chrisvoncsefalvay/vaers-outcomes huggingface dataset:
barely breathing; swelling; aches; every joint and muscle ached; every joint and muscle ached; fever; This spontaneous report was derived from an online article posted on social media platform received via vendor and refers to a 15-year-old female patient. The patient's concurrent conditions and concomitant therapies were not reported. Her medical history included flu vaccine (unspecified) to which she had no ill side effects.  On 25-AUG-2009, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (route of administration, formulation, anatomical location, lot# and expiry date were not reported) for prophylaxis and with influenza virus vaccine (unspecified) nasal spray (dose, lot# and expiry date were not reported) for prophylaxis.   On the same day, a few hours after receiving a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL), she developed aches, fever and swelling. By midnight, the patient was barely breathing and every joint and muscle in her body ached. Her mother drove her to the hospital, where they were met by the patient's pediatrician. There was nothing that could have been done for her, other than to give pain medication (unspecified) and make her comfortable.  The outcome of the events was unknown.  The reporter did not provide causality assessment between the events and the suspect vaccines.  This is one of three reports from the same source.; Sender's Comments:  US-009507513-2004USA003737: US-009507513-2004USA006822:
rapid heartbeat; dizziness; This is a spontaneous report from a contactable consumer or other non-health care professional (patient herself).   A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6200) via an unspecified route of administration, administered in left arm on 19Mar2021 09:00 (at the age 35-years-old) as dose 1, single for COVID-19 immunization. The patient medical history included ongoing Allergy to Amoxicillin from an unknown date in Jan 2015- She had not officially been diagnosed, but she was prescribed it at that time and had been taking it for several days. She broke out in a rash all over her body and had dryness or tightness in her throat. Her doctor said it sounded like she was having an allergic reaction and to stop taking it. No NDC/lot/expiry was reported for Amoxicillin. She was also breastfeeding. The patient concomitant medications were not reported. Family Medical History Relevant to AE(s) included as her mother also got the vaccine on Wednesday and she had the same reaction of rapid heart and dizziness on Wed 24 2021. The patient Prior Vaccinations within 4 weeks was reported as none and no AE(s) following prior vaccinations. No previous immunization with the Pfizer vaccine considered as suspect and no additional Vaccines administered on Same Date of the Pfizer Suspect. It was reported that Patient received her 1st dose of the Pfizer COVID19 Vaccine on 19Mar2021 and experienced a couple side effects. After vaccination on 19Mar2021, during 15 minutes observation window, she experienced rapid heart-beat and dizziness and these symptoms seemed to have faded by time the 15 minute observation window was up. AE did not cause to visit Emergency Room or Physician Office. No Investigation Assessment was reported. She was looking back on the sheet and those symptoms are listed as a severe allergic reaction according to the fact sheet that was given before getting the injection and asked to confirm if it was safe for her to get the second dose. Relevant tests were none. Seriousness was reported as No. The outcome of both events was recovered on 19Mar2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021336494 Same reporter/drug/event, different patient.;US-PFIZER INC-2021351470 same drug/reporter, different patient.
Admit a hospital on 8/1/2021 with 2 to 3 days of fatigue and  as well as headaches.  The pt did have an abnormal covid test that was done on friday.  The decision to due to the possibility of an infiltrate on the xray as well a headache was  to admit the patient to the hospital. Earlier this week he noted at his job in an amusement park he had exposure to someone who was sick and he did have chills at that time. ..a fever. Upon arrival here an xray was done which shows questionable inf vs atelectasis and a ct head was ordered due to persistent headache that was negative.    Hx Heart Transplant 5/2020.    Note: Patient previously received the Moderna COVID-19 Vaccine: First Dose: 02/02/2021 Lot Number 031L20A; Second Dose: 03/02/2021 Lot Number 011A21A 8/3/21: patient discharged.
This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 lot # M035486 for prophylaxis.  Concomitant therapies included sterile diluent. On an unknown date the patient experienced incorrect product storage and no adverse event. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1708USA004959: US-009507513-1708USA011240: US-009507513-1708USA011238.
