chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse refers to an unknown number of patients of unknown age. On an unknown date, the patients were vaccinated with unknown number of doses with GARDASIL 9, L043213 28-AUG-2017, M003659 20-SEP-2017, M004116, 12-OCT-2017, M020103 15-FEB-2018, M021407 30-APR-2018 following a temperature excursion of 33F for 23 days. No adverse effects were reported. Additional information has been requested.
Patient and guardian came to get 2nd dose of Covid vaccine. Medical Assistant went over consent form for both adult and pediatric and consents were signed. She gave the first dose to the pediatric and after giving the dose realized she had given the wrong injection, she had given the Pfizer >12 years old dose to a pediatric under 11. Medical Assistant stopped what she was doing and followed the chain of command in what to do next. Patient and guardian were notified of the error and patient was monitored for half an hour to make sure there were no adverse side effects. Patient had no adverse reaction and was discharged. We are continuing to follow-up throughout the week on any side effects but there have been no side effects reported.
I developed hives on 1/23/21 and currently still have them. Itchy skin over my entire body from the bottom of my feet, to my toes, palms, eyelids, etc. Skin turns red and raised. Initially I took 2 pills of Benadryl every couple of hours, but the symptoms only lessened slightly and were still there. I went to Urgent Care,  on 1/28/21 and was prescribed 50mg prednisone daily, which I took for 5 days (as prescribed). Symptoms continued and did not lessen. I went to Allergist 2/3/21, who prescribed an antihistamine and reported to follow up in a couple of days if symptoms are still present.
headache; fatigue; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 61-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 27Jan2021 (Lot number: EL3248) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing). Concomitant medications included: SYNTHROID, start date: 1994 (ongoing); WELLBUTRIN, start date: Mar2020 (ongoing); NALTREXONE, start date: Mar2020 (ongoing). Vaccination history included: bnt162b2 (Dose 1, single (Lot Number: EL0140) in the left arm at 15:45), administration date: 06Jan2021, when the patient was 61 years old, for Covid-19 Immunization, reactions: "Chills", "Body Aches", "Cold", "fever", "Pain at injection site", "Felt ill", "Fatigue", "Felt like I had COVID again for 24 hrs". The following information was reported: HEADACHE (non-serious) with onset 28Jan2021, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset 28Jan2021, outcome "unknown", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Adverse events did not require a visit to emergency room or physician office. The day after the second dose, she felt fine but maybe a slight headache and fatigue.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021010972 Same patient and drug; Different dose and events
extremely high blood pressure; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Nov2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization; Covid-19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: HYPERTENSION (non-serious) with onset 2022, outcome "recovering", described as "extremely high blood pressure". The event "extremely high blood pressure" required physician office visit. Therapeutic measures were taken as a result of hypertension. Additional information: Other vaccine in four weeks was unknown. COVID prior vaccination and COVID tested post vaccination were unknown  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Covid-19 virus test positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19 virus test positive) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced COVID-19 (Covid-19 virus test positive). At the time of the report, COVID-19 (Covid-19 virus test positive) 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.   No relevant concomitant medications were reported.  Treatment information was not specified.
Hot Red mark appeared on day 8. Did a telehealth appointment and they put me on Keflex for cellulitis, I was told to go to the ER if it got bigger. It got bigger last night, I had a fever, went to the ER they had to cut and drain it and then pack it. They told me at the ER the vaccine was not given in the correct spot.
6/10 Hives-went to ED and was prescribed Prednisone and Vistaril. 6/11 Generalized rash, tachycardia, periorbital edema. Was given IV steroid and IV Benadryl.
Pt. was given 05ml dose of Reombivax HB, and should of gotten 1ml.  Contacted CDC & pt. is to come in for full dose of Adult Hep B.
Severe headache and fatigue, lasted about 6 hours. Have had several headaches throughout the following days but not a severe as first one. Sore arm and elbow
Mesenteritis; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient of an unknown demographics who experienced mesenteritis, while patient received vaccines SHINGRIX and INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's 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 received a dose of suspect SHINGRIX not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious mesenteritis 48 hours following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE and SHINGRIX.  (Other relevant tests included no lab data.)  Final diagnosis was mesenteritis.   It was not reported if the patient received a corrective treatment.  The outcome of the event was Unknown for mesenteritis.  Information on the batch number was requested.
This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. A patient of an unspecified age, gender, race and ethnicity received the first dose of TRUMENBA single dose, and influenza vaccine, both on an unknown date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccinations, the patient experienced fever at 104 Fahrenheit and back pain. The patient went to the emergency room (ER). Clinical outcome of the events was unknown at time of this report.
