chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sick again; diarrhea; intermittent intestinal irritation; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), ILLNESS (sick again), DIARRHOEA (diarrhea) and GASTROINTESTINAL TRACT IRRITATION (intermittent intestinal irritation) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 012L20A) for COVID-19 vaccination.     No Medical History was reported.  The patient's past medical history included No adverse event. Concomitant products included HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE [HYDROXYZINE HYDROCHLORIDE]) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced HEADACHE (headache). On 15-Feb-2021, the patient experienced DIARRHOEA (diarrhea) and GASTROINTESTINAL TRACT IRRITATION (intermittent intestinal irritation). On 22-Feb-2021, the patient experienced ILLNESS (sick again). At the time of the report, HEADACHE (headache) had resolved and ILLNESS (sick again), DIARRHOEA (diarrhea) and GASTROINTESTINAL TRACT IRRITATION (intermittent intestinal irritation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment information  provided
Information has been received from a health professional concerning now a six year old male who on 07/18/1996 was vaccinated with one dose of varicella vaccine. Subsequently, it was reported that on 05/16/2001, the pt was diagnosed with "a mild case of chicken pox." Unspecified medical attention was sought. It was reported that in the spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the pt had an exposure to these cases. Subsequently, the pt recovered. No further info is available.
tightness of the total upper torso; muscle pain; chills; sweating; nausea; dizziness; weakness; headache; This is a spontaneous report from a contactable consumer reported for self. This 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan 2021 15:00 Left arm at single dose (Lot # FL7262) for covid-19 immunisation. Medical history included high blood pressure, diabetes, high cholesterol, covid prior vaccination, known allergies: Penicillin, codeine. No other vaccine in four weeks. Other medications in two weeks. He experienced tightness of the total upper torso, muscle pain, chills, sweating, nausea, dizziness and weakness, headache on 25Jan2021 03:00 AM. No covid tested post vaccination. No treatments were received. Outcome of the events was recovered in Jan2021.
Initial itching at injection site, observed and returned to work. Came back ~30-40 minutes later with itchiness in throat and hives to arm. Given Benadryl PO and observed for extended period of time. Symptoms not resolving. Patient transferred to Emergency Department for further care. At that point observed to have full body rash, SOB. Given Epi while in ED. Developed tachycardia, hypotension. Treatment continued.
On wed the 10th extreme fatigue, low grade fever, headache.  Same on Thursday the 11th and Friday the 12th.  Then arm began to swell plus rash.  As of today arm is still very much swollen.
hives, very bad skin rash w/ bumps, redness and skin sore after expose to ocean (beach) on trip on 4/15/22 lip & eyelid swollen First reaction to cold water was on (trip) ocean water was like 60 degree on 4/15/22  2nd reaction was on 4/17/22 on river on trip water temperature was like 40 deg 3rd reaction was after my trip at my home with the water holes at my back yard sometime on April 2022 I finally was able to see allergist on May 31st and she did skin test w cube ice positive to bumps (test). Without me knowing that it can be even related to vaccine I gave her 3rd dosage of covid vaccine on June 10, 2022. Her allergy is very bad if she even wash her hand w/ cold water.
My daughter complained of severe pain in her right arm.  She continued to complain of intermittent pain in her extremities and abdomen.  On 10/7/2016 she was diagnosed with chronic myelogenous leukemia (CML)based on CBC.  This diagnosis was confirmed by bone marrow biopsy on 10/10/2016.
Initial report received from a healthcare professional on 19 September 2013. This is a summary case to two patients. Two patients of unspecified demographics, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE ID batch number: UT4720AA (Expiry date: 04/03/2014, Route, dose number and anatomical site of administration were not reported) on 16 September 2013. On 19 September 2013, the patients had small blister around the vaccination site. The laboratory tests and corrective treatments were not reported. At the time of this report, the outcome of event was unknown. Documents held by sender were none.
Heart palpitations at night 1 day after receiving 2nd Pfizer dose. Lasted about 12 hours.
