chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Nov2022 as dose 4 (booster), single (Lot number: GJ3277) at the age of 52 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "BP/Blood pressure abnormal" (unspecified if ongoing); "cholesterol/cholesterol abnormal" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "pelvic floor tightness" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "Known Allergies: Keflex". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 07Jun2023 to 12Jun2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300222293 Same patient, different drug, different event;
4/24/12 morning after immunization - (L) deltoid area itchy and a "little red" - mother gave ibuprofen and applied ice - arm has progressively gotten worse. 4/26/12 woke up redness increased swelling from injection site to elbow - warm to touch, itchy sore no fever. Provider note - "diffuse erythema & soft tissue swelling at left upper arm - warmth to touch. Full ROM, neurovascular grossly intact Tx - AUGMENTIN 400 - 57mg/5ml - 1 tsp every 12 hours (100 mL) for 10 days.
Presented to ED for pain and sob on exertion. Patient admitted with moderate bilateral pleural effusion, elevated WBC. Patient improved and discharged to home health care
arrhythmia with many pvcs; Tightness in chest; This spontaneous case was reported by a physician and describes the occurrence of ARRHYTHMIA (arrhythmia with many pvcs) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pre-diabetic.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 100 microgram. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 100 microgram once. On 17-Feb-2021, the patient experienced ARRHYTHMIA (arrhythmia with many pvcs) (seriousness criterion medically significant) and CHEST DISCOMFORT (Tightness in chest). On 27-Jun-2021, ARRHYTHMIA (arrhythmia with many pvcs) and CHEST DISCOMFORT (Tightness in chest) had 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 information was not reported. Patient had undergone a nuclear stress test and echocardiogram on an unknown date, results were not reported. Patient was scheduled for a patch monitor on an unknown date.  Treatment information was not provided. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
09/25/2022 I AWOKE IN THE MIDDLE OF THE NIGHT WITH A THROBBING "TOOTHACHE". i TOOK ADVIL AND WAS ABLE TO FALL ASLEEP. WHEN i WOKE UP. THE AREA WAS TENDER BUT THE PAIN WAS GONE. WEEKS LATER 10/20/2022 I CONTRACTED COVID AND STARTING ON THE FIRST DAY OF SYMPTOMS, MY RIGHT TEETH ALL HURT AND PAIN RADIATES TO MY RIGHT EAR. SKIN IS SENSITIVE TO TOUCH AND ORAL CAVITY SENSITIVE TO TEMPERATURE. PAIN CONTINUES INTERMITTANTLY AND IS RELIEVED WITH ADVIL AND COLD COMPRESS.  11/03/2022 I WENT TO THE DENTIST (DDS) DUE TO PAIN TO CHECK TO SEE IF I HAD ANY DENTAL ISSUES. DR SAID ALL THE TEETH ON THE RIGHT SIDE WERE FINE AND MY GUMS WERE FINE. SHE SUSPECTS TRIGEMINAL NEURALGA ... BASED ON MY SYMPTOM COMPLAINTS AND HER FINDINGS. SHE SUGGESTED I SHOULD KEEP A DIARY AND WAIT A MONTH TO SEE IF IT CORRECTS ON IT'S OWN. I AM TO NOTIFY EITHER MY PRIMARY CARE PHYSICIAN OR DR. IF SYMPTOMS WORSEN. I MAY NEED TO SEE A NEUROLOGIST.
One day post immunizations, mom reported rash on face, neck, torso.  Seen by PMD, records show nonblanchable small brown spots, child not toxic appearing, localized swelling and tenderness at injection site L leg, ?contusion.  On 3/17 mom called with report of increased leg swelling.  Seen by 2nd MD in practice.  On 3/17/05, L leg observed to have increased circumference from R by 1 3/4 ", + adenopathy in L groin, + induration in anterior and posterior spaces.  Area red, warm, painful.  Child could weightbear but was reluctant to do so.  IM Rocephin, Solumedrol given, referred to ER for eval--admitted to hospital x 1 day for IV antibx, r/o cellulitis.  Discharged 3/18/05 to home, improving.
