chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red Blotchy Patches Like a Round Ring around Injection Site; Hot to the touch Injection Site post first vaccine; Tingling Injection Site / Tingling Fingers; Redness below the injection site; Soreness; This spontaneous case was reported by a nurse and describes the occurrence of RASH MACULAR (Red Blotchy Patches Like a Round Ring around Injection Site), VACCINATION SITE WARMTH (Hot to the touch Injection Site post first vaccine), PARAESTHESIA (Tingling Injection Site / Tingling Fingers), VACCINATION SITE ERYTHEMA (Redness below the injection site) and VACCINATION SITE PAIN (Soreness) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced RASH MACULAR (Red Blotchy Patches Like a Round Ring around Injection Site), VACCINATION SITE WARMTH (Hot to the touch Injection Site post first vaccine), PARAESTHESIA (Tingling Injection Site / Tingling Fingers), VACCINATION SITE ERYTHEMA (Redness below the injection site) and VACCINATION SITE PAIN (Soreness). On 30-Jan-2021, RASH MACULAR (Red Blotchy Patches Like a Round Ring around Injection Site), VACCINATION SITE WARMTH (Hot to the touch Injection Site post first vaccine), PARAESTHESIA (Tingling Injection Site / Tingling Fingers), VACCINATION SITE ERYTHEMA (Redness below the injection site) and VACCINATION SITE PAIN (Soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.  Concomitant medication was not provided.   This case was linked to MOD-2021-056348 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up received on Jun 30 2021 contains no significant information
1st dose Pfizer vac at 3:16pm L arm. w/mother/sibling in attendance. Attendee directed to observation area but immediately had reaction after receiving injection. Became pale, faint,dizzy. Stated anxious, fear of needles. Legs elevated while sitting. 3:26pm drank water. Encouraged to stabilize breathing. Skin pinkish, warm, dry. Mom distracted her. After sibling done with vaccine, Attendee walked unassisted to  observation area. 3:40pm  went to observation area check on her laughing and talking with family. Took pulse ox 99% and HR: 63. Gave mother home discharge/adverse reaction instructions to contact Primary doctor/UC prn. Attendee discharged to home w/her mother approximately 3:50pm.
Patient was vaccinated on a Monday evening.  He had systemic reactogenicity the next day with diffuse myalgia and headache that occurred that evening.  The next day headache was worse and that evening/morning he developed chest pain, dyspnea. Was seen at an OSH - had elevated troponin and CRP ECG, ECHO, and cMRI c/w myocarditis without pericardial effusion.  Treatment with NSAID's alone at time of submission
8 hours post vax, the pt developed hives. The hives resolved without treatment. Self-treated with Benadryl.
Redness around injection site and swolleness down to elbow with elevated blood pressure reported patient today.
Initial report received from a healthcare provider on 5/24/2006. A 25 year old female patient, with no past medical history, had received an injection for Decavac, lot number U1587CA, on 4/10/2006. Six hours post immunization, the patient developed a generalized rash with hives. She was examined in an ER and admitted to the hospital for six days for anaphylaxis. The patient was treated with epinephrine. The hives persisted for approximately one week. During an office visit seven days post immunization, she was given Depo Medrol. Nine days post immunization, she was re examined in the office and diagnosed with pneumonia. This resolved on 5/2/2006, 13 days following that office visit. At the time of this report, the patient had recovered. The reporter in this case is the same as for case 200601265.
PATIENT REPORTED PAIN AND INFLAMMATION IN HER ARM 10 DAYS AFTER 1ST SHOT OF MODERNA. SITE ON LEFT ARM WAS RED AND INFLAMMED. PATIENT REPORTED HER ARM WAS STILL VERY SORE (SCORE 4 ON 1-10 SCALE) BUT REPORTED SHE FELT HIGHER PAIN 2-3 DAYS AFTER INJECTION WAS GIVEN. PATIENT ALSO REPORTED THAT SHE HAS BEEN TAKING TYLENOL FOR THE PAIN. SHE HAS ALSO BEEN HAVING HEADACHES THAT STARTED AFTER RECEIVING THE VACCINE. SHE REPORTED THIS IS ABNORMAL FOR HER AND USUALLY DOES NOT HAVE HEADACHES. SHE HAS BEEN DRINKING LOTS OF WATER SO THE HEADACHES ARE UNRELATED TO DEHYDRATION.
