chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm has been hurting so much; difficulty sleeping; tingly and numb in arm; severe headache in her forehead and eyes; This spontaneous case was reported by a pharmacist and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        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.   No concomitant medications reported. Treatment included Pain Killers
Hives, red, itchy below injection site.  Down arm.  BENADRYL 25 mg  and DEPOMEDROL 80mg.  Observed pt for 30 min after administration.
Headache, Myalgia, Diarrhea, sore arm, chills Narrative:  Headache, Diarrhea, Myalgia Sore arm, chills
stiff neck; stiff back; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff neck) and MUSCULOSKELETAL STIFFNESS (stiff back) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included HYDROCODONE BITARTRATE, PARACETAMOL (NORCO), DILTIAZEM HCL, GLUCOSAMINE, GLIMEPIRIDE, HYDROCHLOROTHIAZIDE, LISINOPRIL, MECLIZINE HCL, METFORMIN, PRAVASTATIN SODIUM, SALBUTAMOL SULFATE (PROAIR HFA), SULFAMETHOXAZOLE, ASCORBIC ACID (VITAMIN C), VITAMIN D3, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), INSULIN GLARGINE (LANTUS), METOPROLOL and MIRABEGRON (MYRBETRIQ) for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck) and MUSCULOSKELETAL STIFFNESS (stiff back). At the time of the report, MUSCULOSKELETAL STIFFNESS (stiff neck) and MUSCULOSKELETAL STIFFNESS (stiff back) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant included accucheck was noted. Treatment included heating pad, Norco were provided by the reporter; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded.
Swollen lymph nodes in left armpit area, onset 10/30/21 following evening shower. Event ongoing at time of report.
This spontaneous report as received from a Medical Assistant refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 17-NOV-2017, the patient was vaccinated with an improperly stored dose of VAQTA lot # N023954, expiration date 31-AUG-2018 (dose and route were not reported) for prophylaxis. No adverse effects reported. The temperature involved was 9 degrees Celsius to 25 degrees Celsius for 6 hours. A previous temperature excursion was not reported. A data logger was involved.
INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; OFF LABEL USE; This spontaneous report received from a patient via a company representative concerned a 69 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe chronic plaque psoriasis, moderate to severe adult crohn's disease, and moderate to severe ulcerative colitis. The patient previously received covid-19 vaccine ad26. cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: UNKNOWN) dose, start therapy date were not reported, 1 total, administered on 20-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included adalimumab for moderate to severe chronic plaque psoriasis, moderate to severe adult crohn's disease, and moderate to severe ulcerative colitis. The patient experienced allergy, fatigue aggravated, flare up of diarrhea (diarrhea aggravated), headache with sharp pain, low blood pressure, occasional cramp flare up and sleep apnea when treated with covid-19 vaccine ad26. cov2. s (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (second dose) (suspension for injection, intramuscular, batch number: UNKNOWN) dose, start therapy date were not reported, 1 total, administered on an unspecified date for prophylactic vaccination which was off label use and inappropriate schedule of vaccine administered (dose number in series 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  The patient received additional (third dose, booster) of covid-19 vaccine ad26.cov2.s (dose number in series 3) (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, 1 total, administered on 20-NOV-2021 for prophylactic vaccination. No adverse events were reported after third dose (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious. This case, involving the same patient is linked to 20211021812 (dose number in series 1).
Pt initially given ID vaccine by  vacine leaked out.  Pt revaccinated subcutaneously as per policy
Information has been received from a physician via a representative referring to a patient of unknown age and gender. The physician read that primary ovarian failure was related to GARDASIL (start date, lot#, strength, dose, frequency, route and AE onset date unspecified). The outcome of primacy ovarian failure was unknown. Additional information has been requested.
IM vaccine 11am, moments later c/o injection site pain, eyes closed, slow response, color-pale-lips white, shallow brady resp. O2 face mask with Epi Pen Jr. -EMS to ER  8/5/08 Reviewed ER medical records of 6/12/2008. FINAL DX: anaphylaxis Records reveal patient became cyanotic, diaphoretic & near syncope within 5 min of receiving vaccination.  Tx at scene w/epipen & O2.  Transported by EMS to ER.  No further reaction.  D/C to home w/epipen & steroids.
Day after injection: Left arm in injection area very sore and painful to raise arm to horizontal position. Soreness eventually move to inside of bicep.  Morning after injection Neck Vertebrae were very stiff and painful to turn head to either side. Infrequent headaches that were present in back of skull and left and right side of head, lasting only a few minutes at a time.
