chrisvoncsefalvay/vaers-outcomes huggingface dataset:
initial positive Covid test; initial positive Covid test; He had 3 Moderna + last one was Pfizer; He had 3 Moderna + last one was Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), in 2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Dose 1), for COVID-19 Immunization; Moderna covid-19 vaccine (Dose 2), for COVID-19 Immunization; Moderna covid-19 vaccine (Dose 3), for COVID-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), OFF LABEL USE (medically significant) all with onset 2022, outcome "unknown" and all described as "He had 3 Moderna + last one was Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Sep2022, outcome "unknown" and all described as "initial positive Covid test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Sep2022) positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient came in worsening cough over several days / still in the hospital as of 9/7/21
Onset of arm heaviness 45 min after injection Mild fatigue 4 hours after injection Arm swelled x2 in size, retained small amount of fluid 24 hrs after injection Arm swelling down by half, bruising of underside of arm/armpit 48 hrs after injection Eyelids slightly blue in hue/appearing almost bruised 72 hrs after injection Days 4-6 mild to moderate fatigue, difficulty sleeping Day 7 moderate sore throat
Adverse event: heavy and delayed period 3/21/2021-3/28/21 (Day after vaccine): period started at normal time on cycle, but was heavier and lasted 2 days longer than usual. My period cycle is typically 33-35 days, but period has still not arrived as of 5/4/21.
First day, R arm hurt, then started to get hot - red, itchy, and hard in the area. No meds taken. Took about a week to go away completely.
a week after the vaccine i started noticing shortness of breath fever headaches and dizziness. i wen to the doctor and they told me i had a upper respiratory infection. before they could see me in the office i had to get a covid test as i had all the symptoms. the test came back negative they gave me antibiotic for 5 days they told me i had a ear infection and a trough infection. the symptoms did not go away and i had return to work. sense i had the covid symptoms they told me to leave work and go to the doctor there i found that i had developed a bronchitis was given another set of antibiotic and another covid test that was also negative a week after that my symptoms did not go away i was told to get a chest xray and go to  a pulmonary specialist where i was told i had developed asthma and was subscribed a inhaler. my symptoms still did not go down and was told i had a upper respiratory infection accute sinuss infection and bilateral impacted serum incontrollable hipper tension. after 1 month and 2 weeks my symptoms have been less. but i am left with cough asthma and high blood pressure.
pt recvd vax 6DEC93 & was found to have neg titers; No further details were provided;
pt recv vax 9NOV98 & 1hr & 45min p/vax pt exp myalgia (gen) & muscle stiffness of trapexiles muscle from inj side, nausea & facial flushing;
got doses out of the box of expired Tenivac single-dose syringes with no reported adverse event; Initial information received on 15-Aug-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case is linked to case 2022SA340295.  This case involves a 25 years old male patient who got dose out of the box of expired DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] single-dose syringes with no reported adverse event while receiving vaccine   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 05-Aug-2022, the patient got a dose from  out of the box of expired suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT, single dose syringe (expired product administered)  (latency: same day) , (dose:0.5ml) (frequency: once) ( lot: U5856AA ; expiry date: 26-Jan-2020) via intramuscular route in the left deltoid for immunization. There was no other event reported   Action taken : not applicable.  Outcome: unknown   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 the guidelines. 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.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On 27-May-2021, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had 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 Concomitant Medications were provided by the reporter  No Treatment Information were provided by the reporter
Information has been received from a school nurse concerning a 4 year old male who was vaccinated with Varivax. On approximately 14-SEP-2006, the patient experienced breakthrough chickenpox with red dots on his ankles. The patient sought unspecified medical attention. No treatment was recommended. No further information available.
C/o throat "itchiness" shortly after receiving vaccine - face also flushed. Received relief with Diphenhydramine 25 mg po
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown ages and genders. Nurse mentioned an unknown number of patients might have received GARDASIL injection (lot #, expiry date, dose and route unknown) that was improperly stored. No adverse symptoms reported. Additional information has been requested.
