chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of VARIVAX (Lot #: N021315, Exp Date: 07-AUG-2019) (Lot#: N029632, Exp Date: 23-OCT-2019) or (Lot#: N030571, Exp Date: 31-OCT-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK) (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1805USA009899: Original Case: 1805USA006787; US-009507513-1805USA009900: Original Case: 1805USA006787; US-009507513-1805USA009901: Original Case: 1805USA006787; US-009507513-1805USA009902: Original Case: 1805USA006787; US-009507513-1805USA009903: Original Case: 1805USA006787; US-009507513-1805USA009904: Original Case: 1805USA006787; US-009507513-1805USA009905: Original Case: 1805USA006787; US-009507513-1805USA009906: Original Case: 1805USA006787; US-009507513-1805USA009907: Original Case: 1805USA006787; US-009507513-1805USA009908: Original Case: 1805USA006787; US-009507513-1805USA009909: Original Case: 1805USA006787; US-009507513-1805USA009910:Original Case: 1805USA006787; US-009507513-1805USA009911: Original Case: 1805USA006787; US-009507513-1805USA009912: Original Case: 1805USA006787; US-009507513-1805USA009913: Original Case: 1805USA006787; US-009507513-1805USA009914: Original Case: 1805USA006787; US-009507513-1805USA009915: Original Case: 1805USA006787; US-009507513-1805USA009916: Original Case: 1805USA006787; US-009507513-1805USA009917: Original Case: 1805USA006787; US-009507513-1805USA009918: Original Case: 1805USA006787; US-009507513-1805USA009919: Original Case: 1805USA006787; US-009507513-1805USA009920: Original Case: 1805USA006787; US-009507513-1805USA009921: Original Case: 1805USA006787; US-009507513-1805USA009922: Original Case: 1805USA006787; US-009507513-1805USA009923: Original Case: 1805USA006787; US-009507513-1805USA009924: Original Case: 1805USA006787; US-009507513-1805USA009925: Original Case: 1805USA006787; US-009507513-1805USA009926: Original Case: 1805USA006787; US-009507513-1805USA009927: Original Case: 1805USA006787; US-009507513-1805USA009928: Original Case: 1805USA006787; US-009507513-1805USA006787: Original Case: 1805USA006787; US-009507513-1805USA009930: Original Case: 1805USA006787; US-009507513-1805USA009931: Original Case: 1805USA006787; US-009507513-1805USA009932: Original Case: 1805USA006787; US-009507513-1805USA009933.
heart beat has been really beating fast; throwing up; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart beat has been really beating fast) and VOMITING (throwing up) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history reported.     On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (heart beat has been really beating fast) and VOMITING (throwing up). At the time of the report, HEART RATE INCREASED (heart beat has been really beating fast) and VOMITING (throwing up) outcome was unknown. Not Provided
After second vaccination, an intermittent "squeezing" full head headache (each lasting around 2-3 seconds) starting; This is a spontaneous report from a contactable pharmacist. The 46-year-old male patient received bnt162b2 (COMIRNATY) solution for injection, dose 2 (Batch/Lot Number: EL3249) on 22Jan2021, at 09:30 AM, and dose 1 (Batch/Lot Number: EK9231) on 02Jan2021 at 10:00 AM via an Intramuscular route of administration in right arm as a single dose for covid-19 immunisation. The medical history and concomitant medication were not reported. Patient reported on 22Jan2021 at 01:15 PM after 1st vaccination, mild intermittent headache that subsided after 24 hours. And after second vaccination, a intermittent squeezing full head headache (each lasting around 2-3 seconds) starting 2 hours post vaccination. It seemed to subside after 2 weeks and now has returned. Patient took other medications in two weeks once time. Patient received treatment drug as Ibuprofen. The patient did not have covid prior vaccination. The patient was not tested for covid post vaccination. Patient did not have any known allergies. The outcome of event was Not recovered.
Shingles - started as super itchy spot on my back later in the day/night of 2nd covid shot. Developed into several spots on my back as shingles does.
