chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; chills; Hyperexpanded lungs; Inflamed lungs; Pleural Effusion; Trouble breathing; Pain in her chest when taking deep breath; Liver numbers elevated; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LUNG HYPERINFLATION (Hyperexpanded lungs), PNEUMONITIS (Inflamed lungs), PLEURAL EFFUSION (Pleural Effusion), DYSPNOEA (Trouble breathing) and NON-CARDIAC CHEST PAIN (Pain in her chest when taking deep breath) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in April 2020. Concurrent medical conditions included Hypertension and Cholesterol (Takes cholesterol medicine.).    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced LUNG HYPERINFLATION (Hyperexpanded lungs) (seriousness criterion medically significant), PNEUMONITIS (Inflamed lungs) (seriousness criterion medically significant), PLEURAL EFFUSION (Pleural Effusion) (seriousness criterion medically significant), DYSPNOEA (Trouble breathing) (seriousness criterion medically significant), NON-CARDIAC CHEST PAIN (Pain in her chest when taking deep breath) (seriousness criterion medically significant) and LIVER FUNCTION TEST INCREASED (Liver numbers elevated). On 18-Mar-2021, the patient experienced PYREXIA (Fever) and CHILLS (chills). On 20-Mar-2021, PYREXIA (Fever) and CHILLS (chills) had resolved. At the time of the report, LUNG HYPERINFLATION (Hyperexpanded lungs), PNEUMONITIS (Inflamed lungs), PLEURAL EFFUSION (Pleural Effusion) and NON-CARDIAC CHEST PAIN (Pain in her chest when taking deep breath) had resolved and DYSPNOEA (Trouble breathing) and LIVER FUNCTION TEST INCREASED (Liver numbers elevated) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Chest X-ray: pleural effusion, inflamed and hyperexpanded lungs (abnormal) Pleural effusion, inflamed and hyperexpanded lungs. In March 2021, Liver function test: increased (Inconclusive) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products known to have been used by the patient, within two weeks prior to the event included high blood pressure medication and cholesterol medication.  Treatment for the events included acetaminophen.  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.
Received 1.0 ml of Flu vaccine. Complain of rather severe pain in arm for 3 days, much more severe than usual took Ibuprofen. Bruise large injection site. Arm ached- resolve after 3 days.
fever @ 99.4 p/convuls;seen @ hosp 14OCT96 430Pm;dx w/strep throat ATB therapy instructed;rxn to MMR;tx ATB;
2 weeks after receiving booster, noticed large hives all over random parts of body.  Redness, raised skin, unbearable itching.  Goes away about 2 hours later but moves to other parts of the body.  Controlled temporarily  with Zyrtec.  3 weeks after booster and itching is more severe.
paresthesias right upper extremity starting same day as COVID injection  Narrative:  burning sensation right upper ext same day as COVID  vaccination from right shoulder to right fingers index and middle. still  ongoing as of 2/22/21  Other Relevant History:
fast heart rate, heart fluttering - short term lasting.  Long term - cough and shortness of breath - still having difficulties 3 months later.
After the first shot I had my period immediately, it was more painful than anything I've had in a while and also very short. I haven't had my period since June 16th, just cramping and pains but no blood. Very very unusual for me and worrisome.   Aside from that my side effects seemed normal. The second dose hit me harder than the first with the flue like symptoms but nothing toooooo aweful. I've had some breathing difficulties since the shots but minor. Lots of extra phlegm and feeling the need to cough it up.
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 31-JAN-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1802USA001558:
No additional AE reported; ROTATEQ was administered to a 10 month old; This spontaneous report was received from a medical assistant and refers to a 10-month-old infant of unknown gender.  The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 27-OCT-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1892788, expiration date: 02-DEC-2023, administered for prophylaxis (strength, dose, and route of administration were not provided) (product administered to patient of inappropriate age).  No additional adverse event reported.
patient c/o dizziness at 10:45 Patient was noted to be hypertensive 168/101, VS monitored for an additional 15 minutes with improvement in BP 136/84 patient without further symptom development, released to home at 11:10
Rash all over stomach, sides, legs.  Red raised itchy bumps and welts
The patient was given MMRV vaccine that had been stored in a refrigerator instead of freezer.  The patient had no symptoms of an adverse event.
