chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 13-APR-2017, the patient was inadvertently vaccinated with an expired dose of M-M-R II (lot # L012480, expiration date: 10-APR-2017, dose and route of administration were not reported) reconstituted with sterile diluent (MRK) (lot # L012345, expiration date: 23-JAN-2018). No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA006395:
Patient developed shortness of breath, tachycardia, epigastric and chest pain. A thorough workup was performed to search for other causes and none was found, ultimately patient was treated as moderate anaphylaxis, symptoms improved with fluids, steroids, benedryl, and she was discharged with strict return precautions and outpatient followup.
Right arm where vaccine was administered swelled 2x size. Patient then developed thrombocytopenia ITP received IV Igg. Platelet count dropped to 3,000. Hospitalized 9/14/09. 10/5/09 Discharge summary received for dates of service 9/13/09 to 9/15/09. DX: Immune thrombocytopenia purpura.  Presenting Symptoms: presented with a four day history of increased petechiae over both arms, trunk, and neck. Purpura on both Periorbital sufaces. Pt started on IVIG. Pt experienced HA, emesis x1 as side effect of tx.
Intermittent tingling(not full numbing) all over body(upper lip, left forearm, lower back, right shoulder, left foot), overall feeling of heaviness, and slight lethargy.
Continual left shoulder pain (injection site).  Initially, I had a good sized bruise and a significant amount of shoulder pain.  I was told by my doctor to take naproxen or ibuprofen for the pain.  Neither had any significant or lasting effect and I have discontinued both.  I am unable to raise my arm without pain (getting dressed and undressed is a real task!).  I have trouble sleeping because rolling onto my left side causes enough pain that I waken.  Basically, my shoulder aches all day and when it is used, sharp pains ensue. I am uncertain which flu shot I was given.  My chart only says Influenza Quadrivalent Preservative Free.
Fever, muscle pain, fatigue, headache for one day. Headache continues to persist at this time (5:40 am 11/6/2021).
9 hours after Shingrix vaccine I experienced chills, joint pain, R upper arm redness. I took 600mg Ibuprofen every 6 hours for 24-36 hours then as needed. R upper arm swelling and redness worsened up to 48 hours, approximately the size of a softball and painful. Applied ice pack to the R arm swelling, R arm swelling was getting better by 72 hours and feelin better
Right arm from elbow to shoulder erythemic with edema & warmth with edema extending over top of shoulder to clavicle. Treatment with ice pack, Benadryl & Tylenol call if worsening.
redness, swelling, warm induration 12 cm x 6 cm  Rt upper outer arm Tx: keflex 500 mg tid x 10 days Ice and elevate
Client was to receive HPV and Hep A.  The HPV was not given and an additional dose of Hep  B was given by mistake.
I started having brain zapping and horrible headaches started immediately after vaccine. Felt like my brain was racing and I was hyper aware, I could not relax or sleep. I felt like I was in overdrive. The headache was excruciating and nothing helped.
11/04/2021 in the morning 7:00AM legs, hips, my back was hurting. My legs were shaking.  I felt very weak. I felt like I injured my body. The pain was coming and going.  I went to physical therapy to get better but it didn't help much.  My doctor recommended that I should go to musculoskeletal doctor. I can't work or stand for long time.
A nurse reported that a 34 year old female received an injection of Flu Shield '00-'01 on 11/23/00 and subsequently, developed neck and shoulder pain. She recovered after 2 weeks. This is 1 of 2 pts from this facility who had an adverse experience, post vax, Flu Shield.
Patient became anxious and diaphoretic. Prior to covid-19 vaccination patient stated fear of needles. Patient sat on stretcher. Patient lay on stretcher. Vital signs were taken at 12:37 p.m.  B/P was 111/48, HR was 61, and RR were 20. Patient was responding during the vital signs being taken and answering questions about how he felt and contacting his Mom at store. He also noted he hadn't ate much in the A.M. Wet cloths were put on Patients head. His vital signs were retaken of B/P of 124/66 and HR of 80 at 12:43. The head of the stretcher was lifted and patient ate some peanut butter and crackers and drank some water. Later he dangled on side of the bed before a standing position. Patient stated he was feeling fine now. No medication was given.
