chrisvoncsefalvay/vaers-outcomes huggingface dataset:
left with the vaccine still in her lab coat pocket and drove off. administered 4 doses after she brought it back; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT STORAGE ERROR (left with the vaccine still in her lab coat pocket and drove off. administered 4 doses after she brought it back) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced PRODUCT STORAGE ERROR (left with the vaccine still in her lab coat pocket and drove off. administered 4 doses after she brought it back). On 09-Feb-2021, PRODUCT STORAGE ERROR (left with the vaccine still in her lab coat pocket and drove off. administered 4 doses after she brought it back) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications were provided.   No treatment information was provided by the reporter.
pt recv vax 8DEC97 & 14DEC97 pt devel a varicella type rash, greater than 50 lesions w/a gen distribution (15-20 over chest, 15-20 over back, 5 on each arm, 5 on each leg, 8 in diaper area);18DEC97 pt hosp w/staphylococcal bacteremia;
Soreness on the arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness on the arm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to lisinopril) and Knee pain. Concomitant products included HCTZ for Blood pressure management.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness on the arm). At the time of the report, VACCINATION SITE PAIN (Soreness on the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had steriod injection yesterday for right knee pain of kenolog brand.   This case was linked to MOD-2022-462970 (Patient Link).
Incorrect dosage of booster was administered to patient. Patient reported they were receiving a second dose. After administration, vaccine card was presented showing already received two doses. Instead of half-dose for booster, full dose was given. Patient was informed and notified that they may experience more side effects the following days, and to report any symptoms.
Information has been received from a physician concerning a 4 year old female patient, with no known drug allergies and who was exposed to chicken pox as a neonate, who in approximately January 2000 (at one year of age) was vaccinated with a dose of MMR (second generation). There was no concomitant therapy. It was noted per family history that the patient was supposed to have received all her shots and that her brother had chicken pox when she was an infant, but she not contract chicken pox at that time nor has she had any recent exposure to chicken pox or shingles. Follow up information from the patient's physician, however, indicated that the patient was never vaccinated with varicella virus vaccine live. A physician reported that on approximately 3/4/03, the patient developed severe left ear pain, otitis herpeticus, swelling of the ear and canal, and left facial palsy. A possible case of breakthrough varicella was suspected. On 3/7/03, the patient was hospitalized. Subsequently the patient was diagnosed with Ramsey Hunt Syndrome. It was reported that the patient recovered from her experiences. Additional information is not expected. Follow up info revealed that PCR analysis from a vesicular specimen obtained on 3/6/03 was positive for wild-type varicella. Additional info is not expected.
8-19-13 Urticaria - CLARITIN QD. 8-20-13 Serum sickness - fever 101, diffuse hives widespread with wheals and coalescent lesions.
This study case was received from the investigator in a trial on 08 June 2011. An 18 year-old male subject with no significant medical history was found to have encephalitis following immunization procedures and unspecified cause of encephalitis 11 and 12 days respectively after he had received an injection of ACAM2000 (lot number, route and site of administration not reported) and ANTHRAX 1 (manufacturer, lot number, route and site of administration not reported) on 17 December 2010. He also received on 15 December 2010 TYPHIM VI (lot number, route and site of administration not reported). Relevant laboratory data was not available. Treatments were not reported. Additional information will be requested from the investigator. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Extreme fatigue; I had a fever of 102; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program. A patient of an unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date, at a single dose for covid-19 immunization. Medical history included COVID last April (Apr2020) but otherwise patient was very healthy. Concomitant medications were not reported. On an unspecified date, the patient had fever of 102 and extreme fatigue with the first COVID vaccine. Patient enquired to get the 2nd dose which was scheduled for tomorrow. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Information has been received from a physician's assistant concerning a 62 year old female with a history of immunodeficiency who in approximately April 2008, was vaccinated with a 0.5 mL dose of PNEUMOVAX 23. Subsequently, the patient had titers drawn that showed 4 of 7 titers to be low. The patient sought medical attention. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. No further information is available.
