chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Four days after the injection, my left arm displayed a red area about an inch in diameter.  It also itched.  Today is the 8th day since the injection and my arm is now all red from the shoulder halfway down to my elbow.  The area is warm to the touch and is raised and really itches.  The red area is now 4 1/2" wide and 5 " long.  I have no other symptoms and feel fine.  Just thought you would want to know.
I woke up at 2:30AM with a headache and stuffy nose. The next morning I was achy with some chills. I took an at home COVID-19 test which was positive. I called my doctor and was prescribed Paxlovid. I only took 2 of the pills due to kidney issues and the pharmacist took the one out. I did get the side effect of a metal taste. I took that 5/17/2022. I did take some Sudafed. I did feel kind of normal, like 90 percent asymptomatic for 6 days. On 5/26/2022, I felt like I had a cold with a lot of sinus drainage, coughing, and sneezing. This continued until this morning. My symptoms rebounded. I took another COVID-19 test which was positive.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date, reported as: only 2 or 3 weeks after administration of (Oka/Merck) VARIVAX (dose, route, lot# and expiration date were unknown), the patient was vaccinated with a dose of M-M-R II (dose, route, lot # and expiration date were unknown). No adverse events were reported. Additional information has been requested.
Day after booster shot (Saturday, 5 March 2022), Patient was very lethargic and fatigued, with no appetite. This was the case all day Saturday.  Sunday morning (6 March 2022), around 2:30am, patient was awakened by chest pains bad enough he came and woke his parents. He took Ibuprofen, and was able to fall back to sleep. Later Sunday morning (approx. 8am) he felt said he felt fine and we went about a regular Sunday at that point.  Sunday evening, around 9pm, he said he was having chest pains again. It had mostly gone away by Monday (7 March) morning.
No physical adverse events reported at this time.  10 year old patient given adult COVID-19 Vaccine.
rash areas >4 inches, slightly raised, warm to touch, very sore, no limitation to motion of limbs, short term body chills, shoulder pain persists. Documented the above on VARS for pharmacy record. PCP notified via fax.
Patient complained of her throat "feeling funny"   Patient refused oral Benadryl.  Dr. notified and instructed to hold patient an additional 15 minutes,   Patient stated she was fine and left after 25 minutes,
Initial report received from a parent of a patient on 07 March 2007. An 11 week old, male patient was irritable slightly, a few hours after he received Daptacel (lot number unknown, route of administration not reported) in the right thigh; Act-HIB (lot number unknown, route and site of administration not reported); IPOL (lot number unknown, route and site of administration not reported) and Rotateq (lot number unknown, route and site of administration not reported) on 06 March 2006 at 3PM. At approximately 8PM, he appeared pale in colour for 10 minutes, then his colour was pink. She denied difficulty breathing, illness at the time of vaccination or other medications. It was reported that the patient recovered. Follow-up information received on 08 June 2007 from a health care professional. The date of vaccination was amended to 06 March 2007 (previously reported as 2006). Vaccines administered on that date included Daptacel, lot number C2569AA, ActHIB, lot number UE929AA (lot number Z0579-2), administered in the right thigh; IPOL, lot number Z0547-2, administered in the left thigh; and Rotateq, lot number 1232F, administered orally. The adverse event onset date was also amended to 06 March 2007 (previously reported as 2006).
