chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Post vaccination day 8 developed three small raised red, hot rashes near vaccination site. Patient circled the rashes on day 8, upon awakening on day 9 patient noticed rash has spread but was not as raised.  Rash does not itch but is hot to the touch.
Sudden onset of significant joint pain, body aches, skin pain (even my eyelids hurt) at 9 pm. Went to bed at 10 pm. Woke up at 1:30 am and pain was gone.
some lightheadedness for 1-2 hours after administration; some elevated heartrate in first 15 minutes after administration; This is a spontaneous report from a non-contactable consumer (patient). A 34-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247), via an unspecified route of administration at left arm on 20Jan2021 13:15 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took amoxicillin and experienced allergies. On 20Jan2021, the patient experienced some lightheadedness for 1-2 hours after administration and some elevated heartrate in first 15 minutes after administration. There was no treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in Jan2021.  No follow-up attempts are possible. No further information is expected.
7Feb2022 started with scratchy throat, then I started the cough and fever. The cough and shortness of breath persisted and I had to use my Albuterol and Advair twice a day for the respiratory issues I was having and took cough medicine. I saw the doctor on 9Feb2022. I was tested negative for COVID. I was on antibiotics from the doctor and prednisone for a month. The day I took the COVID test the next day 10FEB2022 and it was positive. I was coughing so much, I had a hard sleeping even though I was tired.
PATIENT WAS UNABLE TO LIFT ARM AND HAD A FAINTING SPELL LATER THAT EVENING AT DINNER TIME
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age. Nurse reported that the patient was administered a second dose of PROQUAD (Merck) (lot# reported as H015601, 0.5 ml, subcutaneous) after the labeled expiration date (reported as 06-JAN-2014) that had been properly stored on 30-JAN-2014. No adverse events were reported. The outcome was unknown. This was one of the three reports that received from the same reporter (linked with MARRS#1407USA004509 and MARRS#1407USA004510). Lot H015601 is not a valid lot number for PROQUAD (Merck). Additional information has been requested.
Information has been received from a physician concerning a 19 year old female with no known medical history, allergies or drug reactions who in March 2007, was vaccinated with the first dose of GARDASIL (lot no. route and site not reported) second dose (lot no. route and site not reported) was given in May 2008. There was no concomitant medication. No adverse effects were reported. Subsequently, she became pregnant. The patient's LMP was in April 2008. On 10-JAN-2008 the patient delivered a baby. No laboratory tests were performed. Follow-up information has been received from a nurse who reported that the patient had received the first and second doses of GARDASIL on 13-MAR-2007 and 17-MAY-2007 at another practice. The nurse confirmed the LMP was in April 2007 and the EDD was 25-JAN-2008. The nurse reported that the patient had come late in her pregnancy at 33 weeks of gestation. The nurse reported that the patient was admitted to the hospital on 12-DEC-2007 for preterm contractions and intrauterine growth restriction (IUGR). The nurse did not know how long hospitalization lasted. The nurse stated that the patient delivered early on 10-JAN-2008. It was a vaginal delivery with repair of a laceration. The patient was discharged from the hospital on 12-JAN-2008 following the birth. The patient did not return for her postpartum visit. The patient was seen in July 2008 for a non-pregnancy issue and her annual exam in December 2008. The nurse reported that the baby "seemed to be doing well", no problems were reported for the baby. Additional information has been requested.
Congestion or runny nose, Nausea or vomiting and Diarrhea
20 hrs after shot, cold chills, headache fever of 100.1 3pm fatigue set in took Tylenol 2-500 mg. Bed. 4/18/21 5 am. Backache, headache, fever of 99.1 Tylenol again. 2 pm all above temp is 99.2
TOOK TWO UNREFRIGERATED DOSES; This spontaneous case (PVX2019-861) was received from a pharmacist on 11-Apr-2019. It describes a male consumer who "took two unrefrigerated doses", while being on oral Vivotif (one dose every other day; lot no: 3003253) for typhoid fever prophylaxis.  Case report: The consumer picked up Vivotif a week ago and then left it unrefrigerated. She took two unrefrigerated doses on 09-Apr-2019 and 11-Apr-2019, respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took two unrefrigerated doses" was unknown.  Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable.
