chrisvoncsefalvay/vaers-outcomes huggingface dataset:
round, raised and warm circle bigger than half dollar on her right arm; Round, raised, warm circle on her arm; raised up\round raised circle on it; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (round, raised and warm circle bigger than half dollar on her right arm), INJECTION SITE WARMTH (Round, raised, warm circle on her arm) and INJECTION SITE SWELLING (raised up\round raised circle on it) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 43821A and 017821A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced VACCINATION SITE REACTION (round, raised and warm circle bigger than half dollar on her right arm), INJECTION SITE WARMTH (Round, raised, warm circle on her arm) and INJECTION SITE SWELLING (raised up\round raised circle on it). At the time of the report, VACCINATION SITE REACTION (round, raised and warm circle bigger than half dollar on her right arm), INJECTION SITE WARMTH (Round, raised, warm circle on her arm) and INJECTION SITE SWELLING (raised up\round raised circle on it) outcome was unknown.            No concomitant medications were reported.   No corrective treatment was provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: No specific follow-up information recorded.
1 week after receiving the vaccine in the right arm, lymph node in the right arm pit became swollen and painful. Also, right upper chest lymph node swelling and pain. Continuing to have vague/dull pain in right upper arm.
patient received expired IPOL vaccine/ NO AE; Initial information received on 12-Oct-2021 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who received expired IPV (VERO) [IPOL] vaccine (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect IPV (VERO) (lot number not reported and expiry date: 03-Oct-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  It was potential medication error case due to expired vaccine used (latency: same day).  Healthcare professional wanted to know what should be done. The nurse was asked for additional adverse event information but she did not have time.  At the time of reporting, no adverse event was reported.  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 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.  There will be no information available on the batch number for this case.
REALLY BAD CRAMPS IN WHOLE BODY ,FEET AND HANDS WERE DRAWING IN MY LEGS WERE CRAMPING SO BAD I COULD NOT WALK ,I HAVE THESE CRAMPS FOR 2 DAYS SECOND DAY I HURT IN BELLY AND AND BACK
Moderna vaccine x 3. Tested positive for covid on 12/29/2021. Admitted to Hospital on 02/20/2022. Self reported he tested positive for COVID on 02/8/2022 but no labs received. Case expired on 03/08/2022 while still hospitalized.
10 month old received 3rd dose of rotavirus; should not be given after 8 months of age ; no adverse reaction occurred.
(R) arm edema and erythema 4 cm diameter-local rxn. 103.6 fever.
the day after my first vaccination I woke with bilateral wrist stiffness and pain, bilateral ankle knee and swelling in my ankles. This subsided in a few days. I was holding off on taking my Orencia infusions because I wasn't sure when I would be able to get the vaccine. Orencia dosing is every 4 weeks and I am supposed to take any vaccinations two weeks post infusion.  After my second vaccination, I had a full flare. Swollen joints, IBS symptoms, fatigue,fevers, decreased appetite.  I went to my rheumatologist and scheduled an infusion as soon as possible. I had to stop taking NSAIDs because my creatinine became abnormal. I had my Orencia 750mg on Februray 1, 2021, but continued to feel ill and started a prednisone
After getting the  second Pfizer vaccine, I experienced shortness of breath. Riding my bike the shortness of breath was noticeable as I had to walk up hills I normally ride up and I was winded.  I went for a complete nuclear stress test with a known cardiologist and got a completely normal heart reading.  My heart is healthy, but I am experiencing shortness of breath all the time, more so when I exercise. My cardiologist said that even though there is only anecdotal evidence, other people have complained about symptoms lasting after the second shot and he recommended that I see how I feel in a month from now, although as an active person, I feel anxious about my symptoms.
Patient with PMH breast cancer on chemotherapy presented to ED on 10/21 with fever, chills c/f sepsis. Due to neutropenia, started on IV cefepime. Pt now afebrile. NO positive cultures at this time.
Violently ill the next 24 hours after shot (vomiting, high fever over 102, chills, and sweating) Period has now been abnormal/not a normal cycle since getting vaccinated.  Used to be every 3.5 weeks and now is unpredictable and cannot get my cycle back on track.
