chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AEs/no PQCs.; HCP called in and reported that the improperly stored vaccine was administered on 09/12/2022; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 12-SEP-2022, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W011625, expiration date: 06-APR-2024, administered for prophylaxis (strength, and route of administration were not provided). The vaccine was exposed to temperature from -10 Celsius to 8 Celsius (-4 C) for 2 Hours 30 Minutes. No previous temperature excursion was reported. No additional AEs/no PQCs.
pt recv vax; dtp lt deltoid on 3jul95 back for TB reading lt deltoid swollen & red, sore to touch from inject site to elbow;
Moderna COVID-19 Vaccine EUA Severe headache on right side (I have migraines often, 1-2times a week), nausea, vomiting, body ache and light fever started 18hrs after injection, and lasted for 10hrs.  Swollen lymph nodes in left side armpit started 36hrs after injection. Very tender to touch or arm movement.
Day of shot: severe chills, fever (102+), headache, body aches Day after: body aches, headache, fever (100-100.7) Day 2 (today): headache, body aches only injection site and shoulders
Mumps - Information has been received from a registered nurse concerning a 2 year old patient who was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation at thirteen months of age.  On 11 Dec 2000 the patient had lab confirmed diagosis of mumps.  according to the nurse, the child failed to seroconvert.  unspecified medical attention was sought for the child.  additional information has been requested.
severe headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (severe headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-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 HEADACHE (severe headache). At the time of the report, HEADACHE (severe headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Dizziness, slight headach and tiredness. The dizziness and started the day after 01-06-21 and the tiredness started 01-07-21. I, also, had a shingles vaccine 15 days prior to taking this vaccine which i told them about and wrote on my form.
Patient received shot (flu) on 11-14-2016. His left arm has been extremely sore since that time. He has been unable to lift his arm. He also had some fever for a couple of days after the shot.
5 days after injection - patient states his arm was sore & itchy - 6 days large 7cm x 10 1/2 cm red area. Warm to touch & itchy.
developed rash after receiving Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RASH (developed rash after receiving Moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (developed rash after receiving Moderna vaccine). At the time of the report, RASH (developed rash after receiving Moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-103423, US-MODERNATX, INC.-MOD-2021-103333 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-103423: US-MODERNATX, INC.-MOD-2021-103333:
Red spot on arm three/four days after shot, pain down arm to hand, could not lift arm past certain point for approximately 5 weeks, February hives on neck, one month later March hives on arm, went to the doctor was diagnosed in Feb with Shingles but diagnosis was not confirm/I was not tested for shingles, March had video conference call with doctor, went to the office to have blood work done for autoimmune disease everything came back negative, I had not issue prior to covid shot, hive are on left side of body where I had the COVID Booster.
Chills, headache, nausea, fatigue, light soreness through body, joint pain in hands it was worse in arm shot was administered
Fever of 100.5; Achiness all over which was pretty bad; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 100.5) and MYALGIA (Achiness all over which was pretty bad) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever of 100.5) and MYALGIA (Achiness all over which was pretty bad). At the time of the report, PYREXIA (Fever of 100.5) and MYALGIA (Achiness all over which was pretty bad) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.5 (High) fever.         No concomitant medications were provided.  Patient stated symptoms occurred for about 2- 4  days.  Treatment medications were unknown.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events was not applicable.   This case was linked to MOD-2021-057694 (Patient Link).   Reporter did not allow further contact
achy body; brain fog; feeling tired; Took the Booster dose 29Sep2021 at around 10:30am; This is a spontaneous report from a contactable consumer (patient) reported for himself that,  A 27-year-old male patient received bnt162b2 (COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0217, Expiry date: 21Dec2021), intramuscular administered in left arm on 29Sep2021 10:30 (Age at vaccination: 27 years old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. The patient medical history was not reported. No, Known allergies. No, relevant past drug history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.Concomitant medications were not reported. The patient received other medications within 2 weeks of vaccination. The patient previously received bnt162b2 (COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3247), intramuscular administered in left arm on 20Jan2021 11:00 AM (Age at vaccination: 27 years old) as dose 1, single for COVID-19 immunisation. The patient received bnt162b2 (COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3247), intramuscular administered in left arm on 10Feb2021 11:00 AM (Age at vaccination: 27 years old) as dose 2, single for COVID-19 immunisation. Took the Booster dose 29Sep2021 at around 10:30am. Symptoms developed about 24 hours later around 10:30am on 30Sep2021 with achy body, brain fog, and feeling tired. No, hospitalization prolonged. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. On 30Sep2021 21:00 the events were recovered. At the time of reporting, the outcome of the immunization was unknown.  Follow-up attempts are completed. No further information is expected.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information regarding patient pertinent medical history, drug reactions, allergies, concurrent conditions and concomitant therapies was not reported. On 06-FEB-2017, the patient was vaccinated with an expired dose of M-M-R II with lot # L000458, expiration date 06-JAN-2017 (strength, dose, frequency, route of administration, and anatomical location were not provided) for prophylaxis. No adverse effect was reported. Additional information has been requested.