A report was received from a healthcare professional on 09/19/2003 concerning an 18 month old vaccinee of unknown sex who inadvertently received Fluvirin on an unspecified date.  On an unspecified date the vaccinee inadvertently received Fluvirin.  There was insufficient information to determine the reporter's causality assessment.
positive covid result, same day. get a runny nose, woke up very tired and congested; positive covid result, same day. get a runny nose, woke up very tired and congested; This is a spontaneous report from a contactable Pharmacist, the Patient.   A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EL3247; Expiration Date: Unknown), as dose 2, via intramuscular route of administration, on Arm Left on 15Mar2021 09:00, dose 1 (Lot Number: EL3247), (at the age of 49 years) as dose 1, via intramuscular route of administration, on Arm Left on 22Feb2021 09:00 as single dose for COVID-19 immunisation. The patient medical history was none and concomitant medications were not reported. On 26Jul2021, patient experienced runny nose, on 27Jul2021, he woke up with very tired and congested. He took a COVID PCR test on 27Jul2021. No Known allergies reported. No other vaccine administered in four weeks. Other medications in two weeks were none. No COVID vaccination prior. Post vaccination patient was not diagnosed with COVID-19. Patient did not received treatment. The outcome of the event was not recovered.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Covid-19 . The case will be reassessed once new information is available.
Patient developed rash/hive 1 hours after receiving the vaccine.  Patient self medicated with a dose of Benadryl when the hives started.  Send to ER and was observed for 2 hours.  Hives resolved in 24 hours with no further treatment.
Received 2nd dose at 10:56  AM on Saturday, March 27, 2021.  At around 9:00 PM that evening started to feel odd.  That entire night had fever, chills, headache and body ache.  Highest temperature was 102.  Did take Tylenol and Ibuprofen intermittently.  Slept most of Sunday and half of Monday, March 29th.  Temperature finally returned to normal at around 4:30 PM on Monday, March 29th.  I had NO adverse reaction to Dose Number one on February 27, 2021.
No Additional AEs; administered PEDVAX HIB after being expired; This spontaneous report was received from a nurse referring to a 6 month old female patient. Information of concurrent conditions, pertinent medical history, concomitant medications and drug reactions/allergies was not reported.  On 10-APR-2023, the patient was administered haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) injection 1 time dose ((lot# T026962, expiration date 06-APR-2023; strength, dose, route were not reported) for prophylaxis after being expired (expired product administered). No additional adverse events (AEs) (no adverse event) was reported.
Patient received Hep A vaccine 2 months after 1st dose and he should have received it 6 months after the 1st one. this makes it ineffective and patient needs another dose in October 2019
Immediate vaccination taste in my mouth. Which lasted for the entire time I was there (they kept me longer than the 15 minutes). The taste faded a bit, but still kept coming back & had a slight burning sensation in my mouth.  I also immediately became cold. After about 20-30 the EMT took my temp read 94.1. I started a little longer & then they released me.  The only other side effect I had was although I was very child, my ears felt like they were burning.
Noticed a rash on her arm beginning  Tuesday, 8/24 at injection site.  Rash began to spread to elbow and thighs by Wednesday. Thursday am, rash on other elbow and face (7:30AM).  Denies any swelling of the mouth or tongue, no difficulty breathing.
This spontaneous report was received from a nurse practitioner and refers to a 68-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 05-JUN-2018, the patient was vaccinated with an expired dose of PNEUMOVAX23, (lot # M041686 , expiration date 20-MAY-2018), (dose, frequency and route of administration were not provided) for prophylaxis. No adverse effects were reported.
