chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HEADACHE; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcoholic user, and non-smoker, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with amoxicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 11:00 to Left Deltoid for prophylactic vaccination. The batch number was not reported and has been reported. No concomitant medications were reported. On 08-MAR-2021 22:00, the subject experienced headache. On 09-MAR-2021, treatment medications included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 09-MAR-2021. This report was non-serious.
Information has been received from a registered nurse concerning a one year old male who was vaccinated "about 4 years ago" in approximately 2002 with a SC 0.5 mL dose of MMR II. It was reported that the child's mother stated that he was fussy and cried more often for several days post-vaccination. It was not reported if medical attention was sought. Subsequently, the patient recovered. There was no product quality complaint involved. Additional information from the registered nurse indicated that she did not have more information on this child. She stated that the child was more fussy after his vaccination with MMR II at one year of age. The mother was concerned about the child receiving the vaccine again. Additional information is not expected.
Case number PHEH2015US019330, is an initial spontaneous report received from a health care professional on 24 Sep 2015. This report refers to a 16-year-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: M14097, expiry date: 31 Dec 2015) on 25 Jun 2015 which was stored on incorrect temperature of (34.0 degrees Fahrenheit, and 50.2 degree Fahrenheit 48-120 hours). No adverse event was reported following this maladministration (incorrect storage of drug). Follow-up information received on 25 November 2015: Previously administered products included MENVEO which was well tolerated. The patient's vaccination status was current. The patient details (height and weight) were provided. MENVEO was administered intramuscularly on the right deltoid.
Patient experienced syncope 1-2 minutes after vaccination. He temporarily lost consciousness. Patient was sitting and was prevented from falling off the chair.
Within the first few minutes I have a weird taste in my mouth. It went away after a couple minutes. The day after getting the first dose (1/7/21) I felt like I was getting that flu all day. Went away day after that (1/8/21). On 1/14/2021 I noticed hives all around the injection site as well as a faded bruise.
Rash on torso (front & back) appeared around 12/11/21.   We did a virtual pediatrician visit on 12/13/21.  We saw doctor at his regular pediatrician.  She believed an allergic rash and advised to give 5ml of zyrtec per day and be seen in person if not better.  The zyrtec did not seem to make any difference.  The rash continued to spread to the face, and arms.   We went to the pediatrician ) and saw Dr.  in person on 12/20/21.  He called in his colleague to confirm and and believed it was likely erythema multiforme.  He explained this is usually an allergic reaction to a medication or a vaccine.  Although no way to know for sure, as we didn't introduce any additional medication other than his regular mutlivitamin before the rash appeared and the rash is not itchy, we believe it is a vaccine reaction.  We were instructed to stop the zyrtec and just do over the counter lotion.  Dr.  thought it might last up to a month.  As of today 12/28/21, it has not gone away yet and continues to spread up his face.  There are no other symptoms except the rash and it doesn't seem to bother him, it looks really red and blotchy.
Right sided sudden hearing loss on day 8 after first vaccine. Treated with prednisone 20 mg tablet  tapering dose. Symptoms resolved, then recurred on day 8 after vaccine # 2. Being treated with prednisone 20 mg tablet tapering dose, dexamethasone sodium phosphate 4 mg/mL injection syringe.
Pt devel vesicles of clear fluid over the trunk area, described as "shingles" approx 1 mo p/receiivng Influenza vax;
covid 19 infection with symptoms including fever,  chills, bilateral flan pain x 2 da;ys, generalied bodyaches/ dysuria, cough and myalgias,  headache, abdominal pain
Developed redness, warm to touch, described as a burning sensation in local area of vaccine. Size of redness on 9/17/2023 is 10cm by 16cm approx. She took tylenol and stated that helped with pain. Previously, with shingrix pt recalled redness extending down entire arm to fingers for shot one making it painful to wear rings. Shot 2 in shingrix series was less severe. Based on previous reaction to shingrix patient expects redness to subside over next week.
I got Moderna booster in November same day as flu shot. While I experienced no side effects for my initial Pfizer doses on April 2021, I experienced 24 hours of headache, fatigue, and chills after Moderna booster and flu shot combo.
