chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe pain in arm one weekafter.; chills within 16 hours of shot lasting 18 hours.; fever within 16 hours of shot lasting 18 hours.; severe muscle aches within 16 hours of shot lasting 18 hours.; This is a spontaneous report from a non-contactable consumer, the patient. A 61-year-old non pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration in left arm on 21Mar2021 at 1200 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient medical history included allergic to codeine. Concomitant medications were not reported. The patient previously received a first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route and site of administration on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19 since the vaccination. On 22Mar2021, at 1500, the patient experienced chills, fever and severe muscle aches within 16 hours of shot which lasted for 18 hours. The patient also experienced severe pain in arm after one week on 29Mar2021. The adverse event did not result in a doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events reported. The clinical outcome of the events chills, fever, muscle aches and pain in arm were recovering at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient came to me on 10-2-19 about 1645 reporting redness/Firmness to vaccination site. No pain or itching. Redness around site appx 1.5" in diameter. Call placed to employee health however it was end of day. FU on 10-3 shows resolution to site. No redness. Slight firmness still noted, no pain/itching. No treatment needed Resolved on its own.
None, no harm to patient. Rotavirus was order per provider and the nurse gave it. 1st dose of this med should not be given after 12 weeks of age. Patient was 4 months.
Patient woke up during the middle of the night approximately 14 hours after vaccine administration. Complained of Headache, Body aches, erythema, swelling, numbness/tingling down entire right arm. Patient came in 2 days to pharmacy and stated that arm is still numb/tingling.
Pt developed fever 9 days post-vaccine administration, without other focal signs of infection. Tx. Acetaminophen every 4hrs. as need for fever and return in case of deterioration.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 29-JUN-2016, the patient was vaccinated with an improperly stored dose of VARIVAX injection (lot# L041296; dose, route of administration and expiry date were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
no adverse event; one dose of PNEUMOVAX 23 was improperly stored and administered to a patient; This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 10-DEC-2021, the patient was vaccinated with one improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe (lot number T039322, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 09-SEP-2022) (frequency, route of administration, anatomical location and vaccination scheme were not reported), as prophylaxis (product storage error). The administered vaccine experienced a temperature excursion of 48.5 Fahrenheit (°F) during a time frame of 4 hours 0 minutes and 0 seconds. There was no previous temperature excursion reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2112USA005883:
This case was reported by a consumer and described the occurrence of decreased therapeutic response in a 48-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has no verified this report. Concurrent medications included LIPITOR. On unspecified dates he subject received three doses of TWINRIX (unknown). At an unspecified time after vaccination with TWINRIX, the subject experienced decreased therapeutic response. On an unspecified date following vaccination, a laboratory test to check for titers was performed. On 2 November 2007, the subject was informed that the results were lower than expected. The subject was not aware if hepatitis A or hepatitis B or both results were lower then expected. Medical attention was not required. The subject also noted that he was not sure if the product was TWINRIX, but believes that it is. At the time of reporting the outcome of the event was unspecified.
Numbness and tingling both hands.  She had left carpal tunnel release on 6/7/13.  States surgeon and neurologist attributed the symptoms to the flu vaccine.
It has been determined that WAES93110247 through WAES93110251 are duplicate reports of WAES 93081164 & 93101002 through 93101005;therefore,WAES 93110247 through 93110251 are being deleted from files & the reports consolidated
Crohn's aggravated; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 11 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 18Feb2022 (Batch/Lot number: unknown) at the age of 11 years as dose 2 (tris), single and intramuscular, administration date 21Jan2022 (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) as unk (cf) for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CROHN'S DISEASE (medically significant), outcome "not recovered", described as "Crohn's aggravated".  The reporter considered "crohn's aggravated" not related to bnt162b2. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Severe chills that caused uncontrollable shaking. Body aches all over. Extreme weakness; walking from bed to bathroom was exhausting.  I slept for 36 hours, only getting up to pee and hydrate.
Erythema, itching, and edema at injection site starting 8 days after injection. Applied cold compress and topical diphenhydramine with minimal relief.
Patient received booster shot (Moderna).  Patient originally received Pfizer shots.  Family found patient unresponsive in recliner.  EMS arrived and found his glucose was 55.  GCS 9.  Incomprehensible speech.   Not following commands.  In ED, patient observed with full body rigidity.    Upon admission to Neuro ICU patient had roving eye movements and apneic breathing,  patient intubated.  Patient unable to move all 4 extremities except for flickers of muscle.
11:00 am - very mild rash on face - 2 spots  started at 4:15 pm - peeked at 5:45 pm - temperature 100 degrees, sever chills, violent shaking, bad body aches especially back area, headache.  Took Advil which reduced violent shaking, chills and body aches by 6:30 pm.  Remained fatigued rest of evening.
