chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever and rash beginning approximately 3 weeks post vaccination and continued to occur approximately every three weeks through the 2nd week in March.  No further rash or fever since the 2nd week in March.
This was my second dose of the Pfizer vaccine.   First day I felt soreness on my left arm where shot was administered and I had stomach cramps through the day. Had to eat very light. Woke up with an intense headache during the night, which continued all through Saturday 1/30/2021 and into the night.  I started with a fever of 100.5 and it climbed to approximately 102 in late afternoon on Saturday. Saturday afternoon got nauseous and remained that way through the night. Most symptoms have stopped on Sunday morning, although my stomach is very unstable and I feel weak. I took Tylenol  through the day and at midnight on Saturday at recommended doses or less.   Temperature 99.1 on Sunday afternoon and haven?t taken a Tylenol since Saturday night.
Headache 12 hours after injection, fever and body aches 12 hours after injection, pain at injection site
pt recv vax;w/in 24 hrs devel local rxn characterized by "fever" to skin,swelling and irritation at inject site as well as burning,chills and sweats;T of 103 & pain from inject site extending into torso area;
This spontaneous report as received from a Licensed Vocational Nurse (LVN) refers to a patient of unknown age and gender. It was reported that on 12-FEB-2015, improperly stored VARIVAX (Merck) (lot # K008820, dose, route of administration and expiration date were not provided) has been administered to unspecified patient. No adverse effects were reported. No further information was provided. Additional information has been requested.
Skin rash/reddish welts that resembles hives, almost entirely concentrated on my scalp, some on my chest, neck, and arms. Very itchy and bothersome. It feels hot/warm.
Pfizer-BioNTech COVID-19 vaccine EUA  On Friday December 18th at 2:45 p.m. I received my first dose of the vaccine.   After the injection while waiting in the observation area, I noticed my arm felt cold and felt weaker.  I was able to move my hand and did not have tingling.  I was cleared to leave after 15 minutes.   While driving home approximately 35 minutes after the injection I had a quick onset hot flash (felt like it came from my left arm which is where I received the injection).  Then my heart started pounding. I noticed my heart rate was climbing.  It topped out at 170.   I was having difficulty in breathing but that was related to my heart rate.  I pulled over and called 911.  I felt as if I was going to pass out.  After 2 minutes or so my heart slowed and stayed at a rate between 120-130.  I never lost consciousness.  I canceled the ambulance and felt as if I could drive home.    30 minutes later the episode happened again.   All the same symptoms as the first. The pounding felt harder and it was slightly harder to breath until the rate came down again.   Again, I felt as if I was going to lose consciousness but never did.  Each episode lasted about 2 minutes from hot flash to slower heart rate.   This time the ambulance came.  No rash.  No hives.  No swelling.   BP-160/90 HR-120-130 Sinus Tachycardia on a 3 lead EKG  I did not need transport to the hospital.   I started feeling much better around 5:00 p.m.   The coldness I felt in my arm was gone.  My arm no longer felt weak.  The hot flash, rapid heart rate and faint feeling did not return.   I am a Paramedic with the Fire Department.  Provided the Vaccine to EMS workers.   I received my vaccine at the: Fire Department December 18, 2020 Injection time 2:45 p.m.
no additional AE; the patient was administered expired M-M-R II; This spontaneous report was received from a registered nurse and refers to a 15-month-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.    On 14-MAY-2021, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin) (M-M-R II), lot # S014436, expiry date: 09-MAY-2021 (formulation, strength, dose, frequency, route of administration were not provided) for prophylaxis. No adverse events and temperature excursion were reported.
Vaccine administered beyond use date; Second dose received 0.25 instead of 0.5 ml; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date) and ACCIDENTAL UNDERDOSE (Second dose received 0.25 instead of 0.5 ml) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     It was unknown if the patient had ever been diagnosed with or tested positive for COVID-19. It was unknown if the patient had any acute illness at the time of vaccination and up to one month before. It was also unknown if the patient had any chronic or long-standing health conditions.     On 28-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date) and ACCIDENTAL UNDERDOSE (Second dose received 0.25 instead of 0.5 ml). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date) and ACCIDENTAL UNDERDOSE (Second dose received 0.25 instead of 0.5 ml) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 25 years and 5 months.  Concomitant medication of the patient was not reported.  The patient did not experience any adverse reactions after the administration of vaccine.  No treatment information was provided by the reporter.
