chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Irregular cells with HPV type 16 infection; This spontaneous report was received from a consumer (patient's mother) referred to her 24-year old daughter. The patient had no medical history, concurrent conditions, drug reaction/allergies and concomitant medications. On 05-MAY-2010, the patient was vaccinated with first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) lot # 0317Y (invalid lot #) (dose, route, expiration date were not reported) for prophylaxis. On 05-JUL-2010, the patient was vaccinated with second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) lot # 1377Y and expiry date 29-JUN-2012. On 11-NOV-2010, the patient was vaccinated with third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) lot # 0331Z and expiry date 20-NOV-2012. Approximately on 02-OCT-2019 (reported as 2 weeks ago), a pap smear test was performed that found irregular cells with human papillomavirus (HPV) type 16 infection. The patient did not receive any treatment for the adverse event. The outcome of the event was not resolved. The reporter did not provide any causality assessment.
6/7/2023 - 6/11/2023 (4 days) Presented to the hospital with altered mental status and diminished blood pressure. 012M20A 1/28/2021 002A21A 3/1/2021 939909 11/13/2021 006M21A 7/13/2022
Extreme arm soreness the day of, unable to sleep because of the pain.  The morning after the shot I woke up covered in large bruises all over.  I'm continuously lightheaded and feel like I also need electrolytes or have low blood pressure. Lost 12 lbs since the shot and have no appetite, and am forcing myself to eat. Cloudy urine.  I normally eat A LOT because of the workouts I used to do. I went from consistently working out 6 days a week for 45 min a day, now I cannot.  I cannot do cardio because I feel like my heart is going to beat out of my throat.  I can only lift weights 3-4 days a week and have to take 2-3 min breaks between sets to allow my heart rate to slow down, so where I should finish weighted workouts in 25-30 min, they can take an hour to an hour and 15 min.  I'm scared that my life will be like this forever.
developed rash on legs, torso and arms on 2-8-21. Ultimately diagnosed with new onset p anca vasculitis.
Patient came in for 12 yr  well and was given 2 vaccines that she had already received at previous well visit.
soreness at the injection site; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of VACCINATION SITE PAIN (soreness at the injection site) and the second episode of VACCINATION SITE PAIN (soreness at the injection site) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced the first episode of VACCINATION SITE PAIN (soreness at the injection site). On 04-Mar-2021, the patient experienced the second episode of VACCINATION SITE PAIN (soreness at the injection site). At the time of the report, last episode of VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Flu like Fever 103 at highest still 101 10/21/2020 Severe headache within 30 minutes  Severe itching systemic, feels like when I had shingles Body pain Bad enough I was tested for COVID on 10/20/2020 @11am- negative as reported on 10/20/2020
PRES requiring hospitalization.  Coma: 4/18/2021 - 4/192021.
This spontaneous report was received from a pharmacist referring to a 13 year old male patient. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On 31-AUG-2016, the patient was vaccinated with GARDASIL for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported). On 10-FEB-2018, the patient was vaccinated with GARDASIL 9 for prophylaxis (strength, route, dosage schedule, lot number and expiration date were not reported). No adverse effects were reported.
with in several hours the patient had fever, chills, and body aches, and has resolved 48 hours later; with in several hours the patient had fever, chills, and body aches, and has resolved 48 hours later; with in several hours the patient had fever, chills, and body aches, and has resolved 48 hours later; This spontaneous report was received from a nurse via a company representative and refers to a 22-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 15-JUN-2021, 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) 1 time dose (site and route of administration, lot# and expiration date were not reported) for prophylaxis. The same day within several hours after the vaccination, the patient experienced fever, chills and body aches. The events had resolved 48 hours later, on 17-JUN-2021.  The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent condition and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored PROQUAD lot # N010865 with expiration date 01-OCT-2018 (also reported as 11-OCT-2018), albumin status: recombinant human albumin (rHA) (dose and route of administration were not reported) and with lot# N013270, expiration date: 25-OCT-2018, albumin status: recombinant human albumin (rHA) (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). Temperature excursion ranged from 15 to 46 degrees Fahrenheit (also reported as 25 degrees Fahrenheit) for the time frame of 1 hour and 15 minutes. No previous temperature excursion was involved. Digital data logger was used. No adverse events were reported. Product quality complaint was not involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA002079.