Since getting the vaccine is having trouble breathing; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 29Jul2021 as a dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, the patient received Pfizer Covid vaccine last week on Thursday and since getting the vaccine was having trouble breathing on an unspecified date in 2021. The reporter seriousness for the event was reported as unspecified. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Vaccine was stored in the practice past the recommended time of 6 hours post puncture of the vial (6 hours) Vaccine stored up to 28 days in the office. Patient had no adverse outcome, no sypmtoms
broke out in generalized hives immed p/adm of vax @ site & on abdo;
Patient is under the age of 12. Father stated on form 12 years of age with DOB incorrect. Once we billed insurance they denied claim. Insurance  states patient's DOB in system is exact date.
Information has been received via the pregnancy registry, from a consumer concerning her 16 year old daughter, who was pregnant with an estimated date of conception on 05-JAN-2007, and on 09-FEB-2007 was vaccinated with the first dose of Gardasil. There was no concomitant medication. On 29-MAR-2007, the mother reported that her daughter, who was then "12 weeks pregnant," experienced a miscarriage; the mother added that the pregnancy was considered to be a blighted ovum, which she also referred to as a "mole pregnancy." The mother added that in April 2007, her daughter received the second dose of Gardasil. At the time of this report, it was unknown if the patient had recovered from the events. Upon internal review, blighted ovum, "mole pregnancy" and miscarriage were determined to be an other important medical event. Additional information has been requested.
SWOLLEN LYMPH NODES IN THE NECK; COUGH; JOINTS INFLAMMATION; This spontaneous report received from a patient concerned a male of unspecified age. 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: 1802070, expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. On 20-MAR-2021, the subject experienced joints inflammation. On 21-MAR-2021, the subject experienced swollen lymph nodes in the neck. On 21-MAR-2021, the subject experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joints inflammation, swollen lymph nodes in the neck, and cough on MAR-2021. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per the standard procedure as the case is assessed as non-serious.
QUADRACEL was given to an 8-year-old male patient with no reported adverse event; patient was running behind with his routine vaccinations due to having Leukemia with no adverse event.; Initial information received on 16-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 8 years old male patient who was adminstered Diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine [Quadracel] with no reported adverse event (product administered to patient of inappropriate age) and patient was running behind with his routine vaccinations due to having Leukemia with no adverse event(Inappropriate schedule of product administration)   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  On an unknown date, the patient received suspect Diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine Suspension for injection at dose of 0.5 ml dose 5 (strength not reported) (lot C6002BA and expiry date- 18-May-2024) via intramuscular route in unknown administration site for Immunization.  On an unknown date,8 years old male patient who was adminstered Diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine [Quadracel] with no reported adverse event (product administered to patient of inappropriate age) and patient was running behind with his routine vaccinations due to having Leukemia with no adverse event(Inappropriate schedule of product administration)   It was reported that Medical Assistant was calling to report that a QUADRACEL was given to an 8-year-old male patient due to the patient being behind with his routine vaccinations due to having Leukemia and currently in remission.    Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event quadracel was given to an 8-year-old male patient.  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.
Lower back pain and stiffness. Pain in left hip. Pain has been continuous for 8 days following second shot.
Pale, lightheaded,faint, eyes rolled back, unresponsive and to after a few seconds. Pt. diaphoretic. EMS called. Patient placed in wheelchair. Vital signs: BP=108/68    HR=88       Sat.O2=99%        NSR on 3 Lead 15 minutes observation with EMS before release.  Discharged home at 16:00 p.m. Patient refused ER visit.
Severe body aches, chills, major headache, hard time lifting right arm due to tightness and pain, fatigue and nausea. These symptoms lasted for 48 hours. Took ibuprofen every 4 to 6 hours and slept on and off for 20 hours. Ended up having to take time off work.
No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced MALAISE (Very Sick), HYPERSOMNIA (Slept all day), IMPAIRED WORK ABILITY (Could not go to work), HEADACHE (Very Bad Headache), CHILLS (Chills), VOMITING (Vomiting), PYREXIA (Fever), VACCINATION SITE PAIN (Sore Arm (Injection Site)) and FATIGUE (Could not go to work). At the time of the report, MALAISE (Very Sick), HYPERSOMNIA (Slept all day), IMPAIRED WORK ABILITY (Could not go to work), HEADACHE (Very Bad Headache), CHILLS (Chills), VOMITING (Vomiting), PYREXIA (Fever), VACCINATION SITE PAIN (Sore Arm (Injection Site)) and FATIGUE (Could not go to work) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Patient stated she did not want to receive second dose of vaccine.  No concomitant medication use was provided by the reporter. Treatment of events was not reported.
Mom called stating patient had redness, swelling, tenderness with low grade fever 24 hrs post getting DTAP in (L) Deltoid swelling went down after 3 days.
Presented with worsening SOB, admitted to ICU on bi-pap, was able to wean O2, transfer to medical floor. Pt did receive Remdesivir, is currently still in pt.