Information has been received from a physician concerning a male child patient who approximately 5-6 month ago, in September 2010, shortly following the birth, was vaccinated with a pediatric/adolescent dose of RECOMBIVAX HB (lot number not provided).  It was reported that the patient was vaccinated and developed seizures and difficulty breathing approximately 6-8 hour later, in the hospital.  Physician reported that the child was diagnosed with "CNS bleeding".  On an unspecified date, the patient appeared to have recovered, though the long term effects were not assessable at that time.  Upon internal review CNS bleeding was considered to be other important medical event.  No further information is available.
Anaphylactic reaction; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion hospitalization). At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ANAPHYLACTIC REACTION (Anaphylactic reaction) to be not related.    No concomitant medication reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, causal relationship cannot be excluded.  Doctor stated event was totally unrelated to the vaccine.
Aching pain and stiffness at injection site, decreased abduction, intact strength on exam, no swelling or neurologic abnormality noted.
Administered Janssen 0.5ml to 14 yo client in Right Deltoid. Client ambulated out of clinic reporting no adverse reactions.
Information has been received form a physician concerning a 14 year old male with a history of attention deficit/hyperactivity disorder and possibly had chickenpox, who on 07-OCT-2008 was vaccinated with VARIVAX vaccine (Oka/Merck) (lot # 660408/0273X). On 13-OCT-2008 the patient came back and diagnosed with shingles (classic dermatome rash). ). The patient was prescribed MOTRIM for the day time and TYLENOL and codeine (manufacturer unspecified) for the night time for the discomfort. The mother of the patient thinks he may had chickenpox previously; however the physician's office could not confirm that. The patient sought unspecified medical attention. Follow up information was received from the doctor of osteopathy who reported that the patient was a 17 year old male student with no pre-existing allergies, birth defects and medical conditions. At 4 PM of 07-OCT-2008 the patient was vaccinated intramuscularly in his left deltoid with a first dose of VARIVAX vaccine (Oka/Merck) (lot # 660408/0273X). On 08-OCT-2008 the patient experienced painful vesicular rash on the right side of Chest. On 13-OCT-2008 the patient went to the office and was diagnosed with shingles. On 30-OCT-2008 the patient recovered. Additional information is not expected.
This spontaneous report was received from a registered nurse and refers to an 11-year-old patient of unknown gender. On 07-AUG-2017, the patient was vaccinated with an improperly stored doses of GARDASIL 9 lot # M041990 and expiration date 28-JUN-2019 (dose and route of administration were not reported) for prophylaxis. There were no adverse symptoms reported. Administered dose of vaccine experienced the temperature excursion from 9 to 25 degrees Celsius (11.1 C) for 1 hour and 31 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA008849.
Arm at injection site became  very warm and I could feel a warmth spreading both down my arm and up through my neck.  The feeling lasted for approximately 5 minutes and then went away.   My arm was very sore about 12 hour later and lasted fir about 3 days.
This spontaneous report was received from a medical assistant, concerning multiple patients of unknown ages and genders. The patients' medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD, lot #N010865, expiration date 01-OCT-2018, albumin status of recombinant human albumin (rHA) (strength, dose, frequency and route of administration were not reported) and with improperly stored doses of VARIVAX, lot #M000997, expiration date 07-JAN-2018 (strength, dose, frequency and route of administration were not reported) for prophylaxis. The vaccines were reconstituted with a properly stored sterile diluent (lot # and expiration date were not reported). The temperature excursion was reported as 15 °F to 46 °F (23.4°F) for a time frame of 2 hours and 57 minutes. Previous temperature excursion was reported as 6 °F to 14 °F (13.4 °F) for 2 hours. Digital data logger was involved to capture the temperature excursions. No product quality complaint (PQC) was involved. Follow-up information was received on 24-JUL-2018. Additional information has been requested. This is non-valid report due to lack of patient identifiers. Follow-up information was received on 24-JUL-2018 from the medical assistant who provided patient identifiers for the reported event. The patient was a 4-year-old male child who on 16-FEB-2018 was vaccinated with improperly stored dose of PROQUAD lot #N010865 with the expiration date of 01-OCT-2018. At the time of the excursion, the vaccine was deemed stable. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1712USA013102: US-009507513-1808USA001953: US-009507513-1807USA012552: US-009507513-1807USA012553: US-009507513-1807USA012554: US-009507513-1807USA012555.
