chrisvoncsefalvay/vaers-outcomes huggingface dataset:
found no antibodies in her system; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION FAILURE (found no antibodies in her system) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder and Rheumatoid arthritis. Concomitant products included METHOTREXATE for Autoimmune disorder and Rheumatoid arthritis, ADALIMUMAB (HUMIRA) for Rheumatoid arthritis and Autoimmune disorder.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced VACCINATION FAILURE (found no antibodies in her system). At the time of the report, VACCINATION FAILURE (found no antibodies in her system) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, SARS-CoV-2 antibody test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the patient had her second dose of Moderna Covid-19 vaccine on 04-Mar-2021.  No treatment information was provided.  Company Comment: This is a case of a 78 year old female with reported adverse event of Vaccination failure after completion  of two doses vaccination with mRNA 1273. There is  very limited information regarding  this event that   has  been provided at this time. No further information  is expected at this time.; Sender's Comments: This is a case of a 78 year old female with reported adverse event of Vaccination failure after completion  of two doses vaccination with mRNA 1273. There is very limited information regarding  this event that   has  been provided at this time. No further information  is expected at this time.
This spontaneous report was received from a licensed practical nurse and refers to unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M000442, expiry date: 31-MAR-2018, dose and route of administration were not reported). No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. Follow up information has been received from the nurse on 08-MAY-2017. This case refers to 6 month old patient, who on 16-AUG-2016 was vaccinated with improperly stored doses of RECOMBIVAX HB and ROTATEQ (lot # L046319, expiry date: 28-SEP-2017, dose and route of administration were not reported). Reporting nurse did know why the temperature excursions occurred but there were no further excursions. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012794: US-009507513-1608USA012794: US-009507513-1608USA012908: Original case: 1608USA012916 US-009507513-1705USA004965: US-009507513-1705USA004973: US-009507513-1705USA004953: Original Case: 1608USA012916 US-009507513-1705USA004954: US-009507513-1705USA004952: Original case 1608USA012916. US-009507513-1705USA004967: US-009507513-1705USA004960:
Patient returned shortly after receiving the shot complaining of dizziness and lightheadedness.  The patient was positioned on the floor with her legs elevated and given a cold compress.  Patient refused to have an ambulance called.  After approximately 10 minutes lying on the floor the patient elevated to a sitting position and complained of nausea as well.  Patient sat for another 5-10 minutes, and then wished to leave.  She was escorted by her father who was with her the entire time to his car.  The pharmacy technician also helped to escort the patient to the car.
"egg" swelling, left upper arm/large egg shaped bump on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION ("egg" swelling, left upper arm/large egg shaped bump on arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included CLONAZEPAM, PRAMIPEXOLE, GABAPENTIN for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE INDURATION ("egg" swelling, left upper arm/large egg shaped bump on arm). On 31-Jan-2021, VACCINATION SITE INDURATION ("egg" swelling, left upper arm/large egg shaped bump on arm) had resolved.        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.   This case was linked to MOD-2021-094972.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Patient stated that she only experienced one event
swelling, redness, itching and pain in left arm; body aches, headache, dizziness, fever, nausea
couldn't do ADLs; throbbing pain; upper trunk weakness; couldn't sleep; loss of grip; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 31Mar2021 at the age of 64 years old (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. The patient was not pregnant at time of vaccination. The patient previously had BNT162B2 on 10-MAR-2021 02:00 PM at the age of 64 years old dose 1 via unspecified route in the left arm for COVID-19 immunisation. Medical history included penicillin allergy, allergies to sulfa drugs and food allergy from an unknown date. Concomitant medications included levothyroxine sodium, losartan, fluticasone propionate, salmeterol xinafoate (ADVAIR HFA), fluticasone, salmeterol (SERETAIDE DISKUS) and hydrochlorothiazide, telmisartan (PRITOR HCT); all taken for an unspecified indication, start and stop date were not reported. The patient previously took Ceclor. The patient experienced throbbing pain, unrelenting, upper trunk weakness, couldn't sleep due to pain and weakness, loss of grip, couldn't do ADLs on 02Apr2021 04:00 AM then went to PCP and was given Toradol shot IM, 6-day Medrol Dosepak,ref Neuro as treatment for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The patient has not been COVID-9 tested since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The facility where the most recent COVID-19 vaccine was administered was in the hospital. he patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On an unknown date, the patient was vaccinated with an improperly stored dose of M-M-R II lot # L027431, expiration date reported as 22-JUL-2017 (therapy type, dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 13.9 degrees Celsius for 3 hours 20 minutes. There was previous excursion of 14.2 degrees Celsius for 5 hours. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Burning sensation on the back of my neck, up behind my ear, and on my scalp.  After the first one I had the same sensation under my arm.
