chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 08-APR-2016 the patient was vaccinated with an improperly stored dose of (Wistar RA 27-3) M-M-R II 0.5 ml (lot #L003856, expiration date 02-FEB-2017, therapy type recombinant human albumin (rHA), dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion eight times. The total cumulative excursion time of the first time was 204 hours with the lowest recorded temperature of 33 Fahrenheit degree; the second time was 444 hours with the lowest recorded temperature of 34 Fahrenheit degree; the third time was 24 hours with the highest recorded temperature of 49 Fahrenheit degree; the fourth time was 24 hours with the lowest recorded temperature of 21.7 Fahrenheit degree; the fifth time was 1192 hours with the lowest recorded temperature of 29 Fahrenheit degree; the sixth time was 24 hours with the lowest recorded temperature of 31 Fahrenheit degree; the seventh time was 96 hours with the highest recorded temperature of 48 Fahrenheit degree; the eighth time was 304 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria and the type of excursion for this type of excursion for this vaccine were refrigerator (R)/ freezer (F). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Loss of appetite on 8/31/10 at dinner, complaining of very sore arms. In the morning she said she was very tired then she vomited. She only vomited once that day, no fever. She remained tired that morning but by afternoon she was back to herself.
while sitting and waiting the 15 minutes after the vaccine was administered I felt this cold sensation go from my feet up my legs throughout my body. It felt like an injection of dye(Iodine). I didn't feel cold, I just felt a cool sensation spread over my whole body.
Patient presented to the ED on 12/26 for longstanding persistent atrial fibrillation. Patient presented to the ED on 12/31/21 and was subsequently hospitalized for auditory hallucination, paroxysmal atrial fibrillation. These visits are within 6 weeks of receiving covid vaccination.
This spontaneous retrospective pregnancy report was received from a registered nurse for GARDASIL, a Pregnancy Registry product, concerning to a 21 years old female patient with no pertinent medical history and no drug reactions or allergies, who on 30-MAY-2012, was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL (lot number 669795/1317AA, Exp. Date: 13-OCT-2013). No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient LMP was 02-MAY-2012 and the estimated date of delivery (EDD) is 06-FEB-2013, at the first trimester. The registered nurse reported that on 07-JUN-2012, the patient experienced a miscarriage. The patient was admitted to an unspecified hospital but details of the hospitalization were unknown. No treatment information was reported. It was noted that therapy with GARDASIL was discontinued. The patient had fully recovered (unspecified date). The relatedness for patient experienced a miscarriage was unknown for GARDASIL. Additional information has been requested.
Report 200003330-1 describes hives in an "adult" female who received a hepatitis-B vaccine. Allergies, medical history and concomitant mediations are not specified. On 11-May-00, the vaccinee received her first dose of the hepatitis-b vaccine. The vaccinee "broke-out with hives almost immediately". The hives persisted for "several months". The vaccinee was treated with corticosteroids (NOS) and antihistamines (NOS). As of 15-NOV-00, the outcome of the event is unknown.
Patient developed Kawasaki disease like symptoms with fever, rash and large coronary aneurysms. He received IVIG and infliximab treatment. Aneurysms remain large 2 weeks out from treatment.
Pale, dizziness, close to fainting because vision was black. Sat down and recovered. Red and slightly swollen.
Anaphylaxis rxn (wheezing) for a period of 30 min-6hrs.
Adverse Reaction to Shingrix Vaccine ongoing Jan 6 Vaccine Shingrix vaccine 2nd dose Jan 9 3am  I wake with knee pain in both knees. I take a sleeping pill. The next morning I read that Shingrix has side effects and wait for pain to end. My fingers and toes joints are aching. My wrists feel achy.  I can?t sleep on my right side because it hurts my collar bone. January  2021 After a few weeks. I research more about Shingrix can have joint pain side effects.  I?m not sure what I should do since what I keep reading states it will subside.  I also read that Shingrix is very effective and safe.  I don?t want to go into a doctor office due to covid 19.  I take over the counter pain medication. February I call the pharmacy and say I am in trouble ? I describe many of my joints aching my joint pain has been ongoing for almost two months. They direct me to call my Primary physician. I call for a Teledoc appt.  March 9th Teledoc appt    I asked Dr if I can have injections in my knees for pain. I tell her I can?t get up and down without pain in both my knees and my collar bone is aching and can?t sleep on my right side. My finger and toe joints are aching.  Dr. asks me if I have hurt my knees If I recall -I explain I have never injured my knees.   I let her know it was the Shingrix vaccine that caused this.   March 9 Blood test results lab Sed Rate Erythrocyte 64 H March 10 Blood test results  She says she will find out what is going on thru blood test first. She prescribes Prednisone 20 mg 3 times a day and to taper off. I?m instructed not to take Prednisone until after my bloodtest.  March 10th I learn that no Rheumatologist are accepting patients .  I am told I have an inflammation indicator in my bloodwork.   March 25th new referral to Rheumatology   March 25th called Rheumatologist office first available appointment June 9 2021 May 1st- I am completing this report on May 1- I am still experiencing joint pain.
pt recvd vax in JUN91 & w/in 1 hr of vax devel blue hands & a swollen throat; pt was treated in ER: No further details were provided;
Patient developed fever - had it for 3 days. Severe nausea and vomiting - lasted almost 3 days. Feeling like diarrhea.
