chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via company representatives and from a support services director, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. There were no concomitant medications provided. On 11-MAR-2015, the patient was vaccinated with an improperly stored and expired dose of RECOMBIVAX HB "PFS 6x1 10mg/1ml w/o SftySyr" (dose, dose number, route and anatomical location were not reported) lot # J010164 and expiration date 05-FEB-2015. On an unspecified date, the RECOMBIVAX HB had 2 temperature excursions of 6660 and 1692 hours. The lowest recorded temperature was 20 degrees Fahrenheit (-6.666666667 degrees Celsius). No adverse effects reported. No product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "Refrigerator (R)". This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a 16-year-old female patient who received BEXSERO (batch number 148901A, expiry date 30th September 2016). Co-suspect products included FLUARIX QUADRIVALENT (batch number 4Z27T, expiry date 25th June 2017). On 23rd September 2016, the patient received BEXSERO .5 ml and FLUARIX QUADRIVALENT .5 m. On 23rd September 2016, less than a day after receiving BEXSERO and FLUARIX QUADRIVALENT, the patient experienced general body pain, fever, burning in eyes, headache and runny nose. On an unknown date, the outcome of the general body pain, fever, burning in eyes, headache and runny nose were not recovered/not resolved. The reporter considered the general body pain, fever, burning in eyes, headache and runny nose to be related to BEXSERO and FLUARIX QUADRIVALENT. Additional details were received as follows: This case was not previously reported to anyone. The age at vaccination was not reported. The caller reported that the patient experienced severe body aches after receiving vaccinations (BEXSERO in right deltoid and FLUARIX QUADRIVALENT in left deltoid). The patient was part of family and all patients reports same events. This case was one of the 4 cases reported by the same reporter.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2 NOS), on 12Sep2022 as dose number unknown, single (Lot number: A57144B) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATOMOXETINE, start date: 01Jun2019; B12 [CYANOCOBALAMIN], start date: 01Jun2019; D3, start date: 01Jun2019. Past drug history included: Amoxicillin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid from 28Jan2023 to 01Feb2023.
Moderna COVID vaccine - first dose:  polyuria, sweating for about 48 hours - oral rehydration salts Moderna COVID vaccine - second dose:  chills, sweating, headache, tiredness for about 36 hours - ibuprofen
COUGHING UP PHLEGM ALL THE TIME; EXTREMELY TIRED; This spontaneous report received from a consumer concerned a 74 year old female. 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 was not reported, administered on 28-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 29-MAR-2021, the subject experienced coughing up phlegm all the time. On 29-MAR-2021, the subject experienced extremely tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extremely tired, and coughing up phlegm all the time. This report was non-serious.
pt recvd vax & devel ax lymphadenopathy which resolved by 21FEB93;
Pt felt nauseated on the first day of injection. Next day patient had shortness of breath and chest pain. Patient reported SOB lasted a couple of days. Pt reported wheezing and Fast heart beat on the second day as well
Received ADACEL in left deltoid area on 05/10/10. Called 5/13/10 with c/o pain/numbness-seen 5/13/10 by NP. C/o numbness and weakness in left forearm->wrist.  Increased tenderness and swelling at injection site-no redness. Slight warmth, decreased sensation and hand grasp-treated with Ibuprofen, ROM, Ice. Follow-up phone call 5/18/10-problem resolving.
I have had 3 cycles of vaccine symptoms  since receiving my first shot 9 days ago. First round of normal symptoms (low grade fever/chills) began approx. 24 hours after first shot. Symptoms lasted for approx. 24 hours. No symptoms for next 2 and 1/2 days and then experienced 2nd round of same symptoms which lasted for approx. 24 hours. And then another 2 and 1/2 days with no symptoms and then experienced 3rd round of same symptoms which lasted for approx. 24 hours. 3rd round of symptoms has just ended as of this morning.
