chrisvoncsefalvay/vaers-outcomes huggingface dataset:
equilibrium lost; lost of appetite; Badly Sick; pounding head ache; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (equilibrium lost), DECREASED APPETITE (lost of appetite), MALAISE (Badly Sick) and HEADACHE (pounding head ache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 046B21A) for COVID-19 vaccination.     No medical history was provided by the reporte.  Concomitant products included MULTI VITAMIN & MINERAL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12), VITAMIN D3, CHOLESTEROL, SIMVASTATIN (BESTATIN [SIMVASTATIN]), RIVAROXABAN (XARELTO), POTASSIUM, FOLIC ACID and LOSARTAN for an unknown indication.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced BALANCE DISORDER (equilibrium lost), DECREASED APPETITE (lost of appetite), MALAISE (Badly Sick) and HEADACHE (pounding head ache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 milligram. At the time of the report, BALANCE DISORDER (equilibrium lost), DECREASED APPETITE (lost of appetite), MALAISE (Badly Sick) and HEADACHE (pounding head ache) had not resolved.            Treatment medication included Tylenol 500 mg and Aleve 200 mg one for every 12 hours   This case was linked to US-MODERNATX, INC.-MOD-2021-085746 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-085746:Second dose case for same reporter patient
4 cm local reaction around injection site - warm, pierchic red, (R) arm.
This spontaneous report as received from a Licensed Practical nurse refers to a patient of unknown age and gender. On 05-NOV-2012, the patient was vaccinated with GARDASIL (lot number was reported as 0636AE and expiry date was 09-JAN-2015, route and dose were not reported) that was exposed to 25 degree Fahrenheit for an unknown period of time. No concomitant medications were reported. No adverse symptoms reported. This is one of the several reports received from the same reporter (MARRS# 1212USA000913, 1212USA000914, 1212USA003709, 1212USA003710, 1212USA003711, 1212USA003712, 1212USA003714 and 1212USA004285) Additional information has been requested.
Patient evaluated and monitored following vaccine. Developed nausea and lightheadedness approximately 20 minutes after dose given. Patient reports that she hadn't had anything to eat or much to drink in the hours leading up to vaccine as she and her husband were going to get lunch after the vaccination appointment. Patient has a history of syncope/presyncope after a blood draw in the past.  Patient had no other stx other than very transient nausea and lightheadedness, which improved significantly in the hour that she was monitored.   BP at time of discharge from clinic was 105/73; pulse 67
Mini stroke. 2/18/09 Neurology consult received dated 1/15/09 with no definite dx: Impression:  Transient word finding difficulties (dysphasia) with R hand numbness.  Raises concern for L hemisphere event, most likely vascular. Pt seen for consult for above sx.  Some loss of peripheral vision, a wierd feeling in legs lasting <1hr.  The following morning pt developed vertigo with N/V. PE WNL.  2/20/2009 2 ER records received for 1/8/09 with DX: Paresthesias, dysarthria, now resolved and 1/9/09 with DX:  Acute N&V, now resolved. Pt presented with sudden onset of paresthesias of the R arm and face and speech problems-talking and making no sense.  Resolved in 1 hr. Recent increase in neck pain following past accident. PE WNL. Started on ASA to f/u with neuro as outpt.  Returned the next day with nausea and 4-5 episodes of vomiting w/in 2 minutes which quickly resolved. Some tingling now in L arm. D/C to f/u as above.
High fever up to 104, muscle twitching, vomiting, stomach pain, general malase.