Mild to moderate erythema/edema at injection site. ZYRTEC 10mg every day/ice to site.
COVID positive; COVID positive; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 at 18:00 as dose 1, single (Lot number: EL9269), in left arm, on 02Mar2021 as dose 2, single (Lot number: EN6206), in left arm, on 06Oct2021 at 13:30 as dose 3 (booster) single (Lot number: FF2590), in left arm and on 19Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FJ9943) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Sulfa drugs" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "seasonal allergy" (unspecified if ongoing); "auto immune angio edema" (unspecified if ongoing); "glaucoma" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC ALLERGY; METOPROLOL; CALTRATE [CALCIUM CARBONATE]; D3; VITAMIN C [ASCORBIC ACID]. Past drug history included: Metoprolol, reaction(s): "Minor cardiac pvc's", notes: Minor cardiac pvc's (metoprolol). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jun2022) Positive; (29Jun2022) Negative; (30Jun2022) Negative; (01Jul2022) Negative; (02Jul2022) Negative; (08Jul2022) Positive, notes: Tested twice on 08Jul2022. Both immediately Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Addition information: Start date of treatment for COVID-19 was 24Jun2022. Stop date of treatment for COVID-19 was 29Jun2022. Paxlovid rebound- return of COVID symptoms 5-8 days after first negative test. (First negative test and last day of paxlovid 5 day caourse are same). 3 consecutive days of negative tests to follow. Initial COVID positive on 22Jun2022. 1st dose paxlovid 24Jun2022 in pm. Last dose paxlovid 29Jun2022 in am. Negative tests 29Jun2022; 30Jun2022; 01Jul2022; 02Jul2022; new mild symptoms may have started as early as 01Jul2022. Or as late as 06Jul2022. Cold symptoms with mild congestion and intermittent cough due to raw throat more apparent on 07Jul2022. Tested twice on 08Jul2022. Both immediately Positive. Slight fever and headache with some congestion on 08Jul2022. I am in the throes of it now.; Sender's Comments: The contribution of the suspect drug to the onset of "COVID positive" cannot be ruled out since drug efficacy varies from one patient to another and affected by different factors.
achy joints; chills; fever; nausea; no appetite; Would like to know why she was sick for so long; This is a spontaneous report from a Pfizer sponsored program from a non contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (Pfizer Covid-19 Vaccine, solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. Medical history included she was sick at the beginning of the pandemic from an unknown date. Patient previously took bnt162b2 (Pfizer Covid-19 Vaccine, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization and experienced marginal side effects. The patient concomitant medications were not reported. On an unspecified date, the patient experienced achy joints, chills, fever, nausea, no appetite, she was sick for so long. The clinical outcome of the events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a consumer refers to her 22 year old daughter with no pertinent medical history and no drug reactions or allergies. In approximately April 2014, "Monday or Tuesday", the patient was vaccinated with a dose of GARDASIL route and lot # not reported). Concomitant therapies included hormonal contraceptives (unspecified). The consumer reported that after receiving GARDASIL in April 2014, the patient experienced sharp shooting pains in her arm and neck. Her arm felt like dead weight and was discolored and swollen. The consumer also explained that the patient called the doctor on "Friday" (date unspecified) who advised her to visit the emergency room. The patient went to the emergency room the same day and was not admitted. The following Tuesday (date unspecified) the patient called the doctor once more because the symptoms were still persisting. The doctor advised the patient to go back to the emergency room. the patient went to the emergency room where they performed an ultrasound to check for blood clots and was not admitted. Result of the ultrasounds showed there were not blood clots. At the time of the report, the patient had not recovered and was experiencing tingling and swelling in her hand. The patient did not receive treatment for the adverse events. This is one of several reports received from the same source. Additional information has been requested.
