chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment drugs were reported.
Mom called 1/13/17 states pt. woke at 2AM C/O throat feeling swollen-low grade fever per mom-vomited-given shower and Ibuprofen. Pt went back to sleep- fine in AM. Throat felt fine next day no vomiting. Never had difficulty breathing. Mom stated same thing happened after last dose of DTaP.
Started with a headache at 8:30pm, body aches started at 9:30pm. Had hot flashes & cold chills all night. Entire body feels like it got hit by a truck at 5am. Soreness at the injection site.
She also had aches and pains; Hands were swollen; Knees were swollen/knee replacements were so swelled up that she couldn't bend them; Lymph nodes were swollen; Fever that went up to 104° F and it went down to 101° F.; knee replacements hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (She also had aches and pains), PERIPHERAL SWELLING (Hands were swollen), JOINT SWELLING (Knees were swollen/knee replacements were so swelled up that she couldn't bend them), LYMPHADENOPATHY (Lymph nodes were swollen) and PYREXIA (Fever that went up to 104° F and it went down to 101° F.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee replacement (Had two knee replacement.). Concomitant products included METFORMIN, ATORVASTATIN CALCIUM (LIPITOR), CARVEDILOL and CANDESARTAN for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced PAIN (She also had aches and pains), PERIPHERAL SWELLING (Hands were swollen), JOINT SWELLING (Knees were swollen/knee replacements were so swelled up that she couldn't bend them), LYMPHADENOPATHY (Lymph nodes were swollen), PYREXIA (Fever that went up to 104° F and it went down to 101° F.) and ARTHRALGIA (knee replacements hurt). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency; IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (She also had aches and pains), PERIPHERAL SWELLING (Hands were swollen), LYMPHADENOPATHY (Lymph nodes were swollen) and PYREXIA (Fever that went up to 104° F and it went down to 101° F.) outcome was unknown and JOINT SWELLING (Knees were swollen/knee replacements were so swelled up that she couldn't bend them) and ARTHRALGIA (knee replacements hurt) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) 104° F and 101 (High) 101° F.         Treatment provided also included cold shower.  Patient reported that she had a pretty violent reaction on  12-Feb-2021,after receiving the vaccine. Patient also reported that it took a couple of days to loosen up the knees.   This case was linked to MOD-2021-362373 (Patient Link).
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report was received from literature: This report concerned a female of an unspecified age, race and ethnic origin. The objective of this study was to describe people with diseases or treatments that suppressed their immune system cannot count on the same protection most vaccinated people had. The patient's height, and weight were not reported. The patient had a rare concurrent condition, mucous membrane pemphigoid, which causes blistering of the gums and other areas. The patient was previously treated with the the steroid prednisone (drug used for unknown indication) in the past. She initially received two doses of the Pfizer vaccine (BNT 162) for prophylactic vaccination, but an antibody test revealed she had no response.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and expiry: unknown) dose, start therapy date were not reported, 1 total was administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included mycophenolate mofetil, an immunosuppressant drug often prescribed for organ transplant recipients. On an unspecified date, the patient again underwent antibody test which was negative. So, later she got three Moderna doses, after which she finally achieved a response similar to healthy people who have had two doses. The whole process lasted for six months. She quoted that "Her ordeal had contributed to approval of boosters for everyone but especially for immunocompromised people, boosters work and are needed!" The author emphasized on the awareness that must be created on how immunocompromised people without strong vaccine protection, are coping with Covid. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211124463-Covid-19 vaccine ad26.cov2.s-Suspected immunological vaccine failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Patient received vaccination on 9/20/2013 in left deltoid muscle.  Muscle soreness was "normal" for first few days and decreased to the point where the pain was almost gone.  On approximately 10/09/2013 the soreness began to get worse and progressed to the point where the patient was unable to lift her arm above her head on the morning of 10/19/2013.  This prompted her to call us at the pharmacy.  According to the patient there are no other symptoms; no redness, no bruising, no other sore muscles.  Patient also denies any new or out of the ordinary activities at the time the muscle soreness worsening.  The only factors she could have attributed the soreness to was the weather getting colder.  The patient has not seeked medical attention yet, but plans to if the pain does not go away within the next week.
