chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling, tenderness and itching around injection site; Rash all over bicep and forearm near injection site; swelling, tenderness and itching around injection site; swelling, tenderness and itching around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (swelling, tenderness and itching around injection site), VACCINATION SITE RASH (Rash all over bicep and forearm near injection site), VACCINATION SITE SWELLING (swelling, tenderness and itching around injection site) and VACCINATION SITE PAIN (swelling, tenderness and itching around injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Aug-2023, the patient received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2023, the patient experienced VACCINATION SITE RASH (Rash all over bicep and forearm near injection site), VACCINATION SITE SWELLING (swelling, tenderness and itching around injection site) and VACCINATION SITE PAIN (swelling, tenderness and itching around injection site). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (swelling, tenderness and itching around injection site). At the time of the report, VACCINATION SITE PRURITUS (swelling, tenderness and itching around injection site) outcome was unknown and VACCINATION SITE RASH (Rash all over bicep and forearm near injection site), VACCINATION SITE SWELLING (swelling, tenderness and itching around injection site) and VACCINATION SITE PAIN (swelling, tenderness and itching around injection site) was resolving.            No concomitant medications were reported. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available. No treatment medications were provided.   Reporter did not allow further contact
This spontaneous report as received from a nurse refers to a 57 years old patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On 08-JUN-2016, the patient was vaccinated with improperly stored PNEUMOVAX 23 (dosing details, lot# and expiry and route of administration were not reported). No adverse effects were reported. It was reported that the vaccines were exposed to the temperature 55F for 30 minutes. The previous temperature excursion was 32.9F for 17 hours. There were no product quality complaints (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested.
knot in injection site; injection site again red; itching in injection site; sore arm; redness in injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (knot in injection site), PAIN IN EXTREMITY (sore arm), VACCINATION SITE ERYTHEMA (redness in injection site), VACCINATION SITE ERYTHEMA (injection site again red) and VACCINATION SITE PRURITUS (itching in injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    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 PAIN IN EXTREMITY (sore arm) and VACCINATION SITE ERYTHEMA (redness in injection site). On 14-Mar-2021, the patient experienced VACCINATION SITE MASS (knot in injection site), VACCINATION SITE ERYTHEMA (injection site again red) and VACCINATION SITE PRURITUS (itching in injection site). On 06-Mar-2021, PAIN IN EXTREMITY (sore arm) and VACCINATION SITE ERYTHEMA (redness in injection site) had resolved. At the time of the report, VACCINATION SITE MASS (knot in injection site), VACCINATION SITE ERYTHEMA (injection site again red) and VACCINATION SITE PRURITUS (itching in injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that she is not on any concomitant medications. She did not took any treatment for symptoms.
After I got home and tried to get patient out of her car seat she started to cry cause I moved her. She didn't stop crying for at least an hour. Then I had to lay her on my bed and not move or try to move her or she would start screaming all over again. The crying went on, off and on, for hours. Also she would wake up to interact with anyone. Her leg was red, swollen, hard and was only hot around the area that she got the shot. She had a fever that I couldn't get to go away with Tylenol. I tried to pick her up to try to give her a bath to try to ease some pain and lower her temp. But she wouldn't let me touch her with out belting out in pain. She decreased how often she was nursing and I couldn't get near her very easily without her screaming in pain. This went on for 24 hrs then I could hold her certain ways without her being in screaming pain. She would still cry while I held her but if I could get her where her leg wasn't touching anything she would be ok. After 2 days she started to get back to a normal eating schedule. We still had to hold her a certain way for at least 4-5 days. I called her and they told me this was normal and not to worry, numerous times.
received his second / vaccine on June 26, 2018 / today he was diagnosed with Shingles/suspected Vaccination failure; today he was diagnosed with Shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 26th June 2018, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 1st dose of Shingrix. On 1st July 2021, 1101 days after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional information was provided as follows: The case was reported by patient himself. The age at vaccination was not reported. The patient stated that at the time of reporting, he was diagnosed with Shingles.  No Lot or Expiration date for the vaccine was known. This case was considered as suspected vaccination failure as details laboratory confirmation were unknown at the time of reporting.  The reporter consented to follow up.
