chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered pharmacist refers to a 38 year old female patient without any pertinent medical history or drug reactions/allergies. On 11-DEC-2013 the patient was vaccinated with PNEUMOVAX23 injection (dose and route not reported, lot # J009827, expired date: 10-AUG-2014). There was no concomitant medication. On 13-DEC-2013 the patient experienced swelling in the administration arm that "went all the way down to her elbow". It was reported that the patient called her unspecified physician on an unspecified date and he prescribed prednisone to treat the swelling. The pharmacist reported that with the administration of prednisone the swelling went away on an unspecified date in December 2013. This is one of the several reports from the same reporter. Additional information has been requested.
ADMINISTRATION ERROR DUE TO AGE. NO ADVERSE REACTION REPORTED BY PATIENT OR IN FOLLOW UP CONVERSATIONS.
injection site soreness, generalized arthralgias (bilateral wrists, elbows, shoulders, and knees)
This is a spontaneous report from a contactable nurse. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), other route on the right arm at the age of 60 years, on 02Feb2021 12:15 at a SINGLE DOSE for covid-19 immunisation. Medical history included depression Depression, Hypothyroidism, High Cholesterol, Osteopenia, Occasional vertigo. Concomitant medication included simvastatin (SIMVASTATIN), duloxetine (DULOXETINE), raloxifene (RALOXIFENE), chlorthalidone (CHLORTHALIDONE), levothyroxine (LEVOTHYROXINE) , calcium (CALCIUM), vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]), folic acid (FOLIC ACID), fish oil (FISH OIL), vitamin b12 nos (VITAMIN B12 NOS) , calcium carbonate, colecalciferol (VITAMIN D 2000) and Tumeric. The patient had the first dose of vaccine on 12Jan2021. After the 2nd shot, the patient's arm didn't get heavy, just felt a weakness going from shoulders down to hands on Feb2021. She couldn't move or feel them for 15 min. Slowly she could move her fingers then hands then lift arms. The next day her brain felt kind of fuzzy and still a little "off kilter" on 2nd day (Feb2021). She did not have any anxiety about either shot, even with what happened with the first one. The outcome of the events was recovering.
got both shots recent vaccine, still get them/suspected vaccination failure; recurring shingles; horrible headaches; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (the patient had shingles 3 times in late 30s).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and headache. On an unknown date, the outcome of the vaccination failure, shingles and headache were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and headache to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient got shingles vaccine, still got shingles 2 to 3 times a year. The patient got both shots of the recent vaccine but still get shingles.  The worst was the horrible headaches for a week before the breakout. The doctor said it's a combination of patient's immune system and genetics that he/she get recurring shingles. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles not reported.
8/1/03 L arm red, hard, swollen-area hot to touch clear bumps around injection site. 8/2/03 child taken to Dr.-child started on Omnicef and Zyrtec medications-child's condition has improved and returned to school 8/4/03.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 59-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included rheumatoid arthritis. Concomitant products included methotrexate. In April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 1 days after receiving SHINGRIX, the patient experienced headache, shivers, skin discoloration, weakness, upset stomach and appetite absent. On an unknown date, the outcome of the headache, shivers, skin discoloration, upset stomach and appetite absent were recovered/resolved and the outcome of the weakness was recovering/resolving. It was unknown if the reporter considered the headache, shivers, skin discoloration, weakness, upset stomach and appetite absent to be related to SHINGRIX. Additional details were provided as follows: The day after receiving SHINGRIX, the patient she the worst headache she has ever had in her life. She also had shivering, weakness and felt sick to her stomach such that she could not eat. She could not get off her sofa for 2 days she felt so bad. A few weeks after the first dose, the patient went to get her hair done and her hairdresser noticed what looked like a burn on the side of her forehead by her hairline. She had not burned herself and it was not painful at all. It resolved after about 3 weeks. This case has been linked with case US2018158113 (for 2nd dose), reported for same patient and case US2018158115 and US2018158117, reported by same reporter.