Approximately 2 hours after the vaccination was given patient experienced shortness of breath, coughing, and decreased 02 stats with a pulse oximeter.  Caregiver applied oxygen supplementation which improved 02 stats.  Vaccinating pharmacist and home health nurse were notified and returned to facility.  When pharmacist arrived patient was eating lunch and appeared to be normal.  No observable breathing problems or swelling.  Local inject site appeared normal with no rash or swelling.  Patient tolerated 1st dose well previously.  Nurse and caregiver attempted to measure oxygen while pharmacist was there but could not obtain a reading.   Observed patient for an additional half an hour with no observable issues.
Information has been received from a healthcare worker concerning multiple unknown patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On multiple unknown dates, the multiple unknown patients received improperly stored ROTATEQ (lot #, expiration date and dose were not reported), orally for prophylaxis. Previous temperature excursion was reported as greater than 10 excursions. No details were provided regarding temperature or time frame for the excursions. No adverse effects was noted. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA014298: US-009507513-1612USA014514: US-009507513-1612USA014512:
Patient received Shingrix in right arm and Fluad in the left arm and the next day reported that she experienced chills, fever, insomnia  and nausea over night. She had pain at the Shingrix  injection site which was alleviated by taking Ibuprofen
I am still experiencing excessive itching at the site of the injection and this is one month after the 2nd dose.  It is usually at night and wakes me up.  The only relief that seems to work is an ice pack. Topical cortisone does not help.   It seems to be happening less and less but I thought I should report it.  There is no rash or swelling.  I had a similar reaction to The Shingrix Vaccine after the 2nd dose.  It lasted six months and was worse!  I would like to know what might be causing this.  I had no problem with the Flu Shot.
several hrs p/vax pt devel fever-seen by MD 26FEB93, t103-rash (hive like) on trunk above naval only; MD feels reaction caused by MMR reaction;
pt received pneumovax in am. returned to clinic in pm c/o L upper arm pain with decreased mobility.L upper arm (deltoid area) warm to touch with minor swelling. no erythema. pt denied numbness, tingling, weakness L hand. unable to raise L arm above head due to "pain." consult with MD. ice pack, rest, otc analgesics recommended. Phoned pt next day: minimal improvement. recommended f/u w MD.  Spoke with pt on 10/13/05. pt stated improved mobility: able to raise arm above head but stated arm still" painful." pt had not seen medical provider.pt missed two days of work.
Pt vaccinated with DTP/OPV/MMR developed fever 102, vomiting, loss of appetite, body aches, headaches, sought ER treatment for vomiting.
Pt c/o GI upset, fever, chills, body aches, lightning bolts to head. Pt appeared in medical with worsening symptoms on this date. No improvement.
Within a few days of the second shot, patient's sense of smell started to become distorted and is continuing to change and get slightly worse.  Favorite foods smell so bad that she cannot eat them.
Pt received FLUZONE 0.5 ml 9-30-14. Migraine started same day. Muscle spasms severe 10/10/14. Had started earlier but not as severe.
Administered a vaccine which has been punctured for more that 12 hours and left at the counter at room for 18 hours; Administered a vaccine which has been punctured for more that 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered a vaccine which has been punctured for more that 12 hours) and PRODUCT STORAGE ERROR (Administered a vaccine which has been punctured for more that 12 hours and left at the counter at room for 18 hours) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056M21A, 012M20A, 013M20A and 939901) 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) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 30-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a vaccine which has been punctured for more that 12 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered a vaccine which has been punctured for more that 12 hours and left at the counter at room for 18 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered a vaccine which has been punctured for more that 12 hours) and PRODUCT STORAGE ERROR (Administered a vaccine which has been punctured for more that 12 hours and left at the counter at room for 18 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter.  The vial was first punctured on  29-Apr-2022 at 5pm and administered on 3- Apr-2022 at 11am. Vaccine was inadvertently administered which has been punctured and left at the counter at room for 18 hours. Vial did not undergone any temperature excursion issue. The vial was initially stored in the refrigerator on 20-Apr-2022.  No treatment medication reported by reporter.
Background: Hospitalized with COVID and Pneumonia March 2020 9 days. Went to urgent care in Jan. 3, 2022, for PCR test, same day antigen test was negative; however a few days later contacted with COVID positive from PCR test. I also had long haul COVID symptoms from having had COVID in March 2020 that dissipated after the Dose 1 vaccination. Side effect symptoms wore off. Gave directive for care with COVID diagnosis. I knew how to self-care.
Patient was given 0.5 mL meningococcal serogroups A, C, Y &W (MENVO) and was supposed to be given meningococcal serogroup B (MEN B). Patient did not have any adverse reactions.
