chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Broke out in hives spreading from his torso and under both breasts; Redness; Red inflammation under the patient's arms and down his sides; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Broke out in hives spreading from his torso and under both breasts), ERYTHEMA (Redness) and INFLAMMATION (Red inflammation under the patient's arms and down his sides) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Bullous pemphigoid, COPD since 06-Jan-2021 and Food allergy (Sensitivity to tomato). Concomitant products included PREDNISONE from 10-May-2020 to an unknown date for Bullous pemphigoid, ACETYLSALICYLIC ACID, DIPYRIDAMOLE (AGGRENOX) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced URTICARIA (Broke out in hives spreading from his torso and under both breasts), ERYTHEMA (Redness) and INFLAMMATION (Red inflammation under the patient's arms and down his sides). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency. On 12-Mar-2021, URTICARIA (Broke out in hives spreading from his torso and under both breasts), ERYTHEMA (Redness) and INFLAMMATION (Red inflammation under the patient's arms and down his sides) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Patient demographics, rechallenge details and additional concomitant medications were updated. On 25-Jul-2021: No new information
My husband was not feeling well and since we have been out of town we decided to get a Covid test. We both came out positive. My treatment was a monoclonal infusion on 09/09/2021.
Patient developed redness, swelling, pain, and tingling to left arm/deltoid region 8 days after vaccination was administered. Believed to developed cellulitis, with possible muscle involvement.
L arm swollen and tender redness present in the center of reddened area is a 10cm blister, not running a fever.
Hives covering entire body which eventually constricted my airway to the point where I was unable to breath well. Went to ER Saturday morning 5am for help. They did chest xray, cat scan for blood clot in chest, blood tests, Iv fluids to flush, and triple doses of nebulizer for breathing. Released later that day and told to report information to my Dr. which I did. Hives are gone and breathing much better but since Saturday night been having Migraine headaches every day, which Dr. said is probably lingering effects from Shot.
Became aware of shortness of breath, did not improve so went to ER - DDimer & CT confirmed multiple blood clots in lungs.
This report described the occurrence of Lyme arthritis and/or Lyme disease in a 52 year old male pt who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. This report was received as part of litigation proceedings, and has not been verified by a physician or other health care professional. According to the attorney, the pt received injections of LYMErix on unspecified dates. On 1/12/04, the pt's attorney alleged that the pt developed "treatment resistant Lyme arthritis and/or treatment resistant Lyme disease," with symptoms including "severe and constant pain in his hands, neck, elbows, knees and wrist, joint pain, fatigue, tingling, headaches, vision problems, poor attention span, short term memory loss, cognitive problems, and loss of concentration." The attorney further alleged that the pt suffered pain that was described as "at times debilitating" and which "severely limited his employment options and opportunities." According to the attorney, the pt was under the care of a rheumatologist, and received anti-inflammatory and other medications without relief of symptoms. Information from Annual Follow-up report states this adverse event was received through the litigation process. Additional information regarding the event, including outcome information, is being pursued through the litigation process and will be reported if obtained.
This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a unk patient who received BOOSTRIX (batch number 41Y24, expiry date 10th April 2016) and (batch number HP4XT, expiry date 21st October 2016). Co-suspect products included HAVRIX (batch number 4B299, expiry date 17th December 2016), INFANRIX (batch number75853, expiry date 27th September 2016), (batch number MP293, expiry date 4th November 2016) and (batch number 5A425, expiry date 27th February 2017), KINRI (batch number 54LZR, expiry date 28th September 2016) and (batch number DR294, expiry date 23rd September 2016), PEDIARIX (batch number E2297, expiry date 1st July 2016) and (batch number 4233K, expiry date 5th September 2016) and ROTARIX (batch number A41FB421A, expiry date 6th September 2016) and (batch number A41FB460A, expiry date 4th February 2016). On an unknown date, the patient received BOOSTRIX. On an unknown date, the dose was an unknown dose. On an unknown date, the patient received HAVRIX and INFANRIX. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On an unknown date, the patient received KINRIX. On an unknown date, the dose was an unknown dose. On an unknown date, the patient received PEDIARIX. On an unknown date, the dose was an unknown dose. On an unknown date, the patient received ROTARIX. On an unknown date, the dose was an unknown dose. On an unknown date, an unknown time after receiving BOOSTRIX, HAVRIX, INFANRIX, KINRIX, PEDIARIX and ROTARIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Additional information received: Vaccines were exposed to temps up to 51.8 degrees for 30mins. The have been administered to a "hand full" of patients. Reporter did not have patient charts.
