chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received second  dose of the pfizer covid vaccine yesterday and developed muscular pain during the night; 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 58 year-old female patient received bnt162b2 (BNT162B2) (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: Covid 19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for covid-19 immunisation. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "received second dose of the pfizer covid vaccine yesterday and developed muscular pain during the night".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Heavy drainage, sore throat, throat swollen, eyes we're very irritated with heavy mucus production, threw up dinner, chills and shaking. Woke up with congestion and experienced fatigue throughout the day on Monday. Slept 3 hours in the afternoon. Other symptoms were absent on Monday. I don't know the name of the vaccine. The pharmacist said it was given. It was the stronger dose for seniors.
Moderna Vaccine 6/25/2021, 5/21/2021. Hospitalized 11/18/21
Terribly ill after booster of Moderna; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Terribly ill after booster of Moderna) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Terribly ill after booster of Moderna). At the time of the report, VACCINATION COMPLICATION (Terribly ill after booster of Moderna) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
had an operation; got the first dose on 08Apr2021 and then got the second dose on 03Jun2021; This spontaneous case was reported by a consumer and describes the occurrence of SURGERY (had an operation) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the first dose on 08Apr2021 and then got the second dose on 03Jun2021). On an unknown date, the patient experienced SURGERY (had an operation) (seriousness criterion medically significant). At the time of the report, SURGERY (had an operation) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the first dose on 08Apr2021 and then got the second dose on 03Jun2021) outcome was unknown.            No concomitant medication information provided.  Patient got the first dose on 08Apr2021. Patient missed the appointment for second dose due to an operation he had and he got it on 3jun2021.  Limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.; Sender's Comments: Limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.
The Hib portion of the DTap/IPV/Hib was not reconstituted into the Dtap/IPV. Hence Hib was not administered. It is uncertain if it was with this patient or another so reports are filed on both.
she appeared diaphoretic and stated she was feeling anxiety and dizziness with nausea and bilateral tingling in hands and arms. Immediately removed mask,  raised her feet and applied cold compress to her neck . She felt sob, O2 sat was 98-99%. Her blood pressure was 168/103. She was taken by wheelchair to treatment are of clinic for further evaluation and she began to vomit around 1105.
This spontaneous report as received from a registered nurse referring to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions or concomitant medications was provided. On 31-MAY-2017, the patient was vaccinated with an expired dose of M-M-R II, therapy type (rHA), ( (lot # L015281 with an expiration date in 30-APR-2017), for prophylaxis (dose, frequency, route and strength were not provided), that was reconstituted with sterile diluent. No adverse effects were reported and no product quality complaint (PQC) was involved. Additional information has been requested.
Information has been received from a registered nurse concerning an adult patient, on dialysis, who was vaccinated with the primary series of RECOMBIVAX HB in the past (dates unspecified), and now is showing "negative titers".  Unspecified medical attention was sought.  There was no product quality complaint.  At the time of reporting the patient was not yet recovered.  Attempts are being made to obtain additional identifying information to distinguish the individual patient mentioned in this report.  Additional information will be provided if available.  This is one of several reports received from the same source.  Additional information has been requested.
Soreness of the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of the arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness of the arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 21-Feb-2021, PAIN IN EXTREMITY (Soreness of the arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to INC.-MOD-2021-073916 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: The follow up received on 24 May 2021 contains information which not in a readable format; Sender's Comments: INC.-MOD-2021-073916:Dose 2
Vial was initially stored in refrigeratore on 11-Jan-2022 and administered on 20-Apr-2022; Vial was initially stored in refrigeratore on 11-Jan-2022 and administered on 20-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial was initially stored in refrigeratore on 11-Jan-2022 and administered on 20-Apr-2022) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigeratore on 11-Jan-2022 and administered on 20-Apr-2022) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Janssen (LOT 1808609, Primary 1) on 31-Mar-2021, Pfizer (LOT FE3590 and Booster 1) on 24-Nov-2021. Past adverse reactions to the above products included No adverse event with Janssen and Pfizer.    On 20-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial was initially stored in refrigeratore on 11-Jan-2022 and administered on 20-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigeratore on 11-Jan-2022 and administered on 20-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial was initially stored in refrigeratore on 11-Jan-2022 and administered on 20-Apr-2022) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigeratore on 11-Jan-2022 and administered on 20-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received booster 2 of Moderna on 20-Apr-2022 No concomitant medications were reported.  Date the vial was initially stored in the refrigerator was 11-Jan-2022. The vial did not undergo any temperature excursions. No patients had reported any adverse reactions  No treatment medication were provided.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 03-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) dose, route and anatomical location were not provided. There was no concomitant medication provided. On an unknown date, the PNEUMOVAX had a temperature excursion for 8 hours, the lowest recorded temperature was 28F (-2.2 Celsius). The vaccine status was reported as "in excursion", and was storage in a Refrigerator (R). There was no product quality complaint involved and no adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.
