chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain; feels warm at the injection site; swollen bigger than a quarter. It is huge; At the injection site, we have noticed that it has gotten red; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (pain), VACCINATION SITE WARMTH (feels warm at the injection site), VACCINATION SITE SWELLING (swollen bigger than a quarter. It is huge) and VACCINATION SITE ERYTHEMA (At the injection site, we have noticed that it has gotten red) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced PAIN (pain), VACCINATION SITE WARMTH (feels warm at the injection site), VACCINATION SITE SWELLING (swollen bigger than a quarter. It is huge) and VACCINATION SITE ERYTHEMA (At the injection site, we have noticed that it has gotten red). At the time of the report, PAIN (pain), VACCINATION SITE WARMTH (feels warm at the injection site), VACCINATION SITE SWELLING (swollen bigger than a quarter. It is huge) and VACCINATION SITE ERYTHEMA (At the injection site, we have noticed that it has gotten red) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment details were not provided Action taken with mRNA -123 is not applicable.
she started smelling sulfa/she is experiencing phantom smells; booster dose; Bruise on left arm where she received the vaccine; Phantom smells was reported as worsened; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 52 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 15Oct2021 10:15 (Batch/Lot number: unknown) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism. Vaccination history included: Bnt162b2 (First dose), administration date: 12Mar2021, when the patient was 52 years old, for COVID-19 immunization; Bnt162b2 (Second dose), administration date: 26Mar2021, when the patient was 52 years old, for COVID-19 immunization. The following information was reported: PAROSMIA (non-serious) with onset 24Oct2021, outcome "not recovered", described as "she started smelling sulfa/she is experiencing phantom smells"; VACCINATION SITE BRUISING (non-serious) with onset 2021, outcome "not recovered", described as "Bruise on left arm where she received the vaccine"; CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "not recovered", described as "Phantom smells was reported as worsened"; IMMUNISATION (non-serious) with onset 15Oct2021, outcome "unknown", described as "booster dose". Therapeutic measures were not taken as a result of parosmia, vaccination site bruising.  Additional information: A few days to a week after patient started smelling sulfa. Patient bought a new puppy and thought he was passing gas but noticed she was still smelling it when he wasn't in the room. Patient asked others around her if they smelled it and no one else did. Phantom Smell that is smelled like sulfur, that's what it is the smell that sounds like sulfur that comes and goes 100's of times a day. Patient wanted to report her side effects that she experienced after receiving her Pfizer COVID-19 vaccine, purple cap booster dose."The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Woke up the morning of 1/24 at the area of my injection site was red and swollen with enlarged lymph nodes. Redness lasted about two days then subsided however the lymph note lasted about 4 months. Felt achy at injection site and lymph nodes was very painful for about 4 weeks.
Hospitalization  Pleuritis  with Extreme pain upon breathing. Controlled with intravenous narcotics, oral agents at discharge Intermittent Atrial fibrillation
11/15/20 pt came in and stated he has constant arm pain in the arm I gave him his flu shot in on 10/30/20. He said when he got the shot it didn't hurt at all. As time went on he noticed pain in his arm (NOT in his shoulder, more in the outside of the arm where the shot goes). Started to hurt part of the day and now he said it hurts all the time.  He showed me his arm. He has a tattoo and he said the inject safe bandaid was right above it, which is in an appropirate location for the shot (not to high). I told him to try apap and heat tonight and call his dr if the pain persists
Upon tending to her daughter, mom reported dizziness, weakness, need to vomit. I helped mom to floor to lie down. She was flushed but spoke with me until EMT arrived.
