chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Adverse event: patient had swelling around injection site. Redness around injection site. Symptoms started morning of 12/06/18. Treatment: Patient stated that placed ice on injection site but did not help. Recommended to use ibuprofen for the pain and swelling and to seek medical attention from physician as soon as possible. Outcomes: patient stated that they will go have the swelling looked at by their physician today 12/06/18.
raised erythematous macular rash with burning and itching measuring 14 by 10 cm with 10 cm clear fluid filled vesicle in center
Patient complain of upper arm pain with Pneumovax injection 2 days ago, firm, sore times 2 days. Last HS (1/30/07) got move sore areas of erythema/induration noted OTC Loratadine #10 recommended.
Patient received 1st vaccine in series at 11:45 am 11/27/21 during hospitalization. She had been in hospital for 10 days after pancreatitis, fall with hip fracture and fixation of hip fractures.  At 11:45pm she was noted to be short of breath.  at 6:15 pm on 11/28/21 she was found unresponsive, coded and expired.
After about 5 minutes of vaccine administration, patient complained of "feeling of passing out", sweating hands and face, racing heart rate. Called 911. After EMT arrived, and checked patient for any issues. From EMT, patient had known history of "fear of needles" and had anxiety attack after the vaccine. After about 20 minutes, patient was stabled and got release by EMT.
FEVER AND GRAND MAL SEIZURE. WAS MILDLY GROUCHY IN THE AFTERNOON. FELT WARM AT 4PM ONE DAY PRIOR TO ADMISSION. FAMILY WAS READY TO GIVE TYLENOL, SHE BECAME LISTLESS AND BEGAN TO SHAKE ALL EXTREMITIES. CALLED 911.THAN BEGAN WITH TONIC CLONIC MOVEMENTS. EMTS TOOK TEMP, IT WAS 106F. TONIC CLONIC LASTED HALF AN HOUR. FAMILY REPORTED MILD UPPER RESPIRATORY SYMPTOMS, EATING WELL ALTHOUGH DECREASED IN AM.SHE HAS HAD RED CHEEKS SINCE FRIDAY. NO NAUSEA OR VOMITING. 10/24/06 Received medical records from PCP which reveal that patient had temp of 99.0 on day of vax.  Taking cows milk.  +GERD.  HX: chickenpox 2/06 & developed fever & cellulitis./ss 11/7/06 Received medical records from hospital which reveal patient admitted 10/15/06-10/17/06 for febrile seizures.  Presented to ER after having seizure for approx 30 min w/fever greater than 106. Ped neuro consult done & included w/D/C summary. Family hx: several paternal aunts w/febrile seizures as children.  Final Dx: Febrile seizures./ss
Patient began experiencing bilateral tinnitus about 16 hours after vaccine; Bil ear ringing has been constant and unchanged.
Diarrhea, NauseaVomiting, injection site itching and pain. Chills and fatigue Narrative:
Very sick with chills, fever, headache after vaccine 2 week late period, second period following second dose. When period did come, very strong (more than ever) cramps for longer period of time prior and pain/bloating. I am usually very regular, was told to report symptoms
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore arm) and fatigue (tired) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 074M20A) for COVID-19 immunization. Concurrent medical conditions included abnormal blood pressure. On Feb 2, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 2, 2021, patient experienced pain in extremity (sore arm) and  fatigue (tired). At the time of the report, pain in extremity (sore arm) and  fatigue (tired) outcome: unknown.   Concomitant medication included blood pressure pills. Treatment information unknown. This case linked to MOD-2021-417555, MOD-2021-417532 (patient link).
After receiving he October vaccine I developed tingling and burning in both feet.  Have been diagnosed with small fiber neuropathy.
Patient experienced shortness of breath, chills, sweating, nausea and fatigue. Ambulance was called and arrived immediately. Patient went to the hospital.
