chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; headache; body pain; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PYREXIA (fever), HEADACHE (headache) and PAIN (body pain) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-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 PYREXIA (fever), HEADACHE (headache) and PAIN (body pain). At the time of the report, PYREXIA (fever), HEADACHE (headache) and PAIN (body pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant  concomitant medications reported No relevant treatment reported
Information has been received from a physician concerning a patient who was vaccinated with PNEUMOVAX 23. It was reported that "the patient had an allergic reaction after administration". It was unknown if the patient sought medical attention. At the time of the reporting, the patient's status was unknown. Additional information has been requested.
Entire body redness, throat itching, painful sensation in lungs with breathing. Yellow drainage from eyes, body aches, general feeling of sickness.
This case was reported by a consumer via (Shingrix GSK) interactive digital media and described the occurrence of vaccination failure in a elderly patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles (had recurring shingles since patient was 18 years old). In March 2021, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. In March 2021, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced drug dose administration interval too short. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, shingles and drug dose administration interval too short were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. At the time of reporting the patient was near 70 years age. The age at vaccination was not reported. The patient had the two Shingles vaccines in March 2021, received second dose of Shingles vaccine earlier than recommended interval, which led to shortening of vaccination schedule and had 2 episodes since then. The patient asked about keep getting shingles after the vaccine. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting.
has not received the 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 patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose a year 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 declined permission to collect information to create an account in our database. The reporter did not consent to follow up.
Sudden onset of tinnitus 4 weeks after receiving vaccine.  This was not a gradual progression.   Level of tinnitus is not debilitating but is significant.
COVID BREAKTHROUGH: Patient is a 94 yo M with PMH Dementia, CVA, BPH, CKD st 4, AOCD, IDDm2, HTN, HLD, appendix adenocarcinoma s/p appendectomy, diverticular perforation s/p colostomy, and advanced age referred to hospital. Pt is evaluated on arrival to hospital. He was speaking in another language only with no family present. He is alert and responsive but HOH and a poor historian even with his language interpretation. Most information obtained from chart review and exam. On my evaluation the pt c/o cough and sore throat with audible rhonchi and rattling, no distress or hypoxia on O2 at 4L. 4TH DOSE 1/11/22.
Moderate headache, increased blood pressure.  I was pregnant at the time of both injections. Due date was 2/8/21 but I delivered via scheduled csection on 2/2/21. Birth weight was 6lb 10oz. Delivery uncomplicated.  History of severe atypical preeclampsia and HELLP syndrome in LAST pregnancy in 2018-2019.   This pregnancy was complicated by obesity, otherwise uncomplicated.  When I developed headache, I checked my BP, which was elevated to 140/90. Talked to my OB/GYN via phone. Was instructed by healthcare provider to check urinalysis in the office in which I work, which was negative for proteinuria. My elevated BP resolved within a few hours.
Information has been received from a nurse concerning a 12 year old female patient with none drug allergies who on 09-MAR-2010 was vaccinated IM with the first dose 0.5 ml of GARDASIL (lot number not available). On 12-MAY-2010 the patient was vaccinated IM with the second dose of GARDASIL (lot number 661954/0075Y, expiration 15-MAR-2010). Within 10 minutes of receiving the second dose, the patient experienced dizziness. The following morning (13-MAY-2010) the patient had diarrhea. The patient was treated with clear liquid diet. Unspecified medical attention was sought. No lab studies were performed. On an unknown date, the patient recovered. Additional information has been requested.
Patient woke me up at 4:00 a.m. Saturday morning, December 18 with 99.7 degrees of fever and extreme soreness in right arm where injection was given.  Was weak and had facial flushing around mouth and nose and on chin.  Injection site was puffy and red.  Gave Tylenol throughout the day.  As of Saturday night at 11:30 p.m. fever was down to normal.
06:30 AM 05/06/23   fever 100 Tylenol 250 mg X1 09:00 AM 05/06/23   fatigue slept most of day (7 hours) 02:30 AM 05/07/23    vomited  X1 extreme nausea  10:00 AM 05/07/23   all events resolved
Pain upon touch all down my right leg, on the inner/top of my thigh and down the right/front side of my shin from my knee through my ankle. It is not muscular, only hurts when touched.  Numbness and tingling in the leg at times as well. They did an ultrasound and I was told that it was not a DVT but that it could possibly be superficial Thrombophlebitis. This started 2 days after the shot and is still paining me a week later.