This spontaneous report was received from a certified medical assistant concerning a 69 year old male patient. On 10-OCT-2013, the patient was vaccinated with an expired dose of PNEUMOVAX23 (lot number and expiry date were reported as 671607/1169AA and 06-MAY-2013 respectively, dose and route unspecified). No concomitant therapy was reported. No adverse effect was reported. Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with Engerix B (GlaxoSmithKline). Concurrent medical conditions included dialysis. Subjects had previously received Recombivax and did not respond to therapy. On an unspecified date the subject received unspecified dose of Engerix B (unknown). At an unspecified time after vaccination with Engerix B, the subject did not respond to therapy as laboratory results did not show anti-hepatitis b antibodies. At the time of reporting the outcome of the event was unspecified. The nurse reported that this occurred in a total of eight patients. GSK case numbers are A0638778A and A638780A through A0638786A.
swelling; red cheeks/ ruddy cheeks; cheeks were hot; chills; blotches on chest; This case was reported by a consumer via call center representative and described the occurrence of facial swelling in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 28th June 2019, less than a day after receiving Shingrix, the patient experienced facial swelling, red face, feeling of warmth facial, chills and blotchy. On 29th June 2019, the outcome of the facial swelling, red face, feeling of warmth facial, chills and blotchy were resolved with sequelae.   It was unknown if the reporter considered the facial swelling, red face, feeling of warmth facial, chills and blotchy to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix in the left arm. The patient stated that on the same day of vaccination experienced swelling on her face and the cheeks were hot and red and ruddy cheeks. The patient also experienced chills and blotches on her chest. The patient consented to follow up.
Patient received vaccine on 10/18/19 complained of injection site soreness, redness, fever and chills. Said it is gradually getting better over the past few days. The redness and swelling extended on the back of her right arm to her elbow. Recommended she try BENADRYL for allergic reaction. She also complained of itching.
Patient was given the shot. Said she went home and had a sore arm. Took a shower that night then went to bed. In the morning around 8AM the arm she recieved the injection in was red and swollen. Patient came in to pharmacy to show the pharmacist and stated the swelling had went down from earlier. Not sure if she took any medications or did anything to alletivate the issue. Counseled her to talk to her PCP about what happened and to recieve gudiance for future flu shot injections. Also told her if she wanted to go the next step she could also recieve an allergy test.
GANGRENOUS APPENDIX; ADVERSE REACTION TO COVID VACCINE; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age and sex and unknown race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency 1 total administered on 11-Apr-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  It was reported that within 6 weeks after vaccination, the patient had symptoms (adverse reaction to covid vaccine) and then had an emergency surgery for a gangrenous appendix. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of gangrenous appendix and adverse reaction to covid vaccine was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210948253-covid-19 vaccine ad26.cov2.s-Gangrenous appendix. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and unknown gender. On an unknown date, the unspecified number of patients were vaccinated with improperly stored doses of GARDASIL 9 (1 dose of lot # L007560 and expiry date: 15-JUN-2017). No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Pt stated vaccine given too high in deltoid which resulted in arm pain for multiple days and difficulty sleeping.
Fever; Tested positive to Covid 19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Tested positive to Covid 19) and PYREXIA (Fever) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2020, the patient experienced COVID-19 (Tested positive to Covid 19). On 29-Dec-2020, the patient experienced PYREXIA (Fever). At the time of the report, COVID-19 (Tested positive to Covid 19) outcome was unknown and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature increased (102-Unknown degree Celsius): 102 degree Celsius (High) Patient developed fever of 102ºC. On an unknown date, COVID-19: 05-jan-2021 (Positive) Patient tested positive to COVID 19 on 05-JAN-2021.     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 product use was not provided by the reporter. No treatment information was provided.
