chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness at injection site; Itchiness at injection site; Heat at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 16Mar2021 at 15:00 (at the age of 31-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no allergies to medications, food, or other products. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), fluoxetine hydrochloride (PROZAC); both taken for unknown indication on an unknown date and ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE) taken for birth control on an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021, the patient experienced redness, itchiness and heat at injection site 10 days post vaccination. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcomes of the events vaccination site itchiness, vaccination site redness and vaccination site warmth were resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient received AFLURIA. The next morning she woke up with a stiff neck and arm and eventually had problems with stiffness down her lgs as well.
After the first shot I had a mild rigidity (more than my normal) of the thoracic muscles just below my breast line and of course a sore arm. After the second shot, 3 days after I woke after working all night to a demyelination response from my MS (which can be caused by weather, stress etc. Also, so did not think much about it) but 2 hours later my lungs started reacting from an overload of mucus (which has happened before after a vaccination so it was obvious my immune kicked in to find the changes going on from the vaccination) I immediately took steps to depress my immune system (mucus and cough syrup, Immersion in an Epsom salt bath with tea tree, lavender, eucalyptus, and peppermint oils (my own breathing treatment solution) 2 glasses of wine (relaxes the muscles, then took 2 Benadryl and 4 Motrin (which knocks me out and completely immobilizes) I have been doing this successfully for years)  Today, I am very sore in the rib area, weak and tired (normal for a day after an episode) my lungs still weak (cough syrup is helping)  Since this has happened before only after a vaccination or TB test I decided to report it for others who have MS, so they can be prepared. I self treat since my health care plan would drain my finances and affect my quality of life.   I still think the vaccine is worth the episode, however, it will be my last Coved Vaccine, since I know it will cause a reaction.
got shingles twice after the vaccine / suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got shingles twice after the vaccine. The physician made the new vaccine and no shingles for several years. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Migraine headache/ gets worse every day; Body aches and pain; Neck, shoulder and upper back pain; Neck, shoulder and upper back pain; Neck, shoulder and upper back pain; This is a spontaneous report from a contactable other healthcare professional (hcp; patient). A 36-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EW0175, expiry date not reported), via an unspecified route of administration, administered in right arm on 07May2021 14:30 (at the age of 36 years old) as second dose, single dose for covid-19 immunisation. Medical history included migraine and known allergies to sulfa, both from an unknown date and unknown if ongoing.  Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of the vaccination. Concomitant medications included amitriptyline at 20 mg, and estrogens conjugated (PREMARIN) at 0.3 mg, daily; both taken for an unspecified indication, start and stop date were not reported. The patient previously took gabapentin, Compazine, SSRIs  (Selective Serotonin Reuptake Inhibitor), oxitriptan (TRIPTAN, reported as Triptans) and promethazine, and experienced known allergy to all of them. Patient received the first dose of COVID-19 Immunization, BNT162B2 (brand=Pfizer, lot number ER8731) on 15Apr2021 14:30 PM, administered in the right arm (at the age of 36 years old). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in the hospital. Following dose 2 of the Covid vaccine, on 07May2021 23:45 patient had severe body aches and pain, and a migraine headache (also reported that this migraine headache started 12hr after the shot). Migraine headache has lasted 6 and a half days so far with no break, and gets worse every day. It started as a 5 on the scale and progressed to a 9 (May2021). On 07May2021 23:45, the patient was also having neck, shoulder and upper back pain the same as the initial body aches. The event migraine headache was reported as serious medically significant. Therapeutic measures were taken as a result of the events reported which included: Advil Dual Action, Caffeine, Zofran, Antihistamines, which were reported to have all failed to treat it. Patient had to contact neurologist for a short term prescription to try and break the cluster.  The events resulted in doctor or other healthcare professional office/clinic visit. Patient then had Toradol 10mg PO TID 4 days, and added steroid if needed. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.; Sender's Comments: Based on the strong temporal relation between the vaccine administration and the onset of the event migraine, the association between them cannot be completely ruled out with the available information
Moderna eua vaccine.  Significant pain upper arm from day 2 after vaccine, redness which started on day 12 after vaccination-upper arm, upper posterior shoulder, anterior axilla
product: COVID 19 Treatment; product: COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 51-year-old patient received BNT162b2 (BNT162B2), in Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, in Jan2021 as dose 2, single (Batch/Lot number: unknown) and in Jun2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing), notes: Other medical history: asthma. Concomitant medication(s) included: ATORVASTATIN, start date: 01Sep2021, stop date: 22May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "product: COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: product: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
SEVERE VERTIGO 6 DAYS POST VACCINATION; HIVES 8 DAYS POST VACCINATION.
