chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine; batch/lot# EN6703), at the age of 68, via an unspecified route of administration, left arm, on Mar 13, 2021, at 12:30, single dose, for COVID-19 immunization. The patient's medical history: none. Concomitant medications not reported. No additional vaccines administered on same date of vaccination with BNT162B2. Prior to vaccination, patient did not receive any vaccines within four weeks. The patient experienced pain in left arm on Mar 13, 2021, at 15:30; injection site pain in her left arm on Mar 13, 2021; headache, joint pain, muscle pain and tiredness on Mar 25, 2021, nausea, dizziness and weakness on Mar 18, 2021. The outcome of pain in left arm and injection site pain in her left arm resolved on Mar 14, 2021. Headache, joint pain, muscle pain and tiredness resolved on Mar 17, 2021. Nausea, dizziness and weakness not resolved. No follow-up attempts possible. No further information expected.
Patient passed out for few seconds, unconscious, shaky after having vaccine Have patient lie down on the floor, elevated the legs, placed ice pack at the back of the neck. Vital signs taken, BP was elevated. Patient regained conscious after few seconds, was stable and went home.
I contracted COVID19 4/25/2022 with symptoms of congestion, cough, sore throat for a couple of hours, fever, and my symptoms resolved on 4/29/2022 with no lingering symptoms. I was prescribed Paxlovid 4/26/2022.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (dose, lot # not reported) on 12-NOV-2012 but had a needle leakage. The patient got less than the recommended dose. The patient was readministering another full dose at the time of reporting. Additional information has been requested.
This is the 3rd shot of Pfizer since I am immunocompromised.  Side effects were very sore and stiff back, stiff neck and head sensitivity at touch as if there was a sinus infection.  This lasted one day and resolved.
gave 2 nd booster to patient who was under 50 years old. patient's card did not have 1st booster dose info and got confused due to mis communication that she was receiving the 2nd booster dose.no side effects no adverse events.
PT RECEIVED J&J VACCINE ON 4/10/21 AT PHARMACY AND PFIZER 1ST DOSE AT A DIFFERENT LOCATION ON 8/14/21.
JITTERY; WARMTH FELT LIKE BREAKING OUT; SORENESS; SEVERE ANXIETY/PANIC ATTACK; UNABLE TO EAT; UNABLE TO SLEEP; HYPERACTIVITY; UNCONTROLLABLE SOBBING; IRRATIONAL THOUGHTS; INJECTION SITE PAIN; HEADACHE; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. 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: 204A21A expiry: UNKNOWN) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced jittery. On JUN-2021, the subject experienced warmth felt like breaking out. On JUN-2021, the subject experienced soreness. On JUN-2021, the subject experienced severe anxiety/panic attack. On JUN-2021, the subject experienced unable to eat. On JUN-2021, the subject experienced unable to sleep. On JUN-2021, the subject experienced hyperactivity. On JUN-2021, the subject experienced uncontrollable sobbing. On JUN-2021, the subject experienced irrational thoughts. On JUN-2021, the subject experienced injection site pain. On JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the jittery, warmth felt like breaking out, injection site pain, soreness, severe anxiety/panic attack, unable to eat, unable to sleep, hyperactivity, uncontrollable sobbing, irrational thoughts and headache was not reported. This report was non-serious.
124AM ER visit for grand mal sx & 911 call; started 28OCT w/a fever (?)- 6PM 29OCT vomited once had a fever; temp in ER was 105; pt rechecked in office 31OCT94 viral exathem present; MD feels it was a viral illness (not related to MMR)
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 19-NOV-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L020189, expiration date: 03-JUN-2017) (incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Myalgia, Arthralgia, Fever, chills, swollen glands-symptoms lasted 5 days Narrative:
Patient is fully vaccinated.  COVID + 1/18/2022.  Admitted 1/24/2022.  71-year-old male who presented from nursing home with altered mental status and fatigue and weakness.He had received a monoclonal antibody infusion. He was found to have bilateral opacities and was started on antibiotics.  He is sedated and on vent. Acute ventilator dependent respiratory Failure.  Treatment:  remdesivir, decadron, HG 8.0. Currently on day 16 of hospitalization.
administered past the 30 day refrigeration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date refrigerated: 13-Apr-2021. Temperature changes (in F): 37-40.  No treatment medications were reported   This case was linked to MOD-2021-316323 (Patient Link).
1430-1630 severe upper arm pain, limited ROM, not able to abduct arm, 400 mg Motrin with minimal relief. 1730-2200 cont'd right arm pain (moderate to severe). Systemic overall aches, felt like being hit by a truck, severe chills, T 101.6. At 2200 took 800 Motrin, went to bed slept 4.5 hr woke up soaking wet. 0230 11/10/06 awoke, soaking wet, but felt better with chills were gone. I was finally able to move my arm around with moderate but not complete ROM. 11/10/06 slept most of day no energy, right arm from elbow to shoulder, complete circumference, including right side chest wall extremely sore and untouchable. Able to move arm though. 11/11/06 pain, soreness right upper arm slowly dissipating, 11/12/06 pain, soreness right upper arm almost gone. 11/13/06 pain completely gone in right arm.
pt presented 2 days post vaccination for ppd reading with erythema, edema, heat and site pain.  advised cold compress for 10m on and 10m off x4 hours today.  advised ibuprofen children's dose OTC one time and prn if symptoms persist.  advised to eat prior to dosage secondary to risk of stomach upset on an empty stomach.