Patient received a second dose of the flu vaccine 15-20 mins after of receiving the first dose on the same day. After the patient found out he had received a second dose he panicked, became dizzy, pale, and stated he felt tingling in his hands and feet. A blood pressure reading was taken and showed low blood pressure. He was sitting down throughout the whole event. Patient stayed in the counsel room with his parent, a pharmacist in charge and fellow pharmacist for observation for 10 to 15 minutes. Patient was offered 911 services but turned it down. Patient received water and a candy bar and recovered well enough to walk with his mom out of pharmacy to go home.
Received his vaccine, he had soreness in the arm, but  nothing else.  On 3/3/21 he went to hospital ER with diagnosis of kidney stones, had a morphine injection, Flomax and a prescription for Oxycontin and Flomax.  At that time he was experiencing also in his right eye swelling and it was reddish, and there was an itching around the eye, and there was a couple blotches on top of his head and his cheek, but did not mention it as he was there for kidney stones.  On 3/9/2021 he saw a Urologist, Dr. and that morning he passed a kidney stone.  The urologist took an x-ray and did not see any more.  The eye then became an issue on 3/9/21 and he made an appointment to see the eye Dr., Dr. at Eye institute on 3/11/21 @ 9:00 AM.  The doctor diagnosed shingles on the face and right eye, and she put him on 2 medications (Durezol ophthalmic drops).  He is still on that medication still 4/16/21.  The other medication that they prescribed for him was Valacyclovir which he took 3 times a day, they reduced it from 1000 mg to 500 mg twice a day.   The swelling of the eye itself has gone down a little bit.  He is still seeing the eye doctor, and has a FU on 5/5/21 as it is getting better but still has symptoms.   He did get a single dose Shingrix shot a couple of years ago.
Difficulty swallowing, vomited contents of stomach, developed severe chills that lasted throughout the night, soreness at injection site with inability to lift left arm higher than shoulder height, erratic heartbeat, leg joints mildly ached, stuffy head.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DAYQUIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received Dayquil in 2 weeks. The patient started treatment with paxlovid for COVID-19 from 11Aug2022 to 15Aug2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Dtap, Hib, IPV, Prevnar given few minutes after injection. Pt broke out into a rash worse on left leg, head, face. Dtap and Hib was given left leg, IPV Prevnar right leg.
Chills; Shaking; Muscle spasm; This is a spontaneous report received from a non-contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 29Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: Feb2021, stop date: Feb2021, notes: She had COVID-19 in February around Valentine's day until the end of Feb2021. The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset Mar2021, outcome "recovering", described as "Chills"; TREMOR (non-serious) with onset Mar2021, outcome "recovering", described as "Shaking"; MUSCLE SPASMS (non-serious) with onset Mar2021, outcome "recovering", described as "Muscle spasm". Therapeutic measures were taken as a result of chills, tremor, muscle spasms.  Additional Information: After the patient got the vaccine, she had chills and shaking like muscle spams. She treated it with ibuprofen and it helped.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a health professional concerning a 13 year old 69 1/2 lb. 57 1/4 in. white male with no pre-existing allergies, birth defects, or medical conditions who on 09-MAR-2001, received his first dose subcutaneous in the left arm of varicella virus vaccine live (Oka/Merck) (lot# 635948/1333K). No illness at time of vaccination, and no adverse events following previous vaccinations were reported. It was reported that on 03-DEC-2007 at 14:00 hours, the patient developed crusted vesicles and papules scattered on his abdomen and forehead. He sought medical attention at the physician's office. There were no relevant diagnostic tests or laboratory data. At the time of this report, it was reported that the patient had recovered. A product quality complaint was not reported. Additional information has been requested.
After 3 days of receiving 1st dose. I started having left side facial spasms.  Symptoms continued with chronic left ear pain, vision loss, hearing loss and speech which lead to left side facial paralysis. ( Bell's Palsy).
My left arm is weak in the muscle and in pain when I stretch it. I cannot use it the way I usto prior to the vaccine. I cannot reach or stretch my arm the way I usto. When I sleep, I especially find it more painful, even though I have not laid on my arm. I just know factually my arm is weaker and in pain.