DVT, PE with life-threatening ischemia Apixaban 5mg BID for 6 months followed by 2.5mg BID thereafter IVC Filter retrieval
On 10/28/2021 at 1530 hrs I was forced to take the Covid shot or be fired from my place of work. With a 2 month baby at home I decided to get the shot to avoid work termination. Soon after the shot my left arm was burning and was very difficult to lift my arm. Keep in mind I already got Covid in March of 2020. The shot was by far worse than actually getting covid. That night I felt like I was on fire with hot sweats a really bad headache. In the morning I found it very difficult to breath out of my nose. Aches and pains all day and I had to call out of work. So far to say the least my out come was terrible and I cannot believe I was forced to take this shot. I am following up with my doctor once I can move around more to see if this shot had any other effects on my health.  In the past with all the shots they gave me I never had a side effect like the Covid-19 vaccine Thanks again ...
Was given my first shot in the series of 2 on 9/7/21 in my left arm. Went home and did some light cleaning around my house. That night or the next night, I can?t remember I started getting restless legs. I could not go to sleep. My legs would not let me relax. It sometimes gets so bad it goes up into my back.
pt recv vax & devel diarrhea w/white chunks which persisted for weeks;
Died on the night of 05Jun2021 or Morning 06Jun2021 not Sure; Gastritis; The reaction came back with a vengeance; was doubling over; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DEATH (Died on the night of 05Jun2021 or Morning 06Jun2021 not Sure) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart disease, unspecified.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced DISEASE RECURRENCE (The reaction came back with a vengeance) and CONDITION AGGRAVATED (was doubling over). On 01-Jun-2021, the patient experienced GASTRITIS (Gastritis). The patient died on 05-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, GASTRITIS (Gastritis), DISEASE RECURRENCE (The reaction came back with a vengeance) and CONDITION AGGRAVATED (was doubling over) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jun-2021, Ultrasound scan: abnormal (abnormal) confirmed gastritis..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Labs included electrocardiogram (EKG) whose results were not provided.  It was reported that on 01-jun-2021 at Emergency room, gastritis was diagnosed and patient was sent home. Treatment information was not provided.  Company comment: This is a case of sudden death in a 53-year-old male patient with a history of Heart disease, who died 1 month 14 days after receiving last dose of vaccine. Very limited information has been provided at this time.   This case was linked to MOD-2021-211580 (Patient Link).; Sender's Comments: This is a case of sudden death in a 53-year-old male patient with a history of Heart disease, who died 1 month 14 days after receiving last dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death
Woke up at 2am with pain at the injection site, chills, and hallucinating dreams.
Patient received Pfizer as first dose on 2/17/21 but erroneously was given Moderna as a second dose on 3/11/21
None. Dr gave pt PREVNAR 13 in July and we gave in October. Did not know pt had already gotten in Dr office.
Got extremely sick, uncontrolled puking, diarrhea. Admitted to the hospital. 2 weeks later. On Dec. 11 I woke up with dizziness, and many neurological symptoms. I have not worked since Dec. 15th. My Neurologist diagnosed with a post infectious phenomenon. Directly relates it to the flu vaccine. Still suffer to this day.
THERE WERE NO ADVERSE EVENTS, GAVE VACCINE AT AGE 7 YRS
Severe itching at injection site, that became generalized all over body - face became red and hot to the touch. Given IV BENADRYL and IV steroid to counter act.
Pt. had vaccine on 11-10-10 322 pm. Reaction noted 11-11-10, seen in ER. 2x2x3cm localized area, red-hot-swollen. Pt also c/o shortness of breath.
This spontaneous report was received from a licensed practical nurse concerning an unknown number of patients of unknown age. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with a dose of (Oka/Merck) VARIVAX (dose, dose number, lot number, expiration date and route were not reported) that was improperly stored. No adverse effects reported. Co-suspect and concomitant therapies were not reported. This is one (1) of two (2) reports from the same source. Additional information has been requested.
