chrisvoncsefalvay/vaers-outcomes huggingface dataset:
loose watery stools; Inconsolable crying; Emesis; This case was retrieved during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2417741-1. The original narrative from the sender is the following:  The day after the vaccines were administered, the infant developed loose watery stools, followed by inconsolable crying and emesis. Parents brought child to the ER, where she was able to eat after taking ondansetron PO and was discharged home. Baby was seen in the office today and appeared happy with a normal abdominal exam. Passed a normal BM today.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Diarrhoea" "Crying" and "Vomiting".  No further information is expected.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug an allergy history were not reported. On 24-MAY-2017, one dose of an improperly stored VAQTA had been administered to the patient, lot # M027879, expiration date 24-JAN-2018 (strength, dose, frequency and route of administration were not provided) for prophylaxis. The patient's concomitant medication was not reported. On an unspecified date, was registered a temperature range between 47° Fahrenheit (F) and 77°F during a time frame of 1 hour. Previous temperature excursion had been reported with the same temperature range and time frame (47° F to 77°F for one hour). Adverse effects were not reported. Additional information has been requested.
113 Bivalent doses administered after the BUD to patients 12 and up.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    No concomitant medication was provided by reporter. Approximately 10 elderly staff in their 60s and over were vaccinated for the 3rd vaccination with 0.3 ml.  No treatment medication was provided by reporter.
Horrible arm pain and headache and continued headaches for 2 weeks after with first one. 2nd dose had a fever, fatigue, and headache  for 24 hours following but it affected my period causing it to come 7 days earlier than normal.
was administered Pentacel/they were supposed to give the child Adacel; Initial information received on 30-Apr-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 10 years old male patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].instead of Adacel..  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-Apr-2019, the patient received a 0.5 ml single dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ073AAA via intramuscular route in the right arm.  It was of actual medication error due to wrong vaccine administered..  It was not reported if adverse event was there.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: ambulance called, paramedics assessed patient and left after seeing her responsive. per patient, they stated  she may have fainted from hypoglycemia or needle phobia.  had patient's husband drive her home
Pt woke up in the middle of the night, night p/vax w/fever & chills; fever to 103, had a rash on back & chest; rt arm swelling & painful; 4NOV still occ getting fever & chills 12x8cm red raised area on rt arms; pt fully recovered;
pt recvd vax & was running low grade fever 101-102, lethargic but arousable;stayed home from work the next day;rxn was in the 1st 24hrs p/vax;limping on lt leg, lasted 24 hrs
Adverse events: Flu like symptoms (Sweating, shaking, fatigue, nausea). Significant testicular swelling/soreness/sensitivity.  - Duration: ~3 days. Treatment: Rest/Sleep, Nyquil, EmergenC, 1/4 dose of Ivermectin Outcomes: 3 days of sickness and soreness, returned to normal afterwards.
Initial report received from a non-healthcare professional (patient) on 13 November 2012. A 51-year-old female patient, who had no illness at the time of vaccination and whose concomitant medications were not reported, received a subcutaneous dose of ACTHIB vaccine (lot number: Unknown) in the back of left arm on 31 October 2102. The patient had allergy to PCN and 'Naproxyn'. On 31 October 2012, at the night of vaccination the patient had chills. The next morning i.e. on 1 November 2012; the patient developed redness, swelling and warmth at the back of the left arm where the vaccine was given. The reaction was bigger than a golf ball. Laboratory investigations were not reported and the patient received BENADRYL and TYLENOL as corrective medications on 31 October 2012. On a unspecified date, the patient had recovered from the chills and on an unspecified date, after the 4 days, the patient had recovered from the redness, swelling and warmth. List of documents held by sender: none.
at approximately 1310 patient was reporting chest pain at 9/10 on verbal pain scale with pain and heat radiating to lower back. In addition, patient reported SOB on exhalation, HA and diaphoresis. Facility staff EMT called 911 and county fire determined patient should be taken to hospital for a full workup. Facility staff EMT was unaware of what hospital patient was being taken to.