Adverse Event:  16 yo given Moderna vaccine which is only recommended for 18 and above,  Nurse reports patient and family saying 18 but wrote correct DOB on consent and she did not notice.  Family speaking as is nurse No known side effects from receiving this vaccine
A 27 YEAR OLD FEMALE CLIENT RECEIVED AN ADULT HEPATITIS A, MCV4, TDAP AND VARICELLA. AFTER RECEIVING THE VACCINES SHE DID NOT REPORT ANY PROBLEMS AND LEFT THE CLINIC. AT 4:30 PM SHE NOTICED THAT HER RIGHT ARM FELT HEAVY, WEAK, TINGLY AND NUMB. SHE NOTICED AT THE INJECTION SITE ON HER RIGHT UPPER ARM SHE HAD A BRUISE THE SIZE OF A HALF DOLLAR AND ON THE SIDE OF THE BRUISE WAS A RED CIRCLE THE SIZE OF A QUARTER. SHE WAS DRIVING HER DAUGHTER HOME FROM SCHOOL AND WAS HAVING SOME DIFFICULTY DRIVING THE CAR. SHE HAD NO REACTIONS TO THE VACCINES SHE RECEIVED ON THE LEFT ARM. SHE HAD TROUBLE SLEEPING THAT NIGHT BECAUSE OF THE PAIN AND HER ARM FELT NUMB AND SHE HAD TROUBLE LIFTING HER ARM. ON 9/23/2010 AT 9:15 AM SHE CALLED THE CLINIC AND REPORTED THE PROBLEM TO ME. SHE WOKE UP THAT MORNING AND HER ARM FELT BETTER BUT STILL WEAK AND TINGLY AND HER PINKIE FINGER ON THE RIGHT HAND FELT NUMB. I TOLD HER IF THE CONDITION WORSENS TO GO SEE HER DOCTOR AND TO CALL THE CLINIC IF SHE HAS FURTHER PROBLEMS. I CALLED HER AT 9:00AM ON THE 24TH OF SEPTEMBER AND SHE FELT A LOT BETTER. SHE HAD SOME SORENESS TO HER ARM AND COULD FEEL HER PINKIE FINGER BUT HER TINGLINESS HAD GONE AWAY. SHE DID HAVE A BUMP THE SIZE OF A HALF DOLLAR.
Trouble swallowing - body aches - fever and chills - however didn't take temperature.
This spontaneous report as received from a 61 year old female consumer reporting on herself. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) in the arm (dose, strength and lot number were not reported). Secondary and concomitant therapies were not reported. Patient reported that in the past (time unspecified) she had numerous adverse reactions including "low grade fever and feeling of a punch in the arm" to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown).  Outcome of the events was  not reported. Additional information has been requested.
Nausea and occasional shortness of breath. Started 6 hours after vaccine and I still have it. It's not as bad but still here.
Pt called pharmacy at 5:45pm and stated she had hives on arms, legs, and torso aprox. the size of a dime or nickel.  Pt took Benadryl and would contact doctor or call 911 if needed.
approx 15-20min p/vax pt was taken to school & devel lightheadedness & broke out in rash & hives on chest & face & upper arms;SOB;pt taken to ER where devel h/a;given epi & sent home;
Illness occurred after the 3rd dose (booster) in November, 2021. Onset was mid-December, with symptoms of sinus infection, mild fatigue. Symptoms worsened over a week and I sought treatment beginning on December 31, 2021. Yellowish discharge from nose, uncontrollable cough, headache and mild fever (99-100). First treated with Augmentin 875 mg (2/day for 7 days), infection did not clear up. Sought treatment again January 14, 2022- diagnosis: acute bacterial sinusitis. Treatment was Doxycycline 100mg (2/day for 7 days and prednisone dosepak for 7 days. Infection did not clear up. Sought treatment again February 11, 2022. Diagnosis acute maxillary sinusitis. Treatment: Levaquin 500mg (1/day for 7 day). Infection finally cleared up and symptoms dwelt away.
First few hours following injection I had pain at injection site.  12 hours after receiving vaccine, got extreme chills, uncontrolled shivering while having fever.  This lasted for several hours.  Following morning had extreme fatigue, muscle weakness and headache.
