chrisvoncsefalvay/vaers-outcomes huggingface dataset:
temperature excursion which was administered to multiple patients.; No additional AE's reported.; This spontaneous report was received from a registered nurse referring to a patient of unknown gender and age.  The reporter did not provide information on the patient's historical drugs or reactions, pertinent medical history and concomitant medications.  On 06-APR-2021 the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX)  with dose reported as 1 administered subcutaneously (lot number T028303 and expiration date 20-AUG-2022) for prophylaxis (vaccination scheme frequency and anatomical location were not reported). It was stated  that the vaccine was administered after temperature excursion (incorrect product storage). It was reported that the vaccine reached a temperature of minus 11.5 degree Celsius. This excursion had a time frame reported of 25 minutes. No previous excursions were reported, and information was provided via data logger. No additional adverse event was reported  and patient was asymptomatic.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2104USA002751:
BRUISED AND SORE AT INJECTION SITE BEGINNING DAY OF ADMINISTRATION. STILL EXPERIENCING SORENESS AND BRUISING TODAY 9/26/2019
This case was reported by a physician via other manufacturer and described the occurrence of hives in a female patient who received Influenza vaccine Quadrivalent unspecified. The patient's past medical history included hernia repair, nasal septum deviation, tonsillectomy, vaginal reconstruction, endometriosis and scar. Concurrent medical conditions included asthma, tendon disorder (congenitally loose tendons or joints or ligaments), post-traumatic stress disorder, bipolar disorder, major depression (with psychotic features), fibromyalgia, hypothyroidism, migraine, irritable bowel syndrome, irregular menstrual cycle (bleeding issues), ichthyosis vulgaris, fatty liver, nearsighted, hearing loss, metabolic disorder, obsessive-compulsive disorder, anemia, premenstrual dysphoric disorder, mood disorder NOS, nausea, vitamin B12 decreased, sleep apnea, brain disorder NOS, neuropathy, tooth impacted, meniscus tear, arthritis, blood potassium decreased, drug allergy (Baclofen, Etodolac, Aspirin, Generic ZYPREXA), food allergy (mushrooms, fresh milk products, sweeteners, shellfish or fish, vegetables or fruits, a lot of processed foods), allergy to molds (Mildew), pollen allergy, allergy to chemicals (Perfumes, Orange or Citrus Scents, most smelly chemicals) and insect bite allergy. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, an unknown time after receiving Influenza vaccine Quadrivalent unspecified, the patient experienced hives, diarrhea and vomiting. On an unknown date, the outcome of the hives, diarrhea and vomiting were unknown. It was unknown if the reporter considered the hives, diarrhea and vomiting to be related to Influenza vaccine Quadrivalent unspecified. Additional details were provided as follows: The age at vaccination was not reported. This case has been linked with case US2016GSK005647, reported by the same reporter for same patient.
Felt like vomiting - nauseous, diahrrea on second day and chills, and abdominal pain. Thought it was normal so let days go by.  Then got pounding headaches by the 5th day and kept getting worse, stronger pain at the same time started to swell from legs and feet.  Again thought it was normal and kept pushing myself by challenging my symptoms thinking that they would go away that it was part of the good side effects of the vaxx.   Then kept coming and started having neck pain, body pain, pain close to my waist and butt and realized that it was progressing and not going away.  After 15 days I called  and I had a video appt with the doctor.  She looked at my legs and feet and said that she did not see any blood clots.  But said I must go to the lab to be tested.  They gave me my test results but no explanation on them yet.  Legs want to get paralyzed.
Vaccine stung when it went in. Left arm was very sore, had shivers and not sure if had fever.  The 2nd day, arm was better, no shivers but felt very weak. Today patient feels fine.   Received first dose on 12/28/18 with no problems.
It didn?t hurt during the process. Went home and later in afternoon I have to cradle my arm when I am up. Then later that night, the whole entire back and my arm so sore. Yesterday morning when I wake up everything is aching, joints and muscle pain. The whole day I was down with a low grade fever with 99 to 100, and low energy. I woke up today a bit better so I took shower ready for work but after taking shower it seems like my energy is gone again. I took my temp and it is 100.3 but less joint pain except the L arm and upper back.
(L) arm numbness down to fingers, difficulty walking, bilateral leg numbness, cramping urinary incontinence. (L) shoulder, arms very weak, weakness, tired. Symptoms lasting 2-3 days.
This spontaneous report as received from a nurse refers to a female patient (who was a physician at the office of nurse) of unknown age. Current condition reported was penicillin allergy. ON an unknown date (as reported as a child) the patient was vaccinated with (Oka/Merck) VARIVAX (dose, strength and route was not reported). No concomitant medication was reported. The nurse stated that within the last month the physician had her varicella titers drawn and the results were negative. The outcome of the results were negative was not recovered. No PQC was involved. The causality between (Oka/Merck) VARIVAX and event was unknown. Additional information has been requested.
