chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt came in for PPD reading this AM, reports that she has a knot on her arm and it has been sore. Slightly red area the size of a silver dollar with swelling noted to RD area. Encourage pt to take TYLENOL for pain, follow up with Primary MD.
Headache, Myalgia, Fever, NauseaVomiting, chills Narrative:
Whole body aches and pains in muscles w/ joint involvement began during the night (estimating 4:00 am as my sleep was disturbed)after the dose was given. Extremely painful in movements on the bed. The pain lasted throughout the day. It felt like having a full-blown case of the Flu. Able to sleep somewhat comfortably the next night (waking up w/ turning around & turning over) w/ about half the aches the following day. Felt fatigued for 4-5 days afterward.
Loose stools; Feels extremely sick and tired; cough and burning in lungs; burning in lungs; Headache; Extreme fatigue; chills; Very High fever-- 103F; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (Loose stools), ILLNESS (Feels extremely sick and tired), COUGH (cough and burning in lungs), RESPIRATORY TRACT IRRITATION (burning in lungs) and HEADACHE (Headache) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Loose stools), ILLNESS (Feels extremely sick and tired), COUGH (cough and burning in lungs), RESPIRATORY TRACT IRRITATION (burning in lungs), HEADACHE (Headache), FATIGUE (Extreme fatigue), CHILLS (chills) and PYREXIA (Very High fever-- 103F). At the time of the report, DIARRHOEA (Loose stools), ILLNESS (Feels extremely sick and tired), COUGH (cough and burning in lungs), RESPIRATORY TRACT IRRITATION (burning in lungs), HEADACHE (Headache), FATIGUE (Extreme fatigue), CHILLS (chills) and PYREXIA (Very High fever-- 103F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103f (High) high. On an unknown date, COVID-19: unknown (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information included Antipyretic.   This case was linked to MOD-2021-106202 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up received on 18-MAY-2021, contains non significant information.( Patient was not interested in pursuing this report and he hopes he would not get sick again in the future)
Swelling of neck, throat, uvula, buzzing of lips and tongue for several days.
The day after receiving the second vaccine I experienced minor headache, fatigue and malaise lasting approximately 24 hours. 2 weeks after receiving the second vaccine I again experienced those same symptoms that I had immediately after the second vaccine,  this time lasting approximately 48 hours.  No symptoms were severe enough to seek medical attention.  Resolved on their own with rest.  Strange that I had same effects 2 weeks after the second shot.  Of note, I have since heard from several other people that experienced the same thing.
PCR Covid 19 Positive test on 7/7/21 with symptoms of nasal congestion on 7/7/21
Patient given first dose of MMR on 7/25/23.  MMR had expired on 7/22/23. Patient was contacted and is to return to clinic in 4 weeks for repeat MMR. Patient did not have any adverse effects from vaccine. Expired medication was removed from freezer immediately.
COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 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: "Elevated cholesterol" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: dietary latex" (unspecified if ongoing); "Known allergies: avocados, water chestnuts, bananas and kiwi" (unspecified if ongoing), notes: avocados, water chestnuts, bananas and kiwi. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative; (2022) Negative; (2022) Negative; (2022) Negative; (2022) Negative; (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.patient previously receive a COVID-19 Vaccine.Rebound symptoms and positive testing. Completed Paxlovid course, tested negative for 5 days in a row, then symptoms recurred and tested positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
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 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) 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: "HTN" (unspecified if ongoing), notes: other medical history: HTN; "prediabetes" (unspecified if ongoing), notes: other medical history: prediabetes; "A fib" (unspecified if ongoing), notes: other medical history: A fib; "BPH" (unspecified if ongoing), notes: other medical history: BPH. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included anti viral Paxlovid COVID 19 Treatment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
24 hours after shot: chills, nausea, muscle aches (legs, back), fatigue, pain at injection site, abdominal cramps
I thought I was imagining my tongue swelling while waiting post vaccine, I drove home where it only became worse and my blood pressure was in hyper tension. I called my doctors office who advised me to go straight to the hospital where I was admitted right away and given benadryl, apinephrine, famotidine, methylprednisolne, and racepinephrine around noon. I was release around four only to have swelling in my face tongue and arms, around 11pm when I went back to the hospital for more of the same treatments and was again released around 6 am on Wednesday the 24th. I have been suffering with headaches, dizziness tiredness and pain in the bottoms of my feet for the last four days.
felt a little fevers; This case was reported by a consumer via call center representative and described the occurrence of fever in a 56-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 6th May 2020, the patient received Shingles vaccine. In May 2020, less than a day after receiving Shingles vaccine, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.  Additional details were provided as follows: The patient received Shingrix around 6 p.m and felt a little fever this afternoon (on the day of reporting) which was recorded as 99.9 degree F. The reporter wanted any suggestion.