3/16/13 developed swelling, redness, pain and tenderness at injection site. Patient given KEFLEX 500mg (3/20/13) one 4 x daily for 7 days. Area 5cm x 5cm. Rechecked on 3/22/13 improved - felt reaction and not cellulitis.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 54-year-old female patient who received SHINGRIX (batch number 3NY5G, expiry date 7th March 2021) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pyrexia (1st dose received, on an unknown date). On 1st October 2018 11:30, the patient received the 2nd dose of SHINGRIX (intramuscular). On 1st October 2018 22:30, 11 hrs after receiving SHINGRIX, the patient experienced fever, chills, joint pain and tremor. Rechallenge with SHINGRIX was positive. On 3rd October 2018 02:00, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the chills, joint pain and tremor were recovered/resolved. It was unknown if the reporter considered the fever, chills, joint pain and tremor to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left deltoid. The patient experienced fever, violent shaking, chills and severe joint pain around 10:30 PM the evening after receiving her dose of SHINGRIX. Her normal temperature was 96.8 degrees Fahrenheit and her fever reached 102 degrees Fahrenheit. The patient's fever broke around 2 PM on 3rd October 2018.  She was feeling better the night before the day of reporting. The patient informed the pharmacist that she experienced a similar experience after her first dose of SHINGRIX for tolerance see case US2018GSK186293.
Has been vaccinated / Shingles and it's broken out down his leg /Suspected vaccination failure; Shingles / broken out down his leg; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male 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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The reporter was patient's wife. The age at vaccination was not reported. The patient received Shingles vaccine and and he was just told that he had Shingles and it was broken out down his leg and was bad. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 11-APR-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # L034724, expiration date 09-DEC-2016 (dose and route of administration were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Weird taste in my mouth and it starts in my sinuses after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Weird taste in my mouth and it starts in my sinuses after the 2nd dose) 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 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 TASTE DISORDER (Weird taste in my mouth and it starts in my sinuses after the 2nd dose). At the time of the report, TASTE DISORDER (Weird taste in my mouth and it starts in my sinuses after the 2nd dose) outcome was unknown.            No concomitant medications were provided. No treatment was reported for the events.
Loss of strength in entire body, falling, increased trouble with speech, increased trouble walking, Inability to bathe and dress alone, inability to complete normal activities around the house.
Strong headache makes her faint; Strong headache makes her faint; Head was going to explode; Too hot; feeling really bad; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 11Jun2021 (Batch/Lot Number: EM0181; Expiration Date: 02Jul2021) (at the age of 42-years-old) as dose 1, single; and via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were none. The patient reported that she had strong headache that makes her faint on an unspecified date in 2021. Patient said she had second dose on unspecified date in 2021. She got her first dose on 11Jun2021. Regarding the second dose, the patient answered twice that her son and herself have the same number (as reported). She said that it was her that has the headache and it wasn't bad. She clarified that yesterday she was in bed all day due to the headache. She said that her head was going to explode, it was too hot, and it hurts, and she doesn't know if she should go to the hospital because she was feeling really bad. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100935715 Same reporter/drug/events, different patients
Pt approached the medical desk stating she felt unwell and then lost consciousness suddenly. She regained consciousness less than one minute after being aroused. She did not have any signs or symptoms previous to the event. 911/EMS was called right away as the patient also hit her head when she took her fall from standing height. She was given supplemental O2 on nasal cannula at 1L/min as she reported chest pain and having some difficulty breathing. She was taken to hospital for further evaluation.
Information has been received from a physician concerning a 36 year old previous healthy patient with sickle cell disease who in  May 2004, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # 646322/0530N). Subsequently in May 2004, the patient developed a local reaction of redness, swelling and pain. A few days following vaccination, the patient returned to the office with a high grade fever of 103 degrees and was then hospitalized. It was noted that the patient developed pneumonia with a left lobe infiltrate of the lung. A sputum culture was not performed. The patient responded well to antibiotics and was discharged. A product quality complaint was not involved. The reporter also mentioned a second patient with sickle cell disease who had a similar experience post vaccination with pneumococcal 23v polysaccharide vaccine (lot # 646322/0530N).  The reporter was concerned with the lot. The records of testing prior to release of this lot have been checked by Quality Assurance and found to satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information is not expected.
Pink warm itchy symmetric oval swelling (6X8 cm) day after received vaccine in right upper thigh. No fever, no pain or fluctuance, improved with ice and MOTRIN. Suspect vaccine DTaP.
There was an administration error and the patient was given 2 doses of Varicella at one time. She was given MMRV, live and Varicella, live.
