chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a female nurse of unknown age refers to herself. On an unspecified date the patient was vaccinated with ZOSTAVAX (lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The nurse mentioned that when she received ZOSTAVAX, the injection was painful. No treatment information was reported. At the time of the report, the patient's status was unknown. This is one of the several reports received from the same source. Additional information is not expected.
One of vials was accidentally diluted with 2mL of diluent; One of vials was accidentally diluted with 2mL of diluent; This is a spontaneous report from a contactable pharmacist via Medical Information Team. This pharmacist reported similar events for two patients. This is the second of two reports.   A 58-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported, NDC number: 59267100001), intramuscularly on 03Feb2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), intramuscularly on an unspecified date at a single dose for COVID-19 immunization. The patient did not receive additional vaccines on same date of vaccination. The pharmacist reported that one of the vials was accidentally diluted with 2mL of diluent. Instead of 1.8mL, he used a whole 2mL and the patient was vaccinated with it on 03Feb2021. The reporter assessed the events as serious, medically significant.  Information on lot/batch number has been requested.; Sender's Comments: The company deems there is not a reasonable possibility that the reported event is related to suspect product BNT162b2. The impacts 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.,Linked Report(s) : US-PFIZER INC-2021121778 same drug/reporter/different patient
On 08/20/01, pt called stating that he received TD on 8/16/01 and the next day awakened with body aches, fever, chills, diarrhea and "felt sick all over". Took Tylenol but temperature remained about 100F on Saturday and Sunday. He had some improvement on 8/20 but was concerned on 8/18/01 and 8/19/01 about symptoms related to TD shot. He was referred to PMD for assessment.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for an unknown indication.     No Medical History information was reported.   On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.   This case was linked to MOD-2021-395985 (Patient Link).
extreme tiredness and muscle fatigue. headache that turns into a migraine. these symptoms occurred Friday evening and have been more prevalent over the weekend. This morning i woke up nauseous and vomited. I also have developed a cough that is painful and rattles my head.
Night of vaccination: blood red eyes, throat swelled, chills, heart racing,  tried to call 911 and passed out. Next morning: sore throat, red eyes, weak, called physician's office and described symptoms and was told they would let the doctor know and would call her back if the doctor wanted to make an appointment.
Over in the morning after the vaccine about 1am I woke up with severe body aches and my lymph node in my left arm pit was swollen and sore. I was super fatigued but I went to work and had to leave work early because I was so sleepy and developed a stomach ache and headache. Throughout the say I felt as if I was coming down with the flu. On Sat 10/10 I went to Urgent Care and while there the lymph node was checked and advised it was fine just to monitor and was given antibiotics because they stated I also had a bladder infection. I took my temp that morning after but didn't have a fever.
Patient reports sitting in his car waiting until 20 minutes had passed before leaving the pharmacy parking lot. He wanted to stay close to the pharmacy, but not be exposed to other patrons during this time. He began driving home and about 30 minutes after receiving the vaccine he "fell asleep" while driving. He awoke in the other lane of the road and didn't experience any other issues (no headache, chest pain, aura, no other symptoms). No damage or injury was sustained due to driving while the incident occurred. He came back to the pharmacy several hours later and wanted to make us aware that this had happened to him so that other people didn't have to experience similar issues.
Patient experienced red, bumpy, hot, blistered skin where the shot/bandage was the day after.  Right after the vaccination, patient experienced pressure from left collar bone to right collar bone instantly.
A report 2001009913-1 described tingling and loss of feeling (hands and feet) in a female of unspecified age who received Lyme disease vaccine recombinant OspA (Lymerix). Allergies, medical history, and concomitant medications were unspecified. On an unspecified date, the vaccinee received her second dose of Lymerix. Subsequently, she experienced "severe" tingling in her fingers and toes which lasted  for several months. Because her general physician could not pinpoint the problem, he sent her to a neurologist who came to the conclusion that "the Lymerix shots caused minor loss of feeling in (her) hands and feet." The tingling resolved after "several months".  the adverse events of "tingling" and "loss of feeling" do not meet ICH serious criteria, but are being submitted as an expedited report by special FDA request per the June 28, 2000 letter.
