chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MUSCLES ARE MELTING AWAY; CHRONIC PAIN; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient via a company representative through social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient was previously received covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin, and batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following covid-19 vaccine ad26. cov2. s (Dose number in series 1). The patient was previously received covid-19 vaccine ad26. cov2. s (Dose number in series 2) (suspension for injection, route of admin, and batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following covid-19 vaccine ad26. cov2. s (Dose number in series 2). The patient additionally received covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, route of admin, and batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The drug was associated with Off label use (Off label dosing frequency) (Dose number in series 3). The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced muscles melting, chronic pain (Dose number in series 3) and it was reported as "On top of getting three of those shots my muscles are melting away. I'm a chronic pain all the time with no relief in sight unless I go buy drugs on the street." (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscles are melting away, and chronic pain, and the outcome of off label dosing frequency was not reported. This report was non-serious.  This case is a duplicate of 20221237009 and 20221237086.
8 days after vaccination, I developed cellulitis at the injection site. Lots of swelling, arm pain, headache, and numbness in fingers.
pt recv vax & exp extreme disorientation & fatigue w/fever;did not take any more of vax;
Patient is a 72-year-old gentleman, who presents to Hospital Emergency Room with an increase in shortness of breath.  The patient was diagnosed with coronavirus.  He had a cough for the last several days' time accompanied by generalized lethargy.  The patient denies chest discomfort, abdominal pain, or other symptoms. Tested positive on 01/11/2022  -this is a 49-year-old male with past medical history Down syndrome, pre diabetes, epilepsy, hyperlipidemia, morbid obesity, chronic GERD, restless leg syndrome, depression, overactive bladder, chronic hepatitis-C, anxiety, allergic rhinitis, functional quadriplegia.      He was sent to the hospital with a chief complaint of worsening cough and shortness of breath.  Most of the history was obtained from the emergency room provider and the previous medical records.  Patient nonverbal at baseline.       Call placed to the patient's group home caretaker using the number listed on the sheet.  Phone was answered by person.  He reported that patient is managed by his brother and provided me another phone number.  I called that number but it also went into voicemail so I was not able to gather more information.
Headache chills ,fatigue, legs ache, nausea, diarrhea . started the day after and the second day by day 3 felt back to normal
Employee received her immunization at 11:15. Her symptoms of numbness and tingling up her (L) arm, up her neck, into (L) side of head. Began 10 minutes after shot. She also had visual disturbance. She went to the Emergency Dept. where a "code stroke" was called. Complete workup was negative, sent home.
Moderna covid-19 vaccine EUA. .05ml given instead of 0.25ml.
Dose 1 - 1/19/21 - On 1/26/21, I got developed a bad case of SOB. I called my cardiologist and she told me to get tested for COVID. I went to the county facility to get tested and it took 3 days for results, which finally came back negative. During my wait, I went to a Urgent care and they did a Chest Xray, EKG and another COVID test, which was negative and the other tests were normal. I was sent back to cardiologist. She scheduled a stress text on 2/11 and everything was fine. I was also feeling fine by then.  Dose 2 - 2/16/21 - The next day, I had a headache, aches, pain, fever and basically felt like I had the flu. I took Tylenol and that lasted about 36 hours. On 2/25, I was doing my 2 mile walk and I start experiencing the SOB again. So, I relaxed and figured it would go away. On 3/1, we drove to a park and back home 3 days later. On 3/3, I was really exhausted, so I took a nap for 3 hours and awakened with calf pain and a low grade fever. That lasted for 3 days, so I went to the ER on 3/6. They did an ultrasound on my leg and found a DVT in my right leg. They did CT Scan of my lung and found several clots (pulmonary emboli). I was in the hospital overnight and put me on a blood thinner, Eliquis 5mg, twice a day. Since then, I've continued to take the Eliquis and I'm following up with a hematologist on June 21. The hematologist has already tested me for two factors came negative and he will test me for the third one at my next visit.
unusual high pitched cry day of vax @ 2mo check up; did not notify MD until 4mo check up;
This spontaneous report as received from a physician via field employee refers to a female patient of unknown age. There were no concomitant therapies concurrent conditions or medical history provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date not reported). On an unknown date, the patient developed shingles. The reporter questioned the efficacy of the ZOSTAVAX. The outcome of shingles was reported as recovered. The outcome of the questioned lack of efficacy was unknown. The reporter did not assess the relatedness between the events and ZOSTAVAX. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a nurse practitioner, via a company representative, concerning a female patient who was vaccinated (date unspecified) with a dose, 0.5ml, of Gardasil. Subsequently the patient "developed a localized reaction after getting (Gardasil)." At the time of this report, the patient had recovered from the reaction. The patient sought unspecified medical attention. Additional information has been requested.
fever, swollen sinus, positive COVID test, fluids, Tylenol, 2 weeks
Severe shivering, cold hands and feet, followed by locking of quads, shoulders, neck into prolonged contraction.  Fever and excessive sweating. Extreme neurological pain, along with ears ringing. Migraine headache. Abdominal pain.  Symptoms onset approx. 12hr post vaccine.  Injection site is fine and shows no signs of infection. The effects of the vaccine have been throughout the body.  Next day, still significant brain fog and muscle cramping, although the complete lock is dissipated. Pain in lower left abdomen.
