chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediately after IM administration of Hep A, mother stood child on floor. Child fell to floor and struck head.  When mother picked her up, child arched back and eyes rolled to back x 5-7 seconds. Did not respond to verbal stimuli.  Child then started to cry.  Pupils equal and reactive.  Continued to cry.  Ice placed to contusion on forehead while mother phoned GP to request child be seen.  Mother left to take child to doctor's office.
Patient immediately stated having difficulty breathing after receiving shot at 11:50, Mask was pulled down.   Eyes rolled. Patient leaned forward placing elbows on knees.. Vision reported as blurry. BP/Pulse/Respirations taken and recorded. Cold compress placed on back of neck vitals were abnormal. EMS called. Patient refused Adveres Reaction Treatment protocol  of epinephrine and benadryl. Patient states "needles make me nervous".  EMS arrives at 12;14. Vitals continue to be erratic and EMS transported patient to Hospital.
PC from pt c/o severe h/a & itching, nausea, dizziness, erythema to ER given DTP & Celestone IM; BP 160/90, P104;
Pt experienced 3 cm x 4 cm area of erythema slightly raised edematous skin with irregular borders on left thigh.
experienced leg & ankle swelling; experienced leg & ankle swelling; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), JOINT SWELLING (non-serious), outcome "unknown" and all described as "experienced leg & ankle swelling".  Additional Information: The caller experienced a leg and ankle swelling 3-4 weeks after receiving the first dose, would that be a reason to not get the second shot. The caller's doctor said no. The caller is unsure if other people are reporting this. The caller is supposed to get the second shot soon.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
little bit tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (little bit tired) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), DULOXETINE, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), MONTELUKAST SODIUM (SINGULAIR), COLECALCIFEROL (VITAMIN D3 1000), OMEPRAZOLE, TRAZODONE, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and ALPRAZOLAM (XANAX) for an unknown indication.    On 13-Jan-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 FATIGUE (little bit tired). At the time of the report, FATIGUE (little bit tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information provided.    This case was linked to MOD-2021-237444, MOD-2021-237444 (Patient Link).
Received booster at 18:30, on 12/18/2021, with no adverse effects. Woke the next morning a little sore but thought nothing of it. As the day progressed, the pain in my groin intensified to the point by 17:30 I was no longer able to walk or even stand without experiencing excruciating pain. The next morning (12/20/2021), the pain had subsided enough for me to make it to the emergency room. It was determined the vaccine was most likely the cause of lymph node swelling.
That evening around midnight/sweats; Chills; armpit pain; 103.4 F temporal; body aches; couldn't move neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient received BNT162b2 (BNT162B2), on 16Apr2021 at 18:00 as dose 2, single (Lot number: EW0170) at the age of 30 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: ER8733; Anatomical Site: Right arm; Vaccine administration time: 18:00), administration date: 26Mar2021, when the patient was 30-year-old, for COVID-19 Immunization, reaction(s): "COVID-19", "Vaccination failure". The following information was reported: BODY TEMPERATURE INCREASED (non-serious) with onset 16Apr2021 at 23:59, outcome "recovered" (18Apr2021), described as "103.4 F temporal"; CHILLS (non-serious) with onset 16Apr2021 at 23:59, outcome "recovered" (18Apr2021); NIGHT SWEATS (non-serious) with onset 16Apr2021 at 23:59, outcome "recovered" (18Apr2021), described as "That evening around midnight/sweats"; AXILLARY PAIN (non-serious) with onset 16Apr2021 at 23:59, outcome "recovered" (18Apr2021), described as "armpit pain"; PAIN (non-serious) with onset 16Apr2021 at 23:59, outcome "recovered" (18Apr2021), described as "body aches"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 16Apr2021 at 23:59, outcome "recovered" (18Apr2021), described as "couldn't move neck". Relevant laboratory tests and procedures are available in the appropriate section.   Additional information: It was reported that events lasted until morning of 18Apr2021. There were no prior vaccinations (within 4 weeks). No relevant or specific relevant test for thromboembolic events with thrombocytopenia were done. Vaccination date and time for dose 2 was also reported as 16Apr2021 at 17:00.
