chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of shivering in a 70-year-old female patient who received SHINGRIX for prophylaxis. In November 2018, the patient received the 2nd dose of SHINGRIX. In November 2018, less than a day after receiving SHINGRIX, the patient experienced shivering, fever and tiredness. On an unknown date, the outcome of the shivering and fever were recovered/resolved and the outcome of the tiredness was not recovered/not resolved. It was unknown if the reporter considered the shivering, fever and tiredness to be related to SHINGRIX. Additional information was reported as follows: The patient was in her early 70s. The reporter did not have any more patient details. In November 2018, about a week ago before the date of reporting, the patient was vaccinated with the second dose of SHINGRIX. The patient was vaccinated around the morning or noon time and started experiencing the events at the midnight. The patient experienced shivering and fever on the same day of vaccination. The patient was recovered from the symptoms. The patient stated that she felt tired as a result of the vaccine, at the time of reporting.
BODY ACHES, JOINT PAIN, TIREDNESS,  INJECTION SITE PAIN
felt faint/dizzy & dec vision & hearing;skin pale, warm & BP 80/40, HR 70 1142AM BP 102/70;vasovagal response;
developed itching about 10 min after receiving the vaccine, localized to chest and no hives, thought I had dry skin. But throughout the day, the itching became more severe, primarily on scalp, eyes, arms, legs, chest and back. There is no redness or hives. Running a low grade temperature, have pain level 6/10 at the injection site, muscle pain, nausea and generally do not feel well. On the advice of a physician, I took 1000mg of Tylenol and 25mg of Benadryl.  Those symptoms continued through 1/10. On 1/11, most of the original symptoms had resolved. However, at 0800, I noticed the lymph node in the axillary area of my left arm was swollen and painful. The tenderness included the side portion of the left breast and radiated down to my elbow. It is painful to have my arm hang regularly down at my side. The pain was mildly reduced with 400mg of Advil in the morning but I did not take any additional medication. The NP stated she had never seen a reaction to a vaccine like this one and instructed me to take doxycycline tomorrow if the swelling or pain increases or does not get better by tomorrow and to continue taking Advil. The itching, which had resolved, has returned; I'm to take Benadryl.
delayed on-site reaction; extreme chronic hives, It is pretty bad, Flare moments; random spots all over the body; Immunologist said that her T-cells were activated, it could be an extreme case of hypersensitivity; This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (delayed on-site reaction), URTICARIA (extreme chronic hives, It is pretty bad, Flare moments), RASH MACULAR (random spots all over the body) and HYPERSENSITIVITY (Immunologist said that her T-cells were activated, it could be an extreme case of hypersensitivity) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 022C21A and 032B21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: flu vaccine in November 2021. Past adverse reactions to the above products included No adverse event with flu vaccine.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jan-2022, the patient experienced SKIN REACTION (delayed on-site reaction), URTICARIA (extreme chronic hives, It is pretty bad, Flare moments), RASH MACULAR (random spots all over the body) and HYPERSENSITIVITY (Immunologist said that her T-cells were activated, it could be an extreme case of hypersensitivity). The patient was treated with FEXOFENADINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ALLEGRA D) for Adverse event, at an unspecified dose and frequency. At the time of the report, SKIN REACTION (delayed on-site reaction), URTICARIA (extreme chronic hives, It is pretty bad, Flare moments), RASH MACULAR (random spots all over the body) and HYPERSENSITIVITY (Immunologist said that her T-cells were activated, it could be an extreme case of hypersensitivity) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2020, SARS-CoV-2 test: the result not reported The result not reported.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient height was reported as 5 feet and 5 inch. The patient had no allergies.  Concomitant medications reported were multivitamins and birth control arm implant.AE caused patient to seek medical care went to PCP and then to immunologist. Symptoms were pretty bad, with same intensity and in the same state. The patient did not experience the similar events in the past.