A report was received from a health care professional on 24 October 2003 concerning a 2 year old male vaccinee who inadvertently received Fluvirin on 21 October 2003. On 21 October a two year old vaccinee inadvertently received Fluvirin. The vaccinee did not complain of any adverse event at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 06 February 2004: A follow-up report was received from a health care professional indicating that the vaccinee had experienced no adverse events. No follow-up pending, all information received.
10/16/22 Patient developed fever and rash then eye redness. Seen at PCP sent to hospital for Kawasaki's evaluation. Admitted 10/20/22.  Negative by PCR for Covid-19 positive covid IgM on 10/21/22.  pt abd pain, vomiting, myalgia.  had elevated inflammatory markers, D-dimers Troponin and BNP. DX MIS-C after ruling out other alt dx.   Mom noted she and patient had mild symptoms cough and runny nose July 2022. Initial notes in hospital visit said Mom noted she and patient both tested positive in July.  Later notes said Mom tested positive by home test and patient tested negative in July Home test.
My are was fine but that evening I had gotten to shots and my hip was really red and I got really weak and then I got a bruised and leg and arm cramps a lot afterwards.
Patient complained of tongue swelling  about 15 minutes after receiving shot. Vitals taken BP 143/86, then repeated 10 minutes later 120/97. EMS called due to patient having tongue swelling and general feeling of unwell. EMS arrived and patient stated she was feeling better but was still examined by EMS. Patient ended up not going to hospital. No medications were given by pharmacy.
Information has been received from a physician concerning a female patient who "1 month ago", on approximately 01-NOV-2009 was vaccinated with her first dose of GARDASIL (Lot # not available). According to the physician, the patient passed out 10-15 minutes after receiving GARDASIL. The patient recovered on the same day of vaccination. The patient sought unspecified medical attention. Additional information has been requested.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.  On 15-Mar-2021, They received shipment, and since they did not know it was refrozen, they used it beyond 14-Apr-2021.  They have a sheet from the first shipment, that showed the transport conditions up to the time they had it. The earliest time on this sheet was 15-Mar-2021 at 6.45 am, and the graph started at 0.4°C at 6.45am, it has a 10-15 minutes time stamp, and states that between 6:45 and 7am it had -2°C.  Once they received the shipment, they placed it at freezer temperature, at around -20°C. After that, they removed a vial from the freezer to use it that same day, whenever they needed a vial to administer the vaccine. Date of first administration was around 17-Mar-2021, could not remember the exact date. Reporter did not know the expiration date, the states stated that by their numbers, the doses were viable up to 14-Apr-2021, the 30 days since it was thawed. Number of vials/doses impacted was 300 doses in total, 71 doses were administered to patients.
Passed out behind the wheel; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out behind the wheel) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passed out behind the wheel) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out behind the wheel) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant or treatment medications were reported. Reportedly, the patient had the shot yesterday and passed out behind the wheel.  Very limited information regarding this event have been provided. No further information is expected.; Sender's Comments: Very limited information regarding this event have been provided. No further information is expected.
About 10 minutes after vaccination, patient stated her Right hand felt, "like it was asleep". It resolved completely about  60-90min later.
Patient walked approximately 20 yards away from vaccination area and fainted. After receiving care from pharmacist, patient then threw up. Patient was monitored for about 30 minutes and did not seek further medical care.
Flu-like symptoms such as chills, aching muscles, headache, nausea, stomach upset.
Patient presented to pharmacy next day. Arm was swollen, painful, warm to touch. Pharmacist referred patient to physician.
I was having cold symptoms and was having small bubbles temple on my face on the right and it spread to the entire top side of face. Lots of swelling on the ear and jaw and pain. I had two at home test that was positive but clinic test was negative. Clinic for covid testing on 12Sep2021 & 1Oct2021. Urgent care on 29Sep2021 diagnosed as shingles and went to eye doctor the next am. Shingles was on eyelid.
Bilateral proximal muscle pain beginning in the thighs and progressing to the feet. CK and LDH were elevated upon initial presentation (537 and 207 respectively). Patient described pain as severe "fatigue" in all lower extremity muscle groups. No constitutional symptoms were noted. Repeat labs showed a decreasing CK over 7 days but LDH remained at 208. Symptoms are still present.
Large local reaction vs. cellulitis 7 inches long, went to ER -> IV ANCEF, then PO KEFLEX.
