chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a consumer regarding herself refers to a 63 year old female patient. No information about medical history, concurrent conditions and concomitant medications were reported. The patient reported side effects she was experiencing with the ZOSTAVAX. Approximately on an unknown date in May 2012 the patient was vaccinated with ZOSTAVAX (dose strength, route not reported) in the left arm. The reporter stated that she said that a little after she got ZOSTAVAX administered in approximately on an unknown date in May 2012 she started experiencing like something wanted to come out of her body, nervousness and some chest pains approximately on an unknown date in 2012. The patient got heart calf done in October 2012 in a hospital and everything was ok with her heart. Approximately on an unknown date in March 2013 the patient started experiencing more tingling sensations in her toes, fingers, mouth and lips and stated that these symptoms came in spurts. Approximately on an unknown date in April 2014 the patient experienced swelling on hands and feet and getting big red marks on her body then they start fading into black and blue marks. The patient consulted a doctor and advised her these symptoms she was having is do to the ZOSTAVAX. The patient was not treated for all these events. The outcome of events reported is unknown. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
General flu like symptoms.; Aching muscles; exhaustion; This is a spontaneous report from a contactable consumer. A 56-years-old male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247) on 11Feb2021 12:15 PM at Left arm as single dose for covid-19 immunisation. Medical history included hypertension, hypertension (controlled). Facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The concomitant medication included atorvastatin calcium (LIPITOR) at 10, amlodipine besilate (NORVASC) at 10, Lisinopril at 2.5. The patient historical vaccine included bnt162b2, lot number=EL3247), first dose on 21Jan2021 12:30 PM at Left arm SINGLE DOSE for covid-19 immunisation. The patient experienced general flu like symptoms, Aching muscles and exhaustion on 12Feb2021 05:30 AM. The patient did not received treatment for the events. The outcome of the events recovering.
Initially was  tender but within 24 hours there was a an area of induration about  3 cm in diameter. 72 hours after the dose the area became extremely itching and red. Used topical steroid which helped a bit. Now 2 weeks out I have a large area of redness encompassing half the circumference of my arm with discreet edges, about 9 inches by 8 inches. It is still itchy
Narrative:  62 yo male patient with substance abuse, etOH abuse and colorectal rectal cancer treated outside of agency died on 11/8/2021. Last medical note on 7/27/21. Pt had received covid vaccines on 3/18/21 & 4/15/21 from a church. Likely death not related to vaccines given cancer diagnosis.
Shortly after GARDASIL vaccine, extreme mood change, depression, erratic behavior, fatigue, pain and tingling in arms/legs, painful heavy period, migraine headaches, insomnia, self harm, lack of interest in anything that she used to enjoy, isolation, very short temper, painful red veins in legs that resemble varicose veins, panic attacks, nervousness, continuous rocking motion, forgetfulness, weakness, weakened range of motion, vision problems, chest pains, severe stomach pains, diarrhea, still has issues all of the above.
Case number PHEH2013US022534 is an initial spontaneous report received from a pharmacist on 16 OCT 2013. This report refers to multiple patients whose identifiers were not reported. The pharmacist reported that he was getting lot of patient complaints of pain at the injection site for FLUCELVAX 2013/2014 (batch number: 006011A, expiry date: JUN 2014) compared to last year's FLUVIRIN 2012/2013. The pharmacist reported that 50% of cases reported that the vaccination  hurt. The event outcome was not reported. No further information was provided.
Elevated activity in my lymph nodes in my left armpit, resulting in my doctor ordering a biopsy of the affected lymph nodes. I had the biopsy and ended up taking a day off of work because of the soreness at the biopsy site limiting how much I could use my arm.
on 4FEB91 pt rec'd MMR; Approx 20-30min p/immun pt passed out in car & began jerking all over; Pt incont of bladder/bowel; Confused when came to; Hx of "drop attacks" since small;
I felt like I was having palpitations, and my blood pressure shot up to 169/119.
Initially small redness around site continued to expand to larger area of arm 5 or 6 inches in the appearance of a band around the upper arm.
Developed rash & pain after 4 days, lasted for 1-2 weeks. Has mass (quarter-sized) at injection site still present almost 3 months later.
Mild redness, swelling, and itching at injection site, approx 2". About 2100, the swelling and redness went from my elbow to shoulder and the itching increased.  I took Benadryl to combat the itching.  Throughout the night, the itching felt internal. I wanted to scratch, but I couldn't reach it.  I was unable to take Benadryl due to working.  After shift, I took Benadryl every 4 hours and called in for work, which I rarely do.  Monday, I started taking Prednisone for the redness and swelling.  Within a week my symptoms resolved.