Ability to speak started changing immediately after vaccine, Pt did not notice it but assessment showed his tongue was swelling. He also reported having an itchy throat.  He went to the ER via ambulance and was given IV Benadryl, symptoms resolved quickly but reports his throat remained 'scratchy' until following day.
Mother of child stated on 9/25/2007 that she wasn't sure but thinks she noticed seizure like activity 1 week after child received shots 5/30/07. Did not check temp. Has had several "episodes" since 5/07. 10/4/07  RN stated that mom says she does not know when last epidose occured but mother states the child is under the care of PMD.
3pm arm started to hurt. Body felt tingly and started feeling cold. 3:15pm started feeling nauseous and  needed to move bowels. 3:35 started violently vomiting.  Then diarrhea took place. Continued to vomit and lose control of my bowels until 1am. During this time I was freezing and sweating. I never took my temperature due to the fact I could not tolerate anything in my mouth due to nausea.  A severe headache took over at 1:20am.  At 2:30 am I took 800mg motion.  I finally fell asleep around 3 am.  When I awoke at 9am I felt beat up.  Later that day I forced down a half of English muffin   Then around dinner time I had a small bowl of Raman noodles. It took me 3 days to recover and I lost 5 lbs.
Tiredness too much of the time; This is a spontaneous report from a contactable consumer. An 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EN5318), via an unspecified route of administration on 04Feb2021 14:30 at SINGLE DOSE in left arm for covid-19 immunisation. Medical history included allergies: yes, Idiopathic Neuropathy.  Concomitant medication included alendronate sodium. On 05Feb2021 06:30, the patient experienced tiredness too much of the time. The patient did not receive treatment for the event. The outcome of the event was not recovered.
It began as what I thought was a headache until I realized the pain was in my eye socket, similar to symptoms of the flu that I've experienced in the past. I did not have fever. I felt pain when I made facial expressions like when I yawned; when I leaned forward, bending over to pick up things; when I would lay down on my left side, causing pressure to the left eye socket; and when I rubbed my left eye.
Shingles (varicella-zoster) breakout on the right side at the L3 vertebral level.  Burning rash over spine and right L3 dermatome.
A report has been received from a Health Professional concerning a 50 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. The patient's concurrent disease(s) included Type 2 diabetes, hypercholesterolemia, GERD and obesity. Concomitant medications included atorvastatin, lisinopril, metformin and ranitidine. FLUMIST QUADRIVALENT (Intranasal) started on 05-Nov-2013. The patient over 50 years of age received FLUMIST QUADRIVALENT which started on 05-Nov-2013. The outcome of the event of received FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious. Follow-up of insignificant information received by AstraZeneca/MedImmune on 17-Dec-2013 from Health Professional: Concomitant disease and concomitant drugs were added.
He felt hot, he hurts all over, slight cough sore throat and tired all the time.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. On 07-FEB-2013, the patient was vaccinated with ZOSTAVAX (dose, route and lot not reported). The pharmacist report that the patient who received ZOSTAVAX had a prescription, dated on 04-MAR-2013 for prednisone (manufacturer unknown) The pharmacist had no information on why the patient needed the prednisone (manufacturer unknown). The prescription was for a three day course of prednisone (60 mg a day for 3 days). The outcome of the adverse event was unknown. The relatedness between the event and ZOSTAVAX was unknown. Additional information has been requested.
