chrisvoncsefalvay/vaers-outcomes huggingface dataset:
woke up with a swollen lymph node in the axilla; some mild pain in the left arm (site of injection); There's only 1 palpable site. It is not very tender, but does induce mild pain; I am unable to lift heavy objects with my left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for COVID-19 Immunization; Bnt162b2 (Second Dose), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 27Oct2021, outcome "unknown", described as "some mild pain in the left arm (site of injection)"; LYMPHADENOPATHY (non-serious) with onset 28Oct2021, outcome "unknown", described as "woke up with a swollen lymph node in the axilla"; LYMPH NODE PAIN (non-serious) with onset Oct2021, outcome "unknown", described as "There's only 1 palpable site. It is not very tender, but does induce mild pain"; LIMB DISCOMFORT (non-serious) with onset Oct2021, outcome "unknown", described as "I am unable to lift heavy objects with my left arm".  Additional information: I meant I didn't have any major issue except some mild pain in the left arm. The lymphadenopathy was not observed until yesterday morning (28th Thursday morning). It seems the lymph node swelled up overnight on the 27th. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
swelling & aching joints  Narrative: Pt reported to the covid clinic dose#2 nurse he had moderately painful swelling of joints and aching on the first covid vaccine shot.
Swollen lymph node in armpit on the same arm of injection - onset on day 1 post-injection to day 3 post-injection (3 day duration) Headache, body ache - started day 1 post-injection to day 2 post-injection (2 day duration)
Patient came back to pharmacy approximately 10-15 minutes after receiving the vaccination to report that she experienced a stinging/tingling feeling at the injection site. She said it comes and goes but hurts. Not a dull pain but sharper in feel.
On Monday I felt pretty terrible. I had a sore throat and a headache. I had a fever of 100.5. I tested negative when I completed a home test. The next day I took another COVID-19 Test and was positive. I called my doctor and he prescribed Paxlovid which I started on Tuesday night. By the next morning I was feeling fine. I was still testing positive, but I immediately felt 100% better. I have felt fine every since like I had a miracle drug.
Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Injection site pain) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced INJECTION SITE PAIN (Injection site pain). At the time of the report, INJECTION SITE PAIN (Injection site pain) had resolved.        mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on an unknown date.       Concomitant medication was not reported.  On an unknown date, the patient experienced injection site hurt. On an unknown date, injection site hurt resolved. Moderna COVID-19 Vaccine (Elasomeran) was also considered suspect.  It was unknown if patient was enrolled in a COVID-19 Vaccine trial.  Primary reporter did not have the lot number information, because the packaging was discarded.   Treatment medication was not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
severe abdominal pain; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer reported for a male patient (Husband). A male patient of an unspecified age received bnt162b2 (COMIRNATY, solution for injection, Batch Number /Lot Number: Not reported) dose number unknown via unspecified route of administration, administered on unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date patient experienced severe abdominal pain. It was reported that, patient's wife was going to take him to the hospital. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
1830 began experiencing numbness and tingling to R arm, the nurse there evaluated associate and noted equal movement/strenght to both arms. 1840: reported feeling better and requested to leave.
Arm very swollen, hard, red and hot to touch.-Given antibiotic-Benadryl
Expired dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. Number of doses or vials includes 1 dose from 1 vial. The vial was initially taken out from the freezer, thawed, and used on 10Jun2022. Never put in the refrigerator for storage. The vial did not undergo any temperature excursions. This was the patient's 2nd booster dose administered in their left arm. Patient was not experiencing any symptoms. No treatment was given. No treatment medication details was reported.
Narrative:  Pt reported to RN, evening of vaccine administration having what may be a mechanical fall out of bed, reports he made too big of a movement and slipped on his silk sheets onto the floor. however he did not use the medical alert to call from help. he laid on the ground for 8 hours. a friend came the next morning to assist him. he took his morning meds on an empty stomach and reported vomiting them back up. otherwise pt. reported being sore which improved and overall felling better as of 10/3/22. he declined evaluation but RN and covering PCP plan to visit.
