chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Constant cough; Itching and swelling of the eyelids; Itching and swelling of the eyelids; Swelling of the face; Shortness of breath/Suffocation could not breathe; Barely speak; Blurred vision due to swelling of the eyes; Blurred vision due to swelling of the eyes; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: FA 7484), at the age of 58 years old, in left arm on 17Aug2021 at 19:15 at single dose for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Medical history included known allergies penicillin. There was no other medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (lot number: FA 7484), at the age of 58 years old, in left arm on 27Jul2021 at 09:00 at single dose for COVID-19 immunisation. On 18Aug2021 at 08:00, the day after the vaccination in the morning hours, the patient started with a constant cough, then itching and swelling of the eyelids, then swelling of the face, shortness of breath. Suffocation could not breathe and barely speak. Blurred vision due to swelling of the eyes. Events resulted in emergency room / department or urgencies. Events were reported as non-serious. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of events and included treatment with intravenous diphenhydramine hydrochloride (BENADRYL) / dexamethasone (DECADRON) and salbutamol (ALBUTEROL) therapy. The outcome of events was recovering.
moderate to sever pain in middle of his back; pain in the thigh and knee; fatigue; mild chills; mild nausea; Moderate muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (moderate to sever pain in middle of his back), PAIN IN EXTREMITY (pain in the thigh and knee), FATIGUE (fatigue), CHILLS (mild chills) and NAUSEA (mild nausea) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced BACK PAIN (moderate to sever pain in middle of his back), PAIN IN EXTREMITY (pain in the thigh and knee), FATIGUE (fatigue), CHILLS (mild chills), NAUSEA (mild nausea) and MYALGIA (Moderate muscle aches). At the time of the report, BACK PAIN (moderate to sever pain in middle of his back), PAIN IN EXTREMITY (pain in the thigh and knee), FATIGUE (fatigue), CHILLS (mild chills), NAUSEA (mild nausea) and MYALGIA (Moderate muscle aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment medications include OTC AspirinExtra strength tylenol and advil
I was exposed to COVID-19 around 12/13/22. I started having symptoms on 12/17/22. The symptoms were a running nose, stuffy nose, cough with phlegm, light chills, and slight fever. I tested on 12/19/22 and tested positive. I had a video visit with the doctor on 12/20/22 and was prescribed Molnupiravir to take twice per day for 5 days. I started the medication on 12/20/22 and completed the regimen on 12/25/22. The symptoms began to subside around 12/27/22, but I continued to test positive until 12/31/22. Other than a periodic running nose, all of the symptoms are now gone.
feels very shaky; has no appetite; is very thirsty; thrown up 8 times; cold sweats; restless leg syndrome; fever of 102.3; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweats), RESTLESS LEGS SYNDROME (restless leg syndrome), NERVOUSNESS (feels very shaky), DECREASED APPETITE (has no appetite) and THIRST (is very thirsty) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A  no ex) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Tested positive three months back).    On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Aug-2021, the patient experienced COLD SWEAT (cold sweats), RESTLESS LEGS SYNDROME (restless leg syndrome), PYREXIA (fever of 102.3), CHILLS (chills) and NAUSEA (nausea). On 09-Aug-2021, the patient experienced VOMITING (thrown up 8 times). On an unknown date, the patient experienced NERVOUSNESS (feels very shaky), DECREASED APPETITE (has no appetite) and THIRST (is very thirsty). At the time of the report, COLD SWEAT (cold sweats), RESTLESS LEGS SYNDROME (restless leg syndrome), NERVOUSNESS (feels very shaky), DECREASED APPETITE (has no appetite), THIRST (is very thirsty), PYREXIA (fever of 102.3), CHILLS (chills), NAUSEA (nausea) and VOMITING (thrown up 8 times) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) positive. On 08-Aug-2021, Body temperature: 102.3 f (High) 102.3 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient takes no concomitant medication. No treatment information was provided.
Patient developed redness and swelling at the injection site with other lesions also developing. Patient was prescribed Loratadine and TAGAMET.
received her first dose about 2 years ago has not received her second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not know the lot number or expiration date of the Shingrix vaccine originally administered. No additional information provided. The reporter did not consent to follow up.
