chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A nurse reported the occurrence of joint pain in an adult male of unspec'd age who was vaccinated w/Hep B vaccine recombinant (Engerix-B) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. On an unspecified date, the subject received his first injection of Engerix-B. At an unspecified time post-immunization, he experienced joint pain, headache, fever, malaise, and chills. As of 10/10/02, the outcomes of the events were unknown. Comment: This report has been linked to report #A0383040A due to same reporter.
Grandmother states client had hives over entire body two days after the Hep B was given.  Hep B was given 03/29/01.  No fever-no other symptoms-Doctor was called-no treatment given.  Grandmother called here 03/31/04-3 years later and told me.  Reason for phone call-clients' new doctor wants to give 2nd and 3rd of Hep B-Doctor had said no too.
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown demographics. No medical history, concurrent conditions or concomitant therapies were reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally (lot #, dose and anatomical location were not provided). No adverse effects were reported. This ss one of several reports received from the same reporter. Additional information is not expected, as the reporter did not wish to be contacted.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 29-OCT-2012 14:46, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Pt complained of numbness at injection site in L arm, radiating down to forearm. BP 151/90, HR89, RR18. No other symptoms or visual changes, self-resolved. Pt discharged in stable condition
This spontaneous report as received from a physician refers to a 19 year old male patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant)(manufacturer unknown) (lot, expiry date, dose, frequency and route of administration were not reported) for prophylaxis, when he was child. The reporter stated that, recent titers showed that the patient did not have immunity(hepatitis b surface antibody negative). The physician noted that he will administer a booster dose to the patient. The outcome of hepatitis b surface antibody negative was unknown. The causality assessment was not provided by the reporter. No product quality complaint was filed.
Local cellulitis and subsequently became septic requiring hospitalization. Discharge summary states fever, chills, hypotension, confusion, asthenia. msv
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 86-year-old patient received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 20Feb2021 as dose 2, single (Batch/Lot number: unknown), in right arm, on 24Oct2021 as dose 3 (booster), single (Lot number: FD8448), in right arm and on 10May2022 as dose 4 (booster), single (Lot number: EN6200) at the age of 86 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Resistant to penicillin" (unspecified if ongoing), notes: Resistant to penicillin. Concomitant medication(s) included: AMLODIPINE BESYLATE, start date: Sep2021, stop date: Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (Jul2022) 110/72, notes: The lowest BP reading was 110/72 during the entire episode; Oxygen saturation: (Jul2022) was above 93%. Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient had Other medication in 2 weeks.Other medication in 2 weeks product :Amlodipine Besylate 5mg.Other medication in 2 weeks brand :Lupin. Anti viral details product=COVID 19 Treatment, brand=Paxlovid, treatment start date=11Jul2022, treatment stop date=15Jul2022, indication=Treatment of COVID-19. Adverse event: Reduced to half dosage by the doctor during and three days after taking. Paxlovid to avoid an excessive drop in blood pressure. The lowest BP reading was 110/72 during the entire episode. Oxygen saturation was above 93% during the entire episode. Paxlovid did its job. Ae treatment: Reduced Amlodipine to 1/2 dosage.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 29Mar2021 (lot number was not reported), as 1st dose, single dose, for COVID-19 immunisation. Medical history included being exposed to someone with COVID-19 on 29Mar2021. The patient's concomitant medications were not reported. It was reported that the patient received the first dose of the Pfizer COVID-19 vaccine on 29Mar2021 and was exposed to someone with COVID-19 on the same day. The patient got sick in the evening of 01Apr2021 and tested positive for COVID-19 on 02Apr2021. The 2nd dose was scheduled on 19Apr2021. The patient wanted to know if the vaccine is helping her out in fighting off the virus and if there is further protection since she had the first dose of the vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
2 inch round rash appeared on right arm above wrist below thumb.  raised and itchy.  applied cortosone to area to reduse irritation.  rash remains as of today.
Left breast pain and tenderness as well as a pulling sensation that was painful. This started approximately 10 days after the shot and are now subsiding seven weeks after the injection.  I want to my oncologist who then sent me for mammogram and ultrasound to check for cancer. All those tests came back negative.