I felt a little strange during the waiting period, but could not define anything specific. I waited 20 minutes to be safe and put it down to a possible anxious feeling, although I was not anxious before I arrived. I felt fine after arriving home.  At midnight when I went to bed I noticed a tingling feeling in my arms , hand and , legs and a slight bit across my chest.  It was obvious enough that it prevented me from sleeping well.  This morning I still feel the tingling but notice that it is most obvious if I am sitting still vs up moving around.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, INJECTION SITE PAIN Narrative:  Other Relevant History:
This spontaneous report was received from a physician refers to a 19 month old male patient. The patient had no known concurrent conditions, medical history, drug reactions, allergies and concomitant medications. On an unknown date in July 2017, the patient was vaccinated with VARIVAX (dose, units, route and frequency not reported) (lot # M004335 and expiration date not reported) in the left thigh. On 30-JAN-2018, the patient experienced left flank shingles rash and patient was brought to the physician's office. The patient received unspecified treatment at the time of presenting to the physician's office. The outcome of the event herpes zoster was reported as recovered/resolved. The reporter did not provide causal relationship for the event herpes zoster with suspect therapy VARIVAX. No product quality complaint was involved. Lot number [M004335] is an invalid lot number for VARIVAX.
dizziness and diaphoresis hypoglycemia orange juice, banana and sandwich given sent to ER
This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, SARS-CoV-2 antibody test: positive (Positive) positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided.
pt recv vax; very sleepy & hard to keep awake for more than 24 hr; screaming session of 2 hr on eve of vax;
adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (adverse reaction) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (adverse reaction). At the time of the report, ADVERSE REACTION (adverse reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitants or treatment medications were reported.
Breakthrough covid case. Patient tested positive at local Health Clinic on 6/22/22 with c/o runny nose, fatigue and covid exposure x 2 days.
Low grade fever (100.3 orally), severe headache, nausea, intestinal cramping, muslce aches, malaise for 36 hours. Minimal pain at injection site. Mild axillary lymph node enlargement.  Treated with acetaminophen, aspirin, benadryl, cyclobenzaprine, cimetidine. Signs resolved in 36 hours.
Headaches; Blood pressure went up; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) and BLOOD PRESSURE INCREASED (Blood pressure went up) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) at an unspecified dose. On an unknown date, the patient experienced HEADACHE (Headaches) and BLOOD PRESSURE INCREASED (Blood pressure went up). At the time of the report, HEADACHE (Headaches) and BLOOD PRESSURE INCREASED (Blood pressure went up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported.  No treatment information was reported by the reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
difficulty with all of the shots; fever of 102 degrees; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (difficulty with all of the shots) and PYREXIA (fever of 102 degrees) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031LR0A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (difficulty with all of the shots) and PYREXIA (fever of 102 degrees). At the time of the report, VACCINATION COMPLICATION (difficulty with all of the shots) outcome was unknown and PYREXIA (fever of 102 degrees) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 degrees 102 degrees.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-538659, MOD-2022-538669, MOD-2022-538668 (Patient Link).
Diagnosis:  thrombocytopenia, horrible bruising and red blotchy spots everywhere on my body
12/24 Same day he got really sick.  Couldn't get out of bed for 5-6  days with flu like symptoms, fatigue, headache and weakness. No fever. Started to move around more after the 8th day but still a lot of nausea, headache, fatigue, chest congestion, dizziness. At week 3 he is falling asleep throughout the day even while talking.  Vomiting in the mornings, difficulty waking up, low energy.  Two covid rapid test  have been Negative.  PCR test on 01/10/2022 Negative. He has not been able to go back to school as of 01/16/2022 because of debilitating symptoms. He coughs at night and sleeps a lot.  A lot of indigestion and vomiting in the mornings more frequently than before. He had a fever 01/15/2021 morning that quickly disappeared.  He has chest congestion and eye sensitivity. He says ?like a migraine without the pain? and  i noticed his eyes were out of alignment. Im attaching a photo showing Strabismus.
hurts like, awful; worth a little discomfort; like awful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain, discomfort and feels awful. On an unknown date, the outcome of the pain, discomfort and feels awful were unknown.   It was unknown if the reporter considered the pain, discomfort and feels awful to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated the 2nd Shingles shot hurts like awful, but it was worth a little discomfort. It was all about being stressed out. The follow-up would not possible as no contact details were available.
- About 20 min after the shot (after I had already sat in the parking lot for 15 min and then left) my throat started to close up and I had a hard time swallowing. Went away after about an hour.  - Around 2 am, I woke up shaking violently with chills that didn't go away until around 6 am (had gotten my shot around 9:30 am the day before) Had a 100.3 fever, pounding headache, complete body ache, and flu/cold like symptoms.  - All day the next day (Tues) I was dizzy, could barely stand, same headache, complete body aches, and ran a 101-101.5 fever most of the day.  - 48 hrs later and still running a small fever (99.5), but most other side effects other than headache and cold symptoms have subsided.
