chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4 days later broke out in itchy rash and raised areas. Took Benadryl and got relief and sleep. Called me this morning at 11:45 a.m. Recommended see MD. Benadryl most likely not strong enough to neutralize out reaction.
Mini seizures; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SEIZURE (Mini seizures) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced SEIZURE (Mini seizures) (seriousness criteria hospitalization and medically significant). The patient was hospitalized until 11-Jan-2022 due to SEIZURE. At the time of the report, SEIZURE (Mini seizures) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter.  No treatment information was provided. on Saturday 08-JAN-2022 at 6 pm his wife had what he thought was a stork.  Company Comment: This spontaneous case concerns a female patient with unknown age with no medical history reported, who experienced , Serious ( Medically significant , Hospitalization ) , unexpected , AESI event of Seizure which occurred sometime January 2022 after vaccination with the 3rd dose of mRNA-1273 ( Moderna Covid 19 vaccine) . This patient was hospitalized because of the event and was discharged on the 11th of January , 4 day post vaccination with the 3rd dose of the vaccine. The re-challenge for this case is not applicable since the event occurred after the 3rd dose and no additional doses will be given and also the event outcome is unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient with unknown age with no medical history reported, who experienced , Serious ( Medically significant , Hospitalization ) , unexpected , AESI event of Seizure which occurred sometime January 2022 after vaccination with the 3rd dose of mRNA-1273 ( Moderna Covid 19 vaccine) . This patient was hospitalized because of the event and was discharged on the 11th of January , 4 day post vaccination with the 3rd dose of the vaccine. The re-challenge for this case is not applicable since the event occurred after the 3rd dose and no additional doses will be given and also the event outcome is unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Patient reports itching at the site around 9pm (she applied anti-itch cream and it resolved; she reports that a bump developed around 10 pm but was resolved by the next morning.
Loss of consciousness, bladder control, loss of awareness and sense of confusion, loss of motor function (couldn?t feel legs or arms) for an estimated total of 15 mins. Assisted by EMT and nurse, monitored breathing and heart rate control. Cause of unconsciousness undetermined
was feeling better, now still symptomatic with cold and cough 3 weeks into the date of infection; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (was feeling better, now still symptomatic with cold and cough 3 weeks into the date of infection) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Sulfa (Sulfa). Past adverse reactions to the above products included Allergy with Sulfa. Concurrent medical conditions included Glaucoma and Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (TIROSINT), DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE (COSOPT) and TRAVOPROST (TRAVATAN Z) for an unknown indication.    On 13-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2022, the patient experienced COVID-19 (was feeling better, now still symptomatic with cold and cough 3 weeks into the date of infection). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 01-May-2022 to 05-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (was feeling better, now still symptomatic with cold and cough 3 weeks into the date of infection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Device Date was reported as 22-May-2022  Company Comment: This is a spontaneous case concerning a 74-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 7 months after receiving a dose of COVID-19 vaccine. The patient was treated with Nirmatrelvir/Ritonavir for 5 days due to COVID-19 (unknown onset date of COVID-19). 3 days after the last dose of Nirmatrelvir/Ritonavir, COVID-19 recurred. The symptoms of cold and cough persisted for 3 weeks since the date of infection but the patient feels better. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 74-year-old female patient with no relevant medical history, who experienced the unexpected, non-serious adverse event of special interest of COVID-19, approximately 7 months after receiving a dose of COVID-19 vaccine. The patient was treated with Nirmatrelvir/Ritonavir for 5 days due to COVID-19 (unknown onset date of COVID-19). 3 days after the last dose of Nirmatrelvir/Ritonavir, COVID-19 recurred. The symptoms of cold and cough persisted for 3 weeks since the date of infection but the patient feels better. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient under age 18 was vaccinated with JModerna, which is a vaccine error.  (If the person may receive a second dose, it will be per policy off-label use for a 17-year old). Troubleshooting: Scribe and vaccinator did not validate age;  screeners at the beginning of the process did not ask or turn away. Parent validated age as 18. Unreported as error, found in data mining.
