chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 weeks after receiving Moderna booster at left deltoid(third moderna injection), patient had onset of pronounced swelling of bilateral hands with associated sense of itching. Also return of pain at injection site, sense of itching at abdomen and back of head, swelling of left ear
Red, swollen and warm face, left side; Red, swollen and warm face, left side; Red, swollen and warm face, left side; This is a spontaneous report from a contactable nurse and a contactable physician.  A 39-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at left arm on an unspecified date at single dose for COVID-19 immunization. The patient medical history included anxiety, depression, cough, pain, paranasal sinus congestion, infection, hypertension, diarrhea, nausea and vomiting, constipation, type 2 diabetes mellitus, skin rash, erythema of skin, anemia, muscle spasm, asthma, hypercholesterolemia, allergy disorder, acute otitis media, gastroesophageal reflux disease, intellectual disability, acne vulgaris, otitis media, hypersensitivity condition, bacterial infection, dental disease, infective otitis externa, generalized ache or pain, allergies to cotton and thistle, each from an unknown date and unknown if ongoing. The patient's concomitant medications included paracetamol (TYLENOL), atorvastatin, cetirizine, cyclobenzaprine, esomeprazole magnesium (ESOMEPRA), ferrous sulfate, lisinopril, loperamide, metformin, venlafaxine, all from an unknown date and unknown if ongoing. On 14Jan2021 at 10:15, the patient experienced red, swollen and warm face, left side. Therapeutic measures were taken as a result of the events and included treatment with BENADRYL. The patient outcome of the events was recovering.   The information on the batch number has been requested.
Stabbing chest pains behind the sternum, with radiating pain into his sides and abdomen. The pain came in waves, rated between 6/10 and 8/10. His pulse and blood pressure remained regular, he was not sweaty or clammy, and had no shortness of breath (only discomfort with deep breaths). Onset was around 9pm, 400mg of Ibuprofen was administered at 9:15pm, and symptoms subsided near midnight. There were no further symptoms the following day.
The consumer received the ROTATEQ vaccine at 18-weeks-old.; Bloody stool; This spontaneous report was received from a consumer referring to an 18 week old female patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 25-FEB-2021, the patient was vaccinated  at 18 weeks old with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) per oral route (strength, dose, frequency, anatomical location, lot # and expiration date were unknown) for routine vaccination.  The reporter was concerned because the patient's age at vacciantion was outside of that 6 to 12 weeks window that was the correct vacciantion schedule. On an unknown date in February 2021, the patient was taken to the Emergency Room, for bloody stools (haematochezia)(patient was not admitted to the Hospital).   At the time of the report, the outcome of haematochezia was unknown. The reporter did not mention the causality assessment between the event and Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ) vacciantion.
Rash starting on injection arm first, but later spreading to both arms and both legs.  Initially very red with small lesions, but later the rash has faded but itching has endured on both arms and both legs.
I had head congestive, fever, and a sore throat. These symptom have been going on for about 5 or 6 days. They tested my for COVID-19, negative result.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021 at 10:22 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Apr-2021 at 10:22 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of the patient was reported as 62.39.  Concomitant medication of the patient was not reported.  Batch number 007C21A underwent temperature excursion on 27-Apr-2021 with temperature of 35 degrees Fahrenheit at 09:00 AM. These vials were moved to fridge on 19-Apr-2021 and beyond use date for the vials was reported as 19-May-2021. The vaccines moved to clinic on 27-Apr-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).
whole body aches; joint paint; headache; insomnia; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received BNT162b2 (BNT162B2), administered in arm right, administration date 31Dec2021 13:00 (Lot number: FL3198) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: RESTASIS. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 23Feb2021, when the patient was 50 years old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EL3247), administration date: 16Mar2021, when the patient was 50 years old, for COVID-19 immunization, reaction(s): "mild body ache", "joint pain", "fatigue". The following information was reported: IMMUNISATION (non-serious) with onset 31Dec2021 13:00, outcome "unknown", described as "booster"; PAIN (non-serious) with onset 01Jan2022 02:00, outcome "recovering", described as "whole body aches"; ARTHRALGIA (non-serious) with onset 01Jan2022 02:00, outcome "recovering", described as "joint paint"; HEADACHE (non-serious) with onset 01Jan2022 02:00, outcome "recovering", described as "headache"; INSOMNIA (non-serious) with onset 01Jan2022 02:00, outcome "recovering", described as "insomnia". Therapeutic measures were not taken as a result of pain, arthralgia, headache, insomnia.  Additional Information: The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The patient was not diagnosed with Covid-19 prior to vaccination. The patient has not been tested for Covid-19 since the vaccination.   No follow-up attempts are possible. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: EN6208), on 12Apr2021 as dose 2, single (Lot number: EW0153) and on 31Dec2021 as dose 3 (booster), single (Lot number: 4302580) at the age of 51 years for covid-19 immunization. The patient's relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing), notes: known allergies: sulfa; "sore throat" (ongoing). Concomitant medication(s) included: LEVOTHYROXINE; LIOTHYRONINE; BUSPIRONE; SAM-E; VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]; SELENIUM; FISH OIL; MAGNESIUM; LUDEN'S taken for oropharyngeal pain; METHYL ASSIST; KSM-66; VCLEAR EPS 7630; also reported as other medication in 2weeks. Past drug history included: Codeine, reaction(s): "known allergies: Codeine"; Macrobid, reaction(s): "known allergies: macrobid"; Frovatriptin, reaction(s): "known allergies: frovatriptin". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 included Paxlovid (Lot number: FY9901) started from 18May2022 to 23May2022. Clinical course was reported as, Metallic taste while taking medication. Burning tongue sensation after stopping or thrush; feels like recurrence of symptoms with cough, exhaustion started on 24May2022. The patient did not receive treatment for the symptoms and was not recovered from the symptoms.