Febrile seizure 10 hours after the vaccines. Observed overnight in the hospital and discharged in good condition the next day.
Dizziness, rapid heart beat, loud heart beat, aware of heart beat,  fatigue--sleeping 12 hours and waking tired, muscle soreness especially chest muscles, loss of appetite,
Kinrix administered intead of Infanrix; Kinrix administered to a 15 months old; Kinrix administered as a 4th dose of DTaP series; 14th Sept 2021 pediarix, 11th Nov 2021 Infanrix and 19th Jan 2022; Received infanrix after Pediarix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 3-month-old female patient who received DTPa-IPV (Kinrix) (batch number Q472N, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device injection syringe for prophylaxis.   Concomitant products included PEDIARIX.   On 20th October 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 19th January 2022, the patient received Pediarix. On 11th November 2021, the patient received Infanrix and dtpa vaccine pre-filled syringe device. On 11th November 2021, unknown after receiving Infanrix and dtpa vaccine pre-filled syringe device, the patient experienced wrong vaccine administered. On 19th January 2022, the patient experienced drug dose administration interval too long. On 20th October 2022, the patient experienced wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the wrong vaccine administered, drug dose administration interval too long, wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 20-Oct-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient received Infanrix vaccine (as 2nd dose of DTap series) after Pediarix, which led to wrong vaccine administered. The patient received a dose of Pediarix vaccine (as 3rd dose of DTap and 2nd dose of IPV series) later the recommended interval, which led to lengthening of vaccine schedule. The patient received Kinrix dose (as 4th dose of DTap and 3rd dose of IPV series) instead of Infanrix at inappropriate age, which led wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. Dose number were not captured in structured field but convention was applied considered in DTap and IPV series.
She developed pain radiating from axilla/upper arm, across chest to lower neck.  Swelling in supraclavicular region noted and nodes palpable.  ON exam in office, pea sized supraclavicular nodes noted in L supraclavicular region, none on R, no axillary nodes palpable.  RE]est of exam normal.
Rash developed on R arm 7 days after receiving Zostavax. Red, flat itchy areas on R arm Spread to L forearm, L groin and R thigh. All areas flat red itchy. Only one spot on L forearm near elbow small clear fluid filled blister apparant. Patient was seen by MD and diagnosed with contact dermatitis. MD didn't feel rash was related to vaccination. Patient feels it is.
Approximately 1-2 weeks after the vaccine I began to develop a stabbing sensation under my skin and generalized joint aches. I would at times feel like I was 80 years old like I could barely walk or move at times. I thought this was just a transitory reaction to the vaccine but it has been almost a year and it is still present.
Breakthrough case admission after 4 vaccines Moderna 2/9/21 no lot#;  Moderna 4/2/21 lot# 045b;  Modern 5/23/21 lot# 022C21A;  Moderna 12/13/21 lot# 013F21A
Nausea, fever, chills, body aches, convulsions, fatigue, difficulty sleeping, arm pain, headache
Pt given first MENACTRA 2/22/12 at clinic. 2nd MENACTRA 8/3/12 in our office. Pt c/o persistent headaches since he received 2nd vaccine.
c/o achiness, and pain in feet, legs and back that progressed to pain and weakness and shakiness.  On 02/04/2010 c/o difficulty urinating but was able to.  On 02/05/2010 woke up unable to urinate.  Went to ER and was catheterized and returned 1200cc clear yellow urine.  Remains c/o back pain.  MRI with and without contrast of brain and spinal cord done. Found inflammation of spinal cord was transferred and admitted to Hospital until 02-09/2010.  Lumbar puncture done.  IV fluids and IV and oral antibiotics given.  Dx: Transverse Myelitis caused by mycoplasma.
family states seemed short of breath since after the covid vaccine.  Staff said beginning on 1/22/21 the patient seemed sluggish, more tired, and nausea noted.  She stayed in her room more after the vaccine because worried about giving/getting COVID to others.  was talking on the phone at 11:30 PM on 1/26/21 to staff person about temperature of room.  at 12:15 AM on 1/27/21 staff noted not breathing, started CPR and called EMS.  When EMS arrived they stopped the code because she was too long deceased.