01/15/22 presents to Center for "Contractions". PMHx of "HSV"
About 4inches down from the injection site. There was bruising all the way down to my elbow. Very sore to the touch Purplish Red. I spoke to my MD CNA and she stated that it should be OK by the time I get my next shot. Eveyday The bruise is getting better but it is not 100% gone
I received my second dose of COVID-19 vaccine the morning of 03/05/2021, and by the morning of 03/06/2021 I was very ill. The day previously I felt perfectly fine, and healthy. When I woke up the morning of 03/06/2021 I had lost my vision, was urinating excessively, and had an insatiable thirst. I went to an emergency room, and was asked what was wrong. I told them I had just had my Covid shot and that I initially thought I was experiencing side effects of the shot, which was why I waited 2-3 days before going in, but that I felt something more serious was going on. I told them I had been having headaches, and so they treated me for a migraine during which time they gave me steroids, and then permitted me to leave and go back home.  A day or two later I received a  call from a triage nurse following up on my condition. I informed her that I was still blind, urinating frequently, and drinking gallons of water. I was told that I needed to come back in. I waited until the following morning, and went back to the Emergency Room, and was asked to give a urine sample this time. The ER doctor also decided to draw blood. They soon after informed me that I was going into diabetic shock (Ketoacidosis), and that I was very lucky to still be conscious. My blood sugar was so high at the time that the blood sample would not register in the in the machine.
Pt. states after receiving Janssen vaccine 03/16/2021, 2 hours after started experiencing light headedness periodically. Still continuing with more frequent bouts. Vertigo symptoms 2 or 3 times through a week's time. APRN communications noted.
Only slight soreness at injection site first day.   I was physically working hard out of town with limited sleep for next three days.  I began experiencing significant body aches and pains, sneezing and minor congestion.  However, activity involved substantial dust as I was sanding a floor.  Saturday, January 2, I began having more extensive cold symptoms, coughing and runny nose with continued body aches and pains.  I scheduled a covid test on Monday, January 4, scheduled for Wed. January 6th.  I received positive results on Friday. January 8.  On Saturday, January 8, I began developing increased light headedness and self monitored my blood pressure.  It was at 191/107 when I went to Hospital to have it checked.  I was released that afternoon.
Pt given Fluvirin vaccine used only for children 4 years and above, instead of Fluzone.  Per his mother there were no adverse reactions.  Pt has required no additional tests or treatment.
On 6/9/00 the pt developed crying and multiple 1-3 second episodes of stiffening, breath holding and color changing where she turned red and purple and was hospitalized. It was reported that she experienced these episodes more than 12 -15 times during the first 2-3 hours, however she did not experience any episodes while she was sleeping. The episodes gradually decreased overnight. Additionally it was indicated that the pt was monitored and that she did not become bradycardic nor did she desaturate. She was treated with acetaminophen and observed for less than 24 hours recovered and then was discharged. As of 9/5/00, the pt remains recovered.
Redness, edema and pain over total upper arm from vaccine in R arm. Area of edema Stretched from deltoid down to elbow, hot to touch, red and painful.
Pt vaccinated with DTP/OPV/MMR developed fever 104, lasted 24 hrs. R/T normal~9 pm 20DEC90
rt upper arm (deltoid) moderately erythematous & swollen (5cm) x 2 days;mom states better today;to apply cold compresses & RTC in 2 days (appt given)
A report was received from a health care professional on 11/13/2002 concerning a 67 year old female vaccinee who was inadvertently administered last years (2001) batch of Fluvirin on 11/13/2002. On 11/13/2002 the vaccinee received 0.5 ml of the 2001 batch of Fluvirin intramuscularly. No adverse reaction was reported in relation to the incident. The reporter has assessed the relationship of the event to the vaccine as related.
This spontaneous report as received from an office manager refers to an unspecified number of patients of unknown age and gender. No information on patient's pertinent medical history or drug reactions or allergies was provided. On unknown dates, multiple unspecified patients were administered improperly stored doses of M-M-R II (Lot # L047133 Expiry date: 24-NOV-2017) (doses and route were unspecified) that underwent temperature excursion in 49 Fahrenheit degree for 227 hours. Data logger was involved. There were no previous excursions and temperature was back in range. No adverse effects were reported. This is the one of the several reports from the same reporter. Additional information has been requested.
