chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19 using paxlovid; Treatment of COVID-19 using paxlovid; This is a spontaneous report received from non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 60 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMLODIPINE; LISINOPRIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "not recovered" and all described as "Treatment of COVID-19 using paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Oct2022) Positive, notes: Rebound COVID with positive Ag test 3 days after completion of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  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.; Sender's Comments: Based on the available reported information, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.
Within one to two weeks after receiving the Flu shot I started to become easily fatigued and progressively weaker. The I started to experience numbness and tingling to my extremities (hands and feet). By December 1999, I got to a point that I was unable to hold up my own body weight without the assist of another person or a stationary object. I began having muscle spasms that started in my legs and progressed up my entire body including my head. I still continue to experience adverse reactions.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 23-MAR-2012, the patient was administered with a dose VARIVAX (Lot # 670851/0869AA, expiry date 26-JUL-2013) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
Patient received ADPT #5 on 6/9/04 at LD and MMR #2, IPV # 4 at RD. Mother had noticed her daughter's left arm swelling since 6/10/04. They came back to see doctor again on 6/11/04. It was local reaction to the immunization from ADPT. Cold compresses and taking Advil every 6 hours PRN for treatments.
Developed itching to lips and left arm 10 mins after injection.  Benadryl 25mg oral given.  Symptoms progressed to tongue and mouth itchiness.  Pt transferred to ED for further eval and care.  IV NS famotidine and methylprednisolone given.     Discharged home.
Information has been received from a nurse concerning a female who was vaccinated with a fourth dose of GARDASIL vaccine because of an unknown vaccination history for the patient, when the fourth dose was given. the day after the fourth dose was given; the patient stated that she felt sick. The patient sought medical attention. No further information is available.
Information has been received from a pharmacist concerning a 61 year old female patient who on 20-SEP-2010 was vaccinated into her right arm (also reported into the left deltoid) with her first dose of PNEUMOVAX 23 (lot # 665904/0866Z). Concomitant therapy included FLUVIRIN into her left arm. The pharmacist reported that on 20-SEP-2010, the patient experienced numbness, fever and decreased limb mobility. The patient sought medical attention by a telephone call. At the time of report, the patient had not recovered from numbness, fever and decreased limb mobility. Additional information has been requested.
Patient with progressively worsening  weakness and frequently  falling.  Noted that her hands were "prickling."   She has actually fallen several times including last night.  She has trouble going up even two steps apparently.  Her feet are numb as well.  She has a change on her torso as well.  She had a "zing" in the anterior portion of her torso.  This is worst than the posterior torso.   She had an EMG (see #19) and LP.   She was started on IVIG.  She reported improvement at the time of this filing (currently on day#3 of IVIG)
severe fast/rapid/speeding heartbeat; This is a spontaneous report from a contactable consumer. This consumer reported for another patient that: A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date patient experienced severe fast/rapid/speeding heartbeat. Reporter stated that the technician doing the EKG said that she was the fourth person with speeding/rapid heart rate from the Pfizer vaccine. The outcome of the event was reported as unknown.   Information about Lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021358507 same reporter/drug/AE, different patient
Patient experienced soreness / inflammation, pain on left arm and fever next day after getting the vaccine up until 11/12/18 when she came to the store to show me the reaction.
Case number PHEH2013US018762 is an initial spontaneous report received from a pharmacist on 04 Sep 2013. This report refers to a 63-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number: A11082) intramuscularly on 01 Sep 2013. No adverse events were reported following the maladministration.
nausea & vomiting high fever;lymph nodes around head,neck under arms & in both groins;petechial rash all over body;
p/vax pt c/o dizziness, diaphoretic, pale, eyes bloodshot p/24hr, site reddened & swollen p/24hr;became SOB 12hr p/vax;
mild Covid-19 infection; Loss of smell one after other; Sore throat; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (mild Covid-19 infection) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced COVID-19 (mild Covid-19 infection) (seriousness criterion hospitalization). On an unknown date, the patient experienced ANOSMIA (Loss of smell one after other), OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (Fever). At the time of the report, COVID-19 (mild Covid-19 infection), ANOSMIA (Loss of smell one after other), OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (Fever) outcome was unknown. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, Blood test: inceased protein (High) blood work showed highly elevated clotting indicator, and increased levels of protein. But the levels are improving.. On 24-Apr-2021, C-reactive protein: increased (High) increased. On 24-Apr-2021, Coagulation factor: increased (High) increased. On 24-Apr-2021, Computerised tomogram normal: unknown (Inconclusive) unknown results. On 24-Apr-2021, SARS-CoV-2 test: positive (Positive) He did the PCR test twice, both showing positive results..         No concomitant medicines were reported. Patient was treated with blood thinners & other medicines.  Action taken with the drug in response to events was not applicable.  Caller is returning a call from safety. Caller provided additional information. Patient provided HCP details and wanted to know next steps safety will take. Wants to share blood test details via email. Denied consent to follow up with HCP, wants to follow up with HCP first and provide more info later.  Based on the current available information and lack of temporal  association between the use of the product and the start date of the events, a causal relationship  is assessed as unlikely related to mRNA-1273.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: New events were added, lab result, hospitalization; Sender's Comments: Based on the current available information and lack of temporal  association between the use of the product and the start date of the events, a causal relationship  is assessed as unlikely related to mRNA-1273.