pt previously received one moderna monovalent vaccine 3/28/23 for first dose in series.  then received moderna bivalent vaccine on 4/25/23 (10mcg, pink cap).  should have received higher dose of moderna bivalent vaccine (25mcg, blue cap) instead.  no symptoms reported.  error noted on 7/18/23 after chart review.   I called moderna for guidance, and was directed to call the CDC.  CDC recommended pt receive a dose of the moderna bivalent vaccine (25mcg, blue cap) since lower than recommended bivalent dose previously received.  no minimum time interval required. family notified by PMD on 7/24/23
1. Patient was administered Pfizer monovalent vaccine after authorized use expired April 18, 2023. 2. Patient was prescribed Pfizer Bivalent covid vaccine and was administered Pfizer monovalent vaccine in error.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 21-JAN-2013, 18-JUN-2013 and 14-AUG-2013 the patient was separately vaccinated with the first, second and third dose of GARDASIL injection (dose, route, lot # and expiration date unknown). No adverse symptoms were reported. Additional information has been requested.
WITHIN  MONITORING TIME PERIOD, PT. COMPLAINED OF INJECTION SITE ITCHINESS AND OVERALL BODY HIVES.  NO OTHER COMPLAINTS.  EMS ON SITE.
[moderna] use for COVID-19 under Emergency Use Authorization (EUA): Patient reports received 3rd dose (booster vaccine) on 11/8/2021. States that she developed "flu-like" symptoms on 11/10; reports fever, nausea, vomiting and diarrhea. Husband reports on 11/11 symptoms continued with fever to 105, patient then started to become unresponsive so he called EMS. Pt was taken to hospital admitted with concern for sepsis with DIC. Pt subsequently developed hepatic failure and renal failure. INR was 4.0 PTT was 51, fibrinogen 84 with LFT's in thousands, lactic acidosis and hypoglycemia. Additionally patient with purpura fulminans to LE/UE bil. Transferred to another hospital for evaluation for liver transplant and additional management.
68yo presents with sore rash on legs and back. Rash occurred about three days after receiving a flu shot. A similar event occurred a year ago, again after receiving a flu shot. Assessment - red papules, coalescing with raised border lesions, vasculitis. Trace hematuria noted. Patient advised not to take the flu vaccine. Symptoms: 1. Skin rash, 2. vasculitis, red papules. Treatment drugs used: fluocinonide, dose: 0.05 units, freq: bid, route: top.
Patient states that he had a red, itchy sunburn type rash down to his elbow for a couple of days , then a little on the same side of his torso starting this morning (10/22/23).  He also stated it was oozing a clear liquid for a couple of days.   It is not anymore.  He has been using an anti-itch cream on it (didn't specify which one).  I recommended him taking some benadryl  by mouth and  seeing his provider to have it checked out but he didn't seem like he was going to, so I stressed if it doesn't get any better or if it starts to get worse at all to definitely have it seen. Patients also stated he felt achy, headache and chills the same night of vaccine and for a couple of days.  He was feeling better from that when he came in to tell us about the rash on 10/22/23.
1:50 pm:  chest pressure, a bit of breathing difficulty tingling in mouth and odd taste in mouth.  Tingling in mouth stopped within an hour or so.  Chest issue and breathing problem lasted about 3-4 hours.  Early evening, about 20 minutes of constant diarrhea.  Late evening, inside bottom lip a bit swollen and outside bottom lip a bit itchy around the edges.
Fever of 101 for hours; chills; shakes; severe joint pain; body aches; dizziness; This is a spontaneous report from a non-contactable consumer (patient).  A 45-year-old female patient received the first dose of BNT162B2 (also reported as Pfizer-BioNTech COVID-19 mRNA vaccine, lot no: ELO140, expiry date not reported), via an unspecified route of administration on the right arm on 18Dec2020 at 10:45 at a single dose in the hospital for immunization.  Medical history included having had COVID-19 prior to vaccination on an unspecified date. The patient had no known allergies. Concomitant medication included bifidobacterium lactis, lactobacillus acidophilus (PRO-IMMUNE) powder (as reported).  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever of 101 for hours, chills and shakes, severe joint pain, body aches, dizziness all on 18Dec2020 at 22:45. Treatment was not received for the reported events. The outcome of the events was recovering. Since the vaccination the patient has not been tested for COVID-19.