headache; very sore at the injection site and under my arm (armpit and into my breast area days after); low grade fever (99.8); general feeling down; This is a spontaneous report from a non-contactable consumer (other HCP). A 35-year-old non-pregnant female patient received second dose of BNT162B2 (Pfizer Vaccine; Lot number: EM9809) via intramuscular route in the left arm on 03Feb2021 at 16:45 as a single dose for covid-19 immunization. Historical Vaccine included first dose of BNT162B2 (Pfizer Vaccine; Lot number: EK4176) via intramuscular route in left arm on 13Jan2021 at 16:30 as a single dose for covid-19 immunization. No known allergies were reported. Patient has not taken any concomitant medications in last two weeks. Patient has not taken any other vaccine in last four weeks. On 04Feb2021 (the following day), patient experienced headache, very sore at the injection site and under my arm (armpit and into my breast area days after), low grade fever (99.8) and general feeling down. The patient underwent lab test which included low grade fever: 99.8 on 04Feb2021. The clinical outcome of the events was recovered on an unknown date.   No follow-up attempts are possible. No further information is expected.
2 x 2 red, raised and hot area around injection site, that lasted for about 7 days.
Immediately felt dizziness; Lower lip swelling; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 01Apr2021 at 15:15(at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and COVID-19 on an unknown date in Jun2020. Concomitant medications included lamotrigine (MANUFACTURER UNKNOWN), vitamin d (MANUFACTURER UNKNOWN) and vitamin b12 (MANUFACTURER UNKNOWN) all from an unknown date for an unknown indication. The patient had no known allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 01Apr2021 at 15:15, immediately after the vaccination the patient experienced felt dizziness and lower lip swelling. The events resulted in emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the dizziness and lip swelling was recovered on unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
3hr p/vax pt noted pain;states later noted reddening & pruritus;sent to PMD-states localized rxn, heating pad rx keflex advised;
no adverse event; an expired dose of MMR II was inadvertently administered; This spontaneous report was received from a certified medical assistant referring to a 12-month-old male patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 13-APR-2020, the patient was inadvertently vaccinated with and expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R010714 (expiration date: 11-APR-2020, additional dosage regimen information was not reported) for prophylaxis. No adverse effects were reported.
Patient can't move right arm, has sharp throbbing pain in right arm, pain is terrible and is radiating between shoulder down to elbow.
Hospitalization due to COVID-19 + (admitted on 2/17 and in ICU on 2/20)
21APR92 fever 103; 2-3 min grand mal seizure 3 hrs p/fever started;
Mom has very broken English but stated pt was tired afternoon of 11-21. Early morning of 11-22, awoke not feeling well, not able to walk, high fever, contractions of arms and hands. Taken to ER and transferred and was released same day.
Since receiving my second dose of Pfizer vaccine, I have had irregularities in my menstrual cycle. In July my period came 5 days early and began with spotting which led to regular bleeding. In August my period came 7 days early with abnormally heavy bleeding. In September my period was 5 days late with abnormally heavy bleeding. In October my period came 10 days early with abnormally light bleeding.
Covid 19 diagnosis; slight headache; stuffy nose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid 19 diagnosis), HEADACHE (slight headache) and RHINORRHOEA (stuffy nose) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported.).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced HEADACHE (slight headache) and RHINORRHOEA (stuffy nose). On 19-Jan-2021, the patient experienced COVID-19 (Covid 19 diagnosis). At the time of the report, COVID-19 (Covid 19 diagnosis), HEADACHE (slight headache) and RHINORRHOEA (stuffy nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment information was provided concomitant medication included vitiams; Sender's Comments: Very limited information regarding the events 'COVID-19' and 'Rhinorrhea' has been provided at this time. Further information has been requested. For the event of 'COVID-19', it is unlikely related to the vaccine.  Based on the current available information and temporal association between the use of the product and the start date of the event 'Headache', a causal relationship cannot be excluded. Further information has been requested.