No additional AE; Public Health called and stated that a dose of PROQUAD was inadvertently administered to a 15 year old patient. Caller stated patient did not have any side effects. No additional AE/no PQC.; This spontaneous report was received from a public health educator, referring to a 15-year-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 22-JUN-2023, the patient was inadvertently vaccinated with 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, vaccination scheme, anatomical site of vaccination, route of administration, lot number and expiration date were not reported) as prophylaxis (product administered to patient of inappropriate age). The patient did not have any side effects.
Bell's palsy Narrative: He notes having developd s/sx concerning for Ball's palsy 5x days after the initial vaccination. This was described as paralysis of the entire left side (inability to wrinkle forehead, drooping eyelid, drooping mouth) of this face a/w nerve pain. He presented a photo that was consistent with concern for Bell's palsy including the described sx + loss of nasolabial fold. The concerns lasted for ~ 14-15 days with no residual deficits. He denied s/sx of CVA including slurred speech (some disruption from associated unilateral mouth droop), confusion, disorientation, unilateral UE or LE weakness. He denies onset of other viral illness around that time. He did not take any therapies.
few hr p/vax arm swelled up almost to elbow x 1wk;sl fever & muscle pain @ first-hurts when lifts up arm or sleeps on it;3 days p/shot fainted;seen in ER;8 days p/shot muscle cramp in  arm, radiated to chest, SOB, rapid heart beat 140;
A little after midnight, I woke up shaking because I was so very cold.  It felt almost like a seizure because my lack of control was evident in my movements.  With my heaviest PJs on, it took 8 blankets to finally warm me up.  I am on a CPAP machine but I was having a hard time getting my breath.  I was also nauseous but never threw up.  I finally got back asleep a little after 3 am but  woke several times after that.  This morning, I had a terrible headache and can't get rid of it. Although I feel better than last night, I feel lousy.  It is now 2 pm and I just want this to be over.  On the first shot, I didn't have any reaction at all.
This case was considered medically important. Information regarding PREVNAR was received from a healthcare professional regarding a 29-month-old female patient who experienced negative pneumococcal titer levels and possible lack of effect with a current sinus infection and tonsillitis. The patient received the fourth dose on 29-Dec-2006, at 12 months of age. On 20-Jun-2008, the patient had pneumococcal titer levels down after experiencing multiple recurrent episodes of chronic sinusitis, upper respiratory tract infections, ear infections, coughing and wheezing (no culture reports were provided. Her history also included an unspecified immunodeficiency). The pneumococcal titer results revealed 'negative' pneumococcal titer levels (see laboratory results) (antibody test abnormal). The reporter noted that the titer levels for all other vaccines were 'normal'. The child had an ENT/allergy workup performed (date unspecified). In Jul-2008, the patient was again evaluated in the office with a current sinus infection and tonsillitis. Treatment included antibiotics. The reporter noted a possible lack of PREVNAR effect. The Physician was planning on administering a 5th dose of PREVNAR. The patient's outcome for all events is unknown. No additional information was available at the time of this report.
Possible administration of invalid dose to patients; Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C) and POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patients) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In April 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C). On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patients). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Freezer temperature never reached an acceptable range and was always warm by at least 2 degree C) and POOR QUALITY PRODUCT ADMINISTERED (Possible administration of invalid dose to patients) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  There were 4 days temperature data for the freezer storage unit between 1-APR-2022 and 4-APR-2022, however it never reached an acceptable range and was always warm by at least 2 degrees C.   Treatment information was not reported.