IMMEDIATELY AFTER INJECTION, WOOZY AND HAD TO SIT DOWN. LATER THAT EVENING ARM STARTED TO SWELL UP TO A POINT THAT THE SKIN WAS TO BURST AND HOT. HIVES, RED PATCHES, ITCHING SEVERE. STARTED TO CREEP UP TO CHEST. HAD TO GO TO THE ER AND THEY HAD TO TREAT ME.
pains; elevated temperature; muscle aches; fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pains), BODY TEMPERATURE INCREASED (elevated temperature), MYALGIA (muscle aches), PYREXIA (fever) and FATIGUE (fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939969) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Sensitivity to penicillin).    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (pains), BODY TEMPERATURE INCREASED (elevated temperature), MYALGIA (muscle aches), PYREXIA (fever) and FATIGUE (fatigue). At the time of the report, PAIN (pains), BODY TEMPERATURE INCREASED (elevated temperature), MYALGIA (muscle aches), PYREXIA (fever) and FATIGUE (fatigue) outcome was unknown.            It was reported that patient received a Tetanus shot in her right arm on 05-May-2022 as an IM injection. No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-580253 (Patient Link).
Rash around injection site. Rash predominantly .around immunization area, 6cm in diameter about 0.5 cm outside existing bordering of immunization. No fluctuance, pustules, or increased warmth. No fevers or difficulty walking.
Anthrax #2  11/17/99 - States that she can only remember having a local reaction with this vaccine. 12/6/99- Anthrax #3 - States that about a week before Christmas she woke up one morning and could not bear weight on her left knee due to severe joint pain. Rated pain as a 10 on pain scale 0-10. Reports that over time it progressed to her right knee and at that point she could not walk and had to be carried.  States that it lasted a couple of weeks and eventually resolved on its own.   Anthrax #4 5/8/00 - States that she had did not note any adverse reaction with this vaccine. Anthrax # 5 1/22/03 - States that she had a local site reaction. Smallpox #2 (RA)1/25/03 Pustule formed and scabbed within 7 days.  2/12/03 States that when she woke up she could not lift her left leg due to severe iliosacral pain.  During the course of the day the pain got worse and she had to be carried to sick call in Omann.  She was told that she had pulled a muscle and was given a shot of Toradol.  Rated pain as a 10 on pain scale 0-10.  Was also given Motrin and flexeril.  The medications helped a little in that she was able to drag her leg.   2/14/03 Two days later she woke up with a red round spot on the top of her left foot and her middle toe and big toe were swelled up.  She states that she was not able to bend her toes and then it proceeded to start on her right foot and progressed to all her toes, then her hands and her wrist.  She also developed a left knee effusion. At that time she started having severe bilateral occipital pain, difficulty swallowing, and restrictive chest wall pain.     Two days later she was diagnosed with a possible stress fracture.  X-rays revealed a normal foot.  At that point the physician decided to do a Lyme titer, which was negative.  Chest x-ray revealed small pleural effusions.  EKG was normal.  WBC count was elevated.  ANA results were positive @ 1:2650.She was sent home from deployment with an incapacitating arthropathy with Raynaud's phenomenon.  She was referred to a rheumatologist and placed on high dose prednisone for a Mixed Connective Tissue Disease.  She is still under the care of the rheumatologist.
