chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in my stomach , throw up ,nausea, diarrhea, swelling in arm bit ( under arm ) redness and pain in shoot area . Same day my shoot I took my shoot at 5:15 pm and The symptoms start around 11:00 pm
A patient was administered an expired dose of the Moderna COVID-19 vaccine.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient was administered an expired dose of the Moderna COVID-19 vaccine.) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A, 029A21A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient was administered an expired dose of the Moderna COVID-19 vaccine.). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (A patient was administered an expired dose of the Moderna COVID-19 vaccine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter reported that it was unknown if the patient experienced any symptoms.  No relevant concomitant medications were reported. No treatment information was provided.
Within 24 hours developed marked swelling, fever and fatigue.  Next developed further swelling 11 cm X 11 cm with red streaking medially away from swelling.  Went to urgent care today - treated for cellulitis. Felt also to be allergic reaction
suspected vaccination failure; shingles, keep getting them; painful; arm swelled up; arm redness; arm hard; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 5 weeks after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, swelling arm, erythema of extremities, induration and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved and the outcome of the swelling arm, erythema of extremities and induration were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, swelling arm, erythema of extremities, induration and pain to be related to Shingles vaccine. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.      Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. Unknown after receiving Shingles vaccine, the patient's whole arm swelled up, red, and hard for 3 weeks. At week 5, the patient got first case of shingles and he/she kept getting them, so excruciatingly painful.  The patient wished he/she had not got the shot. This case was considered as suspected vaccination failure, since the details regarding laboratory confirmation of shingles was not provided.
Same symptoms as when I had Covid in November 2020. Extreme fatigue, headache, nausea, sinus congestion, severe flu-like symptoms. These lasted 48 hours.
FLUZONE HD vaccine from last year, which expired with no reported adverse event; Initial information was regarding an unsolicited valid non serious case was received from a nurse via  Medical Information  (Reference number- 00829588) and transmitted to Sanofi on 27-Oct-2021 in a specific country.  This case is linked to case 2021SA359222 (CLUSTER).  This case involves an 85-year-old female patient who received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On 26-Oct-2021, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (Suspension for injection in pre-filled syringe, lot UJ515AA, expiry date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  It was an actual medication error due to expired vaccine used. (latency: same day).  It was reported "Nurse Practitioner reported that the FLUZONE HD vaccine from last year, which expired on 30JUN2021, was given to 8 patients. The caller would like to know whether this dose should be counted and what the protocol is."  At time of reporting, no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
About 15 minutes after 2nd Pfizer dose was injected into my daughter's left arm (upper), she experienced sharp pain near her sternum and ribs near her sternum. She's never experienced this before.  - The nurse at the doctors office administered a max ibuprofen dose.  - Pain radiated around ribs to her back.  - Dr  performed an examination at 4:45 pm and found sore areas in the ribs, but heart rate seemed normal. -Pain in ribs near her sternum was sporadic and she felt "tiredness" at the front of her chest walking to school the next morning.  - Per advice from doctors office where she received the injection,  - I took her to the emergency room Hospital. - Pain occurred with and without physical activity (activity limited to walking with some stairs)
pt rcvd vax; pt devel a serum sickness reaction described as arthralgia, swelling, pain, fatigue; pt was seen by MD; PE revealed dec synovitis; MD felt pt exp due to immune-related complex arthritis temporally related to onset of vax adm;
shortness of breath; Dizzy; Tachycardia; fever 102-103F; Headache; Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), DIZZINESS (Dizzy), TACHYCARDIA (Tachycardia), PYREXIA (fever 102-103F) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vitrectomy in 2018. Concurrent medical conditions included Stroke (Stroke through eye and loss her vision).    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DYSPNOEA (shortness of breath), DIZZINESS (Dizzy), TACHYCARDIA (Tachycardia), PYREXIA (fever 102-103F), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills). On 16-Apr-2021, TACHYCARDIA (Tachycardia), PYREXIA (fever 102-103F), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Chills) had resolved. At the time of the report, DYSPNOEA (shortness of breath) outcome was unknown and DIZZINESS (Dizzy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: 102-103f (High) fever 102-103F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment information was not reported.   This case was linked to MOD-2021-209164 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow up information received on 2/7/2021 contains significant information. The previously reported adverse event related to second dose i.e., vision had not resolved. On 13-Aug-2021: Follow up received on 13/8/2021 contains No new information
Vagal response 1minute post vaccine..Dizzy and pale, hypotensive ,  all symptoms resolved within 5 minutes..  monitored for 30 minutes before d/c.