This is the Moderna Booster I received on 11/6/21 and the next day I had swelling of my arm from the elbow to my shoulder.  It has been hot to the touch, and itchy.  I am on day 4 and the swelling has gone down but still red and itchy.  I have taken Benadryl orally, at night  and put anti-itch cream on it and icing it a couple times a day.  I received my initial Moderna vaccine on 2/12/21, and the second one on 3/12/21 with no problem except a sore arm for a day.
Myalgia, Arthralgia, chills Narrative: body aches and chills persisted for 24hrs after vaccine. Some relief with 1000mg of acetaminophen
Due to patient's complex PMH, provider asked that patient be monitored overnight after administration of COVID vaccine.  Patient was moved from PICU to general peds floor due to improvement in condition on Thursday.  Vaccine was administered that evening.  Patient did well.  Remained on room air.  Was discharged home on Saturday.  On Monday morning, father checked on patient and she was found pulseless and not breathing.  It is unclear whether or not patient was placed on home CPAP during the night.  EMS called.  Patient arrived to ED as a CPR in progress.  Patient presented with a pH of <6.  Last known well 9pm the evening prior.  Patient expired at  11/22/21 at 11:05 CST.
Injection site very painful at 0415 1/21/2021. Area was red, hard, and feverish. This was about the size of an egg. At 0200 on 1/22/2021, a terrific headache awakened me. Took 800mg Ibuprofen. This helped the injection site, However the headache had remained. Ibuprofen every 6 hours, with mild relief at 1500 on 1/22/2021
I've always had issues with dry eyes and had to have my tear ducts closed surgically in order to prevent loss of the tears I was able to produce naturally.  After the vaccine, my eyes started to tear constantly to the point where I have a hard time reading and driving. My doctor prescribed a mild steroid drop and told me to stay away from eye drops that contain preservatives. He said that he may have to reopen my tear ducts if there is no improvement. Since then, I have been tearing less. At my last visit, he said that I may have developed an allergy to the preservatives in the eye drops or it could've been the vaccine.
THE PATIENT DEVELOPED A BLISTER WITH CLEAR FLUID AT THE SITE OF INJECTION. AFTER HER DOCTOR EXAMINED THE BLISTER IT CHANGED COLOR AND THEN POPPED. SHE WAS INSTRUCTED TO APPLY ANTIBIOTIC OINTMENT TO THE SITE UNTIL THE AREA HEALED AND TO INFORM HER DOCTOR IF THERE ARE ANYMORE COMPLICATIONS.
This is a serious spontaneous case, initially received from other non-health professional on 09-Apr-2019, concerning a female neonate patient. The patient's mother was a 25-years-old female of height 152.4 cm and body weight 64.399 kg. The patient's mother had 1 previous pregnancy with no still birth, miscarriage, birth defect or congenital anomaly. The last menstrual period (LMP) date of the patient's mother was 28-Apr-2018. The type of pregnancy was singleton. On 08-Oct-2018, at 13:50 hours, at gestational age of 23 weeks, the patient's mother received AFLURIA QUADRIVALENT [influenza vaccine, batch number: 02444611A, expiry date: 06-Jun-2018, dose, anatomical location and route of administration: not reported] for influenza prophylaxis and the fetus was exposed to AFLURIA QUADRIVALENT via transplacental route (explicitly coded as fetal exposure during pregnancy). There was no evidence of a defect or adverse event finding from a prenatal test. On 3 months and 11 days after vaccination, the patient's mother gave normal vaginal live birth to a female baby at 38.1 gestational week. The neonate (patient) weighed 3543.69 grams (reported as 7 lb 13 oz), body length was 52.07 cm (reported as 20.5 inches) and head circumference was 34.29 cm (reported as 13.5 inches). The reporter did not have the APGAR (appearance, pulse, grimace, activity, and respiration) scores at 1 minute, 5 minute and 10 minutes. There was no adverse pregnancy outcome, birth defect or congenital anomalies. It was reported that the patient was born very jaundice (as reported). The mother's estimated delivery date (EDD) was reported as 02-Feb-2019. The outcome of the event was not reported. This case is linked to 201804385 (mother case). Reporter's Comments: A female neonate experienced Jaundice neonatal, 3 months 11 days after administration of AFLURIA QUADRIVALENT administered to mother at gestational age of 23 weeks (explicitly coded as foetal exposure during pregnancy). Considering the implausible temporal relationship between vaccination and reported event (Jaundice neonatal), no evidence for a biological mechanism/investigation suggesting a causal role, the event was assessed as not related to the vaccination. The decision to administer a vaccine during pregnancy is related to medical decision making by the mother and her physician and is not related to any property of the medication. The event of foetal exposure during pregnancy was assessed as not related considering the intended use of the vaccine. This company assessed this case as serious (medically significant).
