chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feels pretty sick; stomach is really bad; foggy in the head; headache; very severe back pain; A spontaneous report was received from a consumer concerning a 74-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events very severe backpain/back pain , feels pretty sick/illness, stomach is really bad/abdominal discomfort, foggy in the head/feeling abnormal, headache.  The patient's medical history included sick for 5 month with a novel virus a few years ago. Current condition included asthma. Concomitant medications included gnucola for the lungs, this helped her with her asthma.  On 8 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 039K20A) via unknown route for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the events very severe backpain. On an unknown date, the patient experienced the events feels pretty sick, stomach is really bad, foggy in the head, headache.  Treatment details included Charcoal, acetylsalicylic acid.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), very severe backpain, feels pretty sick, stomach is really bad, foggy in the head, headache was unknown.; Reporter's Comments: This case concerns a 74 Y/O F with a serious unexpected back pain, illness, feeling abnormal, headache, abdominal discomfort.  Event onset Day 2 after first dose mRNA-1273. Treated with charcoal, acetylsalicylic acid. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
This is per school nurse - pt c/o SOB while in class after H1N1 vaccine - pt has hx of asthma pulse ox was 80-90%. BP-ok per school nurse. Pt has no inhaler, called mom and went to Drs for breathing tx.
bodyache; Joint pain; Chills; Headache; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PAIN (bodyache), HEADACHE (Headache), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 001L21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced CHILLS (Chills), PAIN (bodyache), HEADACHE (Headache), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain). The patient was treated with ACETAMINOPHEN (oral) on 01-Apr-2021 at a dose of 500 mg. On 03-Apr-2021, CHILLS (Chills), PAIN (bodyache), HEADACHE (Headache), ARTHRALGIA (Joint pain) and MYALGIA (Muscle pain) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 103 (High) 103F. On 02-Apr-2021, Body temperature: 100 (High) 100F.         Concomitant medications were not provided.     This case was linked to MOD-2021-053226 (Patient Link).
UrticariaPruritus, Facial redness and pruritus Narrative: Employee still in vaccination clinic.
Patient is fully vaccinated. Hospitalized 11/22-11/26, 2021.  Admitting dx:  shortness of breath, hypoxia(saturating at 84%), COVID 19. Patient admitted with COVID 19 and placed on Remdesivir and decadron.  Symptoms improved and discharged with home oxygen.
Rash began two days after injection.  Red raised rash from injection site wrapping to the bicep.  Hot to the touch, itchy and tender. I can wrap my hand around the rash.  It's been 5 days and the rash is still visible.  Not as tender or hot. Still itchy but less red.
Bad Headaches, nose bleeds with heavy blood clots, burning  heat sensation going down left lower leg. Night sweats, cold hands from bad circulation, hard to concentrate at times, depression .
Elevated heart rate of ~115 bpm for 7 continuous hours.  Fever of 102.7.  Severe chills.  Aches.
Sudden onset diplopia. Lasted roughly 6 hours. Was gone next morning, when I woke up.
Narrative:  COVID infection after completion of COVID vaccine series: 01/14/2021 COVID vaccine dose #1 02/04/2021 COVID vaccine dose #2 07/15/2021 COVID positive per pre-procedure nasopharyngeal swab 07/16/2021 Pt presented to ED on HCP advice to receive further tx given age and comorbidities. Also reported productive cough. 07/16/2021 Pt admitted to facility. Steroids initiated. Pt not candidate for remdesivir due to ESRD on HD status. 07/17/2021 MD attending note reported continued cough but no requirement of supplemental O2. Initiation of supportive care and doxycycline therapy for LLE ulcers. 07/18/2021 MD attending note reported pt feels improved 07/19/2021 Pt O2sat dropped to 80s. Pt still hypoxic on 5L so increased to 10L NC. Transferred to ICU. ASA and Plavix resumed. 07/20/2021 Dex switched to solumedrol. Per Crit Care note, plan to continue with current mgmt. 07/21/2021 Per Crit Care note, pt desat to low 80s and was placed on BIPAP 12/7 at 60%. 07/22/2021 Per Crit Care note, no acute events. Planned to decr solumedrol and titrate down FiO2 as tolerated. 07/23/2021 Per Crit Care note, no acute events. Continued decr solumedrol and titration of FiO2. 07/24/2021 Per Crit Care note, pt increased dependence on BIPAP. ID initiated vanco/cefepime therapy for LLE ulcers. 07/25/2021 Per Crit Care note, pt on airvo 100/40 and hemodynamically stable. Continued on chronic HD schedule as well. 07/26/2021 Continuation of steroids and HFNC/NIPPV support. D/C abx. 07/27/2021 Per Crit Care note, pt desat to mid 70s on airvo so placed on BIPAP 12/6 at 80%. Pt had hypoglycemic episode overnight. Solumedrol increased to 80 mg q6h. 07/28/2021 Per Crit Care note, pt continued to desat. Placed on 100% FiO2. Lantus held, Lovenox increased.