Unlike the first 3 covid vaccines that I had prior, this injection slightly burned but otherwise all felt normal for most of the day. By bedtime, about 10:00 pm, I felt a lot pain from my shoulder, down to my finger tips and in my armpit and I was not able to get comfortable laying flat, so I took Tylenol and sat up in a chair to try to get comfortable. It helped but I was still uncomfortable. The next day, Tuesday, I took Tylenol two more times because along with the pain in my entire arm, I felt achy all over my body,  like you feel with the flu. I slept most of that day and by Wednesday I started feeling better, the pain in my arm was easing and I was able to resume my  normal activities. On Friday morning, I noticed that I had a large bruise below my left armpit. There wasn't any pain associated with it, but it was alarming to see because there was no reason for a bruise to be there.
Patient developed cellulitis at site of injection. Required doctors visit and antibiotics tx for 10 days.
Pt awoke with temp of 102 degrees Fahrenheit, very tired and somewhat lethargic. Following day, pt awoke afebrile with a 2x2 red, swollen area at injection site of left deltoid.
ACHY FEELING IN THE BEGINING, NOW SORENESS AND KNOT ON THE ARM
COVID-19/Tested positive; COVID-19/Tested positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 61 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 15Apr2022 as dose 4 (booster), single (Lot number: FM0698), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 10Feb2021 as dose 2, single (Lot number: EL9269), in left arm and on 29Sep2021 as dose 3 (booster), single (Lot number: 301458A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Pre-diabetes" (unspecified if ongoing); "Allergy" (unspecified if ongoing), notes: Known allergies: yes. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Mar2023, outcome "unknown" and all described as "COVID-19/Tested positive". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) High; SARS-CoV-2 test: (09Mar2023) Positive, notes: Tested positive on 09Mar2023 first time; (15Mar2023) negative, notes: tested negative since 15Mar2023. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: All the Pfizer / BioNTech vaccine doses were given at 12:00 AM. Tested positive on 09Mar2023 first time. Started Paxlovid on 10Mar2023 (Treatment of COVID-19, Paxlovid Treatment start date was on 10Mar2023 and stop date was on 14Mar2023). Tested negative since 15Mar2023.; Sender's Comments: The reported "COVID-19/Tested positive" is considered ineffective of BNT162B2 (BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5)), and the Company cannot completely exclude the possible causality between the reported event and suspect vaccines administration.
About an hour after the vaccine, I developed a bad headache.  12 hours after booster, I literally could not move the arm I had the vaccine in (L). I awoke with chills and a fever of 102°. I?ve been sick ever since, now on a full day #2.  I?m exhausted mostly, but still have a slight fever. I?ve also experienced, ?brain zaps??almost like an electrical current traveling in my brain. I?ve read that others have experienced the same.  It doesn?t make sense that a virus that isn?t, ?live? would make people so sick?! Needless to say, I?m concerned.
I always have covid like symptoms and some glandular swelling under the arm on the injection side that start approximately 6-8 hours after the injection and last 1-2 days. It was the same this time with the added new symptom of a gland swollen under my left eye which is the side I received the injection. This happened approximately 24 hours post injection. Today is day 3 and now there is a pocket of fluid under my eye. The selling seems to be decreasing slowly.
Expired vaccine administered to patient,  Parent/patient declined repeat dose with Men Quadfi  during this visit.
Information has been received from a physician concerning a 12 year old female patient with chronic graft versus host disease, hypothyroidism, depression, bone marrow transplant for acute myeloid leukaemia (AML). The physician reported reactions to medications as following: ATIVAN caused the patient to have delusions; vancomycin caused the patient to have Red Man Syndrome; both Azithromycin and BACTRIM resulted in rashes. On 11-MAR-2016, the patient was vaccinated with VARIVAX, 0.5 ml, lot # L040421, expiration date 15-OCT-2017, subcutaneously in the left arm (unspecified if this was the first or second dose). Concomitant therapies included betamethasone ointment, citalopram, vitamins (unspecified), melatonin, levothyroxine sodium (manufacturer unknown) and estradiol vaginal cream. On approximately 13-MAR-2016, after 2 days of vaccination, the patient experienced pain which developed in her lower back, left side of hip, left knee and left foot. On approximately 18-MAR-2016, after 7 days of vaccination, the patient developed 1 vesicle on the lower back and on approximately 19-MAR-2016, by 8 days had multiple vesicles on the left foot area. The patient sought medical attention on an unspecified date in March 2016 with an unspecified health care provider and was admitted to an unspecified hospital on 21-MAR-2016 for a diagnosis of pain control. Acyclovir and unspecified pain medications were prescribed for the events. Both a Magnetic Resonance Imaging (MRI) and an X-ray had been performed on an unspecified date in March 2016, but results were unspecified. On approximately 22-MAR-2016 (reported as now), the patient could not walk due to pain, but this was not anticipated to be long term. At reporting time, the patient did not recover from the events. The reporter did not assess the causality relationship of the events and VARIVAX. The reporting physician considered "could not walk due to pain" to be significant disability. Additional information has been requested.