pt recv vax 24JUN97 940M & 430PM exp visual disturbance (blurry vision) off & onf or 1 1/2hr followed by tiredness otherwise no other sx;
tiredness; Headache; Muscle Pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness), HEADACHE (Headache) and MYALGIA (Muscle Pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (tiredness), HEADACHE (Headache) and MYALGIA (Muscle Pain). At the time of the report, FATIGUE (tiredness), HEADACHE (Headache) and MYALGIA (Muscle Pain) outcome was unknown.            Concomitant medications were not reported.   The patient received his second dose of the Moderna vaccine yesterday, on 26-Feb-2021. He was scheduled for a deep tissue laser procedure and wanted to know whether it may affect the efficacy of the vaccine as he fears it may cause more side effects.   Treatment information was not reported.  He also wanted to know whether it was safe to take Advil or Tylenol and how long it takes for the vaccine to provide protection after the second dose. On 31-Dec-2021,MOD-2021-427838 became invalid as it was confirmed that the patient did not experience any adverse event following vaccine administration. Therefore, this case will be logically deleted from the safety database.   Most recent FOLLOW-UP information incorporated above includes: On 30-Dec-2021: Follow up received contains no newinformation On 09-Jan-2022: Follow up received: In initial version missing valid criteria (adverse event) hence initially case was invalid but in FU version adverse event was reported which made the case valid. Added newevents
Difficulty breathing, swallowing, vision problems 10/4/10, sore throat, vomiting, fatigue 11/11/10. Nausea, dizziness, lower extremity weakness, eye hemorrhage 1/12/10, loss of bladder control, lower extremity weakness, blindness diagnosed with ADEM.
Pain in armpit/lymph node, itching at injection site x 2 days, Redness/hot to the touch/painful since this AM.
Pt came back to employee health about 1 hr after vaccine was given (Hep B vaccine was also given at the same time) and had a bad nose bleed, was unable to stop the bleeding and was taken to ER
Patient received MMR #1 in the right arm on 12/21/2021 at 1635 without reaction or side effect.  She received MMR #2 in  the left arm on 1/21/2022.  On 1/24/2022, she developed itching, 8/10 pain, erythema and deep induration to her right arm (MMR #1) injection site.  By 1/31/2022, her right arm pain decreased to 0-1/10 and itching and erythema resolved.  Induration remained measuring approximately 1 cm x .5 cm.  Otherwise,  history and clinic exam negative.
Suspected Vaccination failure; has had shingles twice; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for an unknown indication.   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, more than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: has had shingles twice). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 03-MAR-2023 The case was received from the patient's daughter/son via interactive digital media. The patient had shingles twice in the last 2 months. The patient had 2 shots in 2018, that was. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Patient experienced left neuralgic amyotrophy.  He got the 1st dose of the Moderna COVID-19 vaccine on Thursday 1/28/2021. He got the 2nd Moderna shot on 2/26/2021. Symptoms started on 2/1/2021. That morning, he awoke with severe localized left shoulder/shoulder blade pain. No weakness or numbness at that time. Left shoulder pain lasted for a week then resolved on 2/7/2021. However, that same day that the left shoulder pain resolved, he started to experience constant tingling paresthesias at the left digits 4-5 and the medial palm/hypothenar eminence. He was recommended physical therapy and went there for 2 weeks then went to occupational therapy who noticed some left hand weakness. He does notice some mild difficulty manipulating left digit 5. Since then, symptoms are present but  improving.
Sore arm at site of injection, fever 104 degrees F, cold shaking chills, nausea, vomiting, muscle cramps, tingling and paresthesia in bilateral heels and fingers.
sore arms; Initial information was received on 13-Oct-2021 regarding an unsolicited valid non-serious case received from a Social Media via consumer/non-health care professional.  This case involves a adult patient (unknown gender) who had sore arms (pain in extremity) after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.   The patient's medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received two doses of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious sore arms (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "I got both shots on the same day. I am glad I got them. But, don't recommend doing them together 2 sore arms!"  It was unknown if the patient experienced any additional symptoms/events.   There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, outcome of event was unknown.  The reporter did not report the causality of event with suspect.  There will be no information available on the batch number for this case.
Admitted to the hospital with complaints of chest pain. Patient received a second Moderna COVID vaccine 2 days prior. EKG showed diffuse concave ST and T wave elevation and troponins were elevated. Cardiology made the diagnosis of acute myopericarditis. Patient underwent a cath and was found to have normal coronaries. Required discharge with life vest, metoprolol, colchicine, and indomethacin.
This spontaneous prospective pregnancy report was received from a pharmacist who is also the female patient of unknown age regarding herself. Medical history, drug allergies and concomitant medications were unknown. On an unknown date in 2016, the patient had inadvertently injected herself with ZOSTAVAX and developed "Shingles". The patient was currently pregnant and when she was finished injecting the sterile water diluent into the via of the ZOSTAVAX she pulled out the syringe to attach another needle and inadvertently stuck the needle in her finger "before she drew up the reconstituted dose of ZOSTAVAX" on an unspecified date approximately in 2016. The primary reporter stated that "two days later" on an unspecified date approximately in 2016 her finger became extremely "itchy, red and swollen" at the site where the needle inadvertently penetrated her skin. The LMP and EDD was not known. The pregnancy outcome was pending. No laboratory tests were performed. The patient stated that she did not seek treatment, and was presently not recovered. The outcome of shingles was unknown. The causality was not reported. Additional information has been requested.