pt exp chills, vomiting, diarrhea, tiredness, pain @ inject site p/flu vax; while lying down reportedly lost consciousness 3 to 4 times for 10-15 seconds & 30-40 seconds;
Patient received incorrect vaccine formulation for age. No adverse reactions or events observed 15 minutes post immunization on 09/02/2022 or reported by mother on 09/29/2022.
So within the first three hours i had vertigo and blurry vision and a day later had a fever and the same weekend was short of breath and it was really painful. My chest was heavy nd at the night it got really bad and I had to go the emergency room and they gave me Toradol and checked my lungs and gave me steroids. I had a pdine when they ran the tests they did the CT scan and X-ray and blood work. Then they sent me home with steroids and by Monday. My eye sight was still blurry and shortness of breath. I went to the eye doctor and they said that I have inflammatory reaction and it was triggering my nerves. because of the inflammation they sent me back to the ER and they had a brain scan and did a scan again to see the inflammation. it was just the inflammation so they sent me back home and gave me a couple of medicines. my breathing is a little bit better and my vision is still blurry a lil bit but I am not comfortable driving. At the end of the day I had a allergic reaction.
Patient within 5 minutes started to feel funny and then passed out/blacked out. According to wife he did shake for less than 15 seconds in his arm and a bit in his head.  They were in the car, so she tilted the seat back for him and came in to get us.  Within the 30 seconds that she was gone he was awake and sweating profusely.  We gave him an ice pack, 25mg of liquid benadryl, and kept him laying back in the seat.  At 5 and 15 minutes mark the patient was checked on and he was completely fine.  After 20 minutes the patient had stopped sweating and reported to be feeling 98% better.
Patient began to experience tingling in the elbow all the way to the tip of their ear and up their neck on 9/1/2018. Patient stated that the injection seemed to be done in the correct spot and showed me where it was done and I can concur that the injection seemed to be administered in the proper location.
Moderate joint pain and stiffness of left shoulder and upper arm (side where injection was given) requiring OTC pain med (Advil or Tylenol) starting 5 days after injection; Moderate joint pain and stiffness of left shoulder and upper arm (side where injection was given) requiring OTC pain med (Advil or Tylenol) starting 5 days after injection; Moderate joint pain and stiffness of left shoulder and upper arm (side where injection was given) requiring OTC pain med (Advil or Tylenol) starting 5 days after injection; This is a spontaneous report from a contactable nurse who reported for herself. A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot #: EJ1685) via an unspecified route of administration on 22Dec2020 at 20:45 (at the age of 58-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included HTN (hypertension), hypothyroidism, and known allergies to PCN (penicillin), sulfa, losartan and lisinopril, all from unspecified dates and unspecified if ongoing. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (taken within 2 weeks of vaccination) included levothyroxine sodium (SYNTHROID), HCTZ and fish oil, all taken for unspecified indications from unspecified dates. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Dec2020 at 09:00, the patient experienced "moderate joint pain and stiffness of left shoulder and upper arm (side where injection was given) requiring OTC (over the counter) pain med (Advil or Tylenol) starting 5 days after injection." It was reported that the event was non-serious and did not require hospitalization. The patient did not receive any treatment for the event (also reported that the patient required OTC pain medications for the event). The clinical outcome of the event "moderate joint pain and stiffness of left shoulder and upper arm (side where injection was given) requiring OTC pain med (Advil or Tylenol) starting 5 days after injection" was not recovered/not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
mom reported high pitch unusual cry also pale/limp episode lasting <1hr w/in 12hr of vax;
Started with headache approx. 2pm that became massive. Progressed over next 4 hours to include fatigue, achiness, nasal congestion, 7 pm chills started. Arm soreness that started about 1 pm that increased in pain over next 6 hours to an extreme level of throbbing pain. Took Tylenol starting 7 pm and again at midnight. By morning chills were gone and nasal congestion started to subside.  Throughout second day remaining symptoms eventually subsided by that evening. Unable to go to work that day.
