chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse, for the Pregnancy registry for GARDASIL, concerning a 22 year old female with no pertinent medical history who on 22-Feb-2007 was vaccinated with the first dose of GARDASIL (lot#: 655617/14477), on 22-Apr-2008 was vaccinated with the second dose (lot#:660389/1968U) and on 16-Dec-2008 was vaccinated with the third dose (lot# 660616/0570x). Concomitant therapy included prenatal vitamins and dose of levonorgestrel (Plan B) on 15-Dec-2008. On an unspecified date in 2009 the patient had an ultrasound confirming the pregnancy and revealed a marginal placenta previa. The due date was calculated to be 09-Oct-2009, making the LMP approximately 02-Jan-2009 (the patient's LMP was unknown). The nurse reported that the pregnancy was normal to date. the patient was seen in the office. Additional information has been requested.
fever for 12 hours  high temp 101.5,  joint pain,  tiredness    Felt normal 48 hours later
After receiving vaccine at approximately 8:30 am mom called the office at 4:15 pm stated child slept almost all day from 10 AM - 4 PM. Woke up very cranky and irritable. Mom observed eyes rolling back and noticed child had a hard time holding his head up right. Advice to go to the emergency room. Followed-up next day and mom did not take child to E.R.
a cyst; stye on eyelid; pain in eyeballs; swollen on left side of neck; joint pain; swollen lymph nodes on right side of face; body aches; chills; fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Mar-2021 and was forwarded to the company on 31-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CYST (a cyst), HORDEOLUM (stye on eyelid), EYE PAIN (pain in eyeballs), SWELLING (swollen on left side of neck) and ARTHRALGIA (joint pain) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CEFALEXIN (CEPHALEXIN AMEL), SALICYLIC ACID, SULFUR (OINTMENT NO.1) and CORTICOSTEROIDS.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CYST (a cyst), HORDEOLUM (stye on eyelid), EYE PAIN (pain in eyeballs), SWELLING (swollen on left side of neck), ARTHRALGIA (joint pain), LYMPHADENOPATHY (swollen lymph nodes on right side of face), MYALGIA (body aches), CHILLS (chills) and PYREXIA (fever). At the time of the report, CYST (a cyst), HORDEOLUM (stye on eyelid), EYE PAIN (pain in eyeballs), SWELLING (swollen on left side of neck), ARTHRALGIA (joint pain), LYMPHADENOPATHY (swollen lymph nodes on right side of face), MYALGIA (body aches), CHILLS (chills) and PYREXIA (fever) had not resolved.
Pt's left upper arm was warm, inflamed, red and welt-like around entire circumference.
Slept 24 hours off and on; Slept 24 hours off and on; knees, back, shoulders, neck and arms hurt badly; back, shoulders, neck and arms hurt badly; neck and arms hurt badly; arms hurt badly; Felt like I had to vomit but couldn't; No taste of food; No appetite; Headache; Dizziness; Coughing; This is a spontaneous report from a contactable consumer, the patient. A 68-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the left arm on 24Mar2021 at 14:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetic, shellfish allergy and COVID-19. Concomitant medication included paracetamol (TYLENOL A) for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in the left arm on 03Mar2021 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was 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 25Mar2021 at 03:00, the patient slept 24 hours off and on and also experienced knees, back, shoulders, neck and arms hurt badly. The patient felt like she had to vomit but couldn't and also experienced no taste of food, no appetite, headache, dizziness and coughing. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events slept 24 hours off and on, knees, back, shoulders, neck and arms hurt badly, felt like to vomit, no taste of food, no appetite, headache, dizziness and coughing was recovered after 3 and half days.  No follow-up attempts are needed. No further information is expected.
it was rpt fr RN concerning a pt who was vax & subsequently pt exp general body aches
Pt got dizzy, about 5-10 mins after vaccine, pt came got off the table to come talk to me the mother, she said mom I feel dizzy, as she was saying that she fell straight back on the back of her head and hit the floor had a few jerking movements and eyes rolled back into her head, we stayed at the doctors office until pt could get up and walk out of office nurse helped her out to the car, doctor checked her throughly before leaving pt has a current goose egg on back of head I was told that night to wake her often and watch for any nausea or severe headache that doesn't go away with Tynelol, I was informed that the vaccination wasn't the cause of her fainting but after reading the walk out sheet and reading the website I see that this is a known side affect. I wished I would of been more proactive and wished I would of known this could of happened I would of made her lay down for the entire 15 mins, but we were informed after 5 mins that we could leave.
