chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse concerning a 51 year old male with a cardiac history with surgery and no drug reaction or allergies who on 06-OCT-2010 was vaccinated with PNEUMOVAX 23 (lot # 667418/0978Z, expiration date 21-DEC-2011). This was the first time the patient received PNEUMOVAX 23. Concomitant therapy included atenolol, lisinopril (manufacturer unknown), ezetimibe (+) simvastatin and CLARINEX. On 07-OCT-2010 the patient experienced arm pain and swelling with 2 raised red areas. One area was 1 cm x 1.5 cm at the injection site. One inch to the left was the second area which was 8 cm x 9 cm raised, warm and red. He was seen in the office on 07-OCT-2010, 08-OCT-2010 and on 11-OCT-2010. The patient was treated with TYLENOL and ice. No lab/diagnostics studies were performed. On 10-OCT-2010 the patient recovered from the events. Follow up information was received from the Registered Nurse (R.N.) who reported that on 05-OCT-2010 (previously reported as 06-OCT-2010), at 13:50 pm, the 51 year old male patient was vaccinated with the first dose of PNEUMOVAX 23 (lot # 667418/0978Z) intramuscularly into the right deltoid. The patient also received on the same day, at 13:50pm, concomitantly the first dose of AFLURIA (Lot # reported as 11049121A) intramuscularly into the left deltoid. It was reported that on 06-OCT-2010, previously reported as 07-OCT-2010, the patient experienced 1cm x 1.5 cm redness at injection site to left of injection site 8cm x 9 cm redness and heat raised. The patient also complained of pain at site. It was reported that the patient recovered on 10-OCT-2010. It was reported that the patient did not seek medical attention. No further information is available.
shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2019, the patient received the 1st dose of Shingrix. In June 2019, less than a year after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient for self. The age at vaccination was not reported. The patient received the Shingrix in mid March 2019 and had mild shingles 4 weeks ago, from the reporting date. The patient was treated by the physician and everything cleared up. The patient was inquiring if 2nd dose could be received, as the patient was okay to get 2nd dose.
Major arm pain from shoulder to hand felt like a charlie horse. Red rash down my arm very feverish felt like an open blister scraping against sand paper. Severe Hot and cold flashes.
2 weeks after vaccine I experienced chest pain, bilateral foot pain and swelling, it felt like something was stuck in my throat, and a large raised itchy rash that moves from different places every day (wrist, feet, arms, hands, neck andlower back).
No adverse effect; Second dose of product administered at earlier than recommended time; This spontaneous report as received from a physician assistant refers to an 18-year-old patient of unknown age. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided.  On 26-DEC-2018, the patient was vaccinated with the first dose of an unspecified hepatitis a vaccine (exact dose, route of administration, injection site, lot# and expiration date were not reported) for prophylaxis. On 16-MAY-2019 in an office, at earlier than recommended time from the first dose, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) intramuscularly (IM) for prophylaxis (exact dose, injection site, lot# and expiration date were not reported). There was no adverse effect reported.
Stinging when injection given.  Arm pain, redness, swelling, 2-3 days after injection.  Covid arm began with soreness  14 days after injection.  Rash with bright red border appeared on 3/29/21.  Painful, hot to touch, swollen.  Rash fadeded after 2 days.  Soreness continued for 2 weeks and has not quite gone away at this time.