Patient with previously undisclosed MDHx epilepsy/narcolepsy complex experienced temporary adverse reaction after injection with Pfizer COVID-19 vaccine. Strike Team RN telephoned me to report that they could not conclude home visit because patient was fading in and out of consciousness. Moderate convulsions on whole body. No loss of pulse nor respirations during whole time. BP and RR WNL. Family insisted that this was normal for patient after other vaccinations. I advised RN to call EMS for paramedic assessment and assistance. RN tried to call EMS, but patient and family were adamant in their refusal for further assistance. RN had Legal Guardian handwrite a statement of refusal and AMA on a blank piece of paper. Both Legal Guardian and RN signed. Strike Team remained with patient for about 1 hour. Before Strike Team left, patient was A/O and VS WNL. RN advised patient and family to call EMS if same S/S recur and to consult with PCP. RN discovered after further interview with patient and Legal Guardian that patient has a long MDHx of neurological conditions involving epilepsy, narcolepsy, and syncope. MDHx was never disclosed to our Homebound Coordinator nor during RN assessment.  VS @ 11:45 = BP 110/80 HR 68 RR 16 Heart Sounds S1/S2 Only @ 11:55 = BP 104/80 HR 68 RR 16 Heart Sounds S1/S2 Only  F/U Legal Guardian was telephoned on 01/13/2022. Guardian stated that patient was doing well the next day and all days after Strike Team's vaccination. No recurrence of S/S. No visit to UC/ED.
Headaches, rapid heart beat, pounding heart, burning in neck and face, red faced and red neck, hot flushes, sweating, fatigued. Very high heart beat at resting 118hb per minute
This is a spontaneous report from a contactable consumer (patient). A 40-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0158), at the age of 40, via an unspecified route of administration, left arm, on Apr 7, 2021, at 08:45, single dose, for COVID-19 immunisation. Medical history not reported. The patient did not take any concomitant medication. The patient had no known allergies to medications, food or other products. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 8, 2021, at 14:00, day after receiving the first dose, patient experienced tinnitus. The patient did not receive any treatment for the event. The events did not result in doctor, other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the tinnitus: not recovered. No follow-up attempts needed. No further information expected.
8/29 3rd dose of moderna vaccine  9/8  Itchy began  9/9 Hives began  9/10 Urgent Care visit (prescribed prednisone for 5 days)  9/12 Followed up with personal doctor.  Said could take 4-6 weeks has seen these rashes before. (Prescribed Zyrtec and Hydroxyzine)   9/17  Emergency Room.  Skin very sensitive, painful/ bruised feeling to touch plus hives and itchy.  Bad headache and chills couldn?t sleep. Felt awful.  They administered IV Steroid. Prescribed 5 days of additional steroid, said use Zyrtec and Hydroxyzine if needed.   9/23-24 less rash, hives and itch. Skin tenderness gone. Face puffy, red spots on body and face all day. Taking hydroxezine at night   9/25 continued progress flare ups on leg and hands. Red hot spots flare up. Some itchy some not itchy.  9/26. No tenderness of skin.  Flare up in late evening on legs and arms.  Hot to the touch, itchy but not too itchy. Using cortisone. Felt good all day. No tenderness on body and face less puffy.   9/27 primary care visit  9/29 continuing to take zyrtec- still have Dermatographia but no skin tenderness- feeling less inflamed.
After receiving the covid vaccine PT stated "I am feeling light  headed and heart palpitations." I asked to take PT vitals, she declined for me to do so but wanted her pulse to be taken. After taking her pulse a couple of times PT stated "I am not feeling any better" so I immediately called RRT. They responded immediately and took her down to urgent for further assessment. Received RRT call from Covid vaccine clinic regarding pt feeling dizzy after Covid vaccine.  Went to assess pt at the Covid vaccine clinic.  Pt A&Ox 4. Pt stated has been feeling dizzy since yesterday. Pt stated in between chemotherapy.  Pt was recommended by staff to move RA after the vaccine. Pt was pacing in the room and moving RA. Pt felt lightheaded.  VS was 122/77 P 83
Fever, headache, runny nose, and sore arm 1-12-2021 around 11 AM. Used 1 tablet of 200mg ibuprofen around 1 PM. Started feeling better around 2:30 PM 1-12-2021 but not 100% better.
Rash the size of silver dollar at injection site started. Did have slight swelling: improved. No pain or itching. Doing well. Reassured probably mild reaction to vaccines. Observe. Can apply the cream to rash if desires. Flu not improving or worsen.
