chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 15DEC95 & 23DEC95 pt exp cold sx (cough, runny nose), fever 102, measles looking, gen maculopapular rash on head, trunk & extremities & fluid in ears;26DEC95 presented to MD office;pt recovered;
This spontaneous report was received from a registered pharmacist concerning an approximately 51 year old female patient with no pertinent medical history. Current condition of the patient included codeine allergy. On 04-SEP-2013, the patient was vaccinated with 0.65 milliliter (ml) of ZOSTAVAX (lot number and expiry date were reported as J003723 and 28-JUN-2014 respectively), subcutaneously. Concomitant therapies included TRIVORA, FLONASE and ASTELIN. On 06-SEP-2013, the patient developed redness and burning sensation at the ZOSTAVAX injection site. It was reported that the patient also complained of headaches on 06-SEP-2013 (reported as this morning). The patient sought medical attention (called the pharmacy). No treatment was given. No lab tests were performed. The patient was not recovered from the events. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been received.
This is a spontaneous report from a contactable consumer (the patient, also a medical assistant) on behalf of a nurse practitioner. A 51-year-old female patient received the first dose of PREVNAR 13, (lot number: S58704 and expiration date: 31Oct2019) intramuscular in the left deltoid, given around 13:00, at 0.5 ml, single and the first dose of SHINGRIX, (lot number: P3777 and expiration date: 30Jan2020) intramuscular in the right deltoid at unknown dose, both on 13Mar2018 for immunization (reported as over 50 and she wanted it). The patient's medical history and concomitant medications were unknown. The patient administered both vaccines then on an unspecified date in Mar2018, experienced significant soreness in arms at injection site, the left arm is worse than the right arm. She had a fever of 102 degrees Fahrenheit, a bad headache, and muscle aches. Therapeutic measures were taken as a result of the events. The patient took ADVIL and put ice on it. It is unknown if any other vaccinations were received within four weeks prior to the administration of the suspect vaccines. The patient did not undergo any relevant tests. The reporter did not know the seriousness criteria of any of the adverse events. Outcome of the events was unknown. Event relatedness for fever of 102 degrees Fahrenheit, bad headaches, and muscle aches was reported as unknown for both PREVENAR 13 and SHINGRIX.
Brain fog, tremors, pinching pain in head. Body felt heavy and barely able to walk at times. Started seeing neurologist about 18 days after first injured. Urgent-Care, Family Doctor and Cardiologist were unable to provide guidance. Neurologist worked with a speech pathologist on various tests which consistently re-triggered the same symptoms. So far, I have been out of work for almost 8 months ... unable to drive most of the last 7 months but recently getting better as long as it is during the day and clear weather.
patient received an expired FLUZONE QIV NP with no reported adverse event; Initial information was received on 14-Nov-2022 regarding an unsolicited valid non-serious case from a other health professional.  This case involves 38 years old female patient who received an expired INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s)and family history were not provided.   On 14-Nov-2022, the patient received an expired 0.5 mL dose, a standard strength of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT7384KA, expiration date: 30-Jun-2022) via intramuscular route in the left deltoid for Immunisation with no reported adverse event (expired product administered) (latency: same day).  No lab data reported.  Action taken: not applicable.  Outcome: Unknown for the event patient received an expired fluzone qiv np with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Patient began vomiting blood and had dizzy spell once he was on his way home from the pharmacy. He was transported to the hospital.
Pt recvd MMR vax 9MAY91 & on 19MAY91 was noted to have a rash, fever, & adenopathy;
Patient called on 7-11-13 complaining of arm pain and swelling. The swelling per patient went 2/3 down her arm, some redness around injection site. Patient to come in for us to measure. Said swelling was on the inside and outside of he arm.
Information has been received from a physician concerning a female who was vaccinated intramuscularly with a dose of Gardasil.  Subsequently the patient became woozy "almost immediately after vaccination".  Medical attention was not sought.  The patient recovered before leaving the office.  Additional information has been requested.
