chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported; the nurse didn't screw the needle tight; the patient got only 1/2 the dose of GARDASIL 9; This spontaneous report was received from a nurse referring to an 11-year-old female patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On 16-JUN-2022, the patient was vaccinated with with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #U035286, expiration date: 21-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided). The reporter informed that the patient got only 1/2 the dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) since the nurse didn't screw the needle tight (underdose and product preparation error). No additional adverse event reported.
Right upper arm swelling, ecchymosis, erythema commencing 24 hours after shot, by 48 hours, 3.5x3.5 inch area of erythema, slight edema, slight ecchymosis, warm to touch; by 72 hours erythema diminished.
Felt fine in office after administration of TDaP last visit, but approx 20m later out in the car felt a "wave" of overall physical sensitivity, body "reactive" that day, no ache at the injection point, no pain.  Went to bed early but had severe ringing in his ears, gone the next AM.  He only had minor soreness in the muscle a couple of days later.  Felt it was odd enough that he should report it.
It is itching; rash got worse after second dose rash enlarged. It reaches down my waist and up to where my bra goes; . This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash got worse after second dose rash enlarged. It reaches down my waist and up to where my bra goes) and PRURITUS (It is itching) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A. and 003C21A) for COVID-19 vaccination.     The patient's past medical history included Cancer. Concurrent medical conditions included Heart disorder and Glaucoma. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), AMLODIPINE, LOSARTAN, ATORVASTATIN, LEVOTHYROXINE and METOPROLOL for an unknown indication.   On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (rash got worse after second dose rash enlarged. It reaches down my waist and up to where my bra goes) and PRURITUS (It is itching). The patient was treated with HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) for Adverse reaction, at an unspecified dose and frequency; CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Adverse reaction, at an unspecified dose and frequency; PREDNISONE for Adverse reaction, at an unspecified dose and frequency and TRIAMCINOLONE for Adverse reaction, at an unspecified dose and frequency. At the time of the report, RASH (rash got worse after second dose rash enlarged. It reaches down my waist and up to where my bra goes) and PRURITUS (It is itching) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-261754.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow received  on 20-JUL-2021 contact details for HCP and vaccination site
Lot # 011L20A- patient reported L arm reddness, swelling and warmth. Lot # 031L20A- patient reported L arm reddness, swelling and warmth, along with palsy of the L side of her face.
Pt began feeling dizzy and lightheaded immediately followig vaccine administration.  Staff witnessed and walked patient to nearby ambulance.  Pt evaluated by EMS and signed refusal after improvement of symptoms.
Varicella diagnosis at hospital on 6/27/14. Generalized rash with reported >500 papular lesions with fever. Lasted 14 days. Did not scab. Also had acute sinusitis and otitis media. Received varicella vaccine dose 1 on 6/18/2014. Reported fever as high at 104.8 degrees F.
Arm was red; Arm was bumpy; Arm was warm to the touch; Broke out in bumps all over her back that are itching and she has been scratching; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm was red), PERIPHERAL SWELLING (Arm was bumpy), SKIN WARM (Arm was warm to the touch), PRURITUS (Broke out in bumps all over her back that are itching and she has been scratching) and NAUSEA (Nauseous) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20a) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy and Seasonal allergy.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced ERYTHEMA (Arm was red), PERIPHERAL SWELLING (Arm was bumpy), SKIN WARM (Arm was warm to the touch), PRURITUS (Broke out in bumps all over her back that are itching and she has been scratching) and NAUSEA (Nauseous). At the time of the report, ERYTHEMA (Arm was red), PERIPHERAL SWELLING (Arm was bumpy), SKIN WARM (Arm was warm to the touch), PRURITUS (Broke out in bumps all over her back that are itching and she has been scratching) and NAUSEA (Nauseous) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It is reported that the itchiness is not as bad, the bumps are still there, and the nausea continues to reoccur  No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Information has been received from a doctor of pharmacy concerning a female (age not given) who was vaccinated on unknown dates with a first and second dose of  measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). The first dose was given when the pt was a child and the second was administered following delivery of her baby. According to the reporter, the pt was tested six weeks after the second dose and she has a low titer of rubella antibodies. Unspecified medical attention was sought. Additional information has been requested.