Profuse vomiting and severe epigastric pain starting 14 hours after receiving vaccine. Unresolved 24 hours after receiving the vaccine. Also felt very nauseous and had severe epigastric pain after receiving first dose of Pfizer vaccine but did not vomit.
very bad arm pain in the middle of the night; gets very tired; feeling very dizzy; weak; This is a spontaneous report from a contactable consumer or other non hcp via medical information team. A 96-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 06Feb2021 (at the age of 96-years-old) as single dose for covid-19 immunisation. The patient's medical history included covid-19 from 08Jan2021 to an unknown date and experienced a bad sore throat as a first symptom and felt very weak and tired. They called the department of health and they said to wait for 10 days before she can be cleared from quarantine, and they consulted with her primary care physician and pulmonologist since she has a history of COPD among other conditions) and they all said that she should go ahead and take the vaccine. The patient's concomitant medications were not reported. On 07Feb2021 Sunday at around 12:30, patient experienced feeling very dizzy and weak (lasted for about an hour) and weak (lasted until evening time that day, has subsequently passed but a bit of weakness is still notable), and in the middle of the night, the patient experienced very bad arm pain on an unspecified date. On Monday, most of the symptoms have disappeared but she still gets very tired on an unspecified date. Reporter concerned since she feels that these side effects are too much at this point, considering the patient's age. She stated that it was listed on the fact sheet that dizziness and weakness is a symptom of a potential severe allergic reaction, and she is not sure whether her mom should get the second dose of the vaccine with this in mind. The outcome of the event feeling very dizzy was recovered on 07Feb2021, event weak and very bad arm pain in the middle of the night was recovered on an unknown date while, the outcome of the event gets very tired was unknown.  Information on Lot /Batch Number has been requested.  Follow-up attempts are completed. No further information is expected.
Information has been received from a medical assistant concerning unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unspecified dates since 29-SEP-2016, the patients received doses of improperly stored GARDASIL 9 ( lot # M016193, expiration date 24-APR-2018). The vaccines were stored at 31.6 F for 30 minutes. The temperature excursions were detected by a " data logger". There was no previous temperature excursion. The medical assistant was not aware of any adverse effects. This is one of several reports received from the same reporter. Additional information has been requested.
Itching and redness where vaccine was administered. Area is slightly raised. Itching  began the evening of 4/13/21 and has bee on off and on. The redness and raised area started not long after and is still there on 4/14/21.
Rash all over body, fever (T Max 99.5) - Benadryl was given in office and pt referred to allergy/immunology clinic. Follow up for eval and call if symptoms are worse.
Initial consumer report received on 18 Dec 2009: This patient received one dose of FLUVIRIN (batch no: 102046P1) intramuscularly on an unknown date. The reporter stated that she saw some liquid came out in the air after the needle was pulled out of her arm. She stated that liquid was from the injection site once the needle was removed. She was vaccinated with a dose from the MDV. No adverse event was reported. No other information was available.
Fever, nausea, headache, vomitting, diarrhea. No treatment needed. Lasted 1 day community is seeing an increase in GI flu symptoms unrelated to immunizations.
After administration of vaccines, patient vomited in the clinic x1. Mother states she just fed patient before coming into the room. When patient went home, Mother states she started vomiting after feeding and had a fever of 103. She was taken to ER at 5pm and was given IV fluids, Tylenol and Motrin. They monitored her at ER and was discharged at about 9:15PM. Mother states she felt better the next day.
Patient was administered Hepatitis A and Menactra shot on the right deltoid by M.A. Patient developed severe pain, burning inside and mild erythema after Menactra administration. Patient was given Tylenol 650 mg and ice was applied. Patient started feeling much better after 30 minutes and erythema disappeared.
About an hour after after receiving the injection I started getting a bad headache and became very very tired I laid down for a few hours I got up around 7 p.m. to eat I still had a terrible headache I started getting nauseous and I was having some muscle aches in my legs and arms I went to bed and in the morning when I woke up the next day 4/23 I still felt very exhausted I had a hard time waking up and while I was laying there awake I had paralysis I couldn't open my eyes, talk or move, I fell back asleep after a couple of minutes and when I woke up the second time I was fine just drowsy still
Small red rash on leg (calf), painful red inflamed area on tongue 2 days after injection.  Pt went to doctor on day 12 (1/24/08) and received prescription for Magic Mouthwash.
Headache, Myalgia, Diarrhea, NauseaVomiting, chills chest flushing Narrative:
temperature excursion due to vaccine not being put into the fridge; Initial information received on 02-Feb-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a patient with unknown demographics who had temperature excursion due to vaccine not being put into the fridge while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE,lot UJ572AAA via (unknown route, administration site,dose,frequency,strength).  On an unknown date the patient had temperature excursion due to vaccine not being put into the fridge (product temperature excursion issue) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (temperature excursion due to vaccine not being put into the fridge).  At time of reporting, the outcome was Unknown for the event temperature excursion due to vaccine not being put into the fridge.