Patient stated that the day of the vaccine he was fine. The next day he had a cough and was getting shortness of breathe. His wife took him to the ER. They found two blood clots in his lungs.
expired dose of ACTHIB was inadvertently administered with no adverse event; Initial information received on 09-Oct-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves 2 months old male patient who was administered expired dose of HIB (PRP/T) vaccine [ACT-HIB] inadvertently with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination (immunization); and Diphtheria vaccine Toxoid, Hepatitis B vaccine RHBSAG (YEAST), Pertussis vaccine Acellular 3-Component, Polio vaccine INACT 3V (VERO), Tetanus vaccine toxoid (PEDIARIX) for Immunisation.  On 09-Oct-2023, the patient received 0.5 ml expired dose (dose 1) (frequency: once; strength: Standard) of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection of lot UJ792AA and expiry: 06-Oct-2023 via intramuscular route in the left thigh for immunization, with no reported adverse event (expired product administered) (Latency: same day).  No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
One day post vax pt developed aching all over noting the jaw, neck and shoulder areas and their lymph nodes were enlarged.  On 10/07/1999 they developed a headache and hives at the injection site.  As of 10/13/1999 the aches were gone but the headache persisted.
got the Covid shot, within 4 hours, his bee sting was swollen about 4-5 inches in diameter with a red mark around it; got the Covid shot, within 4 hours, his bee sting was swollen about 4-5 inches in diameter with a red mark around it; got the Covid shot, within 4 hours, his bee sting was swollen about 4-5 inches in diameter with a red mark around it; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 14Apr2021 at 13:00 (Batch/Lot Number reported as E0138, looked like a EU0138. Caller stated it looks like an E, or maybe a V. Caller verified it was handwritten.) as single dose for covid-19 immunisation. The patient did not get COVID. Medical history included he got stung by a bee. History of all previous immunizations with the Pfizer vaccine considered as suspect was none.  Caller verified it was his first Pfizer Covid vaccine. No Additional Vaccines administered on same date of the Pfizer suspect. The patient did not receive Prior Vaccinations within 4 weeks, no other medical history, family relevant history or tests. The patient had no other concomitant products. Caller stated two days ago he got stung by a bee and about 24 hours later after that, there was nothing wrong where he got stung, he couldn't even see a mark. Caller stated about 24 hours later, he got the Pfizer shot, Covid shot, within 4 hours after that, the bee sting had swollen about 4-5 inches in diameter with a red mark around it and its a little painful, not bad.  Caller stated he got the shot at 13:00 and about 17:00 or 18:00, it started swelling. Caller stated it wasn't any emergency or anything. Caller stated he was stung on the stomach. Caller stated the swelling started about 4 to 5 hours after the shot. Caller stated there's swelling with redness. Caller states it's still swollen, it's about the same. The events onset date was 14Apr2021. The reported events did not require a visit to Emergency Room or Physician Office. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 14-AUG-2015, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). On or about 18-OCT-2016, the patient was treated by a physician at the physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages.  The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
approx 12 days p/vax pt exp a lesion, mild dry cough, mild dyspnea, fever of 102f.
Information has been received from a Nurse for the pregnancy registry for GARDASIL, concerning an approximately 15 year old female patient who on unspecified day was vaccinated with the third dose of GARDASIL (Lot #, dose and route not reported). The nurse reported that after the patient received the vaccine, she immediately reported to the nurse that she may be pregnant. The nurse stated that they were awaiting confirmation of the pregnancy. At the time of the report the outcome of the patient was unknown. Follow-up information has been received from a nurse reporting that the patient had an abortion on 23-DEC-2011. Upon internal review, abortion was considered to be an other important medical event. Additional information has been requested.
Increased off feelings in chest -- resting heart rate increased from 62bpm to a range of 90 - 107bpm, for roughly 5 or so days. No treatment given. Resting heart rate returned to normal after about a week.
Case number PHEH2012US021252, is an initial spontaneous report received from a pharmacist on 18 Oct 2012, with a follow up on 18 Oct 2012 with a follow up information received on 20 Nov 2012. This report refers to 32 year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: UH745AA, expiry date: May 2013) 0.5 ml intramuscular on 08 Sep 2012. About 30 minutes after vaccination the patient noticed spots and experienced nausea, vomiting, migraine and headache. The next day the patient was groggy and had vomiting. Event outcome, seriousness and causality assessment was not reported. Follow up received on 18 Oct 2012. Expiry date added. Follow up information received on 20 Nov 2012: Patient demographics (height and weight), batch number, dose and vaccination date updated and events (migraine).