chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received flu shot 11/17 left arm. Swelling on Tues. Pain started Tues night. Very uncomfortable on Wed., has persisted. Today 11/24.
I gave a 21yo male a Janssen vaccine approximately 508p on 5/15. Vaccination was routine and the patient walked to the observation chair.  Around 520p, an acquaintance of the patient came up asking for a vomit bag.  I went out to the observation chair with a small trash can and paper bag and at 522p the patient stated he felt dizzy and vomited.  My technician stayed with the patient, and I went to the pharmacy to grab paper towels, a new mask, and a bottle of water. I came back and asked the patient how he was feeling (524p). He said that he felt much better after vomiting. I asked if he wanted a cold pack or water, and he took the bottle of water and denied the cold pack. I asked him to continue to stay for observation. At 537p, I went out to see how the patient was feeling.  He stated he was feeling better and was no longer dizzy. At 538p (30 minutes after vaccination) the patient stated he felt comfortable to leave and continue shopping in the store with his acquaintance.
pericarditis; chest pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain) and PERICARDITIS (pericarditis) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 pneumonia (Patient was hospitalized for 2 nights starting 26-Nov-2020. ) on 15-Nov-2020 and Diverticulitis in November 2020. Concomitant products included FINASTERIDE for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced CHEST PAIN (chest pain) (seriousness criterion hospitalization). On an unknown date, the patient experienced PERICARDITIS (pericarditis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 06-Apr-2021 due to CHEST PAIN. The patient was treated with DILTIAZEM for Adverse event, at a dose of 60 mg; OMEPRAZOLE for Adverse event, at a dose of 40 mg; MULTIVITAMIN [VITAMINS NOS] for Adverse event, at an unspecified dose and frequency; CALCIUM for Adverse event, at an unspecified dose and frequency; ACETYLSALICYLIC ACID (ASPIRIN 81) for Adverse event, at a dose of 81 mg and ROSUVASTATIN for Adverse event, at a dose of 20 mg. At the time of the report, CHEST PAIN (chest pain) had not resolved and PERICARDITIS (pericarditis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: increased (High) increased.         Company Comment:  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
MISADMINISTRATION. Pt in for scheduled age appropriate vaccinations and Flu vaccine. Received no doses of flu vaccine last year. Child was inadvertently given FLUZONE 0.5mL IM instead of 0.25mL. Mother was notified. No adverse reactions reported as of 18 hours post injection.
Following day a sore arm and lethargic.  3 days after developed a very foggy mind unable to process information, headache severe at times.  Severe joint pain throughout body.  Nauseous minimal but there.   Anxiety very severe at times . 7 days post symptoms remain and elevated anxiety, tired, lethargic, unable to focus, panic attacks, debilitating at times.  Woken up from deep sleep still 7 days post of incredibly severe arm pain in arm hat was injected.
Body aches; Muscle stiffness; Neck stiffness; muscle fatigue; Dizziness; Diarrhea; Exhaustion; Redness around the injection site; Swelling around the injection site; Injection site is also warm to touch; This is a spontaneous report from a contactable healthcare professional, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 30Apr2021 at 15:30 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, polycystic ovarian syndrome, and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included SERTRALINE, TOPAMAX, METFORMIN, and BOTOX for an unknown indications, from an unknown date and unknown if ongoing. The patient previously received RISPERIDONE and experienced drug allergy on an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 09Apr2021 at 15:30 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. On 30Apr2021 at 18:00, the patient experienced body aches, muscle and neck stiffness, muscle fatigue, dizziness, diarrhea, exhaustion/fatigue, redness and swelling around the injection site, and injection site was also warm to touch. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether any therapeutic measures were 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 body aches, muscle and neck stiffness, muscle fatigue, dizziness, diarrhea, exhaustion fatigue, redness and swelling around the injection site, and injection site is also warm to touch was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient got dizzy and light headed.  She never lost consciousness but did decide to go to the ER just to be safe.
rash on face/head began @ 46hr post vax & over the next few days spread to trunk & extremities 72hr p/vax seen in ER;in ER augmentin prescribed for OM;rash persist;blister on upper arm;
Information was disclosed to me yesterday 11/13/07.  After 6 mo shots, the child developed high fever 103.5, "twitching", and dehydration.  She was treated at ER.