MOTHER BROUGHT CHILD IN TO HD REPORTING OF SWELLING IN LEFT THIGH, L THIGH MEASURES 13" CIRCUMFERENCE, RIGHT THIGH 11 1/2". BOTH CALFS MEASURE 8 3/4". NO REDNESS AT SITE. LEFT THIGH IS SLIGHTLY WARMER TO TOUCH THEN RIGHT THIGH. MOTHER TOOK CHILD TO ER ON 3/30/06. THIGH CONTINUED SWOLLEN 3/31/06. PHONE CALL TO FATHER ON 4/3/06. FATHER STATES SWELLING SUBSIDED ON 4/1/06. NO FURTHER SYMPTOMS FROM VACCINE NOTED.
Could not breathe, chills, entire body aches, headache, congestion in head, could not lay down due to breathing, lasted 12 hours with bad breathing, have never experienced a flu like this. Felt bad up to 3 weeks, still not breathing like before, also high blood pressure for a week until I took additional medication.
9/6/02 woke up front side of arm swollen upper part where DTaP given came to HD referred to private physician. Went to MD and seen by physician assistant diagnosed with postule cellulitis started on Bactrim 200mg BID and alternate hot and ice for 20 mins to arm. On Sunday 9/8/02 arm more swollen and red taken to ER. Diagnosed with local allergic reaction to DTaP by ER doctor. ER doctor prescribed Pediapred dose pack. 4 tsp one day, 3 tsp for two days and 2 tsp for two days and 1tsp for one day. Swelling is dramatically better today 9/9/02 at 5:10pm. Also given one tsp Benadryl every 6 hrs until pediapred gone. Arm has a blister about 1/2" long x 1/4" mid way between shoulder.
4 days after vaccine I started to have trouble catching my breath. Had shortness of breath and chest pain for three days. Continue to have chest pain on occasion.
Felt under the weather; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell 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 feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received a dose of Shingles vaccine and felt a little under the weather for about 24 hours. Follow-up would not be possible as no contact details available.
she felt ill; headache; This is a spontaneous report from a contactable consumer (patient), received via Pfizer. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 16Feb2021 (Batch/Lot number was not reported) as unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient felt ill and had a headache on 23Feb2021. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
On Wednesday (May 12) morning after receiving my 1st COVID-19 Vac -  I felt the sensation of my upper body "slightly" vibrating but didn't over think it because I was driving.   Later that evening while sitting home with family - I was able to confirm my physical body was slightly vibrating. Thursday, I reported this symptom to my doctor she recommended that I report the details to the CDC. If you have any questions or concerns please contact me via email or phone.  Thanks
Day after receiving dose, experience a red bump on knee. Day after that additional 10-12 red bumps on both legs, forearms and 1 on forehead. Very itchy and painful. Used calmine lotion. As of today 1/12/21 symptoms improving.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 29-DEC-2015 the patient was vaccinated with VARIVAX (Merck) (strength, dose, route unknown) (lot# L019130, expiration date 27-MAY-2015 and lot# L026407, expiration date 15-JUL-2015) which were improperly stored (incorrect product storage)(Temperature: 9.5 F, Time frame: 2 hours). No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
At approximately 1630 hrs, a syncopal episode occurred at the location site on 09/01/2021. A 21 yo female vaccination patient had a syncopal episode post-vaccination with JJ. The patient did not experience any trauma and was provided care by 2 RNs and 2 LVNs with a pharmacist as well. Patient woke up after approximately 5 seconds. Patient had ear pressure upon waking but mentioned it was just her anxiety. Vitals were taken and were all within normal range. Heart rate was 56 with the patient mentioning they ?are an acrobat and athletic?. Patient left after 45 minutes of monitoring stating that she ?was feeling much better and will eat a snack soon?. The patient was medically screened appropriately by an RN with no contraindications to vaccination. When the incident occurred, the patient was seated in the observation area. All staff responded appropriately, as discussed in the morning briefing.
