chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022; No adverse event; Patient administered the vaccine after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022).    No concomitant product use was reported.  Patient received half dose.  Vial did not undergone any temperature excursions.  No treatment information was provided
Swelling throughout whole arm and hand with some pain at joints, nausea, diarrhea, headache, clammy skin, fatigue.  Treatment: OTC medicine, heat, rest Outcome: Most symptoms subsided by Sunday at 5pm.  Lingering nausea, headache, fatigue on Monday and Tuesday morning following event.
tightening of throat; 5 hours after 2nd dose I experienced a thickening of my throat; voice change; numbness of nose and left jaw and cheek; swollen lips; Itching of face; This is a spontaneous report from a contactable Consumer (patient). A 47-year-old female (not pregnant) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number FA7485, on 16Aug2021 13:00 at single dose in left arm (at the age of 47-year-old) for COVID-19 immunization. Medical history included Chiari, Syringomylia, allergy to pineapple, and covid. The patient had covid prior vaccination. The patient had no covid tested post vaccination. Concomitant medication was none. The patient had no other vaccine in four weeks. The patient previously received first dose of BNT162B2 lot Number: FA6780 on 26Jul2021 13:00 in left arm for COVID-19 Immunization. On 16Aug2021 18:00 (5 hours after 2nd dose) the patient experienced a thickening of her throat,  tightening of throat, voice change, numbness of nose and left jaw and cheek, swollen lips. Itching of face. No respiratory issues.  She immediately took 2 Benadryl.  Symptoms did not get worse and started to clear within 15-20 min. She called her PC and had them document in her medical record.  The outcome of all events was resolved in Aug2021.  Follow-up attempts are completed. No further information is expected.
1st day after-fatique/headache/weakness/chills  2nd day- better 3rd day- dizziness started late night, subsided next morning.  4th day- same as 3rd 5th day- extreme dizziness at night, continued next day with sick feeling, stomach pain, leg weakness. Heart palpitations and racing(during night) Symptoms continued following 6th-10th days. Went to hospital emergency room 11th day due to doctor concerns of possible aFib. Admitted in Observation Unit overnight with IV fluids & heart monitor. Heart attack ruled out. Tachycardia event with follow up at cardiologist.
sharp pain in heart; feeling run down; Dry cough, comes and goes in waves, coughing; seemed sick; Musle pain; headaches; This spontaneous case was reported by a nurse and describes the occurrence of ANGINA PECTORIS (sharp pain in heart) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In February 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANGINA PECTORIS (sharp pain in heart) (seriousness criterion medically significant), FATIGUE (feeling run down), COUGH (Dry cough, comes and goes in waves, coughing), MALAISE (seemed sick), MYALGIA (Musle pain) and HEADACHE (headaches). The patient was treated with AZITHROMYCIN (Z-PAK) for Adverse event, at an unspecified dose and frequency. At the time of the report, ANGINA PECTORIS (sharp pain in heart), FATIGUE (feeling run down), COUGH (Dry cough, comes and goes in waves, coughing), MALAISE (seemed sick), MYALGIA (Musle pain) and HEADACHE (headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Aug-2021, Blood immunoglobulin G: positive (Positive) antibodies positive for IgG. On 29-Aug-2021, Blood immunoglobulin M: negative (Negative) Antibodies negative for IgM.. On 29-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No  Concomitant medications were provided. Treatment medication includes cough medicine. Patients had taken both the doses and was still producing spike protein.  Company comment: Very limited information regarding these events have been provided at this time. Further information regarding temporal association is necessary to assess causality.   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Follow up received  contains Additional events like sharp chest and heart pain, headache, muscle pain.; Sender's Comments: Very limited information regarding these events have been provided at this time. Further information regarding temporal association is necessary to assess causality.
Patient reported discoloration and white patchy areas on tongue.  Not painful and not raised.  Based on my research the closest thing I could find was "covid tongue".
The patient started complaining of dizziness and nausea a couple of minutes after the vaccine was given. Said he felt how the medication was going in the muscle and he didn't feel comfortable. Called Dr. and then he started getting pale and started shaking as if he had a seizure. Dr. stayed with the patient and he started to get some color back and began to feel better after about 10 minutes. The patient was observed in the room and released after 15 mins. He was able to walk out and advised his mom to keep an eye on him at home. Let us know if there are any questions.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Additional Details: paramedics came to check out patient and he was ok
VACCINE ON 4/29 WAS GIVEN TOO EARLY, PATIENT IS NOT IMMUNOCOMPROMISED NOR MEETS AGE REQUIREMENTS FOR A SECOND BOOSTER YET
The patient experienced hives by the injection site, which lasted 1 hour. The patient was treated with Benadryl.