Pneumonia  01/2021 Stomach inflammation 03/2021 Tendonitis in hand 06/2021
1st shot (4/27/2021,11:30am): Within 5 minutes after shot, I got numbness from left arm all the way to left leg and foot, lasted about 3 hrs. At evening, i started to develop heart issue: fast and irregular heart beat, short breathe, chest pain, tiredness, and trouble to fall in sleep. On 3rd day (4/30/2021),  heart beat and short breathe were getting really dramatic, called my doctor for urgent care.  Had x-ray, EKG study, blood test, results came out normal. But those bad conditions continued for 3 more weeks. After a month, the heart issue/short breathe/chest pain improved, but those symptoms stayed, I couldn?t do normal activities like before as the irregular heart beat and short breathe would make me feeling dying. At end of November, my doctor ordered 48-hr Holter monitor, result showed premature atrial contractions, also prescribed propranolol 10mg tablets.   2nd shot (12/23/2021, 6:30pm): My heart issue was still existing, but for the vaccine mandate from employer, I had to get 2nd short.  After 2nd shot, I started fever the same night for 2 days. On the 3rd night, exactly same dramatic reaction was happened again: Fast and irregular heart beat, short breathe and chest pain. Meanwhile I got joint pain all over my body. Now the heart issue and joint pain are stayed, prevent me doing regular and normal activities prior to 1st shot.
Soreness in my arm the day and night of the vaccine that continued for a couple of days.  Then, a week and a day after I received the vaccine, I developed "Covid Arm" with the red itchy rash, hot to the touch on the arm where I received the injection.  The Covid Arm has faded tremendously but is still itchy and lasted at least 9 days.
The afternoon after I got the shot I went for a jog. When I returned, I got intense chills and a fever of 103 degrees along with some flu like symptoms. I had a slight headache. Ibuprofen helped but the next day I had similar symptoms, but they went away by the end of the day. On the third day I felt a little better, so I went for a run. I had some shortness of breath and it was difficult to breathe when I was running. I normally run 4 miles daily. The shortness of breath was present for a week after that and also started to happen intermittently even at rest. One week after the shot I saw a doctor and they did some testing but did not find anything definitive. Six weeks after the shot I went to the ER and they diagnosed with Thrombocytopenia. At this point it has been seven weeks the shortness of breath has improved, and I haven't experienced it for a few days.
Experiencing very discomforting tinnitus/ear ringing.  Within a day or so after the first dose vaccine.
PATIENT IS HAVING DIFFICULTY MOVING ARM AND STILL EXPERIENCING DISCOMFORT AT INJECTION SITE.
Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a Non-healthcare professional. This case is linked to cases 2018SA279967, 2018SA279973, 2018SA281633, 2018SA281638, 2018SA281635, 2018SA281636, 2018SA281637, 2018SA281634, 2018SA281632, 2018SA279979, 2018SA281687, 2018SA281692 and 2018SA279967. (Same reporter). This case involves an 11 years old female patient who received vaccine ADACEL, lot U5798AB via unknown route in the left deltoid on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. It was a case of actual medication error due to incorrect product storage. It was reported that vaccines given between 11-Sep-2018 to 13-Sep-2018 after temperature was at 30 F for 4 hours: They were below freezing. No adverse event was reported. 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 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. List of documents held by sender: none.
17 years, 10 Months old patient received the Moderna Covid -19 Vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years, 10 Months old patient received the Moderna Covid -19 Vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years, 10 Months old patient received the Moderna Covid -19 Vaccine). On 15-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years, 10 Months old patient received the Moderna Covid -19 Vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication information was provided.
