chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This solicited report has been received from the patient's mother referring to her daughter, a female pregnant female of unknown age who was enrolled in a Patient Support Program. The patient's pertinent medical history, drug reaction/allergies or concomitant medication information was not reported. In approximately 2010 (reported as "about six years ago"), while she was pregnant, the patient received a dose of GARDASIL (route, dosage schedule, lot # and expiration date were not reported) for prophylaxis (exposure during pregnancy). The LMP and EDD was unknown at the reporting time. On an unknown date, the patient had a son who is now experiencing an adverse event (case #: 1612USA000539). This is one of two reports received from the same reporter. Additional information is not expected as the reporter refused contact for follow up. Sender's Comments: US-009507513-1612USA000539.
This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO. On an unknown date, less than a week after receiving BEXSERO, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient had sore arm for a week after vaccine was given.
Swollen very painful, hot to touch site and entire muscle up into shoulder and neck, fever 99- 101 started 24 hrs after shot, weak legs, body aches, nausea, lack of appetite.  Felt just out of it, staggering  when fever high.   Sxs  began within hours of injection. Sxs  abated 48 hours after injection except for sore site. I took 500 mg of Tylenol several  doses  and ondansetron  2 doses/2 days
Patient was given smallpox immunization 2/12/03. I saw him 8 days later c/o pleuritic chest pain along with expected reactions of discomfort at vaccination site and axillary lymphadenopathy. Pt did not have uri sx's. lungs were clear, cxr wnl. I am unsure if the pleuritic chest pain is related to the vaccination and am erring on the side of caution and reporting this as a possible reaction to the vaccination.  Patient did receive other immunizations, I do not have his record available at the time of filling out this report to confirm what they were but I believe one of the other two was a tetanus vaccination.
The adverse reaction is when I am taking a shower with warm water my left arm (where the vaccine was administered) turns red.  After showering the redness dissipates over time. In addition, the area also feels itchy throughout the day.
Donor received a tetanus immunization on 09/12/23. Upon donors return to the center on 09/16/23, the donor stated that he had a reaction to the shot. He stated he felt very fatigued and had flu-like symptoms. He also stated that he felt that his arm had significantly more pain than he expected from getting a vaccine. Donor states that he feels better and no longer has pain.
Initial reaction severe myalgia with night sweats and nausea. Two days after injection, 8/10 I noted that my right great toe joint had a very tender area present, about the size of a dime. I had no known mechanism of injury. This painful area persisted and, during the overnight hours of 8/14, the toe became swollen, reddened and the pain was excruciating; even with light touch to the skin. I went to be evaluated at the doctor's office that day and was sent for x-rays of the foot. The x-rays were negative for any abnormality. I have never been diagnosed with gout before this event. My diet is not consistent with high uric acid intake.
I have had shingles when I was a child and on Monday my head started to pound and I have a painful rash on my forehead.  I was puking and have had a splitting headache for days.
Went to have bowel movement and started bleeding profusely from anal area. No prior symptoms.
Sore arm; Head cold; Sneeze; Postnasal drip; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) (batch number unknown, expiry date 21st October 2022) for prophylaxis.   On 21st October 2021, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm, head cold, sneezing and postnasal drip. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the head cold, sneezing and postnasal drip were recovering/resolving.   It was unknown if the reporter considered the pain in arm, head cold, sneezing and postnasal drip to be related to Shingrix.  Additional details were provided as follows: The case was self reported by the patient. The age at vaccination was not reported. The patient experienced sore arm after getting the Shingrix dose in left arm.  The reporter mentioned that he was recovering from head cold, sneeze, and postnasal drip about 10 days ago from the day of reporting.  The reporter did not think the events (head cold, sneeze, and postnasal drip) were from Shingrix. The reporter did not have lot number for the first dose but, did provide the expiration date. The reporter did not consent to follow up with the Healthcare professional.
I was vaccinated at 3 pm. Just nausea at the beginning. It is now 7 pm. And I went to walk the dog and my vision could not focus far away. I was swing blurry and double. I cannot focus. I only need glasses for reading. My fat sight is perfect. So this was very noticeable immediately when outside. I returned home since I felt worried about my vision.