Pfizer COVID-19 vaccine formulation for 5-11 years (orange cap)  was administered to a patient who was 4 years 6 mo and 14 days at time of vaccine administration.   No adverse reactions reported .
Burning sensation at injection spot that won't go away.  LIghteaded, dizzy, almost fainting.  Slurred speech, feels like head is spinning, exhaustion.
Fast heart rate and SOB w/HA and fatigue x 2 days, started 1700 yesterday after receiving J&J vaccine in AM yesterday, reports SOB upon exertion and "long-winded conversation"; denies any dizziness; last dose 325mg ASA with 500mg Tylenol at 0900.
she had a rapid onset of floaters in her left eye; her appetite kicked in which is unusual for her; felt unwell; she felt extremely hungry which is very unlikely of her.; she experienced extreme fatigue; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9262), via an unspecified route of administration on 26Jan2021 16:30 (Tuesday) as Dose1, SINGLE for an unspecified indication. The patient's medical history and concomitant medications were not reported. On 27Jan2021 (Wednesday), the patient experienced extreme fatigue. She was able to carry out her work duties. On 28Jan2021 (Thursday), the patient felt unwell, she felt extremely hungry which is very unlikely of her, her appetite kicked in which is unusual for her. On 04Feb2021, she had a rapid onset of floaters in her left eye. She went to the eye doctor. She wanted to know if it is safe to take the second dose of the Pfizer COVID-19 vaccine on 16Feb2021. The outcome of all the events was unknown. There was no product quality complaint (PQC) present.  Follow-up attempts completed. No further information expected.
Diagnosed with Deep Vein Thrombosis in lower left leg.  Immediately put on blood thinner medication and elevated leg, with warm compresses.  Removed temporarily from work.  Advised this is very serious as if blood clot gets loose it could be fatal.  Treatment and outcome still in process as this is reported.
Information has been received from a healthcare professional and a female consumer who was vaccinated with a dose of PNEUMOVAX 23 (Lot# 658075/0962U). After receiving the vaccine, the consumer experienced no appetite, muscle and joint pain, swollen lymph glands and pain in her armpit. It was reported that the patient was put on oral antibiotics. The swelling had gone down and the pain had lessened but had not gone away. It was reported that "presently" she felt "shaky." She still has joint and muscle pain and the pain has lessened but not gone away. No product quality complaint was involved. A lot check has been requested. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the government and was released. Additional information has been requested.
erythema lt upper thigh-began evening p/vax tx w/ice then heat;saw NP who recommended tx w/cold compresses & motrin;saw MD 9/16/99 no further tx;
Symptoms started on 1/1/23. Treatment plan includes admission and PT/OT.
immed large amount of swelling, muscles spasms into arm, neck, back, & legs;next day nausea (4 days) muscle spasms lasted 2 wk;lt arm swollen & bruised 2wk;4wk & still lt upper arm tenderness & muscle weakness in lower back w/leg pains;
felt tired for a few days; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic Kidney Disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "felt tired for a few days".  Additional information: Patient had kidney issues, Chronic Kidney Disease. He was advised by his provider to take the Pfizer COVID vaccine and he has since had dose 1, 2 and 3. Patient after receiving the document he dealt with a few days, felt tired for a few days. His Creatinine level jumped 20-25% and took 4,5,6 weeks to go back to normal. He stated when he was reading and took the booster dose 1 week ago and now again noticed that his creatinine levels jumped another 20%. He stated that the levels came back to what it was and then jumped again during his dosing of the vaccines. He felt as though this time he will come back down as well but didn't know if Pfizer MI had any recommendations. He wanted to get better, and he did read in the paperwork from the Pfizer website that the numbers do go higher than 20% at the baseline. He felt okay now but for a week he was "sluggish." He was wondering why his kidney creatinine levels did that with the 2nd shot and then came back down after 6 weeks. He does not regret taking the vaccine & he hopes he gets better. He was not sure if this was a listed side effect. After the "2nd shot" the creatinine went up to 20% and then got better, now happened 2 times where it went up. It could be a good chance that it will get better like it did the 1st time. He doesn't want to panic with seeing an elevated number as he was under medical care. He wanted to know if an alternative vaccine, such as the Moderna or J&J would be better for those with renal issues. If he kept having to take it and it kept elevating his kidney levels, but he noted that it was otherwise you "die" if you have COVID with kidney issues. He felt as though he did the right thing and does not want his provider to send him for dialysis like they almost did last time due to elevated numbers, but he got better 20%. He did not felt any problems, he felt fine. Four days of sluggishness when he took the shot now, he was fine. He has an elevated number when he took blood test today. 2nd shot raised his creatinine numbers 25% and he recovered from that. The booster was received one week ago, and it went up 20% which was exactly what the paper says. He wanted to know that long does it take for the booster to get into the system and work so he can better help gauge possibly how long his concerns may be around for. He wanted to know if the booster dose is the same or if it is half the dose. The booster dose was the same vaccine that was used for the primary series  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Developed rash on face and neck within 1-2 min after receiving immunizations. Also developed redness at injection site. Observed pt X 25 minutes. Soon pt was down playing in waiting area-rash and redness fading away when allowed to leave the health dept.