Feelings of narcolepsy for 2 days.; Inflamed and sore lymph nodes in left armpit and clavicle; Inflamed and sore lymph nodes in left armpit and clavicle; Headache in front of head, back of head and neck pain; Headache in front of head, back of head and neck pain; This is a spontaneous report from a non-contactable consumer (patient). This 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Left on 21Oct2021 16:00 (at age of 43-year-old) (Lot Number: FE3590) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in Arm Left on 29Sep2021 (at age of 42-year-old) (Batch/Lot No: 30145BA) for covid-19 immunisation. No other vaccine in four weeks. The patient experienced inflamed and sore lymph nodes in left armpit and clavicle, headache in front of head, back of head and neck pain, feelings of narcolepsy for 2 days. Event start date was 21Oct2021. No Covid prior vaccination.  Covid tested post vaccination. Covid test type post vaccination was nasal swab on 15Oct2021 with unknown results. Event outcome was unknown.  No follow up attempts are possible; No further information is expected.
woke up - left arm upper injection site erythematous - swelling - tight  painful. temp 99 3 has gotten tylenol.
20-22 hours of flu-like symptoms, not feeling well, aches, feverish
Pt was vaccinated on 4/12/21 and 5/12/21 and presented to the emergency department on 5/16 with complaint of worsening shortness of breath and cough.  According to the patient her shortness of breath started couple of weeks back just after her first covid vaccine  but it got worse in the last few days following her second vaccine. imaging revealed a large R pleural effusion. a thoracentesis was done. and she was sent home. she was tested and was covid neg . cytology was significant for reactive mesothelial cells and negative for any malignancy. CT chest showed Vague ground-glass opacities left lung base possibly representing pneumonitis or atelectasis.   Confluent right hilar lymphadenopathy and a large effusion was seen she was discharged home to follow up with her pcp on 5/17
HARD LUMP ON HAND; This spontaneous report received from a consumer concerned a 39 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 15-APR-2021, the subject experienced hard lump on hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hard lump on hand. This report was non-serious.
rheumatoid arthritis minor flared; rheumatoid arthritis flare up; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4385706-00.  A 37-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; upadacitinib (RINVOQ), (Batch/Lot number: unknown), oral for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "recovering", described as "rheumatoid arthritis minor flared"; RHEUMATOID ARTHRITIS (medically significant), outcome "recovered", described as "rheumatoid arthritis flare up". The action taken for upadacitinib was unknown. The reporter considered "rheumatoid arthritis flare up" related to BNT162b2.   Clinical course: The events were non-serious Rheumatoid arthritis minor flared and Rheumatoid arthritis flare up with Rinvoq (Upadacitinib). There was no reported medical history. On unknown dates, the patient experienced Rheumatoid arthritis minor flared and Rheumatoid arthritis flare up. On unknown date, Rheumatoid arthritis flare up and covid booster was worse/patient was completely down resolved. Pfizer BioNTech Covid-19 Vaccine (Tozinameran) was also considered suspect. The patient had minor Rheumatoid arthritis flare and also she had rheumatoid arthritis flare up after received covid vaccination. It was unknown if patient was enrolled in a COVID-19 Vaccine trial.   Causality for Rinvoq (Upadacitinib): The reporter's causality for the event(s) of Rheumatoid arthritis minor flared and Rheumatoid arthritis flare up with RINVOQ (UPADACITINIB) was no reasonable possibility. Causality for Pfizer BioNTech covid-19 vaccine (Tozinameran): The reporter's causality for the event(s) rheumatoid arthritis minor flared (Rheumatoid arthritis flare up, Rheumatoid arthritis) was not reported. Causality for Pfizer BioNTech covid-19 vaccine (Tozinameran): The reporter's causality for the event(s) Rheumatoid arthritis flare up (Rheumatoid arthritis) was reported as 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 known safety profile of the vaccine  BNT162b2, a causal relation between the reported events  Rheumatoid arthritis minor flared and Rheumatoid arthritis flare up and the administration of the vaccine cannot be excluded. 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.
