chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Small papules on anterior thighs the day after the vaccines.  Bloody diarrhea 6 days after the vaccines.  Treated in ER, local hospital, transferred to pediatric facility, treated with vasopressors and dialysis for presumed hemolytic uremic syndrome.  10/07/2008 Reviewed hospital medical records of 8/14-8/30/2008. FINAL DX: post infection HUS characterized by hemolytic anemia, thrombocytopenia & ARF requiring CRRT; E.coli enterocolitis Records reveal patient experienced emesis, diarrhea which became bloody diarrhea, fever.  Transferred from outlying hospital.  Exam revealed rash on thighs s/p vaccination, resolving.  Admitted to PICU.  Transfused PRBCs, platletets.  Received 11 days of CRRT.  Nephro consult done.  During hospital stay, blood pressures very labile.  Tx w/norepinephrine for hypotension & nicardipine for hypertension; IV antibiotics.  Had mild pancreatitis on admit.  NPO for few days then fed breast milk via NJ tube until able to take orally.  BUN/creatinine, Hct, plts slowed improved as did UOP. D/C to home w/weekly labs, PCP & nephro f/u.  9/19/08 Reviewed hospital medical records of 8/13-8/14/2008. FINAL DX: vomiting, diarrhea & dehydration. Records reveal patient experienced vomiting, fever, pale, irritable, lethargy & diarrhea w/blood in stool x 1 day.  Seen in PCP office w/guiaic (+) stools.  Breastfed.  Tx w/IVF.  Papular rash on thighs & under neck.  GI & ID consults done.  Transferred to higher level of care.
Itching at injection site.  Redness.  Headache.  Lump under skin.  Lasting for a week.
This spontaneous report as received from a Certified Medical Assistant refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 26-NOV-2014, the patient was vaccinated with PROQUAD (Merck), 0.5 ml, subcutaneous (strength and lot number were not reported). Secondary and concomitant therapies were not reported. Medical assistant reported that patient was administered PROQUAD (Merck) that had been improperly stored. No adverse effects reported. Additional information has been requested.
Weak; Heart pounding; Her body was feeling funny; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (Weak), PALPITATIONS (Heart pounding) and FEELING ABNORMAL (Her body was feeling funny) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced ASTHENIA (Weak), PALPITATIONS (Heart pounding) and FEELING ABNORMAL (Her body was feeling funny). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 20-Mar-2021, ASTHENIA (Weak), PALPITATIONS (Heart pounding) and FEELING ABNORMAL (Her body was feeling funny) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2021, Blood pressure measurement: Blood pressure shot way up..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Migraine, muscle cramps, fever, chills, fatigue. Seen in ER for migraine after 4 days
Information has been received from a medical assistant concerning a female patient who on an unspecified date, was vaccinated with a dose of GARDASIL (lot# not reported).  Subsequently, the patient fainted after administration of GARDASIL.  She was revived with smelling salts but it took the patient a good 30 minutes to feel normal again.  Additional information has been requested.
Simple febrile seizure- Seen in ER for febrile seizure (simple), that occurred 24 hours after the vaccines were administered. The seizure was not witnessed in the ER but mother reported 1.5 minutes of seizure activity before calling EMS. No other significant signs of infection on ER workup. Was discharged from ER after evaluation.
moderate fever x 3day;vomiting x 3day;lethargy x3day;
Swelling of right arm, massive bruise about the size of an orange and red/purple as a berry. Low-grade fever, chills and hot flashes so severe that sometimes I can't put on five blankets and get warm and/or take off all the blankets and get cool. Systemic weakness that makes it next to impossible to move and/or do any activity; this issue has kept me housebound since the evening of the injections. A migraine so terrible that if I move my head, it sends sharp shots of pain all over my skull. And finally, random aches, throbs and pains in various muscles across my body that seem to have no pattern whatsoever. Again, these symptoms have kept me bedridden since the injections.
Numbness on left side of tongue within 4 minutes of receiving vaccine. Transient Dizziness and shortness of breath 2 hours later. Fatigue 3-10 hours later. Severe joint pain in hands about 8-12 hours later. Transient. Pain and stiffness in hands and feet/Achilles tendons 36 hours later. Transient. Reduced sensation and feeling of heaviness, puffiness on left side of face 40 hours later. Unknown duration.
