chrisvoncsefalvay/vaers-outcomes huggingface dataset:
AFTER COVID-19 BOOSTER NEXT MORNING FELT IF HAD BEEN IN A CAR ACCIDENT; PAINS WORSENING AFTER GETTING ON HUMIRA/ACHES/PAINS/VERY SORE AFTER TAKING COVID-19 BOOSTER; ON NECK DOWN JOINTS ACHE; Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (AFTER COVID-19 BOOSTER NEXT MORNING FELT IF HAD BEEN IN A CAR ACCIDENT), PAIN (PAINS WORSENING AFTER GETTING ON HUMIRA/ACHES/PAINS/VERY SORE AFTER TAKING COVID-19 BOOSTER), ARTHRALGIA (ON NECK DOWN JOINTS ACHE) and FATIGUE (Fatigued) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Previously administered products included for Drug use for unknown indication: ENBREL. Past adverse reactions to the above products included No adverse event with ENBREL. Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced FEELING ABNORMAL (AFTER COVID-19 BOOSTER NEXT MORNING FELT IF HAD BEEN IN A CAR ACCIDENT), PAIN (PAINS WORSENING AFTER GETTING ON HUMIRA/ACHES/PAINS/VERY SORE AFTER TAKING COVID-19 BOOSTER), ARTHRALGIA (ON NECK DOWN JOINTS ACHE) and FATIGUE (Fatigued). At the time of the report, FEELING ABNORMAL (AFTER COVID-19 BOOSTER NEXT MORNING FELT IF HAD BEEN IN A CAR ACCIDENT) had resolved, PAIN (PAINS WORSENING AFTER GETTING ON HUMIRA/ACHES/PAINS/VERY SORE AFTER TAKING COVID-19 BOOSTER) and ARTHRALGIA (ON NECK DOWN JOINTS ACHE) had not resolved and FATIGUE (Fatigued) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant and treatment medication information was provided.  The reporter's causality with Humira (adalimumab): not provided for fatigued, on neck down joints ache and aches/pains/very sore after taking covid-19 booster, no reasonable possibility for event after covid-19 booster next morning felt if had been in a car accident and reasonable possibility for event pains worsening after getting on humira.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
10/16/2021- right eye swollen, 2 hours later the swelling went down 10/16/2021-  Skin is itching under neck, stomach, all over upper body and it has turned very dark
Moderna COVID-19 Vaccine EUA. Chills, fever, swollen throat, sore-red-itchy arm, headache, swollen sore lymph nodes, mild nausea, generally felt TERRIBLE.
This spontaneous report was received from a registered nurse concerning to a male patient of unknown age. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 11-SEP-2017, the patient was vaccinated with the first dose of ROTATEQ lot # M043836, expiration date 17-JUN-2018, orally, for prophylaxis (dose was not reported). On 02-OCT-2017, three weeks after the first dose was administered, the patient received a second dose of ROTATEQ lot # N005618 with expiration date 04-OCT-2018, orally (dose was not reported), also for prophylaxis.
Information has been received through the pregnancy registry for GARDASIL, from a registered nurse concerning a 21 year old female with no medical history or drugs allergies, who on 13-MAY-2009 was vaccinated with a dose of GARDASIL (lot # 661953/1130X). There was no concomitant medication. The patient is now pregnant, the pregnancy is normal to date; her LMP was 11-APR-2009. The patient had a urine pregnancy test. The patient sought medical attention through an office visit. Follow up information received on 30-JUN-2009 from a registered nurse stated that the patient was a female, who on 13-MAY-2009 was vaccinated with a first dose of GARDASIL (lot # 661953/1130X). Concomitant therapy included prenatal vitamins. It was also reported that the patient didn't have any previous pregnancies. Follow up information received from a physician indicated that the patient had a medical history of Rhesus antibodies negative. On 26-OCT-2009 the patient was given RHOGAM times 1 for RH negative and on 13-JAN-2010 the patient was placed on therapy with labetalol 100 mg twice a day for increased blood pressure. On 16-JAN-2010 at 39.6 weeks from her last menstrual period the patient gave birth to a normal baby boy who weighed 8.10; length 20. Due to failure to progress the patient had a C-section done. It was also reported that on an unspecified date the patient developed pregnancy induced hypertension. Upon internal review C-section due to failure to progress was determined to be an other important medical event. No further information is available.
Per resident he received the Pfizer vaccine in Jan or feb. of 2021. This information was noted after receiving the Janssen vaccine. No adverse effects have been noted.
On May 14, 2005 had fine rash and 102 degree fever, Mom is on vacation with pt and family. Pt was taken to Emergency Care Clinic, doctor did not know what pt had, on May 16th he broke out in whelps, no fever.