No additional AEs; Caller reported vaccines administered after temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  The patient's pertinent medical history, current conditions, drug reactions or allergies and concomitant medications were not reported.  On 16-JUN-2022, the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II) subcutaneous injection, 0.5 milliliter, lot #U025200 was confirmed to be valid, expiration date: 13-AUG-2023, administered subcutaneously (reported as "SQ") (strength and site of administration were not provided) and hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 milliliter, lot #U031911 was confirmed to be valid, expiration date: 11-NOV-2022, administered intramuscularly (reported as "IM") both for prophylaxis (strength and site of administration were not provided). Both vaccines were exposed to the temperature of 13.5 degrees Celsius for 10 minutes (product storage error). No previous temperature excursions were reported. No additional adverse events or product quality complaints were reported (no adverse event).
I began to have the following symptoms about 3 hours following the shot: high Fever, Hallucinations, soreness, joint pain, aches and fatigue. Once this began, I took 4 ibuprofen tablets at 200 mg each. I received the vaccination on a Thursday morning and I did not feel better until Sunday.
Six hours following shot I became very cold and achy. Around 2:00pm that afternoon (9 hours after) I had a 102 degree fever, horrible headache, and body aches. My fever spiked at 104 degrees around 5:00 and stayed steady at 102 until 5am the next morning. Severe body aches, chills, nausea, and headache persisted. I was unable to eat or drink for 36 hours. Once the fever broke, fatigue and headache persisted until 3/10/21.
This spontaneous report was received from a physician via company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 28-JUL-2015, the patient was vaccinated with an improperly stored PEDVAXHIB Single Dose Vaccine, 10-pack, lot number K004541, expiration date 04-DEC-2016, (dose, route and anatomical location were not reported). The improperly stored PEDVAXHIB was in a Refrigerator, and, the highest temperature of excursion was 47 Fahrenheit degrees (8.33 Celsius degrees) with a sum of 24 hours of excursion. No adverse effects were reported and no product quality complain was involved. This is one of several reports from the same reporter. Additional information has been requested.
Pt LP received SHINGRIX vaccine 2/14/18. Pt is extremely hard of hearing. His wife came in to the store on 2/15/18 and reported pt had blood coming from his rectum yesterday 8 hours after receiving SHINGRIX. He has had about 5 spouts of rectal bleeding, bright red - some with stools. Wife did not know if he has a history of hemorrhoids. He takes 81mg of ASA. I contacted his primary care doctor whom did not know if he had hemorrhoids. His nurse, did say he has refused colonoscopies d/t having a son that died from colon cancer. I called the manufacture they did not have any reports of blood spewing from the rectum, blood in stools, etc. Only GI - nausea, vomiting, diarrhea, and abdominal pain. Cannot determine if vaccine caused ADR or not. Pt has follow up with PCP on Monday.
35 years old women, after the Pfizer vaccine she complain  to the paramedic in the observation that she was feeling itchy in her trout and eye. At this moment the paramedic pass the patient to the triage zone, paramedic took the vitals: BP:130/85, HR:105, Temperature: 36.6C and dextro 113.  The patient report feeling  numbness in her tongue and we give 25mg of Benadryl. We observed the patient for 30 minutes and we retake the vitals: BP: 130/865, HR 90 SO2:98.
This spontaneous report was received from a back office lead and refers to a 33 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 26-MAR-2016, the patient was vaccinated with an improperly stored dose of VAQTA lot # L014265, expiration date: 28-APR-2017, 1 ml, intramuscularly, in left deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
I have been experiencing shortness of breath, swollen arm, red rash around injection site, fever, fatigue, increased heart rate, headache, and joint pain. Most symptoms appeared overnight (about 8-12 hours post injection on 3/24) and have continued throughout the day (3/25). The shortness of breath began about an hour after injection (3/24), and has continued through the next day (3/25). So far treatment has involved taking ibuprofen at 10:30pm (3/24).
Information has been received from a nurse concerning a 5 year old male, who was vaccinated with varicella virus vaccine live (Oka/Merck) (lot# 658430/1183U) in his thigh. He experienced "profuse swelling the size of a golf ball" at the injection site. Medical attention (unspecified) was sought. Current patient status was not reported. A product quality complaint was not reported. No further information was available. Additional information has been requested.
Beginning 5 days later, and persisting for the last 3-4 weeks (on and off): GI issues, headaches, lightheadedness, dizziness, palpitations, high blood pressure.
Fever greater than 101 for 18 hours post vaccination along with muscle body aches.  Regular menstrual cycle followed by 2+ weeks of spotting, headaches accompanied with nausea.
