chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chills; pretty bad headache; elevated blood pressure; I had obviously the swollen arm, feverish arm; 101.7 fever for most of the day; A spontaneous report was received from a consumer concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypertension (elevated blood pressure), peripheral swelling (swollen arm), pyrexia (101.7 fever), chills and headache.  The patient's medical history was not provided. Concomitant medications reported were diltiazem ER 180 mg for drug use for unknown indication.  On 19 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 025L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 19 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 010M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 19 Feb 2021, the patient experienced swollen arm and feverish arm and also stated that she had elevated blood pressure and 101.7 fever. On 20 Feb 2021, the patient experienced pretty bad headache and chills.  Treatment details included Patient reports taking Tylenol for headache.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown.
Patient complained of chest pain for 3-4 hours 6 days after his first COVID shot. Family was on vacation and did not seek any medical attention. Symptons had been resolved for over a week before reporting them to me
Shortness of breath for 4 hour period in the middle of the night, extreme hot flashes & heart palpitations for 7 days.
This report was received from a consumer on 09 March 2009. A 47-year-old female patient received an injection of ADACEL (lot number not reported) on 05 March 2009. She stated that a 5/8 inch needle was used, and that she believes the injection may have been given subcutaneously. Within one day of vaccination, she experienced a red, hard, tender, itchy knot at the injection site, approximately the size of a 50 cent piece. The event was ongoing at the time of the report.
3 days after getting fully vaccinated, patient started having episodes of heat flashes and fainting It has occurred 3 times in a 6 week span since getting the vaccine. No prior health history of this ever occurring. Currently trying to diagnose to rule out other possibilities
DIARRHOEA; This spontaneous report received from a patient 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 not reported, batch number: Unk) dose was not reported, administered on 22-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced diarrhoea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diarrhoea. This report was non-serious.
Developed an area with erythema, increased warmth, swelling and tenderness in left upper leg at immunization site of DTAP.     Diagnosis: Cellulitis
Prior to leaving for school on 4/8/03, complaints of progressive pain and swelling in left anterior/lateral upper area of thigh. Warm to touch, hurts to walk. At office by 9AM 4/8/03. Site mildy warm, non-fluctuant, pale pine approximately 10cm diameter, mildly tender to touch. Felt to be sterile abscess but covered with antibiotic (Cephalexin). Use PO Ibuprofen and intermittent warm moist packs.
sorethroat and sinus congestion. Has some chills but not fever. Mild cough without any SOB, CP or pedal edema. symptoms started on 8/21/21
A non-serious spontaneous report of administration of expired FLUMIST to a female was received from a health professional concerning a 16-year-old female after receiving FLUMIST. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 08-Dec-2010. The patient received the expired FLUMIST on 20-Dec-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. Additional information was received on 09-Mar-2011: no late occurring adverse events.
Lt arm red, hot to touch & swollen lasted approx 72 hrs; mom gave DPH & APAP;
Day after vaccine, large swelling around area with redness. Hot and tender to touch. Continued for approximately 3-4 days with redness spreading further. Lymph nodes in general area of vaccination swelled. Discoloration around injection site once redness and swelling went away. About a week after initial symptoms injection site became red and itchy, lasted for three days. Discoloration still there, now muscles around injection site feel fatigued with movement.
After her shot, Patient felt dizzy sitting down on floor, I helped her lift up and had her seat in the chair. She might have passed out for a few seconds because her head was leaning on one side, upon asking her if she was ok, she did respond and complained of feeling dizzy and loss of hearing. After giving water to her, she started feeling better, her hearing came back but she still felt a little light headed and dizzy. We still monitored her and mom was called to pick her up. She was doing lot better after few minutes. Mom came to pick her up and we explained what happened to her to mom.
had light red rash all over her body that started after getting the vaccine; Caller reports she's had "severe itching" in addition to the rash; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received bnt162b2 (Batch/Lot number was not reported), first dose via an unspecified route of administration on 13Sep2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had light red rash all over her body that started after getting the vaccine, she had "severe itching" in addition to the rash in Sep2021. Caller was calling for herself, she received the first dose of the Pfizer-Biontech Covid19 vaccine on 13Sep2021.  caller had light red rash all over her body that started after getting the vaccine. Caller reported she's had "severe itching" in addition to the rash, and "no relief from taking diphenhydramine hydrochloride (BENADRYL)". Her HCP (health professional) told her to switch to cetirizine hydrochloride (ZYRTEC), and she still hasn't had any relief. Therapeutic measures were taken as a result of events. The outcome of events was not resolved.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
2/3/03 nausea, dizzines (mild): noon-3pm. Muscle aches, joint pain: 6pm 2/3/03. Fever late PM of 2/3 thru 4am of 2/4-2/6/03.
I did have the most severe response to this one compared to any other. I was in bed with flu like symptoms for a while, and then on Wednesday the 27th, about 2 weeks after, my throat was super sore. I gurgled salt water, thinking it would go away. A few days later I was wheezing and coughing and I thought I would go seen by a doctor on the 29th. They tested me for COVID and flu and that came back negative however the x-ray showed that I contracted pneumonia. They gave an inhaler and cough medicine.