Patient passed out and convulsed for approx. 30 seconds. patient regained consciousness; EMS arrived; patient's vitals were WNL.
8 days AFTER receiving the vaccine, injection site is red, raised, itchy like there is a welt under the skin
a red rash and itching around the injection site; a red rash and itching around the injection site; red doughnut like area around the injection site; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: EL9263) via an unspecified route of administration in left arm (upper left shoulder area) on 25Jan2021 at 19:00 as single dose for COVID-19 immunisation. There were no additional vaccines administered on same date of the Pfizer Suspect and prior vaccinations (within 4 weeks). The patient's medical history had pacemaker. Patient's Medical History (including any illness at time of vaccination) was none. No historical vaccination, he has never had a reaction to a vaccine. Concomitant medications were not reported. On Saturday 06Feb2021, the patient started experiencing a red rash doughnut like area and itching around the injection site. He was due for his second dose and wants to know if he should be concerned. The patient explains he got a shot about 3 weeks ago and thinks he was having a reaction. He explains he has a red doughnut like area around the injection site. It is round and with little dots and was red. He was wondering if that was something to worry about and was this serious. He was scheduled for the second dose in the next 2 or 3 weeks and wants to know should he get the second dose. Adverse event following prior vaccinations was none. There was no family medical history and tests relevant to adverse event. His wife put a little cortisone cream as treatment to help with the itching. The outcome of the event was not recovered.  Follow-up (09Feb2021): New information from same consumer included: Patient details, Relevant medical history, Product and events details and clinical information added.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Started not feeling well; really feeling bad; teeth was chattering and getting chills at 6PM; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Started not feeling well), FEELING ABNORMAL (really feeling bad) and CHILLS (teeth was chattering and getting chills at 6PM) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ALBUTEROL [SALBUTAMOL] for Asthma, THYROID (ARMOUR THYROID) for an unknown indication.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Dec-2020, the patient experienced MALAISE (Started not feeling well), FEELING ABNORMAL (really feeling bad) and CHILLS (teeth was chattering and getting chills at 6PM). The patient was treated with PARACETAMOL (TYLENOL) at a dose of Every 6 hours for 3 times and ALBUTEROL [SALBUTAMOL] at a dose of 1 puff. At the time of the report, MALAISE (Started not feeling well), FEELING ABNORMAL (really feeling bad) and CHILLS (teeth was chattering and getting chills at 6PM) outcome was unknown.            No treatment medication was reported. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-178675, MOD-2021-178675 (Patient Link).
Subsequent to receiving vax, the pt developed an injection site reaction characterized by focal fatty atrophy in the subcutaneous tissue and numbness.
I woke up with a fever on 10/19  around 2am. I also experienced diarrhea and body aches.
Vaccine was received and placed in the fridge on 11-Jan-2022 and administered on 20-Apr-2022; 82 patients administered expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (82 patients administered expired moderna vaccine) and PRODUCT STORAGE ERROR (Vaccine was received and placed in the fridge on 11-Jan-2022 and administered on 20-Apr-2022) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 038B21A and 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (82 patients administered expired moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was received and placed in the fridge on 11-Jan-2022 and administered on 20-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (82 patients administered expired moderna vaccine) and PRODUCT STORAGE ERROR (Vaccine was received and placed in the fridge on 11-Jan-2022 and administered on 20-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that health care facility inadvertently administered expired dose of the Moderna Covid-19 vaccine. lot number 084J21A was received and placed in the fridge on 11-Jan-2022, which means that all doses administered more than 30 days of use by date were not in accordance with the EUA. The vial did not undergo any temperature excursions. They identified an additional issue that staff were not dating the boxes of vaccine when placing them in the fridge for storage. Patient not reported adverse reaction to the HCP's knowledge. No treatment medications were provided.