Exactly 11 days after receiving the J&J vaccine my husband developed leg pain in his right lower inner leg, he was taken to the hospital on 04/20/2021 which a ultrasound was completed but resulted no blood clots, no other labs or treatment was performed that day, the next day he developed severe diarrhea and flu like symptoms with continued leg pain and difficulty breathing, He was then rushed to the hospital by ambulance where he was suffering from very low BP 41/31 was the lowest, a line was placed and he was put on pressors to increase his BP.  He was transferred to the hospital where he was diagnosed with a flesh eating bacteria in the right leg where the pain was at and Sepsis.  He was taken to surgery to debride the right leg and was started on CVVHD because his new kidney was now failing, he eventually was started back on Hemodialysis and taken to surgery 2 more times where he cardiac arrested on the table in surgery and died.  A private autopsy is being performed but the preliminary results shows he had multi-system organ failure, including his liver which was NEVER a problem in the past.
Instantly had involuntary muscle spasms in my legs and arms. The muscle spasms have continued through out my body for months now. Some are painful. within days I had blisters around my knee joints which left scars. They were painful and itched.
Redness discovered the same afternoon (started out as about 2 inches x 2 inches) with some warmth and soreness the first few days. 4th day became itchy. Redness spread to about 10 cm x 12 cm. No induration. Redness is blanching.
Dose given more that 12 hour post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given more that 12 hour post puncture) in a 60-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 033K21-2A and 068H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Mar-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given more that 12 hour post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose given more that 12 hour post puncture) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.   Reporter stated that the vial was initially stored in the refrigerator on 10-Mar-2022 and was first punctured on the same day of 10-Mar-2022 at 9:24 AM. The vial was then stored in the fridge after puncturing and the vial did not undergo any temperature excursions. The total amount of time the vial was exposed to room temperature range was very minimal (only taken out to draw the doses).  No treatment medications were provided.
Chills, abdominal pain, diarrhea, headache, fatigue, dizziness
soreness in arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 31-AUG-2022 Reporter's Comments: This case was received from consumer vi interactive digital media. The reporter just wanted to know if he/she allowed to take ibuprofen after his/her Shingrix shot for the soreness in arm. The follow-up could not be possible as no contact details were available.
Body aches through neck, shoulders, back; Body aches through neck, shoulders, back; Body aches through neck, shoulders, back; Temp of 100.4; Swollen lymph nodes in left armpit - very painful; swollen lymph nodes in left armpit - very painful; Tired - very tired; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0182) via an unspecified route of administration in the left arm on 02May2021 at 14:30 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any concomitant medication. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0153) via an unspecified route of administration in the left  arm on 04Apr2021 at 14:15 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 03May2021 at 12:00, the patient was experienced body aches through neck, shoulders, back, temp of 100.4,swollen lymph nodes in left armpit - very painful and tired - very tired. The patient underwent lab tests and procedures which included body temperature on 03May2021 and the result was 100.4 (units unspecified). The clinical outcome of  body aches through neck, shoulders, back, temp of 100.4,swollen lymph nodes in left armpit - very painful and tired - very tired were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Red hard swollen and hot spot at vax site. Growing daily. Seems like cellulitis which I?m prone to. Showed up late in day of vaccine but grew overnight and again over the night of 15th to 16th.
SWOLLEN LYMPH NODES UNDER ARM AND BREAST; TIGHTNESS OF THE COLLAR BONE; CRAMPING OF MUSCLE; STOMACH CRAMPING; NIGHT SWEATS; DIZZY; NAUSEA; FEVER; WAKING UP OCCASIONALLY; This spontaneous report received from a patient concerned a 39 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1802070, and batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced waking up occasionally. On 08-MAR-2021, the subject experienced cramping of muscle. On 08-MAR-2021, the subject experienced stomach cramping. On 08-MAR-2021, the subject experienced night sweats. On 08-MAR-2021, the subject experienced dizzy. On 08-MAR-2021, the subject experienced nausea. On 08-MAR-2021, the subject experienced fever. On 15-MAR-2021, the subject experienced swollen lymph nodes under arm and breast. On 15-MAR-2021, the subject experienced tightness of the collar bone. The action taken with covid-19 vaccine  was not applicable. The patient recovered from cramping of muscle, stomach cramping, dizzy, nausea, and fever on 09-MAR-2021, had not recovered from night sweats, swollen lymph nodes under arm and breast, and tightness of the collar bone, and the outcome of waking up occasionally was not reported. This report was non-serious.