W/in 1 hrs post 2nd vax developed muscle aching in arm of inject w/tingling in fingers; Rec'd 1st dose of vax w/o adverse experience;
COLLAPSE(DIZZINESS/FAINTNESS); DEPRESSION; EMOTIONAL DISTRESS; HIGH BLOOD PRESSURE; HIT HEAD(HEADACHE); This spontaneous report received from a patient via legal source (legal reference number: JJL2021007215) concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient had no pre-existing conditions at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up would be requested for this case. No concomitant medications were reported. On an unspecified date in APR-2021 after vaccination, the patient experienced dizziness-faintness and was collapsed and hit head. The patient also had depression, emotional distress, high blood pressure, and extreme headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the collapse(dizziness/faintness), emotional distress, depression, high blood pressure and hit head(headache) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  Medical Assessment comment not required as per standard operating procedure for legal case.
This spontaneous report as received from a nurse refers to a 6 month old patient. The patients drug allergies and pertinent medical history was not reported. On 22-DEC-2011 the patient was vaccinated with first dose of M-M-R II (dose/frequency and route were not reported) when the patient was 6 months old. Concomitant medications were not reported. The second dose of M-M-R II was administered on 17-OCT-2012. No adverse effects reported. No product quality complaint (PQC) was reported for M-M-R II. Additional information has been requested.
Sore arm where injection was administered; Slight bruising at injection site; This is a spontaneous report from a contactable consumer. A 33-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 17Mar2021 at 09:00(at the age of 33 years old) as a single dose for COVID-19 immunisation. The patients Medical history was not reported. Concomitant medications included Escitolopram (MANUFACTURER UNKNOWN), doxycycline (MANUFACTURER UNKNOWN) and Omeprazol (MANUFACTURER UNKNOWN), all for an unknown indication from an unknown date. The Patient did not have any allergies to medications, food, or other products. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccination. Prior to vaccination, patient was not diagnosed with Covid-19. The Patient had not tested positive for COVID-19 since the vaccination. The patient experienced sore arm where injection was administered and slight bruising at injection sight on 17Mar2021 at 10:30. The patient did not receive treatment for the reported event. The clinical outcome of the vaccination site pain and vaccination site bruising was recovering.  Information about lot/batch number cannot be obtained. No further information expected.
Pt is 33 yo female with h/o multiple drug allergies , including allergy to benadryl. She has received first dose of COVID vaccine made by Phfizer at 3:45. She reports about 10 minutes after the vaccination she started feeling tingling in her lips, throat and prickly sensation on her chest and feeling "off". Felt dizzy, developed small hives on her chest. She was attended to immediately at the vaccine site and our team was called to white code. Pt was sitting on the floor, alert , breathing comfortably. Her BP was 151/84, HR 90, O2 Sats 100%. Her lungs were clear the whole time, no wheezing, no difficulty swallowing or talking.  Patient received 125 mg of IV solumedrol and 20 mg of pepcid in vaccination room, she felt the same, still breathing comfotably, speaking full sentences, hives faiding away. She was transported to Urgent Care clinic on wheelchair. Pt kept her EpiPen by her site the whole time but refused to used it, states she is afraid to use it and wants to hold off or get it in ER if necessary. About 16:30 patient reported her tingling, prickly sensation  In her chest is getting worse, developed sensation of lump in her throat, able to swallow and breath without problems, lungs exam clear. Again recommended to give Epipen but patient again refused as she feels very anxious about getting new medicine. She was able to speak full sentences and breathing well, O2 Sats 100% the whole time, she repetitively refused EpiPen. EMS called and patient transported to ER, ER notified. Pt left in stable condition.