Parent reports new onset of esotropia. Diagnosis confirmed by pediatric opthamologist-patching of eye began 9/1/2009.
Frozen vials, removed and transported at refrigerated temperature, re-frozen at the time of arrival; Total duration of the excursion refrigerated temps for maximum of 4 hours; They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge); This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temperature, re-frozen at the time of arrival), PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for maximum of 4 hours) and EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temperature, re-frozen at the time of arrival) and PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for maximum of 4 hours). At the time of the report, PRODUCT STORAGE ERROR (Frozen vials, removed and transported at refrigerated temperature, re-frozen at the time of arrival), PRODUCT TEMPERATURE EXCURSION ISSUE (Total duration of the excursion refrigerated temps for maximum of 4 hours) and EXPIRED PRODUCT ADMINISTERED (They have been accidentally administering refrozen vials to their patients (more than 30 days after moving to fridge)) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient Id was reported.  No concomitant medications were reported.  No treatment medications were reported.  It was reported that the vial was moved to fridge on 06-Oct-2021.  The storage condition of the vial at the time of the excursion was frozen storage/refrigerated storage/ambient room temperature frozen storage/refrigerated storage.  The state of the vaccine at the time of the excursion was reported as partially thawed/liquid.   The maximum or minimum temperature reached by the vial was 8 degree Celsius.  It was reported that the total duration of excursion at refrigerated temperature was for a maximum of 4 hours.  It was reported that the vials were re-frozen. Temperature fluctuations had occurred from frozen state to refrigerated state to being re-frozen.
Today, at 2pm, patient had her 2nd COVID vaccine and subsequently developed a rash with lip swelling and chest pain, despite taking Benadryl 50 mg PO before the vaccine. Patient was treated with Benadryl 50 mg IM while at the clinic,was observed for an hour with improvement of rash, and lip swelling. No epi was given. However, patient had persistent chest discomfort, prompting ED visit. Denies chest pain, SOB, fevers, myalgias, leg swelling, difficulty swallowing, sore throat, or voice changes.
AT SITE OF SHOT CHILD'S ARM SWELLED TO THREE TIMES THE SIZE IT IS SUPPOSE TO BE. REDNESS, HEAT,BLUISH COLOR ON UNDERNEATH SIDE. THIS RUNS FROM ELBOW TO SHOLDER.
Patient became unresponsive and vomited while driving.  He had probable seizure activity.  Patient was transported by ambulance to the ER and had several more episodes of unresponsiveness with elevated heart rate and shakes.
Expired vaccine beyond MFG Exp. Date administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond MFG Exp. Date administered) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) 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 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond MFG Exp. Date administered). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond MFG Exp. Date administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported. No treatment medications were reported.   This case was linked to MOD-2021-354610 (Patient Link).
Narrative:  Patient was admitted to local hospital for severe flu like illness with nausea and vomitting and coughing up blood. He was treated at hospital with IV fluids and then released the next day. He did not end up receiving the second vaccination due to this severe illness he got with his first injection.