Breakthrough case admission after 3 vaccines Pfizer 2/18/21 Lot# EL9267;  Pfizer 3/11/21 Lot# EN6199;  Pfizer 10/19/21 Lot# FF2593
PATIENT FELT CONSTRICTION OF THE THROAT AND ITCH AROUND THE NECK AREA (NO DIFFICULTY BREATHING) 10 MIN AFTER THE MODERNA BIVALENT INJECTION AROUND 4:20, PATIENT STAYED FOR ADDITIONAL 20 MIN AFTER WHICH HE FELT BETTER BUT STILL HAD SOME CONSTRICTION, PATIENT WAS GIVEN BENADRYL 50MG AT 4:55 AND STAYED FOR AN ADDITIONAL 15MIN, HE WAS DOING BETTER AND WENT HOME, INFORMED HIM TO GO STRAIGHT TO THE ER IF THERE WAS ANY DIFFICULTY BREATHING OR IF THE CONDITION GOT WORSE...   CHECKED IN ON PATIENT 9/29/22 AT 12:40PM, HE WAS DOING MUCH BETTER AND SAID THE SWELLING WENT DOWN.   9/29/22 RA
This spontaneous report was received from a nurse refers to a patient of unknown gender and age. Information regarding patient's medical history, current conditions, drug reactions/allergies and concomitant medications information were not provided. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 (lot # L038503, expiry date: 18-DEC-2017) via intramuscular route. Nurse reported that the vaccine underwent a temperature excursion at 35 degree Fahrenheit for 21 minutes. There were no previous temperature excursions. No adverse effects were reported. Additional information has been requested.
Broke out w/rash on 4/15/03. Small blisters, which scabbed over on stomach - couple on back - none on arm, legs or face - no fever - fine rash ??vable on trunk on 4/21/03.
Large red welt appeared about 10 hours after vaccination. Welt is tender, but not painful. It is about the size of the patients hand. No other symptoms reported and patient is doing fine otherwise.
Nausea, diarrhea, fever for 24 hours after vaccine administration. After these symptoms resolved, patient noticed a rash started on her legs and spreading upward. Rash on her legs, abdomen, back, chest, and neck. Symptoms include: itching, redness, scaly and painful. Patient presented to UC 48 hours after onset of symptoms. Given IV saline, famotidine and Benadryl.
Hives, redness, itching at site and surrounding skin for approx. 20cm diameter.
Pt received vaccines around 2p on august 20th. Pt contacted pharmacy around 730 that night stating that she was vomiting perfusely and felt very ill. She was not willing to go to hospital, hung up on pharmacist. Pharmacist called 911 to send ambulance to pt home. Pt was taken to hospital to be treated.
Red and very sore, rash with pimple like sore. Red around injection site with red going down side of arm.
Decedent on hospice for acute respiratory failure due to chronic obstructive pulmonary disease.
SORE; RASH ALL OVER THE BODY; SHIVERING; FEVER; TIREDNESS; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included graves disease, abstains from alcohol, and non-smoker, and other pre-existing medical conditions included patient had no known allergies. no drug abuse/ illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 14-APR-2021, the subject experienced sore. On 14-APR-2021, the subject experienced rash all over the body. On 14-APR-2021, the subject experienced shivering. On 14-APR-2021, the subject experienced fever. On 14-APR-2021, the subject experienced tiredness. Treatment medications (dates unspecified) included: methylprednisolone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore, rash all over the body, shivering, fever, and tiredness on 14-APR-2021. This report was non-serious.
Rash and Lump on inj site staring after the vaccine was given , per mom pt had a red rash and is sensitive to touch.
PATIENT FAINTED AFTER RECIEVING A BOOSTER DOSE OF JANSSEN
severe dizziness followed by ringing in the ears.  Ringing has not stopped to this day.  Seams to be getting worse or I am just more intuned to it.
