chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Suspected vaccination failure; Recovering from shingles / have had the very first vaccine and the most recent two shot vaccine; This case was reported by a consumer via media and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine and Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine, Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that one should not think that,  just because they got the vaccine they won't have shingles. The patient was recovering from shingles and have had the very first vaccine of Shingles and the most recent two shot vaccine. This case was considered as suspected vaccination failure since the details regarding time to onset and lab test confirmation was unknown at the time of reporting.
Pt recvd 3 doses of Engerix-B vax on 1DEC90, 3JAN91, & 17MAY91 & 28DEC91 showed non-immune status on anti-HBS testing; 3JAN92 recvd a booster dose of Engerix-B;
General side effects: fatigue, joint pain, headache, nausea, chills, weakness, excessive pain on injection area. Began approximately 6 hours after injection and quickly got worse. Administered flu medicine and Ibuprofen as directed per package on the day of vaccination and the following day. Symptoms began to subside the following day after vaccination.
pt recv vax & devel an inj site rxn characterized by redness & induration 49 to 72hrs p/vax;pt also devel fever ranging from 103 to 104;the pt was seen in ER & sent home;this is one of six patients from this site w/the above rxn;
Erythema, induration, warmth, pain to palp over (R) upper arm. Began 2 days ago.
Swollen injection site, hot injection site, fever, body aches, fatigue, chills.
1036 Pt reported feeling lightheadedness and dizziness 10 minutes after receiving vaccine dose. Pt transported via wheelchair to medical observation area and placed in supine position on stretcher. VS upon admission to med observ area BP 116/79 P 69 pox 100%. Pt verbalized feeling better upon laying on gurney and asked to sit up slightly , HOB elevated to 45 degrees and pt given 4oz apple juice and some crackers.  1055 pt verbalized feeling " much better" and asked to sit in chair.  VS taken sitting in chair BP 110/75 P 63 pox 99%.  1100 Pt reported feeling "back to normal" and was discharged from med observ to home with instruction given to contact PCP if any furthur symptoms were to develop. Also instructed to stay well hydrated and eat a healthy lunch and dinner today.
Four days, after the MMR & Chicken pox shot, pt lost all words, did not understand, was in his own world, starting shaking his head back and forth. Dx'd with Autistic Spectrum disorder.
lost all motion and feeling in her right arm/no feeling in right arm or hand/no feeling in her fingers; developed a horrible rash; problems breathing; flu-like symptoms; fever; body aches; vomiting; diarrhea; still really painful at injection site; chills; This is a spontaneous report from a contactable nurse (patient herself). A 21-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EJ1686/PF2), via an unspecified route of administration in right arm on 02Jan2021 13:15 at single dose for COVID-19 immunization. The patient's medical history were not reported. Allergies to medications, food, or other products was none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Not any other medications the patient received within 2 weeks of vaccination. Facility type vaccine was workplace clinic. Caller reported to have taken the vaccine last Saturday (02Jan2021 13:15) and 2 hours (02Jan2021 15:15) after had experienced vomiting and then an hour later (02Jan2021 14:15) 3 times with diarrhea. She also experienced flu-like symptoms which included fever, body aches, problems breathing and chills later that evening. On Sunday morning (03Jan2021), patient woke up with no feeling in right arm or hand. She lost all motion and feeling in her right arm and developed a horrible rash. The rash and other symptoms have been resolved but she still has no feeling in her fingers as of the moment. Doctor on call said to rest and take paracetamol (TYLENOL) every 4 to 6 hours. Patient had feeling in arm started to come back but still really painful at injection site and still had no feeling in fingers or thumb. The patient underwent lab tests and procedures which included nasal Swab: pending results on 04Jan2021.  Events result in doctor or other healthcare professional office/clinic visit.  All events were reported as non-serious. Outcome of lost all motion and feeling in her right arm/no feeling in right arm or hand/no feeling in her fingers, painful at injection site was not recovered and outcome of other events were recovered in Jan2021.
