chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very small blister to interior portion of hand beneath the ring finger on same arm of injection (Left hand); I had involuntary movement to my left hand; pain radiating up and down my left arm; pain radiating up and down my left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 14:00 (Lot number: ER2613) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "frontal fibrosing alopecia" (unspecified if ongoing); "known_allergies: Singular" (unspecified if ongoing). Concomitant medication(s) included: VENTOLIN [SALBUTAMOL]; TRELEGY; ALBUTEROL SULFATE; SIMETHICONE. The following information was reported: BLISTER (non-serious) with onset 19Mar2021 10:00, outcome "not recovered", described as "Very small blister to interior portion of hand beneath the ring finger on same arm of injection (Left hand)"; DYSKINESIA (non-serious) with onset 18Mar2021, outcome "unknown", described as "I had involuntary movement to my left hand"; PAIN IN EXTREMITY (non-serious), PAIN (non-serious) all with onset Mar2021, outcome "unknown" and all described as "pain radiating up and down my left arm". Therapeutic measures were taken as a result of blister.  Additional information: Patient was not Pregnant at the time of Vaccination. Patient received recent COVID-19 vaccine in Hospital facility. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine Prior to vaccination, patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since the vaccination. blisters required antibiotics and creams.
Large, painful swelling at vaccine site 10 x 13 cm over 3 days with joint pain on L arm & shoulder x >3 days.  Given Benadryl & local ice.
swelling and redness on the area; swelling and redness on the area; itching on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching on the injection site), VACCINATION SITE ERYTHEMA (swelling and redness on the area) and VACCINATION SITE SWELLING (swelling and redness on the area) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching on the injection site). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (swelling and redness on the area) and VACCINATION SITE SWELLING (swelling and redness on the area). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (itching on the injection site), VACCINATION SITE ERYTHEMA (swelling and redness on the area) and VACCINATION SITE SWELLING (swelling and redness on the area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.    This case was linked to MOD-2021-084525 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: No specific follow-up information recorded.
Patient saw liquid squirt out of injection (at connection site at needle and syringe) thus received incomplete second dose.
Received Vaccine on the 4/8 that night I was very cold had 5 blankets, teeth shattering, severe headache, & knees like if they were breaking them. The following day slight headache, weakness, not feeling good.  On the evening of 4/15, it hurt to breathe and I had a burning sensation on my rib cage going to my back. I thought I could handle it until Monday to see my Dr.  but by the time I went to the ER it hurt to walk, talk, breathe and the burning sensation would not go away.  I went to the ER on 4/17 he said I had a collapsed lung, gave me something for pain via IV.  Did an EKG, Chest X-Ray, CT Scan, and Lab work. He let me go and said to take deep breaths every hour on the hour and to drink lots of water.  I got in to see my regular Dr. on 4/22 and he said I had an allergic reaction to the vaccine.  He gave me Gabapentin 100 mg 3 times a day and Tramadol q 6 hours for pain.  I called him back because I still have the pain and now I am taking 300 mg Gabapentin in the am and 300 in the pm.  It is still not working.  I am constantly hurting the burning sensation on my rib cage and goes back to my back, it hurts to breathe, walk, talk, drive, I have blurred vision , dizziness and weakness.  I have an appointment with Dr.   again tomorrow.
Delayed Reaction; Itching Injection Site came back worst than the first time/Erythema and Redness restarted larger area 4-5" Site of injection; Moderate Itching Injection Site; Moderate Erythema Injection Site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Jan-2021 and was forwarded to Moderna on 28-Jan-2021.    This spontaneous case was reported by a physician and describes the occurrence of SKIN REACTION (Delayed Reaction), CONDITION AGGRAVATED (Itching Injection Site came back worst than the first time/Erythema and Redness restarted larger area 4-5" Site of injection), VACCINATION SITE PRURITUS (Moderate Itching Injection Site) and VACCINATION SITE ERYTHEMA (Moderate Erythema Injection Site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Moderate Itching Injection Site) and VACCINATION SITE ERYTHEMA (Moderate Erythema Injection Site). On 18-Jan-2021, the patient experienced SKIN REACTION (Delayed Reaction) and CONDITION AGGRAVATED (Itching Injection Site came back worst than the first time/Erythema and Redness restarted larger area 4-5" Site of injection). On 11-Jan-2021, VACCINATION SITE PRURITUS (Moderate Itching Injection Site) and VACCINATION SITE ERYTHEMA (Moderate Erythema Injection Site) had resolved. On 22-Jan-2021, SKIN REACTION (Delayed Reaction) and CONDITION AGGRAVATED (Itching Injection Site came back worst than the first time/Erythema and Redness restarted larger area 4-5" Site of injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: No specific follow-up information recorded.