She indicates she had difficulty breathing; But her nose closed up; She as well had weakness; Sinuses immediately filled up; She as well had nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (She indicates she had difficulty breathing), NASAL CONGESTION (But her nose closed up), ASTHENIA (She as well had weakness), SINUS CONGESTION (Sinuses immediately filled up) and NAUSEA (She as well had nausea) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (Phenergan), Drug allergy (Pyridium), Drug allergy (Keflex), Allergy to antibiotic (Doxycycline), Drug allergy (Tessalon perles) and Drug allergy (Dextromethorphan). Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT), CARBAMAZEPINE, PERPHENAZINE, FISH OIL, GLUCOSAMINE, CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM & VITAMIN D3), MINERALS NOS, VITAMINS NOS (EYEVITE), MULTIVITAMIN [VITAMINS NOS] and GARLIC [ALLIUM SATIVUM] for an unknown indication.    On 18-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 DYSPNOEA (She indicates she had difficulty breathing), NASAL CONGESTION (But her nose closed up), ASTHENIA (She as well had weakness), SINUS CONGESTION (Sinuses immediately filled up) and NAUSEA (She as well had nausea). At the time of the report, DYSPNOEA (She indicates she had difficulty breathing), NASAL CONGESTION (But her nose closed up), ASTHENIA (She as well had weakness), SINUS CONGESTION (Sinuses immediately filled up) and NAUSEA (She as well had nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided by the reporter.  The patient reported that she take carbamazepine as concomitant medication which makes her white blood cell count low.
COVID-19 INFECTION; CONGESTION IN EAR CLOGGED; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series:1) (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 10-APR-2021 on left arm for prophylactic vaccination. No adverse events were reported following covid-19 vaccine ad26.cov2.s (Dose number in series: 1)  Non-company suspect vaccine included: mrna 1273 ( Moderna) (dose number in series:2) ( batch number: 033F21A expiry: UNKNOWN, form of admin, route of admin, and were not reported) dose was not reported, administered on 03-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 31-JAN-2022, the patient experienced covid-19 infection, using the binax home rapid antigen test and congestion in ear clogged (dose number in series:2). Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from covid-19 infection, and the outcome of congestion in ear clogged was not reported. This report was non-serious.
Swelling, tension, and pain in both knees. Sudden onset. Sharp decrease  of flexibility and mobility.
Cried all night & next day; Broke out in pruritic rash won't walk;
Sweating profusely; Felt off; Headachy; Tired; Feverish; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HYPERHIDROSIS (Sweating profusely), ASTHENIA (Felt off), HEADACHE (Headachy) and FATIGUE (Tired) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no reported medical history).   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 26-Mar-2021, the patient experienced HYPERHIDROSIS (Sweating profusely), ASTHENIA (Felt off), HEADACHE (Headachy), FATIGUE (Tired) and PYREXIA (Feverish). At the time of the report, PAIN IN EXTREMITY (Sore arm), HYPERHIDROSIS (Sweating profusely), ASTHENIA (Felt off), HEADACHE (Headachy), FATIGUE (Tired) and PYREXIA (Feverish) had not resolved. Not Provided          Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications were reported. Treatment for the events included ibuprofen
This spontaneous report was received from a physician refers to approximately 4 month old female patient. No concurrent or medical history was reported. On 15-APR-2015, the patient was vaccinated with ROTATEQ, (2 ml, oral). Concomitant therapies included PENTACEL and PREVNAR. On 15-APR-2015, the patient vomited immediately after the vaccine was administered. The child was crying at the time of administration. The outcome of vomiting was unknown. The reporter did not provide the causality between the event and the suspect drug. No product quality issue was involved. This is one of the 2 reports from the same reporter. Additional information has been requested.
Onset pink papular scattered lesions 2/4/04. Progression of rash-centralized lumbar/ abd/ thigh macular localized rash. C/O itching. Hx with Zyrtec  d/c Atarax po.
