chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer who is the mother of an 8 month old male child who on approximately 15JUL2004, "2 months ago" was vaccinated IM with a 0.5ml dose of hepatitis b virus vaccine + Hib conj vaccine. It was reported that on approximately 15JUL2004, "since the vaccination", there has been a bruise and knot in the muscle at the injection site. It was also noted that the patient changed physician's and "the new pediatrician thought the symptoms were due to a reaction to the vaccine". Unspecified medical attention was sought. The patient had not recovered. There was no product quality complaint involved. Follow up 03/03/05: Lot number for vaccine not provided.  Follow-up information from the physician indicated that the patient had "severe bruising per mom" and a lump the size of a quarter. It was noted that the patient still had the lump which was slightly "bigger than a nickel now:.  Follow-up information from the physician indicated that the lump on the leg went from the size of a quarter down to the size of a dime and that it lasted three months. The patient's outcome was not reported. Additional information has been requested.
none . Vial sent with wrong Expiration date .  expired 2 days after vaccine was administered
I only want to report that the varicella vaccine in 2 of my children was not effective as thought.
Information has been received from a female patient less than 50 years of age, who was also a pharmacist, via a company representative referring to the patient herself. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose and frequency were not reported) (Inappropriate schedule of vaccine administered). This is one of several cases received from the same source. Additional information has been requested.
This spontaneous report as received from a nurse refers to an 8 months 22 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Adult Hep A given to 17 yo patient instead of peds dose. Father informed.
insomnia and headache throughout the night, then passed out/fainted  multiple times the next morning falling on the bathroom floor after getting up.
I had recurrently nose bleeds that lasted for about 15 minutes to 30 minutes. The frequency are spread out. They seem to get worst with stress but are not caused by stress. I went to an ENT specialist.
Patient was here to receive her second dose of Spikevax for primary series but was accidentally vaccinated with Moderna Bivalent.  I made a phone call to patient today 11/23/2022 @ 11:30 am to inform her about the error. The patient stated the symptoms she was having are tiredness, dizziness and headaches.
dry cough; off colored phlegm; he cannot go through his usual activities; soreness; slight temperature; tiredness; covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19), COUGH (dry cough), SPUTUM DISCOLOURED (off colored phlegm), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (he cannot go through his usual activities) and PAIN (soreness) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013B22A, 030L20A, 011A21A and 012H21B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Pain: HYDROCODONE. Past adverse reactions to the above products included No adverse event with HYDROCODONE. Concurrent medical conditions included Blood pressure high and Intervertebral disc bulging.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jul-2023, the patient experienced COVID-19 (covid 19). On an unknown date, the patient experienced COUGH (dry cough), SPUTUM DISCOLOURED (off colored phlegm), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (he cannot go through his usual activities), PAIN (soreness), PYREXIA (slight temperature) and FATIGUE (tiredness). At the time of the report, COVID-19 (covid 19), COUGH (dry cough), PAIN (soreness), PYREXIA (slight temperature) and FATIGUE (tiredness) was resolving and SPUTUM DISCOLOURED (off colored phlegm) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (he cannot go through his usual activities) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jul-2023, SARS-CoV-2 test: Positive. On an unknown date, Body temperature: 100 degree Celsius hardly 100 degrees.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was taking blood pressure medication as concomitant medication. Treatment details was not reported by the reporter.
Breakthrough case admission after 4 vaccines Moderna 2/1/21 Lot# 031M20A;  Moderna 3/13/21 Lot# 045A21A;  Moderna 11/1/21 Lot# 039F21A;  Pfizer 10/24/22 Lot # GJ3277
This spontaneous report was received from a healthcare worker refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 28-MAY-2015, the patient was vaccinated with an improperly stored M-M-R II (lot number, expiry date, dose and route of administration were not reported). No adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
PATIENT APPEARED NORMAL IMMEDIATELY AFTER INJECTION. AS SHE WAS WALKING OUT OF THE CONSULTATION ROOM WITH HER SISTER SHE BEGIN TO SLUMP OVER, HER SISTER HELD HER AND THE INTERN SECURED HER UNDER THE ARMS FROM BEHIND. PHARMACIST IN CHARGE WAS ALERTED. PATIENT CAME ALERT AS PHARMACIST ARRIVED, SUPPORTED HER, ASKED IF SHE WAS OKAY? PATIENT RESPONDED YES THAN REQUESTED TO LAY DOWN. SENT INTERN FOR COLD CLOTH AS PATIENT WAS WARM, SWEATY AND CLAMY TO THE TOUCH. WE HELPED HER TO THE FLOOR, SUPPORTED HER HEAD AND PATIENT LOSS CONCISENESS, BEGAN TO BREATHE DEEPLY, ABDOMEN CONTRACTING IN, HANDS CLENCHING.  CALLED 911, SISTER DENIED H/O SEIZURES, PREVIOUS RXN WITH FRIST DOSE OR ANY OTHER ILLNESSES. PATIENT REGAINED CONCISENESS AND SIAD SHE WAS FINE. SHE DID URINATE, NO VOMITTING.   EMT WAS ALERTED CONCERNED SHE HAD A SEIZURE
High fevers, mouth sores (HSV), cough, shortness of breath, headache, fatigue---still ongoing cough and now heart failure--EF is at 40% and grade 1 diastolic dysfunction- 2 chest xrays, CT of chest, 3 covid tests all tests negative--echocardiogram done- 3 different kinds of antibiotics and 2 rounds of steroids, inhaler also, fluids for dehydration-- still out of work
Developed a raised, very painful, hot to the touch red rash under the injection site on my arm 2 days after the shot. No medical treatment. The rash has slowly decreased in size, pain, and heat but is still present 4 days later.
Myocarditis; Body aches; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "Body aches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, a possible contributory role of the suspect product cannot be excluded for the reported events 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
Mom took child to the ED 1/11/18 for redness ~12mm per ED report, heat, pain and swelling (larger than the area of redness) in right thigh and fever of 102 (at home, 101.2 at the ED).  Provider at ED felt thigh symptoms were a vaccine reaction but did not think the fever was related to this so checked a U/A which was suggestive of a urinary tract infection and the patient was started on Keflex. The child was seen in the office 1/12/18 for follow-up. Thigh symptoms were noted to be better, still somewhat hard and red,"~ 1 cm subcutaneous mass with erythema, no warmth R upper thigh. NO: discharge". Temp was 98.5 in the office. Parent was advised to continue Keflex as prescribed and return to the office with worsening or persistent symptoms or any other concerns. There was no further follow-up after that.
After receiving his flu vaccination, the patient was in his usual state of health until he began to experience bilateral lower extremity weakness and tongue numbness. On initial presentation, due to his history of colon cancer in the past, the primary concern was metastatic disease.  Therefore, full new imaging of neural axis including the brain and entire spine was done.  MRI of the brain was within normal limits for age.  MRI of the spine showed mild degenerative changes with no evidence of any spinal cord or nerve root involvement.  Bone scan of the whole body did not show any metastatic disease. Upon admission, an EMG was performed which was negative for any acute neuropathic changes.  A lumbar puncture was performed which demonstrated albuminocytologic dissociation.  The patient was started on IVIG and completed 5 days of therapy without any adverse reactions.  A repeat EMG was performed 10 days after initial EMG and demonstrated features of Guillain Barre syndome.
Fever, body aches, chills, treated with fluids, rest, and Tylenol
due to syringe malfunction a patient given less than 1/4 of the dose; syringe malfunction; This case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 24-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 52SA4, expiry date 30th June 2022) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included flu seasonal tiv dresden pre-filled syringe device (Fluarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th September 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Pre-Filled Syringe Device. On 30th September 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Pre-Filled Syringe Device, the patient experienced accidental underdose and syringe issue. On an unknown date, the outcome of the accidental underdose and syringe issue were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: This case was reported by the nurse. The nurse reported that due to syringe malfunction a patient was given less than 1/4 of the complete dose of Fluarix, which led to accidental underdose and syringe issue. The reporter consented to follow-up.
ate more than usual; vomited; refused to take any daytime naps; Baby had 3 breast feeding sessions after patient received vaccine; This is a spontaneous report from a contactable consumer. This consumer reported information for both mother and baby. This case is the baby report. A 9-month-Old male patient received BNT162B2 (lot number EL0104), transmammary on 30Dec2020 18:45 at 9 Months at single dose for COVID-19 immunization. The medical history was not reported. The patient was not allergies to medications, food, or other products. The concomitant medications were levothyroxine sodium (SYNTHROID), calcitriol, calcium, fish oil and multivitamin. On the day following the vaccine, the baby refused to take any daytime naps, ate more than usual, and vomited on 31Dec2020 10:00 AM. None of these were typical behavior for the baby. Baby had 3 breast feeding sessions after patient received vaccine, and then was eating frozen reserves. We do not know at this point whether the baby will revert to his norm or whether the change in behavior will continue. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not allergies to medications, food, or other products. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020521814 same vaccine, different patient and AE.
Extreme stomach cramping and start of painful period despite having birth control that prevents it and not having one for 13 years. Still ongoing.
Severe lower back pain within 2 hoursof second shot; couldn't walk, sit, stand orlie down; pain into buttocks; pain into ribs; This is a spontaneous report from a contactable consumer, the patient. A 68-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: ER8727), via unspecified route of administration in Right arm on 20Mar2021 at 10:00, (age at vaccination 68 years) as a single dose for COVID-19 immunisation. Medical history included degenerative disc disease and heart disease. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), naproxen (MANUFACTURER UNKNOWN). Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 20Mar2021 at 12:00 patient experienced Severe lower back pain after second shot. Within 4 hours, pain was so bad couldn't walk, sit, stand or lie down. Ice and heat did not help. Next morning pain into buttocks and ribs. Lasted for 48 hours. Ibuprofen was taken as therapeutic measure for the events lower back pain, pain into buttocks and ribs which did not help. The clinical outcome of the events lower back pain, pain into buttocks and ribs were resolving at the time of reporting.   No follow-up attempts are needed. No further information is expected
DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE/PATIENT WAS GIVEN THE JANSSEN  COVID-19 VACCINE, PT IS ONLY 16 YEARS; OFF LABEL USE; HEADACHE; This spontaneous report received from a patient concerned a 16 year old male. The patient's weight was not reported and height was 5.9 inches. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: 23/JUN/2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced drug administered to subject of inappropriate age. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 09-APR-2021, and the outcome of drug administered to patient of inappropriate age and off label use was not reported. This report was non-serious.