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 10:57 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 11:06 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 49.45 for dose administered on 28-Feb-2021 and 49.53 for dose administered on 28-Mar-2021.  No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion on 28-Feb-2021 with temperature 27 degrees Fahrenheit at 09:00 AM and 26-degree Fahrenheit at 01:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021.  Batch number 019B21A underwent temperature excursion on 28-Mar-2021 with temperature 35 degrees Fahrenheit at 10:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
Loss of taste. Onset was approximately 2/15/2021 to present (2/25/2021)
Patient reported that upon rcvding the 1st dose she experienced an immediate electric shock in her joints specifically in the knees and ankles, which went away immediately. Then approx. 25 minutes later she experienced tingling lips which went away, and soreness in her left arm (lasted for approx. 30 hours before it went away). Approx. 30 hours from rcvding the vaccine she reported having a hive reaction on her left upper arm (described as 1 small bump size of a pencil eraser and it was itchy), and then approx. 48 hours from the vaccine she noticed another hive spot on her left shoulder blader (described as 1 small bump size of a pencil eraser also) - upon discovering these hive spots she reported they disppear immediately. Approx. 4 days from the vaccine date she experienced diarrhea which lasted for 4 days (diarrhea was worse in the morning compared to in the evening). She also experienced food diversion for a few days.    What happened as a result of the adverse event? (doctor visit, ED or urgent care visit, hospitalization, life threatening illness, disability/permanent damage, death, none of these): Patiented reported she had applied an ice pack on her left arm - this caused the bump to disappear immediately. Also stated she took Tylenol for her headache.    Ever have a reaction to a previous vaccine?  If yes, what? None.  ***NOTE*** Patient called because she was concerned about getting her 2nd Pfizer dose (schedule for 4/6/2021) based on her 1st reactions to the vaccine. Patient reported she had been in contact with her PCP and even reached out to Pfizer regarding her concerns but got no where. Discussed with patient that based on the ADE she provided and her medical history, these are not a contraindication from getting the 2nd dose. The decision would be up to her based on the informations provided and benefits vs risks assessment. Suggested that she can consider getting her 2nd dose at a hospital or at PCP office so she can be monitor a little longer by a healthcare professional if she was concern (patient reported that she have the 2nd dose schedule to be administer at a hospital on 4/6/2021). Recommend that if she experience any localized reactions upon rcvding 2nd dose, can take Benadryl (counseled can experience drowsiness).
patient states she had seizures the weekend following the vaccine administration; patient got home in the afternoon, patient was eating baked potato and felt choking sensation, couldn't open mouth, stuck fingers in her mouth, popped jaw open, and started throwing up. She thought "i need to go to the bathroom" but doesn't know if she made it or not. Then she woke up 3 times (living room, kitchen, in front of bathroom door), and she recalls body was jerking, shaking, and she had no control, until she gained recollection on Monday, where she found herself on the couch without knowing how she got there (she lives alone).
Pt. states that after receiving the 3rd dose of Phizer 12/03/2021, started experiencing symptoms 12/09/2021 of shortness of breath and fluttering in the heart. Still experiencing symptoms, No noted Primary visit/communications. (Previous 1st dose of Phizer 04/05/2021. 04/21/2021 Blood Work = White Blood Cell count Low)
2/2 - immediate dizziness, pallor. 2/3 - next day chest pain - seen urgent care. 2/20 - urgent care - DX sinusitis. 3/3, 3/6 - still C/O chest pain and wheezing and cough - despite ABX for sinobronchitis from 3/3/17 visit, CXR (-). 3/9/17 - C/O feeling hot and flushed.
Red Eyes, swollen palete under tongue and cough. Treatment -IV and medication at home: diphenhydramine, famotidine, prednisone.
Patient not feeling well, vomiting, color pale. EMT's called, smelling salts given.
This spontaneous report was received from a male patient of unknown age, referring on himself. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency, route, lot # and expiration date were not reported). No concomitant medications were reported. Subsequently a week later (on an unspecified date), the patient got a case of shingles. At the time of the report, the outcome of shingles was unknown. The relatedness between the shingles and ZOSTAVAX was not provided. No product quality complaint was involved. Additional information is not expected as no reporter's contact details were provided.
(L) arm pain/redness/swelling at injection site, myalgias felt like flu symptoms. Was warm/subjective fever, took ADVIL. Temp in office 99.4, feels better now.
Five mins after getting the vaccine while waiting the patient stated shaking and coughing. She was stuttering and grab her throat. The pharmacist noticed what was going on and came over to assist. The pharmacist ejected her with a epic pin. Patient became to calm down. Patient stated that she is still stuttering over a few words. Patient also received a dry cough that she did not have until after getting the receiving,
Approximately two days after flu mist received, I had flu symptoms of sneezing, runny nose, headache, sore throat.  Symptoms worsened to include chest and ear pain, joint pain, and dizziness over the next few days, and then a cough.  All symptoms liveable with over the counter medications.  Biggest problem is that flu mist was recommended since I have a 4 month old daughter who could not be vaccinated, but now I am very contagious and coughing and sneezing.  I don't understand why it was recommended for me to get the flu mist to protect my daughter when it is creating a problem that otherwise might not have existed.    I'm still sick so I don't know how this will end, but it feels very much like I just have an ordinary miserable case of the flu, so I expect it to run its course.