PATIENT GIVEN COVID VACCINE AFTER EXPIRATION WITHOUT PRIOR KNOWLEDGE OF EXPIRATION DATE: EXPIRED ON 10/8/2021 AND GOVEN ON 10/15/2021
UrticariaPruritus 1/16 itchiness at injection site 1/17 erythema, swelling, itchiness at injection site.  Narrative:  1/16 itchiness at injection site 1/17 erythema, swelling, itchiness at injection site. Improving since. Instructed to take antihistamine, ibuprofen, and apply cold compress and hydrocortisone cream. Will continue to monitor.
feels like he got insufficient or zero quantity of the dose; The syringe leaked; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (feels like he got insufficient or zero quantity of the dose) and SYRINGE ISSUE (The syringe leaked) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced UNDERDOSE (feels like he got insufficient or zero quantity of the dose) and SYRINGE ISSUE (The syringe leaked). On 25-Mar-2021, UNDERDOSE (feels like he got insufficient or zero quantity of the dose) and SYRINGE ISSUE (The syringe leaked) had resolved.            No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.
On the evening of the vaccine, I experienced a metallic taste in my mouth a few times and my Left arm was sore.  12 hours after getting the vaccine, I woke up with severe chills and muscle/joint aches (especially my knees and lower back).  At 3:55am the chills had resolved, but my body was sore all over.  All day the following day, I felt as if I'd been hit by a truck--I had severe muscle aches (especially my quadriceps and lower back).  My knees and fingers hurt.  I was exhausted.  I felt better by about 4-5pm that afternoon, but still had fatigue, weak legs, heavy feeling in my chest, occasional heart palpitations and occasionally mild labored breathing.  The second day post vaccine (5/9/21) I woke up feeling terrible again after not sleeping well over night.  I had mid and upper lumbar pain, mild headache, exhaustion and a rapid heart rate.  By later that afternoon, I was feeling much better.
Transient heart attack; Chest pain; Patient did not receive the second dose with 36 days from the first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Transient heart attack) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Congestive heart failure.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Transient heart attack) (seriousness criterion medically significant), CHEST PAIN (Chest pain) and PRODUCT DOSE OMISSION ISSUE (Patient did not receive the second dose with 36 days from the first dose). The patient was treated with Surgery (Stent placement in heart) for Transient ischaemic attack. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (Transient heart attack), CHEST PAIN (Chest pain) and PRODUCT DOSE OMISSION ISSUE (Patient did not receive the second dose with 36 days from the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications reported. No treatment medications reported.  Caller who is a Pharmacy intern states that she had a patient who has Congestive Heart Failure who came in yesterday to receive the second dose of the Moderna Covid-19 vaccine. The patient received the first dose back in March in a different location and had a heart attack after fours hours of receiving the first dose. Caller states that the patient had chest pain and he went to the Emergency Room and he was told he had a transient heart attack; the patient has a stent put into his heart.  Very limited information regarding this event has been provided at this time.; Sender's Comments: Very limited information regarding this event has been provided at this time.
Same day swollen tongue.  Next day severe back pain that signaled shingles outbreak.  Multiple lab tests ruled out kidney disease and other diagnoses until shingle blisters finally appeared 8 days later.
