chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Wed. (Recieved Smallpox)-Sun. = No symptoms of any sort.   Mon.-Tues 25-26 Aug = Felt aches and pains in my body and had a head ache.  Took Motrin for it.  A lump formed in my left side neck Tuesday afternoon.  Wed. 27 Aug =  Woke up dizzy and tired, couldn't concentrate on road while driving to work.  Vision was swimming and blurred while I worked at my computer and still felt fatigued.   Went to Dr. and had a throat culture for strep and blood drawn for mono and others.  I recieved a "Z-pack" of antibiotics and Sudafed for my congestion.  Thurs 28 Aug = Woke up with a second lump in my neck and severe pain and stiffness.  Pain subsided with Motrin, but stiffness stiff apparant.  Went for follow up. Dr. performed rapid strep, mono test: both negative. I still have 2 painful lumps on my necks.
Unknown date of vaccination and appearance of adverse event.  Reported he had a itchy rash on his back after he received the Moderna covid vaccine and is now on Dupixent to clear his rash.
Chills and Fever 100.1 lasting 9 or 10 hours the evening of shot.  Headache and joint pain.  Tiredness lasting next day & day after. Took Tylenol every 6 hours.
Pentacel was reconstituted only with the liquid portion, no AE; Initial information regarding an unsolicited valid non-serious case received from other healthcare professional via The Agency (Reference number- 00328233) and transmitted to Sanofi on 22-Oct-2020.  This case involves a patient (age and gender not reported) who was administered with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number U6841SAA and expiry date 22-Jun-2021) via an unknown route at an unknown administration site for prophylactic vaccination where PENTACEL was reconstituted only with the liquid portion (product preparation issue), in Oct-2020.  Medical history, past medical treatment, vaccination, concomitant medications and family history were not provided.  This was an actual medication error case due to inappropriate reconstitution technique (latency same day).  It was reported that medical assistant (MA) called with concern if Pentacel was reconstituted only with the liquid portion. MA had a follow up question how can she obtain a proper diluent. MA was advised that there was no recommendation in obtaining proper diluent. MA also asked how are they going to make sure it was documented properly now because when she enter another HIB dose, it does not count as first one because Pentacel was documented, unless they document it separately. She then proceeded to say that she has other doses of HIB like PVAX HIB and asked that if she gives the dose, was the consumer protected or was the dose valid.   At the time of reporting, no adverse event was reported.  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pain in her arm that went away and now has come back; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in her arm that went away and now has come back) 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.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in her arm that went away and now has come back). At the time of the report, PAIN IN EXTREMITY (Pain in her arm that went away and now has come back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient wants to know if it fine to take pain relievers like Advil and Alieve.
On 12/02/2022 did a PCR Covid-19 test and it was positive. I had a sore throat and cough. I did take PAXLOVID for 5 days from 12/02/22-12/07/2022.
ON THE THIRD DAY I FEEL LIKE PINS ON MY BACK AND A SLOPE CAME OUT OF MY NOSE AND ON MY LIP. I TAKE BENADRYL TABLETS 50MG  TWO TIMES.
Case number PHEH2012US020569 is an initial spontaneous report from pharmacist received on 12 Oct 2012. This case refers to 30-year-old female patient. The patient was vaccinated with FLUVIRIN (batch number: 12241P) intramuscularly on 10 Oct 2012. Two hours after the vaccine administration, the patient experienced chest pain, difficulty swallowing, hives and itchiness all over the body. The patient was treated with corticosteroids, ATIVAN and BENADRYL for the events. The outcome of events was reported as complete recovery as of an unspecified date. Following internal review on 05 Nov 2012, for the information received on 12 Oct 2012, the following correction was done. The seriousness of the events chest pain, difficulty swallowing, hives and itchiness all over the body was assessed as serious (medically significant).
first dose of the Shingrix vaccine 8/22/2019 has not received the second dose.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 22nd August 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up. This case had been linked with case US2021179653, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021179653:Same reporter
Hives urticaria angioedema - persistent cough immediately after - 5 minutes of varicella vaccine # 2 Pt started having pruritic rash - hives - urticaria on face & neck - swelling of eyelids, tachycardia - Pt was coughing - immediately - after giving - varicella - Pt was given Albuterol neb treatment, Oral steroids - sent to ER was given BENADRYL.