Localized pain at injection site.  Now past 3 months. Hurts to touch and with movement of arm.
Shingles began after first dose of Moderna Vaccine  four days later received second dose four days later shingles worsened. My wife  got a case of shingles one week after first dose a light case on forehead. I treated her with Acyclovir spray and Valaciclovir tablets 1000 mg  / 8hrs. Hers cleared up and she got her second dose of Moderna one week after she was clear. I believe that because I was starting out with my case the second dose exacerbated it. I read about shingles as an adverse reaction in people with compromised immune systems, but we are not immune compromised.
Patient received MMR-V & PCV-13 on 4/1/22 in the right leg. She has now developed cellulitis of her leg.
Both hands swollen and red splotches and burning sensation. Also, a 1 inch round bumpy red splotch on right forearm.
Information has been received from a licensed practical nurse concerning a female who was vaccinated IM with a dose of Gardasil. It was reported that the patient may have received more than one other unspecified vaccination. Subsequently, the patient fainted. The patient did not seek medical attention. The patient outcome was unknown. This is one of three reports from the same source. Additional information is not expected.
Bell's palsy; tongue went numb; body aches; regular sore arm; headache; This is a spontaneous report from a contactable consumer reporting for herself. A 21-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EW0153/expiration date: not provided), via an unspecified route of administration, on 15Apr2021 10:45 (at the age of 21 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Apr2021, the patient experienced regular sore arm, headache. On 16Apr2021, the patient experienced body aches. On 17Apr2021, the patient's tongue went numb. On 20Apr2021, the patient experienced Bell's palsy and described it as getting worse. The outcome of the event regular sore arm was recovered on 16Apr2021. The outcome of the event body aches was recovered on 19Apr2021. The outcome of the events headache, tongue went numb and Bell's palsy was not recovered.
This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The medical assistant reported that the vaccine was exposed to temperature of 26 F (Fahrenheit) for a total of 135 hours. No adverse effects reported. Follow-up received. Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the medical assistant regarding an unknown age, female patient with no pertinent medical history reported. On 23-NOV-2012 the patient was vaccinated with a dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). On 20-FEB-2013 the patient received another dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). It was reported that the patient did not see medical attention. This is one of the several reports from the same source. Additional information is not expected.
Experienced a headache before and after the first dose; This is a spontaneous report received from a Pfizer and medical information team. This consumer reported for her husband (patient) that a male patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on 23Apr2021 as single dose for COVID-19 immunisation. The patient's medical history included headache. The concomitant medications were not reported. The reporter (patient's wife) mentioned that her husband just had the first dose today 23Apr2021 and experienced a headache before and after the first dose. The outcome of the event headache was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
A covid vaccine vial was reconstituted twice, this patient received a diluted dose of the vaccine, the patient was contacted about the issue, and patient came into to be revaccinated.
4/4-date of vaccine. 4/6-symptoms feeling very tired, pain at site red/swelling, warm. (MD not seen). 4/7-feeling ok but site of injection red/swollen/warm. Pt had placed ice, and went to ER and confirmed to be cellulitis, 6 inches and raised. 4/8-Cephalexin given for 7 days - [4/10]- PCP- to put heat= 4/17. 4/10- Pt. has a rash on hand/calf -feeling itching. 4/17-Pt being treated for yeast infection.
Nauseated, fatigued, loss of appetite, fever, inflammation at injection site, headache
Child had swelling from right elbow up to his shoulder. Father took child to Dr, who diagnosed child with cellulitis due to the injection. He was placed on antibiotics. Dad was contacted after antibiotic treatment was completed and he stated child was doing well.
Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PYREXIA (Fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced HEADACHE (Headache) and PYREXIA (Fever). On 28-Mar-2021, HEADACHE (Headache) and PYREXIA (Fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant products used were not proved by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-269057 (Patient Link).
Unusual bleeding patterns and breaks  through bleeding in menstrual cycle . This has been  consistent for almost 4 months, post birth with my two previous children I never bled this soon while 100% breast-feeding the only difference between this post birth and the other post birth is my age and most importantly I got the vaccine the day I left the hospital. 24 hours after giving birth.