chest pain, nausea, sweating w/ alternate chills, and headaches onset at approximately 10-11 a.m. Sunday, 5/23/21. Because he was reporting for work to a camp, he reported to the camp nurse. After conferring with parents, he reported to Hospital for testing. EKG there was normal; minimal labwork performed - Troponin test requested by parent came back at 0.03.  Advil taken earlier had resolved pain at that time, but pain was persistent the following day. Parent retrieved patient, and he reported to his pediatrician at the PCP Clinic and more labwork was performed at approximately 10 a.m.  Troponin level had increased to 14, with other inflammatory markers elevated and abnormal EKG result.  Pediatrician consulted with pediatric cardiologists, and parents were advised to proceed to the ER.  Mother arrived with Hospital at approximately 5:30 p.m.  Troponin results from 6:45 elevated to 16.  Ped. Cardiologist performed echo-cardiogram, which showed no abnormal heart functioning. Ped. Cardiolgist diagnosed myocarditis and prescribed 15-hour IVIg infusion.  As of Wednesday, 5/26, at noon, troponin level had decreased to 10.8 and other inflammatory markers were improving. Patient is currently still hospitalized in the  ICU Step Down Unit at Hospital.
No adverse effect; patients who received improperly stored GARDASIL 9 since 8/13/2019; This spontaneous report as received from a phlebotomist refers to a 12-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.  On an unknown date in 2019 (reported as since 13-AUG-2019), the patient was vaccinated with incorrect stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot # 1602281, expiration date 21-JUL-2021 (dose and route of administration were not reported) for prophylaxis. The temperature excursion occurred on 13-AUG-2019. The vaccine was stored in temperature 30.60 degrees Fahrenheit for 41 minutes and in temperature 56.80 degrees Fahrenheit for 4 hours 30 minutes. There was no previous temperature excursion. The digital data logger was involved. No adverse effects were reported.; Sender's Comments:  US-009507513-1909USA004622:
I left and my face started feeling tingly, then my tongue started feeling swollen. After about an hour it felt like I had been to the dentist and it was settling in the center and left side of my face, neck and shoulder.  The next day I called my doctors office, they said I was fine. I asked if I should follow through with getting the 2nd dose and was told "most definitely, it is recommended". It has been almost 2 weeks and I still have numbness and tingling in the left side of my face.
Muscle weakness started the afternoon after vaccine was administered. Right arm pain and weakness radiated down into fingers. She also C/O headache, fatigue, insomnia D/T pain, muscle tenderness and trouble lifting arm. Patient was started on Steroids 10/5/18. Advised to return with worsening symptoms. If no better by Tuesday will refer.
Headache, extreme fatigue. Patient has been having ongoing, continuous severe headaches, and extreme fatigue. Symptoms are debilitation at times patient has to stay home, and hot flashes.
Severe welts on mid/lower/anterior torso area and bilateral lateral torso and severe itching
3 days after vaccine, second dose given on day 16, developed ascending paresthesia, no weakness, up to abd from LEs and to elbows on BUE
He started with a low grade fever.  the injection site started to swell and he was diagnosed with Cellulitus.
Headache; fatigue; chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single, MANUFACTURER UNKNOWN), for covid-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; CHILLS (non-serious), outcome "unknown", described as "chills".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever, muscle ache, slept 2 days off and on, head ache, site of shot red and hard and hot to touch and was 6 inches long.
Abdominal pain; Vomiting; Diarrhea; Sweating; Chills; Migraine; Sore arm; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 20Apr2021 at 11:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to food, medications or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.The patient did not receive any medication within two weeks of vaccination.  The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 22Mar2021 at 18:45 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 08:15, the patient experienced abdominal pain, vomiting, diarrhea, sweating, chills, migraine, sore arm and fatigue . No therapeutic measures were taken as a result of events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the event Abdominal pain, vomiting, diarrhea, sweating, chills, migraine, sore arm, fatigue was resolved on an unknown date in Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
WEIGHT GAIN AROUND MIDDLE; ANXIETY BECAME WORSE; INSULIN RESISTANCE OVERNIGHT; BRAIN FOG BECAME WORSE; DEPRESSION BECAME WORSE; FEMALE ISSUES WORSENED; HIGH A1C; NEGATIVELY IMPACTED HORMONES, FEMALE MOSTLY; MADDENING; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hormone replacement therapy, anxiety, brain fog, and depression, and other pre-existing medical conditions included: She never had a high A1C, and already follow a lower carb diet. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced weight gain around middle, anxiety became worse, insulin resistance overnight, brain fog became worse, depression became worse, female issues worsened, high a1c, negatively impacted hormones, female mostly, and maddening. Laboratory data (dates unspecified) included: HbA1C (NR: not provided) high, and Lab test (NR: not provided) negatively impacted hormones. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from negatively impacted hormones, female mostly, weight gain around middle, anxiety became worse, insulin resistance overnight, brain fog became worse, depression became worse, female issues worsened, high a1c, and maddening. This report was non-serious.