Systemic: Lost consciousness-Medium, Systemic: Shakiness-Mild, Additional Details: After receiving vaccine, patient lost consciousness briefly while sitting in a chair. Per a witness, the patient slowly fell onto the ground, but did not hit her head against floor or any other surfaces. She regained consciousness after a couple minutes. After resting for about half an hour, the patient was able to stand and leave the pharmacy. I escorted her to her husband's car.
No issues during or immediately after injection. Aching at injection site and arm a few hours later, followed by severe flu like symptoms with body aches within 7 hours (~9:30p). Woke up in the middle of night with shooting pain from upper left arm down to middle 2-3 fingers. Tried to relieve shooting pain by rubbing and stroking entire length of left arm to fingertips. Pain continued and manifested into chronic ache. Loss in range of motion and strength by Dec2022. Severe and lingering pain in upper left arm when moved, can not lift items.
chest pains/sob started within 72 hours resulting in visit to ER and where pt was admitted
Patient experienced some unspecified medical event over the weekend prior to the date of the event noted. He only said he "didn't feel well" and canceled a dinner event. The morning of the adverse event, he obviously lost significant cognitive ability. He "forgot" how to answer the phone which was right next to him, "forgot" to do his normal morning activities (make and eat breakfast, take medications, etc) and was fixated on trying to work the TV remote to the point he was ignoring everything around him. Presented with stroke symptoms but no evidence was found. Admitted to hospital for observation, some blood chemistry imbalance which was corrected and then moved to a rehab facility, discharged in 10 days and was somewhat improved from a cognitive perspective. His cognitive disability is compartmentalized to specific areas such as inability to manage technology, but he continues to slowly decline. His social interactions are becoming more and more one sided.
Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 05E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in December 2020 and the estimated date of delivery was 15-Nov-2021. On 31-Aug-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 31-Aug-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported Treatment medication were not reported Patient was 29 weeks pregnant. Patient got injection to the shoulder; Sender's Comments: This is a case of maternal exposure during pregnancy with no associated AEs for this 39-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
The day after the vaccine I experienced weakness, dizziness and headache that went away without needing any kind of specific treatment and only lasted for a day. Since day three I started experiencing an increase in my arterial tension; the usual values are between 110/70 mmHg to 120/80 mmHg, currently it has been above 130/85 mmHg up to 145/95 mmHg.  Along with my increased TA I've been experiencing headache whenever the values go up.
Pt called the day after receiving the moderna vaccine and said that her right big toe was numb and the toe next to it was partially numb
fever, cough, congestion, chills, shaking, fingers turning blue, shallow breathing, pulmonary fibrosis - occurred same day as vaccination leading to ER visit on 10/22
Excess fluid hands, legs, feet, when received vaccine. Had instant sting and burn in spine; center of shoulders and then all over for a couple of seconds. Seems to be going away.
6/19 Lt arm youth complained of pain, 3" diameter area of redness slightly raised and warm on Lt deltoid area. Recommended ice application, Ibuprofen 400mg PO PRN.
mild body aches lasting one day after the first vaccination.; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (mild body aches lasting one day after the first vaccination.) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced MYALGIA (mild body aches lasting one day after the first vaccination.). At the time of the report, MYALGIA (mild body aches lasting one day after the first vaccination.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient date of birth was reported as 21-FEB-2021 No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-417941, MOD-2021-417942 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Follow up received included non significant information
pt recvd vax; extremely upset, crying spells; large lump, size of goose egg w/in 8 hrs of shot; no fever;
Day of vaccine. Dizziness. Fatigue. Arm pain at site. One week later. Covid arm rash. Right pain in breast. 9 days out blackout feeling. 11 days out. Another blackout feeling. Feeling dizzy. 12 days out. Muscle joint pain. Numbness in feet. Feet hurt to walk. Legs feel like jelly. Calf pain. Each day pain in feet continues. Fatigued. Two weeks out back pain. Calf pain. Feet numbing burning pain. Eyes feel disoriented. Can?t focus. Mind fog.  Dizzy and light headed. 16 days out symptoms continue. No relief.