The patient contacted public health, via interpreter, approximately 30 min after vaccination to report a rash started on her face and has now spread to her trunk and arms.  Rash was reported as red and very itchy.  The client returned to the clinic approximately 3 hours after vaccination and received a dose of diphenhydramine and written instructions on continued use.  We then consulted with Dr., volunteer advisor to Public Health COVID Vaccine clinics.  Dr spoke with the client and then submitted this situation to Dr., with the following information:  "a 26 yo woman without any prior hx/o of allergy or atopy developed a pruitic rash 30 minutes after
starting  5 hrs after 9:30 am vaccine, shoulder stiffness started. Took alleve and applied heat.  9:30 pm noticed 2 welts and redness around vaccine site. No itching. Took Tylenol and benedril.  Could not raise arm palm down in front of me. Pain 8/10.  Next morning redness started to go away.  Welts stayed and appeared to have fluid in them.  Took alleve. Could not raise arm in front or side without much difficulty pain still 8/10.. day 2 following redness is less, welts same with fluid, and pain raising arm is still8/10.  I have very limited motion with left arm. Shot was in lower deltoid of left arm.
patient received an expired dose of Shingrix; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a male patient who received Herpes zoster (Shingrix) (batch number 49R72, expiry date 13th March 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient received an expired dose of Shingrix, the vaccine expired on 13th March 2021, which led to expired vaccine used. The reporter consent to follow up.
Patient with 2 Moderna COVID vaccinations who tested detected for COVID during facility admission testing.  He was asymptomatic for COVID during stay.  Admitted for gangrene and osteomyeltisi of the left foot secondary to peripheral vascular disease.
I was not feeling well Wednesday and Thursday but Friday I felt fine. On Saturday I had a sore throat on Sunday I woke up with a head cold. I took two home COVID-19 test that came back negative. I still felt off so I went in for a Rapid PCR COVID-19 Test that came back positive. I did get a prescription for the Paxlovid but decided not to take it. I do feel fine as of today but I am still testing positive.
Pt had a history of severe psoriasis, covering >75% of body, and pt had stable abscess in left jaw (no change in size or character in 6 months). 1 week after vaccination, the psoriasis cleared, and, by 3 weeks later, was nearly entirely resolved (which has only been seen before with long term high dose steroids - it has never cleared, and never this extent, without aggressive medical intervention; none was had, with the only event being the vaccination); psoriatic arthritis resolved by week 2 after the vaccination. Additionally, pt has developed multiple warts. Finally, the stable abscess suddenly, nearly 3 weeks after the vaccination,  expanded, tripling in size and expanding into soft tissue of mouth. Small cuts that would ordinarily just heal without incident are ALL becoming infected, demonstrating significant purulence that cannot be overcome with the use of antibiotics (this started 1 week after the vaccination). Ultimately, for these reasons, the patient is demonstrating symptoms consistent with a significant reduction in immune competence, all since the vaccination. Oddly, though, the autoimmune encephalitis, also a disease of hyper-immune activity, has worsened, rather than improved, as would have been expected with global disabling of the immune system.
Initially one week after vaccine severe arm swelling at injection site like a circle (no pain) resolved after several days Today entire lip swollen (two weeks post vaccine)
Hives all over the body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over the body) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced URTICARIA (Hives all over the body). At the time of the report, URTICARIA (Hives all over the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details included cortisone injection.
Three-day fever, average 100.2 F, listlessness, fatigue, myalgias, headache
Onset of nausea about 10 minutes after receiving vaccines. On the way home, she complained "can't get it in". Mom thinks she was short of breath. Mom noticed hives at home (about 45 minutes after getting shots) and gave Benadryl po and was referred to ER. Given Epi X 1 and Benadryl po q 4 hr prn.
headache; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and NAUSEA (nauseous) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced HEADACHE (headache) and NAUSEA (nauseous). At the time of the report, HEADACHE (headache) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
- The following message was transmitted to my PCP on Sunday, 04/11/2021, about 11 PM. -  Hello, yesterday, Saturday, April 10th, 2021, I received the Janssen (O42A21A) single-dose vaccine around 10 AM.   About an hour after arriving home, i started having some of the most common symptoms reported, as in the following: Low-grade fever 99.3', Marked fatigue, mild muscle aches, some dizziness and generalized weakness. Took one 800mg Ibuprofen and rested.  Last night, at around 10 PM, I had one episode of hematuria with some visible small-to-medium sized red clots, with no pain or discomfort on urination.   Today, in the AM, I took another 800m  Additional information for Item 18:  800mg Ibuprofen tablet, and by 12 noon, there was less fatigue and weakness, as I moved on in the day, the other symptoms improved or sub-sided, Except, for some, small clots, in a otherwise normal-appearing colored urine, around 1 PM.  My B/P was 148/78, pulse 70, which is normal range for me.   Additional information for Item 18: On Monday, 04/12/2021, during the day-time, I again experienced severe-to-moderate fatigue, and some dizziness, and then, last night, at around 7 PM, and 10 PM, I had two separate episode's of hematuria with some visible small-to-medium sized, Dark red clots this time, with no pain or discomfort on urination.
