chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Passing out feeling when trying to stand up; Severe abdominal pain; Problem to breath in air all the way because of  abdominal pain; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passing out feeling when trying to stand up) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ARIPIPRAZOLE (ABILIFY) for an unknown indication.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passing out feeling when trying to stand up) (seriousness criterion medically significant), ABDOMINAL PAIN (Severe abdominal pain), DYSPNOEA (Problem to breath in air all the way because of  abdominal pain), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, LOSS OF CONSCIOUSNESS (Passing out feeling when trying to stand up), DYSPNOEA (Problem to breath in air all the way because of  abdominal pain), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown and ABDOMINAL PAIN (Severe abdominal pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Since 20 May 2021, roughly since 9:00pm onwards, patient started the symptoms like fever, chills and passing out feeling when trying to stand up and severe abdominal pain and having problem to breath in air all the way because of abdominal pain. Patient took Ibuprofen two tablets for the symptoms developed and the abdominal pain still not better, according to the patient. Patient did not take the regular medication Abilify, today (on day of report) which patient used to take daily, because of abdominal pain.  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.   This case was linked to MOD-2021-162196 (Patient Link).; 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.
Red spots on front and back of my body and some on both legs; extreme itching, hundred of itchy spots; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9263) via an unspecified route of administration in the left arm on 11Feb2021 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, sarcoid and rheumatoid arthritis (RA). Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and tamsulosin (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263) via an unspecified route of administration in the left arm on 21Jan2021 as a single dose for COVID-19 immunisation. The patient also previously received niacin (MANUFACTURER UNKNOWN), methotrexate (MANUFACTURER UNKNOWN) and rosuvastatin (MANUFACTURER UNKNOWN) and developed allergy to all the drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021, the patient experienced red spots on front and back of his body and some on both legs, extreme itching and hundreds of itchy spots. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with prednisolone and photo therapy. The clinical outcome for the events red spots on front and back of his body and some on both legs and extreme itching, hundreds of itchy spots were resolving.   No follow-up attempts are needed. No further information is expected.
Sick for 5 days. Temperature of 100 -101. Aches and fatigue.  Felt like I had a milder case of COVID   Diarrhea but no respiratory issusses. Lost taste and smell continues
Dizziness about 5 minutes after shot, general tiredness for two days. Monday started getting some random chest pains, Tuesday I was having chest pains and tightness and went to the ER. Currently still getting random chest paints and feeling very tired and fatigued.
Injection site tenderness for 5 days. mild fatigue that began 24h post injection resolved in 16 hours. Chills without fever began 32 h post injection resolved in 4h. Acetaminophen 1000mg taken PO 24h post injection with resolution of symptoms for 8 hours.
approx 30 minutes after vaccine became lite headed, dizzy and things looked blurry.  Was asked to move vehicle over to the side and a nurse was coming to vehicle. I then felt like I had been given a shot of novicaine like at a dentist office and my bottom jaw began to feel numb. I was told I because unresponsive for a few seconds  so Benadryl was given to me {50ml}. I was asked to check with my primary doctor prior to the date to receive my second dose. I contacted my oncologist and primary care doctor.  My oncologist told me to check with my primary who has advised me Not to get the second dose.
Child received Hep-A #2 and Pneumococcal conjugate. Had no reaction to Hep-A #1. Injection site clear; no redness or swelling noted. Small rash on face (cheeks) and on arms. Rash was mild; no hives noted; child playing. No itching noted. Treated with Benadryl po.
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: TINGLING DOWN LEFT ARM AND NUMBNESS IN NECK AND BACK OF HEAD. GAVE 2 TYLENOL AND WATER AND MONITORED FOR 30 MINUTES. CALLED TO CHECK ON PATIENT AND STATED SHE WAS FEELING BETTER BUT STILL SLIGHT TINGLING ON LEFT SIDE OF FACE. ADVISED TO CALL MD TOMORROW IF STILL EXPERIENCING.
