chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of influenza-like illness (flu-like symptoms), pain in extremity (pain in arm), chills and pyrexia (low fever) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 027B21A) for COVID-19 vaccination. Concurrent medical conditions included penicillin and sulfa allergy. On Apr 5, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 5, 2021, patient experienced influenza-like illness (flu-like symptoms), pain in extremity (pain in arm), chills and pyrexia (low fever). The patient treated with Advil (ibuprofen) for fever; unknown dosage form. At the time of the report, influenza-like illness (flu-like symptoms), pain in extremity (pain in arm), chills and pyrexia (low fever) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown.
pt devel an inj site rxn characterized by redness, swelling & warmth;this is 1 of 7 pt of this facility to have an adverse exp p/vax lot#4978167;
This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), MYALGIA (Body aches), FATIGUE (Tiredness) and HEADACHE (Headache) in a patient of an unknown age and gender 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 DECREASED APPETITE (Loss of appetite), MYALGIA (Body aches), FATIGUE (Tiredness) and HEADACHE (Headache). At the time of the report, DECREASED APPETITE (Loss of appetite), MYALGIA (Body aches), FATIGUE (Tiredness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment information not reported.   Reporter did not allow further contact
None at first, a little discomprot, but nothing to speak of. Then last night, after 9 days of getting the shot I felt itching and after I scratched a little I looked and saw it was a lot of pink  all aound it  and maybe swollen a little, but not much.  I startd using cold compress  every so often to take away the heat.  This morning it's much lighter and pink, and only slight discomfort there.
child complained of itching within 2 hours after the shot was received. She was given benadryl and aqaphor was applied to the skin.  the next day after school the child complained of more itching and at night after bathing. The same over the counter products were applied on this day. Then today 11/17/2021 the child is still complaining of itching all over the legs and back, only now a rash has developed on the inner thighs. Child was seen by the school nurse who advised me (parent) to notify the clinic and contact the pediatrician office about these symptoms.
I received the shot in the morning at work; worked rest of day, went home and fell asleep around 6:00 pm, exhausted; woke up around 10 pm with severe leg cramps, which lasted on and off through the night for hours.  The following night the same exact thing.  Legs were tired, during the day and then notived movement in my muscles, like twitching, slight cramps.  Continued muscle fatigue for few weeks and i finally went to the doctor; she prescribed me a medication called Cyclobenzaprine; which made me dizzy.  Then she put me on gabapentin 300mg Cap, one pill in the evening; i had to start taking  2 in the evening as i cannot sleep anymore through the night because my legs continue to twitch, roll, ache.  I have this sensation 24 hours a day.
Patient c/o "cellulitis" at the injection site. She received AFLURIA and PNEUMOVAX 23 in right arm. Treated by ARNP --> Prescribed antibiotic.
Paresthesia of hands and feet, purple colored toe and fingernails, feeling of heavyweight on chest with lightheadedness. Symptoms were at their worst Monday and slowly dissapated over the next 72 hours.
I had my 2nd vaccine on 4/5 @ 4:30pm. I felt slightly tired afterwards and noticed that I couldn't stop yawning. After getting home, I ate dinner and went to bed at around 9pm. At around 2:30am, I woke up feeling an intense heaviness on my chest as if something was sitting on top of me and crushing my upper chest.  I stood up and had to immediately crouch over due to the intensity of the pain and heaviness. My husband had to hold me up and suggested going to the hospital. I was terrified and just wanted to wait and catch my breath. It was hard to believe what was happening and I did not want to go to the hospital. After about 5 mins, the intensity of the pain subsided and I was able to breathe normally. I was able to go back to sleep with minor discomfort and woke up at around 6am without any symptoms.  About 2 weeks later, I started to have chest pain, which I had never experienced before. I tried to attribute it to all sorts of things, but it didn't go away so on 5/1, I went to City MD to have an EKG and chest X Ray. Both came out normal and they told me to follow up with a cardiologist for due diligence. I followed up with a cardiologist and they also ran an EKG and X Ray with normal results. Depsite normal results, I thought it was important to report this because I am a healthy and fit 42 year old with no prior heart history and found it uncanny that I had my first "heart event" within 12 hours of my 2nd vaccine.
