chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lower back pain; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain), NAUSEA (nausea) and HEADACHE (headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (lower back pain), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, BACK PAIN (lower back pain), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products usage were not reported by the reporter. treatment details not included.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Reporter email was updated.
Pt recvd 2nd Hep B 4NOV92 & approx 8 1/2 hrs later pt was irritable, lethargic; slept for 9 hrs; mom noted pt staring but no sz; pt had rubbery legs; taken to MD; nystagmus, weak rt arm, no reflexes; cerebellar ataxia, 140RBC, dysmetria
Diarrhea; soreness; Pink rash; chills; Fever; Nausea; fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PAIN (soreness), RASH (Pink rash), CHILLS (chills) and PYREXIA (Fever) in a female 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 Sulfonamide allergy, Drug allergy (NSAID's) and Allergy to antibiotic (Cipro, Amoxicillin.). Concomitant products included LEVOTHYROXINE, DILTIAZEM and HYDROCHLOROTHIAZIDE (THIAZIDE) for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), PAIN (soreness), RASH (Pink rash), CHILLS (chills), PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (fatigue) and HEADACHE (Headache). At the time of the report, DIARRHOEA (Diarrhea), PAIN (soreness), RASH (Pink rash), CHILLS (chills), PYREXIA (Fever), NAUSEA (Nausea), FATIGUE (fatigue) and HEADACHE (Headache) outcome was unknown.            No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Non-Significant follow up: Reporters contact details updated.
INCORRECT VACCINE GIVEN - SHOULDVE BEEN PEDIATRIC, NO ADE REPORTED
side effect from third dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effect from third dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effect from third dose). At the time of the report, VACCINATION COMPLICATION (side effect from third dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medication was not reported. The treatment history was not provided. Patient was immunodeficient and a titer test showed no detectable levels of Ig-m or Ig-g COVID -19 antibodies.
Extremely sore upper left arm, which affected my sleep very badly. Generalized aches and pains.  Headache on left side. Fatigue. Lasted for 5 days after the vaccination.
Had the shingle shot it gave me the shingles three yrs ago/ suspected vaccination failure; Had the shingle shot it gave me the shingles three yrs ago; awful pain; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   The reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported case for herself/himself. The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient had the shingle shot and the patient stated that it gave the patient shingles three years ago from the time of reporting. The patient stated he/she had awful pain. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.
Extreme headache, neck ache, for five days;  elevated BP  180/90. 160/88, etc.  De. prescribed additional BP medication after a week, and BP is gradually coming down...I hope.
soreness to Rt arm and pain , and inability to lift arm since receiving vaccine ( 3 weeks ago). Patient reports intense sharp pain when grabbing or lifting items with said arm consistently over the past 3+ wks since receiving vaccine.
Bilateral unprovoked pulmonary embolisms; A spontaneous report was received from a consumer concerning a 35-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bilateral unprovoked pulmonary embolisms.  The patient's medical history was not reported. Concomitant product use was not reported.  On 14-Jan-2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection.   On 31-Jan-2021, approximately 17 days after receiving vaccine, the patient was diagnosed with bilateral unprovoked pulmonary embolisms after a chest computerized tomogram (CT) was performed. Treatment included hospitalization and starting of anticoagulation therapy.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event was considered not resolved.  The reporter did not provide the causality assessment for the events.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Pt began to complain of abdominal pain and nausea the night after receiving the vaccine. The morning after complaint of "feeling bad" with abdominal pain, fever 101.2F for 12 hrs. Night of 1/29/03 complaint of nausea, dizziness, and shortness of breath. morning of 1/30/03 Pt had no complaints. Fever broke after every 4 hrs of tylenol on 1/29/03.
Severe fatigue day of injection and following day.  Neck broke out in an angry red rash (severe eczema, especially throat latch).  Hives all over torso.  Not getting better at day 8.