Persistent large amounts of blood in baby's stool after 2 month vaccines. Blood worsened after 4 month vaccines. Nursing mother went on total elimination diet suspecting food allergies, refused 6 month rota-virus vaccine and later added all foods including dairy back in to nursing mother's diet when baby was 7 months. No reaction was observed when all foods were added back into diet. Believe bloody stools were caused from rotavirus vaccine.
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Hypotension-Severe, Systemic: Nausea-Medium, Systemic: Weakness-Medium, Additional Details: Patient's face turned very pale/yellow. His blood pressure and pulse were very low.
No adverse effects; patient received VARIVAX via intramuscular route; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported.  On 14-SEP-2019, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) intramuscularly into left deltoid, lot# R010469, expiration date: 10-APR-2020 (exact dose and frequency were not reported), reconstituted with sterile diluent. No adverse effects were reported.
She received first dose of Moderna vaccination on 1/5/2021 into left deltoid. It was painless. Approximately half an hour after injection, she began to feel tingling in the left arm, hand, and fingers. It resolved on its own and she was fatigued that evening and went to bed early. The next day she had soreness of the arm, fatigue coming through the day in waves. On 1/7, low grade fever of 99.1, headache, and fatigue. She slept for 14 hours. From 1/8-11 she had no significant issues although she did feel slightly off balance. On 1/12, she noticed left axillae lymphadenopathy and had soreness at the injection site again, which worsened the next day. On 1/14, arm was red, swollen, and tender to touch. These symptoms persisted the next day and she began to have numbness and pins and needles of the left hand. She was given 7 days of dexamethadone and cephalexin by her PCP. She slept very poorly. The next day, the numbness, swelling, and redness were all improved. On 1/17, she continued to gradually improve and there was no swelling and only slight numbness. She did have fatigue, headaches, and insomnia.    On 1/21, she had visit with an allergist to discuss preventative measure for second dose. A delayed reaction was theorized and a preventative course of premedications was outlined. The next day, the numbness in the hand worsened and headache returned. On 1/23, she felt headache, confsuoin, anger, imbalance, pins and needles in the hand, difficulty holding a glass with one hand. On 1/24 pain at the injection site recurred. She felt there was change in her vision and hearing, nausea, vibration throughout the body, mouth numbness, and heart racing. On 1/25 all these symptoms persisted other than improvement in confusion. On 1/26-27, she had continued pins and needles in hands and feet. Still felt vision and hearing were "off". She was fatigued and body felt "like jello". On 1/28, she was prescribed a second course of dexamethasone as well as citalopram 20mg and diazepam. With citalopram, she had nausea, hot/cold sensations, dizziness, insomnia. She also had itching of the arm, back, leg; tremor, thirst, and pallaor. She reported symptoms to PCP and citalopram was discontinued next day. On 1/30-31 she felt disoriented at times, intermittent arm soreness, noted small abnormal bruising, hot/cold, off balance, headache, and fatigue.    Since that time, predominant symptoms have been daily headache. Wakes with left posterior dull aching which escalates through the day 5/10 but will become 8/10 if she does not take anything. She is taking ASA in AM daily with second dose around 3PM when headache recurs approximately 5x/week. Sensation in feet has normalized, but she continues to have numbness in left>right hand. She feels off balance with need to specifically concentrate when walking. No falls. She also has persistent abnormal tremor of left finger. When she goes to type, she will press key 3-4 times. She feels difficulty opening water bottles, but is able to do some. She is lifting pans with both hands.
The patient reports pain in the deltoid area of the left arm and pain with movement of the shoulder. The patient did not report the pain to the medical provider after the vaccination in February and had not been back in clinic for an appointment until September 6th when she mentioned the symptom to the medical provider during an exam.
When completing vaccine administration, needle scratched the child's skin and cut them due to child moving. Scratch is approximately 20-25mm in length but intermittent.
pt was given vax 29APR95  11AM & by 8PM pt was red all over body; pt was also on Bactrim @ the time; pt was seen in ER & recovered well;
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of Vaccine exposure during pregnancy in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (occasional), Nicotine abuse in 2017, Childhood asthma, Eosinophilia, and Pregnancy on 09-Oct-2018. Concurrent medical conditions included Acid reflux. Concomitant products included FAMOTIDINE for Acid reflux, PRENATAL VITAMINS for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 30-Dec-2020, the patient experienced Vaccine exposure during pregnancy. On 30-Dec-2020, Vaccine exposure during pregnancy had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jul-2020, Pregnancy test: positive. On an unknown date, Amniocentesis: normal. On an unknown date, Glucose tolerance test: normal. On an unknown date, Ultrasound scan: normal.         The date of positive pregnancy test was 28-Jul-2020. The patient has an established prenatal care. No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 18-Mar-2021: Internal review on 28-Jul-2021 resulted in updates to the pregnancy information.