No additional AE; Customer called for a temperature excursion in case 02261220. Caller reported that PROQUAD that had undergone temperature excursion was administered to a patient. No additional AE reported. No PQC reported. No further information was provided.    ?; This spontaneous report was received from nurse, concerning to patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 19-SEP-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) product quantity 1, (lot #W012743 has been verified to be a valid lot for PROQUAD, expiration date: 16-OCT-2023) for prophylaxis (strength, dose regimen, route of administration and anatomical location were not provided). In addition the measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) underwent to temperature excursion of -11-8 degree Celsius for 1 hour and 45 minutes. (product storage error).  It was also mentioned that previously temperature excursion happened. No additional adverse event was reported.; Sender's Comments:  US-009507513-2210USA001209: US-009507513-2210USA000872:
Pt received Moderna Dose 1 on 2/10/21 and Dose 2 on 3/10/21. On approximately 3/15 she began to develop intermittent fever, chills, diffuse myalgias, headache, followed by onset of sore throat and intermittent rash, leading to hospitalization on 3/21 after presenting with syncope. She is now undergoing evaluation for MIS-A vs. adult onset Still's.
Information has been received from a registered nurse (R.N.) concerning an unspecified patient (age and gender were not reported). The patient's pertinent  medical history and concurrent conditions were not provided. It was reported that on an unknown date the patient received the first two doses in the series of three GARDASIL (lot #, expiration date, concentration, dose and therapy route were not reported), on unspecified date, the third dose in the series of three was given of GARDASIL 9 (lot #, expiration date, concentration, dose and therapy route were not reported). Concomitant therapies were not provided. The R.N. stated that on an unknown date another dose of GARDASIL 9 was inadvertently administered on 05-AUG-2016. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Mother states rash developed first to left leg on 3/20 and then spread to right leg and pelvis 3/21. Mother states blisters developed in mouth and fever of 101 developed on 3/22. Mother states fever of 101 still present on 3/23 but that rash began to fade. Fever of 101 still present on 3/24 but that rash was gone. Denies fever on 3/25. Seen in ER on 3/22 and diagnosed with thrush. ER record denies rash with ROS and physical exam reports skin as free of rashes. ER told mom rash was reaction to vaccine.
Initial information received on 06-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves female patient (age unknown) who experienced bruising and soreness at the injection site, while she received vaccine INFLUENZA. 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 produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious bruising and soreness at the injection site following the administration of INFLUENZA. It was reported that patient received another 3 strain flu vaccine last year and had smaller arms, and gets bruising and soreness at the injection site after her flu vaccines each year. Other relevant tests included no lab data. Final diagnosis was soreness at the injection site and bruising. It was not reported if the patient received a corrective treatment. On an unknown date, the patient outcome is unknown for bruising and soreness at the injection site. List of documents held by sender none.
Accelerated heartbeat, low grade fever, chills, aches, fatigue.  Felt like I had the flu. Lasted 12 hours.
Information has been received from an office manager concerning a 17 year old female patient who on an unspecified date was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast), 0.5 mL, injection. concomitant medication was not reported.  Subsequently on an unspecified date, the patient fainted after she received the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). The patient sough unspecified medical attention.  The office manager stated that the patient did not have anything to eat prior to receiving the injection.  Subsequently on an unspecified date, the patient recovered from the event. Additional information has been requested.
Arm was red. Extending roughly 1 inch from injection site the redness was at the elbow 3 days after injection but had receded greatly when seen on 8/6, 5 days after. Area was warm initially but subsided after a couple days. Also reported arthralgia in the shoulders. Counseled to take Ibuprofen and follow-up in 1 mo.
red arm; Dizziness; No energy all day; arm hard as a rock; itchy arm; Could barely get out of bed; Sore arm; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (Swollen arm), DIZZINESS (Dizziness), MALAISE (No energy all day) and VACCINATION SITE INDURATION (arm hard as a rock) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by reporter.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (Swollen arm) and FATIGUE (Could barely get out of bed). On 13-Feb-2021, the patient experienced DIZZINESS (Dizziness), MALAISE (No energy all day), VACCINATION SITE INDURATION (arm hard as a rock) and VACCINATION SITE PRURITUS (itchy arm). On 15-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing from 12-Feb-2021 at a dose of UNK, q4h. At the time of the report, PAIN IN EXTREMITY (Sore arm), PERIPHERAL SWELLING (Swollen arm), DIZZINESS (Dizziness), MALAISE (No energy all day), VACCINATION SITE INDURATION (arm hard as a rock), VACCINATION SITE PRURITUS (itchy arm), FATIGUE (Could barely get out of bed) and VACCINATION SITE ERYTHEMA (red arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Body temperature: 98.7 (High) Body temperature increased. On 13-Feb-2021, Body temperature: 98.3 (Inconclusive) 98.3. On 14-Feb-2021, Body temperature: 97.3 (Inconclusive) 97.3.         No concomitant medication were provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received included no new significant information - contact information added
Experienced general aches, headache, soreness and irritation at the injection site as well as muscle pain in the shoulders and back. Symptoms began around 2000 on 01/09 and subsided overnight between 01/10 and 01/11.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium
I developed Shingles the day after receiving the COVID booster and Flu vaccine (I don't know what brand flu vaccine it was). I am on Acyclovir and Prednisone for the shingles. I am 37 years old and have had chicken pox before.
Exposed to Covid on September 18th. Evening of the 21st had fever, coughing (lots), fatigue, bad headache, difficulty breathing, body pains, runny nose.
Previous 2 vaccinations, no issue besides sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Feb2021 16:00 (Lot number: EL3248) at the age of 50 years as dose 2, single and intramuscular, administered in arm left, administration date 25Jan2021 16:00 (Lot number: EL3248) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Previous 2 vaccinations, no issue besides sore arm".  Additional Information: Previous 2 vaccinations no issue besides sore arm (with first two doses). She experienced slight fever, horrible headache, vomiting, Nausea which symptoms 12 hrs after injection. Had 3 days malaise, exhausted 2 other days after dose 3. She did not take a 4th vaccination. The patient did not take any other vaccine prior or within 4 week of vaccination. Her family medical history did not relevant to adverse event. She did not perform any relevant tests. Specific relevant test for thromboembolic events with thrombocytopenia were none.  No follow-up attempts are possible. No further information is expected.
I felt fine after the vaccination until around 3 pm when I presented with extreme fatigue. Around 6 pm, I developed a large, red bump at the injection site that was warm to the touch. The bump has reduced in size but has not gone away yet. The fatigue is better but still exists.
This spontaneous report as received from a healthcare worker- Certified medical assistant (CMA) on 13-OCT-2015 reported that unspecified patients received improperly stored M-M-R II, RECOMBIVAX HB (reported by CMA as RECOMBIVAX (reference MARRS # 1510USA011361), GARDASIL (reported as GARDASIL (HPV-4)), and PNEUMOVAX23. Lot number and expiration dates of vaccines that were administered were not known. No adverse effects were reported. No further information was provided. On 15OCT2015, the healthcare worker- Certified medical assistant (CMA) called back to provide data as follows on administered doses: GARDASIL (Lot number k016966, expiration date 10MAY2017) (Reference MARRS # 1510USA009473.) and PNEUMOVAX23 (Lot number 1005563 (as reported), expiration date 03NOV2016). (Lot number 1005563 is an invalid lot number for PNEUMOVAX23 (Reference MARRS # 1510USA009474.) The healthcare worker did not report that any other products or doses were administered to patients as noted previously. (This is conflicting information. It is unclear if other patients had received a dose of improperly stored vaccine(s).) No adverse effects reported. No further information provided. Additional information has been requested. This is one of several reports received from same source.