My arm has been sore & inflamed for several days at & around the injection site. The day after the vaccination, I experienced fatigue & overall body aches. That night, my temperature was slightly elevated (99.7). In the morning, my temperature had returned to normal (97.9) & the overall aches & fatigue improved, but my arm remained sore & red.
Pt reports post vaccine she went to give blood and was told that she was borderline positive for Hep B surface antigen.
Family lost a baby about 1 year ago D/T accidental asphyxiation (wedging against parent and couch cushion. Undetermined category II SIDS. 9/19/06 Received Autopsy Report which reveals COD as SIDS with hx of cosleeping in adult bed with parent & twin sibling.  Patient was preemie due to c-section delivery of twin gestation & PDA./ss
Left arm swelling redness, soreness at injection site, joint swelling, pain both knees, hips, elbows, shoulders, neck pain in neck and back, muscle aches, loss of stamina, weakness, oral temperature 100.1, swollen eyes, face skin eruptions on face and chest, general malaise, fatigue-symptoms improved but recurrent.
Generalized edema and light redness over thigh-mild increase in temp. No other rashes. No respiratory distress-using leg without problems.
Patient reported a severely swollen arm (size of a football), pain interfering with activities of daily living (dressing, etc). Patient received care through walk in clinic/ER and was treated for cellulitis (antibiotic).
PT has a known cardiac history on Lopressor and Imdur.  He was vaccinated on 3/24/03 did fine until 4/2 when he developed "twinges" of chest discomfort.  He saw his cardiologist who did an EKG, showed bradycardia, lopressor was d/ced.  On 4/3 had further "twinges", seen in the ER and admitted overnight for observation.  EKG, CK and troponins were normal.  He was d/ced on Imdur, Lotensin, and aspirin.  He is to have a stress test as an outpatient.
Information has been received from the mother of a pt who in November and December 99 was vaccinated with one dose of varicella vaccine. Subsequently, the pt did not develop antibodies. Additionally, the pt's mother noted that her daughter has recently been diagnosed with juvenile rheumatic arthritis. The pt sought unspecified medical attention.
Case number PHEH2015US022720, is an initial spontaneous report from a pharmacist received on 03 Nov 2015. This report refers to a 57 years old female patient. Medical history and concomitant medications were not reported, The patient was vaccinated with FLUCELVAX (batch number: 173906) intramuscular on 01 May 2015. On 02 May 2015 the patient complained of hematuria which was recovered on the same day. The seriousness and causality of the event was not reported. Seriousness assessment of hematuria was upgraded based on information in the source document.
blood in stool; vomited; Tiredness; This is a solicited report from the marketing program marketing program FACILITATED COLLECT based on information received by Pfizer from facilitating company, manufacturer control number: 21K-163-4115580-00.    A contactable consumer (patient) reported that a 16-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular on 01Oct2021 (vaccination age was 16 years old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot number was not reported)  at unknown dose and frequency for an unspecified indication.  The patient's medical history and concomitant medications was not reported. On 09Oct2021, the patient experienced used bathroom more. On 11Oct2021, the patient experienced vomited, tired, stool had blood. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken in response to the event(s) for adalimumab was unknown. The outcome of events was unknown.  The causality assessment per reporter for used bathroom more, vomited, tired, stool had blood to bnt162b2 was possible.  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 current information available and considering drug-event temporal association a possible contributory role of the suspect BNT162B2 cannot be completely excluded for the reported events of Blood in stool, Vomiting and Fatigue. The case will be reassessed further upon receipt of additional information. 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.