Started same evening after receiving vaccine. Woke up chattering and had difficulty standing. Pain in most muscles. Did not feel right the next day. One day later felt normal again. Injection site tender for 4 days without redness or rash.
Patient describes a sensation that a needle is still in her arm and itchy. She does not have any change to her range or motion or moving her shoulder/ arm. She still has a slight bruise from where she had the vaccine, although she says she has had other vaccines since then. She says all other vaccines she has had since then have aggravated it.
L upper arm 3 1/2 x 3 1/2 cm round, raised, red, tenderness.
I only received the first dose of Moderna; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I only received the first dose of Moderna) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I only received the first dose of Moderna). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I only received the first dose of Moderna) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  Treatment medication was not provided.
the patient is dignosed with dermatomyositis. His life is changed completely and he is receiving treatments and medical care for the illness. There is no known family history for this disease or anything similar. He has been a healthy 32 years old that exercise regularly. Beginning in early Feburary, he started to have shoulder and arm soreness. The soreness intensified over time. By early April, he couldn't use/lift his arms without excruciating pain. Both of his arms are heavy swollen, as well as his throat muscle. He's not able to eat or drink safely. He is currently ingesting with a NG tube as ordered by the doctor. He saw a rhumatologist and he is dignosed with dermatomyositis.
Individual became flushed, vision blurred shortly after receiving vaccine.  Face red.  Stated he was dizzy and lights made vision blurred.  Onsite EMS attended to patient, vitals obtained. B/P taken several times and manual remained consistent at 176/104.  After resting for short time, B/P remained high along with blurred vision and flushed face. Wife was onsite with husband.  Decision was made to sent patient to Hospital for further evaluation.  IV was placed by onsite EMS crew prior to Fire Dept arrival.  Patient was stable, talking and alert x4 at time of Fire dept transfer.  Was able to ambulate self to cot with min assist by crew for safety.  Was transferred from Vaccine clinic to Hospital by  Fire Dept. Wife meeting patient at hospital, was provided directions to hospital as well.
Tired, chills, overall not feeling right, pain at injection site, large red area and bump at injection site.
Rash appeared within half an hour of being vaccinated. 7-29-19 patient developed varicella rash.
no adverse effects; the administration of one dose of PROQUAD to a 17 year old patient; the dose was reported to have been administered outside of the Prescribing Information; This spontaneous report as received from a physician refers to a 17-year-old patient of an unknown gender. No information regarding the patient's concurrent conditions and medical history was provided.  On 12-OCT-2019, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter, one time subcutaneously for prophylaxis (lot # S012501, expiration date 20-OCT-2020); also one dose of sterile diluent (lot # S024968, expiration date 28-FEB-2022) was used to reconstitute the vaccine.  The suspect vaccine was reported to have been administered outside of the prescribing information. Primary reporter reported no adverse effects for the patient. Primary reporter reported that both the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) and the sterile diluent were stored in the correct temperature storage according to the prescribing information.  Lot number S012501 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD).
Herpes zoster in a 2-dose varicella vaccine recipient. Symptoms: painful rash.
varivax administered on  17-JUL-2000 then on 27-MAY-2010; This spontaneous report has been received from a health care professional via medical records from a case in litigation for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (MARRS# 2110USA001194) concerning 10 years-old female patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 17-JUL-2000, the patient was vaccinated with dose# 1 of varicella virus vaccine live (oka/merck) (VARIVAX) administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).   On 27-MAY-2010 the patient received the second dose of  varicella virus vaccine live (oka/merck) (VARIVAX) (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate schedule of vaccine administered).  This is one from 4 cases from the same patient.; Sender's Comments:  US-009507513-2110USA001194: US-009507513-2303USA008561: US-009507513-2303USA008558: US-009507513-2110USA001194:
Nearly completely incapacitated.  Head spinning, very weak limbs, barely able to get out of bed and stand after extreme effort, no arm strength, could only move to the bathroom via baby steps with while holding on to whatever was available to steady myself.  I ended up on the floor and was barely able to get up and back into bed after considerable effort.  My arms and legs were like rubber.  I had fever and severe night sweats.  I was virtually unable to function.  This lasted from the night of 02/03 and continued through 02/04.  Finally 02/05 I was able to get out of bed and shakily stand. But I couldn't stay up long, as I had the aches and pains and a headache still.  Finally 02/06 I was able to get out of bed and stay out.  I hope my description describes the magnitude of my symptoms.  I wasn't sure I was going to survive.