Projectile vomiting for 6+ hours followed by 2 days of diarrhea and fever spike of 101.5. Next 5 days were flu symptoms including body aches and low grade fever
Patient reported mild swelling of left arm.  Pt advised to take diphenhydramine and report to her doctor if symptoms continued to worsen.  Pt advised that symptoms would likely resolve in 2 days.  Symptoms did resolve.
Itchy Throat, Light headed and nausea.  Treatment: 1605 patient chewable benadryl/ prior to discharge
On 12/3/99, the pt experienced a mild case of chickenpox. She experienced approximately 15 lesions mainly on her back, vaginal area, mouth and lips with no fever. The pt sought medical attention. Treatment was initiated and followed by resolution of symptoms. No further information is available.
Pt developed hives and swelling in his mouth within 30 mins following hep B injection. No more info after many attemps could not get mother to return my call to obtain more info.
2 Month old female btought to ER with fever of 101 occurring in AM with associated cough, vomiting, and inability to hold down food. Mother also states that patient has been fussy with excessive salivation and has not been given any Tylenol or Motrin.
Onset of hives on entire body within an hour of receiving the Hepatitis A vaccine. Rx'd Benadryl at ER. Hives gone within 24 hours.
Pt developed itching of her mouth with upset stomach within minutes of receiving vaccine. She then developed dyspnea with cough within 5-10 minutes of administration. On exam she had wheezes in her bilateral bases with desaturation of SpO2 to 87%. Pt was given adult Epi Pen and sx resolved. However, after 10 minutes, sx returned and pt was redosed with epinephrine and given IM BENADRYL. Pt was sent to ED and Observed for a period of 8 hours during which symptoms did not return and pt was found fit for discharge.
shingles vaccine, got shingles later/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows:  The patient self-reported this case.  The age at vaccination was not reported. The patient paid for Shingle vaccine and still got the shingles later and it was very mild case. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
OBSTRUCTIVE SLEEP APNEA 8/4/2022 ACUTE MYELOID LEUKEMIA
sore arm; fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE and COLLAGEN for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (sore arm), PYREXIA (fever) and HEADACHE (Headache) had resolved.            Treatment included unspecified antibiotic.   This case was linked to US-MODERNATX, INC.-MOD-2021-226811 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-226811:Same reporter, reporters case
severe autoimmune hemolytic anemia receiving prednisone, rituximab and transfusions still hospitalized
Vaccine #1 received on 2/11. On 2/13 experienced polyarthralgias (wrists, shoulders, knees, ankles, hips), headache, scalp tenderness, and swelling and pain of testes. These had resolved by 3/4, after receipt of ceftriaxone, azithromycin, doxycycline, and ibuprofen. But on 3/10 he developed loss of vision in his right eye and new frontal headache and was referred to Ophthalmology on 3/11 where he was diagnosed with Giant Cell arteritis (GCA) and prescribed corticosteroids. Within 1-2 days of receiving the latter, his headaches and vision loss had resolved.
Pt reports the day after inj #2 of Twinrix that he noted an itching rash on chest and upper back. Also reported his lips felt swollen. Denied SOB or difficulty swallowing.
Information has been received from a licensed practical nurse concerning a 12 year old patient of unknown gender. On 14-OCT-2014 the patient was vaccinated with GARDASIL lot # J010668, expiration date 29-APR-2016) (dose and routed not reported). The vaccine was reported to have temperature excursions from 10-SEP-2014 to 12-SEP-2014. No adverse reports. This is one of several reports from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
I took the booster then, few minutes later  I Fainted  unconscious for several minutes
Agitation, Dizziness, Headache, & Myalgia & Fever Narrative:
HEADACHE MUSCLE ACHE JOINT PAIN CHILLS FRBER NAUSEA