This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. No information about medical history concurrent conditions and concomitant medications was reported. The reported stated that she held a ZOSTAVAX clinic and 9 out of 11 patients were administered ZOSTAVAX lot number K000456, expiration date 15-DEC-2014, dose single dose, route SQ. One patient developed an itchy patch few inches from the injection site. At the time of report none of the patients had required medical treatment. The outcome of developed an itchy patch few inches from the injection site is unknown. The patient sought medical attention. No product quality complaint was involved. This case is linked to the case 1405USA003395 via same reporter link. Additional information has been requested.
Child broke out in welts on both arms and legs, chest, eyelids swollen. No respiratory distress. Benadryl PO and Lopasil given.
itching; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (itching) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching). At the time of the report, PRURITUS (itching) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Had the shingles shot but I still got the shingles years later/Suspected vaccination failure; Shingles / horrible; Painful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per vaccine indication. The patient had the Shingles shot but still got the shingles years later, it was horrible very painful. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, event onset time and laboratory confirmation for shingles were unknown at the time of reporting.
This is a spontaneous report from a contactable nurse. A 78-year-old  male patient received PREVENAR 13 (Lot Number: N16515, Expiration Date: Oct2017), via an unspecified route of administration on 30Sep2016 at 0.5 ml single dose for immunization. Medical history included ongoing hypertension and ongoing hyperlipidaemia. The patient's concomitant medications included unspecified hypertension and hyperlipidemia medications. On 30Sep2016, the patient experienced systemic myalgia, body aches, and severe local reaction, described as pain and redness that started about an hour after the shot. On an unknown date in 2016, the patient also reported warmness at the site and an area that was swollen and getting bigger and spreading out. It was unknown how long after the shot the warmness and swollen area began getting bigger and spreading. On 04Oct2016, the patient was in the office to see a healthcare provider. The clinical outcome of the events, warmness at the site and an area that was swollen and getting bigger and spreading out, was unknown. The clinical outcome of events, systemic myalgia, body aches, and severe local reaction, described as pain and redness, was not recovered.
Patient contracted COVID after being fully vaccinated. Headache, Sweating, congestion, muscle aches, brain fog, loss of smell Booster shot Pfizer on 10/1/2021
Cardiac arrest; This is a spontaneous report from a contactable physician. A 28-year-old female patient received the third dose of BNT162B2 at 28-year-old, intramuscularly on 01Oct2021 (Batch/Lot Number: EW0168) at single dose (booster) for COVID-19 immunisation. Medical history was none. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ethinylestradiol/ferrous fumarate/norethisterone (NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously received the first dose of BNT162B2, intramuscularly on 03Jan2021 (lot number: EL0142) at 27-year-old, and the second dose intramuscularly on 23Jan2021 (lot number: EL9262) at 27-year-old for COVID-19 immunisation. The patient experienced cardiac arrest on 15Oct2021. Unwitnessed at home. When found, patient passed away already without any signs of calling 911 or rescue. No treatment received. Since the vaccination, the patient had not been tested for COVID-19. The patient died on 15Oct2021. An autopsy was performed and results were not provided.; Reported Cause(s) of Death: Cardiac arrest
Pfizer-BioNTech COVID-19 Vaccine EUA First symptom on 4/16/21 at 12:30 am was skin becoming sensitive to the touch and difficulty sleeping. In less than an hour, chills began with shaking all over my body. Nausea began shortly afterward with a headache in the front of the head. Took 1 extra strength Tylenol and 2 chewable Tums. Extra blankets eventually helped with chills, nausea subsided after a couple of hours. Woke up around 5:00 am with a severe headache like a band all around my head. Took 1 ibuprofen. Headache eventually became mild around 9:00 am.  During the daytime on 4/16/21, I experienced fatigue, muscle weakness, muscle soreness, fogginess, mild headache, and difficulty staying warm. I took ibuprofen during the day to help with pain/headache.  On 4/17/21, I experienced muscle weakness/pain and fatigue.  On 4/18/21, I continued to experience fatigue and mild muscle weakness. I am still unable to exert myself with any amount of energy.
