chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Following vaccine administration, patient was noted to be fussier than normal, not eating as well; 3 days later, mom noticed a small amount of blood in a soft stool. No fevers/URI symptoms/constipation. Tx: Avoidance of dairy/soy in mom's diet (breastfeeding)/NUTRAMIGEN supplementation. Monitoring further bloody stools/abdomen changes.
pt recv vax & became floppy (hypotonic), hyporesponsive, & stopped breathing x30sec;pt was hosp overnoc for observation;poss tx r/o sepsis;
Received HAV on 6/10/08. On 6/15/08 developed lower abdominal cramping, loss of appetite.  On 6/16/08 had fever 100.9 degrees F, chills, body aches.  Did not seek treatment resolved by 6/17/08.
Information has been received from a mother concerning her daughter who on unspecified dates was vaccinated with all the three doses of GARDASIL (lot number, route and site not reported). On an unspecified date, the patient developed HPV. The outcome of the event was not reported. No further information is available.
When nurse was administering dose in patient arm the connection between  needle spilled out; Syringe connection issue; A spontaneous report was received from a pharmacist concerning a patient (age and gender not provided) who received Moderna's COVID-19 vaccine (mRNA-1273) and when nurse was administering dose in patient arm the connection between needle spilled out.   The patient's medical history was not provided. Concomitant product use was not provided.  On 05 Feb 2021 the patient was set to receive their second of two planned doses of mRNA-1273 (Lot #: 013L20a) intramuscularly for prophylaxis of COVID-19 infection.    When the nurse was administering the dose in the patient's arm, the connection between the needle spilled out. The nurse's assessment was that she didn't think the patient received the dose or maybe little of the dose.   Action taken with mRNA-1273 in response to the event was unknown.  The event, when nurse was administering dose in patient arm the connection between needle spilled out, was considered resolved.; Reporter's Comments: This report refers to a case of Incorrect dose administered for mRNA-1273, lot # 013L20a with no associated AEs.
I had both shots and I got shingles/ Suspected vaccination failure; Shingles but a light case; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 16-June-2022 Reporter's comment: The patient self-reported the case via interactive digital media. The patient had both shots and got a light case of shingles.  Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles was not provided. Additional Supportive Information: Consent to follow up was not possible as no contact details were available.
very very bad nausea; throwing up all night; A spontaneous report was received from a reporter, concerning a female patient of 40-Years - age, who received Moderna's COVID-19 vaccine and experienced very very bad nausea, throwing up all night.  The patient's medical history was not provided. No relevant  Concomitant product medication was provided by reporter.  On22 -feb-2021 , prior to onset of event  patient  received their second of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis.    On 22-Feb-2021,the patient experienced a "very very bad nausea" and has been throwing up all night. Treatment information was not provided.    Action taken with mRNA-1273 in response to the event was not  applicable.  The outcome of the events considered  was unknown at the time of this report.
Child fainted briefly within 5 minutes of receiving vaccine.  Episode was short lived. Patient was made to lie down on exam table & drink cool liquids. Child recovered completely within 10-15 minutes.
Sharp pain when abducting or rotation or lifting of the arm that the injection was in. Injection site still painful to touch. rotator cuff feels to be messed up.
Had a very difficult time breathing.  Was taking short breaths. Diagnosed with croup at Dr.'s office that day.  Given Oprapred 15mg. Was told by physician to call 911 if he experiences an attack of shortness of breath like earlier that day. Never had any respiratory problems like this.
Mother states Kolbie's arm (site) swelled to the size of the palm of a hand. MD looked at child's arm in ER while brother being seen. Mother says MD stated it was swelled larger than usual but ok. No meds prescribed.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   There are no treatment, concomitant medications given    This case was linked to MOD-2021-333557 (Patient Link).
Major swelling under right arm, extreme soreness of lympnode and underarm.  Majority of swelling lasted 2 week, as of 11/30/21 underarm still has signs of swelling
Narrative: Patient with breakthrough covid infection. He received only 1/2 doses of moderna vaccine. Treated with monoclonal antibody
blurry vision; diaphoretic; This is a spontaneous report from a non-contactable pharmacist. A 81-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an intramuscular route of administration in the left arm on 24Feb2021 (at the age of 81-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in 2021, the patient experienced blurry vision, code med and diaphoretic and transferred to emergency department. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of events and received unspecified treatment. Since the vaccination, it was unknown whether the patient have tested for COVID-19. The clinical outcome of the events blurry vision, code med and diaphoretic was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Felt very shaky; Hot to touch injection site; It was like she was having the flu; Swollen injection site; Bad Headache; Very tired; Red injection site; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (Felt very shaky), INJECTION SITE WARMTH (Hot to touch injection site), INFLUENZA LIKE ILLNESS (It was like she was having the flu), INJECTION SITE SWELLING (Swollen injection site) and HEADACHE (Bad Headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced NERVOUSNESS (Felt very shaky), INJECTION SITE WARMTH (Hot to touch injection site), INFLUENZA LIKE ILLNESS (It was like she was having the flu), INJECTION SITE SWELLING (Swollen injection site), HEADACHE (Bad Headache), FATIGUE (Very tired) and INJECTION SITE ERYTHEMA (Red injection site). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, NERVOUSNESS (Felt very shaky), INJECTION SITE WARMTH (Hot to touch injection site), INFLUENZA LIKE ILLNESS (It was like she was having the flu), INJECTION SITE SWELLING (Swollen injection site), HEADACHE (Bad Headache), FATIGUE (Very tired) and INJECTION SITE ERYTHEMA (Red injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not reported.