Fever developed 22MAY91 did not improve p/giving APAP; called clinic; was referred to pvt MD for eval;
First Dose: Sore arm; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0175) via an unspecified route of administration in left arm on 04May2021 as 1st dose, single for COVID-19 immunization. Medical history included allergies. Concomitant medication included unspecified allergy pill, but does not really have to take if she was wearing a mask and because she was not going out as much. On 04May2021, patient experienced only sore arm if she touched it. Patient reported that she would not have even known that her arm was sore if she had not touched it. Patient was taking Pfizer Covid-19 Vaccine to preventing coronavirus and to protect herself. It was reported that patient received second dose of Pfizer vaccine on 25May2021 (Lot Number: EW0186) in left arm and experienced left leg felt weird, Joint pain, Back pain, Foot was swollen and painful. Patient reported that with the second dose of the Covid-19 vaccine, she did not have any soreness at the injection site. Patient underwent lab test after second dose for an ultrasound to check for a blood clot but did not find anything. Patient reported that she was diagnosed with tenosynovitis, inflammation of the tendon or sheath around the tendon after the second dose. The outcome of the event was recovered on 05May2021.  Information on Lot/Batch number was available. Additional information has been requested.
Fatigue, onset 4 hours. Myalgia, onset 6 hours. Fever & chills onset 7 hours.
Immediately after immunizations were given per mom infant had a hyperextension of the neck and seemed to develop a "tic" or twitch. Later that day mother had to call 911 for a poss seizure.
On 1/10/13 patient stated neighbor saw patient "having a seizure" 2 days ago. Patient also aware of waking up a "couple times" and wondering how he got on sofa. On 2/21/13 MD reports patient had syncope episodes over last several months (at least 4 times) no numbness, tingling, weakness in extremities. 4/26/13 neurologist reports patient states he is "missing a block of time" usually at night, feels "like is waking up". Patient reports about 20 episodes since episodes first started with a "wave" or "pulse" of light and feeling tired with episodes.
This spontaneous report as received from a pharmacist refers to a 69 year old male patient. The patient's medical history included shingles (previous episode in February 2014). On 17-APR-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # J001698, expiration date: 08-MAY-2014, dose: 0.65 ml, subcutaneously in the left deltoid). The patient started to experience symptoms of shingles on 10-AUG-2014. He sought medical attention by consulting his healthcare provider on an unspecified date (in August 2014). None laboratory diagnostic was performed. He was prescribed VALTREX 1000 mg, NEURONTIN 300 mg and MEDROL Dosepak for which he was in the pharmacy at the time of the report (15-AUG-2014). The patient informed the pharmacist that he has been applying an antiviral ointment to his lesions twice a day since 10-AUG-2014, but he has not applied any antiviral ointment to his lesions on 15-AUG-2014. At the time of the report the patient has not recovered from shingles. The relatedness between the ZOSTAVAX and the event was not reported. Additional information has been requested.
Infection site reaction- pain discomfort. General symptoms- muscle pains, fatigue, allergic reaction- itching. Narrative:
Vaccinated with 1/2 dose of H1N1 pm of 13 May in left arm. Later that afternoon he noticed congestion of nose, throat and chest. Felt like he was developing pneumonia again with a tickle sensation in his lungs but he could not cough anything up. Later that night he began to notice problems with his balance, +head congestion and falling to right. Ears did not feel stuffy. No dizziness, no fever. Went to bed and slept remainder of night and most of next day. Had worked for 37 hrs prior to vaccination. Balance was feeling better on Friday, 14 May. On Sat 15 May began to notice foul taste in mouth, with nose and chest congestion. Used inhaler, no relief. Developed dizziness (room was not spinning he was, even with eyes closed), he stated he felt weak and was fatigued. Stated "Like I am drunk without the happiness". Went to the ED - dx as having vertigo and prescribed meclizine. Did not fill script as he felt he did not have vertigo. On Sun he slept most of day. Today 17 May reported that his sx are easing, balance has improved, slight stumbling. Vision with slight photosensitivity and slight pressure behind the eyes. States it is like it is hard to keep eyes open.
Pt. states that after receiving the Booster 3rd dose of Moderna 08/24/2021, started experiencing symptoms 08/25/2021 of vertigo, loss of function throughout the body, joints in the upper body pain, and mild fatigue. Primary recommendation for Neurologist follow-up 09/15/2021.