Grandmother reports that the child has a rash over his entire body and a low grade fever. Instructed to give TYLENOL for fever. Use CALAMINE lotion if itching. BENADRYL liquid after consulting with his doctor. Instructed to seek immediate medical attention if symptoms become worse or breathing difficulties occur.
sinus tachycardia; Palpitation; booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Nov2021 16:45 (Lot number: fs1620) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Sulfite antibiotics, reaction(s): "Allergy", notes: known allergies: sulfite antibiotics. Vaccination history included: Bnt162b2 (Dose Number: 2 Batch/Lot No: ew0161., Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 15Apr2021, when the patient was 40 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: er8730, Location of injection: Arm Right, Vaccine Administration Time: 11:00 AM), administration date: 25Mar2021, when the patient was 40 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Nov2021 16:45, outcome "unknown", described as "booster"; SINUS TACHYCARDIA (non-serious) with onset 01Dec2021 12:00, outcome "recovered" (Dec2021), described as "sinus tachycardia"; PALPITATIONS (non-serious) with onset 01Dec2021 12:00, outcome "recovered" (Dec2021), described as "Palpitation". The events "sinus tachycardia" and "palpitation" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of sinus tachycardia, palpitations.  Additional information: No hospitalization Prolonged. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Patient was not diagnosed with COVID-19 prior to vaccination. Patient was not tested for COVID-19 since the vaccination. Device Date: 02Dec2021  No follow-up attempts are possible. No further information is expected.
Patient started to not feel well about 15 minutes after shot. He was sweating profusely and feeling dizzy. I gave him some water and had him sit down. He finished his first water and we gave him another. Then his wife showed up and I realized he is diabetic. I gave him a couple of glucose tablets and his wife gave him a couple of bottles of orange juice. He said he felt a little better but was still dizzy so his with took him home.
A non-spontaneous report of received FLUMIST vaccine via parenteral (IM) injection has been received from a physician and a combat medic concerning a male soldier. Medical history and concomitant medication were not reported. On 17-Oct-2008, the patient received FLUMIST via parenteral (intramuscular) injection in the upper arm along with four other soldiers. The medic removed the cap and attached a needle to the end of the FLUMIST syringe. There was no adverse event associated with this medication error; therefor, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow up information received on 03-Nov-2008, 17 days after the patient received FLUMIST, indicated that there were no adverse events.
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. No concomitant therapies were reported. On 13-MAR-2015, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (10mcg/1mL, 10X1DS/VTF) lot number K003533, expiration date of 07-FEB-2016 (route of administration was not reported), which was stored at -3.333 Celsius Degrees; for 472 hours, -1.111 Celsius Degree for 352 hours, -2.222 Celsius Degree for 480 hours and -2.777 Celsius Degree for 168 hours. The type of storage was refrigerator. No adverse effects were reported. No product quality complaint (PC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
Patient described that immediately after she had the J&J vaccine, she developed issues with her uterus. She experienced abnormal menses, anemia, pain, fatigue. Patient has undergone blood transfusions multiple times now for her anemia. She also has had ongoing surgical procedures including, hystereoscopies, D/C, and hysterectomy. Patient states her life has completely changed and that is has completely messed up her ability to patriciate in every day life.
pt recvd vax 21NOV95 & 30NOV95 & pt devel frank varicella w/chicken-pox type rash of 100 lesions on back & face w/1 or 2 vesicular lesions;also exp myalgia;MD felt it was chicken pox rash & that it was related to varicella vax;
Ulcerative colitis; Vaccination site pain; This is a solicited report based on the information received by Pfizer from a company (MFR Control No. # 21K-163-4054866-00). A contactable consumer (patient) reported for himself that a 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 17Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 vaccination at age of 65 years old; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date to an unspecified date, at 'CF' for moderate to severe ulcerative colitis. There was no reported medical history. Concomitant medication included prednisone taken for an unspecified indication, start and stop date were not reported. The patient experienced ulcerative colitis and vaccination site pain in Feb2021. The action taken in response to the events for adalimumab was unknown. The outcome of the events was resolved in 2021. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 13Mar2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer.  Causality for Adalimumab: The reporter's causality for the events of issues with ulcerative colitis and vaccination site pain with Humira (Adalimumab) was no reasonable possibility.  Causality for bnt162b2: The reporter's causality for the event of vaccination site pain with bnt162b2 was possible, for event of ulcerative colitis with bnt162b2 was not provided.   The reporter's assessment of the causal relationship of the event ulcerative colitis with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and events Ulcerative colitis and vaccination site pain cannot be fully assessed/excluded. The case will be reassessed if additional information becomes 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.