Pulmonary embolism; Unprovoked dvt; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) and DEEP VEIN THROMBOSIS (Unprovoked dvt) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 2ec5g) for COVID-19 vaccination.     The patient was non smoker. No medical history was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-May-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization and medically significant) and DEEP VEIN THROMBOSIS (Unprovoked dvt) (seriousness criteria hospitalization and medically significant). At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism) and DEEP VEIN THROMBOSIS (Unprovoked dvt) had not resolved.            Concomitant medication was not reported. Treatment medication included anticoagulants  Action taken with mRNA-1273 in response to the event was Not Applicable  This is a report of a 35-years non-smoker male, whose medical history was unremarkable; who presented DVT and pulmonary embolism, 102  days after receiving the second dose of the product. The patient required hospitalization  Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
no additional AE's; temperature excursion / temperature 34.1 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 08-FEB-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), dose/frequency reported as 1 (unit not provided), lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in temperature of 34.1 degrees Fahrenheit (F) for 4 hours and 15 minutes. Previous temperature excursions were reported as follows: 34.8 F for 45 minutes and 34.7 F for 2 hours and 45 minutes (dates not provided). Digital data logger was involved. The patient was reported to be asymptomatic, no adverse events (AE's) were reported.  This is one of several reports from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007278: US-009507513-2104USA007277: US-009507513-2104USA007276: US-009507513-2104USA007270:
12 hrs after 1st vaccine on 2/2/2021 I started to feel actual COVID symptoms. I had COVID in Nov 2020, and this was 90 days after my COVID infection that I got my 1st vaccine. I was violently shaking, fever up to 102 F, joint pain in every joint in my body even my finger joints, 1 episode of diarrhea. These symptoms were debilitating and I was in bed for 48 hrs post 1st Vaccine. I also had night sweats, had to sleep on towels and change my clothes up to 6 times per night. Same as COVID. On 2/3/2021 I developed a red rash, and lump on my Left upper arm where I got the vaccine. It was swollen, painful and hot to touch, thought it may be infected but my MD advised via text that it was a normal reaction. I put ice on the arm and took Tylenol/Motrin [alternationg] scheduled every 3 hrs until my symptoms stopped. After 48 hrs from onset of symptoms, my reaction stopped. Had to call off work the symptoms were so severe.   2nd vaccine was on 03/01/2021, again 12 hrs after shot started getting chills, fever, body aches, so tired had to lay down. Had to call off work the symptoms were so severe. This time the reaction only lasted 24 hrs total. After that I was just tired and my arm was sore. Same treatment of symptoms as listed above, this time did not have vaccine site reaction, thank goodness.
Dizziness, Myalgia, Extreme fatigue. Onset the morning after vaccine was received. Slept on and off throughout the day on 1/21/2021. Narrative:
Dose administered on 5/3/23.  Vaccine viability ended on 5/1/23.
Pt did not develop "protective titers" p/3 injects of Engerix-B "plan to revax" pt; Reporter states the non-protective titers can be possibly disabling and/or life threatening "if person contracts Hepatitis";
THE PATIENT COMPLAINS OF PAIN OR DISCOMFORT   AT RIGHT SHOULDER WHERE SHOT WAS GIVEN WHEN THE PAINT SLEEPS ON THE SHOULDER. PATIENT TO TAKE OTC PAIN MEDICAION AND CONTACT HIS DOCTOR IF PAIN CONTINUES FOR MORE THAN A FEW DAYS OR A WEEK.  The patient called to complain that his right shoulder ( deltoid)  where he received his moderna covid-19 booster vaccine still gives him some pain or discomfort when he sleeps on that shoulder. He says he does not always have pain again only if he sleeps on that shoulder. I told him the pain from a shot typically would last a few days to a week or longer in some cases. I instructed him to take a over the counter pain medication if he can and report it to his doctor if it continues.
incredibly sick for almost a week; had COVID all over again; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (incredibly sick for almost a week) and COVID-19 (had COVID all over again) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 ILLNESS (incredibly sick for almost a week) and COVID-19 (had COVID all over again). At the time of the report, ILLNESS (incredibly sick for almost a week) and COVID-19 (had COVID all over again) outcome was unknown.        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.   Concomitant medication not reported.  Treatment medication not reported.