Patient fainted for a few seconds and regained consciousness quickly. We gave him some water and he was fine.
Information has been received from a RN concerning a 5 yr old white male pt with no illness at the time of vaccination who on 29Mar04 at about 2:30PM was vaccinated SC in the left arm with a second dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 646707/0815N). Follow up information indicated that secondary suspect therapy included vaccination on 29Mar04 in the right deltoid with a fifth dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (Tripedia) (lot C1625AA). Concomitant therapy included vaccination on 29Mar04 in the right arm with a fourth dose of poliovirus vaccine inactivated (IPOL) (lot X0316). On 31Mar04 at 4:30PM the pt experienced swelling and some color (redness to pink) seven inches down the right arm including elbow and below. No other symptoms were noted by mother. Follow up information from someone at the physician's office reported that the injection was DTaP not MMR and he was fine within 2 days. No further information is available.
Lt upper arm w/mild swelling, point of inject & resolving eccymosis; 8mm x 8mm, +pain throughout bicep & tricep tender;
On the night of vaccine I had a fever up to 101 degrees, aches and fatigue into the next day.  Two days later I started having diffuse sporadic and intermittent tingling on various parts of my body.  That lasted about 2 days in its greatest severity.  On day 6 post vaccine, I was walking in an airport and developed chest pain, tachycardia, and shortness of breath out of proportion to my level of exertion.  This chest pain, shortness of breath and tachycardia with minimal exertion (a flight of stairs.  A walk to the end of driveway.) has persisted since then.  A cardiac w/u with Echo and  treadmill stress ECHO were negative.  I also have intermittent fatigue, headaches, and a mild "brain fog."
worried about the side effects  / She is now scared of a blood clot cause the arm there is very hard.; the arm there is very hard; arm is quite swollen there; is in a lot of pain; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (worried about the side effects  / She is now scared of a blood clot cause the arm there is very hard.), VACCINATION SITE INDURATION (the arm there is very hard), VACCINATION SITE SWELLING (arm is quite swollen there) and VACCINATION SITE PAIN (is in a lot of pain) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANXIETY (worried about the side effects  / She is now scared of a blood clot cause the arm there is very hard.), VACCINATION SITE INDURATION (the arm there is very hard), VACCINATION SITE SWELLING (arm is quite swollen there) and VACCINATION SITE PAIN (is in a lot of pain). At the time of the report, ANXIETY (worried about the side effects  / She is now scared of a blood clot cause the arm there is very hard.), VACCINATION SITE INDURATION (the arm there is very hard), VACCINATION SITE SWELLING (arm is quite swollen there) and VACCINATION SITE PAIN (is in a lot of pain) outcome was unknown.            No concomitant medication listed.  No treatment information reported.
patient with stage IV tonsil cancer in remission with  portacath presents to ed with neck pain.  Found to have an acute, provoked internal jugular DVT
no additional adverse event reported; Product use in unapproved indication; Nurse practitioner reported patient received a dose of GARDASIL 9 on Apr 10, 2023 and then later on the same day patient found out that she was pregnant. Pregnancy Gestation or LMP: Unknown by nurse practitioner. Nurse practitioner stated patient has; This spontaneous report was received from nurse practicioner and refers to a 24-year-old female.  The patient's medical history included papanicolaou smear abnormal. The patient's concurrent conditions included mildasthma. Concomitant therapies were not reported.  On 10-APR-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, once, lot #U019412, expiration date: 30-OCT-2023, administered intramuscularly for smear cervix abnormal and papilloma viral infection (strength was not provided) (product use in unapproved indication).  On an unknown date (also reported as: last week), pregnancy test was negative. On unknown date, nurse practitioner reported that on 10-APR-2023, patient received a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On the same day, patient found out that she was pregnant (maternal exposure druring pregnancy). Pregnancy Gestation or LMP: Unknown by nurse practitioner. Nurse practitioner stated patient has irregular periods and did not think it was possible to get pregnant. No further information provided. No additional AE reported. No PQC reported.