Patient has previous covid test positive from 4/18/21  04/19/21 1301  Respiratory virus detection panel  Collected: 04/19/21 0943 | Final result | Specimen: Swab from Nasopharynx   Adenovirus Not Detected Mycoplasma pneumoniae Not Detected Chlamydophila pneumoniae Not Detected Parainfluenza Not Detected COVID-19 SARS-CoV-2 Overall Result DetectedCritical  Enterovirus/Rhinovirus Not Detected Coronavirus Not Detected Respiratory Synctial Virus Not Detected Influenza A Not Detected Bordetella pertussis Not Detected Influenza B Not Detected Bordetella parapertussis Not Detected
Note: this was Booster shot. Reaction was full body aches overnight, severe headache, sore arm, swelling at injection site, all continuing still into next day.  fever/chills overnight which broke by next morning.
10 hours after shot, woke with chills, shakes, and dizziness & nausea. Nausea last 36 hours.
Arrives complaining of shortness of breath for 3 days, especially with exertion.  Minor cough.  Patient was diagnosed with Covid over 2 weeks ago.  And was cleared to go back to work 2 days ago.  He states his initial illness was very mild with out significant cough or shortness of breath its only recently over the last few days that he short of breath.  No high fever.  No chest pain.  No syncope.
appetite lost; mild fever; headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (appetite lost), PYREXIA (mild fever), HEADACHE (headache) and FATIGUE (fatigue) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced DECREASED APPETITE (appetite lost), PYREXIA (mild fever), HEADACHE (headache) and FATIGUE (fatigue). On 03-May-2021, DECREASED APPETITE (appetite lost), PYREXIA (mild fever), HEADACHE (headache) and FATIGUE (fatigue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       the concomitant medications were not provided. the Treatment information was not provided.
Allodynia on the left side of my head that lasted for a week. I reported it because my law partner experienced the same thing I discovered after the fact after he got his Pfizer vaccine on the same timeline
Systemic: Abdominal Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Additional Details: Patient recieved the vaccine and said it hurt when she got the injection and was crying. Patient was with her mom. Patient requested to go to the bathroom and her mother went with her. Patient then stated she was dizzy and laid down. After a few minutes patient stated she was feeling better and sat in a chair. After a few more minutes the patient went home with her mother. Rph talked to mom and told her to have patient seen by a doctor if symptoms progess or get worse.
The patient was admitted for hospitalization on 4/28/2021 from a Unit with an ongoing COVID outbreak. Patient presented with a fever and hypotensive. Patient also reports a UTI. Tested for COVID has a part of hospital admission guidelines. The test returned positive.
Late 2nd dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 30-JUN-2023 The reporter was an office manager. The reporter asked if patient get Shingrix out of the 2-6 month window, what was the expected efficacy. The reporter would share the response with the providers. The reporter did not speak with the Health Care Provider and asked to follow up with the Sales Rep for more information.  The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule.