Information has been received from a physician concerning an 18 year old female patient, for the Pregnancy Registry for GARDASIL, who in August 2009 was vaccinated with her third dose of GARDASIL. On approximately 21-NOV-2009, "over the weekend", the patient went to the emergency room with abdominal pain and was confirmed to be pregnant. The patient was also evaluated for ectopic pregnancy. On 23-NOV-2009 the patient was 6 weeks pregnant. The patient's estimated LMP was 12-OCT-2009 and her EDD was estimated to be 08-JUL-2010. At the time of the report, the outcome of the patient was unknown. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Patient presents to ER with SOB, chest pain and cough. Patient has a hx of MI and stent.
pt recv vax 31OCT96 & pt exp red flushing all over, tingling all over, & paresthesia in arms, trunk & legs;pt treated w/DPH;sx resolved w/in 1hr;pt was not hosp;skin test indicated was not allergic to chicken egg;
Within a day after Shingles shot, I developed stiffness and pain on movement of my left shoulder which has persisted from 5/23/09  to the present. Prolem is worse after inactivity, especially if I have been exercising those muscles previously. Most persistent soreness is near biceps tendon, but pain occurs in other areas around the shoulder and neck.
Headache Vertigo; Headache Vertigo; This is a spontaneous report from a contactable other health care professional (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685 and expiration date not provided), intramuscular (left arm) second dose on 14Jan2021 08:00 at single dose for covid-19 immunisation. The patient's medical history included Diabetes and PKD.  The patient's concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1686) via Intramuscular left arm first dose on 22Dec2020 08:00 AM for covid-19 immunisation. On 16Jan2021 08:00, the patient experienced headache and Vertigo. The patient did not received treatment for the events.  The outcome of the events was recovering.
Adverse symptoms experienced: odd discomfort getting dose, felt like skin was splitting, Or that something was slicing skin  ( more like getting TB test than injection), bled for a while,  blistered and scabbed; never any muscle soreness  but skin eruption and scabbing, bruising; had fever 3 days later otherwise no other symptoms
To be clear i do not have the vaccine card with me so I do not know which seasonal flu vaccine my son received.  At the injection site my son has what appears to be a chemical burn.  The affected skin had a raised, bumpy, rash like appearance.  The affected area turned dark purple (about 1 in by 1/2 inch area).   he reported pain from the injection, but no other symptoms.   I did not notify the pharmacy nor the PCPA as the last time one of my children had a reaction to a vaccine, I was told to call the number on the information sheet and report it.
Acid reflux; Having really bad pain at that time; hand got swollen, like under arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (hand got swollen, like under arm), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) and PAIN IN EXTREMITY (Having really bad pain at that time) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0251321A) for COVID-19 vaccination.     Concomitant products included IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PERIPHERAL SWELLING (hand got swollen, like under arm). On an unknown date, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) and PAIN IN EXTREMITY (Having really bad pain at that time). At the time of the report, PERIPHERAL SWELLING (hand got swollen, like under arm) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux) outcome was unknown and PAIN IN EXTREMITY (Having really bad pain at that time) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.   This case was linked to MOD-2021-311791 (Patient Link).
ringing in left ear, hearing loss left ear  Narrative:  Vaccine 02/04/2021 and ringing in left ear and hearing loss started on  02/07/2021.  Audiogram on 02/12/2021 showed significant hearing loss. Referred to ENT and will be scheduled for an MRI. 02/17/2021 still has ringing in left ear  and hearing loss.   Other Relevant History: