chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (sore arm). At the time of the report, INJECTION SITE PAIN (sore arm) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not reported. Action taken with mRNA-1273 in response to the event was not applicable.
pt recv vax 16OCT98 & reportedly w/in 3hr of vax pt exp dysarthria that lasted 45min;pt also exp diff controlling lt index finger & thumb;pt hosp over night for observation;
Change to menstrual cycle - started 10 days early and very heavy flow. Tiredness
REDNESS ALONG ARM , DIFFUSE NON SPECIFIC LOCATION. MD REVIEWED  GAVE ANTIBIOTIC AS A PRECAUTION , FELT MORE LIKELY  A REACTION TO SHOT.
8 hours after vaccination I got headache, fever (101), fatigue and body aches.  Woke up in the middle of the night with headache and slight nausea. The next morning and through the day/ night had some joint pain and extremely tired.
It was reported in a published article, title as stated above that 1 child experienced true vaccination failure and developed invasive Hib disease, also referred to as meningitis, despite vaccination with doses of PedvaxHib. (manufacturer unknown). It was reported that the patient experience death, cause unspecified. No further information was available at the time of this report. No outcome information was reported. Upon internal review, invasive Hib disease was determined to be an other important medical event. Additional information has been requested.
Pain from neck to wrist in arm flu shot was given. Onset 2 hours after vaccination. Skin also felt clammy. Lasted 6-7 hours. Treatment w/ BUFFERIN (OTC).
pt recv vax;exp itch,pain,swelling & inflamed at inject site w/in 24hrs post vax;the inflamed area was as large as silver dollar coin;this is one of 11 patients who exp the above rxn p/vax
Within 8 hrs of receiving vaccine my throat became real sore, then developed low grade fever & muscle aches later that evening. Next day, the 6th & 7th had fever of 103 degrees with bad muscle aches, loss of appetite and continued sore throat with neck stiffness. Also had trouble with deep inspiration but was not short of breath. On the 8th fever continued so went to local PCP who dx reactive airway disease and was placed on prednisone 40mg x 5 days and albuterol inhaler.
Am prone to headaches, but had severe headache over two days with pain radiating down the side of my face.  Also had chills.  Took very long hot shower but no relief.  Bundled up with sweaters and blankets.  I normally like to be cool.
had hearing loss; Facial paralysis; his right ear was inflamed; sores in the ear/ ear pain/ ear sore; Ramsey Hunt Syndrome; Headache; This case was reported by a consumer via call center representative and described the occurrence of ramsay-hunt syndrome in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number 2N9CT, expiry date 31st March 2022) for prophylaxis.   On 22nd February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 22nd February 2020, less than a day after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced headache. On 23rd February 2020, the patient experienced ramsay-hunt syndrome (serious criteria GSK medically significant) and ear pain. On 26th February 2020, the patient experienced otitis. On 27th February 2020, the patient experienced facial paralysis (serious criteria GSK medically significant). On 2nd March 2020, the patient experienced hearing loss unilateral (serious criteria GSK medically significant). The patient was treated with cefalexin (Keflex), valaciclovir hydrochloride (Valtrex) and prednisone. On an unknown date, the outcome of the ramsay-hunt syndrome and facial paralysis were not recovered/not resolved and the outcome of the hearing loss unilateral, headache, otitis and ear pain were recovered/resolved.   It was unknown if the reporter considered the ramsay-hunt syndrome, facial paralysis, hearing loss unilateral, headache, otitis and ear pain to be related to Shingrix.  Additional case details were reported as follows: The case was reported by the patient's wife. The patient received Shingrix and had headache on the same day.  On 23rd February 2020S, he had ear pain and that on 26th February 2020, his right ear was inflamed.  On the day after that (27th February) he developed sores in the ear and facial paralysis.  On 2nd March 2020, he had full blown Ramsay Hunt syndrome.  The patient was initially treated with Keflex, because the doctor thought he had a bacterial infection, but that the symptoms progressed.  He was then given Valtrex, 1 gram in every 8 hours and was also placed on Prednisone for several days. The patient also had hearing loss of the right ear.  The patient's condition had improved but that he still had residual facial paralysis. The reporter consented to follow up.
Information has been received from a physician concerning a male who was vaccinated with a single dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot# 653369/0312F). The patient developed a rash from the trunk up to the neck and face. Unspecified medical attention was sought. At the time of this report, the patient was noted to be recovering. No product quality complaint reported. Additional information has been requested.
