chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SLIGHTLY INFLAMMED LUNG; CONSTIPATION; NAILS AND TOE NAILS BREAKING AND BRUISING; SEVERE PAIN ON BODY THAT WOULD NOT LET HER SLEEP, EXTREME PAIN; PAIN AT HEART AREA; PAIN AT LUNG AREA; WATER BLISTERS ON LEFT BREAST; RASH IN ELBOWS THAT DRIED OFF, RASH RED ON CHEST AND UNDER ARM LEFT, BREAST AND SPINE; RED SPOTS LIKE A BITE BUT BIG, 2-3 ON LEG, 1 ON LEFT THIGH AND 1 ON BACK; VOMITING; HEADACHE; DIARRHEA; HIGH BLOOD PRESSURE; BLURRED VISION; RINGING IN THE EAR; WHEEZING; DIFFICULTY BREATHING; CHICKENPOX; OUT OF CONTROL, FELT HEART BIT ON LEFT EAR, FELT WEIRD; FOOT AND UNDER ARM SWOLLEN; PINS AND NEEDLES AND TINGLING ON LEFT SIDE OF BODY, TINGLING ON SKIN; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, copd, 2 heart prolapses, and seafood allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 22-AUG-2021 for prophylactic vaccination. Concomitant medications included loratadine, and montelukast sodium.  On 22-AUG-2021, the patient experienced foot and under arm swollen, out of control, felt heart bit on left ear, felt weird, and pins and needles and tingling on left side of body, tingling on skin. On OCT-2021, the patient experienced chickenpox. On NOV-2021, the patient experienced difficulty breathing, and wheezing. On 08-JAN-2022, the patient experienced blurred vision, and ringing in the ear. On 10-JAN-2022, the patient experienced high blood pressure. Laboratory data included: Blood pressure (NR: not provided) High. On an unspecified date, the patient experienced slightly inflammed lung, constipation, nails and toe nails breaking and bruising, severe pain on body that would not let her sleep, extreme pain, pain at heart area, pain at lung area, water blisters on left breast, rash in elbows that dried off, rash red on chest and under arm left, breast and spine, red spots like a bite but big, 2-3 on leg, 1 on left thigh and 1 on back, vomiting, headache, and diarrhea. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from water blisters on left breast, had not recovered from pins and needles and tingling on left side of body, tingling on skin, and rash in elbows that dried off, rash red on chest and under arm left, breast and spine, and the outcome of foot and under arm swollen, high blood pressure, blurred vision, ringing in the ear, diarrhea, slightly inflammed lung, red spots like a bite but big, 2-3 on leg, 1 on left thigh and 1 on back, constipation, nails and toe nails breaking and bruising, headache, difficulty breathing, severe pain on body that would not let her sleep, extreme pain, vomiting, pain at heart area, pain at lung area, chickenpox, out of control, felt heart bit on left ear, felt weird and wheezing was not reported. This report was non-serious.
This spontaneous report has been received from a pharmacist via a sales representative concerning to a patient of unknown age and gender. Current conditions, medical history and drug reactions/allergies were not reported. In approximately November 2013 the patient was vaccinated with ZOSTAVAX injections, (dose, lot# and route not provided). Concomitant medication was not reported. On approximately 07-NOV-2013 (reported as one week ago), the patient experienced a baseball-sized swollen area on the arm that was warm to touch after patient received ZOSTAVAX. The outcome of the adverse events was unknown. Additional information has been requested.
Case number PHEH2016US023809, is an initial spontaneous report received from a consumer on 15 Sep 2016. This is also a quality complaint report (QA reference number: 1016893). This report refers to a patient of unknown age and gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with one single dose of FLUCELVAX Quadrivalent (batch number: 185325A) at a dose of 0.4 ml, intramuscularly on 07 Sep 2016. It was reported that, the syringe leaked at the bottom during administration and feels that they are not giving a full vaccination at administration on 07 Sep 2016. Not sure how many doses are affected. No adverse event was reported following this medication error. The case was assessed as non-serious by the consumer.