Headache, fatigue, body aches, cough, shortness of breath, difficulty breathing
expired vaccine administered; felt weak; couldn´t stay awake/slept her whole working shift from 8-2/just woke up periodically; a little swelling; felt very tired; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt weak), SOMNOLENCE (couldn´t stay awake/slept her whole working shift from 8-2/just woke up periodically), SWELLING (a little swelling), FATIGUE (felt very tired) and EXPIRED PRODUCT ADMINISTERED (expired vaccine administered) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2022 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced ASTHENIA (felt weak), SOMNOLENCE (couldn´t stay awake/slept her whole working shift from 8-2/just woke up periodically), SWELLING (a little swelling) and FATIGUE (felt very tired). On 22-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine administered). On 22-Jan-2022, EXPIRED PRODUCT ADMINISTERED (expired vaccine administered) had resolved. At the time of the report, ASTHENIA (felt weak), SOMNOLENCE (couldn´t stay awake/slept her whole working shift from 8-2/just woke up periodically), SWELLING (a little swelling) and FATIGUE (felt very tired) outcome was unknown.            No concomitant medications were reported No treatment medications were reported   This case was linked to MOD-2022-460314 (Patient Link).   Reporter did not allow further contact
3 seizures 2 days after administration MMR, VARIVAX and Hep A. Had full septic work up including LP - all negative.
Patient received his routine vaccinations (DTap-IPV  - L thigh and pneumococcal 23 - R thigh) on 6/22. He was initially sore afterwards bilaterally. On the morning of 6/23, he woke up with worsened right lower extremity pain that began where he received his shots but progressed to involve the entire right leg throughout the day on 6/23. He began to progressively limp and refuse to bear weight on his right leg, causing mother to have to carry him around. Mother noted tactile fever that evening. Upon measuring, Tmax 103.3F. Given fever in the setting of prior liver transplant, mother called on call hepatologist for recommendations. It was recommended to come to emergency room for evaluation at Hospital. Associated symptoms include one episode of NBNB emesis, abdominal pain, and looser stools on day of admission. Denied diarrhea, cough, sore throat, cough, rashes. No sick contacts at home.
Pt received COVID vaccine 1 st dose on 3/4.  2nd dose  vaccine given on 4/2/21- received VACCINE. Disclosed to pt. Voiced no concerns. She was informed that she has completed her vaccine series at this time.
Very tired on the day of the vaccine, then starting to have period cramp, then 4 days later started my period after not having a period for 2 years due to IUD.
Information has been received from a registered nurse concerning a female, pediatric patient, who was vaccinated with Gardasil, (lot not reported). Subsequently the patient experienced severe injection site pain. It was reported that the pain was in the muscle and started at the tiem of injection. The pain lasted for 2 days and then resolved. The patient was treated with warm compresses. The patient sought unspecified medical attention. Additional information has been requested.
Next day after his vaccines, he was dazed and not focusing well.  Low muscle tone.  Not holding head up as well.  More fussy than usual.  Drooling more.  Less smiling than prior.  Very sleepy.  Possibly not opening eyes as far.  Seems unresponsive at times.    Follow up appointment with Dr on 3/9/23.   Referral to neurology.
Became congested with both chest and vocal cords involved.  No head congestion.  Also had joint pain that lasted the 1st 1-2 days.  Congestion with large amt of mucus continues to present.
Rash began 1/1/03 on chest and spread today 1/2/03 to back, face and upper extremities eyes are swollen, reported by Mom. See Attached note for MD visit. ( no note attached)
Several hours after shot, arm soreness and redness - next few days very sore arm, large red round raised splotch on arm - hot to the touch - 3rd day arm was less sore, red turned to black and blue bruise looking, 4th day arm clear.  On 8th day, large red round splotch re-appeared is hot to the touch and itchy - still there day 10.
Narrative:  75yo male pt who was covid vaccinated with 2 Moderna shots on 2/14/21 & 3/13/21 developed covid positive infection at outside hospital. Pt died at this hospital from covid infection. Vaccine failure leading to pt's death.