This spontaneous report as received from a physician refers to a 60 year old patient. The patient had no pertinent medical history and no drug reactions or allergies. On 19-APR-2013 the patient was vaccinated with ZOSTAVAX (lot number, dose, route and injection site were not reported). Concomitant therapies included cholesterol and heart pressure. On 20-APR-2012 the patient experienced redness around the injection sit, felt the bruising, headache lasting one day and also had the itching sensation. There was no treatment given for adverse events and no diagnostics studies performed. The action taken was not provided at the time of report. The causality and outcome were unknown. The patient did not seek any medical attention. Additional information is not expected.
At around 4 am on 9/3/21, I woke up with severe itching and swelling at the injection site in the rear of my right arm, a strong headache and tingling around my mouth and neck. I took 1000 mg of Acetaminophen and 50 mg of Benadryl. The strong headache persisted for several days, but was relieved with acetaminophen. The Benadryl seemed to help the itching and sensation around my mouth and neck, but I did have to take an additional 50 mg around 5pm that afternoon as the symptoms had returned. By the morning of 9/5, only the local arm irritation, itching and headache persisted. I continued to alternate with Tylenol and Motrin for  approximately the next 3 days, after which the headache and local irritation in my arm seem to have improved.
Ten days following vaccine I developed a red, warm blotch that increased in size. It began about 2 inches below the injection site. I am having a virtual visit today to determine what if anything I should do. This is day 5 of the  single blotch.
Posterior headache with intermittent throbbing on right side. Lasted from 4/16 8:30pm until 4/19 12 pm. Unrelieved by Tylenol, Ibuprofen, heat, arnica. I was well hydrated, well rested.  No other symptoms besides headache. I rarely get headaches and, if so, they are relieved by Tylenol or ibuprofen.
Mom reported the following; noticed swelling under eyes of child at approximately 1:45 pm today 6/21/2018, eyes are "half shut", daughter did not realize eyes were swollen, denied child having difficulty breathing, eating, talking, daughter is running and playing as usual. Mom reports that vaccination sites on right leg are slightly bruised and have small "knot" at site. No difficulties reported with left leg vaccination sites.  Mom denies daughter having any allergies, no insect or other bites, no different or usual foods.
received a dose of Shingrix that was reconstituted with sterile non approved diluent.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number FD47S, expiry date 09-FEB-2024) for prophylaxis.   On 05-OCT-2023, the patient received the 2nd dose of Shingrix. On 05-OCT-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: received a dose of Shingrix that was reconstituted with sterile non approved diluent.). The outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 06-SEP-2023 A pharmacy technician reported that a patient received a dose of Shingrix that was reconstituted with sterile non approved diluent, which led to wrong solution used in drug reconstitution. No symptoms reported. The reporter consented to follow up.
Fell several days ago and fractured her leg; Fell several days ago and fractured her leg; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer, the patient. A female patient of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular on 13Mar2021 (at an unknown age) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The patient received the first Pfizer vaccine on 13Mar2021 and was scheduled to receive second vaccine today (03Apr2021). The patient fell several days ago and fractured her leg in Mar2021, would like to reschedule. The outcome of the event fractured her leg and fell was unknown.  Information about lot/batch number cannot be obtained.
I started with a mild scratchy throat. I tested for COVID-19 only because I had just returned from an international trip. My symptoms were mild, I developed a mild cough that would occur at night. I had some fatigue but mild. No fever. I lost my sense of taste and smell, and since has not fully recovered my smell like I used to be able to.
A non-serious report of "full dosage of vaccine delivered up one nostril" was received from a consumer concerning a male patient.  The patient's medical history and concomitant medications were not reported.  The patient received FLUMIST vaccine intranasally on 08-Nov-2007.  The patient inadvertently received the full dosage of the FLUMIST vaccine up on one nostril, instead of the recommended half dose for each nostril.  No adverse event was reported.  No outcome was provided by the reporter.  Rechallange is not applicable.  The reporter did not provide a statement of causality.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
9 hours after the vaccine, the patient was extremely fatigued, experiencing hot flashes, muscle aches, and a fever.  Treated with 1000 mg Tylenol. The patient felt relief at hour 26 after vaccination
Local pain and erythema (10 x 19 cm), positive axillary lymph enlargement, low grade temp 99.5.
