chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AEs/no PQCs; a dose of PROQUAD was administered after a temperature excursion.; This spontaneous report has been received from an office manager referring to a 12 month old patient. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions, or concomitant medications.     On 10-OCT-2022, the patient was vaccinated with an improperly storage dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA)(PROQUAD) lot # W017571 with an expiration date on 29-NOV-2023, for prophylaxis, after a temperature excursion.  The dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA)(PROQUAD) was exposed to a temperature excursion of 6 degrees Fahrenheit (°F) up to 14°F (10.91 F), during a time frame of 1 hour. There was no prior temperature excursion and no adverse events were reported.
Patient received Tetanus/diphtheria/pertussis toxoid on 6/28/16 at 14:13 pm. C/o at 15:11 pm "itching, throat closing" Dr. notified. Patient brought to ER treatment
Information has been received from a 68 year old female with type 2 diabetes mellitus and parotid cancer and a history of hall bladder removed and appendicectomy who on 31-MAR-2008 was vaccinated with one single dose of ZOSTAVAX vaccine (Oka/Merck) (injection, dose and lot number not reported). concomitant therapy included ACTONEL, PRAVACHOL, NORVASC, SYNTHROID, ACIPHEX, EZETIMIBE, SPIRONOLACTONE, INDERAL, NASONEX, SEROQUEL, MIRALAX and  ACTOS. On 03-APR-2008 "three days after receiving ZOSTAVAX vaccine (Oka/Merck), a lesion developed on the face of the patient between her eye and her nose. She also experienced "numbness of a nerve under the skin of her face which was approximately three inches over from the lesion was located. Both the lesion and the numbness lasted approximately three months. No medical attention was sought. Subsequently, the patient recovered from the adverse events. Additional information has been requested.
Vaccine area is pink & warm to the touch. Approximately 1 inch below the pink area, there is a larger square patch that is red and hot to the touch.
Started fatigue, then muscle aches, headache, sore throat, eyes hurt, then congestion nasal, ears progressed to chest cough, flunofproductiveproductive
About 25 hours after the injection, I started getting chest pain & dizziness.  The chest pain lasted about 1.5 week but the dizziness has continued for nearly 3 weeks after full work-up by PCP.
Little trouble breathing and using a humidifier at night; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: Not Provided) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was handicapped and on a cane. Unable to confirm if patient was handicapped and using a cane prior to taking the vaccine. Historical vaccine included BNT162B2 (solution for injection) via an unspecified route of administration, administered on an unspecified date as dose 1 single for COVID-19 immunization. On an unspecified date the patient experienced little trouble breathing and using a humidifier at night. Treatment received for the event. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
She has started to have chronic back pain which is weird when you're 10. It's intermittent, not constant. She experiences dull achy pain anywhere from her shoulder blades to her hip area. It is on both sides. It can be managed with ibuprofen, but it comes up 3-4 times a week. It is not related to more or less physical activity. Not related to anything that she has done in school. Doesn't seem to be related to carrying a backpack or anything like that.
Within 30 minutes, post vax of TD, pt felt flushed. Later that evening, she developed a fever of 101F, swelling and erythema at the injection site. Her "arm was useless, couldn't pick it up" per pt. Pt reported feeling pain into the neck, shoulders and head. Ibuprofen did not help. Took Goody body ache powder Saturday night and felt better by Sunday AM.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 020H22A) for COVID-19 prophylaxis.     The patient's past medical history included Non-smoker.    On 22-Dec-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant and Treatment medication was not provided.   Patient received her 4th Bivalent booster and approximately 10 days later she caught COVID-19. Patient was experiencing sore throat, running nose, sinus congestion and nagging cough and was still recovering for the past 3 weeks. Patient  primary problem was Head congestion and discolored mucus.   This case was linked to MOD-2021-065563 (Patient Link).
Aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Aches). At the time of the report, MYALGIA (Aches) outcome was unknown.            Concomitant product use was not provided.   Treatment information was not provided.   This case was linked to MOD-2021-303445, MOD-2021-303640 (Patient Link).