Barking cough relieved with Albuterol Nebulizer treatment then next morning facial and peri-orbital edema reported.
Administration to patient under 50; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 35-year-old male patient who received Herpes zoster (Shingrix) (batch number 4RP9E, expiry date 07-JUL-2024) for prophylaxis.   On 16-MAY-2023, the patient received the 1st dose of Shingrix. On 16-MAY-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Administration to patient under 50). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 19-MAY-2023 A registered nurse reported that a patient under the age of 50 was administered the first dose of Shingrix and wished to know how to proceed.  Information about the vaccine, patient and vaccination was provided. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  The patient with under age of 50 was administered Shingrix vaccine, which led to inappropriate age at vaccine administration.
According to hospitalization discharge summary paperwork, patient presented to Hospital with bilateral leg swelling and calf pain shortly after receiving the Johnson and Johnson Covid-19 vaccine.
Patient fainted a few minutes after receiving the vaccine. She has fainted after vaccines in the past, and fainted for about a minute after receiving the Janssen Covid-19 vaccine. After she returned to consciousness, she reported no difficulty breathing or other adverse reactions at the time. She was monitored in store for 30 minutes following the fainting episode and was feeling much better at the time of departure.  Her husband safely drove her home.
HIVES, RASH AROUND INJECTION SITE WITH SEVERE PAIN AND SWELLING.
Presented with heart palpitations in the morning.  Normal heart rate is 56, was above 95 for 4 straight hours.  Felt faint a d had some numbness in my arms.
per web report from (Privacy) Medical Center. Patient was vaccinated with Pfizer 2/2/21 and 2/24/21. no vaccine lot information available.  Web report stated patient was symptomatic on 12/3/2021. no additional hospital data was submitted on Web report to the Health Department. Received Death abstract reported that patient died of COVID -19  on 1/3/2022 at 16:44.
Induration, swelling and redness at injection site and asthmatic bronchitis requiring hospitalization.
Bell?s palsy, Rashes on trunk, rashes on face, weakness in hand on injection side, TSH level went up despite being on medication, fatigue, low grade fevers
Patient was given first dose of pfizer vaccine at approximately 3:20 pm. At 3:24 pm she developed a mild, red rash that was not raised on her chest and back. After 5 minutes, the rash spread to her neck. She did not have a generalized rash or itching at that time but within 20 minutes she developed itching to the area affected, with no breathing difficulty or throat swelling noted. VS were checked and within normal limits at the time the event started and 15 minutes afterward. After 30 minutes, she stated she felt her skin on her neck was "tight," and after 45 minutes she developed mild swelling on the left forearm. No breathing difficulty, no oropharyngeal edema or generalized hives or itching were present at any time. EMS was offered and called at 4:13 pm as symptoms seemed to progress and BP became elevated. EMS arrived 4:23 pm. She was given 50 mg Benadryl IM and transported to hospital for observation out of an abundance of caution.