Patient developed hives after flu shot. To ER; Benadryl given. To PMD; steroid and medication given. To dermatologist.
sciatic pain in the back; the patient is in such pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administration date 17Feb2021 (Lot number: EL9269) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SCIATICA (non-serious) with onset 02Mar2021, outcome "unknown", described as "sciatic pain in the back; the patient is in such pain". The event "sciatic pain in the back; the patient is in such pain" was evaluated at the physician office visit. Therapeutic measures were taken as a result of sciatica.  Additional Information: The patient was treated with methylprednisolone steroid, hydrocodone/acetaminophen and receiving "something" for nerve pain/sciatic pain. The patient was advised by her doctor not to take the 2nd dose on 10Mar2021 as she will be taking steroids through 07Mar2021. The reporter/patient was concerned with the second dose because she was taking steroids.  No follow-up attempts are needed. No further information is expected.
A non-serious spontaneous report of two patients were given expired FLUMIST was received from a health professional concerning a 37-month-old male after receiving FLUMIST. Neither past medical history nor concomitant medications were reported for this patient. The product expired on 29-Dec-2010. On 05-Jan-2011, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Severe lower abdomen cramping/pain with no vomiting or diarrhea, decreasing discomfort by Wednesday. Then light headiness through the night. On Thurs, lower back pain in the morning, then chest pain towards the end of day through Friday morning. Symptoms have subsided by Friday afternoon.
Contracted COVID On 6-17-22. Used home test to verify. Husband contracted on 6-13-22. Blood Pressure dropped to 74/54. Taken to Emergency Room to get re-hydrated and then returned home. Emergency Room confirmed with their COVID test that I had it. I was shivering and had a headache in the front of the forehead. Did not have a fever. My throat was very sore and roof of mouth swelled up. Both sore throat and swelling continued even after completion of Paxlovid and 10 day quarantine. Blood pressure continues to remain low at times.
12MAY92 c/o sore throat, swollen lymph glands, h/a; 13MAY92 WBC 22,000; t99.5 c/o n/v, sore throat, swollen lymph glands; 14MAY92 WBC 22,3000, no diarrhea;
good size swelling on my arm; the swelling on the arm iches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (good size swelling on my arm) and PRURITUS (the swelling on the arm iches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 PERIPHERAL SWELLING (good size swelling on my arm) and PRURITUS (the swelling on the arm iches). At the time of the report, PERIPHERAL SWELLING (good size swelling on my arm) and PRURITUS (the swelling on the arm iches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Paralyzed; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration in the right high shoulder (right deltoid) on 27Mar2021 at 10:03 at the age of 47 years old (Batch/Lot Number: ERZ613 OR ER2613) as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), at the age of 47 years old, batch number: EN6205 on 06Mar2021 at 10:11AM or 09:11AM given in her right high shoulder as an injection for COVID-19 immunisation. The patient was calling about the COVID 19 vaccination that she received. She stated that with the first dose, she did not feel anything, and she is calling to report on the second dose. She has spoken with Pfizer before, but she had questions and she was told how to go about it. She stated she received the vaccine and the symptom started exactly 8 hours after. She got the vaccine at 10:05AM or 10:03AM and it was about 9:03PM when the symptom started. She stated she got the vaccine probably at 10:03AM on 27Mar2021 and she was paralyzed. She stated picture someone laying there, it went into the right arm and then went into left and paralyzed there then it came down from the top to across her chest and shot straight down and missed the breast area and went into the ribs then it paralyzed her left leg and shot right across and paralyzed her whole right thigh and all she knows was that she could not move. She was paralyzed, and it shot into her and came across and then straight down. She stated it just did it at the moment exactly 8 hours and it started at around 9:08pm. She clarified, well it started actually 11 hours after the vaccine and not 8 hours. She wanted to say it lasted for 2 minutes where she could not move for a while and it was strange. The exact time was maybe 2 minutes after it started was when it stopped. She clarified and stated, well actually it lasted a couple of hours and stopped at 11:08PM. She stated she is not sure if she has recovered completely from this. The event outcome was unknown.
fever 103.5 d, site area swollen, red, warm to touch, vomting, aches (body), generalized non pruritic exanthema on 7/14-15
Day after injection around 8:09pm, I suddenly started having chest pain, tachycardia of 130-160?s, shortness of breath, onset of a migraine, and lightheadedness. I had to be transported by ambulance to the local ER after not seeing any improvement in my condition. I was given 4 baby aspirin, 1 sublingual nitroglycerin, and oxygen. On the EKG they took, I kept showing clear signs of tachycardia. The biggest issue is that I?ve had a TIA (mini stroke) due to the oral contraceptive I was taking when I was 16. At the hospital, they just monitored me and gave me fluids before sending me home. This was about three hours after the onset of symptoms. I still have lingering chest pain that comes and goes. I?ve never had this type of reaction before other than when I was 16.