2 day after getting the Pfizer vaccination, I broke out in hives and rashes all over my entire body.  There was NOTHING abnormal prior to the shot.
multi-system inflammatory syndrome; abdominal pain /abdominal cramping; unable to walk; muscle cramping; fever/ horrible fever; body was completely wiped out; she feels like shards of glass going down leg, she's in constant pain; she's been sick for the last 5 weeks; This is a spontaneous report from a contactable consumer (patient's spouse) via Pfizer-sponsored program.   A 51-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left shoulder on 24Aug2021 (at the age of 51-year-old) (Batch/Lot Number: FA6780) as single dose for COVID-19 immunisation, administered at Pharmacy.  Medical history was none.   The patient's concomitant medications were not reported. No previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No other prior vaccinations within four weeks prior to the first. No events following prior vaccinations. No relevant tests.0 The patient experienced abdominal pain (non-serious) on 25Aug2021 with outcome of not recovered and worsened, unable to walk (non-serious) on 25Aug2021 with outcome of not recovered and worsened, muscle cramping (non-serious) on 25Aug2021 with outcome of not recovered and worsened, fever/ horrible fever (non-serious) on 25Aug2021 with outcome of not recovered and worsened, multi-system inflammatory syndrome (medically significant) on an unspecified date with outcome of unknown, body was completely wiped out (non-serious) on 25Aug2021 with outcome of not recovered and worsened, she feels like shards of glass going down leg, she's in constant pain (non-serious) on 25Aug2021 with outcome of not recovered and worsened, she's been sick for the last 5 weeks (non-serious) on 25Aug2021 with outcome of not recovered, abdominal cramping (non-serious) on 25Aug2021 with outcome of not recovered. The events required a visit to Physician Office and Emergency Room. She has been in the emergency room. The clinical course of events was as follows: She received first dose of Pfizer Covid 19 vaccine last month, first she started getting abdominal pain and it continued to worsen, she was been unable to walk, had muscle cramping and fever, the symptoms have not worn off, they continue to get worse, they spoke to a provider, and the provider said it was normal after receiving the vaccine. All symptoms began the day after the shot, 25Aug2021, are ongoing, worsening. The doctor said she had multi system inflammatory syndrome. She had a horrible fever, abdominal cramping, her body was completely wiped out, still having trouble walking hasn't been able to go to work, it has been pretty horrendous, she's having muscle cramping, it was constant, one thing after another, she felt like shards of glass going down leg, she was in constant pain. She's been sick for the last 5 weeks.  Follow-up attempts are completed. No further information is expected.
Arm swelling; red circle size of a 50 cent piece; severe itching; This is a spontaneous report from a contactable consumer reporting for herself. A 44-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) (Manufacturer Pfizer-BionTech, lot# EH9899), via an unspecified route of administration in arm left, on 16Dec2020 at 01:45 PM, at single dose, for COVID-19 immunisation. Medical history included rheumatoid arthritis, Hashimoto's thyroiditis, vitiligo and alopecia all from an unknown date and unknown if ongoing. The patient had no allergies to medications, food or other products. Concomitant medications included unspecified drugs in two weeks. The patient experienced arm swelling, red circle size of a 50 cent piece and severe itching all on 16Dec2020 at 03:00 PM with outcome of recovering. The events were considered non serious.
ON 4/25/21, PT STOPPED AT PHARMACY COMPLAINING OF ADVERSE REACTIONS SHE WAS HAVING DUE TO THE JOHNSON AND JOHNSON VACCINE SHE GOT. SHE C/O NAUSEA AND HANDS SHAKING.  I TOLD HER I WOULD SUBMIT A REPORTAND FOR HER TO SEEK TREATMENT FROM HER PCP.  I ASKED THAT SHE CONTACT ME WITH ANY CONCERNS OR SHARE COMMENTS THAT DR SHARES WITH HER.
Information has been received from a physician concerning an 8 year old female who on 7/1/98 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 4/1/04 the patient developed 20-25 lesions. There were no diagnostic laboratory tests performed. It was noted that treatment was required and that the physician advised treatment with diphenhydramine HCl. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Pt did not have an adverse event but a vaccine was administered in error by someone else (worker) on 2/8/23. Pt received her 1st Bivalent booster on 11/9/22 and another bivalent booster on 2/8/23.  Pt made aware of error,  did not have any reactions while waiting her 15 min after vaccination in clinic. Pt instructed to make us aware if any adverse reactions should occur after vaccination.