This spontaneous report as received from a nurse refers to an unknown number of patients of unkonwn demographics. The patient's current conditions or medical history were not reported. On an unknown date, the patients were vaccinated with an unknown number of doses of PNEUMOVAX 23 (dose, route, lot number and expiration date were not reported) that were exposed to temperatures outsides of those specified in the prescribing information (improperly stored). No adverse effect reported. This is one of several reports from the same reporter. Additional information has been requested.
1st dose on 24Sep2020 and did not receive 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 24th September 2020).   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 case. The patient received her 1st dose of Shingrix and did not receive 2nd dose till the time of reporting, which led to incomplete course of vaccination. No lot or Expiry Date provided when asked as 1st dose was administered at different facility. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021212544:Same patient - FU1 deleted case
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer, Case MOD22-013894. The manufacturer tested the lot number 084J21A. Data revealed that the vaccine administered on Feb16-March 31st, 2022, from lot number 084J21A maintained activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. No ill effect post administration was reported.
The patient received the monovalent covid vaccine versus the bivalent vaccine. The patient did not experience any adverse side effects.
2hrs p/vax chills,hyperventilation,malaise,cough,fever (t100.9);APAP,motrin,IV Nacl,heparin lock
Patient reports waking up in the morning weeks after vaccine administered with a migraine and feeling generally "same as after the vaccine", upon rising up he experienced strong nosebleed...first time in his life.
1/3/2022- Arrived at ER, c/o weakness, dizziness, chills and cough. T-100.7 .WBC-14. CRP-13.9 Covid + test. O2 sat 88% placed on 4L o2 via NC, maintaining O2 around mid 90's. Admit with acute hypoxic respiratory failure with sepsis and bilateral Covid-19 pneumonia. Started on IV decadron, baricitinib and remdesivir. IV Ceftriaxone and Doxycycline.  1/6/2022- D/C decadron-volume overload. Continue baricitinib, remdesivir and Doxycycline. Positive Blood culture Beta-hemolytic strep B, ceftriaxone ordered. D/C Vancomycin. 1/7/2022- WBC 10.8. CRP 5.7, afrebile and no supplemental oxygen needed.  1/10/2022- LFT's- AST 61 ALT 92, CRP 3.1.  WBC-17.2 1/12/2022- WBC down to 16.3 Continue IV antibiotics for bacteremia.TEE co 1/12/2022- TEE completed-unremarkable.  1/13/2022- WBC down to 11.4 and CRP was 3.1. Continue Rocephin for 4 weeks. Discharged to home.
This past weekend, I noticed that my arm had a dull ache. I happened to look at it, and I found a hive/welt where I received the Covid vaccine.  My arm hurt right after getting the vaccine for a day or two but then it seemed find until this past weekend.
no additional AE's; PNEUMOVAX 23 was administered to 3 year 1 month old patient on 9/2/2021 rather than 4th dose of PREVNAR 13; This spontaneous report has been received from a medical assistant regarding to a and refers to a 3-year-old male patient.  The patient's medical history, concurrent conditions, concomitant therapies, and previous drugs reactions or allergies were not reported.  On 02-SEP-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, at a dose of 0.5 milliliters (mL) once (lot #T021329 confirmed to be valid, expiration date: reported and stablished as 03-OCT-2021) administered for prophylaxis (strength, and route of administration were not provided), instead of the fourth dose of pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) (wrong product adminsitered). Prior to that, the third dose of pneumococcal vaccine conj 13v (crm197) (PREVENAR 13) was administered on 14-MAR-2019. No additional adverse events (AEs).
Injection site pain; Swollen lymph nodes under left armpit..inject site; Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever 100.1; Nausea; Slight breathlessness; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO173) via an unspecified route of administration in the left arm on 08May2021 at 14:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included daily vitamins (MANUFACTURER UNKNOWN), from an unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO162) via an unspecified route of administration in the left arm on 17Apr2021, at 15:00 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. On 09May2021 at 00:00, the patient experienced injection site pain, swollen lymph nodes under left armpit inject site, tiredness, headache, muscle pain, chills, joint pain, fever 100.1 (units unspecified), nausea and slight breathlessness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of events. The clinical outcome of the events injection site pain, swollen lymph nodes under left armpit inject site, tiredness, headache, muscle pain, chills, joint pain, fever 100.1 (units unspecified), nausea and slight breathlessness was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Day after vaccine, vaccinate arm was sore in the morning, consistent soreness continued for 4-6 weeks, in recent past, pain has mitigated (less severe) and in past few days no pain. Pain comes and goes, not aggrevated by moving arm. No swelling at injection site, not arthritis pain, felt like I was punched in the arm.
