chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a non-healthcare professional on 12 November 2014. A female patient (age not reported) whose medical history and concomitant medication were not reported, received a dose of FLU SHOT (batch number, expiry date of vaccine, route and site of vaccination was not reported) on an unspecified date. On an unspecified date, patient experienced pleurisy and soreness at the injection. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of the event was reported as unknown. Documents held by sender: none.
high fever-parents weren't sure exactly ?103 (2 days);acted fussy for 8 hours-sort of jerked off & on;APAP given for fever exact amount unk;
Fatigue; swelling and redness at and around injection site, the area is also warm to the touch.; swelling and redness at and around injection site, the area is also warm to the touch.; swelling and redness at and around injection site, the area is also warm to the touch.; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 17Apr2021 at 10:15 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included supraventricular tachycardia, asthma, asthma, acid reflux (esophageal), blood pressure high and allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included acebutolol hydrochloride (SECTRAL), omeprazole (MANUFACTURER UNKNOWN), formoterol fumarate, mometasone furoate (DULERA), montelukast sodium (SINGULAIR) and fexofenadine hydrochloride (ALLEGRA) and vi (MANUFACTURER UNKNOWN), all from unknown date for unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 27Mar2021 at 10:00 (at the age of 47-year-old) as a single dose for COVID-19 immunisation and took doxycycline (MANUFACTURER UNKNOWN) on an unknown date for unknown indication and experienced drug allergy.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Apr2021 at 21:00, the patient experienced fatigue, swelling and redness at and around injection site, the area was also warm to the touch. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, swelling and redness at and around injection site, the area was also warm to the touch was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Racing heartbeat; Light headedness; I was afraid to stand up; Immunosuppressed, autoimmune problems; Immunosuppressed, autoimmune problems; I have low blood pressure.  Blood Pressure shot up.; Anxiety; This is a spontaneous report from a contactable consumer (patient herself). A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE formulation: Solution for injection, Lot number EN6203 and expiration date: 30Jun2021) via an unspecified route of administration on 06Mar2021 as single dose for COVID-19 immunization. Medical history included she was allergic to resin, polymer and fatty acid. Concomitant medications were not reported. Patient previously took epinephrine for which she experienced with allergic. On an unspecified date in Mar2021 patient stared that that she was "Immunosuppressed, autoimmune problems. She was allergic to resin, polymer, fatty acid. She don't have a heart problem. She has low blood pressure. Blood Pressure shot up. She was afraid to stand up. They gave her water. They told her it was anxiety. "Asking if it should receive second dose. States she previously did safety report. When probed about the reaction patient stated "she had a racing heartbeat and light headedness, right five minutes after she got it." On an unspecified date it was reported as treatment was included as consumer stated that "she just sat there. She had to stay. She was afraid to stand up. She thought it was going to be tough. She had to like sit there and they gave her water and just rest until her heartbeat slowed down." Outcome of events was unknown.  Consumer was informed about Pfizer Medical Information and the contact was provided.
Second dose of SHINGRIX administered by Pharmacy Saturday 10-20-2018 @ 2:00PM. Sunday 7:00AM 10-21-2018 woke with fatigue and a fever of 100.9. The injection site was extremely painful. I went to the CDC website for adverse reactions to SHINGRIX, and read the data, etc. As suggested by the website I took two 325mg Tylenol and by 11:00am 10-21-2018 my temperature was 99.7. I took two more doses of Tylenol during the day Sunday 10-21-2018 and by 5:00pm Sunday my temperature returned to normal. My pulse rate also returned to normal, which had been at 94. Sunday night and early Monday morning 10-22-2018 I had light night sweats. Feeling better today @ 1:00pm 10-22-2018.
history of cerebral palsy who presents from her facility for concerns of chills, nonbloody emesis x1, and fever.  T-max of 102° F.
Patient was erroneously given Pfizer instead of Moderna for dose 2 on 3/5/21. Patient was contacted to notify patient of error on 3/5/21. Noted slight soreness in arm but otherwise felt fine during the call.  MD called patient on 3/9/21 for follow-up with patient to discuss error.
On 2 nd day after vaccine i developed red welts on my limbs ! I thought they would disappear but its been 20days ! The eelts are raised, red and itchy.
