chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced DYSPNOEA (shortness of breath). At the time of the report, DYSPNOEA (shortness of breath) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Heart rate: high (High) fast Heart Beat.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was provided by the reporter.  No Treatment medications was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: AE contact Info update On 08-Jul-2021: Follow-up received and event outcomes updated.
Three hours after first  Pfizer vaccine, patient staring having right armpits swelling, head hurting. Several days later patients heart started hurting and was taken to ER. Also trouble breathing.
Bump behind my left knee. From doctor visit on 3/23/2021: On exam of the left knee there is a soft ballotable nontender 4 x 4 centimeter cystic lesion in the popliteal fossa.  No distal edema.  Negative Homans' sign  This appeared on 3/18/2021. It is not painful and is not stopping me from exercising.  There is some mild swelling in my right leg.
Very sore/heavy arm, redness, swelling at  injection site, headache, extreme fatigue, body aches, brain fog;  no treatment except rest and fluids.
no additional adverse event; The healthcare worker reported that a patient received improperly stored vaccine.  The patient received only one dose but the healthcare worker did not specify which actual lot the patient received the vaccine.  No additional AEs were reported, no fu; This spontaneous report was received from a health care worker concerning a 2-year-old patient of unknown gender.  The patient's medical, concurrent conditions and concomitant therapies were not reported.   On 24-AUG-2022, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #W003118, expiration date: 13-JUL-2023, or lot #W015191, expiration date: 27-OCT-2023, administered as prophylaxis (strength, and route of administration were not provided) (product storage error). The patient received only one dose but the reporter did not specify which actual lot # the patient received.    It was reported that the vaccines were stored at a temperature of 11.3 Celsius degrees for 34 minutes. No previous temperature excursions and no additional adverse events were reported.
This case was reported by a lawyer and described the occurrence of neurological injuries in a 10 yr old male subject who was vaccinated with hep B vaccine recombinant (Engerix B), combination diphtheria and tetanus toxoids, pertussis adsorbed and Haemophilus influenzae type b conjugate vaccine (Tetramune) and haemophilus influenzae type b conjugate (HibTiter) and combination diphtheria and tetanus toxoids, pertussis adsorbed and haemophilus influenzae type b conjugate vaccine (Acel Imune) for prophylaxis and who was exposed to Hyprho D (Rh immune globulin) in utero. A physician or other health care professional has not verified this report. On 14Sep98, 11Nov96 and 09Feb96, the subject received Engerix B (unk). On 03Jul96 the subject received  unspecified dose of Tetramune (unk). On 01Jul97 the subject received unspecified dose of Hibtiter (unk) and Acel Imune (unk). While the subject's mother was pregnant with the subject, she received HypRho D (Rh immune globulin). Per the statement of claim it was reported that as a result of his pre and post natal exposure to the thimerosal containing products above, the subject received a cumulative dose of between 202-223 micrograms of organic  mercury. It was reported that the mercury causing his injuries was contained in thimerosal a preservative added both to the vaccines he received during his first three years of life and to HypRho D administered to his mother while she was pregnant with him. After an unspecified time after exposure to HypRho D and vaccination with Engerix B, Hibtiter, Acel Imune, and Tetramune, the subject experienced neurological injuries included developmental delays, learning disabilities, social delays and deficits, impairment of fine motor skills, gastrointestinal illness, immune system dysfunction, and other unspecified symptoms of mercury poisoning. It was reported that some of his injuries were likely to be permanent. At the time of reporting the outcome of the events were was unspecified. This information was received via a complaint and jury demand. Follow up information received via another manf on April 06, 2006, indicated that the events were disabling. It was also noted that the pt experienced a nerve root injury.
A non-serious spontaneous report of croup and cough was received from a physician concerning a five-year-old male, subsequent to FLUMIST. No medical history or concomitant medications were reported. The patient received FLUMIST (date not reported). On 27-Oct-2008 the child experienced cough/croup and was taken to the emergency room. While there he was treated with dexamethason and albuterol. The health status of the child was reported as unchanged. The reporter stated that in his opinion FLUMIST did not cause the coughing experienced by the child. There was no report of causality for the croup.
Received first shot on 3/15/21. On 3/25/21, I developed a rash (hives) around 6:30-7pm. After dinner, around 7:30pm I noticed that my lips were swollen and the rash was spreading. Took one Benadryl and waited 1 hour. Condition worsened so left for ER around 8:45pm. Once there, I was diagnosed with an anaphylatic reaction. I was given Prednisone, Pepcid and Benadryl intervaneously. The Benadryl injection caused my throat to close for a few seconds. Things calmed down so we waited an hour to see if I was responding. There was not a lot of improvement so ER doctor decided to use Epinephrine (EP pen injection). After 2 hours of observation, I was set home to follow up with primary care physcian.
Pt given Pneumovax in L Deltoid at approx 10am on 8/12/04. Pt returned to clinic on 8/13/04 at 12:15 with c/o extreme soreness, redness and swelling at injection site. Pt examined by Physician on duty, Dx of Cellulitis given and pt was prescribed Cephalexin 500mg TID X 10days. Instructed to use Ibuprofen and ice at injections sight.