Severe red arm and swollen. Mark still there  on my arm  11 days later though not as red and large. It looks like a birthmark now. Worried if I should get second shot. Also I had fevers for 5 days after thank you
little blister; bruises; deep Itching; rash is located on the hands, arms, face and legs/rash was also on the torso/having puss that crusts over; Initial information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 58 years old female patient who experienced little blister (blister), bruises (contusion), deep itching (pruritus) and rash is located on the hands, arms, face and legs/rash was also on the torso/having puss that crusts over (rash pustular), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history included Arthropod bite with placed on antibiotics. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Allergy to metals and Drug hypersensitivity.   On 10-Oct-2018, the patient received a dose  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6069BA via unknown route.  On an unknown date, The patient developed a non-serious little blister (blister), bruises (contusion), deep itching (pruritus) and rash is located on the hands, arms, face and legs/rash was also on the torso/having puss that crusts over (rash pustular) Unknown latency following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Patient had allergy test showing she is allergic to: gold, nickel, thimersol, tixocortol -21 pivalate, bacitracin, neomycin; that she was given an anti itch cream that she found out contains tixocortol -21 pivalate; that the providers have treated her for poison ivy which she has an allergy too; that she has always sown with needles and that she is always in poison ivy; that the providers now are thinking this may be Uticaria or eczema like; and that she is being referred to bigger hospitals out of state now  No lab test reported.  Final diagnosis was rash is located on the hands, arms, face and legs/rash was also on the torso/having puss that crusts over, deep itching, bruises and little blister.   The patient was treated with PREDNISONE (PREDNISONE).  The patient outcome is reported as Unknown for the events.
pt recvd vax;devel redness, swelling & tenderness at inject site; lasted x 2 days;
Information has been received from a registered nurse concerning a 75 year old female with a cardiac history who sometime in the first week of March 2007, was vaccinated with a subcutaneous dose of Zostavax. Concomitant therapy included cardiac medication (unspecified). "Shortly after she got the Zostavax vaccine", in approximately 3007, the patient experienced soreness at the site of the injection, pain in the muscle and it hurt when she moved her arm. At the time of this report, the patient had not recovered. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.  Follow up: Information has been received from a 75 year old female registered nurse, reporting on herself, with allergies to pollen and perfume and a cardiac history who on 01-March-2007, was vaccinated with a .5cc subcutaneous dose of ZOSTAVAX (Merck) (Lot # "9035U") in the left deltoid. Concomitant therapy included cardiac medication (unspecified). About 3 days after vaccination with the ZOSTAVAX (Merck) on approximately 04-MAR-2007, the patient developed severe sharp pain which shot up the left upper arm from the elbow to the shoulder without pain in the joints. This lasted 3.75 months, mainly when lifting the arm. The patient recovered during the 4th week of June 2007. Unspecified medical attention was sought. No product quality complaint was involved.  Additional information is not expected.
Member was given YF vaccine on 09/28/2021 that expired 09/26/2021
Document Nurse assessment, provided care and resident's response to care provided : Called to check on resident due to having a crooked smile and slurring her words.  Assessment has patient sitting in her recliner. She is alert and oriented. There is a definite right side of no movement, even with talking. Her right eye is not blinking, speech is slightly slurred. All grips are equal, her leg strength is equal. She denies HA or dizziness. Call was made to the daughter due to her unequal smile. It was decided to send her out to the hospital for possible stroke. She was later diagnosed with Bell's Palsy
This spontaneous report was received from a healthcare worker regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. Since 08-AUG-2015, the patients were vaccinated with improperly stored oral, ROTATEQ, lot number- L004453 expiration date 27-MAY-2016, lot # K023159 expiration date 26-JUL-2016. No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
8 days after vaccine, patient developed hard mass with redness, tenderness, warmth and itching at vaccine site.  She had arm soreness 1-2 days after vaccine but then felt fine until waking up with hard lump on her arm at vaccine site on day 8
Developed rash/swelling to lower extremities and buttocks, gait problem, joint swelling.
Pt has known arthritis. Had a bad Arthritis Flare in both knees 5-7 days after second vaccine, Has not subsided. Has recieved cortisone shot in right knee as a results and will require an MRI in the left knee.
Patient received zoster shingles on 9/07/2012. Wife was ill on 9/15 and seen and treated at Urgent Care, later seen by Dr. on 9/28/2012 who diagnosed it as disseminated shingles/chicken pox.
Blister on leg; This case was reported by a pharmacist via call center representative and described the occurrence of blister in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 227FL, expiry date 30th November 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced blister. On an unknown date, the outcome of the blister was unknown.   It was unknown if the reporter considered the blister to be related to Shingrix.  Additional details were provided as follows: The patient developed blister on leg at some time after receiving first dose of Shingrix.  The patient did not see a physician, no diagnosis. The reporter consented to follow up.