chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe reaction in the injection arm; Red raw rash around the injection site; Covid arm; Felt dizzy; Fuzzy thinking; Talked a little bit strange; A spontaneous report was received from a consumer concerning a 76-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dizzy / dizziness, speech disorder/ speech impairment, thinking abnormal, vaccination site reaction, adverse reaction, rash erythematous.  The patient's medical history was  provided. as blood pressure. Concomitant medications reported were unknown medications for blood pressure.  On 29 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 004M20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 29 Jan 2021, the patient experienced  felt dizzy, fuzzy thinking, talked a little bit strange. Approximately after a week on 5 Feb 2021, the patient experienced severe reaction in the injection arm, red raw rash around the injection site and covid arm.  The treatment informations  included  diphenhydramine.  Action taken with mRNA-1273 in response to the events was not reported.   On 29 Jan 2021, the outcome of events felt dizzy, fuzzy thinking, talked a little bit strange were considered as  resolved. On 7 Feb 2021, the outcome of events, severe reaction in the injection arm, red raw rash around the injection site, covid arm were considered  resolved.
Bradycardia leading to pacemaker  Neuropathy right side Original Vaccine (1) administered was expired when given
Woke from nap, arms and legs jerking and patient unresponsive x 5 mins. Seizure like activity.
Client was vaccinated with Moderna vaccines on December 28, 2020 and January 28, 2021 (client not exactly sure about dates but they are correct within a few days.  Vaccines given at hospital.  Client tested positive for Covid on 8/1/2021 with PCR and was symptomatic.  Reported as breakthrough Covid case in previously fully vaccinated  person.
1st dose in 2018, 2nd 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 04-NOV-2022 Reporter's Comment: The reporter was a pharmacist. The reporter reported that the patient received 2nd dose in 2022. The reporter did not provide other information to the agent as reporter promptly ended the call without any further information reported. The reporter did not consent to follow up. Additional supportive information: The patient received 2nd dose of Shingrix late than recommended time frame, which led to lengthening of vaccination schedule.
Red area 4-5 cm in diameter.  Very warm to the touch and indicated at injection site. +2 edema in the 4-5 cm red area. Purification and tender to touch
This case was reported by a consumer via Merck and described the occurrence of full body rash in a female subject of unspecified age who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of ENGERIX B (unknown). At an unspecified time after vaccination with ENGERIX B, the subject experienced full body rash and unspecified event. The subject reported that she experienced a full body rash after receiving Hepatitis B vaccine. She also reported that the vaccine "did not take". At the time of the report, no other information was provided. At the time of reporting the outcome of the full body rash and unspecified event was unspecified. Follow-up information was reported on 16 March 2010 via consumer. The subject reported with the 1st dose of hepatitis B vaccine a rash covered body that night. She stated she reported the rash and was instructed to discontinue the vaccination series. The subject reported her transplant nephrologist arranged for her received the hepatitis B vaccine from a different pharmaceutical company (brand name not provided) and the doses were administered at his office in 2005. She was approved for a kidney transplant in 2005, started and completed vaccinations before January 2006 when she began dialysis followed by transplant in March 2006. On an unspecified date in 2010, the subject's blood was drawn and she was found to have no immunity to Hepatitis B. The subject restarted the Hepatitis B vaccination series with Merck product and is doing "o.k. so far". Follow-up information was received on 20 April 2010, via healthcare professional who reported the earliest onset of the events was 23 June 2005. The outcome of the events was noted to have improved, end date was unknown. The subject had no previous adverse event following first dose. The vaccination series was discontinued. No biopsy was performed. The reporting healthcare professional considered the events not serious. The healthcare professional associated the event to unknown, received multiple vaccines following kidney transplant surgery.