2hr p/shot leg swelling around inj site lt thigh to an eeg size area of sl redness & hard to touch;no fever;resolved the next day according to mom;tx w/APAP, heat;
Heart Attack-Mild/Heart Attack; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EL9267) via an unspecified route of administration in left arm on 23Feb2021 at 12:00 (at the age of 70-year-old) as single dose for COVID-19 immunization. Patient had no medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EL8982) via an unspecified route of administration in left arm on 03Feb2021 (at the age of 70-year-old) as single dose for COVID-19 immunization and experienced severe heart burn and was overall not feeling well. On 24Feb2021, at 17:00, the patient experienced mild heart attack. Adverse event resulted in visit to emergency room and physician office. Patient was admitted to the hospital in response to the event. Patient received the treatment in response to the event which included stent implant (Surgery: stent). Surgery was not planned before taking the vaccination. Outcome of the event was resolved on an unspecified date on 2021.
This spontaneous report as received from a healthcare worker via field employee refers to a now 22 year old female patient. The patient was vaccinated with the first dose of GARDASIL, injection, (dose, route, lot # and expired date were not reported) on 04-AUG-2008. Concomitant therapy was not reported. The patient was performed pap smear. The patient was diagnosed with an unspecified strain of human papillomavirus (HPV) on an unspecified date prior to receiving the 2nd and 3rd doses of GARDASIL. The patient had a physician office visit for medical attention. Therapy with GARDASIL was continued. The outcome of adverse event was unspecified. On 30-JUN-2014, the patient was vaccinated with the second dose of GARDASIL. On 12-AUG-2014, the patient was vaccinated with the third dose of GARDASIL. Additional information has been requested.
1st shot 18 months ago didn´t get 2nd shot yet; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date, 18 months ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient self-reported this case.  The patient asked ok to get his/her second shot. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination.
Moderna COVID-19 Vaccine EUA  Headache starting at around 1 PM the following day of receiving the vaccine.
Kinrix received 10/9/19 on left upper arm and ~ 18 hours later arm became red & swollen a not ithchy, started improving w/ redenss cleared by 5th day and now w/ firm swollen bump, never had fever, area now itchy. No reaction to prior IZs. No meds given
Patient received an extra HIB vaccine. Was given Pentacel and Hib. No reactions were noted with follow-up.
patient suddenly started feeling anxious and had her heart racing after administration of vaccine. vitals taken stable. observed for 30 minutes,  clinically stable and vitals normal. advised to be observed for 30 minutes after next visit.
10/29/2021 about 8 p.m., started with chills, progressed to shaking chills, back ache, thirst, during the early morning hours of 10/30/2021 started with headache, fever. nausea from not eating well the night before, very thirsty.  All day 10/30/2021, stayed in bed, very weak, alternated fever, chills, headache, low back ache, neck ache, taste was off, Coke did not taste right, stuck with water and saltines.  Chicken soup didn't taste right.  10/31/2021, felt I could get out of bed, still had headache and some warm sweats, but only lasted part of the day.  Started with front of the neck pain, like swollen. Still very weak, did nothing.  11/01/2021, felt good, but no stamina.  Rescheduled postop cataract follow-up, due to bad weekend, and still not feeling well.  Clinic was appreciative of the reschedule.  11/02/2021, bad front neck pain, like swollen glands.  No stamina still, could only do one thing, then had to go rest, still some front neck pain, like swollen glands.  A little headache, relieved with Tylenol.  Most other symptoms gone.  Stamina a little better, but not much.  11/03/2021 no front neck pain or headache.  Fever gone.  Still little stamina.
