chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue, loss of appetite, high fever (highest measured 104 degrees Fahrenheit 48 hours after vaccine), starting 12 hours after the shot (fever started 24 hours after shot) and continuing for a full three days/72 hours (i. e., went away 96 how after shot)
The shipment of vaccine was received outside the 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside the 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via agency (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310901, 2020SA310354, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA310705, 2020SA277871, 2020SA310707, 2020SA310708, 2020SA310759, 2020SA310760, 2020SA310761, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769 and 2020SA310770 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021, form: prefilled syringe) via unknown route in unknown administration site for prophylactic vaccination on 05-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue).  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product. No thermometer was in packaging and product was cold when they received it.  At the time of report, 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.
pressure points and hot spots and burning sensation that lasted 2 days... and still experiencing those hot spots.
The patient developed a fever six hour               The patient developed a fever six hours after Prevnar. Then the patient was diagnosed with pneumonia 2 days later.  The patient improved with Amoxicillin. Unclear if chance or related.
Heart palpitation; Emotions; Anxiety; brain fog; Sweat; Shaking; Joint stiffness; Dry cough; Neck stiffness; Muscle pain; Chills; Nausea; under arm lymph pain on the side she got the shot; Fatigue/extreme fatigue; Sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PALPITATIONS (Heart palpitation), EMOTIONAL DISORDER (Emotions), ANXIETY (Anxiety) and FEELING ABNORMAL (brain fog) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037kz0A/037K70A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue/extreme fatigue). On 07-Jan-2021, the patient experienced PALPITATIONS (Heart palpitation), EMOTIONAL DISORDER (Emotions), ANXIETY (Anxiety), FEELING ABNORMAL (brain fog), HYPERHIDROSIS (Sweat), TREMOR (Shaking), JOINT STIFFNESS (Joint stiffness), COUGH (Dry cough), MUSCULOSKELETAL STIFFNESS (Neck stiffness), MYALGIA (Muscle pain), CHILLS (Chills), NAUSEA (Nausea) and LYMPH NODE PAIN (under arm lymph pain on the side she got the shot). On 06-Jan-2021, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue/extreme fatigue) had resolved. At the time of the report, PALPITATIONS (Heart palpitation), EMOTIONAL DISORDER (Emotions), ANXIETY (Anxiety), FEELING ABNORMAL (brain fog), HYPERHIDROSIS (Sweat), TREMOR (Shaking), JOINT STIFFNESS (Joint stiffness), COUGH (Dry cough), MUSCULOSKELETAL STIFFNESS (Neck stiffness), MYALGIA (Muscle pain), CHILLS (Chills), NAUSEA (Nausea) and LYMPH NODE PAIN (under arm lymph pain on the side she got the shot) 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 concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
once again experiencing just pain arm pain; once again experiencing just pain arm pain; Lump in his left arm pit; Just pain, arm pain; Just pain, arm pain; This spontaneous report was received from a male consumer of 64 year old referring to himself. The patient's concurrent condition included mitral valve prolapse, diabetes mellitus and drug hypersensitivity (the patient was allergic to sulfa drugs). Concomitant therapies included metformin hydrochloride (reported as Metformin ER), sitagliptin phosphate(JANUVIA), ramipril, atorvastatin and vitamins (unspecified).   On 21-JAN-2019 (reported as for the first time), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) dose 1 in the left deltoid (reported as in left shoulder) for prophylaxis (reported as protection) (strength, dose, lot/batch#, expiry date, route was not reported). On the same day, the patient experienced pain and arm pain for which the patient was treated with unspecified ibuprofen. The patient sought no medical attention. The events were recovered/resolved on 24-JAN-2019 (reported that it took 3 days to recover from the pain). On 22-JAN-2020 (reported as for the second time), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) dose 2 in the left deltoid for prophylaxis (strength, dose, lot/batch#, expiry date, route was not reported). On the same day, the patient experienced pain and arm pain for which the patient was treated with unspecified ibuprofen. The events were recovered/resolved on 25-JAN-2020 (reported that it took 3 days to recover from the pain). On an unknown date in January 2020 (reported as on an unspecified date after 22-JAN-2020), the patient noticed a lump on his left armpit which was initially a size of a ping pong ball (mass). It was reported that the lump had subsided over the past 3 weeks but was still there (recovering/resolving). The patient sought medical attention. No product quality complaint was involved.   The reporter's causality assessment was not reported.
