chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A pain in the center of their chest/ The pain appears to only occur with certain movements; Swollen arm; Full body soreness; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (A pain in the center of their chest/ The pain appears to only occur with certain movements), PERIPHERAL SWELLING (Swollen arm) and MYALGIA (Full body soreness) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jun-2021, the patient experienced CHEST PAIN (A pain in the center of their chest/ The pain appears to only occur with certain movements), PERIPHERAL SWELLING (Swollen arm) and MYALGIA (Full body soreness). At the time of the report, CHEST PAIN (A pain in the center of their chest/ The pain appears to only occur with certain movements), PERIPHERAL SWELLING (Swollen arm) and MYALGIA (Full body soreness) had not resolved.            No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.  The patient was not sure if the chest pain is muscle related or possible inflammation of the heart.   This case was linked to MOD-2021-225765 (Patient Link).
We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). In October 2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.   This case was linked to MOD-2021-374648, MOD-2021-374432, MOD-2021-374264 (Patient Link).
1/2/21 extreme soreness 4 hours after until 36 hours after. Rash presented on 1/8 evening and is very itchy. Injection site is swollen and a bit firm. Rash is present and ongoing.
Dizziness, severe weakness, severe tiredness, headache, muscle pain, joint pain, severe nausea, feeling unwell, arm pain
Pt received 2nd dose of Shingrix vaccine at 1600. No problems prior to administration. Fine immediately post. Went to gym but did no arm exercises. At 2000 I received a all asking me, spouse, to pick him up as he was ill and unable to drive. He displayed blurry vision, ataxia and severe Lt arm pain (site of injection). Opted to take him to ED. By now, approx. 2020 he displayed rigors. Temp spiked from afebrile to 100.8 in hour and BP dropped to 90/52 which is relative hypotension for him. Fluid resuscitated with 2L of NSS. Initial Lactate was elevated to 2.6, 2nd dropped to 1.2 post fluids. Pain was temporarily relieved with .05mg of Dilaudid. He was discharged at 0130 1/3/20. Today continues with Lt arm pain (5-6/10) will see PCP regarding pain control. Tylenol is not effective and NSAIDs are out of the picture due to renal insufficiency. He did fine with the first dose, just having just an achy arm. I appears that the side effects he experienced are listed as possible but severely exacerbated in my husband. No signs of anaphylaxis.
This non-serious spontaneous case, initially received from other health professional (nurse), on 12-Oct-2018, concerns a 29-year-old, adult female pregnancy patient. On 10-Oct-2018, the pregnant patient was administered an expired suspect vaccine FLUCELVAX QIVc [batch number: 195215, expiry date: 30-Apr-2018, dose, route of administration and anatomical location: not reported]. At the time of this report, no adverse events were reported. This case was linked to case 201804438 due to the same reporter.
Employee reported itching arms, ears, back, hip areas approx. 2 hours after receiving vaccine. Employee declined to go to ER only accepted BENADRYL 25-50mg dose. States alleviated somewhat.
After vaccinations were given pt. stood up, picked out stickers, then fainted in moms arms. I placed her on the floor. She "woke up" a few seconds later. Coloring was poor. Weak pulse, shallow breathing. She acted like she was going to vomit. Paramedics called & responded BP low. Slow, delayed responses to questions. Sent to ED for evaluation.
A non-serious, report of pregnancy was received from a registered nurse concerning a 20-year-old female. On 17-Nov-2009, the patient received FLUMIST. Neither relevant medical history nor obstetrical history have been reported for this patient. The patient tested positive for pregnancy on 20-Nov-2009. Treatment and reporter causality assessments are not applicable.
Leg swelling and erythema, warmth, fussiness 4 1/2 hours after shot. Left leg DTaP and HIB. Right leg normal Hep B, IPV, PCV7.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Jul2023 as dose 1, single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "dysautonomia" (unspecified if ongoing). Concomitant medication(s) included: SYMBICORT, start date: Jan2007, stop date: 19Sep2023; FLOVENT, start date: Jun2021, stop date: 19Sep2023; NALTREXONE, start date: Jan2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovered" (27Sep2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Positive, notes: Treatment of COVID-19; (27Sep2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid from 19Sep2023 to 24Sep2023 as Treatment of COVID-19.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300314834 same patient, different drug/event;
Information has been received from a pharmacist referring to a currently 22 years old female patient. On unknown dates the patient received a full 3-dose series of unspecified hepatitis b vaccine (recombinant) (manufacturer unknown) (dose and route were not reported). In March 2016 (reported as currently) the patient had a titer of 3. The desired level was 10. The outcome of the event was unknown. Causality was not reported. The patient was "healthy" and had not experienced any other adverse effects. Additional information has been requested.