Okay so when I took my first dose, I know we haven't talked about the first dose, but I had the same regular after vaccination symptoms that everyone says it normal. The fever, body aches and such. By the third week after my first dose I felt a bit better. So I considered delaying my second dose, but I got it. So when I got my second dose I had baby aspirin and braced for what may happen. I got it much worse, I got chills, nightmares, fever, generally very tired, very foggy and body aches as well. I look back not I cannot even believe I was teaching my classes. Later on I could not even remember what I taught my college students. I was not feeling well weeks later, we lost power in a snow storm here. I could not even stay with family or friends because I was not feeling well during the power outages. I started having breathing problems during this time, cold weather, lack of electricity and whatever else we had to deal with. By the third week I started getting that breathlessness and I was thinking maybe it was the cold weather. We were without power for maybe two days. I kept wondering is it the vaccine is it that, is it that. It was like always exaggerating (my breathlessness) when I was moving. When I park in front of the college, and I walk to the classroom I cannot even catch my breath or say good morning to my students. I have been teaching for such a long time and this is all new for me. The breathlessness came first, and then chest pains. One day as I was teaching in class, I got that chest pain and it scared me. I did not know what was happening and I just told my students just wait, I cannot talk and I sat down and thought, "What is happening". Every single class I get it 3-4x now so I'm starting to worry. Now I'd be talking and I can hear my heart beating. Just the effort of talking makes me lose my breath. Sometimes I will just have to lay down when taking phone calls or meetings. I now mitigate around conditions that I am going through. Sometimes maybe a month after my vaccine I started thinking no I cannot just let this be, I expected it to go away. My headache was still persistent so I checked my BP it was 160/103. By the time I went to go see my DR, she searched everywhere and said it was not related to the vaccine but I know it is, it all started happening after the vaccine. I have never had this issue with my heartbeats before. When my DR first saw me, she was worried I may have a clot on my lungs because I could not hold a conversation with her, Eliquis is the medication she put me on for ten days. I looked really sick, like there was something wrong with me. My students said to take time off because I looked so physically sick. My DR did some blood work. By the way Eliquis is a blood thinner. My lung CT came back normal, which was 10 days of being on the blood thinner. No DRs really gave me any conclusions.
On Friday, May 14, 2021 started to have aches and flu-like symptoms. Then on Saturday, May 15, 2021. developed a migraine-like headache and chest pain along with worsening flu-like symptoms.  By midnight Sunday, May 16, 2021 awoke with 8-9 out of 10 chest pain, with copious amounts of vomiting, a 9 out of 10 headache, abdominal pain with a feeling of hot than freezing, shivering, unable to keep clear liquids down. No loose stools,  reported having a normal bowel movement. reported that since the vomiting started overnight the chest pain got no better but felt worse like an elephant was sitting on his chest. was taken to Hospital emergency department where he was originally treated, Tests performed were bloodwork including Troponin levels, EKG, Chest X-Rays, and CT scan. Per the Physician Assistant who initially saw stated that his EKG was abnormal than his Troponin level was elevated. Due to concerns withs history of Marfan Syndrome and the possibility of a torn aorta, increased Troponin, abnormal EKG the ED doctor wanted him helicoptered to Hospital's Cardiac Cath Lab to rule out a torn aorta. was helicoptered to  Hospital taken to the Cardiac Cath Lab ruling out a torn aorta. After IV fluid hydration and other treatment, was diagnosed with myocarditis. Upon discharge,  was placed on medication and to follow up with his PCP and cardiologist  on 6/25/21.
I ended up loosing my sense of smell on 1/10/2021 around 9 am in the evening.  I am not sure if this is related to the vaccine or just that i might have covid but I got tested this morning at the drive thru testing.  I will get my results in 2-3 days.  I have not received any other treatment as of this morning I am not having anything but the lost of smell and still congested.
Redness around site, resolved knot small; no sx vomiting; During < days.
Had delayed hypersensitivity reaction which was pretty severe. Started with typical soreness then developed small wheal on day 2 (about 2cm diameter). Rapidly progressed by that night to almost entirety of upper deltoid. At it?s maximal spread was probably 13 cm across. Main symptom was severe pruritis and and fairly hot and swollen. Now have hyperpigmentation in the area where lesion was which I assume is post inflammatory
Within 2 hours I was dizzy, nausea an light headed. Within 4 hours I had a fever (uncontrollable), I laid down. I wasn't able to get up and my arm swelled up really bad.  I was having streak in my vison and really bad dey eyes and mouth.  I had a fever on going for about 3 weeks straight. I called my Doctor the following day and she said it was a normal reaction, if it get's worse to call her again. I called her again because it got worse, my neck got swollen. left arm was trembling, lymph nodes were swollen, leg leg was pulsating. I started having chills and hot flashes ( I still have some till this day). My Doctor recommended seeing a specialist- Neurologist, Infectious Disease Dr.  The Neurologist said he can see where I get the trembles but does not  want to put me on medication and see if it goes away on it's own. I have a follow up with him regarding trembles, headache, flashing in my eyes. The Infectious Disease Dr. I'm following up her her again regarding my arm swelling, they prescribed me steroids but had not gone down.  Since all of this I have been very fatigue, this is everyday.