High temp, headache, vomiting, dizziness x 2 days much improved now.
joints stiffness; muscle pain; joint pain; Fingers on both hands were stocked (Could not make a fist) After the SECOND Dose; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Fingers on both hands were stocked (Could not make a fist) After the SECOND Dose), JOINT STIFFNESS (joints stiffness), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 037K20A) for COVID-19 immunisation.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Fingers on both hands were stocked (Could not make a fist) After the SECOND Dose), MYALGIA (muscle pain) and ARTHRALGIA (joint pain). On 28-Mar-2021, the patient experienced JOINT STIFFNESS (joints stiffness). On 25-Feb-2021, MUSCULOSKELETAL STIFFNESS (Fingers on both hands were stocked (Could not make a fist) After the SECOND Dose), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) had resolved. At the time of the report, JOINT STIFFNESS (joints stiffness) had not resolved.            No relevant concomitant medications were reported. The patient did not take any treatment medication. Action taken with mRNA-1273 in response to the events was not applicable.
Six hrs after vax, face became red, blotchy and hot. Rash on neck, shoulders, arms and (L) leg. Face puffy and eyes swollen the next day. Saw PCP - dx with allergic reaction - lasted 5-6 days.
Immediated post-vaccination, patient reported swelling of face and jaw, chest tightness, and anxious. Able to speak, swallowing, and breath. No swollen of throat, denied n/v. Vital signs were within the normal range. Oriented x3. Patient reported she also suffer from anxiety disorder. Patient reported worsening of chest tightness and difficulty breathing after 5 minutes. Encouraged deep breathing exercise, water and icepack offered. EMS activited. Patient was sent to the hospital  via EMS, accompanied by her boyfriend.
Highest temp measured 106, "brief jerking" described by family on @ least 3 occasions;
chill, hot flashes day of vaccine and during the first night, extreme headache for the first week , fatigue for at least 2 months, nausea, dizziness for the first day, mild headaches lasted for at least 2 months since vaccination
"he felt hot, then felt cold"; "tight muscles in his neck"; "it hurt really bad"; chills; "super bad headache"; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Jun-2021 and was forwarded to Moderna on 03-Jun-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE ("he felt hot, then felt cold"), MUSCLE TIGHTNESS ("tight muscles in his neck"), MYALGIA ("it hurt really bad"), CHILLS (chills) and HEADACHE ("super bad headache") in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE ("he felt hot, then felt cold"), MUSCLE TIGHTNESS ("tight muscles in his neck"), MYALGIA ("it hurt really bad"), CHILLS (chills) and HEADACHE ("super bad headache"). The patient was treated with IBUPROFEN at a dose of 200mg. On 27-May-2021, FEELING OF BODY TEMPERATURE CHANGE ("he felt hot, then felt cold"), MUSCLE TIGHTNESS ("tight muscles in his neck"), MYALGIA ("it hurt really bad"), CHILLS (chills) and HEADACHE ("super bad headache") 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.   No concomitant medications were provided.
Administered above vaccine past 75 days of storage in the fridge to 25 days past BUD. I'm calling all 55 patients to let them know their options.
No adverse effects were reported; Patients were administered improperly stored vaccines doses; This spontaneous report was received from a registered nurse, concerning a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 16-APR-2019, the patient was vaccinated with improperly storage doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis, lot #R034700 and expiration date 16-JUN-2020 (strength, dose, frequency and route of administration were not reported); with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, lot #R033080 and expiration date 06-JUN-2020 (strength, dose, frequency and route of administration were not reported); and with hepatitis a vaccine, inactivated (VAQTA) for prophylaxis lot #S001485, expiration date 12-MAY-2020 and lot #R012988 and expiration date 30-MAY-2019. No adverse effects were reported.   The temperature excursion was reported as below 36°F (35.4°F) during a time frame of 27 minutes. Previous temperature excursion was reported as below 36°F (35.4°F) during a time frame of 15 minutes.   A digital data logger was involved.    This is one of several reports received from the same  reporter.; Sender's Comments:  US-009507513-1904USA012221: US-009507513-1905USA002744: US-009507513-1905USA002745: US-009507513-1905USA002746: US-009507513-1905USA002747: US-009507513-1905USA002748: US-009507513-1905USA002749: US-009507513-1905USA002750: US-009507513-1905USA002751: US-009507513-1905USA002752: US-009507513-1905USA002753: US-009507513-1905USA002754: US-009507513-1905USA002755: US-009507513-1905USA002756: US-009507513-1905USA002757: US-009507513-1905USA002758: US-009507513-1905USA002759: US-009507513-1905USA002760: US-009507513-1905USA002761: US-009507513-1905USA002762: US-009507513-1905USA002770: US-009507513-1905USA002764: US-009507513-1905USA002765: US-009507513-1905USA002766: US-009507513-1905USA002767: US-009507513-1905USA002768: US-009507513-1905USA002769:
The single use diluent that was used to prepare the COVID vaccines was used to prepare 2 other COVID vaccines given that day.