(Noted Auto-Immune Disease) Pt. states after receiving the dose of J&J vaccine 05/11/2021, started to experiencing symptoms 05/16/2021 a pulling pain in the right thigh, broken blood vessels through the leg (right), uncomfortable sensations going from groin to feet (both), pain beneath the fingernails, abdominal bloating, and chronic UTIs. Nerve sensations running through the facial area and (pinching) back of the head.
This case was reported by a pharmacist via call center representative and described the occurrence of taste peculiar in a 30-year-old female patient who was reconstituting SHINGRIX (batch number M77B4, expiry date 8th February 2021) and (batch number 97H72, expiry date 8th February 2021) to the patient for prophylaxis. On 7th August 2018, the patient received SHINGRIX. On an unknown date, the dose was an unknown dose. On 7th August 2018, less than a day after receiving SHINGRIX, the patient experienced taste peculiar, inadvertent exposure to vaccine, exposure via skin contact and product complaint. On an unknown date, the outcome of the taste peculiar, inadvertent exposure to vaccine, exposure via skin contact and product complaint were unknown. It was unknown if the reporter considered the taste peculiar to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist stated that when she was attempting to withdraw SHINGRIX on the date of reporting, it was pretty pressurized and adjuvant from the vial, the liquid squirted out of the vial onto her face and flew into her mouth, which led to inadvertent exposure to vaccine, exposure via skin contact. The pharmacist may have got into her mouth since she had a funny taste in her mouth afterwards. She was not sure if she swallowed any. The pharmacist believes it was due to the vial being very pressurized. The pharmacist was unsure how much adjuvant was left in the affected vial. The pharmacist used a 3 ml BD syringe with a 25 gauge 1 inch safety needle. The stopper was pierced in the circular area dedicated to perforation and the vial was being held upside down when the adjuvant was being withdrawn. The liquid came out of the puncture in the stopper. The vial rubber stopper or metallic skirt did not detach or become loose at any time. The pharmacist only removed the plastic flip-off from the vial before handling and did not inject air from the syringe into the vial. The stopper was pierced once. The vaccine was stored in the refrigerator on the middle shelf. The average temperature of the refrigerator was 40 degree F and there were no temperature excursions after receipt and storage. Defect was observed after handling and there was no evidence of leakage in the package or carton. The pharmacist was an experienced user of the product and has not had this issue with previous SHINGRIX vials. There were no pictures available of the defect. In QA notes batch number of SHINGRIX and diluent were reported. The pharmacist was requested credit for (1) dose of SHINGRIX for replacement. The pharmacy would return vial in question to GlaxoSmithKline and filled related adverse event.
fever; vomiting; This is a spontaneous report from a contactable consumer. This consumer reported for a (age group: adult) male patient received 2nd dose of BNT162B2 on 20Jan2021 at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. Historical Vaccine was 1st dose of BNT162B2 in Jan2021, had soreness in his arm. He had a fever and is vomiting from 21Jan2021 with outcome was not recovered. No covid prior vaccination. No covid tested post vaccination.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021061327 Same reporter/patient, same vaccine in different dose, different events
pt recvd vax; w/in 2 hrs of inject, pt devel generalized hives &  pruritus; pt treated w/ benadryl;
Pt exp inj site pain & warmth.Pain traveled down arm & up right side of neck.Right side was stiff. Right thumb had spasms.Arm weak & tight. Right shoulder hard & swollen. 2 Physical Therapists felt spasms due to shot nicking a nerve
Information has been received from a medical assistant, referring to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with an improperly stored doses of PROQUAD lot number M035690 with an expiration date on 06-FEB-2018; lot number M032496 with an expiration date on 02-JAN-2018 or lot number reported as "M037012 with an expiration date on 21-FEB-2018" (strength, dose, administration route and anatomical location were not reported) for prophylaxis. No adverse effects were reported. The vaccines had an unspecified temperature excursion (reported as more than 14 Fahrenheit (F) and less than 46 F) during a time frame of 1125 hours. Also it was reported that no previous temperature excursions occurred or a digital data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1703USA001163.