Rapid heart rate (100-130) for approximately 6 hours, dizziness, arm pain at injection site, lower back pain, mild headache, tired
Developed  Fever, Blisters, and a Tic after shots. Would jerk ear down toward shoulder while wincing. Reported to the pediatrician. Eventually went away.
I had listed side effects start on 1/22 (the date the injection was administered), starting around 5 pm. This consisted of fever (102), chills, sweats, muscle aches, fatigue, tenderness at the injection site, and headache. The fever (reduced 100ish), muscle aches, tenderness at the injection site, sudden waves of heat flashes, and headache persisted into 1/23. I also had an onset of nausea that evening. On 1/24 I continued to experience a headache, tenderness at the injection site, and sudden waves of heat flashes. However, around 5 pm I noticed my arm (localized to below the injection site) was very red, inflamed, and radiating significant heat. It may have been that way since 1/22, but I didn't notice. Those same symptoms persisted into 1/25 and I contacted my PCP. I went in for a visit, it was assessed, with no infection noted, and recommendations to watch and belief it would subside. On 1/26 it continues to maintain some redness and radiates heat.
Right forearm with redness, 20mm in diameter with 10mm red/indurated area.  Pt reports site itches.  Also c/o malaise, chills (no known fever), body aches, and digestive system discomfort since 2nd dose.
A report was received from a healthcare professional on 22Nov02 concerning a group of vaccinees less than 4 year old of unk demography who inadvertently received Fluvirin from approx 07Nov02 onwards. From 07Nov02 Fluvirin was administered to vaccinees less than 4 years old. There were no reported adverse events. There was insufficient information to determine the reporter's causality assessment. Update 1 10Dec02: A follow up report was received from a health professional indicated that a 13 month old female was inadvertently administered Fluvirin IM on 21Nov02. Cross reference: PJP200200805, PJP200200849, PJP200200850, PJP200200851, PJP200200852, PJP200200853, PJP200200854, PJP200200855, PJP200200856, PJP200200857, PJP200200858, PJP200200859, PJP200200860, PJP200200861, PJP200200862, PJP200200863, PJP200200864, PJP200200866, PJP200200867, PJP200200868, PJP200200869, PJP200200870, PJP200200871, PJP200200872, PJP200200873, PJP200200874, PJP200200875, PJP200200876, PJP200200877.
Some spots on underside of hands; Psoriasis flare-up; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (Some spots on underside of hands), PSORIASIS (Psoriasis flare-up) and FATIGUE (Fatigue) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and RISANKIZUMAB for Plaque psoriasis.    No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced SKIN DISORDER (Some spots on underside of hands), PSORIASIS (Psoriasis flare-up) and FATIGUE (Fatigue). At the time of the report, SKIN DISORDER (Some spots on underside of hands) and PSORIASIS (Psoriasis flare-up) had not resolved and FATIGUE (Fatigue) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Rash started to develop at home, patient seen in clinic on 2/9/16 and discussed with infection disease attending and thought to be a post-vaccination measles rash.
LANDED IN THE HOSPITAL; This spontaneous report received from a patient via a company representative via media concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date was not reported, 01 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient landed in the hospital for an unspecified adverse event. Number of days hospitalized and discharge information was not reported. As per the patient, "Thanks for sharing the J and J shot landed me in the hospital too. I was told not to take another one either. I really need more info on this too" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of landed in the hospital was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20220861145-covid-19 vaccine ad26.cov2.s-Landed in the hospital. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
injection arm is really hurting; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (injection arm is really hurting) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Cholesterol, Type 2 diabetes mellitus and Reflux gastritis.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PAIN IN EXTREMITY (injection arm is really hurting). At the time of the report, PAIN IN EXTREMITY (injection arm is really hurting) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient did not receive treatment for the events, but she enquired if she can consume Aspirin or Tylenol as treatment.  Concomitant medications were taken for high blood pressure, cholesterol, diabetes type 2 and reflux.
Symptoms: difficulty breathing diaphragm region Outcomes: resolved with PO Benadryl and extended monitoring
After my vaccine I started to experience recurrent hearing problems in both ears. It would feel like I was completely underwater, with muffled hearing and throbbing sensation in my ears.
This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 07-OCT-2015, the patient was vaccinated with an improperly stored dose of MMRII (lot # K024036 exp date 26-NOV-2016) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Fever, vomiting, loose stools.  Doctor informed us the next day that our child was mistakenly GIVEN THE DOSAGE INTENDED FOR CHILDREN 3 AND UP. OUR SON WAS JUST UNDER 17 M AT THE TIME OF HIS VACCINE.