Vasovagal symptoms- Dizziness, lightheadedness, nausea, headache, fatigue
pt had left sided bell's palsy after receiving shingrix on 7/29/2019
Flu-ish; nauseous; feeling quite wonderful; This is a spontaneous report received from a contactable consumer, the patient . A 60-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in the left arm on 05Mar2021 at 16:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported and he was A-1 healthy specimen. Concomitant medications were not reported. The patient received no other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient reported that he was not advised not to drink alcohol, and as this shot happened to be administered on a friday late afternoon, he went home and about an hour later had a glass of Scotch. About an hour after that, he apparently was feeling quite wonderful (loopy)(05Mar2021 at 18:15) but do not remember saying or doing things much at all. The next day the felt nauseous and flu-ish all day long. The patient did not receive any treatment for the event. The clinical outcome of events nauseous ,flu like symptoms and Euphoric mood was recovered with sequelae at the time of the report..  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a Medical Assistant and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, drug reactions, allergies, concurrent conditions and concomitant medications were not reported. On an unspecified dates, the unspecified patients were vaccinated with a doses of improperly stored VARIVAX lot number reported as: M008173; expiration date reported as: 16-FEB-2018 (dose, route of administration, anatomical location were not reported). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
This spontaneous case was reported by a health care professional and describes the occurrence of FEELING ABNORMAL (Feeling miserable), HEADACHE (Headache) and PYREXIA (High temperature) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 18-Feb-2021, the patient 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 received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 18-Feb-2021, the patient experienced FEELING ABNORMAL (Feeling miserable), HEADACHE (Headache) and PYREXIA (High temperature). At the time of the report, FEELING ABNORMAL (Feeling miserable), HEADACHE (Headache) and PYREXIA (High temperature) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment information include Aspirin, Acetaminophen 500 mg. Action taken with mRNA-1273 is not applicable.
was given Pneumovax 7/29/08 (L) delt was seen in office 8/4/08 raised, red warm 6cm2 area around injection site. Dx Cellulitis Keflex 500 tid #21 given
Patient fainted but also seem to be having a seizure.  After she fainted she was talking about a dream that she had. Patient lay on the bed for 10 minutes. A juice was given. Patient stated that she had not eaten since 6:00 AM.
Coughing a lot; A spontaneous report was received from a health care provider who was a 51 year-old female patient that received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced a lot.of coughing.   The patient's medical history was not provided. Concomitant medications reported included montelukast and vitamins.   On 30 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (batch number: 025L20A) Intramuscular, in her left arm for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the patient reported that she received the vaccine on 30 Dec 2020 and about an hour later she started coughing a lot. She also stated that she had taken a Covid PCR test on Monday and the results received on 31 Dec 2020 were positive. Treatment for the events included a lozenge.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events, coughing a lot, was considered not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
approx. 18 hrs after DTaP vaccine Pt mother noticed R-arm swelling, eryth, subjective fever, full ROM and NTTP R-arm.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 01-SEP-2015 the patient was vaccinated with ZOSTAVAX, 1 DF, (route and lot# unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 06-JUN-2016, the patient was treated by a physician for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Numbness and tingling in hands and feet for a few hours. Went away after taking vitamin b complex.
This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD which had lot # M018638 with expiry: 11-OCT-2017, lot# M021731 with expiry: 17-OCT-2017, and lot # M015695 with expiry: 26-SEP-2017, exposed to temperature of -11.2 degree Celsius for 1 hour 18 minutes. A second freezer containing different lots such as lot # M011663 with expiry: 08-SEP-2017, lot# M015698 with expiry: 26-SEP-2017 and lot # M029595 with expiry: 31-DEC-2017 had a temperature excursion of -12.9 degree Celsius for 48 minutes. Also, one lot of PROQUAD, with lot# M015695 and expiry: 26-SEP-2017, had an additional excursion of -9 C for 2 hours. No adverse effects reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Patient is fully vaccinated and boosted 11/18/2021.COVID + 4/5/2022  81-year-old female who presents to the hospital secondary to difficulty in breathing.  History is extremely limited as patient is in severe respiratory distress with altered mentation.  Patient was found to have an oxygen saturation at the nursing home at 79%.Patient stated that she was having difficulty in breathing and cough for the past several days. Patient was placed on BiPAP with improvement of oxygenation to 96%. Troponin .29; PLTS 103; D dimer 6,444. Medications: remdesivir, dexamethason, antibiotics (for bacterial pneumonia), heparin. Acute kidney injury. Discharged back to nursing home.
achy, pain in rt arm increased sweating profusely;rx given;T101.4;rash on rt arm from inj 1/2 down arm to elbow x 2 days;
It started off as a forehead headache about 24 hours after I got the vaccine. The pain went down the left sinus and jaw over a period of 6 hours. Then the pain went up my right jaw and right sinus. The pain was excruciating. I did not go to a doctor. I was in bed the whole time, I thought I was having a stroke.