Tested positive for Covid virus after first Covid vaccine; Tested positive for Covid virus after first Covid vaccine; This is a spontaneous report from a Pfizer sponsored program. A contactable reporter reported for a patient (reporter's father). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter reported that the patient (reporter's father) tested positive for COVID virus after first of COVID vaccine on an unknown date. The patient's wife (reporter's mother) was also tested positive for COVID virus after the first dose of the COVID vaccine. The reporter asked that his father (patient) would like to make an appointment for his second COVID vaccine. The reporter notified that Pfizer did not participate in scheduling vaccinations. The reporter was referred back to healthcare provider, and/or local county and state resources that may possibly be of some assistance. The report was related to a study or programme. There was a Product Complaint and description of complaint was COVID 19 vaccine. Outcome of the events was unknown.  Reporter seriousness for At risk: needs to schedule second Covid vaccine: Unspecified  Information about lot/batch number has been requested.
He got his vaccine, was in the store at the meat counter and then had a visual effect as people were looking at him funny, and things went from black/white to black/gray/white and passed out (told he had a seizure and on film at the grocery store), then woke up in the back of the ambulance on the way to the hospital.   In the hospital he was given an injection to slow his heart rate down, said that he drank a pot of coffee and then had another 16 oz coffee after that.   He was not admitted, treated in the ER, fed him and was discharged home and then walked about  1/2 mile to his truck at the supermarket, and finished his shopping.   He has been a little tired since then, has been taking it easy and not pushing himself too hard and not working too many hours.
Pfizer vaccine was administered outside - reported by patient- ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------------------- J96.00 ACUTE RESPIRATORY FAILURE 3/13/2023 PNEUMONIA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/24/2023 PNEUMONIA J96.00 ACUTE RESPIRATORY FAILURE 3/13/2023 THROMBOCYTOPENIA, UNSPECIFIED (UNKNOWN ETIOLOGY) J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/24/2023 THROMBOCYTOPENIA, UNSPECIFIED (UNKNOWN ETIOLOGY)
Migratory rash - urticaria vs. erythema multiforme, has generally improved slightly over about 4 weeks, otherwise well, thriving, no fevers or other symtpoms.
The full dose of the moderna bivalent booster (0.5 ml) was administered to the patient (11 years old) instead of the reduced dose (0.25 ml).  patient's
This patient was given the Adult Pfizer COVID-19, Bivalent instead of the Pediatric Pfizer COVID-19, Bivalent. The patient did not report any adverse events.
onset of reaction 16 mins after injection: pt reported dizziness, sweating, throat irritation. No difficulty swallowing, no difficulty breathing. VSS, pt A&Ox4. MD at bedside, pt c/o lip and tongue numbness. MD ordered IM Benadryl 50mg. medication administered. EMS called for further observation and treatment. Pt left facility A&Ox4 in stable condition via EMS to ER.
fever 101.5 noted 6 hrs. after injection generalized malaise 6 hrs. after injection nausea starting 6 hrs. after injection redness at site and red splotches to upper arm     started 24 hrs. after injection swelling/tightness/pain to upper arm tissue      and into breast and to area above     clavicle, started 12 hrs. after      injection and progressively worsened.     Tylenol every 4 hrs. + Ibuprofen      800 mg. every 6 hrs. ineffective     for symptom management.              Responded well to Solu-Medrol 125 mg. IM and Medrol dose pak + Zantac 150 mg. p.o. twice daily + Claritin 10 mg. p.o. once a day.
Numbness noted right side of upper mouth /progressed to numbness of mouth/lips; Mild lip swelling; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female nurse (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3246) at right arm via an unspecified route of administration on 14Jan2021 16:15 at single dose for COVID-19 immunization. Medical history included none. Concomitant medications included unspecified medications. The patient previously received the first dose of bnt162b2 (lot number: EH9899) at right arm via an unspecified route of administration on 21Dec2020 18:15 at single dose for COVID-19 immunization. The patient experienced numbness noted right side of upper mouth day after 2nd injection on 15Jan2021 16:00. It has progressed to numbness of mouth/lips 5 days post injection. Mild lip swelling on 15Jan2021 16:00. No difficulty breathing etc. Very noticeable with eating and talking in appearance like she have been to the dentist and given novocaine. The adverse events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if treatment received. The reporter considered the events were non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. The outcome of the events was not recovered.
