chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 4 week old patient who was vaccinated with a dose of Rotateq (Lot #657049/0503U). No symptoms have been reported. Additional information has been requested.
Covid vaccine #1 3 days ago. Last night she started having chills diaphoresis broke out in sweats and having abdominal pain
doctor said nothing about second dose; This case was reported by a consumer via interactive digital media and described the occurrence of drug prescribing error in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug prescribing error. On an unknown date, the outcome of the drug prescribing error was unknown.  Additional details were provided as follows: The patient self-reported the case. The age at vaccination was not reported. After receiving 1st dose of Shingrix, the patient lost side effects and went to GlaxoSmithKline's site to look them up and found that the site said it was 2 doses. The patient's doctor's office said nothing about a second dose, which led to drug prescribing error.  The patient asked, if 2 doses still recommended.
This case was reported in a literature article and described the occurrence of influenza A (H3N2) in a child female subject who was vaccinated with Influenza vaccine (unspecified) (manufacturer unspecified). This case refers to patient 4 in the literature article. The subject had an underlying medical condition which was not specified. On an unspecified date, the subject received an unspecified dose of Influenza vaccine (unspecified) (administration site and route unknown, batch number not provided). The subject attended a local agricultural fair in August 2011 and had direct contact with a pig. In August 2011, at an unspecified time after vaccination with Influenza vaccine (unspecified), the subject experienced influenza A (H3N2), fever, cough, dyspnea, diarrhea and vomiting on 18 August 2011. The subject was hospitalised due to influenza A. At the time of reporting, the events were resolved. Summary of the literature article: During August 2011 until April 2012, 13 human infections with Influenza A (H3N2) variant (H3N2v) virus were identified; 8 occurred in the prior 2 years. This virus differs from previous variant influenza viruses in that it contains the matrix (M) gene from the Influenza A (H1N1) pdm09 pandemic influenza virus. A case was defined as a person with laboratory-confirmed H3N2v virus infection. Cases and contacts were interviewed to determine exposure to swine and other animals and to assess potential person-to-person transmission. The median age of cases was 4 years, and 12 of 13 (92%) were children. Pig exposure was identified in 7 (54%) cases. Six of 7 cases with swine exposure (86%) touched pigs, and 1 (14%) was close to pigs without known direct contact. Six cases had no swine exposure, including 2 clusters of suspected person-to-person transmission. All cases had fever; 12 (92%) had respiratory symptoms, and 3 (23%) were hospitalized for influenza. All 13 cases recovered. The author's conclusion stated that H3N2v virus infections were identified at a high rate from August 2011 to April 2012, and cases without swine exposure were identified in influenza-like illness outbreaks, indicating that limited person-to-person transmission likely occurred. Variant influenza viruses rarely result in sustained person-to-person transmission; however, the potential for this H3N2v virus to transmit efficiently is of concern. With minimal preexisting immunity in children and the limited cross-protective effect from seasonal influenza vaccine, the majority of children are susceptible to infection with this novel influenza virus.
This spontaneous report was received from a physician via a Company representative concerning to an unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On 06-APR-2016, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB lot # K020336, the expiration date: 17-AUG-2017 (dose and route were not reported). The total cumulative hours out of range were 360 hours with 34 C and 168 hours with 33 C as the lowest recorded temperature and the storage type was a refrigerator. There was no concomitant medication provided nor no Product Quality Complaint(PQC) involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
pt recv vax 25JUN97 11AM;baby crying inconsolably until 12ND:temp 104.2;leg swollen to 1 1/2 x the regular size;mom called PMD who told her to give motrin;PMD recommends ped DT for subsequent doses;
Systemic: Hypertension-Mild, Additional Details: Patient complains of having HTN since receiving first Pfizer COVID vaccine. Describes his head feeling "heavy" one week later and symptoms persist. Went to his PCP and Dr changed his HTN medication to control his blood pressure
overall body aches to the point of nausea with pain particularly bad around joints, headache and difficulty sleeping.
Received the first shot on 08/21/2021. Had a blood clot in my neck that caused a major stroke on 08/31/2021. The stroke left my right side paralyzed with limited movement. No prior medical history present that would warrant a blood clot or stroke.
