101.4 degrees fever, cough, runny nose, sore throat and headache three weeks after getting the shot on 1st  September 2021, less than 36 hours after giving my Covid-19 booster. Other relevant laboratory test not reported. It was not reported if the patient received any corrective treatment for the events.
Came to our office 2 days after vaccinations with rash that had started that morning (3/5/14) and had spread throughout the day. Per doctors assessment rash was generalized and located on her face, scalp, trunk, and buttocks. No other symptoms.
fever for  3 days, fatigue, body ache (to be expected)...but on day 3, Monday, March 8th, I had shortness of breath, sharp pains, and it felt like my breasts were on fire. I have never experienced anything like it before. It only lasted a few hours, but it was a very strange feeling. I also had waves of fatigue and felt achey  on and off for two weeks afterward.
Redness, edema, heat, itching and tenderness at injection site approx. 3 inch area day after injection worse by day two.
Pt was seen on 4/19/21 and noted left arm swelling that started 2d post her 2nd Moderna vaccination on 3/31/21. She had a LUE U/S done on 4/22/21 that revealed
Pt reported sudden onset of shortness of breath and general weakness.  symptoms resolved in less than 5 minutes with no treatment.   BP 126/74, HR 76 strong and regular, RR 16, Skin PWD.  PT denied further treatment.
No adverse event; Administered the vaccine to 346 patients after the 30 day by used; Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 29-Jul-2022; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 29-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 29-Jul-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 29-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 29-Jul-2022).    Concomitant product use was not provided by the reporter.  Patient received full dose.  Number of vials: 35 vials.  On 04-Jun-2022 the vial was initially stored in the refrigerator. The vial did not underwent any temperature excursions.  Treatment information was not provided.
Patient received vaccine on date 31-MAR-2022 which was expired 24-MAR-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on date 31-MAR-2022 which was expired 24-MAR-2022) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.  On 31-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on date 31-MAR-2022 which was expired 24-MAR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine on date 31-MAR-2022 which was expired 24-MAR-2022) outcome was unknown. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  Patient received 2nd booster dose.  No treatment medications were reported
shingles; dime sized, tiny blisters, eventually crusted over; painful; rash was in his mustache area; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced shingles, blister, pain and rash. On an unknown date, the outcome of the shingles, blister, pain and rash were recovered/resolved.   It was unknown if the reporter considered the shingles, blister, pain and rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-APR-2022 Reporter's Comments: The patient reported case for herself. The patient received his first dose of Shingrix about 2.5 months ago.    The patient stated that after 3 days after his dose, he developed shingles on his face. He described it as dime sized, tiny blisters, painful and it eventually crusted over. The patient stated that it lasted for about 2 weeks and resolved.  The location of the rash was in his mustache area. The reporter consented to follow up.
Had mild tinnitus from time to time, tinnitus resurfaced and became much worse, constant and almost intolerable.
Systemic: Abdominal Pain-Medium, Systemic: Miscarriage-Severe, Additional Details: Pt had miscarriage after first dose of Pfizer vaccination. Bleeding started hours after shot.
Urticaria upon shots-treatment with Benadryl. Decreased range of motion. Epinephrine. Pulse  x 2 degrees
1/20/2021 03:30 am ibuprofen taken for arm pain due to injection 1/30/2021 05:00 pm Injection site round, red, itchy rash. applied hydrocortisone cream  1/31/2021 10:02 pm injection site is still raised, painful, and itchy. 2/5/2021 05:27 pm slightly raised, red bump that is about 4 inches in diameter. It's a very distinct raised circle and has still been itching when her hair rubs over it. It's slightly warm to the touch. 2/6/2021 04:44 pm are of injection site as large today as yesterday, but hasn't gotten worse.
Initial report received on 19 October 2006 from a health care provider.  A patient (age and gender not reported) had received an injection of Fluzone SV, lot number not reported, on an unspecified date.  At an unknown time post-vaccination, the patient developed fever blisters.  Additional information was not provided.  Recovery status was unknown.