Inappropriate schedule of vaccine; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix received in 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 22-APR-2022 Reporter's Comments: This case was self reported by patient. The patient reported that, the patient did not receive her second dose of Shingrix and it had been longer than six months since the first dose. The patient indicated that she would be taking the second dose. The reporter did not consent to follow up. AE (Adverse Event) filed.  The reporter was given medical disclaimer. Referred to HCP (Heath Care Professional). Spoked per package insert and content. Offered after call survey. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Shingrix - Expired dose administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 51-year-old male patient who received Herpes zoster (Shingrix) (batch number 4XA55, expiry date 13-JUL-2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: Shingrix - Expired dose administration).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 20-SEP-2023 A pharmacist reported that a 51 year old patient received an expired dose of Shingrix, which led to expired vaccine used. The HCP asked for guidance on this situation. The reporter consented to follow up.
received its first dose of the Moderna Covid19 vaccine last 22Oct.2021 that is already refrigerated for 35 days (unopened). received its first dose of the Moderna Covid19 vaccine last 22Oct.2021 that is already refrigerated for 35 days (unopened). Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received its first dose of the Moderna Covid19 vaccine last 22Oct.2021 that is already refrigerated for 35 days (unopened).) and PRODUCT STORAGE ERROR (received its first dose of the Moderna Covid19 vaccine last 22Oct.2021 that is already refrigerated for 35 days (unopened).) 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 22-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received its first dose of the Moderna Covid19 vaccine last 22Oct.2021 that is already refrigerated for 35 days (unopened).) and PRODUCT STORAGE ERROR (received its first dose of the Moderna Covid19 vaccine last 22Oct.2021 that is already refrigerated for 35 days (unopened).). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received its first dose of the Moderna Covid19 vaccine last 22Oct.2021 that is already refrigerated for 35 days (unopened).) and PRODUCT STORAGE ERROR (received its first dose of the Moderna Covid19 vaccine last 22Oct.2021 that is already refrigerated for 35 days (unopened).) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.
After receiving my second dose (1st dose of Pfizer), I have been having 1-2 severe headaches per week. I become nauseated and I'm unable to even function. I also experience restlessness. I'm unable to go running like I used to before. I did test positive for COVID-19 in June of 2021.
Flu vaccine (FLUZONE by Sanofi Pasteur) and PNEUMOVAX-23 given in (L) deltoid. (L) deltoid down to elbow swollen after 4 days. Notified office on-call Dr. on 11/24/12 - pt went to ER on 11/25/12.
Pulmonary Embolism diagnosed. Blood thinners administered by sub-q abdominal injection then prescription rivaroxaban 15 mg twice per day for three weeks then 20 mg once per day indefinite
I had a breakthrough Covid-19 infection beginning January 6, 2022. I had a crazy bad headache for an entire day. Sometime overnight I had a fever that lasted two or three days and my breathing was difficult. I went to doctor on January 10, 2022 and was monitored for oxygen level. I went back to the doctor the following week because of more difficulty breathing. Due to my allergies, I was unable to take the prescribed meds. I now experience long Covid-19 symptoms; extreme fatigue, brain fog and I cannot breathe cold air, sleep inconstancies.
Quarter sized red spot at site of injection that was itchy.  Site of injection was L arm Subq
I was feeling cold throughout the day, at about 9:00 pm I took a shower to try to get warmed up, I just kept getting colder and colder until I was severely shaking uncontrollably. Every muscle was so tense and I was shaking so badly I could barely walk or breathe. I went to the bedroom and got under blankets with a heater and in a few minutes the shaking diminished to where I could start breathing normal again. It took about an hour before my shakiness went away completely but I still needed to stay under the blankets and near the heater as I felt I was still cold and on the verge of getting the severe chills again. I had no fever. Next morning (as I'm writing) I'm still worried about getting out of bed as I still don't feel right and am scared of getting the chills like that again.
When I woke up I noticed circular rashes from the tip of my fingers up my forearm. The rash spots started pretty small like the size of dimes and quarters and the largest ones were like fifty cent pieces. They didn't hurt until they would dry up it would crack and that would hurt. I did have a tele visit with my doctor and he told me to take over the counter allergy pills. They also gave me mometasone furoate steroid cream, Singulair, Claritin, hydrocortisone cream and Pepcid. I didn't take the Singulair. This medication made the rash dry up and the skin began to heal. I still have skin discoloration.
Immunizations given 2/18. Started that day with cough & nasal congestion, followed by fever. On 2/21/11 had increased work of breathing which lead to ER visit & admission. Chest Xray at that time showed right sided pneumonia. Treated with O2, antibiotics, albuterol, chest PT, fluids, steroids. Transferred to hospital 2/21, 2/22 developed (R) pneumothorax --> intubated, chest tube, central line - resolution of symptoms hospital also reports a rash. See attached notes.
Patient developed bruising around her left eye 24 hours after the second vaccine.  This subsided, but then she had bleeding from her right ear on 6/14/21. This also resolved, but then she had atraumatic bruising on left upper arm 7/13/21
Patient complained of ear pressure and racing heart 15 minutes after shot . EMT came and cleared patient no sign of reaction
developed Atrial Fibrillation in November, had to increase current beta blockers and add Xarelto
Moderna on 1/25 and 2/18. Positive on 8/20 admitted 8/22-current
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient's mother said he always passes out after getting any vaccine..he passed out for few seconds. he fell on his head. I called 911. he was responsive and doing okay by the time they arrived.
I'm an Emergency Physician who received Pfizer #1 on 12/1820 (Lot EJ1685) then Pfizer #2 on 1/7/21 (Lot EH3899).   Due to delta peaking in local area and me having some risk factors, opted to get a "booster" and went with Moderna lot as above on 7/20/21.  On 8/7/21 on way to work in the ER at 520am, started to develop left arm tingling, left shoulder pain, then chest pain that became severe enough by 545am that I had to pull to the side of the road.  Had diaphoresis, dyspnea, pre-syncope.  Had to call an ambulance which led to the workup below.
Overall weakness; Sick; Nauseous; Lack of appetite; Soreness in her arm; This is a non-serious spontaneous case, initially received from other health professional (nurse) via pharmaceutical manufacturer (Merck) on 02-Jan-2019, concerning a female patient of unspecified age.  On an unspecified date (reported as a year and half ago), the patient was administered Fluad TIV (Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose, route of administration, anatomical location, batch number, expiry date: not reported) for an unknown indication.   On an unspecified day after vaccination, the patient got sick and experienced nausea, soreness in her arm, lack of appetite and overall weakness.  The patient had recovered from the events.; Reporter's Comments: A female patient developed sickness, nausea, pain in arm, lack of appetite and weakness on an unspecified day after receiving Fluad TIV. The company assessed the causality of the events as unassessable due to lack of information regarding the onset latency.
Incredible pain in entire arm, unable to move. 10 on pain scale I have never felt anything so painful. The next day the pain was much less.
This is a spontaneous report from a contactable consumer (patient). A non-pregnant 66-year-old female patient BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8727), dose 2 via an unspecified route of administration, administered in arm left on 05Apr2021 13:00 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. No other vaccine in four weeks. The patient previously received the 1st single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: En6204) on 15Mar2021 13:00 PM (at the age of 66-year-old) for COVID-19 immunization. On 12Jun2021, patient had a mini stroke. Thought patient should report this. Maybe, maybe not related. Patient was admitted to hospital due to that for 3 days and received treatment. AE caused Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered.
Pt recv vax on 10/6/98; 4 hr later pt exp swelling of upper lip & bridge of nose;  tx=Benadryl 25mg.
Diaphoresis, nausea, h/a upon awakening; Headache all day & p/dinner, diarrhea; pain @ inject site, unable to sleep on her arm;
After the typical side effects (muscle aches, chills, fever, foggy brain) started to subside around 9pm-ish on Tuesday 5/11/21, I noticed the left side of my neck was more sore than earlier in the day.  I spent the day on the couch resting, so I did nothing that day or previous days to feel like I severely pulled a muscle.  When I awoke this morning at 5:45am, I could barely move my head; I cannot look up nor turn my head to the left.  My other side affect symptoms are gone, but this neck pain is getting worse as the day goes on.  The specific site is: just above where my neck meets my back on the left side, approx an inch to my left of my spine, spanning to the side of my neck to my clavicle.  No treatment yet.  Thought I might take some acetminophen.
Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong; Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jan-2023, the patient received 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, the patient experienced TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong) and NO ADVERSE EVENT (No adverse event). At the time of the report, TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for TRANSCRIPTION MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Cards reflects the wrong lot numbers and we can not figure out which patient's records are wrong).    This case contains information for the 12th of 16 patients described by the reporter.  No concomitant medications were reported.  Patient received additional booster.  It has been reported that 26 patients received bivalent vaccines from 2 different Bivalent lot numbers on 09-Jan-2023 they were lot numbers: 061F22A and AS7170B. For all 26 patients' vaccine cards lot number has been written as AS7170B.  For 16 patients Vaccination Cards reflected the wrong lot numbers. Additionally, it has been reported that all patients received the correct vaccine and bivalent dose and the error only involved in documentation.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-696236 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696236:Master case
Joint and muscle pain, fatigue, dizziness. Left arm is very swollen at injection site still two days later; very painful.  Took Tylenol, no benefit.
Vaccine given 13 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 13 days post expiry) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 13 days post expiry). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 13 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not experience any adverse event.  No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2021-395985 (Patient Link).
Headache, dizziness, muscle fatigue, tiredness, fever, brain fog.  24 hour point after injection couldn't even get out of bed.  Took fever reducer and started to feel better 36 hour mark.  Was dizzy with headache and brain fog until 48 hour mark.