Injection site Wheal - Information has been received from a health cre professional concerning a 1 year  old male patient who is approximately August 2000 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (635466/0782k).  Subsequently the patient developed a large wheal at the the injection site that when treated with ice resolved within 30 minutes.  the reporter stated concern regarding the lot of the vaccine.  It was reported that 3 other patients (Waes #0008164, 00082071 and 000282072) had a similar experience following exposure to measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  No further information is expected.
the third dose would have been due on 22-JUN-2020; This spontaneous report as received from a pharmacist refers to a 36 year old male patient. No information was given regarding the patient's concurrent conditions, concomitant medications or medical history.  In 2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 0.5 milliliter for prophylaxis (route of administration, lot number and expiration date were not reported). 22-DEC-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  0,5 milliliter for prophylaxis (route of administration, lot number and expiration date were not reported). On 22-JUN-2020, the patient was supposed to received the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) but at the time of this report had not received yet.
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 68-year-old male patient received BNT162b2 (BNT162B2), on 29Mar2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jun2022) Positive, notes: COVID symptoms returned after 5 days. Positive antigen test; (unspecified date) Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient had no known allergies. The patient did not receive any other medication in 2weeks. The covid symptoms returned after 5 days on 15Jun2022 at 12 PM. Positive antigen test. The patient took Paxlovid for Covid 19 treatment. The treatment start date was reported as 05Jun2022 and stop date was 10Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt recv vax on 12/10/96; on 10/29/98 pt exp post vax neuropathy-polyperipheral type w/ multi-limp weakness; f/u info reports pt exp first sx 10/29/96
Headache, light sensitivity, tight shoulder and neck muscles, skin feels light pain when touched, full body muscle aches, fatigue, brain fog, chills, hot flashes
sick; Initial information was received on 18-Oct-2020 regarding an unsolicited valid non-serious social media case from the patient.  This case involves an unknown demographic patient who was sick (malaise), while the patient received vaccine INFLUENZA VACCINE.  The patient had flu 4 times in the last 15 years (however not specified if had after vaccination).  The patient's past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient was sick (malaise), (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, the patient had absolute sickest year after taking vaccine and shot was only 40-60 % effective most years.  Details of laboratory data were not reported.  The patient ate food and took vitamins that supported her immune system as corrective treatment.  The patient had recovered from the event on an unknown date.  There will be no information available on the batch number for this case.    This case is linked to cases 2020SA294135, 2020SA294140, 2020SA294160, 2020SA294161, 2020SA294162, 2020SA294163, 2020SA294142, 2020SA294143, 2020SA294164, 2020SA294165, 2020SA294144, 2020SA294145, 2020SA294166, 2020SA294167, 2020SA294174, 2020SA294175, 2020SA294146, 2020SA294147, 2020SA294148, 2020SA294168, 2020SA294169, 2020SA294149, 2020SA294170, 2020SA294171, 2020SA294151, 2020SA294172, 2020SA294173, 2020SA294150, 2020SA294152, 2020SA294153, 2020SA294154, 2020SA294155, 2020SA294156, 2020SA294136, 2020SA294137, 2020SA294157, 2020SA294158, 2020SA294138, 2020SA294139, 2020SA294159 and 2020SA294231 (same reporter).
Generalized hives; OTC Benadryl per PCP recommendation; resolved after 1 week
Injection site reaction (half-dollar sized), fever >100 , swollen lymph node under left arm x 7 days
Severe pain in forearm; 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 PAIN IN EXTREMITY (Severe pain in forearm) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced PAIN IN EXTREMITY (Severe pain in forearm). At the time of the report, PAIN IN EXTREMITY (Severe pain in forearm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported. No treatment information was reported by the reporter.
Day 2: tired,muscle pain,shivering,fever,foot cramps - Day 3: redness, pain and swelling at injection site. Tylenol taken day 2 and at bedtime.
Injected into left shoulder. Did push ups to make arm feel better. Woke up next day and arm was extremly sore. About a 6-8 inch diameter swollen red area visible just under the injection site from tricept to bicept. Red area stretching to armpit. Armit very tight and sore. Upper arm very achy/painful. Arm still red and swollen 4 days after shot.
About 5 hrs after shot, ringing in left ear for 10 sec followed by pressure in ear. Next morning, ear ringing again.
Child experienced syncope for 5 seconds and/or seizure. Eyes rolled back, had some jerking movements, became sweaty and wet his pants. Blood pressure dropped to 70s/30s. Blood sugar was 79. Transported to hospital via ambulance.
Wheal & flare reaction within 3 hours of vaccination, milder during 1st reaction.  Txd warm compress, TYLENOL, BENADRYL.
First dose / on 1/27/2020 / never received the second dose; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received a year ago on 27th January 2020, batch number 4ME42, expiry date 14th November 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The nurse stated that, they plan to administer second Shingrix dose on the day of reporting but, but till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
This morning I woke up and the site of my injection (left deltoid) was itchy. When I looked at my arm there was a large, red splotch over the vaccination site. The red splotch was warm to touch. It continues to be itchy periodically. It has been about 11 hours since I first notice the red area and it does not seem to have improved at all.
Dizziness, Headache, Myalgia & NauseaVomiting Narrative:
Pt called 1/13/12 to report bilateral arm erythema and temp of 101 degrees one day after ADACEL immunization.