This was my second dose. I have been experiencing pain, swelling, redness for over 4 days. In addition, 1 day after the vaccination, I experienced chills and a low grade fever (100.5) overnight.
Pt vax 63 doses; titer indicated no seroprotection.  Recv 4th dose 22Apr91.
I had a flare of my ischemic colitis on Sunday evening following my vaccine on Friday morning.  I had been in remission for about a year, with no other symptoms before the flare.   Since I didn't have any blood, I did not go to the hospital or see a physician, per long-standing instructions from my gastroenterologist. I did increase my medication for two days, also per his long-standing instructions.  The attack lasted from about 9pm until 3am.  Afterwards, I slept. I missed work on Monday.  I have gotten better since the attack.  Today is Thursday, and I am back to nearly normal eating.
No adverse event; HCP called in to report that 16 patients was given the Moderna dose instead of the bivalent booster dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna dose instead of the bivalent booster dose.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jan-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2023, the patient experienced WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna dose instead of the bivalent booster dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna dose instead of the bivalent booster dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (HCP called in to report that 16 patients was given the Moderna dose instead of the bivalent booster dose.).    This case contains information for the 2 of 16 patients described by the reporter.  No concomitant medications were reported.  It was reported no adverse event reported on any of the patients involved.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697687 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697687:Master case
Red swollen. Benadryl 12 5mg orally every 6 hours. Ice. Elevation. Return as needed.
pt recvd HIB on 4APR92 & the following day had noticeable weakness in the rt lower extremity & was dragging rt foot; @ time of report 13APR92 no change in recovery status; 26MAY appears to be no sequelae; gait nl for age;
Patient inadvertently received 100mcg of the monovalent Moderna vaccine. The patient previously had J&J vaccine on 5/12/2021 and a booster of Moderna on 08/19/2022. No adverse reaction noted after the event. Attending physician was made aware with no new orders.
About 8-9 hours later after getting vaccinated I started feeling body aches and feverish. About 24 hours later, the fever kept came back and I started getting abdominal pain. At 48 hours later I started vomiting and went to the ER. At the ER they told me I had appendicitis. I was admitted to the hospital for surgery to remove appendix. I was sent home after surgery about 24 hours later.
a sever nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "a sever nausea". The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Prolonged muscle aches in lower extremities. Left Chest pain, fatigue, headache, chills, loss of appetite
High pitched screaming or persistent crying for hours; Extreme sleepiness or long periods of unresponsiveness;  High fever (over 103 F)  Sleep disturbances that change wake/sleep pattern;  Muscle weakness;  Swollen Soft Spot on her head;  She felt bad about three hours after recieving the standard two month vaccines. She was unconsolable and she has always been a happy baby.
I recently was recovered from Benzodiazepin withdrawals and got the 1st shot of Pfizer and started having headache and nausea and then started having the withdrawal symptoms come back. Insomnia, air hunger, back and shoulder pain after eating and fatigue, burning feet and Tinnitus.
Around 8 hours after vaccination, patient started to break out in a rash.  Throughout the evening, it continued to spread down both arms and all over torso.  Pt also reports headache, 103 degree fever and being extra tired.   Rash reported as sounding like hives. Upon discussing with pt the afternoon of 9/30, symptoms have gotten better.  Benadryl is keeping rash at bay.  Headache and being tired is still present.  Fever only lasted for a few hours.
SMALL BUMPS/COLD SORES DEVELOPED AROUND PATIENTS LOWER LIP/CHIN AREA. HAS NEVER HAD BEFORE. HAS IMPROVED SINCE, BUT STILL REMNANTS OF THESE BUMPS.
Pt received Pfizer vaccine and was sitting outside for the 15 minute observation period when she had a syncope episode about 5 minutes after the vacciine. Patient was on the chair and her head tilted back and her fiancé called for help.  I went and as I was adjusting her she woke up and was completely alert. We called Ems and they came and  assessed patient and she was ok to go home. Her vitals were stable and they ruled it was a syncope episode.
Dizzy, heart rate increase over 100, BP over 200. Shaking, chills, tremors.
Fever of 102 after her DTAP, Prevnar IPV and Comvax, lasted approx 32 hours. With the fever had 4 episodes in 30 minutes of throwing back her head, thrusting tongue out, face turning bright red, then apneic for a few seconds then quiet afterward; normal video recorded EEG.