It was reported that a 70 year old female pt was vaccinated with first dose of Fluzone (U0672AA), IM in the left deltoid at 2 pm on 10/21/01. In January of 2002, the pt stated that it caused coughing, specific date and time not reported. Chest x-ray was performed and the result was normal. The pt was treated with antibiotics, Nexium and was sent to a Pulmonologist who treated her for reactive airway disease. The pt reported has not recovered from the event. Linked to case: U2002-01139.
Experienced depressed thinking, including suicidal thoughts in the very early hours of 2/11/21. Throughout the daytime (2/11/21), I experienced general malaise and lacked motivation to do anything. However, slept well the night of 2/11 through 2/12 and felt fine from 2/12 onward.
2nd Dose of Moderna Vaccine administered on 9/6/21 from Lot #011A21A expired 8/16/21.  *Site leadership consulted with the Moderna Medical Safety Department and received the below confirmation: * If the dose given in error is the first dose, a second dose should be administered 28 days later. If this dose is the second dose, the series is complete and no additional doses are needed.
3/23 developed chest tightness with shortness of breath 3/26 dry cough 3/30 +D-Dimer 14,103. CT showing pulmonary emboli right main pulmonary artery and left lower lobar artery.
The night of my vaccine I woke up feeling really hot, sweating, but felt like I needed to throw up. I attempted to get up but felt I would not make it to the bathroom therefore I laid back down and woke up my husband. We both leapt out of bed to try and make it to the bathroom and while I was walking, I passed completely out cold. I landed on my face, lower back and right shoulder. When I came to I was shaking and my hands were tingling. My back continued to hurt really bad for the next two weeks. On Friday 12/17/2021 the pain finally went away on my back and a rash appeared under my right armpit. The rash never got better therefore I called the doctor whom stated I have shingles and she believes it was a effect of my vaccine. I am currently taking ValAcyclovir 3 times a day to help with the length of this. It is really painful.
Was out shopping with friends and feeling fine but when driving home I noticed a high pitch sound in my left ear that abruptly started for no known reason.   I have pollen allergies to trees and due to staying indoors and wearing a mask I was having no bad allergy symptoms and never had tinnitus on my worse pollen day.   The tinnitus symptom was loud enough to notice over all other noise and very irritating in a quiet room.    The high pitch sound was non stop and constant.  I went to sleep that night and woke up Saturday morning still hearing it.  I felt that morning like I was having a very mild cold with very mild congestion.  I felt likeI had swelling under my ears    I was not tired but I did feel like staying in bed and sleeping  as if my body was mildly requesting it.  I slept most of the day.  Woke up with the high pitch sound but it seemed a little bit lower in volume.  Around 8 pm the sound left as quickly as it came
Believe that I contracted COVID-19 at a memorial service. A couple days later I developed a runny nose and tested positive for COVID-19. Mostly felt like head cold, sore throat, and headache. Called Dr and was prescribed Paxlovid. Paxlovid helped resolve symptoms but I experienced a rebound case of COVID-19. Took 3 weeks total for symptoms to resolve.
Received 1st shot on 3/10/99, 2nd shot on 4/8/99. In September, '99, I started feeling extremely light-headed and ill over my entire body. Temperature would drop to about 94F. Went to MD. It was so bad I couldn't function in early October, I was in the hospital for 4 days. Could find no problem. Dx'd with Lyme disease in July, 2000. Still being treated. Diagnosis in hospital was also intermitant chest pressure.  Follow up report: "According to the nurse at the doctor's office, the lot # was not recorded."
Itching after 8 days, then large red firm area and continued itching. This is the third day and redness is larger
Received flu vaccine at approx 10:00 AM and then about 13:30 PM start to have cough, SOB, extreme weakness, Chills, Sore throat, hoarseness and puffy eyes. She stated no fever. She called me at approx 10:00 on 09/30/09 and said that she felt better and did not seed medical attention. she did have residual hoarseness, but other symptoms have resolved.
Nothing happened for a couple of weeks until my body itches and it will go from one place to the other. At this moment no other symptoms.
Patient fainted after receiving  Janssen Covid-19 vaccination, immediate upon removal of syringe needle at 3:24 pm on 5/16/21. Patient recovered consciousness about 10-15 seconds later and complained of feeling dizzy and light-headed. Wet paper towels were applied to patient's neck wrist and forehead for 5 minutes but he still felt light headed. Patient then was instructed to lie on the floor and elevate his feet on a chair.  After doing this for 5 minutes he felt well enough to sit in the waiting/observation area for another 10 minutes after which he felt well enough to leave.