4/29/21- date of shot, tongue tingling, throat swelling  within 10min of shot  4/30/21- fatigue, sore arm 5/3/21- headache, sore throat, tongue tingling/swelling, throat swelling (moderate)
Delayed regional allergic reaction to entire (L) upper arm. Severe pain, itching, redness and swelling. Headache, nausea and fever. Mental confusion.
Chills, fever, overall body aches then later localized to arm that only lasted a few days. Headache persist throughout. 2mo and counting.
congested; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (congested) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (congested). At the time of the report, NASAL CONGESTION (congested) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant drugs and treatment medication were provided.
rash on arm for the week following the shot (both times)  swelling/pain in right underarm (axillary area)- same side as shot received - 4 weeks after second shot, lasted 2 weeks
Information has been received from a physician via a company representative concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. On 28-JUN-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 10 single DS, 0.5 mLVIs 10SDV, (lot number L035882, with an expiration date of 19-APR-2017) (route and anatomical location were not reported) that was improperly stored. On an unspecified date, the PNEUMOVAX 23 vaccine had a temperature excursion. The lowest temperature excursion was 34 Fahrenheit (F), (1.111111111 Celsius degrees) for a total of 176 hours. No adverse effects were reported. The vaccine storage criteria and the type of the excursion were reported as refrigerator (R), and the vaccine status was reported as "in excursion". Furthermore, no product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
19 weeks pregnant at time of vaccine, estimated due date February 20, 2022.  first day after vaccine just had a slight upset stomach, fever/chills and fatigue for most of the day. 2nd day post shot was able to get out of bed in the morning, by mid day was back in bed. By early afternoon started having extreme stomach pain in the middle upper portion of my belly. For the remainder of the day I could not sit up for more than 5-10 mins at a time without feeling like I had to lie back down. The two times I tried to get out of bed, I got sick. 3rd day post vaccine continued to be mainly bed ridden, threw up twice (in the morning and early evening) and again, by evening stomach pain returned. Day 4 post vaccine was still throwing up (twice by mid day) so went to L&D triage. Received IV fluids and Zofran, since at this point very little food/water had been consumer over the past 3 1/2 days. That helped for a few hours, but woke up at 11pm to extreme stomach pain. Day 5 post vaccine was starting to feel slightly better, mainly just residual fatigue, but by evening was throwing up again, and the severe stomach pain started again. Went back to L&D. they did an ultrasound of the gall bladder, which came back normal. suspected I might have a stomach ulcer so doctor recommended taking Prilosec for a few days to see if this helped. Day 6, 7 and 8 continue throwing up 2-3 times a day but over all felt better. Day 6 continued to get some stomach pain, but not longer severe. By day 7 and 8 stomach pain subsided even though the throwing up continued.
Emotional disturbance (exceptionally bad PMS), suddenly onset of acne, bright pink spotting in the middle of period. It appears to be a hormonal fluctuation. This patient has never experienced mid-cycle spotting before.
Reported swelling at injection site and entire arm. Within 8-12 hours of injection. She did not report reaction to provider until today 5/28/15. Site still reddened today about the size of a fifty cent piece. No further treatment necessary.
Patient is a 94 y.o. male with a history of CKD and BPH who presented to a HCF 5/8/2023 from a senior living facility for 1-2 days of malaise and diarrhea. CXR showed left hilar markings concerning for early infiltrate. Found to have COVID-19 pneumonia and rotavirus. Discharged back to Assisted Living facility 5/10/23.   1. Acute hypoxemic respiratory failure: Suspect related to COVID-19 pneumonia. No evidence of bacterial PNA. CXR showed left hilar markings, infiltrate vs atelectasis. Improved. 2. COVID-19 Pneumonia: initially negative on admit. Positive 5/9/23. Improved to room air 5/9/23. ID econsulted for paxlovid.  3. Acute metabolic encephalopathy: CAM positive on initial evaluation of letter testing. 3. Acute metabolic encephalopathy: CAM positive on initial evaluation of letter testing. Suspect related to acute infections. Therapies followed. Improved. 4. Acute Diarrhea: Developed over past 48 hrs PTA. Reported outbreak of gastroenteritis at his facility. No recent ATB. GI consulted for melena noted 5/9/23. Stool PCR with rotavirus. Imodium prn. 5. Melena: GI deferred EGD. Hb remained stable. GI recommended PPI BID x 1 month. Consider OP endoscopies. 6. Dysphagia: SLP recommended chopped solids with thin liquids per MBS 5/10/23. 7. Abnormal Urinalysis: UA with 22 WBCs. Started on IV rocephin on admit. Culture collected 5/9/23. Completed 3 day course of rocephin 5/10/23. 8. Elevated troponin: Troponin 86 on admission. Delta of -5. ECG showed chronic non-specific t wave changes. Demand ischemia. No further inpatient workup. 9. Mood disorder: held buspar while on paxlovid and additional 3 days afterwards.
