chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrhea and Cramping : I felt fine on Friday I was doing well. My arm was sore but over the course of Saturday it started to go away. The one thing that I have been clocking is diarrhea. I would have a cramping cramping feeling in my stomach on my left side it would feel like it?s coming from my uterus. I had first thought it was because I was in a sitting position and the 90° angle wasn?t great for my body and so I thought I just had to leave straight because even as I?m talking this right now like I feel a little bit of cramping sitting in a 90° angle. But the diarrhea is still ongoing it?s been waking me up at five almost 6 AM and I woken up at least three times in the middle of the night going into Sunday. I was actually fine during the whole entire day of Saturday because I was able to like be on a long meeting call but after that was done my body just needed to expel things. I did eat a tiny bit while I was in a meeting I ate cake   chocolate, A bunch of sweets. Also after I?ve woken up right now at 6 AM I drink some water and the water felt like it was sitting in the top of my stomach and I have to slowly very very slowly go down not in my esophagus in my throat in my stomach like it bloated me and as I was walking around it slowly went away I am trying to drink a lot of water because I?m conscious that I?m having diarrhea.   Is the diarrhea an an allergic reaction? Is the diarrhea a reaction to an active ingredient in the vaccine? (polyethylene glycol)
my husband has asthma and this shot made him very sick.  today is day 4 and he still has fever, chills, is perspiring profusely.  an hour after his shot was administered, he started to feel cold, shortly after, he was having chest pains, not long after his fever spiked to 104.   his side effects were, fever, chills, vomiting, chest pains, perspiring, asthma attaches, sever body aches, head aches.
No other adverse events reported; Caller reports that seven doses of improperly stored GARDASIL 9 were administered to 7 different patients; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies and medical history were not provided.  On 16-MAR-2022, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe, 1 dose, lot # U008899, expiration date 12-AUG-2023 (exact dose number, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The temperature excursion was 33.4 Fahrenheit degrees for 2595 hours. There were no previous temperature excursions. No other adverse events were reported (no adverse event).  This is one of several cases received from the same reporter. ; Sender's Comments:  US-009507513-2203USA008097: US-009507513-2203USA007812: US-009507513-2203USA008063: US-009507513-2203USA007915: US-009507513-2203USA008053:
Loss of pregnancy.  I received my first dose at approximately 4 weeks pregnant on 3/30. I had a positive home pregnancy test the following day on 3/31.  On 4.29, I had my first confirmation ultrasound where a heartbeat was found, but the fetus was not measuring as expected. On 4.30, I received my 2nd dose of the Moderna vaccine. A follow-up ultrasound was done on 4.12, at that time, no heartbeat was indicated and the fetus had stopped developing shortly after receiving the 2nd does on 4.30. This was my first pregnancy.
Pt started to have itching that started at the top of the head at approximately 2 hours after vaccination. Pt reported that the itching seemed to start to travel to the body. Pt was advised to take 50 mg of Benadryl.
I am a physician working in multiple companies. I am reporting an usual adverse event that occurred when I received the Moderna bivalent vaccine 10 months after having received a booster dose (original series Jan, Feb 2021, booster Nov 2021). I have had local and systemic reactions after all 3 doses, but no hypersensitivity symptoms. I am allergic to sulfa (rash) but no other vaccines or drugs and no known allergy to PEG. Approximately 10 minutes after receiving the vaccine, I experienced severe facial flushing and tachycardia (HR 94). BP was 140/85 (I have hypertension so probably not unusually high). I was given Benadryl 50 mg and my symptoms improved within about 20 min, then resolved. I understand from the publication that the vaccine product has the same composition as the original mRNA vaccine with the exception of the mRNA component. As an expert in postmarketing surveillance, I am reporting it so that you can investigate whether there is an issue with the lot I received. I understand that Moderna's contract manufacturing facility recently received an FDA form following a manufacturing inspection.  I ask that you followup with me directly and would like to know the outcome of this evaluation. Thank you.
I have had this in the past. I now have again, Chronic Idiopathic Urticaria now. Chronic hives with an unknown cause. It may have even started on August 1st. It's an immune triggered event, it's linked to inflammatory triggers. I had it in the past for about two years. It's been gone for about six years. I have hives all over my body. I have them in the morning when I wake up and they go away for a little bit in the afternoon and then come back at night at different locations. Treatment is allergy pills, I take Claritin, Zyrtec and Allegra. I take one of those in the morning and one of those in the evening. I also take Famotidine, and I take that every day twice a day.