Continued weakness and aching of wrists and hands and multiple onset severe headaches every day since.
Client c/o swelling on (L) arm and itching internally on arm. C/O arm feeling heavy - PHN notes raised area of erythema 6 1/4 in x 6 1/4 in with area of darker redness with "blisterlike" appearance 60 x 30 mm. Area is warm to touch. Client states she iced arm off and on yesterday.
Information has been received from a consumer concerning her daughter who on 3/20/01 was vaccinated with a 2nd dose of Hep-B vaccine recombinant (yeast). The mother reported that "within months" of vaccination, her daughter "developed a liver condition". It was noted that the pt experienced "increased liver enzyme levels, jaundice, fever and an enlarged and inflamed liver". Her gall bladder was removed because it "shut down". It was noted that the pt had been hospitalized several times. It was reported that the caller did not know the name of the vaccine and did not know if it was Hep-A or Hep-B. The caller was very difficult, threatened legal action, and refused to provide demographics. She disconnected the call before a legal address was able to be obtained. No further information is available.
Got my first injection 1 month ago. Now it's time for second injection. and i am pregnant for 2 weeks now; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE BEFORE PREGNANCY (Got my first injection 1 month ago. Now it's time for second injection. and i am pregnant for 2 weeks now) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In 2021, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Got my first injection 1 month ago. Now it's time for second injection. and i am pregnant for 2 weeks now). In 2021, MATERNAL EXPOSURE BEFORE PREGNANCY (Got my first injection 1 month ago. Now it's time for second injection. and i am pregnant for 2 weeks now) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were reported.  No treatment medications were reported.  This case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected event of Maternal exposure before pregnancy. The event occurred at the time of the first dose of Moderna COVID-19 vaccine. The patient received the first dose of vaccine before the gestation period, at the time of the report patient was 2 weeks pregnant and vaccination occurred one month prior, no exact date provided. The rechallenge was not applicable. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected event of Maternal exposure before pregnancy. The event occurred at the time of the first dose of Moderna COVID-19 vaccine. The patient received the first dose of vaccine before the gestation period, at the time of the report patient was 2 weeks pregnant and vaccination occurred one month prior, no exact date provided. The rechallenge was not applicable. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
I had and recovered from COVID-19 in December 2020. I got my first shot on 10/4 and on 10/15 I had experienced chest pain and tightness and left arm numbness that resulted in an ER visit where I had an abnormal EKG (arrhythmia found) and very high blood pressure. I stayed in the ER till about 11:00 pm. The ER doctor said given there is no family history of heart issues and I am a healthy 35 year that exercises regularly they couldn't find any reason to keep me. I keep having irregular spikes in my heart rate. Never had issues before this with my heart at all. I was referred to Cardiologist who said that given the timing of my shot and the onset of these symptoms as well as having recovered from COVID infection in December 2020,  it is an adverse reaction to the shot. He ordered an echo, stress test and holter monitor that I wore for a week. The echo and stress test came back normal but they did continue to see the arrhythmia on the echo so they referred me to an electro physiologist that I will see on Monday 11/22 and started taking a beta blocker prescribed.
21SEP95 parents reported that prev shots given 20JUL95 were followed by 2hrs & 20 mins of high pitched cry, diff to console
This spontaneous report was received from a consumer and refers to a female patient of unknown age. Her concurrent conditions, medical history and concomitant therapies were not provided. On 15-OCT-2013, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot# and expiration date were not provided) for prophylaxis (reported as: to prevent the shingles illness from infecting her). On an unknown date, the patient said that ZOSTAVAX gave her shingles. It was considered as special situation - lack of effect. The outcome of the events was unknown. The reporter considered shingles to be related to ZOSTAVAX. The causality assessment between lack of effect and ZOSTAVAX was not provided.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medication, drug reactions/allergies and concomitant medication were not reported. Between late June 2016 and 12-AUG-2016, the patients were vaccinated with doses of PNEUMOVAX 23 (lot # L022795 with 05-NOV-2016; dose and route were not reported), which were improperly stored (Excursion details: Time/Temperature: 9 degree Centigrade for 1 hour; Previous excursion: Yes, 12 degree Centigrade for 2.5 hours). No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 9:00 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 22.60.  Concomitant products were not provided.  On 13-FEB-2021, Excursion time was 08 AM. temperature was 32 respectively. total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-FEB-2021, vial was moved to clinic on 13-JAN-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-MAR-2021. No hourly temperature recordings were available. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 at 16:00 as dose 3 (booster), single (Lot number: FL3197) 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) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "mild lupus non organ threatening" (unspecified if ongoing), notes: mild lupus: non organ threatening. Daughter has the same and same thing happened to her.; "Known allergies sulfites, sulfa," (unspecified if ongoing), notes: Known allergies sulfites, sulfa,; "Known allergies walnuts" (unspecified if ongoing), notes: Known allergies walnuts. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Nov2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Tested NEG 2 X; (20Nov2022) Negative, notes: Tested NEG 2 X; (24Nov2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that case was non-serious. No any seriousness criteria was reported. It was reported that vaccine was received. Patient received Allegra via oral route as other medication in 2 weeks. Patient received anti-viral Product for COVID 19 Treatment which brand name as Paxlovid from 15Nov2022 to 19Nov2022, lot number=GF2796, with Oral route. Patient felt great on the Paxlovid except the bitter taste. Mild COVID symptoms fatigue and sore throat. Tested NEG 2 X Sunday 20Nov2022. Worked 3 days then felt fatigued and tested positive again 24Nov2022. Fatigued, Nasal congestion, no fever.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162b2 cannot be excluded for the reported event-COVID-19 and Drug Ineffective.