12 Hours after vaccine pain in left arm 15 hours after vaccine, fever started and lasted on and off for two days.  Reached 102 and did not drop below 101 even using Tylenol or Ibuprofen. On day two fever went down but at about 36-48 hours went back up to 99.5 until finally going away after 48 hours. During the first 48 hours experienced body chills, fatigue, some nausea, body aches, some joint shooting pain randomly, headache. On days 2-3 started developing a hot red painful patch about 2 inches below the shot location. On day 4 it is light pink and almost gone, the pain has localized in one spot which seems to have some swelling under the skin (not the actual shot location).   Item 20 asks if there has been recovery.  That's not a yes/no answer as most symptoms have gone away, but the lingering pain and patch are still there, but seem to be getting better by the day.
This spontaneous report was received from a consumer refers to her second brother as a male patient of unknown age. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with MMR II (dose, route, lot # were not reported). Concomitant therapy was not reported. On an unknown date, the patient experienced bad reaction after a dose of MMR II. The reporter was unspecified what type of reactions. The reporter states she was a young child when this occurred. The reporter also stated that her mother told her the rest of the MMR II was not administered to her brother. Action taken was not applicable. The outcome of event was unknown. Causality was not assessed by the reporter. This is one of the several reports from the same source. Additional information has been requested.
Pt to ED 2/11 stating he felt his equilibrium off with weakness on left side, hx of TIA. Pt COVID positive on 2/11, placed on 2L SpO2. Neuro-surgery evaluated patient and did not recommend thrombectomy and patient was out of TPA window. CT showed focal area of ischemia however patient symptoms improved and stabilized. Patient was started on Plavix for 30 days. On 2/12 pt remained A&Ox4, breathing even and unlabored, pt was discharged.
no adverse event; PROQUAD was administered to a 4 month old; This spontaneous report was received from a medical assistant concerning to a 4-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 29-JUL-2020, the patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) 0.5 ml (route not reported) (lot# S03021, expiration date 25-MAR-2021) for prophylaxis (product administered to patient of inappropriate age) which was diluted with sterile diluent (lot # N032756, expiration date 05-AUG-2020) (dose and frequency were not reported). No adverse event reported.
Chill, headache, upset stomach, nausea. (However, the symptoms decreased as days went by).
Pain at the sight, chest pain, short of breath, fever, body aches, rapid heartbeat, and lightheadedness.
Bright red, swollen arm around site of injection. Appeared day after injection and still present 1 week later. Red area the size of a tennis ball.
Vaccine related malaise; Feels really bad; severe pain; Arthritis flare; fever of 103; Great fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccine related malaise), FEELING ABNORMAL (Feels really bad), PAIN (severe pain), ARTHRITIS (Arthritis flare) and PYREXIA (fever of 103) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Hospitalized for a week due to COVID-19 infection) from December 2020 to January 2021.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Vaccine related malaise), FEELING ABNORMAL (Feels really bad), PAIN (severe pain), ARTHRITIS (Arthritis flare), PYREXIA (fever of 103) and FATIGUE (Great fatigue). At the time of the report, VACCINATION COMPLICATION (Vaccine related malaise), FEELING ABNORMAL (Feels really bad), PAIN (severe pain), ARTHRITIS (Arthritis flare), PYREXIA (fever of 103) and FATIGUE (Great fatigue) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) 103 fever.         Patient stated that second dose reactions are stronger than first dose reactions.  Concomitant medications were not provided.  Treatment medications were not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-080493 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Added New event Vaccine related malaise
Really really sick after receiving the vaccine; Got all the side effects except the rash; Felt horrible; Sweating; Difficulty breathing; Feeling weak; Felt freezing cold; Fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Really really sick after receiving the vaccine), VACCINATION COMPLICATION (Got all the side effects except the rash), DISCOMFORT (Felt horrible), HYPERHIDROSIS (Sweating) and DYSPNOEA (Difficulty breathing) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure management.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced MALAISE (Really really sick after receiving the vaccine), VACCINATION COMPLICATION (Got all the side effects except the rash), DISCOMFORT (Felt horrible), HYPERHIDROSIS (Sweating), DYSPNOEA (Difficulty breathing), ASTHENIA (Feeling weak), CHILLS (Felt freezing cold), PYREXIA (Fever) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. On 07-Mar-2021, MALAISE (Really really sick after receiving the vaccine), VACCINATION COMPLICATION (Got all the side effects except the rash), DISCOMFORT (Felt horrible), HYPERHIDROSIS (Sweating), DYSPNOEA (Difficulty breathing), CHILLS (Felt freezing cold), PYREXIA (Fever) and NAUSEA (Nausea) had resolved. On 08-Mar-2021, ASTHENIA (Feeling weak) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include Blood pressure medications