The vaccine that was given should have been discarded 12 hours prior. the vial was punctured at 10am on 11/3 and was given to a patient at 9:30am on 11/4
This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID-19) in a 34-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 prophylaxis. The patient had no medical history, concomitant disease or risk factor. On 03-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 18-Sep-2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Sep-2022, SARS-CoV-2 test: (Positive) Positive. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. Patient tested positive for COVID-19 on 18-Sep-2022 after having received omicron-specific booster on 03-Sep-2022. It was unknown if the patient experienced any additional symptoms/events. No treatment drugs were reported. Company comment: This spontaneous case concerns a 34-year-old male patient with no reported medical history, who experienced unexpected, non-serious AESI Covid-19 (with positive Sars-CoV test), which occurred 15 days after vaccination of a fourth dose of mRNA-1273.222. No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Reporter did not allow further contact. Sender's Comments: This spontaneous case concerns a 34-year-old male patient with no reported medical history, who experienced unexpected, non-serious AESI Covid-19 (with positive Sars-CoV test), which occurred 15 days after vaccination of a fourth dose of mRNA-1273.222. No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
No other AE; The caller said there was a patient who received a dose of PROQUAD that was diluted with 0.9% sodium chloride. Caller said the diluent used to reconstitute was manufactured; This spontaneous report has been received form a nurse, regarding a 12-months-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not reported.  On 02-AUG-2022, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (recombinant human albumin (rHA) (lot number: U039258, which was determined to be valid, with an expiration date on 09-JUN-2023)  as prophylaxis (dose, route and anatomical location of administration were not reported). The Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was diluted with sodium chloride (lot number: 29-203-DK, with an expiration date on 01-MAY-2023) (Wrong solution used in drug reconstitution). No other adverse event occurred.
Patient having pain in shoulder joint-unable to move arm backwards but can put forward and raise. He states there is a little improvement 10/31/15.
similar aura in left eye; aura in both eyes/ migraine arc auro in left eye, it stopped and a short time later had a similar aura in right eye; color blotches in both eyes; This spontaneous case was reported by a consumer and describes the occurrence of CHROMATOPSIA (color blotches in both eyes), AURA (aura in both eyes/ migraine arc auro in left eye, it stopped and a short time later had a similar aura in right eye) and AURA (similar aura in left eye) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy, Kidney function abnormal, Enlarged prostate since 2019, Arthritis and Sinus pressure (from allergies). Concomitant products included CLARITIN for Allergy, COLCHICINE for Arthritis, MAXFLO for Enlarged prostate, CALCIUM CITRATE for Osteopenia, D3 for an unknown indication.    On 25-Feb-2021 at 5:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced CHROMATOPSIA (color blotches in both eyes). On 05-Mar-2021 at 8:00 AM, the patient experienced AURA (aura in both eyes/ migraine arc auro in left eye, it stopped and a short time later had a similar aura in right eye). On 06-Mar-2021 at 8:15 AM, the patient experienced AURA (similar aura in left eye). On 07-Mar-2021, CHROMATOPSIA (color blotches in both eyes) had resolved. At the time of the report, AURA (aura in both eyes/ migraine arc auro in left eye, it stopped and a short time later had a similar aura in right eye) and AURA (similar aura in left eye) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Treatment information provided.    Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021 Follow up received contains significant information outcome of events updated, concomitant medication added, medical history of the patient, and patient initials.
Not an adverse event. Patient was given the 2017-2018 formula in error. We were able to contact him the following day and notified him of the error and that Public health recommended revaccination with the current vaccine. Patient will come in in the following weeks for revaccination, he states. 2017-2018 formula was transferred to our store in error along with current 2018-2019 formula, and this was not noticed until after several vaccinations were given around the same time. Last year's formula was immediately taken out of inventory.
Pt had a bout of nausea that started shortly after and lasted approx 72 hours.
arm was sore; body ache; Headache; Exhausted; The spontaneous report from was received from a consumer concerning a 75 years old female patient who received Moderna COVID-19 vaccine (mRNA-1273) and experienced arm  sore, exhausted had a major fatigue, headache and body ache.   The patient's medical history was not provided.  The concomitant medication included: Vitamin D3, Vitamin C, Probiotic and Aspirin with Crestor.  On 22 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot no. 032L20H) of COVID-19 infection.  On 23 Jan 2021, the patient experienced the events arm was sore, was exhausted had a major fatigue, headache and body ache.  Laboratory details are not provided.  The treatment medication included Ibuprofen  The outcomes of all the events was unknown.; Sender's Comments: Based on 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.
Acute coronary syndrome with normal coronary arteries on coronary angiogram. Clinical presentation suggestive of myocarditis.
This case was reported by a physician via sales rep and described the occurrence of headache in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced headache, electric shock sensation and fever. On an unknown date, the outcome of the headache, electric shock sensation and fever were unknown. It was unknown if the reporter considered the headache, electric shock sensation and fever to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced electric feeling down the leg, headache and fever.