Immediate shortness of breath  (wheezing)   Wait until November 22nd to visit ER with clamy skin   Major trouble exerting energy - going up stairs was terrible with restriction of breath
Diarrhea; This is a spontaneous report received from a contactable consumer A 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, on Arm Right on 27Feb2021 at 08:00  as single dose for covid-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included allergy to Lisinopril. The patient took other medications within two weeks.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.The patient was not tested for COVID-19 post vaccination and was not diagnosed with COVID-19 prior to vaccination.On 28Feb2021,the patient developed diarrhea and continued to have on 01Mar2021 this day reported. The patient was taking loperamide for treatment and consulted via phone call and spoke with PCP regarding the diarrhea on morning of 01Mar2021.The outcome of event was recovering.  No follow-up attempts are possible. No further information is expected.
Patient Reports he had his first COVID-19 vaccine 4-5 weeks ago at a church. Patient did not know which vaccine he received. He reports he got his first Shingrix vaccine over a week ago at the Pharmacy. He reports about 3 days after receiving his shingles vaccine he started breaking out in a rash. He reports it started in the middle of his forehead. Now the rash is on his hands, elbows, and feet. He says the rash has been there for almost a week now. Patient prescribed a prednisone taper to help with rash and itching on 4/25/2021.
This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. On August 2012 the patient was vaccinated with a dose of VARIVAX (merck) (dose number, route, concentration and lot number unknown). On AUG-2012 (reported as after receiving vaccine) the patient experienced scarring on buttocks from rash with lesions. The outcome of scarring on buttocks and rash with lesion was unknown. Additional information has been requested.
Arm became sore around 5 1/2 to 6 hours, post vax. There's slight redness in upper left arm.
Initial information received on 10-Aug-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves an unknown age adult male patient who experienced severe malaise, severe pain, redness and swelling at injection site and fever over 102 Fahrenheit (38.8 degree Celsius), while he received vaccine ADACEL. 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 ADACEL lot number not reported. On an unknown date, patient developed a non-serious severe malaise (malaise), severe pain, redness and swelling at injection site (vaccination site inflammation) and fever over 102 Fahrenheit (38.8 degree Celsius) (pyrexia) following the administration of ADACEL. Relevant lab tests include fever over 102 Fahrenheit. Final diagnosis was fever over 102 Fahrenheit (38.8 degree Celsius), severe pain, redness and swelling at injection site and severe malaise. It was not reported if the patient received a corrective treatment. The patient outcome was reported as recovered for severe malaise (lasting for seven days) and fever (lasting for 4 days) and unknown for severe pain, redness and swelling at injection site and fever.
It started with a scratchy throat and I didn't think much of it. On my way home from work it went from scratchy to a stinging sore throat then runny nose to a cough. I got home and took a at home COVID-19 test and within 3 minutes it turned positive. That night I had chills, got hot, and got a fever. I have a lingering cough and today I'm on the 3rd dose of Paxlovid. I've also lost my sense of taste and smell. It was an all of sudden onset of symptoms when I left work that day. I'm feeling better today than I did the previous days.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date in 2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions.  Subsequent to patient's inoculation, patient was treated by a healthcare provider for shingles.. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.   At the reporting time, the outcome of shingles was considered.  The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).
15APR pt awoke w/faint red marks on chest & arms; c/o sl itching; given APAP & sent to school;  came home from school numerous welts over entire body;
seizure; I fell of my hight; headache; total amnesia; my waking is wobbly and not steady; This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: ER8727) via an unspecified route of administration, administered in Arm Left on 22Mar2021 12:30, at the age of 44-year-old, as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported. The patient was not diagnosed with COVID prior to vaccination. Concomitant medications included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); colecalciferol (VITAMIN D [COLECALCIFEROL]); fish oil (OMEGA 3 [FISH OIL]). On 23Mar2021, at 03:00 AM, the patient fell off his height and had a seizure. This was his first seizure in his life. The patient was rushed to the ED where a CT of the head and neck was done in Mar2021. The CT did not show any bleeding or fracture. The Neurologist dismissed the patient home and had the patient go back and see him in 2 days. The patient has been complaining of headache and taking Tylenol PRN for it. His walking was wobbly and not steady. The patient had a total amnesia of the accident. The patient did not receive treatment for seizure, fall, total amnesia and walking was wobbly and not steady. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not tested for COVID since the vaccination. Outcome the events was not recovered.
