chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist concerning a patient who on an unspecified date was vaccinated with a 0.65mL dose of ZOSTER vaccine live (Merck) (route and lot number not reported).  The pharmacist reported that the patient developed a case of ZOSTER within one week following vaccination.  The patient sought medical attention by contacting the pharmacist.  This is one of several reports received from the same source.  Additional information has been requested.
ERYTHEMATOUS RASH ON SCALP AND UPPER TRUNK. PT ALSO STARTED ON A NEW FORMULA (SOY) AND THE RASH APPEARED 2 HOURS LATER.
Mother noticed 2-3cm nodule two days post injections then area around nodule became red. Erythema 9 x 6cm surrounding nodule, no tenderness, slightly warmer than surrounding tissue.
Patient started feeling cold and shivering just after 10pm. He checked his temperature and didn't have a fever, didn't have a blood glucose monitor to check blood sugar, but had a blood pressure monitor and checked that. His blood pressure readings were 160-188 systolic and 112-120 diastolic. I advised him to go to the ER. Blood pressure was still 130/95 when he arrived, but went down after about another hour. He still felt cold, but within 2 hours there he started with a fever of 100 degrees. It was treated with acetaminophen and he received 1 liter of IV fluid. After fever started to resolve and blood pressure was normal he was sent home instructed to follow up with primary care if needed.
Got up at 6:00 a.m. feeling fine.  Drove 15-20 minutes on the highway and began to feel lightheaded, so I immediately took the exit next to me.  Before I could get to the side of the road, I lost consciousness.  I do not know how long I was unconscious.  The car hit something, waking my daughter, who was asleep in the passenger seat.  She said that she shook me vigorously and called my name, but that I didn't wake up for about 20 seconds.  I was able to pull in to the gas station to wait for my husband to arrive and drive us home. I did not seek medical attention because I had experienced lightheadedness, nearly "passing out" and vomiting with the first Moderna booster and was sure I would not have further problems by the following day.  I am reporting this because of the potential safety hazard.
This spontaneous report was received from a registered nurse refers to a 6 month old patient. The medical history, concurrent condition and concomitant medications were not reported. On 26-MAY-2016, the patient was inadvertently vaccinated with ROTATEQ lot # L039297, 19-JUN-2017, dose 1, oral. No adverse effect was reported. Additional information has been requested.
This case was reported by a physician and described the occurrence of jaundice in a 2 month old subject of unspecified gender who was vaccinated with hep B vaccine recombinant (Engerix) for prophylaxis. At the time of the subject's birth, the mother was negative for hep B. On an unspecified date before 10May06, the subject received 2nd dose of Engerix B. On an unspecified date on or before 10May06, 2 days after vaccination with Engerix B, the subject experienced jaundice. The subject was seen at a physician's office. The physician reported that a hep B test was performed and results were positive for hep B. At the time of initial reporting, 10May06, the events were ongoing. Jaundice was assessed as medically serious by manf (OMIC).
Temperature (high 101.2), chills, body aches, fatigue began 10:30 pm 2/3 until 2/4 6pm, 2/5 fatigue and stomach pain 2/3 to 2/4 treated with ibuprofen every 6-8 hours
stopped breathing, could not breathe, lasted no more than 45 seconds.; increased heart rate; Chills; Fever; stomach aching; indigestion; This is a spontaneous report from a contactable consumer or other non hcp. A 68-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6202, Expiration date: unknown), via an unspecified route of administration, administered at an unspecified anatomical location on 10Mar2021 (age at the age of 68-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history included atrial fibrillation (AFib diagnosed 10 years ago), diabetes mellitus (Diabetes diagnosed about 20 years ago). Concomitant medication included carvedilol taken for atrial fibrillation, start and stop date were not reported. On 13Mar2021 the patient experienced chills, fever, stomach aching and indigestion. On 15Mar2021, the patient experienced increased heart rate. On an unspecified date the patient experienced stopped breathing, could not breathe, lasted no more than 45 seconds. Patient states that on Saturday he felt like the wrath of God came down and hit him, he had bad chills- shaking so bad he couldn't hold on to anything, then fever kicked in, went as high as 103.9, severe stomach ache and indigestion, states what scared him the most last night he stopped breathing, could not breathe, lasted no more than 45 seconds. Patient states he has a history of swelling of the legs, since this started his foot and his leg have cracked open there was so much pressure, has been dealing with this for another 20 years, he does not have good control in the lymph nodes because he had cancer and that was removed from his groin. The outcome of the event chills, fever, stomach aching, indigestion and increased heart rate was not recovered. The outcome of the event stopped breathing, could not breathe, lasted no more than 45 seconds was unknown.  No follow-up attempts are possible. No further information is expected.