body aches; feeling pretty miserable; worn out; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  An 80 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 30Mar2021 11:30 (Batch/Lot number: unknown) at the age of 80 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications for blood pressure, cholesterol and a stroke. Vaccination history included: Bnt162b2 (dose 1), administration date: 09Mar2021, for Covid-19 Immunisation. The following information was reported: PAIN (non-serious) with onset 30Mar2021, outcome "not recovered", described as "body aches"; FEELING ABNORMAL (non-serious) with onset 30Mar2021, outcome "not recovered", described as "feeling pretty miserable"; FATIGUE (non-serious) with onset 30Mar2021, outcome "unknown", described as "worn out". Therapeutic measures was taken as a result of pain, feeling abnormal, fatigue that included Tylenol.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021366836 same reporter/drug/different events, different patient.
Arm sore; Arm sensitive; Feel tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm sore), LIMB DISCOMFORT (Arm sensitive) and FATIGUE (Feel tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Cough.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm sore), LIMB DISCOMFORT (Arm sensitive) and FATIGUE (Feel tired). At the time of the report, PAIN IN EXTREMITY (Arm sore), LIMB DISCOMFORT (Arm sensitive) and FATIGUE (Feel tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the events were not reported.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
pt stated that she felt like she had mild side effects from the vaccine but at day 8 noticed her arm had increased swelling, redness and was warm at the injection site and surrounding area.  She called on day 10 to report the reaction, she stated that it had not gotten any worse and was using cold compresses on it and taking some ibuprofen.
Patient stated that immediately following vaccination she had soreness in arm/shoulder. Couldn't lift arm on car door. No redness, fever or swelling. Reported to me on 10/6/11 that she is still having shoulder pain. Recommended she see her PCP.
Expired Havrix Administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 41-year-old male patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   On 22nd December 2022, the patient received Havrix. On 22nd December 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 22-DEC-2022 Reporter's Comments: The nurse reported that a patient received a Havrix expired dose by error. The reporter consented to follow up. Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Currently pregnant - due date 11/08/21   Sore arm, fatigue, nausea, lack of appetite, chills, headache and body aches   No treatment, rested
she experiences a severe allergic reaction with the Pfizer BioNTech COVID-19 vaccine; This is a spontaneous report from a Pfizer sponsored program COVAX US support. A contactable 68-year-old female consumer (patient) reported that: A 68-year-old female patient received unspecified dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, single dose for covid-19 immunisation. Medical history included, animal bite, panic attack, agoraphobia from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously took penicillin b and experienced drug hypersensitivity, tetanus vaccines. On an unspecified date, she experiences a severe allergic reaction with the Pfizer BioNTech covid-19 vaccine. Patient has Agoraphobia and panic disorder for 30 years and is taking MAO Inhibitor which is Phenelzine and wanted to know if this and other medications she is on has an interaction or contraindication with the Pfizer BioNTech COVID-19 vaccine. She wanted to know if Penicillin is in the Pfizer BioNTech COVID-19 vaccine because she mentioned that when she was 6 years old, she had a shot of Penicillin and died on the kitchen table and her father got a doctor who gave her a shot, took her to the hospital and she lived. Patient mentioned that she had a lethal allergic reaction to Penicillin. She mentioned that she had severe reactions with other medications before. She mentioned that when she got bitten by her cat, they had to give her medicines in half doses, the medication was Tetnus perhaps. She wanted to know if there is an interaction with Tetnus and the Pfizer BioNTech COVID-19 vaccine. She mentioned that Phenelzine is a tricky medicine, but it works and that she tried different medicines that didn't work. She mentioned that she had horrible panic attacks and couldn't leave the house and with the medicine, she got better, she got her master's in fine arts and she became a full professor. She mentioned that she is on MAO Inhibitor Phenelzine and is not sure if she can be given an Epi pen or Epinephrine since she can't have any decongestants in case, she experiences a severe allergic reaction with the Pfizer BioNTech COVID-19 vaccine. She decided to call Pfizer because Pfizer makes the MAO Inhibitor. AE. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
On 4/12/22 at 3:40am, I had sharp severe chest pain under left breast that woke me up, it would repeat if I tried to lay back down or take a regular breath in. I went to Medical Center ER for treatment & admitted to their observation unit to monitor until 4/13/22. I was diagnosed with pericarditis & a small amount of pericardial infusion.
