chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; Monovalent doses administered after the BUD to patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients.) and NO ADVERSE EVENT (no adverse event) in a 64-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patients.).      The concomitant medication was not reported. The treatment medication was not reported. The information was unknown whether the patient received other vaccines in the 4 wees prior to COVID-19 vaccination.   This case was linked to MOD-2022-691041 (Patient Link).
Reports symptoms started 1/7/21 7 AM with pounding headache, nausea, rapid heart rate.  Had chills that shook her in night.  Went to work. HR has been 100 since awakening.  Injection site is red and inflamed.  B/P 142/100. Instructed to go to urgent care.  Urgent care sent her to Emergency Dept.  Per Dr., ED provider, he wanted VAERS completed.  Patient has tachycardia 140-150.  No rash or swelling.  Has body aches and Headache.  Temp is 100.3.  Undecided if will be admit to hospital at this time.
Dystonic Reaction:  Hyperthermia, Tachypnea, Tachycardia, Distal muscular rigidity, Distal cyanosis, Hemiballismus, and Altered mentation.
inadvertently administered the Menveo liquid component without the lyophilized component to a patient today on 6/8/23; inadvertently administered the Menveo liquid component without the lyophilized component to a patient today on 6/8/23; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA944A, expiry date 31-JUL-2024) for prophylaxis.   On 08-JUN-2023, the patient received Menveo (left deltoid). On 08-JUN-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: inadvertently administered the Menveo liquid component without the lyophilized component to a patient today on 6/8/23) and inappropriate dose of vaccine administered (Verbatim: inadvertently administered the Menveo liquid component without the lyophilized component to a patient today on 6/8/23). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 8-Jun-2023 The phlebotomist called to inquired that they should revaccinate with a complete dose. The reporter asked that how to proceed. The reporter did not consent to follow-up. The patient inadvertently administered the Menveo liquid component without the lyophilized component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
1354-vaccine received; 1400-felt a squeezing in chest; blackness in the outside of vision; tingling hands; nausea1420-symptoms resolved
No adverse side effects reported; The PROQUAD expired on 4/11/2022 and was administered today, 4/19/2022; It was also reported that ther PROQUAD was administered intramuscularly instead of subcutaneosuly; This spontaneous report was received from a licensed practical nurse and refers to a 40-year-old female patient. The patient's concurrent conditions and medical history were not provided.   On 19-APR-2022, the patient was vaccinated with 1 dose of an expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant Human albumin (rHA) (PROQUAD), lot # T034828, expiration date 11-APR-2022, 0.5 ml administered intramuscularly instead of subcutaneously (exact dose number and anatomical location were not provided) for prophylaxis (expired product administered, incorrect route of product administration). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (PROQUAD) was reconstituted with an sterile diluent (MERCK STERILE DILUENT), lot # U005104, expiration date 01-JUL-2023. It was reported that measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (PROQUAD) and sterile diluent (MERCK STERILE DILUENT) have had no temperature excursions. No adverse side effects were reported (no adverse event).
Low grade fever (highest was 99.6) for appr. 24 hours, muscle/joint aches (mild), felt "flu-like," fatigue.  All resolved within 36 hours of injection except for fatigue.  Still feel fatigue 5 days later.
This is a spontaneous report based on information received by Pfizer from GlaxoSmithKline (Manufacturer Report Number: A1025426A). This case was reported by a physician via sales representative and described the occurrence of seizure in a child subject around 2 months of age of unspecified gender who was vaccinated with ROTARIX (GlaxoSmithKline), PEDIARIX, PREVENAR (non-gsk) and PEDVAXHIB (non-gsk). On an unspecified date, around 2 months of age, the subject received first dose of ROTARIX (oral), first dose of PEDIARIX (unknown details), first dose of PREVNAR (unknown details), first dose of PEDVAXHIB (unknown details). It was not specified as to which vaccination was co-suspect to the events. No dates of administration were provided. The physician reported that the subject "got their normal schedule of pediatric vaccines (2, 4 months schedule). On an unspecified date and an unspecified time after vaccination with the first dose of ROTARIX, PEDIARIX, PEDVAXHIB, and PREVNAR, the subject experienced a seizure. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified. Follow-up (16Aug2013): Follow-up attempts completed. No further information expected.