HIGH BLOOD PRESSURE; BLOODY  NOSE; This spontaneous report received from a patient via social media via a company representative concerned a 23 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient never gotten a bloody nose without an injury, and no history of blood pressure was never that high. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on an unspecified date on SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date after vaccination, the patient experienced high blood pressure, and bloody nose. On an unspecified date at NOV-2021, Laboratory data included: Blood pressure (NR: not provided) 220/113 mmHg (millimetre(s) of mercury). As per reporter it was reported that "patient reported that "I am a 23y/o male and I received your Covid vaccine back in September 2021, ever since I was vaccinated my blood pressure has been through the roof. I get bloody noses about once a week. Before the shot I had never gotten a bloody nose without an injury Also my blood pressure was never that high. In November I measured it at 220/113." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from high blood pressure, and bloody nose. This report was serious (Other Medically Important Condition).  Version created to amend previously reported information on 22-JAN-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V1: Upon review the following information was amended: the case validity assessment was updated to valid from the previously incorrect assessment of non-valid. This updated information does not alter the causality of previously reported event   20220144642-COVID-19 VACCINE AD26.COV2.S-high blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
A LARGE (ABOUT 4 INCHES IN LENGTH) PAIN FULL BRUISE APPEARED ABOVE THE RIGHT KNEE; PAIN AND SWELLING DOWN THE LEG, ANKLE AND  FOOT SWELLING; MILD FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced mild flu like symptoms. On 24-MAY-2021, the subject experienced a large (about 4 inches in length) pain full bruise appeared above the right knee. On 24-MAY-2021, the subject experienced pain and swelling down the leg, ankle and foot swelling. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from pain and swelling down the leg, ankle and foot swelling, and the outcome of mild flu like symptoms and a large (about 4 inches in length) pain full bruise appeared above the right knee was not reported. This report was non-serious.
The patient acquired a low fever, body aches and a headache the night following the vaccination. Patient self treated with a fever reducer and took time to recover. No further medical attention was required for patient.
Pain on the right side after my COVID Vaccine.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2) (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: PAIN (non-serious), outcome "unknown", described as "Pain on the right side after my COVID Vaccine.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Six hours of vomiting, diahrrea for 2+ days, fever of 101 for 18 hours. Light headed and overall weakness for 2+ days
Constant metallic taste in mouth, wanting to retch,  Red rash / extreme itching over entire body Loss of balance, feeling off balance Swelling of feet, ankles, and legs
developed red, itchy sore area surrounding injection site of covid vaccine approx 10d after vaccine, has been using Advil and ice, no resp/thrt sx, otherwise well
No additional adverse effect reported; a set of twins were "likely both" administered a dose of MMRll past the expiration date; This spontaneous report was received from a nurse referring to a 13 months old patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.      On 28-OCT-2014, the patient (one of a set of twins) was likely administered a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA (recombinant human albumin)) (M-M-R II) (lot # H018948, expiration date 18-OCT-2014; strength, dose and route were not reported) which past the expiration date for prophylaxis (expired product administered). No additional adverse effect was reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1912USA006949:
Patient received the vaccine and passed out in the waiting room about 5 minutes after; EMS was called, vitals taken, and patient cleared to go home by EMT
Progressive bilateral ascending muscular weakness - Guillain-Barre - hosp and rec IVIG. No resp. issues - in PT still recovering started 4 days after Var given.
Several days after the booster shot I noticed a large tennis size red whelp around the injection site.  I cannot remember if it hurt or not but I remember it lasted about 7-10 days.
Information has been received from a nurse and a certified medical assistant concerning a 12 month old male, who on an unknown date was vaccinated with PNEUMOVAX (Lot number 663012/1163X). The reporters stated that the patient was inadvertently given PNEUMOVAX instead of the third dose of PREVENAR. The medical assistant reported that this was an office error. The patient sought medical attention. Additional information has been requested. Follow up information has been received from a certified medical assistant concerning a 12 month old male who on 23-FEB-2009 was vaccinated intramuscularly with 0.5mL dose of PNEUMOVAX. Concomitant therapy included MMR II (lot number 661679/1247X), VARICELLA vaccine (lot number 658964/1466U) and POLIO (lot number A11092) (unknown manufacturer). The reporter stated that the reason for the confusion was name error and that vaccines were stored in the same refrigerator. The patient did not experience any adverse events. Additional information has been requested.