Resident admitted to Hospital on 6/29/2021 for hemiplegia.  Diagnosed with a cerebral infarct.  Resulting aphasia and right hemiplegia.
Information has been received from a pharmacist concerning an 86 yr old female inpt with a diagnosis of cardiac arrhythmia who on 10Dec05 was vaccinated IM in the arm with a dose of pneumococcal 23v polysaccharide vaccine (lot 651572/0741R) as a routine immunization during hospital stay. Concomitant therapy included warfarin sodium (Coumadin), atorvastatin calcium (Lipitor), isosorbide mononitrate (IMDUR), tolterodine tartrate (Detrol LA), diltiazem hydrochloride (Cardizem CD), and an unspecified influenza virus vaccine (given the same day, in the other arm). Later on 10Dec05, the pt developed a red raised area at the pneumococcal 23v polysaccharide vaccine injection site. The pt reported that the area was sore to the touch. On 12Dec05, the area of redness had increased to approx 4 by 6 inches in size. Tylenol was ordered for discomfort but had not been taken. Cold compresses had been used. At the time of the report, the pt had not recovered. Additional information has been requested.
This spontaneous report as received from a consumer via Clinic refers to a currently 87 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-APR-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 1 dose unit (lot # M036728, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1801USA000166.
Information has been received from a consumer concerning her son who was vaccinated with VARIVAX (Merck) (Injection site, dose/ frequency and lot# unspecified). Subsequently the patient experienced seizures. No additional information was provided. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
This spontaneous report was received from a healthcare worker (also reported as nurse) refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 02-DEC-2014, the patient was vaccinated with a dose of M-M-R II, (strength, dose, route and anatomical location were not reported), (lot # J006995, expiration date: 14-JUN-2015), which was incorrect stored since 02-DEC-2014. No adverse effects were reported and no product quality complaint (PQC) was filled. This is one of several reports received from the same reporter. Additional information has been requested.
The patient was supposed to be given 0.25mL for his booster dose and received 0.15mL. The CDC recommends that this is a complete dose and no other follow up is necessary.
4-6cm area of erythema and swelling around the vaccination site.  Edema extending 10cm distally towards elbow and approximately 4 cm upward towards axilla.  Rash is very puritic and slightly tender to palpation.
Consistent Itchiness throughout the body. Some temporary hives which lasted about a half hour or so.
Tongue/mouth tingling Seen by onsite EMT. Vital signs: BP 151/92 Pulse: 47 O2:98% Room Air Recorded by RN Discharged at 16:00
Heart palpitations; chest tightness starting within 12 hours of vaccine.; burning sensations at back of neck and scalp; burning sensations at back of neck and scalp; Tingling in both arms.; pain in legs and pelvis.; pain in legs and pelvis.; This is a spontaneous report from a contactable consumer (patient). A 31-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration in arm right on 08Apr2021 09:45 (age at vaccination 31 year) as dose number unknown, single for COVID-19 immunisation. Medical history included latex allergy. The patient's concomitant medication received included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]), on an unspecified date for unspecified indication. No other vaccine in four weeks, no covid prior vaccination, not tested for covid post vaccination, no other medical history and other medications in two weeks was prenatal. On 08Apr2021, the patient experience heart palpitations and chest tightness starting within 12 hours of vaccine, burning sensations at back of neck and scalp, tingling in both arms, pain in legs and pelvis. No treatment received. The outcome of the events was not recovered.  No follow up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Itching started in the vaccine area 6 hours after the second dose. The area began to become red, hot, and inflamed. It looked like cellulite. The reddened area is about 2 inches. Yesterday I took Zyrtec at night and today I woke up less red but the itching continues.
This case was reported by a consumer and described the occurrence of rash in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced a bad rash all over the face, eyes and nose. The patient could not get rid of it and was really suffering.
Pt reported to me on 4/23/2021: dry mouth, difficulty getting out of bed, h/a, fever and chills, feeling like was going to fall, some memory difficulties  and ringing in ears. Reported that the sx gradually resolved and are completely resolved by date of reporting (4/23/2021)
Rash to abd and back area patient treated with BENADRYL and triamcinolone cream.
This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 10-SEP-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Arm and shoulder were sore an hour after vaccine for 2 days.  8 days following 1st dose, a raised itchy area arose around injection site which has gotten more defined and warm over the course of approximately 4 hours and is also becoming painful.