12/31/2020 - About 3 was nauseated until 7:30 PM - Tried to rest then was fine. 1/6/2021 - About 12Am - Had aches & pain felt like I was getting sick. Took some tylenol and went to sleep. Was fine in the morning.
Day 11 after smallpox immunization.  Developed generalized maculopapular rash on trunk, upper extremities.  Pruritic target lesions.  Was seen and treated symptomatically with Atarax, Eucerin Cream.
Progressive L arm / shoulder pain with weakness. Medical records requested. Symptoms: Joint Pain, isolated start: 6/12/2003 comment: left shoulder.
Sneezing, hard to breathe, forehead and ears were on fire, heart was pounding.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 12-year-old patient of unknown gender. On 18-JUN-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot number N020352 (expiration date 10-APR-2020). This is one of multiple reports received from the same reporter.; Sender's Comments: US-009507513-1807USA011661:
35 minutes after first Moderna shot, I experienced a very rapid heartbeat. It was so fast that I turned around my car and headed back to the clinic where I'd received the vaccine. While I was only 5 minutes from the clinic (I had waited 1/2 hour at clinic after getting shot,) it took me over an hour to find the clinic again, as I was experiencing foggy thinking. Indeed, it was 2 weeks after the shot before my brain seemed finally cleared of its "fogginess."   While I've never been poisoned, I would say the experience felt like what being poisoned must feel like.  (I found out in 2019 that I was allergic to wasp stings when my tongue swelled up after a sting and I went to the E.R.) Otherwise  am a very healthy 75 year old. Take no meds, and have no health problems.  Nurse at clinic dismissed my side effects as anxiety. Have never before had a so-called anxiety attack, and do not feel it was anxiety, but rather the shot that caused the symptoms.
Information has been reported in a study. The report includes VAERS reports following PNEUMOVAX 23 or Pneumococcal polysaccharide vaccine (PPSV23) brand unknown after 2002. The report includes reports information from 01-JAN-1990 to 31-JAN-2014. This spontaneous report as received from an other health professional refers to 16 patients. The median age of the patients was 69 years old; range being 23 to 98 years. Between 01-JAN-1990 and 31-DEC-2013 patients were vaccinated with PNEUMOVAX 23. On an unknown date the patients experienced death. The outcome of death was reported as fatal. The cause of death was reported as Cardiovascular. The death of the patients was confirmed with medical records, autopsy reports and/or death certificates. The report has been split into cases according to cause of death. This case is linked to same reporter linked cases 1406USA003857 (respiratory disorder), 1406USA003858 (Other infectious disorder), 1406USA003859 (other non infectious disorder), 1406USA003860 (gastrointestinal), 1406USA003861 (Neurological), 1406USA003862 (Undetermined) and 1406USA003863 (Unknown). Additional information has been requested.
Very short of breath a week after receiving vaccine. Wasn't sure if related to exercise-induced bronchospasm which I've never been diagnosed with or Covid (healthcare worker) so I went to my PCP for a Covid test and to check my lungs.  Was given a prescription for rescue albuterol inhaler which did make the shortness of breath subside.  Used it every 4 hours for the rest of the day and the following day and have no had another occurrence.  Have exercised many times since and have not had to use the inhaler before or after exercise.
Very high fever, crying, swelling of area received MMR - pertussis- shots - did not sleep that night - fever did not go down for days - language decreased after this time period - hypotonia.
He received the Moderna vaccine dose #1 at 10:27. He sat in a chair for  his 15 minute monitoring period. He was noted at 10:36 to be unresponsive in the chair as well as pale and limp. He was moved to the floor where he had agonal breathing and HR >100. His neck was tilted to facilitate respirations. He was clammy and continued to be unresponsive for 90 seconds. EMS called. He had a period of postictal agitation with bilateral lower extremity failing for approximately 20 seconds. He then became responsive but still pale and clammy. He moved to a sitting position after 4 minutes of being awake and alert. EMS arrived, assessed him and left without transport. He left with his cousin who is driving him home. Instructed him to seek medical care for evaluation of this and prior episodes. Instructed him to seek clearance before next vaccination.