Unable to keep any liquid or food down (vomiting), temp. dropped to 96.6F//2000ml IV & shot for vomiting.
on second day after dose arm was red ; swollen and heated; each day area of redness, swollen and heat increased; on 4th day severe itch started; placed ice packs on arm; by Monday 19th area measured about 5 inches by 6 inches with raised swelling about 1/8 - 1/4 inch. Saw Dr.who prescribed Zyrtec and if needed cortisone cream,  today one day after starting Zyrtec swelling is down, no itch and only slight redness.
sister has had 2 shots of the covid vaccine by pfizer and diagnosed with Covid; sister has had 2 shots of the covid vaccine by pfizer and diagnosed with Covid; This is a spontaneous report based on information received by Pfizer/Merck and Co., Inc. from a contactable consumer or other non-health care professional reported for her sister. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: not reported), via an unspecified route of administration, administer at an unspecified anatomical location on an unspecified date as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: not reported), via an unspecified route of administration, administer at an unspecified anatomical location on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sister has had 2 shots of the covid vaccine by Pfizer and diagnosed with covid. The patient underwent lab tests and procedures which included sars-cov-2 test diagnosed with covid on diagnosed with COVID. The outcome of the event was unknown.  The lot number for (BNT162B2), was not provided and will be requested during follow-up.
Pt recvd first Engerix-B vax on 01JUL91,2nd vax 31JUL91; later exp elevated liver enzymes, malaise, nausea, vomiting; tx meds;Hepatitis profile neg; RN felt pt had som other virus;
(R) Deltoid 4 1/2 x 4 1/4 cm erythema, induration, pain onset 5/23/07 AM (L) upper arm 1 x 1 cm area mild erythema, no pain
19JAN92 had fever up to 105 R w/rash; mom gave pt DPH & APAP; 21JAN92 this AM had temp of 104; rash (hives) comes & goes;
Pt experienced red, splotchy rash that itched around injection site and spreading to chest and neck approximately 30 minutes post vax. Pt was treated with Benadryl and symptoms resolved within 4 hours.
No adverse event; Temperature excursion involving administered PROQUAD vaccines; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. No information regarding the patient's concurrent condition, medical history, drug reactions or allergies and concomitant medications was provided.   On an unknown date, the patient was vaccinated with a dose of measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (exact dose, vaccination site, frequency, anatomical site of vaccination, lot # U022726, expiration date 16-JAN-2023) subcutaneously for prophylaxis.  On 21-DEC-2021, measles, mumps, rubella, and varicella (oka-merck) virus vaccine live (PROQUAD) was involved in temperature excursion (product storage error).  No product quality complaint (PQC) and no additional adverse event (AEs) were reported.
This case was reported by a physician via call center representative and described the occurrence of tenderness in a 76-year-old male patient who received SHINGRIX. On 24th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 25th May 2018, 1 days after receiving SHINGRIX, the patient experienced tenderness. On 27th May 2018, the outcome of the tenderness was recovered/resolved. The reporter considered the tenderness to be related to SHINGRIX. Additional information was reported as follows: This case was reported by patient who is a physician. The patient was vaccinated by intramuscular route. The patient experienced tenderness which lasted for about 2 days. The patient's wife notified to their physician about the event. The patient wanted to know, if the same events would be expected with the 2nd dose of SHINGRIX vaccine. The patient had denied permission to contact their physician. This case was linked with case US2018097672 (wife case), reporter by the same reporter.
seizures and went to the hospital; He is debilitated; This is a spontaneous report from a contactable consumer(parent). A 40-year-old male patient started to receive her second dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: Not reported) via an unspecified route of administration, administered on 15May2021 as DOSE 2, SINGLE for COVID-19 immunization. The patients medical history and concomitant medications were not reported. Historical vaccine included received his first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: Not reported) on an unknown date via an unspecified route of administration, as DOSE 1, SINGLE for COVID-19 immunization. On an unknown date the caller stated that her son had severe side effects and can get no help. He's in the hospital now. After the second dose that he had seizures and went to the hospital and released and problems every since. He's had problems since May. He is debilitated. On an unknown date patient took MRIs and CATs in the hospital and the results were unknown. Outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up
"Pt w/ hx of allergy to sulfa medications (rash) and Hep B vaccine (rash). 5mins post vaccination, pt c/o flushing/sweating and dizziness.  Vitals: @14:35 BP 147/65, HR 100, RR 26, 100%RA, Temp 97.8 -- > @14:48 134/68, 92, 100% RA -- > @14:58 125/79, 78, 100%RA Symptoms resolved, pt stable and released from the vaccination site."
ON DAY 6 POST VACCINATION, I DEVELOPED 12 HOURS OF IRREGULAR (MID-CYCLE) VAGINAL BLEEDING.