Red, hot, swollen; 4 inches below left shoulder and 6 inches above left elbow according to patient. Swollen area is about 5 inches in length and 5 inches in height according to patient. Adverse events started 10/17/2019. Doctor advise patient to start treatment of ibuprofen 800 mg every 6 hours and alternating between hot/cold pads today (10/18/2019).
Soreness at the injection site; A spontaneous report was received from a consumer concerning himself, a 65-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness at the injection site (vaccination site pain).  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 06 Jan 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Batch Number: unknown) in the left deltoid for prophylaxis of COVID-19 infection.  On 06 Jan 2021, after the vaccination, the patient experienced soreness at the injection. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was unknown.    The outcome of the event, soreness at the injection site, was resolved on 06 Jan 2021.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Sat evening past vaccines pt c/o burning sensation on internal parts of body, felt confused. Pt last seen Mon am 3 and found at 5pm ER Intubated, hypothermia, T 89 core, no B/P, to ICU x 3 days 3 days of floor.  11/10/06 Received only partial medical records requested from hospital.  T/C to hospital to request remainder of records.  Available records reveal patient admitted 10/23/06.  Was found unresponsive & unclothed in her bed by parent.  Last seen several hours prior.  EMS found her w/agonal respiration & O2sat of 73%, hypotensive, glucose 102, initial rectal temp 87.8.  Intubated in ER & given aggressive fluids. Admit DX: hypotension & shock of unclear etiology; altered mental status; profound hypothermia; anion gap metabolic acidosis most likely lactic acidosis; respiratory failure; elevated creatinine; mild leukocytosis; significantly elevated CPK most likely due to rhabdomyolysis; mily hypernatremia; hx of thyroid cancer; chronic back pain; hx of partial seizure disorder; bipolar disorder; PCOD; and obstructive sleep apnea.  Admitted to ICU & put on multiple antibiotics after cultured.   2/16/07 Received medical records from hospital which reveal patient d/c to home on 10/28 on inhaler, KCL supplement & continued oral antibiotics. FINAL DX: altered mental status w/acute respiratory failure with respiratory acidosis, metabolic acidosis, resolved, etiology uncertain; fever, probable aspiration pneumonia, improved; fatty liver w/elevated LFTs; rhabdomyolysis, resolved; mild hypokalemia; hx of bipolar dx; polycystic ovarian disease; partial seizures; chronic pain syndrome.
Fever (101), chills, muscle aches, headache, strong fatigue.  I had Covid-19  in Oct, 2020.
Approximately 18 hours after the vaccination (the next day when I awoke) I experienced a very sore arm with tenderness at the injection site, plus headache, body aches and chills. This subsided later that day, after approximately 10 hours. The arm at the injection site is slightly tender after 42 hours.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, once, lot # M004116, expiration date: 12-OCT-2017, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the vaccine underwent temperature excursions of 30 degrees Fahrenheit for 73 hours and 49 degrees Fahrenheit for 25 hours, respectively, that were captured using digital data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
A report has been received from a physician concerning herself who was exposed to a vaccinated person who received FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 02-Sep-2014. The patient was exposed to vaccinated person and experienced fever, headache and stuffy nose and which started on 05-Sep-2014. The outcome of the event of fever, headache, stuffy nose and exposure to vaccinated person is unknown. The report was considered to be non-serious by the reporter. The event of exposure to vaccinated person was identified by company physician from the source document and it was added as non serious event.