BREAKTHROUGH COVID: FULLY VACCINATED WITH BOOSTER: 80 YO FEMALE with Acute Hypoxic Respiratory Failure 2/2 Covid-19 Infection (Positive PCR), Covid Severity Score 2 (on 2L now RA). Pt presents to Advent Health WP ED via EMS for generalized weakness, unable to ambulate and fever and confusion. PT care taker dx positive day before admission 6/9/22. Pt was coughing, disoriented and had a fever. Upon arrival to the ED, vitals showed patient was febrile with the temperature of 102.4°, tachycardic with heart rate of 113, hypertensive with a systolic pressure of 180 over diastolic pressure of 71. Pt ANTIBIOTIC treated with Rocephin and 2 doses of remdesivir antiviral therapy. Pt placed on heparin.
pt stated feeling lightheaded then collapsed to the floor. Ems was immediately called and pt was layed on his side until consciousness was regained. he refused an ambulance and visit to hospital.
Tinnitus - onset on shortly after midnight on Thursday, 27 October. Patient woke up due to a loud ringing in the left ear.  Intensity had decreased in the morning, but ringing is still noticeable. A feeling of numbness due to underlying sensorineural hearing loss is present.  No treatment adminstered, PCP contacted outcome: tinnitus ongoing
just stung by a bee; He is feeling really funny; feels like his throat is closing or tightening; This is a spontaneous report from a contactable consumer (patient's wife). A 35-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single for COVID-19 immunization. Medical history included arthropod sting adverse reactions to bee stings which include swelling of his throat and itching, pharyngeal swelling adverse reactions to bee stings which include swelling of his throat and itching, pruritus adverse reactions to bee stings which include swelling of his throat and itching. The patient's concomitant medications were not reported. The patient experienced just stung by a bee, he is feeling really funny, feels like his throat is closing or tightening on an unspecified date. The outcome of the events was unknown.  Information about batch/Lot number has been requested.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Patient complained of lip, throat and tongue swelling following first dose of COVID-19 vaccine. Patient was administered 50mg of Diphenhyramine IM. Less than a minute later patient said that swelling is gone. Patient was observed for an additional 55 minutes in a private room.
Pt recvd a series of 3 Hep B vax; doses 1 & 2 were Recombivax HB given on 4JAN90 & 14FEB90 & 3rd dose was Engerix-B given 12JUL90 & pt was a poss non-responder;
Red Rash wrists and hands 4-6 hours after first shot with itchiness. Severe Red Rash all over body with tiredness, cough, muscle pain, joint pain in wrists and feeling unwell within 12-24 hours after receiving first shot.
Exposed to chicken pox 3 weeks ago, has a rash.  Diagnosed with chickenpox 03/31/2006.
This case was reported by a other health professional via call center representative and described the occurrence of presyncope in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced presyncope and injection site cellulitis. On an unknown date, the outcome of the presyncope and injection site cellulitis were unknown. It was unknown if the reporter considered the presyncope and injection site cellulitis to be related to SHINGRIX. Additional details were reported as follows: This case was reported by pharmacy student. The age at vaccination was not applicable for this report. The health care professional reported several patients reported cellulitis site reaction and presyncopal episodes after receiving either the initial or booster dose of SHINGRIX. No further details were reported regarding the event.
Beginning about 7PM 6JUN91, pt had 2 episodes of elevated temp assoc w/extreme irritability & shaking (?seizure); asympotomatic by 12 hrs later;
Blood clots; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clots) outcome was unknown. Not Provided          No concomitant medications were reported.  The patient had no problems after her second dose. Treatment information was not provided. Action taken with mRNA-1273 in response to events was not applicable.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient contracted COVID after being fully vaccinated Muscle aches, runny nose, fatigue, congestion, cough, headache
Redo IMMS 10/15/07 then 10/16/07 developed large red itchy area on back of R Thigh. Follow up 10/18/07, redness and swelling decreased. 10/22/07 no swelling, no redness, no itching.
hives; migranies; muscle aches; pain at injection site; Joint Pain; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), MIGRAINE (migranies), MYALGIA (muscle aches), VACCINATION SITE PAIN (pain at injection site) and ARTHRALGIA (Joint Pain) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives), MIGRAINE (migranies), MYALGIA (muscle aches), VACCINATION SITE PAIN (pain at injection site), ARTHRALGIA (Joint Pain) and HEADACHE (Headaches). At the time of the report, URTICARIA (hives), MIGRAINE (migranies), MYALGIA (muscle aches), VACCINATION SITE PAIN (pain at injection site), ARTHRALGIA (Joint Pain) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medicines include Tylenol and Benadryl which helped alleviate some symptoms.
