chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had generalized seizure Activity about 15 min after Receiving 1st Dose MoDeRNA Patient had 4 episodes of generalized shaking Movement each lasting 15-30 seconds. 911 wAs cAlleD. Seizure hAd ResolveD when EMS arrived. Pt seems to be Post Ictal during the TRAnsFer. No Incontinence 0 Fainting or Injury to Mouth.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.     This case was linked to (Patient Link).
This is only the second time I got the Flu vaccination and both times I had the exact reaction. 3 hours after the shot I get tightness on my chest, which lasts about 1 to 2 hours. I then begin to vomit about 3 time. After I vomit the symptoms start to sudside. What common ingredient was in both these vaccinations? I know it is not Thimerosal because I spoke to the doctor before this shot and we had single dose vial which did not contain the Thimerosal.
A 62-year-old male patient, who had medical condition of glaucoma and erectile dysfunction , had received a left deltoid booster dose of DECAVAC (lot number U2032CA) on 22 December 2008. One day post vaccination; the patient experienced swelling of the entire left arm and had joint pain. The patient was evaluated by a physician and prescribed Ibuprofen and over the counter Benadryl. No relevant diagnostic tests or laboratory data were performed. The patient recovered three to five days after onset of the adverse events. Follow-up information received 09 February 2009 from a health care professional  who confirmed the patient had no illness at the time of vaccination. No additional information was provided at the time of the report. Documents held by sender: None The reporter for this case is the same as for 2009-02244.
2nd dose has not been administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received a year ago in 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose has not been administered). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 22-JUN-2023 Sales representative called informing that was not able to race information. The nurse who was also a patient had not been administered yet with second dose. The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
No additional AE details are available; administered a dise on 04/01/2021 and the product had expired on 2/27/2021; This spontaneous report was received from a medical assistant referring to an 18-month-old patient of unknown gender.  The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On 01-APR-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (lot # S006048 with an expiration date on 27-FEB-2021) at a dose of 0.5 milliliters for prophylaxis (strength, anatomical location, and route of administration were not reported).         The vaccine had never been involved in a temperature excursión.
Fever(101.8 F), headache, joint pain, swollen sinuses, fatigue
Patient present the next day with swelling and redness on the underside of arm that vaccine was given. No reaction at vaccine sight. Treated with diphenhydramine and ice. Symptoms have subsided but not gone away completely as of today 10/14/14.
patient sought medical attention from ambulance due to cardiac distress.  she was taken to Hospital and stated the physician there does not feel this was related to the flu shot.
tumor markers were at 0 prior to the vaccine and when she got her two shots of the Covid-19 vaccine she went in for blood work and her tumor marker shot back up and she had stage 4 cancer; tumor markers were at 0 prior to the vaccine and when she got her two shots of the Covid-19 vaccine she went in for blood work and her tumor marker shot back up and she had stage 4 cancer; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2), administration date Jan2021 (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 1), administration date: Dec2020, for Covid 19 immunization. The following information was reported: NEOPLASM MALIGNANT (medically significant), TUMOUR MARKER INCREASED (medically significant), outcome "unknown" and all described as "tumor markers were at 0 prior to the vaccine and when she got her two shots of the Covid-19 vaccine she went in for blood work and her tumor marker shot back up and she had stage 4 cancer". The patient underwent the following laboratory tests and procedures: tumor marker test: 0, notes: were at 0 prior to the vaccine; tumor marker shot back up, notes: she went in for blood work and her tumor marker shot back up and she had stage 4 cancer.  Clinical course: Patient got her 1st dose of the vaccine in Dec2020 and her 2nd dose of the vaccine in Jan2021, where 6 months later she was diagnosed with breast cancer on the same side she received the vaccines. Caller would like to know if breast cancer has been reported after receiving the vaccine and if it is contraindicated to receiving the booster and they are mandating the booster. Caller stated she has no history of breast cancer on either side of her family, and she is nervous to receive the booster since she is uncertain if the breast cancer is related to the vaccine. Caller stated she is a Nurse that works in hospital and deals with cancer patients. Caller stated one of her patients held off on getting the Covid 19 vaccine and tumor markers were at 0 prior to the vaccine and when she got her two shots of the Covid 19 vaccine she went in for blood work and her tumor marker shot back up and she had stage 4 cancer, which is why the caller is nervous about receiving the booster.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between events Neoplasm malignant, tumour marker increased and suspect drug BNT162B2 cannot be excluded. 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
PT STATED THAT HIS ARM HAD A PINK MARK AFTER THE INJECTION AND NOW AT THE SITE INJECTION WAS GIVEN ALMOST 5 MONTHS LATER HE HAS A RED MARK ON ARM. PT STATES IT HAS TO BE FROM VACCINE AND COULD NOT BE FROM ANYTHING ELSE
Pt recv vax on 10/27/98; on 10/28/98 pt exp bruised, swollen, warm, red streak of vax site-LA
May be in no relation at all but day after vaccination patient woke up with ankle pain.  It was hard for the patient to walk/run.  During the evening time he reports possible pulling of muscle/ligament while walking in a parking lot at the store during a snow storm.
