chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received flu vaccine 9/8/14 developed chills, T. 100.2, low backache on 9/15/14 developed rash from knees down bilaterally and pain. Seen at ED on 9/15/14. Seen by PCP 9/16/14 referred to Derm 9/16/14 skin biopsy result vesicular rash. Seen by Rheumatology 9/17/14 blood work positive cryoprotein. Started on Prednisone final Dx autoimmune response to flu vaccine start Rituximab infusion 11/29/14.
A 13 year old male is brought to the office today by his father for well child examination. Father states that he has concerns regarding enuresis. Father explains that the child has nighttime loss of bladder control every night. Father states that the child restricts fluid intake in the evening and micturition occurs before sleep. In addition, the patient denies any burning, change in frequency or change in odor of urine. Father states that there is maternal family history of nocturnal enuresis. Father further explains that the child's bed time is 9:30PM on weekdays and between 2-3 AM on weekends. Patient lives with his father and high school aged brother. Mother has separated from family 2 years ago. Father works at a truck company where most of his time is spent away from the home, out of the state of origin. Patient is currently in 7th grade. Patient explains that school is going well and grades are described as good. Patient states that he participates in football and basketball activities at school. Patient explains that his mood is good. Denies any feelings of depression. During the course of the office visit, patient received a needle injection for influenza vaccination in his upper left arm. After injection, patient subsequently explained that he felt dizzy, anxious and generally 'not ok'. At this time clinicians present in the exam room observed the patient's face become flushed with color. In addition, patient lost muscle tone. Vital signs were assessed: Temperature: 98.3 degrees Fahrenheit Blood pressure: 144/84 Pulse: 64. Subsequently, patient's lips were then observed to become pale for a few minutes. Extremities became cold and moist. During this period of time, the patient was able to state his name, location and identify family members in the exam room. Patient was kept under observation in exam room for 15 minutes. Vital signs reassessed: Blood pressure 132/74 Pulse: 65. Patient was observed to lose muscle tone in his upper right arm and lower left leg. Patient was unable to stand or ambulated without assistance. Patient was then sent to the emergency department. ?
Jaw, lips, mouth area - numb for 45 hours.  Pain under right rib for 18 hours.  Severe pain in left arm & hand with a band across my lower back that came on with the arm/hand pain - hand/arm pain lasted 18 hours with the lower back taking 5 days to subside.  Severe head to toe itching - no rash  found anywhere- took Benadryl evening of the shot and itching was alleviated.  Severe headache just at the forehead and up with extreme dizziness - lasted 33 hours.  Fatigue lasted 5 days - severe the first 33 hours.
Pt completed a 66min observation with the following symptoms: palpitations, dizziness, flushing, itching, SOB, nausea, headache.  No medications was given.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.   This case was linked to MOD-2021-395985 (Patient Link).
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from a practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 02-FEB-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N021475 and expiration date 03-JAN-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001957; US-009507513-1810USA001958; US-009507513-1810USA001959; US-009507513-1809USA003709.
4 hours after injection of Hep B, Prevnar, DTP, IPV and Hib, inject site became very red and hot, slight fever and baby continued to cry uncontrollably (very abnormal crying for this baby who cries very little).
Pressure in head within 1 hour of vaccine-progressed to dull headache lasting weeks. Severe pain in back day after- progressing to lungs, chest, abdomen. Hoarse voice for 6 + weeks. Severely tired - getting less - still present. Shortness of breath - severe at times started day 1 lasted 5 - 6 weeks. Heart palpitations for 4-5 weeks. Memory problems - pause in thinking. Very weak - getting better. Chill lasting 4-5 weeks.
my ears won't stop ringing, specifically my left one on the same side as the arm I got the shot in, and it is driving me crazy
Myalgia. SAME DAY AS INJECTION REPORTED ARM SORENESS AND INJECTION SITE PAIN/SWELLING, JOINT PAIN, FATIGUE. PT REPORTED FATIGUE AND BODY ACHES CONTINUED FOR APPROX 7 DAYS AFTER INJECTION.
This spontaneous report as received from a 63 year old male patient with rheumatoid arthritis and no drug reactions/allergies refers to himself. On 19-JAN-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # K007825, Expiry Date: 13-JAN-2016) 0.5 ml (route was not reported). Concomitant therapies included HUMIRA, methotrexate (manufacturer unknown), hydroxychloroquine sulfate, CELBREX and TRAVATAN. On 19-JAN-2015, the patient experienced injection site redness and injection site soreness. No treatment was given for adverse events. No Lab diagnostics were performed. The patient did not seek medical attention. The outcome of the events was reported as recovered/resolved on 21-JAN-2015. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Warm to the touch and it was below the site of injection; Delayed type of reaction where she developed a red splotch; Slight tenderness at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch and it was below the site of injection), VACCINATION SITE PAIN (Slight tenderness at the site of injection) and VACCINATION SITE ERYTHEMA (Delayed type of reaction where she developed a red splotch) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (Slight tenderness at the site of injection). On 05-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch and it was below the site of injection) and VACCINATION SITE ERYTHEMA (Delayed type of reaction where she developed a red splotch). At the time of the report, VACCINATION SITE WARMTH (Warm to the touch and it was below the site of injection), VACCINATION SITE PAIN (Slight tenderness at the site of injection) and VACCINATION SITE ERYTHEMA (Delayed type of reaction where she developed a red splotch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication information was reported.
