chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative via media concerned a patient of unspecified age and sex, race and ethnic origin. Initial information was processed along with the additional information received on 10-MAR-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetic, and heart issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total was administered on MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date in mid JAN-2022, the patient experienced suspected covid-19 infection and had suspected clinical vaccination failure. As per reporter, "We got the J and J shot last May, We traveled the whole country for work, ended up with covid mid January, felt like flu for a week, no issues at time of shot or after, I am diabetic and have heart issues, no side affects." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000220818. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0:20220316300-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sore arm for a few days with fatigue, resolved after a week. On the morning of 4/23 the bottom of my shot (left) arm felt bruised, tender. By the night of 4/23 my left armpit was also sore, tender. Late night 4/23 my left breast was extremely sore and I noticed lumps, very swollen ducts? As of now, late night on 4/28, or very early morn 4/29, the lumps are large, extremely painful and don?t seem to be going away . I?m anxious about my second shot.
aches; minor ear ache; double vision; fatigue; chills; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 22Apr2021 at 17:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient had no other medical history. The patient had no known allergies to medications, food, or other products. Concomitant medications taken within two weeks of vaccination included ethinylestradiol, norgestimate (TRI LO MARZIA) on unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 01Apr2021 at 18:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021 at 07:30, the patient experienced headache, fatigue, aches, chills, minor ear ache, double vision. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events headache, fatigue, aches, chills, minor ear ache, double vision was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
6/15/99 730PM fever, h/a, lethargy;7:15 given APAP woke 5AM very warm w/severe h/a-no other sx;T104 seek MD attention;
This spontaneous report was received from a healthcare professional regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 20-MAY-2016, the patient was vaccinated with improperly stored dose of VAQTA lot # L039659 expiration date: 15-MAR-2017 (dose, strength, and route unknown). The vaccine was exposed to temperature of 33.6 Fahrenheit for 12 hours. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
It was like the flu for 4 days, I was bedridden, exhausted. I couldn?t take care of my kids and coughed and had congestion. Only difference then the flu was no stomachache or nausea. I was very weak and had chills and sweating all 4 days. I had a high fever the first three days. I also had heart palpitations on and off for the following 6 weeks, about 4 or 5 times?it felt like when I had a panic attack in 2011.  Also the couch lasted at least through 5/04/2021
Per medical record-light rash all over body and can feel it. MOB reported baby developed mild chicken pox with varicella vaccination. MOB exposed to HUMIRA from LMP through about 30 to 31 weeks gestation. MOB restarted HUMIRA medication after delivery and breastfed baby while taking HUMIRA. Eight days after vaccination baby developed a single pustule/lesion over injection site. Three days later developed mild case of chicken pox.
1 hr p/vax c/o bodyaches & fever (did not take temp); next morning 6OCT93 c/o stiff nick on lt side by 1130AM was unable to move head stiffness extended down shoulder & lt arm; c/o muscle spasm; seen by MD;
1. Muscle aches, 14 hours, no treatment 2. Fatigue, 24 hours, no treatment 3. Joint pain, 14 hours, no treatment 4. Headache, 3 hours, no treatment  5. Fever, 102 degrees, 2 hour duration, no treatment 6. Rash at injection site, started 36 hours after injection, unresolved in 12 hours, no treatment 7. Rash on torso, neck, and back, started 36 hours after injection, unresolved in 12 hours, no treatment
fever 103.8 lasted 1.5 days; cried for 4 hrs; pale & weak 1 day; listless 1 day all day of shot;
pt did not have a reaction to vaccine. Pt was given vaccine after beyond use for refrigeration. Lot number was not expired
About a week after the area at the injection site developed a rash and became swollen, red, and itchy.  It has persisted for over a day, but the itching has subsided.  It it still warm, red and swollen.  I had mild pain under my left armpit as well, similar to muscle tenderness, but it is to painful to the touch, just when I lift my arm or move it in certain ways.
No adverse event; The patient got bivalent pink cap 0.25mL pink instead of the blue cap for their second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (The patient got bivalent pink cap 0.25mL pink instead of the blue cap for their second dose) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 216K22A and AS7643E) for COVID-19 prophylaxis.     Relevant medical history or conditions, allergy, concomitant diseases and risk factor were none.    On 28-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Jul-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .25 milliliter. On 26-Jul-2023, the patient experienced WRONG PRODUCT ADMINISTERED (The patient got bivalent pink cap 0.25mL pink instead of the blue cap for their second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (The patient got bivalent pink cap 0.25mL pink instead of the blue cap for their second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (The patient got bivalent pink cap 0.25mL pink instead of the blue cap for their second dose).    Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Patient one bivalent toddler dose previously and no monovalent doses. First dose was bivalent blue cap. No side effects were reported by parent.  Treatment information was not provided.
Chills, body ache,headache, and fever (101).  These symptoms started at 3:00 am on 01/09/2021.