I noticed increased fatigue after the 3rd dose. In October I had a really bad AS flair up and had to go into the ER and hadn't had one in 2 years and had to get a steroid infusion. I don't know if these are all related to vaccine but this year I've overall felt worse. I also got a very sore arm.
This spontaneous report was received from a registered nurse and was referring to a 12 month old male patient. There were no relevant history and concurrent conditions. On 24-MAR-2016, the patient was vaccinated with a dose of (Merck) PROQUAD in the right thigh, with the lot # L045678 and expiration date 09-MAR-2017 (route, dose number and dose were not provided). On the same date, the patient was also vaccinated with a dose of (Merck) VARIVAX in the left thigh, with the lot # L037559 and expiration date 29-SEP-2017 (route, dose number and dose were not provided). The patient did not have any concomitant medication. At the time of reporting, it was unknown if relevant test was preformed. Additional information has been requested.
He had blurred vision for a period of time. Extremely high aggression, a little delusional and confused.
8 days after 2nd moderna covid vaccine kept waking up due to pain upon inhalation.  by 2:48  am I could only take shallow, open mouth breathes because it hurt too much to take a deep breath.  All mucles were sore, but especially the thigh muscles, headache, chills, temp = 100,
I recorded the following in my exercise diary:  Half-mile swim on Sept 7 (5-6 pm), Sept 12 (2-3 pm) & Sept 16 (6:40-7:40 pm); 2-mile jog on Sept 17 (7-9 pm); swim on Sept 20 (7-8 pm), Sept 22 (7:30-8 pm) & Sept 24 (7:50-8:30 pm); 2-mile jog on Sept 27 (1-2:30 pm), swim on Sept 28 (7-9 pm).  Super strong arrhythmia attack Sept 30 (11 pm-5am): couldn't sleepconsidered seeking medical attention. Medium arrhythmia attack Oct 1 (11 pm-1 am): kept me up. Light arrhythmia attack on Oct 2 (11 pm-midnight): not too bothersome.  Nothing like this has ever happened to me before that I recall, other than after 1st COVID vaccine, per separate report, and occasional tachycardia attacks prior to radio ablation in April, 2000.
Reports when she got the shot it hurt so bad. A lot of pressure. Arm was sore for quite a while. Took 4 advil and by 2:30 was feeling great. Came home picked up husband got something to eat. 3:30 started feeling funny. Sore stomach, dizzy. Got home and that's when is started hitting. Sick to stomach. Felt her entire body was burning and stingy. Felt like heat wanted to escape thru mouth. Did not take her temp. Felt loopy. Headache. Tired. No vomiting. States she couldn't lay down and get comfortable. At midnight took mylanta, layed back down. Continued with dizziness. When getting up tues morning, continued with dizziness and feeling loopy. All other symptoms subsided. Did not feel safe to drive so she called in sick to work. Pt states she has had reaction to sulfate in the past, and wondered if sulfate was in the injection. Learned that there is no sulfate in the flu vaccine. States she slept all day Tuesday. Wednesday felt tired, weak and started moving around, went golfing, rode a cart. When got done golfing slept all night. Thursday was feeling a little better. A little lightheaded but not to bad. Feeling lightheaded up till Saturday and again today and also feeling tired. States her boss and 'health nurse' has recommended that she call her PCP and report this. States she has never had a reaction with a flu shot. Reports she did get stung by a bee 9/22/17. No recent change in medication. Has recently started weigh watchers (about 3 weeks). Has been cutting portions. Was 191.4 and now 188.4lbs. States she felt fine before the flu shot. Husband also wants to report right shoulder spasms that was happening before the flu vaccine.
Pain and swelling of leg, warm to touch, redness. Advise to continue ICE, and ibuprofen for pain. If worsening f/u, if any fevers f/u immediately.
Within minutes had shortness of breath, elevated heart rate, dizziness, flushed feeling and almost passed out.  Had fuzzy head, fatique, elevated heart rate, very sore injection site, and headache feeling for 24-48 hours.  24 hours after had chills and flushed feelings, body aches and soreness, dizziness.  3-5 days after still have elevated heart rate and  had swollen lymph nodes under arm of injection and swollen lymph nodes in face with extreme soreness.  Was instructed by MD to not take second dose.