two days: shaking chills, fever, fatigue (could not stay awake more than 2 hours in row, nap for 3 hours before wake up) two more days fatigue (4th day went to library and food cart for less than two hours, so tired could not walk up stairs in home until rested for an hour reading) two more days low energy but functional. Issues with temperature (5th day went to chiropractor and temperature 95.6  instead of normal 96.8. Fine after a week (temperature still slightly low at 96.4 at 9 days out)
Initial report received on 02 October 2013 from a healthcare professional (nurse). This case involves an unidentified male patient, date of birth not reported who received influenza vaccine (manufacturer unknown) on an unreported date. The route, dose and site of administration were not reported. The reporter received the information from the patient's sister as the patient is not a client at her facility. It was reported that the patient had a medical history which included allergies to sesame seeds and nuts. Concomitant medications were not reported. It is unknown if the patient had any illness at the time of vaccination. On an unreported date following vaccination, the patient had an allergic reaction where he experienced a feeling of throat closing and his throat was itchy. The patient outcome was unknown by the reporter. The reporter denied having any further information about the patient or event and refused to be contacted for further information. Documents held by sender: None.
At 2nd dose, sore arm for 2 days; body aches from neck down to legs that lasted 1 day; massive headaches off and on for 2 days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 11:45 (Lot number: ER8737) at the age of 33 years as dose 2, single 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=EN1199, administration time=12:30 PM, vaccine location=Left arm), administration date: 09Mar2021, when the patient was 33 years old, for covid-19 immunization, reaction(s): "Sore arm for 1 day after 1st dose", "Diagnosed with CRVO of the eye -March 30th", "Mini Stroke/blockage in left eye". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "At 2nd dose, sore arm for 2 days"; PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "body aches from neck down to legs that lasted 1 day"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "massive headaches off and on for 2 days". The events "at 2nd dose, sore arm for 2 days", "body aches from neck down to legs that lasted 1 day" and "massive headaches off and on for 2 days" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of pain in extremity, pain, headache.  Additional information: Facility type vaccine was Pharmacy or Drug Store. No Known allergies. No other vaccine in four weeks. No other medications in two weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a licensed practical nurse refers to an unspecified patients of unknown ages and genders who between 06-MAR-2015 and 15-APR-2015 were inadvertently vaccinated with an improperly stored doses (incorrect product storage) of ROTATEQ (lot # K005397, expiration date 29-FEB-2016 and lot # reported as K016278, expiration date 21-APR-2016) (dose not reported) by oral route. No adverse effects reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. Additional information has been requested.
after administration of hepA,pt.became pale and fell on exam table.her muscle got stiff.her body arched and her eyes rolled upward.she had seizure. it lasted for few seconds and she started crying before any treatment given.
Painful and very stiff neck. Symptoms got progressively worse over 72 hours. Very difficult to make movements up and down of my head and side to side hurts as well. Feels like the pain is deeper and closer to the back of the head than typical muscular pain/strain. Don't know if it is related to the vaccine, but it's a very strange feeling and not something I have ever experienced before.
This is a spontaneous report from a Pfizer-sponsored program, from a contactable consumer reporting for his/her daughter. This female child patient of an unspecified age, race and ethnicity received a single dose of meningococcal group b rlp2086 via an unspecified route of administration on an unspecified date for immunization.  The patient medical history and concomitant medications were not reported. On an unspecified date the patient was injured by the vaccine, she lost muscle mass and her ability to do work was affected. The patient recovered on an unspecified date. Pfizer is a marketing authorization holder of meningococcal b recombinant vaccine in the reporter's country. This may be a duplicate report if another marketing authorization holder of meningococcal b recombinant vaccine has submitted the same report to the regulatory authorities. No follow-up attempts are possible. No further information is expected.
very ill,didn't do well, very sick; very tired; left arm hurting all of the time for 21 days now; left shoulder hurting all of the time for 21 days now; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very ill,didn't do well, very sick), FATIGUE (very tired), VACCINATION SITE PAIN (left arm hurting all of the time for 21 days now) and ARTHRALGIA (left shoulder hurting all of the time for 21 days now) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001F21A, 011A21A and 025A21A) for COVID-19 vaccination.     The patient's past medical history included Acute bronchitis, Diabetic neuropathy, Chronic pain and Stroke (4 strokes). Concurrent medical conditions included Asthma and Arthritis. Concomitant products included HYDROCODONE, LIDOCAINE, METHOCARBAMOL, ALBUTEROL [SALBUTAMOL], LACTULOSE, DILTIAZEM HYDROCHLORIDE (DILTIAZEM XR), PRAVASTATIN, FLUTICASONE, TERAZOSIN, MONTELUKAST SODIUM and FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced VACCINATION SITE PAIN (left arm hurting all of the time for 21 days now) and ARTHRALGIA (left shoulder hurting all of the time for 21 days now). On an unknown date, the patient experienced ILLNESS (very ill,didn't do well, very sick) and FATIGUE (very tired). At the time of the report, ILLNESS (very ill,didn't do well, very sick) outcome was unknown and FATIGUE (very tired), VACCINATION SITE PAIN (left arm hurting all of the time for 21 days now) and ARTHRALGIA (left shoulder hurting all of the time for 21 days now) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.  It was reported that, Doctor told to take antihistamines and forget about it.  Treatment information was not provided.