I have consistently gotten it every 28 days, except this month and the months of Mar and Apr (which was around the time of my first and second shot); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 03Mar2021 (Lot number: er8730) at the age of 34 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset Mar2021, outcome "unknown", described as "I have consistently gotten it every 28 days, except this month and the months of Mar and Apr (which was around the time of my first and second shot)". Additional information: No other vaccine in four weeks. Other medications in two weeks included birth control pill. Adverse event included that she got her period 2 days after shot which was one week early. She had tracked her period for the last year and has consistently gotten it every 28 days, except this month and the months of Mar and Apr (which was around the time of her first and second shot). No treatment. No covid prior vaccination and no covid tested post vaccination.
Chills started in the middle of the night around 1:30 am and did not resolve until almost lunchtime. The chills were not reduced with clothing, blankets, or heat. By 9:00 am I felt achy and had a headache and very fatigued. I could not work, and I could not even telework I felt so bad. These symptoms ended aroound midnight with the exception of fatigue. Additionally, every time I took a sip of water or tea or tried to eat anything throughout the day, no matter how little, I felt like vomiting. Yesterday I ate 1 piece of toast, 3 crackers, and just 24 oz of liquid (ginger tea, ginger ale) These symptoms have reduced a bit where I don't feel like vomiting, but still feel slightly nauseous when I eat or drink.
Uncontrollable shivering, high grade fever (103.5 degrees f), while body muscle aches, extreme headache. Over the course of 24 hours, ibuprofen and cold compress used as treatment.
I am an RN who received my second Shingrix injection in my LEFT BICEP muscle and NOT in my deltoid causing extreme discomfort at the injection site during the injection. I am not certain if it was given IM or SubQ.  Over the next five days I had a more then expected adverse reaction at the injection site resulting in pain, sever redness and swelling at the injection site. The injection site was very hot to touch for three days. I have photos should you require them.  It is obvious that the Pharmacy technician requires additional training to learn the difference between the deltoid and bicep muscles as I consider this an ADMINISTRATION MEDICATION ERROR.
This spontaneous report as received from a pharmacy technician refers to a 4-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 02-FEB-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
After 1 week of first dose of moderna vaccine, patient experienced breakthrough bleeding and on and off spotting through out until she received the 2nd dose 28 days after.
patient felt very dizzy and faint immediately after receiving the vaccine.  She said her arm where she got the vaccine felt numb.  her blood pressure was 88/54 HR 60 O2 98 when first checked.  her BP was checked every 5 minutes for 30 minutes and was in the range of 88/54 -118/93 her HR was 60-75 and her O2 remained in the 96-99 range. She was given an icepack to put on her arm, a cold towel for her forehead and neck and she lay down on the floor.  her feet were elevated the entire time she was lying down.  She eventually was able to sit up and said was feeling better.  her final bp reading was 118/93 HR 75 O2 99
PULMONARY EMBOLISM, BILATERAL SEGMENTAL AND SUBSEGMENTAL AREAS OF THROMBUS
about 5-10 minutes after administration, my lips began to move and shake uncontrollably and became tingling and a bit numb. Soon right after my heart rate was very fast, highest 160's. My throat felt weird but I never had any difficulty swallowing or breathing and my mouth, lips, or tongue never became swollen.
Severe body/muscle aches, headache, chills, lethargy and site pain as I awakened the following morning.   Lasting all day.   Second day, symptoms are not as severe,  but still there.
This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired) and DIZZINESS (lightheaded) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced FATIGUE (tired) and DIZZINESS (lightheaded). At the time of the report, FATIGUE (tired) and DIZZINESS (lightheaded) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.