Patient received on May 19th 2021 first dose of Bexsero instead of Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA93AA, expiry date 28th February 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th May 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 19th May 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The patient received Bexsero instead of Boostrix, which led to wrong vaccine administered. The patient went physician's office for his regular check up. The reporter consented to follow up via email.
allergy to Pneumovax23; This spontaneous report was received from a other health professional and refers to a female patient of unknown age. The patient's concurrent condition, medical history and concomitant medication were not provided.   On an unspecified date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot#, expiration date, strength, frequency and route of administration were not provided) for prophylaxis. On an unspecified date, the patient experienced allergy to vaccine. The outcome was unknown.  The relationship between the event and the vaccine was determined to be related.; Sender's Comments:  US-009507513-2105USA001067:
Patient presented to clinic at approximately 0615 the morning of 17 September 2021 complaining of diplopia in both eyes. Denied any headache, vertigo, nausea, vomiting, or pain associated with diplopia. Physical exam findings were unremarkable and patient was observed for approximately one hour before being released with return precautions and artificial tears for comfort. Patient returned to clinic approximately 4 hours later complaining of increased frequency of diplopia without any associated systems. Provider boarded patient on facilities Patient Care Unit for observation. Patient had no further complaints until the afternoon of 19 September where he began to complain that his diplopia was now constant with associated headache and vertigo. Patient transported to local hospital and was admitted for observation. Subsequent MRI on 20 September was negative for any abnormalities but patient began to lose Ocular Motor function later that day. Spinal tap on 23 September showed elevated protein levels in CSF and a subsequent diagnosis of Miller Fisher Syndrome was given. He was started on IgG therapy and currently remains at the inpatient unit with an anticipated discharge date of 28 September.
11PM- BODY ACHES, CHILLS, SWEATS 12AM- ALL THE ABOVE PLUS BONE PAIN 2AM- ALL THE ABOVE PLUS FAST HEART RATE 120'S 3AM - HEAR RATE ABOVE 135 3:30AM-5AM- ER HEART RATE 157, FEELING VERY HOT, FLUSHED FACE AND NECK. PERFORMED LABS, CHEST XRAY, URINE TEST. GIVEN IV FLUIDS, TYLENOL, METOPROLOL AND ATIVAN. ALL RESULTS CAME BACK FINE. A FEW DAYS LATER I DEVELOPED SHORTNESS OF BREATH, WENT TO URGENT CARE TESTED NEGATIVE FOR COVID. LASTED 10 DAYS OVER THE NEXT MONTH I DEVELOPED TACHYCARDIA, HIGH BLOOD PRESSURE, INSOMNIA, NUMBNESS AND TINGLING IN BOTH HANDS AND FACE, ANXIETY AND PANIC ATTACKS HAD AN EPISODE OF SVT IN MAY, HAD A CHEST XRAY, HEART MONITOR FOR 10 DAYS. ALL CLEAR. WAS PUT ON METOPROLOL AND LEXAPRO DAILY THESE SYMPTOMS LASTED FOR ABOUT 9 MONTHS
This case was received from a physician on 06 August 2009.  It was reported as part of a cluster of two patients; information for the other patient is captured in case number 2009-03593.  A 42-year-old female patient, with no past medical history, received the following vaccines on 04 August 2009: IPOL (lot number B0475); a left deltoid, subcutaneous dose of YF VAX (lot number UF645AA); HAVRIX vaccine (GSK, lot number AHAVB302BA); and MMR (Merck, lot number 3055Y).  The patient had previously received oral polio vaccine and MMR as a child.  One day post-vaccination, she experienced diffuse erythema, with generalized discomfort and tingling over her entire body surface.  No additional information was reported.  Documents held by sender:  None.
Received MMR, Varivax and IPV on 8/9/00; on 8/10/00 pt began running a fever and had decreased appetite. On 8/11/00, pt saw doctor with dehydration; that night was seen in ER with increased temperature. On 8/14/00 saw doctor and was dx'd with UTI and viral illness and was treated with Bactrim. On 8/20, was seen in ER again for increased temperature of 103.3F (ax.) and was given injection of Rocephin. On 8/21/00, saw pediatrician, still running low-grade temperature. On 8/28/00, had no temperature and feeling better.
