chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I came down with a virus and am still fighting the virus; Medication Details and reason for taking the medicine: Thera-Flu and Flonase in response to the vaccine.; This spontaneous case was reported by a patient and describes the occurrence of VIRAL INFECTION (I came down with a virus and am still fighting the virus) and PRODUCT USE IN UNAPPROVED INDICATION (Medication Details and reason for taking the medicine: Thera-Flu and Flonase in response to the vaccine.) in a 77-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for Flu.     The patient had no medical history, concomitant disease or risk factor.     On 11-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 11-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced PRODUCT USE IN UNAPPROVED INDICATION (Medication Details and reason for taking the medicine: Thera-Flu and Flonase in response to the vaccine.). On 13-Nov-2023, the patient experienced VIRAL INFECTION (I came down with a virus and am still fighting the virus). At the time of the report, VIRAL INFECTION (I came down with a virus and am still fighting the virus) had not resolved and PRODUCT USE IN UNAPPROVED INDICATION (Medication Details and reason for taking the medicine: Thera-Flu and Flonase in response to the vaccine.) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       No concomitant were provided.  The patient came down with a virus and am still fighting the virus. It was unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine was Thera-Flu and Flonase in response to the vaccine.  No treatment medications were provided   This case was linked to US-MODERNATX, INC.-MOD-2023-750400 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750400:Invalid case for many people
rash as itchy; Rash; Pain; rash as itchy at times and swollen and red; rash as itchy at times and swollen and red; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, less than a week after receiving Shingrix, the patient experienced swelling and erythema. On 21st August 2020, the patient experienced pain. On 22nd August 2020, the patient experienced rash. On 24th August 2020, the patient experienced pruritus. On an unknown date, the outcome of the pruritus, rash and pain were not recovered/not resolved and the outcome of the swelling and erythema were unknown.   It was unknown if the reporter considered the pruritus, rash, pain, swelling and erythema to be related to Shingrix.  Additional information was provided as follows: The patient would be 62 in September 2020. The patient noticed pain on the same day of injection. The patient stated she had a rash that she noticed 1 day after the injection and each day it got larger up to 4 inches wide but below the injection site. She described the rash as itchy at times and swollen and red. The reporter did not consent to follow up. No DOB, LOT, or EXP provided. Caller did want to provide her demographics but did state her Birthday was in September and she was born in 1958.
This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a adolescent female patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On an unknown date, unknown after receiving BEXSERO, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be almost certainly related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO vaccine on an unknown arm. The patient experienced arm pain on the injected arm. Limited information was provided by the sales representative from the nurse practitioner.
Child's mom reported low fever since day of immunizations.  Multiple blisters behind one ear noticed by mom 3 days after immunizations received. Child seen by physician 8/11/16 and was DX and treated for Staph infection, dermatitis and impetigo. 8/22/16 - Mom reported all symptoms have resolved.
sore throat; Sore Arm; Chills; fever 102; extreme tiredness; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the second dose of bnt162b2 via unspecified route of administration in left arm on 09Apr2021 12:00 (Lot number ER8737) at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history included pleurisy, COVID-19 diagnosed prior to vaccination. The patient had no allergy to medications, food, or other products. The patient's concomitant medications included estradiol (ESTROGEN), celecoxib (CELEXA), methylphenidate hydrochloride (CONCERTA). The patient previously received the first dose of bnt162b2 via unspecified route of administration in left arm on 16Mar2021 11:00 AM (Lot number EP7534) at single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Apr2021 20:00, the patient was experiencing sore arm, chills, fever 102 F, and extreme tiredness. On 12Apr2021 12:00, the patient was experiencing sore throat. No treatment received. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was resolving.   No follow-up attempts are needed. No further information is expected.
Information has been received from a RN concerning an approximately 45 year old female nurse who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On 04/13/04 the pt developed splotches on her arm at and around the site of injection. Unspecified medical attention was sought and no treatment was required. It was reported that the pt had not yet recovered. No product quality complaint was involved.  Additional information has been requested.