Patient missed his second dose of his primary series; no adverse event; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Patient missed his second dose of his primary series) and NO ADVERSE EVENT (no adverse event) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Patient missed his second dose of his primary series) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Patient missed his second dose of his primary series) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Patient missed his second dose of his primary series).    No concomitant medication details was reported. No treatment medication details was reported.
Information has been received from a physician concerning a 3 month old patient who 12-DEC-2007 was vaccinated with a dose of Hib conj vaccine (OMPC). Subsequently the patient experienced some slight redness. They have not seen the patient since then. They are going to follow up with the patient. At the time of the report the patient's outcome was unknown. Additional information has been requested.
severe pain in my left ear; I have been in severe pain; This is a spontaneous report from a contactable consumer or other non hcp. A 67-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 03Mar2021 at 11:15 (Batch/Lot Number: EN6200) as dose 2, single for covid-19 immunisation. Medical history included Breast Cancer survivor. Concomitant medications included hydrochlorothiazide, triamterene (TRIAM TIAZIDA R) and hctz (HCTZ). The patient received first dose of BNT162B2 on 28Feb2021 (lot number EN6207, administration time 10:00 AM vaccine location Left arm) for covid-19 immunisation. The patient had no known allergies. The patient did not have Covid prior to the vaccination. The patient was not tested for covid post vaccination. The patient did not receive other vaccine in four weeks. On 25Mar2021 at 12:00 AM the patient experienced severe pain in my left ear and i have been in severe pain. Therapeutic measures were taken as a result of both the events. It was reported After the second vaccine, she started having severe pain in left ear and it was going on since March. She had a physical the following month and the doctor saw nothing, but she was given 800 mg IBUPROFIN, which did not help. She went to the ENT Doctor 2 times and they saw nothing. She tried over the counter ear drops for the pain and that did not work. That is when she went to the ENT Doctor which saw nothing but she gave her a prescription, which did not help. She went back to the ENT and saw a different doctor and he saw nothing, she has been in severe pain and do not know what to do. She had a physical last Tuesday and her Doctor mentioned that 3 other patients complained about the same issue. The events resulted in [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. The outcome of both the events was not resolved. Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a female patient of unknown age. Medical history and concomitant medications were not provided. On an unspecified date, the patient received ZOSTAVAX. The patient reported that she had "many problems" after receiving ZOSTAVAX.  She did not explain what "many problems" meant". The outcome of the "many problems" was unknown. Additional information is not expected as the patient did not provide contact information.
APPROXIMATELY 5 MINUTES AFTER VACCINATION PATIENT FAINTED.  PT RECOVERED WITHIN 30 SECONDS. PT WAS CLAMMY AND PALE FOR ABOUT 10 MINUTES.  PT RECOVERED AND FELT WELL AFTER ABOUT 30 MINUTES.  HER FATHER REQUESTED PARAMEDICS TO BE CALLED.  PARAMEDICS CAME AND CHECKED HER OUT.  PARAMEDICS CLEARED HER TO LEAVE IN JUST A COUPLE OF MINUTES.  PT WAS FEELING WELL WHEN SHE LEFT THE PHARMACY AREA.
Patient ambulating out of room and states to mother "I don't feel good". Patient immediately became pale and urinated on herself. Pt RR even and unlabored, eyes closed; ammonia used; pt immediately aroused and assisted to bed; during episode pt urinated on herself. VS WNL.
cold; hoarse voice; running nose; cough; bad headache; This is a spontaneous report from a contactable consumer (patient). A 72 (Unit: Unknown) female patient received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were not reported), via an unspecified route of administration on 06Mar2021 as a single dose for covid-19 immunisation. Medical history and concomitant medication were not reported. Patient had previously received first dose of vaccine. On an unknown date, patient experienced cold, hoarse voice, running nose ("like crazy"), cough, she also had a bad headache but it went away. The outcome of the headache was resolved and for other events was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
This spontaneous report was received from a certified medical assistant refers to an unspecified patients of unknown age. On an unknown date, the patients were vaccinated with unspecified doses of improperly stored PEDVAXHIB, M001813, 14-OCT-2018. No adverse events were reported. Temperature of 49.3 F for 24 hours and there was no previous temperature excursion. This is one of the 4 reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route not provided). No other co-suspect therapy was reported. Concomitant medications were not provided. The pharmacist reported that a patient told her that a different patient who had received ZOSTAVAX was now (approximately in October 2013) undergoing chemotherapy. At the time of the report patient's outcome was unknown. Additional information is not expected.