COAGULOPATHY, UNSPECIFIED TYPE 4/18/2023 BACK PAIN
mobility issues...feels like a really bad psoriatic arthritis flair..  unable to move feeling locked in the body taking a long time to loosen up w stretching and move   unable to move the left shoulder having difficulty w dexterity...unable to open pill bottles ...unlock locks...put on socks...left side is a lot worse than the right  cold...can't get warm  took a sick day to rest and get fluids  day is just extremely slow moving and not at my baseline even for a flair....  I just pray this is not the future living w paoriasis...bv it's not functional and worrisome...  I just figured someone should know of these s&so for.other folks like me  I'm usually controlled very well w methotrexate and the otezla supplements and diet and am very active...  I'm a nurse working full time and pick up perdiem hrs 2 weekends a month and am an avid walker...and enjoy the outdoors...  no hospital or ED needed  just rest and time are needed at this time thank you
Extreme pain in upper back and chest/abdomen area. Any slight movement felt like internals were being stabbed by hot blade. Could not lay down to sleep because of excruciating pain in back and chest/abdomen. Severe pain lasted for about 5 days and started to calm down after that but it was at least 2 weeks before could sleep without pain. I contacted the doctor on Oct 11.. Dr. felt pain was due to reflux but I never had pain like that before with reflux. He changed reflux medicine to pantoprazole and had me take raglan too. I'm not sure if that helped or not because the pain had already started subsiding before the change in medicine. Since then I have had 3 similar pain attacks on my right side. The excruciating pain last for at least 3 days and then starts to subside. Seems to be happening every couple of weeks
Severe vomiting all night after receiving immunization (FLUZONE HD) on 11-16-12.
I received a shot, but it was very low, not in the deltoid region. I can provide a photo of where it is located. At this time I am not having any out of the ordinary side effects besides being sore in the middle/distal area of my upper arm.
No adverse events at this time, But child is 15 years of age and should not have received  the Johnson & Johnson vaccine but the Pfizer vaccination instead.
Developed red rash on most of upper arm morning after receiving vaccine.  Pt reported some arm pain but not itchiness. Pt also had some headache and fever.
The shot was given 30th of Sept 30 2017. My sister got a shot the same day the nurse did not change gloves. 4 times I have had flu shots before they never bother me the 5th time I ended in hospital. It give me head sinus drainage and it went to my chest congest and a bad cough the Dr. treated me. Urgent care. I had flu shots every yr this flu shot was a bad shot I about died I even had a seizure and I don't have seizures.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 08-JUN-2015, the patient was vaccinated with a dose of ZOSTAVAX, intramuscularly, (strength, dose, frequency and anatomical location were not reported), (lot # K000326 with expiration date: 27-FEB-2015), which was expired. No adverse effects were reported. Additional information has been requested.
received only the diluent of menveo; received only the diluent of menveo; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA687A, expiry date 30th April 2023) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.    Additional Information: GSK Receipt Date: 24-May-2022 Reporter's comments: Medical assistant reported that the patient received only the diluent of Menveo. The consent to follow up was given.  Additional Supportive Information: The patient received only the diluent of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Patient accidentally given Pfizer vaccine as second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Patient accidentally given Pfizer vaccine as second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    The patient's past medical history included Hepatitis C (Desires treatment). Concurrent medical conditions included Drug allergy, Hypertension, Depression, Arthritis since 2013 and Anxiety. Concomitant products included BUPROPION from 24-May-2021 to an unknown date for Depression and Anxiety, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HCTZ) from 24-May-2021 to an unknown date for Hypertension.   On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Patient accidentally given Pfizer vaccine as second dose). On 22-Jun-2021, PRODUCT ADMINISTRATION ERROR (Patient accidentally given Pfizer vaccine as second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PRODUCT ADMINISTRATION ERROR (Patient accidentally given Pfizer vaccine as second dose) to be not related.    Treatment information was unknown.  Patient had second covid vaccine given as Pfizer with first covid vaccine given as Moderna.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Medical history and concomitant drugs were added. Patient demographics updated. Start date of Moderna vaccine updated. Reporter causality was updated.