On 9-18-18 client was seen in clinic and given IPV & Hib on the R thigh. Client's mother called on 9-20-18 to report the child has had fever X2day ranging between 100- 102, she has been giving the child TYLENOL q3hr. Mother stated child has also not wanted to eat, and has had soar throat, headache, and ear pain, has been laying around crying. Clinic Nurse advise mother to take child into the ER to have a doctor evaluate her, and to follow the TYLENOL guidelines of q4hr, unless otherwise told by a doctor.
Bell''s palsy; Her speech is still off; This is a spontaneous report from a contactable consumer (patient herself). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration, administered in Arm Right on 02Jun2021 (at the age of 41years) as dose 1, single for COVID-19 immunization. Medical history included none. There were no concomitant medications. The patient confirms she was not on any new medications, she states everything was the same. She had been on the same medication, the only thing that was different was this shot. The patient did not receive any vaccines on same date with the Pfizer vaccine considered as suspect. Prior Vaccinations within 4 weeks the patient did not receive any other vaccine. The patient did not have any adverse events following prior vaccinations. The patient experienced bells palsy, her speech is still off in 2021. She confirms the Bells Palsy developed some time in between the two shots The patient underwent lab tests and procedures which included sars-cov-2 test negative on unspecified date. Therapeutic measures were taken because of bells palsy. The patient visited Emergency Room, Physician Office, because she thought she was having a stroke, but it was diagnosed as bells palsy the patient was hospitalized. The patients state the dates of her hospitalization are unknown but confirms it was between her first and second dose. The outcome of events bells palsy was recovering. The outcome of event her speech is still off is unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101453391 Same reporter/durg, different patients.
Pt Given Hep A vaccine meant for another pt.  This Pt was not scheduled to receive this vaccine.
Severe Headache for 4 days, constant. Triage RN advised ER now for disposition. No history of Migraines or severe headaches per patient statement.
No adverse event noted.  previous vaccine history noted to be pfizer 10/4/2022
had a severe breakout of cold sores on my face; This case was reported by a consumer via call center representative and described the occurrence of cold sores in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included cold sores.   On 31st January 2020, the patient received Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced cold sores. On an unknown date, the outcome of the cold sores was unknown.   It was unknown if the reporter considered the cold sores to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient reported that the patient just had a severe breakout of cold sores on face. The patient also specified that the patient never had cold sores this bad before. The patient wanted to know whether there any possible correlation between vaccine and event. No other information was reported.
pt brought to ED via EMS after pt being found at home unconscious; c/o SOB increasing over the past 2 days, more sleepy, orthopnea; found to be positive for COVID; started on ABX; MRI showed new strokes in the brain; pt's condition worsened, became more lethargic; sent for a second MRI and shortly afterward he had a PEA arrest; CPR done with achieving ROSC; pt died in the hospital
Only right arm low grade fever, body aches, chills, headache and nausea. Site reaction of redness, swelling, hives localized and rash near the site. PT. has a hot-to-touch lump near immunization site-on her right arm.
Significant muscle tightness in left trapezoid muscle.  I have seen the chiropractor twice, with little relief. My muscles and joints all over my body ache. I am fatigued. NONE of these were true before the vaccine on 11/6/23.  All of these symptoms occurred within 48 hours of the vaccine and are not improving.
Woke up and felt like she was going to vomit. Severe pain in arm and tingling in fingers. She felt hot. Was told to take ibuprofen by Dr.
Tinnitus became extremely loud.  I have had to join a support group for the anxiety it causes.  It's chronic, very loud and never subsides.  It's very disturbing and disrupts my sleep as well.
nausea; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunisation. On an unspecified date, the patient experienced nausea after the second dose. Outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient only received 0.25mL booster dose instead of 0.5mL.  Patient was contacted and informed of the error.
Received Hep A & Var 11/5/10 am. Pt. c/o pain back of (L) upper arm with some itching. 11/6/10 am - (L) upper arm swollen, very red & hot to the touch with 2 prominent raised red areas size of quarter & nickel-painful. Mom gave MOTRIN.
This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates since 27-JUL-2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # L037554, expiration date 25-DEC-2017 (dose and route of administration were not reported). There was no adverse effect reported. The outcome was reported as supported. Additional information has been requested.
Red blotches on arms,back, chest, feeling itchy. Administered 0.5mg epinephrine subcutaniously at 11:09 AM. Pt began to feel jittery after Epi. Itchiness subsided. participant called PCP. PCP advised as long as participant was feeling ok to schedule an appointment at a later date. At 13:40hrs puls 84 and resp regular participant went back to work.
About 24 hours post 2nd COVID vaccine by Pfizer, experiencing increasing fatigue, chills and body aches impairing my ability to work.