Patient given 0.25ml instead of 0.5ml; A spontaneous report was received from a physician concerning a patient of unknown age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) was given 0.25ml instead of 0.5ml.   There were no medical history and concomitant medications reported.  On 16 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 16 Jan 2021, the patient was vaccinated with 0.25ml instead of 0.5ml.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, "patient given 0.25ml instead of 0.5m" was considered resolved on 16 Jan 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273, lot # unknown.  There were no reported AEs associated with this case of incorrect dose administered.
Fever and generalized seizure approximately 12 hours after 2nd set of shots (Pediarix, Hib, Prevnar, and Rotateq given). Evaluated at Temple Pediatric Emergency Room. Diagnosed with a febrile seizure. Well appearing. No therapy required.
CAUSED MY HS DISEASE TO GET OUT OF CONTROL. BREAKOUTS UNDER MY ARMS AND GROIN AREAS. VERY PAINFUL, REQUIRED DRS VISIT AND SHOT TO TRY AND CALM THINGS DOWN.  THIS TOOK WEEKS TO GET UNDER CONTROL.  I DID NOT HAVE ANY REACTIONS TO THE FIRST 2 SHOTS, BUT THE BOOSTER WAS A NIGHTMARE.
pt came to clinic 23FEB98 recv vax & had extreme bradycardia;had influenza x 3;NOV, DEC, JAN98;problems w/leg muscles spasms began APR97-muscle spasms inc DEC97;could no longer walk;walks only w/walker;
Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 70 years old male patient who experienced testicular pain, weakness, fever, night sweats, while he received vaccine YELLOW FEVER VACCINE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On an unknown date (11 days prior to October 30th), the patient received a 0.5 ml once dose of suspect YELLOW FEVER VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, patient developed a non-serious weakness (asthenia) following the administration of YELLOW FEVER VACCINE. On an unknown date, patient developed a non-serious fever (pyrexia) following the administration of YELLOW FEVER VACCINE. On an unknown date, patient developed a non-serious night sweats following the administration of YELLOW FEVER VACCINE. On an unknown date, patient developed a non-serious testicular pain following the administration of YELLOW FEVER VACCINE. Patient admitted to emergency room on 30-Oct-2018. It was also reported There were no sign of neurological deficit, kidney failure or encephalopathy. Relevant tests included he had elevated ALT and AST, high sed rate and CRP and positive PCR. Final diagnosis was testicular pain, night sweats, fever and weakness. The patient was treated with IVIGLOB-EX (also reported as IVIG). The outcome of all event was not reported. List of documents held by sender- none.
This spontaneous report as received from a pharmacist via a company representative refers to 4 or 5 patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patient were vaccinated with ZOSTAVAX lot # K000456, expiration date 15-DEC-2014 subcutaneous. The patients were vaccinated in the same "reasonable amount of time" out of the same box and each experienced a very large injection site welt "giant, the size of a racquetball" in addition the area was red, swollen and itching (on an unknown date). Each consumer's adverse reaction resolved in a few days without treatment (on an unknown date). Patients did not seek medical attention. Additional information has been requested.
Flu like symptoms; Joint aches; Muscle aches; Fever; Pain in the arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm), INFLUENZA LIKE ILLNESS (Flu like symptoms), ARTHRALGIA (Joint aches), MYALGIA (Muscle aches) and PYREXIA (Fever) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm). On 27-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), ARTHRALGIA (Joint aches), MYALGIA (Muscle aches) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Pain in the arm), INFLUENZA LIKE ILLNESS (Flu like symptoms), ARTHRALGIA (Joint aches), MYALGIA (Muscle aches) and PYREXIA (Fever) was resolving.        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.   Patient denies allergies, past medical history and taking any concomitant medications. No treatment information was provided.
Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient have reported symptoms. Concomitant product information was not provided. Treatment information was not provided.