Rash started 1 week later with itching at injection site, 4.5inches long by 2 inches wide. Resolved within 10 days. Throbbing pain to jaw and/or tooth, went to dentist and was told it was a bad tooth with food lodged; started sunday Feb 7th 2021.  throbbing has lessened in intensity and is intermittent. Diarrhea started 2-10-2021 X4 epsiodes. recommended she drink plenty of fluids, states she had previously taken tylenol for tha jaw/tooth pain which helped. recommended she touch base with cardiologist due to cardiac history and jaw pain being a presenting factor in women for a MI. Patient states its intermittent and would do so if it continues. she is eating toast and bananas which is consistent with a bland diet and suggested she continue to follow to help with symptoms. patient verbalized understanding. informed her she has no contraindictions to receiving the 2nd dose today .
75 year old M, worsening weakness for the past several weeks.  Seems to have gotten worse since Monday when he had his first Covid vaccine here at the hospital.  Denies any headaches or neck pain.  No fevers or chills.  No cough or shortness of breath.  No abdominal pain.  No vomiting or diarrhea.  No black or bloody stools.  No dizziness.  Today he almost fell and the son had to catch him.  He did not suffer any trauma.  He offers no symptoms of pain.  Here he is fully awake and alert.  Nothing to clinically suspect a stroke.  His vitals are stable.  Chest x-ray shows nothing acute.  Creatinine is better than baseline.  Electrolytes are stable.  Troponin reassuring.  He had no chest pain or shortness of breath to suspect angina.  Spoke to the wife via telephone, he is getting so weak that he was unable to walk.  Paramedics report they had lift him as he could not take a step.  He was unable to ambulate here in the emergency room.  At this time it does not seem like I can safely discharge him home.
Redness in upper right arm (injection site), approximately size of half dollar. Site itches & is warm to touch. Patient developed 3 lesions on anterior chest on 6/7/10. Lesions were red, raised, and fluid-filled. Lesions scabbed and dried by 6/10/10 (as reported by patient's mother).
Client was vaccinated around 09:30. Parent reports child took a nap and when awake, complained of headache, sites on arm were reddened but not over swollen or hot to touch.  Fever of 102 was noted. Parent administered OTC Tylenol alternating with Ibuprofen. Symptoms persisted and  parent called our office to report the situation. I was out of the office on 5/7/20. Today, 5/8/20, I called to f/u with parent. She reports the S/S are subsiding but a low grade temp was still present  this morning.  Parent is confident the girls (twins) will be fine. She asks that we make a notation on chart to be aware when the next Vaccince (Hep A) is administered.  Parent is an RN; she feels that the only new vaccine was the Hep A  that may have caused this as the twins have not had any previous trouble  with vaccines. She plans on continuing  vaccine schedule  as appropriate.
Patient had adverse reaction to shot #1 including rash, increased heart rate, nausea so she decided that she wanted to get Moderna instead of Pfizer.  Appointment was scheduled and she received her 2nd shot Moderna.  Side effects included 3 days  of severe symptoms of fatigue, nausea, vomiting, chills, fever and over all severe body aches.  Aside from the above, no other reactions noted from 2 different vaccines.  Patient was called and educated.
Pt had flu shot in left deltoid/arm hurt after shot, came back had reaction in area below where shot was given. Skin had sac of fluid looks like infection. Pt went to Dr. Dr prescribe Cephalexin and Mupirocin.
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (name and manufacturer of the vaccine unspecified).  Subsequently the patient experienced chickenpox.  The physician was not the patient's physician.  Unspecified medical attention was sought.  It was unknown if lab studies performed.  The outcome of the patient was not reported.  No further information is available.
Father called on 7/30/15 and reported that on 7/21/15, patient developed bruise with blister in the middle of bruise at injection site on left leg.  Said took to MD who gave them Benadryl and told to give Aveno baths.  Also using Aveno lotion.  Father said patient now has additional "bumps" that started as a bruise and with a blister developing two days later.  Father said there are 2 on right leg, 1 on back of left leg, and one on right arm between elbow and wrist.  Father states patient has not had fever and does not appear to have itching. Spoke with father again 7/31/15 who called pediatrician to report changes since patient evaluation with onset of symptoms and said was told to continue with Benadryl.
ongoing persistent vertigo.  started with occasional loss of balance then developing into significant vertigo interfering with daily activities.   the vertigo has improved from continuous to sporadic episodes throughout the day.  some days it is less frequent than others.
