chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse concerning a 16 year old male patient who on an unspecified date was vaccinated with the first dose of GARDASIL (Lot# not reported). It was reported that the patient had a syncopal episode in the exam room and was examined. At the time of the report the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Menstrual cycle hasnt been normal since second vaccination. Its either very very light or doesnt come at all. started in sept after second vaccination.
BODY ACHES; TIREDNESS; This spontaneous report received from a patient concerned a 79 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and tiredness on MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210356833.
COLD; TROUBLE WALKING; LEGS ARE SHAKING; FREEZING; CHILLS; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not 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 31-MAR-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 an unspecified date, the subject experienced cold, difficulty in walking, legs are shaking, freezing, chills, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cold, difficulty in walking, legs are shaking, chills, freezing and nausea was not reported. This report was non-serious.
Severe diarrhea w/in 48 hrs. of 3rd vaccine, vomiting, chronic fatigue, headache, abdominal pain, heart palpitations, sensitivity to light & noise. All except vomiting have continued. Low grade fever of "unknown origin".  8/14/2009 PCP records rec'd dated 7/20-8/3/2009 with dx:  Headache. Fatigue. Abdominal Pain. Pt initially presented 7/20/09 with 2 week hx of headaches and abdomminal pain. Nausea associated with abd pain.  Parent reports reduced activity level.   F/U 8/1/09. Tenderness to palpation in RUQ. Returned 8/3/09 with worsening sx. MD notes sx began following HPV and TDaP vax in June. Reports need frequent breaks with activity, spending days in bed 2' to fatigue, dizziness, lightheadedness, seeing spots, epigastric pain, several episodes of syncope with myoclonic movements.  Referred to cardiology and neurology.
Dizziness, fever, body aches, malaise, sinus congestion, took Tylenol & Claritin D.  Rest & slept.
Pt received Td injection on Saturday November 4th .Pt presented 8 Nov with induration and erythema over right deltoid 40x45mm (golf ball size).  She states it was "twice as big on Monday" (6 Nov).  She states she felt burning pain over right deltoid approximately 1 hour after injection received.  She states swelling and readness with muscle pain peaked 48 hours later.  She also states she had "tiny blisters" over site. Blisters were not visible on 8 Nov.
Dr. wrote a prescription for PREVNAR 13. I administered vaccine on 10/21/16. Patient came back on 11/18/16 for PNEUMOVAX and stated she has sore arm from the 1st vaccination. I advised her about potential side effect with the vaccination. Patient came back on 1/28/17 and states she is still having a sore arm. Her Dr. told her to take Ibuprofen but no improvement.
A day later participant notice Breast inflammation, Lymph nodes were swollen. High blood pressure issues for three days. Went to see doctor and was prescribed Prednisone.
Soreness in the left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included INSULIN for an unknown indication.    On 05-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN. The patient was treated with ACETAMINOPHEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient also takes unspecified blood pressure medication as concomitant medication.
Vomited x 1 6 hours after vaccine administrationDiarrhea x 1 - 6 hours after vaccine administration; Diarrhea x 1 - 6 hours after vaccine administration; This is a spontaneous report from a contactable other hcp. A 35-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6203), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 19:30 as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included fish oil (FISH OIL) taken for an unspecified indication, start and stop date were not reported; magnesium (MAGNESIUM) taken for an unspecified indication, start and stop date were not reported; ubidecarenone (COQ 10) taken for an unspecified indication, start and stop date were not reported; rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported; vitamin b2 [riboflavin] (VITAMIN B2 [RIBOFLAVIN]) taken for an unspecified indication, start and stop date were not reported. The patient previously took bnt162b2 for covid-19 immunisation, amoxicillin and experienced drug hypersensitivity, aspirin [acetylsalicylic acid] and experienced drug hypersensitivity, ibuprofen and experienced drug hypersensitivity. The patient experienced vomited x 1 6 hours after vaccine administration diarrhea x 1 - 6 hours after vaccine administration on 19Feb2021 01:30, diarrhea x 1 - 6 hours after vaccine administration. The outcome of the events were recovered. Follow-up (20May2021): Follow-up attempts completed. No further information expected.
pt recv 2 dose of varicella & JUL96 did not seroconvert (ELISA 0.30 for varicella antibody);
Patient fell at home on 08/19/2021; He was admitted to the hospital and diagnosed with Guillais-Barre' syndrome shortly into the stay.