nausea, light headedness, chills, fatigue,  fever, headache, body aches  advil for headache  symptoms lasted ~12 hours
no adverse effects were reported; improperly stored vaccine administered; This spontaneous report was received from a physician regarding a patient of an unknown age and gender. The patient's pertinent medical history, drug reaction and drug allergies were unknown. The patient's concomitant therapies included sterile diluent. On 17-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R027993 and expiry date: 01-OCT-2020 (strength, dose, frequency, route not reported) for prophylaxis (product storage error). The vaccine underwent temperature excursion of 15 degree Fahrenheit (F) to 46 degree Fahrenheit (23F) for 3 hours. There was no previous temperature excursion involved. The call was due to digital data logger. No adverse effects reported (no adverse event). Product quality complaint was not involved.  This is one of several reports received from the same reporter.; Sender's Comments:  USA-009507513-1904USA010577: USA-009507513-1904USA011971: USA-009507513-1904USA011972: USA-009507513-1904USA011973: USA-009507513-1904USA011974: USA-009507513-1904USA011975: USA-009507513-1904USA011976: USA-009507513-1904USA011978: USA-009507513-1904USA011979:
Pt recv vax on 10/22/98; on 10/23/98 pt exp swelling at vax site, redness
5 cm circular around injection site. Local,red reaction on right deltoid. Benadryl prn itching and redness, follow-up if redness increases or tenderness.
Pt vaccinated /w DTP experienced pallor, hypotonia, Unresponsiviness for 60min.
Swollen lymph nodes in neck, both sides. Sore lower back Small hives on both hands
Patient developed a fever of 102F within 24 hours of receiving the vaccination.  Patient had nausea, headache, fluttering heart beat, and painful and itchy swelling of the arm that vaccination was given in.  This reaction proceded for 48 hours before begining to subside.
Prior to administering the vaccine, the patient had expressed an intense phobia of needles to pharmacy staff, and this was communicated to the pharmacist.  After administering the vaccine, the patient stated that they felt lightheaded.  The pharmacist then asked the patient if they wanted to remain seated, and the patient lost consciousness for approx. 60 seconds.  Per Pharmacy protocol, code white, (indicating injury) was declared over the stores radio system.  The patient was lowered onto the floor, legs were elevated and cold compress applied as per protocol.  Following the patent regaining consciousness, they declined paramedic assistance and was provided with an electric cart to aid in leaving the premises.
Fever temp 103 F 62 days. Rash 6 days post vaccine. No bleed raised, red area 3 days after vaccine administration.
NASAL CONGESTION, SORE THROAT, EAR ACHE, FEVER, FATIGUE MAB TREATMENT
I experienced an allergic reaction at the injection site (red circle with swelling and pain) when I got the shot. It went away and came back even larger a week after the shot. No anaphylaxis. Please let me know if I should consult my doctor.
Headache, Myalgia, Arthralgia,  chills, fatigue Narrative:
Racing heart, itchy (no rash); Racing heart, itchy (no rash); This is a spontaneous report received from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown) via unspecified route of administration in left arm on 18Mar2021 at 11:00 (at the age of 37-year-old) for COVID-19 immunisation. Medical history of the patient was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested positive for COVID-19 since having the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. Concomitant medication was not reported. The patient did not have allergies to medication, food or other products. The patient experienced racing heart, itchy (no rash) on 18Mar2021 at 12:00PM. No therapeutic measures were taken as a result of the events. The clinical outcome of racing heart, itchy (no rash) was not recovered at the time of this report.   No follow-up attempts are needed. Information about lot number cannot be obtained.
pt recvd vax;slghtly irritated & warm in pm;apap given by mom;slept & waked w/ t 105 R;v x 2;examined by MD;given apap & clear liquids;fever cont until next am;to er & apap & ibuprophen given;t down to 102 2 hrs later;
I have been breastfeeding for 8 months. I noticed a major dip in supply beginning the day after the shot. It has been 1 week and my supply levels have not returned. I pump and only pump about half of what I did prior to the vaccine.
LITTLE HEADACHE; TIREDNESS; This spontaneous report received from a consumer concerned multiple patients of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and have been requested. No concomitant medications were reported. On an unspecified date, the patient experienced little headache, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the little headache and tiredness was not reported. This report was non-serious.
The next morning after the vaccine I woke up extremely stiff. My back was in excruciating pain and anytime I tried to move the pain was so severe it was at crying level. EMT was called because my husband couldn't get me into the car for transport. I was transported to ER and was diagnosed that the disc in my back from L3 to S1  had completely swollen applying pressure on all the nerves and muscles in my back. I was treated with morphine and several steroid shots and was monitored until I could finally sit up and was released. I visited my PCP the next day and by that time I could walk on a walker and he again gave more steroid shots to help elevate the swelling. This persisted for about a week where I had a hard time walking and was still taking the steroid pills to help make the additional swelling go down. The early part of the summer I was beginning to develop various red spots all over my body. My dermatologist stated something upset my whole immune system and diagnosed me with Sudden Onset Psoriasis. I have never, nor does my family have a history of Psoriasis so she attributed it back to the COVID vaccine as well because nothing else had changed to make this occur. My Dermatologist stated this is now a chronic issue and will never go away and I have to use an expensive cream to help treat for the rest of my life and she also has advised Phototherapy where I will be treated with pills and shots the remainder of my life and to date I am still seeing a Physical Therapist as well for my back.
