chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 12MAR96 2PM & w/in 2hr began to exp rxn;exp large lump, redness & severe pain @ the inj site;also had uncontrollable crying lasted 4-5hr;red, swelling, pain @ inj site, pale bluish color under skin;
NO ADVERSE.  Reporting clinical deviation only.  Patient received Moderna 0.5mL as Booster #1.  Monitored for 30 minutes and no adverse effects.  F/U 2 days later with facility nursing: patient had minimal side effects and is her normal status.
Varicella lesions noted on 1/15/03, with a total of about 25-30 lesions. No other illness.
Moderate injection site pain, worst at 6-7hrs after injection, improving by 9am the next morning.  Chills, night sweats, headache, myalgias, nausea started at 4am. All except headache resolved by 9am the next morning.
After she took the vaccine her sense of smell and taste have reappeared / As days go on her pain is getting better and she is feeling better everyday; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (After she took the vaccine her sense of smell and taste have reappeared / As days go on her pain is getting better and she is feeling better everyday) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Oral pain in 2018, Loss of smell in 2018 and Loss of taste in 2018. Concurrent medical conditions included Herpes infection (resulted in needle pricking pain in mouth, loss of taste and smell) since 2018.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (After she took the vaccine her sense of smell and taste have reappeared / As days go on her pain is getting better and she is feeling better everyday). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (After she took the vaccine her sense of smell and taste have reappeared / As days go on her pain is getting better and she is feeling better everyday) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.
At second dose today, patient stated his opposite arm (right arm) was sore after his first dose of the vaccine. He said the soreness started the day of the vaccine and continued for four days.
Information has been received from a medical assistant, concerning patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with PROQUAD (lot #: M033215 with expiration date: 09-JAN-2018, lot# M038229 with expiration date 06-MAR-2018 and lot# M034691 with expiration date 21-JAN-2018) (dose, strength, frequency, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature greater than 47°F but less than 77°F for 52 hours, at temperature greater than 15°F but less than 46°F for 3.5 hours and at temperature greater than 6°F but less than 14°F for 30 minutes without any previous temperature excursion. It was unknown if this information was registered in a digital data logger. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1707USA006628.
Next day post vax, the pt was found blue and unresponsive. Efforts to resuscitate were unsuccessful. Autopsy states cause of death as sudden infant death syndrome.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ALLERGIC REACTION, SUBSEQ  4/27/2022 --  RECURRENCE OF SAME SYMPTOMS
Crying at night, had episode of shaking and being unresponsive per Dad. Temp 104.1 at presentation to ER. Dx w/febrile seizure.
Right arm can barely move, burning in right arm, chemical taste in mouth, body aches, chills, fever , joint pain
rash; numbness; This is a spontaneous report received from a non-contactable consumer via Health Authority. A female patient (reporter's mother) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date in 2021 as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Enquired, the consumer called on behalf of her mother for information about whether a rash and numbness would be a side effect for the administration of the Pfizer's COVID-19 vaccine. The consumer reported that, the patient (mother) was administered with the first dose of the vaccine 3 weeks ago and she was feeling these symptoms since Sunday. On 14Mar2021, the patient experienced rash and numbness. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
started losing my muscle mass; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE ATROPHY (started losing my muscle mass) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) at an unspecified dose. On an unknown date, the patient experienced MUSCLE ATROPHY (started losing my muscle mass). At the time of the report, MUSCLE ATROPHY (started losing my muscle mass) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
not an adverse event, but we thought someone should know about this, as it was 3-4 days after  he received his vaccine, that he had an embolic stroke
Shot given 04/21/10 and on 04/22/10 pt said called out of work - due to fever (told to take APAP, which controlled fever, on 4/22/10 he said he DC'd APAP and fever increase 102 degrees, he was told cont. APAP. On 04/24/10 had trouble breathing and went to urgent care and on 04/25 he had hives and went to ER. ER told him DC Lamotrigine.
Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 22 years old female patient who experienced whole body itching and red, swelling, hard-red and hot at site, while she received vaccine FLUBLOK QIV. The patient' past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious whole body itching and red, swelling, hard-red and hot at site (Unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. It was reported that all the symptoms lasted for one week. (Other relevant tests included No lab data.) Final diagnosis was red, swelling, hard-red and hot at site and whole body itching. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Recovered / Resolved on an unknown date for whole body itching and red, swelling, hard-red and hot at site. List of documents held by sender: none.
This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm, erythema of extremities and swelling arm. On an unknown date, the outcome of the pain in arm, erythema of extremities and swelling arm were unknown. It was unknown if the reporter considered the pain in arm, erythema of extremities and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced extreme pain, redness, and swelling on her arm. The reporter did not agree to follow up from GlaxoSmithKline.