Typhoid Oral Vaccine Ty21a, Berna Biotech Lot #3001391.  Dose 1, 30 Sept, 2008, 23:15, first sign of blistery rash noticed in morning. Started on trunk.  Called Butte County Health 1 October, approximately 16:15.  Explained that I had a rash, and I was told to keep taking the vaccine.  I asked if the rash should be considered a reason to stop the vaccination process, and I was told that if it wasn't a major problem, just keep taking the vaccine.  Dose 2, 2 Oct., 2008, 22:30, rash spread to arms back of neck and legs by 3 Oct.  Dose 3, 4 Oct., 21:30.  Rash spreading down arms and legs and neck.  Final does will be @ 21:30, 6 October, 2008  No fever, abdominal discomfort, vomiting, or nausea.
Tongue pain (perhaps a lie bump); This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the right arm on 11Mar2021 at 13:45 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, gout, reflux and psoriasis. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included nebivolol hydrochloride (BYSTOLIC), allopurinol (MANUFACTURER UNKNOWN), amlodipine besilate/benazepril hydrochloride (LOTREL) and omeprazole (PRILOSEC), all for an unknown indication from an unknown date and unknown if ongoing. On 13Mar2021 at 21:00, the patient experienced tongue pain (perhaps a lie bump). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of reported events. The clinical outcome of the event tongue pain (perhaps a lie bump) was not recovered at the time of this report   No follow-up attempts are possible. No further information is expected.
PATIENT HAD NAUSEA, HEADACHE AND FLUSHING/WARM STARTING AROUND 5 MINTUTES AFTER INJECTION.  WE SENT HER HOME FROM WORK.
Immediate allergic reaction; Hives on arms; Trouble breathing; Irregular heartbeat; This is a spontaneous report received from a contactable reporter (Pharmacist) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose 1, 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: HYPERSENSITIVITY (non-serious), 1 hr after the suspect product(s) administration, outcome "unknown", described as "Immediate allergic reaction"; URTICARIA (non-serious), 1 hr after the suspect product(s) administration, outcome "unknown", described as "Hives on arms"; DYSPNOEA (non-serious), 1 hr after the suspect product(s) administration, outcome "unknown", described as "Trouble breathing"; HEART RATE IRREGULAR (non-serious), 1 hr after the suspect product(s) administration, outcome "unknown", described as "Irregular heartbeat". Additional information: The pharmacist was seeking for guidance on determining next steps for the patient. The patient developed an immediate allergic reaction within an hour of first dose of Comirnaty. They included hives on arms, trouble breathing, and irregular heartbeat. The pharmacist asked if this would be classified as severe allergic reaction.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Urticaria throughout torso. Extreme pain if itched or agitated. Started the night of receiving the vaccine. Urticaria has lasted for 48 hours and still not resolved. Pain has slowly subsided since.
felt really sick with flu symptoms fever, severe body aches very ill for now 5 days and still sick
Severe swelling, redness and heat at the injection site.  The affected leg was twice the size of the other.
Headache; Chills; Fatigue; Nausea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Jul-2021 and was forwarded to Moderna on 13-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced HEADACHE (Headache), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea). At the time of the report, HEADACHE (Headache), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     No concomitant product use was provided by the reporter.  No treatment medication was provided for the first dose.  Drop in folic acid was extremely low after the second dose. The caller said she already spoke to her doctor and had a laboratory test done. She was given folic acid for the low folic acid test.    This case was linked to MOD-2021-255306 (Patient Link).
Vaccine was expired on 07-JUN-2023 and stored in refrigerator on 13-JUN-2023; No adverse event; Dose administered after Manufacturer Date of Expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry), PRODUCT STORAGE ERROR (Vaccine was expired on 07-JUN-2023 and stored in refrigerator on 13-JUN-2023) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (Dose 1), Moderna COVID-19 vaccine (Dose 3) and Moderna COVID-19 vaccine (Dose 2). Past adverse reactions to the above products included No adverse event with Moderna COVID-19 vaccine, Moderna COVID-19 vaccine and Moderna COVID-19 vaccine.    On 13-Jun-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 07-JUN-2023 and stored in refrigerator on 13-JUN-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry), PRODUCT STORAGE ERROR (Vaccine was expired on 07-JUN-2023 and stored in refrigerator on 13-JUN-2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after Manufacturer Date of Expiry) and PRODUCT STORAGE ERROR (Vaccine was expired on 07-JUN-2023 and stored in refrigerator on 13-JUN-2023).    Patient received all Moderna vaccines and have never had any problems with the vaccines. Concomitant medication details not reported by the reporter. Vial was initially stored in refrigerator was on 13-JUN-2023.  Vial size was reported as 0.5 ml. Vial did not undergo any temperature excursion. NDC number was reported as 8077728205. Treatment details was not reported by the reporter.   Reporter did not allow further contact
Acute onset of Trigeminal Neuralgia on right side of face within 30 minutes of receiving vaccine. Pain did not subside after five days and went to emergency room the morning of 8/12/22. Given a shot of Toradol, a six-day cycle of methylprednisolone, Gabapentin 300mg up to three times a day, ibuprofen 800mg around the clock, and a prescription for Norco. Following up with general practitioner on 8/15/22.