8-6-07 Patient phones to report pain to the injection site shortly after receiving vaccine and continues to have the pain. Also reports a raised red rash developed to the injection site area approximately 2 weeks ago. Will check with MD before she receives last vaccination.
Patient reported getting pneumonia after receiving vaccine. Also stated eye related issues including morning watering, itching, lack of clearness of vision in the morning (cloudy).
Palpitations; Weakness; sore throat; Burning sensation and the soreness in tongue; Burning sensation and the soreness in tongue; vomiting severely 5 times; could not eat and breathe; could not eat and breathe; abdomen was upset; cramps and pain; cramps and pain; diarrhea; This is a spontaneous report from a contactable nurse (patient).  A 60-year-old female patient received the receive bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration on 21Dec2020 at 60-years-old at a single dose for COVID-19 immunization.  Medical history included high cholesterol from an unknown date and unknown if ongoing.  Concomitant medications included rosuvastatin calcium (CRESTOR) taken for high cholesterol from an unspecified date to an unspecified date.  The patient experienced the following events and outcomes: palpitations (non-serious) on 22Dec2020 with outcome of unknown , weakness (non-serious) on 22Dec2020 with outcome of unknown, sore throat (non-serious) on 22Dec2020 with outcome of unknown, burning sensation and the soreness in tongue (non-serious) on 22Dec2020 with outcome of unknown, vomiting severely 5 times (non-serious) in Dec2020 with outcome of unknown, could not eat and breathe (non-serious) in Dec2020 with outcome of unknown, abdomen was upset (non-serious) in Dec2020 with outcome of unknown, cramps and pain (non-serious) in Dec2020 with outcome of unknown, diarrhea (non-serious) in Dec2020 with outcome of unknown.  The nurse stated she received the COVID vaccine on 21Dec2020. The nurse stated she did not have any adverse reaction immediately on the first day but on the second day, after 24 hours, she started to have "little bit palpitations that too for a short period of time and a little bit weakness for a short period of time and sore throat. It is not just soring or swelling but it is burning sensation and, on my tongue, also I feel the same thing, burning sensation and the soreness. That was for a small period of time but on my tongue, it is still there, and my throat is still there and last night I experienced vomiting severely 5 times. After the vomiting, I could not eat and breathe." Then, the nurse slept about 3-5 hours, and woke up and her abdomen was upset. The nurse had cramps and pain and when she went to the bathroom and she had huge diarrhea, 2 times."
Ear disorder; Eye irritation; Cold; COVID-19; Drug ineffective; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISORDER (Ear disorder), EYE IRRITATION (Eye irritation), NASOPHARYNGITIS (Cold), COVID-19 (COVID-19) and DRUG INEFFECTIVE (Drug ineffective) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis and Psoriatic arthritis.    There was no reported medical history.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-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 started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced EAR DISORDER (Ear disorder), EYE IRRITATION (Eye irritation), NASOPHARYNGITIS (Cold), COVID-19 (COVID-19) and DRUG INEFFECTIVE (Drug ineffective). At the time of the report, EAR DISORDER (Ear disorder) and NASOPHARYNGITIS (Cold) was resolving and EYE IRRITATION (Eye irritation), COVID-19 (COVID-19) and DRUG INEFFECTIVE (Drug ineffective) outcome was unknown.            Concomitant medications were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient was sick at the time when patient was due flu shot. Patient had a cold and was just getting over it when it was time to do the COVID booster. Also patient was just getting her second Skyrizi shot. Patient had COVID, trouble with one of ears, felt cotton like was something stuck in eye and cold. Primary reporter did not have the lot number information, because the packaging was discarded.  Treatment medications were not reported.  Company comment- This spontaneous concerns a female patient of unknown age with no relevant medical history, who experienced unexpected, non-serious Covid-19 which occurred at an unknown time with regards to vaccination with a second dose of mRNA-1273. The interval between the first and second doses of mRNA was noted to be 29 days, hence Drug ineffective was noted. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous concerns a female patient of unknown age with no relevant medical history, who experienced unexpected, non-serious  Covid-19 which occurred at an unknown time with regards to vaccination with a second dose of mRNA-1273. The interval between the first and second doses of mRNA was noted to be 29 days, hence Drug ineffective was noted. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Spoke with parent via phone. Multiple pustule lesions on trunk, groin area and cheek.
