chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE; improperly stored vaccine was administered to 10 separate patients; This spontaneous report was received from an office manager and refers to a 12-month-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 18-APR-2022, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot #T042013, expiration date: 22-JUL-2023 (strength, site and route of administration were not provided) for prophylaxis (Product storage error). No adverse events were reported (No adverse event).  On an unknown date, before the administration, the vaccine underwent a temperature excursion at 11.3 Celsius degrees (C) for 4 hours and 45 minutes. No previous temperature excursions were reported.   This is one of several reports from the same person.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 13-MAR-2019, the patient was vaccinated with an expired ROTATEQ lot # N030364 with expiration date on 06-MAR-2019, orally for prophylaxis (dose was not reported). However, no adverse effects were reported.
Caller had all the covid-19 vaccine shot, He mentioned that this is his 2nd Covid/has sinus and chest symtoms; Caller had all the covid-19 vaccine shot, He mentioned that this is his 2nd Covid/has sinus and chest symtoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: loss of taste, fatigue and intense chill. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Caller had all the covid-19 vaccine shot, He mentioned that this is his 2nd Covid/has sinus and chest symtoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment included Paxlovid.  Clinical course: Caller had all the covid-19 vaccine shot and just started Paxlovid yesterday because he still tested positive. He would like to know whats going on. The patient started Paxlovid yesterday because he tested positive for Covid. He currently has metallic taste as a side effect. He mentioned that this is his 2nd Covid and it's not like his 1st Covid when he experienced loss of taste, fatigue and intense chill. He says he only has sinus and chest symtoms, no loss of taste and smell with the 2nd Covid. He said he is like a guinea pig for this medication and so he wants to know why is he still positive with Covid and need information about the metallic taste too. He is also asking if Comirnaty or the Pfizer Covid vaccine is going to be an annual thing like flu shots. Advised him that Paxlovid is indicated for the treatment of mild-to-moderate (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. The goal of the medication is not to result in a negative test necessarily but to prevent hospitalization from Covid in high-risk patients.  Also told him that altered sense of taste or that metallic taste he is experiencing is one of the most common side effects reported for Paxlovid.   The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
3 hrs after immunization, child began screaming, difficult to console, refused to eat, choking, vomited, stopped breathing (10 sec), leg purple, swollen.  No fever.  Taken to ER:  treated for reflux, heart murmur, had ECHO done, given Zantac, admitted for observation 01/24/07-records received and reviewed for DOS 01/16-01/18/07 DC DX:GE reflux Presented with unusual crying since vaccines, per parents both legs turned purple and were swollen for a period of a few hours. Child began to choke and stopped breathing for a few seconds. Child has felt warm but temperature not taken at home. Temp in ER 98.9 (R).  PE:WNL. lower extremity non erythematous or edematous. Child expressed discomfort when right thigh palpated.  Emesis and reflux since vaccine.  additional DX: murmur VSD,  Immunization reaction.
Mother noted abnormal movements of the upper and lower extremities, eyes rolled to the back and lasted a few minutes and she was unresponsive.
Presented in ER with numbness in feet with difficulty walking-admitted to ICU. Became totally paralized. Dx GBS- per EMG, MRI, increase CSF Protein. No seroxy or motor functions from head to feet, intubated, Rx plasma phoresis. Now some movement in upper arm. The 60 day follow up received on 8/9/03 states she required intermittent ventilatorassistance as of Feb. 2003. Feb. 2003, family had the pt transferred.  Annual follow up on 12/12/03: "Vaccine recipient is unknown to recovery status."
I did not feel the shot when I got it. In 2 hours it felt like a bee sting. There was no redness, but it was painful. Approximately 3 weeks later, the pain spread further down my arm to just above my right elbow. My right shoulder blade also was painful. About the 5 week point, I started to feel like the area where I got the shot was hot and swollen. I also started to have a lot of pain in my thumb and a burn in my shoulder. The Nurse Advice line advised me to go to Urgent Care because there were no appointments available at the health Clinic. The Urgent Care doctor only gave me KENALOG to apply to my arm. I reported this treatment to the Health Clinic. They advised me to go to the ER. The ER doctor X-Rayed my arm and prescribed me SOMA and hydrocodone. The diagnosis was shoulder pain (Deltoid area) of Unknown cause. I am currently in Physical therapy.
difficulty breathing, hoarseness, paleness, weakness, fast heart beat-MD dx spasmatic bronchial bronchial tubes;given meds amoxicillin-Benzonalate;
Shot administered in patient's right shoulder above bi-cep. Patient experienced significant pain at the site of injection. Patient also developed a swelling, discolored red skin, and sensitivity to touch from the site of injection extending down the arm and around the inner bicep. Symptoms lasted 6 days and was treated with ibuprofin.
Shot given Saturday at 12:15. Pm. Immediately neck pain started. I assumed it was from looking at my phone while I waited for the 15 minute wait to be up, but the pain never stopped, but it did move around my body. Fever every evening starting the day after the shot. Searing muscular pain since shot, worsens when fever happens, and the pain is moving throughout my body. On Monday, It is day 3 after the shot and my arm is swelling more today than any other day. Advil 400mg every 4 hours, rest, and plenty of fluids.