1. Extreme exhaustion, had to nap a few hours right after.  slept a LOT 1.5-2 days after - had to cancel some work things.  2. Very dizzy, almost tipsy / fuzzy cognitively 3. Strong mucous about 20 minutes after leaving, for about an hour, seriously flowing!  4. Sore throat - severe - about a few hours after and the next few days - off and on - feeling severe for like 20 minutes then medium again. 5. Headache - 1-2 days after off and on - sometimes shooting pains 6. TINGLY hands - for 18 hours after  7. Tingly all over my body for 1-3 days off and on 8. Soreness at the site of the shot
This is a spontaneous report from a contactable consumer (patient). A 50-years-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8737, Expiration date was not reported), via an unspecified route of administration in arm left on 20Apr2021 at 14:00 (at the age of 50-years-old) as a dose 1, single for COVID-19 immunization. The patient's medical history included known allergies (unspecified), fibromyalgia, lupus. The patient's concomitant medications received within 2 weeks of vaccination included hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), taken for an unspecified indication. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. It was reported that, on 20Apr2021 at 14:05, the patient throat started burning about 5 minutes after the injection and on 20Apr2021 at 14:15, the patient had upset stomach with gas. Stated that, within 24 hrs, on an unspecified date in Apr2021, the patient had chest congestion with a cough and stated that, she lost her voice for two days, sore left arm, headache and body aches. The patient received the second dose in arm left on 07May2021 at 14:00, with lot number: ER8737. Treatment was not received for the events. The outcome of the events for she lost her voice for two days was recovered on an unspecified date in Apr2021 while for the other events was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101465327 Same drug/reporter/patient, different dose
flu; Initial information was received on 18-Dec-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional (patient).  This case involves a patient (unknown demographics) who had flu (influenza) and received INFLUENZA VACCINE.  The patient's medical history included flu (Influenza) and past vaccination(s) included Influenza Vaccine for 20 years.  The patient had no concomitant disease or risk factor.  Past medical treatment (s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency)and administered INFLUENZA VACCINE.  The patient had flu every time (for 4 years) but after receiving flu shot no flu occurred.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment.  On an unknown date, the patient recovered from the event.  There will be no information available on batch number for this case.
On 9/14/00, at school, had a seizure (apparently grand mal), loss consciousness, had large contusion/black eye on the left. Seen in ER and also saw a neurologist on 9/15/00. Pt had a fever at time of seizure (unknown) but was afebrile at ER.
Patient felt lightheaded in the bathroom several minutes after injection.  He laid down on the ground to avoid passing out.  Light headedness persisted for 15 - 30 minutes.  Ambulance was called but patient refused transport to ED.  He was able to leave the clinic with minimal symptoms 30 - 45 minutes after vaccine.  He has a history of panic disorder and fear of needles.
Nausea, blurred vision, loss of vision, loss of hearing, out of it, heart racing, body became hot, ice packs were placed all over my body, in a couple minutes my vision came back and my heart rate started to slow
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/9/2023 SECONDARY HYPERCOAGULABLE STATE DUE TO UNSPECIFIED ATRIAL FIBRILLATION J96.91 HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 5/4/2023 SECONDARY HYPERCOAGULABLE STATE DUE TO UNSPECIFIED ATRIAL FIBRILLATION J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/9/2023 FLANK PAIN J96.91 HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 5/4/2023 FLANK PAIN
I went to a wedding on June 18. June 19, started having a scratchy throat. June 20, I woke up after 9 hours of sleep still feeling super tired. Later that night I started feeling lightheaded, so I took a COVID-19 test which was positive. While trying to sleep I had fever (102.0) chills. 21-22 unsure, I called my doctor through tele-med and was prescribed PAXLOVID. Almost within 24 hours all symptoms cleared. June 27, A week later I started to feel sick all over again and I had completed the medication PAXLOVID. I developed a dry cough, I went to travel and before leaving I knew I was having some sinus issues so I asked my PCP to write me something so it wouldn't get worse. I didn't realize it until it was too late the pharmacy forgot to put the medication in the bag. I was forced to travel without the medication, and I was miserable. July 8, Upon returning home I went to get the medication that they didn't put in the bag. I started taking CEFTIN which brings me to five days in as of 07/14/2022. I have now recovered from the back drip and I still have a cough but it isn't nearly as bad as it was before.