Chills; Temperature of 100.8F; Diarrhea; Nausea; Fatigue; she was sick; blood sugar got up to 258; This is a spontaneous report received from a contactable consumer (Patient). A 80-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in left upper arm on 26Feb2021 at 11:15 (at the age of 80-year-old) as a single dose for covid-19 immunisation. The patient medical history included ongoing diabetes mellitus (diagnosed 25 yrs ago. She was keeping control with medication and started insulin in Jun2020), arthritis, pain, ache, blood pressure, blood sugar and blood cholesterol (abnormal). Patient did not receive any prior vaccinations within 4 weeks and did not experienced any AEs following prior vaccinations. Concomitant medications included paracetamol (TYLENOL, once a day, started it probably 10 years ago) taken for arthritis, meloxicam (15mg, tablet once a day by mouth, has been taking for 5-6 years) taken for aches/pain, enalapril (20mg twice a day tablet by mouth) taken for blood pressure (abnormal), glipizide (10mg, 1 tablet in the morning and 1/2 a tablet in the evening with meal by mouth) taken for diabetes mellitus, saxagliptin hydrochloride (ONGLYZA, 5mg once a day by mouth, started about 2 years ago) taken for diabetes/to help with blood sugar, atorvastatin (40mg, once a day, by mouth, started taking it years ago) taken for blood cholesterol, insulin (10units once a day, injection, subcutaneous) taken to control her blood sugar/diabetes from Jun2020 and paracetamol (TYLENOL ARTHRITIS, 2 tablets a day by mouth, started it 10 years ago) taken for arthritis and all were ongoing. The patient family medical history relevant to AE and pertinent details (Include surgical procedures and dates) was none. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9809) administered in left upper arm on 05Feb2021 (at the age of 80-year-old) as a single dose for Covid-19 immunization. On 27Feb2021 at 13:30, the patient experienced chills, temperature of 100.8 F, diarrhea, nausea, fatigue (she could not even get out of bed) and when she was sick her blood sugar got up to 258 and on sunday (28Feb2021) came back down to 96. Chills ended 9 hours after they started, and she was back to normal. Patient received 2 regular Tylenol as a treatment for the events. Patient did not visit emergency room or physician office due to adverse events. The outcome of the event sick was recovered on an unspecified date in 2021, diarrhea, fatigue, her blood sugar got up to 258 was recovered on 28Feb2021 and rest of the events were recovered on 27Feb2021.  No follow-up attempts are possible. No further information is expected.
Shot was given in Lt arm.  Patient reported tingling & itching running up it.  Arm to Lt side of face.  Welting observed.  Throat also tingling.  FNP called.  DIPHENHYDRAMINE 50 mg given in Lt hip & an oral XYZAL mg given.  Pt responded well.
That night she had some soreness on her arm , and a fever. The  next day it was fine, then come Thursday her entire are was red.
PATIENT STATING NEXT DAY SHE DEVELOPED REDNESS, SWELLING AND BURNING EFFECT AT THE INJECTIONS SITE ON HER RIGHT ARM (WHERE SHINGRIX GIVEN). TODAY IS DAY 7 TH, AND HER REDNESS AND SWELLING GOING DOWN BUT BURNING EFFECT IS NOW SPREADING TO HER ARM AND NECK AREA.
Tingling sensation on hands and feet; Palpitations; Temporary blurry vision; This is a spontaneous report from a contactable other healthcare professional, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 16Apr2021 at 13:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety. The patient had no known allergies to medications, food, or other products. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), folic acid (MANUFACTURER UNKNOWN) and unspecified multivitamin; all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 26Mar2021 at 13:00 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. 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. On 17Apr2021 at 16:30, the patient experienced tingling sensation on hands and feet, palpitations and temporary blurry vision (lasted a few seconds). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tingling sensation on hands and feet and palpitations were resolved on an unknown date in Apr2021 and the event temporary blurry vision was resolved on 17Apr2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Still birth at 22 weeks.  Said the case was for patients who dealt with drug problems and or smoking as well. I do not do drugs or have ever smoked.
Patient was readmitted to the hospital after failed outpatient management of acute hypoxic respiratory failure secondary to Covid pneumonia. This was patient's second hospital admission. The patient was found to have hypoxia, Covid pneumonia with bilateral segmental and subsegmental pulmonary emboli found. There was initial concern for hospital-acquired pneumonia secondary to questionable infiltrate seen on imaging and the patient was initially started on antibiotic therapy. The following day antibiotics were discontinued due to a low pro-Cal and a low suspicion for a bacterial ideology. The patient received a heparin drip for the bilateral pulmonary emboli and then switched to oral Eliquis on day 3 of hospitalization. The patient continued to have worsening hypoxia and respiratory status requiring escalating amounts of oxygen. The patient did receive remdesivir during her first hospitalization and continue to receive all appropriate supportive cares including incentive spirometry, proning and a Combivent inhaler throughout her hospital stay. The patient's respiratory status became worse. Pulmonology was consulted Decadron was initiated, and a trial of diuresis failed to improve the patient's oxygen requirement and respiratory status. Repeat CT scan demonstrated worsening of pulmonary fibrosis and echocardiogram was unremarkable. Palliative care was consulted and family. The decision was made to pursue hospice. Patient met criteria for inpatient hospice. Patient died on 1/6/2022 at 11:34pm. Health Dept has no further information is known on this case.