After receiving the booster I had pain in the upper left arm for about a day and a half.  About 4 days after getting the booster  as I was taking a shower I noticed a red area on my left arm (circular about the size  of a tennis ball).  The area was about 3-4 inches below where I received the booster shot.  It was warm to the touch  and sometimes I would feel a "prick" as if someone was sticking me with a needle.  There is some soreness that comes and goes and sometimes I can't see the red area but then it reappears.
This spontaneous report as received from a Licensed Vocational Nurse regarding unspecified patients of unknown demographics. There was no information about pertinent medical history, drug reactions or drug allergies. On 24-AUG-2015, the patient was vaccinated with 8 doses of improperly stored (Merck) PROQUAD lot # L005297 and expiry date: 17-AUG-2016. No adverse effect was reported. The outcome of the event was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
Very strong reaction; This spontaneous report was received a currently 42-year-old female patient. No information was reported regarding the patient's medical history, concurrent conditions or concomitant medications.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown) for prophylaxis (dose, route, lot number and expiration date were not reported).  On an unknown date, the patient experienced a very strong reaction to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown). The outcome of the event was not provided.  The reporter considered the event to be related to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(manufacturer unknown).
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date the patient was administered with an improperly stored dose of VAQTA (strength, dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No concomitant therapies were reported. No adverse events were reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
flu; Initial information was received on 08-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case is linked to cases 2020SA296404, 2020SA296528, 2020SA296430, 2020SA296471, 2020SA296492, 2020SA296544, 2020SA296581, 2020SA296589, 2020SA296655, 2020SA296676, 2020SA296689, 2020SA296710, 2020SA296764, 2020SA296765, 2020SA296803, 2020SA296817, 2020SA296865, 2020SA296885, 2020SA296898, 2020SA296916, 2020SA296968, 2020SA297003, 2020SA297018, 2020SA297058, 2020SA297073, 2020SA296492, 2020SA296528, 2020SA296710, 2020SA296430 and 2020SA297065.  This case involves patient (unknown demographic) who had flu (influenza), while patient received INFLUENZA VACCINE.  Medical history, medical treatment(s), past vaccination(s) concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) after administration of INFLUENZA VACCINE.  Laboratory data was not provided.  It was not reported if the patient received a corrective treatment.  At the time of reporting the outcome of event was unknown.
spoke with staff at retirement center & pt completed 2 doses of Pfizer vaccine & today at clinic had #1 Moderna.
This spontaneous report as received from a registered nurse refers to a 20 years old male patient with no pertinent medical history and no drug reactions/allergies. The patient was subcutaneously vaccinated with first dose of 0.5 ml VARIVAX (Lot# and expiration unspecified) on 22-MAY-2002, second dose (route, dose, Lot# and expiration unspecified) co-suspects were reported. Concomitant medications were included oral acne medication and topical acne medication. The registered nurse reported that the patient who received 2 doses of VARIVAX was found to have immunity to chickenpox that was lacking. The patient had sought medical attention via phone call. No treatment information was reported. The outcome was unknown. Additional information is not expected.
Rash all over body, light headedness, then the next day swollen hands and feet.
Began itching 08-1-11 about 2 hrs after vaccine and broke out in rash. Patient came into clinic on 08-2-11 was given Rx for BENADRYL 12.5mg/5ml one PO every 6 hrs PRN.