STROKES IN THE BRAIN; CLOTS IN THE HEART; SUSPECTED COVID-19 INFECTION; LUNGS WERE BAD; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer via a company representative via social media concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total (first dose) administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced strokes in the brain, clots in the heart, suspected covid-19 infection, lungs were bad, suspected clinical vaccination failure and on unspecified date, the patient was hospitalized for unspecified number of days. The reporter stated that; "my brother is in the hospital with strokes in the brain, clots in the heart, sick with C-19, his lungs are bad, they give very bad health news and his shot was from this company". The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from strokes in the brain, clots in the heart, suspected covid-19 infection, and lungs were bad, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000218419.; Sender's Comments: V0: 20220247928-COVID-19 VACCIN-strokes in the brain, clots in the heart, suspected covid-19 infection, and lungs were bad. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20220247928-COVID-19 VACCINE -suspected clinical vaccination failure. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 09-AUG-2013, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # H011417 and expiry date: 07-JUN-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
The patient did not experience any other adverse event; 6 month old patient received first dose of ROT ATEQ; This spontaneous report was received from a nurse via company representative and refers to a 6 (also reported as 7) month old female patient. The patient did not have any underlying health issues and was a full-term infant. Historical vaccine included birth dose of the hepatitis B vaccine (manufacturer unknown).      On 24-MAR-2021, the patient was vaccinated with a first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally, lot # 1742460, expiration date 16-NOV-2021, 1 dosage form, for prophylaxis.    Concomitant therapies included pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) and diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (PEDIARIX). The patient did not experience any other adverse event.
Dizziness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stroke.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant medications was not provided.  Treatment medications was not provided.  ER gave her Cat-scan, Blood work and cardiogram. No sign of stroke.   Reporter did not allow further contact
Patient received a first dose of Moderna on 2/26/2021. Patient unintentionally received a dose of Pfizer on 3/25/2021. Patient reported no signs or symptoms.
Student received Gardasil at 1500 on 4/2/07 - tolerated vaccine well - returned to dorm - subsequently passed out in dorm bathroom causing laceration to head.
Pt reports 3 weeks after her shot, she began feeling severe arm pain (throbbing). Was not present prior to this time. Pain is regional to injection site but radiates slightly.
Arm pain that happened right after vaccine was given and has continued for up to 1 month after and has not subsided.
This spontaneous report as received from a registered nurse refers to a 16 year old patient (gender unknown). On 31-MAR-2014 the patient was vaccinated with GARDASIL dose 2, intramuscular for vaccination (dose, lot# and injection site not reported). The patient was vaccinated with GARDASIL dose 1 at his/her nine years old (in approximately 2007). No adverse effects reported. Additional information is not expected.
Patient  presented in DKA. She received insulin and our 2 bag system. Her gap closed nicely and she was started on intermittent insulin. Her lantus was increased by endocrine to 31 units on day of discharge. She will be following up this week with endocrine team. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
pt recv vax 11DEC96 & 14DEC96 pt exp h/a, coughing, congestion, fatigue, eyes felt swollen & felt like had temp;pt has not yet recovered;
No additional AEs, no PQCs; ROTATEQ was administered in a temperature excursion.; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies/reactions or concomitant medications was not provided.  On 08-MAR-2023, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), administered orally for prophylaxis (lot #1892784 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 03-DEC-2023) (dosage, vaccination scheme, frequency, route of administration, and anatomical site of injection were not reported). The administered dose of the vaccine was stored at a temperature of 46.4 degrees Fahrenheit (F), for a time frame of 5 minutes, as recorded by a digital data logger. There was a previous temperature excursion reported as: 47.9 Fahrenheit (F),  There was no adverse effect reported.
inadvertently administered a YF-VAX to a severely immunocompromised patient with no reported adverse event; Initial information received on 27-Jul-2022 regarding an unsolicited valid  serious case received from a other health professional.  This case involves a 56 years old female patient who was inadvertently administered a yf-vax vaccine to a severely immunocompromised patient, while receiving vaccine YELLOW FEVER VACCINE - [YF-VAX].  At the time of event , the patient had an ongoing history of severely immunocompromised. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) for Immunisation; HEPATITIS A VACCINE INACT (HAVRIX) for Immunisation; and TYPHOID VACCINE POLYSACCH VI (TYPHIM VI) for Immunisation.  On 26-Jul-2022, the patient received a  dose of suspect YELLOW FEVER VACCINE ( lot UJ412AB and expiration date: 25-Nov-2022) at a dose of 0.5ml once via unknown route at unknown administration site for immunization.  On 26-Jul-2022 (latency: same day), the patient inadvertently administered a yf-vax ( Contraindicated product administered) to a severely immunocompromised patient that currently receives IV immune therapy following the administration of YELLOW FEVER VACCINE.  Action taken: not applicable  Outcome: unknown for the event   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
On awakening this morning this patient noted mild paresthesia involving left upper extremity possibly a portion of the left lower extremity as well.   Had been having some leg paresthesia recently.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/5/2022 HOSPICE CARE
joint pain, 2 days after vaccination, wrist, hands, ankles, knees and neck. swelling of right wrist