This case was reported by a nurse and described the occurrence of muscle weakness in a male patient who received Lyme disease vaccine recombinant for prophylaxis. On unspecified dates several years ago, the patient received an unspecified number of injections of Lymerix. The injections were administered in the right thigh, instead of the recommended deltoid muscle. At an unspecified time post immunization, the patient experienced muscle weakness and muscle pain. As of 7/8/03, the outcomes of the events were unknown.
Pharmacy staff was alerted by patient's girlfriend that he had passed out. I went to the waiting area where she was propping him up in a chair. Patient was not responsive and completely limp. Together we lowered him to the floor where he quickly began to regain consciousness and tried to sit up. Patient was fairly alert within 1-2 minutes. Patient was given water, ice packs for the back of his neck and forehead, and ED was called. Patient stated he was feeling much better and did not need EMS, but due to store policy they were called. Patient relayed a history of fainting after receiving tattoos, that was not notated on his form. Patient remained on floor until EMS arrived about 20 minutes later and checked on patient. Patient's heart rate and BP were taken by EMS laying down, sitting, and standing and was cleared by EMS to leave.
March 3 - switched from daily 10mg Loratadine to Zyrtect. Continued till current. March 5, about 10AM   Vaccine Shot: Went over allergy/Zyrtec info with pharmacist, she had no concern. Within about half an hour, sinuses filled up, got a bit of a sore shoulder, faint headache, a bit fatigued.  Got through the day fine ?  monthly paperwork, chopped salad veggies, outside to take a short walk twice.  Noon -- ears got itchy, tinnitus increased.   3PM ? sinus pressure has increased.  4:15PM - hands cold and clammy.  6PM ? below waist joints all getting a bit achy and have lots of after-dinner gas. 8PM -- Bedtime will sleep propped up at 45 degree angle, just in case wheeziness begins. March 6 ?4:15AM  up to bathroom at and headache is gone, joints not aching. The Day -- Tired and resting as needed. Did some laundry, dishes, hand sewing on a couple of projects.   Did a couple of short walks again. 8PM -- Bedtime will sleep propped up at 45 degree angle, again just in case wheeziness begins. March 7 ?7:15AM woke feeling much more tired. Made some tea and have some light nausea, so holding off on toast.  Put yesterday?s folded laundry away and found myself a bit light-headed and getting short of breath. Tried some yoga breathing, seemed to help. 7:40AM (about 46 hrs. after shot) ? Short of breath, sweaty and cold clammy hands. Hard gut cramps and 2 trips to toilet that emptied my colon. 8:15AM airways/neck feel tight.  For SOB, tightness, a bit of wheeze -- drinking cold cool water, cool cranberry tea, yoga breathing, meditation to calm, related Reiki energy work. By 8:45AM all symptoms done. Resting with tea, water. 9:25AM ? another round gut cramps and trip to toilet.  By 10AM OK.
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 08-NOV-2012, a healthcare provider at a family clinic administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 28-DEC-2015, the patient was treated by a physician at the family clinic for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
This spontaneous report  as received from a pharmacist refers to a patient of unknown age gender. On an unknown date in 2010 the patient was vaccinated intramuscularly with first dose of RECOMBIVAX HB. On an unknown date in 2011 the patient was vaccinated intramuscularly with second dose of RECOMBIVAX HB. On 18-AUG-2014 the patient presented in the office to received third dose of RECOMBIVAX HB. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
I broke out in extremely itchy and hot hives exactly 10 days after receiving the flu shot and Moderna booster. They were all over my body (from my scalp to my feet) and worsened if they were itched. The hives didn?t respond to Claritin, Benadryl, or Prednisone, but were first managed with 40mg of Zyrtec daily. The Zyrtec reduced the hives but didn?t fix red splotches all over my skin and very reactive dermatographia. My PCP prescribed 40mg Famotidine/Pepcid + 20mg Zyrtec daily on 11/29/21. Both of those medications controlled the dermatographia and hives. I went on vacation on 12/31/21 and ran out of Pepcid, and the dermatographia worsened for a few days until I found more at a drug store on 01/04/2022. I recently experienced hives again on 01/09/2022 and 01/14/2022, where my arms suddenly became extremely itchy and broke out in small bumps and some larger welts when I scratched. Both of these episodes lasted about 20-30 minutes before the hives went away. Initially, around 11/18/2021, I also experienced joint pain, especially in my fingers and wrists. For about a week I could barely text on my phone or open a can/bottle of soda. I had difficulty pumping gas because my hands hurt so badly. The joint pain dissipated and didn?t return. I saw 2 urgent care doctors (about 2 days after initial onset, and one at a local urgent care about 5 days after onset), my PCP on 11/29/2021, and I have an upcoming appointment with an allergist.