Hidradenitis suppurativa; This spontaneous case was reported by a consumer and describes the occurrence of HIDRADENITIS (Hidradenitis suppurativa) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced HIDRADENITIS (Hidradenitis suppurativa). At the time of the report, HIDRADENITIS (Hidradenitis suppurativa) outcome was unknown.            No concomitant medications were reported.  Patient had hidradenitis suppurativa flare up.  No treatment medications were reported.  The reporter assessed the event as probably related to Moderna vaccine and not reasonably possible with Humira.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
pt recvd vax at checkup; onset of vomiting 2 days after vax; v sporadic, then freq til onset of focal sz 2 days later; ct scan showed cerebral hemorrhage; analysis showed DIC-like picture; cont cns bleeding, eventual death; no post mortem;
Headache fatigue, slept for several hours, brother reporting she looked swollen in face Narrative:
Releases protein through my urine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single; Pfizer Product: Covid Vaccine), for COVID-19 Immunization; Bnt162b2 (Dose 2, Single; Pfizer Product: Covid Vaccine.), for COVID-19 Immunization. The following information was reported: PROTEIN URINE (non-serious), outcome "unknown", described as "Releases protein through my urine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: A potential AE has been reported to the Pfizer Clinical Trials Contact Center. Patient reported, I had new product syndrome which releases protein through my urine. I've had three COVID vaccines.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unspecified dates the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot# J003707, exp. 27-MAR-2015) or (lot# K005426, exp. 15-APR-2016) (dose, route and dose number were unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
I felt severe back pain that moved from my back to my thigh and back again for 1 week on my left side of my body; I felt severe back pain that moved from my back to my thigh and back again for 1 week on my left side of my body; I felt severe back pain that moved from my back to my thigh and back again for 1 week on my left side of my body; This is a spontaneous report from a contactable consumer (reporting on herself). A 61-years-old Non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 26Jan2021 14:30 as dose 1 single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported; hctz (HCTZ) taken for an unspecified indication, start and stop date were not reported; metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported; potassium chloride (K+10) taken for an unspecified indication, start and stop date were not reported.  On 29Jan2021 12:00 the patient experienced she felt severe back pain that moved from her back to her thigh and back again for 1 week on her left side of her body. Patient visited physician office and received treatment for adverse events. The outcome of the events was not recovered.  Follow-up attempts have been completed and no further information is expected.
Late in the day on 8/31/22, the FDA rescinded the EUA order for the use of the monovalent Pfizer and Moderna vaccine as boosters for people aged 12 years and older. The information took a little time to trickle from the local authority to regional staff and then to clinic and the staff administering vaccine. Because of this delay, some monovalent vaccine throughout clinics were inadvertently given after 8/31/22. The CDC stated that any monovalent vaccine administered as a booster dose after the EUA was rescinded would be considered a vaccine error. At a recent Immunization Subcommittee meeting, we discussed this and our medical providers stated that any monovalent vaccine given as a booster dose on 9/1/2022 or after should have VAERS report completed on them per the CDC's requirements.
Exhausted entire day, Friday, 2/26/2021. Site painful. Small area - circular rash appeared on Saturday. Used freezer ice paks on rash area.  From 2nd day until today March 2, 2021 rash 6" lengthwise and 4" width wise on left arm at injection site. No pain since Sunday night.
The first time I had the J&J in April 2021, I had the chills, fever, headaches, could not breathe and was called in an inhaler (never used inhaler in his life), a cyst developed on my nipple after lymph nodes swelled. I received the booster in January 2022 and had headaches and hives started on my right arm a day later, then stopped, and then started again a day later. The hives are itchy and all over my arm.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 17Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN, start date: 31Jul2018, stop date: 20Jun2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jun2022) negative, notes: tested negative on day 1 after treatment; (28Jun2022) positive, notes: Tested positive after 9 days. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Clinical information: Anti viral details: product was COVID 19 Treatment, brand was Paxlovid, treatment start date was 14Jun2022, treatment stop date was 18Jun2022, indication was Treatment of COVID-19. Adverse event: Tested positive after 9 days post Paxlovid treatment. Previously had tested negative on day 1 after treatment. Adverse event start date was 29Jun2022. If patient recovered: Recovering, If treatment ae: No.
318 patients received dose from vials beyond 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30 day use by date) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30 day use by date). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30 day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  The date of refrigeration was reported to be on 07-May-2021.  Treatment information was not provided.