63 yo who presented to the ZOSTAVAX clinic and had a vaccination today. Approximately 10 minutes after the injection, he felt cold/clammy and dizzy. He had no associated headache, vision change, chest pain, dyspnea, nausea/vomiting, or abdominal pain. He had eaten this morning without problems. He exercises regularly without any recent change in exercise tolerance He felt back to normal within a few minutes of being in the Walk-in center. He had had similar symptoms once before after getting blood work dose. Dizziness.
4 YR 7MO old given a COVID vaccine indicated for ages 5-11 years. Patient monitored for 20 minutes without side effects.
flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received 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 INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown. Not Provided          Concomitant medication was not provided. Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD21-082687, MOD-2021-092714, MOD-2021-092653 (Patient Link).
not feeling good; fatigue; joints are hurting a lot/arthritis joint pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (not feeling good), FATIGUE (fatigue) and ARTHRALGIA (joints are hurting a lot/arthritis joint pain) in a 14-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. GH9694) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1, Lot number: EW0181) on 16-Jul-2021, Pfizer (Dose 2, Lot number: EW0181) on 04-Aug-2021, Pfizer (Booster , Lot number: L3198) on 13-Jan-2022, Pfizer (Booster , Lot number: GH9694) on 16-Sep-2022 and Flu shot on 27-Sep-2023. Past adverse reactions to the above products included No adverse event with Flu shot, Pfizer, Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Asthma, Appetite lost and Nauseous. Concomitant products included PARACETAMOL (TYLENOL) for Pain, IBUPROFEN (MOTRIN CHILDS) for an unknown indication.    On 10-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 10-Oct-2023, the patient experienced FEELING ABNORMAL (not feeling good), FATIGUE (fatigue) and ARTHRALGIA (joints are hurting a lot/arthritis joint pain). At the time of the report, FEELING ABNORMAL (not feeling good) and ARTHRALGIA (joints are hurting a lot/arthritis joint pain) outcome was unknown and FATIGUE (fatigue) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient had the vaccine and reported his joints were hurting a lot, fatigue and not feeling good. One of the other vaccines, he had some of the issues too. He had some arthritis joint pain. He has been taking Tylenol and Motrin. He was high tolerance for pain.   No treatment medications were provided.
extreme swelling and soreness of injection site. and underarm area.  Injection site has golf ball size bump which is very red and hot to the touch
Mother with patient returned to health center about 5-10 minutes after leaving (approximately 25 minutes after vaccination took place). Mother reported that just a few minutes after leaving health center she had seizure in car. Was significant seizure where she stopped breathing/turned blue/foaming at mouth. Required several dose of nasal Midazolam. She returned immediately to health center. By time she arrived here seizure had stopped and patient post-ictal. Monitored in car. Offered to bring her back into health center and repeat vitals but mother felt comfortable bringing home. Checked in with mother shortly after and she made it home safely with pt. Will monitor closely for further seizures/issues. Unclear at this time if seizure related to vaccine or not.
Lack of hunger, fever, extreme tiredness, weakness, nausea, hoarseness, slight dizziness; blood tests showed hepatitis virus in the liver; further tests now being done.
a 44 yo F with a PMHx of morbid obesity, COPD, pickwickian syndrome, HFpEF, OSA, tobacco abuse, diabetes, who was admitted to MICU on 9/16 as a transfer for cardiac arrest in the setting of COVID-19. Patient started having have respiratory distress on 9/12 and called 911. Outside records note that she has chronic shortness of breath.  EMS arrived and patient was on her CPAP and sats were 78-80. Patient was placed on a nonrebreather and she started to show improvement. Initial labs at the ED revealed glucose 239, BNP 2771, lactate 23, troponin negative. pH 7.250, pC)2 72, pO2 92. While in the ED, patient's blood pressure continued to drop. Levophed was started and patient was admitted. Vanc and meropenem was started on 9/13. Patient only had peripheral access. On 9/14 1327, patient had PEA. 2 rounds of Epi and 2 amps of bicarb were given. Rhythm went to VT and underwent defib twice and rhythm converted to ST. Intubation failed during the code, so NIPPV was continued. Patient was transferred to UH MICU for further care. Course: Patient presents with post cardiac arrest. GCS of 6 on arrival. Will obtain CT Head. Arrest likely due from acute on chronic hypoxic respiratory failure from COVID-19. Given prolonged course of hypoxia while not being on mechanical ventilation, severe lactic acidosis and septic shock, prognosis is poor. Will continue broad spectrum antibiotics and COVID -19 labs and management.