On Wednesday May 12th around 615 pm I started having symptoms of a stroke. I was scrambling my words, couldn?t talk right and my left side of my face wouldn?t move when I spoke or smiled. When I smiled my whole smile shifted to the right.  I had my girlfriend call 911 because I knew I was having a stroke. The symptoms lasted about 6 or 7 minutes. By the time the emt got there I was talking fine and my face was back to normal. I went to hospital where a cat scan was done on Wednesday night and came back fine. The doctors decided to admit me because they wanted me to get an MRI in the morning, which I did and came back that I had a minor stroke. The doctors think the stroke had something to with me being on an estrogen birth control as well as some family history but my primary care doctor recommend me report this because I did get the Jansen vaccine and it could have triggered what happened. I was discharged on Friday 5/14/2021 and I know have to take aspirin every day for the rest of my life, plavix for 21 days, and Lipitor until my doctor thinks I can come off.
ON 01/26/21 THE DAY FOLLOWING MY FIRST DOSE OF COVID-19 I BEGAN FEELING SOME LIGHTHEADNESS & WEAKNESS. I ALSO EXPERIENCED SEVERE STOMACH CRAMPS & SEVERE DIARRHEA. THE SECOND DAY (01/27/21) AFTER MY VACCINE, I BEGAN FEELING WEAKER, LIGHTHEADED, AND THEN LATER THAT EVENING I EXPERIENCED A PEIRCING HEADACHE WITH INTENSE PAIN ON FRONT LEFT SIDE OF MY HEAD. THE LIGHTHEADNESS CONTINUED FOR 3-4 DAYS. IT WAS WITHIN  THAT FIRST WEEK  I REALIZED MY PULSE  OX WAS READING 88-90 bpm . PRIOR TO THIS MY PULSE RATE ROUTINELY WAS BETWEEN 60-64 bpm. I SAW CARDIOLOGIST ON 2/5/21, AFTER ECG AND EXAM DOCTOR STATED MY HEART RATE WAS IRREGULAR, POSSIBLY A FLUTTER, AND ORDERED A HEART MONITOR TO WEAR AT HOME FOR 2 WEEKS.
Pt reports feeling tunnel vision, dizziness, and LOC. Pt briefly lost consciousness and assisted to floor by staff. BLE elevated on chair while pt in supine position on floor PTA of med obs team with stretcher. Pt placed in stretcher, able to stand and ambulate independently without difficulty. Pt given water, refused snack d/t gluten intolerance. VS at 0934: BP 139/79, HR 51, RR 17, O2 sat 100% RA. VS at 0944: BP 124/84, HR 60, RR 16, O2 sat 100% on RA. VS at 0951: BP 119/83, HR 59, RR 17, O2 sat 96% on RA. VSS at time of discharge. Pt escorted to exit via w/c by staff per protocol.
On day 8 after getting my first Moderna injection, I had deep soreness, redness and swelling in my right arm. The injection site was warm to the touch and discolored. It was painful enough for it to interrupt my ability to sleep. Taking Tylenol helped. After three days, it went away. I called the office to let them know. But it thankfully didn't get worse.
Side affects from vaccine at first - just mainly vertigo - I felt really drunk. Everything was moving without me for a few hours and that was it. I started getting Headaches a week later and those were tested for COVID August 26 - negative result at the Nurse Practitioner's office at Clinic and then a second test at home on  8/30  -positive result. 8/31/2021 - I had flu like symptoms for about a day. Headaches were bad the whole time before that and during that. COVID brain fog - but I am on Topiramate also so that contributes to it. I didn't have to go to hospital. I had an monoclonal antibodies infusion on the 3rd of September. I think it helped. I didn't have a high fever too much after that. My COVID symptoms lasted for about a week after the headache started. I had a negative COVID result yesterday for a test and I'm getting over my symptoms. I am really nauseous today.
While giving Imms PROQUAD grabbed out of freezer instead of MMR. Was later realized after given. PCP and family notified. Family reports no adverse reaction.
Patient had just recovered from COVID and ended quarantine on 1/1/21. On 1/4/21, she received the first COVID vaccination. While driving home on 1/6/21, she experienced an MI diagnosed in the emergency room 30 minutes later. She was admitted to the hospital and underwent a heart catheterization and received a STENT. She had previous cardiogenic shock in 2003.
Felt good the day I received the shot.  Only a little soreness at site of injection.  I got up out of bed at about 10:30 PM to urinate and still felt good.  At 5 AM. 17 hours after receiving the vaccine I woke up and tried to sit up in bed and was very dizzy; the worst I had ever experienced.  I could not walk or stand without holding on to something.  This condition gradually improved over the next 10 to 12 hours.  There was no nausea associated with the dizziness.  The next day I felt fine.