BREAKTHROUGH COVID INFECTION. PATIENT TESTED POSITIVE ON 08/03/2021. PATIENT FULLY VACCINATED ON 02/25/2021.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 77-year-old female patient received BNT162b2 (BNT162B2), on 23Feb2021 at 13:00 as dose 2, single (Lot number: EL3302) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diverticulosis" (unspecified if ongoing), notes: other medical history: Diverticulosis; "osteoporosis" (unspecified if ongoing), notes: other medical history: Osteoporosis; "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EJ1686, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 02Feb2021, when the patient was 77-year-old, for Covid-19 immunization. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 24Feb2021, outcome "recovered", described as "The morning following the day of the second shot and again the morning following the day of the third shot, I passed out". Therapeutic measures were not taken as a result of loss of consciousness. Clinical course: The morning following the day of the second shot, I passed out. This happened 12 plus hours after the shot, so was not a reaction from fear of the shot. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 Since the vaccination. Patient did not receive any other vaccine on the same day of COVID vaccination. Patient was vaccinated with third dose of Pfizer COVID 19  vaccine (Lot number: FF8839) on 21Sep2021 at 09:00 AM, in Left arm for covid-19 immunization. Sender's Comments: Linked Report(s) : US-PFIZER INC-202201156976 same reporter/patient, different drug dose/AE;
Immunization given 8/24/07 fever 102 and large swelling of (R) leg site of ProQuad 8/27/07 fever 104.3 po, large sore leg; extreme fatigue 8/28/07 fever and fatigue cont. 8/29/07 fever broke swelling gone 8/30/07 very irritable 8/31/07 recovered
I had an upper respiratory cold. I had a sore throat, and phlegmy cough. I tested myself for COVID-19 and it was negative. I went to an urgent care just to make sure I didn't have COVID-19. I tested negative again for COVID-19. This cold lasted for about 10-11 days.
Patient rcv'd Bivalent Booster with no issues followed by her Flu vaccine.  Immediately following she experienced a 30 second syncopal episode.   She fell to the floor landing partially on her mom.  PE completed with no findings, vitals were monitored and remained within normal limits, patient was provided with water and a snack.  Within 5 minutes patient was feeling 100% better.
Patient seen by dr on 1/15/12 for (L) deltoid cellulitis (arm, erythemic patch), probably MRSA - treated with BACTRIM DS. - Post PPV.
1:30:  Headache    2:00 Chills, extremely hot going back and forth through the night.  6:00  Headache so severe nausea set in.    By the next morning all symptoms were  except minor headache and extreme heat and pain in injection sight.  2 days later still pain and heat at injection sight
I developed hives on my chest, neck, both cheeks, and forehead approximately 3-4 hours after the vaccine that resolved overnight after taking  Benadryl large red raised bump (4 inches by 2 inches oval) that was warm to the touch at injection site that began 1 hour after injection and lasted 2 days, then turned into purple bruise that persisted for 2 more days itching at injection site beginning  1 hour after administering and persisted 4 days
This spontaneous report was received from a registered nurse refers to a 6 month old patient. On 11-JUL-2013, the patient was vaccinated with first dose of ROTATEQ (lot number, expiry date and route was unknown). On 14-SEP-2013, the patient was vaccinated with second dose of ROTATEQ (lot number, expiry date and route was unknown). No adverse symptoms reported. Additional information is not expected.
Headache, nausea, fatigue-couldn't eat because of nausea, fever. Cough from nearly-healed bronchitis recurred
The pt developed a large red circle (5" diameter), hard and hot at the site of injection. The pt was put on Cehalexin antibiotic.
pt recv vax;w/in 24 hr, devel n, v & d; may have devel flu like illness, dyspnea & abd cramps; sx lasted 2 days & then subsided
Patient got Moderna vaccine about 2:30 pm . He indicated he was nervous and asked to have his girlfriend hold his hand while he was vaccinated.  He then sat in the waiting area afterwards. Approximately 10 minutes later approached the counter and said he was not feeling well.  He started to wobble and our staff sat him in a chair nearby. He said maybe he "blacked out" for a moment. He indicated he had not had much to eat that day. We gave him a water and a cookie. Seemed to be okay, talking with staff,  but then started to shiver . EMTs  were called and he was checked by them . Heart rate just over 100 , O2 saturation at 99% , no hives per EMT .Possible vasovagal event per EMT  .  Patient declined to go to hospital and left shortly after with his girlfriend driving him home.