Received shot in left arm about 5 pm on 6/29/18  started to feel pain in the mussel about 8 pm  The pain during the night woke me up  about 3 am when I went to turn over. In morning arm started to swell and became red. I didn't think too much of it since I had previous shots in the arm., by Saturday night it became red below the shot almost down to the elbow. I experienced  itch throat and headache. I took Advil. Today (July 2) the arm is still red and itchy.
On 10-13-14, I was diagnosed with dermatomyositis. Dr. advised me "to get the flu vaccine since my immune system was already compromised." I was able to walk with a 4 prong cane at this time. My health declined rapidly after the flu vaccine. On 12-24-14, I was hospitalized with internal bleeding. My overall strength was rapidly declining. I was so weak, I could only lift my arm 3 inches off the mattress. I had multiple surgeries for the internal bleeding. I was given a colostomy which was reversed to an ileostomy in May 2016 (I think). That surgery took 7 1/2 hours. I spent 32 months in 2 nursing homes. I am home as of Aug. 4, 2017. I am still weak, and can only walk 50 ft. with a walker. I took methotrexate prescribed on 10-13-14. I took 20 mg. once a week. I did not take it prior to 10-13-14. I will have the ileostomy the rest of my life. I can stand for about a duration of 3 minutes with a walker to support me. I was able to climb two steps on a full stepladder. I was painting my kitchen. Now I am confined to a wheelchair and housebound.
Swelling, redness and itching at injection site. I believe it is Covid-arm. Also pain in lymph node near arm pit. Fatigue.
Days 1 - 5: Headache consistently around the clock Days 6 - 7: Headache from beginning of morning until noon Days 1 - 2: Fever of 99 degrees, slight body aches Days 1 - 7: Rash that develops acutely for 10 minutes at a time, itches significantly
Hives, vertigo, headache, neck pain, swelling of eyes, runny nose, gas and diarrhea, lethargy, pain
Had Var and MMR on 7-6-17. Mom states on 7-9-17 client had a low grade fever, malaise, and a rash. Client states rash started on ankles and legs. Mom states she had some on waist and on her back and states it was chicken pox. Mom also states client possibly had some flea bites on lower legs. Came in today to report reaction. Client has a resolving rash to lower legs and a few on arms. All areas are dry. Mom states the low grade fever only last one day. She had applied calamine lotion to rash and gave some Benadryl. Did not go to a doctor. Mom had client stay home, rest,  and avoided babies and older people. Client states she feels well now. No complaints.
Redness 2" x 1 1/2", itching, and pain to touch at injection site. No systemic symptoms. Treat with oral BENADRYL, ice to site.
Hives on lips - tiny red bumps on outer edge of top and bottom lips, swollen lips - both top and bottom, both lips bright red
Client was seated in chair in clinic room waiting for his siblings to receive their vaccinations.  Approximately five minutes after receiving his shots, client lost consciousness and started to shake rhythmically in his legs while his arms were drawn to his chest with clenched fists. His eyes rolled back and he fell to the side where his mother caught and supported him from falling out of chair. He regained consciousness about a minute later and asked "what happened?  was I dreaming?" Client was moved with two person assist to a cot where he was placed in the supine position with legs elevated.  Vitals were assessed:  BP 120/62, pulse 96 regular, RRR 16. He was able to drink a juice box and was talkative. Monitored him x 10 minutes and he was then transferred to a chair for 5 minutes. Remained stable and talkative. He sat in our waiting room for another 10 minutes with his family before leaving in stable condition.
Initial symptoms within 6 hours were headache and body ache.  Within 24 hours had fever 102 degrees Fahrenheit with chills and nausea. Fever lasted for approximately 6 hours. Body aches and headache lasted approximately 36 hours.