Fatigue, aches, malaise, bilat ear pain, fever, generalized red rash x 10-14 days all beginning 1 day p/MMR;
Patient's left arm is extremely painful, red, hot, and mobility is limited due to pain. Antibiotics were ordered educated to follow up as needed
Heard heartbeat of baby at the regular OB check-up - their was arrithymia in baby's heartbeat that hadn't been there before. We had to track it - fetal specialist - full anatomy scan of heart - monitored it much more closely throughout the rest of the pregnancy. The arrithymia got less through the course of the pregnancy.  Everything is well after delivery of baby.  Pregnancy history - 2nd pregnancy; 1st pregnancy was full-term. Estimated date of delivery May 18th; Baby was born on May 10, 2021.
I had swollen eyes and cheeks. It looked like eczema, but it wasn't. It was an itchy rash, on my back, up and down my arms and legs, front and back of my shoulders, across my chest, front and back of my neck, back of my hands, and on my scalp and a little on my face, and lower torso. I also had dry itchy eyes.
Runny nose, headache, body aches, fever, chills, sweats, malaise lasted 9 days then progressed to Guillain-Barre type symptoms of overwhelming fatigue, muscle aches and headaches that have not resolves as of 02/08/2013.
Approximately four hours after vaccination patient experienced quite a bit of pain, some swelling, and a temperature around 100 degrees.  I recommended alternating Aleve 220 mg every 12 hours, Acetaminophen 500mg every eight hours, and Benadryl 50mg every six hours as need to control reaction.  Thirty-six hours after vaccination redness from about 4 inches below the right shoulder extending to two inches above the elbow.  We are now six days post vaccination and symptoms resolving with no expected additional complications expected.
pt recv vax 19JUL95 & 18APR96 pt exp being covered in varicella lesions;
Superficial thrombophlebitis of the forearm distal to injection site.  Persistent nausea and vomiting following injection
mild cases of Covid every time he traveled and this happened after getting the vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (mild cases of Covid every time he traveled and this happened after getting the vaccine) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 055B22F) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (mild cases of Covid every time he traveled and this happened after getting the vaccine). At the time of the report, COVID-19 (mild cases of Covid every time he traveled and this happened after getting the vaccine) outcome was unknown.            Concomitant product use was not provided by the reporter.  It was reported that patient had 5 Moderna Covid-19 vaccines, 2 original and 3 boosters.  On an unknown dates patient receives 2 monovalent doses of Moderna Covid-19 vaccine.   Patient had mild cases of Covid every time he traveled and this happened after getting the vaccine.  Treatment information was not provided.
Not her normal bubbly self not as talkative not making eye contact as usual and not playing as much also running a low grade fever sometime will just act as if she is just out of it.
Information has been received from a 61 year old female consumer with no known history or allergies who on 18-APR-2007 was vaccinated SC with a dose of Zostavax. There was no concomitant medication. On 25-APR-2007 the patient developed muscle ache and pain in the bicep and tricep of the arm used for the injection. She also had "pringling sensation" in the same arm. Unspecified medical attention was sought. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Information has been received from a physician concerning a child who was vaccinated with varicella virus vaccine live.  Subsequently the patient developed uveitis.  No other information was provided regarding the adverse event.  The patient's outcome was reported as not recovered.  There was no product quality complaint reported.  Unspecified medical attention was sought.  Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a female patient of 70 years old with none pertinent medical history or drug reactions/allergies. About "4-5 years ago" (in 2009 or 2010), the patient was vaccinated with ZOSTAVAX, lot# and expiration date not reported, single dose, subcutaneous. There was no concomitant medication. In 2014 ("recently"), the patient developed shingles on her torso. At the time of the report, the patient was planning to schedule an appointment with her unspecified physician for an evaluation. No treatment was given for the adverse event. None lab diagnostics studies was performed. The outcome of the event was reported as not recovered. The patient had sought medical attention by calling the pharmacy. Additional information has been requested.
About 24 hours after I received the vaccination, I had chills and also was extremely exhausted to the point that I missed an evening work engagement to go home. Later in the evening, I began running a fever of about 101 degrees. I was exhausted and chilled all evening, face flushed and red. By 9:00 a.m. the next morning, I was fine with no more fever.  For 7 days, my arm was red, about the size of a 3x3 post-it note. Also, about days 4-7, my arm was very itchy.
Slight headache; pregnancy; Fatigue; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnancy), FATIGUE (Fatigue) and HEADACHE (Slight headache) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (5 total).    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 10-Aug-2021. On 09-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnancy) and FATIGUE (Fatigue). On 10-Jan-2021, the patient experienced HEADACHE (Slight headache). On 09-Jan-2021, EXPOSURE DURING PREGNANCY (pregnancy) had resolved. On 10-Jan-2021, FATIGUE (Fatigue) and HEADACHE (Slight headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.; Sender's Comments: This is a case of product exposure during pregnancy for this 34-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.  For the events of fatigue and headache, 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.
Covid Booster given to 17 year old on 12/02/21. Prior doses 03/25/21 and 04/15/21. No adverse events or treatments.