Severe pain and swelling in armpit area, hot to touch, pain and swelling in neck and shoulder area.  Low grade fever and bad headache, tingling in right hand and throbbing in arm.  Saw Dr Sat morning because pain was intense, he took one look at it and sent me to ER.  I had an ultra sound done for a possible DVT which was negative.  I was given pain meds and sent home and was to watch for other symptoms.  I still have severe pain and swelling and no real changes in my symptoms today.
Vaccines given on 02/19/18 at 9:15 AM. Began sneezing at 9:45 AM. At noon pt reported feeling very fatigued, left eye had blurred vision, then became SOB. She was at school and called father to come get her. Went to ER and was given steroid shot and BENADRYL. Was monitored for 4 hours then released.
Moderate to severe rash, spreading steadily for the past two days.  Currently presenting on both elbows, both palms and backs of hands, abdomen (both sides), and tops of thighs/groin.  Rash includes raised red bumps, swelling, hives, and itching.  Bumps are from 1mm to 1cm, swollen, red, and itching.  Widespread across much of body, and progressive (expanding).
This infant had uncontrollable crying for 24 hours. No fever. Now resolving.
Diarrhea and upset stomach (started 2 days after the vaccine, still ongoing 4 days post vaccine. Treating with rehydration and pepto) Headache (started 1 day after the vaccine, still ongoing 4 days post vaccine. Treating with ibuprofen and rest.) Fatigue (started 1 day after the vaccine, still ongoing 4 days post vaccine)
shortness of breath; chest pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included BUPROPION HYDROBROMIDE (APLENZIN), LAMOTRIGINE, ALPRAZOLAM (XANAX), OLMESARTAN MEDOXOMIL (BENICAR), LURASIDONE HYDROCHLORIDE (LATUDA), BENZATROPINE MESILATE (COGENTIN), ESTRADIOL, VITAMIN D2 and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced DYSPNOEA (shortness of breath) (seriousness criterion medically significant), CHEST PAIN (chest pain) and HEADACHE (headache). At the time of the report, DYSPNOEA (shortness of breath), CHEST PAIN (chest pain) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for events include rescue inhaler, nebulizer, ibuprofen 800 mg.  The events of Chest pain and Headache are NON-serious and NOT Medically Significant.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
She can't raise her arm , Difficulty to move her arm; difficulty to move her left arm, she can't raise her arm and it is painful whenever she tries to raise it. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (She can't raise her arm , Difficulty to move her arm) and VACCINATION SITE PAIN (difficulty to move her left arm, she can't raise her arm and it is painful whenever she tries to raise it.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076621A) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder, Thyroid disorder and Blood pressure high. Concomitant products included LOSARTAN for Blood pressure high, CARVEDILOL and ACETYLSALICYLIC ACID (BABY ASPIRIN) for Heart disorder, LEVOTHYROXINE for Thyroid disorder, PANTOPRAZOLE and ROSUVASTATIN for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (She can't raise her arm , Difficulty to move her arm) and VACCINATION SITE PAIN (difficulty to move her left arm, she can't raise her arm and it is painful whenever she tries to raise it.). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (She can't raise her arm , Difficulty to move her arm) and VACCINATION SITE PAIN (difficulty to move her left arm, she can't raise her arm and it is painful whenever she tries to raise it.) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  The patient had no fever and no chills. Also the patient is still experiencing the side-effect for about 4months until now. Patient did not take any pain killers.the events are still ongoing since 26-Oct-2021.   This case was linked to MOD-2022-474637 (Patient Link).
Shaking chills and then fever to 100.7  3.5 days after administration.
Had seizure next day after vaccine on 8/12/2021 at school and transported by ambulance  to Medical Center with kepra and follow up with Neurologist Dr. Dr. added Zimpat to Kepra for treatment.