About 3 days post/vax, pain on R/side that worsened with flu-like symptoms, including lymph node pain, fatigue & weakness, joint & muscle pain & weakness, numbness in hands & feet, sore throat, elev lvr enz,etc, dx:Prog Chron Polyneuropathy. Follow-up information received and this pt continues to have above symptoms with additional problems. He is presently experiencing progressive peripheral neuropathy, fibromyalgia, chronic fatigue syndrome, difficulty swallowing. Pt is presently being tyreated with high dose chemotherapy, anti-inflammatory injections, antibiotics, accupuncture, and IV vitamins.
Malaise and L arm inj site pain, lasted 4 days.  Narrative:
I lost my sense of smell. It also affects my taste. I have not regained either sense to date.
This case was reported by a physician and described the occurrence of pertussis in a 17 month old female patient who received tetanus and diphtheria toxoids and acellular pertussis vaccine absorbed for prophylaxis. On unspecified dates, the patient received two doses of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed; the second dose was Infanrix (lot DTPA542A2). The immunization series was delayed due to parental choice. On 4/4/02, the patient received injections of Haemophilus influenzae type B conjugate vaccine, inactivated poliomyelitis virus vaccine, hepatitis B vaccine, and 7-valent pneumococcal conjugate vaccine. On 7/21/03, the patient developed a persistent cough. At that time, there was an outbreak of pertussis where the patient lived. The patient was hospitalized. A diagnosis of pertussis was made and the patient was treated with erythromycin. Others in the same household had positive Bordatella pertussis cultures. The pertussis resolved on 8/31/03. The reporter considered that the event had jeopardized the patient. He also considered the event to be unrelated to Infanrix administration.
Information has been received from a pharmacist student concerning an adult patient who was vaccinated with Varivax. Subsequently the patient experienced varicella breakthrough. Patient outcome was not reported. Additional information has been requested. This is in follow-up to report(s) previously submitted on 5/16/2007. Information has been received from a pharmacist student concerning an adult patient who was vaccinated with VARIVAX. Subsequently the patient experienced varicella breakthrough. Patient outcome was not reported. Additional information has been requested.
Client was seen by public health nurse during a jail vaccine clinic. Client opted to receive a flu vaccine. Upon insertion of needle in right deltoid, client complained of severe pain. Nurse withdrew needle and asked client if this had ever happened before. Client indicated it had not. Nurse asked if client wished to continue with vaccine. Client opted to do so. Nurse replaced needle on syringe and administered vaccine in left deltoid. Client reported no pain with at that site. Jail nurse was present during this interaction.
Swollen, red, large area (L) arm, shoulder, itchy it spread almost around whole arm, it was hot painful.
On 11/9/01, pt had a red area on right arm at injection site that was painful. On 11/9/01 and 11/10/01 he had nausea and 1 episode of vomiting. On 11/10/01, he had a numb sensation on right forearm and a burning on right foot. On 11/12/01, the red area was 8cm in diameter. He also had a fever of 101.2F on 11/9/01. Pt is improving. By 11/12/01, all was resolved.
5-year-old patient received a dose of Flublok with no adverse event; Initial information regarding this unsolicited valid non-serious case from a pharmacist.  This case involved a 5-year-old patient received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot number- UJ497AA, Expiration date- 03-May-2021) via unknown route in unknown administration site (Product administered to patient of inappropriate age) for prophylactic vaccination on 11-Oct-2020.  The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant vaccine included a dose of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX).  It was a case of actual medication error due to Inappropriate age at vaccine administration.(Latency: Same day).  At the time of reporting 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.
Ct. developed "nickle size" bump on arm on 5/24/2006.  Right arm became edematous to elbow and ct.'s mother took ct. to ER on 5/25/2006 where they administered IV antibiotics.