Vaccine was expired on 1Apr2022, stored in refrigerator on 04Apr2022 and administered on 11Apr2022; Expired vaccine administered to 155 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine was expired on 1Apr2022, stored in refrigerator on 04Apr2022 and administered on 11Apr2022) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 1Apr2022, stored in refrigerator on 04Apr2022 and administered on 11Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 155 patients) and PRODUCT STORAGE ERROR (Vaccine was expired on 1Apr2022, stored in refrigerator on 04Apr2022 and administered on 11Apr2022) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant drug information was provided. It was reported that the pharmacist thought that the expiry date of the vaccine was JUNE 2022, however the vaccine expired on 01-Apr-2022. Vial was initially stored in refrigerator on 04-Apr-2022. It was confirmed that the vial had not undergone any temperature excursion issue.  No treatment drug information was provided.
Vomiting, flu-like symptoms, migraine, no appetite, severe arm tenderness/redness and swelling day following shot Headache continued through day 2 with arm tenderness and nausea (decreased from previous day).
Acutely Migraines, Prolonged Headaches, 5/4/2021   Until present (6/24/2021)
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/06/21 pfizer,Lot#EL3246 2nd dose01/27/21Pfizer,lot#EL9262 Diagnosed covid positive:08.02.21 Symptom onset:07.30.21 Exposure:unknown Symptoms:headache ,body aches, runny nose
Tingling in left arm and left leg; Headache; Dose number 3; This is a spontaneous report from a non-contactable reporter (consumer or non-HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 21Dec2021 at 16:30 (Lot number: FD7218) at the age of 33 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included: LEXAPRO; TOPAMAX and AMOXICILLIN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Anatomical location: left arm; Lot number: EP7533), administration date: 05Apr2021, when the patient was 32 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Anatomical location: left arm; Lot number: EW0171), administration date: 26Apr2021, when the patient was 32 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 21Dec2021 at 16:30, outcome "unknown", described as "Dose number 3"; PARAESTHESIA (non-serious) with onset 21Dec2021 at 17:30, outcome "unknown", described as "Tingling in left arm and left leg"; HEADACHE (non-serious) with onset 21Dec2021 at 17:30, outcome "unknown", described as "Headache". Therapeutic measures were not taken as a result of paraesthesia and headache.  Additional information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine.  No follow-up attempts are possible. No further information is expected.
Patient presents to the ER with fine tremor of the arms. She states that she was sent by employee health. She states that she had the flu shot earlier today. She states she has a history of migraines and feels like she is about to get a migraine. She denies any numbness, tingling, weakness. She denies a history of tremor. She denies any chest pain or abdominal pain. She has no other complaints at this time.
Erythema and bruising on left upper arm that stayed present for nearly 2 weeks. No fevers. Large local reaction after DTaP #5; It gradually resolved on its own.
arm was more sore; Initial information received on 09-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves male patient of an unknown age who experienced arm was more sore (pain in extremity), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Past vaccination included FLUZONE QUADRIVALENT.  Medical history, medical treatment and family history were not provided.   Concomitant medication was not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious arm was more sore (pain in extremity), (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event pain in extremity was reported as unknown.   There will be no information available on the batch number for this case.
Headache, Myalgia, Arthralgia, Fever, Fatigue Narrative:
Heart racing, dizzy upon standing, and numbness in face occured within 5 minutes of injection. Sore arm, fatigue, and feverishness set in around 5 hours after injection. Headache began about 20 hours after injection and has persisted (as of 3/18/21, 3 days after injection). Sore throat, hoarse voice, and feelings of malaise set in around 40 hours after injection.
Noticed lesions 3/8/15 during  bath. On date of visit, 3/11/15 they were starting to dry up. Lesions on (R) lateral mid thigh with approx 1.5 x 3cm eryth indurated area. Within this area, there are 3 small scabbed vesicular lesions. Parent apply cortisone cream from OTC. painful to patient when touched.
Information was received from a physician concerning a 14 month old male with no medical history and no allergies who on 12 JAN 2005 was vaccinated with a first dose of MMR.  On 23 JAN 2005 the patient broke out in hives and was seen in the office on 24 JAN 2005.  The patient was treated with oral Benadryl.  Subsequently the patient had a follow-up visit and the hives had resolved.  Additional information has had requested.
He got his vaccine, and had to go from the roof to the parking lot.  He was in his car and thought he had put his car in park, but it was in neutral and he hit another car, which he thought he was hit.  The gentleman informed him that he was the one that hit him as he had watched him slowly advance to hitting him.  He did not know or was aware that he was even moving.  He has headaches normally but they have gotten worse since then.   He also has motion sickness but has learned to deal with it and get used to the side effects.  He also has blurry vision and just not feeling normal.  He did go see his PCP and she put him on Meclizine for the dizziness, which works about 50%, but not completely.     He did have the 2nd vaccine on 2/22/21 and still had the symptoms, which have stayed since then as well.  He then saw his PCP a week ago and she is scheduling for a CT scan to see if he has any blood clots.    He did have an aneurysm in his brain 28 years ago and they felt that he would not be able to survive it and deemed that he would be left as a vegetable, but has survived that and does have a little residual headache, but nothing severe.   He now is still having these three symptoms that he did not have prior to the vaccine.
