chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired Dose of Heplisav-B; Initial Report Received on 22-SEP-2022  This is a spontaneous report received from a pharmacist regarding a patient who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On 22-Sep-2022, dose 2 of HEPLISAV B (Lot #935840, expiration date 11-Sep-2022, NDC # 43528-0003-05), intramuscular in the left deltoid, was administered for hepatitis B immunisation.   The dose administered was  reportedly 11 days past the expiration date. The patient has not reported any adverse reactions.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
pt recv vax 1995 & 24SEP97 10 min p/vax pt exp nausea & vomiting;
A spontaneous, non-serious report of difficulty sleeping, fever and runny nose was received from a patient's mother concerning a five-year-old female patient subsequent to H1N1, intranasal. Medical history nor concomitant medications were not reported. On an unknown date, the patient received H1N1, intranasal. During the week of 11-17-Oct-2009, the patient developed difficulty sleeping, fever and runny nose. No further information was available. The outcome of the events, difficulty sleeping, fever and runny nose, was unknown.
Patient came for 2nd Pfizer COVID-19 pediatric vaccine as walk-in appointment with her father. I verified patient came for the 2nd COVID-19 pediatric vaccine dose (her father said yes). I confirmed patient's identity with her father. I gave 0.2mL of pediatric COVID-19 vaccine in left thigh. Patient waited in lobby for 15 minutes playing perfectly fine with her dad during that time. No sign of acute distress or discomfort noted.  No adverse effect and/or events noted with patient while waiting in lobby for 15 minutes after the vaccination. Patient left perfectly fine the clinic with her dad after waiting 15 minutes in lobby.
5 min post injection angioedema s begin; flushing, flushing to genital area, progressed to GI, throat, HA, B/P170 (never this high); eyesight blurred.  Systemic w/o urticaria
6:30 pm, June  19 until Monday morning, June 20:  Started having Afib episode.. 150- 220 BPM.
Swelling and redness measuring up to approximately 4 inches in diameter, excessive itching and pain on right arm. Swelling and redness measuring up to 3 inches in diameter. excessive itching and pain.  Onset of symptoms were about 24 hrs after receiving vaccines.
It was probably a Pleurisy and put me on a steroid (Unspecified Medication); I am a little bit more winded today than I was before and my heart rate is a little faster than I normally run; I am a little bit more winded today than I was before and my heart rate is a little faster than I normally run; Pain in my left shoulder clavicle area when I took a really deep breath and it got worse; Pain in my left shoulder clavicle area when I took a really deep breath and it got worse; This is a spontaneous report from a contactable consumer (patient). A patient received second dose of bnt162b2 (Lot Number and Expiration Date unknown) via an unspecified route of administration on an unknown date at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on an unknown date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. Patient had second Covid vaccination (manufacturer not clarified, hence is this a Pfizer product tab left unchecked) on the 8th (not clarified). This Friday (15Jan2021), patient started getting pain in left shoulder clavicle area when took a really deep breath and it got worse yesterday. So, patient went to Institute, they did a test X-ray on 16Jan2021 and they did not see anything. He said, it was probably Pleurisy and put me on a steroid (Unspecified Medication). Today, like the pain is a little bit better but patient was a little bit more winded today than it was before and heart rate was a little faster (17Jan2021) than normally run and just do not know if this was something that was being reported or what. The outcome of events was unknown.  Information on the lot/batch number has been requested.
This report describes the occurrence of mercury poisoning in an 18 month old male who was vaccinated with hep B vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings and ahs not been verified by a physician or other health care professional. The subject was allegedly "born a perfectly normal, healthy boy whose Apgar scores at birth were well within the normal range. Developmentally, neurologically and socially, he achieved every developmental milestone anticipated of all normally developing children until the age of 18 months. The subject received injections of Engerix B on 1/18/96 (1950A2) and 2/28/96 (1965A2). He also received injections of hep B vaccine 9/20/96; Tetramune 2/28/96; diphtheria and tetanus toxoids and pertussis vaccine 4/24/96 and 8/14/96; and Hib-TITER 8/14/97. The subject's attorney alleged that the subject "suffered devastating injuries through mercury toxicity and associated complications and sequelae and the aggravation of other conditions directly through exposure, via an IM injection of mercury." The subject's attorney further alleged that "At approximately 18 months of age, the subject was neurologically devastated by the accumulation of mercury in his body, havingbeen exposed via IM vaccinations, and suddently regressed developmentally, losing milestones of neurological developmenta previously achieved, specifically including, but not limited to: a. Becoming withdrawn, unable to speak, unresponsive to his environment, engaging in repetitive behavior; and b. The loss of language skills, motor skills and affect." Treatment and outcomes of these events were not specified. The mercury poisoning and developmental regression in this report are considered medically serious (OMIC).