Dose 1 was given to me on 12/30/20. Arm was sore at injection site x2 days which was fine. On 1/12/21 I experienced SOB/labored breathing for approximately 24 hours. O2 sat did not go below 95%. HR was between 80 and 105 for approximately four hours (75 is a typical resting heart rate). No history of asthma, but I felt how people with asthma describe difficulty breathing. Given the length of time between the dose and the SOB, I don't know if it's related to the vaccine. But I am submitting this just in case you end up with other, similar reports. Thank you.
no adverse event; 11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) and NO ADVERSE EVENT (no adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2023, the patient experienced WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (11 patients (6M-5Y old) received first dose Moderna COVID-19 vaccine Bivalent from a vial with pink cap).    It was unknown if the patient receives any other vaccine in the 4 weeks prior to Moderna Pink Cap COVID-19 vaccine. These patients were never vaccinated with any other COVID-19 vaccine in the past. Patient age was between 6 months to 5 years.  Concomitant product use was not provided by the reporter.  It was reported that the incidents started in May-2023 and they just noticed it (Lot number 215K22A and  Exp. Date: unknown), (Lot number 216K22A and Exp. Date: unknown).  Treatment information was not provided.  This case contains information about patient 6th out of 11 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-740029 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-740029:Master case (Patient 1)
After receiving the flucelvax patient had very severe allergic reaction. Arm went numb and to her legs and neck, trouble breathing went to the hospital. After one month patient is still suffering.
Moderna COVID-19 Vaccine EUA - Migraine    Day 2 - I had terrible fatigue and migraine. I work from home so I couldn?t focus. Found it difficult to concentrate with the migraine. I clicked out work and went to sleep.   Day 3 - I had mild headache but not even to not be able to concentrate. At around 8-9pm the migraines started again. I went to bed at around 12am. Woke up at around 3am. The migraines are now as bad as they were on day 2. Feeling the migraine from the right side of my face
The left calf is swollen 3/4 inch; Left knee effusion/ she got the Bakers cyst test, the fluid leaked into the area that formed into this area; swollen cervical and supraclavicular lymph nodes on the left side/ swollen axillary lymph nodes on both sides; This is a spontaneous report from a contactable healthcare professional (Physician Assistant) reporting for self. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EL0142, Dose 1, intramuscularly on 07Jan2021 07:15 (at the age of 48 years old) as a single dose in left arm for COVID-19 immunization.  Medical history included ongoing undifferentiated spondyloarthropathy diagnosed more than 10 years ago.  Concomitant medication included golimumab (SIMPONI), 0.5mg subcutaneous injection once a month for undifferentiated spondyloarthropathy.  There were no prior vaccinations in the past 4 weeks. There were no adverse events with prior vaccinations. Two days after the vaccine on 09Jan2021 she experienced swollen cervical and supraclavicular lymph nodes on the left side. On 12Jan2021 by 09:00 she developed left knee effusion and swollen axillary lymph nodes on both sides. It was worse "now" (as of Jan252021); she states she got the Bakers cyst test, the fluid leaked into the area that formed into this area. On an unspecified date, the left calf was swollen 3/4 inch. The events did not require a visit to the Emergency Room. The events did require a visit to her rheumatologist on Friday, 22Jan2021. There reporter declined having had treatment for the events. The outcome of the left knee effusion was not recovered; left knee effusion was reported as worsened. The outcome of swollen on axillary lymph nodes on both sides, swollen cervical and supraclavicular lymph nodes on the left side was recovering. The outcome of left calf was swollen 3/4 inch was unknown. Her rheumatologist was asking if he can drain it or send fluid for any studies prior to any treatment, and for any advice or if any special markers need to be drawn in case Pfizer would like more information on this.
Patient given Pfizer bivalent as first dose in series intead of Novavax or Pfizer monovalent primary series.   Patient called and he returned to vaccination site for assessment and explanation.  No adverse effects noted at that time.
patient was given covid vaccine at 6 weeks from previous covid vaccine. instead of 8 weeks. No signs and symptoms of adverse reaction noted. Patient states "I feel fine". MD and patient notified within 10 minutes. patient observed for approximately 20 minutes. no adverse reactions observed
ITCHING AND SWOLLEN RIGHT ARM FOLLOWING IMMUNUZATION 2 DAYS AGO IN RIGHT ANTERIOR DELTOID
Redness & soreness around injection site. Pt. stated it was very painful & she couldn't move her arm.