48 hours after nasal flu mist vaccination-became ill with severe headache, fever of 102.5 under armpit and continued for 4 days (missed 4 days of school)-even after fever free,severe headache continued for 2 additional days.  Last year, same occurence (did not report last year) but much more severe with uncontrolled 105 temp, severe lethargy and headache and missed 5 days of school-nearly took to ER but out of town and uncomfortable with medical care there
Site: Swelling at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Details: Roughly 10 minute after receiving Pfizer covid vaccine patient was feeling palpitations and throat tightness. Patient was given 2 Benadryls and waited an extra 30mins. Patient said he was feeling fine and went home after. Will followup on 4/11/2021
Post vax, pt had redness, swelling and itching at site of injection, erythema 6cm and warm to touch. Provider thought reaction to bandaid, due to print of bandaid on arm; no redness. On 1/16/01, pt had Hep-B/MSD/0721K/IM/LA/#6 with redness, swelling and itching, middle to lower third of upper arm and warm to touch but non-tender. Nothing at site of injection. No bandaid applied at this site. Pt received 3 doses of HBV, out of state, 2 years ago but had no reaction. Needed proof so repeated series.
Continuous rash on lips, mild swelling, itching, broken skin. Brief blister/sore on first day of symptoms with significant swelling of upper and lower lip lasting for an hour or two.
This skin irritation started on my upper chest and I thought it was psoriasis. I went to the dermatologist, and they took a skin sample and discover it as being eczema. I was giving prescription hydrocodone. This treatment plan is working so far the area on my chest has cleared up but not on some of the other areas but this still in my opinion is better than dealing with COVID-19 itself. Even after I discovered the rash was due to the vaccine, I have still gotten the booster and I plan on continuing getting vaccinated.
On March 24 I got the first dose of the Pfizer COVID-19 vaccine and I experienced side effects almost immediately. By the time I got to the resting/observation area I felt that the site of the injection got really warm and I became dizzy/lightheaded and started to feel heavy on the chest and little problem in swallowing and breathing. I was taken to the paramedics on site, they checked my blood pressure (which a little high 150/90), oxygenation, pulse, and EKG (which were normal). It did not became too bad after and was allowed to come back home.  However, the heavy chest and swallowing problem lasted for three days. The heaviness in the chested turned into a sensation of feeling like my trachea or the anything under the sternum area was behind strangled. Although I felt like this my breathing and swallowing was almost normal. Every now and then when I swallowed I felt some pain but I could withstand it.
pt recv vax 13JUL98 & 19JUL98 mild rash face, neck, hairline, fever coryza;20JUL98 rash, face, neck, trunk, arms, cough, fever, coryza;22JUL98 rash, redder, more coverage-fever coryza;23JUL98 rash, conjunctivitis;teary eyes;24JUL98 rash
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated orally with unknown doses of oral, ROTATEQ (lot # L008057, expiry date: 01-DEC-2016), which were improperly stored. There was no adverse effect reported after improperly stored vaccine was given to the patients. This is one of two reports received form the same reporter. Additional information has been requested.
Information has been received from a nurse concerning a 26 year old female patient who on 27-APR-2007 was vaccinated IM with a 0.5 ml first dose Gardasil. There was no concomitant medication. Since 28-APR-2007 the patient felt depressed and fatigued. Unspecified medical attention was sought. Additional information has been requested.