48hours and still have fatigue and joint pain; 48hours and still have fatigue and joint pain; This is a spontaneous report from a contactable consumer (Patient). A 73-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown, expiration date unknown), via an unspecified route of administration on the left arm on 28Jan2021 at 09:00 AM at a single dose for COVID-19 immunisation. The patient medical history was none. There were no allergies to medications, food, or other products. Concomitant medications included rosuvastatin calcium (CRESTOR) at 5mg, vitamin D and zinc. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient experienced fatigue and joint pain on 28Jan2021 at 14:00 and after 48 hours also, was experiencing the events. The patient assessed the events as non-serious. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
1 of 2 pts vaxed from same vial exp an adverse event w/in 24 hrs of vax; pt exp high fever & abn high pitched screaming; pt recovered; no further clinical details available;
Sore arm; Vaccine given after being dropped and patient is not sure if it was shaken while dropped; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Vaccine given after being dropped and patient is not sure if it was shaken while dropped) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 immunisation.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Vaccine given after being dropped and patient is not sure if it was shaken while dropped). On 17-Mar-2021, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Vaccine given after being dropped and patient is not sure if it was shaken while dropped) had resolved. On 18-Mar-2021, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.    Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow up information was received and  contained no new information. On 12-May-2021: Follow up information was received and contained non significant information. The reporter information was updated. On 13-May-2021: Non-significant Follow up information was received and contained non significant  information, contact information was updated.; Sender's Comments: This case concerns a 64-year-old female patient who experienced vaccine given after being dropped and patient is not sure if it was shaken while dropped (wrong technique in device usage process).  Patient experienced the event of sore arm  which was temporarily associated with product use.  Hence, causal relationship cannot be excluded. event of wrong technique in device usage process is assessed as not applicable.
Coughing so hard; coughed during COVID but not like this; Hard to stand up; Pain/body wrecking pains; Fever; Started heaving; Dizzy; Nauseous; Throwing up; Chills; Draining; This is a spontaneous report from a contactable consumer. An adult female patient (consumer's daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Medical history included covid-19 from Nov2020. The patient had COVID in the middle of Nov2020 and her father and reporter had it two weeks before and then about two weeks later, she got it. She took her 14 days quarantine, she coughed and had some tummy issues. She had fever, the aches and pains with Covid, a little bit of dry cough. She did not feel good for probably about 5 days, after that she started working again. She had COVID and did not have to be hospitalized, any IV drip or anything before vaccination. 6 weeks later, she got the vaccine shot. The patient's concomitant medications were not reported. The vaccine came out on Wednesday (30Dec2020), the patient signed up at work to take it. Within about 12 hours  (unknown onset date), she did start to feel 'oily', and had started having aches, pains and very shortly after that she started running a fever, all of a sudden the cough came out of the blue, she started heaving, dizzy, nauseous and it's three days later, she was coughing so hard. She coughed during COVID but not like this, this was like COVID ten times over, same symptoms though, throwing up, throwing up, hard to stand up, aches, pains, fever, chills, body wrecking pains. The patient can hardly talk because she kept coughing and draining. The reporter asked that "Should her daughter be given vaccine? Does her antibodies, daughter was asked - Did you have any severe case, and she told - No, I was able to stay home and just stay in bed, they said - Okay we'll give it to you. Should she have gotten so close to the signs that she had COVID? Why her daughter be asked that question? What is going on regarding the symptoms. What should we do about it?" Consumer tried to get daughter to go to a COVID Clinic today (02Jan2021), and know she didn't have COVID, that's not how it worked, but normal doctors didn't want to see her daughter. Consumer called the COVID Clinic and they said "Yes, we could probably see her". The outcome of events was unknown.  Information about lot/batch number has been requested; Sender's Comments: A causal association between BNT162B2 and the reported events cough and difficulty standing cannot be excluded based on temporal relation of vaccination and onset of events. 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 RAs, Ethics Committees, and Investigators, as appropriate.