Central Retinal Vein Occlusion with Cystoid Macular Edema
Had some neurological, like tingling on her face; like near her chin and cheek; Had some neurological, like tingling on her face; like near her chin and cheek; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "stroke" (unspecified if ongoing), notes: he did say that, she had an MRI. Because they wanted to rule out a stroke so, she had an MRI. The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Dose number unknown, Mention that she did have Moderna, prior to this (Pfizer covid vaccine)), for Covid-19 Immunization. The following information was reported: PARAESTHESIA (non-serious), NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown" and all described as "Had some neurological, like tingling on her face; like near her chin and cheek". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of paraesthesia, nervous system disorder. Additional information: Patient actually did mention that, she is 65. Because she said that if she was due for the, she waited 15 years and hasn't got the Shingrix shot vaccine and she is like so, since 15 years since she was supposed to get, so, that would make her 65. She is 15 years older than, when she was supposed to get Shingrix so, that would make her 65. Her doctor told her to get it 15 years ago but she has not got it. Because they wanted to rule out a stroke so, she had an MRI. From her description it was quite a while ago, it's over a year now.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient is having soreness and pain from injection site cascading down her arm and leg on the left. It is consistent. Advised patient that soreness and pain is normal but if it does not resolve before the end of this week to contact her PCP.
Rash - papular red nonpuritic localized above/around the vaccine site (left thigh)
His eyes felt hard and it was hard to focus and he had a little headache and little dizziness; wobbling around; Headache; Dizzy; Sleeping a lot; Fever; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received BNT162B2 (BNT162B2, Solution for injection, Batch number: Unknown) via an unspecified route of administration, administered in the right arm on 28Jun2021 at 15:30 (at the age of 65-year-old) as 1st dose, single for COVID-19 immunisation. The patient medical history included ongoing blood pressure high (started 20 years ago). Concomitant medications were not provided. On 28Jun2021, the patient experienced fever, on 29Jun2021, he was dizzy and was sleeping a lot, and on 30Jun2021, he had headache. On an unspecified date, his eyes felt hard and it was hard to focus and he had a little headache and little dizziness and wobbling around. The clinical course of the events was reported as: he mentioned he had gotten the COVID-19 shot on Monday 28Jun2021 and had been dizzy for two days since he took it. He was also sleeping a lot. He got up and was dizzy and wobbling around. He wanted to know if this last a while. The events described as: dizzy: he clarified he first felt it when he got out of be yesterday, on Tuesday (as reported). His eyes felt hard and it was hard to focus and he had a little headache and little dizziness. Fever: He also had a fever, initially stated it was when he went to bed on that first night. He clarified while sleeping he woke up with a fever that first night. Headache: He believed he had headache because his eyes cold not focus and clarified he first felt it this morning and he was unable to provide an outcome, stating it just started this morning. Sleeping a lot: he first noticed this yesterday (as reported). He was sleeping all day yesterday and had been sleeping today. He drunk something, drank some tea, and ate, then went back to sleep. Now he had back up. He stated that he had already slept most of the day today, but he was up now. He further explained it seemed to be a little better now. Investigations: He confirmed he had not gone to the doctor's office, emergency room, or had any labs or testing due to events. He stated that was one of the reasons he was calling to determine if he should go. The outcome of the event dizzy was not recovered, sleeping a lot and fever were recovering, and the outcome of the other events was unknown.
pt recvd vax 13APR93 & c/o ache 13APR93 @ noc sl red & painful 14APR93 large, red indurated area 10.5x6.0 cm 15APR93 warm;
Nausea onset maybe 5 hours post vaccine followed by severe vomiting and diarrhea for 5 days. Went to urgent care on day 5 and was given an IV for dehydration. Blood test was taken, WBC count was low.
Temp 100. 5x3 area warm to touch, sore, very red, welted area.
Minor symptoms immediately after vaccinations, including vertigo at first vaccine and brown out on second. Pain developed over a few hours, including a bad headache after first vaccine. In four days this moved to fairly severe whole body muscular and nerve pain. Had second vaccination 4/17/2021, lot number ER8731. Pain still persisting almost a month later. Myalgia?
I had the expected headache and sore arm. Later that night I began developing diarrhea which then became bloody. After 3 weeks of work up, I have been diagnosed with Ulcerative Colitis
This spontaneous report was received from a nurse refers to unspecified number of unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not reported. On unspecified dates in 2016 (reported as starting on or after 09-FEB-2016), the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L020015, expiry date: 16-AUG-2017). Nurse stated that the mentioned lot number of the vaccine underwent temperature excursion at 22.7 and -1.2 degree Celsius for 10 hours 8 minutes and 37 hours 6 minutes, respectively. She also reported the details of unsupported vaccine administered to unspecified patients: lot # L016428 (expiry date: 30-JUL-2017; underwent a temperature excursion at -1.2 degree Celsius for 25 hours 40 minutes) was administered on 28-MAR-2016, lot # L020015 (temperature excursion at -1.2 degree Celsius for 26 hours 58 minutes) was administered on 29-MAR-2016. No adverse effect was reported. This is one of the five reports received from the same reporter. Additional information has been requested.