RED, ITCHY, BLISTERED RASH BEGINNING AT 4" SQUARE IMMEDIATELY BELOW INJECTION SITE NEAR TOP OF LEFT SHOULDER, AND GRADUALLY EXTENDING TO MID-FOREARM, RECEDING UP TO ELBOW AS OF 12 DAYS POST-INJECTION, TREATED WITH TOPICAL CORTISONE CREAM, RASH STILL EXTANT
thinning of hair, is losing his hair all the time, has hair loss and stated that his whole set of hair is thin; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (thinning of hair, is losing his hair all the time, has hair loss and stated that his whole set of hair is thin) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 041C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ALOPECIA (thinning of hair, is losing his hair all the time, has hair loss and stated that his whole set of hair is thin). At the time of the report, ALOPECIA (thinning of hair, is losing his hair all the time, has hair loss and stated that his whole set of hair is thin) outcome was unknown.            Concomitant medication was not reported. Treatment information was not reported.   This case was linked to MOD-2021-414611 (Patient Link).
parent describes onset 4-5 days p/vax of 2 days of fussiness followed by 3-4 days of extreme sleepiness-diff to arouse;marked dec in appetite;parents went to ER 6-7 days p/vax;
Diarrhea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
received 2nd dose of Moderna vaccine on D21st, after receiving the 1st dose of vaccine; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose of Moderna vaccine on D21st, after receiving the 1st dose of vaccine) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 21-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose of Moderna vaccine on D21st, after receiving the 1st dose of vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2nd dose of Moderna vaccine on D21st, after receiving the 1st dose of vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medications and treatment information were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-162267, US-MODERNATX, INC.-MOD-2021-162156, US-MODERNATX, INC.-MOD-2021-162328, US-MODERNATX, INC.-MOD-2021-162176, US-MODERNATX, INC.-MOD-2021-162133 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Non-significant follow up appended.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-162267: US-MODERNATX, INC.-MOD-2021-162156: US-MODERNATX, INC.-MOD-2021-162328: US-MODERNATX, INC.-MOD-2021-162176: US-MODERNATX, INC.-MOD-2021-162133:
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for hx of subdural intracranial hematoma, cognitive disorder, functional gait abnormality, dysphagia with peg tube placement. Patient was taken to outside entity hospital on 4/30/21 with CC of blurriness and headache. Was admitted and diagnosed with meningitis. Craniectomy and washout performed 5/1. Also suffered from P/E and DVT. Patient deceased 5/13/2021. Lack of information regarding death and hospital records.
Developed a rash/hives about 4inch inches in diameter around the injection site. Very itchy, hot, and red. Tried to use hydrocortisone cream to relieve the itchiness with little relief.
Patient is a 14 year old and 18 weeks 1 day of gestation at the time of event was erroneously counseled and given the Moderna Covid vaccine on 11/12/21 at 9:58 am on left arm. This was done during her initial prenatal intake where she presented as a new arrival, late to care and counseled by Certified Nurse Midwife who also administered the vaccine.
Patient got PCR Covid test positive after completing 2 doses.; This spontaneous case was reported by a physician and describes the occurrence of SARS-COV-2 TEST POSITIVE (Patient got PCR Covid test positive after completing 2 doses.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).    In February 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 SARS-COV-2 TEST POSITIVE (Patient got PCR Covid test positive after completing 2 doses.). At the time of the report, SARS-COV-2 TEST POSITIVE (Patient got PCR Covid test positive after completing 2 doses.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Polymerase chain reaction: positive (Positive) positive.     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.      Reporter did not allow further contact
Raised circular area noted at injection site (R) deltoid measures 4 cm (L) x 2 cm W. Red raised warm to touch.
Right arm is swollen 13 cm in diameter with erythema. Pt given single vaccine to right deltoid and buttocks? No fever or pain or limited movement of arm.
Weird sensation in tongue felling like it was swelling. then had chills the next day w/ a running nose.
Patient reported having significant pain in the arm which the vaccine was administered starting the night after the injection.  Reported that although minor improvements, that she still has pain and discomfort and reduced range of motion in her arm.