This spontaneous report as received from a healthcare professional refers to unspecified patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of improperly stored ZOSTAVAX (lot #, expiration date, dose and route were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected due to no consent to contact Health Care Professional was given.
Right arm edema, erythema and pain from shoulder to elbow with marked dermatitis at inoculation site. Very warm to touch, resembling cellulitis.
Site: Itching at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: PATIENT STATED THAT ARM ITCHED AND HAS SMALL BUMPS ON ARM
No adverse effects at the time of immunization or following. Patient was given the MMR vaccine by the wrong route of immunization. It was given IM instead of SQ.
Vomiting, injection site pain, muscle aches whole body, confusion, weakness, no coordination, dizziness, blurred vision, couldnt stand or sit due to lack of muscle control, chills, slight temperature, severe diarrhea
Hospitalized for COVID, pneumonia, and respiratory failure with hypoxia. Died at nursing home on 2-8-22.
pt recvd vax & sometime p/the dose exp mild fatigue; event resolved in couple of days;
Second day started feeling very tired arm swollen painful chills lips tingled and dizzy. Very lethargic went to be about 9 that night and woke up Sunday feeling fine.
patient, who is pregnant received a dose of gardasil 9; no adverse effects; This spontaneous prospective pregnancy report was received from a medical assistant referring to a 30-year-old female patient. Her concurrent conditions, medical history, concomitant medications and drug reactions/allergies were not reported.  On 14-OCT-2019, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R011630 and expiration date: 12-DEC-2020) for prophylaxis (strength, route and anatomical location were not reported) (exposure during pregnancy). The last menstrual period (LMP) and estimated date of conception was estimated to be 02-FEB-2019 and 16-FEB-2019. The gestational age was reported to be 36 weeks and 4 days. The estimated date of delivery was reported to be 09-NOV-2019. No adverse effects were reported. The pregnancy outcome was outcome pending. The outcome of exposure during pregnancy was unknown. No product quality complaint (PQC) was involved.
Started feeling bad, throat started hurting, lost voice.  Still am unable to talk very well and has been going on for  4 weeks.
Immediately after vax, pt noticed pain & tingling in lower arm. Was seen in ER & told "probable injection to bursa". Pt received physical therapy.
20 minutes after receiving her second COVID dose, patient began having symptoms of an allergic reaction.  We were in the car, and her hands began tingling and getting numb, her lips got red and a bit swollen, and she began to have a throbbing headache.  Within 10 minutes of symptoms, I gave her 15 ml Benadryl.  She slept for an hour and woke feeling better with none of previous symptoms. .
Within 48 hours severe headache and HBP (134/92) even with HBP medication. Lethargy for 4 days. Reduced energy level and "brain fog" continues through today. Physical activity presents muscle cramps and tingling. Extended recovery after physical activity. I typically ride my bike 20-30 miles 3-4 times a week. That activity has been reduced to 12 miles a month.
The evening of vaccine, patient started experiencing ringing in both ears and loss of hearing. The next day, hearing and ringing had not improved. Patient began vomiting and experienced extreme vertigo. On the third day, condition had not changed. Patient's urine is dark and he cannot keep down any food.
11/2/07: general malaise, myalgia, sinus, hoarseness, dizziness.  11/12/07: Hoarseness, dizziness, general malaise, resolving, still some myalgia.
Prevnar given at age 3 yrs patient has received 5 doses, no adverse reaction.
Telemedicine 3/18/2021    MD  Close exposure to COVID-19 virus +1 more Dx Sinusitis  Reason for Visit Progress Notes  MD (Physician) Family Medicine Encounter Date: 3/18/2021Signed    Reviewed.  Letter provided for the patient.     Please be aware since you saw the patient on 3/15/21.  Her symptoms started later that day.  Progress Notes  MD (Physician) medical Encounter Date: 3/18/2021  Signed Expand AllCollapse All      Assessment/Plan      Diagnoses and all orders for this visit:   Close exposure to COVID-19 virus   Cough   Recommend covid 19 testing.  Tylenol Hydration mucinex