The right eye swelled up 45 mins after the shot and feels sore to the touch; The right eye swelled up 45 mins after the shot and feels sore to the touch; eyeball is bloodshot; This is a spontaneous report received from a contactable consumer.   This 44-year-old male consumer (patient) reported that he received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6207) via an unspecified route of administration into the right arm on 06Apr2021 at 09:15 AM (at the age of 44-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history included reflux/reflux gastritis from an unknown date and unknown if ongoing. Concomitant medications included cyanocobalamin (B12-VITAMIIN) and atenolol (ATENOLOL) taken for unspecified indications, start and stop dates were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6207) via an unspecified route of administration into the left arm on 16Mar2021 at 02:30 PM (at the age of 44-year-old) as dose 1, single for COVID-19 immunisation. On 06Apr2021 at around 10:00 AM, the patient experienced the right eye swelled up 45 minutes after the shot and feels sore to the touch and eyeball was bloodshot. It was unknown if treatment was received for the adverse event. Outcome was unknown for all the events.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a physician refers to a currently 63 years old female patient who was asthmatic. The patient was vaccinated with a dose of PNEUMOVAX23 (Lot #, dose and route not reported) on 28-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient was using PNEUMOVAX23 and experienced a soft tissue reaction in 2012. The patient was given antibiotics as treatment for the event. At the time of the report, the patient's outcome was unknown. The patient sought medical attention by an office visit. The relatedness for soft tissue reaction was unknown for PNEUMOVAX23. Additional information has been requested.
Initial unsolicited report received from a non-healthcare professional on 21 MAY 2015. A patient (age not reported) 8 years ago had received a dose of unknown INFLUENZA (dose of vaccine, route and site of vaccination were not reported) on an unspecified date. On an unspecified date, few weeks post vaccination patient developed bilateral upper eyelid ptosis. Illness at the time of vaccination and pre-existing physician diagnosed allergies was not reported that the patient required to ER/doctor visit. Corrective treatments were not  reported and laboratory investigations reported as unknown. At the time of this report, outcome of the patient was unknown. Document's held by sender: none.
administered to a patient 17 years of age; Pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered to a patient 17 years of age) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 31-Mar-2022. On 14-Oct-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered to a patient 17 years of age) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 14-Oct-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered to a patient 17 years of age) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   ? No treatment information was provided.  No underlying medical conditions identified.  CC:This case concerns a 17 year old pregnant female with unknown LMP, EDC and weeks gestation and no reported history who experienced the non-serious unlisted events of Maternal exposure during pregnancy and Product administered to patient of inappropriate age the day of dose 1 of mRNA-1273. Re-challenge is not applicable as dose 2 not scheduled yet. Benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 17 year old pregnant female with unknown LMP, EDC and weeks gestation and no reported history who experienced the non-serious unlisted events of Maternal exposure during pregnancy and Product administered to patient of inappropriate age the day of dose 1 of mRNA-1273. Re-challenge is not applicable as dose 2 not scheduled yet. Benefit-risk relationship of mRNA-1273 is not affected by this report.
NOT FEELING WELL; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (NOT FEELING WELL) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced MALAISE (NOT FEELING WELL). At the time of the report, MALAISE (NOT FEELING WELL) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Heart rate: unknown (High) Both pulse and heart rate went up from 68 to 110.         Patient stated that her heart rate and pulse came back to normal on the drive home which is about 10minutes.  No concomitant medication were provided.  Treatment medication was not provided.  Action taken with mRNA-1273 Moderna vaccine was Not applicable   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Received follow up:  Events outcome was updated to recovered/resolved. Second Dose was updated.Consumer does not need any further follow up.
Expanding injection-site erythema 10x10cm, warmth, and tenderness.
Itchy, red rash at injection site on left arm. Appeared exactly one week from date of first injection.  The rash started out about 1.5 inches in diameter,  and has grown to about 4 inches in diameter 3 days later.
injection site is inflamed/warm to the touch, red rash that is spreading over the course of 3 days
Two days after receiving 2nd dose of COVID19 vaccine, red itchy areas to upper legs and arms. Progressed next day. Today 1/12/21 employee showed me additional red areas to arms, face, outer eyes and states red areas to abdomen. Otherwise feels well.