Patient received vaccine after expiry date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that Patient received 1st Janssen dose on 12 May 2021, lot number was 205A21A.  Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
Headache, Fever, Diarrhea, NauseaVomiting, Fatigue, Chills Narrative:
Client light headed/dizzy, sweaty within a couple minutes after vaccination. Had client lay on floor/feet elevated. Initial BP 134/79, p: 70-easy to palpate. Symptoms resolved.  Observed additional 30 minutes. Feeling better, declined further evaluation and released. Vitals before leaving: 122/75, pulse 75, rr 16.
dizziness, severe h/a, inability to focus eyes-near syncope-to ER 9MAR95; CBC, & Vicodin PRN pain
Pt received 1st dose of Pfizer vaccine at 11 years and 8 months old
Received Tdap and Flu shot in left deltoid on 12/18/17. Approximately 1 week later starting on 12/25/17 experiencing pain at injection site when she moves her arm and pain when she tries to lift anything. Took TYLENOL and FLEXERIL and the ES TYLENOL lessens the pain. Injection site appears slightly swollen.
Brief strong headache, severe chills, fever 102.7,  muscle aches,  brief upset stomach, slept for 36 hours due to exhaustion
This employee presented for Janssen vaccination on 7.16.21.  He filled out the COVID 19 form as never having had a covid vaccination.  In addition he verbally asked this question and denied.     On 7/20/21 I received a call notifying us that he had previously had a Janssen vaccination on April 10th, 2021  (LOT # 1808982)     Never presented to this medical facility with any c/o or s/s of adverse reaction.
Pt has developed severe L arm pain w/ mild swelling and warmth after getting her Moderna mRNA vaccination in the LUE.  She reports the injection was given high in her shoulder.  She was treated w/ diclofenac and cold compress.  CBC, ESR, and CRP were drawn.  Pt to follow up as needed.
Patient had a syncope/near syncope episode in the car on the way home. She was unable to see and everything went black. Her arms were shaking for a few minutes.  Event lasted several minutes. Proceeded to the ER.
Neck pain when turning head to the right. 75% of the time turning to the right there is pain no pain other times.
Had mederna-19 vaccine shots and recently contacted Covid-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Had mederna-19 vaccine shots and recently contacted Covid-19) in a  patient of an unknown age and gender 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 COVID-19 (Had mederna-19 vaccine shots and recently contacted Covid-19). At the time of the report, COVID-19 (Had mederna-19 vaccine shots and recently contacted Covid-19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter. This case concerns a patient with unknown age and gender, with no medical history reported, who experienced non serious unexpected AESI of COVID-19 after dose of mRNA-1273. No information regarding start date of the event neither vaccination dates. The re-challenge is not applicable due to the nature of the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a patient with unknown age and gender, with no medical history reported, who experienced non serious unexpected AESI of COVID-19 after dose of mRNA-1273. No information regarding start date of the event neither vaccination dates. The re-challenge is not applicable due to the nature of the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
UrticariaPruritus & NauseaVomiting Narrative: 1000-Patient stated right hand itching no hives seen; VS-126/84;P-76;R-16;SAT-100%; MD at bedside to evaluate. Denies Respiratory difficulties; CP. 1007-Patient states nauseated, RRT at bedside, patient trying to vomit, turned to right side. Dr. from RRT ordered Epi 0.3mg/ml to be given, Epi administered to left thigh, EMS called. 1015- VS; P-69;R-16;BP-110/72, Sat-98, EMS on scene. Patient A & O x4. No difficulty breathing, loaded on EMS stretcher. 1022- VS-127/63; P-73; R-16: Sat-96 and capnography-41. Patient left T205 via EMS at 1022.
Covid19 Moderna vaccine administered, no serious adverse effects other than some arm soreness and general tiredness for first 24 hours,  but 2 days afterward noticed rash on skin near injection site, and 5 days later noticed constant itching and a lump formed under the injection site.  Lump is not protruding much and feels about the size of a large marble if palpated.   I am reporting it for collection of data, mostly, but do wonder if a second shot will produce a more pronounced reaction on this score?