chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Directly after vaccination administration, patients states, "Should I feel dizzy and sweaty?" Upon observation, patient was pale and diaphoretic. Nurse asked patient if he needed to lie down. Patient states, "I have multiple panic attacks a day, and i think I will be ok." Patient then stated that he wanted to lie down. Patient was placed in a wheel chair at 12:23 and taken to a private area for observation. Assisted patient to lie down, feet elevated, cool rags applied to forehead and anterior neck. Patient then continued diaphoretic, blood pressure 172/92. HR 78/PO2 / 98%. During this time, patient was accompanied by Uncle. Patient was continued to be observed with frequent vital sign measurements. 12:29 - 155/95, HR 72, PO2 - 99%, diaphoretic, and complaints / shortness of breath. 12:32 - 158/108, HR 76, PO2 98%. 12:35 - 166/111, HR 83, skin-dry, continues SOB. 12:42 - 171/114, HR 105,  PO2 -98%. Patient consented to Ambulance for further evaluation in ER. (12:49) Fire-fighters arrived first  w/ evaluation of patient w/ manual blood pressure / 162/114, and HR - 99, PO2 - 98%. Ambulance arrived at 12:52, and care was transferred to the hospital.
Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and CHILLS (Chills) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced FATIGUE (Fatigue) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FATIGUE (Fatigue) and CHILLS (Chills) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications were reported.    Reporter did not allow further contact
difficulty breathing, wheezing, hives, paleness, weakness, fast heart beat, dizziness, swollen glands behind head;
Patient stated that she experienced typical side effects after first dose of SHINGRIX (i.e., soreness in arm, redness/swelling at injection site, fatigue, "belly ache", & headache). All symptoms subsided after 3 days except for headache which lingered x 1 week per patient. She took TYLENOL for her headache and stated that she did NOT need to seek medical attention.
On 4/13/19: child had rash on torso lasted 2-3 days; then revolved. On 4/20/19: In am, child with eye rolling, unable to speak, lethargic, gait issues, child went to sleep after 1 hr symptoms resolved
I had a severe reaction to the pneumonia vaccine. I was told never to get one again; This spontaneous information has been received from a 66-years-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number and expiration date were not reported).  On an unknown date, the patient had a severe reaction to the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine and it was told to never got one again (vaccination adverse reaction). The outcome of the vaccination adverse reaction was unknown.  The vaccination adverse reaction was related to the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine.
General weakness; Pain at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (General weakness) and VACCINATION SITE PAIN (Pain at the site of injection) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0141M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included ALLOPURINOL, METOPROLOL, FINASTERIDE, ZOLPIDEM, LORAZEPAM and VENLAFAXINE for an unknown indication.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at the site of injection). On an unknown date, the patient experienced ASTHENIA (General weakness). At the time of the report, ASTHENIA (General weakness) and VACCINATION SITE PAIN (Pain at the site of injection) outcome was unknown.            No treatment information were reported.
Patient received her 2nd dose of the Pfizer vaccine at the clinic. Noted that she became fatigue after this occurred.  They called the health department at 5:40pm, but the clinic was closed.  The phone call came, but the phone number left was different.  A call was returned on 6-1-2021. Informed that patient was taken to ER and admitted x 4 days.  She had bleeding behind her eyes and other complications: dehydration and kidney problems.
sick; Initial information was received on 07-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a patient (age and gender unspecified) who was sick (malaise), when received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (malaise) (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE. The patient was sick for 3 months and then 2 months   No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
This spontaneous report as received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 08-MAR-2011, patient received improperly stored VARIVAX dose 2, from batch/lot # 666869/0469Z (expiry date, dose units, route and anatomical location were not specified. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
A non-serious spontaneous report of received approximately three-quarter of the total dose went onto the child's face was received from a health professional concerning a five-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 13-Dec-2011, the patient received approximately three-quarters of the dose of FLUMIST. The first half of the dose was administered to the first nostril. However, during administration to the second nostril, the child moved and approximately one-quarter of the total dose went onto the patient's face. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Here is the patient info for the temp excursion/beyond use date excursion; Here is the patient info for the temp excursion/beyond use date excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Here is the patient info for the temp excursion/beyond use date excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Here is the patient info for the temp excursion/beyond use date excursion) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Here is the patient info for the temp excursion/beyond use date excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Here is the patient info for the temp excursion/beyond use date excursion). On 20-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Here is the patient info for the temp excursion/beyond use date excursion) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Here is the patient info for the temp excursion/beyond use date excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatments medications were reported.