Within a few minutes of receiving the shot, I felt incredibly dizzy. Ever since then, I've his visual and auditory disturbances, diastolic hypertension, severe dizzy spells requiring hospitalization. These did not begin until after I got the flu shot.
This spontaneous report as received from a medical assistant refers to a female patient of approximately 67 year old with congestive heart failure, diverticulosis, hiatal hernia, hemorrhoids, hyperlipidemia, malaise, fatigue, valvular disease, chronic obstructive pulmonary disease and hypertension. On an unspecified date in the past, the patient received a dose of PNEUMOVAX23 and did not have any adverse reactions. Drug reaction and allergies were reported as none. On 02-DEC-2013, the patient was vaccinated with PNEUMOVAX23 (lot # J010332, expiration date 14-JAN-2013, dose 2, 0.5 ml, intramuscular). Concomitant therapies included COUMADIN, NEXIUM, atorvastatin, amlodipine, PROAIR, vitamin D, hydrochlorothiazide (manufacturer unknown), loratadine (manufacturer unknown), ULTRACET, BUSPAR, ZANAFLEX, LINZESS, amikacin, FOSAMAX and NORCO. In December 2013, the patient experienced redness, blotching and a rash around the injection site and extending down her arm. Patient sought medical attention, she saw a physician. Lab diagnostics studies were not performed. No treatment was given for the events. The outcome of the events was reported as not recovered. Additional information has been requested.
Initial healthcare professional report received on 26 May 2010: The patient received MENVEO (box lot. No. 100003, powder lot. No. 028011, liquid lot. No. 0910010), 0.45 ml, intramuscularly, on an unspecified date. The patient received partial dose on an unspecified date. The outcome of event was not reported.
throbbing pain both sides of kidneys; Difficulty breathing, feels like film on the lungs; nausea and diarrhea; tingling of the tongue; Body aches; nausea and diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (throbbing pain both sides of kidneys), DYSPNOEA (Difficulty breathing, feels like film on the lungs), DIARRHOEA (nausea and diarrhea), PARAESTHESIA ORAL (tingling of the tongue) and MYALGIA (Body aches) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Reaction to previous exposure to any vaccine (He has always had problems with various vaccines), Diverticulitis intestinal, Cyst (Complex Cyst bleeder), Ulcer bleeding, Stroke and Inflammation (Full Body Inflamation). Concurrent medical conditions included Kidney stones (Kidneys-Chronic Stones).   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced DYSPNOEA (Difficulty breathing, feels like film on the lungs), DIARRHOEA (nausea and diarrhea), PARAESTHESIA ORAL (tingling of the tongue), MYALGIA (Body aches) and NAUSEA (nausea and diarrhea). On an unknown date, the patient experienced RENAL PAIN (throbbing pain both sides of kidneys). At the time of the report, RENAL PAIN (throbbing pain both sides of kidneys), DYSPNOEA (Difficulty breathing, feels like film on the lungs), DIARRHOEA (nausea and diarrhea), PARAESTHESIA ORAL (tingling of the tongue), MYALGIA (Body aches) and NAUSEA (nausea and diarrhea) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow up was received on 20 Apr 2021 included reporter details, medical history, dose details & events were updated. On 21-May-2021: Follow up was received on 21 May 2021 included medical history and event was updated.
Patient had numbness in the arm that was injected, heavy arm, swelling, soreness, rash. Symptoms last for 5 days. on 3rd day she developed cough, lasted for a week.
swelling of the throat; knees look like water balloons; shaking like a jitterbug and twitching; stuffy nose; cough that is getting worse; feels over heated/ temperature of 103.7F; Squeezing the life out of her neck; both legs went numb; cant stand; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (both legs went numb), PHARYNGEAL SWELLING (swelling of the throat), JOINT SWELLING (knees look like water balloons), TREMOR (shaking like a jitterbug and twitching) and NASAL CONGESTION (stuffy nose) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced HYPOAESTHESIA (both legs went numb) and DYSSTASIA (cant stand). On 03-Jun-2021, the patient experienced FEELING ABNORMAL (Squeezing the life out of her neck). On an unknown date, the patient experienced PHARYNGEAL SWELLING (swelling of the throat), JOINT SWELLING (knees look like water balloons), TREMOR (shaking like a jitterbug and twitching), NASAL CONGESTION (stuffy nose), COUGH (cough that is getting worse) and PYREXIA (feels over heated/ temperature of 103.7F). At the time of the report, HYPOAESTHESIA (both legs went numb), PHARYNGEAL SWELLING (swelling of the throat), JOINT SWELLING (knees look like water balloons), TREMOR (shaking like a jitterbug and twitching), NASAL CONGESTION (stuffy nose), DYSSTASIA (cant stand), FEELING ABNORMAL (Squeezing the life out of her neck), COUGH (cough that is getting worse) and PYREXIA (feels over heated/ temperature of 103.7F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.7 (Inconclusive) 103.7 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided by the reporter and no concomitant medication reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient mother returned to clinic approximately 15 minutes after receiving DTAP and IPV stating child had urticaria, hives, rash from mid thighs up to face.  Chest was clear no wheezing, rhonch, or rales.  Epi 0.15mg and Benadryl 25mg administered intramuscularly with good response.  Patient discharged at 17:30 with prescription for Benadryl and prednisone syrup.  Patient returned to doctor's office 06/24 - rash cleared.
at 1014 c/o itchy mouth and lip; 1020 lips are better but throat was itchy; voice was gravely and had a cough non productive; given solumedrol 125 mg IVP; 1038 given xopenex HHN per protocol; Benadryl 25mg IVP; 1115 tightness gone voice clear and less cough
36 y.o. female referred for the above chief complaint.   She has no significant medical history and presented with a headache that became severe 3 days ago.  She received the Johnson and Johnson COVID vaccine on March 25th and had a mild headache following that which she attributed to the vaccine.  3 days ago the pain became excruciating and was associated with vomiting.  This prompted presentation to the ED where she was treated with Dilaudid. She was discharged home and has been using her mom's headache cocktail with some transient relief.  She presented back to the ED today with continued symptoms.  MRV revealed a venous sinus thrombosis and neurology was therefore consulted.   She has no history of clots personally or in the family.  Her dad did have a stroke in his 50s.  Patient otherwise denies any other associated speech change, vision change, extremity numbness, extremity weakness, coordination difficulty, or dizziness. Patient admitted to the neurology ICU and started on anticoagulation.
Patient temperature rose to 103.5 approximately midnight as reported by mother.  Per mother patient temperature dropped to 99 later the same day.  No time given when temperature dropped.
Left calf pain & swelling on 1/28/21.  Seen in ED on 1/28; diagnosis left calf DVT.  Started double dosing of Eliquis twice daily.  Leg swelling increased and upper left leg began to swell.  Seen in ED again on 1/3121; new ultrasound showed extensive clotting both lower and upper left extremity.  Continued double dosing of Eliquis with no resolution of clots.  Seen by cardiovascular surgeon on 2/10/21; new ultrasound showed continued extensive clotting, now in pelvis as well as entire left leg.  Referred to Interventional Radiologist.  Procedure performed on 2/12/21:  TPA & heparin infused through popliteal vein for 24 hours/in the intensive care unit
This spontaneous report was received from a nurse referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medication were not reported. On 24-JAN-2018, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M040412 with expiration date 30-JUN-2019, for prophylaxis (dose and route of administration was not reported). No adverse effects were reported in any patient. It was reported that the vaccine was exposed to a temperature between 32 to 35 degrees Fahrenheit for 8 hours. A digital data logger was involved. No previous temperature excursion was reported. There was no product quality complaint (PQC) reported. Follow up information has been received from the nurse on 26-FEB-2018, referring to a 17 years old female patient. On 24-JAN-2018, the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly in the right deltoid. The refrigerator temperature was at 35 degrees Fahrenheit on 18-JAN-2018. No adverse reaction reported for the patient. The patient tolerated well. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1803USA006840.
cough, nasal congestion, sore throat, chills, shortness of breath with activity, body aches, loss of taste, loss of smell, chest congestion. starting on 10/21/21
Baby was found dead of unknown cause on 9/29/22 at 8:30 am. Child sent for autopsy.
Information has been received from a registered nurse concerning a 14 year male with no relevant medical history reported and no allergies reported, who on 23-MAR-1998 was vaccinated SQ with the first 0.5mL dose of VARIVAX (Oka/Merck) and on 26-JAN-2009 was vaccinated SQ with second 0.5mL dose of VARIVAX (Oka/Merck) (lot number 662441/1326X)> There was no concomitant medication. On 02-FEB-2009, the patient was seen at the office and was diagnosed with the flu. On 19-FEB-2009 the patient's mother called the office and reported that the child had a couple of bumps on his body. On 20-FEB-2009, he was seen and had about 20 varicella-like vesicles in  face, arms and trunks. Additional information has been requested.