Shot given on Friday 10/17/2003.  Immediately following shot had metallic taste in mouth that lasted all day, dizziness on and off and shortness of breath on and off all day.  By evening had back ache, on saturday, back, legs and hips; sunday whole body ache that continued until wednesday.
COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies : Penicillin" (unspecified if ongoing). Patient didn't took other medication in 2 weeks. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer from Regulatory Authority (manufacturer control number: PR-AMGEN-PRISL2021060593). A 53 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 53 years as dose number unknown, single for Covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (ongoing). Concomitant medication(s) included: ENBREL taken for rheumatoid arthritis. The following information was reported: ABDOMINAL PAIN (non-serious), outcome "unknown", described as "After she got the vaccine she had abdominal pain, like when she used to get her periods". Therapeutic measures were not taken as a result of abdominal pain. Additional information: The patient began Enbrel, Reusable Autoinjector on an unknown date. The patient missed one dose of Enbrel after her vaccine of COVID. After she got the vaccine she had abdominal pain, like when she used to get her periods. This happened twice already. The patient would check if it happens again and she would let the doctor know at the time of appointment. Action taken with Enbrel and Reusable Autoinjector was reported as unknown for the event abdominal pain. The causal relationship between the event abdominal pain and Enbrel with Reusable Autoinjector was not provided by the consumer. The reporter could not read/could not find lot number. The reporter declined consent for follow up. No follow up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 19.5 year old female patient with penicillin and AUGMENTIN allergy who had two doses of MMR II (1990-1992) and had a low titer for mumps. No other details at the time of this report. The outcome was unknown. Additional information has been requested.
Information has been received from a nurse practitioner concerning a female child who on 17-APR-2003 was vaccinated SQ with a 0.5 mL dose of Varivax. Recently, the patient developed "full blown case" of chickenpox. The child had several hundred lesions and went to the ER. The patient's outcome was reported as recovered. There was no product quality complaint involved. Additional information has been requested.
Hives all over body and itching w/ swelling. ER prescribed prednisone and BENADRYL.
Sore arm, itchy nerve path, extreme tiredness, very sore hands, neck, upper back, chills but temp is normal.
bruised the right side of his face/walking into door leading to bruise on face; Bell's Palsy; sinus infection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Bell's Palsy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Sclerosis of liver and Stent placement.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SINUSITIS (sinus infection). On 05-Apr-2021, the patient experienced FACIAL PARALYSIS (Bell's Palsy) (seriousness criterion medically significant). On 07-Apr-2021, the patient experienced CONTUSION (bruised the right side of his face). On 07-Apr-2021, PAIN (pain is almost 100% gone) had resolved. At the time of the report, FACIAL PARALYSIS (Bell's Palsy), SINUSITIS (sinus infection) and CONTUSION (bruised the right side of his face) had resolved.; Sender's Comments: This case is regarding a Male patient of unknown age who experienced the events Facial paralysis, pain, sinusitis, and contusion.  The events of sinusitis and contusion were assessed as unlikely related to study drug as the contusion occurred due to patient walking into a door.   The sinusitis can be due to an infection causing inflammation of sinus.  Based on the current available information and temporal association between the use of the product and the start date of the event, Facial paralysis, a causal relationship cannot be excluded.
Patient got pain for 3 days after having shot. Patient experienced redness, itchy along the rib, lower left chest within couple days and got worse after 3 days. Patient got better on 11/11. We consulted patient get Benadryl and the redness and itchy's clear now.