Severe joint pain, most noticeable in wrists; Large red circle about 3-4 inches belowthe injection site; The redness patch increased in size and became itchy.; Metal taste in mouth; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Very tired), ERYTHEMA (Large red circle about 3-4 inches belowthe injection site), PRURITUS (The redness patch increased in size and became itchy.), ARTHRALGIA (Severe joint pain, most noticeable in wrists) and DYSGEUSIA (Metal taste in mouth) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 030L20A) for COVID-19 vaccination.     no medical history is reported by reporter.  The patient's past medical history included Thyroidectomy. Previously administered products included for Shingles: Shingles vaccine and Shingles vaccine. Past adverse reactions to the above products included Redness with Shingles vaccine; and Swelling with Shingles vaccine. Concurrent medical conditions included Hypertension (Controlled with medication) since June 2001, Thyroid disorder (Thyroid removed / medication) since May 2001, Environmental allergy, Allergy to surgical sutures, Drug allergy, Vitamin D low and Bone disorder. Concomitant products included CALCIUM for Bone disorder, OLMESARTAN for Hypertension, LEVOTHYROXINE SODIUM (LEVOXYL) for Thyroidectomy, VITAMIN D3 for Vitamin D low.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 24-Dec-2020, the patient experienced FATIGUE (Very tired) and DYSGEUSIA (Metal taste in mouth). On 31-Dec-2020, the patient experienced ERYTHEMA (Large red circle about 3-4 inches belowthe injection site) and PRURITUS (The redness patch increased in size and became itchy.). On 02-Jan-2021, the patient experienced ARTHRALGIA (Severe joint pain, most noticeable in wrists). On 25-Dec-2020, FATIGUE (Very tired) and DYSGEUSIA (Metal taste in mouth) had resolved. On 04-Jan-2021, ARTHRALGIA (Severe joint pain, most noticeable in wrists) had resolved. On 07-Jan-2021, PRURITUS (The redness patch increased in size and became itchy.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   conmeds added    Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: No specific follow-up information recorded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Local injection site reaction. Had temperature of 102 deg the evening that dose was given. Had redness and swelling lasting 3 days. Totally resolved within 3 days. No new symptoms.
This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. The pharmacist stated that on an unspecified date the patient was administered a partial dose of ZOSTAVAX due to a syringe malfunction. No adverse effect was reported. The outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Raised red rash at injection site. Warm to the touch and approx 2 inches in diameter. Itchy.
21OCTthrough 24OCT temp & 25OCT rash till 27OCT;
On 12-16-20 received the vaccine. On 12/17/2020 develop Headache, Nausea, vomiting, diarrhea, chills and fever. After taking some Zofran employee improved on 12/18/2020. Symptoms have resolved.
TIREDNESS/TIRED; HEADACHES; CHILLS; RUNNY NOSE; RED EYE IN BOTH; COUGH; This spontaneous report received from a patient concerned a 59 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 08-MAR-2021 to Left Deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-MAR-2021, the subject experienced runny nose. On 08-MAR-2021, the subject experienced red eye in both. On 08-MAR-2021, the subject experienced cough. On 09-MAR-2021, the subject experienced tiredness/tired. On 09-MAR-2021, the subject experienced headaches. On 09-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 09-MAR-2021, was recovering from headaches, and had not recovered from runny nose, cough, red eye in both, and tiredness/tired. This report was non-serious.
Patient c/o extreme fatigue, pain and swelling to right neckline onset 3/4/21. She states the pain and swelling increased over the next  4 days, swollen area was now the size of a golf ball. She was seen and evaluated on 3/9 by her PCP, DR.  CMP, Thyroid Profile and Lipid Panel were completed, all results were within normal limits. Pain began to ease up on 3/11/21. On 3/17/21 she is still c/o extreme fatigue, no change in the swelling to her neck. She is calling her PCP to schedule another appointment for next Friday 3/26.
Not feeling well; Really bad headache; This is a spontaneous report from a non-contactable consumer via the Medical Information Team. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported by the patient that she was not feeling well and have a really bad headache. The outcome of the events was unknown.  No follow-up attempts are possible: information about lot/batch number cannot be obtained.
