chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative:  Per note dated 5/8/20: -Anaphylactic protocol immediately initiated. EpiPen administered, 50 mg Benadryl IV, 20 mg famotidine IV, Solu-Medrol 125 mg IM stat issued. 500 mL normal saline started. EKG obtained which demonstrated normal sinus rhythm. Within 5 minutes of medications administration, patient states all symptoms are resolved however now complaining of some diffuse abdominal cramping and some nausea. Zofran 4 mg by mouth administered, CBC, CMP, UA and culture, hCG test ordered Symptoms:  Dizziness, SkinRash, Rash, UrticariaPruritus, NauseaVomiting, HYPERtension & Tachycardia Treatment:
Itching and red. Itchiness is similar to a mosquito bite.  Size of circumference of side can. Slightly swollen. Occurred 7 days after injection and continues to last 2 days later.
Fever, chills, sore arm Three week menustral  cycle following second vaccine.  No cycle at all now. Thrown into menopause due to vaccine.
right arm became a little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (right arm became a little sore) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (right arm became a little sore). At the time of the report, VACCINATION SITE PAIN (right arm became a little sore) 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.   No treatment information provided.   This case was linked to MOD-2021-368775, MOD-2021-368774 (Patient Link).
Information has been received from a registered nurse concerning a 39 month old white male with no pre-existing medical conditions or allergies, who on 15-Oct-2001 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live (Lot #639432/0787L). Concomitant vaccine therapy administered IM in the left arm on 15-Oct-2001 included a fourth dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar) (Lot #481548). It was reported the patient was not ill at the time of vaccination and the patient did not have any adverse events following prior vaccinations. On 12-Jan-2004 the patient developed an itchy rash described as "papules on face, head, trunk, legs". The registered nurse reported that the patient visited the physician, who treated the patient with diphenhydramine hydrochloride (Benadryl). There were no laboratory or diagnostic tests performed. The patient recovered. No further information is expected.
Began having severe itching and cracking of skin in the vulva and perianal area. I assumed was possibly bacterial vaginosis. I went to my regular doctor's office gave me antibiotics and told me that if it didn't get better to go see my OB/GYN.  It did not get better, so I made an appointment with my OB/GYN.  He said this is what I think that it is, but let me look to verify. Upon examination he said yes it is Lichen Sclerosus.  It is an autoimmune disease.  It is a lifelong chronic skin condition.  It usually effects pre-pubescent and post-menopausal women, which I am neither. The clobetasol propionate has helped to some degree, but I'm trying to limit the use due to the fact that it is a steroid, and it causes my blood sugar to increase.  I haven't made it to my regular doctor yet to discuss how to handle my diabetes with the use of the cream. Per a tele appointment 8/10/21,  Dr. said if I was still having issues I needed to come back in. I haven't scheduled to  go back to the OB/GYN because I know it will result in having to have a biopsy done of my genitals.   And who wants to do that???
This is a spontaneous report from a contactable consumer or other non hcp. A 66-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL3246, Expiration Date: Apr2021), intramuscular, administered in Arm Left on 25Jan2021 11:00 as 0.3 mL, single for covid-19 immunisation. Medical history included hypersensitivity, immunodeficiency, respiratory disorder, cytogenetic abnormality, endocrine disorder, diabetes mellitus, obesity, asthma from 1990 to an unknown date, Asthmatic diagnosed 1990. Patient's concomitant medication was not reported. The patient experienced caller experienced side effects including chills, dizziness, tiredness, weakness, generally feeling unwell on 28Jan2021 was reported as worsened on Jan2021. Reporter stated that "Did not think about it and could not explain why he was not feeling well until he looked at the side effect sheet. It has been going on a couple of days and he does not know when it started". NO ER or physician's office required Prior. Outcome of the event worsened was unknown and others were not recovered.  Follow-up attempts are completed. No further information is expected.