pt recv vax & devel a few spots that looked like bruises which spread over entire body;pt was seen by MD who dx acute infantile hemorrhagic edema;
This spontaneous report was received from a consumer regarding her mother, a 65 year old female patient with no pertinent medical history reported. On an unknown date the patient was vaccinated with ZOSTAVAX, (0.65 ml, subcutaneous). No other suspect therapies or concomitant medications were reported. 18-JUL-2013 the patient experienced shingles like symptoms of rash, headache and blistering after receiving ZOSTAVAX. It was reported that the above mentioned adverse events had not improved. It was reported that the patient did not seek medical attention. Additional information is not expected.
shingles; Information has been received from a lawyer and a female patient of unknown age regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or around 15-NOV-2012, the pt was inoculated with ZOSTAVAX (strength, dose, lot#, expiration date and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles. Shortly after receiving the ZOSTAVAX vaccine, the pt suffered painful rash across her abdomen and was diagnosed with shingles. As a direct and proximate result of the ZOSTAVAX vaccine, the pt's symptoms had resulted in physical limitations not present prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the ZOSTAVAX, the pt sustained severe and permanent personal injuries. Further, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the product, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. Outcome of the event was not reported. The reporter considered the event to be related to ZOSTAVAX.  The event of shingles was considered disabling by the reporter
This report describes the occurrence of Lyme disease in a 40 year old female who was vaccinated with Lyme disease vaccine recombinant for prophylaxis. This report was received from the subject and has not been verified by a physician or other health care professional. The subject "suspected" that she had Lyme disease in 1990 and "it took a very long time" for her to recover. Concurrent medications were not reported. On an unspecified date, the subject reportedly received her third LYMErix injection. Reportedly, the third LYMErix injection "caused her to contract Lyme disease again." The subject stated that she "could hardly walk due to the Lyme disease." She was seen by her physician, who ordered Lyme serology. According to the subject, Lyme western blot was positive for 30 and 31 kD bands. The subject declined to provide additional info and declined to grant authorization to manufacturer to contact her physician for additional info.
19th received Covid Vaccine at noon  21st negative Covid surveillance test completed due to ED Cluster 22nd Bedtime approx. 2100 A very strange feeling of overwhelming fatigue "spacey feeling"" 23rd nausea dizzy general malaise 24th nausea dizzy general malaise 25th nausea dizzy general malaise Contacted Health Service 26th still nauseous dizzy general malaise and then chills Health Service Ordered Covid Test  26th negative Covid.  26th video appointment with PCP states no need for labs feels it's Vaccine related  27th minimal nausea no chills episodes of feeling ?spacey? and tired  28th Minimal nausea  29th Morning nausea and fatigue  30th Morning nausea and fatigue  31st increased nausea and fatigue all day easing  as day progresses "spacey" with fatigue
2nd Dose given at 830 am on June 5th. At 5pm sameday pt. Was having weak legs,dizzy, slight headache trouble standing . By 9 pm pt. Was very weak, chills and she felt as if she had fever but temp was 97.3 , by 10pm she could not get out of bed because she felt so weak and achy,, her arm was so sore I couldn?t even touch it & she couldn?t lift it , had severe chills but also started to run a fever of 101.3. She could not sleep and was quite scared. I slept in her room with her to make sure she didn?t stop breathing. Gave sips of Gatorade and at 1130 gave her 1 pill tylenol rapid gel release for pain/fever sips of Gatorade through the night
Inj site pain L arm, letargy and above symtoms for 3 days. Narrative:
uour tongue swell up after ghe shot; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (uour tongue swell up after ghe shot) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWOLLEN TONGUE (uour tongue swell up after ghe shot). At the time of the report, SWOLLEN TONGUE (uour tongue swell up after ghe shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided.  No treatment information provided.
I tested positive for Strep throat I experienced a fever; sore throat; body aches; head aches; runny nose; sharp pain above right ear. I was prescribed antibiotics for my diagnosis.
Swollen left leg; rash covering whole leg; rash turning purple for two weeks, hematoma, wetting pants every night after shots for a week, wetting pants during day, foul smelling urine for a week, developed Fifths disease from vaccine (foreign virus entering body and causing immune extreme immune response where body goes into hyper reaction, thus the large scale rash all over body (a year later child is developing rash similar to the one from vaccine administration, is currently being investigated by physicians for known virus or cause?); spot where injection was given last November is still visible and flares up out of no where from time to time (looks like large white blister sometimes, injection site.)
Pt received vaccines to left deltoid region 10/19/2005 as has had Flu vaccine before but not Pneumococcal PPV 23. C.O 2 days after vaccine developed moderate swelling and reddened area from shoulder to elbow, painful to touch. Applied cold compresses. Area warm to touch. no numbness, tingling or continuous pain. Pt voices able to move extremity without discomfort. No fever.
On 10/27/04 Mother stated baby had fever 103-104 with last shots (last 2 sets).
internal itching; extreme body warmth; rash in midsection of torso and neck; severe sore throat; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (severe sore throat), PRURITUS (internal itching), FEELING HOT (extreme body warmth) and RASH (rash in midsection of torso and neck) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (severe sore throat) and RASH (rash in midsection of torso and neck). On an unknown date, the patient experienced PRURITUS (internal itching) and FEELING HOT (extreme body warmth). At the time of the report, OROPHARYNGEAL PAIN (severe sore throat), PRURITUS (internal itching), FEELING HOT (extreme body warmth) and RASH (rash in midsection of torso and neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Immunizations at Clinic approx 4:00pm 03/21/2005 Left arm upper injected. Reddened, hard, not swollen approximately 2"x3 "area.
Diagnosed with Shingles after the first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Diagnosed with Shingles after the first dose) 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 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced HERPES ZOSTER (Diagnosed with Shingles after the first dose). At the time of the report, HERPES ZOSTER (Diagnosed with Shingles after the first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment :Anti-viral drugs
No ADR, timing ERROR, 2nd dose given 46 days after 1st dose Narrative: No ADR, timing ERROR, 2nd dose given 46 days after 1st dose
Pt called today 3/27/13 - reported red, swollen, pain, itchy, warm to touch at the injection site. Increased thirst. Advise pt to take Ibu/ALEVE & BENADRYL and drink lots of water and watch it.
DTaP given 7/28/03-mother noted swelling and erythema at site 7/30/03-continuing to enlarge at the point right thigh swollen and warm to knee. Mobility not limited. No evidence for cellulitis.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 044A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020. Concomitant products included LORAZEPAM for an unknown indication.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            On 17-APR-2021, patient stated that her fatigue improved, her energy level improved more, her sense of smell and taste slightly and both of those things were improved and returned at the time of this report.  Treatment details were not reported by the reporter.   This case was linked to MOD-2021-086772 (Patient Link).
Anaphylaxis as a result of COVID-19 vaccination. Chest pain, chest burning, swollen tongue, nausea, dizziness, lightheadedness.
PT states after her J&J vaccine of 05-05-2021, she experienced phlebitis in the vein, left leg that resulted in a blood clot as per PCP. She states her PCP told her that her phlebitis would go away in a few weeks. PT states she still continues with the phlebitis in her left leg but now is less painful but still present.
Severely ill chills 101 temp shaking uncontrollable swollen hands hands were red throwing up Headache  whole body felt like her nerve endings were inflamed
Pharmacist reported on behalf of patient receiving the first dose of Moderna  4/23/2021.Pt reported sore arm and fever of 99 degrees 24 hours later on 4/24/2021 and ,fatigue for 4-5 days. Pt reported fever lasted 24 hours and did not take any medication for the fever. Pt reported dizziness for 24 hours and it resolved. Pt reported "weirdest symptom": got period 2 weeks early and was very heavy for 4-5 days.Pt called dr who advised her to "just" monitor and report back to dr if worse. Pt is fine but concerned about receiving second Moderna shot.
- Tender  and induration on right deltoid. treatment: KEFLEX 500 mg PO QTD.
Information has been received from a health professional concerning a 9 year old male with migraines and speech impairment and no known drug reactions or allergies who on 04 January 2000, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy included cyproheptadine hydrochloride. On 13 February 2006, the patient presented with 50-100 varicella lesions and was diagnosed with varicella. There was no fever or other symptoms. The lesions were papular with no scabbing. The patient recovered in 7 days. No laboratory diagnostic tests were performed. There was no product quality complaint involved. It was reported that the patient's brother (WAES# 0603USA00313) had a similar experience after vaccination with varicella virus vaccine live (Oka/Merck). No further information is available.
Breakthrough but not fully vaxxed  EW01755 Pfizer - 11/2/2021
Face swelled up; Really pronounced red spots; Face swelled up with sores; This spontaneous case was reported by a non-health professional and describes the occurrence of SWELLING FACE (Face swelled up), RASH MACULAR (Really pronounced red spots) and RASH (Face swelled up with sores) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced SWELLING FACE (Face swelled up), RASH MACULAR (Really pronounced red spots) and RASH (Face swelled up with sores). At the time of the report, SWELLING FACE (Face swelled up), RASH MACULAR (Really pronounced red spots) and RASH (Face swelled up with sores) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported. No treatment medications were reported.
My arm was sore to the touch.; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (My arm was sore to the touch.) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced MYALGIA (My arm was sore to the touch.). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at a dose of 500mg, about 3 in 24hrs. At the time of the report, MYALGIA (My arm was sore to the touch.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications were not reported.   This case was linked to MOD-2021-403057, MOD-2021-403033 (Patient Link).
Chest pain, palpitations. Diagnosed with myocarditis at hospital. (admitted 5/14/21-5/16/21).