CHILLS; MUSCLE ACHES; SWEATING; FEVER; HOT FLASHES; STOMACH PAINS; DIARRHEA; HEADACHES; EXTREME WEAKNESS AND FATIGUE; UNABLE TO DO ANYTHING AT ALL EXCEPT STAY IN BED ALL DAY; BODY ACHES; COULD BARELY EAT ANYTHING EXCEPT DRINK WATER AND SOUPS; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (CHILLS), MYALGIA (MUSCLE ACHES), HYPERHIDROSIS (SWEATING), PYREXIA (FEVER) and HOT FLUSH (HOT FLASHES) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history provided).    On 13-Feb-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 CHILLS (CHILLS), MYALGIA (MUSCLE ACHES), HYPERHIDROSIS (SWEATING), PYREXIA (FEVER), HOT FLUSH (HOT FLASHES), ABDOMINAL PAIN UPPER (STOMACH PAINS), DIARRHOEA (DIARRHEA), HEADACHE (HEADACHES), ASTHENIA (EXTREME WEAKNESS AND FATIGUE), MALAISE (UNABLE TO DO ANYTHING AT ALL EXCEPT STAY IN BED ALL DAY), PAIN (BODY ACHES) and DECREASED APPETITE (COULD BARELY EAT ANYTHING EXCEPT DRINK WATER AND SOUPS). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, CHILLS (CHILLS), MYALGIA (MUSCLE ACHES), HYPERHIDROSIS (SWEATING), PYREXIA (FEVER), HOT FLUSH (HOT FLASHES), ABDOMINAL PAIN UPPER (STOMACH PAINS), DIARRHOEA (DIARRHEA), HEADACHE (HEADACHES), ASTHENIA (EXTREME WEAKNESS AND FATIGUE), MALAISE (UNABLE TO DO ANYTHING AT ALL EXCEPT STAY IN BED ALL DAY), PAIN (BODY ACHES) and DECREASED APPETITE (COULD BARELY EAT ANYTHING EXCEPT DRINK WATER AND SOUPS) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medication provided patient felling better after taking treatment
unable to open mouth more than 1/2";(had soreness in arm w/in 15min, which lasted 1wk)saw MD on 14NOV95 & was treated w/Ibuprofen;had 2-3 blinding h/a's since recvd vax
Patient received a FLUZONE HD shot on 11/11/15. On 11/19/15 she returns to the pharmacy complaining of arm pain. Patient does not mention any treatment for the pain. She mentions a desire to file a complaint.
This spontaneous report as received from a physician refers to a male patient of unknown age. In the summer of 2013 the patient was vaccinated with first dose of GARDASIL (lot #, expiration date, dose, route not reported) for vaccination. The patient was observed for 15 minutes and left to go home. 45 minutes after leaving the office, the patient experienced an "out of body experience" and felt faint and woozy. The patient did not seek medical attention. The outcome of the event was unknown. Additional information has been requested.
pt recvd vax; adm to hosp 9dec w/ weakness in legs;tx for GBS w/ IV IgG,complete recovery;
The patient is a 59 y.o. male with a hx of COPD who presents to the Emergency Department with SOB. He received the COVID vaccine on 3/18/2021 and has felt bad since then. Patient has experienced increased SOB and a productive cough with yellow sputum.. He experienced fevers for 2 days after receiving the vaccine but has not had any since then. He is on 4-5 liters oxygen at a time. He experienced some diarrhea today but took a laxative. He denies blood in stool, dysuria, or urinary symptoms. Patient reports some body aches. He is on chronic pain medications for back and leg pain. He has not been on any steroids or antibiotics recently.
My arm was sore and swollen for 2 days after the shot; My arm was sore and swollen for 2 days after the shot; I received the PNEUMOVAX 23 shot while I was unknowingly 3 weeks pregnant.; Indication: "Pneumonia"; This spontaneous prospective pregnancy report was received from a 26 year old female patient, reporting on herself. The patient's historical conditions included pneumonia and the patient's concurrent conditions included asthma. The patient had no allergies and her concomitant therapies included albuterol inhaler (manufacturer unknown).  On 19-MAR-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, one dose (strength, route of administration, anatomical location, lot number and expiration date were not reported) for pneumonia. At the vaccination time, the patient was unknowingly 3 weeks pregnant (the last menstrual period (LMP) was calculated as 27-FEB-2020 and estimated date of delivery (EDD) was calculated as 03-DEC-2020).   On 19-MAR-2020, the patient's arm was sore (pain in extremity) and swollen (peripheral swelling). No treatment was provided and laboratory diagnostics studies were not performed. On 21-MAR-2020, 2 days after the shot, the patient recovered from the events. The patient did not report any other adverse reactions. At the reporting time, the pregnancy outcome was pending. The reporter did not assess the causal relationship between therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events.