itching; rash in the upper arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) and INJECTION SITE RASH (rash in the upper arm) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching) and INJECTION SITE RASH (rash in the upper arm). At the time of the report, PRURITUS (itching) and INJECTION SITE RASH (rash in the upper arm) outcome was unknown.            No concomitant and treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.
Left arm swelling, shot #3 no swelling with the first 2 shots. Dizziness X 24 hrs.
vaccine administered from a vial punctured more than 18 hours ago; A spontaneous report was received from a (Pharmacist) concerning a  55 Years-old Female patient who received Moderna 's COVID-19 vaccine (mRNA-1273) and experienced  vaccine administered from a vial punctured more than 18 hours ago / Expired product administered.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 11 Mar 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 027A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 11 Mar 2021, the patient experienced Expired product administered.    Action taken with mRNA-1273 in response to the events was not reported.   On 11 Mar 2021, the outcome of the event was considered as resolved.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273, lot # 027A21A with no associated AEs.; Sender's Comments:  MOD-2021-041075:cross link MOD21-051431 MOD21-051527:cross link MOD-2021-027628:cross link MOD21-051523 MOD21-051528:cross link
Pt. was waiting outside bathroom door and fainted. Hit head on wall and twisted previously injured knee.
Moderna Covid-19 vaccine was initially stored in the refrigerator on 23-Feb-2022 and administered on 27-Mar-2022; dose administered from vial 33 days after stored in fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered from vial 33 days after stored in fridge) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was initially stored in the refrigerator on 23-Feb-2022 and administered on 27-Mar-2022) in a 24-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered from vial 33 days after stored in fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was initially stored in the refrigerator on 23-Feb-2022 and administered on 27-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered from vial 33 days after stored in fridge) and PRODUCT STORAGE ERROR (Moderna Covid-19 vaccine was initially stored in the refrigerator on 23-Feb-2022 and administered on 27-Mar-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Vial did not undergo any temperature excursions.  It was reported that, analysis of the vials associated with storage excursion was complete and likely did not maintain the activity necessary to fully protect against the SARS-CoV-2 (COVID-19) virus at time of administration.  Treatment medications were not provided.   This case was linked to MOD-2022-534453 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2022: Follow up received included suspect administration date, onset date of event expired vaccine use and updated narrative supplement.
patient developed headache the night he received the vaccine followed by stabbing pain and chest tightness 2 days after the vaccination. he was found to have diffuse ST elevation on EKG, troponin of 10223, admitted to the hospital of troponin monitoring, ibuprofen for pain control
Approx 10-15 minutes after vaccine administered, patient complaining of "funny feeling" in left side of neck.  Denied any difficulty breathing, but reported the "funny feeling" was how she first reacted to some antibiotics--to which she now reports as known allergies.
Pt received booster vaccine from DPH on 11/16/21. Next day pt is coughing and running a fever of  100. Having episodes of vomiting'.  11/18/21 Lethargic, not eating very productive cough noted /lung clear to auscultations with increased fever of 100.8. Chest x-ray ordered. Evening with decreased 02 sats requiring breathing treatments and 02.  Started on Levaquin daily.  11/19/21 Continued issue with fever and coughing requiring O2.  Coughing event during mealtime that required non-breather mask and transfer by EMS to outside hospital. Now on ventilator at other Hospital
No adverse event; First moderna dose on 10DEC2021 and second moderna dose on 22FEB2022; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First moderna dose on 10DEC2021 and second moderna dose on 22FEB2022) and NO ADVERSE EVENT (No adverse event) in a 36-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Feb-2022 at 2:23 PM, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 22-Feb-2022 at 2:23 PM, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First moderna dose on 10DEC2021 and second moderna dose on 22FEB2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First moderna dose on 10DEC2021 and second moderna dose on 22FEB2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First moderna dose on 10DEC2021 and second moderna dose on 22FEB2022).    Concomitant medications were not reported.  Patient had no acute illnesses at the time of vaccination and up to one month before. Patient had no chronic long standing health conditions. On 10-Dec-2021, at 12:38 PM patient received first dose of Moderna Covid-19 vaccine at a posology of 0.5 ml intramuscularly on left deltoid. The batch number was reported as 037f21a.  There was no ill reaction associated with this event.  Treatment medications were not reported.   This case was linked to MOD-2022-632620 (Patient Link).