Sudden swollen left arm/arm is now as big as 'Popeyes'; Warm to touch; Pain concentrating at the back of the elbow; Sudden painful left arm; pain scale of 10; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Sudden swollen left arm/arm is now as big as 'Popeyes'), FEELING HOT (Warm to touch), ARTHRALGIA (Pain concentrating at the back of the elbow) and VACCINATION SITE PAIN (Sudden painful left arm; pain scale of 10) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to moulds and Penicillin allergy.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jul-2021, the patient experienced PERIPHERAL SWELLING (Sudden swollen left arm/arm is now as big as 'Popeyes'), FEELING HOT (Warm to touch), ARTHRALGIA (Pain concentrating at the back of the elbow) and VACCINATION SITE PAIN (Sudden painful left arm; pain scale of 10). At the time of the report, PERIPHERAL SWELLING (Sudden swollen left arm/arm is now as big as 'Popeyes'), FEELING HOT (Warm to touch), ARTHRALGIA (Pain concentrating at the back of the elbow) and VACCINATION SITE PAIN (Sudden painful left arm; pain scale of 10) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was not taking any prescribed medication or supplements.  Patient took CVS patch for pain, applied on the affected part.
1st vaccination -Head ache, muscle ache,  fever,  fatigued- lasting 2 days Ibuprofen and Tylenol  bedrest  2nd vaccination- Head ache, muscle ache, joint pain, blurry vision, fever fatigued - lasting 3 days Ibuprofen and Tylenol and bedrest
Large itchy sore welt appeared on day 8 after first vaccine below the injection site. Looked like a hive at first. Applied hydrocortisone cream with relief. This rash is,still present 12 hours later. In morning had some fleeting jaw,pain too. Arm was,sore few days then no symptoms until today. Read about this on Google, seems to fit COVID arm.
vaccine was not given according to the recommended schedule it was given to early.  Called and discussed with father.  Do not expect an adverse effect from an extra dose, but will need a fourth dose.  Recommend waiting at least three months or longer for this.
Shot location in arm became very painful over Sunday night. Full body pain began around 1 a.m. on Monday and persisted until around 9 a.m. Decreased for a while, then came back strong around 11 a.m. with a fever of 101. Lasted about 2 hours, I fell asleep really hard, and woke up at 3 p.m. with no fever and mild body aches. Today, Tuesday, I feel slightly tired but otherwise normal.
Patient reports being diagnosed with encephalopathy after first dose of the Moderna COVID vaccine.  She was hospitalized and discharged on 5/13/21.  She reports having confusion and a fall before being hospitalized.
A prefilled Adult 0.5 ml FLUZONE vaccine was given by mistake - Lot # UT445AA. This should have been a prefilled Pedi 0.25 ml FLUZONE vaccine. On 8/27/11 child was seen for cold sx, fever, fussiness and dx w/ otitis media.
2nd dose: Hearing problems and tinnitus in left ear; 2nd dose: Hearing problems and tinnitus in left ear; concerning to him; high pitched ringing in both ears; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Sep2021 (Lot number: FC3183) at the age of 57 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BC [ACETYLSALICYLIC ACID;CAFFEINE] taken for headache. Vaccination history included: Bnt162b2 (1st Dose, at around 6pm in Left arm. Lot: FD8448, Expiry/NDC: Unknown), administration date: 13Sep2021, for Covid-19 immunisation, reaction(s): "tinnitus in left ear", "tinnitus in left ear"; Bnt162b2 (1st Dose, at around 6pm in Left arm. Lot: FD8448, Expiry/NDC: Unknown), administration date: 26Aug2021, for Covid-19 immunisation.  The following information was reported: HYPOACUSIS (non-serious), TINNITUS (non-serious) all with onset 27Sep2021, outcome "not recovered" and all described as "2nd dose: Hearing problems and tinnitus in left ear"; ANXIETY (non-serious) with onset 27Sep2021, outcome "not recovered", described as "concerning to him"; TINNITUS (non-serious) with onset 27Sep2021, outcome "not recovered", described as "high pitched ringing in both ears". The events "2nd dose: hearing problems and tinnitus in left ear", "2nd dose: hearing problems and tinnitus in left ear" and "high pitched ringing in both ears" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
LITTLE BIT TIREDNESS; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 180Z068, and  expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced little bit tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little bit tiredness was not reported. This report was non-serious. This case, from the same reporter is linked to 20210422535.
persistent pain @ inject site 1 wk p/inject; 14AUG92 received letter; no additional info available;
Joint and muscle pain in lower extremities since first shot given (per pt report) - pt has seen her PCP for workup.
Large itchy painful swollen rash that appeared 7 days after the day of the shot.