Pt devel rash & inc temp; mom reported t104 had been seen in ER pt had measles placed on Amoxicillin sent home;
Pt felt constriction in back of throat ,tongue within 5 min of receiving shot. "It felt like a tight turtle neck was around my neck". She felt like she had a elevated HR.  This was followed by a feeling of being flushed and her whole body was itchey. Para-medics attended her and noted Elevated heart rate, and BP. O2 sats were good. No epinephrine was given. She went home and took some Benadril.
Swelling up to the size of tennis ball; pretty inflammed under armpit; lump under injection arm on the left side; lymph node is pretty sore- under the arm pit; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE INDURATION (lump under injection arm on the left side), LYMPHADENOPATHY (lymph node is pretty sore- under the arm pit), INJECTION SITE INFLAMMATION (pretty inflammed under armpit) and PERIPHERAL SWELLING (Swelling up to the size of tennis ball) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (lump under injection arm on the left side), LYMPHADENOPATHY (lymph node is pretty sore- under the arm pit), INJECTION SITE INFLAMMATION (pretty inflammed under armpit) and PERIPHERAL SWELLING (Swelling up to the size of tennis ball). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Inflammation, at an unspecified dose and frequency and SULFAMETHOXAZOLE, TRIMETHOPRIM (MORTIN) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE INDURATION (lump under injection arm on the left side), LYMPHADENOPATHY (lymph node is pretty sore- under the arm pit), INJECTION SITE INFLAMMATION (pretty inflammed under armpit) and PERIPHERAL SWELLING (Swelling up to the size of tennis ball) 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.   The second dose of mRNA-1273 will be between 09- 12Feb2021. Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2021: Added Reporter details , Patient details , Treatment medications and updated Events.
Patient reports experiencing fever and cough the day after receiving the vaccination.  He is still stating that he is having symptoms on 1/25/2021
IgA-dominant leukocytoclastic vasculitis; IgA nephropathy; Within 2 days, the rash reappeared; proteinuria; This is a literature report.  A 50-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation, reaction(s): "rash".  The following information was reported: CUTANEOUS VASCULITIS (medically significant), outcome "recovered", described as "IgA-dominant leukocytoclastic vasculitis"; IGA NEPHROPATHY (medically significant), outcome "recovered"; RASH (non-serious), 2 days after the suspect product(s) administration, outcome "recovered", described as "Within 2 days, the rash reappeared"; PROTEINURIA (non-serious), outcome "recovered". The patient underwent the following laboratory tests and procedures: Biopsy kidney: IgA nephropathy; Biopsy skin: revealed IgA-dominant leukocytoclastic vasculitis; Blood creatinine: 0.9 mg/dl; Complement factor: normal; Immunology test: IgA nephropathy; On examination: healing papules were noted, notes: on his legs but otherwise exam  was normal; Microscopy: revealed acanthocytes; Serology test: Negative; Urine analysis: proteinuria; Urine protein/creatinine ratio: 1.1, notes: g/g; 0.7, notes: g/g. Therapeutic measures were taken as a result of cutaneous vasculitis, iga nephropathy, rash, proteinuria.; Sender's Comments: Based on the available information, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
pt recv vax 10JUL96 & 11JUL96 pt devel a sl round, red, blotchy rash & sl itching @ inj site;19JUL96 pt passed out for approx 30sec;pulse @ time passed out was approx 60 beats per min;BP nl;recv 02;exp weakness;vasovagal episode;
As has happened after every Covid vaccine I've received, approximately two months after the injection I broke out in chronic hives which lasted for months. This time, the hives weren't confined to my face and neck, but covered my entire body, requiring  trips to doctors and dermatologists. I have made several reports to the VAERS site, and I have never received a response. Except for one dermatologist, none of my doctors acknowledged chronic spontaneous urticaria as a potential side effect of the vaccine. I see now that several studies have documented a link, which I hope will inspire researchers to explore this serious side effect.
a pediatric dose of VAQTA was administered to a 36-year-old male by mistake; a pediatric dose of VAQTA was administered to a 36-year-old male by mistake; No additional AE's reported; This spontaneous report was received from medical assistant and refers to a 36-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with pediatric dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5ml x 1 dose, administered intramuscularly for prophylaxis (anatomical location, lot #, and expiry date were not provided). It was reported that a pediatric dose of hepatitis a vaccine, inactivated (VAQTA) was administered to a 36-year-old male by mistake (incorrect dose administered, product administered to patient of inappropriate age).  There were no adverse events reported (no adverse event).
Pt recvd 3 Engerix-B vax given 29AUG89, 25SEP89 & 20FEB90; Following these, titer=19; 20FEB91 titer was neg; Pt was given a 4th dose of vax 26APR91; following this titer=33;
Pediatric dose (0.2mL) was given to a 14 year old.
Tachycardia-160 rates/min for 2-3 minutes. Then better. Decreased to 92/min.