BlurredVision, Confusion, Dizziness, Headache, NauseaVomting, Mild/ Migraine and dizziness/ No known previous reactions  Narrative:  10 minutes after injection she felt a migraine, with hx migraines. Vitals were stable. 20 minutes post injection she said she felt dizzy, woozy and slightly confused.
Noticed area of erythema to side of neck and spotty erythema to cheek after administration of vaccines.
He got his vaccine, he got real tired, and came down with flu-like symptoms to the extreme.  He had pain from his elbow to his shoulders, neck, upper back achy in nature.  He wasn't nauseated, but he had some cramps and then he had diarrhea.  It knocked him out, he slept through Sunday, he does recall anything about Sunday, slept for 24 hours.  On Monday he was feeling weak, but cramps had gone away.  The aching has also eased up within the next couple of days and is gone now.  He has never had a reaction this bad before.  He had both Moderna vaccines, and only had a reaction for about a 1/2 a day, and this is the worst one he ever had.  He did not take anything for it, he just slept.
Site injection left arm - swollen, hot, very sore.  Nauseated, extreme muscle aches, 102 Fever.
Bones ache; Feet were really bad muscles ache; The pain was in legs; This spontaneous case was reported by a patient and describes the occurrence of BONE PAIN (Bones ache), MYALGIA (Feet were really bad muscles ache) and PAIN IN EXTREMITY (The pain was in legs) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 prophylaxis.     Acute illness at the time of vaccination and up to one month before: None.  The patient's past medical history included Blood cholesterol abnormal (Cholesterol). Concurrent medical conditions included Lower extremities discomfort (Legs, feet and ankles and from  start date: 02-May-2021 having the same status) since 30-Mar-2021, Temper tantrum (Temper), Heart disorder and Heartburn. Concomitant products included ATORVASTATIN from 20-Jan-2021 to an unknown date for Blood cholesterol abnormal, LISINOPRIL from 17-Feb-2019 to an unknown date for Heart disorder, OMEPRAZOLE from 15-Jan-2017 to an unknown date for Heartburn, ARIPIPRAZOLE from 02-Mar-2020 to an unknown date and DULOXETINE from 07-Feb-2019 to an unknown date for Temper tantrum.    On 30-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BONE PAIN (Bones ache), MYALGIA (Feet were really bad muscles ache) and PAIN IN EXTREMITY (The pain was in legs). At the time of the report, BONE PAIN (Bones ache), MYALGIA (Feet were really bad muscles ache) and PAIN IN EXTREMITY (The pain was in legs) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       It was reported by the patient that this had been ongoing and was very painful. The patient legs had not got any better, was bad and all this had started after first Moderna Shot. The treatment information included that the patient hafted to walk with boots on up to the knees.  No treatment medications were reported.   This case was linked to MOD-2021-273083 (Patient Link).
Tested positive for COVID 19; This is a spontaneous report from a contactable consumer reporting the same events under the same suspect product for 3 patients. This is one of the 3 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EN6208), via an unspecified route of administration on 16Mar2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was COVID tested post vaccination via nasal swab on an 22Mar2021 with positive result. The patient tested positive for COVID 19 on 22Mar2021. The event resulted in a doctor or healthcare professional office/clinic visit. The patient has not recovered from the event.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021332607 Same reporter/drug/event for different patients;US-PFIZER INC-2021330055 Same reporter/drug/event for different patients
pt recvd 2nd dose of vax 4FEB92 & 3 wks post inject exp double vision, dizziness & encephalitis; pt's MD states devel vertigo, nystagmus, truncal ataxia, aphasia & numbness of the lt side of face; MRI's done; demyelination of cerebellum;
pt became very pale; all of a sudden it seemed to hit pt-laid moaned, ate poorly; sl temp; paleness;
current excursion (49.1F) for 34 minutes; with two previous excursions at (35.9F) for 2 minutes and again at (35.9F) for 2 minutes; No additional AE information provided.; This spontaneous report was received from a medical assistant and referred to a 12-month-old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On an unknown date, the suspect vaccine went through temperature excursion as follows: current excursion (49.1 degree Fahrenheit [F]) for 34 minutes; with two previous excursions at (35.9 F) for 2 minutes and again at (35.9 F) for 2 minutes (Product storage error). On 01-JUN-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 0.5 mL, lot #W039033, expiration date: 01-OCT-2024, administered intramuscularly in left thigh for prophylaxis (strength was not provided). No adverse side effects were reported with the administration of the vaccine. ; Sender's Comments:  US-009507513-2307USA004472: