chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received Pfizer COVID19 vaccine at 03:50 PM to left deltoid by EMT.   Patients skin began to become pale.  Patient reported nausea.  Her eyes closed and her head went limp for approximately 10 seconds or less.  Patient remained upright in chair with support from this RN.  Patient was moved to cot with assistance from EMT and placed in prone position with feet elevated.  Blood pressure, pulse oximetry and pulse obtained by this RN.  Initial blood pressure of 90/58, heart rate 71, and oxygen saturation of 98% on room air at 03:52 PM.   At 04:00 patient reported she began to feel better.  Patient was assisted to sitting position.  Patient denied dizziness or nausea upon rising to sitting position.  Vital signs at 04:00 PM blood pressure 102/68, heart rate of 81, and oxygen saturation of 98% on room air.  Patient stated she was feeling much better.  Patient left building with her mother accompanied by this RN.
No adverse event; Dose-1 administered on (11-03-2021) and Dose-2 administered on (15-11-2021); This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1 administered on (11-03-2021) and Dose-2 administered on (15-11-2021)) and NO ADVERSE EVENT (No adverse event) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 prophylaxis.     It was unknown if patient ever diagnosed or tested positive for COVID-19. It was unknown if patient had any acute illness at the time of vaccination and up to one month before. It was unknown if patient had any chronic or long-standing health conditions.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 15-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1 administered on (11-03-2021) and Dose-2 administered on (15-11-2021)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1 administered on (11-03-2021) and Dose-2 administered on (15-11-2021)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose-1 administered on (11-03-2021) and Dose-2 administered on (15-11-2021)).    No concomitant medication information provided.  No treatment information provided.   This case was linked to MOD-2023-704537 (Patient Link).
My right arm has been knotting up at injection site. It also goes to sleep from the shoulder to the elbow. This has been going on for over a week.
Shortness of breath; cough; low energy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2), for Covid-19 immunization; Bnt162b2 (Dose 1), for Covid-19 immunization. The following information was reported: DYSPNOEA (non-serious) with onset 14Aug2022, outcome "recovering", described as "Shortness of breath"; COUGH (non-serious) with onset 14Aug2022, outcome "recovering"; ASTHENIA (non-serious) with onset 14Aug2022, outcome "recovering", described as "low energy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dyspnoea, cough, asthenia.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201063839 Same patient and product, different AEs;
Daughter received HPV on 9/30/2013 and 12/5/2013 recently daughter was diagnosed with shingles which led into issues with walking.  All tests are coming back negative and not sure why she is having issues walking.
Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; she is feeling kind of sweaty; This is a spontaneous report from a contactable consumer (patient's mother). A 15-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FA7485), via an unspecified route of administration, administered in Arm Left on 06Aug2021 (at the age 15-years-old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FA6780), via an unspecified route of administration, administered in Arm Left on 16Jul2021 (at the age 15-years-old) as dose 1, single for COVID-19 immunisation. There was no prior vaccination. The patient experienced tiredness, headache, muscle pain, chills, joint pain, fever and she was feeling kind of sweaty on an unspecified date in Aug2021. Consumer reported that they got their daughter her second shot yesterday morning and she was 15 almost, she would be 16 next month and she didn't have any issues with the first one and she thought this maybe normal but she just felt better if he check to know when its your child. She was suffering from some of those side effects from the paperwork like the tiredness, the headache, the muscle pain, the chills, joint pain, the fever. her husband didn't get a new battery for thermometer, so she couldn't tell exactly what her fever was but she thought its breaking because she was feeling kind of sweaty now (further clarification unknown). But she gave her a couple of Ibuprofen (treatment) to help with the aches and the fever. Reporter guesses that she would have to watch her closely or call her physician or the pharmacy where she got her. Reporter stated, she gave her Ibuprofen and plenty of fluids. It was Ibuprofen, she gave her two 200 mg tablets, so, it would be 400 mg, each capsule was 200 mg, so it would have been a total of 400 and she said that she took 3 of them last night and she did not know that (further clarification about dose of Ibuprofen was unknown). Reporter was advised to call withheld or visit nearest ER in case of any emergency. The patient underwent lab tests and procedures which included body temperature: unknown result (Fever) on an unknown date of 2021. Therapeutic measures were taken as a result of all the events included Ibuprofen (two 200 mg tablets) and plenty of fluids. The clinical outcome of all the events were unknown.  Follow-up attempts are completed. No further information is expected.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned multiple patients of an unspecified age and sex. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 01 total, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  It was reported that "I have known people having J&J vaccine get COVID (suspected covid-19 infection, suspected clinical vaccination failure), my family they have been vaccinated." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0- 20220200536-Covid-19 vaccine ad26.CoV-2.s- Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Received vaccination on 3/24/21.  Awoke with a slight headache the following morning  (3/25/21) approx 6;00 am.   By 10:00 that morning,  the headache worsened and I started experiencing fatigue and body aches.  By 3:00,  the body aches and headache were horrible and I could hardly stay awake. My temp was 99.5.   Kept experiencing hot and cold flashes.   I slept off and on the remainder of that day.   I had a fever most of the night.   I awoke the next day (3/26/21) with same symptoms.  I alternated acetaminophen and ibuprofen for aches and pains.  I rested and slept off and on that morning.   By 2:00 that afternoon  I was not as fatigued and the headaches and body aches were lessening and I quit taking acetaminophen and ibuprofen..    By 7:00 that evening I felt much better and  awoke the next morning not feeling any effects.                                                                                                                      One other side effect was the red ring approx 2" diameter on my arm at the injection site.  It was raised and warm to the touch.  The site is still red and bruised on 3/28.