3/16/2016: The pt. developed Right wrist, finger hand pain and stiffness and was seen at Medical Center - stroke was ruled out. XR R hand XR was normal. Joint pain migrated to all over the body since. Her Rheumatoid factor was elevated and she was seen by multiple specialists including Rheumatologist, pain management, neurologist and still did not achieve good symptoms control. Pertinent labs and imagings as below. I ordered Lyme titer which was positive and consulted infectious disease, but without exposure history, it was concluded as sero-reactivity and not true infection.
rash from elbow to finger tips on both arms (blisters that resembled poison ivy reaction or chicken pox) started two days after first dose and persisted for about three weeks. Started again a few days after second dose and persisted for about six weeks.  Intense itching and some scarring. No other symptoms.
Pt presented to pharmacy 10/7 w/ redness/itching in band on arm from near the elbow to near the shoulder. Pt stated she had soreness at injection site on day of vaccination but not to the extent of redness that developed 101.5 and persisted to 107F mfg also was contacted 101F.
Sudden onset of lower extremity weakness, lower extremity DTRs absent. Significant difficulty walking, ataxic gait. Unable to sit up without assistance, unable to walk without assistance.
!0 minutes into waiting time, patient came to staff and reported that she was having "scratchiness in the back of her throat" congestion in her face and pain in the first 2 fingers of her right hand. (this is the arm her vaccine was given in).
My periods are messed up; had the worst cramps; excruciating crippling pain; this was worse than anything I've ever felt; flare up of pityriasis rosea; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Feb2021 (Lot number: 14364) at the age of 31 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Gluten" (unspecified if ongoing); "Intermittent Cushing's syndrome reoccurrence" (unspecified if ongoing); "Addison's disease due to bilateral adrenalectomy" (unspecified if ongoing); "Addison's disease due to bilateral adrenalectomy" (unspecified if ongoing); "vulvodynia" (unspecified if ongoing); "chronic pelvic pain" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes; "Pityriasis rosea" (unspecified if ongoing), notes: I also had a flare up of pityriasis rosea when I had my second injection in Feb. The last time I had that virus was 10 years ago; "birth control" (unspecified if ongoing), notes: I don't remember ever missing a period except for on birth control and I, am not currently on any. Concomitant medication(s) included: HYDROCORTISONE; FLUDROCORTISONE; PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]. Past drug history included: Augmentin, reaction(s): "Known allergies: Augmentin". Vaccination history included: Bnt162b2 (Dose:1, lot number=14165, location=Left arm), administration date: 25Jan2021, when the patient was 31 years old, for covid 19 immunization. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 18Feb2021, outcome "not recovered", described as "My periods are messed up"; DYSMENORRHOEA (non-serious) with onset 18Feb2021, outcome "not recovered", described as "had the worst cramps"; PAIN (non-serious) with onset 18Feb2021, outcome "not recovered", described as "excruciating crippling pain"; CONDITION AGGRAVATED (non-serious) with onset 18Feb2021, outcome "not recovered", described as "this was worse than anything I've ever felt"; PITYRIASIS ROSEA (non-serious) with onset 18Feb2021, outcome "not recovered", described as "flare up of pityriasis rosea". Therapeutic measures were not taken as a result of menstruation irregular, dysmenorrhoea, pain, condition aggravated, pityriasis rosea.  Additional information:Patient was not tested Covid post vaccination. The patient was not taken other vaccine in fourweeks.  No follow-up attempts are possible. No further information is expected.
Sickness; Initial information was received on 17-Nov-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.   This case involves a patient (age and gender unspecified) who was sickness (malaise), when received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(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 not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sickness (malaise) (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE.  Only time got the shot was sick for 2 weeks no shot no sick.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
I have had pain on my right thumb woke up with it swollen, and it still has not gone down . I will be contacting my dr today  to see what is going on .
Tiredness, swelling at the injection site, headache, sore throat, chills, runny nose and feels overwhelmingly terrible. Feels better today.