Joint pain noted a little more than 24 hours after vaccine. Ibuprofen taken and pain subsided.
this is one of 5 pt who recv vax & devel a nodule @ the inj site 24 to 48hr later;the inj site nodule was 4 to 6mm in diameter, red, arm, & tender;
About 2 weeks after my first shot, I started to have intense shoulder pain followed by a numb hand a couple of days later. The next day, my vision was weird, and the day after that I had dizziness, nausea, lack of balance, sensitivity to light, vertigo, a tingling sensation in my head, and a range of vision changes (hallucinations, lack of depth perception, blurriness, double vision, trouble focusing, two-dimensional objects looking three-dimensional, narrow field of vision). All of these symptoms were relatively constant and lasted from 4/19-5/6. Then they all went away. On May 21 I got my second shot, and about 6 hours later I had some of the same 3D vision changes, which only lasted that night. Then on June 10th I had a range of vision changes (hallucinations, seeing lights when I close my eyes, seeing lots of floaters, static quality to vision in dim light). I also had dizziness, vertigo, and nausea on and off. These symptoms continued until July 20th. I now am mostly better, but I still have a few lingering vision issues.
17X14.5 CM RED PATCH ON LEFT OUTER UPPER ARM. MILDLY EDEMATOUS. NO WARMTH. NO TENDERNESS, SOME ITCHING. NO FEVER.
Fever; Sick with Strep; The following information was received from a nurse on 26 Feb 2020.  A 6 year old male received one dose of IXIARO (Japanese encephalitis vaccine, batch number not reported) about one month ago [calculated as Jan 2020]. He has been sick with Strep since vaccination and recovered on an unknown date. At time of reporting, he experienced fever, but outcome was not reported.  No further information available.; Sender's Comments: Causality assessed as not related, as inactivated vaccines do not cause bacterial infections and the time to onset for the event fever is not plausible (one month after vaccination) and can be seen in the context of the streptococcal infection. Reporter most likely suspected IXIARO to cause only the fever as adverse event.
Herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation concerning to a currently 68 years old patient of unknown gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 23-MAR-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) at a clinic (dosage regimen, route of administration, lot number and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequently the patient was treated by a physician for the following injuries resulting from Plaintiffs ZOSTAVAX use: herpes zoster. The outcome of the event was considered as not recovered. The reporter considered the events to be related to zoster Vaccine Live (ZOSTAVAX).
Pt passed out at front of store, pt states she felt lightheaded and passed out, pt immediately regained consciousness I observed pt sitting in floor, pt states that she feels fine and has no injury, pt continued to sit for 15 minutes and drink sprite, pt states that she feels fine and has not eaten since previous day.
Initial unsolicited report received from pharmacist on 08-Sep-2017. This case involves a patient (age and sex not reported) who was vaccinated with dose of FLUZONE HD (batch number, expiry date route and site was unknown) on an unknown date. The patient's medical history and concomitant medications were not reported. On unknown dates, following the vaccination, the patients experienced reaction after a FLUZONE HD injection on the inside of arm and not injection site. It was hot to the touch. The patient's laboratory data and corrective treatment were not reported. The event outcome was not reported. List of documents held by sender: none.
vomiting; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting) and DIARRHOEA (diarrhea) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jul-2021, the patient experienced VOMITING (vomiting) and DIARRHOEA (diarrhea). At the time of the report, VOMITING (vomiting) and DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant and treatment information were reported by the reporter.
(R) thigh 5cm x 5cm redness and swollen. Mom apply ice and gave ibuprofen. Notice today (7/20/10) felt warm.
1-15-16 - Yesterday, about 5 min after the vaccine, child developed central apnea, not breathing for 10-15 sec at a time, and then gasping. He cried with stimuli but quickly went back into the apneic breathing pattern when it was stopped. Color was pale. Infant was very still. I repeated the painful stimuli (fingers in axillae) about 7 times. He had intermittent periods of breathing spontaneously which lasted 1-2 min at a time, and then recurred with the central apnea. We fed 1 ounce of formula with a dropper. No dramatic change. Color improved. Gave oxygen and put pulse ox on him, pulse ox was 100%. Called 911. They arrived about 15 min later, and by that point, the infant was breathing spontaneously and regularly. Spoke to hospital at time of discharge today and they reported that ECG was normal, no abnormalities found, final dx likely breath holding from the pain of the vaccine.
A BIT OF SORE ARM; This spontaneous report received from a patient via a company representative 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 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced a bit of sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of a bit of sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210925834.
Localized swelling, redness, itching 3 cm x 2cm area around injection site.