PATIENT RECEIVED INFLUENZA VACCINE ON 10/04/2022. PATIENT HAD PREVIOUSLY RECEIVED AN INFLUENZA VACCINE ON 09/20/2022 AT ANOTHER FACILITY.
HYPOXIA 1/23/2022 ATAXIA HYPOXIA 1/23/2022 NASOPHARYNGEAL CANCER, UNSPECIFIED SITE HYPOXIA 1/23/2022 NASOPHARYNGEAL CANCER, UNSPECIFIED SITE HYPOXIA 1/23/2022 HEADACHE
Information has been received from a pharmacist concerning 2 patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On unknown dates, the patients were vaccinated with the first and second dose of Human Papillomavirus (HPV) series with GARDASIL (dose, strength, route of administration, anatomical location, frequency, lot# and expiration date were not reported), for prophylaxis. On 19-JUN-2017, the patients were vaccinated with the third dose of HPV series with GARDASIL 9 lot# N004799 with expiration date 15-NOV-2019 (dose, strength, route of administration, anatomical location and frequency were not reported), for prophylaxis. No adverse effect reported. Additional information has been requested.
The patient started having numbness and tingling in his lower legs 2 days after vaccine.  The right leg has nearly resolved and the left leg symptoms persist.
Pain n the injection site, acute headache, nausea, vomiting, diarrhea.
PREVNAR-13 given 10/08/18. Pt. presented to pharmacy on 10/15/18 with swollen rash at injection site. Referred pt to PCP who administered steroid shot.
woke up with her left arm swollen( same arm where she got the injection) and lymph node under the arm is present.; woke up with her left arm swollen( same arm where she got the injection) and lymph node under the arm is present.; 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 32 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19May2021 (Batch/Lot number: unknown) at the age of 32 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION SITE SWELLING (non-serious), LYMPHADENOPATHY (non-serious) all with onset 20May2021, outcome "unknown" and all described as "woke up with her left arm swollen( same arm where she got the injection) and lymph node under the arm is present.".  Additional information: She got her first dose yesterday. She woke up today and had left underarm swollen lymph node. It is the same arm that she got the vaccine in.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received Moderna vaccine #2 at 1451. After 28 minutes patient alerted staff she developed a rash on her chest. Patient taken to a private room by the RN.   Initial assessment:              Patient denies any SOB or difficulty breathing. Denies any swelling in the throat. C/o rash localized to chest that itches.              VSS. Lung sounds clear to auscultation. A maculopapular rash noted on patients chest. Mild erythema noted on patient bilateral cheeks. Mild bilateral cervical lymph nodes swollen.   1545: Patient c/o increased swelling in cheeks. Mild perioribital swelling noted on exam. Lungs clear to auscultation. Rash has spread to bilateral upper extremities and chest. BP increased to 158/100. HR stable. 25 mg benadryl provided to patient.      1600: Patient states that the swelling in her face has improved. She states the rash has decreased and her itching has improved.  On exam periorbital swelling decreased. Rash has decreased in size and localized to chest.       1615: Vital signs reviewed. Patient's symptoms improving. Patient appears stable at this time and in no acute respiratory distress. Patient is able to ambulate without difficulty.          Discharge instructions verbally provided to patient. If patient's rash reappears she may take OTC benadryl as prescribed on bottle. Explained to patient that if she develops any difficulty breathing, SOB, or angioedema she should call 911 and be evaluated in ER. Patient in agreement with plan of care.    Writer plans to call patient tomorrow to follow up on status.