Experienced immediate body shakes from cold (severe) and unable to stop physically shaking until a heated blanket was used on the highest setting for about an hour; temperature 101.8; nausea; headache; dizziness; weakness; heart pounding.  Felt weak and shaky for three days after fever broke.  Fever broke two and a half days after vaccine administration.
PAIN IN SHOULDERS AND WORSE (LAID HAND ON TOP OF SHOULDER AND SLIDE HAND TO DELTOID AREA); CONSTANT ACHE AND SORENESS OF MUSCLES FROM BOTH SHOULDERS TO BOTH ELBOW (FEELS LIKE BEEN BEAT)/PAIN IN BICEPS; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. The patient's past medical history included: anaphylactic reaction, and concurrent conditions included: arthritis, breast cancer, diabetic, alcohol user, non smoker, and penicillin allergy, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient past medication included prochlorperazine edisylate (compazine) whenever she experienced burning of mucus membrane, nausea, severe abdominal pain and vomiting. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 1808980 and expiry: 20-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced pain in shoulders and worse (laid hand on top of shoulder and slide hand to deltoid area). On APR-2021, the patient experienced constant ache and soreness of muscles from both shoulders to both elbow (feels like been beat) /pain in biceps (Dose number in series: 1). Treatment medications (dates unspecified) included: ibuprofen, diclofenac sodium, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in shoulders and worse (laid hand on top of shoulder and slide hand to deltoid area), and constant ache and soreness of muscles from both shoulders to both elbow (feels like been beat)/pain in biceps. This report was non-serious. This case, involving the same patient is linked to 20211240486 (Dose number in series: 2) This case, from the same reporter is linked to 20211240355, 20211241144 and 20211240211.
The patient did not experience any other AE; The caller said the patient received a dose after a temperature excursion occurred.; This spontaneous report was received from medical assistant, referring to patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 21-JUN-2022, the patient was vaccinated with one dose rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot #1858935 has been verified to be a valid lot, expiration date: 25-MAR-2023), administered orally for prophylaxis (strength was not provided).   Additionally, it was reported that rotavirus vaccine, live, oral, pentavalent (ROTATEQ) underwent to a temperature excursion of 9.8 degree Celsius (°C) for 47 minutes (product storage error). There was no previous temperature excursion. No additional adverse event was reported.
Initial misuse report received from a healthcare professional on 24 July 2013. A patient was administered a dose of ACTHIB vaccine that was reconstituted with Merck diluent. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
horrible migraine headache; chills; fever; body aches; fatigue; could not get out of bed; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 06Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 01), administration date: 30Dec2020, for COVID-19 immunization, reaction(s): "tired", "fatigued"; Bnt162b2 (DOSE 02), for COVID-19 immunization, reaction(s): "chills", "Fatigue", "could not get out of bed", "horrible migraine headache", "body aches", "fever". The following information was reported: MIGRAINE (non-serious) with onset 2021, outcome "unknown", described as "horrible migraine headache"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "body aches"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigue"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "could not get out of bed". Therapeutic measures were taken as a result of pyrexia.  Additional Information: After first dose on 30Dec she was tired and fatigued. After the second dose, 12 hours post dose she had a horrible migraine headache, chills, fever, body aches, fatigue and could not get out of bed. Took Advil and Tylenol-neither helped. This lasted 36 hours. After the booster on 06Oct. 24 hours post dose she developed the same symptoms as after the second dose. This lasted for 24 hours then felt better for 12 hours then felt horrible again for 24 more hours. She reports no other health issues. She says she is otherwise healthy and reports nothing .Event took place after use of product.  Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101478504 same patient/drug, different event and dose;US-PFIZER_INC-202101478505 same patient/drug, different event and dose
patient reported that cellulitis was diagnosed at hospital emergency room. Doxycyline  capsules and prednisone 40 mg prescribed. I spoke to patient on 11/06/2019 and reported improvement and good mobility although sourness was still present. Patient is to see her pCP next day 11/07/2019
Sore arm for 2 days which was expected.  Went away.  Then on day 8 the injection site got red, swollen, and hard and very sore and slightly itchy
Site: Bruising at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: PT has swelling redness and warm to the touch 3 inches below injection site. Area is about size of a baseball. Brusing at injection site. Advised to take benadryl and ice warm area. Pt is not feverish or in pain no itching. PT was advised to monitor through today and seek medical attention if fever, enlargment of arm, or pain occurs. Or if lasts into tomorrow. Will follow up with pt at close (6 hours) and again tomorrow
Tiredness, back muscle pain, headache, i took Aleve every 4 hours
Shot on Saturday.  Chills\Sweats on Saturday Night and Sunday Night.  Monday afternoon entire body weak and achy.  Extreme Chills and sweating at night.  Symptoms came and went, but were worst usually at night.  Now 5+ days past vaccination and still feeling tired, achy and getting extreme chills.  Sometimes have small amount of diarrhea and nausea.  Bad headaches.  Able to control by taking 2-3 advil but symptoms return after advil wears off.