NO NEGATIVE OUTCOME OBSERVED AFTER RECEIVING FIRST DOSE OF COVID VACCINE RESIDENT DIED IN HOUSE AFTER MULTIPLE CO MORBIDITIES PRIOR TO ADMISSION
Starting 12/09/2022, I had a runny nose and mild sinus drainage like allergies. On Saturday, I felt achy and my chest felt tight. I usually have upper respiratory infections so I thought I should see urgent care to get treatment for it. When I went to urgent care, 12/10/2022, they tested me for COVID-19 and I was positive. They gave me a prescription for an antiviral but I did not need to use it because my symptoms were not severe. When I got home, I tested myself for COVID-19 because I didn't believe I actually had COVID-19 and it was positive. I had the symptoms for about 2 days then felt fine and normal after words. I feel like I was experiencing my normal allergy symptoms with the COVID-19 infection.
Patient reported it caused his asthma to resurface and he had a hard time breathing. This resolved spontaneously gradually over the next 3 days.
Patient was give vaccine and she is under the age of 18. No adverse side effects/events reported
The patient developed a bump on lhe inside of the arm/ the bump grew larger and the patient had the bump excised/ the bump was sent to the lab for pathology and the report shows that is it kikuchi disease; This spontaneous report was received from a medical assistant referring to a 12-year-old female patient. The patient did not has any pertinent concurrent condition, medical history, concomitant medication or previous drug reactions or allergies.  On 27-FEB-2020, the patient was vaccinated with a standard dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), intramuscularly, as prophylaxis (concentration, number of administered dose; lot number R027576 and expiration date 23-JUN-2021).  On 02-MAR-2020, the patient developed a bump on the inside of the arm, not where the vaccine was administered. On 10-MAR-2020, the patient sought medical attention from the physician who used a low set heating pad with a 4 inch ace wrap around the bump, the bump grew larger and the patient had the bump excised on 24-MAR-2020 and she had no longer the bump inside the arm. The bump was sent to the laboratory for pathology and the report showed that was kikuchi disease (histiocytic necrotising lymphadenitis).   At the time of this report, the outcome of histiocytic necrotising lymphadenitis was not reported.     The causality assessment between therapy with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) ( GARDASIL 9) and the aforementioned event was not reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: R027576; expirationdate: 23-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
This spontaneous report was received from a pharmacist and refers to a 62 year old male patient. No information was provided about the patient's pertinent medical history, drug reactions or allergies. His concurrent conditions included issues with blood pressure. On 12-MAR-2017, the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml, subcutaneously, lot # reported as M038351, expiration date 06-DEC-2017. The patient's concomitant medications included unspecified medication for blood pressure. On 12-MAR-2017, upon administration of ZOSTAVAX the patient experienced pain upon injection. The patient sought medical attention, he contacted the pharmacist and received an unspecified treatment for the event. The pharmacist also reported, that the patient could not remember if they had a previous dose of ZOSTAVAX in the past, he might have received 2 doses. The outcome of pain during injection and the relatedness between the event and ZOSTAVAX were not reported. Additional information has been requested.
This case was reported by a physician via call center representative and described the occurrence of extensive swelling of vaccinated limb in a adult patient who received Influenza vaccine Quadrivalent 2018-2019 season for prophylaxis. On 9th October 2018 10:00, the patient received Influenza vaccine Quadrivalent 2018-2019 season (intramuscular). On 9th October 2018, less than a day after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced extensive swelling of vaccinated limb, injection site itching and injection site hives. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site itching and injection site hives were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site itching and injection site hives to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: The age at vaccination was not reported. After receiving Flu vaccine, the patient experienced itching, swelling over an 8cm by 8cm by 3cm area and hives at the injection site. The reporter knows it was a GSK product but was unable to provide the name or any other information at the time of the call. The staff member would call back to provide additional information. This case was transferred to medical information. This case has been linked with the case US2018183707, US2018GSK186849 and US2018GSK186850 reported by same reporter.