Approx 3 hrs after admin Td, developed lightheaded. Self treatment water, candy, coffee with sugar with effect.
hives around injection site; body aches; chills so bad and can't get warm; pounding headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), CHILLS (chills so bad and can't get warm), HEADACHE (pounding headache), PYREXIA (fever) and VACCINATION SITE URTICARIA (hives around injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN (body aches), CHILLS (chills so bad and can't get warm), HEADACHE (pounding headache) and PYREXIA (fever). On 26-Mar-2021, the patient experienced VACCINATION SITE URTICARIA (hives around injection site). At the time of the report, PAIN (body aches), CHILLS (chills so bad and can't get warm), HEADACHE (pounding headache), PYREXIA (fever) and VACCINATION SITE URTICARIA (hives around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was not provided.   Reporter did not allow further contact
Pain started in left knee, and left hip; discomfort in left ankle; Left leg still weak and feels unstable; still achy; Left leg still weak and feels unstable/unstable; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in left arm at the age of 55-year-old on 26Mar2021 09:15 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  Medical history included Restless Legs Syndrome. No known allergies. No covid prior vaccination. Concomitant medications included ropinirole and statin. The patient experienced pain started in left knee, and left hip. Very severe at times. Some lighter discomfort in left ankle. Left leg still weak and feels unstable. It's gotten a bit better, but still achy and unstable. Events onset date was all on 27Mar2021 11:00. AE resulted in Disability or permanent damage. No treatment received for the events. The outcome of events was reported as resolved with sequel.   Information on the lot/batch number has been requested.
Broke out in blotchy rash on the chest, neck area, dizziness, occurred two hours after vaccination.
some swelling /kinda looks like I got bit by a giant mosquito; a rash; This spontaneous case was reported by an other health care professional and describes the occurrence of SWELLING (some swelling /kinda looks like I got bit by a giant mosquito) and RASH (a rash) 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 13-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (some swelling /kinda looks like I got bit by a giant mosquito) and RASH (a rash). At the time of the report, SWELLING (some swelling /kinda looks like I got bit by a giant mosquito) and RASH (a rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment drugs were reported.
day after receiving vaccine pt woke up with very large red rash covering her arm where she received the injection as well as her neck and her chest. she went to the md office and md stated it was a cellulitis and prescribed cephalexin to treat it. md told her it was due to the injection.
Sores in mouth for 2+ weeks Night sweats for 2 weeks Low grade fevers for 1 week Frontal headache behind eyes x 2 days (occurring at end week one post vaccine) Fatigue
hands and feet cold; jaw aching; chills; shaky; lethargic; unable to walk or move; Blood pressure was elevated; bad headache; numbness in my limbs, jaw, and face/numbness in left thigh; swelling of her neck; itchiness; swelling of her face; hives on her face; Initial information received on 08-Jun-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 60 years old female patient who experienced swelling of her face, lethargic, unable to walk or move, blood pressure was elevated, hands and feet cold, jaw aching, hives on her face, bad headache, numbness in my limbs, jaw, and face/numbness in left thigh, swelling of her neck, itchiness, chills and shaky after receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included BETAMETHASONE; HYDROXYCHLOROQUINE; RIZATRIPTAN; SERTRALINE; MONTELUKAST SODIUM (SINGULAIR); TRAZODONE; and FAMOTIDINE (PEPCID [FAMOTIDINE]).  On 25-May-2023, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (strength, expiry date and lot number: not reported) via unknown route in unknown administration site for Immunization. Information on the batch number was requested.  On 27-May-2023 the patient developed swelling of her face (swelling face), hives on her face (urticaria), swelling of her neck (swelling), itchiness (pruritus) (latency: 2 days).  On 04-Jun-2023 the patient developed lethargic (lethargy), unable to walk or move (gait inability), blood pressure was elevated (blood pressure increased), bad headache (headache), numbness in my limbs, jaw, and face/numbness in left thigh (hypoesthesia) (latency: 10 days).  On 06-Jun-2023 the patient developed hands and feet cold (peripheral coldness), jaw aching (pain in jaw), chills, shaky (tremor) (latency: 12 days).  Relevant laboratory test results included: Blood pressure measurement - On 04-Jun-2023:  [175/140]  Action taken: not applicable.  The patient was treated with EPINEPHRINE for swelling of her face, hives on her face/neck, itchiness and Urticaria and was unknown for other events (bad headache, numbness in my limbs, jaw, and face/numbness in left thigh, lethargic, unable to walk or move, Blood pressure was elevated, hands and feet cold, chills, shaky, jaw aching).  At time of reporting, the outcome was Unknown for the events.