Moderna COVID?19 Vaccine EUA: Hives on both arms, hips and legs 1 week after 1st dosage
101.  5 fever headache. cant eat can?t walk well hot feel ill.   had BOTH FLU AND MODERNA COVID VAX AT SAME TIME
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Aug2022 at 18:00 as dose 4 (booster), single (Lot number: FP7150) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Other medical history: High blood pressure but being treated for it" (unspecified if ongoing), notes: Other medical history: High blood pressure but being treated for it. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "not recovered" and all described as "COVID 19"; DISEASE RECURRENCE (medically significant) with onset 24Aug2022, outcome "not recovered", described as "feeling pretty sick again/ tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Aug2022) Negative, notes: I actually tested negative on 20Aug2022; (22Aug2022) Negative, notes: I actually tested negative on 20Aug2022; (24Aug2022) Positive, notes: Today the 24th I started feeling pretty sick again. Coughing worse and low grade fever. I tested this evening and I tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included tab Paxlovid. Therapeutic measures were not taken as a result of disease recurrence. Clinical information: The patient received vaccine received. No other medications in two weeks. The patient took anti-viral product Paxlovid for COVID 19 Treatment starting from 15Aug2022 till 20Aug2022. No follow-up attempts are possible. No further information is expected.
woke up on 6/30/21, no problems, felt normal. An hour later, got up to go to kitchen, right leg stated to go numb. Within 5 mins, right leg and hip and buttock were numb, could not feel or move it. Ended up going to ER, had L-spine MRI done, negative. Was told it was muscle inflammation causing nerve inflammation and irritation. Given one dose of IV steroids and a prednisone taper pack and sent home. The following day, 7/1/21, numbness had increased to include perineum and buttocks, and worse in the right leg. Went to see a spine specialist, who sent me to the ER to get a bigger workup. In the ER, they ended up doing a complete spine and brain MRI, all of which were negative for any structural abnormality. Diagnosed it as possible transverse myelitis, admitted to the hospital for high dose IV steroids. Had lumbar puncture 7/2/21. Had 4 doses IV steroids, then started on prednisone taper (will be for 2.5 weeks).
Vaccine given 10/3/09 at 3:30 pm. "Felt good today" pt. states had flu-like symptoms 10/5/09 pt. states could not see out of left eye 10/6/09 pt. states saw eye doctor three times and was told he was rejecting a cornea (transplant) probably from flu vaccine. 10/29/09 Medical record received from optometrist. DX: iritis OS. Presenting SX: pt c/o pain, redness in OS.   11/16/09:  Optometry record from 10/14/09.  No new information./rmc
This spontaneous report was received from a Nurse regarding patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 29-SEP-2016, patient was vaccinated with improperly stored GARDASIL 9 injection (lot # M009378, expiration date 23-APR-2018) for prophylaxis (dosage not reported). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected, as no additional information is available. Sender's Comments: US-009507513-1612USA009000: US-009507513-1612USA009001: US-009507513-1610USA002776.
fainted; A spontaneous report was received from a consumer who was an 83-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and fainted.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 4 Mar 2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 030421a) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 5 Mar 2021, the patient reported that he fainted and had to be taken to the hospital by a family member.  He reported that he had been hooked up to multiple machines for testing.  He believed that the syncopal event was related to his heart rate.  No treatment information was provided.  Patient received both scheduled doses of mRNA-1273, therefore, action taken with the drug in response to the event was not applicable.   The outcome of event, fainted the day after 2nd dose, was considered unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sudden unexplained 20 pound weight gain in one week. Difficulty breathing, walking and sleeping. Lower leg, face and hand/arm swelling. General feeling of not feeling well. Constant headache. Took a diuretic twice a day for a week to assist with getting rid of excess fluid weight gain. Still trying to get rid of excess fluid weight gain in June.