Post vaccination pt, developed severe hyperemia swelling and pain wh/progressed from the injection site to involve the entire upper (L) arm pt self medicated and the situation resolved over several wks. Pt reported  this on 9/17/13.
1. SHOT - SEVERE ITCHING uppER ARM  2 START OF CYST ON MIDDLE BACK  CYST GETTING BIGGER AND BIGGER UNTIL IT FINALLY BURST WITH  A LOT OF BLOOD + PUSS
area of the injection is red and itchy, the itchiness comes and goes; area of the injection is red and itchy, the itchiness comes and goes; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (area of the injection is red and itchy, the itchiness comes and goes) and VACCINATION SITE PRURITUS (area of the injection is red and itchy, the itchiness comes and goes) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Cholesterol and Hypothyroidism.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (area of the injection is red and itchy, the itchiness comes and goes). In February 2021, the patient experienced VACCINATION SITE ERYTHEMA (area of the injection is red and itchy, the itchiness comes and goes). The patient was treated with CORTISONE at a dose of unknown. At the time of the report, VACCINATION SITE ERYTHEMA (area of the injection is red and itchy, the itchiness comes and goes) and VACCINATION SITE PRURITUS (area of the injection is red and itchy, the itchiness comes and goes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient uses unspecified blood pressure, cholesterol and hypothyroidism medications as concomitant medication
SHAKING; SHIVERING; LINGERING MUSCLE ACHES; TIREDNESS; HEADACHE; This spontaneous report received from a patient concerned a 45 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: Unknown) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-APR-2021, the subject experienced shaking. On 27-APR-2021, the subject experienced shivering. On 27-APR-2021, the subject experienced lingering muscle aches. On 27-APR-2021, the subject experienced tiredness. On 27-APR-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 shaking, shivering, and headache on 27-APR-2021, and was recovering from lingering muscle aches, and tiredness. This report was non-serious.
Near-syncope, dizziness, vomiting. Photosensitivity fatigue - 9/24/12 1:30 PM (4 hours after vaccination). Recurrence of above, seen by MD. 9/27/12 - 3 PM. worst vomiting, near syncope, vertigo - 10/02/12 6 PM taken to ER, admitted to hospital. Discharged 10/04/12.
Pt having severe pain to both arms. No redness but slightly swollen per pt. No other symptoms as well per pt.
One patient received a Moderna COVID-19 booster dose given > 12 hours post puncture on 08Dec2021 at 7AM; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (One patient received a Moderna COVID-19 booster dose given > 12 hours post puncture on 08Dec2021 at 7AM) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 606H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Dec-2021 at 7:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Dec-2021 at 7:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (One patient received a Moderna COVID-19 booster dose given > 12 hours post puncture on 08Dec2021 at 7AM). On 08-Dec-2021 at 7:00 AM, EXPIRED PRODUCT ADMINISTERED (One patient received a Moderna COVID-19 booster dose given > 12 hours post puncture on 08Dec2021 at 7AM) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 06 Dec 2021. The vial was first punctured on 06 Dec 2021 at 8 PM. The vial was stored post puncture on room temperature (RT) and did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was 35 hours.  No relevant concomitant medications were reported.  No treatment information was provided.
Chills started at 10:00am 2/20/21 and lasted about and hour.  Fever and body aches occurred around 2:00pm and lasted overnight.  Symptoms improved with rest and acetaminophen use.  At 8:00am 2/21/21 symptoms were completely resolved.
I got a second shingles shot and had a very bad reaction within hours. I was throwing up, cramping, every muscle hurt, I was as sick as I have ever been. I went to ER the next morning. I was given antibiotics and stuff. But the ER blamed an absyseded tooth for my fever and sickness. I have had trouble with that tooth for years, but never like that. The problem was the second dose of shingles shot. There was something wrong with the batch I was injected with. It hurt more even while it was being injected and within hours I was so sick I could barely get back and forth to the bathroom, I was throwing up. This happened to me about a month ago and it was awful. I think some health care providers don't want to report a bad vaccine. But the second shingles shot that I got at the store was definitely bad. I'm mad that I wasn't told how sick I was going to get either. It was awful!!!!!!!