sensitive hands; sore hands; itching /itching on her body; red hand; sore arm / sore arm where she got the injection; Fever; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 20th October 2019, 1 days after receiving Shingrix, the patient experienced fever. On 21st October 2019, the patient experienced injection site pain, increased skin sensitivity, pain in arm, generalized pruritus and red hands. On 21st October 2019, the outcome of the fever, increased skin sensitivity, pain in arm and generalized pruritus were recovered/resolved. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the red hands was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, fever, increased skin sensitivity, pain in arm, generalized pruritus and red hands to be related to Shingrix.  Additional case details were reported as follows: The patient received Shngrix on an unknown arm. On Sunday, the patient ran a fever, but that resolved Monday morning.  On Monday, 2 days after vaccination, the patient noticed that her hands were very red, painful and sensitive to temperature changes like hot or cold water. They were more sensitive to hot water.  The patient also had a little itching on her body.  On day of reporting, her hands were less red and sensitive and no longer painful, the itching had also resolved.  She also had a sore arm where she got the injection, which was improving. The reporter consent to follow up.
Premature menstrual cycle  immediately following vaccination  and heavy bleeding for 3 additional cycles.
her eyes and everything else that swelled up; having a problem talking because her lips are so swollen now; having a problem talking because her lips are so swollen now; Face swelling; This is a spontaneous report from a contactable Nurse (patient). A 75-years-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 10Mar2021 (at the age of 75-years) as a single dose in the left arm for COVID-19 immunization. The patient medical history included blood pressure high, type II diabetes, high cholesterol was ongoing. The patient concomitant medications included Amlodipine 10mg once a day for Blood pressure high, Lisinopril 10mg once a day for unspecified indication, sitagliptin phosphate (JANUVIA) for unspecified indication from an unknown date and unknown if ongoing. On unspecified date of 2021, the patient experienced face swelling. After she got the shot, her face swelled up. She got the shot in Mar and her face swelled up about a week after that. However, her tongue did not swell up. It was her eyes and everything else that swelled up. Then when she went to get the second shot they did not give it to her. Due to face swelling she was placed on Prednisone therapy. After completing the Prednisone Therapy they would not give the second dose. Since that date each month since getting the first dose her face swells up. Like this morning it started to swell up again. She wonders if she can still get the COVID vaccine, but a different one instead, or does it have to be Pfizer, or can she not take any COVID vaccine. The swelling continues, but she can wear masks and it covers it up. Like cannot see her lip under the masks, but it is swollen. She was having a problem talking because her lips are so swollen now. Each month when the facial swelling begins it last for 2-3 days. The event face swelling was assessed as serious medically significant. The clinical outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event face swelling and the suspect drug.  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.
site of injection has remained reddened, swollen, and painful to touch. Have seen physician for evaluation.
Ten days post receiving the Moderna booster on 11/11/21, I started to experience chronic hives and dermatographia.  The hives appear anywhere on my body- specifically my legs, arms, back, and torso, and will move throughout the course of a few hours if I do not take an antihistamine. My skin will react where I scratch the hives, resulting in long marks and raised itchy welts at contact. I have tracked food intake and other possible contributing factors and the hives are not linked to any specific cause, other than they started post booster. I have had hives at a minimum of four times a week since the start of this issue.
A FEW MINUTES AFTER RECIEVING HPV VACCINE, PATIENT CRYING C/O SEVERE LT ARM PAIN AND STATING SHE COULDN'T MOVE IT. IMMEDIATELY AFTER RECEIVING TYLENOL, PATIENT BECAME DAZED AND WAS RESPONDING VERY SLOW.
Left arm (Bicep) Red & swollen Fever up to 102' since 6/4/19. Body aches.