PER PT, STATED THAT SHE EXPERIENCED MOST SIGNS/SX OF INFLAMMATION: REDNESS, SWELLING, HEAT, PAIN. I ADVISED THAT IS EXPECTED FROM MOST VACCINES, BUT SHE INSISTED IT WAS WORSE THAN HER 1ST SHOT. PT'S ARM WAS VISIBLY RED FROM INJ SITE TO ELBOW, BUT SWELLING WAS LOCALIZED AT INJ SITE
Roughly 5 minutes after receiving the vaccine that patient felt extremely faint, light headed, jittery and cold. A trained EMT on-site was monitoring heart rate and noted it was low but did not give specific BPM. EMS services were called and the patient was taken to a near by ER of their choice. They were seen in the ER and returned to work the following day.
No additional AE.; HCP reporting a patient that is older than 12 years of age was accidently administered PROQUAD.; This spontaneous report was received from a registered nurse and refers to a patient of unknown exact age and unknown gender.  The patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies were not reported.  On 03-OCT-2022, the patient, who was older than 12 years of age was accidently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (strength, dose, route of administration, vaccination site, lot number, expiration date and albumin status were not reported) for prophylaxis (product administered to patient of inappropriate age). No additional adverse events were reported.
No significant adverse event- Vaccine expired 06/06/2023 and was administered 06/09/2023.
12 years and 2 months old patient given pediatric Pfizer as the 2nd shot by mistake. Informed the patient's mother he does not need to repeat the 2nd dose based on the current interim guideline. We will contact the patient's doctor's office Monday.
7-10 days post vax, the pt developed a rash which is pruritic in nature with macular papules on entire body.
On 04/2/04, pt called reporting having left arm pain, red, swollen started on 03/31/04 after immunization on 3/30/04. Received warm pack to arm and Ibuprofen PRN.
Patient became flushed, hot, and lightheaded. Slumped to side but did not pass out. Symptoms resolved about 10 minutes after start.
On 8/10/21 at 5:33pm, patient called the pharmacy that she had a reaction to moderna shot. Had  red swollen  arm and getting fever. She called her dr and her dr recommended tylenol for the pain and fever.  I said if not doing better to check back with the doctor.
Requested proper dose in writing, filed proper paperwork and that indicated hi dose be given and still administered low dose without advisement or choice prior notice!
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The reporter stated that, on an unspecified date, an unknown number of doses of LIQUID PEDVAXHIB, (dose, lot#, expiration dates not provided) that were stored at 48 degrees F for 20 minutes, then exposed to 47 degrees for 9 minutes have been administered. No adverse effects were reported.   Follow up information had been received on 22-JUL-2014 from a receptionist. The reporter stated that there were two different lot numbers of LIQUID PEDVAXHIB that were included in the temperature excursion: Lot # J016188, expiration date: 02-OCT-2016 and lot # J015437, expiration date: 09-OCT-2016. The receptionist did not have any additional information to share.  Follow-up information has been received from the registered nurse who provided patients details. This report refers to a 9 weeks old patient of unknown gender. On 13-JUN-2014 the patient was vaccinated with a dose of LIQUID PEDVAXHIB (dose and route were not reported), lot#J016188, expiration date: 02-OCT-2016 that was improperly stored. No adverse effects were reported.  This is one of several reports received from the same reporter. Additional information is not expected.
CDC reports: 5 yo child developed weakness & pallor - fell to the floor following DTP/OPV immunization.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 05-JUN-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX, 0.5 ml, subcutaneous (lot number and expiration date were not provided). No concomitant therapies were reported. No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
Patient presented to the ED and was subsequently hospitalized for cryptogenic stroke within 6 weeks of receiving COVID vaccination.
p/vax pt went to ER c/o rt arm red & swollen 5inches to 3.5inches rt deltoid;pt cont to be swollen p/vax;ER report VS pulse 98, BP 143/85, T97;arm cont swollen p/vax over 72hr;
After 2 days felt numbness and tingling left arm (50mmx50mm), (+) erythema and no edema. Left mid tricep region. Ibuprofen Rx.