Left upper spine and arm went into flames as if someone had thrown lighter fluid on it and thrown a match. The pain was so great, Flames lasted for at least 5 days and slowly receded to point of vaccine. This part of my back was injured in 1995 when I was rolled underneath a car. My breathing was also impaired, I couldn't take a deep breath. If I exerted myself at all I could only take very shallow breaths. I felt like I would turn blue. I could only breath if I fell to ground and rolled on my side. It was terrifying. A week later hospital x-rays showed some swelling in lung and gave me Flovent. A week later gave me antibiotics. 10 days later breathing better; not great; swelling subsided and antibiotics stopped.
Rt deltoid area of inject site swelling & redness approx 40mm x 60mm- no firm induration noted; Dev this AM 16-20hrs post vax; Mom adm APAP q4hrs cold packs to arm & states area has improved;
He couldn't move his leg where he got the injection on. I had to hold him for 2 days. He hurt him too much to move it. He also developed a 103.4 tempature that evening. It continued and went to 104.8 that Friday the 05/13/2016. I had to take him in the ER for a fluid IV. He wasn't drinking or eating those 5 days. Medicine didn't help but it finally went down 05/16/2016.
Hives all over my body; Severe abdominal pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot/batch number and expiry date unknown), intramuscular on 06Jan2021 13:00 at a single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient's concomitant medications were not reported. The patient experienced hives all over her body and severe abdominal pain on 07Jan2021. The patient received treatment for the events. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. The outcome of the events were recovered on an unspecified date. The events were reported as non-serious. No seriousness criteria provided. The facility where the most recent COVID-19 vaccine was administered was in the hospital.  Information on the lot/batch number has been requested.
Pruritus at injection site, slowly progressing to mild pain and inflammation expanding up the shoulder about 5inches long. 12 hours after initial signs lightheadedness and slight nausea.
Information has been received from a 38 year old white female who on 9/13/89 was vaccinated with MMR. Subsequently, the pt experienced pain in the hip and knee joint, hives and a bright red rash on her face and chest. Also she experienced "feeling of weakness several times a week." Additional information has been requested.
Patient received flu shot at pharmacy about 11:30 am. Within about 10 minutes of receiving the shot, the patient stated she was having some chest pain and back pain. She did state the back pain was more intense. She stated she did not know if it was from the shot, but she felt fine before. She did state she had flu shots before with no problems. We called for an ambulance. While waiting EMT's to arrive the patient stated she did have a stent put in earlier in the year, but had no problems recently. She stated she did have prescription of nitroglycerin, but did not have it with her. I checked her file, she had a prescription for nitroglycerin 0.4mg she had picked up back in February. I gave her one nitroglycerin 0.4mg tablet. By the time the EMT's arrived she state she the chest pains had only slightly lessened she thought, but no changes in the back pain. The EMT's took her outside to assess her and then took her on to the hospital.
On 9/22 around 10pm neuropathic pain began in my right foot with intense burning that progressed over the next few hours to my leg and arms.  I then began to spasm in all of these limbs.  I was able to obtain gabapentin to try and calm the symptoms - these lasted throughout the night.  These symptoms have progressed and worsened since this night moving to both of my feet/legs , both hands and arms.  Gabapentin was no longer helping and i began to have difficulty walking and performing my ADLS without pain.  I saw my primary care provider  on 9/29/21 who referred me to neurology.  I had to go to the ED per neurology on 9/29 as they could not see me in the office until after holiday.  At the ED, they wanted to admit me for a full workup for Guilian Barre syndrome but I didn't think this was necessary as I could still walk but was in pain.  We agreed to try a steroid injection first and to start Lyrica for the nerve pain.  As of this morning 9/30, my symptoms have improved but I do not know how the next few weeks will unfold.  I will continue taking the Lyrica and follow back up with neurology and my primary care provider or report to the ED  if weakness and numbness worsen.