Eye sight  White spots started forming until I couldn't see.  Face was white, lips were blue.  Lasted about 40 minute, when eyesight was coming back, I could see it moving like a line slowing from right to left until it disappeared & my sight was back completely.  Had to be driven home from work.  When eyesight was back hen chills, sick to stomach, fever.  These symptoms lasted about 12 hours.
Diagnosed with COVID days PTA; admitted with worsening SOB, N/V/D; dx with COVID pna. progressed to severe with ARDS. Treated with O2, steroids, abx, toci, pepcid, singulair, zinc, remdesivir, ovenox, velteri/sildenafil. Required mechanical vent. Transferred to a medical facility at request of family.
Sharp neurological pains in right hip and going down right leg.  Unable to sleep at night because of pain. Pain lasted past 3 weeks. Went to doctor to report it.
Swelling & redness of left arm; body sore - given oral prednisone & BENADRYL.
w/in 24hr of vax pt devel low grade fever, myalgia, n/v, fatigue & an 8cm hive @ the inj site;pt seen by MD tx w/advil & recovered;
Shingrix #1-received December 30, 2019. Following morning at appx. 7:00am felt nauseous and then dizzy enroute to bathroom. Increased dizziness,difficulty seeing and then lost consciousness. Fell striking undersink cabinet door which shattered inside. When I regained consciousness,my husband helped me into bed. Applied ice pack to back of neck. Thursday January 2, 2020 got eye exam to check for detached retinas  at Clinic.  On  Saturday evening January 4, 2020,my husband noticed swelling and bruising  on  left forehead. Evaluated at Hospital ER. Emergency Room staff ordered x-rays of my neck.
Anxiety increased through taking the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety increased through taking the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANXIETY (Anxiety increased through taking the vaccine). At the time of the report, ANXIETY (Anxiety increased through taking the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Treatment information was not provided.
7-10 days after vaccine developed shingles. Visit doctor who prescribed pain killers. Improving slowly.
I started experiencing vertigo/dizziness episodes the day after I received the moderna vaccine. I then had a severe episode in the middle of the night on April 7, 2021. In the middle of the night on April 7th I woke up and out of nowhere I started experiencing severe nausea, dizzinesss/vertigo, and uncontrollable vomiting. I was taken to the emergency room via ambulance where they did labs and a head CT. They were unable to figure out what was going on. Ever since this severe episode I've had moderate to severe tinnitus that has kept me from sleeping at night it has been so loud. I also have permanent and significant hearing loss in my right ear. I also have ongoing dizziness and vertigo daily that worsens if my vestibular system gets overstimulated. These issues affect my daily life.
This spontaneous report as received from an office manager via a company representative refers to a 24 year old male patient. On an unknown date the patient was vaccinated with a dose of GARDASIL (Lot # not provided) (dose and route not reported). Concomitant therapy was not reported. On an unknown date after receiving GARDASIL the patient complained of tinnitus. The outcome of tinnitus was unknown. Additional information has been requested.
I had a breakthrough case of Covid 19 with mild cough body aches fatigue I was prescribed Paxlovid.
Info has been received from a surgical supply company concerning a pt who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot #641116/1160L). Subsequently the pt developed swelling, dizziness, vomiting and a rash. Unspecified medical attention was sought. "Dr. requests a lot check". The reporter also mentioned 2 other pts (WAES #0303USA00570 and 0303USA00571). The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
Only liquid portion only of Menveo used; Only liquid portion only of Menveo administered; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amxa724z, expiry date 30th September 2023) for prophylaxis.   On 8th December 2022, the patient received Menveo. On 8th December 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 9-Dec-2022 Reporter's comment: The reporter reported that was not aware that both portions should be mixed before the administration and the nurse in charge was no available at the time of the administration.  The vaccine administration facility was the same as primary reporter. Did not consent to follow-up. Additional supportive information: The patient was administered the liquid portion only of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Patient 13 weeks pregnant. To view with OB/GYN at apt-revaccination. At Clinic, box of Hepatitis A pediatric in cooler instead of adult formulation and pediatric dose given.