Rebound case of covid 19 after completing 5 day course of Paxlovid treatment/testing positive again on rapid antigen test.; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 26Aug2022, outcome "not recovered", described as "Rebound case of covid 19 after completing 5 day course of Paxlovid treatment/testing positive again on rapid antigen test.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Negative, notes: after completing 5 day  course of paxlovid treatment; (Aug2022) Positive, notes: 3 days after completing paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Clinical course: Paxlovid was started on 17Aug2022 to 22Aug2022 for the treatment of COVID-19. Rebound case of covid 19 after completing 5 day course of Paxlovid treatment and testing negative. 3 days after completing Paxlovid sore throat began followed by congestion and now testing positive again on rapid antigen test.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received dose of Moderna Covid vaccine at 8:07 am and at 8:15 am she begin to complain of throat feeling "hot and tingling".  She was assisted to an exam room to be monitored.  B/P 140/80, pulse 74, O2 sat 99%.  Skin cool to touch but not clammy,  coherent in speech, no shortness of breath noted.  She requested water to drink and stated her throat felt better.  VS checked every 15 minutes and were normal.  No SOB through out visit. At 8:55 am VS were:  b/p 120/70, pulse 71,  O2 sat 99%.  Patient escorted to car at the end of monitoring for 55 minutes.  She states she was afraid as others she worked with had a lot of side effects with the second dose. No meds given as it appeared patient was anxious and not having an anaphlylactic reaction.  Phone call to patient at 11;30 am and she stated she feels better only soreness to arm where vaccine was given.
2y6m old pt here on nurse schedule for influenza vaccine dose #2. He did fine with dose #1 which was his first flu shot ever. Brother had a clinic appt and was being seen while said event occurred. Pt had been noted to be eating candy that mom brought along while exam of sibling took place. At approx 440-442, mom looked over and pt was slouched down by the chair, kneeling. She picked him up, said something is wrong. He had candy in his hands. Mouth was open and looked straight faced. Denies hx of food allergy, egg allergy. This was a rather sudden onset of change in behavior-along with the candy in his hand and the appearance of mouth open and lack of immediate breath suggested that he was choking. Back thrusts were given and child picked up his head, took a big breath and said "ok". I thought he had cleared his airway and he seemed improved but still "tired". Altered behavior involving weakness, palor, possible choking on candy began about 40 min post flu immun #2 with no hx of reaction to flu #1. Further evaluation took place, pt. monitored and provided repeat evaluations of over the course of 1 hour after this began. Vitals remained stable with BP stable, no desats, no angioedema, no rash or hives. Main symptoms were vomiting, palor, weakness. Improved after large amount of emesis x 1. Was able to drink water. Small sips.
Patient presented with guardian at Health Department on 03/15/2010 L arm edematous shoulder to hand, skin red warm. Sent Patient to Health Center for evaluation. The MD there sent patient to Emergency room.
APPROXIMATELY 5 TO 10 MINUTES AFTER SHOT, PATIENT COMPLAINED OF CRAMPING/PAIN IN FACE AROUND EAR. SWELLING AT BASE OF NECK AND BURNING IN CHEST AND BREAST AND TINGLING IN FINGERS AND HAND, ALL OF THIS ON LEFT SIDE WHERE SHOT WAS ADMINISTERED. PATIENT GIVEN AN ICE PACK TO APPLY TO SWELLING AND OBSERVED FOR AT LEAST 30 MINUTES. SWELLING WENT DOWN, PATIENT WAS OFFERED BENADRYL BUT DID NOT WANT TO TAKE UNTIL SHE GOT HOME. NO DIFFICULTY BREATHING OR PRESSURE IN CHEST. NO CHANGE IN MENTAL OR ALERT STATUS.
pt found apneic & pulseless 18MAR94 AM; vax had been administered 16MAR94;
Patient parent states that child was seen at Emergency Room 24 hours after receiving vaccines on August 17, 2017 due to localized swelling, redness, and localized itching of right arm. Parent states no cold compresses were used prior to visit to ER. During visit at hospital, parent states medical staff applied cold compress to child's right arm and administered Benadryl. Patient discharged from ER at 2:29 PM August 18, 2017. Post discharge prescription for Benadryl 25 mg given to patient from ER.
headaches, body aches, changes in menstrual  cycle( severe cramping, headaches, multiple periods in one cycle) asprin
Pt had localized red/endurated reaction appro. 14 cm at injectoin site without abcess. Generalized althragia and malaise.
Patient had 8cm redness around injections sites the day after the vaccines.  Two days after he had swelling of the left side of the face, eye swollen shut.  Temp 98.7  BP 118/88  Treatment was Benadryl and Orapred.
Muscle soreness at site - began 2nd day, lasted about 2 days Nausea - lasted about 2 days Paraesthesia of both feet - began same day, lasted about a week, some residual sensation remains (is has now been 1 month) Pain of both feet extending up to knee - began same day, symptoms have not subsided to date (is has now been 1 month) Headaches/migraines - began same day of injection, has not seized completely to date (it has now been 1 month)
Patient had a syncopal episode after receiving dose of vaccine and after asking for some water stating she felt dizzy and faint, pale, stiff, unaware of surroundings, nonverbal for approximately 1 minute. Hx of getting anxious at times and hx of seizures. EMS activated - and patient went with EMS for further evaluation.