SEVERE SIDE EFFECTS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (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. The company is unable to perform follow up to request batch number. No concomitant medications were reported. On an unspecified date, the subject experienced severe side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe side effects was not reported. This report was non-serious.
Took 1 hour to drive to pharmacy. Noticeable effects started on way home. Started to feel nauseous, and from my neck to entire head, I felt swollen. Got home, collapsed in chair, had a faint sign of difficulty breathing, but not bad. Still felt swollen. Disappeared about 2 hours at home. Nausea getting worse. Feeling chilled, feverish, and dizzy.  Unable to sleep that night, so nauseated I couldn?t even swallow water without wanting to puke. Shot on Tuesday, didn?t feel much better till Friday. Ok now.
Patient waited 15 minutes after the vaccination at the facilities, then indicated she went home but while on the way she already manifested symptoms of fatigue, drowsiness, arm pain and headache. Between January 29 and January 31, she had strong symptoms that kept her on bed during those days. She described the following symptoms: no appetite, nausea, headache, tiredness, fever, arm numbness, chills and pain in the vaccination area.
Patient reports sx started around 830am: headache on right side, muscle tenderness/soreness, difficulty concentrating, fatigue, radiating pain from arm to neck (unable to move head), injection site reaction (warmth, inflammation).
No additional adverse effects; one male patient was administered improperly stored ROTATEQ; This spontaneous report has been received from a vaccine coordinator, concerning a 7 months-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medication, previous drug reactions or allergies were not reported.  On 02-MAR-2020, the patient was vaccinated with an improperly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), 1 dosage form for prophylaxis (product storage error) (lot number 1658255 has been verified to be a valid number; expiration date reported and validated as 07-FEB-2021) (concentration, route of administration, frequency of vaccination scheme and anatomical location of vaccination were not reported).  The reporter stated that the Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) underwent multiple temperature excursions below 2 degrees Celsius.  On 02-MAR-2020, the temperature was 0.8 degrees Celsius for a time frame of 5 hours and 9 minutes, on 04-MAR-2020, the temperature was 0.9 degrees Celsius for 11 hours; and on 05-MAR-2020, the temperature was minus 1.3 degrees Celsius for 9 hours and 29 minutes as recorded by the data logger.    Other temperature excursions occurred on 25-FEB-2020 and the temperature was above 9 degrees Celsius (9.3 degrees Celsius) for 3 hours and 33 minutes and on 03-MAR-2020, the temperature was below 2 degrees Celsius (0.8 degrees Celsius) for 11 hours and 39 minutes, also recorded by the data logger.   No adverse effects were reported.  This is one of the multiple reports from the same reporter.; Sender's Comments:  US-009507513- 2003USA006305: US-009507513- 2003USA006317:
Pt recvd 2nd dose of vax & 5 to 10 seconds following the vax exp chest pain which persisted for 15 mins; exp dizzness; BP was nl range & exp no palpitations; chest pressure;
After eight hours after receiving the second dose, the normal sx of the COVID vaccine occurred (muscle aches, fatigue). On the morning of 04/23/21, the patient completely lost consciousness and was not breathing. The caregiver (son) performed CPR and the patient regained consciousness. Paramedics were called and performed and EKG, blood glucose, and BP/HR - all were normal.  Pt is resting but still in pain.
Pt recvd vax & 72 hrs p/2nd dose exp a sz while sleeping; eyes rolled back, arched back & was seizing w/stiff body; lasted approx 45 seconds - 1 min; p/sz pt disoriented, could not talk, wanted to sleep & was drooling;
Information has been received from a nurse concerning a 56 year old patient (gender not reported) who was vaccinated (date,route, dosage and site not reported) with pneumococcal 23v polysaccharide vaccine (lot# 658451/0963U). Subsequently, post vaccination, the patient experienced "severe injection site reaction". The patient did receive unspecified medical attention and improved. Additional information has been requested.
No additional AEs were reported.; Physician reported that a patient received the first dose of ROTATEQ later than recommended. The patient received the first dose of ROTATEQ today 7/26/2022 and the patient was 6 month old.; This spontaneous report was received from a physician and refers to a 6-month-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 26-JUL-2022, the 6-month-old patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 dose, lot # reported as: U021367 upon internal validation was confirmed as valid, expiration date was reported: 07-MAR-2023 and was confirmed as valid (exact dose, strength, formulation and route of administration were not provided) for prophylaxis (product administered to patient of inappropriate age). There was no additional adverse event reported.
Patient was on a 30 min observation due to previous anaphylaxis to emgality. As she was leaving, she c/o swelling and tingling of lips and appeared anxious. We asked to stay so we can monitor her a little longer. She appeared to stabilize, then she began coughing and trying to clear her throat. She stated it seems have worsened. Epi given and she was transferred to ED.
T. 102,  whole body shaking, weakness . The former two lasted about 3 hours. The weakness lasted 2 days. Also, sore injection site for 3 days (which I always get).
Severe arm pain in right arm.  Loss of strength in arm and hand, Tendonitis in shoulder, elbow, wrist and hand.
Per father, Pt experienced soreness in both arms with more in the right arm than the left last night.  His son took Tylenol for discomfort in the evening and went to bet with no issues. This morning, he said the son had no complaints before going to school.
Within 15 minutes began feeling itching on head and neck, told the nurse who checked with me before leaving and they said I could take Benadryl. 45 minutes later experienced painful burning and swollen welts on small of my back in several spots. Largest spot was about 6 inches wide and 3 inches tall, felt warm and rigid and itched after burning sensation ebbed (about an hour). Took Benadryl but didn't seem to change the swelling or itching. Now three days later it is reduced to one spot about an inch in diameter, no longer taking the Benadryl.
Developed asthma by mid February. I am a nurse myself, so I got it diagnosed quickly, but I went from comfortably going on 8 mile runs, to wheezing walking up a flight of steps. I was prescribed an albuterol inhaler and use it regularly. There has been no change in my symptoms.
Reaction that looks like hives (red bumpy skin) at the site of injection 1 week after the first dose. Spread to 3 inches in diameter in the next 10 hours and was itchy. At the same time, experienced body aches. Still experiencing red, itchy skin 3 days after the start of the reaction.
She had received her first Covid vaccination this afternoon and following that she became dizzy and had a syncope spell.  She tells me that with previous vaccinations this has routinely happened and so it is not different.  She was not aware of her surroundings for about 2 minutes after this happened although there was no witnessed jerking or seizure movement.  At this point she feels about 90 to 95% back to normal and denies any pain anywhere including in her chest.  Initially she had some tingling in her arms although that has resolved.
Began experiencing signs and symptoms on 10/30/18 around 2:30pm -nausea (intermittent throughout that morning) -numbness in left hand -dizzy -dilated pupils -pallor -hot flashes -sweating -cold/shivering -headache -feelings of passing out -fatigue -decreases appetite -weakness.
This case was reported by a consumer via call center representative and described the occurrence of abnormal vision in a 65-year-old female patient who received SHINGRIX for prophylaxis.  On 28th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In January 2019, 21 hrs 45 min after receiving SHINGRIX, the patient experienced abnormal vision. On 29th January 2019, the patient experienced dizziness and pain in arm. On an unknown date, the outcome of the abnormal vision and pain in arm were unknown and the outcome of the dizziness was not recovered/not resolved. It was unknown if the reporter considered the abnormal vision, dizziness and pain in arm to be related to SHINGRIX. Additional details were provided as follows: At 4:15 PM, the patient received SHINGRIX. The next day, at around 2 PM, the patient noticed her vision was off while she was driving home. One day after receiving SHINGRIX, by the time she got in her house things were spinning. She shut her eyes and it was better, but when she opened her eyes she started getting dizzy again. Her arm also hurts. The reporter consented to follow up.
urticaria widespread anasarca x 3d No pulmonary and cardiovascular problems Resolved with Benadryl
I think he had covid but did not get tested; He got sick like I did a week before me; He had a reaction to the vaccine really bad; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (He got sick like I did a week before me), VACCINATION COMPLICATION (He had a reaction to the vaccine really bad) and COVID-19 (I think he had covid but did not get tested) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced ILLNESS (He got sick like I did a week before me) and VACCINATION COMPLICATION (He had a reaction to the vaccine really bad). On an unknown date, the patient experienced COVID-19 (I think he had covid but did not get tested). At the time of the report, ILLNESS (He got sick like I did a week before me), VACCINATION COMPLICATION (He had a reaction to the vaccine really bad) and COVID-19 (I think he had covid but did not get tested) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had a reaction to the vaccine really bad.  No concomitant medications were reported.                   No treatment information was reported.
Time line of events: ? 08-18-20  Routine protocol cranial MRI without contrast under sedation. Dx: Macrocephaly/Gorlin Sydrome ? 08-24-20 at 3:00 PM  Patient here at Clinic for 9 mo WCC appt and received vaccines at 3:30 PM (Pediarix and PCV13).  Normal WCC for age  ? 08-25-20 at 1:48 PM  EMS called by parent for cyanosis and apnea. EMS arrived on scene at 1:54 PM (per EMS: approx. 30 min downtime prior to EMS arrival), found patient to be apneic and with very faint pulse.  Per EMS, patient was fine earlier in the morning.  Transported to Hosp Emergency Department arriving at 2:14 PM  presenting in full cardiopulmonary arrest.  From there transferred to Hosp. ? 08-26-20  Discharged from Hosp with Dx Level 1 ? Medical treatment with full resuscitation and transferred to the Cardiac Critical Care Uni. ? 08-27-20  Decease at 10:57 AM  (an autopsy is planned)
Patient was inadvertently given the bivalent vaccine rather that monovalent for their first dose in their primary series. No reported reaction or other issues.
uncontrollable head movement; head vobling; head node is uncontrollable; arm got sore; big lump at the injection site; at the injection site white center and red dot around; then pink dot; red dote inch away from injection site; This spontaneous case was reported by a consumer and describes the occurrence of DYSKINESIA (uncontrollable head movement), HEAD DISCOMFORT (head vobling), MOVEMENT DISORDER (head node is uncontrollable), PAIN IN EXTREMITY (arm got sore) and INJECTION SITE MASS (big lump at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included BUSPIRONE and OXCARBAZEPINE.    On 14-Apr-2021 at 11:26 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced DYSKINESIA (uncontrollable head movement), HEAD DISCOMFORT (head vobling), MOVEMENT DISORDER (head node is uncontrollable), PAIN IN EXTREMITY (arm got sore), INJECTION SITE MASS (big lump at the injection site), SKIN DISCOLOURATION (at the injection site white center and red dot around), SKIN DISCOLOURATION (then pink dot) and INJECTION SITE ERYTHEMA (red dote inch away from injection site). At the time of the report, DYSKINESIA (uncontrollable head movement), PAIN IN EXTREMITY (arm got sore), INJECTION SITE MASS (big lump at the injection site), SKIN DISCOLOURATION (at the injection site white center and red dot around), SKIN DISCOLOURATION (then pink dot) and INJECTION SITE ERYTHEMA (red dote inch away from injection site) outcome was unknown and HEAD DISCOMFORT (head vobling) and MOVEMENT DISORDER (head node is uncontrollable) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication not provided
Headache, nausea, malaise.  Took Tylenol.  Felt better by nighttime
muscle twitching the day after vaccines were given that are brief (3 seconds) and stopped when mother held the extremity.  Also was a rightward twitch of the head.  No additional seizure descriptions per history.
Patient stated her arm is in severe pain, she can't rotate it or lift her arm. She would get awaken at night due to the pain, and takes about 4 tablets of OTC ADVIL everyday for the pain.
Dx: Dyspnea upon exertion. This was a new onset. I have never had dyspnea before with or without a cold. I have no prior history of asthma or other breathing problems.  Treatment: Albuterol inhaler 2 puff(s) Inhalation Every 6 hours as needed as needed for wheezing and/or chest tightness. Please dispense with a spacer.. Refills: 0.  Outcome: Dyspnea resolved after 1 week on albuterol inhaler when URI resolved.
Fever with seizure x3  within 16 hours of shot, vomiting, dehydration admitted for IV fluids. Dis Sum rec'd 10/26/2005, added symptoms were couch, rhinorrhea, decreased PO intake and pneumonia.
Vaccine was improperly stored and administered; No additional AE; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided.  On an unknown date the patient was vaccinated with improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) dose of 0.5 milliliter (lot # T011167, expiration date 27-MAY-2022; exact dose, anatomical location and route of administration were not reported) for prophylaxis.  Administered dose of vaccine was stored in a temperature below 36 degrees Fahrenheit (35.70 degrees Fahrenheit)for 1.5 hours on 27-OCT-2020 and in a temperature below 36 degrees Fahrenheit (30.20 degrees Fahrenheit) for 1.5 hours on 28-OCT-2020. Digital data logger was involved. Previous temperature excursions was experienced on 14-OCT-2020, and the vaccine was stored in temperature above 47 degrees Fahrenheit (64.36 degrees Fahrenheit) for 3 hours. No adverse event was reported.
Client presented with Diaphoresis, light-headend feeling.  Administered one, 4 oz. orange juice and 4 oz. h2o over fifteen minutes.   Client reported  feeling recovered after fifteen minutes rest.  Client left ambulating under his own control with his mother and father.