Developed blurriness in the left eye which progressed and was subsequently evaluated by ophthalmology.  Patient had findings consistent with central retinal vein thrombosis of the left eye with associated macular edema.
I am having allergic reaction to it;  the kind of reaction that I am having.; I am swelling; I am itching; This is a spontaneous report from a Non-Contactable Consumer (patient). A patient with an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: Unknown) via unknown route of administration on an unknown date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was stated that, patient had the Pfizer shot (confirmed as Pfizer Covid19 shot) and so, what it was that patient was told to give you all a call because patient had the shot on 29Jul2021 and patient was having allergic reaction to it on an unspecified date. Anyway, before did go by the pharmacist, the pharmacist said, you know, could call this number here, you had to let them know, the kind of reaction that, patient was having." Patient stated that, "And do you recommend. Yeah, because patient was swelling and patient was itching in so, patient was probably would have gone to the doctor or something." It was also reported that patient was go on to the doctor and then, was going to call back cause right now. At the time of this report the outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Leucopenia/ white blood cell count was down; Felt like being stabbed with the needle; This spontaneous case was reported by a consumer and describes the occurrence of LEUKOPENIA (Leucopenia/ white blood cell count was down) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced VACCINATION SITE PAIN (Felt like being stabbed with the needle). On 08-Jul-2021, the patient experienced LEUKOPENIA (Leucopenia/ white blood cell count was down) (seriousness criterion medically significant). At the time of the report, LEUKOPENIA (Leucopenia/ white blood cell count was down) and VACCINATION SITE PAIN (Felt like being stabbed with the needle) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jul-2021, Blood test: everything was ok except for the white blood cell (abnormal) white blood cell count that was down.         Concomitant medications were not reported. Treatment information was not provided. Very limited information regarding the event has been provided at this time.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding the event has been provided at this time.
On 4/18/02 in the evening, had 101F (Rectal) temperature and fussy. During the night, temperature was 104F (Rectal). Went to MD on 4/19/02 and temperature was 105F with ear thermometer. Child had total of 5-6 pox at various places. Friday, activity level was very low but they progressively got better over the weekend. MD did Strept test, CXR's and UA-all were negative. On 4/20/02, temperature was 102F (Rectal). No fever by Sunday night; activity level was normal by Tuesday 4/23/02 or Wednesday 4/24/02.
After receiving the vaccine the patient started experiencing  numbness on the left side of the body, dizziness, headache, blurry vision, muscle pain.  The patient has been treated by Dr and given a prescription for Prednisone.
Site: Pain at Injection Site-Mild, Systemic: Headache-Medium, Additional Details: pt states that this is a different headache then she normally gets (more migraine like, behind eyes), headaches for her normally go away with sleep and/or Tylenol, neither has helped
Patient received Moderna shot, during observation period he reported burning in the throat, metallic taste and left lower arm swelling and red.  Blood pressure at 10:00 am 136/82, pulse 76, SaO2 97% on room air.   Respirations normal, cardiac eval normal, throat normal, tongue normal, lips normal.  No rash, swelling, redness or bruising noted at site of the injection.  Denies any other symptoms.   Diphen 25 mg given, after 20 minutes patient reports improvement of throat symptoms and decreased redness of left lower arm.  second dose of Diphen 25 mg given and after 20 minutes patient reports metalic taste resolved, burning in throat resolved, redness of arm resolved.  Only remaining symptom was mild hand swelling.  Follow up blood pressure  at 10:14 am 126/82.  Follow up exam, no swelling or erythema of lips, tongue, throat.  no shortness of breath, wheezing or difficulty breathing.  Discharged ambulating.