Besides a slightly sore of arm and slightly elevated but normal temp,  I had what I would call brain fog for about 4 hours on day 2. I took 2 tylenol and took a 3 hour nap.  When I woke I had several questions about events of the day that I did not recall.  Plus my daughter was with me and kept asking me if I was ok during prior to nap time.
Pt recv 1 dose vax 08/97. lab test show failure to seroconvert.
High fever, Delirium. 10/26/09 Medical records received for date 10/4/09. DX: Fever, delirium, poss. Flu vax rx. Presenting SX: pt received flu vaccine earlier in day and later c/o fever, delirium, trouble breathing, feel cold. Assessment: chronically abnormal looking left ear (usual for pt.), recent URI at time of flu vaccination. Pt. treated with antipyretics and abx. Fever reduced, delirium resolved, pt stable and dc.  12/30/2009 clinic progress notes and hospital records received for DOS 10/03/09-10/22/09. DX: Fever, delirium, possible Flu. Patient felt fine, and then received flu shot in afternoon. Later while with friends, felt sick and showed signs of delirium. Upon emergency room presentation that evening, patient was crying, fighting, mumbling and had delusions. Temperature up to 104 degrees Fahrenheit. Patient admitted and treated with Tylenol, ibuprofen and IV Rocephin. Given sponge bath. Delirium resolved. Patient noted to have mild cough, mild headache and mild sore throat (patient's family sick w/cough, HA, fever, ST). The next day, patient was discharged. Follow-up clinic note: non-acute. Examination: joint swelling, muscle tenderness. No treatment prescribed.
Anaphylaxis reaction with hives, stridor/airway edema, wheezing
3 immunizations were administered at the visit.  RT arm became swollen to the size of a baseball.  Area was red, warm to touch.  No fever or streaking but hurts to move arm   Seen the next day in clinic.
Moderna COVID-19 Vaccine EUA A rash approximately the 2" long by 1" wide developed.  It worsened the next day, but then started to go away and is almost completely gone now.
Mild pain in the arm; 3  to 4 purplish, blackish and  raised spots on his face, chin and lips; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Mild pain in the arm), RASH MACULAR (3  to 4 purplish, blackish and  raised spots on his face, chin and lips) and FATIGUE (Fatigue) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine and Tennis elbow. Concomitant products included GABAPENTIN and SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for Migraine, MELOXICAM for Tennis elbow.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced PAIN IN EXTREMITY (Mild pain in the arm), RASH MACULAR (3  to 4 purplish, blackish and  raised spots on his face, chin and lips) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Mild pain in the arm), RASH MACULAR (3  to 4 purplish, blackish and  raised spots on his face, chin and lips) and FATIGUE (Fatigue) outcome was unknown.            It was reported that the patient got 1st dose of the Moderna COVID-19 Vaccine on 03 Apr 2021 in left arm, intramuscularly. Initially, Patient developed mild pain in the arm and fatigue. After 3 to 4 days of the first dose, Patient developed 3 to 4 purplish, blackish and  raised spots on face, chin and lips.  Patient was not  given any medication to treat the symptoms.  Consent for safety follow-up was granted.  Consumer declined to provide HCP information and vaccination facility information.  Consent to contact the HCP for further followup was declined.   This case was linked to MOD-2021-254063 (Patient Link).
Walking difficulty/ HARD TIME WALKING BECAUSE OF PAIN/SWELLING; Pain legs; Neck pain; Swelling of limbs/HANDS/FEET SWELLED; Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Walking difficulty/ HARD TIME WALKING BECAUSE OF PAIN/SWELLING), PAIN IN EXTREMITY (Pain legs), NECK PAIN (Neck pain), PERIPHERAL SWELLING (Swelling of limbs/HANDS/FEET SWELLED) and ARTHRALGIA (Shoulder pain) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2022, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to UNK, Citrate free. 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) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced GAIT DISTURBANCE (Walking difficulty/ HARD TIME WALKING BECAUSE OF PAIN/SWELLING), PAIN IN EXTREMITY (Pain legs), NECK PAIN (Neck pain), PERIPHERAL SWELLING (Swelling of limbs/HANDS/FEET SWELLED) and ARTHRALGIA (Shoulder pain). At the time of the report, GAIT DISTURBANCE (Walking difficulty/ HARD TIME WALKING BECAUSE OF PAIN/SWELLING) outcome was unknown and PAIN IN EXTREMITY (Pain legs), NECK PAIN (Neck pain), PERIPHERAL SWELLING (Swelling of limbs/HANDS/FEET SWELLED) and ARTHRALGIA (Shoulder pain) had not resolved.            The patient had other concomitant therapy of steroids. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial Humira formulation was Solution for injection in pre-filled pen No treatment medications were reported.