c/o of hands itching at 1125am Benadryl  25mg given at 1125am bp 169/95 p 69 99% r 18 1133am itching decreased bp 159/92 p 73 r 18  1150am vitals at 135/83 70 16 98% itching resolved and sent home.
Patient developed chest pain and difficulty breathing 2 days after COVID Pfizer vaccine #2 administered. Diagnosed with myopericarditis in the setting of acute inflammatory reaction to mRNA vaccine.
RED, TENDER SWELLING ON RIGHT LATERAL DELTOID 2 1/2" X 1 3/4"
Site became red, swollen, and tender. Redness area became larger over the following days and site became hardened and red.
Patient states that he woke up about midnight after his flu and pneumonia shots on 10/30/19 and felt like he had a "whoosh" rushing feeling into his head, followed by weakness and inability to walk. He states that he felt this way for two days and that at one point he passed out. He did not go in to the ER or to be evaluated.
Fever spiked at 102.6 ,  twenty hours after second dose.  Left arm was very sore for 24 hours.  Upper arm  was warm to the touch,  very hard,  noticeable lump about 5" -6" in diameter. Upper arm is itchy, painful to touch and red below the vaccine sight
shingles / started on his left side and back between his arm and shoulder blade and is spreading towards the center of his back; itchy spot which he described as a nuisance; burning to pain; burning sensation; soreness in the upper arm / felt like he was punched in the arm hard; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th February 2020, the patient received the 1st dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced pain in arm. On 25th February 2020, the patient experienced shingles, itchy rash, pain and burning sensation. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the shingles, pain in arm, itchy rash, pain and burning sensation were not recovered/not resolved.   The reporter considered the shingles, itchy rash, pain and burning sensation to be possibly related to Shingrix. It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and had soreness in the upper arm that resolved two days later and claims that it felt like he was punched in the arm hard.  On the night of 25th February 2020, 5 days after receiving vaccination, the patient shingles symptoms started as an itchy spot which he described as a nuisance. Before the day of reporting and on the day of reporting the shingles, rash was spreading and was worse. There was itchiness and burning to pain.  He reported that the shingles started on his left side and back between his arm and shoulder blade and was spreading towards the center of his back but mostly on his left side. He saw his physician today and he prescribed an antiviral medication which he started today at lunchtime.  The patient claims that he has never received any dose of Shingrix previously and has never been diagnosed with shingles before.  The reporter requested information on our legal department because he believes that it was suspect that he received the Shingrix vaccine and then developed shingles.  The reporter inquired if GlaxoSmithKline would be paying for his antiviral medications.  The reporter consented to follow up. This was a legally significant report.
CoughWheeze Chills, night sweats, arm sore, eyes swollen Narrative:
4-28-2016 - Hep B, Tdap, Typhoid given. 4-29-16 Swelling and bruising, pain RT arm. 5-1-16 Left arm tingling, left hand tingling. 5-4-16 Left face and lips tingling. Advised contact PMD ASAP.
Information has been received from the administering pharmacist concerning a 78 year old retired female with no known allergies and no other pertinent medical history who on 23-AUG-2007 at 14:15 was vaccinated SC with a dose of Zostavax (Oka/Merck) (lot #658211/0884U) in the left deltoid. There was no illness at the time of vaccination. Concomitant drug therapy included lovastatin (manufacturer unknown). On 23-AUG-2007 th e patient experienced severe neuropathy type pain in the areas of a previous shingles rash. The patient phoned the reporting pharmacist and it was reported that no labs/diagnostics were performed. As of 04-SEP-2007, the pharmacist and it was reported that no labs/diagnostics were performed. As of 04-SEP-2007, the patient's severe neuropathy type pain persisted. Follow-up information from a pharmacist indicating that the patient had history of severe shingles but there was no rash or outbreak of shingles. On approximately 24-AUG-2007 (also reported as 23-AUG-2007) within a few days of receiving Zostavax (Oka/Merck) (lot #658211/0884U), the patient experienced severe neuropathy pain. The patient sought unspecified medical attention. It was also noted that the patient was still experiencing pain. The pharmacist considered severe neuropathic pain to be disabling.  Additional information has been requested.