Soft lump on left side clavicle. Very sore; Soft lump on left side clavicle. Very sore; This is a spontaneous report from a contactable consumer, the patient. A 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL5248, second dose) solution for injection intramuscular in the left arm on 16Jan2021 at 11:00 (at the age of 83-years-old) at single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included macular degeneration, glaucoma, and allergies: dairy products, penicillin and sulfa antibiotics. Concomitant medications included ascorbic acid/betacarotene/cupric oxide/tocopheryl acetate/zinc oxide (PRESERVISION), calcium, fish oil and vitamin D. Historical vaccine included BNT162B2 (Lot EL0140, first dose) for COVID-19 vaccination on 26Dec2020 with no adverse effect reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 05Feb2021 at 10:00, the patient felt a soft lump on left side clavicle very sore. No treatment was provided for the events sore and lump. The outcome of the events sore and lump was recovering. Since the vaccination, the patient has not been tested for COVID-19.
This spontaneous report was received from a back office lead and refers to a 29 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-JAN-2016, the patient was vaccinated with the improperly stored dose of RECOMBIVAX HB (1 ml, intramuscularly in right deltoid, lot # L038499, expiration date 26-JUN-2017). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected as all the correspondence was returned by the post office.
Injection given, child calm then began crying and holding (L) leg. (L) leg red with firm raised area at injection site, area covering lateral aspect between hip and knee.
Nausea, vomiting, diarrhea, extreme chills with teeth chattering, fever at 101 degree Fahrenheit, fatigue, headache
Joint pain, temp of 100.5, dizziness and nausea, headache, asthma irritation/cough/tightness.
It started at 10:30 that night with a fever, about 02:30am I woke up in the most horrific pain, I have never experienced anything like it, I was shaking so hard that my teeth were chattering, I fainted toward the end of that week hit my head and wound up with a mild concussion and went to the ER. I had not been feeling well at all. I was almost delirious, when I woke up I was vomiting . I wound up with a huge knot on my head.
Felt sluggish; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Felt sluggish) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Nauseated (sometimes feeling nauseated), Dizziness (occasional) and Muscle pain.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 16-Aug-2021, the patient experienced SLUGGISHNESS (Felt sluggish). At the time of the report, SLUGGISHNESS (Felt sluggish) outcome was unknown.            No concomitant medication information was provided. No treatment medication information was provided.  Patient received third full dose of Moderna vaccine. Patient considered himself immunocompromised although he reported he has not been classified as being immunocompromised by his doctor.   This case was linked to MOD-2022-455587, MOD-2022-455604, MOD-2022-455785 (Patient Link).   Reporter did not allow further contact
My right arm became very swollen, red and painful from the injection site down to below the elbow. Clinic does mention whether or not vaccine contains thimersol when they ask about allergic reactios.
2 Weeks after receiving the Hep A vaccine, patient began developing a rash on her left hip right above where the vaccine was administered. The rash continued to spread over the course of several days and did not respond to creams. A follow up visit with her pediatrician resulted in a diagnosis of dermatitis.
Narrative: Patient states he recieved his first COVID injection and an influenza vaccine yesterday, "Went home, and a few  hours later I got very, very sick." Patient is c/o "severe joint pains, fever all night ' broke this morning ' headache for a while, that went away, but the joint pain has not." Patient states the pain in his R knee is "severe today, I can walk on it, but barely." Patient did not check his temperature, but states he was having chills all night, Vomited about 7-8 times between 2:30 am - 4:30am, "the nausea and vomiting are gone now." No abdominal pain or diarrhea. Overall he is feeling better except the joint pains, "those are actually worse today." No joint swelling or erythema.
Patient received SHINGRIX 3/20/18 and on Wednesday and Thursday (3/21 and 3/22) patient noted a firm red area, warm at site of vaccine. Since then, redness resolved, but on Saturday (3/24) patient noted redness, swelling of forearm, ipsilateral side. Patient reports feeling flushed, not sure if fever or chills. Left forearm is red, swollen and tender. Redness seems to be tracking down her arm, following gravity. Clearing from more proximal areas per her pen marks and extending distally. Patient diagnoses with cellulitis and prescribed Amoxicillin/Clavulanate 875/125mg to treat.
Acute monoarthritis right knee treated with Motrin, rest, ice (x-rays (-).