This spontaneous report as received from a pharmacist refers to a currently 86 year old female patient with hypertension. The patient had no drug reactions or allergies. In 2009, the patient was vaccinated subcutaneously with an unknown dose of ZOSTAVAX (lot # and expiry date were not reported). Concomitant therapies included NORVASC, DIOVAN and hydrochlorothiazide (manufacturer unknown). On an unknown date (reported as recently), the patient was diagnosed with shingles on the left side of her head and left eye. The patient sought medical attention and she was evaluated by her physician. It was unknown if the patient received medical treatment. At the time of the report, the patient was recovering, but still had neuralgia in the area of her left eye. The relatedness between the events and ZOSTAVAX was not reported. Upon internal review, the event of shingles on the left eye was considered to be medically significant. Additional information is not expected as the reporter did not wish further contact.
Moderate swelling on the day when administered. Redness the following day with fever of 102.6. The 3rd day started feeling better, redness remains and less painful. Pt took Benadryl 50mg and aspirin 325mg twice the day after vaccines administered.
There was no adverse event. I was told to fill this out by Department of Public Health.  This patient was given two doses of the Moderna brand vaccine in March and April of 2021. She had her antibodies drawn for COVID19 2 months later and they were negative. Due to the fact that patient is on IV immunosuppressive therapy for myasthenia gravis and had failed to develop antibodies, the doctor here ok'd her to have a second set of vaccinations. This was completed in July and August 2021. Patient is fine. No adverse reaction. Again, filling this out at the direction of Department of Public Health.
At 0400 woke up with tachycardia HR 120-140s, Chest pain when deep breathing, SOB, Chills, Hypotension. Went to ER. Was tested negative COVID and CXR negative. Currently 2 days after initial reaction- still having SOB/ Chest pain/ Tachy when exerting 100-120s.
Large area of confluent erythema with central injection area having slight induration. There is a clear geographic border where the erythema stops. No urticarial lesions noted. The whole area is warm to touch but not painful, no fluid collection seen, no abscess palpated.  Not pruritic.
pain in left shoulder and arm  This was followed by blisters on the left all the way to the wrist and a few on left upper quadrant of my back  The injection date was 12/7/2022  and the pain from in my arm started the next day   The rash and blisters started around 12/14/2022  I had an appointment with my doctor on 12/19/2022 and he expected Shingles.  Lab test confirmed his diagnosis.  He prescribed Valtrex and I am recovering
Information has been received from a physician concerning a patient who was vaccinated with MMR. Subsequently, the patient developed autism. The physician reported that a mother wanted to delay the vaccination of her younger child with MMR because her older child had autism. The physician stated that he does not believe there was any connection between the older child receiving MMR and then developing autism. However, the mother believes if she waits until younger child is a little older, it will be safer for her child. Unspecified medical attention was sought. No product quality complaint involved. Upon internal review, autism was considered an important medical event (OMIC). Additional information has been requested.
Information has been received from a physician concerning an 80 year old male with high triglycerides, peripheral neuropathy, and an erythematous rash on his left ear, face, neck and scapular since September 2006 and a history of chickenpox who on 15-DEC-2006 and 19-JAN-2007 was vaccinated SC with a 0.5 mL dose of Varivax. Concomitant therapy included losartan potassium. The reporter noted that although the patient had a history of chickenpox, he requested to be vaccinated with Varivax in December of 2006. After the first vaccination, in approximately December 2006, the patient's tongue became swollen and oral prednisone was needed to reduce the reaction. After the second dose, in approximately January 2007, the patient developed a pimple-like rash on both legs below the knee. The patient believed that some of  the pimples were fluid filled at one time. but they were not currently. He was treated with ELOCON cream, prednisone, and ALLEGRA. Unspecified medical attention was sought. At the time of the report, the patient was recovering. A product quality complaint was not involved. The patient's experiences were considered to be other important medical events by the reporter. Additional information has been requested.  Additional information has been received from the physician who reported that on 19-DEC-2006, the patient's tongue became swollen and he had a dry mouth. His tongue "felt like a glove was on it." The patient had erythema, and urticaria on the left lateral neck and left clavicular region with scratch marks. Chickenpox was noted. At the time of the report, the patient had not recovered. The patient's experiences were considered to be other importance medical events by the reporter. Additional information has been requested.
Started with itching on my neck and scalp and developed into full body hives and facial swelling. Currently on my 4th day
Patient fainted approximately 5 minutes after receiving 2nd dose of Pfizer vaccine. Vaccine adminstered at approximately 12:20pm. Witnesses reported patient fell to floor and hit his head. This writer assessed patient after fainting. Patient was diaphoretic but oriented. Patient was given water and advised to sit on the floor for a few minutes. Patient then transferred to a chair where is sat for an extra 20 minutes. No EMS activated. Patient reported feeling better after sitting. Patient reported that he was with his significant other. Advised patient to have significant other drive him home.
I did have leg injury in April - and ever since the vaccine, I  now have an issue with swelling that won't stop - still have swelling. I was checked with blood clots - and it was elevated so they gave me an ultrasound in leg - no blood clot. Swelling on right leg was enlarged after the vaccine. Two missed menstrual cycles; now I have had the cycle but it's a longer cycle than I normally would have. It's abnormal - the length and flow is off. Spotted for a week before I started bleeding. I had slightly elevated blood pressure after the vaccine - 117/83 usual  but it was elevated 141/95 - and it's never high ever like that before. So they had thought I had a potential blood clot. Have an upcoming doctor's appt scheduled.
BD Integra syringe using  failed, small amount leaked out of connection of needle to syringe (LOT#1054572, exp. 2-28-2026)...dose not repeated as wasn't a large enough amount.
Client was seen by his doctor on April 13th related to severe headaches .  He stated that he had headaches prevaccine and was given Tropromax for it which he only took for  2 days as it caused him dizziness. He had CT scan of Head and MRIs on April 13 and 14th and then again on April 27th.  The scan on April 27th showd a blood clot with 80% blockage  in carotid artery and was dxd with a blood clot via CT scan.  .  He was told to get to  Hospital  where he was admitted to ICU for 4 days   Client was also dxd with Factor5 Leiden at that time.  Per client he ha a stroke and is recovering.  Per client still unable to work r/t poor balance and dizziness
Vaccine gave recurring shingles/ had recurring shingles ever since got the vaccine/ Suspected vaccination failure; Had recurring shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 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: 02-OCT-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The reporter stated that the vaccine gave him/her recurring shingles ever since he/she had got the Shingles vaccine. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
My lymph nodes/breasts were continuous pain from 2/8  for like a week and then they the pain would come and go. I went to primary/ they did pregnancy test : negative. It was definitely from shot. My lymph nodes and armpit pain was stopped but 2 months later my breasts still hurt, my breasts have grown a size and I can?t touch them some days or lay on them.
I became perimenopausal over the summer which is not surprising, I started having hot flashes, sleep disturbance, memory issues that were disruptive enough that I spoke to my nurse practitioner in March 2021. I had lab work to confirm where I was in terms of hormonal status to confirm I was technically in menopause which I am and I was started on low dose HRT to address those issues. I am about that age. Because I am part of the V-Safe Surveillance this event met criteria for reporting as  Treatment-Emergent Adverse Event.  I am ashamed I didn't realize this myself since this is what I do for a living so am following up to report it because it may or may not be significant but definitely indicative that public health surveillance works! WOOHOO!!!    Since beginning HRT my life has stabilized and I am quite fine. So the the event has reached major symptoms resolved (sleep issues, hot flashes, memory issues) and root diagnosis has improved and managed in chronicity"
About 1 week after injection, my left shoulder around the injection site started becoming swollen, red, inflamed, and itchy. Within a few days, the swelling engulfed my entire shoulder and upper arm. The physical sensation was like an enormous, hot mosquito bite. No pain, unless I scratched it too much. I called my doctor for a telephone consultation, and he advised that I apply heat to it. I used a hot towel for the heat pad, and after a cumulative of 8-12 hours over the course of 2 days, the symptoms subsided, and my shoulder was completely back to normal.
Information has been received from a physician concerning a six year old Asian Filipino pt who on 01Apr02 was vaccinated with varicella virus vaccine live in another country.  On 20May05 the pt experienced break through. Additional information has been requested. This is in follow-up to report (s) previously submitted on 5/12/2006. Information has been received from a physician concerning a six-year-old patient who on 01-APR-2002 was vaccinated with VARIVAX (Merck) in another country. There was no concomitant medication. On 20-MAY-2005 the patient experienced break through. Follow up information received from the physician report the patient did not undergo any lab/diagnostic tests. The only reported adverse reactionwere the vericella lesions, a few lesions with no fever or puritis. Additional information is not expected.
Muscle and injection site very swollen, warm to the touch, very achy, as if I had the shot yesterday (not a week later).  Didn?t have any other side effects or symptoms up to this day.
Received ZOSTAVAX 10/15/12 and presented to pharmacy 10/18/12 with baseball size red, warm rash at injection site. Patient treated with OTC TYLENOL.
Flu Vaccine given 9/15/2010. That night, patient'a arm began to hurt and turned red just below deltoid muscle to just above the elbow. On 09/17/2010 pt. saw Nurse Practitioner and was prescribed Bactrim DS BID x 10d. On 09/18/2010 the redness had spread to elbow, saw MD in ER and given Atarax and triamcinol cream. Supervisor saw pt. in home 09/20/2010 and reports arm still red down to the elbow. Called NP, and reported assessment, instructed to return to MD 09/21/2010 if worse or no better.
The child walked out of the office after receiving the shots then fell on the floor in the hallway. She denied hitting her head. She also reported that she did not lose any consciousness. Answered the questions coherently. Stated that she just felt dizzy after receiving the shots. A pouch of juice and a pack of crackers were given. Legs were elevated. Stood up with assistance after 10 minutes,  walked with a steady gait and claimed that she's "fine". Sent home, accompanied by parents.
Headache about 2 hours post injection; pain spread throughout her entire body; This is a spontaneous report from a contactable other non-health care professional (nurse). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, the patient stated that she had recovered from contracting COVID-19 a few months prior. She began having a headache about 2 hours post injection this pain spread throughout her entire body. She presented at the Emergency Room later. She was treated by an  physician (Released after a few days. Event took place after use of product. The adverse events resulted in emergency room visit. The clinical outcome of the events was reported as unknown.  Information on the lot/batch number has been requested.
Headache, Myalgia, Tachycardia, Migraine headache, cramping in chest/neck Narrative:
Urticaria that is coming and going on multiple areas of my body throughout the days without any apparent pattern that began the day after receiving the flu shot. Large welts that persist for several hours and patches of hives that also persist for several hours.
A hard red lump formed at the injection site.  The site was itchy, hot and sore.  I also had a headache and nausea.
Patient was sitting on exam table in room 1. She had received a TB test placement without difficulty, also received influenza vaccine injection into left deltoid without difficulty. Patient exhibited no symptoms and was talking to mom. Patient did not state that she was feeling faint. Patient suddenly fell from exam table from sitting position and hit face on floor. Patient was unable to be aroused to consciousness for approximately 30-60 seconds. Palpable carotid pulse, breathing was visible via chest movements, color pale, lips dusky. Patient aroused to verbal commands at 4:19 PM, oriented to person, place and situation. Reported nasal pain and on forehead upon arousal. Erythema of nasal bridge noted and mild nasal bruising. Denied pain other locations, Moving head freely. 911 called immediately at 4:20 PM with arrival at 4:25 PM. Patient able to stand and walk to EMS cart. Conversation appropriate. Taken by EMS personnel to ER for evaluation. Mom present with patient during entire situation. EMS squad updated on events.
STARTED ITCHING AT SITE.  LATER PROGRESSED TO FINE RASH OVER ENTIRE BODY.  EXTREME ITCHING ALL OVER.  UNABLE TO CONTROL WITH OTC MEDS. WENT TO FREE STANDING CLINIC THE NEXT DAY-RECEIVED CORTISONE INJECTIONS X 2 AND TOLD TO TAKE ANTIHISTAMINE
Syncope; This case was reported by a physician via call center representative and described the occurrence of syncope in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA050A, expiry date 13th October 2019) for prophylaxis.   Co-suspect products included Men B NVS (Bexsero) (batch number ABX770AA, expiry date 31st July 2020) for prophylaxis and tuberculin purified protein derivative (Tuberculin Ppd) for product used for unknown indication.   The patient's past medical history included syncope (when gave blood).   On 17th June 2019, the patient received Menveo, the 1st dose of Bexsero and Tuberculin Ppd at an unknown dose and frequency. On 17th June 2019, less than an hour after receiving Menveo and Bexsero, the patient experienced syncope (serious criteria GSK medically significant). On an unknown date, the outcome of the syncope was unknown.   It was unknown if the reporter considered the syncope to be related to Menveo. The reporter considered the syncope to be related to Bexsero.  Additional information was provided as follows: The patient had history of syncope when she gave blood previously. The patient received Bexsero and Tuberculin PPD in left deltoid and Menveo in right deltoid. Within 5 minutes after receiving these vaccines, the patient had syncope. The healthcare professional (HCP) thought that Bexsero was the cause of syncope and wanted to know if GSK was aware of more reporting for syncope since Bexsero's approval in the US. The reporter had reported syncope previously in 2-3 times for different patients. The HCP recommended to patient and her mother to get 2nd dose of Bexsero. The reported batch number AVX770AA for Bexsero did not exist and was updated to ABX770AAas per the sales database.