This spontaneous report was received from a registered nurse via physician and medical assistant regarding a patient of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ROTATEQ lot # M038724 with unknown expiry date, (strength, dose and route of administration were not reported) for prophylaxis. The vaccine was exposed to 31 Fahrenheit degree (F) or colder (25F) for 1 hour 53 minutes and 47 Fahrenheit degree (F) to 77 Fahrenheit degree (F) (49F) for 3 hours 59 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from same reporter.; Sender's Comments: US-009507513-1708USA003308: US-009507513-1709USA011730: US-009507513-1709USA011731: US-009507513-1709USA011732: US-009507513-1709USA011733: US-009507513-1709USA011734: US-009507513-1709USA011736: US-009507513-1709USA011737: US-009507513-1708USA003070:
Administration of Expired Vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine). On 15-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Administration of Expired Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  No Relevant concomitant medications was reported.  Treatment information was not provided.   This case was linked to (Patient Link).
hard lump on the injection site; hive on injection site; soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hard lump on the injection site), VACCINATION SITE URTICARIA (hive on injection site) and INJECTION SITE PAIN (soreness) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction (no medical history reported).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced INJECTION SITE PAIN (soreness). On 15-Jan-2021, the patient experienced VACCINATION SITE INDURATION (hard lump on the injection site) and VACCINATION SITE URTICARIA (hive on injection site). At the time of the report, VACCINATION SITE INDURATION (hard lump on the injection site) and VACCINATION SITE URTICARIA (hive on injection site) had not resolved and INJECTION SITE PAIN (soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.; 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.
This case was reported by a physician via sales rep and described the occurrence of generalized urticaria in a patient who received FLUARIX TETRA (batch number ZE4G7, expiry date 19th June 2015). On 7th October 2014, the patient experienced FLUARIX TETRA. On 8th October 2014, 1 days after receiving FLUARIX TETRA, the patient experienced generalized urticaria. The patient was treated with prednisone and ATARAX (nos). On an unknown date, the outcome of the generalized urticaria was unknown. The reporter considered the generalized urticaria to be possibly related to FLUARIX TETRA. Additional information received: A patient received FLUARIX QIV on 07 October 2014 and then developed local urticaria on 08 October 2014 in the arm the patient received the vaccination. It then gradually became a generalized urticaria, the patient went to emergency room on 12 October 2014 and was prescribed Prednisone, ATARAX and "H2B".
approx +-1 minute p/vax pt tried to cry- held breath & turned cyanotic;had tonic & clonic convuls of all 4 extremities;paramedic stated poss sz;pt postictal stare;
Mom noticed the reaction yesterday 8/29/13 around 6:00 PM red, warm and swelling. Pt. got PROQUAD on the left arm on 8/27/13. Reaction's measurements 20 x 30 mm.
Red streaks coming directly up from the injection site, lasted about a week. Headache that no medication would get rid of, last one week.
Initially I only had a bad headache and sore arm the day after I got my vaccine. Then a couple days later I started to get really tired and dizzy. That continued so I went to the doctor today (a week after injection). My resting heart rate was over 100. For context, when I was donating blood last month it was 64. Over 100 is very high for me.  My doctor advised me that all I can do is rest, and I am not allowed to exercise for the time being.
Headaches, sore arm, rash, shot site itches, fever, upset stomach, abdominal pain on lower left side off and on, feel off, lethargic and loss of appetite.
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In 2017, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (strength, dose number, route, lot# and expiration date were 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 healthcare provider for herpes zoster. The outcome of the event was not reported. The reporter considered herpes zoster to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Lichen Schlerosus came out approximately two weeks after second shot.  Never had this before.  Dr. wanted me to report it.  Shot did something to my immune system to bring this out.
COVID like symptoms for the last 12 hours or longer; flu like symptoms.; feels very tired; Slight headache; arm is really sore; fever of over 100; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (COVID like symptoms for the last 12 hours or longer), INFLUENZA LIKE ILLNESS (flu like symptoms.), FATIGUE (feels very tired), HEADACHE (Slight headache) and MYALGIA (arm is really sore) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A and 017E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (COVID like symptoms for the last 12 hours or longer), INFLUENZA LIKE ILLNESS (flu like symptoms.), FATIGUE (feels very tired), HEADACHE (Slight headache), MYALGIA (arm is really sore) and PYREXIA (fever of over 100). At the time of the report, SUSPECTED COVID-19 (COVID like symptoms for the last 12 hours or longer), INFLUENZA LIKE ILLNESS (flu like symptoms.), FATIGUE (feels very tired), HEADACHE (Slight headache), MYALGIA (arm is really sore) and PYREXIA (fever of over 100) outcome was unknown.            No concomitant medication was provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-317894 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Non Significant follow up appended
This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. On an unknown date, a couple of years ago the patient was vaccinated with GARDASIL (lot#, expiration date, dose, route, indication not reported). On an unknown date the patient experienced pulmonary embolism, and the patient had to be hospitalized at a hospital. The outcome of the event was unknown. Upon internal review, pulmonary embolism is considered as medically significant. Additional information has been requested.