No additional AE reported; second dose of the vaccine was given 23 days after the first dose; This spontaneous report was received from a medical assistant referring to a patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.     On 15-OCT-2021, the patient was vaccinated with the second dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # T030710, expiration date 15-APR-2023, at a dose of 0.5 milliliter for prophylaxis. The vaccine was given 23 days after the first dose (inappropriate schedule of product administration). No additional adverse event reported.
Patient received the Moderna Covid 19 vaccine after temperature excursion; Patient received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there had been temperature excursions with the freezer that was happened for weeks since April 2022. Storage condition at the time of the excursion were frozen.  It was reported that Lot numbers: 065K21A and Lot numbers 045L21A had undergone temperature excursion and maximum and minimum temperatures reached were 30 Fahrenheit Degrees and minus 18.9 Fahrenheit Degrees respectively.  It was reported that the vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute and date the vials moved from freezer to refrigerator was unknown, they were now stored in frozen condition and no vaccine state change was observed by visual inspection.  Proposed desired use by date was not provided.  No treatment medications were reported.
Loss of appetite; Nausea; Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), PYREXIA (Fever) and NAUSEA (Nausea) 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 28-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced PYREXIA (Fever). On 29-May-2021, the patient experienced DECREASED APPETITE (Loss of appetite) and NAUSEA (Nausea). At the time of the report, DECREASED APPETITE (Loss of appetite), PYREXIA (Fever) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-May-2021, Body temperature: 102 degree (High) 102 degree.         No concomitant medications were reported. No treatment was reported.  Action taken with mRNA-1273 in response to the event was not applicable.
Around 2 pm on 4/1, began to have arm soreness at injection site which I expected.  Became increasingly more tired.  I woke up on the morning of 4/2 and noticed that there was swelling underneath my arm pit.  I believe it was my lymph node that was swollen.  This was more sore than the injection site.  It has since dissipated.   Item to note: I was diagnosed with covid on 2/5/2021 so it had been almost 2 months post COVID.
Patient reports experiencing menstrual changes following vaccination. She reports regular very predictable periods monthly. She received the vaccination in the middle of her cycle and the same day she received the vaccination she started spotting. She reports having no spotting between periods for as long as she can remember. She then had pain and cramping daily during the remainder of the cycle. She missed her normal period date by ~2weeks and reports that when she then did finally get it her period was much more painful and heavy compared to her usual periods. Patient received her second vaccination dose on 29Sep2021 during her period. Unsure at this time how second dose will effect her monthly cycle.
After my second shot.  I returned to work.  Within 30 minutes my eyes got blurry and I lost control of my fingers.  I couldn't hold anything.  I quickly got in my car and drove home.  To this day, I am struggling with my fingers.  I will be holding something and it just falls out of my hand a breaks.  Anything from keys, sunglasses, dishes.  I think they are firmly in my hand but I drop things involuntarily.  It is affecting my quality of life and getting expensive since I am breaking thing by dropping them on a regular basis.