Upper left arm bruised, hardened, and swollen an inch in area shot administerd. Warm to touch and very painful. Lymph nodes under that arm painful and advised to see Dr. and follow-up.
flu; Initial information received on 05-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer (patient) via social media.  This case involves an unknown gender child patient who experienced flu (influenza) after receiving INFLUENZA VACCINE.  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Did as an elementary kid and have never taken the shot as an adult! I got deathly sick as a kid with flu more than once have never contracted it as an adult!!!!"  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the event outcome reported as unknown for the event.
Shortly after receiving the vaccination I started to experience chronic exhaustion, leg cramping and pain in my lower back right side, upper right thigh, behind my right knee and down into my right calf. I figured that the pain would go away but the pain increased and my leg started swelling and the pain increased making it very difficult for me to put my leg down on the ground and put pressure on my right leg.
Hives on upper left and right arms, shoulder, left and right ankles. Prednazone .  Hives slowly went away but areas itched.
Chills 15 hours after, sore arm, sore armpit starting 15 hours after, swollen armpit, menstrual period started early after both shots (2 days after shot administered)
A 24 year old male who has completed a 15-minute observation period with the following signs and symptoms of an adverse reaction: loss of consiousness and other - dizziness. Pt endorsed he is very anxious about the vaccination. Had a hx of fainting spells during vaccinations. Pt endorsed that while he was on the chair, he felt anxious and dizzy, then tried to take deep breath and passed out. Pt was found on the ground for 5 seconds but regained consciousness right away. No headache, chest pain, SOB, swelling of lips/tongue/throat.   Denies any urinary/bowel incontinence.    PMHx: none  Pt was sent to examination via wheelchair. Vital signs check. Given water for hydration and apple juice.  Felt better.  vital signs stable Have abrasion on right knee and left dorsal wrist. Physical exam unremarkable.  No hematoma or laceration on the head Observed for additional 30 minutes  More likely syncopal episode vasovagal This is not an  allergic reaction to the vaccine
A child (demographics not provided) with a reported expected date of birth as 25 May 2003, had received transplacental vaccination with 0.5 milliliter of Fluzone, lot number U0931AA, on 16 December 2002 when his mother was vaccinated with the Fluzone vaccine. The expiration date of the Fluzone vaccine was reported as 30 June 2003. Reportedly, the patient has developmental disabilities. The date of diagnosis, and description of the developmental disabilities was not reported. It is important to note that the mother has a history of hypothyroidism that is treated with Synthroid, and she has scoliosis. No other medical information was provided.
Patient called pharmacy on 11/03/2016 and stated her arm had been sore since her flu vaccine given on 10/14/2016.  She saw her CNP on 11/04/2016 and had a pea sized sore area on her arm.  Patient does not blame pharmacy and said her body reacts different to medicine.  She is fine with shot.
Severe brain fog for days.  Dizziness and off balance.  Forgets what he's talking about mid sentence.  Pain at injection site.  Feels funky still after 4 days.
Severe chills; fever (101°); tightness in chest; body aches. All seem to have substantially resolved within 8 hours of onset.
Information has been received from a pharmacist concerning a female pt who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot 640577/0995L). Subsequently, a few hours post vax, the pt experienced pain and swelling and went to the ER. In the ER, she was treated with diphenhydramine hydrochloride (Benadryl) and was observed for 3 hours prior to being released. It was reported that another pt (WAES0201USA00517) had a similar experience following exposure to pneumococcal vaccine 23 polyvalent. The reporter expressed a concern regarding the lot. Follow-up information from a registered nurse indicated that the patient experienced swelling and pain at the injection site within 3 hours of her vaccination. The patient's pain and swelling became so bad that she went to the emergency room. She was treated with Benadryl PO, observed for three hours and then released. It was reported that the patient took Benadryl for a few days after her emergency room visit and subsequently recovered. Upon internal review, the pt's events were considered to be "Other Important Medical Events". Additional information has been requested.
Narrative: Patient received COVID 19 Vaccine (Moderna) on 4/13/22. The patient complained of redness, swelling, and warmth and tenderness to the touch on 16 April 2022. The patient was treated with a warm compress. Reported per EUA.