chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left shot clinic after 15 min with no adverse effects.  Driving home mouth and tongue went completely dry instantly and could not swallow.  This was 28 min after initial shot (2nd dose).  Concerned that airway would be restricted.  In a panic went to ER at different hospital that I was near.  No signs of anaphylaxis.  Waited in hospital for ~3 hours.  Symptoms did not get worse and could breath through nose.  Decided no steroid shot (did not want to negate covid shot).  Went home without additional treatment.  Mouth was dry for 1 additional day, but not as extreme as initial dryness.
Pain flare in a rectovaginal fistula. It had been closed previous to vaccine but after 1st shot it became painful and open.
Reaction: 12 hours after receiving the injection, I started to get the chills. I went to bed and literally felt I was on fire all night. I went from burning up to freezing and not until 12 hours later did the fever go away.   Although I don't have the specifics on the first shot, I felt "horrible" with that shot too for 12 hours but did not have the fever like I had the second time.
Sudden Sensorineural Hearing loss in left ear; 100% loss, on August 11, 2021. I feel the vaccine was associated with this apparent anti immune and very serious event. Took dose one on February 11, 2021 and second on March 11, 2021.
Bruised/red/spot. Whole arm is sore. Started day after injection & continuing. TYLENOL not helping.
I am getting hives and rashes in multiple parts of my body- neck, chest, face, armpits, stomach, back, legs. They are very itchy. The palms of my hands and bottom of my feet itch as well. These last for about 30 minutes then go away. Then they come back in a new spot 30-60 minutes later. *This occurred 12 days after my booster
hives; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), on unspecified date as unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced hives on unspecified date. The outcome of the event was not reported.  Information about lot/batch number has been requested.
Within hours,I felt ill.  Nausea, profound fatigue, fever, body aches, chills, loss of appetite, severe migraine- all symptoms got progressively worse.  Could not get out of bed. By next day, was considering reaching out to my doctors to discuss at what point do I go to hospital because I felt so incredibly ill.   Symptoms peaked 2nd and 3rd day after.  By day 4, symptoms started to be less severe.  I also missed my period the following cycle after receiving vaccination which has never happened to me before.  Usually my periods are very regular.  When I did finally get the period it was with severe symptoms.
Got a shingrix vaccine #1 dose and developed red blotches at the injection site. Also a lot of soreness in that shoulder. I've had achy muscles and joints for two days and I've been taking ibuprofen. I've had extreme tiredness and headache for two days. Today I developed red blotches on both sides of my neck
Guillain-Barre syndrome, no feeling both hands, feet. Urinary retention, motor and sensory deficit, dizziness, blurred vision, loss of facial feeling. Received IVIgG, taking gabapentin, PERCOCET. OT and physical therapy.
Patient says his arm is numb at times from elbow to shoulder but also says he has been lifting 5 gallon pail fulls of water or material and that probably has something  to do with it.
Severe Respiratory Infection, Cough, Phlegm, Sneezing, Rhinorrhea.
Nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and HEADACHE (headache) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea) and HEADACHE (headache). At the time of the report, NAUSEA (Nausea) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Headache, Fever, Cough Wheeze, Nausea Vomiting & Syncope Narrative:
Panicing; Cracking of the joints; This spontaneous case was reported by an other caregiver and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Cracking of the joints) and PANIC REACTION (Panicing) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Asthma (She has severe asthma from age of 18.) and Allergy (She has allergy from age of 18.).   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Cracking of the joints). On 16-Apr-2021, the patient experienced PANIC REACTION (Panicing). At the time of the report, MUSCULOSKELETAL DISCOMFORT (Cracking of the joints) and PANIC REACTION (Panicing) had not resolved. Not Provided          The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported. No treatment reported    This case was linked to MOD-2021-079077 (Patient Link).
Widespread erythematous papules, plagues and wheels to neck, face, scalp - no respiratory complications.  Treated with Medrol dose pack and Atarax.
Pneumonia; COVID-19; Fever of 100.4; A spontaneous report was received from a health care professional concerning a 73-year-old, male, patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced fever, pneumonia, and COVID-19.  The patient's medical history, as provided by the reporter, included a previous COVID-19 infection diagnosis. Concomitant medications were not reported.  On 29 Dec 2020, the patient received their first dose of two planned doses of mRNA-1273 (Batch number: 039K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 30 Dec 2020, the patient experienced fever of 100.4 and was given paracetamol.   On 31 Dec 2020, the patient had a chest x-ray and was admitted to the hospital for pneumonia.   On 03 Jan 2021 the patient tested positive for COVID-19. The patient had previously tested positive for COVID-19 in November. No additional treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events, fever, pneumonia, and COVID-19, was unknown.; Reporter's Comments: This case concerns a 73-year-old, male patient, with a previous COVID-19 infection prior to vaccination, who experienced a serious event of Pneumonia and non-serious events of Covid-19, and Pyrexia after receiving first dose of mRNA-1273 (Lot# 039K20A). Based on the mechanism of action of mRNA-1273, the event of Covid-19 is assessed as unlikely related to mRNA-1273. Very limited information regarding these events has been provided at this time.  Further information has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. 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 ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2012, a healthcare provider at a physician's office administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 2015, the patient was treated by a physician 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.