My husband got it three times after the shot/Suspected vaccination failure; Got it three times; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving 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.   Additional Information: GSK Receipt Date: 09-AUG-2022 Reporter's Comment: This case was reported by a patient's wife via interactive digital media. The reporter stated that, did not get the shingles shot. The patient got the shingles shot and had shingles three times after the shot. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule ,time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Additional booster: administered expired Bivalent booster Moderna COVID-19 vaccine after the 30 day beyond use date. Vial was initially stored in the refrigerator on October 24, 2022 and administered to patient December 5, 2022. No symptoms.
mixed Shingrix reconstituted with unproved sterile diluent; mixed Shingrix reconstituted with unproved sterile 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 patient who received Herpes zoster (Shingrix) (batch number 97LJ7, expiry date 06-AUG-2024) for prophylaxis.   On 12-JUN-2023, the patient received Shingrix. On 12-JUN-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: mixed Shingrix reconstituted with unproved sterile diluent) and inappropriate dose of vaccine administered (Verbatim: mixed Shingrix reconstituted with unproved sterile diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 13-JUN-2023 The reporter was administrative assistant. No patient details were available. The reporter consented to follow up. The reporter called in behalf of healthcare professional and stated that a medical assistant mixed Shingrix reconstituted with unproved sterile diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Swelling of hands, feet, ears with erythema of hands, feet, ears. Extremities with erythematous splotchy areas, some with duskiness. Tx'd with Benadryl.
This spontaneous report was received from a nurse refers to a patient of unknown age. The patient's pertinent medical history, drug reaction/allergies and concomitant medications were not reported. On 28-JUL-2016, the patient was inadvertently administered M-M-R II (lot # K009956), which expired on 14-JUL-2016. No adverse effects reported. Additional information is not expected as the reporter did not wish to be contacted.
Based on photographs the patient developed right sided ptosis and an enlarged pupil between September 1st and 7th.  The parents noticed abnormal gaze in February (maybe in Oct/November using retrospective look at photographs) and sought care.  In February she was complaining of double vision.  She was found to have 3rd nerve palsy. She was sent for neurology and ophthamology and neurophthamology - had studies done including myasthenia gravis panel, CT angiogram, MR angiogram, MRI, thyroid studies, and some screening autoimmune and inflammatory disease labs all of which were unrevealing by report, except an apparently abnormal ANA (result not known).  She had a trial of Mestinon 12mg TID without help. 6/11/09 office note for 9/4/08 received C/O right hip pain. Left eye complaint, red, dilated, double vision, right eye dilated not reactive, lid ptosis and limited full EOM. Three weeks prior c/O eye turning out.   6/11/09 Neurology records received DOS 3/10/09 to 5/18/09. Assessment: Idiopathic 3rd nerve palsy. Post vaccination: double vision, squinting, pupillary discrepancy, disconjugate gaze and intermittent ptosis. Difficulty with adduction and upgaze of right eye. Ophthalmologic surgery planned.  9/16/09 Ophthlamology Consult DOS 3/19/09 to 4/6/09. Assessment: Third nerve palsy of right eye. Right pupil dilated. Inability to raise or depress right eye. Ptosis of right upper eyelid.  Follow-up: She continues with 3rd nerve palsy. Some mobility is returning but she's not fully recovered.
AEs: Fatigue, Head Ache, Body Ache, Chills, Fever (moderate for all) Treatment: Advil, Rest, Drinking Water Outcome:  19 hours post onset > Head Ache, Fatigue, Body Ache (mild)
Homebound offsite nurse vaccinated at a nursing home for flu vaccines. Per homebound nurse, "The owner of the nursing home facility filled out the flu forms prior to our arrival on scene and told us which of his patients required a flu shot." The patient received a flu vaccine previously for this season on 09/28/2021 per database. Therefore, the patient received an extra dose of flu vaccine this 2021-2022 season. Per homebound nurse: The owner of the facilities, was notified on 12/14/2021 and the patient was doing fine. Per homebound nurse, two attempts were made to speak with the owner of facility, but the owner was uncooperative and dismissive in the procedure to follow up and address the situation.
