chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chest pain; shortness of breath; 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 CHEST PAIN (chest pain) and DYSPNOEA (shortness of breath) 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 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pain) and DYSPNOEA (shortness of breath). At the time of the report, CHEST PAIN (chest pain) and DYSPNOEA (shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment medications were not provided by the reporter
Allergic reaction at time of injection, almost fainted, lost hearing, vision blurry, basically disabled for 15 mins
Pt presented with covid and chf exacerbation. treated with remdesivir and oxygen. pt discharged home with oxygen.
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 A0639778A and A638780A through A0638786A.
allergic vasculitis; Joint pain; body rash to his torso and part of his legs/ Itchy body rash/ itching; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL9266), via an unspecified route of administration, administered in Arm Left on 26Feb2021 15:00 as SINGLE DOSE for covid-19 immunisation, at 66 years old. Medical history included hypertension (Verbatim: Blood pressure high, takes blood thinner), Heart issue (Verbatim: stents), cholesterol, and sinus disorder from an unknown date. Concomitant medication included olmesartan medoxomil (BENICAR); metoprolol succinate (TOPROL); dexlansoprazole (DEXILANT); eluxadoline (VIBERZI); and acetylsalicylic acid (BABY ASPIRIN), taken for an unspecified indication; and clopidogrel bisulfate (PLAVIX) for blood pressure high, takes blood thinner, start and stop date were not reported. Patient had no new medications or recent vaccinations. The patient reported that his side effect on an unspecified date in Mar2021, is a body rash (itchy body rash) to his torso and part of his legs. His doctor called it allergic vasculitis, and she put him on an unspecified steroid (cortisone to be picked up), antibiotic, an antihistamine to help control the itching, and an unspecified treatment. The rash was described as about the same, it is getting crusty in some of the rash area, and there was new popping up, and also experienced unexplained joint pain. Patient stated he started notice some issues maybe on 01Mar2021 (not specified). Treatment was given for hypersensitivity vasculitis and itchy body rash. Outcome of the events was unknown.
product were exposed to -0.5 degrees celsius for 45 minutes/ NO AE; Initial information regarding an unsolicited valid non-serious case was received from other Health Care Professional via Global Medical Information (GMI) (Reference number- 00708327) and transmitted to Sanofi on 03-Aug-2021.  This case involves MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA], DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL], DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] and IPV (VERO) [IPOL] and while treated with TUBERCULIN TEST [TUBERSOL] that were exposed to -0.5 degree Celsius for 45 minutes and a patient received a dose of received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (product storage error).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (UJ542AA and expiry date: 10-JUL-2022), DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (C5863AA and expiry date: 13-APR-2023), TUBERSOL (TUBERCULIN TEST) (lot C65751AA and expiry date: 19-Sep-2022), MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (06920AA and expiry date: 15-APR-2022) and IPV (VERO) (lot R1F973M and expiry date:30-Oct-2021) exposed to -0.5 degree Celsius for 45 minutes.  On 02-Aug-2021, the patient received as dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE via unknown route at an unknown administration site for prophylactic vaccination.  This was potential medication error case due to product storage error temperature too low (on same day).  It was reported that "the refrigerator temperature went down and Caller states that excursion was caused by the door being left open."  It was not reported if patient experienced any 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 by the regulatory authority. 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.
Reactions to first vaccination given on 03 April 2007 (Bioport Corp, Lot#FAV102 Dosage 0.5ml, VIS Ver. 16 Dec 05) were, Migraine lasting for days with no relief, hot/cold flashes, weakness always feeling tired, body and joints aches, dizziness and fatigue lasting for 12 days. Symptoms started within 12 hrs after getting vaccinated. Second vaccination PT had the same symptoms with a large swelling in the left arm from the shoulder to the elbow. The area was bright red in color with a golf ball size knot 9cm in diameter in the area of the vaccination. PT stated edema started around Sunday afternoon with the redness and swelling early Monday morning. Symptoms lasting for 2 ½ to 3 weeks. Treatment warm pack over area for 15 mins., Motrin 800mg  1tablet 3X a day.
Lt arm injection site is very red, swollen, warm to touch and painful.  Applied ice for 15 minutes at a time several times a day.  Took Tylenol ES Q4H as needed without relief.
Within 2 minutes of vaccine administration there was a 4cm area of induration, erythema and tenderness. Just lateral to the injection site there was a small hive 1cm in size, raised. Benadryl was given and the hive improved and so did the size of the induration.
4-18-21 woke up with N/V/neck pain and stiffness which   subsided over the next couple of days.   Patient treated the symptoms with Acetaminophen 1g twice daily as needed. with some relief. 5-3-2021  am  Patient was unable to move his neck  and was in pain. He went to immediate care center  He was given a dose of Solumedrol and a Medrol pack.  He was informed that he had swollen lymph nodes in his neck and follow up with his primary
Local reaction to injection site with erythema from L upper arm to elbow on 3/14/02 - improved when seen on 3/15/02 area around upper arm still swollen and leg 3cm in diameter. No systemic effects, no hives, now wheezing. RX Zyrtec and cool soaks.
No adverse event; BUD was reported as 18-Feb-2022 and vaccine was administered on 23-Dec-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (BUD was reported as 18-Feb-2022 and vaccine was administered on 23-Dec-2021) and NO ADVERSE EVENT (No adverse event) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (BUD was reported as 18-Feb-2022 and vaccine was administered on 23-Dec-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (BUD was reported as 18-Feb-2022 and vaccine was administered on 23-Dec-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (BUD was reported as 18-Feb-2022 and vaccine was administered on 23-Dec-2021).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Follow-up received contains additional no new information was received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:master case
This case was reported by a healthcare professional and described the occurrence of eyes splashed with vaccine in a 26-year-old female subject who was vaccinating a patient with KINRIX (GlaxoSmithKline). On 18 May 2011 the subject was going to administer a dose of KINRIX to a patient and half to three fourths of the KINRIX dose was squirted into the subject's eyes. This was an accidental exposure. No further details were provided. Follow-up information was received on 27 June 2011. It was reported that the subject was accidentally exposed to KINRIX vaccine when it splashed in her eyes during administration to a patient on 18 May 2011. It was reported that the subject had an eye exam on 20 May 2011 that was abnormal. It was indicated that the event was resolved as of 23 May 2011. The events were not considered to be serious. No additional details were provided.
1st shot:  2/25/2003.  2nd shot 9/7/07.  3d shot 9/20/07.  2 days following receipt of his 3rd Anthrax shot, pt reports onset of pain, 1st in his jaw, only with opening.  That pain continues.  About 2 weeks ago he began to have pain in his elbows w/ exacerbatoin of pain during flexion or extension of elbow as well as with pronation or supination of wrists.  Wrist pain began at the same time as elbow pain and increases with any motion at the wrists.  Pain is 8/10 sharp, non-radiating.  For the 1st 2 weeks after the shot, he had bilateral knee pain which made him limp.  He continues to have sever pain in those joints when squatting.  The pain is such that he requires assistance to stand back up.  He has no h/o similar pain in any of his joints.  Pt has tx'd pain at home with ibuprofen 800mg tabs.  1-2 hours after taking the tab, his pain resolves for about 4 hours before returning to full strength.
Mom states patient developed a blistered, dry flaky rash on left arm on the evening on 8/4/22. Mom has applied aloe but no other treatment.
rash on face 2 hr p/shot next day progressed to swollen hands eyes; inc fatigue 19DEC94 went to MD t101, thyroid not working; inc sed rate 30; pain & burning @ inj site; + ANA r/o epstein barr/myofibrolitis
Swelled Up Left Arm; Red spots on the injection site; Fever (does not remember how high); Headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelled Up Left Arm), VACCINATION SITE ERYTHEMA (Red spots on the injection site), PYREXIA (Fever (does not remember how high)) and HEADACHE (Headache) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swelled Up Left Arm), VACCINATION SITE ERYTHEMA (Red spots on the injection site), PYREXIA (Fever (does not remember how high)) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 31-Mar-2021, PERIPHERAL SWELLING (Swelled Up Left Arm), VACCINATION SITE ERYTHEMA (Red spots on the injection site), PYREXIA (Fever (does not remember how high)) and HEADACHE (Headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported. Treatment information was not provided.
Fatigue, aching body, muscle pain, joint pain, multiple joints involved, low grade fever max 99.8. Loss of muscle strength, worse at night with intense pain on pressure areas in bed. This continue for three weeks easing off on third week but remaining on fourth. Headaches also like never before. On third week seems to have Neuromuscular involvement with decrease musculature, fatigue and much decrease strength even on regular activity. Cannot stand for too long. Waking without symptoms, is limited now. Pain was deep in muscle structures involving fascia and compromising bone as well. This fourth week post vaccination is somewhat better but not normal. Except for fluids increase,Vit C 100mg/day, and Aleve/Advil for pain no other drug was use. Temp was never over 1.
Started with feeling dizzy, shaky, nausea, weakness, muscle aches, vomiting, diarrhea, sore throat, fever, chills, headache x 5 days. Sore arm.
Received COVID-19 vaccine (Pfizer dose 1) at 6:05PM. She was then instructed to wait in the waiting room for 15 minutes. Notified by PCT that patient had ask for an ice pack stating that "she felt like she was going to pass out." PCT retrieved water for pt and informed NP of situation. Upon entering waiting room patient appeared to be passed out in chair. Patient unable to speak, pale in color, and limp in chair. Placed cool paper towels on pts forehead - continually ask patient to speak or respond - patient was unable to. Call placed to 911 at 6:11PM. Patients vital signs BP 86/58, pulse 79, 02sat 97%. Sternal rub performed. Patient regained consciousness while PCT was on the phone with EMS. Patient then stated that this happens to her with medical procedures such as drawing blood. Assisted patient into exam room. Upon assessment lung sounds clear throughout, heart sounds normal. EMS arrived and discussed situation with NP and pt. Decision was made by pt to decline further workup at this time stating that she "feels fine now." Repeat vital signs at 6:39 BP 92/70 Pulse 115, and o2sat 97%.
This initial spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. There was no pertinent medical history, concurrent conditions or drug allergies/drug reactions described. On an unknown date, the patient was vaccinated with ZOSTAVAX injection (dose, route, lot# and expiration date were not provided). There was not concomitant medication described. On an unknown date following administration of ZOSTAVAX, the patient experienced transverse myelitis. It was reported that the patient sought an unspecified medical attention. Product quality complaint (PQC) was not involved. At the time of the report, the outcome of the event was unknown. The relatedness between the event to the suspect drug was not reported. Additional information has been requested.
The RA, injected me with the first dose of the Moderna vaccine without asking a single question. I arrived at the clinic to receive my second dose of Pfizer and ended up receiving my first dose of Moderna.
I woke up in the middle of the night with difficulty breathing. I thought I had a stuffy nose. I used a nasal spray, but it burned. I realized my nose was really dry and not stuffy. I sound like I'm sniffling, but I'm just trying to get air up my nose during the day. Now, its day and night. I made an appointment with my doctor. They ran some tests but they all came back clear. My doctor made an appointment for me to see an ENT doctor. My nose is still the same. It hasn't changed. I can't seem to get a lot of air. I take deep breaths through my nose and exhale through my mouth to get a bit gush of oxygen.
Arm flapping, innapropriate laughing, aggressive behavior, losing eye contact, entering in his own world  within a few weeks.
Body aches, cold, stiff, shivering (sometime violently) coughing, shortness of breath, extreme weakness. (Started AM of 5/13 and got progressively worse until emergency room visit 5/16/15.
This spontaneous report as received from a pharmacist refers to a 69 year old female patient. The patient had no pertinent medical history, had no drug reactions or allergies and did not take any concomitant medications. On 24-AUG-2016, the patient was vaccinated with ZOSTAVAX (strength, dose, lot # and expiry date were not reported), subcutaneously in the triceps muscle. At the same time, she was also vaccinated with diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 24-AUG-2016, the patient experienced rash at injection site. There was no treatment given for the event. The outcome of the event was reported as not recovered/not resolved at the time of the report. The patient sought medical attention via contacting pharmacist. The relatedness between the event and ZOSTAVAX was not provided. Additional information has been requested.
sore arm; fatigue; chills; vomitng; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue), CHILLS (chills) and VOMITING (vomitng) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 immunization.     Concurrent medical conditions included Drug allergy and Food allergy. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, ARIPIPRAZOLE (ABILIFY) for Depression, ESTRADIOL (ESTRACE) for In vitro fertilization.    On 13-May-2021 at 1:45 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 13-May-2021, the patient experienced PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue), CHILLS (chills) and VOMITING (vomitng). At the time of the report, PAIN IN EXTREMITY (sore arm), FATIGUE (fatigue), CHILLS (chills) and VOMITING (vomitng) had resolved.            Treatment medication for these events were not reported by the reporter.   This case was linked to MOD-2021-083767 (Patient Link).
Seriousness: Does not really know what it is, it could be thrombosis; Caller has experienced redness/redness in thumb and finger tips; tingling/tingling in left hand; decrease sensation in his finger tips/numbness and decreased sensation in left hand; He is still experiencing all of these and has gotten worse; This is a spontaneous report from a contactable physician (patient). A 53-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 13May2021 (Batch/Lot Number: EW0183) in the morning between 10:00 and 11:00 am as single dose for covid-19 immunisation at the age of 53-year-old.  Medical history included an open reduction internal fixation, surgery on his right clavicle 5 years ago, which is what made him want to get the vaccine. Concomitant drugs included Multivitamin, Vitamin A and Vitamin D. The patient had an exam in December and all of the test results were normal. On 16May or 17May2021, the patient has experienced redness in thumb and fingertips, numbness, and decreased sensation in left hand, tingling in left hand. Symptoms have been ongoing for 10 days; it has progressively gotten worse. It was reported that the symptoms started 2 days after getting the vaccine on 13May2021, was 16May2021 or 17May2021. He takes multi vitamins and minerals and thought it may be related to that. He takes high doses of Vitamin A and Vitamin D. He actually thought it was due to the Vitamin A and Vitamin D. He stopped the vitamins for a few days. Treatment included: Thought maybe, apart from the vitamins, it may be because he was washing his hands so much that it may be from that. He used Aveno lotion to try and lubricate them. The outcome of event Thrombosis was unknown, outcome of other events was not recovered. The reported considered the events were related to the vaccine as it was the left finger tips, especially the thumb, compared to the right. That's why he thinks it is related to the vaccine.   The clinical course was reported as: The redness was first, then the tingling. He doesn't remember the exact day. The numbness and decreased sensation were afterward. He is still experiencing all of these and has gotten worse. The thumb on the left hand looks pink and wrinkled. When comparing the right see the difference tell they are different. Seriousness: Does not really know what it is, it could be thrombosis. The redness in the thumb and finger tips is in the right as well but is not as bad as in the left.   Follow attempts needed. Further information is expected.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported event of thrombosis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Patient received vaccine yesterday 6/28-07. Later that day he developed a rash on his face, dizziness, headache, weakness and difficulty breathing (per patient) and fever, strep test done to rule out strep - negative. Blood drawn including LFT's. Given Tylenol and mom to observe.
Six hours after receiving the vaccination, I woke up with a high fever and severe, uncontrollable shaking in my whole body. Something like quivering shock waves started to radiate from the center of my chest and shuddered out through my entire body, causing every muscle to shake uncontrollably; the shaking became increasingly violent. My heart was racing. I took deep breaths and applied a cool, wet hand towel to my forehead/neck to relax, but none of it helped.  After about 20 minutes, the violent shaking was only getting worse, so I took one Aleve. The shaking continued for another 20 minutes. Finally, it became less frequent and I could tell I had a little more control but was still shivering. My thumbs were also numb and tingly for the duration of the shaking (about 40 minutes) and afterwards. Eventually I completely relaxed and fell asleep, but I am now sore from being so tense.   Still have slight fever and aches.
Pt recvd 2nd dose of Hep B vax on 19SEP91 & 2 days later pt devel discomfort radiating down arm from site of inject;
feeling achy; tired; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th August 2021, the patient received the 2nd dose of Shingrix. In August 2021, less than a week after receiving Shingrix, the patient experienced pain and tiredness. On an unknown date, the outcome of the pain and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the pain and tiredness to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. One day before reporting, the patient received Shingles shot and felt achy and tired. The patient enquired about how long side effects would last.