5 days after 2nd dose.  3 days in bed--nausea, headache, chills, fever, body and joint aches, dizzyness and unsteady on my feet.   on 4th day after 2nd dose I went to emergency because I could not form a sentence,  and forgot my family member names.
Child was given H1N1 mist on 10/17/2009 and then on 10/21/2009 was given H1N1 injectable
returned to clinic 2 hrs p/vax; pt w/urticaria over most of body; worse on legs;
The patient came in 6 days after vaccination with redness and warmth that had radiated 6 plus inches from injection site. It was very sore the first few days and the soreness has decreased but the redness is still there.
Shot received 01/25/2004, approx 2 weeks later started with shortness of breath and elevated heart rate on mild exertion. On evening of 02/27 started mild chest pain, increasing thru next day when hospitalized. Information received from Discharge summary states Myocarditis, cardiomyopathy, hypertension as symptoms. msv Medical records state fever. msv
On 12/25/2021 around 10pm I began experiencing pulsating tinnitus in left ear. It made it very difficult to go to sleep. I only experienced the tinnitus at night. When the tinnitus began it was nearly every night and then the frequency seemed to decrease. About two weeks after the tinnitus began, I began having episodes where there would be a high-pitched noise in both ears, and I would have hearing loss. Then there would be another high-pitched noise and my hearing would return. These episodes would last 5-10 seconds. The episodes continued and I went to my PCP in Mid-February. She thought it could be anemia, but blood work came back that I was not anemic and no thyroid issues. She then referred me to an audiologist, in mid-March. Audiologist found hearing loss and referred me to ENT. ENT tested me for Lyme disease which returned negative and ordered an MRI of brain, which came back normal. Placed me on Prednisone but didn't help tinnitus. Return to ENT 05/04/2022.
45 year old male with history of sleep apnea,  COVID positive past few days  with worsening SOB over past few days. Pt with O2 sats mid 80's on RA. CTA no PE. Pt requiring 4L O2, and no beds available locally.
Painful cramping (contraction like) for 4 days after 2nd vaccine dose. I have not received my menstrual cycle since August 15th. I am 39 years old and am not pregnant. This has never occurred prior to receiving the vaccine. I also began experiencing hot flashes. I still have not had a menstrual cycle.
Extreme swelling in arm.  Red streaks leading downward from where the injection site was.  Arm twice the size of the unvaccinated arm.  Fever of 100.  Injection site very hot to the touch.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The reporter stated that, since 08-JUL-2014 (exact dates not provided) RECOMBIVAX HB was administered to patients after improper storage (dose, route, lot number and expiration date not reported). No adverse effects were noted.  This case is linked to case MARRS#1407USA004179, 1408USA013887 and 1408USA013888 (same reporter link). Additional information is not expected because the reporter declined any further contact regarding this report.
Headache; Chills; Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 11Mar2021 (Batch/Lot number: unknown) at the age of 79 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "covid-19", start date: 10Dec2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 11Mar2021, outcome "recovered" (12Mar2021), described as "Headache"; CHILLS (non-serious) with onset 11Mar2021, outcome "recovered" (12Mar2021), described as "Chills"; FATIGUE (non-serious) with onset 11Mar2021, outcome "recovered" (12Mar2021), described as "Tired". Additional information: The patient felt uncomfortable for about 3 hours due to headache and chills, but had no fever. She started having problems about 8-10 hours after vaccination. She also added that she had headache, tired, and chills for about 14 hours. The patient was scheduled for her next shot on 01Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
During the evening of administration, patient reports feeling fever (100.6 F). Following evening 102.4 F, HA, bodyaches, decreasing sx over the next 2 days, 100.9 3 days later; motrin and Tylenol alternated for sx relief.
Stomach pain, cramps, nausea, IBS - occurred beginning at approximately 2:00 AM Thursday, Nov. 11th.  Communicated by email to PCP, who advised to monitor symptoms and offered rx if needed. Requested RX via email to PCP Friday, Nov. 12th. PCP prescribed Hyoscyamine Sulfate 0.125 mg tablet. Taking as prescribed, symptoms have subsided almost completely.