Fever; Chills; Sweating; Nausea; Severe diarrhea; Uncontrolled shaking; Muscle pain; Muscle vibration; Fatigue; numbness; tingling; Tinnitus; Plugged ears; Neck pain; Chest pain; Lower back pain; Abdominal pain; Pulsating/pain quads; Calf pain (ripping sensation); Ankle/foot/toe pain; Knuckle and finger- swelling; Increased heart rate; Irregular heartbeat; Anxiety; Depression; uncontrolled crying; feelings of doom; Knuckle and finger- swelling; This is a spontaneous report from a contactable consumer(patient herself). A 49-years-old non-pregnant female patient received second dose of BNT162B2, Solution for injection, Batch/Lot Number: ER8734) via an unspecified route of administration, administered in Arm Right on 13Apr2021 at 15:00 as dose 2, single for COVID-19 immunization. Other vaccine same date details: other vaccine same date vaccine date 13Apr2021. Medical history included wolff-parkinson-white syndrome, crest syndrome, crohn's disease and drug hypersensitivity from an unknown date and unknown if ongoing. Known allergies: Sulfa, flagyl, Cipro. If covid prior vaccination: No. If covid tested post vaccination: No. The patient did not receive other vaccine in four weeks. Other medications in two weeks was reported as none. There were no concomitant medications reported. The patient previously took BNT162B2, Solution for injection, Lot number:ER6208) in right arm on 23Mar2021at 03:00 for covid-19 immunization. On 13Apr2021 at 04:45 pm, the patient experienced Fever, Chills, Sweating, Nausea, Severe diarrhea, Uncontrolled shaking, Muscle pain, Muscle spasms, Muscle vibration, Fatigue, Total body numbness and tingling (waves), Tinnitus, Plugged ears, Neck pain, Chest pain, Lower back pain, Abdominal pain, Pulsating/pain quads, Calf pain (ripping sensation), Ankle/foot/toe pain, Knuckle and finger swelling/excruciating pain, Increased heart rate Irregular heartbeat, Anxiety/panic, Depression (uncontrolled crying and feelings of doom). These symptoms varied over a 10 day period. She kept in very close contact with her primary physician in order to avoid an in person consult. Had she not, she would have visited the ER on more than one occasion. The patient did not receive any treatment. The outcome of the events was recovering.  No follow up attempts are possible. No further information is expected.   Other vaccine same date details: other vaccine same date vaccine date 13Apr2021.
Information has been received from a physician concerning an "at least 60 year old" patient who on an unspecified date was vaccinated SC with a single first dose of Zostavax. Subsequently the patient developed a rash at the injection site that looked like "little pox with pustules." Unspecified medical attention was sought. The patient recovered on 05-FEB-2007. There was no product quality complaint involved. No further information was provided. Additional information has been requested. 06/22/07 This is in follow-up to report(s) previously submitted on 3/14/2007. Initial and follow-up information has been received from a physician concerning an 82 year old female with allergies to sulfa, KEFLEX, MEPERGAN, MACRODANTIN and horse serum, who on 22-DEC-2006 was vaccinated SC in the left arm with a single first dose of ZOSTAVAX (Oka/Merck) (lot # 652947/1212F). The patient had bronchiectasis and post herpetic neuralgia at the time of vaccination. On the same day the patient developed a vesicular eruption rash at the injection site which was 2.5 cm in diameter and looked like "little pox with pustules." The pustules had some weeping. Unspecified medical attention was sought. The patient recovered "over 2 weeks time" on approximately 06-JAN-2007 (previously reported as 05-FEB-2007). There was no product quality complaint involved. No further information was provided. Additional information is not expected.
pt recvd vax; exp varicella like rash w/ 28 vesicles;
Approx. 2 min after vaccine patient showed signs of seizure activity.  She became stiff from head to toe with no shaking, she became unconscious and urinated herself.  This lasted about 60seconds.  I held the patient until she came out of the spell.  She stated she felt like she was dreaming.    Patient was given fruit juice and was given a neurological exam.
52 y/o patient was administered FLUMIST flu vaccine, which was not indicated for her age group. The vaccine was administered as ordered by practitioner by the medical assistant. Medication administered to or used by the patient: Yes. Type of staff made Initial error: Medical Assistant. Patient counseling provided: Unknown. Patient's Age: Adult (18-64 years). Patient's Gender: Unknown. Relevant materials provided: None.
Vertigo, 24 hours since second shot, lasted 48 hours Missed Period, ongoing
Fever 101 degrees --> 12 hr. after vaccine administration. Emesis multiple times at night (2-8 hr later).