Fell onto floor and couldn't get up/No strength at all; couldn't get off the floor; couldn't stand up or get on knees to get into chair; still had infection after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Fell onto floor and couldn't get up/No strength at all; couldn't get off the floor), DYSSTASIA (couldn't stand up or get on knees to get into chair) and URINARY TRACT INFECTION (still had infection after vaccine) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stroke (took cholesterol medicine.). Concurrent medical conditions included Urinary tract infection (Patient was on antibiotic for urinary tract infection prior to the shot. Still had infection after vaccine so took another antibiotic.) and Liver enzyme abnormal (Patient has stopped cholesterol medicine due to high liver enzyme). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Stroke.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced ASTHENIA (Fell onto floor and couldn't get up/No strength at all; couldn't get off the floor), DYSSTASIA (couldn't stand up or get on knees to get into chair) and URINARY TRACT INFECTION (still had infection after vaccine). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 01-Feb-2021, DYSSTASIA (couldn't stand up or get on knees to get into chair) and URINARY TRACT INFECTION (still had infection after vaccine) had resolved. At the time of the report, ASTHENIA (Fell onto floor and couldn't get up/No strength at all; couldn't get off the floor) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hepatic enzyme: high (High) high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that she fell on the floor and had two people help on the floor. It had happened twice. Patient was nervous about getting the shot again but nervous about not getting it. Antibiotic for urinary tract infection was 10 days course and then cleared up.   This case was linked to MOD-2021-016905, MOD-2021-016843 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Patient mentioned she got the Pfizer vaccine and not Moderna.
Respiratory infection started about 30 hours ago and progressively getting worse. She has now also developed a fever. She also had the polio vaccine and has complained of joint pain in her leg for the last 5 days.
Fever of 101.5. Red and swollen throat. Swabbed two days later for strep and flu and both came back negative. Fever lasted almost 72 hours after shot. Doctor prescribed antibiotics anyway. Gave MOTRIN for fever around the clock.
Symptoms started at approximately 8 hours after receiving the vaccination.  Symptoms started as headache, muscle ache, fatigue and chills.  Overnight I spiked a fever of 102.5 even with fever reducing medications.  I also suffered from dizziness and sensation of fainting when standing for more than 15 minutes for the first 48 hours after the vaccine.  Severe Muscle aches, headache, and fatigue noted for 48 hours after vaccine and symptoms were mild for day 3.
Patient was recommended to wait for 15 minutes to monitor for any adverse reactions.  Within 15 minutes patient has reactions of nausea, dizziness, paleness of face.  We advised patient to sit down and elevated his feet.  We gave patient some water.  In a few minutes patient was doing better, after 15 more minutes patient was able to go home.  No medications given.
28APR94 between 6PM & 630PM pt started vomiting; was taken to ER 814PM w/hx of vomiting 5-6 times in last hr; t99.8 R, P160, R44; states pale & leghargic; 1/3 of phenergan 12.5;
Baby developed a fever 10-12 hours later to 103.6 About 24 hours later the infant devloped a rash over entire body sparing only her face.The rash resolved 24 hours after it began.The fever resloved 36 hours after vaccine.
Metallic taste directly after, lasted all day; This is a spontaneous report from a contactable consumer, the patient. A 36-years-old non-pregnant female patient received an unspecified dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the right arm on 14Apr2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had known allergies to latex. Concomitant medications included intrauterine contraceptive device (IUD) used for unknown indication, from unspecified dates. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021, the patient experienced metallic taste directly after which lasted all day. No therapeutic measures were taken as a result of reported events. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/ department or urgent care. The clinical outcome of the event metallic taste recovered on an unknown date in 2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sore arm, headache, low fever, high pulse, low blood pressure, tiredness. Vaccination administered by pharmacy
Early April peripheral  neuropathy began.  Hands and feet were affected.  Irritating profound numbness from the knee down was especially noted that seemingly increased at night time.  Right hand was surgically corrected with a carpal tunnel release do you to nerve conduction studies an EMG. Left hand has resolved on its own. Numbness below the knee has improved and only toes are now affected  particularly notable at night time.
Increased pain, minimal swelling of the R shoulder joint, significantly decreased range of motion due to discomfort, burning sensation has been persistent since a few hours after the vaccinations were administered on 3/22, suspect subacromial bursitis resulting from the injection.
Chills, fever, body aches, headache, nauseousness, lethargy for 20 hours after onset
Began with generalized body achiness, fever, malaise, developed erythema and induration at site and involving forearm.
breakthrough case of CoVid; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (breakthrough case of CoVid) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced COVID-19 (breakthrough case of CoVid). At the time of the report, COVID-19 (breakthrough case of CoVid) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Company comment: This is a spontaneous case concerning a unknown age and gender patient with no  medical history reported, who experienced the non- serious unexpected , according CCDS, AESI of COVID-19. The event occurred after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable since the event happened after the second dose and no information on additional dosing is available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-403259 (Patient Link). Sender's Comments: This is a spontaneous case concerning a unknown age and gender patient with no  medical history reported, who experienced the non- serious unexpected , according CCDS, AESI of COVID-19. The event occurred after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable since the event happened after the second dose and no information on additional dosing is available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
After recieving the injection within the next couple of months; experienced fatigue, presyncope, syncope and headaches. Visited cardiologist to address concerns and symptoms. Later diagnosed with POTS on 12/27/2023 after enduring a tilt table test, and echo and wearing a heart monitor.
Twelve Moderna vaccines were given in office. Only 11 were drawn up this morning and the 12th dose was, most likely, a left over dose from yesterday. After incident was discovered, Moderna manufacturer was contacted per CDC recommendation. (Case #: MOD21-060693). Quality department was also notified.  Communication to patient: The Moderna Vaccine you  received may have been outside of the 6 hour thaw recommendation. We contacted the Moderna manufacturer and CDC. At this time, there are no recommendations for revaccination. You will still receive your 2nd dose as previously scheduled. Titers will be available at no cost in 2-3 months after your second vaccine.
he noticed little rashes or bumps below his navel, under his right arm, on his back, and on his thigh; his arm where the injection occurred was very sore; little fatigued; not been feeling good; tightness in his chest for the past couple days; This spontaneous case was reported by a consumer and describes the occurrence of RASH PAPULAR (he noticed little rashes or bumps below his navel, under his right arm, on his back, and on his thigh), MALAISE (not been feeling good), CHEST DISCOMFORT (tightness in his chest for the past couple days), VACCINATION SITE PAIN (his arm where the injection occurred was very sore) and FATIGUE (little fatigued) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045L21A, 029K20A, 027A21A and 033F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (his arm where the injection occurred was very sore). On 09-Apr-2022, the patient experienced RASH PAPULAR (he noticed little rashes or bumps below his navel, under his right arm, on his back, and on his thigh). In April 2022, the patient experienced MALAISE (not been feeling good), CHEST DISCOMFORT (tightness in his chest for the past couple days) and FATIGUE (little fatigued). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. At the time of the report, RASH PAPULAR (he noticed little rashes or bumps below his navel, under his right arm, on his back, and on his thigh), MALAISE (not been feeling good), CHEST DISCOMFORT (tightness in his chest for the past couple days), VACCINATION SITE PAIN (his arm where the injection occurred was very sore) and FATIGUE (little fatigued) outcome was unknown.      Concomitant medication was not provided.  Prior to the second booster dose of the vaccine patient had only experienced a little arm soreness.  The patient received 2 booster doses of the Moderna vaccine by intramuscular injection on 05-Nov-2021 (Lot: 033F21A and expiry date unknown) and 06-Apr-2022 (Lot: 045L21A and expiry date unknown) respectively.   This case was linked to MOD-2022-537938 (Patient Link).   Reporter did not allow further contact
Pt developed swollen, indurated region around injection site on left buttock. Mother estimates area was 8cm in diameter. No other signs or symptoms of illness.
Awoke w/fever of 104 treated by parents w/APAP; fever continued until 17DEC & was treated w/APAP; seen by MD 730AM 17DEC dx as virus no evidence of OM; no treatment prescribed; afebrile for past 32 hrs; remains fussy;
A week after my original shot, the injection location became red, hot, and itchy. I used hydrocortisone cream to relieve the itch and applied cool cloth for the red. This lasted about 1 day. The spot is still red but the itch has gone away. The spot on the arm feels a bit hard compared to just below the injection spot.
Diagnosed with Covid on 4/20/2021, more than 2 weeks after receiving
a 17 yo was inadvertently given ProQuad, a combination MMR/Varicella vaccine, instead of Separate MMR & Varicella. ProQuad is licensed through 12 years of age.
Broken ulna and radius bones on the arm; Broken ulna and radius bones on the arm; tripped and fell down on rigth arm; Fever; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of ulna fracture in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced ulna fracture, radius fracture, fall, fever and pain in arm. On an unknown date, the outcome of the ulna fracture, radius fracture and fall were unknown and the outcome of the fever and pain in arm were recovered/resolved.   It was unknown if the reporter considered the ulna fracture, radius fracture, fall, fever and pain in arm to be related to Shingrix.  Additional details were received as follows: About 17 to 18 days before the reporting date, the patient received Shingrix.  The patient experienced sore arm that lasted for 2 days.  About a week later, the patient tripped and fell down on her right arm. She broke her ulna and radius bones on the arm.  The patient had a surgery with plates and screws.  The patient also had a fever of 102 degree C before going into the surgery which lasted for 24 hours post surgery. The patient consented to follow up and provided her physician's details. The patient did not have a zip code for her doctor. The patient stated that her doctor briefly mentioned to her that anyone that received Shingrix vaccine came in with a fever. No further details were provided.      Lab Comments: on an unknown date, the lab test was performed.
8 days after immunization had erythema surrounding site with axillary adenopathy and fever 102F.
Patient developed a 6 cm area of erythema/hives surrounding injection site for MMR and varicella on right thigh within 5 minutes of receiving vaccine. The patient was monitored in our office but no additional treatments were given. No other symptoms developed and the rash almost completely resolved within 20 minutes.
11JAN96 730AM pt woke up tremulous, t103.6 ax; mom phoned MD, Motrin & APAP started;later in day had 3 tonic-clonic szs;12JAN96 vomited;14JAN96 vomited 18JAN96 pt doing ok-family had flu
Myalgia & Fever Narrative: low grade fever of 101 and generalized achiness
Information has been received from a nurse practitioner concerning a 19 year old female patient with no other pertinent medical history who on 02-APR-2010 was vaccinated intramuscularly with the first 0.5ml dose of GARDASIL (lot# 659054/0311Y). There was no concomitant medication. The patient came to the office today, 23-JUL-2010, to receive the second dose of GARDASIL. The patient mentioned that on 02-APR-2010, 2 hours after receiving the first dose of GARDASIL, she developed nausea and vomiting. No medical attention was sought. There were no laboratory diagnostics studies performed. The nausea and vomiting resolved spontaneously that day without requiring treatment. Follow up information has been received from the nurse practitioner who stated that she did not remember who this patient was. She had nausea and vomiting post first dose of GARDASIL. The patient had no problems with the second dose of GARDASIL. So she doubted that the nausea and vomiting were related to the first dose of GARDASIL. Additional information is not expected.
Patient had vaccination at approximately 12: 30 pm and remained for an initial observation of 20 minutes. The patient returned to the observation area after 1:30 pm complaining of symptom onset at approximately 1:35 pm of "wooziness", faster heart beat, and legs tingling.  She did not want medical help but stayed for an hour of observation in which her blood pressure was taken at least twice in the normal range, sat with her legs elevated for a few minutes but not most of that time.  At 2:30pm  she reported not feeling any better but now reported tingling in hand and leg of her right side only.  BP/hr at 2:35pm were 121/96 and 112 from a seated position and both legs on floor. The patient said she would touch base with her physician who is unnamed. She was also given information and encouraged to fill a report herself with VAERS.
Information has been received from a pharmacist referring to a 71 year old male patient. The patient had no concomitant therapy, pertinent medical history or drug reactions/allergies. On 04-MAY-2018, the patient was vaccinated with PNEUMOVAX 23 (lot # N024384, expiration date: 18-MAY-2019, one dose, route: intramuscular) for prophylaxis at the pharmacy. On 11-OCT-2018, the patient returned to the pharmacy to explain that on an unspecified date after injection, he experienced pain at injection site which had persisted. The pharmacist was unable to specify if pain was constant or intensity of pain. No treatment was given for the event. No lab diagnostics or studies were performed for the event. The patient had sought medical attention. The outcome of the event was not recovered. The causality assessment was not provided by the reporter.
Cried hard for 30 min /p shot.Took nap on way home& slept until 430,awoke crying attempted to eat& began screaming& jerking to lt side.No loss of conc.Taken to ER screaming& jerking(lasting 5 hrs)@ 6:pm.RX:Benedryl,T:98.6,P140, R:unable to