might be lymph glands in the brachial; small swelling in upper arm; she went up a bit in weight; she has felt something in her upper right arm that has been uncomfortable; swelling in elbows / swelling in the elbow (size of a 25 cent piece; 3 quarters an inch); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021344901 (Pfizer).  A 95 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 13:00 (Batch/Lot number: unknown) at the age of 95 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (ongoing), notes: diagnosed about a year ago. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE taken for blood pressure abnormal (ongoing). Vaccination history included: Bnt162b2 (1st dose), administration date: 04Feb2021, when the patient was 95 years old, for COVID-19 immunisation. The following information was reported: JOINT SWELLING (non-serious) with onset Mar2021, outcome "recovering", described as "swelling in elbows / swelling in the elbow (size of a 25 cent piece; 3 quarters an inch)"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "might be lymph glands in the brachial"; PERIPHERAL SWELLING (non-serious), outcome "recovering", described as "small swelling in upper arm"; WEIGHT INCREASED (non-serious), outcome "unknown", described as "she went up a bit in weight"; LIMB DISCOMFORT (non-serious), outcome "recovering", described as "she has felt something in her upper right arm that has been uncomfortable". The event "swelling in elbows / swelling in the elbow (size of a 25 cent piece; 3 quarters an inch)" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of limb discomfort.  Additional information: The events did not result to ER visit. The patient had not received any other vaccines within 4 weeks prior vaccination. The patient reported that she was using just a little heating pad type thing because at night the discomfort in her arm would keep her awake for the first week.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had covid-19 in January, lab confirmed. After I recovered, my resting heart rate increased a little each month and I had palpitations. I went to a cardiologist in March 2021 and wore a heart monitor for a couple weeks, the doctor said my heart was fine. While wearing the heart monitor I got my first vaccine shot on March 30. My heart rate and stress levels went up, but I was also exercising more so I figured it was that. I was always tired and could not recover from the workouts, so I went to a doctor, who diagnosed acid reflux. I got a vaccine shot shortly after that in November. I could never sleep and always felt hot. Finally my mom noticed my eyes changed shape and told me to get checked for a thyroid problem. I went to a doctor who took a blood test on December 14th and she confirmed I have hyperthyroidism. I believe it was triggered by COVID-19 and then each vaccine made it worse.
Starting around 5:30 pm, arm starting feeling "dead", yet painful.  By 7:00 pm, could not move left arm unless it was moved using the right arm and also started having shaking and chills followed by an awful headache.  As the night progressed, felt like blood was on fire and I was burning from the inside out, but my body was having chills and I was hallucinating.  By 10:00 am the next day, I was feeling better but continued with the headache for another 24 hours and complete loss of appetite until 5 days after 2nd dose was administered.
Fatigue, chills, high fever(101.4), body aches, diarrhea, headache-lasted 24 hours and still going
Presented to ED w/COVID-like symptoms; admitted for COVID-pna; tx w/ abx, Vit-C, zinc, Singulair, bronchodilators; did not need O2 therapy; discharged home w/ HHC.
Patient reported to this RN on 4/10/2023, that he had developed a rash approximately 7 days after the Shingrix vaccine was administered. The patient verbalized the rash spread from his back to his shoulders. Patient reported the rash lasted approximatley one week. Patient reported he took benadryl to ease  the rash. Patient did not notify Proivder's office at time of reaction. Dr. notified on 4/10/2023 of patient reaction. Shingles vaccine added to patient's allergy list. Patient advised to not recieve second dose of vaccination.
several pt @ this site devel redness, swelling & tenderness below the inj site p/vax;each pt recovered;
have premature baby; mother received Abrysvo; This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team.  An infant patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for maternal exposure timing unspecified. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PREMATURE BABY (non-serious), outcome "unknown", described as "have premature baby"; MATERNAL EXPOSURE TIMING UNSPECIFIED (non-serious), outcome "unknown", described as "mother received Abrysvo". Additional information: The mother received Abrysvo and have premature baby that qualify for Synagis.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Right after vaccination, pt experiences soreness in left arm (whole left arm), tingly feeling in left arm. patchy light rash on arm went away after about 10 min. and appears on left palm.
I got chronic cough, shortness of breath, and occasional chest pains. I also, tested positive for Covid-19 1/21/2022. About three months following dose 3.
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 65 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 21-AUG-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
pt recv vax;lt upper arm appears red, swollen, hard, warm w/ small blisters ; dx: allergic rxn;
Pneumococcal Polysaccharide recieved on 23-SEP-2013 and Pneumococcal Conjugate received on 05-NOV-2015; No adverse event; This spontaneous report was received from a 69-year-old male patient, concerning to himself. The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.   On 23-SEP-2013 the patient was vaccinated with  Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23) for prophylaxis (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided). Therefore, it was reported that on 05-NOV-2015 another dose of  pneumococcal conj vaccine (unspecified) was administered to the patient (inappropriate schedule of product administration). No adverse event was reported.   This is one of two reports received from the same patient.; Sender's Comments:  US-009507513-1905USA009910:
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified patients were vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow-up information which has been unsuccessful) has been received from nurse concerning VARIVAX temperature excursion and two patients of unspecified age and gender who was vaccinated with VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot# J003711, exp. date: 10-JUL-2015 also reported as 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
Numbness in given arm travelled across shoulders to other arm nausea, vomiting, diarrhea.