Sleepy; This is a spontaneous report from a contactable consumer (patient). This 71-year-old female patient received dose 1 of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot number EP6955) via an unspecified route of administration on 08Mar2021 at 15:45 (at the age of 71-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included hypothyroidism and gastroesophageal reflux disease (GERD). The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included levothyroxine, omeprazole, meloxicam, and calcium (CALCIUM 500) from unknown dates for unknown indications. The patient previously received acetaminophen, codeine (TYLENOL WITH CODEINE) and acetaminophen, hydrocodone (VICODIN) from unknown dates for unknown indications and experienced allergy. On 08Mar2021 at 19:00 the patient felt sleepy. The patient did not receive any treatment for the event. The outcome of sleepy was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Fever (102.6 F), vomiting, loose stool, rapid pule (184).  Treated at emergency room.
This spontaneous report as received from a nurse practitioner refers to a 4 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 16-JAN-2015, the patient was vaccinated with the dose of PEDVAX HIB lot # K008874 (dose, strength, route of administration and expiration date were not reported), which had temperature excursion. No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
C/O pain, redness at injection site, pain extending down right arm (no time documented). Slight erythema noted at site of injection with minimal swelling. Local reaction. BENADRYL 50 MG at 12:20 PM; Cold compress, BENADRYL PRN. To Clinic if no improvement. As documented per Medical Event at School. School of Pharmacy students administered flu vaccine. 10-09-18 per School of Pharmacy Students and Pharmacist, two(2) other recipients of flu vaccines with same lot number C/O localized reactions. Evaluated by medical personnel at Event 10-06-18, cold compresses applied. No other treatment. The information needed to complete VAERS report on the other two(2) flu vaccine recipients were unavailable, Health Nurse.
Aggressive Vomitting, Diarrhea, 103 degree fever, body aches, chills
A report has been received from a Physician concerning, two pregnant Female subject, who had been receiving FLUMIST quadrivalent (intranasal). This case is created for the first patient. FLUMIST quadrivalent (intranasal) started on 04-Oct-2014. The pregnant woman in the second trimester was administered FLUMIST quadrivalent on 04-Oct-2014. The outcome of the event of pregnant woman was administered FLUMIST quadrivalent is unknown. The report was considered to be non-serious by the reporter.
Information has been received from a registered nurse concerning a 7 year old female with no pertinent medical history and no drug reactions/allergies, who on 03-DEC-2001 and 17-JAN-2008 at 2:00 PM (previously reported ass 2:30 PM) was vaccinated SC in the right arm with a first 0.5 mL dose and a second dose of varicella virus vaccine live (Oka/Merck) (lot number: 659608/1761U). There was no concomitant medication. On 19-JAN-2008 in the AM the patient returned to the office because of an injection site reaction. Her upper right arm was erythematous and slightly raised 10 cm in diameter. The middle of this area was red and indurated approximately 5 cm. The periphery was more pink and there was no streaking. The area was very tender to the touch especially over the indurated area. The physician who examined her prescribed cephalexin (KEFLEX). No other details were provided. There were no lab diagnostic studies performed. Unspecified medical attention was sought in the office. The outcome was reported as recovering. There was no product quality complaint. Follow-up information indicated that there were no adverse events following prior vaccination. There was no illness at time of vaccination. The outcome was reported as recovered. No additional information has been requested.
Pt was driving down the road 18-24 hours after receiving vaccine when all of a sudden  he experienced dizziness, rapid heartrate,  headache, blurred vision,  hives to chest and arms, edema and redness at injection site. Pt went to  Hospital via EMS on 1-21-20 and was given 50mg Benadryl on ambulance.  Pt states that he was diagnosed with a "reaction to the vaccine and I was given prednisone, pepcid and Tylenol in ED."  Pt was called on 1-22-21 by  Public Health nurse and states that he was feeling much better today but still had the redness and swelling at injection site.
Condition aggravated/FLARE UPS; Modera first dose of on FEB-2021 and second dose on SEP-2021; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Condition aggravated/FLARE UPS) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Modera first dose of on FEB-2021 and second dose on SEP-2021) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) and PREDNISONE for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. In September 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Modera first dose of on FEB-2021 and second dose on SEP-2021). On an unknown date, the patient experienced CONDITION AGGRAVATED (Condition aggravated/FLARE UPS). At the time of the report, CONDITION AGGRAVATED (Condition aggravated/FLARE UPS) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Modera first dose of on FEB-2021 and second dose on SEP-2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: increased.         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment medication was provided.  Patient experienced HUMIRA NOT HELPING with HUMIRA (ADALIMUMAB)  The reporter's causality for the event(s) of FLARE UPS and WEIGHT GAIN with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of HUMIRA NOT HELPING was not provided.