tongue is cracking and sore; Face red and hot; This spontaneous case was reported by a consumer and describes the occurrence of PLICATED TONGUE (tongue is cracking and sore) and FLUSHING (Face red and hot) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced PLICATED TONGUE (tongue is cracking and sore) and FLUSHING (Face red and hot). On 14-Mar-2021, FLUSHING (Face red and hot) outcome was unknown. At the time of the report, PLICATED TONGUE (tongue is cracking and sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment medications were provided
A 78 year old female reported that she received 1/3 of a normal dose of a flu vaccine in 1998 at 74 years of age. Her medical history includes diabetes, stent placement for blocked arteries, an unspecified thyroid condition, and allergies to eggs, nuts, shellfish, and penicillin. Concomitant medications at the time of the event included Synthroid and Premarin. Following vaccination, she developed redness at the injection site. She recovered. No further information was available at the date of this report.
swelling in her feet; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in her feet) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced PERIPHERAL SWELLING (swelling in her feet). At the time of the report, PERIPHERAL SWELLING (swelling in her feet) outcome was unknown.            Concomitant product use was not provided. No treatment was reported. Action taken in response to mRNA-1273 was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Updated patient demographics, added vaccine information(second dose) and added a new event.
Missed miscarriage. LMP March 7, positive pregnancy test on March 31. COVID vaccinations on March 18 and April 22. April 27, first ultrasound measured fetus at 6w1d (behind what was expected given LMP, should have measured 7w2d), embryonic cardiac activity was present, but could not be documented by M-mode. Provider warned 60% chance of abnormal pregnancy. BetaHCG testing results: April 27 was 28,247H; April 29 was 29,925H. A follow-up ultrasound on May 6 showed no fetal heart tones, and and fetus still measured 6w1d, unchanged from last visit. Provider prescribed misoprostol which was taken same day (May 6) to complete the miscarriage. Follow-up ultrasound May 13 showed gestational sac was gone and endometrium was less than 1cm in thickness.
A report has been received from a Health Professional concerning a 15 year old, male subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 28-JAN-2015. It was reported that patient was administered expired FLUMIST Quadrivalent which started on 28-JAN-2015. The outcome of the event of expired FLUMIST Quadrivalent is unknown. The report was considered to be non-serious.
nauseated-vomited;diaphoretic;loss consciousness for 6sec;BP 120/90, P60, T97;sensation of warmth;recovered spontaneously w/vital signs returning to baseline;
Headache; Fever; Soreness of my arm; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administration date 02Aug2021 (Lot number: EW0202, Expiration Date: 30Sep2021) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Verbatim: Blood pressure high; "Prostate cancer" (unspecified if ongoing), notes: Verbatim: Prostate cancer, I had Prostate cancer and treated 3 years back in December.; "Blood thinners" (unspecified if ongoing), notes: I take Eliquis Blood thinner. Concomitant medication(s) included: AMLODIPINE taken for hypertension; LOSARTAN taken for hypertension; ELIQUIS taken for blood disorder. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "unknown", described as "Soreness of my arm"; HEADACHE (non-serious) with onset 03Aug2021, outcome "not recovered", described as "Headache"; PYREXIA (non-serious) with onset 03Aug2021, outcome "not recovered", described as "Fever".  Additional Information: Concomitant Products Losartan: Dose, consumer stated, "It is 125mg, it says "100-25" (not clarified) tab that says on the label.", Eliquis: Consumer stated, "I take Eliquis Blood thinner." Additional Information for Other Conditions: Consumer stated, "I had Prostate cancer and treated 3 years back in December." When probed for the concern, consumer stated, "I got the Pfizer (first dose) shot Monday morning and I did feel side effects and that need to go away soreness of my arm but from last yesterday evening till today night I have a headache and fever." Any Prior vaccination (within 4 weeks): No  Follow-up attempts are completed. No further information is expected.
Awoke with swollen upper lip 9/16/00. May be L lower jaw was slightly swollen ( ?) Swelling lasted until Sunday, almost gone 9/18/00. Now remembers  had  upper lip swelling before.
Mouth swelling 12 hours after the shot. The patient called us today (3/8/13) to report this happened. She also felt fatigued.
Systemic: Joint Pain-Severe, Additional Details: Patient's wife reports that pt experienced muscle pain in shoulders, chest, back, and arm after 30 mins of administration. Later that evening, pt was unconscious and went to the emergency room where he was transferred to the ICU. He has since progressed positively and currently in rehab.