Client  received the 1st COVID vaccine Janssen Lot: 1805020 on 03/09/2021, unknown expiration date and is requesting a Janssen COVIF Booster and Flu vaccine. PHN verified previous dose on databases and only had indicated a initial dose, therefore per CDC guidelines okay to proceed with booster. PHN proceeded with vaccinating client with the Janssen COVID booster when client stated "I think I got my booster before". PHN searched in databases and no booster dose displayed. Upon searching for a third time on database, client was listed under "Check-in" for booster dose on October 26, 2021. participant forms from October 26, 2021 show client listed as receiving Janssen COVID booster. PHN spoke with clinical supervisor who has been made aware of incident. No adverse symptoms noted or reported during observation period. Client was educated on s/sx of when to seek care, follow up with MD, and use of V-Safe.
Pt is a 51yo otherwise healthy F with no cardiac or anaphylactic/allergic reaction hx presenting with concern for reaction from Moderna vaccination.  Pt had vaccination at 11:40am.  At 12:15n, pt returned to the clinic after leaving with CC of "lump in throat" She describes lump in throat, dizzy and feeling as though her symptoms are becoming worse. Her VS were obtained: 155/87, 98%, HR 81  Rechecked at 12:26p - pt describes worsening symptoms 12:27p - lying down, pt feels improved, sitting upright, her symptoms returned 12:29 - pt was given 50mg PO Benadryl and 0.3 epinephrine. Pt feels slightly tachy, but overall, feeling improved.  12:40p continues to have heart racing, moderate in severity. VS obtained: 118/77, 98%, HR 106  Pt transported to the ED by EMS at 12:45p.  Pt feels improved.  Ambulating well.  No additional symptoms.
Fainted shortly after administration of vaccines.  Hep A, and Yellow Fever had been administered. Pt passed out for approx 1 minute. Smelling salts used. Recovered, and was observed for approx 1 hour due to nausea and feeling tired.
Left arm tD given 08/28/2003, symptoms with severe redness noted, itching.  Had knot 1-2 days after Td shot then began having redness.  The arm itches.  Feels poorly in general. 09/05/2003: Spoke to the patient, the redness is a little better although she only took 1 of the steroid pills yesterday and the rest of the 1st days steroid pills today.  Will go to the ER if symptoms perist/worsen.
10/04/2021 A week after my COVID-19 vaccine I had a flu shot and everything was fine even for the day after. Two days after this vaccine I noticed a bullseye rash forming and then it eventually spread across my upper left arm. Eventually it did go away and then eventually it came back. It never produced pain or itching. This rash did come back a few more times over the course of a few months. I did not receive any prescriptions for this rash.  I also received my COVID-19 2nd Booster and it did make me feel tired and overall unhealthy for about 2 days long.
Temp 104 16DEC90 still present, given Tylenol every 4 hrs. PHN instructed her to contact MD. Rec'd shot MMR on 10DEC90. Dx w/tonsillitis.
RIGHT BREAST PAIN; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included sudden onset of pain.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: 26-MAY-2021) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced right breast pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right breast pain. This report was non-serious.
Developed tinnitus one week after receiving my first dose. The tinnitus intensified after my second dose on January 13, 2021.
2nd injection was was March 13, 9:30 am.  Slept that night (Saturday) for 10 hours.  Sunday stayed at home.  Monday  (3-15-21) did a few errands and had constant diarrhia  By 7:00 pm did not feel well and went to bed.  Had nothing to eat all day, and by 8:00pm was vomiting fluids only and more diarrhia. slept fitfully with muscle cramps, shivers, then seats-cold and hot throughout the night.  Finally awake and out of bed my 11:00 am
Arm pain on side she received injection; Hard to lift her arm; GI upset; Just felt "off"; This spontaneous case was reported by an other health care professional and describes the occurrence of ABDOMINAL DISCOMFORT (GI upset), MALAISE (Just felt "off"), PAIN IN EXTREMITY (Arm pain on side she received injection) and INJECTED LIMB MOBILITY DECREASED (Hard to lift her arm) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced ABDOMINAL DISCOMFORT (GI upset) and MALAISE (Just felt "off"). On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm pain on side she received injection) and INJECTED LIMB MOBILITY DECREASED (Hard to lift her arm). At the time of the report, ABDOMINAL DISCOMFORT (GI upset), MALAISE (Just felt "off"), PAIN IN EXTREMITY (Arm pain on side she received injection) and INJECTED LIMB MOBILITY DECREASED (Hard to lift her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment medications were reported.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Vaccine stored (post puncture of vial) beyond recommended length of storage (>27 days)
This is a spontaneous report from a contactable nurse (patient) via Pfizer sales representative. A patient of unspecified age and gender started to receive PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain at the injection site on an unspecified date. Outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.