Thigh abscess 8 days following vaccine. Swelling and fluctuance. TX with clindamycin x 10 days.
received another dose of MENVEO; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA912A, expiry date 31-MAR-2024) for prophylaxis.   Previously administered products included Menactra (received a dose in 2017). Concomitant products included MENVEO.   On 08-AUG-2023, the patient received the 2nd dose of Menveo. On 08-AUG-2023, an unknown time after receiving Menveo and an unknown time after receiving MENVEO, the patient experienced extra dose administered (Verbatim: received another dose of MENVEO). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 08-AUG-2023 The reporter was a Nurse Practitioner (NP).   The HCP/Reporter (NP) gave consent to follow up.  The patient received an extra dose of Menveo, which led to extra dose administered
I got my first shot in march and still need second; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I got my first shot in march and still need second) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I got my first shot in march and still need second). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I got my first shot in march and still need second) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.
p/vax pt reported not feeling well;pt was shaking uncontrollable;T97.6, pulse 96, resp 18, BP 80/60;mom phoned & pt taken to MD;
No AEs; RN called to report temperature excursion that occurred on 7/12/2022. Caller states that 100 doses of PROQUAD and 94 doses of VARIVAX were administered since 7/12/2022 from mobile unit. No further information provided. No add; This spontaneous report was received from a nurse and refers to a child of unknown gender. The patient's concurrent conditions, medical history, allergies or concomitant therapies were not reported.  On 12-JUL-2022, 60 doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # W002782 with expiration date 24-JUL-2023) underwent a temperature excursion during storage.   On an unknown date, the patient was one of 60 patients vaccinated with vaccine Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # W002782  with expiration date 24-JUL-2023) administered as prophylaxis (dose regimen details were not provided).   No adverse event was reported. No further information was reported.  This is one of several reports received from the same reporter.
We were real sick with virus and cold like symptoms. I lost my sense of smell and taste. It lingered for about 3 or 4 weeks with cough symptoms. I experienced headache and fatigue. No vomiting but diarrhea and nausea. I had a low grade fever. I took OTC Mucinex and Dayquil for a while.
On 01-25-2021, I started to experience left arm soreness. I felt like my left arm was going to "drop-off" with extremely pain. I also had a high fever, was extreme cold, was disoriented, felt my brain foggy and these symptoms lasted up until 3AM. I also felt extremely fatigued. By Friday  01-29-2021, I was getting back to normal.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19) (seriousness criterion death). The reported cause of death was covid-19. It is unknown if an autopsy was performed.            No relevant concomitant medications were reported.  It was reported that the patient passed away from COVID-19. It was unknown if they previously received COVID-19 vaccines. They closed his primary healthcare clinic because of this. No treatment medication reported.  Company Comment: This is a spontaneous case concerning a male patient of an unknown age with no reported medical history, who experienced the serious, fatal, unexpected, event of COVID-19, which occurred on an unknown date after a dose of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine (unknown COVID-19 vaccination schedule). The reported cause of death was Covid-19. It is unknown if an autopsy was performed. No further information was disclosed. The benefit-risk relationship of mRNA-1273.815 (SPIKEVAX 2023-2024) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2021-396655 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-396655:Reporter's case; Reported Cause(s) of Death: COVID-19
Information has been received from a nurse concerning a 24 year old female patient who on 11-JUN-2009 was vaccinated with the first dose of GARDASIL (lot # not specified). It was reported that the patient was already pregnant when received the first dose of GARDASIL. No adverse effects were reported. The patient sought unspecified medical attention. Follow up information has been received from the nurse who reported that on 20-JAN-2010, at approximately 36 weeks of gestation, the patient delivered twins by planned C-section. It was noted that it was a repeat C-section for this patient. The patient due date was on 20-FEB-2010. The nurse did not known the birth weights of the twins. The nurse also reported that there was nothing mentioned about any problems with either baby. The baby's experience has been captured in WAES 0906USA04966B1 and WAES 0906USA04966B2. No further information is available.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Feb2022 at 13:00 as dose 3 (single), booster (Lot number: FK9896) at the age of 53 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hyperthyroid" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL TARTRATE, start date: 02Dec2013; METHIMAZOLE, start date: 02Dec2013; ZOLOFT, start date: 01Oct2018. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "report with Pfizer BioNTech Vaccine administered(patient also took plaxvid for covid-19 treatment)". Therapeutic measures were taken as a result of suspected covid-19.