Headache, Myalgia, Fever, NauseaVomiting, FATIGUE, CHILLS Narrative:
Depression, Myalgia, ErythemaMultiform & UrticariaPruritus Narrative:
Pain at injection site, redness, within the week, redness, pain, swelling from shoulder to elbow, by 1st evening was sore-to-touch, later in week, a rash on effected arm. Worst shot ever. Had CBC 11/19/14 Platelet count depressed (< 48,000 K/ul). Had CBC's 11/28/14, 12/8/14, 12/15/14, 1/2/15, 1/9/15, 1/16/15, 1/23/15, 1/30/15. Platelet count less than or equal to 48,000. Referred to Hematologist.
Adjuvant not mixed with  antigen/only adjuvant administered; Adjuvant not mixed with  antigen/only adjuvant administered; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 12-Jan-2023 Reporter's comment: The reporter was pressed for time during the call, but follow-up via email would be okay. The reporter consented to follow-up. Additional supportive information: The patient inadvertently was administered only the adjuvant component of Shingrix without the powder antigen component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
This spontaneous report was received from a healthcare worker (also reported as nurse) refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 29-DEC-2014, the patient was vaccinated with a dose of GARDASIL, (strength, dose, route and anatomical location were not reported), (lot # K009482, expiration date: 06-MAR-2017), which was incorrect stored since 02-DEC-2014. No adverse effects were reported and no product quality complaint (PWC) was filled. This is one of several reports received from the same reporter. Additional information has been requested.
After 3 doses, they tested positive for covid with in 2 weeks post vaccination; After 3 doses, they tested positive for covid with in 2 weeks post vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 18 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 01Jan2022, outcome "unknown", COVID-19 (medically significant) with onset 01Jan2022, outcome "recovered" (Jan2022) and all described as "After 3 doses, they tested positive for covid with in 2 weeks post vaccination". The event "after 3 doses, they tested positive for covid with in 2 weeks post vaccination" and "after 3 doses, they tested positive for covid with in 2 weeks post vaccination" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jan2022) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Additional information: The patient had no other vaccine in four weeks. It was reported that after 3 doses, patient tested positive for covid within 2 weeks post vaccination. It was unknown if patient had covid prior vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient reported an egg allergy on his paper consent form to receive the annual influenza vaccination; however, the pharmacy inadvertently administered the Fluad product (which may contain eggs) instead of the Flucelvax product (which does not contain eggs). The patient noticed the product he received on 09/21/21 was different than in years past when he was reviewing his paperwork at home several days later. He reported experiencing no allergic reaction symptoms, and was not upset. He reported the error to the pharmacist manager in person at a later date. It was advised to the pharmacist manager to report the administration error despite the fact that the patient had no adverse events.
This spontaneous case, initially received on 19-Dec-2016, was reported by a health professional and concerns a(n) 41-year-old male patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s); The patient received AFLURIA from 21-NOV-2016 to 21-NOV-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular, Batch number: WT57008. No additional suspect drugs. Between 20-Nov-2016 and 21-Nov-2016, the AFLURIA vaccine underwent first excursion. The vaccine was stored at 35.78 degree F for about 2 hours. The pharmacist stated that the thermometer was fluctuating in the previous location in the refrigerator and was moved to the top shelf. On 21-Nov-2016, the patient received the vaccine that underwent temperature excursion. Special circumstances: Incorrect product storage without adverse event. Drug administration error without adverse event.
Broke out in raised hives all over upper and lower body/extremities during physical exercise after receiving 2nd or 3rd instance of the Anthrax vaccine. Skin was burning and extremely itchy. These conditions have persisted to this day. There is no family history of this condition. Now, anytime body temperature is elevated, hives and itching/burning ensues.
increased heart rate; very frequent PVC's; chronotropic; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 78 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Apr2021 10:00 (Batch/Lot number: unknown) at the age of 78 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "hypothyroidism (corrected)" (unspecified if ongoing), notes: Verbatim: hypothyroidism (corrected); "mild hypertension" (unspecified if ongoing), notes: Verbatim: mild hypertension. Concomitant medication(s) included: HCTZ; TESTOSTERONE; LIPITOR; ASPIRIN (E.C.); SYNTHROID. The following information was reported: HEART RATE INCREASED (non-serious) with onset 13Apr2021 10:00, outcome "recovered", described as "increased heart rate"; VENTRICULAR EXTRASYSTOLES (non-serious) with onset Apr2021, outcome "recovered", described as "very frequent PVC's"; CARDIAC DISORDER (non-serious) with onset Apr2021, outcome "recovered", described as "chronotropic". The events "increased heart rate", "very frequent pvc's" and "chronotropic" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of heart rate increased, ventricular extrasystoles, cardiac disorder.  Additional information: No covid prior vaccination and not  covid tested post vaccination. The patient had no known allergies. 48 hours after injection, patient experienced increased heart rate and very frequent PVC's. No chest pain or shortness of breath. Verapamil was started and PVC's almost completely disappeared. There was chronotropic and inotropic cardiac reported by patient who is a physician.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.