chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Event took place at an off-site event, in a detention facility. Pt received Janssen COVID vaccine around 4:00 pm. Pt immediately reported nausea. Nurse accompanied pt to the restroom about 2 minutes after receiving vaccine, where she gagged into the sink and spit up a little clear fluid. Pt reported feeling hot and sat down in a chair available in the restroom. Pt and nurse joined by a second nurse. Shortly after sitting down pt complained of feeling dizzy and was moved to the floor to lay down. When laying down, pt appeared flushed under her chin and complained of chest tightness. She requested to sit up to help with breathing. Called 911 and first dose of epinephrine (0.5 mL of 1mg/1mL) administered, both at 4:10 pm. Pt reported no change in chest tightness following epi, but continued to respond to questions. She said she felt tired and wanted to go to sleep. Pt continued to report difficulty breathing, and another dose of epinephrine administered at 4:15 pm. A physician at GEO arrived and administered oxygen. He listened to pt's heart and lungs and reported that there was air movement in her lungs. Pt ceased to respond coherently to questions, slurring and moaning, but did not lose consciousness. Pt started tapping her lips and, upon questioning, said they felt numb. Third dose of epinephrine administered at 4:20 pm. Nurse continued to jostle patient and ask her questions, and patient continued to respond with short, slurred answers. EMS arrived at 4:23 pm and transported patient to the hospital.
child receives vaccines on delayed schedule; Initial information received on 01-Nov-2021 regarding an unsolicited valid  non-serious case received from a consumer or non-healthcare professional.  This case involves child male patient who receives vaccines on delayed schedule while receiving vaccines HIB (PRP/T) VACCINE [ACT-HIB], DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and IPV (VERO) [IPOL] (inappropriate schedule of vaccine administered).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect IPV (VERO), DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE and HIB (PRP/T) VACCINE lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to inappropriate schedule of product administration.  It was reported ''asks if there is a maximum length of time between vaccine schedule for Daptacel, ActHIB, Ipol. She asks why is it not necessary to get ActHIB vaccine if not completed series at age 5. She reports child receives vaccines on delayed schedule, individually, not as combined products like Pentacel.''  At the time of reporting, no adverse event was reported.  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.  There will be no information available on the batch number for this case.
Patient started to feel some nausea after the vaccine was given, patient sitting down, vitals obtained, ice pack applied.
Patient was waiting in the lobby after the vaccination was given. It has been about 5-10 minutes since his shot when he started shaking and eventually fainted. He came to relatively quickly but still seemed out of it. He started sweating and vomited twice. He did not experience any sort of itching or trouble breathing. 911 was called and the fire department arrived on the scene within about 5 minutes from the call. He was monitored and eventually was able to be released to go home. His family member was with him throughout the encounter.
Treatmentof COVID-19; Treatmentof COVID-19; Moderna Dose Number 3 / Pfizer / BioNTech Dose Number: 4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Lot number: GH9694), in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 10Apr2022 as dose 4 (booster), single (Lot number: fk9894), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Feb2021 as dose 1, single (Lot number: 007M20A), in left arm, on 02Mar2021 as dose 2, single (Lot number: 025A21A), in left arm and on 26Oct2021 as dose 3 (booster), single (Lot number: 432F21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. No Known allergies. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Apr2022, outcome "unknown", described as "Moderna Dose Number 3 / Pfizer / BioNTech Dose Number: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatmentof COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including paxlovid.  No follow-up attempts are possible. No further information is expected.
Information has been received from a pharmacist concerning a male pediatric patient with unknown medical history and allergies who was vaccinated one time with a dose of MMR vaccine live (lot # unknown). The reporter indicated that the patient had a reaction to the vaccine. No further information was available. Unspecified medical attention was sought. Additional information has been requested.
Client reports pain in left upper arm which started 12/15/2006 after she received a vaccination in that area.  The pain has continued for 1 week.  Client reports she has pain whenever she lifts her left arm.  No redness/swelling noted per this nurse upon visual exam.  Client has been taking Tylenol 325mg/tab, 2 tablets, about every 6 hours since the pain started on 12/15.
headache; dizzy; getting tired; was trying to catch her breath; She feels like she is getting her taste buds back; Covid after being vaccinated/  Covid: positive/ contracted Covid; Covid after being vaccinated/  Covid: positive/ contracted Covid; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), vaccinated at age of 56 year old, dose 2 via an unspecified route of administration, administered in Arm Left on 24Mar2021 (Batch/Lot Number: BP7534) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 (Batch/Lot Number: SN6205) as DOSE 1, SINGLE for covid-19 immunisation. There were no concomitant medications and medical history. Patient just contracted Covid. She felt like she was getting her taste buds back and reported that she had a headache at the beginning of the week that got worse at night. She said that with standing up and moving she got dizzy. She was getting tired and was trying to catch her breath. She had no fever and she was keeping up with her pulse. She had no infection in the chest or anything. Patient got Covid after being vaccinated on 04Nov2021. The patient underwent lab tests and procedures which included Covid: positive on 04Nov2021. The outcomes of events were unknown.
Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concomitant products included ATENOLOL and LOSARTAN POTASSIUM for Blood pressure, HYDROXYCARBAMIDE (HYDROXYUREA) for Cancer, SIMVASTATIN for Cholesterol, GABAPENTIN for Nerve pain, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) had resolved.            No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up received on. Patient second dose was reported.Concomitant product was reported. On 06-Aug-2021: Follow up information was received on 06-Aug-2021. Outcome of event rash updated.
Believed to be a moderate case of guillain Barre syndrome.  My the communication to my legs is disrupted and it feels as though my legs are going to give out, but I can't communicate with them and as though they are separate.  They have not given out.  It is in both legs, and it is frightening and I don't feel safe.  The best I can describe it is as though there is a paralysis except my legs are working on their own.  This is not related to my health conditions and completely different from anything I have ever experienced.  It is slowly improving but still ongoing.
This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 80-year-old female patient who received Influenza vaccine Quadrivalent unspecified season. Co-suspect products included BREO ELLIPTA unknown for chronic obstructive pulmonary disease. Concurrent medical conditions included heart disorder, tiredness (normally tired) and pneumonia (1 year before reporting date). Concomitant products included PROAIR. In October 2017, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, the patient started BREO ELLIPTA 1 puff(s) once daily. On 15th December 2017, less than a year after receiving Influenza vaccine Quadrivalent unspecified season and BREO ELLIPTA, the patient experienced feeling unwell. In December 2017, the patient experienced condition aggravated and tiredness. On 17th December 2017, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. The patient was treated with ondansetron hydrochloride and oseltamivir. Influenza vaccine Quadrivalent unspecified season was continued with no change. BREO ELLIPTA was continued with no change. On an unknown date, the outcome of the vaccination failure, condition aggravated and tiredness were unknown and the outcome of the influenza and feeling unwell were recovering/resolving. The reporter considered the vaccination failure, influenza, feeling unwell, condition aggravated and tiredness to be unrelated to Influenza vaccine Quadrivalent unspecified season and BREO ELLIPTA. Additional details were reported as follows: The patient had been on BREO ELLIPTA for about a year, it was been between 6 months to a year. She stated that she also got a flu shot in late October or early November at a Pharmacy. The patient did not know the manufacturer of the flu vaccine. The patient noted before last Friday she was not feeling good and tired, but was always tired. On Saturday the patient felt worse and then on Sunday she went to an outpatient care and they diagnosed her with the flu. This case was considered as suspected vaccination failure case since the laboratory test for influenza was unknown. The patient noted she almost completed the medications. The reporter does not relate any of these events to the medications. She noted she took a lot of medications on routine, but did not want to provide those. The healthcare professional declined for information and does not want him contacted. The patient denied permission to contact their physician.
This spontaneous report was received from a 66 year old male pharmacist regarding himself. The patient has sulfa allergy and psoriasis. The patient's medical history included heart attack 8 months ago. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was not reported). Concomitant therapies included aspirin, TOPROL XL TABLETS, COZAAR, EFFIENT, LIPITOR, DOVONEX, DIPROLENE, UV light treatments daily, multivitamins (vitamins unspecified), Vitamin B Complex, Ascorbic Acid, Vitamin D(UNSPECIFIED), Vitamin E and OMEGA-3 MARINE TRIGLYCERIDES. On 20-APR-2013, the patient developed shingles. The patient was treated with VALTREX. There were no laboratory tests performed. The outcome of the event was reported as not recovered. The patient sought medical attention. Additional information has been requested.
Asthma attack went to clinic needed nebulizer as inhaler not helping (have not had and attack like this in two years. by 10/31/2009 9am developed severe headache and Nausea and vomiting that lasted til 5pm that night. feel somewhat better on 11/1/2009 just achy all over
5x4cm swelling or the site of DTP inj (rt thight); 4x3cm induration @ the same site
Pt reported to ER on 4/16/00 with complaints of 3 inch hive at injection site, tenderness and redness 5 inches down from site. Also had low grade fever, stiff neck. Client was treated with Benadryl and Prednisone. had both Hep A and tetanus in the same site. MD felt reaction was from tetanus as client had previous dose.
Patient missed 48 hrs of work due to generalized myalgia, fever (did not exceed 102 F) and localized left sided lymphadenophathy.  Presented with a major rx (10 x 10 mm pustule c 30x30 mm surrounding erythema/congestion) he also had three satellite lesions inferior and smaller to the primary pustule.  SC imporved with NSAID administration and non-sedating anti-histamine.