High temperature.  Mom gave Tylenol at 4p x 8p.  Febrile seizure occurred 6/11/08 9pm.  Transported 1 squad to hospital.  Treated with Ibuprofen and Actomephen.  Discharged to home.
Muscle spasms through out body so bad that I was unable to stand on my own, fatigue, fever (99.5-103.1), vomiting, and diarrhea for the first 24 hours. Continued fever (99-100.7), body pain, and fatigue for the following 48hours. Missed work due to symptoms
No Adverse reaction.  Patient received the dose outside of the 42 day maximum window.  Per patient stated at time not to get second dose by son in law.  First dose on 3/20/2021. They were then advised to get second dose.
Patient received Pfizer COVID vaccine on 1/20/21 (lot # EL3302), 2/8/21 (lot # EL9262), 9/29/21 (lot # 30145BA), and Moderna COVID vaccine on 4/11/22 (lot # 065K21A). On 6/2/22, patient admitted to our inpatient facility (med/surg unit) with acute on chronic heart failure with moderately reduced EF-45-50%, COVID19 pneumonia, acute hypoxemic respiratory failure, and moderate right pleural effusion. As of today (6/6/22), patient is still admitted in our med/surg unit.
Redness, swelling, tenderness of left lower limb 2 days post admin.
Neonatal seizures (ongoing - included hospital admission in previously healthy 2 month old (within 72 hrs of vaccine administration).
appendix ruptured/aapendicitis; mild flu symptoms; energy level was low; stool is soft; bowel movements are not consistent; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, Lot Number: ER8737), via an unspecified route of administration, administered in the right arm on 29Mar2021 as a single dose for COVID-19 immunization.  Medical history included allergy to penicillin from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lisdexamfetamine mesilate (VYVANSE, reported as 'VYVANSE Xr'); duloxetine (manufacturer unknown) and lamotrigine (manufacturer unknown) all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05Apr2021, the patient had stomach ache and pains. On 06Apr2021, the stomach pains were constant and sometimes sharp and there were mild flu symptoms. On 07Apr2021, the patient had severe stomach pain and flu symptoms. The patient took a nasal swab rapid COVID test also which came back negative. In the afternoon of 07Apr2021, the patient's temperature hit 104 and she went to the ER. After the CT scan, appendicitis was confirmed and the patient went into an emergency appendectomy. The patient's appendix ruptured. On 09Apr2021, the patient was released from the hospital. As of 28Apr2021, the most of the patient's symptoms are gone but bowel movements are not consistent and stool is soft. The patient's energy level was low and there was slight lower stomach pain at times. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
After each COVID shot, she gets acute leg weakness, bilaterally, unable to get up from sitting or support own weight. Also cognitive decline.
painful, red inflamed joints, rash, afebrile was given Medrol dose pack; 18MAR94 follow up call sx subside p/wk;
Developed diffuse vesicular rash, that was VZV PCR positive c/w Chicken Pox Disease. Extended hospitalization stay which had been for the management of TB pulmonary infection (approximately an additional 1 week) to receive IV therapy (acyclovir), developed an infiltration while on therapy requiring antidote administration.  Plan to complete total 14 day course of acyclovir/valtrex pending rash improvement.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported.
Based on additional information received on 31 August 2015, this case became medically confirmed. Initial unsolicited report received from a non healthcare professional on 19-Aug-2015. A female patient (age not reported), had received a dose of ADACEL (batch number: U5271AA, expiry date: 10 February 2018, dose details, route and site of administration were not reported) on an unspecified date. The illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. Concomitant medications were not provided. On an unspecified date post-vaccination, the patient experienced swelling and redness that resolved in one week. Laboratory investigations and corrective treatments were not provided. The patient recovered from the above mentioned events on an unspecified date. Follow-up information received from a nurse on 31 August 2015. This case was linked to 2015SA126700, 2015SA126832, 2015SA126715 (same reporter, same vaccine, different patient). No new information reported. Documents held by sender: none.
I started experiencing a fever in the middle of the night with severe joint pain in every joint in my body. I took Tylenol. That morning I still felt pain until this day. I have an appointment with my doctor next week due to still experiencing this issue.