Nasty metal taste in mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Nasty metal taste in mouth) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced DYSGEUSIA (Nasty metal taste in mouth). At the time of the report, DYSGEUSIA (Nasty metal taste in mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
THIRST; BATHROOM ISSUES; UP WHOLE NIGHT; GENERAL CRAPPINESS; FEVER; HEADACHE; WEIRD NUMBING ON AND OFF, LIKE IN HANDS FOR NEXT FEW WEEKS; This spontaneous report received from a consumer via a company representative concerned a male patient of unspecified sex. 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On AUG-2021, the patient experienced thirst. On AUG-2021, the patient experienced bathroom issues. On AUG-2021, the patient experienced up whole night. On AUG-2021, the patient experienced general crappiness. On AUG-2021, the patient experienced fever. On AUG-2021, the patient experienced headache. On AUG-2021, the patient experienced weird numbing on and off, like in hands for next few weeks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, headache, thirst, bathroom issues, general crappiness, and up whole night, and the outcome of weird numbing on and off, like in hands for next few weeks was not reported. This report was non-serious.
On 8/4/01, pt had lack of energy; on 8/5/01, she went for a hike and thinks she got dehydrated so she drank water; later afternoon she had a fever of 102F and took aspirin and felt much better by 20:00. On 8/6/01, she felt good; got hepatitis B #3 vaccine in the morning; on 8/7/01, pt had a headache in the evening, rather strong so she took ibuprofen. She also had profuse sweating from head/neck/chest area at night. On 8/8/01, she had strong headache in the evening and woke up with a strong headache at 03:00 so she took ibuprofen and Tylenol and still had profuse sweating from head/neck/chest area at night. On 8/9/01, still with same symptoms so on 8/10/01 she saw MD in Infectious Diseases in the afternoon and he ordered a battery of tests, blood work and a CT of head. On 8/11/01, had a very mild headache at midday so took Advil. On 8/12/01, felt ok; on 8/13/01, felt ok and had blood work done which showed Alkaline phosphatase, AST and ALT were very high. On 8/14/01, she felt ok but a rash had appeared on her abdomen on either side of the midline and the area was about 2 X 4, they were eruption, not blisters, slowly disappeared over the next 3 days and by 8/17/01, they were gone; rash was not itchy. On 8/15/01, no other symptoms. On 8/22/01, saw MD and CT test returned as normal; he ordered an abdominal sonogram to make sure gallbladder, liver and pancreas are OK; sonogram scheduled for 8/28/01; he ordered liver function enzymes to be redone and I will redo that on 8/27/01.
Hives about 10-15 min after PREVNAR 13 -> BENADRYL given & hives resolved.
Received 2nd Hep B injection 8/30/02 on 9/2/02 noted itching and swelling. Seen on 9/6/02 9cm erythematous circular target-like lesion on L arm. Given Benadryl 50mg po x T. Allegra 60mg BID x 7 days.
I got the vaccine and still ended up getting COVID; I got the vaccine and still ended up getting COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 18-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "I got the vaccine and still ended up getting COVID".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Extreme, ongoing fatigue Brain fog Complete inability to concentrate for long periods Shoulder and thumb on my right arm will twitch periodically for long periods throughout the day Shoulder is still tight, tense, and stiff and my entire right arm is weak and my right hand cramps frequently every day My hair has thinned significantly and continues to thin I have experienced continued full body muscle weakness and sometimes, I cannot even hold a pen or pencil to write. I continue to have a constant full body ache Constant diarrhea - constant! I can count the number of solid movements that I have had since April My teeth and gums
TERRIBLE ACHES; FELT ROPEY; FEVER FROM HELL; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced terrible aches, feeling ropey, and fever from hell. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from feeling ropey, and the outcome of terrible aches and fever from hell was not reported. This report was non-serious.
Feels like I got hit with a baseball bat; pain in toes; Vaccination site pain; sore throughout body; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore throughout body), PAIN (general body pain), PAIN IN EXTREMITY (pain in toes) and VACCINATION SITE PAIN (Vaccination site pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included Lyme disease since an unknown date and Leukopenia. Concomitant products included LEVOTHYROXINE, CETIRIZINE and VITAMINS NOS for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN (sore throughout body), PAIN IN EXTREMITY (pain in toes) and VACCINATION SITE PAIN (Vaccination site pain). On an unknown date, the patient experienced PAIN (general body pain). At the time of the report, PAIN (sore throughout body), PAIN (general body pain), PAIN IN EXTREMITY (pain in toes) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Patient was given PREVNAR 13, should have received Pneumo Poly 23 based on chronic conditions. Age of patient at time of event: 63 years.
