chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid received from 12Aug2023 to 16Aug2023. No known allergies. No other medication in 2weeks.  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.
Severe pain of lower lip, so dry that they are almost raw, dry cracking of skin on and around edges of lips.  2+  weeks later has subsided with treatment and still persists.    Treating with interleukens to reduce cytokine over reaction and allergy homeopath
At site of vaccine injection, patient developed redness, swelling and pain-left upper arm/deltoid.
Tgey said exactly injected 0.3 ml undiluted doze; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (Tgey said exactly injected 0.3 ml undiluted doze) 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 08-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .3 milliliter. On 08-Jan-2022, the patient experienced ACCIDENTAL OVERDOSE (Tgey said exactly injected 0.3 ml undiluted doze). On 08-Jan-2022, ACCIDENTAL OVERDOSE (Tgey said exactly injected 0.3 ml undiluted doze) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.
Child found by sister unresponsive and on floor of their home around 4 pm, while he had been playing video games. Sister reported one hand shaking. Child was also incontinent of bladder, taken to Hospital and thought to have first time seizure. Records from hospital ER indicate he was thought to have a seizure as there was a period of reported unresponsiveness, incontinent bladder, biting tongue and a post-ictal period.
dose number: 3; Swollen at  the site of injection.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Lot number: FF2589) 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 Number: 2, Batch/Lot No: EL3247), for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "dose number: 3"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "Swollen at  the site of injection."  Follow-Up (21Dec2021): Follow-up attempts are completed. No further information is expected.
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038b21a and 060h21a) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy.   On 12-Apr-2021 at 8:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022 at 1:00 PM, received 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 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 23-May-2022 to 28-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.            Company comment: This is a spontaneous case concerning a 36-year-old male  patient with no relevant medical history, who experienced the non-serious unexpected event of COVID-19 (AESI), more than 4 months after receiving an unspecified dose of mRNA-1273 vaccine. Clinical course and diagnostic test were not provided. Patient was treated with Paxlovid for 5 days, and one week after finishing it got fever, chills and congestion. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   No concomitant medications were reported.  The patient did not take any other medications/products within 2 weeks of starting COVID-19 treatment. On 2-JUN-2022 08:00  One week after finishing paxlovid series got a fever, chills, and congestion with Outcome of reaction as unknown.  Device Date :03-Jun-2022.; Sender's Comments: Company comment: This is a spontaneous case concerning a 36-year-old male  patient with no relevant medical history, who experienced the non-serious unexpected event of COVID-19 (AESI), more than 4 months after receiving an unspecified dose of mRNA-1273 vaccine. Clinical course and diagnostic test were not provided. Patient was treated with Paxlovid for 5 days, and one week after finishing it got fever, chills and congestion. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
At time of shot, left deltoid pain with shooting pain into left hand. Persistent left deltoid pain with exacerbation on froward flexion and lifting to horizontal.
I called PT's mother and confirmed that her daughter received a Pfizer Bivalent vaccination on 9/26/2022. Pt's mother states that her daughter is ok. Mother also stated that her daughter was "very sick" the day following the vaccination.
Swollen glands, chills, low fever, nasal discharge, pressure in sinuses, headache, dizzy, thirsty.
This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received PREVNAR 13 via an unspecified route of administration on 19Dec2018 at single dose for immunisation. Relevant medical history included allergy to iodine and sulfa. Concomitant medications were not reported. The patient reported that on an unspecified date her arm blew up from her shoulder to her elbow and she had burning. By the 3rd day, she had a sore throat and felt like her airway was closing and she was choking. She was coughing and choking so much tears were coming out of her eyes. She saw three doctors and was given cough syrup and one recommended she get an EPIPEN because of her allergic reaction to the vaccine. She has an allergy to iodine and sulfa but never had a reaction to a vaccine. It's been about a month and she still feels her immune system was and is wiped out. She went outside and felt her nose tingling and like she has walking pneumonia. She feels weak and just can't get better.  She is trying to figure out what caused this. At the time of the report, the outcome of the events was unknown. The information on the batch number has been requested.
Pt recvd Hep B vax on 13MAY91 & 13JUN91 & devel URI a few days following inject; pt refused 3rd dose of vax;
24 hour fever and chills Headache Loss of appetite Body aches Metallic taste in mouth
This is an instance of breakthrough COVID-19 disease after which death occurred.   The individual was vaccinated with the Pfizer product on 03/01/2021 and 03/22/2021. They tested positive for COVID-19 on 12/29/2021. They were admitted to hospital on 01/02/2022. They remained hospitalized until their death on 01/11/2022.
Headache, Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting, Chills, Redness/Swelling @ injection site Narrative:
Within 20 minutes of receiving the vaccination, I started getting dizzy, mouth, tongue and throat started tingling and becoming numb, nausea, tightness in chest, metallic taste in mouth. Was seen and monitored in the ER, released a couple of hours later. Tingling and numbness in mouth, tongue and throat and dizziness still persist over 24 hours later (at time of this report).
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for an unknown indication.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medications details were provided. No Treatment Medications details were provided.   This case was linked to MOD-2021-395985 (Patient Link).
Patient received BOOSTRIX and PREVNAR 13 vaccine (same office visit) injections in office - different syringes/sites. Pt. immediately became diaphoretic, hypotensive and nauseated. Diaphoresis and hypotension resolved over 30-60 min. Orthostatic hypoten. Nausea persisted x 1 hrs.
After her second dose, she reported some vaccine product leaking from the injection site as the needle was removed. She subsequently developed pain/pruritis and an erythematous rash with swelling at the injection site the next day. Pain was localized to the muscle at the surface of the skin. The pain at the skin resolved after 2 days. She still has some soreness in the muscle today
Client stated she woke up Sat morning with red welts on arm, nausea, shortness of breath.
discomfort in arm; Another blood test said they were anemic; feeling uncomfortable; They are in bed everyday with no energy at all; Started to get tired; started to get nauseous; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (discomfort in arm), ANAEMIA (Another blood test said they were anemic), FEELING ABNORMAL (feeling uncomfortable), ASTHENIA (They are in bed everyday with no energy at all) and FATIGUE (Started to get tired) in an 84-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with MODERNA COVID-19 VACCINE, Moderna COVID-19 Vaccine and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Seasonal allergy.    On 20-Jun-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (discomfort in arm), ANAEMIA (Another blood test said they were anemic), FEELING ABNORMAL (feeling uncomfortable), ASTHENIA (They are in bed everyday with no energy at all), FATIGUE (Started to get tired) and NAUSEA (started to get nauseous). At the time of the report, LIMB DISCOMFORT (discomfort in arm), ANAEMIA (Another blood test said they were anemic), FEELING ABNORMAL (feeling uncomfortable), ASTHENIA (They are in bed everyday with no energy at all), FATIGUE (Started to get tired) and NAUSEA (started to get nauseous) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood creatine: creatine was off the scale. On an unknown date, Blood test: Anemic. On an unknown date, Chest X-ray: everything was okay. On an unknown date, Red blood cell count: Decreased. On an unknown date, Weight: loss.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient had an oral contrast of their abdomen and everything was relatively okay.Doctor has not prescribed any medications to them. Patient also reported losing weight like mad.  No treatment information was reported.
full body aches, tem spike to 103, could not get out of bed the next day..2nd day after still pain, body aches, fever but seems to be improving
fever, shaking chills, fatigue for 4 days, starting the evening of the shot
feeling really bad during the 24 hour period.; experienced 103 degree fever starting 12 hours after her first vaccine shot; This is a spontaneous report from a non-contactable consumer or other non hcp. A 46-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Not reported) via an unspecified route of administration, administered on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history included the patient was affected with COVID-19 on Nov2020 to an unknown date which required hospitalization. The patient's concomitant medications were not reported. It was reported that on an unspecified date in 2021 after 12 hours of first vaccine shot the patient experienced 103-degree fever and It was lasted about 24 hours and the patient felt really bad during the 24-hour period. On an unspecified date the patient underwent lab tests and procedures which included fever was 103 degree. The patient was recovered from the event 103-degree fever in 2021. The outcome of the event feeling really bad during the 24 hours period was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a nurse prescriber refers to a 66-year-old female patient. The patient did not have any pertinent medical history and she did not use any concomitant medications. The patient was allergic to penicillin. On 22-AUG-2018, she was vaccinated with a dose of PNEUMOVAX 23 in the right upper arm, lot # R009162, expiration date: 06-JAN-2020 (exact dose and route of administration were not reported) for prophylaxis. On the same day, after PNEUMOVAX 23 was administered to the patient, she experienced induration in the area of right shoulder to antecubital region of the right arm. On 24-AUG-2018, the patient sought medical attention and was seen by the nurse prescriber. Blood work was performed (results not provided) and unspecified treatment was given for the adverse event. The patient appeared doing well but she did not recover. The relatedness between the event and PNEUMOVAX 23 was not provided.
Acute ischemic stroke, LVO occlusion L ICA terminus on 11/16
Breakthrough case of COVID. I had a low grade fever, chills, very tired and a headache which lasted about 24-48 hours. Lost my taste and smell.
Presented to ED after leaving AMA from another hospital in which she was being treated for Covid but felt she was not receiving proper care; dx with Covid PTA on 1/26/22; previously rec'd antibiotics and ivermectin at other hospital; TX: Zithromax, Rocephin, lovenox and zinc; REmained on room air for hospitalization
Vaccine brand other = Moderna; Vaccine administration date = 05Aug2022/ Vaccine brand = Pfizer / BioNTech; Vaccine administration date = 21Oct2021; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EN5318), in left arm, on 25Feb2021 as dose 2, single (Lot number: EN6201), in left arm and on 21Oct2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 77 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Aug2022 as dose 4 (booster), single (Lot number: A51866), in left arm and on 25Oct2022 as dose 5 (booster), single (Lot number: 020H22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient had no allergy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 05Aug2022, outcome "unknown", described as "Vaccine brand other = Moderna; Vaccine administration date = 05Aug2022/ Vaccine brand = Pfizer / BioNTech; Vaccine administration date = 21Oct2021". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 18Dec2022.
Patient was sick when it was time for his first set of shots, so when it came time for his second the doctor doubled up so that he would be up to date on his vaccinations. The date they were administered maybe entered incorrectly as I have been waiting for a call back from the doctor but it was his initial immunization that caused the change in patient.
I feel off like I'm not sick but I feel sick; numb in the arm I got the shot; I feel hot; sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old male patient received BNT162b2 (BNT162B2), on 08Feb2023 as dose 1, single (Batch/Lot number: unknown) at the age of 24 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION SITE WARMTH (non-serious) with onset 08Feb2023, outcome "recovering", described as "I feel hot"; MALAISE (non-serious) with onset 08Feb2023, outcome "recovering", described as "I feel off like I'm not sick but I feel sick"; VACCINATION SITE HYPOAESTHESIA (non-serious) with onset 08Feb2023, outcome "recovering", described as "numb in the arm I got the shot"; VACCINATION SITE PAIN (non-serious) with onset 08Feb2023, outcome "recovering", described as "sore". Therapeutic measures were not taken as a result of malaise, vaccination site hypoaesthesia, vaccination site warmth, vaccination site pain. Additional information: The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient did not received a COVID-19 Vaccine previously. No treatment for AE. No covid tested post vaccination. No covid prior vaccination: Patient felt off like he is not sick but felt sick, numb in the arm he got the shot and felt hot and sore. Patient not aware of any known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient developed nausea, itchy throat, headache and coughing. Patient refused EPIPEN/call 911 but did take BENADRYL and feels recovered.