No additional AE reported; Patient was administered VAQTA after temperature excursion on Dec 30, 2021; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies and medical history was not provided.  On 30-DEC-2021, the patient was vaccinated with improperly stored hepatitis aAvaccine, inactivated (VAQTA) prefilled syringe, lot # 1792241, expiration date 01-OCT-2022 (route of administration and anatomical location were not reported) for prophylaxis (Product storage error). Temperature 35.9 Fahrenheit degrees for 20 minutes. There was no previous temperature excursions. No additional adverse event was reported (No adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2202USA006998: US-009507513-2202USA007571: US-009507513-2202USA007118: US-009507513-2202USA007032: US-009507513-2202USA007028:
24 hrs later i began to become tired then developed a low grade temp 101.5 orally then my right arm pit same side of the shot given my lymph node in the arm pit swelled to the size of a softball then the swelling went into the right side of my neck and down into the right side of my peck also noted pain in the back of neck near my spin going down to just below the scapula this lasted 4 days with the exception of the arm pit swelling I still have that but not painfull it is now the size of a tennis ball on my 5th day after 1 st shot temp lasted 2 days just took advil for the temp no other symptoms occured with this so far
Headache, Myalgia, Arthralgia, Diarrhea, NauseaVomiting, sweats, chills, fatigue Narrative:
PATIENT IS REPORTING PROLONGED YELLOW/GREEN BRUISING IN THE AREA OF THE VACCINE. HAS EXPERIENCED SYMPTOMS FOR AROUND A WEEK. NO PAIN OR SORENESS TO THE TOUCH. MOVEMENT IS NORMAL.
Information has been received from a consumer concerning his 24 week old son with no pertinent medical history, drug reactions/allergies who in November 2007 (exact date not reported), was vaccinated (route and site not reported) with a dose of PEDVAXHIB (OMPC) (lot# not reported).  The patient was taking medication but specifics were unknown.  On approximately 10-NOV-2007, the patient experienced stomach problems, diarrhea and vomiting, all 3 issues caused him sleeping problems.  The patient's father stated that the symptoms occurred a day after receiving the PEDVAXHIB vaccine.  The patient did receive unspecified medical attention, no diagnostic tests were performed.  At the time of this report the patient had not recovered.  Additional information has been requested.
Patient had syncope episode, seizure activities,anxiety disorder,twitching of body, fainting spells,headaches, bed wetting,hallucinations. nightmares that woke her from dead sleep. Patient had none of these problems prior to this situation. 07/17/08-records received-DOS 9/5/07-presented to ED with C/O difficulty breathing after runing laps. Sharp pain in head, body numb, staring, unresponsive to stimuli. Assessment:syncopal episode. Presented to ED on 9/7/07 after DC from hospital breathng became rapid and hands tingle and feel painful. Assessment:tingling sensation in hand possible due to hyperventilation representing an anxiety attack or conversion disorder. 9/8/07-presented to ED with C/O a spell-assessment; Hyperventilation syndrome.  1/25/2010 Follow up: The patient is on medication to control the syncope episodes and to help manage her problem. She has to take extreme caustion in regard to her health to avoid having an episode of syncope. She has mornings where she is having an episode and smelling salts have to be used to break her from her episode.
Patient developed tinnitus approximately 2 hours after receiving the Covid vaccine.  He  noted loss of hearing the same night.  The following day he had dizziness and would vomit with certain movements.  As of 4/20 hearing test shows severe loss of hearing in his left ear.  Unsure at this time if hearing will return.
Just a little soreness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Just a little soreness on the injection site) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Ulcerative colitis (in remission) since 15-Sep-2018. Concomitant products included BUDESONIDE from 01-Oct-2018 to an unknown date for Diarrhea.    On 27-Feb-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Just a little soreness on the injection site). At the time of the report, VACCINATION SITE PAIN (Just a little soreness on the injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-May-2021: Reporter Information updated, Patient Medical History and Concomitant Medications added,
He comes in today for follow-up of the shingles. He developed the shingles in the ophthalmic division of the trigeminal nerve about 48 hours ago and was started on valacyclovir yesterday. He states that this is really helped his symptoms and, he did go to see his ophthalmologist this morning. He has had no visual changes. He still does have discomfort as a result of the shingles that is periodic and would like something for the pain. Shingles (ICD10-CM B02.9). Course: Progressing as expected. Plan: I gave him a prescription for tramadol and recommended cool compresses. I also told him to take valacyclovir 1 g every 8 hours and gave him an additional prescription for this as well. He will continue following with the ophthalmologist in 2 days as they have requested and have asked him to call me in the meantime for any other problems or questions.
Pt. stated that since June, after receiving COVID 19 Vaccine he has had a stiff neck that is sometimes also sore.
sore left arm; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (sore left arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, the patient experienced VACCINATION SITE PAIN (sore left arm). At the time of the report, VACCINATION SITE PAIN (sore left arm) 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.   The patient received the first dose of Moderna Covid-19 vaccine in the left arm shoulder deltoid muscle.  The treatment information was not reported.  No concomitant medication was reported.   This case was linked to MOD-2022-474520 (Patient Link).