Red rash on arm for a week. Head aches, body aches. Arm pits lymph nodes swollen, extreme exhaustion
Triggered shingles; neuralgia; This is a spontaneous report from a contactable consumer, the patient. A 71-year-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 on 04Mar2021 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, psoriasis and hypothyroidism. The patient was allergic to latex adhesive, cinnamon and pineapple. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine, dapagliflozin propanediol monohydrate (FARXIGA), ezetimibe and methotrexate all for unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had been tested for COVID-19. On 06Mar2021, the patient experienced triggered shingles, which the patient was still battling, as well as neuralgia. The events resulted in doctor or other healthcare professional office/clinic visit. Post the vaccination, on 09Mar2021 the patient underwent nasal swab test (COVID-19) and tested negative. Therapeutic measures were taken as a result of adverse events and included acyclovir, tramadol and Zofran. The clinical outcome of the events triggered shingles and neuralgia were not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Reported delayed localized vaccine reaction after 1st  Moderna dose on 1/1/2021. (large area of erythema ) with Mild systemic symptoms (malaise, fatigue).- seen in ED 1/8/2021 Tested negative for Covid on 1/8.  Per MAR, was given second vaccine 1/28/2021.   Attempt to reach her to discuss outcome. Phone @ not taking messages.   No VAERS completed. : patient is a 33 y.o. female who presents with redness to her L deltoid erythema and enlarged axillary lymph nodes 2 days ago and erythema at the injection site of her COVID vaccine since yesterday. She had the COVID vaccine to the left deltoid on 1/1/21. She has had injection site pain, but no redness - but she is having some itching. She had had fatigue, malaise for the past week. She has taken OTC tylenol and ibuprofen, but has not taken Benadryl. She called the hotline and they wanted her to be evaluated and possibly tested for COVID.
pt recv vax 10APR96 & 10APR96 pt exp pain @ inj site & rash on arms;pt presented to MD or ER & was tx w/ MSD & DPH;
still red from shoulder to elbow; now it is pink; hurting in the shoulder; Arm really hurt, aching from shoulder to finger; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (now it is pink), ERYTHEMA (still red from shoulder to elbow), ARTHRALGIA (hurting in the shoulder) and PAIN IN EXTREMITY (Arm really hurt, aching from shoulder to finger) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Previously administered products included for COVID-19 vaccination: Pfizer COVID-19 vaccine (third dose). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine.   In January 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022, the patient experienced ARTHRALGIA (hurting in the shoulder) and PAIN IN EXTREMITY (Arm really hurt, aching from shoulder to finger). On 02-May-2022, the patient experienced SKIN DISCOLOURATION (now it is pink). On an unknown date, the patient experienced ERYTHEMA (still red from shoulder to elbow). At the time of the report, SKIN DISCOLOURATION (now it is pink), ERYTHEMA (still red from shoulder to elbow) and ARTHRALGIA (hurting in the shoulder) had not resolved and PAIN IN EXTREMITY (Arm really hurt, aching from shoulder to finger) outcome was unknown.            No concomitant medications were reported.  It was reported that after receiving second booster dose, that night patient hurt her arm really, aching from shoulder down to finger. Patient stated that she thinks she received a higher dosage, or an elderly shot from the pharmacist. Patient reported that she did not have these reactions from the first 2 Moderna COVID-19 doses.  No treatment medications were reported.
This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. The patients' pertinent medical history, drug reactions and allergies and concomitant medications were not reported. On unspecified dates the patients were vaccinated with improperly stored doses of ROTATEQ (dose and route were not reported) lot # M019690, expiry date: 02-NOV-2017 and lot # M019691, expiry date: 02-NOV-2017. The vaccine was exposed to a temperature frame of 34.9 Fahrenheit for 336 hours. A data logger was used to record the temperatures. No adverse effects were reported. No additional information was provided. There was no product quality complaint involved. This is one of the several reports from the same reporter. Additional information has been requested.
I felt like I was catching a cold, stuffy nose, sore throat, tickle in my throat. I was going to have a gathering at my house, so I felt that I needed to test myself as some of the ladies are a bit older than myself and I was to pick one of the ladies up that afternoon. I tested myself, the test came back positive, I thought it must be wrong, so I tested again. This test also came back positive. i called my doctor to have a telehealth visit to let them know I was positive and to find out if I qualified for Paxlovid. I started taking the medication immediately. I have finished the medication, I am still feeling fatigued, my cough, runny and congestion is gone. I have a heavy head that feels like I am getting a headache, I feel weak.