11-2-07:  Received pneumovax and influenza vaccinations in the morning.  In the evening patient's arm was swollen and warm.  11-3-07:  Developed localized hives (about 15-20) in right arm near injection site.  Also had a headache upon awakening and arm pain.  Pt took 800 mg of ibuprofen for headache and pain.  Pt's pain decreased however headache remained so pt took Axert.  11-4-07:  Hives stopped but pt still had redness and swelling down arm.  11-5-07:  Pt still had headache and upper arm showed some warmth and swelling but did improve.  Pt went to see PCP on this day and PCP advised to apply heat or cold pack and to take benadryl and ibuprofen for symptom control.  11-6-07:  Pt felt better on this day.
Joint and muscle aches, low-grade fever, lethargy, loss of appetite, weakness.
This spontaneous report was received from a pharmacy student concerning a patient of unknown age. Concurrent conditions and medical history were not reported. On an unknown date the patient was vaccinated with an improperly stored dose of ZOSTACAX lot # L033311 (expiration date 01-DEC-2016) (dose and route not reported). Concomitant therapies were not provided. No adverse effects were reported. No adverse effects were reported. The was no product quality complaint (PQC) involved. Additional information has been requested.
Started seeing flare-ups of hand dermatitis (usually a reaction to food allergies / histamine intolerance) after first dose (Pfizer EN6204 on 3/11/21). Really ramped up after second dose (Pfizer ER8133 on 4/1/21). Much harder to clear up even with prescription steroid cream, constant flares ever since. I had gotten my flares to be minimal, less frequent, and easy to clear before I got vaccinated. I'm still having these issues. My dietician said she has seen multiple patients have continued, long-term side effects. My doctor was also not surprised and seems to have seen other patients with continued side effects like this. Both suggested I take a long-acting antihistamine like Claritin for a while.
Patient vaccinated 8/23/2021, 7/21/2021. Hospitalized COVID positive 1/11/22
On Day 8 of vaccination (1/3/21) woke up with a sore arm, swelling and hard area.  Slight pink area and warm to the touch. Mild itching occurred evening of 1/3/21. Cold compress applied, not helpful. On day 9 (1/4/21) all symptoms continue but increase of pain and heavy feeling in arm. Swelling is increased, pink area is increased. Remains warm to touch.
Information has been received from a registered nurse concerning an 18 day old male patient who on 11-SEP-2009 was vaccinated with a dose of ROTATEQ (lot number not reported).  Concomitantly the patient received a dose of PEDVAXHIB (manufacturer unspecified), a dose of PREVNAR, DTAP and IPOL.  No adverse effect reported.  Additional information has been requested.
Torso rash - from underneath breasts all over abdomen and down to very tops of thighs. Looked like measles, not very itchy, lasted a week or so.; Torso rash - from underneath breasts all over abdomen and down to very tops of thighs. Looked like measles, not very itchy, lasted a week or so.; Torso rash - from underneath breasts all over abdomen and down to very tops of thighs. Looked like measles, not very itchy, lasted a week or so.; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose, via an unspecified route of administration, administered in arm right on 13Jun2021 15:00 (Lot Number: EWO185) at the age of 54 years old as single dose for covid-19 immunisation. Other medical history: No. The patient previously took alatrofloxacin mesylate (TROVAN) and experienced allergy, and previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in left arm on 23May2021 15:00 (Lot Number: EWO185) at the age of 54 years old, for covid-19 immunisation. There was no other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. And the patient had other medications in two weeks. On 14Jun2021 10:00, the patient experienced torso rash - from underneath breasts all over abdomen and down to very tops of thighs. Looked like measles, not very itchy, lasted a week or so. No treatment was received. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovered in Jun2021.