from metformin she developed diarrhea; intercostal neuralgia; pain from the injection; redness; itches a great deal; pain; This spontaneous report was received from a 52 year old female patient consumer reporting on herself, diabetic with allergy to acetaminophen, hydrocodone bitartrate (VICODIN) and a history of hysterectomy.      On 19-OCT-2012, the patient was vaccinated with vaccine live zoster (ZOSTAVAX), right arm (lot # H012578; exp date: 23-SEP-2013) (route and dose not provided) for prevention of shingles. No other co-suspects were reported. Concomitant medications included sitagliptin phosphate (JANUVIA), metformin hydrochloride (GLUMETZA) and glipizide.     On 30-OCT-2012 (11 days after vaccination), the patient suffered pain from the injection. The pain started in her armpit under her right arm. The patient visually saw redness under her arm that was the size of her hand. The patient stated that there were no lumps or swelling. The patient could not see any signs of shingles under her arm but it itched a great deal. The patient also mentioned that the pain had developed in her right breast first and from the breast exam and mammogram tests (results not provided) the pain then occurred in the left breast as well. She has been in pain for 3 months. Treatment was not given. The patient sought medical attention, she went to the doctors office.   On unknown date, the patient had developed diarrhea from the metformin. At the time of the report, she was taking metformin hydrochloride (GLUMETZA) which cleared the diarrhea up for her.   The outcome of pain from the injection, pain, itches a great deal and redness was unknown.    Follow-up information has been received from a consumer reporting on herself. The consumer reported that her physician confirmed that she developed intercostal neuralgia on both sides of her body.  The outcome of intercostal neuralgia is unknown.  Follow-up information received confirmed that Hysterectomy was the patients medical history.  Follow-up information has been received from a layer on 24-JAN-2022 regarding a case in litigation. In or around October 2012, the patient received a dose of Zoster Vaccine Live (ZOSTAVAX) for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving the dose, the patient suffered from neuralgia. The patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment. At the time of the report, the outcome of neuralgia was not recovered. The reporter considered the event of neuralgia to be related to Zoster Vaccine Live (ZOSTAVAX).  The event of neuralgia was considered disabling.
No symptoms to date. Booster dose was given sooner than 6 months after second dose. Patient did not show any signs of reaction so far, just reporting that booster was given earlier than 6 months after second dose.
Patient called the pharmacy one month after receiving vaccine to report the following symptoms that started 4 hours after vaccine administration: felt hot/feverish (did not take temperature) headache blood sugar of 170 (pt is diabetic) shaking when stood up/dizzy (ran in to door)
Event: administering LAIV to child w/asthma. Tx: observation and consultation to follow usual medical management as recommended by PMD. Parent to observe x 24 hours and follow PMD's direction for medical management.
Pt rec'd 2 doses Pfizer/BioNTech, 2nd dose May 9,2021 at outside facility. Presented to hospital on 06/08/21 after cardiac arrest, sudden collapse at home, refractory PEA with ongoing CPR >4hrs, cardiogenic shock (EF20%), refractory DIC, MOSF and coma. Uncertain antecedent history, pt had tolerated vaccine well w/o untoward reactions, was possibly "sick" in the 2 days prior to admission 06/08, but limited history available. SARS2 PCR and resp path PCR panels negative, no clear bacterial source of shock/collapse initially identified, thus concern for primary myocarditis resulting in refractory shock (perhaps also with ischemic CVA); Tpn not c/w type I ACS/MI. Workup negative for PE, hemorrhagic stroke, PTX/tamponade, etc. 6hrs after death (in evening 06/08/21) BCx x2 resulted Grp A strep, thus pt may have had TSS at home then collapsed in PEA, however source of TSS is uncertain.  Notably patient usually healthy, active, no medications, favorable lipid panel, no illicits; + EtOH binge-drinking last several months but no cirrhosis/ESLD previously doubt primarily Etoh-related process.  Pt had ongoing PEA arrests with brief ROSC for approx 7 hrs in field -> ED > ICU until death declared.
36 hours after the injection he started to develop a full body itch from head to toe. Also he started having breathing problems. He took Benadryl which subsided the itch. His eyes became dry and he started to develop mild respiratory difficulties.
12.18.2022 - one month exactly after my booster, felt dizzy/lightheaded. Never went away.......turned into jumpy vision/loss of balance. Admitted to the hospital on 12.20.2022 for a stroke. MRI showed 3 lesions on my brainstem.....3 blood clots. Treatment is PT/OT and aspirin & Lipitor.
Very painful periods with heavy flow and multiple periods during the same month. Vomiting diarrhea and abdominal pain. Night sweats and fatigue. Weight gain
Nausea - but this only lasted about 8 hours or so; Extreme exhaustion - still occurring; The most significant adverse reaction is uncontrolled high blood sugar; Patient is a type 1 diabetic and about 16 hours after receiving first dose, his blood sugar has been between 300-400 mg/dl. He has received large doses of insulin but he is not responding to the insulin as he normally should.
Pt developed sz w/fever 105F, 12 days p/vax, inject site red raised the size of a quarter;
Former 30 week premie twin refused to eat x 18 hours, inconsolable crying for 18 hours. Started two hours after injection. No fever.