Pt. got shot vaccine on 9-23 and she called on 9-27 at 12 noon stating that the injection site is now plum size-got worse in 3 days.
No immediate reaction to injection.   8/3 at approx 1AM developed extreme "Brain fog" symptom. Loss of clarity, ability to focus, overall sluggish mental feeling. Reaction time seems slightly delayed, somewhat difficulty driving, feeling of tightness/fullness in head/jaw area. Feels like my cognition became impaired in some way. *This is the most severe/impacting of the symptoms.*  Other symptoms:   Infrequent muscle twitching 8/4-onward, usually only at night while trying to sleep.   8/4- present - complete loss of appetite. No nausea, just no desire to eat, difficulty chewing. Liquids seem fine.   Minor Intermittent chills at night 8/4.   8/4 onward sleep patterns disturbed, wake up every 2-3 hrs.     Minor chest pains 8/8 - 8/10, both sides, mostly subsided now. EKG, xrays, blood work showed no related issues.   Slight sensation change in tip of right thumb 8/5, and right foot noticed 8/10. Not numb, not painful, just feels different to the touch, like some form of neuropathy.
Patient states she developed the typical flu-like symptoms over the first 2 days after receiving vaccine (achy, fatigued, sore arm) and improved after these first 2 days.  On day 8 post vaccination, she began to develop a whole body rash that she describes as itchy and irritated.  They are still present today 4/14/21, 2 weeks after vaccine administration
12 hrs post vaccination: headache, chills, pain at injection site, and significant joint pain (hips, knees, shoulders) with some bone pain (lower back, femurs) I had no reaction to previous 2 vaccines given in Dec 2020 and Jan 2021
I was vaccinating the patient with his 2 month vaccinations I grabbed the wrong vaccine from the refrigerator. Instead of Hib, I mistakenly drew up and administered MENVEO. The error was detected with weekly counts, the health department was contacted, and now I am reporting this error, charting accordingly in the patient's EMR, and after all of the proper information is obtained on adverse events from the manufacturer, the patient's parent will be contacted and provided with the information. The patient did not experience any symptoms due to the event.
pt recvd vax; erythematous sl indurated area LL & inject site;
Patient received second dose of Pfizer COVID-19 vaccine today. While in recovery area, patient alerted staff to feeling of swelling in the mouth. Patient was observed sitting in the recovery area in no acute distress, speaking without difficulty, no dyspnea observed. Patient reported feeling of tingling in her mouth/tongue and tingling in the left arm. Patient reported history of reaction to nuts that caused the same sensation in mouth.  Denied history of anaphylaxis. Following reaction to nuts, the patient sought care at an Urgent Care facility where they administered benadryl and a steroid. Patient stated she was very nervous to receive this vaccine. I requested for an additional RN to observe patient and assess condition. Second RN assessed patient, discussed recommendation to visit emergency department, and escorted patient to the Emergency Department for treatment.
Post vaccination after approx. 15 min. of observation pt. noted blotchy cheeks. 1616 HR 82, BP 157/110, O2 SAT 99% RA - No complaint of SOB or difficulty breathing.  No pruitis. No chest pain or pressure. - back with blotchy redness, no hives, no difficulty swallowing - no history of HTN, multiple environmental allergies - A&Ox3, HRR, S1S2, LS clear throughout 1619 BP 174/112 - feels flushed - Benadryl 25 mg PO administered 1622 BP 164/107 1629 BP 144/101 1635 BP 161/112, HR 74, O2 SAT 99% RA - feels better, less flushed, not itchy, no new symptoms - rash on back fainter 1640 BP 151/106, HR 80 - "I feel fine." - Discussed risks associated with elevated BP, denies additional questions and concerns.  Works at Bangs as EMS and feels comfortable monitoring at home. - Reviewed repeating benadryl 25 mg PO once home and monitoring rash, reviewed S/S progressive reaction.  Stated good understanding and repeated feeling well.  Ambulated out of clinic without difficulty.