Weak, tired, cold, nausea, off balance, migraine headache, eye pain, blurry vision, foggy brain, face pain, trigeminal neuralgia, neck and face hot and red, sweating and shaking, threw up like acid, insomnia, frequent urination, diarrhea.
Patient received Zostavax on 3-3-08. She called on 3-7-08, and states she noticed on 3-6-08 that she had a tender, red area about 3 inches oblong where shot was given. Was bright red yesterday, lighter today. Will observe, call if doesn't resolve.
She felt like she had the flu for 5-7 days; sore arm on the injection arm; arm felt feverish; This is a spontaneous report from a Pfizer sponsored program COVAX US Support via a contactable consumer. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot/batch number was not reported) via an unspecified route of administration on an unspecified date in 2021 as dose number unknown, single for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. On an unspecified date in 2021 patient experienced She felt like she had the flu for 5-7 days and a She had the sore arm and her arm felt feverish after both vaccines. The outcome of the event (She felt like she had the flu) was recovered on an unspecified date in 2021 and was unknown for other events.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Dizzy, trembling, muscular aches, headache, upset stomach, painful area of injection site, red, deep pain, deep itching, swollen. This is day three of post injection, are still has pain, but better. Lethargic, but today better. Phar. that gave injection suggested two Tylenol when I got home. Have continued 2-4 Tylenol, daily.
Appendicitis; Stomach cramps; A  spontaneous case report was received from  a consumer concerning a 25 years old, female patient  who had received Moderna's COVID-19 and experienced  events as appendicitis, stomach cramps.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter..   On 17 Mar 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (batch number: 047A21A) via Intramuscular route on Left Arm for COVID-19 infection prophylaxis.   On 20 Mar 2021, the patient experienced stomach cramps.  on 21Mar and was diagnosed to have Appendicitis and underwent appendicectomy on the same day. The patient was treated with Tylenol  and Advil for stomach cramps. The event Appendicitis seriousness were considered as hospitalization and medically significant.   The action taken with mRNA-1273, in response to events was unknown.  The outcome of the events appendicitis and stomach cramps was not resolved at the time of this report.; Reporter's Comments: This case concerns a 25 Y/O F hospitalized with a serious unexpected event of appendicitis and nonserious unexpected abdominal pain upper.  Event onset 4 days after first dose mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
No other adverse effects were reported in any patients; An unknown number of patients, received an unknown number of doses of VARIVAX following a temperature excursion; This spontaneous report has been received from a physician assistant concerning a female patient of  unknown age. The patient's concomitant therapies included sterile diluent. The patient's concurrent conditions and previous medical history were not reported.    From 30-MAR-2020 to 26-APR-2020, varicella virus vaccine live (oka/merck)(VARIVAX), was exposed to a range of temperature excursion between -4°C up to 0°C for 30 minutes.Information was extracted from data logger.     On 26-APR-2020, the  patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # S021321, expiration date 09-JUL-2021 for prophylaxis (dose, strength, formulation and patient route of  administration  were not reported) following a temperature excursion (product storage error).  A total of 12 hours of maximum temperature excursion was reported.  No other adverse effects were reported in any patients.   Due to the defrost cycle approximately once every 26 hours, there was  a 30-60 minute excursion above -15°C. On most of those days, the amount of time spent between 0°C and -9°C was 30 minutes. A cumulative time-frame for varicella virus vaccine live (oka/merck)(VARIVAX)temperature excursion of -9°C to 8°C (0°C) was 28 hours and 30 minutes  This is one of two  reports received from the same reporter.
Extreme fatigue within 2 hours and which persisted for for 48 hours. Head to toe itchy red rash began at day 6 and is currently persistent but responds moderately well to an anti-histamine (Benadryl PO).  Does not appear to be hives.  Worse with heat and pressure.   Better with cold.
Within 36 hours of injection, developed an itchy rash all over his body.  Lasted for about 36 hours. Rash resolved except for his back.  The rash became red painful rash on his back - not vesicular by report.  Lasted 10 days. Used topical cortisol cream and ice.  All symptoms have resolved.  This was a phoned in report.  the patient declined to come to be seen, but wanted this information reported.  Past injections with quadrivalent flu vaccines uneventful.
Ringing in the ears ... like a hiss or a shhhh sound (crickets in the background)
chills, fever up to 102, body ache started at 3.30 am.  Heart rate increased to 124bpm in the morning at 7am.  HR in relaxed state remained more than 100 throughout the day, in 80-90s the next day and below 70s on 3rd day.  Fever lasted for a day. Headache and body ache for 2 days.