Had bilateral pulmonary embolisms on 10/01/2021. Also had caught COVID and started having symptoms that mirrored the vaccine side effects the day after the vaccine was administered. Covid was confirmed on Tuesday following the shot. Could have been covid, the moderna shot, or both. Confirmed PE with CT and elevated labs. On Xarelto now.
After 24 hours I broke out in hives on my lower legs, trunk area, neck, and forearms. I also had trouble deep breathing.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION (COVID REBOUND); REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a patient of unspecified age and sex. Initial information was processed along with additional information on 06-OCT-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy, and diuretic for acne. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, 01 total, administered on left arm on 09-APR-2021 for covid-19 prophylaxis. Concomitant medications included spironolactone for diuretic for acne. On an unspecified date in SEP-2022, patient experienced Covid-19 symptoms which resulted to confirmed clinical vaccination failure (Dose number in series 1). The patient received additional dose of non-company suspect vaccine Moderna COVID-19 vaccine (elasomeran, Spikevax) (Dose number in series 2) (form of administration and route of administration were not reported, batch number: 017F21A, expiry: unknown) dose was not reported, administered on left arm on 03-NOV-2021 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 2). On an unspecified date in SEP-2022 patient experienced Covid-19 symptoms (confirmed Covid-19 infection) (Dose number in series 2) and received non company suspect paxlovid (form of administration and route of administration were not reported, batch number: unknown and expiry: unknown) dose was not reported, administered from 13-SEP-2022 till 17-SEP-2022 for covid-19 treatment and symptoms were ended on 18-SEP-2022 after paxlovid treatment completion but again new symptoms started (covid rebound) on 24-SEP-2022 and patient tested positive on 24-SEP-2022 (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran was not applicable and with paxlovid was withdrawn on 17-SEP-2022. The patient had not recovered from confirmed covid-19 infection (covid rebound), and the outcome of confirmed clinical vaccination failure and revaccination with different covid-19 vaccine was not reported.  This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000254381.; Sender's Comments: V0: 20221008913.-covid-19 vaccine ad26.cov2.s- Confirmed Clinical Vaccination failure. The event(s) has a compatible/suggestive 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. Therefore, this event(s) is considered not related.
Redness, swelling, and warm to the touch area measuring 3.5cm around the injection site 1 week after first dose. Slight itching at times but no pain or limited Range of motion to the arm.
No additional AE; temperature excursion; This spontaneous report was received from an HBP with responsibility for vaccine storage referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 21-APR-2023, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (1x dose, lot#: W025273, expiration date: 10-AUG-2024; strength, dose, route of administration, and anatomical location were not reported) for prophylaxis. The vaccine administered experienced temperature excursion at -10 C for 59 minutes on an unknown date (product storage error). No additional adverse events (no adverse event).
Chills; fever like 99.8; fatigue; body aches; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Chills), PYREXIA (fever like 99.8), FATIGUE (fatigue) and MYALGIA (body aches) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 16-Apr-2021, the patient experienced CHILLS (Chills), PYREXIA (fever like 99.8), FATIGUE (fatigue) and MYALGIA (body aches). At the time of the report, CHILLS (Chills), PYREXIA (fever like 99.8), FATIGUE (fatigue) and MYALGIA (body aches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were not provided.
This spontaneous report was received from a nurse referring to an adolescent patient of unknown gender. Information regarding medical history, concurrent conditions and concomitant medication not provided. On an unknown date in 2018, reported as when the patient was 13 years old, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, route, lot number and expiration date not reported). It was reported that the patient was now 16 years of age and wanting to receive the rest of the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) series (inappropriate schedule of product administration).
Developed shortness of breath afterward that worsened over time.  He was then diagnosed of extensive bilateral pulmonary embolism on 9/24/21