J96.00 ACUTE RESPIRATORY FAILURE 9/23/2021 COVID-19 PNEUMONIA
inject site red hot swollen feels hard 2"x 2"; red area 6" around inject site; onset 48 hrs p/inject; pt c/o itching, tenderness, discomfort; pt came to clinic 7 days p/inject; advised to use cold compresses, take DPH;
administered FLUZONE HIGH DOSE QUADRIVALENT to a 47-year-old patient with no reported adverse event; Initial information received on 27-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 47 years old female patient who stated that administered influenza quadrival A-B high dose hv vaccine [Fluzone high-dose quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza quadrival A-B high dose hv vaccine at a dose of 0.7 ml once (lot UJ875AB, expiry date- 30-Jun-2023) (formulation and strength was unknown) via intramuscular route in the left deltoid, indication: Immunization.  On an unknown date the 47 years old patient had administered fluzone high dose quadrivalent with no reported adverse event (product use issue) (unknown latency) following the administration of vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the 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.
16 year old got the Moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got the Moderna shot) in a 16-year-old female patient 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 ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got the Moderna shot). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got the Moderna shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   ? No treatment information was provided. ?   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up document was received on 29-Jun-2021 and contains no new information.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old female) for mRNA-1273 (lot number unknown) with no associated AEs reported.
LIGHTHEADED; WEAKNESS; DIARRHEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on left arm on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced diarrhea. On 14-MAR-2021, the subject experienced lightheaded. On 14-MAR-2021, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhea on 14-MAR-2021, and had not recovered from weakness, and lightheaded. This report was non-serious.
where she would receive the vaccine she would develop a swollen lymph node within two days after the vaccine which began on 23Apr2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4625954.  A 31-year-old female patient received BNT162b2 (BNT162B2), on 14May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 31 years for covid-19 immunisation. The patient's relevant medical history included: "Swollen lymph node" (unspecified if ongoing); "Marijuana usage" (unspecified if ongoing); "Relapsing remitting multiple sclerosis" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Fatigue" (unspecified if ongoing); "Complex ptsd" (unspecified if ongoing); "Lactose intolerant" (unspecified if ongoing); "Vitamin D deficiency" (unspecified if ongoing); "Disk bulging" (unspecified if ongoing); "Disk degeneration" (unspecified if ongoing); "Dysphagia" (unspecified if ongoing); "Covid" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN XL; PAXLOVID; VITAMIN B COMPLEX; VITAMIN D3; CALCIUM MAGNESIUM WITH VITAMIN D3; TYLENOL; IBUPROFEN; CBD CANNABIDIOL HANFOEL EXTRAKT. Vaccination history included: BNT162b2, administration date: 21Apr2021, for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered" (May2021), described as "where she would receive the vaccine she would develop a swollen lymph node within two days after the vaccine which began on 23Apr2021".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
My arm swelled up with a big knot under my arm in armpit  area.  That night of taking the vaccine I had the dry heaves, fever, night sweats, nausea, very weak/tired. And tongue was swelled.. Shortness of breath and hurting/fullness/tightness in my chest started gradually over the next week.  On June 7, 2021 I went to my family doctor for cough, SOB, stuffiness in head and nose. On June 11, 2021 I reported to my co-workers and office management that I was having trouble breathing then, I felt something was wrong. I finished work that day .  Over that weekend my shortness of breath was getting worse.  I was supposed to work on the following Monday which was June 14 2021 and I called off and went back to the doctor and was sent for Chest X-ray. Then I called off  June 15,16,17 due to my worsening symptoms. I worked June 19, 20 and was increasingly getting more SOB. I was admitted to the hospital on June 21, 2021 for SOB. I got discharged on Friday June 25, 2021. I was put on bipap and weaned to a nasal cannula and then eventually off oxygen when I got discharged.  I now have to take breathing treatments every 4 hours, I?m on my 4th round of steroids, I?m taking mucinex, I?m on three different inhalers.