This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (They have been in bed and), MIGRAINE (4 hours after the shot they developed migraine like headache,), NECK PAIN (neck pain), VACCINATION SITE MASS (huge lump on their arm that is growing and spreading/) and BREAST SWELLING (right breast is swollen) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced BEDRIDDEN (They have been in bed and), PAIN IN EXTREMITY (arm pain), PYREXIA (103°F fever) and MYALGIA (large muscle pain). 30-Nov-2021, the patient experienced MIGRAINE (4 hours after the shot they developed migraine like headache,), NECK PAIN (neck pain), VACCINATION SITE MASS (huge lump on their arm that is growing and spreading/), BREAST SWELLING (right breast is swollen), ILLNESS (felt sick  instantaneously / have been in bed/unable to function) and VACCINATION SITE LYMPHADENOPATHY (right arm lymph nodes are hugely swollen). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, BEDRIDDEN (They have been in bed and), MIGRAINE (4 hours after the shot they developed migraine like headache,), NECK PAIN (neck pain), VACCINATION SITE MASS (huge lump on their arm that is growing and spreading/), BREAST SWELLING (right breast is swollen), ILLNESS (felt sick  instantaneously / have been in bed/unable to function), PAIN IN EXTREMITY (arm pain), PYREXIA (103°F fever), VACCINATION SITE LYMPHADENOPATHY (right arm lymph nodes are hugely swollen) and MYALGIA (large muscle pain) outcome was unknown. No concomitant medications were reported. This case was linked to MOD-2021-404048 (Patient Link).
Swollen painful and itchy arm.  Dizziness, headache, fever and swollen lymph nodes.
About 6 hours after receiving the vaccine soreness started in the left arm. By 8 hours post injection, the soreness spread to a a muscle ache in the left shoulder and chest/lungs. By 9 hours post injection, the aches spread to the right shoulder. At 10 hours post injection, it has spread down my back and to the legs with full body aches. Severe soreness/aches over the entire body lasted for about 2-3 hours before gradually subsiding. At 21 hours post injection (current time), still feeling extreme fatigue. It is unclear if the fatigue is a direct result of the vaccine, lack of sleep from the body aches, or both.
He knows someone who now has tinnitus (ringing in the ears) right after second of covid vaccine; This is a spontaneous report received from a contactable consumer via Pfizer sponsored Program. A patient of unspecified age and gender received 2nd dose of bnt162b2 (COMIRNATY,Batch/Lot number was not reported),via an unspecified route of administration on an unspecified date as Dose 2,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The reporter stated that he knows someone who now has tinnitus right after second of covid vaccine on an unspecified date.Medical inquiry forwarded or referred to MI.The outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101069074 same reporter, same drug/event, different patient
This is a cluster of 2 patients who experienced adverse events following administration of FLUZONE HIGH-DOSE; lot number UH436AB. The event for the other patient was captured in case number 2011-10927. Initial report was received from a healthcare professional, on 08 November 2011. A 72-year-old female patient had received an Intramuscular (IM) injection of FLUZONE HIGH-DOSE; lot number UH436AB on 18 October 2011. On an unspecified date, the patients arm swelled up from the shoulder to the elbow; the area was red and painful. The patient received corrected treatment with pain medications and ice packs. No further information was available at the time of the report. The patient outcome was reported as resolved/recovered. Follow-up information was received from a healthcare professional on 17 January 2012. The patient received an Intramuscular injection of FLUZONE HIGH-DOSE in upper arm. The patient was not seen in follow-up for the symptoms described and no additional corrective treatment provided. Documents held by sender: none.
After 5 minutes of finishing all the immunization, patient reports feeling very nauseous and going to pass out. Patient became very diaphoretic, pulses weak, and loss consciousness for less than 10 second with no seizure activity noticed at that time. EPI injection given activated 911 call and patient pulse weak and thread 30s and BP 80/60s, alert and oriented and but very pale looking and second dose of Epinephrine is given and HR became 40-50s, BP is 90/62. EMS came and 12 lead EKG done, sinus bradycardia 40s, BP 100/70s, 500 ml fluid bolus given and transfered the patient to the emergency room.