Sudden onset of extreme fatigue and systemic pain in joints (hands, shoulders, knees)
Treatment of COVID-19; Treatment of COVID-19; Pfizer BioNTech COVID19 Vaccine 4th dose, and dose 1, 2 and 3 of the Moderna Vaccine; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 06Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 51 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 28Mar2021 at 16:00 as dose 1, single (Lot number: 018B21A), in right arm, on 25Apr2021 at 16:00 as dose 2, single (Lot number: 048B21A), in right arm and on 22Nov2021 at 14:00 as dose 3, single (Lot number: 033F21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 06Apr2022, outcome "unknown", described as "Pfizer BioNTech COVID19 Vaccine 4th dose, and dose 1, 2 and 3 of the Moderna Vaccine"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Sep2022) Negative; (21Sep2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received "Paxlovid" to treat "drug ineffective", "covid-19",  treatment start date:14Sep2022, treatment stop date:18Sep2022. Clinical course: Rebound COVID symptoms and infection. Cold symptoms began 20Sep2022; symptoms worsened, tested positive for COVID again on 21Sep22. Had tested negative on 19Sep2022 following 5 days Paxlovid.
Fat necrosis at the injection site (beginning at 4 days following treatment) followed by localized lipoatrophy (beginning at 15 days following treatment).
Information has been received from a physician via company representative, who provided a letter written by an unspecified child's mother. Follow-up information was received on 10-AUG-2018 from an online news article (see case # 1808USA005972 for infant's case). The writer of the article noted that he wrote an article back in 2015 (title not specified) to warn the public and expose the facts that were absent from the corporate-sponsored "mainstream" media, clearly showing that the measles vaccine was far more dangerous than the measles itself, known historically as a non-fatal common childhood infection. The article also discussed a story in 2014, in which a senior Epidemiologist at the Centers for Disease Control (CDC) co-authored and published research on the measles, mumps, rubella (MMR) vaccine (manufacturer not specified) for the CDC in 2004, and his decision to become a whistleblower and reveal data that was concealed by the CDC linking the MMR vaccine to autism among boys. Causality assessment was considered related. No further information was reported. Upon internal review, autism was considered to be medially significant. This is one of two reports from the same reporter. Additional information is not expected.
Injection site mass; Injection site swelling; Tenderness at the injection site; Joint ache; Muscle ache; Fever; Injected twice with the same syringe; A spontaneous report was received from a consumer concerning a 66 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injected twice with the same syringe, injection site mass, injection site swelling, tenderness at the injection site, muscle ache, joint ache and fever.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, 0 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch: unknown ) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient was injected twice during vaccination. She reported the vaccinating pharmacist made a mistake and had to start over using the same syringe. On unknown dates following vaccination, the patient experienced injection site swelling, tenderness at the injection site, muscle ache, joint ache and fever. She reported the fever is now gone. Treatment for the events included ibuprofen.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, injected twice with the same syringe, was resolved on 12 Feb 2021. The outcome of the event fever, was resolved on an unknown date. The outcome of the events, injection site mass, injection site swelling, tenderness at the injection site, muscle ache and joint ache  were unknown.; Reporter's Comments: This case concerns a 66-year-old female who had NS unexpected Product administration error, injection site mass and NS expected fever, arthralgia, myalgia, injection site swelling, injection site pain.  She was injected twice with the same syringe. Events occurred the same day as first dose mRNA-1273. Treated with ibuprofen. Fever resolved. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report was received from a pharmacist and refers to a 56-year-old female patient. The patient's drug reactions/allergies included allergy to an adhesive tape and cephalexin allergy. No information regarding the patient's pertinent medical history and concomitant therapies was provided. On 16-DEC-2016, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, injection site, lot# and expiration date were not provided) for "vaccination". On 16-DEC-2016 (also reported as "at an unknown date and time after receiving an injection", the patient's arm became swollen, red and hot. The patient sought medical attention, as he called to the pharmacist. No treatment was given for the adverse events. The outcome of the events was reported as unresolved, at the time of the report. The relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
Period was 8 days late after receiving first dose of my Covid vaccination.  Aside from being late, it was a  normal period.