Swollen; Red; Sore arm; Itchy; Warm; Tiredness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swollen), ERYTHEMA (Red), PAIN IN EXTREMITY (Sore arm), PRURITUS (Itchy) and FEELING HOT (Warm) 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.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (Swollen). an unknown date, the patient experienced ERYTHEMA (Red), PAIN IN EXTREMITY (Sore arm), PRURITUS (Itchy), FEELING HOT (Warm), FATIGUE (Tiredness) and HEADACHE (Headache). At the time of the report, SWELLING (Swollen), ERYTHEMA (Red), PAIN IN EXTREMITY (Sore arm), PRURITUS (Itchy), FEELING HOT (Warm), FATIGUE (Tiredness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant  medication was provided by the reporter. No treatment medication was provided by the reporter.
Patient was administered a dose that was expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 3LP72, expiry date 22nd May 2022) for prophylaxis.   On 16th June 2022, the patient received Shingrix. On 16th June 2022, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 24-June-2022 Reporter's comment: The nurse reported that 59 year old patient was administered a dose of Shingrix that was expired.   At the time of reporting, repeat dose had not been administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up. The case was for 4 of 5 patients. Additional supportive information: The patient received an expired dose of Shingrix, which led to expired vaccine used.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022097903:Same Reporter US-GLAXOSMITHKLINE-US2022097904:Same Reporter US-GLAXOSMITHKLINE-US2022097898:Same Reporter US-GLAXOSMITHKLINE-US2022097908:Same Reporter
slight anemia.; Hair loss is everywhere on his body((eyebrows, chest, arms, legs); hair is so thin and light; he started losing hair on his head first./hair loss is progressively worse; This spontaneous case was reported by a consumer and describes the occurrence of ANAEMIA (slight anemia.), ALOPECIA (Hair loss is everywhere on his body((eyebrows, chest, arms, legs)), ALOPECIA (hair is so thin and light) and ALOPECIA (he started losing hair on his head first./hair loss is progressively worse) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included SIMVASTATIN, LISINOPRIL, COLLAGEN, ACETYLSALICYLIC ACID (BABY ASPIRIN), SERENOA REPENS (PROSTATE HEALTH [SERENOA REPENS]), TURMERIC [CURCUMA LONGA RHIZOME] and BIFIDOBACTERIUM INFANTIS, LACTOBACILLUS ACIDOPHILUS (PROBIOTIC [BIFIDOBACTERIUM INFANTIS;LACTOBACILLUS ACIDOPHILUS]) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced ANAEMIA (slight anemia.), ALOPECIA (Hair loss is everywhere on his body((eyebrows, chest, arms, legs)), ALOPECIA (hair is so thin and light) and ALOPECIA (he started losing hair on his head first./hair loss is progressively worse). At the time of the report, ANAEMIA (slight anemia.), ALOPECIA (Hair loss is everywhere on his body((eyebrows, chest, arms, legs)), ALOPECIA (hair is so thin and light) and ALOPECIA (he started losing hair on his head first./hair loss is progressively worse) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: slight anemia (abnormal) SLIGHT ANEMIA and the blood work showed that the anemia is doing bet (normal) the blood work showed that the anemia is doing better, closer to normal ranges.. On an unknown date, Endoscopy: no bleeding (normal) no bleeding.         The patient was also taking Acu vitamin concomitantly. No treatment information was provided.
Redness, swelling and pain suggestive of cellulitis on left thigh at site of injection. Treatment consisted of IV and oral antibiotics.
Patient did not experience any adverse events but did receive the preservative flu vaccine as opposed to the preservative free vaccined while pregnant.