Patient reported difficulty swallowing after about 25 minutes post injection.  Patient was able to talk, drink water with no changes to cognitive function. Vitals were monitored and stable. BP 4:00 138/117, 4:31 132/97, 4:40 131/96.  Patient was given a total of 50 mg of diphenhydramine between 3:55 and 4:05pm.  Patient remained at pharmacy for over an hour after administration and felt comfortable leaving.  Followed up with patient around 6:30 pm and she stated felt better.
27MAR95 immunizations given around 430PM; 9PM-130AM inconsolable crying & redness, swelling & rash where DTP/HOBC given; seen @ ER
Two grand mal seizures and went unconscious. Prior to seizures felt very lethargic.
Patient developed arm pain immediately after vaccination per her report later.  She returned to the office 8/4/2021 (greater than two months after vaccination) to report that arm pain had never resolved and had developed nerve pain down her arm, with some arm weakness, decreased strength and ROM.
Began throwing up; Face swelled up; A spontaneous report  was received from a consumer concerning her sister, a 75-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced face swelled up/swelling face and began throwing up/ vomiting.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 20 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch Number: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 20 Feb 2021, immediately after the second dose, the patient experienced face swelled up. A few hours later, patient began throwing up and had to go to the hospital and was hospitalized for 3 days.   Treatment details not provided.   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  The outcome of events, face swelled up and began throwing up was resolved (ok now) on an unspecified date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
AFTER THE VACCINATION ON 1/6/21 I EXPERIENCED FEVER, BODY ACHES AND WEAKNESS
She got her vaccine, came home, knew it was Passover, and told her husband to take over.  She was very tired, went to lie down and said that she could not feel her legs.  She is still just sleeping and sleeping and under a lot of stress due to her mother's death.  Her husband kept trying to wake her up and she told him not too.  She feels she has no hope and is not able to can't work, and her husband can't either, and she can't walk due to the weakness.  This is very unusual for her as she is a very active person.  She went to her doctor and told her to come and show him her legs, and feels that they are crazy and she got on the wrong side of the nurse, and does not feel that she is very intelligent.  Her left knee hurts a lot.  She has light sensitivity.  She was very active prior to the 1st vaccine ,and was told not to take the 2nd one and was influenced to take it, and has worsening symptoms since the 2nd vaccine.  She did go to the ER and they took X-rays of her legs.  Complained of a headache and had CAT scans done which did not show any abnormalities.
Arm painful. Started 4/10/03. Injection site is reddened. 4/10/03 pain and swelling started. Area reddened approx 5 cm. Can see bruising on arm when he takes a bath - will see MD today.
Patient began coughing intermittently and then began having difficulty breathing. Was clutching counter and had significant wheeze with each breath. No swelling observed in face but breathing difficulties were significant and concerning. Gave patient one epipen dose in left upper leg. Patient's breathing improved but then was not responding well and appeared to be losing consciousness. Had staff call 911 and EMTs arrived. They gave patient IM diphenhydramine in left upper arm and took patient to ER.