I noticed some itching at the injection sight. Then a day or so later I noticed it was hard and red. It has been red and a little warm since. I haven't noticed it going down any in size or redness and it still itches some. I had the shot at my local Pharmacy and have not notified them or my dr.
Temperature 101.4, muscle aches, joint aches.  Began 20 hours after vaccination.
male adult received Havrix pediatric second dose; male adult received Havrix pediatric second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 61-year-old male patient who received HAV (Havrix pediatric) (batch number 943Y2, expiry date 05-MAY-2025) for prophylaxis.   On 05-SEP-2023, the patient received the 2nd dose of Havrix pediatric. On 05-SEP-2023, an unknown time after receiving Havrix pediatric, the patient experienced underdose (Verbatim: male adult received Havrix pediatric second dose) and adult use of a child product (Verbatim: male adult received Havrix pediatric second dose).  The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date: 5-Sept-2023 The clinic manager reported that an adult patient received Havrix pediatric second dose by error. The reporter consented to follow-up via email. An adult patient received a pediatric dose of Engerix-B, which led to underdose and adult use of child product.
I started coughing on November the twenty ninth 2022 for several days so on December first 2022 I was very congested by the third of December my lungs were filled so I sought medical care to have someone listen to my lungs. I was put on steroids, antibiotics, and an inhaler. I had no other symptoms other than my coughing and congestion.
Very tired, nausea, extremely sore left arm, drained of energy. Unable to work the next day. Left arm a little itchy. Took Benadryl , slept and then felt better. Did fine with first shot.
Changes in menstrual cycle. Significantly worse symptoms than prior to taking the shot - including abdominal cramps, passing clots, headaches, and fatigue. Cycle is also longer than prior to receiving the vaccination. Stopped taking birth control in order to rule out if that was a contributing factor and the symptoms persisted after stopping hormonal birth control. These symptoms were not present or not as strong prior to the Covid-19 vaccination.
Flu like symptoms, severe headache, swelling of injection site.  4' diameter red, warm to touch, raised, very sore injection site.  Temp of 99.3 beginning at 6:00PM on 9/23/2014.  Swelling and redness continued to worsen.  Saw my physician on 9/25/2014.  Headache better by 9/25/2014.  Swelling still at injection site on 9/26/2014, but not as bad.  Itching as of 9/25/2014. Photos available if needed.
My son was supposed to be given the second Pfizer Covid vaccine, instead they injected him with the adult Pfizer booster shot.
A report has been received from a Pharmacist concerning a 37 year old female patient. No information regarding relevant history, concomitant disease and concomitant medications were provided. The patient received FLUMIST QUADRIVALENT (intranasal) on 24-Oct-2014. The pharmacist reported that they accidentally administered FLUMIST QUADRIVALENT into one nostril of a patient. Patient had not reported any adverse effects. The outcome of the event of accidentally administered FLUMIST QUADRIVALENT into one nostril of a patient was unknown. The reporter considered the event to be non-serious.
I woke up I had a sore throat and saw I had sinus drainage but no spots or signs in my throat but did have congestion I became dizzy on Sunday 06/12/2022 and was fatigued and our of it then developed a fever of 101.4 I called out of work yesterday 06/13/2022 made an appointment with my PCP
Immunization given on 3/23/04 (Hep A only). Starting on 3/29/04 clieNt complains of headache in the morning and misses school. 4/1/04 Mother calls and states client still waking with headache and now has upset stomach. Mother states he has been home from school for four days and questions if vaccine has anything to to with symptoms.