Chills, Low temp, Arm swollen. Rash on neck. Red rash 5" high and 9" around width of arm. Felt sick. Too weak to continue normal functions. Loss of appetite. Sick in bed 2 days. After 4 days arm still has big rash 5" x 9" & swollen & hot to touch but rest of body feels ok.  Will call doctor tomorrow to report symptoms.
About 2 weeks after getting my second vaccination, I started to have mild but then severe heart palpitations. I thought it was the anxiety meds I was on, and adjusted the dosage but it wasn't helping. I stopped taking them. After about a month I started gradually feeling better. Palpitations would worsen if I worked out and or stood up too fast. Today my PCP and I scheduled for me to see a Cardiologist at the end of June. My PCP did some tests that included an EKG after first 6 weeks which was normal. She also did a troponin test, which was also normal. A CRP and Sed rate which were also normal. I still struggle with heart palpitations to this day.
Rash on trunk, slightly swollen eyelids, and tongue discomfort x 3 days.
Patient noted swelling and itching around her R abdominal port site in May.  She mentioned this when she presented for surveillance colonoscopy in July. Biopsy of the lump was performed by Dr.  at the time of colonoscopy. Path showed infiltrating adenocarcinoma.  I fully understand that the cells causing this cancer were probably left at the time of the surgery. She had a normal CT surveillance with no sign of metastasis on 12/16/2020.  I am just wondering again if the inflammatory reaction noted with vaccination may be an accelerant  to any residual cancer cells. I haven't seen a port site recurrence since our early days of laparoscopy in the 1990's.
Immediate numbness in my left hand (pinky and ring finger). Slight numbness in left elbow region that is sporatic.
On 07Apr2021, he tested positive for Covid; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 02Apr2021 (batch/lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received his first Pfizer Covid vaccine dose on 02Apr2021. On 07Apr2021, he tested positive for Covid. He stated that this past week he has started to feel better. He wanted to know if he can get the second dose tomorrow 23Apr2021 or should he wait. The case was assessed as non-serious. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Slight chest pain; Rhabdomyolysis; This is a spontaneous report from a contactable pharmacist. This pharmacist reporting same events under the same suspect product for 3 patients. This is the third of three reports This is a spontaneous report from a contactable pharmacist. A 16-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 15Sep2021 (Lot Number: FC3180; Expiration Date: 16Sep2021) (at the age of 16-years old) as dose 2, single for covid-19 immunisation. The patient had no medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient was complaining of slight chest pain and the reporter was unsure if it was rhabdomyolysis. The chest pain started on the morning of 16Sep2021. The reporter stated patient had Rhabo issues (also reported as rhabdomyolysis) in Sep2021. The reporter stated that the patient was still being evaluated at the time of reporting. The reporter questioned if there was a link between the 2nd dose and Rhabdomyolysis in younger patients as they have not seen this in the past. The reporter seriousness for slight chest pain was medically significant. The outcome of chest pain was not recovered, and outcome of rhabdomyolysis was unknown. The reporter's verbatim event relatedness of Pfizer covid 19 vaccine with slight chest pain was related.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events rhabdomyolysis  and chest pain and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
A non-serious spontaneous report of administration of expired FLUMIST to a 52 year old female was received from a health professional concerning a 52-year-old female subsequent to administration of FLUMIST. Relevant medical history and concomitant medications were not reported. On 24-Aug-2009, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered to be resolved. Additional information was received on 15-Oct-2009 and incorporated into the narrative: confirmed the patient did not experience any adverse events associated with the medication error and the patient was re-vaccinated with FLUMIST.