Post 2nd vaccination I have experience severe chronic Psoriatic Arthritis flare ups. These were not just localized to joints. These included lung tightness and eye symptoms (Uvetitis). I have had my PSA under control for the last 5 years and these flare ups were certainly due to the vaccine.
Patient complaint of cough, chest tightness after vaccine.  Lungs clear, heart rate regular 80, respiratory rate at 20-24, with spo2 at 96-100%.  Moist mucus membranes with no redness or edema to post pharynx, noted mild cobble stoning to post pharynx. Oxygen applied at 2 L per NC.  Appears to have bronchial spasm, from URI, which she verbalized she had, with a large fire in area.  Benadryl 25 mg given along with solumedrol 40 mg IM and sent home to use albuterol inhaler.  Husband here to take patient home.  Patient was in waiting area with myself for 30 minutes, with stable condition.  To follow up with PCP later this eve or am.  Patient called a few hours later and doing fine.
Pt recvd Td vax & devel a rash on forearms & chills;
tested Covid positive; tested Covid positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 11Jan2022, outcome "unknown" and all described as "tested Covid positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Jan2022) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
pericarditis per doctor; pain in chest; This is a spontaneous report from a contactable consumer (patient)   A 55-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 27Jul2021 15:00 (Batch/Lot Number: fa7484) as single dose (at the age of 55) for covid-19 immunisation. The patient received the first dose at the age of 55, Lot number: ew0173, on 02Jul2021 03:00 PM, left arm. Medical history included high blood pressure from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced pericarditis per doctor on 15Aug2021 12:00, pain in chest on 15Aug2021 12:00. Patient was treated with 600 mg ibuprofen. No Covid prior vaccination. No Covid tested post vaccination. No known allergies. The events outcome was not recovered.
Patient seen in nurse clinic with c/o bruising and redness at injection site and feeling "drained and achy". VSS and WNL. Right shoulder bruise and redness noted. Provider examined patient. EXAM: SKIN: 2cm area of ecchymoses at the injection site with 3-4 cm area of erythema, induration and warmth distal to ecchymotic area. A/P: Atopic dermatitis at site of Pneumovax injection; prednisone 20mg twice x 5  days #10 RF0; diphenhydramine 25mng q6h prn #30 RF0 for fill at pharmacy, ER if symptoms worsen.
Pt called with adverse rxn of redness, soreness, swelling at injection site of Pneumovax 23.
Syncopal episode approximately 1 minute post vaccination.  Loss of consciousness 15 seconds.  No injury.
Pt recvd 1 dose of Engerix-B & 2 days later 20JUN92 ? devel a severe vaginal yeast infection; tx unk;
First day felt sluggish and had expected severe pain in arm (L.) that was injected, could not use that arm for several hours. Second day woke up with the beginnings of a sore throat and had random arthritis-like pain in left hand and in knees and ankles when walking. Second day sore throat was severe and painful, was coughing up a lot of mucus, sinuses extremely congested so had to breathe out of mouth, felt warm and had some headaches, 3rd day the sore throat was still severe and was coughing up traces of blood and what felt and looked like tissue, and took temperature for the first time on a reliable digital thermometer (102.8), fourth day (today) fever is lower (averaging 99-100) but still coughing, sinus congestion, and extremely painful and inflamed sore throat, being this sick and having a fever this high is VERY unusual for me, in fact I have NEVER to my knowledge had a fever this high.
Individual reported workplace exposure to COVID-19.  Patient experienced fever/fatigue being the evening of 2/12/2021.
Red, hot, burning rashes on both upper outer-arms that turned into extreme dry patches of skin that hardened like scabs. They healed on their own, went away only to recur just a few weeks later. Healed again on their own. I used over the counter treatments for eczema, but they did not help.
Information has been received from a mother concerning her daughter who was vaccinated with two doses of Gardasil.  The mother reported that after the second dose of vaccine the patient developed an "adverse event."  The patient sought unspecified medical attention.  At the time of this report, the patient's adverse event persisted.  No further information is available.
Patient reported pain in her right arm which radiated to her fingers. She had trouble lifting items and moving her arm. The patient lasted four plus weeks. The pain decreased with time. Patient reported that she also spoke to her physician.
A few hours after injection I began to feel faint pins and needles feelings on skin throughout my body. Not concentrated in any specific location. Comes and goes. Is not painful, but has lasted 4 days now.