Death Narrative:  Patient received first dose of COVID vaccine on 1/30/21. Reported by his wife to agency that he passed away at an outside hospital on 2/14/21. By report of his wife: "due to sepsis (related to bed sores) and aspiration pneumonia"
Within several hours shoulder became extremely painful and difficult to move and I began to experience PACs/PVCs at frequent intervals. Within 48 hours developed gastroenteritis which persisted for about 10 days. PACs continued during this time and began to abate slowly following end of digestive problems. I submitted several EKG readings from implanted loop recorder to cardiologist. Results showed PACs/PVCs but no AFib. Was advised to increase atenolol dosage from 25mg X 2 to 25 mg AM and 50mg PM as symptoms were worse at night. PACs have continued to decrease over time. Shoulder soreness at injection site is virtually gone as of this date.
pt recv vax 18OCT96 & w/in 1/2hr post inj pt devel a narrowing of visual field (homonymous hemianopsia) followed by lightheadedness & fatigue;sx abated w/in a few hr;
on 4/5/2021 patient started experiencing shortness of breath and pleuritic pain.  Admitted to hospital 4/12 with bilateral PE's per diagnostic tests.
Immediately after receiving the vaccine, I experienced muscle pain which lasted for approximately two hours. At 7:00, three hours after receiving the vaccine, I developed a fever and slight nausea, as well as fatigue. I went to sleep at 9:00 and woke up several times during the night with a fever. At 3:00am, I woke up with severe nausea which lasted for an hour. At 6:30am, I woke up with a fever, headache, and muscle pain in my left arm and legs. I took two Advil at 6:40. At around 10:40 my symptoms were relieved.
Patient called back to pharmacy stating that she was experiencing trouble fulling expanding her lungs, and that she was also expectorating mucus.  Patient also stated that she was an asthmatic as a child and that this event felt like it did as a child.  Patient was instructed to take diphenhydramine to limit the reaction and that if she experienced any additional trouble to visit the emergency room.  Patient was contacted on 09/03/2011 to assess her current status.  The patient said that she felt better, and was breathing easier, but that her arm was sore.  She also stated that she did not need to visit the emergency room last night but was okay with the diphenhydramine.
Patient became weak, fatigued, softball size red area and golf ball size hard knot/swelling at injection site, inj site hot to touch, and fever for several days after injection. On 3/8/2017 pt still has hard knot at injection site.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Rheumatoid arthritis since an unknown date. Concomitant products included METHYLPREDNISOLONE for Arthritis, FLUTICASONE PROPIONATE and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Nasal congestion, TOFACITINIB CITRATE (XELJANZ) from 01-Feb-2019 to an unknown date for Rheumatoid arthritis, KETOTIFEN FUMARATE, TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), ACYCLOVIR [ACICLOVIR], VITAMIN D3, SALBUTAMOL SULFATE (VENTOLIN HFA), ALBUTEROL SULFATE and RANITIDINE HCL for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            This case was linked to MOD-2021-102454, MOD-2021-102454 (Patient Link).
Redness and swelling at injection site, warm to touch. Pt. took BENADRYL7-16 and 7-17 and resolved 7-18.
crying greater than 3 hrs w/in 24 hrs of receiving vax; transient hematoma & erythema @ vax site;
bleeding from inject site initially but otherwise not problems noted until p/1st 24 hrs then devel lumping-swelling @ site; no pain; no temp; skin eruptions-maculopapular/vesicular some tenderness @ site; w/scabbing @ site;
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 26-FEB-2018, the patient was vaccinated with improperly stored dose of Oka/Merck VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The Oka/Merck VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558:
welt; itchy; lump under skin; This is a spontaneous report from a contactable consumer or other non hcp.   A 75-years-old patient of an unspecified gender received bnt162b2 (BNT162B2 PFIZER BIOTECH MRNA SOLUTION FOR INJECTION (Batch/Lot Number: EP9534), dose 2 intramuscularly, administered in Arm right on 17Mar2021 15:05 as dose 2, single for covid-19 immunisation. Medical history included, osteoporosis, hypertonic bladder. Concomitant medication(s) included tolterodine (TOLTERODINE) taken for hypertonic bladder from 2000 and ongoing; raloxifene (RALOXIFENE) taken for osteoporosis from Sep2020 to 17Mar2021.Historical vaccine included BNT162B2 PFIZER BIOTECH MRNA SOLUTION FOR INJECTION (Batch/Lot Number: EN6203), dose 1 intramuscularly, administered in Arm left on 24Feb2021 14:35 as dose 1, single for covid-19 immunisation.The patient previously took Levaquin, cipro and Benadryl, polymyxin b sulphate experienced hypersensitivity. It was reported that, on 02Mar2021 08:30, The patient experienced welt, Itchy, lump under skin with outcome of not recovered.The patient underwent lab tests and procedures which included c-reactive protein: normal on 23Feb2021 <1 , full blood count: normal on 23Feb2021. Therapeutic measures were taken as a result of welt (urticaria), itchy (pruritus), lump under skin (mass).  Regardless, symptoms first recorded 0.3 Mar2021. Ongoing daily (with exception of 5 to 6 days) until 11Jul2021. No hives since then. I'm considering having the booster shot so I would like some guidance about possibility of first doses causing the hives.  Follow-Up (11Nov2021): Follow-up attempts are completed. No further information is expected.