pt recvd vax & exp achiness, fatigue, headache, nausea, vomiting; t 99.7;
Information has been received from a 51 year old registered nurse with a history of hyperthyroidism, asthma and a drug reactions/allergies that include sensitivity to aspirin, who on 20-DEC-2007 felt burning in her eye during an administration of ZOSTAVAX (lot number: 658398/1087U).  Concomitant therapy included albuterol (VENTOLIN) (albuterol), fluticasone propionate (+) salmeterol xinafoate (ADVAIR) and thyroid (ARMOUR THYROID TABLETS).  The patient stated that she usually gets splash backs during reconstitution and withdrawing of ZOSTAVAX and that it was possible that the vaccine may have entered her eyes.  She did not feel any liquid go into her eye but is reporting the event as a precaution.  No other information.  Unspecified medical attention was sought at the office.  There was no product quality complaint.  Additional information has been requested.
Mild nausea; dizziness; slight wheezing; muscle pain & weakness; low-grade fever.
This case was reported by a nurse and described an adult female patient who did not respond to the hepatitis B vaccine.  The patient's medical history, concurrent conditions and concurrent medications were not reported.  On unspecified dates the patient received the hepatitis B vaccine series.  On an unspecified date in 2004, a hepatitis B surface antibody titer was negative.
Red circle about 2 inches in diameter; It was warm to the touch; The area was itchy; A spontaneous report was received from a health care professional concerning a 75 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed vaccination site erythema, vaccination site pruritus, and vaccination site warmth.     The patient's medical history was not provided. Concomitant medications included blood pressure and cholesterol medications.  On 14 JAN 2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (lot#: 013L20A) in the arm for the prophylaxis of COVID-19 infection.  On 21 JAN 2021, the area was itchy (vaccination site erythema). On 22-JAN-2021, the patient developed a red circle about 2 inches in diameter (vaccination site erythema) which was warm to touch (vaccination site warmth). Treatment included doxycycline.  Action taken with mRNA-1273 in response to the events was not reported.  The outcomes of the events,vaccination site warmth, vaccination site pruritus, and vaccination site erythema, was resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt developed rashes in the injection area on Monday and Tuesday, and woke up Wednesday with water pockets.  Dr. has prescribed Mupirocin 2 % External Ointment and Acyclovir 800 MG Oral Tablet.
Patient received vaccine outside of 6 hour storage window following reconstitution. Pfizer was contacted and reported that the vaccine dose was still viable. Patient was contacted and informed of the error. No adverse reactions were reported.
Combined doctor an nurse notes:  30 minutes post rabies after already home got numbness of perioral area with nurse noting some decreased movement of mouth.  Tongue numbness.  Red hands (palms) and face and hands  stiff and hard to flex.  Pruritis all over.  Headache.  Bp 118/72 and pulse 100.  As MD observed over 30 minutes no facial movement abnormality.  Tongue movements normal.  Said he felt like he was wheezing but breath sounds equal bilaterally and no wheezes - normal sounding.  Redness and rash which initially was on palms spread to whole body with clear urticaria on upper arms and axilla.  His breathing is fine and non-labored.  We gave Benadryl 50 mg PO and observed.  3:15 had growing skin rash, but no other advancement of s/s noted.  Pt sitting upright, talking with wife and MD.  Per MD order gave Benadryl 25 mg IM.  3:46 - breathing fine - hands less erythematous - urticaria on arms decreasing - "feels fine." breathing fine - lungs clear - RR 20, P 80.  I think fine and can go home - continue Benadryl.   Face now normal color and can make fist. Has option of changing tomrrow to Zyrtec or Claritin - if last > a couple of days may need steroids so let us know.  I wrote them letter for future reference if he ever needs rabies vaccine again.  Also said he should only get it where they had excellent care and set up for severe reaction.  Not sure but if available Imovax might be less likely to cause reaction than Imovax.