Momentary facial paralysis, only lasted a few minutes, 8/9/2021 9 pm
she had low grade fever, chills,  headache, but next day she complain  of pain on the left side of her body (not just the arm)  I was told this was normal and to give her Tylenol or ibu. she has swelling in her left axilla. on Sunday she notice  some blister on the inner corner of her mouth. I have messaged her PCP with no response
Sore arm; Headache (Slight); Low grade temaperature; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache (Slight)) and PYREXIA (Low grade temaperature) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (Sulfa), Lupus nephritis (Lupkynis (Vaclosporin) Since 12/1/21 for lupus nephritis) and Sjogren's. Concomitant products included VOCLOSPORIN (LUPKYNIS) from 12-Jan-2021 to an unknown date for Lupus nephritis, MYCOPHENOLATE MOFETIL HYDROCHLORIDE (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache (Slight)) and PYREXIA (Low grade temaperature). At the time of the report, PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache (Slight)) and PYREXIA (Low grade temaperature) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient received both dose (1st and 2nd dose) in the morning (am) No treatment details were provided.   This case was linked to MOD-2022-538122, MOD-2022-569113, MOD-2022-569115 (Patient Link).
This spontaneous report as received from a pharmacist refers to an unknown number of patients of unknown age and gender. The pharmacist reported that an unknown number of doses of RECOMBIVAX HB, in (lot # and expiration date not provided) (dose  not reported) that were exposed to temperatures below 36 degrees F had been administered (dates unspecified). In the past 3 months the temperature in the refrigerator dropped below 36 degrees F, 8 different times, for a period of 30 minutes each time. The coldest temperature was 34.1 F, for a total time of 4 hours. No adverse effect reported. Additional information has been requested.
12/16/99, mother stated daughter received chicken pox shot yesterday and is broke out all over with chicken pox today.  Temp of 101.Denies past exposure.  Instructed if child worsens or doesn't inprove seek medical attention.
patient was given YF-Vax reconstituted with sterile water with no reported adverse event; Initial information received on 12-Dec-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a patient of unknown age and gender was given yellow fever vaccine - [YF-VAX] reconstituted with sterile water with no reported adverse event.  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 unknown dose of suspect yellow fever vaccine - (dose, strength, frequency, formulation, lot number and expiry date unknown) reconstituted with sterile water with no reported adverse event (product preparation error) (unknown latency) via unknown route in unknown administration site for Immunization.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
No adverse event; received expired dose; This spontaneous report as received from a other health professional refers to a patient of unknown age.    On 21-AUG-2019 the patient was inadvertently vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # N030175 expiry date: 16-JUN-2019) for prophylaxis.       On 21-AUG-2019, 1 day after onset of therapy the patient experienced expired product administered.  On an unknown date the patient experienced no adverse event.
1 of 3 pts vaxed from the same lot# who exp an inj site rxn;pt devel red, swollen, indurated area-size of an egg following vax;required MD visit-treatment included cool compresses topical steroid cream & DPH; pt recovered;
Within 30 minutes I began to feel somewhat jittery and felt very hot . Then I began sweating profusely. I was not tachycardic but my pulse felt very strong.  The sweating lasted about 20 minutes.  The jittery nervous feeling about two hours.
01-04-13- Reported soreness/pain to arm within first few days, then a red smooth rash developed (after pain gone) size of her first; thinks it lasted 2 weeks.
Fever, chills, myalgias, arthralgias, weakness, nightmares.
2 days post vax fever 104-105 w/congestion, lethargy, cough, anorexia; nausea, vomiting, swollen glands, sore throat, generalized rash; seen by MD 17MAY93;
2 days p/vax pt devel an inj site rxn characterized by erythema & itching;pt also devel unspecified systemic sx which caused pt to miss 1 day of work;tx w/claritin & applications of ice & recovered;this is 1 of 3 pt from this facility w/rxn
she thinks she did not get the full effect of the vaccine.; she experienced extreme pain and tenderness after the vaccine; she experienced extreme pain and tenderness after the vaccine; vaccine was administered to the fatty layer of her arm not in the muscle.; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) of an unspecified age received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE)via an unspecified route of administration on 03Feb2021, second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 24Feb2021, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported that the vaccine was administered to the fatty layer of her arm not in the muscle. She said that she experienced extreme pain and tenderness after the vaccine. Her daughter who is a nurse practitioner said that the vaccine site is too high. She also explained how they administer the vaccine. She also wants to ask if there is some test for the efficacy of the vaccine because she thinks she did not get the full effect of the vaccine. She wanted to be revaccinated. She got her first dose on 03Feb2021 and her second dose was done on 24Feb2021.The outcome of the events was unknown.  Information about the Lot/batch number has been requested.