Hard, red, swollen 11 1/2 cm long, 12 3/4 cm width.
I went to bed for 12 hours before I could even get up and function, its kind of stroke'; Nauseous; Lack of balance; I went to bed for 12 hours before I could even get up and function; I am speeding up a clear substance looks like white blood cell or something ''flams'' it comes up all the times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "I went to bed for 12 hours before I could even get up and function, its kind of 'stroke'; NAUSEA (non-serious), outcome "unknown", described as "Nauseous"; BALANCE DISORDER (non-serious), outcome "unknown", described as "Lack of balance"; SLEEP DISORDER (non-serious), outcome "unknown", described as "I went to bed for 12 hours before I could even get up and function"; SPUTUM ABNORMAL (non-serious), outcome "unknown", described as "I am speeding up a clear substance looks like white blood cell or something ''flams'' it comes up all the times". The patient underwent the following laboratory tests and procedures: white blood cell counts abnormal: unknown result.  Additional information: Consumer was informed about the Pfizer Medical Information department and telephone# was shared as # option 3, 8 AM to 8 PM, Monday to Friday, as per time zone.  The lot number for bnt162b2 was not provided and will be requested during follow up.
4 year old patient receiving ADACEL instead of DAPTACEL with no reported adverse event; Initial information received on 12-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old male patient who experienced 4 year old patient receiving adacel instead of daptacel with no reported adverse event while receiving vaccine diphtheria-2/tetanus/5 AC pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 21-Sep-2018, the patient received a 5th dose of suspect diphtheria-2/tetanus/5 AC pertussis vaccine once Suspension for injection (dose, lot number, strength, expiry date not reported) via unknown route in unknown administration site as prophylactic vaccination.  On 21-Sep-2018, the 4 year old patient receiving diphtheria-2/tetanus/5 AC pertussis vaccine instead of daptacel with no reported adverse event (product use issue) (latency: same day).The HCP asks how they should proceed with the immunizations and if the ADACEL dose was valid.  Action taken : not applicable.  At time of reporting, the outcome was Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Systemic: Dizziness / Lightheadness-Mild, Systemic: cold sweat and slight shortness of breath-Mild
Limp, hives around eyes & ears, head swollen; Temp 104F, given DPH & Adrenalin;
Redness and tenderness initially, on 10/3/13 the area was swollen, red, painful and she had a significant headache. Was advised to use Tylenol 650mg q4h and apply alternating warm compresses and ice pack to the area.  To notify me if symptoms exacerbated.
Discharge Provider: DO Primary Care Provider, MD Admission Date: 3/4/2023 Discharge Date: 3/6/2023  PRESENTING PROBLEM: Generalized weakness [R53.1] COVID-19 virus infection [U07.1] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a 6-year-old male who presented to the ER on 03/04/2023 with chief complaint of weakness.  At home patient was having increased weakness with inability to get off the toilet by himself.  He was helped back to bed however continued to have difficulty ambulating and was brought to the ER by EMS. In the emergency department he was positive for COVID-19.  Chest x-ray is negative.  CT scan of the abdomen done in the emergency department is consistent with constipation.  He was admitted to the hospitalist service for further management of generalized weakness and COVID-19.  He was started on remdesivir and completed 2 doses PT and OT were consulted during hospitalization who recommend outpatient therapy services.  The patient remained on room air throughout hospitalization.  On day of discharge patient states that he has been feeling well and agrees with plan to discharge home with additional outpatient resources.  All questions and concerns were addressed to patient's satisfaction and he was discharged in stable condition.
04/01, 5:00pm :Starting experiencing body aches and chills 04/01, 9:00pm - 04/02 8:00am: Pounding headache, body aches, 103.5 fever, night sweats, chills, feeling dehydrated, extreme fatigue. Took 625mg of Tylenol every 6 hours 04/02, 9:00am-9:00pm: Fatigue, headache and lingering fever of 100-101. Took 625mg of Tylenol every 6 hours, drank Gaterade/water, chicken soup.  04/03, 8:00am: Fatigue and fever of 99.5. Took 625mg of Tylenol