This spontaneous consumer report (initial receipt: 21-Sep-2012) concerns a female patient. On 20-Sep-2012 the patient received AFLURIA (batch number was not provided) intramuscularly. The patient only received a partial dose of AFLURIA. She stated that an unspecified amount of vaccine dripped on her arm during administration. No adverse effect reported.
w/in 12hr of vax pt devel a fever of 107 & was taken to ER;hosp is presumed, although not documented;this is 1 of 2 pt from this facility to devel a fever p/vax;
Patient received the wrong COVID vaccine for their second dose. Patient's first dose was Moderna given on 9/10/21. Patient then came in on 10/08/21 but received a dose of Pfizer. During the 10-15 minute stay, the patient reported no adverse effects.
Swelling, redness, hives at left deltoid muscle.  No fever or pain.  Mild itchiness at injection site.
leg weakness; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received  first dose of BNT162B2(PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose (Batch/Lot number was not reported), and received second dose of BNT162B2(PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose (Batch/Lot number was not reported) for covid-19 immunisation; teriflunomide (AUBAGIO), oral from 16Aug2019 and was ongoing, at 14 mg, 1x/day for multiple sclerosis. The patient medical history and concomitant medications were not reported. On an unknown date the patient developed a non-serious legs weakness after receiving both covid vaccines. The action taken for teriflunomide was unknown. It was not reported if the patient received a corrective treatment for the event (legs weakness after receiving both covid vaccines). At time of reporting, the outcome was Unknown for the event legs weakness after receiving both covid vaccines.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
On 6/4/2021 was  diagnosed with high blood pressure, had usually been low to regular.  Was prescribed Amlodipine to correct.  On 6/28/2021 experienced pressure and pain in the heart area and went to emergency room.  They found signs of possible blood clots, so also performed additional tests.  Found lymph nodes under the right arm enlarged (lymphadenopathy)
This spontaneous report as received from a registered nurse refers to an unspecified amount of patients. The patients were vaccinated with VARIVAX (Merck) lot # H007704, expiry date 30-MAR-2014, doses and routes not reported on: 05-OCT-2012 (2 doses), 17-OCT-2012 (1 dose), 26-OCT-2012 (2 doses), 16-NOV-2012 (1 dose), 20-NOV-2012 (1 dose), 30-NOV-2012 (1 dose), 12-DEC-2012 (1 dose), 29-APR-2013 (1 dose), 02-MAY-2013 (1 dose), 09-MAY-2013 (1 dose), 15-MAY-2013 (1 dose), 20-MAY-2013 (1 dose) 24-MAY-2013 (1 dose), 31-MAY-2013 (1 dose), 13-JUN-2013 (1 dose) and 14-JUN-2013 (1 dose). The vaccine was reported to be improperly stored (exposed to a temperature of -2.5C for a total time of 650.5 hours) since 06-SEP-2012. No patient specific information was provided for any administered doses. The administered doses were not specified as first dose or second dose of VARIVAX (Merck). It was not specified whether any one patient might have received both series from the affected VARIVAX (Merck) doses. No adverse effect reported. Additional information has been requested.
Patient provided incorrect date of birth to pharmacy: at time of administration and therefore received moderna vaccination but instead should have gotten pfizer vaccination; Patient correct date of birth is (17 years old)
Pt developed a 2.5 x 2.75 circle on R upper arm after rabies vaccine.  Pt was treated with Benadryl.
it's warm to the touch; there's still some hardness to it; it was bright red; their arm was 2 by 3 inches red; it was raised; it was painful; did not feet well; chest was tight; it was itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (their arm was 2 by 3 inches red), PERIPHERAL SWELLING (it was raised), PRURITUS (it was itchy), PAIN IN EXTREMITY (it was painful) and MALAISE (did not feet well) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy. Concomitant products included FENOFIBRATE and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PRURITUS (it was itchy), MALAISE (did not feet well) and CHEST DISCOMFORT (chest was tight). On 28-Jan-2021, the patient experienced ERYTHEMA (their arm was 2 by 3 inches red), PERIPHERAL SWELLING (it was raised), PAIN IN EXTREMITY (it was painful) and VACCINATION SITE ERYTHEMA (it was bright red). On an unknown date, the patient experienced VACCINATION SITE WARMTH (it's warm to the touch) and VACCINATION SITE INDURATION (there's still some hardness to it). At the time of the report, ERYTHEMA (their arm was 2 by 3 inches red), PERIPHERAL SWELLING (it was raised), PRURITUS (it was itchy), PAIN IN EXTREMITY (it was painful), MALAISE (did not feet well), CHEST DISCOMFORT (chest was tight) and VACCINATION SITE ERYTHEMA (it was bright red) had not resolved and VACCINATION SITE WARMTH (it's warm to the touch) and VACCINATION SITE INDURATION (there's still some hardness to it) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   In treatment Topical steroid cream and increased the dosing of Sertac.
Pt started to have lip swelling and throat closing on the morning of the 3rd day after receiving FLU vaccine.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 56-year-old female patient received BNT162b2 (BNT162B2), on 06Jan2022 as dose 3 (booster), single (Lot number: FJ1611) at the age of 55 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: REMIFEMIN. Past drug history included: Tetracycline, reaction(s): "Known allergies: Tetracycline".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162b2.