Myalgia, Arthralgia, Fever, Diarrhea, CHILLS, WEAKNESS
Onset 6-8 hours after flu vaccine administered, fine rash over her body. Stated her face felt like "sandpaper".
Needle became detached from syringe during injection. Participant stated she she felt some vaccine leak down her arm, and a couple of drops of vaccine were visible on the table. Participant was worried that she did not receive full dose. Participant was informed that the amount she received was more than plenty to elicit the appropriate immune response, and that protocol was to not administer additional vaccine in this instance. Participant stated understanding, although still uneasy. Participant information was collected for VAERS report.
SWOLLEN EYES; SWOLLEN MOUTH; SWOLLEN FACE; HIVES; 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: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced swollen eyes, swollen mouth, swollen face, and hives. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen eyes, swollen mouth, swollen face, and hives. This report was non-serious.
FELT WORSE WITH BLOCKING OF BOTH EARS AND SOME PRESSURE IN BOTH EARS; FELT WORSE WITH RINGING IN BOTH EARS; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and nonsmoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 at around 11:00 on right arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced felt worse with blocking of both ears and some pressure in both ears. On 02-APR-2021, the subject experienced felt worse with ringing in both ears. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt worse with blocking of both ears and some pressure in both ears, and felt worse with ringing in both ears. This report was non-serious.
Received flu vaccine 9/24/12 - 8:30 AM (L) deltoid. Started feeling bad around 530pm. Light headed, nausea, fever-chills. 2 TYLENOL & ZOFRAM. Temp 101.0 broke around midnight. This A.M. fever back.
After receiving my first series of Lymerix injections, I started to have gout like symptoms alternating between both of my ankles along with my knees. During this period a couple of uric acid test showed normal levels. My doctor has sent me to a podiatrist, who took x-rays, and extensive blood work, and he could not find anything wrong with my ankles. He then referred me to a rheumatologist, his diagnosis was I do not have arthritis, he thinks it is the gout. For the past 8 years I have a history of getting the gout once or twice a year without taking any preventative medication, only watching my diet. Since May 2000, I started with 100 mg of Alapurinol, then was increased to 300 mg, along with watching my diet without any help with the pain. When I do get the gout after taking my medication, colchicine 0.6 mg the swelling starts to subside within a few hours. This other swelling takes a few days to subside. None of the three doctors will admit to me my problems were from the Lymerix injections.
arm pain; numbness in her hand; This is an initial spontaneous report received from a contactable consumer (Patient). A 53-Year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not provided) first dose via an unspecified route of administration in arm on03Apr2021 as single dose for COVID-19 immunization. The patient medical history was reported. The patient concomitant medication was not reported. The patient experienced that she stated she has been having issues with her arm. She reported arm pain and numbness in her hand. She asked if this is a side effect? She stated she needs to know if it is from the vaccine or if it is potentially another medical problem. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Pt. rec'd GARDASIL-9 (#2) at annual V-up on 07/17/17. During 15 min. 'wait period' pt. with report of numbness/tingling to (LT) arm. Pt. evaluated by Dr and NP = normal strength: Rec. D/C to home for rest/monitoring. If increasing go to ER. PCN C/D next day. (Positive) pain to (LT) arm, but no numbness/tingling.
On 11-19-07 pt developed itching spots on hands around 5:30 - 6:00 pm. Progressed to (B) lower and upper extremities and waist. Hives started about 8:00pm with hands/feet swelling. Seen at health center 11/20/07 9:15 am - T 97. Given Benadryl 50mg at 945 am and to repeat every 6 hrs for at least 48 hours then decrease as tolerated.
I received the second Covid 19 vaccine and Tinnitus has developed at a very high pitch. This has effected my quality of life on a daily basis.