Throwing up foamy stuff; Oxygen saturation was in the 80%s; confused; This is a spontaneous report from a contactable nurse. An 88-year-old male patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL3302), intramuscular at the right arm on 25Jan2021 02:30 at a single dose for COVID-19 immunization. The vaccine was administered in a Nursing Home. No other vaccine was given to the patient in four weeks. Medical history included Parkinsons, dementia, diastolic heart failure and known allergies: Iodine, Propranolol. Concomitant medication included paracetamol (TYLENOL), melatonin, quetiapine fumarate (SEROQUEL), ropinirole and sertraline hydrochloride (ZOLOFT).  On 26Jan2021 11:30 AM, the patient was throwing up foamy stuff and his oxygen saturation was in the 80%s and was confused. The events led to Emergency room/department or urgent care visit. Treatment was given for the events. The patient has no COVID-19 prior to vaccination. He was tested for COVID-19 on 26Jan2021 with Nasal Swab, Rapid Test and the result was negative. The outcome of the events was unknown.; Sender's Comments: Based on the information provided and temporal relationship, a causal association between BNT162B2 and the reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Still feels warm; Body aches; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Still feels warm), MYALGIA (Body aches), PYREXIA (Fever) and HEADACHE (Headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Still feels warm), MYALGIA (Body aches), PYREXIA (Fever) and HEADACHE (Headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, FEELING HOT (Still feels warm), MYALGIA (Body aches), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.3 (High) A fever of 101.3.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications provided.
Information has been received from a 25 year old female patient with anxiety and allergy to amoxicillin who on 04-JUN-2007 was vaccinated with her first dose of Gardasil. Concomitant therapy included unspecified anxiety medication. The patient reported that after she received the injection, she experienced itching at the injection site and nausea. On 06-JUN-2007 the patient developed diarrhea. The patient's symptoms persisted. Additional information has been requested.
Pt received PNEUMOVAX 23 shot in right arm, few days later arm is swollen red and painful to touch. Pt informed to take BENADRYL, and see MD within 1 day.
3 inch welt on injection site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of INJECTION SITE BRUISING (3 inch welt on injection site) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE BRUISING (3 inch welt on injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency; OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, INJECTION SITE BRUISING (3 inch welt on injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicine   Treatment include Benadryl and Claritin (did not resolve after a week),The PCP then prescribed prednisone (dose and duration unknown) which resulted in the resolution of the welts.
lower back pain 22MAY in bed x 3 days; unable to stand; no meds; 2JUN92 seen by MD legs ache; 25MAY92 cont w/sx; 15JUN92 sx gone;
Swelling, hardness, pain and a red rash at injection site; lethargy; swollen lymph glands, especially in the feet and redness and swelling of the feet; heart symptoms: an uncomfortable sensation with each heartbeat - it felt like the heart was having difficulty pumping the blood up. It took longer for the heart to suction up the blood before each heartbeat and I could feel a beat or a thud after each succioning up of the blood. The sequence felt like: slow suctioning, then a pounding; slow succioning followed by a pounding, etc. I also felt a frequent fluttering of the heart.   The rash on the arm has turned to redness. The swelling and hardness are still there. The feet are still red and swollen and I can feel the enlarged, hard lymph glands. I'm still lethargic and sleep throughout the day. The heart problems only began to subside this afternoon.  Because of the above symptoms (and other symptoms I cannot directly connect to the injection, but that occurred at the same time), I am afraid to get the second injection.
Patient was fine for 15minutes post administration, stood up to leave store and fainted in aisle about 100 ft from immunization site. Patient then became extremely pale and couldn't stand up. She then started to vomit. Paramedics were called to have patient monitored per patient and mother's request.
Seriousness criteria: Other-Medically Significant. Initial report received on 15 November 2007 from a nurse. A 34-year-old male with concurrent illness of cough and sore throat, and who had a past medical history of "(?) leaky valve", had received a left deltoid intramuscular dose of Decavac (lot number U1954AB) on 05 November 2007. Twenty-four hours post-vaccination, the patient developed brachial neuritis and had pain from the shoulder to the fingers. His third and fourth fingers were numb. Three days after vaccination (approximately 08 November 2007) the numbness in the fingers were gone; and the patient had developed numbness from the left elbow to the left shoulder and left ribs. At the time of this report, the patient had not sought medical attention and no treatment was reported. At the time of this report, the patient had not recovered