No additional AE reported; Patient was administered both improperly stored ROTATEQ, improperly stored VAXELIS; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 20-FEB-2022, the patient was vaccinated with an improperly stored of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis (lot # 1741817, has been verified to be a valid lot number rotavirus vaccine, live, oral, pentavalent, expiration date reported and establish as 30-JUL-2022) (strength, dose, route of administration and anatomical location were not provided) and diphtheria vaccine toxoid (+)  hepatitis b vaccine rhbsag (yeast) (+) hib vaccine conj (menigococcal protein) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (vero) (+) tetanus vaccine toxoid (VAXELIS) (lot # U7124AA, expiration date reported as 13-JUL-2024) (strength, dose, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were 0.8° Celsius (C) for 35 minutes respectively.  If a digital data logger was involved was not reported.  The vaccines experienced a previous temperature excursion.  No adverse event reported.
had a positive test on 01Aug2022; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 21Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 21Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing), notes: other medical history: Diabetic, Morbid obesity; "Morbid obesity" (unspecified if ongoing), notes: other medical history: Diabetic, Morbid obesity. Concomitant medication(s) included: METFORMIN; OZEMPIC; LOSARTAN; SINVASTATINA. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 01Aug2022, outcome "recovering", described as "had a positive test on 01Aug2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (28Jul2022) Negative; (30Jul2022) Negative; (01Aug2022) Positive; (03Aug2022) Positive; (09Aug2022) Positive; (11Aug2022) Negative; (12Aug2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Clinical course: subject had two boosters in addition to two vaccinations reported, after completing Paxlovid on 27Jul2022 and testing negative on 28Jul and 30Jul2022, had a positive test on 01Aug, 03Aug and 09Aug. Negative again on 11Aug and 12Aug. If treatment ae: No, Known allergies: No. Other medical history: Diabetic, Morbid obesity.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
After receiving the second dose on 6/15, my son woke up at 3:30am on 6/16 with a nose bleed that lasted as a steady light stream for about 5 minutes.  He also had a slight fever of 100.  By 7:30am on 6/16 his fever was slowly increasing and the nausea began.  He did not throw up but it is now 10:45am on 6/16 and his fever is 102.6 and he is still nauseous.  I'm not too worried since these are all common symptoms but I felt like I should should report them since he is 12 years old.
Patient is experiencing severe arm and shoulder pain.  Medication was likely given too high, just below the acromium process.  At this time the primary care physician's office is to treat conservatively, refer to physical therapy and hope it resolves in a few weeks.
Pneumonia; A spontaneous report was received from a consumer, concerning herself, a 87-year-old, male patient who Moderna's COVID-19 Vaccine (mRNA-1273) and developed pneumonia.    The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.     On 24 JAN 2021, approximately 1 day prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Batch number:0138) intramuscularly for prophylaxis of COVID-19 infection.   On 25 JAN 2021, approximately 1 day after receiving the vaccine, the patient went to the emergency room for pneumonia, fever, cough, where in patient could not stop coughing hence he was hospitalized on an unspecified date in 2021. The event pneumonia was also considered to be medically significant. Patient would like to know if he can receive the second vaccine shot scheduled for 20 FEB 2021 and if he can receive the shingles vaccine because he has not yet received it. Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event, pneumonia was considered unknown at the time of this report.; Reporter's Comments: This case concerns an 87 year old male patient, who experienced a serious unexpected event of Pneumonia, 1 day after receiving first dose mRNA- 1273 (Lot# 0138). Very limited information regarding this event has been provided at this time. Further information has been requested.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. No concurrent condition or medical history was reported. On 27-NOV-2015, the patient was vaccinated with improperly stored dose of ROTATEQ (Lot # L013192, dose and route of administration not provided). No concomitant therapy was reported. No adverse effect was reported. The outcome of the event was unknown. No product quality issue was reported. This is one of the several reports from the same reporter link. Additional information has been requested.
The day after I received the vaccine I was very ill. I had a fever of 103 for most of 24 hours after the shot. I had body aches and chills and just felt generally horrible. I was 8 weeks pregnant with twins at the time of the vaccine. 3 days after the vaccine I had an ultrasound which showed a large blood vessel between the twins. On March 23rd I had another ultrasound and neither of one of my twins had a heartbeat. From the measurements they could tell that I lost one twin the week of March 15th and I lost the other one the week of March 22nd.