Localized reaction at injection site. Approx 1 1/2 inch inflamed area. Patient complained of itching with redness and swelling. No septemic symptoms.
Regularly scheduled blood work completed 4/5/21.  Discovered thyrotoxic crisis on 4/8/21.  Was referred to an Endocrinologist (Dr.) and diagnosed with Hyperthyroidism (Graves Disease).  Was given Methmizole to treat.  Had follow up lab work completed on 11/12/21 and met with doctor on 11/17/21 and my thyroid numbers are normal.  I stopped taking thyroid medication in September 2021.  Also started experiencing (and still experiencing significant hair loss).
Patient did not receive the second dose within the recommended window; 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 did not receive the second dose within the recommended window) 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 DOSE OMISSION ISSUE (Patient did not receive the second dose within the recommended window). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not receive the second dose within the recommended window) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.
pt recvd vax 19OCT95 & 28OCT95 pt devel spots on trunk, face & back of legs-spots turned into patches;temp 100 to 101;to ER;30OCT95 rash spread over body;to MD-skin rash d/t poss viral synd vs vax rxn
About 40 minutes after the injection I developed itching of my face and neck and a large hive on my forehead.
Presented emergency room with a complaint of tremor and fever x2 days. COVID-19 test returned positive. Tx w/abx, steroids, remdesivir, VitC, zinc; pt did not require O2. DC'd home
MEMBER COMPLAINED OF ITCHY RAISED RASH ON SCALP, BACK, CHEST. STARTED 2 DAYS AFTER VACCINATION. AS OF TODAY IS STILL ITCHY BUT HAS STARTED TO RESOLVE.
No adverse effect reported.; patient was inadvertently administered a dose of PROQUAD instead of an intended dose of M-M-R II,; Both PROQUAD and VARIVAX were inadvertently administered intramuscularly; It was administered Proquad, concomitantly was administered Varivax.; have mistakenly selected Proquad from the freezer instead of M-M-R II; This spontaneous report was received from a Registered nurse refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  On 20-JUN-2019, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # R021101, expiration date 20-JAN-2020, intramuscular for prophylaxis (dose was not reported), instead of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II) as the health care worker had mistakenly selected measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) from the freezer instead of the intended Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live(M-M-R II). Concomitantly, the patient was administered varicella virus vaccine live (oka/merck) (VARIVAX) lot number N026075, expiration date 20-SEP-2019, intramuscularly (dose was not reported). Both vaccines were reconstituted with the same lot of  sterile diluent (lot number N026075). No adverse effects were reported.
it was calming down some until I received my second vaccine on March 24th at the same location.; arms now look like I am an IV drug user and the rash on my back is getting larger.; Both hands are loaded with bumps as well as both arms; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown, 66-year-old age at the time of vaccination), via an unspecified route of administration on 24Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included arthritis and eczema (I have Eczema and on occasion will get a flare up lasting a few days). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since, the vaccination, the patient has not been tested for COVID-19. Allergies to medications, food, or other products: None. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6202, 66-year-old age at the time of vaccination), via an unspecified route of administration, administered on left arm on 03Mar2021 at 10:30 AM as single for covid-19 immunisation and experienced rash and pustules. On an unknown date in Mar2021 patient claimed that "it was calming down some until I received my second vaccine on March 24th at the same location", arms now look like I am an IV drug user and the rash on my back is getting larger and both hands are loaded with bumps as well as both arms. He had an appointment with a Dermatologist on 07Apr2021. Treatment was not given for the events. Event outcome was resolving for "it was calming down some until I received my second vaccine on March 24th at the same location" and not resolved for rest of the events.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report was received from a licensed practical nurse and refers to a 12-year-old male patient. No information regarding the patient's concurrent conditions, medical history and concomitant therapies was reported. On 24-APR-2017, the patient was vaccinated with GARDASIL intramuscularly (dose, lot# and expiration date were not reported) and GARDASIL 9 intramuscularly (dose, lot# and expiration date were not reported), both vaccines were administered during the same vaccination session. No adverse effects were reported. Additional information has been requested.