heavy sweat; night of shot arm hurt so bad I could not sleep, arm still sore; night of shot arm hurt so bad I could not sleep; achy; chills; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on 19Jan2021 10:30 AM at single dose for COVID-19 immunisation. Vaccine location was Left arm. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Patient was allergies to penicillin, keflex lisinopril and Spiriva Respimat. Other medical history included asthma and heart electrical problem. Concomitant medications the patient received within 2 weeks of vaccination included many for asthma and heart etc. Patient administered the most recent COVID-19 vaccine at Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced shot arm hurt so bad and she could not sleep became achy and chills in the night of 19Jan2021, slept deeply Wed (20Jan2021) and Thursday (21Jan2021) nights. The patient experienced heavy sweat in the night of 21Jan2021 (Thursday) bedclothes very wet in morning Friday (22Jan2021) feel better but arm still sore. Patient was not received treatment for the adverse events. The outcome of events reported as recovering. All events reported as non-serious: adverse event resulted in none of seriousness criteria.
Janssen vaccine given to patient not in age group for which it has EUA. The 16 year old female received the Janssen vaccine with no adverse effects observed during the waiting period. She was accompanied by her mother.
3 x 8 cm redness, induration, itching and soreness left arm around injection site beginning 4 days after vaccination. Presently improving on 2/23/2021 10 days after injection.
Lost appetite; feels very fatigued.; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Lost appetite) and FATIGUE (feels very fatigued.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 07-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced DECREASED APPETITE (Lost appetite) and FATIGUE (feels very fatigued.). At the time of the report, DECREASED APPETITE (Lost appetite) and FATIGUE (feels very fatigued.) outcome was unknown. Not Provided          No relevant concomitant medication was reported.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-076538 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076538:CROSS LINKED WITH DOSE 1
This spontaneous report as received from a patient's mother refers to her son of 6 year old. The reporter stated that her son received first dose of VARIVAX (Merck) (dose and route of administration unknown) on 28-DEC-2013 without any adverse effects. On 30-JUN-2014 the patient was vaccinated with second dose of VARIVAX (Merck) (lot # J013907, expiry date: unspecified, dose unknown) in the left arm. Pertinent medical history and concomitant medications were unknown. Within hours of the administration the patient developed a 2 inch red, raised circle that was warm to touch. On an unspecified date the reporter called the physician's office. Treatment was not given for the event. The outcome of the events was reported as recovering/resolving. The causality was unknown. No further AE information was provided. Additional information has been requested.
Nurse had 2  unpackaged, unlabeled syringes with a liquid in them . I felt it was poor practice to have in labeled injections and advised her.   She felt there was no issue with it.
Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient did not experience temperature excursion previously. On 27-APR-2016 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (dose and route were unknown, lot #: L050910, expiration date: 14-JUN-2017, therapy type: digital data logger). The vaccine was exposure on 9.9 Fahrenheit (F) for 1 hour and 20 minutes. No adverse events were reported. This case was one of several case received from the same reporter. Additional information has been requested.
Developed rash after receiving 2nd dose. rash spread over whole body. treated with antihistamines and cortisone. acute flares for about 1year, small patches persist up to today.
No additional AE reported; A patient was administered PEDVAXHIB after a temperature excursion. Caller stated the patient was administered PEDVAXHIB on 8NOV2021; This spontaneous report has been received from other reporter (reported as: "HBP") and referred to patient of unknown gender an age. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.   On 08-NOV-2021, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) at a dose of 0.5 milliliter (strength, vaccine scheme and route of administration were not provided; lot number T037650 has been verified to be a valid lot number, expiration date reported and established as 21-JUL-2023), as prophylaxis, after a temperature excursion (product storage error).  The vaccine was expose to a temperature of 47.29 Fahrenheit degree, for a time frame of 3 hours and 22 minutes. It was not reported if there was a previous temperature excursion. No additional adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA003366: US-009507513-2112USA003663: US-009507513-2112USA003742:
Neck pain, joint pain, flu-like symptoms, forgetfulness, memory loss, irritability, fatigue, rage. Undergoing antibiotic treatment for 1 yr.
numbness of mouth & teeth @ approx 10AM; also dizziness; 1015AM numbness spreading to ears & tongue w/difficulty swallowing; ER tx w/Epi; exp itching of extremities later that noc;