Narrative: COVID infection following COVID vaccine series 04/02, Pfizer, dose #1 04/23, Pfizer, dose #2 01/10 COVID swab, result: detected 01/01 cxr impression: No evidence of acute cardiopulmonary abnormality. 01/01 cta pe impression: 1. No acute pulmonary emboli. 2. Findings of mild pulmonary edema. Superimposed infectious/ inflammatory process possible. 01/01 pt admit ED cc: sob, chest pain 12/21 pt cc: cough, sob, chest pain exposure: unknown 01/06 clinically resolved
p/vax pt devel high fever; was totally motionless; & was almost in a coma for wk; laid limp few days;lost his language & became distant; did not respond to voices/his name;eating/sleeping habits changed;sought MD attention;Dx:autism
Very red at site of injection. Have never had any adverse reaction from any shots for first yr,  had two flu shots last yr with no problem.  Bruising and large bump under skin at site of injection. Continues to have medium bump under skin where she was given the shot.  Two other shots given that day with no other problems reported or noted.
This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. On 10-MAR-2014 the patient was vaccinated with M-M-R II and VAQTA (dosing regimen unspecified). No concomitant medications were reported. On an unknown date medication error was reported as the patient received doses on 10-MAR-2014 that were exposed to temperatures outside of the recommended storage range noted in the prescribing information. No adverse effect reported. No product quality complaint involved. The outcome of medication error was unknown. This case is linked to: 1403USA005417, 1403USA011256, 1403USA011262, 1403USA011268, 1403USA011301, 1403USA011335, 1403USA011343, 1403USA011350, 1403USA011356, 1403USA011363, 1403USA011380, 1403USA011414, 1403USA011416, 1403USA011418, 1403USA011420, 1403USA011422, 1403USA011424, 1403USA011425, 1403USA011427. (Same reporter link). Additional information has been requested.
Pt recvd Hep B vax on 11SEP91 & 1 wk follwoing vax devel flu-like illness;
Swollen lymph nodes in armpit on right arm. The same arm where the shot was given. Lot of fluid in armpit. Tender as well.  This was my second Pfizer Covid shot.
When the patient returned for her second dose, she reported a rash at the site of the first injection, beginning 10 days after her first injection (she stated she first noticed the rash on 1/16/21). Patient described the rash as raised, red, itchy, and hot, and stated it lasted 3-4 days and then cleared up. Per patient report, rash was 2 to 2.5 inches in diameter at the site of the first injection on her upper left arm. Patient stated she did not seek medical attention for the rash or treat it with any medications. Second dose administered in opposite arm.
The patient reported bruising and soreness in the upper left arm. He noted his arm was hurting. It has improved since he noticed it on 10/8/18.
p/vax pt devel maculopapular rash all over body;pt seen by MD & dx w/rubella;
Patient started with some rashing on her arms, but waited for the post administration time. She then stated she was okay and went shopping. Approximately an hour later she came back to the pharmacy reporting she was having a hard time breathing and she felt like her throat was closing. She was seated in a chair. BP at 4:58pm was 173/104; at 504pm was 133/86; and then 152/90 at 513pm. She as given 10ml (25mg) of liquid Benadryl at 458pm. One dose of 0.3mg  epinephrine auto injector was administered at 459pm. A code white was called for store management and  911 was called. EMS arrived shortly after around 510pm to take of patient who reported continued trouble breathing.
Received 1st MMR, Hep A, flu shot and Hib #4 on 11/26/12. When mother took child home he developed fever of 101.2 axillary though continued playing. Suddenly pt cried, turned blue and stopped breathing. Mothers friend gave CPR, ambulance called. Today 11/27/12 child appears well per ER - febrile seizures or allergic reaction.
headache; fatigue; soreness in the arm; he has a ball in the arm which he have never had before; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; FATIGUE (non-serious), outcome "not recovered", described as "fatigue"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "soreness in the arm"; LIMB MASS (non-serious), outcome "unknown", described as "he has a ball in the arm which he have never had before".  Additional information: Events did not result to physician office visit.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
103 temperature. Severe chills. Severe headache. Couldn't breathe. Oxygen dropped to 70.  Severe body aches.
Pt was given a COVID vaccine on 5/6/22 and the BUD (best used date) for the vaccine was 4/25/22.  Patient is currently pregnant in her 2nd trimester