Pt was given 3 doses of Hep B vax, 3rd dose given 23JAN89 & p/completion of the vax series, it was determined that the pt was a non responder & was not protected;
MORE BLEEDING AND PASSING MORE CLOTS THAN NORMAL ONE HOUR POST GETTING THE SHOT; This spontaneous report received from a patient concerned a 79 year female. The patient's height, and weight were not reported. The patient's concurrent conditions included uterine cancer, high blood pressure, seasonal allergy, and thyroid, and other pre-existing medical conditions included the patient had no known drug allergies. The patient had no DM and no cholesterol.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: UNKNOWN) dose was not reported,1 total, administered on 19-MAR-2021 12:05 to right arm for prophylactic vaccination. Concomitant medications included unspecified thyroid pill. On 19-MAR-2021, one hour post getting the shot the patient noticed more bleeding and passing more clots than normal. The patient denies abdominal pain or any other symptoms of concern. The patient also mentioned that uterine cancer - surgery planned for end of March 2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from more bleeding and passing more clots than normal one hour post getting the shot. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210340677-Covid-19 vaccine ad26.cov2.s-Bleeding. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
Starting at about 11 am the day after my 2nd covid vaccine, heavy bouts of vomiting, unable to keep down any fluids or liquids for several hours. I had a fever from about noon-5pm, alternating between extreme hot and cold chills.
I had almost violent shivers for 3 hours along with an elevated heart rate, it was hard to stand up.If I was alone, I would have went to the hospital My head was very cloudy. The following day I had a fever of up to 102 degrees for most of the day. It was the sickest I've ever felt in my life.
I had a sudden Subarachnoid Hemorrhage (SAH). I experienced this as a massive, debilitating, instant headache on 12/26/21.  -- The local hospital emergency room performed a quick CT scan, diagnosed the likely SAH and sent me by abulance to Facility Nuero-ICU -- Daily blood tests in neuro-ICU. Stroke functional and other tests at least every 4 hours. -- 12/26/21-1/5/22: Symptoms progressed-- massive headache moderated over days. Pain descended from top of head to neck, down back and into my tail bone. -- 12/26/21 CT Scan with contrast at Facility. Possible but very hard to see aneurysm found. -- 12/27/21 Angiogram with contrast and intent to treat. No aneurysm or other SAH cause found. -- 12/28/21 MRI. Nothing found. -- Nuero-ICU through12/30/21 -- Normal observation in hospital through 12/31/21. Released 12/31/21 -- Course of nimodipine 12/27/21-1/16/22 -- Follow-up angiogram with contrast 1/12/22 at Facility. Nothing found.
Initial and follow-up information has been received concerning a few patients who were vaccinated with their first doses of Rotateq after 12 weeks of age.  No adverse experience related to this event.  There was no product quality complaint.  Attempts made to obtain identifying information to distinguish the individuals mentioned in this report were unsuccessful. . This is in follow-up to report (s) previously submitted on 1/15/2008.  Follow-up information indicated that the physician was not sure who the patients were, but additional information is expected. No additional information is expected.
Pt c/o pain and weakness in Lt arm persistent since admin. of vaccine in Lt arm. Dr notes pt has decrease muscle strength in Lt arm unable to make a fist and decrease tone in Lt arm.  4/10/07 Received medical records from PCP which include vax records & reveal that on day of vax patient experienced UTI s/s, UA was done & patient started on antibiotics.  Returned to PCP on 4/4/07 w/complaints of left arm weakness since vax.  Exam revealed decreased left arm muscle strength.  Patient was unable to make a fist w/left hand & had decreased muscle tone in left arm.  Received neuro & PT referrals.
Stated fingers and palm were tingling/numb when she went to go home.  Vitals taken, juice given, stable, decided she was ok to go home.