rigors; headache; low grade temp; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 62-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 at 12:30 as dose 5 (booster), single (Lot number: GJ3275) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "elevated intraocular pressure" (unspecified if ongoing); "known allergies: Mango" (unspecified if ongoing), notes: nausea, rash; "Known allergies: lobster" (unspecified if ongoing), notes: vomit/diarrhea; "Known allergies: tetracycline" (unspecified if ongoing), notes: g.i. The patient's concomitant medications were not reported. Past drug history included: Fentanyl, reaction(s): "Drug allergy", notes: nausea/vomit/itch. Vaccination history included: BNT162b2 (DOSE 4 (BOOSTER), Vaccine administration time=09:30 AM, Vaccine lot number=FK9894, Vaccine location=Left arm), administration date: 08Apr2022, when the patient was 62-year-old, for COVID-19 IMMUNIZATION; BNT162b2 (DOSE 3 (BOOSTER), Vaccine administration time=04:00 PM, Vaccine lot number=CJ511-06, Vaccine location=Left arm), administration date: 05Oct2021, when the patient was 61-year-old, for COVID-19 IMMUNIZATION; BNT162b2 (DOSE 2, Vaccine administration time=11:45 AM, Vaccine lot number=EL3246, Vaccine location=Left arm), administration date: 14Jan2021, when the patient was 61-year-old, for COVID-19 IMMUNIZATION; BNT162b2 (DOSE 1, Vaccine lot number=EH9899, Vaccine location=Left arm), administration date: 22Dec2020, when the patient was 60-year-old, for COVID-19 IMMUNIZATION. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "rigors"; HEADACHE (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "low grade temp". Patient got rigors/headache/low grade temp reaction after Covid vaccinations, which were severe enough that she scheduled time off work.
had second dose of COVID vaccine on 1/8/2021, notes initially with rash and swelling of face which went away when she got home. Since then, patient has had HA but noticed swelling to left shoulder on 1/9/21. neck: 3 cm x 3 cm left supraclavicular lymphadenopathy with tenderness to palpation give ibuprofen 600mg PO x1 and discharged with Ibuprofen
Extreme site reaction. Noticed a bit of redness the morning of 7/31/2021 which was the morning after my vaccine. By the evening of 7/31/2021, I had started running a fever, having chills and a headache. The fever, chills, headache and overall fatigue continued through today, 8/4/2021. In addition, the injection site reaction continued to spread across most of my upper left arm. The site was red, feverish and sore. The area was as large as 4 inches by 6 inches. I do have progressive pictures of the site. I have taken Tylenol almost every 4 hours since my initial reaction on 7/31/2021 and today is 8/4/2021. I have also taken 3 days of sick leave due to the pain, fever, headache and overall fatigue.  As of today, the site is still red and feverish but not as sore as the past several days. My fever, headache and fatigue are finally getting better it seems. In block 20, I am marking that I have recovered because the site reaction has seemed to stop spreading, however it?s still red and feverish.
Raised red area just below injection site about the size of half-dollar coin. Warm to the touch, but she denies pain, temperature, or oozing fluid from site.  Instructed to keep clean and call provider if it gets worse.
Information has been received from a nurse concerning a her great-niece 13 year old female with no known allergies or medical history reported, who on 28-APR-2009 was vaccinated with her first dose of GARDASIL (dose, route of administration and lot number not reported). There was no concomitant medication. The nurse reported, the patient two seizures soon after receiving her first dose of the vaccine. The first seizure was described as violent jerking, stiffness, frothing at the mouth, tongue deviated to the right and eyes rolled back lasting five minutes. The patient experienced a second seizure within the hour as she was being escorted from the office. The patient was transported home by her mother and was recovering, although still "weak and pale". The patient sought unspecified medical attention. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
c/o diffuse red rash over bilateral arms .   Rash extends from elbow to hands.  No itching.  Areas of rash are raised.  Denies SOB, edema, fever or other symptoms.