No adverse event; patient received a Moderna monovalent booster instead of bivalent booster; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received a Moderna monovalent booster instead of bivalent booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (patient received a Moderna monovalent booster instead of bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received a Moderna monovalent booster instead of bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient received a Moderna monovalent booster instead of bivalent booster).    No concomitant medication were reported. No treatment information was provided by the reporter.   Reporter did not allow further contact
Infantile spasms, similar events occurred sporadically prior to his immunizations at 6 months, but increased dramatically in severity and frequency on 12/06/2006 12/19/06-records received and reviewed. PMH: Possible infantile spasm Regression 2 week history. Developed normally for 5 1/2 month old baby when he developed head nodding spells approximately 1 month prior to admission.  Formulation: 6 month old baby boy with onset of likely infantile spasms with an abnormal EEG.  DC DX: for DOS 12/11-12/14/06 Infantile spasms West's syndrome development regression, acute. Subtle infantile spasms identified 4 weeks prior to admission  MRI brain, normal for age Annual follow up information received indicates patient is now seizure free for a year and development is normal. Per 60 day follow up: Infantile spasms resolved. At this time, he still has hypertension related to ACTH treatment for infantile spasms.
area of redness where injection given area approx. 6in long & 4in with with warm areas + pain.  Started around 12 hours after inj + worsening over 48 hour period.  Gave compresses applied & examined by physician.
vaccine given 9/27/07 died in sleep 9/29/07 presumed cardiac arrest by autopsy.  1/15/08 Reviewed autopsy report which states COD as occlusive coronary artery disease with HTN & sleep apnea as contributing factors.  Findings at autopsy included: RCA 70% occluded; LAD 80-90% occluded; LCA 70% occluded; microscopic evidence of ischemic heart disease w/increased fibrosis in tissue; fatty infiltration into RV wall of heart; and chronic HTN.  Patient died in his sleep after recently c/o being tired.
This spontaneous report received from a physician assistant refers to an unspecified patient with unknown demographics. No medical history was reported. On an unknown date in August 2015, the patient was vaccinated with firs dose of GARDASIL (route, dose and frequency: unknown). On 28-DEC-2015, the patient was in the reporting physician assistant office to receive second dose in the HPV series with GARDASIL 9. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Post DTaP, priapism x few hrs, 3 cm induration, 3 cm erythema R thigh at site. Also 1.5 cm LN in R inguinal area.
4cm induration-left anterior thigh;T102-103 p/vax 19JUN98 & again on 23JUN98;
No additional adverse effect reported.; Nurse called to report that on two different dates a patient was administered a less than recommended dose of RECOMBIVAX; Nurse called to report that on two different dates a patient was administered a less than recommended dose of RECOMBIVAX; Information has been received from a nurse reporting on a 53-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 05-NOV-2019, the patient was vaccinated with the first dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) pediatric; on 06-DEC-2019, the patient was vaccinated with the first dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) pediatric; and on 11-JUN-2020, the patient was vaccinated with the third dose of Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB),  after previously receiving 2 pediatric strength doses in the past, all vaccines were administered for prophylaxis (dose, route of administration, lot number and expiration date were not reported). No additional adverse effect reported.
pt recv vax 9AM & 130Pm vomited forcefully & again twice more by 2PM;sleepy since 1230PM;t97.7ax;no rash;
When LPN administered the vaccine, she reports that the needle disconnected from the syringe. An unknown amount of vaccine went into the patient's deltoid, and the remainder went onto the table.  Spoke to DON. Patient was educated on efficacy of 1st dose, and told that he received a partial 2nd dose.
Approximately 18 hours after second shot (date above) had very bad chills, feverish and dizziness.
red around shot area;about 3" in diameter;patchy;put hot compresses on 3 times day;still kind of hard;no fever just big-no pain @ site;
administered subconsciously, should've been given IM; This case was reported by a consumer via interactive digital media and described the occurrence of intramuscular formulation administered by other route in a 74-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.       Additional Information: GSK receipt date: 29 Apr 2022 Reporter's comment: The case was reported by patient. The patient received a Shingrix vaccine last month. It was administered subconsciously. The patient just read that it should have been given intramuscularly. The patient asked if it was problem for him/her.  The patient got more info and he stated he was not sure if he received SHINGRIX subcutaneously or intramuscularly. He would contact the pharmacist. Additional supportive information: The patient received Shingrix subcutaneously which led to intramuscular formulation administered by other route.