His doctor said that the lab report looked like Polycythemia Vera, but they were not sure; This spontaneous case was reported by a consumer and describes the occurrence of POLYCYTHAEMIA VERA (His doctor said that the lab report looked like Polycythemia Vera, but they were not sure) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-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 POLYCYTHAEMIA VERA (His doctor said that the lab report looked like Polycythemia Vera, but they were not sure) (seriousness criterion medically significant). At the time of the report, POLYCYTHAEMIA VERA (His doctor said that the lab report looked like Polycythemia Vera, but they were not sure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2021, Blood count: elevated (abnormal) Elevated. On 10-May-2021, Haematocrit increased: increased (abnormal) Increased. On 10-May-2021, Haemoglobin increased: increased (abnormal) Increased. On 10-May-2021, Red blood cell count increased: increased (abnormal) Increased.         It was reported that it look like Polycythemia. No concomitant medication was reported.   Treatment medication was not provided.  Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time.Further information has been requested.
I really don't know if this is at all related to the second vaccination but we were encouraged to report any odd experience.  About 27 hours after receiving the second shot, what appears to be a menstrual cycle began.  I last had my period in 2015.  For additional context, I have a history of fibroids and still have a good sized one.  In late February I had a spotting issue but what I'm experiencing now is a full on period.  I was already in contact with my PCP and an OB/GYN for testing related to the Feb. spotting event and as a result of that will be having an endometrial biopsy and hysteroscopy.  Outside of the above, I had a sore arm and bruising at the injection site.  Thank you
Injection arm became swollen; body aches; Injection arm became painful; Injection arm became warm; headache; rash and itch at injection site; rash and itch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Injection arm became swollen), VACCINATION SITE PRURITUS (rash and itch at injection site), MYALGIA (body aches), VACCINATION SITE PAIN (Injection arm became painful) and VACCINATION SITE RASH (rash and itch at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A27A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included RAMIPRIL, PROPRANOLOL and ROSUVASTATIN for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 09-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (rash and itch at injection site) and VACCINATION SITE RASH (rash and itch at injection site). On 30-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Injection arm became swollen), MYALGIA (body aches), VACCINATION SITE PAIN (Injection arm became painful), VACCINATION SITE WARMTH (Injection arm became warm) and HEADACHE (headache). At the time of the report, VACCINATION SITE SWELLING (Injection arm became swollen), VACCINATION SITE PRURITUS (rash and itch at injection site), MYALGIA (body aches), VACCINATION SITE PAIN (Injection arm became painful), VACCINATION SITE RASH (rash and itch at injection site), VACCINATION SITE WARMTH (Injection arm became warm) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up information received on 13-May-2021 contains non-significant information, Reporter contact information updated On 13-May-2021: no new information was reported
Provider ordered Dtap, I gave kinrix (Dtap, IPV) instead of Dtap. Patient had last Dtap on 12/20/2019 Last Polio 12/20/2019. Spoke with on call nurse with vaccination information, she stated patient will need Polio at age 4.
PREPARATION AND ADMINISTRATION ERROR. PATIENT RECEIVED 180 MCG OF PFIZER COVID 19 VACCINE IMx1.
MAY97 mom states pt rt arm started to swell from shoulder to elbow from Thursday PM thru Sunday;devel t102.6;c/o extreme achyness & fatigue;By monday moset of swelling gone feeling fine;mom did not seek med care;instructed to call MD
My son reported eye hurt on 6/13 afternoon, lasting about 30-45 min, then the pain moved to the nose for about another 45 min. Then both the eye and the nose pain were gone. He was having a headache and a fever at about 100.3 for the afternoon and night.  He is all better today, no more side effect.