No symptoms were reported by any of the patients; Improperly stored vaccines administered; MMR II Lot: S039309 Exp: 4-DEC-2021, but upon internal validation established as 31-MAR-2018; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On 14-MAY-2021, the patient was vaccinated with one improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (formulation, strength, exact dose, vaccination scheme frequency, route of administration, and anatomical location were not reported; lot number S039309, which have been verified to be a valid lot number, expiration date reported as 04-DEC-2021, but upon internal validation established as 31-MAR-2018) as prophylaxis (product storage error and expired product administered).  The administered dose of the vaccine experienced a temperature excursion of 50 degrees Fahrenheit (F) for 10 minutes, as recorded by a data logger. There was no previous temperature excursion reported. No adverse events were reported.; Sender's Comments:  US-009507513-2105USA003872: US-009507513-2105USA003873: US-009507513-2105USA003867:
roughly the middle of March started experiencing occasional numbness and tingling in hands and forearms. then in beginning of June started experiencing more frequent numbness and tingling, that turned into shock-type pains in my elbows, and pin-prick type feelings in my fingers. my hands and arms began feeling like they were asleep a good portion of the day as well. in the last week or so I have also started getting numbness in my feet as well, and that "fallen asleep" feeling.
Per Mom immediately after immunization patient had itching and slight redness at site. Swelling and redness at site has grown since date she had immunization. Mother became concerned and returned today to have rechecked on day 5. Upon inspecting site, on left deltoid area it is red, and slightly raised in circular pattern around site. Approx 2 inch in diameter or the size of a small apple. Slightly warm to touch. Site was being actively scratched by patient. Advised to use cold compress for site reaction. TYLENOL is needed for discomfort. Mother is to report back if symptoms do not lesson or if she is concerned or has questions.
3-21-12 fainted briefly, dizziness, chest tightness, headache, tiredness, body jerking, throat swelled, burning sensation in my chest and throat tasted like metal, felt like my veins were on fire. Weakness brought to E.R was told it was vertigo. Was sent home 2 hours later was back in E.R they said allergic reaction gave me something for anxiety sent me back home. 3-22-12 numbness in tongue, headache, tired, nausea, muscle weakness, dizzy, lightheaded, pain in all my joints. 3-23-12 radiating pain at injection site in my shoulder down my arm hand went numb. Other wise still feeling the same as the day before. 3-25-12 blurry vision, stomach pain, fever headache, joint pain, muscle weakness, still dizzy, burning chest pain. 3-26-12 still feeling the same. 4-4-12 gastrointestinal problems. 4-11-12 new onset pain in other shoulder with numbness in hand, still weak, dizzy, headache, stomach ache, joint pain, muscle weakness, pain is in both shoulders and arms now.
pt recv vax in 1987 & pt devel severe myalgias that lasted for 3wk a/pt recovered;
Headache & tinnitus.  Prednisone steroids prescription for 5 days and allergy nasal spray.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Severe, Additional Details: Patient stated having increased nerve pain from injection site down to her fingers, and has visible red bruise from injection site
The injection seemed weirdly placed. Not in my deltoid muscle but rather in between my triceps and deltoid (I took a picture for record). The injection was very painful and my arm began to slightly twitch near after, but very greatly noticeably later that evening around 8:30. The twitching persisted for 5 days and inhibited sleep one night.
Administered Monovalent vaccine after the 9/1/22 switch to the Bivalent for the Boosters.  Unaware of any signs or symptoms of negative reaction occurred to patient.