Rash on face; Swollen Tongue; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received BNT162B2 (Pfizer BioNTech covid 19 vaccine) (Lot/batch no.: EN6206), first dose via unspecified route of administration on right arm for COVID-19 immunisation on 05Mar2021 at 18:00. Medical history included PSA and rheumatoid arthritis. The patient had not reported any allergies. Concomitant medication included Xjejanz (MANUFACTURER UNKNOWN) within 2 weeks for an unknown indication. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not been diagnosed with COVID-19 prior to the vaccination and had not tested positive for COVID-19 after vaccination. On 09Mar2021 patient had experienced rash on face and swollen tongue. Therapeutic measures were not taken for the events. The clinical outcome of the events of rash on face and swollen tongue was unresolved. No follow-up attempts are needed. No further information is expected.
Approximately 6 weeks post vax, the pt experienced nausea and fatigue. She was seen by her physician who performed a hepatitis profile and hepatitis A antibody titer. The hepatitis profile was negative; the hepatitis A titer was positive. The pt recovered after two weeks.
Collapsed at school 20 hours after vaccination. Conscious but incoherent; unable to stand; incoherent when answering questions; cold sweats;
3:50 pm mother called to say pt has been screaming since immunization was given this am. Afebrile. No reported redness or swelling at injection site. These findings were reported to RN.
Rash started 1 day after vaccines given. Red mostly macular, initially on trunk but spreading to face and extremities. Now present 2 weeks.
mild itching rash on left arm and across chest; This is a spontaneous report from a contactable other HCP (patient).A 66-years-old male patient received received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: El9265) intramuscularly in deltoid left on 29Jan2021 as single dose for covid-19 immunisation. Medical history included CAD,COPD/Asthma.The known allergies of patient were reported as Bactrim/Sulfa drugs. Concomitant medications included ibuprofen, metformin,pioglitazone hydrochloride (ACTOS) ,enalaprilat (VASOTEC),clonidine (CATAPRES) ,pregabalin (LYRICA),ticagrelor (BRILINTA), alfuzosin hydrochloride (UROXATRAL) ,atenolol/chlortalidone (TENORETIC).On 29Jan2021 09:00 the patient experienced mild itching rash on left arm and across chest.Therapeutic measures were taken as a result of mild itching rash on left arm and across chest. The patient was given Benadryl 50 mg .The Outcome of the event was recovered. Patient did not receive other vaccine in four weeks. The patient is not covid tested post vaccination.
pt recv vax & arm was instantly sore as if someone beat it w/a hammer; few wk passed & soreness persisted, causing the pt to wake up in the noc w/discomfort; also pt could not lift arm above head w/o sharp pain; consulted MD 13JAN95;
General malaise the day following vaccination with uncomfortable arm soreness, worse than the day of vaccination. Similar fatigue one week after vaccination, though not severe. Red, slightly hard ?rash?, not itchy or painful, around vaccination site a week and a day after vaccination. No severe reactions.
ACUTE NON ST ELEVATION MI 9/9/2022 HYPOTHYROIDISM  CARDIOGENIC SHOCK 9/6/2022 HYPOTHYROIDISM  ACUTE NON ST ELEVATION MI 9/9/2022 DM 2 W DYSLIPIDEMIA  CARDIOGENIC SHOCK 9/6/2022 DM 2 W DYSLIPIDEMIA  ACUTE NON ST ELEVATION MI 9/9/2022 ACUTE NON ST ELEVATION MI  CARDIOGENIC SHOCK 9/6/2022 ACUTE NON ST ELEVATION MI  ACUTE NON ST ELEVATION MI 9/9/2022 ACUTE NON ST ELEVATION MI         CARDIOGENIC SHOCK 9/6/2022 ACUTE NON ST ELEVATION MI
Information has been received from an office manager referring to a patient of unknown age and gender. Information about medical history and concurrent condition was unspecified. On an unknown date the patient was vaccinated with an improperly stored dose of M-M-R II (lot number, expiration date and dose were unknown, subcutaneous). The vaccine was exposed to unsupported temperature excursion. No adverse effects were reported. No PQC was involved. This is one of two reports received from the same reporter. Additional information has been requested.
impressive level of sore; deep tissue bruise; extremely uncomfortable; a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (impressive level of sore), CONTUSION (deep tissue bruise), FEELING ABNORMAL (extremely uncomfortable) and PAIN (a little sore) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (impressive level of sore), CONTUSION (deep tissue bruise), FEELING ABNORMAL (extremely uncomfortable) and PAIN (a little sore). At the time of the report, PAIN (impressive level of sore), CONTUSION (deep tissue bruise), FEELING ABNORMAL (extremely uncomfortable) and PAIN (a little sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
6 days after vaccine administration, he developed swelling and redness of L arm central arm swelling. Diagnosed with cellulitis and started on Clindamycin