Vaccination Site Reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Vaccination Site Reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Vaccination Site Reaction). At the time of the report, VACCINATION SITE REACTION (Vaccination Site Reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Bad chest pains, shortness of breath, sharp shooting pains behind left breast, fatigue, irregular heartbeat, headaches that felt like burning inside head on top of right side never had before followed by nearly daily migraines for over a month now. All symptoms of myocarditis. Extreme pain in left arm after first injection lasting 3 days. Really bad ache in left arm down to hand similar to ?growing pains?, or like a headache but in the arm leading to numbness in hand and arm feeling as if having a heart attack is the best way to describe never having had a heart attack in my life, all starting on the 2nd day after the 2nd dose.  Changes in period after first vaccination leading to spotting 8 days before period for 2 months now. Heavier period, more painful period including painful ovulation.
Five (6) vials of Moderna COVID vaccine (NDC:80777-0273-99 (5010700) Lot #011J20A) that was supposed to contain (10) doses per vial contained only (9) doses.  (Medical Group) received 250, 5ML (10) dose vials in a shipment received 12/22/2020. At onset of vaccinations, the immunizations Clinic noted five of the vials did not contain the appropriate amount of vaccine as stated per the manufacturer. No adverse impact. No mission degradation. PQDR is submitted to address this discrepancy on current and future vaccine shipments.
10-26-17 Early morning started with high fever and very red and swollen arm where her flu was given. She also reacted last year but not as bad.
Info has been received from a health care professional concerning a disabled 59 year old female pt with no known drug allergies who on 11/11/2002 was vaccinated with a 2nd dose of pneumococcal vaccine 23 polyvalent intramuscularly in the bicep (lot #643785/0872M). Concomitant vaccination the same day included a dose of influenza virus vaccine. After administration, the pt went to the ER because her arm was swollen and painful. She was treated with diphenhydramine hydrochloride (BENADRYL) and unspecified steroids. Follow-up info from a health care professional reported that on 11/11/2002 at 6:30 PM the pt called to report she had developed a rash with no itching and swelling the size of an egg that was extremely tender to the touch. She went to the ER where her arm was extremely painful with burning to the shoulder. It was also reported that this arm pain caused her blood pressure to go up. Subsequently, the pt recovered. It was also reported that a 62 year old male was vaccinated with a dose of pneumococcal vaccine 23 polyvalent and extremely sore and painful arm. (WAES #0211USA01581). No further info is expected.
Vaccine Administration Error; client under age 50, not approved to receive 2nd booster Covid vaccine dose yet.
very large lump under his arm and it is painful to put it down; it is painful to put it down/arm sore; whole right arm pit hurts; This is a spontaneous report from a contactable consumer. This consumer (patient's mother) reporting for a 16-year-old male patient.  A 16-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Aug2021 14:30 (Lot number: FA7485) at the age of 16 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LIMB MASS (non-serious) with onset 05Aug2021, outcome "not recovered", described as "very large lump under his arm and it is painful to put it down"; PAIN IN EXTREMITY (non-serious) with onset 05Aug2021, outcome "not recovered", described as "it is painful to put it down/arm sore"; AXILLARY PAIN (non-serious) with onset 05Aug2021, outcome "not recovered", described as "whole right arm pit hurts". Therapeutic measures were taken as a result of limb mass, pain in extremity, axillary pain.  Additional information: Mother calling on behalf of her 16-year-old son.He received his first dose of the Pfizer Covid-19 Vaccine on 03Aug2021.He exp very large lump under his arm and it was painful to put it down.Caller was asking was that a usual side effect reported. Caller stated she was calling regarding the Pfizer vaccine, provided the number FA7485 as stated on the card. Was calling regarding her son who got the first vaccine. Clarified that she was referring to the Pfizer Covid vaccine. She knew that everybody has different side effects. Her whole family already got it. He hadn't gotten it yet. He has a really large lump under his arm put and it hurts him to put his arm down. She wanted to know if this was a usual side effect from the vaccine. Has a really large lump under his arm put and it hurts him to put his arm down: This morning, he noticed and states that it had been sore but, this morning, he noticed there was a lump there. His whole arm pit hurts. Clarified that it is the right arm, and it started this morning. It still feels the same. Treatment: He did take Ibuprofen. They wanted him to get protected from getting Covid, since they all had it and he hadn't had it. He has been practicing for football. Between 1:00 and 3:00 pm, then states that she believes it was between 1:30pm and 2:30 pm. The patient was not in emergency room for the reported events. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine.   No follow-up attempts are possible. No further information is expected.