My arm swelled starting  24 hours after my first Moderna vaccine dose. The swelling was painful and sunk down towards my elbow. I took Advil, which didn't help much. This swelling and pain was pretty severe for a week and a half, finally subsiding by week 2.  This hurt far more and lasted far longer than the "expected" side effects stated.
same numbness but no discoloration; This spontaneous case was reported by a health care professional and describes the occurrence of HYPOAESTHESIA (same numbness but no discoloration) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.     On 07-Mar-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 HYPOAESTHESIA (same numbness but no discoloration). At the time of the report, HYPOAESTHESIA (same numbness but no discoloration) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-077916 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077916:CROSSLINKED WITH DOSE 2
Headache, Myalgia, Fever, RIGORS/CHILLS; FATIGUE; INSOMNIA; NAUSEA Narrative:  SX WOULD COME AND GO OVER 24 HOURS  Other Relevant History:
Tinnitus of the left ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus of the left ear) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced TINNITUS (Tinnitus of the left ear). At the time of the report, TINNITUS (Tinnitus of the left ear) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient used over the counter ear drops to try to alleviate the symptoms. No concomitant medications reported by investigator
This spontaneous report as received from a physician refers to unspecified number of patients of unknown age. Current conditions and medical history was not reported. On an unknown date, the patients were vaccinated with VAQTA (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On an unknown date, VAQTA was improperly stored for an unspecified amount of time and administered to an unspecified number of patients. No adverse effects reported. The outcome was unknown.. Product quality complaint was not reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax & devel cellulitis @ the inj site;this is 1 of 4 pt from this site to have an adverse exp p/vax;
pt recv vax 8NOV94 & w/in 24 hr p/vax pt had a fever of 99-101; APAP given; 3rd day p/vax pt had a croupy cough; seen by MD; dx croup; treated w/a 3 day course of dexamethasone; pt improving;
This spontaneous report as received from a school vaccine program coordinator refers to an 11 year old male patient. On 02-FEB-2013 the patient was vaccinated inadvertently with a dose of ZOSTAVAX (lot # dose and site of administration were not provided) instead of the second dose of VARIVAX (Merck). The patient did not report any adverse effect. Additional information has been requested.
Feel only pain; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Feel only pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Aug-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 MYALGIA (Feel only pain). At the time of the report, MYALGIA (Feel only pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.   This case was linked to MOD-2021-620512 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2021: Upon internal review on 29-Sep-2022, significant correction was performed to update the suspect product coding. Invalid classification was removed.
Tingly feeling in nose (like that of water up the nose); Diminished sense of smell and taste, followed by total loss of smell and taste; Diminished sense of smell and taste, followed by total loss of smell and taste; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Sep2021 at 09:15 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 16Sep2021 at 17:15, 7-8 hours after injection, the patient experienced tingly feeling in nose (like that of water up the nose) followed by diminished sense of smell and taste, followed by total loss of smell and taste. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tingly feeling in nose (like that of water up the nose) and diminished sense of smell and taste, followed by total loss of smell and taste was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
68-year-old woman with history of DM2, fatty liver disease with dyslipidemia, HTN, colonic polyposis, and pancreatic insufficiency, who presented to ED late 02/02/2023 status post fall in her bathroom and emesis with associated confusion. Earlier in the day she had episodes of headache which has since resolved.  There was a question of her left upper extremity weakness.  She is diagnosed with severe sepsis (organ dysfunctions included abnormal LFT and metabolic encephalopathy plus elevated lactic acid) secondary to urinary tract infection with associated COVID.  With respect to her COVID infection she was vaccinated against the virus and did not have respiratory symptoms.  She was given remdesivir given the abnormality of her mental status and abnormal LFTs x 3 doses only