Swollen nymph nodes under arms for 3 weeks now.  Still continues to be swollen today.
covid vaccine breakthrough case  dose 1 Pfizer 4/7/21 037A21B
Patient endorsing throat tightness, difficulty talking deep breath, swelling of face and lips post #2 covid vaccine. Premedicated at home with singulair last night and this morning. VSS, 02 100%, slightly tachycardic, hypertensive with ongoing stressors of appointment. No chest pain or palpitations. Due to ongoing HSR symptoms and lack of response to premedications at home, administered EPIPEN in infusion room at 105pm in right lateral thigh. VSS monitored every 10 minutes remained stable.  Continued to report mild throat tightness, slight improvement in breathing, improvement in facial edema.  Administered Benadryl 25mg IM in clinic, referred to ED for continued monitoring due to incomplete resolution of symptoms. Of note, patient is able to tolerate low doses of benadryl, experiences pruritus with high dosing.  Unable to obtain IV access to collect tryptase level in light of HSR, requested to obtain at ED in order to avoid delay in transit.
This spontaneous report as received from a nurse refers to an 8 months 4 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) LIQUID PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
joint pains; headaches; This is a spontaneous report from a contactable other health professional. A 66-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3246), intramuscularly on 11Jan2021 at 10:00 at a single dose for COVID-19 immunization.  Medical history included pre-diabetic from an unknown date and unknown if ongoing, high cholesterol from an unknown date and unknown if ongoing; known allergies: no. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; first dose-lot number: EJ1685, intramuscularly, in the left arm at 19:30) for COVID-19 immunization on 22Dec2020. Concomitant medications included calcium (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), vitamin d (MANUFACTURER UNKNOWN), simvastatin (ZOCOR); all taken for an unspecified indication from an unspecified date to an unspecified date. On 12Jan2021 at 03:00, the patient experienced: joint pains and headaches; no treatment was reached.  The clinical outcome of the events was recovered in Jan2021. There were no other vaccines within four weeks of the suspected vaccine. The patient did not have COVID prior to the vaccination. The patient was not tested for COVID post vaccination.
Chest pain, having to take deep breaths starting approximately 8/16.  As week went on it continued and increased.  Crushing feeling, pain, especially in evenings.  Worse with laying on back.  Fatigue.  Today is 8/20/21.  Persist.
Golf ball size knot in upper left arm. It was extremely sore, red and hot to the touch. My doctor put me on antibiotics for 7 days.
Started screaming and croupy cough for 1/2 hour after both 2 month and 4 month shots. Mom states he was unconsolable and extremely fussy.
Information has been received from a certified nurse midwife concerning a 21 year old female with asthma, oesophageal acid reflux, penicillin allergy and a history of mononucleosis syndrome (Mono) in 2001 who on 24-MAY-2007 was vaccinated with Gardasil (lot# 657736/0389U) IM left deltoid. Concomitant therapy included LOESTRIN. On 25-MAY-2007 "24 hours after vaccination" the patient experienced high fever and viral type symptoms (type of symptoms unspecified). Medical attention was sought. The patient went to the emergency room. At the time of reporting it is unknown if the patient had recovered. No further information is available. This is one of two reports from the same source. Additional information has been requested.
After vaccine was introduced felt slight swelling discomfort of left arm (had to remove and reseat my watch strap) followed by both arms seeming flushed (reddish).  Ignored both symptoms at the time. About 30 minutes after vaccine on my way home in the car throat started feeling swollen and I found it difficult to swallow. Lips and tongue felt swollen (even though they didn't loot it). Metallic taste in mouth and could smell a weird earthy smell. Went to ER to seek assistance, by the time I got to the ER symptoms were starting to subside.  Kept under observation for the rest of the afternoon before being discharged Prescribed an EpiPen and followed up with Primary Care Physician.  After about a week started feeling a pain deep in my right calf, no other symptoms so have not sought medical care.  Today 2 weeks after vaccine still have slight pain in calf, seems to be subsiding with time.