I felt fine until 5pm on Nov 5th: left eyelid swelled up so took Flonase, Woke up repeatedly throughout night with splitting headache, sore arm, night sweats and warm. On Nov 6th swelling in upper right arm extending to armpit, and progressed until Sunday, Nov 7th: Swelled through right breast and rib cage, stopped on Thursday, Nov 11th. Soreness and pinkness in right armpit and right breast, and sense warm.
Patient received Pfizer vaccine on 3/3/2021.  Then came back on 4/1/2021 for second dose Pfizer.  He received a dose of Pfizer as a second dose.   He was monitored for 30 minutes. Did not have any side effects.  He was sent home and told to report to us if he had any complications.  None was ever noted.
I had abdominal pain - upper abdominal pain - a fair amount of nausea but no vomiting; bowel disturbances - occasional diarrhea; went on for 2-3 weeks. On the 10th I went to Urgent Care Center. Did stool samples and blood samples - they didn't really show anything. By then it may have gone out of my system. 2 days later, I got the lab results and saw a primary care doctor. It was some infection of some sort. I was starting to get better by that point. The doctor said to watch it - she said it was some kind of intestinal virus and it went away and I have been fine since.
I got my shot Thursday. On Friday I just had a sore left arm and mild fever at the end of the day. Saturday I woke up with a few itchy red hives on different parts of my body. The hives multiplied that night. Sunday there were hives pretty much all over my body, and this continued into Monday as well. The hives would switch locations but in general there were so many of them in a single place that they were these massive red patches of itchy raised skin. Tuesday it started to calm down and fade. Now, Wednesday, it's largely faded but has left some areas of discoloration particularly on my legs, which I'm hoping will just fade these next couple of days as well.
c/o sore throat & itchy eyes & mouth;c/o thick drainage for eyes;had small amount of greenish exudate over rt pupil;VS 110/70, P70, R18;states low BP is nl for pt;25SEP97 2PM pt suffered stomach ache, n/v, chills fever,tinnitis,loss of tast
Patient intradermal dose of Jynneos vaccine was unsuccessfully administered. Nurse was provided education that he needs to have another intradermal dosage d/t vaccine was administered through subcutaneous instead of intradermal. Patient verbally understand the procedure and was able to proceed with another intradermal of Monkeypox(Jynneos) vaccine. Patient was stable and denies any concerns or issues regarding the process. Clinical leads were aware and notified regarding the incident. No further treatment was required.
This case was reported by a consumer via call center representative and described the occurrence of cold in a 61-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received on an unknown date). On 7th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 9th June 2018, 2 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the patient experienced cold and product supply issue. On 13th June 2018, the outcome of the influenza-like symptoms was recovered/resolved. On an unknown date, the outcome of the cold was recovered/resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the cold and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving 1st dose of SHINGRIX, the patient experienced a bad reaction described as a flu like symptoms for about 4 days. The patient stated, more than 6 months had gone and till the time of reporting the patient did not receive the 2nd dose of SHINGRIX, due to availability issues. The patient reported that about a month before the date of reporting, a pharmacy had SHINGRIX in stock but she decided not to get the dose because she had a cold that day. The patient provided limited information.
Having a localized reaction; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE REACTION (Having a localized reaction) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Having a localized reaction). At the time of the report, VACCINATION SITE REACTION (Having a localized reaction) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.   This case was linked to MOD-2021-023329 (Patient Link).
Hepatitis b vaccine adult dose given for first series 1.0 cc instead of .5cc.
Had a stroke 3 days after round one of Covid vaccine and subsequently died the next week due to complications of stroke. Upon admission to hospital, was in afib.
Went to doctors office a few weeks later. Vaccine caused blood to drop. April 21, 2021 Doctor gave Prednisone. He was very weak and dizzy. Also, had large knots under both arms.