Baby had a fever; nursing; This is a spontaneous report received from a contactable consumer. This consumer reported for a 11-month-old patient (baby) of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via trans mammary route of administration on 07Mar2021 at 08:00 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 08Mar2021, baby had a fever starting the day after, went up to 105 and doctor could not find any cause, despite running many tests. Wanted you to know to keep track. The patient underwent lab tests and procedures which included fever was went up to 105 (unknown units) on 08Mar2021. The action taken in response to the event(s) for bnt162b2 was not applicable. Motrin and fluids for baby given as treatment for fever. The outcome of the fever was reported as resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021330473 Mother/Baby case
High fever up to 104 started 2 hours after immunization persistent for > 48 hours despite fever medications. Redness and swelling in 24 hours after vaccine at site of Pneumococcal 23 vaccine.
Went to ER for pain near gallbladder, 1 wk later ended up with shingles,  nerve pain continues to this day.
This is a spontaneous report from a contactable consumer. A male patient of unspecified age received first dose of bnt162b2 (COMIRANTY; Formulation: solution for injection; Lot number: not reported, Expiration date: not reported) via an unspecified route of administration on 20Jan2021 as DOSE 1, SINGLE for COVID-19 immunization and second dose of bnt162b2 (COMIRANTY; Formulation: solution for injection; Lot number: not reported, Expiration date: not reported) via an unspecified route of administration on 10Feb2021 as DOSE 2, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. Other vaccine administered in four weeks was unknown. Other medications administered in two weeks was unknown. Prior to vaccination, the patient was diagnosed with covid-19 was unknown. Since the vaccination, patient has been tested for COVID-19. On 10Aug2021, the patient started noticing COVID symptoms and tested positive for COVID on 11Aug2021. Reporter also stated patient had no symptoms after receiving the doses of the vaccine. AE resulted in doctor or other healthcare professional office/clinic visit. Treatment took for AE was unknown. Lab test included COVID test positive on 11Aug2021. The events was reported as non serious. Outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Chills, body aches, exhaustion Chills gone next day but body aches remain
pt recvd vax;fever of 103-105;sz while mom holding him;mom states his eyes rolled back & he became stiff for 1-2 min;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age.  No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 08-JUL-2016, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date patient was diagnosed with shingles and/or other zoster-related injuries (Herpes zoster) after and despite being inoculated with the ZOSTAVAX vaccine (Vaccination failure). On an unknown date in 2016, the patient was treated by a health care provider for shingles (Herpes zoster). The lawyer reported that as a direct and proximate result of the ZOSTAVAX vaccine, Patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering (pain), extensive medical care and treatment for these injuries, significant medical and related expenses because of these injuries; including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. Causality assessment was reported as related for the events.
Chief Complaint (1/1): This 12 month old female presents today for evaluation of a rash. Rash-Associated Signs and Symptoms: The following characteristics of the rash are noted. Location first noted: shot site, spread to right foot then right hand and then right eye and started 1 days. Sx associated signs and symptoms: Associated signs and symptoms include Received Hep A and PREVNAR on 5-22-09 in right thigh. Woke morning of 5-23-09 with swelling and redness at shot site. On the afternoon of 5-23-09 she had swelling and hives of right foot followed by hives and swelling of right hand. Shortly after had swelling of right eye. Gave BENADRYL after our pc yesterday. Last dose before bed. Rash gone this morning. No changes or new foods. Pt was accompanied by her mother and father. Seen after posted regular office hours at 9:24 AM.
No reaction to vaccines.  19yo COVID + patient (tested + on 9/20/2021) presented for Regeneron infusion on 9/22/2021. About 5 minutes into infusion, patient became light-headed with mild central chest discomfort. SpO2 >95%, RR in 20s initially, normotensive, HR 60-70s. After stopping infusion, patient's symptoms completely resolved. Patient was responsive throughout episode.  On exam, normal work of breathing with clear lungs on auscultation. No evidence of rash. No reported GI symptoms per patient. Monitored patient for 60 minutes following cessation of infusion.