Patient tested Covid + on 4/17/21.  Admitted to Hospital on 4/19/21 with acute pancreatitis.
Pt recvd vax & had a pos hep B Test; both pts were seen by a MD & did not receive treatment;
This initial spontaneous case, was received on 22-Sep-2017, from other health professional (nurse), concerning a 24-year-old, adult, female patient. The patient's medical history and concomitant medications were not reported. On 21-Sep-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: less than 0.5 ml (as reported), route of administration: intramuscular, batch number: 00144621A, expiry date:31-May-2018, anatomical location: not reported). It was reported that, the patient was administered the vaccine with a 0.5 inches needle (explicitly considered as wrong injection technique), hence possibly received only a partial dose (explicitly considered as incomplete dose administered). It was reported that, the patient had not experienced any adverse event. At the time of this report, the outcome was not reported for the events. The reporter considered the events as non-serious. Follow-up received on 25-Oct-2017: The additional event (no adverse event) was added. It was reported that, the patient had not experienced any adverse event. The narrative was amended accordingly.
her right arm was sore for a day and a half; she felt aching in her joint for a couple of days /  the pain abated in her hip / intense 12 hours of pain in her right hip joint; pain worked its way out of her glute muscle; she was limping; This case was reported by a consumer via call center representative and described the occurrence of pain in extremity in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hip replacement (surgery done on 11th January 2019).   On 26th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 26th February 2020, less than a day after receiving Shingrix, the patient experienced pain in extremity, pain in hip, muscle pain and limping. On an unknown date, the outcome of the pain in extremity was recovering/resolving and the outcome of the pain in hip, muscle pain and limping were recovered/resolved.   It was unknown if the reporter considered the pain in extremity, pain in hip, muscle pain and limping to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and her right arm was sore for a day and a half and then she felt aching in her joint for a couple of days. Then in 36 hours the pain abated in her hip. The patient reported that the pain worked its way out of her glute muscle but for two days it was painful in her hip joint and she was limping. She described it as an intense 12 hours of pain in her right hip joint and then the pain abated and resolved. The reporter consented to follow up.
The patient presented to Medical Clinic 2 weeks post immunizations with small fine red raised bumps under his R eye, above both brows, on the bridge of his nose, and bilateral hands. The Patient thought the red raised areas may be a rash r/t his multiple immunizations. Upon inspection by the Provider it was determined that all of the areas of concern were/are weather related eczema. The Provider sent scripts for steroidal treatment in addition to salve/cream. The Patient was educated on adverse vs normal vaccine reactions, and re-educated on Smallpox aftercare. The Patient was also provided gloves and proper bandages for Pox site. The Patient verbalized understanding and was in agreement with the plan of care.
vertigo, nausea, headache, fatigue at 12 hours post vaccination. Headache unresolved at Severe joint pain in left hand and left foot 16 hours post vaccine. Unresolved at 70 hours.     Rash  and hives at injection site 70 hours post injection site. Unresolved. Rash and hive on right arm at inside of elbow at 71 hours. Loratadine taken
Case number PHEH2011US07957 is an initial spontaneous report received from a consumer (patient) on 27 Oct 2011. This report refers to a 78 year old female patient. She had concurrent condition of COPD (chronic obstructive pulmonary disease). She was vaccinated with a seasonal influenza vaccine (manufacturer and batch number: unknown) on unspecified date (3-4 years ago). The patient became ill on unspecified date after vaccination. The patient could hardly walk around and remained in bed. The patient also had a fever, diarrhea, hard time breathing and flu like symptoms. The doctor treated her with ZPAK and CIPRO, but they were not effective. She was taken to a hospital and was given oxygen. Later she started treatment with alendronate (manufacturer unknown) at a dose of 70 mg for unspecified indication in Jan 2010. Further, she developed a swallowing problem, acid reflux, burping, and had shorter breaths. The outcome was not reported. Both influenza vaccine and alendronate were suspected to cause the events.