Fever 101, Chills, Nausea, Itching, body shakes, weakness, body aches Flu Like Symptom's Lasted 48 hours
2nd dose of Moderna vaccine was given 2/15/2021 and on 2/28/2021 was treated for Shingles. Also on 4/17/2021 was treated for Shingles again.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 23-DEC-2015 at 15:48, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 6.1 and 5.2 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Some injection site soreness day of injection with fatigue lasting for about 24 hours. THEN, on day 6 after the vaccination extreme arm, neck, shoulder pain (30 on a 1-10 scale, "dead arm" -- couldn't forcibly move my arm for 3 days without excruciating pain.  Went to MD for pain, sent to ER by a physician. Spent 9 hours in ER on day 8 after injection.
This is a spontaneous report from a contactable consumer. A male patient, of an unspecified age, received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, left arm, on Apr 23, 2021, at 14:35, single dose, for COVID-19 immunisation. Medical history reported as none. Concomitant medications included ibuprofen. The patient received the first dose of BNT162B2 on Apr 2, 2021, at 14:30, for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not tested for COVID-19. It has been 5 days since patient's second dose. On Apr 24, 2021, at 12:00, patient still felt extremely weak, have headaches, nausea, and muscle spasms/fatigue. The side effects were not going away as fast as expected. It was unknown if patient received the treatment or not. AE resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events: not resolved. No follow-up attempts possible: information about lot/batch number/expiry date cannot be obtained. No further information expected. Sender's comments: Linked report(s): PFIZER INC-2021501866 same reporter/product/event, different patient.
Redness, fever, swollen, hardness of arm, approximately 3 inches of arm all around are affected. Blister formed along with smaller blisters which formed into 1 blister the size of a tennis ball 48 hours from vaccination.  Pictures were taken with each change of the vaccination site.
Live vaccine (Rotavirus) given to a complex medical needs child with multiple medical problems including DiGeorge Syndrome (hypocalcemia, immunodeficiency and at risk for developing SCID). Risk for adverse events.
No additional AE; the patient only received the first dose and didn't complete the series; This spontaneous report was received from a pharmacy technician referring to a currently 46 years old patient of unknown gender. The patient's pertinent medical history, drug reactions/ allergies and concomitant medication were not reported.  On 07-NOV-2019, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, strength, route, lot# and expiration date unknown) for prophylaxis. The patient only received the first dose and didn't completed the series (Inappropriate schedule of product administration). No additional AE.
Child woke up AM of 16JAN91 w/fever, swelling of scrotum & bilateral inguinal lymph nodes. Fever to 103. Seen by MD dx w/orchitis & ear infect given Augmentin for ear infect. Dx w/uremia from MMR resulting in a epididmitis & hydrocele.
Patient reported to RN when needle withdrawn that he felt "tingly".  A/O x 33, color pink, mild SOB, denies anxiety history with vaccines.  EMS staff notified and responded to patient who RN maintained in chair.  Staff escorted patient to med eval area.    Pt on initial evaluation began to feel symptomatcially improved. Initial vitals inc HR 90, SBP 177. Pt denies SOB, nausea, throat tightening or tongue swelling sensation, chest pain. Pt had felt lightheaded but this has resolved. Pt observed for over 30 minutes, with repeat SBP of 156. 12 lead performed showed NSR, no ST changes. Pt taking PO, feels resolution of symptoms at end of obs time. Pt verbally instructed on strict return precauti
2 months, Intermittent myalgia and joint pain in knees, legs, and shoulders bilaterally
Considerable worsening of existing tinnitus. Extreme rushing sounds. Hearing music. Much much worse than before vaccine
For 11 days nothing happened from 10/19/2021 I woke up at the middle of night my heart was raising, I felt like a panic attack, my right arm got very tight. Within 30 seconds to a minute I went to the emergency room. At the emergency room they gave me EKG Test, they gave me IV of fluids, they gave me a chest X-ray and they did blood work. At 7:00AM (6 hrs. after) they discharged me and said that everything is fine. I should follow with the cardiologist.