Narrative:  Approximately one week after receiving 2nd COVID 19 vaccine,  patient reports he had arm swelling and rash to arm and neck. On 3/20/2021, ED physician described rash as flat pink macular rash over the left upper extremity and a fine pruritic rash on the left side of the neck. Patient prescribed diphenhydramine, triamcinolone cream, and medrol dose pack. Patient returned to  ED again on 3/25/2021 still complaining of symptoms despite medications  prescribed on 3/20/2021. ED physician added montelukast, hydroxyzine, and initiated a dexamethasone taper.
Full body rash apprising 1 to 2 days after each dose of vaccine. Symptoms not helped by steroids or antihistamines. Rash was present for approximately two weeks after first dose.
This spontaneous report was received from a physician via a company representative, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 18-JUN-2014, the patient was vaccinated with an improperly stored dose of Gardasil "HPV 10x1 sdv", lot # J009788 with expiration date of 17-MAR-2016 (strength, dose and route of administration were not reported). No concomitant medications were reported. No adverse effects and no product quality complaints were involved. On an unknown date the vaccine was stored at a refrigerator and the longest reported temperature excursion lasted 72 hours, where the lowest recorded temperature of 34 F (1.111111111 Celsius degrees). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several reports received from the same source. Additional information has been requested.
Prevnar injection (5cc) IM given (R gm) at approximately 10:30 am. Returned to clinic 10/28/2001 at 14:00 pm. c/o redness, swelling and heat around injection site, extending downward covering R buttock (child did not fight or move during injection) Dr gave Keflex 125/5 TID and Zyrtec 1 tsp qd and to return if s/s increase or fever.
Chills, rigors, fever, and malaise. The pt has a large local reaction on left deltoid of arm.
Child kept falling down when walking and acted clumsy. Banged head on floor frequently and would throw fits which was unusual for him. This lasted for 2 months. He wore sandals frequently but got a blister on his toe, so they changed him to tennis shoes 4 days after his shots. Shoes did not correct the falling. Went to Chiropractic and had an adjustment. Slowly got over it on his own.
devel herpes zoster shortly p/vax (had not had prev) in same area as inj;
Redness and swelling of arm where vaccine was administered with area of redness measuring 12X8 cm.
Two mild strokes. First on 6/15/21 the second on 7/14/21. Treated consisted of heart monitoring, CT scan, MRI on brain. Prescribed medication, blood pressure meds, and baby Aspirin.
Pt recvd 3 doses of Engerix-B 7MAY91, 4JUN91 & 11NOV91 & 11NOV91 immed p/3rd inject pt exp burning while inject was being given which cont for a few hrs;
urinary infection; A spontaneous report was received from a Consumer who is a 82 years-old female patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced urinary infection (urinary tract infection).  The patient's medical history was not provided. Concomitant medications were not reported.  On 17-Jan-2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot/batch: 006M20A) for prophylaxis of COVID-19 infection.  On an unknown date, the patient was diagnosed with a urinary infection and was treated with ciprofloxacin from 12-Feb-2021 to 15-Feb-2021.  On 16-Feb-2021, after to the onset of the events, the patient received the second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the event urinary infection was unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time. No further follow-up information is expected.
Fever, fatigue, overall body aches - persisted over 12hours, minimal relief from Advil.
March 17, 2021 developed raised rash and itchiness  around the injection site. Area was red and warm to touch. March 18,  2021 rash went down but, remained itchy and warm at site.  I went to Physicians office and was told to treat symptoms with Zyrtec, Tylenol and Benadryl. March 19, 2021 Symptoms have subsided
mom stated pt had temp of 105 7 days following vax 7JUN95;mom also described 1 sz episode 1mo p/vax;seen @ ER for elevated temp;sent home w/instructions to use APAP
After receiving the vaccine, I had intermittent pain but the next day it was constant. The pain is on the right side and is a radiating pain. It progresses all day long. I have been to my doctor and to a pain management doctor. I am at a point of trying to figure out what is going on.