"New subtle Ground glass opacity", 3.0cm, left lower lobe on CT scan done 5/26/2021.  I had been having pain in left chest/abdomen and  was having a hard time catching my breath, especially when bending over so I was sent to have chest/abdomen/pelvic CT scan with contrast media (Omnipaque).   I've been asked to repeat the CT scan in about 6 months to follow up.
felt his feet were cold; joint pain; muscle pain; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (felt his feet were cold), ARTHRALGIA (joint pain), MYALGIA (muscle pain), HEADACHE (headache) and FATIGUE (fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history provided).   On 06-Apr-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) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PERIPHERAL COLDNESS (felt his feet were cold), ARTHRALGIA (joint pain), MYALGIA (muscle pain), HEADACHE (headache) and FATIGUE (fatigue). On 07-Apr-2021, PERIPHERAL COLDNESS (felt his feet were cold), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) had resolved. At the time of the report, HEADACHE (headache) and FATIGUE (fatigue) outcome was unknown.            No medical history and concomitant medications were provided.  No treatment information provided
Get out of breath easily; Feeling light headed the next day after vaccine; Sharp stabbing pain in chest twice; Palpitations; Hear racing, pounding, hot and cold flashes; hear racing, pounding, hot and cold flashes; Heart felt like it was being squeezed,heaviness in chest; Heart felt like it was being squeezed, heaviness in chest; High BP and heart rate; High BP and heart rate; This is a spontaneous report from a contactable consumer (patient). A 37-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8733), via an unspecified route of administration on 21May2021 (at the age of 37-years) as single dose in the left arm for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22May2021, the patient experienced started feeling light headed the next day after vaccine, then sharp stabbing pain in chest twice, palpitations, hear racing, pounding, hot and cold flashes a few times. Heart felt like it was being squeezed, heaviness in chest and get out of breath easily. Still ongoing and had to be taken to the ER for this with high BP and heart rate. Patient stated that not normal for her, never had BP issues, or any health issues like this or ever been on any meds for anything. The patient did not received treatment for events. The patient had visited to emergency room and physician office. The outcome of the events was not recovered.  Information on the lot/ batch number has been requested.
vomiting, sweats, shortness of breath, weakness, chest discomfort.  911 call was dispatched to my home and they administered oxgen and an iv before transporting me to the emergency room.  symptoms began around 2:00 pm and continued to worsen until iv and oxygen were administered.
headache, muscle aches, fever, shivering, stomach pain, nausea, fatigue, fast heartbeat, pain and redness at site
Information has been received from a registered nurse concerning a 7 year old male, with no past medical history and no known drug allergies who on 4/3/97 was vaccinated SC in the left thigh with a first 0.5ml dose of varicella virus vaccine live (lot # 621071/1552D). There was no illness at the time of vaccination. On 3/30/03 the patient presented with a zoster like rash on his left buttock and left thigh. No other symptoms were noted. Unspecified medical attention was sought. There was no product quality complaint. Follow up information received from a registered nurse provided information that the patient's rash was noted by his mother on 3/28/04 (previously reported as 3/28/03). The patient presented to the office on 3/30/04, and at that time the rash was vesicular. It was noted to begin on the left buttocks and proceed in a dermatome fashion across the left thigh to the knee (also described  as from the left superior buttocks to the left medial malleolus across the anterior thigh to the knee and medial calf). There were many lesions too numerous to count. The rash did not occur at the site of injection or elsewhere within 42 days of the vaccination. Herpes zoster was diagnosed on 3/30/04. The patient's maximum temperature was 98.9 degrees F. There were no other relevant diagnostic tests or laboratory data. The patient's pain was quantified at a 2 (with 0 being the least and 10 being the most). The were no other systemic symptoms. There was no history of chicken pox and there was no recent exposure to chicken pox or herpes zoster. A direct flurorescent antibody was not done. A specimen was not collected for PCR. No photo was taken. No fever and no other complaints were noted. The outcome was reported as recovered. No additional information is expected.
Pain in one of her teeth / Teeth pain; The root of the upper tooth on the right side of her mouth was very sensitive / the root of the teeth are sensitive/ sensitive to hot / bottom right was sensitive to hot and cold; Earache that comes and goes; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TOOTHACHE (Pain in one of her teeth / Teeth pain), HYPERAESTHESIA TEETH (The root of the upper tooth on the right side of her mouth was very sensitive / the root of the teeth are sensitive/ sensitive to hot / bottom right was sensitive to hot and cold) and EAR PAIN (Earache that comes and goes) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010MZ0A and 006MZ0A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), LISINOPRIL, HCTZ, FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA), AMLODIPINE, LEVOTHYROXINE, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and VITAMIN D NOS for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-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 TOOTHACHE (Pain in one of her teeth / Teeth pain), HYPERAESTHESIA TEETH (The root of the upper tooth on the right side of her mouth was very sensitive / the root of the teeth are sensitive/ sensitive to hot / bottom right was sensitive to hot and cold) and EAR PAIN (Earache that comes and goes). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event NOS, at an unspecified dose and frequency and IBUPROFEN for Adverse event NOS, at an unspecified dose and frequency. At the time of the report, TOOTHACHE (Pain in one of her teeth / Teeth pain), HYPERAESTHESIA TEETH (The root of the upper tooth on the right side of her mouth was very sensitive / the root of the teeth are sensitive/ sensitive to hot / bottom right was sensitive to hot and cold) and EAR PAIN (Earache that comes and goes) outcome was unknown.            The patient did not experience any side effects with the first dose.
Fevers, shaky, vomiting, nausea, dizziness 15-20 min. after injection. Injection site swollen and red. In ER - told it was local reaction.