This spontaneous report as received from a consumer concerning his child. On an unknown date the patient was vaccinated with recalled GARDASIL lot # J007354 and expiry date 20-FEB-2016 (dose number and route unknown) and vaccination and no adverse event were reported. The outcome of child received the recalled GARDASIL and no adverse event was unknown. No further information was provided. Additional information has been requested.
Patient's daughter reports patient has extreme fatigue/immobility and rash; can't physically dress oneself despite trying.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 at 08:30 as dose 1, single (Batch/Lot number: unknown), in left arm, on 08Apr2021 at 08:45 as dose 2, single (Batch/Lot number: unknown), in left arm and on 15Dec2021 at 13:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SERTRALINE; DICLOFENAC; CLARITINE; VITAMIN C [ASCORBIC ACID].  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: The patient has no known allergies. The patient took other medication in 2weeks. The patient was also taking multivitamin. Anti viral details: Product was COVID 19 Treatment, Brand was Paxlovid, Treatment start date was 24May2022, Treatment stop date was 28May2022, Indication was Treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Per the Patient: "Hives present on the forehead, back of the neck, and triceps area of the right arm".
Weakness; Nausea; In bad shape; Pain; This is a spontaneous report from a contactable consumer.This Consumer reported for a male patient. A male patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID19-VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced weakness, nausea, in bad shape, pain. The outcome event was unknown.  Follow-up attempts have been completed and no further information is expected.
Muscle pain at the injection site; Rash on the bicep; This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on 26th July 2020, refer case US2020AMR213680).   On 20th October 2020, the patient received the 2nd dose of Shingrix. In October 2020, less than a week after receiving Shingrix, the patient experienced injection site muscle pain and rash. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site muscle pain was recovered/resolved and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the injection site muscle pain and rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had injection site muscle pain and rash on the bicep that was 4 to 5 inches. The 2nd dose was given in the lower deltoid and rash was still there. The reporter did not consent to follow up. Not all information was available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR213680:1st dose, same patient
It knocks your arm down for a few days; Hurts the first 72 hours; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine (unknown arm). On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Hurts the first 72 hours) and arm discomfort (Verbatim: It knocks your arm down for a few days). The outcome of the pain in arm was resolved (duration 72 hrs) and the outcome of the arm discomfort was resolved.   It was unknown if the reporter considered the pain in arm and arm discomfort to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and arm discomfort to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-JUL-2023 This case was reported by a patient via interactive digital media. By coincidence the patient went to the pharmacy and received free Shingles vaccine. The patient reported that the vaccine knocked out arm for a few days and it hurt for the first 72 hours.
High Fever 103.2 for 2 days, followed by 3 days without fever but baby very irritable and cranky. In those 3 days baby cried a lot and drank 1/2 of normal amount of fluids did not eat solids, lethargic.
A Tdap was given instead of a Dtap. Mother informed and apologized to . Informed her of the recommendation to get Dtap in 4 weeks . also informed her that the injection that was given was a lesser strength than what she should have received. Mom does not want to get the Dtap in 4 weeks as recommended.
shingles rash and in her eyes and lips; shingles rash; Information has been received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On or about 11-JUL-2017, the pt was vaccinated in a pharmacy with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot #, expiration date were unknown) for the prevention of shingles and routine health maintenance. Shortly after receiving zoster vaccine live (ZOSTAVAX) inoculation, pt suffered severe side effects including shingles rash and in her eyes and lips and was diagnosed by physicians with shingles and herpes zoster ophthalmicus. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX); pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries; also suffered serious, progressive, permanent and incurable injuries; as well as conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct result of use of zoster vaccine live (ZOSTAVAX), the pt incurred medical expenses and other economic harm. The outcome of shingles and herpes zoster ophthalmicus was considered as not recovered. The causal relationship between shingles, herpes zoster ophthalmicus and zoster vaccine live (ZOSTAVAX) was considered related. Upon internal review, the events were considered as disabling.
POSSIBLE GUILLAIN-BARRE SYNDROME; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and 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: Unknown) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. The patient's vaccine Anatomical Approach site was not reported. The batch number was not reported and has been requested.  No concomitant medications were reported.  On Easter (04-APR-2021), 12 days after vaccine administration, the patient started having symptoms which led to the patient being tentatively diagnosed with Guillain-Barre syndrome.  No further details provided.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of possible Guillain-Barre syndrome was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210510750-covid-19 vaccine ad26.cov2.s-possible Guillain-Barre syndrome. 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).
Follow up information received on 05/09/2003 from the physician previously reported as the vaccine provider indicated that the patient did not receive a flu vaccine from this facility.  A medical assistant reported that a 67 year old female received a flu vaccine (manufacturer unknown) "earlier this year" and experienced nausea and vomiting post-vaccination.