9cm x 7cm area of warmth, redness and tenderness extending from vaccine site. Given 11mg oral dexamethasone for swelling.
Pt said she felt faint, lightheaded. Had her lie down with legs elevated. Stated she felt better and requested a bottle of water which was provided. Pt refused any other treatment.
Pt received injection 12/5/07 at 1PM- per pt, around 4PM edema around injection site, severe Left arm pain- "could barely move it", facial swelling-periorbital edema and 'tingling lips'. No SOB or difficulty swallowing. Felt 'weak and clammy'. Pt took 800mg of IB and slept most of the day. No residual symptoms. Advised pt to take Benedryl. No further treatment. Pt states "back in the 80's I had a reaction to a rubella vaccination where my knee swelled up to 3 times its normal size."
born with several airway birth defects and almost died; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the parent.  A neonate male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RESPIRATORY TRACT MALFORMATION (congenital anomaly, life threatening), outcome "unknown", described as "born with several airway birth defects and almost died". The father reported that his son was born with several airway birth defects and almost died.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt sitting and talking for 2-3 min after injection of HPV and Tdap, pt states dizzy - fell over to side - jerking movements. Pt stiff and had decorticate positioning, severe more jerking movements. Pt not breathing during this time, pt turned on side - started breathing. B/P 129/75, P 56, O2 sat 100%.
SkinRash History of allergy to Fluarix (SOB and hives, treated with Benadryl and recovered); latex and seafood Narrative:  Dr. present assessed employee. Mild localized uticaria left upper arm. Resolved after observation 40 min.
Swelling of injection site two weeks after injection.  Sustained tingly sensation in left pinky finger 3 weeks after vaccination.
I got my vaccine at 1:15pm and I had no symptoms for the first 9 hours and then I began experiencing a very extreme pulsing pain throughout my entire body. The pain felt very deep like it was at a skeletal level and lasted 24 hours. I took my first Advil at 2am, my second at 9am, and a Tylenol around 1pm and 4pm. My temperature at first dropped to 97 degrees but later rose as high as 100.84 degrees. I felt constant pulsing and painful chills that were overwhelming and the pain never let up at all for the first 16 hours and then began to subside slowly. I mostly laid in bed the entire day trying to sleep as it was impossible to sleep with the pain the first night. After waking up today 06/13/2021 my symptoms feel about 85% relieved with only mild chills and body aches remaining. I didn't feel a typical headache but I did feel periodic sharp pains in my head as well as my ears during the first 24 hours.
An adult female consumer called to report she was vaccinated with H1N1 somewhere between 21-Oct-2009 and 23-Oct-2009 (manufacturer specified as CSL but lot unknown).  The patient received the vaccine at a clinic (name unknown to reporter) when she was knowingly 4 months pregnant, after her pediatrician's office refused to vaccinate her.  The baby was born with no apparent issues, however she now has concerns that he moves his right arm rapidly which she does not notice with the left arm.  Based on recent publications regarding the safety of the seasonal flu vaccine, she is concerned about neurological damage to her baby (see associated case 2010026133).  Awaiting further information.  The company considers the event unassessable to the suspect drug, H1N1 vaccine.  Information derived from this AE report does not change the current safety of the profile.
p/vax pt given a boil came up on rt arm;started aching & throbbing, pain in shoulder & down arm;has hurt everyday;went to jail for 1yr & would not have any tx while in jail;
Child admitted w/hx of lethargic & vomiting followed by sz. Had retinal hemorrhage & bilateral subdural hematoma. Dx: Shaken baby synd.
cried & screamed inconsolably for 1 hr starting 3 hrs p/vax was given then slept restlessly for the next 3 hrs; no evidence of illness a/ or p/ event;
Mild hives and wheezing one hour after second dose of vaccine. Employee health provider administered 25 mg Benadryl IM with relief. I have needed to use albuterol daily since which is unusual for me.