Very sore arm for 4 days, could not lift it for 2 days Headache/migraine starting same day as vaccine and ending 4 days later Nausea starting same day as vaccine, would come and go up until 4 days later  Ibuprofen 800 was taken once a day to help with headache
pt recvd vax;swollen lt upper arm, pain, low grade T;recvd IV unasym & po augmentin;c/o small air pockets (deltoid abscess) incision & drainage;po cynoflexacin;
Vaccine that had been refrigerated for 34 days.; Vaccine that had been refrigerated for 34 days; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that had been refrigerated for 34 days.) and PRODUCT STORAGE ERROR (Vaccine that had been refrigerated for 34 days) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021 at 10:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021 at 9:44 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021 at 10:15 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that had been refrigerated for 34 days.) and PRODUCT STORAGE ERROR (Vaccine that had been refrigerated for 34 days). On 29-Mar-2021 at 10:15 AM, EXPIRED PRODUCT ADMINISTERED (Vaccine that had been refrigerated for 34 days.) and PRODUCT STORAGE ERROR (Vaccine that had been refrigerated for 34 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication not provided. Treatment medication not provided   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up document received on 26-May-2021 contains Non-Significant information.
Patient received a dose of 0.25ml on 9/14/22 but will be coming back next week to receive a full dose of 0.5ml.
Patient' bilateral hands itchy, red, and swollen Benadryl 25mg po at 16:15 Prednisone 40mg po at 16:42
Reports burning sensation in feet 3 hours after immunization while working outside and wearing boots.  When took boots off, noticed blisters around ankle of one foot and across toe line of other foot.  Took a diphenhydramine and blisters scabbed over 24 hours later.
chalky taste; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (chalky taste) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DYSGEUSIA (chalky taste). At the time of the report, DYSGEUSIA (chalky taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
On 03/02/2001 the patient developed one dot on his back and a cluster of 3 on his right hip. They were "red mosquito bite looking dots". On 03/03/2001 the patient was seen by his physician and diagnosed with chicken pox. The spots were then white in the middle and itching. On 03/04/2001 2 more developed. FOLLOW-UP unformation received from a physician indicated that there was "no vacccine reaction". The patient experienced mild varicella 1 year following administration of the vaccine. Additional information is not expected.
Rash noted in right armpit day following vaccine, spread down the same side of torso, then appeared in other armpit a few days later. Continued to spread down that second side of torso. Saw partner of my PCP who put me on Doxycycline 100mg BID for 7 days with no change. Saw dermatologist who dx with pityriasis rosea and suggested reporting to VAERS.
Has developed rashes on the site of the arm where vaccine was injected. The area has become reddish with blisters turned to white/yellow. Visted a family Dr. He has prescribed the following prescriptions: 1. MUPIROCIN 2% OINTMENT 22GM APPLY 3 times a day for 5 days 2. SULFAMETH-TRIMETH SUSP(grape) 1 tsp by mouth twice daily for 10 days.
WITHIN 5 MINUTES OF RECEIVING VACCINE PATIENT BEGAN FEELING VERY LIGHTHEADED, SWEATING, AND SPINNING.  PATIENT SAID SHE NEEDED TO LAY DOWN.  AS WE BEGAN LAYING HER DOWN SHE DID PASS OUT. AFTER LAYING ON THE GROUND WITH ELEVATED LEGS SHE REGAINED CONCIOUSNESS WITHIN ABOUT 30 SECONDS OR SO. PATIENT CONTINUED TO LAY AND THEN SLOWLY SIT UP. AFTER APROX 20 TO 30 MINUTES SHE WAS FEELING OK AND WAS ABLE TO GO HOME
Arm pain; Chest pain when the patient breathes; Stomach hurts; Back hurts; This is a spontaneous report received from a contactable consumer.  An 8 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 01Dec2021 (Batch/Lot number: unknown) at the age of 8 years as first single dose for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: amoxicillin, reaction(s): "allergy: amoxicillin".  The following information was reported: Pain in extremity (non-serious) with onset 02Dec2021, outcome "not recovered", described as "Arm pain"; Chest pain (non-serious) with onset 02Dec2021, outcome "not recovered", described as "Chest pain when the patient breathes"; Abdominal pain upper  (non-serious) with onset 02Dec2021, outcome "not recovered", described as "Stomach hurts"; Back pain (non-serious) with onset 02Dec2021, outcome "not recovered", described as "Back hurts". It was unknown if therapeutic measures were taken as a result of pain in extremity, chest pain, abdominal pain upper, back pain.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Ok I went to bed in the evening of the shot and it wasn't long before I was very uncomfortable and feeling aches all over. This went on all throughout the night and when I got up I was faint and nauseas a few times through the night. I did not sleep at all. And late morning/mid day I took something like an Advil/ibuprofen and some tums and felt better the next evening.