chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 9 pm I felt fatigue, I went to bed. I took 800 mg of ibuprofen and 1000 mg Tylenol as a pain medication. I drank a bunch of water and took an Emergen-C. I fell asleep by 10:00. I slept and I woke up - shocked awake around 04:30 am - I was super thirsty. My whole body was really sore and stiff and I had a headache.  It was uncomfortable but not unmanageable. I decided to take more Tylenol and Ibuprofen and drink more water again. I got back in bed and was feeling a lot of symptoms - I was really sore in my thigh muscles, lower back, knees and forearms. I had slight chills; I was pretty uncomfortable. I couldn't get back to sleep - I couldn't sleep on my arm with the injection site. This was about 5 pm. I never actually had a fever. But just a lot of fatigue and body aches. For the next day or two - I took 800 mg of ibuprofen and 1000 mg Tylenol every 6 hours. Within 48 hours, the body aches started to subside. I still felt a bit fatigued and I still do feel fatigued to this day. Into the next week, I started feeling like (towards the middle of the week - about the 7th) I was having an urinary urgency feeling. It was a sensation in my lower back like a UTI was coming on. I haven't gotten one in a long time ( I use to). On Friday or Saturday, when I wiped, I was seeing a slight pinkish hue  - a trace of blood - in my urine. Decided to take probiotics and Vit C. and I started to feel better. But Sunday morning, I was back to feeling pretty bad. I visited the Urgent Care on Sunday, the 11th. In the visit, they took a urine specimen. Dr. saw blood in my urine from the test. And an absence of nitrates in the urine and she said it wasn't  a typical UTI. They decided to culture the urine specimen. Macrobid - 2 times a day for 7 days - antibiotics was prescribed. I felt a little better the second day of taking it, I thought, but it was up and down. Culture showed there was no UTI.  Friday, the 16th, I had my annual visit with my PCP, I was feeling okay by this time. But I still had a sensation in my lower back - not a pain but a sensation and I still feel this sensation now (on my left side). She asked me to come back after the antibiotics to take another urine sample. Lab test. I feel some fatigue but I'm doing normal daily life.
patient received 4 COVID-19 primary series vaccinations. Three Pfizer and one Moderna; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received 4 COVID-19 primary series vaccinations. Three Pfizer and one Moderna) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received 4 COVID-19 primary series vaccinations. Three Pfizer and one Moderna) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received 4 COVID-19 primary series vaccinations. Three Pfizer and one Moderna) 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 assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received 4 COVID-19 primary series vaccinations. Three Pfizer and one Moderna).    No concomitant medications were provided by the reporter.  It was reported that patient received 4 COVID-19 primary series vaccinations which was three Pfizer and one Moderna vaccine.  No treatment medications were provided by the reporter.
Potentially got their doses from vials punctured longer than 12 hours ago; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant informations were reported. No Treatment informations were reported.
Moderate pain near injection site; Moderate to severe pain and swelling  in armpit nearest to injection site.; Moderate to severe pain and swelling  in armpit nearest to injection site.; Mild rash on chest nearest to injection site; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 03Aug2021 at 18:30 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included celiac disease, gastrooesophageal reflux disease (GERD), anxiety, hypogonadism, and COVID-19. The patient had known allergies to gluten. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had received other medications (unspecified) within two weeks of vaccination. On 04Aug2021 at 04:30, the patient experienced moderate pain near injection site, moderate to severe pain and swelling in armpit nearest to injection site and mild rash on chest nearest to injection site. The events did not result in doctor or other health care professional office or clinic visit and emergency room department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events moderate pain near injection site, moderate to severe pain and swelling in armpit nearest to injection site and mild rash on chest nearest to injection site was not resolved at the time of the report.
Pt stated she felt dizzy/lightheaded while on her phone nearing the end of her observation period. She got up to leave stating she thought she just needed fresh air and promptly returned to the observation area with dizziness and palpitations. This was 45 minutes roughly post vaccine administration. B/P and heart rate were elevated. Pt began feeling short of breath and a rapid response was initiated.
Injection SUNDAY.  within 2 hrs of the 2nd injection, he was amazed to no longer feeling the chronic pain throughout his shoulder.  MONDAY: The following evening (after supper) he experienced severe light-headedness, followed by violent, prolonged projectile vomiting, during which, his eyes rolled back and he passed out while continuing to vomit. Low BP. transported to hospital;  CT scan showed perforated esophagus, air in chest lining. 2nd CT: air and fluid spread to neck area, bowel obstruction/infection.  TUESDAY: 5am: Transferred to hospice ward, unresponsive. Tuesday, 2:20pm: died.
Rash, itching around injection site about 5 to 8 days after injection - has continued- over 24 hours - "Covid arm"
Shortness of breath, wheezing, chest pain and tightness, difficulty breathing. More frequent asthma attacks requiring rescue inhaler use around the clock x several days. Routine/daily inhaler dose doubled for reduction of symptoms. Today, asthma attacks continue since last Monday.
This is a spontaneous report received from a contactable reporter(s) (Physician). A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2, Solution for injection), on 14Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE, solution for injection), 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: "Hypothyroid" (unspecified if ongoing), notes: Hypothyroid; "hyperlipidemia" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing), notes: Sulfa allergy. Concomitant medication(s) included: LEVOTHYROXINE oral, start date: 01Apr2022. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 28Apr2022, outcome "not recovered" and all described as "tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Apr2022) Positive. Therapeutic measures were taken as a result of Covid-19, drug ineffective. Clinical information: She developed new cough and tested positive for COVID-19 by rapid antigen Binax test 8 days after completing Paxlovid. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: As there is limited information in the case provided, the causal association between the events Covid-19, drug ineffective and the suspect product BNT162b2 cannot be excluded. The case will be reassessed once new information is available.
arm is swollen; arm is red; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 1st October 2021, the patient received Shingles vaccine. In October 2021, less than a week after receiving Shingles vaccine, the patient experienced swelling arm and erythema of extremities. On an unknown date, the outcome of the swelling arm and erythema of extremities were not recovered/not resolved.   It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The patient received the Shingles vaccine on Friday before reporting and the patient's arm was swollen and red. The patient enquired about what should be done. The follow-up would not possible as no contact details were available.
felt like i was hit by a truck; fever; dry heaves; headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), RETCHING (dry heaves), CHILLS (chills), PYREXIA (fever) and FEELING ABNORMAL (felt like i was hit by a truck) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for an unknown indication.     The patient's past medical history included No adverse event.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced HEADACHE (headache), RETCHING (dry heaves) and CHILLS (chills). On an unknown date, the patient experienced PYREXIA (fever) and FEELING ABNORMAL (felt like i was hit by a truck). At the time of the report, HEADACHE (headache), RETCHING (dry heaves), CHILLS (chills), PYREXIA (fever) and FEELING ABNORMAL (felt like i was hit by a truck) outcome was unknown. Not Provided
This spontaneous case, initially received from the other health professional (nurse) on 07-Nov-2018, concerns a 34-year-old adult female patient. On an unspecified date, the vaccines were stored in the refrigerator and eventually a temperature drop was noted for a moment up to plus 0.3 Celsius for less than 115 minutes, which was considered as first temperature excursion. It was reported that the vaccines were moved immediately. On 26-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252227 and expiry date: 31-May-2019) which underwent temperature excursion. No adverse events were reported after the vaccine administration. The reporter assessed this case as non-serious. This case 201805330 was cross linked to source case 201805327 due to same reporter. Follow-up report received from other health profession on 28-Nov-2018: The patient's age (34-year-old) was added. The route of administration (intramuscular) and anatomical location (left deltoid) of suspect vaccine were added in the product tab. The reporter confirmed that the patient did not experience any adverse reactions. The narrative and case comment were amended accordingly.
Sore arm, chills, fever, muscle aches, headache, fatigue for 48 + hours
Received her first dose of Modena vaccine 24 hours after the vial had been punctured; A spontaneous report was received from a pharmacist concerning a 46-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and received her first dose of Modena vaccine 24 hours after the vial had been punctured.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 24 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 24 Dec 2020, the patient received her first dose of Modena vaccine 24 hours after the vial had been punctured. The vaccine was refrigerated during the 24-hour period. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.  The event, received her first dose of Modena vaccine 24 hours after the vial had been punctured, was considered resolved on 24 Dec 2020.; Reporter's Comments: This case concerns a 46-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product storage error without any associated adverse events.
NO known ADR.  Just reporting that a dose was given to a 15.5 year old adolescent with parental consent granted.  Staff thought that if recipient was going to turn 16 in 6 months that it would be ok.  Education repeated to staff that recipients must be at least 16 years old.
Pain at injection site, pain radiating to elbow and shoulder on same arm, red itchy area around injection site (baseball size), swelling around injection site, small patch of hives on right side of upper body.
had recently gotten over covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (had recently gotten over covid) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In September 2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In April 2023, the patient experienced COVID-19 (had recently gotten over covid). At the time of the report, COVID-19 (had recently gotten over covid) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that the patient had gotten over covid recently 2 months ago after receiving the vaccine in September of last year and wanted to know when the patient could receive an additional vaccine. No treatment medication was reported.   Reporter did not allow further contact
Nausea beginning 2 am 03/23/2021; vomiting beginning 5 am same day and stopping within an hour; severe fatigue and headache throughout the day with low-grade fever (99.1-99.8) despite frequent hydration, beginning late afternoon until shortly after midnight. Symptoms alleviated to mild-moderate fatigue, headache and body aches 03/24/2021 10:00 am.
Headache combined with large rash and swelling at injection site (rash 3x2" and lighter red swelling of entire tricep vicinity- elbow to lower deltoid). Returned to Pharmacy where they stated reaction was severe and not normal. Arm swelling has increased each day (3 days since injection). Will visit doctor this week.
Subsequently post vax, the pt developed persistent arm pain and tenderness at the injection site. The pt was seen by the vaccine provider, who prescribed analgesics and non-steroidal anti-inflammatory drugs, they produced little or no response.
No additional AE details; improper storage of product in use; This spontaneous report was received from Other Health Professional and refers to a 5-year-old female patient. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.  On 22-APR-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #U025790, expiration date: 19-AUG-2023, administered subcutaneously for prophylaxis (strength was not provided).  The temperature excursion occurred on 23-MAR-2022, the vaccine was stored in a temperature of -14 degree Celsius (C) up to 10 C  for 3 hours; -10 C up to 8 C for 1 hour 30 minutes as recorded by a data logger. There was no previous temperature excursion reported. No additional adverse event details.
Day after vaccine Body ache, temp 100.4, headache, nausea, stomach ache, felt like an elephant walked on me, ears and neck and head hurt really bad with stabbing pain in ears and felt like neck would break and eyeballs hurt to move them. 2nd day still have fever 99.4 and still some body aches, stomach hurts and felt very sluggish.
Pt devel fever 102 during 24hrs post vax w/vomiting (recurrent, 24hrs w/out dehydration); full recovery @ 3 days post vax;
11 pts did not seroconvert /p 4th dose & are waiting for possible 5th dose
Day after vaccine, experienced elevated heart rate, pain at injection site, fatigue, and dizziness which passed over 3 days. Developed itchy skin and elevated heart rate again about 7 days after vaccination. Itchy skin subsided after 3-4 days but elevated heart rate has been getting worse since day of vaccination. Normal heart rate was 60-70 pre-vaccination, but since vaccination has been 85+ at all times even when at rest. Heart rate randomly spikes to 100-120 when resting and remains there for hours which is causing dizziness and disabling me. I am always short of breath even at rest. I experience disturbing heart palpitations. Every time I stand my heart rate spikes to 120-140+, I get dizzy and very short of breath, and cannot walk for long without having to sit down again. I was diagnosed with POTS about 3 years ago, but it had been in remission for about 2 years. These symptoms are similar to my POTS, so I believe the vaccination has caused my POTS to come out of remission or possibly caused heart inflammation. It is now over 2 weeks since vaccination and all my other side effects have cleared, but my elevated heart rate continues to worsen. I called 911 and was seen by paramedics on 6/1/2021 due to heart rate randomly spiking to 140 and refusing to go down for hours, causing me to feel faint. I declined hospital transport as heart rate went down to 110 after paramedics arrived.