Patient was given the vaccine. After sitting in a chair for a few minutes post vaccination, he said he  felt dizzy and then fell over and hit the floor face first but had blacked out and did not remember fainting or passing out. He was bleeding because he had hit his face and his lip was split and his tooth was chipped. He also continued to be very dizzy, was extremely pale, and was sweating profusely. The EMT arrived about 20 minutes later and took him to the emergency room.
Swollen throat day after injection, fever started day 7, body aches day 9, cough & cold symptoms day 9 - all sx ongoing.
Information has been received from a licensed practical nurse concerning a 48 year old female with an allergy to Biaxin who on 10/28/2004 at 1548 was vaccinated in the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (lot 647724/0946N).  Concomitant vaccine therapy given in the left deltoid included a first dose of influenza virus vaccine (unspecified) (lot u1449AA).  There was no illness at the time of vaccination.  At 1730 the patient developed pain, redness, warmth and swelling at the injection site.  The arm was very sore and it hurt to use it.  The patient was afebrile.  Unspecified medical attention was sought.  No diagnostic lab tests were performed.  The symptoms lasted one day and the patient recovered.  It was also noted that the patient had no AE's following prior vaccinations.  No product quality complaint was involved.  No further information is expected.  It was also reported that another patient was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot 647724/0946N) and developed an AE (WAES0411USA01318).
Large red area bigger than patient hand on patient's left arm. Area has grown in size over the last couple of days.  It is warm to the touch, and patient has reported a fever of 100.8 F. Patient has not tried any treatments to relieve the symptoms. Patient has not contacted her provider about the incident.
Headache Started about 6pm 03/10/2006 after receiving MMR and Adult TD vaccine at 10:30am. Felt burning sensation left neck. Woke 3/11/06 with edema, nodule left neck, noted edema at injection site.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included chickenpox. On 15th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 15th October 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the patient experienced injection site itching and injection site irritation. The patient was treated with BENADRYL. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the injection site itching and injection site irritation were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, injection site itching and injection site irritation to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient experienced pain at the injection site during the injection. The injection site became sore and then when the soreness resolved, less than a month after receiving SHINGRIX, the injection site started to itch and was irritated. The patient had been scratching the injection site and the site had become sore again. He was using topical BENADRYL at the injection site to deal with the symptoms. He already had a physical scheduled with his physician this upcoming Thursday, so he would have the physician to look at his arm then. Consent to follow up was given.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-395985 (Patient Link).
On 08/20/2018, patient presented with swollen eyes and was treated with 25mg diphenhydramine. On 08/21/2018, patient presented to acute care again with continued swollen eyes and blurry vision with no change in symptoms. She reported to the provider that the diphenhydramine given the day before did not improve symptoms. She was then prescribed prednisone 20mg daily for 10 days. The patient was referred out to an ophthalmologist and neurologist because she continued to have weakness of her eyelids and difficulty walking and holding items. Case is still under investigation with health care providers.
Pfizer-BioNTech COVID-19 Vaccine EUA  Approximately 3 mins after vaccination, pt reports nausea, dizziness, chest pressure, and profound weakness. Brought to Emergency Department by crisis RN where she remains achy with weakness, fatigue and had no energy.  Pt reports "feeling tired" and "my speech is slower". On exam, slight R facial droop noted, tongue noted to be leaning towards the right, pronator drift noted in R arm. Code Brain activated with real time audio video interaction. MRI completed with normal results. Symptoms resolved.  Stroke team ok with discharge to home with f/u with PCP.
Soreness in arm at injection sight. Muscular pain and general fogginess of thinking for the next 24 hours with intermittent migraines.
Full body itch, severe headache, nausea, fatigue...within 5 minutes after injection
That night I had pain in the other arm, not vaccinated arm. Pain got worse, by Thursday or Friday I had a rash on my right side and chest. Friday night pain was worse. Went to Urgent Care on Saturday morning, rash was identified as Shingles. Prescribed 2 meds, antiviral & pain med. Rash went away within 2 weeks. Soreness remained for about 3 weeks.
Dull headache began with 15-30 minutes after receiving the vaccine and lasted for about 30 hours.  I treated it with Ibuprofen.
After administering this vaccine I realized the patient is 64 years old, not 65 which is the indicated starting age for this vaccine. My supervisor was advised of my error and I discussed this with the patient and his family as well. Patient was observed for 15 minutes after vaccine administration with no adverse reaction noted at that time. Patient and his family were advised to contact the clinic with any questions or concerns post vaccine.
HARD UNDER THE SKIN AT INJECTION SITE; REDNESS AT INJECTION SITE; WARMTH AT INJECTION SITE; HEADACHE; BURNING AS INJECTION WAS GIVEN; SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 44 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced burning as injection was given. On 10-MAR-2021, the subject experienced soreness at injection site. On 12-MAR-2021, the subject experienced hard under the skin at injection site. On 12-MAR-2021, the subject experienced redness at injection site. On 12-MAR-2021, the subject experienced warmth at injection site. On 12-MAR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from burning as injection was given on 10-MAR-2021, and headache on 12-MAR-2021, and had not recovered from soreness at injection site, redness at injection site, warmth at injection site, and hard under the skin at injection site. This report was non-serious.
Faint high pitched ringing; Faint high pitched ringing; Higher pitches not audible; This is a spontaneous report from program. A 46-year-old male consumer (patient) reported for himself that he received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection), dose 1 via an unspecified route of administration, administered in right arm on 01Apr2021 13:30 (Batch/Lot Number: EP6955) at a single dose for covid-19 immunisation.  The patient medical history was not reported. Patient did not receive any other vaccine within 4 weeks prior to Covid vaccine. He was not also diagnosed with COVI-19 prior and since vaccination. He has not been tested positive with Covid-19.  Concomitant medication included ibuprofen taken for an unspecified indication, start and stop date were not reported.  The patient previously took penicillin and experienced penicillin allergy.  The patient experienced faint high pitched ringing and higher pitches not audible on 02Apr2021 02:00 with outcome of not recovered. In addition, it was also described as faint high pitched ringing began about 12 hours after administration. Persists. Frequency ~ 13kHz (I do music/audio stuff so checked against tone generator). Higher pitches not audible, unknown if related to the symptom or simply age.
Patient said 10 minutes after the vaccine she experienced dizziness and feeling faint but quickly recovered. Approximately 2 hours later, patient reported that the left side of her face and hands became numb and "felt like when Novacaine is wearing off". She went to ER and was worked up for a stroke. No abnormalities found. She continues to experience a "stabbing pain" in her head intermittently that resolves as soon as it happens. She reports past history of vertigo several years ago, however facial numbness and head pain is new for her.  She followed up with her primary doctor 4 days ago and they feel it was vaccine related.
very, very bad rash; couldn't breathe through my nose; rash was all over my face; Per voicemail 20Jan2021 at 0929 EST: Patient is reporting adverse effects from her first Moderna vaccination and also requesting advisability on second dose. Her physician, who did not administer the first dose, told her to call and report. She developed a very, very bad rash that traveled from the arm and kept her in the urgent care that vaccinated her. By the night, the rash was all over her face. She had difficulty breathing through her nose. She was advised to take 50mg of Benadryl, but she felt a little SOB for about 2 days following this. Upon calling back 20Jan2021 1404 EST: Caller is a psychologist. Vaccine was given on left arm on 09Jan2021. She had a torn rotator cuff two years ago, so she felt it was safer to get the vaccine on her left arm. At the urgent care, her blood pressure, temperature, and respiration were normal. She took the Benadryl 25mg at home approximately 5:30 PM. On 09Jan2021, 7 hours post vaccination, she couldn't breathe through her nose; she was breathing through her mouth. Her nose was swollen. She never had anything like this before. Then she took another Benadryl 25 mg around 11:00 PM. She was uncomfortable that night and was up until 04:00 in the morning. Patient states she is very healthy and active. She had trouble breathing when she was taking a walk. Consent given for safety to contact patient. Patient states her HCP was not the one who administered the vaccine, but safety is ok to contact her HCP.
Vaccine given 10/6/14, 12 days later patient started w/vesicular rash at site of immunization which became firm, red, mildly painful. After 3 days improving but small vesicles present.