This spontaneous prospective pregnancy report was received from a physician and refers to a 25 year old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 15-JUN-2016, the patient, who was 4 weeks pregnant, was inadvertently vaccinated with a dose of VARIVAX (lot # K021484, expiration date 03-NOV-2016, exact dose and route of administration were not reported). The patient became pregnant with last menstrual period (LMP) date of 18-MAY-2016 (calculated based on number of pregnancy weeks at the time of report) and estimated date of delivery (EDD) of 22-FEB-2017. No adverse effect was reported. The pregnancy outcome was pending. Additional information has been requested.
pt recvd vax & devel sweating, palpitations, & dizziness; rt arm was hard @ the inject site, swollen & painful; pt devel a red blotch on the inside of arm & it was difficult to lift; pt seen by MD & was treated w/DPH;
Information has been received from a nurse referring to a 4 month old male patient. The patient had no relevant medical history or concomitant medications. On 18-FEB-2019, the patient was unintentionally administered a GARDASIL 9 (0.5 ml, intramuscularly into unknown which leg, lot # R020948, expiration date 04-MAY-2020) for prophylaxis. The nurse reported that the GARDASIL 9 was in a PREVNAR box and was administered to the patient by accident instead of PREVNAR (wrong product administered). At the time of the report, the patient had no untoward reaction as a result of the unintentional administration of GARDASIL 9, which was not a vaccine inidicated for his age group. As of 18-FEB-2019, it was unknown if the patient would receive additional GARDASIL 9 doses in the future, and the outcome of the unintentional administration of GARDASIL 9 was unknown.
Patient hadn't eaten lunch and felt lightheaded and dizzy after receiving the shot. Laid down on a pillor with legs up, gave ice pack. Monitored BP & pulse 115/59 54, 116/69 63, 113/92 54. Once he sat up we gave orange juice
Severe onset of right shoulder and arm pain. Then Oct.31, 2011 I develop right arm weakness in the hand and shoulder. The treatment included PT, massage, rest and steroids.  I have been unable to return to full time work due to ongoing symptoms and weakness.
After last booster on 9/16/22, developed tinnitus in both ears. Tinnitus came on suddenly and loudly. Primary doctor in October said no year problem she could see. I had no injury or infection previous to tinnitus, no high blood pressure and no medication usage. Saw ENT on 5/8/23, diagnosed with hearing loss due to tinnitus and hearing aids suggested. Hearing had been EXCELLENT prior to that last injection.
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 15-year-old female patient, who had no known drug allergy. The reporter stated that it was unknown if the patient had any illness at time of vaccination. The reported informed that this patient was vaccinated with the third dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 21-JAN-2016, in the left arm, route not reported), on 04-FEB-2014 at 3:30 PM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). The patient was informed and revaccinated on 22-APR-2014 at no charge. The reporter reported the outcome as recovered. No adverse event was reported for the patient. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 67 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 14-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 14-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
On Tuesday late morning,  she texted from school - that her heart was racing. shaking, headache, tummy ache.   We brought her home from school.  These symptoms - especially the severe headache, nausea, dizziness lasted for 3 days.   She missed school as she stayed in bed.
After receiving the COVID immunization client complained of tightness in chest.  She had a hard time swallowing and speaking.  RN asked if she could swallow Zyrtec and client shook head no.  RN asked if she was OK having epinephrine injection and client shook head yes.  Three minutes after epinephrine 0.3 injection in left thigh client was able to answer questions appropriately and stated she could breathe better.  Vital signs were taken at beginning of client complaints and continued throughout event.  EMS called and client was transported to hospital.
Metallic taste, tingling of tongue approximately 3 hrs. after vaccinations. Sx improved overnight.
On May 24, 1999 the pt experienced varicella like rash with approximately 12 lesions.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 58-year-old female patient who received SHINGRIX for prophylaxis. On 30th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st May 2018, 1 days after receiving SHINGRIX, 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 SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the left arm. The next day after receiving the 1st injection, she experienced soreness in her left arm that lasted for approximately 2 to 3 days. This case has been linked to the US2018180185, reported by the same reporter.
Fever, Chills, Full Body Aches, Weakness / Heavy Fatigue, and Headaches from 08/16/2013 to 08/19/2013.
administration of first dose to patient younger than 18 years old; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Jul-2021 and was forwarded to Moderna on 27-Jul-2021.    This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administration of first dose to patient younger than 18 years old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administration of first dose to patient younger than 18 years old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administration of first dose to patient younger than 18 years old) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided by the reporter.