Arm pain/ numbness around 1:00 PM. Nausea, chills, generalized fatigue, muscle cramps, weakness, fever of 38.2 at 4:00 PM when I woke up for work the next day.
Developed fever, high 103 degrees after IZS on 4/7/09. F/U in our office on 4/8/09 temp 100.9 taken TYLENOL. Mom states household sick.
This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age and ethnicity received PREVNAR, via an unspecified route of administration on an unspecified date at a single dose. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced redness at injection site, swelling at injection site, pain at injection site, and severe case of the chills. The clinical outcome of the events, redness at injection site, swelling at injection site, pain at injection site, and severe case of the chills, was unknown. No follow-up attempts are possible. No further information is expected.
her arm is still very sore; neck is sore this time, very tight and sore; Fatigue; headache; Arm is still really sensitive; very bruised in her arm.; Neck is very sore.; Got like a very red; Seems like it must have been swollen; This spontaneous case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (Arm is still really sensitive), CONTUSION (very bruised in her arm.), NECK PAIN (Neck is very sore.), PAIN IN EXTREMITY (her arm is still very sore) and MUSCLE TIGHTNESS (neck is sore this time, very tight and sore) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026021A, 023M20A and 004M2014) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced SENSITIVE SKIN (Arm is still really sensitive), CONTUSION (very bruised in her arm.), NECK PAIN (Neck is very sore.), VACCINATION SITE ERYTHEMA (Got like a very red) and VACCINATION SITE SWELLING (Seems like it must have been swollen). On 26-Oct-2021, the patient experienced PAIN IN EXTREMITY (her arm is still very sore), MUSCLE TIGHTNESS (neck is sore this time, very tight and sore), FATIGUE (Fatigue) and HEADACHE (headache). At the time of the report, SENSITIVE SKIN (Arm is still really sensitive), CONTUSION (very bruised in her arm.), NECK PAIN (Neck is very sore.), PAIN IN EXTREMITY (her arm is still very sore), MUSCLE TIGHTNESS (neck is sore this time, very tight and sore), VACCINATION SITE ERYTHEMA (Got like a very red), VACCINATION SITE SWELLING (Seems like it must have been swollen), FATIGUE (Fatigue) and HEADACHE (headache) outcome was unknown.            The patient stated that the events fatigue, headache, the typical that they had the first time,but worse even which she didn't expect with booster because she received half dose  No concomitant medications were reported  No treatment information was provided   This case was linked to MOD-2021-369214 (Patient Link).
Dizziness, Headache, Fever,  Employee's temperature is 99.9 Narrative:
Fatigue, malaise, body aches, mild headache starting 12 hours after vaccination  Fever of 101.3 24 hours after vaccination
Left thigh red around injection sites, slightly swollen, warm 5x8cm (approximate size), slightly raised, hard welt. Lumps under sites. Fever 103.0 (axillary) x 2 days with Tylenol, came down to 100.1. Fussy, no eating well. Symptoms resided after 2-3 days.
severe hives approximately 1 week after 2nd shot; began to clear with non-stop Benadryl after about 4 days.
Diagnosed with cellulitis; both lower legs broke out with a rash; A spontaneous report was received from a  Consumer concerning himself,75 years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced both lower legs broke out with a rash(rash) and diagnosed with cellulitis(cellulitis).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 01 Mar 2021,approximately six hours prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (batch: 010M20A) in the right non-dominant arm for prophylaxis of COVID-19 infection.  On 01 Mar 2021,the patient experienced both lower legs broke out with a rash. On 03 Mar 2021, Patient saw a physician and was diagnosed with cellulitis. The event cellulitis was medically significant.  Treatment for the event included beta methasone 0.1% topical cream.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  The outcome of the events, both lower legs broke out with a rash and diagnosed with cellulitis were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Copd before but now i have had heart an lung problems was in hosp for 6 days; Copd before but now i have had heart an lung problems was in hosp for 6 days; Bad breathing; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (Copd before but now i have had heart an lung problems was in hosp for 6 days), LUNG DISORDER (Copd before but now i have had heart an lung problems was in hosp for 6 days) and DYSPNOEA (Bad breathing) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COPD.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (Copd before but now i have had heart an lung problems was in hosp for 6 days) (seriousness criterion hospitalization), LUNG DISORDER (Copd before but now i have had heart an lung problems was in hosp for 6 days) (seriousness criterion hospitalization) and DYSPNOEA (Bad breathing) (seriousness criterion hospitalization). At the time of the report, CARDIAC DISORDER (Copd before but now i have had heart an lung problems was in hosp for 6 days), LUNG DISORDER (Copd before but now i have had heart an lung problems was in hosp for 6 days) and DYSPNOEA (Bad breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not provided.  Treatment medications were not provided.  Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Sender's Comments: Very limited information regarding these events has been provided at this time. No further follow-up information is expected.
Patient received expired vaccine. Agency and Pfizer recommend revaccination. Patient was contacted to do so.