Discharge Physician: MD Primary Care Physician: MD   Date of Admission: 1/26/2023 Discharge Date: 1/31/2023 Room Number: 2023/2023-1    PRESENTING PROBLEM: Pleural effusion [J90] Generalized weakness [R53.1] Pulmonary nodules [R91.8] Community acquired bacterial pneumonia [J15.9] Atrial fibrillation with rapid ventricular response   [I48.91] Fall, initial encounter [W19.XXXA]   HOSPITAL COURSE: Patient is a 96-year-old man who presented to Hospital with altered mental status and weakness, including a fall in the bathroom.  Patient was recently treated for bilateral pneumonia as an outpatient with two courses of antibiotics. He was also given Xanax for anxiety but unclear if he had taken any of this.    In the emergency department images demonstrated new infiltrate, and his COVID test was noted to be positive.  Due to the new infiltrative sites he was started on IV antibiotics.  He was on room air.  Images also demonstrated bilateral pleural effusions.  He was admitted under the hospitalist service. Negative pro calcitonin and antibiotics stopped.  He was not hypoxic and thus did not meet criteria for any specific treatment for COVID, but did clinically improve.  He worked with Physical therapy and Occupational therapy and felt to benefit from subacute rehab.  Discussions with his daughter and Case Management, she is unable to continue caring for him at this time and will require long-term placement.   Case management and his daughter were able to secure long term care at facility. A hospital bed was requested and ordered.    He clinically improved overall throughout his admission but continued to have some mild hyponatremia and a small pleural effusion on imaging the day of discharge. He had no hypoxia, fevers, increased WOB or other indication for thoracentesis. Recommended avoiding any further xanax at this time.    Electrolytes were monitored and repleted PRN throughout the admission. Patient hemodynamically stable for discharge.  Discussed plan of care discharge with patient and daughter including outpatient follow-up PCP within 7 days, as well as follow up labs and chest XR to assess hyponatremia and pleural effusion. Patient voiced understanding was agreeable with plan of care discharge.
Started having period, haven't had a period in over a year. Horrible cramps, migraine also. Started 3 days after shot.; Started having period haven't had a period in over a year. Horrible cramps; Horrible cramps, migraine also.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the arm right on 13Apr2021 at 14:00(at the age of 46-years-old) as a single dose for COVID-19 immunisation. The medical history included blood pressure high, migraines, contraceptive implants and allergy to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified medications of  blood pressure, migraine and implant for birth control. On 16Apr2021 at 17:00, 3 days after shot, the patient started having period, horrible cramps and migraine also. The patient reported that she had not have a period in over a year. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events started having period, horrible cramps and migraine was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
The patient was experiencing a swollen lymph node under her right arm that was very tender to touch. She went to her doctor, and the doctor thought it was a reaction to the shot. No treatment was given.
Baby developed flushing to face and arms and legs within 3 minutes of vaccines. Cool compress was done and flushing resolved, fading to face. Re-examination done and normal except flushed cheeks.
Meniere's disease/have noticed it has been a little worse since getting the vaccine; This is a spontaneous report from a contactable consumer (patient). A 67 years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on 02Feb2021 as a single dose for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing and ongoing Meniere's disease. The patient's concomitant medications were not reported. It was reported that the patient asked if there was anything in the vaccine that stimulates people who have Meniere's disease as she noticed that it has been a little worse since getting the vaccine. The patient received the first dose of the vaccine but already had COVID before the vaccine but read that she should not get the vaccine for 90 days after having COVID infection. As she received her vaccine last Tuesday, she was asking if she should get her second dose. The outcome of the event was unknown.   Information on the batch/lot number has been requested.
Site pain, headache, muscle pain, nausea, dizziness, tired, fever (99.6). No treatment.. Symptoms resolved in 24 hours.
Patient experienced breast pain starting 3 days after vaccination and the pain has continued until the time it was reported to the pharmacy.
2/182021: Witnessed cardiorespiratory arrest with PEA arrest upon EMS arrival
This is a spontaneous report from two contactable pharmacists via a sales representative. A 13-year-old male patient received TRUMENBA (Lot # J28923, Expires 30Jun2016), intramuscular in left deltoid at 0.5 ml, single on 14Feb2015 at 20:30. The following vaccinations were schedule for 15Apr2015 and for 15Aug2015. The patient medical history was not reported. Concomitant medications were none. On 17Feb2015, the patient experienced high fever of 102 degrees F, no appetite, self nauseated and blew up and sore arms. The events resolved after 2 or 3 days without treatments. The events did not require an emergency room or physician visit. No specific tests and/or treatments were required. According to the second reporting pharmacist, there was a reasonable possibility that all the events was related to suspect product. Follow up (06Apr2015): New information from another contactable pharmacist includes: updated patient age, updated vaccine lot number, route of administration, anatomical location, vaccination date/time, following vaccination schedule. Follow-up attempts completed. No further information expected.
Fatigue over a week, then a week following receiving the vaccine had a fever, bad aches, dry cough, headache, and still persisting at day 8
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates, the patient were vaccinated with improperly stored doses of GARDASIL 9, lot # K026247, expiration date 29-JAN-2017 (strength, dose and route of administration were not provided). No adverse effects were reported. This is one of several reprots received from the same source. Additional information is not expected as there was no consent to contact any physician.