hives on pt arms & throat 90min post vax;NO SOB, no diff breathing reported;no hx of allergies to any of the vaccine components;tx w/DPH;
Fatigue, headache, joint pain, chills, fever, slight nausea. Started Saturday day after vaccination with fatigue to the point couldn't stay awake and weak. Sunday woke with bad ache all over and harder to move along with fatigue. Small headache along with slight nausea in afternoon. Woke about 5 am Monday with total sweat, then chills and couldn't warm up. still had fatigue but not as much pain. Called Hospital Covid Hotline as directed by my Dr.s office (never talked to my Dr.) Nurse with Hotline discussed it with me and we determined it was probably side effects. Since I am aware of allergic reactions, I didn't feel threatened, only messed up. The fatigue and some aches lasted throughout the weak, and I am still fatigued and weak compared to normal.Aches seem better.
Patient had immediate severe pain in the affected arm.  Pain started hours after receiving the vaccine and has continued for over one month. Pain has affected his daily activities.  After several days of applying warm compresses and taking over the counter anti-inflammatory medications without relief, patient sought medical care.  Patient has since continued to follow up with Dr.  at the facility and is undergoing physical therapy sessions as well as new medications. As of today, 3/3/21, patient still has pain in his arm that limits daily acitivities.
Severe chills - 3 hrs Severe fever - 3 hrs Headache - 1 week Muscle ache -1 hr Joint ache -1 hr
PATIENT SAID SHE DEVELOPED A METALLIC TASTE IN HER MOUTH 12 HOURS AFTER FLUARIX AND IT LASTED FOR 5 DAYS.
After receiving the Flu vaccine, my son developed a fever about 5-7 hrs. later.  At 4 hours later his eyes and nose began running and he was cranky.  Throughout the night of 1/15-1/16 his fever continued to rise.  At 12:20pm on 1/16 he had a seizure due to rapid rise from fever.  His limbs turned blue, became rigid, had difficulty breathing.  Had CT scan, x-ray, blood, and urine test.  He is continued being treated with Motrin and Tylenol at a higher dosage.  He needs to go in for follow up chest x-rays-has developed an URI.
Pt. has been vaccinated on 05/05/2016 on right arm. ZOSTAVAX and MMR. Has developed rash on left and hump. Look like milk shingles. Pt will check with MD today.
Information has been received for the Merck Pregnancy Registry from a licensed practical nurse concerning a 22 year old female with no pertinent medical history who on 26-FEB-2007 was vaccinated with 0.5 ml of the first dose of Gardasil (Lot # 654540/0800F). There was no concomitant medication. On 02-MAY-2007, the patient was vaccinated with 0.5 ml of the second dose of the Gardasil (Lot # 656050/0245U). It was reported that the patient was pregnant. Unspecified medical attention was sought. Her last menstrual period was approximately 14-MAY-2007. The estimated date of delivery was 18-FEB-2008. Two ultrasounds were performed (results not provided), and "hormone levels for pregnancy levels dropping was monitored by beta-human chorionic gonadotropin test (bHCG)", On 18-JUN-2007, the patient went to the emergency room and experienced a miscarriage at 5 weeks gestation. It was reported that the patient was recovering. Upon internal review, the miscarriage was determined to be an other important medical event. Additional information has been requested.
Patient received MMR vaccine on 9/8/08. 2 weeks later patient began experiencing joint pain in his left ankle and left knee. The pain is intermittent but continues.
Vertigo - 1st time ever had happened.  Came on all of a sudden, no accident occurred, without any warning, didn't hit my head...was just sitting in a car that wasn't moving.  The weirdest feeling started in my head, felt dizzy, lightheaded, when tried to walk couldn't walk in a straight line, felt all this pressure in my left ear and my head almost like I was getting a headache, but didn't....within a couple hours it progressed and ended up in the ER because every time I tried to walk my whole body would start shaking and felt nausea as well, that the room was spinning.  Have battled vertigo, dizziness, pressure in my left ear, and head since that day.
Upon waking up the morning of 12/06/2017 my daughter had slightly swollen eyes. They continued to bother her for the day. The morning of 12/07/2017 they are still slightly swollen and are still bothering her but a bit better.