Severe muscle aches, exhaustion and extreme dizziness for about 36 hours  Took Tylenol and slept a lot
Initial information received on 21-Feb-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves female patient who experienced shortness of breath, while she received vaccine FLUBLOK QIV. The patient had known egg allergy. The patient's past medical history, past medical treatment(s), vaccination(s) and family history were not provided. In Sep-2018, the patient received a dose of suspect FLUBLOCK QIV lot number not reported via unknown route in unknown administration site. In Sep-2018, the patient developed a non-serious shortness of breath, (dyspnoea) immediately after the administration of FLUBLOCK QIV. Details: Reporter stated that the practice feels the patient may be allergic to some other ingredient in the FLUBLOCK vaccine, since it contains no egg component. Reporter stated that to the best of her knowledge the patient had previously avoided getting a flu shot because of her allergy to eggs. Other relevant tests not reported. Final diagnosis was shortness of breath. It was not reported if the patient received a corrective treatment. The patient recovered from shortness of breath. List of documents held by sender: none.
lt arm pain-intense local react gross edema redness-warm & tender to touch; limited use secondary to pain;
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case contains information for the 28th of 190 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
I was having light headeness and fainting. I also was having abdominal pain.I end up having a miscarriage at 8 weeks.
Daughter had significant trouble waking her up.  She states that her mom had a fever of 101 and that her mom's roommate was positive for COVID on Thursday 1/20.  She states she had asked the facility to check her mom for COVID and they refused and so she brought her own home test and tested her mom which came back positive.  The patient is vaccinated times 3, she is currently on room air, satting 90%.  Chest x-ray is normal. Urine also suspicious for possible UTI which may also be contributing to her fever.
Head was hurting; Temperature was 101.4; This is a spontaneous report from a contactable consumer. A 15-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EW0185) via an unspecified route of administration, administered in right arm on 04Jun2021 (age at vaccination: 15 years) as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have any prior vaccinations. On 05Jun2021, the patient experienced head was hurting, and temperature was 101.4. The patient was given paracetamol (TYLENOL) 500mg (1 pill) for headache. Reporter stated just gave him the pill a minute ago before calling, so it was not going to work that fast. It was reported that, the patient was scheduled in 26th for the second shot. Therapeutic measures were taken as a result of adverse events. The outcome of the events was not recovered.   Follow-up attempts are needed. Further information is expected.
Information has been received from a clerk in a physician's office concerning her 19 year old daughter who in approximately June 2008 "Summer 2008", was vaccinated with first dose of GARDASIL (Lot # not reported).  Approximately 24 hours after she became lethargic and developed a fever.  The symptoms resolved after 3-4 days.  The patient has since had the second and third dose of GARDASIL (Lot # not reported) without any problems or adverse reactions.  Patient sought unspecified medical attention.  Additional information has been request.
Severe pain in left arm from shoulder to elbow concentrated more around injection site. Unable to raise arm, pain goes down "front of arm" significant swelling. Taking Tylenol for pain, icing area qid
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. The patient was vaccinated with ZOSTAVAX (lot # 664444/0722Y, exp 21-NOV-2010) on 11-JUN-2012. It was reported that the patient was inadvertently administered ZOSTAVAX that had expired on 21-NOV-2010. No adverse effects reported. Whether the patient sought for medical attention was not reported. The outcome was unknown. Additional information is not expected.
Entire upper extremity was very painful for about a week; still has some pain in that arm 3 weeks later. Mom thinks shot was not given in muscle.
loud ringing in ears like crystal shattering two days after vaccine and continuing to present time..Never had tinnitus prior to this
This case was reported by a consumer (also the subject) and described the occurrence of itching in a 68-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On 22 November 2011 at 10:30 the subject received a dose of FLUARIX (unknown route, left arm). On 22 November 2011, less than one day after vaccination with FLUARIX, the subject experienced itching on wrist and itching on arm. At the time of reporting the event was improved. The consumer also reported that her husband experienced adverse events following vaccination with FLUARIX (see case ID A0968632A for details).
It felt immediate like my throat was closing up and mild itching but will going to the observation phase, it stopped. However, my shoulder was sore; by the next morning, it was a small knot under the skin.  But most said that you could apply some alcohol to it; I did several times. But by Sunday, there was still swelling, and the bump is bigger. Thus I am going to call my primary physician to see what steps do I need to take.
Really severe headache with intense sharp pain for over 3 days when he never had a migraine before, forgetfulness/confusion, soreness, tired, not feeling well, congestion, sinus drainage, felt like his brain was swollen and inflamed, sensitivity to light, lack of appetite, coughing up mucus.
Information has been received from a pharmacist concerning a female who in June 2009, was vaccinated with a dose of GARDASIL (lot number, route and site of vaccination not reported). It was reported that the patient developed syncope immediately after a dose of GARDASIL. The patient sought an unspecified medical attention. At the time of reporting the patient's outcome was unknown additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. It was reported that on 07-AUG-2015, a dose of an expired sterile diluent, lot number reported as H021470, (dose not provided) was inadvertently used to reconstitute a dose of ZOSTAVAX that was administered to the patient (dose, route of administration, injection site, lot number and expiration were not reported). No adverse effects were reported. Additional information has been requested.