p/vax pt exp lethargic; fever; h/a; fast heartbeat; arms feel like concrete blocks; tingling sensation (pins & needles; numbness in hands & arms; med: APAP PM; Aleve; Motrin; reg APAP
Soreness in upper arm, loss of mobility. Given two rounds of steroids but pain rerturns when steroids begin to wear off
11 days following the single shot I developed severe pain in my right calf muscle that felt like a charlie horse and on my leg from knee to my ankle felt a squeezing sensation like I was wearing a very tight sock that I couldn't take off.  After a few days the pain subsided and the similar pain began in my left leg however not as severe.  The pain would seemingly move around and come and go.  Some days it was so bad I couldn't walk or balance.  I believed I had a muscular issue.  I then began having swelling on the top of my left foot and around the ankle of my left foot.  After about a week, my right leg began to swell from the knee to ankle fairly significantly.  New veins appeared on the front of my right leg and other veins on the back of my right leg began to bulge.   Pain on both legs started to subside on the evening of 5/23, however swelling continued.   On the evening of 5/25 I was experiencing severe squeezing sensation and bulging veins in my right leg.
3 weeks after the first dose I developed sudden onset severe myalgias in the cervical neck,  shoulders, deltoid, gluteal, and hamstring muscles.  These were my only symptoms at onset. No fever, No Sand S of infection, etc.  VItals were stable. Lab work, including complete chemistries CBCD, ESR, and CRP, was all WNL. However, 5 days after onset with no improvement in the myalgias, my creatinine kinase (CK)was 402 ( normal up to 175). Over a period of an additional 8 days, the myalgias have gradually decreased, and my current CK level, as of 2/17, is 275.  My physician is terming it autoimmune myositis and believes it is from the vaccine. I have also had some mild tingling in my hands and feet intermittently that started soon after the myalgias. No true neurological deficits.  No other symptoms. I am the patient but also a docotrally prepared nurse practitioner, so that is why this patient report is in medical terminology.
experienced profuse nose bleeding from right nostril; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6208), via an unspecified route of administration in the left arm on 20Mar2021 at 13:30 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had previously received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6198), via an unspecified route of administration in the left arm on 27Feb2021 at 15:30 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 22Mar2021 at 16:45, the patient experienced profuse nose bleeding from right nostril and no treatment was received for this event. On 17Mar2021, 10Mar2021 and 03Mar2021, the patient underwent nasal swab test for COVID-19 and the result was negative for all the three times. The clinical outcome of the event profuse nose bleeding was resolved.   No follow-up attempts are needed. No further information is expected.
pt recv 2 doses of vax 1DEC95 & 29JAN96 & lab eval on 28AUG96 revealed negative immunity;
Sunday, February 28, 2021 around 7:30 to 9:00 consumer said the left side of his mouth felt different. Then as time went by we both noticed the left side was different. Couldn't smile on left side like the right side. His right eye blinked a lot more than the left eye. We did FAST testing for strokes. He was fine with his arms & legs. We went to the medical center around 2:00 p.m. They checked him out did a CAT Scan, they seem to think it is Bell's Palsy.  The put him on Prednisone and Valacyclovir and Eye Lubricant Drops. Consumer had a follow up with Dr on Tuesday March 2, 2021 at 8:45. He agrees with the diagnosis, however Dr wants consumer to Have an Ultra Sound on Neck and MRI Wednesday March 3, 2021 at 3:00 for US and 4:00 for MRI.
Patient states day after receiving Adacel injection she had vomiting and diarrhea.  No reddness or pain at injection site.  Symptoms have resolved.  Best friend (who did not receive adacel)also had diarrhea and vomiting.)
This case was reported by a physician and described the occurrence of syncope in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date in 2013 the subject received a dose of FLULAVAL (unknown details). In 2013, approximately 2 weeks after vaccination with FLULAVAL, the subject experienced syncope and tonic-clonic activity. In 2013, within months of vaccination with FLULAVAL, the subject experienced loss of consciousness. The subject is currently hospitalized. No further details were reported. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events were unspecified. The physician reported another case with FLULAVAL. See case A1045807A for details on the other case.
headache; lightheadedness; facial swelling; This is a spontaneous report received from a non-contactable healthcare professional. A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration and unspecified anatomical site on 16Mar2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 16Mar2021, during 15-minute waiting period after the vaccination, the patient experienced headache, lightheadedness, dizziness and facial swelling. The patient was treated with water, snacks and TYLENOL. The response to treatment was excellent. The patient was discharged on 16Mar2021 as she was stable to go home and was advised to follow up with the primary care physician. The clinical outcome of the events headache, lightheadedness and facial swelling were unknown.  No follow-up attempts are needed. No further information is expected.
Rising blood pressures and severe headache that wakes me from sleep. Blood pressures continued to rise until  2 days after when BP medication was switched to spironolactone.  3 days later, I presented to ER and additional medication was added to lower my blood pressure. Remains higher than baseline and headache persists although less intense
Patient reported to throat tightness, watery eyes and sore throat following first dose.  History of shellfish allergies.
I had a sore arm which is normal for me because I had it with the first one; This is a spontaneous report from a contactable consumer (Patient). A 61-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE mRNA, formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date (Age at vaccination was 61 years) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient was inquiring about side effect information regarding the Pfizer COVID-19 vaccine. Patient states She had recently gotten vaccinated, her first dose a little over 3 weeks ago and her second dose Wednesday. On Wednesday night, she had a sore arm which was normal for her because she had it with the first one. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up
Same day - some slight dizziness, and slight headache with sore right arm within 1 hour Same day - sharp tingling pain in neck  2nd day  -  sharp legs, and right fore finger, still sore left arm (injection site) 3rd day  - continual pin needle pain in legs, muscle aches, and joint pain, no longer pain in left arm of injection site 4th day - over-the-counter "Aleve" taken to treat muscle aches and join pain, still  need points pain in: calves, finger and neck 5th day - racing heart symptom (never had before), along with same nerve tingles in calves, finger, neck and now through-out back 6th day - miler symptoms
Sounds like Covid Arm.  Vaccine date : 2/15/21No treatment - just discovered it.  pink arm with itch.  Arm sore  for 4 days
COMPLAINS OF REDNESS AT INJECTION SITE, SEVERE PAIN.  FINE RASH ON ARM FROM SHOLDER TO WAIST ON 3/23/04.  GIVEN NAPROSYN 500MG TID - SUBSEQUENT REACTION TO NAPROSYN REQUIRED ED VISIT FOR BENADRYL AND SOLUCORTEF.
Sharp pin prickly feelings in my legs and arms. Less frequent now. Also I haves experienced mild hives intermittent since then.