T/C received from mom: states, immunization site red, hot to touch, no temp, afebrile, okay to use OTC. Return if worsens
No PQC or additional AEs reported.; Caller reported expired dose of PNEUMOVAX 23 was administered.; This spontaneous report has been received from a registered nurse and refers to patient of unspecified age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions, or allergies.  On 15-JUL-2021, the patient was vaccinated with an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliters (mL), administered intramuscularly (IM) (dose number, vaccination scheme frequency, and anatomical site of administration were not provided; lot number S029916, has been verified to be a valid lot number, with an expiration date reported and verified as 12-JUN-2021) as prophylaxis (expired product administered). No additional adverse events were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S029916; expirationdate: 12-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
This spontaneous case, reported by physician and initially received on 22-Feb-2018, concerns a male patient of unspecified age. The patient's relevant medical history was not reported. On 19-Jan-2018, the patient was vaccinated with FLUCELVAX QIV (batch number: 195250, expiry date: 30-Jun-2018 (reported as Jun-2018), dose, route of administration and anatomical location: not reported) (considered as vaccination failure). On an unspecified date in Feb-2018, after vaccination, the patient experienced flu. Reportedly as per the 'MD note', the patient stated that 'he needs to be out of work due to the flu'. The outcome of the event was not reported.
Green stools with mucus and blood beginning about 8 days after 1st dose of ROTARIX
11/25/05 Patient called and spoke with Branch Manager in re: to having a flu and pneumonia shot on 11/22 and is experiencing swelling in arm....(it was not documented which arm this was occuring in). Director has attempted several times to reach patient to get more information.....calls were not successful..phone not answered.
Chills (I felt very cold deep into my bones) off and on for 24 hours. Sleepy was right after the vaccine. Arm pain right after still have after 48 hours and swollen lymph node 4 days after
This spontaneous report was received from a nurse and health professional and refers to a 5 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medial history provided. On 20-JAN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD, lot # L030586, expiry date: 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Swelling and tenderness at site of shot for at least two days, low-grade fever for several hours, tiredness and crankiness for remainder of day and following night.
Patient has Autism. Patient was held by caregiver. Left arm was facing towards vaccinator. Patient was unable to keep arm still. While supervisor had informed vaccinator not to vaccinate as it looked unsafe for both vaccinator and patient, patient's other caregiver was saying to give vaccine. Vaccinator did not stop and vaccinated. When vaccinator went to vaccinate, patient turned his arm. It was not given directly into the deltoid but rather it looked like it was given on the underside of the arm instead.  Caregivers were informed of error and told them to seek medical attention should there be any local reactions that don't go away, wide spread rash, difficulty breathing, swelling, and anything out of the ordinary.
Pt. was given the MMR on 4-19-17. He presented to our office on 4-24-17 with temp of 100, ear pulling, runny nose and fussy. He was Dx with a virus. Went to ER on 4-25 due to temp of 102 and an episode of eyes rolling into back of head and altered mental status. Dx with febrile seizure.
N/A. NO ADVERSE EVENT TO VACCINE. VACCINE OUTSIDE OF STORAGE REQUIREMENTS. REVACCINATION RECOMMENDED.
I experienced swelling at the injection site, extreme headache, coughing, aches, and chest pains that made me feel as though I had COVID again while awaiting a half hour after receiving the vaccine. I felt very energized the very next day.
This is a spontaneous report from a non-contactable consumer (patient) via company representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date were not reported) via an unspecified route of administration, on unspecified date, as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced fatigue, headache, body aches, overall malaise on an unspecified date. The outcome of the event was unknown at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient came in for a nurse visit for his COVID booster. He has had 2 COVID Pfizer-BioNTech doses and was due for his third. We did not have COVID Pfizer-BioNTech Bivalent vaccine in stock yet so the nurse mistakenly gave the non-bivalent dose instead of canceling the appointment.  The patient suffered no adverse affects of getting this vaccine.
Ongoing chest pain intermittently since the vaccine administration consistent with costochodritis, patient has a mvp that appears to have worsened with a louder murmur, will obtain echocardiogram
Swollen lymph nodes on left side near clavicle for 13 days so far.
Pt recvd 1st dose of vax 6AUG92; pt exp al h/a; @ the time of the report pt recovered; No further details were provided;
2 days following vaccine some mild pain, next day mild itching and four days later2.5 inches approximately, circular red rash and itching.  I applied cortisone cream.
This case was reported by a consumer via sales rep and described the occurrence of adverse event in a female patient who received FLUARIX QUADRIVALENT. On 6th October 2017, the patient received FLUARIX QUADRIVALENT. In October 2017, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced adverse event (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to FLUARIX QUADRIVALENT. Additional details were provided as follow: The age at vaccination was not reported. The representative reported that, he overheard an adverse event and the hospitalization in the hospital clinic with a female patient. On 10th October 2017, the patient was hospitalised. The representative did not know if the hospitalization was related to the vaccine. The representative was unable to get any more information than was reported here. The representative had informed the person that mentioned the adverse event to please call the GlaxoSmithKline to provide a full report. The GSK receipt date was reported as 16th September 2017, however it was considered as a typo error and the date was considered as 16th October 2017. The clarification was requested for the same, however, it was not obtained.
anaphylactic rxn to hep B vax <30min;fell out of chair then convulsed;