Fetal demise in COVID detected patient.  Provider ED noteL  "33-year-old female G4P3 at 18 weeks presenting for vaginal bleeding that started today.  Patient denies previous history of this or other complications with other pregnancies.  States that she has not felt baby move.  Endorses being treated for a yeast infection with Monistat if she is not able to do Diflucan given her current pregnancy.  Denies any concern for sexually transmitted infections or vaginal discharge.  Reports a light pink vaginal bleeding when she wiped today.  Has not been going through more than 1 pad per hour.  Denies any urinary symptoms.  Denies any fever.  Reports some right-sided low back pain.  Denies any contractions.   CNM note:  She had pos home Covid test 10/1/22 and just started ASA 162mg daily and wonders if this is related to her sx" Provider d/c note:  "Hospital Course:  Patient presented to the ED for evaluation of possible UTI / pyelonephritis secondary to dysuria and right low back pain.  Upon initial evaluation in the ED FHR could not be identified.  A formal ultrasound was performed to confirm second trimester demise.  The fetal demise was confirmed.  Her GA was 18w3d by LMP dating which was consistent with 10 wk ultrasound.  Estimated GA at time of death was unable to be estimated as the fetus was noted to have generalized skin edema and femur length was not assessed.  No other gross anomalies were noted, but a full anatomy survey was not performed.   She was also diagnosed with a UT and started on Keflex 500 mg in the ED.   She was transferred to L&D for induction.  She underwent an uncomplicated induction of labor with initial dose of 600 mcg followed by 2 doses of 400 mcg ever 4 - 6 hours.  She delivered the fetus intact at  04:21 am on 10/9/2022.  The placenta remained in place until 7:50 am despite an additional dose of misoprostol and Hemabate.  Her bleeding was minimal until her procedure.  Her QBL total from the time of fetal delivery to procedure complete was 640 ml, with the vast majority occurring during removal of the placenta.   Patient did well following the procedure.  Her bleeding and pain were minimal.  She requested discharge home.  She remained stable with minimal vaginal bleeding.  Her RLQ pain was resolved.  She denied any flank pain and she did not have any CVA tendernss."
Rash starting from Elbow on both arms down to her hands.  Rash is itchy and arm is swollen.  Pt has dry patches in some areas.  Pt has rash on both palms  of her hands.  Pt was taken to Dr.  office where she saw NP.  Pt was given steroids for this and will be seen in 3 weeks.  Pt told that if it is not better to call the office before time.
Employee received 2010-2011 flu vaccine (FLUZONE) and felt like throat was closing up. Pt had headaches and blurred vision as well as dizziness briefly. Pt went to ER was placed on steroid, BENADRYL, and PEPCID. Of note employee has had influenza in the past without problems. She opted not to receive H1N1 last year. It is highly possible that pt had an issue with the H1N1 component from this year flu batch.
Started with confusion and disorientation abou 3-4 days afterwards which developed into a full bown encephalitis.  Presently in an intensive care unit at Medical Center.  1/6/09 Received hospital medical records of 11/13/08-12/20/2008 FINAL DX: No d/c summary dictated.  Consults mention multisystem organ failure, fever, cellulitis, UTI, acute renal failure, syncope Records reveal patient being treated for UTI x approx 1 week.  Developed confusion, weakness, malaise, dizziness, fever, fall w/amnesia, lethargy, rash mostly over LEs.  Fever 101.5 in ER.  ID, Neuro, Uro,  Nephro, Pulmo, Heme consults done.  Developed diabetes, dysphagia, hypernatremia, drug induced thrombocytopenia, liver encephalitis, polymicrobial sepsis w/feeding tube disruption, intra-abdominal infection & acute respiratory distress.  Admitted ICU & intubated.  LP done.  Tx w/IV antibiotics, antivirals, antiseizure meds, steroids, PEG tube feeding, plasmapheresis, dialysis.  Continued downhill course & transferred to hospice on 12/20/08.
Had a fever of 101, went to sleep and had a seizure about 20 minutes later. All happened about 52 to 56 hours after immunizations were given.
PATIENT WAS GIVEN A BOOSTER DOSE OF 0.5MLS INSTEAD OF 0.25MLS FOLLOWING THE JANSSEN VACCINE. PATIENT REPORTED FATIGUE FOR A DAY.
Bruise size of quarter hot and red around site 2.5 inches in diameter. Very sore to touch
She stayed positive for COVID for 15 days.; She stayed positive for COVID for 15 days.; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 76-year-old female patient received BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose 4 (booster), single (Lot number: CJ6665) at the age of 75 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Lot number: CN9581), on 11Mar2021 as dose 2, single (Lot number: EN6204) and on 14Dec2021 as dose 3 (booster), single (Lot number: FJ8762) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She stayed positive for COVID for 15 days.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: She stayed positive for COVID for 15 days. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient received all of the Pfizer COVID vaccines too, and got COVID. The patient received Paxlovid to treated the Covid-19. Date and Time of Start of Drug: 23Feb2023. Date and Time of Last Administration: 24Feb2023.