First dose /administered on November 2019 / not sure of receiving the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 95-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, the patient did not remember receiving the 2nd dose of Shingrix. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Became lightheaded and sweaty 12:02 BP 98/71 HR 60 12:18 BP 113/80 HR 88
The patient presents to a local HCF on 12/30/2021 with altered mental status.  Upon admission to the ER patient was noted to be in severe sepsis with significant lactic acidosis metabolic acidosis leukocytosis and borderline low blood pressure and rapid Covid positive.  PNA on CT of chest.  MRI of brain shows punctate recent infarction.  The patient was intubated after a few hours in the ER, and had a central line was started on pressor and empiric antibiotics.  The patient had multiorgan failure including acute renal failure and severe metabolic acidosis.  Patient was given bicarb boluses and initiated on bicarb drip.  On 01/02/2022 patient underwent cardiac arrest without successful resuscitation and was pronounced dead.
shivering; running a fever; weakness; barely walk; This case was reported by a consumer via call center representative and described the occurrence of shivering in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th May 2019, the patient received Shingrix. On 9th May 2019, less than a day after receiving Shingrix, the patient experienced shivering, fever, weakness and walking difficulty. On an unknown date, the outcome of the shivering, fever, weakness and walking difficulty were unknown.   It was unknown if the reporter considered the shivering, fever, weakness and walking difficulty to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had the vaccine and started shivering, running a fever and am so weak that the patient can not barely walk.  The reporter asked how long would the patient feel like this.
Arm was sore as expected.  Red spots developed on chest first.  They do not itch or hurt.  I didn?t notice that the spots were all over the torso  - back,  abdomen, breast, and I may have some on scalp.     My allergy  Dr described as  fixed drug eruption and said the spots look like nummelar dermatitis - even though no itching.    She prescribed  Triamcinolone and I just started using.    I first went to my internist and she had no clue what it was or how to help.   I?ve never had anything like this  ever -  the only thing I?ve done differently in the last 3 weeks was getting vaccinated.   No way I?m getting the second dose.
medication error FLUBLOK was administered to two pediatric patients with no adverse event reported; Initial information received on 14-Feb-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 years old male patient who was administered Flublok with no adverse event reported, while receiving vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) (unknown dose, formulation, Lot number via unknown route in unknown administration site) as prophylactic vaccination; HEPATITIS A VACCINE INACT (HAVRIX) (unknown dose, formulation, Lot number via unknown route in unknown administration site) as prophylactic vaccination; and MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) (unknown dose, formulation, Lot number via unknown route in unknown administration site) as prophylactic vaccination.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (formulation: not reported)(lot QFAA2152 and expiry date: 30-Jun-2022) at a dose of 0.5 ml once via intramuscular route to the left quadriceps as prophylactic vaccination.  On 14-FEB-2022, the patient developed a non-serious event " flublok was administered to two pediatric patients with no adverse event reported" (off label use) (latency: same day) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Action taken with QUADRIVALENT RECOMBINANT INFLUENZA VACCINE (FLUBLOK QIV) was not applicable.  It was not reported if the patient received a corrective treatment for the event  At time of reporting, the outcome was Unknown for the event
Child had MMR and Prevnar on 4/11/06 at 12 month old well child visit. On 4/15/06 developed diarrhea and a bumpy diaper rash per mom. both of which have resolved. Developed fever last evening up to 103.1, 101.4 this am. Today 4/19/06 is playful happy but somewhat ataxic (wobbly legs, falls easily, different from exam last week). Child walks well normally. Some what better 4/20/06.
Date and time of vaccination: (list both if they received both shots):  Second shot was taken 2/16/21 at 1100 and first was taken 2 weeks prior.noticed fever after shower after work, about 2100 on 2/16/21
Headache, muscle aches, fatigue, nausea, insomnia, started around 4pm on 1/20/2021 and ended by the time I woke up at 6am on 1/22/2021. Took acetomenophen (unable to take NSAIDs) and lay down in darkened room. Ate small amount of BRAT diet. Felt totally recovered by 6am 1/22/2021.