Initial report received from a health care professional on 25 February 2014. A patient whose demographics, medical history and concomitant medications were not reported, had received a dose of FLUZINE ID (batch number, dose number, route and site of vaccination were not reported) on an unspecified date. On an unspecified date, the patient had a scar from the injection. Corrective treatment and laboratory details were not reported. At the time of this report, the outcome unknown. Documents held by sender: none
Inadvertently gave a dose of Pfizer Covid 19 instead of dose of Bexero as per pt request.  Patient's last Pfizer Covid 19 dose was given on 1/20/2022.  Event reported to Poison Control Hotline
Within 3 minutes of vaccine the patient reported flushing of the face, lower back spasm, and sciatic type pain shooting down her left leg. Symptoms resolved in 15 minutes.
Chills, Aches & Pain, Fever, Bedridden; Chills, Aches & Pain, Fever, Bedridden; Chills, Aches & Pain, Fever, Bedridden; Chills, Aches & Pain, Fever, Bedridden; This is a spontaneous report from a contactable consumer (Patient). A 56-years-old female patient received bnt162b2 (BNT162B2,solution for injection,Lot Number was en6204,expiry date was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 04Mar2021 as(Age at vaccination was 56 years) DOSE 2, SINGLE for covid 19 immunization, Patient was not pregnant at the time of vaccination. Medical history included pulmonary embolism, lung disorder, back pain, surgery from an unknown date and unknown if ongoing. Concomitant medication(s) included gabapentin from 04Mar2021 to an unspecified stop date, hydrocortisone, warfarin sodium (COUMADIN),omeprazole, eszopiclone (LUNESTA) taken for an unspecified indication, start and stop date were not reported and the patient previously took respaire and experienced drug hypersensitivity, flexeril [cefixime] and experienced drug hypersensitivity, Neosporin and burn relief and experienced drug hypersensitivity. The patient previously had received bnt162b2 (BNT162B2,solution for injection, lot number was EN9581,expiry date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 11Feb2021 as DOSE 1, SINGLE for covid-19 immunisation.On 11Feb2021 the patient experienced chills, aches & pain, fever, bedridden,Patient received no treatment for the event,The patient had not received any other vaccine within 4 weeks.Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The clinical outcome of the events was recovered with sequels.  Follow-Up (06Aug2021): Follow-up attempts are completed. No further information is expected.
Tuesday 4/15/08 at school not feeling good - low grade fever, laid down in nurses office.  4/16/08 Wednesday night after shot with fever 101-102 degrees, headache.  Friday 4/18/08 sore throat.  Monday 4/21/08 CNP at urgent care "sick to begin with bacterial infection, sore throat, upset stomach".
Information has been received on 14-MAY-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a medical clinic as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. During June 2016, the patient was treated at a medical clinic for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Flu shot in left shoulder. Soreness/tightness in shoulder muscle area in the injection area. Movement is not limited, but soreness/pain is lingering from September to December. Received the Influenza, Injectable, Quadrivalent, Preservative Free shot.
The patient has not reported any adverse reactions. On 6/1/2022 a vial was used for COVID clinic. After use, the vial was placed in the refrigerator (this should have been wasted after 12 hours). On 07/27/2022, the vial was taken out of the fridge and used for this patient.
Initial unsolicited report received from a non healthcare professional (office manager)on 09-May-2016. This case involves a three patients (age and gender not reported) who were vaccinated with a dose of DAPTACEL (batch number C4756AA, expiry date: 11-Jun-2017, route of administration: not reported) in the deltoid on an unspecified date (reported as vaccinated on different days from 26-Apr to 30 Apr). Patient's illness at time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Concomitant medications were not reported. On an unspecified date, following the vaccination, the patients had redness at the injection site warmed and hardness. The patients were previously vaccinated with DAPTACEL vaccine (details not provided). It was reported that the patients required doctor visit (unspecified date, reported as next day). Laboratory investigations was reported as none. The patients received corrective treatment warm compresses and TYLENOL. On an unspecified date, within three days, the patient recovered from the events. List of documents held by sender: none.
At 4:00 pm on Saturday 1/2/2021, onset of L scapular pain, L chest discomfort and pain with inspiration. Presented to the Emergency Department for cardiac work up and discharged home. Follow up with personal provider on Monday 1/4/2021.  Continued to have musculoskelatal and chest wall pain through Wednesday 1/6/2021.
Fatigue, chills. Erythema and warmth around injection site measuring 12 x 15.5cm.