INADVERTENT AUTO-INNOCULATION OF VACCINIA FROM LEFT ARM TO LEFT FACE; WITH BACTERIAL SUPERINFECTION (IMPETIGO).  PT SENT TO MEDICAL CENTER TO CONFIRM/REFUTE PRESUMPTIVE DIAGNOSIS; AND TO PROVIDE OBSERVATION AND/OR TREATMENT IF NECESSARY
No sense of smell; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two reports. This is the second of two reports.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date not reported), via an unspecified route of administration on 04Feb2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient went to get the COVID-19 vaccine and it was reported that she also experienced no sense of smell in Feb2021 with outcome of unknown.   Information on the lot/batch number has been requested.;
Shoulder and elbow pain, weakness, numbness and fingers tingled. The whole arm hurt.
weakness Pt states that he became so weak that he was unable to move and het OOB. When he did, he fell and hurt his head. Went to ER following day from Injection and has been in Rehab since.
Pt c/o redness, itching, mild swelling to left side of eye. Noted redness w/ swelling approximately "10 mL" (per observer). Pt provided w/ Benadryl. Maintaining airway, secretions. No additional swelling or rash. D/c home after additional 15 minute observation
Patient came in the next morning, 5/30/2018, complaining about his experience following the flu shot.  Complaints included lightheadedness and near syncopal episode starting roughly a half hour after the immunization and lasting 3 to 4 hours later. Patient also complained of severe flu-like symptoms with several episodes diarrhea through the evening and vomiting once in the morning during breakfast.  Complaints also included arm pain at the injection site. All protocols were followed during the immunization process. Patient also received a testosterone injection from a nurse at 10:05AM  before going to the pharmacy for the SHINGRIX vaccine.
Short of breath, sweating, palpitations, tachycardia, pain at injection site, right calf leg pain
I had extreme chills and weakness for 4 days from the vaccine. Symptoms were so bad I was incapacitated for 4 days. I ended calling my doctor and was told if symptoms don't improve by 5th day to call back. He also mentioned that there reports of women my age having this type of reaction to the vaccine, especially if I hadn't had covid (which at the time of the vaccine I hadn't). I was sicker from the vaccine then people I know that had covid. My reaction was so severe I did ask my doctor if I should have the 2nd vaccine (which I did). I also had a small reaction to the 2nd vaccine.
Patient developed unconsolable crying at 11:00 pm on 11/19/2008. This was approximately 14 hours after the immunizations were given. Patient's mother attempted to calm infant through the night but did take infant to Hospital at 9:00 am on 11/20/2008. At admission to ER patient was still crying and was running a fever of 101.6. Patient was admitted to ICU. Rule out diagnosis included: MRSA, menningitis, and CMV. All tests for these were negative. Patient was treated palitatively while hospitalized. Patient was discharged home on 11/22/2008 with the diagnosis of a pertusis reaction.  12/1/08 MR received for DOS 11/20-22/2008 with DX: Inconsolability associated with fever.  Inconsolability 2' to DTaP.  Thrush.  Leukocytosis. Pt presented with abrupt onset of fever and inconsolability. Seen by PCP and dx with otitis media and concern for meningitis due to a far off stare.  Recent foul smelling diarrhea. PE (+) for screaming when moved, fussiness, dry mucous membranes, tachycardia, nuchal rigidity and injection site swelling on the R.  Improved in IVF and abx.
walking and overcompensating on right side,  Losing balance and falling.  Hypersensitive to light this morning.  More lethargic, more needy, more cranky.    Starting at 36 hrs, had tendency to veer left. That is still present at 48 hrs  1. Cerebellar ataxia  2. Post-immunization reaction, initial encounter  Treatment: Close Observation
08/07/2021: -Headache -Fatigue -Nausea 08/08/2021: -(all symptoms above and;) -Vertigo -Pain / lump in back of mouth (bottom left jaw) -Inflammation in joints (hands/fingers) 08/09/2021: -Headache -Fever -Fatigue -Nausea -Pain / lump in left mouth / jaw -Pain in left ear canal 08/10/2021: -(all side effects from 08/09/2021)
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On 22-FEB-2016, the patient was vaccinated with a dose of VARIVAX (Merck) lot # L035124, expiration date 14-SEP-2017 (route was not provided). Concomitant therapy information was not provided. On 22-FEB-2016, there was an incorrect product storage, the patient received an improperly stored dose of VARIVAX (Merck). No adverse event was reported. It was reported that the total cumulative excursions and time were 10.4 F for 7 hours and 20.4 F for 1 hour and 30 minutes. The patient's status was unknown. Additional information has been requested.