Sore first finger and joint; Red first finger and joint; Swollen arm /swollen first finger and joint; Swollen first finger and joint; Sore first finger and joint; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore first finger and joint), ERYTHEMA (Red first finger and joint), PERIPHERAL SWELLING (Swollen arm /swollen first finger and joint), JOINT SWELLING (Swollen first finger and joint) and ARTHRALGIA (Sore first finger and joint) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, LEVOTHYROXINE and ACETYLSALICYLIC ACID (ASPIRINE) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced ARTHRALGIA (Sore first finger and joint). On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore first finger and joint), ERYTHEMA (Red first finger and joint), PERIPHERAL SWELLING (Swollen arm /swollen first finger and joint) and JOINT SWELLING (Swollen first finger and joint). The patient was treated with AMOXICILLIN at an unspecified dose and frequency and DICLOFENAC at an unspecified dose and frequency. On 22-Mar-2021, PAIN IN EXTREMITY (Sore first finger and joint), ERYTHEMA (Red first finger and joint), PERIPHERAL SWELLING (Swollen arm /swollen first finger and joint) and ARTHRALGIA (Sore first finger and joint) had resolved. At the time of the report, JOINT SWELLING (Swollen first finger and joint) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other  treatment  medication included sodium cream.   The patient was instructed by the doctor to not to take second dose due to adverse event.
Headache, Sedation, Myalgia, CHILLS AND PAIN, SORE THROAT AND EARS Narrative:
Lots of itching in the right breast; Underneath the nipple it got a little hard; Underneath the breast itchy time to time; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Lots of itching in the right breast), NIPPLE PAIN (Underneath the nipple it got a little hard) and PRURITUS (Underneath the breast itchy time to time) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PRURITUS (Lots of itching in the right breast), NIPPLE PAIN (Underneath the nipple it got a little hard) and PRURITUS (Underneath the breast itchy time to time). At the time of the report, PRURITUS (Lots of itching in the right breast), NIPPLE PAIN (Underneath the nipple it got a little hard) and PRURITUS (Underneath the breast itchy time to time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
11FEB91 (approx) throat infect; 11MAR91 n/v w/low grade fever 12MAR91, mild rash x 1day; 15MAR91 unable to focus eyes "eyes turned to side"; 16MAR91 Hospitalized dx Bacterial Menengeal Encephalitis produced by HIB Group B;
on 1/15 patient noticed a raised "pimple" at injection site, then 1/16 red streaks with hives about 4 inches around injection site, then on 1/17 the hives started joining together.  Patient contacted us at 12:50 pm.
VACCINE INJURY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine injury. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine injury was not reported. This report was non-serious
patient was anxious before getting vaccine. When she got her shot, she was panicking about the pain. .15-20 mins after vaccine administration patient complained of nausea. Patient looked pale and nervous .We had her lie down with her legs elevated and alerted Code White.  Patient was responsive and talking .We did some cold compress around her neck and face. Patient started feeling better afterwards ,waited in the pharmacy for about 30 mins post episode.
Pt received vaccines on 6/22/2005.  On 6/23/2005 mom called reporting severe swelling and redness to the left arm deltoid area. She reported that the swelling was warm, tight, and hard and extended down to elbow.  Instructed to use cold compresses and tylenol/motrin for discomfort. Mom was worried it would get tight to the point of weeping but it never did. Called on 6/24 and she reported the arm was some better.  By 6/29 the swelling was almost all gone just some hardness remained.
knot under her right arm (the side she received her vaccine) and she was assuming it was a swollen lymph node; assuming it was a swollen lymph node, it was real sore; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration (reported as injection in the right arm) on 09Jan2021 at single dose for Covid-19 immunization. The patient's medical history was reported as none. There were no concomitant medications. It was reported that the patient received the first dose of the Covid vaccine and now (10Jan2021) has a knot under her right arm (the side she received her vaccine) and she was assuming it was a swollen lymph node. The patient added that it was real sore but now it is not quite as sore, it doesn't hurt. The patient asked if it could be from the vaccine and how long should it be there. She also asked if she should still get her second dose on the 30th (30Jan2021). The outcome of events was recovering.
Employee received her second dose of Hep B. on 11/26/2021. Upon completion of the injection donor stated that she had a knot (ball) in deltoid after her first injection. This site is covered with a tattoo from the shoulder joint to the bottom of the deltoid muscle most of the ink was red. Employee stated that there was a big knot(ball) in injection site. Employee stated that she rubbed it, put ice on it, and also heat trying to get the pain to stop and the knot(ball) to go down. She stated that this took almost two weeks to go down and once it did the area was sore and tender to touch (and still is) once this knot (ball) went away it began to itch and get bumps. Today all she stated is that it was tender and sore to touch.