Spots or pimples appeared on stomach and face; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 08Apr2021 at 13:00 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, hay fever and grass allergy. Concomitant medications included vitamins nos and minerals nos (CENTRUM), lisinopril (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPRIN) low dose used for unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 08:00, 19 hours after receiving second shot, the patient experienced spots or pimples appeared on stomach and face. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event spots or pimples appeared on stomach and face was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient went to urgent care reporting symptoms of numb feet, light headedness/being dizzy, and blurry vision after receiving the covid-19 Moderna vaccine.
itching.  Given oral benadryl with resolution.  Itching, hives previsouly after first vaccine resolved after oral benadryl.
Sunday I just felt tired and slightly flu-ish which is common but my face did feel sunburned. On Monday, my face was more itchy and I took Benadryl. On Tues morning, I woke up and my face was swollen, especially around my eyes and the itching was worse.
I received my second vaccine on 2/27/2021 around 11:00AM ET. The only symptoms I had was a sore arm and typical symptoms that was expected that lasted 24 to 30 hours. I had very minor oral surgery a week before.  On 4/3/2021 I had tingling in my lip and then I took a nap with my son and when I woke up the left side of my face was numb. The numbness and tingling spread to my face and neck.  I went to the emergency room, prednisone and told me it should go away.  It continued over the course of the next few weeks and began to spread into my left arm.  I went to the ER and was told I had swelling in my lymph noes that was causing the issue.  I went to a different ER and they imaging, I was admitted because they were concerned because the numbness had gone to my left.  While there I started to have the numbness on my right arm, I began having like a wave sensation go over me every now and then, it still comes and goes.  I also have a sensation that I am vibrating on the left side.  At one point I did start to have tremors in my left fingers, also at one time I my lounge had some tremors.  I was on a very high dose of Prednisone and wondered if that was the cause of the tremors. Currently, more days than not I have that internal vibration and numbness on my left side, very light sensation and my left foot on the side is very numb.  It is not as bad as it was in April but it has subsided.  The tingling still occurs lightly on the left side.
Had rapid heart beat; 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 HEART RATE INCREASED (Had rapid heart beat) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (Had rapid heart beat). At the time of the report, HEART RATE INCREASED (Had rapid heart beat) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
Nurse administered COVID PFIZER BIVALENT BOOSTER, when patient was due for COVID PFIZER SECOND DOSE PRIMARY SERIES. Nurse did not pay attention when reading the printed immunization record that patient had only received one dose of Pfizer. Patient was called and notified that he received the wrong vaccine. Patient stated that he did not have any symptoms and they will come back in 2 months for their booster.
On 6/8/2021 patient c/o fever to 102.5 then at 1:15 PM woke up from a nap with upper left chest pain described as burning. Parent treated with Tums and ibuprofen and pain lasted about 8 hrs. Also c/o nausea but no vomiting. Had dizziness earlier in the day but not when she had chest pain.  No shortness of breath or palpitations. All symptoms resolved by the morning on 6/9/2021. Parents did not seek medical attention until 6/15/2021 when they learned about possible myocarditis as a vaccine side effect. Patient is currently asymptomatic but is not able to seek medical attention today. Recommended to go to nearest UC or ER to check a troponin and ECG.
SOB and HTN on 1/30/21, 3 wks after 1st Covid shot. Submassive acute saddle pulmonary embolism. Pt was sent by ambulance to ER. On arrival, CT revealed a saddle embolism. Heparin was initiated and pt was transported to hospital. Admitted to ICU and bil thrombolytic catheters were placed. On 1/31/21 thrombosis has dissolved. on cessation of thrombolysis and removal of lytic stents on 1/31/21 pt was placed on Xarelto. Pt was D/C on 2/1/21.
Received the shot on a Thursday. Sunday morning when I woke up I noticed my left armpit was sore. This is the same side where I received the shot. I also noticed that there was some swelling in the area of the left armpit as well.
This spontaneous report was received from a registered nurse refers to a female patient of unknown age. On 06-APR-1972, the patient was vaccinated with a dose of M-M-R II, (lot number, expiry date and route was not reported). No concomitant medications were reported. The nurse reported that within the last 6 months (since starting a new job requiring employee testing for rubella). She had a blood test titer for rubella and it was reported to be equivocal. As a child she had mumps. The nurse reported that a few years ago when she was last pregnant her titer to rubella was acceptable. No adverse event reported other than equivocal to rubella. Additional information has been requested.
Chills; Fatigue; Joint pain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), FATIGUE (Fatigue), ARTHRALGIA (Joint pain) and PYREXIA (Fever) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 006M20A and 012L20A) for COVID-19 vaccination.     The patient's past medical history included Leukemia (Blood cancer).   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced CHILLS (Chills), FATIGUE (Fatigue), ARTHRALGIA (Joint pain) and PYREXIA (Fever). At the time of the report, CHILLS (Chills), FATIGUE (Fatigue), ARTHRALGIA (Joint pain) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The Patient Date of birth was reported as date in the Source document.  Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-375441 (Patient Link).