01/12/04: TD administered 12/30/03 15:00 approximately.  Complained of pain starting same day late PM.  Continues to have pain whenever arm is lifted.  Telephone call, spoke with LPN.  She will consult with MD and Pt. 1/28/2003-checked witih patient's doctor. Problems resolved and patient doing well.
Patient and family verbally vetted as all over 18.  Shot given. Upon entering, discovered as 15.5 years old
Moderna COVID-19 Vaccine EUA.  I received the COVID-19 Vaccine (Moderna) shot in my upper left arm on Wednesday, Feburary 3, 2021.   I had a sore arm for a couple of days and I thought that was the worst of the adverse events.   But, i was feeling fine when I went to bed on Thursday night.   But, when I woke up on Friday, February 5, 2021 at 8:30 am, I had this horrible pain in my lower leftside of my back in my kidney.    The pain was so bad that it hurt every time that I would move, pass gas, cough, sneeze, or getting in and out of the car.  I couldn't lay flat on my back to sleep . This horrible kidney pain lasted until I got up on Sunday, February 7, 2021 at 8:30 am.
Ringing in my ears. A buzzing feeling in my head. Started 48 hours later and i still have it now.
No adverse event; 4 patients inadvertently received  Bivalent booster dose from a Moderna "for booster dose only vial"; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (4 patients inadvertently received  Bivalent booster dose from a Moderna "for booster dose only vial") and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (4 patients inadvertently received  Bivalent booster dose from a Moderna "for booster dose only vial"). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (4 patients inadvertently received  Bivalent booster dose from a Moderna "for booster dose only vial") and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (4 patients inadvertently received  Bivalent booster dose from a Moderna "for booster dose only vial").    No concomitant medications were reported.  The adult patient (above 18) inadvertently received Bivalent booster dose from a Moderna "for booster dose only vial" which was intended for pediatric primary series age group 6-11 yrs old.  No treatment medications were reported.  This case contains information for the 2nd of 4 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-675704, US-MODERNATX, INC.-MOD-2022-675671 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-675704:Patient 4 US-MODERNATX, INC.-MOD-2022-675671:Patient 1
This spontaneous report as received from a nurse refers to a patient of unknown age. On 02-MAY-2013 the patient was vaccinated with expired ZOSTAVAX lot # 0467AE, subcutaneous, dosing information was not provided, expiry date 04-apr-2013. No adverse effect was reported. Additional information has been requested.
temperature was 100.6; scratchy throat/sore throat/throat is killing him and it's hard for him to drink water; aches in his joints, elbows, wrists, and lower back; body aches; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (scratchy throat/sore throat/throat is killing him and it's hard for him to drink water), ARTHRALGIA (aches in his joints, elbows, wrists, and lower back), PAIN (body aches) and PYREXIA (temperature was 100.6) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced OROPHARYNGEAL PAIN (scratchy throat/sore throat/throat is killing him and it's hard for him to drink water), ARTHRALGIA (aches in his joints, elbows, wrists, and lower back) and PAIN (body aches). On 04-May-2021, the patient experienced PYREXIA (temperature was 100.6). The patient was treated with PARACETAMOL (TYLENOL) for Sore throat, at a dose of 100 milligram and IBUPROFEN at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (scratchy throat/sore throat/throat is killing him and it's hard for him to drink water) and ARTHRALGIA (aches in his joints, elbows, wrists, and lower back) had not resolved and PAIN (body aches) and PYREXIA (temperature was 100.6) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. Treatment details include  Patient reported about  taking 1000 mg of Tylenol every 4 hours instead of 6 hours. It helped with his sore throat, but now it's not working. He tried Halls, which are the lozenges, but it only helped the first time. Patient stated that  he started taking ibuprofen because he maxed out on the Tylenol dosage