not feeling good; This is a spontaneous report from a contactable consumer, the patient, from Pfizer-sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: UNKNOWN), dose 1 via an unspecified route of administration on 24Mar2021 as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient missed his 2nd dose on 14Ap2021 because he has been not feeling good that day. The clinical outcome of the event was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Pt erroneously received expired Pfizer dose on 12/1/21. Staff contacted Pfizer to inquire if lot of vaccines were still viable at time of vaccination. Following discussion  pt did not need to be revaccinated as Pfizer  had stability data to support this excursion for 1 day post expiry from manufacturing data
She fainted and collapsed about 18 hours after receiving the second dose (6:30 am). She was confused for about an hour after she fainted.  She was on ibuprofen (400 mg taken at 5:30 am). Other than weakness, headache, and fever, she has had no other adverse reactions so far besides the  single fainting episode.
approx 2 yrs p/vax pt exp fever & an unknown number of skin lesions.
I had tired, fatigue, and soreness.  I had a rash on my neck for 2 days.  Several weeks later, I had ear pain.  I went to urgent care about the ear pain last week.  They just exam my ear.  I am still dealing with the pain.  On Monday, I went to ENT specialist.  He said I had an ear infection and gave me medicine for it.
Forehead feeling tingly and a bit numb equally on both sides lasting about 24 hours on and off. Comparing to when you go have dental work and the local numbing agent is wearing off
4 hours after receiving my first dose of the vaccine, the left side of my face and head went numb. This lasted for approximately 2 hours. It slowly went away and has not returned
Fever; Soreness at the injection site; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever) and VACCINATION SITE PAIN (Soreness at the injection site) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and unknown) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in June 2020.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced PYREXIA (Fever) and VACCINATION SITE PAIN (Soreness at the injection site). On 30-Apr-2021, PYREXIA (Fever) and VACCINATION SITE PAIN (Soreness at the injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable  No concomitant medications were reported  No treatment drugs were reported
1st and 2nd dose: Pfizer/ 3rd and 4th dose: Moderna; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 at 10:00 as dose 1, single (Lot number: EK5730), in right arm and on 21Jan2021 at 12:00 as dose 2, single (Lot number: EJ1686) at the age of 48 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Oct2021 at 16:00 as dose 3 (booster), single (Lot number: 077C218), in right arm and on 26May2022 at 12:00 as dose 4 (booster), single (Lot number: 057M21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (unspecified if ongoing), notes: Thyroid; "cystic fibrosis" (unspecified if ongoing); "obese" (unspecified if ongoing), notes: obese. Concomitant medication(s) included: SYNTHROID taken for thyroid disorder, start date: 14Mar2001; VITAMIN D [COLECALCIFEROL], start date: 25May2018; CYTOMEL, start date: 11Jun2020; VYVANSE, start date: 01Apr2022; METFORMIN, start date: 25Feb2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "recovered" (13Sep2022 at 17:00) and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "1st and 2nd dose: Pfizer/ 3rd and 4th dose: Moderna". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Sep2022) Negative, notes: Home test confirmed negative on 13Sep2022 at 5 PM. Therapeutic measures were taken as a result of vaccination failure, covid-19 include Paxlovid from 06Sep2022 to 11Sep2022. Patient took Other medication in 2weeks. Finished Paxlovid PM hours 11Sep2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2 to the reported events Vaccination failure, COVID-19 and Interchange of vaccine products cannot be ruled out.
redness, pain to right arm, hive like rash on right side of neck and right cheek 2 days after vaccination without dyspnea, angioedema, other rash location, nausea, lightheadedness. prescribed cetirizine and famotidine
Subsequent to receiving one dose of varicella virus vaccine live on 7/25/95, the pt was exposed to her mother with shingles. On 5/2/99, the pt developed a full blown case of chickenpox with lesions in mouth, nose, and near eyes. The pt also developed a fever and sore throat.
Pain, discomfort, blurred vision in left and right eye. No treatment yet. No outcome yet. Might be MS exacerbation.
Severe painful muscle spasms lasting ten days, foggy-headed for two weeks, trouble sleeping for one week, canker sores in mouth and sensitive gums for two weeks.