The vial was moved from freezer to refrigerator and expired on 20-Jan-2022; Maximum or minimum temperatures reached, as applicable Maximum 44.6°F minimum 38.8°F; Patient received an expired vaccine for a booster dose on 01-Mar-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine for a booster dose on 01-Mar-2022), PRODUCT STORAGE ERROR (The vial was moved from freezer to refrigerator and expired on 20-Jan-2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (Maximum or minimum temperatures reached, as applicable Maximum 44.6°F minimum 38.8°F) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Moderna Vaccine (First dose with lot number 014B21A) on 02-May-2021 and MODERNA COVID-19 VACCINE (Second dose with lot number 037C21A) on 30-May-2021. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE and Moderna Vaccine. Concurrent medical conditions included Allergy to venom (Bee venom) and Sulfonamide allergy (Sulfa antibiotics).    On 01-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine for a booster dose on 01-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was moved from freezer to refrigerator and expired on 20-Jan-2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (Maximum or minimum temperatures reached, as applicable Maximum 44.6°F minimum 38.8°F). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine for a booster dose on 01-Mar-2022), PRODUCT STORAGE ERROR (The vial was moved from freezer to refrigerator and expired on 20-Jan-2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (Maximum or minimum temperatures reached, as applicable Maximum 44.6°F minimum 38.8°F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided.  The date the vial was initially stored in the refrigerator on 20-Jan-2022.  The vial undergo any temperature excursions: yes  Storage condition at the time of the excursion: refrigerated storage  Maximum or minimum temperatures reached, as applicable : Maximum 44.6°F minimum 38.8°F  Excursion duration: 3 months  No treatment medication was provided.
need second shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (need second shot) in a patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (need second shot). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (need second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Towards end of 15 min wait period, started walking, experienced lightheadedness and limb numbness. Following Monday, experienced Charlie horse like pulling pain from back of knee to upper thigh/groin area, sharp stabbing pain above left eyebrow lasting about a minute. During week, experienced pain feeling like bones were about to snap. Ongoing since injection, continued severe limb numbness and lightheadedness some dull "sinus" headache and extreme fatigue.
pt recvd Hep B vax in ER on 14SEP92 @ 2100; also recvd gamma globulin & tetanus & exp nausea began 2 hrs later; the next day had n,v,d; sx were resolved; sent home from work sick;
rash / spots in round circles; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash / spots in round circles) and VACCINATION SITE PAIN (sore arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (rash / spots in round circles) and VACCINATION SITE PAIN (sore arm). At the time of the report, RASH (rash / spots in round circles) and VACCINATION SITE PAIN (sore arm) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: NNI
Patient received her influenza vaccine, appeared normal and complained of no issues.  She went to the waiting room and fainted approximately 5 minutes after receiving the vaccine.  She regained consciousness immediately.  Patient was standing and hit her head on a shelf.
I felt a muscle was cramping hard on the left side about the size of clenched hand. I thought I may have a heart attack, so I went to get an aspirin and sat down until I could be taken to the ER. There they took an EKG, Blood, and Chest X-Ray. (All normal) Suggested that I set up an appointment with PCP. (11/15) At my PCP office, they checked vitals and ordered ECG and Stress Test. (Not yet completed).
employee received the vaccine at 3:45 PM, and at 4:00 PM began feeling a sensation in her mouth of having lots of saliva. Did not get nauseated. Also experienced metallic taste in mouth. 5 minutes later felt dizzy, then 5 minutes later felt shaky BP was 159/93, HR 107 felt well enough to finish out shift, and went home. Following day felt lethargic, but recovered from that at home.
Immediate onset of pain within the left deltoid. This progressed to swelling of the entire left arm with a welt approximately 5 cm in diameter by that evening. Joint pain in the hips, shoulders, elbows and back the following day with frontal headache. The swelling lasted 7 days and the joint pain lasted 4 days. The day following injection it was examined by both provider and chief medical director (MD) with prescription of BENADRYL and steroid.
Patient has not reported any adverse events. (Duplicate flu shot - FLUZONE HD - given within last 4 weeks of each other). One also given at Dr. office and one at pharmacy.
No adverse event; Vaccine administered after beyond use date 07-Jul-2022; This spontaneous case was reported by a non-health professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date 07-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 9-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date 07-Jul-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date 07-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medication was reported.  The vaccine beyond use date was 07Jul 2022.  No treatment information was provided.
no symptoms after 1st dose   had swelling and redness over 48 hours after 2nd dose.  experienced flu like symptoms 12-24 hours after 2nd dose.  started experiencing headaches 48 hours after 2nd dose. Headaches have continued since 2nd dose for over 2 1/2 weeks.  started experiencing exhaustion post 2nd dose. Exhaustion has continued for over 2 1/2 weeks.  Now starting to experience symptoms of confusion and dizziness
vision loss R-eye 3/9/2022  retinal specialist seen;  central retinal vein thrombus and occlusion identified ASA 81mg, Avastin intraorbit injections  hematologist seen; coag workup revealed Factor-V Leiden heterozygote, no other coag abnormalities or other thrombotic risk factors identified continues to be seen by retinal specialist and hematologist Xarelto initiated immediately  Also note: Patient is believed to have had mild case COVID-19 1/5/2022 (not testing confirmed)
administer expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patient, after the manufacture date of expiration) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The expiry date was reported as 09-Nov-2021.  The date the vial was initially stored in the refrigerator was unknown.  The vial did not undergo any temperature excursions.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up document received included updated reporter details