Non Hodgkins Lymohoma post Pizer vaccine/non-Hodgkin's lymphoma which infected the skin "mycosis fungoides"; non-Hodgkin's lymphoma which infected the skin "mycosis fungoides"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 57-year-old female patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 2, single (Lot number: EL8982) at the age of 56 years for covid-19 immunisation. The patient's relevant medical history included: "Raynauds" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Migraine" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism; TOPIRAMATE taken for migraine. Vaccination history included: BNT162b2 (Batch/lot number: EL0142   , Dose 1), administration date: 15Jan2021, when the patient was 55-year-old, for covid-19 immunization. The following information was reported: NON-HODGKIN'S LYMPHOMA (medically significant), outcome "unknown", described as "Non Hodgkins Lymohoma post Pizer vaccine/non-Hodgkin's lymphoma which infected the skin "mycosis fungoides""; CUTANEOUS T-CELL LYMPHOMA (medically significant), outcome "unknown", described as "non-Hodgkin's lymphoma which infected the skin "mycosis fungoides"". The patient underwent the following laboratory tests and procedures: Lab test: Unknown results. Therapeutic measures were taken as a result of non-hodgkin's lymphoma, cutaneous t-cell lymphoma.  Additional information: Consumer stated, "I received an email after I reported some symptoms post COVID vaccination and they emailed me back saying that they would like to speak to me directly and they gave me a reference#." When asked if have any questions regarding the Side effects: Consumer stated, "I only have one. I have Non-Hodgkin's Lymphoma now, It's a Mycosis Fungoides. There are only 6 cases per million reported. I want to know if there are other reported cases post COVID vaccination." Prior Vaccinations (within 4 weeks): Consumer stated, "No." Consumer further stated, "I am now on a chemotherapy ointment. It is called Valchlor. It is a topical ointment. That is for my Mycosis Fungoides, the Non-Hodgkin's Lymphoma. Consumer stated, "I am in treatment now. The last prescription (Valchlor) that I told you, that is the treatment that I am in now. Prior to the chemotherapy ointment, I was using Triamcinolone Acetonide ointment. Those are the two treatments that I am currently using for my Non-Hodgkin's Lymphoma. I am using both."
Light headed; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed) and PAIN IN EXTREMITY (Sore arm) 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 DIZZINESS (Light headed) and PAIN IN EXTREMITY (Sore arm). At the time of the report, DIZZINESS (Light headed) and PAIN IN EXTREMITY (Sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication history not reported. Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: TCR  received and Updated the event outcome to Recovered/Resolved
Redness to bilateral thighs after vaccines, right was greater than left.  Right thigh has redness, swelling, warm to touch.
My blood pressure was 101/52/ low blood pressure; CHEST PAIN; NAUSEA; CHILLS; MYALGIA; I received the dose at 4pm, I wasn't feeling well when I went to bed.; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (I received the dose at 4pm, I wasn't feeling well when I went to bed.), HYPOTENSION (My blood pressure was 101/52/ low blood pressure), CHEST PAIN (CHEST PAIN), NAUSEA (NAUSEA) and CHILLS (CHILLS) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020F21A and 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not provided by the reporter.  Concomitant products included MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021 at 4:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MALAISE (I received the dose at 4pm, I wasn't feeling well when I went to bed.). On 09-Sep-2021, the patient experienced HYPOTENSION (My blood pressure was 101/52/ low blood pressure), CHEST PAIN (CHEST PAIN), NAUSEA (NAUSEA), CHILLS (CHILLS) and MYALGIA (MYALGIA). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (I received the dose at 4pm, I wasn't feeling well when I went to bed.), HYPOTENSION (My blood pressure was 101/52/ low blood pressure), CHEST PAIN (CHEST PAIN), NAUSEA (NAUSEA), CHILLS (CHILLS) and MYALGIA (MYALGIA) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2021, Blood pressure measurement: 101/52 (Low) LOW. On 09-Sep-2021, Heart rate: 116 (High) HIGH.
unusual fatigue about 30 hours after shot. I stopped mowing and quit working for the day.