It started within 15 minutes, very vague sensations so I wasn't even sure it was happening.  Tingling in lips, metallic taste, kind of pin prick sensation at back of tongue.  Tingling very gradually got stronger and recognizable.  At about 2 hours after the vaccine, I checked the mirror and inside my upper lip was swelling.  Entire event lasted about 2 1/2 hours, resolved without treatment.
Large red blotchy area 4 inches below the injection site. Hot to touch sore and itchy.  Red spot goes away for a few days, then returns. Red area is 2 inches wide going across my arm.
pt recvd vax & 24 hrs p/vax exp weakness, h/a, fever, & muscle aches;
Redness below injection site from entire tricep to shoulder on outer aspect of child's arm. Appeared hot, red, swollen. No white areas noted. High temperature noted throughout reaction was 99.2 orally. Child did not complain of pain. Mom medicated with Benadryl throughout the reaction until resolved on 1/14/2013 in the night hours but realized resolved at 0630 when child awoke for school.
Information has been received from a registered nurse concerning a 23 year old female, with no medical history, who on 06-DEC-2006 got a small amount of MMR II (Lot# 654821/0805F) splashed into her right eye. Concomitant therapy included Naproxen and MIRENA. Initially, on 06-DEC-2006, the patient experienced burning. A medical assistant irrigated the affected eye and the eye was no longer burning. It was noted that the patient was doing fine and she went to see a health care professional. No product quality complaint was involved. No other information was provided. Additional information has been requested. Follow-up received 06/18/2008. Medical attention was sought and general labs were performed. No medical problems were reported. No further information is expected. This is in follow-up to report (s) previously submitted on 5/30/2007.  It has been determined that WAES #0612USA00966 is a duplicate of WAES #0612USA01077.  Therefore, WAES #0612USA00966 is being deleted from our files and the reports consolidated into WAES #0612USA01077.  Additional information has been requested.
Rash and itching.  Took benadryl.  About 4 days straight.  Not immediately after injection but about a week later.
11/30/2006 Itchy skin. 12/12/06 Full onset of disease (Rubella) fever, rash from head to tow (moderate rash) severe joint pain and inflammation (hands, feet, hips, feet, spine) weakness, fatigue, loss appetite pain with walking, standing, light sensitivity.
Pain level 6 headaches, pain level 4 body pains in muscles and joint, pain level 5 at site of the injection, mild elevation in body temperature, nighttime chills and exhaustion.
Approximately 1 hours after receiving immunizations, mom noticed urticaria over body. Mom later brought child in to office to re-examine and urticaria was almost completely gone. Mom did give Benedryl between visits.
Shortness of Breath and heart palpations on 1/27/21 at 4AM. another shortness of breath on 2/6/21 at 9AM. Had follow up of stress test and wore a heart monitor. Both test showed heart dysfunction (stiff heart and doesn't relax). Have had no problems since 2/6/21
The patient was immunocompromised and received full booster dose; This spontaneous case was reported by a consumer and describes the occurrence of OVERDOSE (The patient was immunocompromised and received full booster dose) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OVERDOSE (The patient was immunocompromised and received full booster dose). At the time of the report, OVERDOSE (The patient was immunocompromised and received full booster dose) outcome was unknown.            Concomitant medications were not reported.  The patient was immunocompromised and got three full shot and went for the booster and received a full shot.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-600670 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-600670:
Headache, Myalgia, NauseaVomiting, Chills Narrative:   Other Relevant History:
Shortly after 1st dose pt developed SOB and cough, was treated for pneumonia w/ marginal improvement. After 2nd dose, symptoms worsened and on March 26, pt was hospitalized w/ hypoxic respiratory failure 2/2 organizing pneumonia. Is now improving with high dose steroids.   Pt had no prior respiratory problems. May have had COVID in March 2020.
Muscle pain at injection site radiating across (R) pectoral muscle. Itching across same area as well as in arm pit.
Systemic: Hoarseness-Medium, Additional Details: Hoarseness but nothing beyond that