Patient has had arm soreness from injection site up to the top of the shoulder from the time since first vaccine and has not gotten any better. Patient is currently scheduled for follow up doctors appointment related to the arm pain on 11-15-21.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old male patient received BNT162b2 (BNT162B2), on 22Sep2022 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 82 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hairy cell leukemia" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "DVT" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: XARELTO, start date: 08Feb2022; ROSUVASTATIN, start date: 09Aug2022; LEVOTHYROXINE; DILTIAZEM, start date: 04Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received COVID 19 Treatment with Paxlovid from 18Dec2022 to 22Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
MANY SIDE EFFECTS; This spontaneous report received from a consumer via a company representative concerned a 57 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced many side effects (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of many side effects was not reported. The patient additionally received non-company vaccine Tozinameran (Pfizer) (dose number in series 2) (form of admin, route of admin, and batch number were not reported, expiry: unknown), dose was not reported, administered on unspecified date for prophylactic vaccination. It was unknown whether the patient had any adverse events following vaccination with Tozinameran (dose number in series 2). This report was non-serious.
Immediately following vax, the pt experienced dizziness, diaphoretic, decreases blood pressure to 70/30, heart rate increased to 140's. The pt also experienced a rash on the trunk and arms.
COVID-19 case. I had a sore throat and was getting a little more tired. My Mom got sick first. I tested positive. I started PAXLOVID within 24 hours of symptoms starting. My throat hurt really bad and I had some headache symptoms. I had trouble staying up some days. It was really bad for 2 days and I got better pretty quickly.
Muscle/joint pains, nausea, headache, exhaustion, no appetite, low grade fever everyday; took tylenol/ibuprophine to take fever down.
Swelling of Derma Filler and after having virus May 6-15 excessive swelling and after having neurotoxin June of 2022 major allergic reaction.  See Dr.  Swelling, redness, ears ringing, soars PHOTOS of entire process starting in April  21 with swelling
This spontaneous report as received from a 38 year old male patient refers to himself. The patient had unspecified seasonal allergies. He had no pertinent medical history nor concomitant medications. On 12-JUL-2017, the patient was vaccinated with the first dose of VARIVAX (single injection in the left arm; route of administration, lot#, and expiration date were not provided) as required vaccine. On 23-JUL-2017, the patient experienced 7 lesions on his right leg. The lesions go from the ankle to mid thigh. The patient sought medical attention and called his physician's nurses hotline at the office. No treatment was given for the adverse event and no laboratory studies were performed. At the time of the report, the patient did not recover from the adverse event. The relatedness between the adverse event and VARIVAX was not provided.
pt recvd vax 10NOV93 & told MD pt had high pitch cry, shrill screaming for 1 hr; p/last DTP had not called before;
Swollen axillary lymph node with pain radiating through breast tissue. Joint pain/swelling  throughout arm.
pt recv vax;devel a mild chicken pox rash on face,neck & chest p/ vax
Pt received Dtap, IPV, MMR in office 9/16/04. Pt seen back 9/17/04. Red swollen thigh at injection site. Swelling in ant. thigh down to knee cap. Erythema, warmth to touch. Sl indurated right leg. Started on Keflex 250mg/5ml T tsp PO TID x 10 d. Pt saw in office 9/20/04, no erythema of right leg. Swelling decreased, but still sl. No warmth. Instructed to cont ABX.
devel fever of 102 ax by 2AM 10NOV92; used APAP & sponge bathing; temp came down to 101 but cont up to 102 ax through 13NOV92; measles type rash devel on 19NOV92; vomiting began 20NOV92 & cont through 22NOV; seen by MD @ clinic 23NOV92;
Still has arm pain today; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "not recovered", described as "Still has arm pain today".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
By the end of day (10/27) my left arm felt dead. I could barely move it. For the next 2-3 days I had a burning sensation in my upper arm. I could only sleep for 2-3 hours at a time for the first 2-3 days after receiving the vaccination. Now 3 plus weeks later my shoulder still hurts. I still cannot raise my arm above my head without pain. I cannot pick up objects with my left arm without pain. The pain is mostly in my upper shoulder area.
Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 69-year-old male patient received BNT162b2, BNT162b2 OMI BA.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "recovered" and all described as "Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: He got Covid recently, was sick, but got better and is now negative; (Dec2022) Negative, notes: He got Covid recently, was sick, but got better and is now negative. Clinical course: The reporter stated "My brother (69) and I (65) get boosted each time it's necessary. He got Covid recently, was sick, but got better and is now negative. "  The information on the batch/lot number for BNT162b2, BNT162b2 OMI BA.4-5 has been requested and will be submitted if and when received.
Patient received her second dose of the Pfizer Covid-19 vaccine at 1634 this date.  At about 1640 she began to experience chest heaviness, a scratchy throat, and dizziness. Patient had told clinic staff that she had a similar experience at home after receiving her first dose of the vaccine last month. At that time she took 50 mg Benadryl by mouth and her symptoms resolved. The clinic staff had been monitoring the patient for indications of a reaction and when she did start to experience her symptoms, she was moved into a vaccination cubical for privacy. Vital signs were recorded and the patient used her own Albuterol rescue inhaler once. 50 mg Benadryl was administered IM in the right deltoid by Paramedic at 1658. By 1705, patient stated her symptoms were resolving. She called her husband by cell phone to arrange for him to come get her. Vital signs were re-checked and patient was given cool water to sip. Her husband arrived at about 1710. Both the patient and her husband were advised to be cognizant of a return of any symptoms and to seek medical attention if symptoms returned or worsened.  Patient was released to the care of her husband at 1720
This spontaneous report was received from a licensed practical nurse (L.P.N) referring to unspecified number of patients of unknown age and gender. The patients' medical histories and concurrent conditions were not reported. On an unknown dates, the patients were vaccinated with doses of VARIVAX (Merck) (Lot# K002046, expiration date: 10-FEB-2016), which were exposed to temperatures outside of the recommended range. No adverse experiences have been reported. There was no product quality compliant (PQC) involved. This is one of the several reports from the same source. Additional information has been requested.
I had abrupt and sudden chills and extreme rigors. I had to cover myself up with 4 blankets I felt so cold. I had a temperature of 101.5. My respiratory rate was 22 to 26. I literally had no energy to eat, drink or swallow. I just wanted to curl up in fetal position. I took 2 Tylenol for fever. Around 10:00 the rigors stopped. Fever lasted until next morning around 09:00AM.
VIIS ID: 8574817. 18 yo female had syncope with seizure after vaccine at table. Previous episode of same 15+ years ago with neuro consult. Discharged to family. Vasomotor collapse and loss of consciousness. 19:15 119/63 p90 r 16- 19:18 117/73 p88 r16.
I had a runny nose, it felt like someone had turned on a faucet. I started getting really tired, so I went to bed early. Sometime throughout the night I started getting chills, then very hot. The next morning, I tested using a home COVID-19 test that came back positive. I called my doctor to let him know that I had tested positive, they called my pharmacy, I had a prescription of PAXLOVID waiting for me to pick up. My fever had spiked to 103F, I started the PAXLOVID, the next day my fever dropped to 102F, the fever continued to drop daily. I was feeling better after five days, the PAXLOVID did help despite the taste. I felt good for two days, then I felt exhausted, congestion in my ears. I called my doctor he felt that I may have rebound COVID-19, he advised me to take SUDAFED for two days, off for two days to keep my sinuses clear, drink warm drinks. I had severe brain fog; it took four weeks for me to recover from this. My left shoulder started hurting me, I called my doctor, he had me come in to discuss my symptoms. He ordered an MRI of my shoulder. I have now been diagnosed with adhesive capsulitis of the shoulder or frozen shoulder in my left shoulder. I am now in physical therapy to help me get the range of motion and use of my left shoulder.
Pfizer-BioNTech COVID-19 Vaccine EUA Rash on both arms
Joint pain, permanent damage. Depression, G.A.D. Behavior problems. Arthritis.
11/10/06 - Patient reported fever 102.3  11/11/06 - Patient reported fever 102.4.  Treated with Advil 11/12/06 - Patient reported headache/diarrhea, fever.  Treated with Advil.
I received the Shingles vaccination on 1/17/2022. Since then I've had tingling and numbness in my lower arms, fingers, toes and lower legs since the vaccine and double vision.