This spontaneous report was received from a healthcare worker (also reported as other; details unspecified) referring to multiple unspecified patients. No information about patients' medical history, concurrent condition and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored doses of VAQTA which had lot # M00978, expiry date: 26-MAY-2017 (dose and route not provided). The vaccines were exposed to unspecified multiple previous excursions since March 2016 and a current excursion in July 2016 for 15 days exposed to a minimum of 27 degree Fahrenheit and maximum of 57 degree Fahrenheit. The temperature excursions were detected by a data logger. No adverse effects were reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Baby couldn't move her leg. She was shrieking for close to an hour. She refuses to nurse until approx 9pm. She has fitful sleep accompanied by "what can best be described as "jerking" until approx 4am.
pt recv vax 29APR96 & the next day pt exp wheezing, chest congestion & red, raised contact dermatitis @ the site of the inj;taken to ER dx w/allerg rxn;
he's not feeling well; diarrhea; feeling weak; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 04Feb2021 (Batch/Lot number: unknown) at the age of 73 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: ATEZOLIZUMAB, start date: 25Feb2021. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "he's not feeling well"; DIARRHOEA (non-serious) with onset 04Mar2021, outcome "unknown", described as "diarrhea"; ASTHENIA (non-serious) with onset 04Mar2021, outcome "unknown", described as "feeling weak". Additional information: Patient received his first shot on 04Feb2021 and scheduled to get his 2nd dose on 26Feb2021 however his appointment was cancelled because he's not feeling well. He tried to reschedule his 2nd dose again and was scheduled today 04Mar2021. However, the caller said he is not feeling well today.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Some tightening of the throat (lump).  Lasted a couple of hours.  Affected swallowing. Fatigue, headache, fever, sore arm for 24 hours.   Fatigue, headache still continuing  36 hours later after injection.
Myalgia, Fever, fever 101.5 muscle aches fatigue chills Symptoms began 1/21 Narrative:
Fatigue at the end of the day I received the flu shot and headaches until 10/13/23. Headaches were ongoing in the evenings and I experienced unusual fatigue throughout the day.
Per recovery RN notes:  05/10/2021 1026 AM Patient Female Vaccine Time: 1018 Symptoms: Patient stated,  " I don't feel well I feel clammy".  Intervention: RN had patient sit on floor, VS taken  BP 95/59. Right arm lying down, HR 62, RR12, 02sat 100%. RN had patient lay down  and after about 10-14 minutes patient reported she felt better and could sit up in chair. Patient rested for another 10 minutes and reported she felt well enough to leave.
PATIENT HAD PFIZER VACCINE ON 12/27/2020 and 01/14/2021, AND TESTED POSITIVE TO COVID.
pt recv vax;fever approx 100; then staring; arms & legs jerking for few seconds;irritable p/ 45 min;had trunk stiffening & arms/legs jerking for few sec;30 min later,pt appearing nl;
Cerebrovascular Hemorrhage (Stroke), left occipital zone; This is a spontaneous report from a contactable consumer.   A 78-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EK4176) at single dose, in the left arm, on 13Jan2021, at 15:00, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not experienced Covid-19 prior vaccination. Relevant medical history included Sulfa allergy (Sulfonamide allergy) and drug hypersensitivity due to pethidine hydrochloride (DEMEROL) was reported as past drug event. On 03Feb2021, received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN5318) at single dose, in the left arm, for COVID-19 immunisation. Concomitant medications included levothyroxine sodium (SYNTHROID) and estrogens conjugated, medroxyprogesterone acetate (PREMPRO). On 18Jan2021, at 12:30 PM, the patient experienced cerebrovascular hemorrhage (stroke), left occipital zone. Hospitalization and treatment (stroke Center ICU care) were required (duration of hospitalization 4 days). Clinical outcome of the adverse event was recovering at time of this report. Post the vaccination, the patient has been tested for COVID-19 (Nasal Swab) on 18Jan2021 and resulted negative.