Patient experienced: Severe headache, abdominal and stomach pain, lower leg pain and shortness of breath
NO visual adverse reaction per staff present. patient received 1st dose of Pfizer vaccine 4/24/2021 and 2nd dose of Pfizer vaccine 5/1/2021. per staff present patient denied any sided effects. called and spoke to patient today 5/3/2021 patient still denies any adverse reactions. stated " I feel perfectly fine"
8 days after the shot, I experienced swelling and sensitive skin with a bright red mark on the location of the injection.
This spontaneous report was received from a doctor of pharmacy concerning an approximately 75 year old female patient. On 05-JUN-2013, the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date unspecified), subcutaneously in the left arm. No concomitant medications were reported. On 07-JUN-2013, the patient experienced a 2 inch wide circle and rash at the injection site. The patient sought medical attention (contacted pharmacist). She was treated with hydrocortisone (over the counter product). The outcome of the events was reported as not resolved. The relatedness for the events was unknown for ZOSTAVAX. Additional information is not expected.
Patient received his second dose of Moderna SARS-CoV-2 vaccine on 05/14/2022 at approximately 1000 hours in the Aid Station.  Approximately 3 hours after vaccination, he began feeling "bad" while in his room.  He returned to the same aid station on 05/15/2022 complaining of malaise and displayed heart rate 135, BP 138/90, and 97% saturation by pulse oximetry on room air.  The medic in the aid station deferred him to Emergency Room.   He presented to Emergency Room approximately 1530 hours on 05/15/2022 and endorsed about one day experiencing shortness of breath, fever greater than 100.4 F, general malaise/fatigue, severe myalgia, headache, loss of appetite or nausea, and "feeling feverish, temperature not measured".  He denied chest pain, coughing, runny nose/rhinorrhea, sore throat, altered or lost sense of taste and smell, diarrhea or loose stools.  Patient was diagnosed by ED physician with "viral syndrome" and discharged by about 1615 hours with prescriptions for Zofran 4 mg PO q8h prn "nausea & vomiting" (#12), meclizine 12.5 mg PO q6-8h "for dizziness" (#10), and ibuprofen 600 mg PO q8h "as needed" (#24).  The ED physician recommended Patient could return to work on 5/18/22.  When PA-C encountered Patient at the aid station on 5/20/22 for routine follow up, he was asymptomatic with unremarkable physical exam.  Patient was subsequently referred to a local clinic on or after 5/25/22 for CBC to re-assess platelet count and MPV.  Pending a normal CBC, he was advised on or after 5/25/22 to repeat SARS-CoV-2 vaccination with Moderna at 28 days after his most recent dose (i.e., on 6/11/22) due to the long delay between his initial dose on 12/13/21 and his most recent dose on 5/14/22.  He was also advised to pre-medicate with ibuprofen 800 mg PO with food about one hour before vaccination, thereafter every 8 hours with food for the next 24-32 hours to reduce potential symptoms associated with vaccination.
Case number PHEH2015US000723, is an initial spontaneous report from a nurse received on 06 Jan 2015 and with follow-up information received from a nurse received on 09 Mar 2015. This report refers to an 11-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. Concomitant vaccinations included VARIVAX (batch number: unknown, other manufacturer) and BOOSTRIX (batch number: unknown, other manufacturer). She was administered only MenCYW-135 liquid component of MENVEO (batch number: M14021, X14021) without being reconstituted with MenA, intramuscularly into right arm on 30 Dec 2014. No adverse event was reported following this administration error. Follow-up received from a nurse received on 09 Mar 2015: Concomitant vaccinations (VARIVAX and BOOSTRIX), batch number of MENVEO (M14021) and site of vaccination (right arm) were updated.
After my second Moderna vaccine on 5/11/21 I started my menstrual cycle a few hours later. This was over a week early. After that initial early cycle I did not get another period until 7/28/21.  As of this date, 10/6/21 I have yet to have another menstrual cycle. This is unusual for me as my periods have been regular around every 23 days.
A few hours after 2nd dose of vaccine started having pain to entire left side of body including left arm, left chest, left neck, left leg. Presented to the ED 2 days later for her symptoms.  Found to have elevated troponin consistent with NSTEMI vs. myocarditis.
Erythema and swelling at the injection site. Low grade fever and malaise, even with Ibuprofen and Tylenol.  Lasted for about 48hrs.