42 y/o female with discrete erythematous rash to right upper arm at injection site of 1st Moderna vaccine.  Consistent with known large local reaction related to Covid-19 vaccine. Vaccine was given 8 days ago at  Library.  Rash does not extend distally, nor is resulting in fever or systemic symptoms, non-tender  - no evidence of cellulitis.  No ulceration, lesion, or spreading edema is present.  Plan to treat locally with cool compress, benadryl or zyrtec, and hydrocortisone cream.  Patient would prefer to utilize the medicines she has at home rather than prescription strength medication.  Explained rash should resolve in a few days and the importance of returning for 2nd shot in spite of local reaction. The patient indicates understanding of these issues and agrees with the plan.
Medical Assistant didn't combine the diluent with the powder. Only diluent was administered to patient. No outcome/symptoms reported by patient after diluent was administered. Patient was contacted to reschedule nursing appt. to reapply vaccine.
Patient was given the Pfizer vaccine as the second dose in series, when he received Moderna as the first dose in series
Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. Initial solicited report received from an investigator (Health Agency) in the trial on 21 September 2017. This case involves a 19 year-old female subject with no significant medical history. The subject's concomitant medication was not reported. The subject received. On 18 October 2016, 28 days after receiving a dose of ACAM2000 on 20 September 2016 (lot number, site of administration not reported) the subject was diagnosed with I20.9 angina pectoris, unspecified. The lab data of Troponin I result, ECG, and Echocardiogram was not available. MRI of brain, spinal cord and heart and lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. Outcome of the event, I20.9 angina pectoris, unspecified was not reported. Relationship to investigational product according to company: associated. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none. Sender's Comments: This case involves a healthy 19-year-old female subject who developed angina pectoris unspecified with favorable temporal association post vaccination with ACAM200. Angina is a listed event for ACAM2000 vaccine. Additional information on electrocardiogram, cardiac enzymes and final diagnosis is needed to further assess this event. Based on data available, the sponsor assesses this event as possibly related to study vaccine.
chills; mild HA; felt cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 67 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 09Mar2021 12:00 (Lot number: EN6199) at the age of 67 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TYLENOL taken for pain in extremity, headache, start date: 16Feb2021, stop date: 11Mar2021; POLYSPORIN COMPLETE taken for pain in extremity, start date: 09Mar2021, stop date: 15Mar2021. Vaccination history included: Bnt162b2 (Dose 1, Single; 12:15; Batch/Lot number: EL9267; Intramuscular, Anatomical site of injection: Right arm), administration date: 16Feb2021, when the patient was 67 years old, for COVID-19 immunization, reaction(s): "Headache", "Dizziness", "Nausea", "Fatigue", "Photophobia", "Right arm pain".  The following information was reported: FEELING COLD (non-serious) with onset 09Mar2021, outcome "recovered" (09Mar2021), described as "felt cold"; CHILLS (non-serious) with onset 09Mar2021 18:00, outcome "recovered" (09Mar2021), described as "chills"; HEADACHE (non-serious) with onset 09Mar2021, outcome "recovered" (09Mar2021), described as "mild HA". Therapeutic measures were not taken as a result of feeling cold, chills.  No follow-up attempts are possible. No further information is expected.
Red blotchy rash at injection site started approximately 2 days after administration. Rash is warm to the touch and swollen (upper arm feels tight). Tender to touch.  On a pain scale of 1-10 would rate it a 1. On an itchiness scale of 1-10 would rate it a 3.
Patient developed swelling, redness, warmth, tenderness 9 hrs after vaccine administration in the same area as the vaccine. Patient went to the ER and was diagnosed with cellulitis and was prescribed doxycycline 100 mg BID x 7 days.