This case was reported by a consumer and described the occurrence of muscle wasting in a male pt in his twenties who received Lyme disease vaccine recombinant OspA (LYMErix). The reporter is the pt's mother. A physician or other health care professional has not verified this report. The pt's medical history was notable for diagnosis of Lyme disease (stage 3) in 1989, right leg pain and right knee swelling in 1994, and a family history of muscle disease. At the time of vaccinations, the pt was not receiving concurrent medications. On 2/16/00, the pt received the first dose of LYMErix. On 4/22/00, the pt received the second dose of LYMErix. On 4/2/01, the pt received the third dose of LYMErix. This represented a schedule of 0, 2, and 14 months rather than the recommended schedule of 0, 1, and 12 months. At an unspecified time following administration of LYMErix, the pt developed muscle wasting in his right leg and pain in his right leg. On 6/14/01, the pt was diagnosed with benign fibroma of the right knee. The events were unresolved. The consumer stated that as of 1/13/04, her son "can only lift 10 pounds with his right leg (but can lift) 100 pounds with his left leg." comment: This case was assessed as medically serious (OMIC) by manufacturer. Information from Annual Follow-up report states lost to follow-up.
Occasional hidradenitis suppurativa flare.; Occasional hidradenitis suppurativa flare; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Fatigue), HIDRADENITIS (Occasional hidradenitis suppurativa flare.) and CONDITION AGGRAVATED (Occasional hidradenitis suppurativa flare) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    The patient had a relevant medical history of had horrible issues all over the body.  Concurrent medical conditions included Hidradenitis suppurativa (Moderate to severe hidradenitis suppurativa).   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to Citrate free. In February 2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced HIDRADENITIS (Occasional hidradenitis suppurativa flare.) and CONDITION AGGRAVATED (Occasional hidradenitis suppurativa flare). In February 2021, FATIGUE (Fatigue) had resolved. At the time of the report, HIDRADENITIS (Occasional hidradenitis suppurativa flare.) and CONDITION AGGRAVATED (Occasional hidradenitis suppurativa flare) was resolving.            No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.  The reporter's causality for the event of fatigue with Humira(adalimumab) was no reasonable possibility. the reporter's causality for the event of occasional hidradenitis suppurativa flare with Humira(adalimumab)was a reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow-up received, Medical history, event information, reporter causality for event of fatigue updated. On 23-Dec-2021: Follow-up received, reporter causality for event Occasional hidradenitis suppurativa flare updated.
COLD SWEATS; WEAK; VERTIGO; UNSTEADY GAIT; DIZZINESS; UNBALANCED; MILD SORENESS AT THE LOCATION; This spontaneous report received from a patient concerned a female of unspecified age. 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: unknown) dose was not reported, administered on 11-MAR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced mild soreness at the location. On 18-MAR-2021, the subject experienced vertigo. On 18-MAR-2021, the subject experienced unsteady gait. On 18-MAR-2021, the subject experienced dizziness. On 18-MAR-2021, the subject experienced unbalanced. On 18-MAR-2021, the subject experienced weak. On 19-MAR-2021, the subject experienced cold sweats. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild soreness at the location on 11-MAR-2021, was recovering from cold sweats, had not recovered from vertigo, weak, and dizziness, and the outcome of unsteady gait and unbalanced was not reported. This report was non-serious.
This is a spontaneous report from a Non-Clinical Study Program (IBCC (Inbound Call Center for healthcare professionals)) from a contactable nurse who reported for the patient, her friend. A 73-year-old male patient received PREVNAR13, subcutaneously in the left deltoid muscle at a single dose on 09DEC2014. Medical history was not reported. Concomitant medications included simvastatin 20 mg per day. On 09DEC2014, the patient received PREVNAR13, which seemed to be given subcutaneously and when the nurse ran her finger over it felt like a pump like it went in subcutaneously rather than intramuscularly. It also seemed to bleed more and was more painful than normal. It  hurt him a lot. The discomfort at the site only lasted about a  day. The outcome of the events was recovered on an unknown date. Follow-up (29JAN2015): New information received from the same contactable nurse includes: outcome (recovered). Follow-up attempts completed. No further information expected.
Hot flashes and flushing. Hot/sunburn feeling in neck and back and face without any rash visible. Lasted for approximately 5 days.
Red, itchy, hot, sore, swollen upper right arm beginning five days after vaccine. Began with area immediately around vaccine site, about 3" diameter. Over the next five days redness, etc. continued spreading all the way around arm to just above elbow.  By the 14th day the redness was nearly gone. Enlarged lymph nodes under right arm beginning five days after vaccine.  By the third day swollen about 2 1/2" diameter. Sore and aching.  Swelling and pain began to go down a little after one week.  Four weeks after vaccine nodes are still visibly larger than before the vaccine but nearly back to the size before and no longer painful.
Guillain Barre; started w/weakness on rt leg & spread to lt leg; adm to hosp on 30OCT92 & is still hospitalized;
A few hours after receiving the "Janssen COVID-19 Vaccine EUA" I started to experience the following side-effects:  headache, fever, muscle aches, tired and weakness.  I also felt a little dizzie.  I monitored my temperature thoughout the night; I recorded  at 7:54pm 99.7; 9:23pm 99.2; 10:45pm 99.8; and at 6:00 am on 4/9 my temperature was back to normal at 97.5. The muscle ache were gone and the headache was mild.  I do still  feel a little dizzie and weak.