Aura with migraine. I've had migraines before, but have never had aura before. My headaches and migraines have been more frequent in the weeks following the vaccine as well.
No A/E; Nurse calling to report temperature excursion. She states PROQUAD was administered. No PQC. No additional information.          ?    Names of vaccines involved (including lot/exp) : PROQUAD W023870 1/24/2024        ?    Temperature : see below; prescribing error; Dispensing error; Preparation for administration error; administration error; This spontaneous report was received from a nurse concerning to a 14-year-old male.The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-DEC-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) subcutaneous injection, 0.5 ml, lot #W023870, expiration date: 24-JAN-2024, administered subcutaneously for prophylaxis (strength was not provided). The temperature excursion was reported by the nurse, the followings results were reported: 14°F up to 46°F (33.4 F) 8 hours 45 minutes; 14°F up to 46°F (28.6 F) for 5 hours 11 minutes; 14°F up to 46°F (20.3 F) for 7 hours 46 minutes; 14°F up to 46°F (19.9 F) for 7 hours 56 minutes ; 14°F up to 46°F (15.6 F) for 0 hours 41 minutes ; 6°F up to 14°F (6.8 F) for 0 hours 12 minutes ; 6°F up to 14°F (7.2 F) for 0 hours 13 minutes; 6°F up to 14°F (9.1 F) for 0 hours 19 minutes. There was previous temperature excursion and the temperature excursion was reading from a digital data logger.   Additionally was reported that no treatment was required, and the point in the processes where the medication occurred was in prescribing (prescribing error), storage in clinical practice (Product storage error), dispensing (Dispensing error), preparation for administration (Preparation for administration error) and administration (administration error). The operator of vaccine was a health care professional who had corrected trained. The reporter was previously reported to the doctor. No additional adverse event reported.
On Dec 4th 2021 I started to get high heart rate and chest pain that radiated to my shoulder and down my arm on the left. And that persisted for 4 days. On 12/6/21 I went to my family doctor's office and they did bloodwork to check heart enzymes to check if it was cardiac related. It came back with elevated troponin and it was severely elevated so I was sent to the er and taken in immediately and had more bloodwork. I was having chest pain at that time. They did EKG and everything looked ok. They took me to the cath lab and they went into my heart and found I was having a heart attack and they placed a stent in my artery because it was 95%. Blocked. I was kept overnight and placed on blood thinners and medication and aspirin regimen. I have 3 other arteries in my hear 70% blocked and diagnoses with coronary artery and heart disease.
burning at injection site; heat at injection site; unable to lift arm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site burning in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number NG5N7, expiry date 1st April 2022) for prophylaxis.   On 25th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 25th February 2020, 2 hrs after receiving Shingrix, the patient experienced injection site burning, injection site warmth and injected limb mobility decreased. On an unknown date, the outcome of the injection site burning, injection site warmth and injected limb mobility decreased were recovered/resolved.   It was unknown if the reporter considered the injection site burning, injection site warmth and injected limb mobility decreased to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix in the left arm and felt heat at the injection site and that it burned at the injection site.   The patient was also not able to lift her arm.   Events had resolved. The reporter consented to follow up.
My throat swollen up; hard for me to swallow; felt like throat was closing; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 65-year-old female non-pregnant patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: En6205) via an unspecified route of administration and administered in left arm (at the age of 65-years-old) on 09Mar2021 11:00 as 1st dose, single dose for COVID-19 immunization. The patient's medical history included allergies (food allergies, environmental allergies, and allergies to unspecified medication), high blood pressure. The patient did not have and not tested for COVID-19 prior to vaccination. The patient's concomitant medications which were received in two weeks included vitamins, blood pressure meds, allergy meds and received no other vaccines received in four weeks. The patient experienced throat swollen up and hard for me to swallow. Felt like throat was closing on 09Mar2021 on 11:30 AM. Events resulted in Emergency room/department or urgent care. Therapeutic measures were taken for the events throat swollen up and hard for me to swallow, felt like throat was closing with liquid Steroids. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.