This spontaneous report as received from a pharmacist via a field employee refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date approximately in 2009, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot number and expiration date were not reported). Concomitant therapy was not reported. On an unknown date approximately in 2009, the patient experienced an unspecified anaphylactic reaction. The outcome of the event was not reported. The relatedness between the event and the ZOSTAVAX was not reported. The event of anaphylactic reaction was considered as life threatening by the reporter. Additional information has been requested.
receiving doses after its beyond use date and previously affected by a temperature excursion; No adverse event; received dose after its beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose after its beyond use date), PRODUCT TEMPERATURE EXCURSION ISSUE (receiving doses after its beyond use date and previously affected by a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011b22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose after its beyond use date). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (receiving doses after its beyond use date and previously affected by a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received dose after its beyond use date), PRODUCT TEMPERATURE EXCURSION ISSUE (receiving doses after its beyond use date and previously affected by a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (received dose after its beyond use date) and PRODUCT TEMPERATURE EXCURSION ISSUE (receiving doses after its beyond use date and previously affected by a temperature excursion).    No concomitant medications information was reported. Date the vial was initially stored in the refrigerator and initially thawed was reported as July 26 2022. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-638955, US-MODERNATX, INC.-MOD-2022-638948.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-638955:Same Reporter US-MODERNATX, INC.-MOD-2022-638948:Same Reporter
Suspected accidental innoculation of vaccinia vaccine (smallpox vaccine) from father to his son. Father had vaccine placed approximately 10 days prior to the development of a lesion described as a "mosquito bite" by the parents on 23 June. By 25 June, the rash had gotten slightly larger and fluid-filled, so the parents became concerned that the father's vaccine had been spread. The patient is otherwise asymtpomatic and has no other problems at this time besides the rash on his right calf. It appears like a collection of several small vessicles approx 2-3mm diam without any erythema on his right calf.
Mom reports swollen, red, painful left arm. Temps at night of 1 greater than or equal to 104 degrees Fahrenheit . Patient stated difficult to breath. 8/15/08, mom states child still has elevated temp of 102-103 degrees, sore arm and "hoarseness." Child has no visible sign of difficult breathing per mom. Mom has not taken child to see ER or PMD.
After 3 days of receiving the shot I became very dizzy and naseuas which led to a series of panic attacks
When I took the first shot I had normal reactions. When I was given the second shot, I woke up in the middle of the night with a fever of 103.9, difficulty breathing, uncontrollable shaking, and headaches. I did not go to the doctors office not did I go to the hospital since it was the middle of the night, and I could not think straight at the time.  I did dial 9-1 on my phone and did not complete the call because I thought I was feeling a little better and would be okay. I took some Motrin and put some ice packs in my armpits and neck. I do not know the exact time that I had a reaction. I had my first shot at a Medial Clinic Health Department. I got my second shot at another location.
While the patient only received 0.2 ml of the vaccine, which was the appropriate dosage, the adult formulation was used for administration when it should have been pediatric.
Information has been received from a physician concerning a 16-month-old female with no pertinent medical history or allergies, who was vaccinated with a dose of Varivax. There was no concomitant medication. on 17-AUG-2006 the patient presented with varicella zoster. Unspecified medical attention was sought. It was reported that the rash was about 60 vesicular lesions that followed the L-4 dermatome. It was reported that she was treated with "Burrows Solution". The physician did not request PCR testing. At the time of this report the patient was recovering. No product quality complaint was involved. Additional information has been requested.
My period was due to begin September 2nd, 2021. My mensural cycle has been accurate with the help of hormonal birth control for the past 15 years. As of September 20, 2021, my period has not begun. I am 18 days late.
At first pt felt weird, became weak, shaking, cold sweat, threw up, blood pressure bottomed out, shallow breathing, itching, dry mouth, tired and dizzy. Symptoms started approximately 15 minutes post vax, was made to sit in clinic until strong enough to go down the hall and out to ER. There pt was treated with epinephrine and Benadryl. The next day the pt experienced tiredness and dry mouth.
My son's upper left thigh started to swell within a day after receiving the shots. Area was warm to the touch, VERY swollen, red, and I could feel a hard knot beneath his skin.
I95.9 HYPOTENSION 1/29/2022 HYPOTENSION J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/29/2022 HYPOTENSION
Caller stated that he received his first dose of Moderna on 3/28/2021 and 24hrs later he developed SOB, he has followed up with an allergist and PCP and was given an inhaler, but the SOB has not improved. Whenever he goes upstairs he runs out breath and has to sit down. He plays sports but, cannot play because of SOB.