1FEB94, 1PM student @ class noticed itching, swollen, & felt tingly all over; pt seen @ clinic VS 122/82,P88 no resp distress noted; DPH given & ice compress applied to inject site; LD was red, swollen, & warm to touch;
Client reported that her face felt like it was burning and she felt "odd".  Client wanted to sit outside to get fresh air.  Client stated that she was very nervous about getting the vaccine.  After sitting outside x 15 minutes, client felt much better and wanted to leave.  Client called on 2/11/2021 to report redness and warmth to injection site.  Client could also feel a lump that was slightly smaller than the palm of her hand.  Recommended client follow up with her PCP.
Angioedema Tongue Tingling Narrative:  Tingling decreased after 20 mins.
Syringe only contained about 0.1 ml of vaccine instead of the usual 0.5 ml dose. No one knows how the error occurred. Since the immunizer did not realize the dose was less than expected until the needle was already in the patient's arm, the patient agreed to immediately get another full dose in the opposite arm to ensure a full dose was received.
About 10 mins after vaccination patient stated she wasn't feeling well. When pharmacist went to check on the patient she was seizing. 911 was called. Patient's eyes were fluttering and unresponsive,  but breathing. Patient came in and out of seizure a few times. 1 full body seizure about 20 to 30 seconds. Patient was laid on the ground on her side till paramedics arrived. She was then taken by ambulance.
REDNESS, HARD NODULE AND ITCHING AT THE INJECTION SITE THAT STARTED LATER IN THE EVENING AFTER THE INJECTION. TOOK IBUPROFEN AND THE SWELLING DECREASED. EXAMINED ON 2/20/2017 AND NON TENDER, REDNESS DECREASED.
Pain and erythema and swelling at left deltoid where Td booster injection given 4/15/05 day after injection some tenderness at left upper shoulder and decreased left shoulder ROM.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 81-year-old female patient who received SHINGRIX. On 22nd May 2018, the patient received SHINGRIX. In May 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm and tenderness. On an unknown date, the outcome of the pain in arm and tenderness were recovering/resolving. The reporter considered the pain in arm and tenderness to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be either 81 or 82 years old. The patient experienced a sore arm that lasted for about 3 days, but it still hurt if she touches the area for 5 days. The patient had denied permission to contact their physician. This case has been linked with case US2018096132, reported by the same reporter.
Nausea, vomiting (profuse) x 2, fatigue. Once at 11pm on 10/21/09 (approximately 32 hours after receiving the LAIV against H1N1) and again on 10/22/09 at 9am. Continued to feel nauseated and weak for another day.
had 2 Pfizer vaccines and the booster vaccine of Pfizer and she just got COVID; had 2 Pfizer vaccines and the booster vaccine of Pfizer and she just got COVID; just got like a cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "had 2 Pfizer vaccines and the booster vaccine of Pfizer and she just got COVID"; NASOPHARYNGITIS (non-serious) with onset May2022, outcome "unknown", described as "just got like a cold".  Clinical course: Caller calling about her daughter have received two of your vaccine plus the booster and she got COVID, 3 days ago and wanted to find out this is for her daughter, the medication that they are giving people, who are they giving that medication to, the Pfizer medication. Reporter stated, she doesn't know the name of the medication, you know when they get COVID. just want to know my daughter had 2 Pfizer vaccines and the booster vaccine of Pfizer and she just got COVID and there is a medication that they are giving people when they get sick with COVID but it's supposedly for high-risk people, don't what the name of it is. caller don't know the name, it's the COVID medication (As reporter was unsure about the name of medication hence Suspect captured as per verbatim for MI query).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
1. 0949 Tingling both lower extremities, no weakness. Second vaccine. BP 126/63,HR 83 reg, sats 98%, resp 18. 1016 expressed symptoms improved HR 83, sats 97%, Resp 16. Left ambulating for home.
Intense pain at the injection site and radiating down right arm for 24 hours after the injection. 72 hours after injection paralysis of right wrist possible radial nerve damage.
Patient presented to the pharmacy on 11/17 with a large bruise on his left arm. The bruise was underneath where the vaccine was given and radiated around the arm to the elbow. The bruise was dark blue and purple. Patient said it was tender to the touch but wasn't bothering him.
rapid heart rate and headache upon falling asleep, woke 30 minutes later with drenching sweat and feelings of doom. Jumped out of bed due to anxiety and rapid breathing from feelings of doom. paced the halls of house, attempted to go back to bed but feelings of doom would not go away. finally after an hour my breathing settled down, heart rate returned to normal and sweating dissipated.  symptoms did not return but did wake with severe headache and nausea.
5/7/11 p.m., infant had emesis x 3, diarrhea x 1 with a "small amount" of blood in stool. No fever or other symptoms. Seen at local ER, ultrasound showed intussuception. Transferred to Pediatric ER. Admitted; air enema successfully reduced intussuception. Kept npo overnight with IV fluids. Discharged 5/10/11 in good health. This is per admitting hospital's record and report from mother at 7/22/11 visit with Pediatrician.
NauseaVomiting Narrative:  1518: VS 128/90 87 c/o nausea water offered, FEELING BETTER AT END OF 15 MINS OBSERVATION