Death SHORTNESS OF BREATH Hyponatremia Atrial fibrillation (CMS/HCC) Generalized weakness SIADH (syndrome of inappropriate ADH production) (CMS/HCC) Pleural effusion on right Syndrome of inappropriate secretion of antidiuretic hormone Sick sinus syndrome
I woke up the morning after receiving the flu shot and became clammy, feverish, and severely overheated soon after, and my eyes started to black out/lose sight. I headed for my bedroom to lie down and I fainted, falling to the ground halfway there. Soon after coming to, I grew very thirsty and had a family member bring me water, but then became nauseous and threw up several times. My stomach was also upset at the time, and after the vomiting stopped, I had severe chills and continuous nausea, accompanied by a headache. Today, the nausea is still slightly present and I'm slightly dizzy, along with body pain caused by fainting and hitting the floor.
Patient contacted me today 2/17/21 that on 2/16/21 she had a severe allergic reaction.  On day of injection 2/12/21 she had some body itching and slight rash on left arm.  She took benadryl and stated it helped.  On the 2nd, 3rd, and 4th day nothing more noted.  Then on the 5th day, 2/16/21, patient's rash moved down arm, throat was itchy and possibly some swelling.  She stated she felt like body was burning internally.  She took benadryl which helped.
DTAP-hepatitis B-IPV (PEDIARIX) administered on 5/21/12 1700 & then received ACTHIB & PREVNAR on 5/22/12 1800. Started to have apnea & bradycardic events on 5/22/12 at 2100. Had multiple events and was placed on a ventilator due to periodic breathing and apnea on 5/23/12. Able to be extubated on 5/24/ at 0800.
Anaphylaxis (tongue tingle, sore throat, nausea, diffuse hives)
headache turned migraine hasn't gone away and been over 2 weeks since vaccine  fatigue nausea and sensitive to sound
Admitted 1/11/10 with poor coordination and general parethesias starting 3 days prior. On 1/13 he developed respiratory failure requiring intubation. Based on a working diagnosis of post-vaccine GBS, he was started on plasmapheresis on 1/20 and then transferred to another facility on 1/21 for further treatment. He was transferred back to our acute inpatient rehab facility on 2/2 secondary to residual paraplegia from the GBS. At time of admission he was min assist with eating and max to dependent for mobility and ADLs. Follow-up: I saw this patient one time in the hospital while covering for my partner. He was subsequently transferred. I thought that he had GBS secondary to vaccination for flu and/or H1N1. We do not have any records here in our office.
TRANSIENT ISCHAEMIC ATTACK; This spontaneous report received from a patient via a company representative concerned a 30 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) frequency 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, 7 days after the vaccine, the patient  experienced Transient Ischaemic attack. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of transient ischaemic attack was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- covid-19 vaccine ad26.cov2.s-transient ischaemic attack .This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Administered BIVALENT dose after reportedly checking in for BOOSTER  dose.  Veteran should have received the initial MONOVALENT dose.  DR and  contacted for guidance.  CDC guidelines state that veteran should  immediately receive the 1st of 2 MONOVALENT doses and the 2nd of 2 in at least  28 days.  Veteran able to state an understanding of the information given and  agreed to return to clinic tomorrow to start the series.  Veteran monitored in  the clinic for 30 minutes.
Bruising soreness at injection site, fever ,chills, vertigo, muscle aches for 36 hours. Not as bad as the FIRST shot, though rather unpleasant. First shot was so bad that I considered not doing the second.  I was told I could have the flu shot at the same time, which was a BIG mistake! Muscle aches and fever were overwhelming , and it was hard to even go as far as the bathroom. 36 hours of nausea as well.
generalized body ache, vomiting, feeling a numbness in the hands, face, and toes.
Vaccine was given IM instead of SQ. No noted adverse reactions at time of injection. Nurse spoke with patients mother via phone and she advised patient was doing good and voiced no problems.