This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (after second dose, her arm was tender for a day or two) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M204 and 041620A) for COVID-19 vaccination. No Medical History information was reported.On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced TENDERNESS (after second dose, her arm was tender for a day or two). In February 2021, TENDERNESS (after second dose, her arm was tender for a day or two) had resolved. No concomitant information provided by the reporter,No treatment information provided by the reporter. This case was linked to MOD-2021-396212, MOD-2021-396346 (Patient Link).
Moderna COVID-19 Vaccine EUA  Red, itchy area at injection site, about 3? in diameter
Injection at 1700 of influenza virus vaccine Fluzone.  Complained of lightheadedness, "tingly all over", feet feel numb, and face feels numb, began about 15 seconds after injection.  Had similar reaction to 3rd anthrax injection.  No food/medicine allergies.  Currently is recovering from cold/flu.
swelling on my wrist up to the bend of my arm; swollen pockets under eyes; Large Lumps on both arms/ lumps under my elbow; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Large Lumps on both arms/ lumps under my elbow), PERIPHERAL SWELLING (swelling on my wrist up to the bend of my arm) and PERIORBITAL SWELLING (swollen pockets under eyes) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MASS (Large Lumps on both arms/ lumps under my elbow). On an unknown date, the patient experienced PERIPHERAL SWELLING (swelling on my wrist up to the bend of my arm) and PERIORBITAL SWELLING (swollen pockets under eyes). At the time of the report, MASS (Large Lumps on both arms/ lumps under my elbow), PERIPHERAL SWELLING (swelling on my wrist up to the bend of my arm) and PERIORBITAL SWELLING (swollen pockets under eyes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Ultrasound scan: normal (normal) normal.     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.   Concomitant product information, if any, was not provided by the reporter.  On an unknown date, the patient's physician performed an x-ray to see if the patient had blood clots and it was reported that there were no blood clots.  Treatment information, if any, was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: TCR follow up received: AE's added
I was dropping the syringe into the sharps container after I finished the injection, and the needle landed on my middle knuckle on my right hand. It was a superficial puncture with no visible blood. I was able to see a small mark where it landed after I removed my glove.
Headache  Narrative: Per supervisor report: "received COVID  injection 2nd dose on 3/23/2021, C/O Severe Headache"
Red rash/itching on arm of vaccine...patient doing ok, treating with antihistamines and topicals
No pain from shot. At 4 minutes in, sweating, 5 minutes in, burning tongue. At 10 minutes, lips burned, tingled. Told pharmacist I was fine, had daughter with me, we left. In car at about 10 min, dizzy, vertigo, mild headache, neck became stiff. At the 1 hour mark, red patchy skin on arm, hot to the touch, slight hives near elbow, GI issues, slight muscle fatigue in legs.  Took temp twice. 99 and 100 at separate times. Symptoms lasted about 3 hours. Once began subsiding, all over body itch. Took 2 Benadryl, waited a bit, took 1 more Benadryl. Felt better on 8/18, but had difficulty keeping food/liquid down in morning. Skipped all meds. All over tired feeling. Never had any real pain like a typical vaccine. Felt like an allergic reaction. Notified doctor and the vsafe. Did not seek medical attention, as it did not involve difficulty breathing.
sore arm; This is a spontaneous report from a contactable consumer. A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number and expiration date unknown, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization and ibuprofen (MOTRIN), via an unspecified route of administration from an unspecified date at 600 mg for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient took ibuprofen 600mg 1hr before getting 1st dose of vaccine on Wednesday. He only had a sore arm after the 1st dose. The patient read that he should not have taken medication before vaccine. He was asking for information about the vaccine efficacy since he took ibuprofen before the dose. He mentioned that maybe he should stop taking his antihistamine before the next dose. He was most concerned that he messed up the vaccine. The action taken in response to the event for ibuprofen and the outcome of the event was unknown.   Information on the lot/batch number has been requested.
Got intense pain in upper thigh, right leg, so bad I could barely walk.  Had to told onto walls.  Went on all night.  Next morning I also had bad, but not AS bad, pain in upper left thigh, closer to groin.  It went away completely by 2pm on 3/5.  Had made with apptmt with my PCP for getting bloodwork and xrays.  When pain was mysteriously gone, I canceled.  But pain was incredibly intense on 3/3 and into morning.