Covid / very ill / hospitalized; very ill; perhaps / shouldn't do the second dose / patient was six month post first dose / was unsure about finishing the series; This case was reported by a nurse via sales rep and described the occurrence of covid-19 in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced covid-19 (serious criteria hospitalization), illness (serious criteria hospitalization) and incomplete course of vaccination. On an unknown date, the outcome of the covid-19 and illness were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   The reporter considered the covid-19 and illness to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shngrix last year from the date of reporting. After receiving Shingrix, the patient had covid. The reporter was unsure of the order of events and which was first or second.  She said that, the patient became very ill and ended up hospitalized.  Because of the timing of the vaccine being so close to the illness, she said that, the hospital provider had told that, the patient that perhaps they should not do the second dose of Shingrix.  When the patient was six-month post first dose, she was healthy and said that, the patient was unsure about finishing the series.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The sales representative told that, he/she legally needed to report the possible adverse event.  The reporter said that, she did not believe that, her illness and hospitalization was due to the vaccine and did not want anyone to reach out. The reporter did not consent to follow up.
Employee reports immediate fatigue after immunization. On 4/17/15 employee reports signs and symptoms of diarrhea and nausea, contiued fatigue, body aches, complained of febrile symptoms; no temperature taken, rhinitis; duration of symptoms is concurrent; per employee, self treatment with otc Immodium, otc ibuprofen, and otc cold and flu, and oral hydration; did not seek outside medical treatment.
Information has been received from a registered nurse concerning a female who was vaccinated with a dose of ZOSTAVAX. It was reported that the patient experienced itching after vaccination. A product quality complaint was not involved. Additional information has been requested. This is one of several reports received from the same source.
Dizziness, Headache, Myalgia, Arthralgia, UrticariaPruritus & NauseaVomiting Narrative: dose 1: day 1-2 sore arm;1 wk later itching readness and soreness on arm x 2 d. dose 2:pain at injection site;chills;hotflash;ha;dizziness;fatigue;tired;muscle&bodyache;nausea/vomiting
Injection site red, swollen, sore and hot. Approx. 16 hrs after injection I had a bad headache and nausea, diarrhea and vomiting. Symptoms resolved within 24 hrs or so from onset on 11/2/14 approximately 10 AM.
Pain and stiffness in joints, needle jabbing pain in legs, tingling skin, pain in bottom of feet, pain in groin severe, overall stiffness of muscles, pain in muscles, could not raise arms over my shoulders to turn down my collar when I put on a tie. Pain in right arm muscle and left arm muscle, walk in a halting fashion, right lower back pain, stiff neck.    11/18 and 11/19 Medical records received.  Labwork  DOS 10/31/09. 12/14/2009 MD visit for 12/1/2009, patient with 2 month hx of chest pain that radiates to shoulder, neck and jaw. no meds Rx'd, advised to go to ED if sx reoccur
A spouse reported that her 74 year old husband developed atrial fibrillation and polymyalgia rheumatica approximately 3 weeks post vax. He was then prescribed Lasix for his heart, Coumadin for his blood, prednisone for his PMR and synthroid for his thyroid. He had previously not been on any medication and had no medical problems. He has has previous flu shots in the past without any problems. His symptoms included achiness in his hips, thighs and calves. He normally works out at a club three times per week, but has not been able to return to that activity. Additional information has been requested. Follow-up information received on 4/24/01, states that the physician identified as PCP wrote: "I did not administer a flu shot to this patient". Additional information received on 06/05/2001, states that the day after receiving the flu vaccine, the pt woke up with severe pain in thighs, calves, and hips. A few days later, joint pain began. This pt also had fever to 102 and lost 22 lbs. The family physician started him on prednisone, plaquenil,and NHAID with good effect. As of 06/22/2001, his positive RF has persisted.
Erythema, pain, and swelling of left upper arm extending from shoulder to elbow.