Severe swelling at injection arm swollen to 1.5 -2 times normal size  entire triceps area very sore and hot, nausea, dizziness, Fever 99-100 degrees, mental confusion, very sleepy, loss of appetite, 07/11/2015 triceps still very sore...some nausea and dizzeness remaining.
Redness, swelling, firm, painful in upper arm around injection site. 10x6cm area of swelling
Extreme fatigue, 101.7 temperature, no appetite, lasted from 8 am to 7 pm
REDNESS AND SWELLING AT INJECTION SITE IN ARM, TREATED WITH BACTRIM FOR 1ST AND 2ND DOSE
Swollen and Inflamed Arm Rash Knee pain Gastric pain nausea dizziness
1JUN95 pt devel t105R; irritable & cranky; didn't want to eat or drink; devel a few spots; 4JUN95 devel spots on stomach & legs; seen by MD;
I went to the Family Care the day after receiving my first dose of the Pfizer vaccine. I was experiencing very sore throat and low grade fever (I believe the highest was 100.1). The symptoms felt similar to times I had strep in the past. I did note that my posterior pharynx, in addition to my tonsils, looked abnormally swollen that morning. I truly thought I had strep but the test was negative. I was also tested for the flu which was negative. Later that week I had a Rapid Covid test at the hospital where I work which was also negative. After my second dose, I had no issues.
Case number PHEH2013US005126, is an initial spontaneous report received from a physician via sales representative on 28 Feb 2013: This report refers to 12-year-old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with MENVEO (batch number: A12002, Expiry date: Oct 2014) and Tdap (batch number and manufacturer unknown) on 31 Jan 2013. On 25 Feb 2013, she developed symptoms of Guillain barre syndrome. The patient was hospitalized on an unspecified date. The outcome of the event was not reported as of 01 Mar 2013. Causality of the event was not reported.
On 01/23/2023, I woke up around 02:00AM and I was flushed, and I had chest pain and my left arm was numb. I could feel my heart beating really hard. That's what led me to the emergency room. When I was at the emergency room, my blood pressure was 221 over 109 and my pulse was 65. I also had a bad headache and left calf pain. They gave me an x-ray to make sure my lungs were clear, and they were. I had a lot of blood work done that did not indicate a cardiac event. They discharged me without any other testing and told me to follow up with a cardiologist. I followed up and I had an echocardiogram, a stress test, and an ultrasound of my left calf. I have subsequently had high blood pressure. I have been placed on losartan. I started at 25 milligrams, and I am now up to 100 milligrams and my blood pressure is not yet controlled.
This is in follow-up to report(s) previously submitted on 6/24/2008. Information has been received from a physician concerning a female with multiple sclerosis (MS) and is wheelchair bound who on the morning of 29-AUG-2007 was vaccinated with zoster vaccine live (Oka/Merck) subcutaneously (lot#: 658085/0882U). Subsequently, the patient experienced excessive weakness; even more weakness than she usually felt with her multiple sclerosis. She was sliding out of her chair. Subsequently, the patient recovered. Additional information is not expected.
Missed my period in April. Started bleeding on May 15th and didn't stop for 5 months. Some days were lighter than others, but still bleeding every day. Had an OBGYN apt in June and they said it would regulate/reset soon. It didn't. Went back in July for an ultrasound (7/8) they gave me progesterone and said to stop when the bleeding got heavy.  I ended up getting my period (7/19) and then it stopped after 6 days. I started bleeding again on August 3rd and had a massive blood clot on the 5th. Started birth control on Sunday, August 8th. Bleeding eventually slowed and stopped. Was supposed to get my period the second week in September but on the 1st I had another blook clot and terrible cramping. Went to the OBGYN that day and they got me ready for surgery for the next day. That night I was in intense pain. Showed up for surgery- D&C, and hysteroscopy. Was dilated and in active labor.  They removed 27 mm of tissue from the uterus. The bleeding has since stopped and I am still on birth control, which I do not want to be on. Praying that I have regular periods for the next two cycles.