lower arm pain; shoulder pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   In July 2020, the patient received Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced pain in arm and shoulder pain. On an unknown date, the outcome of the pain in arm and shoulder pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingrix, the patient had lower arm and shoulder pain very similar to when the patient had shingles in other arm.
typical arm swelling; headache; tiredness; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 17 patients. This is the tenth (10th) of seventeen (17) reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date were not provided) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated that they all got the vaccine shot in the village and all had the typical arm swelling, headache, and tiredness on an unspecified date. The reporter stated that also multiple friends (unspecified) had the regular side effect of soreness in the arm. The outcome of the events arm swelling, headache, and tiredness was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018227 same reporter/drug/event, different patient
Weak, shaky, feeling at base of throat/top of chest like difficulty breating, itchy nose, congestion, eyesight not clear, dizziness, few hives on face, pain at site of injection and down arm and into hand, hand was pulsing as if it had been hurt, pain at base of skull on left side of head, accelerated heart beat, followed by headache.  Very frightening feeling.
Patient experienced facial swelling that she described similarly to pitting edema that spanned across her forehead and temple area. The patient described it as not being red or typical of that of an allergic reaction. She did not experience this from her first shot in the series, and has never experienced these symptoms before.
injection site had extreme pain and after 12 hours chest tightness and had fever shievring and muscle achiness, it went on for the whole night and the next day.
allergies; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose No: 1), for Covid-19 immunization. The following information was reported: DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergies".  Additional information: Caller stated that he received his second dose of the Pfizer BioNTech COVID-19 vaccine today and would like to know if it is okay for him to take his seasonal medication for allergies. Response: Let caller know that there is no information regarding a potential interaction between the vaccine and allergy medications. Spoke from attached document to let caller know that during the clinical trials, participants were allowed to take antihistamines for seasonal allergies. Referred caller to HCP for further guidance. Response: Spoke from the attached document regarding CDC's guidance on the use of fever reducing and pain reducing medications like Tylenol after vaccination to treat symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Case number PHEH2012US010783 is an initial spontaneous report received from nurse on 23 May 2012 with a follow-up received on 12 Jun 2012: This case refers to a patient of unknown age and gender. The patient received MENVEO (batch number: A10032) intramuscularly on an unspecified date. The patient received MenCWY liquid conjugate component, without reconstituting with MenA. This was discovered after taking an inventory of refrigerator contents, and discovering one extra MenA lyophilized powder vial. No other adverse events were reported. This patient's parents were notified to revaccinate the patient with correctly reconstituted MENVEO. Follow-up received from the nurse on 12 Jun 2012: Updated comment about revaccination.
Was prior COVID POSITIVE patient in April, 2020. Inpatient at Facility. Experiencing mild symptoms similar to COVID. General body aches, mild fever (99.7), chills, muscle soreness at injection site and fatigue. Symptoms first noticed about 0600 - approximately 18 hours after vaccination. Treating with CareOne Daytime Multi Symptom Cold/Flu relief, distributed by FOODHOLD.
On September 3, 2021 I had trouble breathing so my wife sent me to the hospital. They then sent me to the ICU and the doctors said my lungs had filled up with water. They put a catheter on me and put 2 stents in my heart. They said that I did not have a heart attack or a stroke.  On October7,2021 I have a doctors appointment.