Pt was fine receiving the vaccine. Right afterward, she started feeling faint, and she broke out in a sweat. We called 911, and layed her down on the ground, so she wouldn't fall. We gave her water and an ice pack. The paramedics came here and checked her vitals. All was fine. She fully recovered and was able to go home. Pt's faintness was due to anxiety after receiving the vaccine.
tested positive for covid on  - this was a pretravel swab. She had symptoms of congestion which have resolved. Pfizer vaccination completed outside of our clinic but we have dates listed as 4/8/21 and 4/29/21.   4/29/2021 Given     ER8736    4/8/2021 Given     EW0158
Large local reaction - red - purplish color - hard lump - no fever only local discomfort - vaccine on 7/28/14 - reported 7/31/14 - 8/5/14 much better no redness now.
Patient is outside of 42 day window for second dose administration; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient is outside of 42 day window for second dose administration) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient is outside of 42 day window for second dose administration). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient is outside of 42 day window for second dose administration) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Reporter did not allow further contact
Approximately five minutes post-vaccine administration (while patient was sitting in a chair in a monitored waiting area), she grabbed her right arm, stated "that does hurt," and briefly fainted. Public health RN and APRN responded within seconds. Patient alert and oriented to person, place, time and situation. Checked patient vitals signs at 16:05 (BP 108/41) and 16:10 (BP 95/65); all others within normal limits. Provided patient with bottle water, ice pack and cool wet cloth on forehead. After patient waited for an additional 15 minutes, she requested to be allowed to leave the facility.
Rapid heart rate (130-140) within a half hour  severe committing headache nausea tight chest / shortness of breath within an hour - two , vomiting all night the first night  Headache chills fever cough chest tightness all next day
Approx 40minutes post DTP/OPV pt was playing & started screaming that head hurt frontol area; mom gave APAP & went to clinic; BP 112/50, p108, R 16; skin cool & dry; color pale, pupils equal & reacted equally; pt awake & walking around;
Patient received Pfizer Covid Vaccine on 3/15/21. Patient admitted on 3/25/21 due to Covid-19 pneumonia.  Patient reports tested positive 3/20/20.
Sore injection site; arm gets fatigued easily within few days and lasting till today's visit (10-14-16); R shoulder sore anteriorly.
patient did not receive the full dose with no adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received via health professional. number: 01318866.  This case involves a patient of unspecified demographics who did not receive the full dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to case 2022SA425199.   On an unknown date, one of the nurses was administering suspect PENTACEL (VERO) vaccine to patient at (unknown: formulation, strength, dose, lot number, route in unknown administration site) for prophylactic vaccination, patient did not receive the full dose with no adverse event (incorrect dose administered) at unknown latency. The caller reported the needle was displaced and the medication squirted out. The caller inquired does the patient need to be revaccinated.   Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the 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.
Dizziness I got very dizzy; Nausea; Headache; Tired; Chills; Sick; she did not feel well for 2 days, stated that it was hard for her to get off the bed; This is a spontaneous report from a contactable consumer (Patient).  A 90-year-old female received first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: UNKNOWN), via an unspecified route of administration on 23Jan2021, as SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. On the same date, the patient had side effects right after she got home, one hour after the shot, she walked in the house and that's when she had side effects right away, first side effect was dizziness she got very dizzy, then she got nausea, then she got a headache, she was very tired, she had a chills and she did not feel well for 2 days, stated that it was hard for her to get off the bed. Patient stated that she got a shot on Saturday (23Jan2021) was sick right away after she was in bed Saturday and Sunday and Monday started to feel a little bit better. Patient notified her doctor about her side effects. Patient asked that unusual to get side effects after first dose. Is that mean that she will have the same side effects on second shot. Patient stated that most of her friends and the people she know did not have a side effects after first dose. She stated that she was very susceptible to medications, she did not react well to medications. It was very rare whoever she spoke to did not have reaction to the first dose of vaccine some people that she knew had a reaction to the second (dose of the vaccine) but when she told them that she had reaction to the first (dose) they thought that she was making it up because most of them did not have reaction to first just to the second. At the time of this report Sickness was recovering and outcome other events was unknown.   Information on the lot/batch number has been requested.