Headache; Feverish; Pain in injection side after one day of vaccine; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FR8737) via an unspecified route of administration in the arm left on 07Apr2021 at 12:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and cholesterol high. Concomitant medications included metformin hydrochloride 1000 (METFORMIN), atorvastatin 40 (MANUFACTURER UNKNOWN), acetylsalicylic acid 81 (ASPRIN) and glimepiride 4 (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Apr2021 at 08:00, the patient experienced headache, feverish, pain in injection side after one day of vaccine. The clinical outcome of the event headache, feverish, vaccination site pain was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Fever over 102 degrees. Persisting for several days. Cough, fatigue, chills.
soreness at the injection site.; 4 days later symptoms at the injection site got worse, now red and hot and swollen; 4 days later symptoms at the injection site got worse, now red and hot and swollen; 4 days later symptoms at the injection site got worse, now red and hot and swollen; This is a spontaneous report from a contactable consumer (patient wife). This consumer reported similar events for 2 patients. This is the 2nd of 2 reports.   A 77-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Dec2020 at 12:00 pm at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced the "usual reaction", soreness at the injection site, 4 days later symptoms at the injection site got worse, now red and hot and swollen on an unspecified date with outcome of unknown. This report is assessed as non-serious. Consumer asked if this was normal and if was ok to use paracetamol (TYLENOL) or ibuprofen (MOTRIN) to help bring down the swelling. Outcome of events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021002891 same reporter/drug, similar event, different patient
15 min later, lasting 2 days - light headed out of body and loss of hunger 4hrs later, lasting 4 days  - severe arm, shoulder, neck, jaw, pain with inability or lift arm or use fingers due to pain.  Ice and rest did nothing. Sleepless and considered going hospital, except that I could not drive and had no support.  day 2-day4, all over exhaustion. was unable to sleep due to arm, neck and face pain,
Had ringing in the right ear occur/start at 7pm the night of his vaccines which he got around 10am that morning. The ringing in the right has not gone away and is persistent.
Pt received the 1st GARDASIL 9 vaccine this morning. Within 2-3 minutes he became pale and fainted, was assisted to ground. His vital signs were monitored, legs elevated, cool rag on forehead. He awoke within 1 minute or less, color improved. He did report some lingering dizziness. He had history of fainting during an xray. He was given hard candy, juice, water. Was monitored in office approx. 50 minutes before discharge home. Initially BP 146/74, HR 90. At discharge BP 111/73, HR 67.
About 30 minutes following vaccine developed arm pain and a sensation that her throat was closing and wheezing.  Took a Benadryl tablet.   Presented to emergency department the following day at 1433 at that time no feeling of throat closing.  No swelling of the uvula or any tissues examined in the pharynx.  No wheezing.
STILLBIRTH; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a health care professional concerned multiple female (three mothers) patients with unspecified ethnic origin and race. No past medical history or concurrent conditions were reported. It was not reported whether the patient had been pregnant before. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date was unknown) dose was not reported, therapy start date were not reported, 1 total dose administered for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. unspecified date, the patients experienced stillbirth, and vaccine exposure during pregnancy. Reporter stated that, the patients (three mothers) had stillbirths due to the vaccine (the pregnancy resulted in a stillbirth). The date of the patient's last menstrual period and expected delivery date were not reported.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stillbirth and vaccine exposure during pregnancy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210955784-COVID-19 VACCINE AD26.COV2.S- Still birth. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20210955784-COVID-19 VACCINE AD26.COV2.S- Vaccine exposure during pregnancy. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Patient received a Flu vaccine on 9/22/20. On 9/23 Patient states she could not move her arm. On 10/5 she sought treatment and received a steroid pack. The doctor thought vaccine may have been given too high. She has since had two more doses of Medrol 10/14/20 & 11/3/20. Patient is now awaiting an appointment with a specialist to determine next course of action.
Systemic: Allergic: Anaphylaxis-Mild, Systemic: Confusion-Mild, Systemic: DRY MOUTH-Mild
Information has been received from a physician concerning a patient who was vaccinated as a child with a dose of MMR II. Subsequently the patient developed idiopathic thrombocytopenic purpura. Unspecified medical attention was sought. The patient's outcome was unknown. There was no product quality complaint involved. Upon internal review, idiopathic thrombocytopenic purpura was considered to be an other important medical event. Additional information is not expected.
Mom reported that <24 hrs after receiving vaccines, pt devrveloped fever, body aches, shakiness, vomiting.
Sudden behavior change, skin itching, breathing difficulty, felt tired, very angry can't sleep act strange. From this result he could not go to school.
Redness and swelling at injection site (Left deltoid).  On 10/28/2010 patient noted more redness also pain 2/10.  No treatment.
Low grade temp x several days, lesions started 2 days ago and are spreading - very itchy. Approximately 40 red papules -> scratching at them.