chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID Disease 2 months after 2nd booster; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID Disease 2 months after 2nd booster) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054A22A, 032L20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2022, the patient experienced COVID-19 (COVID Disease 2 months after 2nd booster). At the time of the report, COVID-19 (COVID Disease 2 months after 2nd booster) had resolved.            No Concomitant medication was reported. No treatment information was provided.  Company comment: This spontaneous case concerns a 73-year-old male patient with no medical history reported, who experienced the adverse event of special interest of COVID-19 2 months after the fourth dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 73-year-old male patient with no medical history reported, who experienced the adverse event of special interest of COVID-19 2 months after the fourth dose of mRNA-1273. Information regarding clinical evaluation, diagnostic tests and treatment provided has not been disclosed. Outcome was reported as resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Heavy flushing coming over her; Lightheaded; Dizzy; General feeling of being unwell; The injection site was red; Injection site the size of a quarter; Injection site spread to the size of a coffee can lid; It looked bruised; She wondered if she had cellulitis; the lymph nodes in injection site were swollen; A Spontaneous report was received from  Non healthcare professional concerning a 59 year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced lightheaded, dizzy, fast heart rate of 80-90, The injection site was red, Injection site the size of a quarter, lymph nodes in injection site were swollen  The patient's medical history, as reported include Have had anaphylaxis shock with chemo allergic reactions.fibromyalgia - muscle ache every day, nausea, Diabetic. Low vit D and concomitant medications Cyclobenzaprine, Pioglitazone 30mg a day, Probiotic daily, Atorvastatin, Benadryl when needed, Colestipol two a day, Losartan potassium, Metformin 1000 two a day, Nebivolol at night, Vit D3, Tylenol or Aleve if needed.  On 14 JAN 2021, the patient received their one dose of the two planned doses of COVID-19 Vaccine (mRNA-1273) intramuscularly in the left arm for prophylaxis of COVID-19 infection and had a reaction to the first dose that thinks it maybe an allergic reaction. Within a couple of minutes, she felt like a heavy flushing coming over her. She stayed for 30 mins to get checked up and then went away. She also felt lightheaded and dizzy and had a fast heart rate of 80-90. She had a general feeling of being unwell. These went away in an hour, and she is used to feeling like that and nauseous. She usually has vertigo episodes The injection site was also red and the size of a quarter, but then it spread to the size of a coffee can lid. For the next 10 days it kept getting lighter, maybe because she is fair skinned, it looked bruised. She wondered if she had cellulitis. Also, the lymph nodes in injection site were swollen.   No treatment information is provided  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event is resolved/recovered
Information has been received from a nurse practitioner concerning an 11 week old female patient with no pertinent medical history, drug reactions/allergies, who on 13-APR-2010 was vaccinated orally with the first dose of ROTATEQ (Lot No. 664945/0147Z), 3 days later (on 16-APR-2010) the patient had small vomiting along with blood that occurred twice on the same day. The patient sought medical attention at office visit. The patient had hemoglobin and guaic (hemoccult) laboratories performed (results not reported). On 23-APR-2010, the patient recovered. Follow up information has been received which reported that an 11 week old female patient with no pre-existing allergies, birth defects or medical conditions, who on 13-APR-2010 at 14:40, was vaccinated orally with the first dose of ROTATEQ (Lot No. 664945/0147Z). There was no illness at the time of vaccination. It was reported that 3 days after the vaccine was ingested the patient vomited blood twice (reported as on 23-APR-2010, also reported as on 16-APR-2010 by the nurse practitioner), at 14:00. The outcome of the patient was recovered soon after the doctor visit. Additional information is not expected.
pt recvd 3 doses of Engerix-B; titer drawn p/exposure, seronegative; recvd 4th dose of Engerix-B-2nd titer drawn, still neg;
Information has been received from a health professional concerning an 18 year old female patient for a VARIVAX (Merck), a Pregnancy Registry product. The patient has a history of no previous pregnancies and 0 live births. On 22-JAN-2013, the patient was vaccinated with a dose of VARIVAX (Merck), 0.5 ml, lot # reported as H017133, route not provided. The patient became pregnant with LMP estimated on 17-SEP-2012 and EDD of 24-JUN-2013 (method of confirmation not reported). Initial exposure to VARIVAX (Merck) was at 18 weeks. Laboratory tests included ultrasound on 16-NOV-2012 (reason: "dating"; result unknown) and varicella antibody test on 15-JAN-2013 (negative). Additional information was received regarding lot # H017133 for VARIVAX (Merck) which has been verified as valid lot number. Additional information was received from the nurse. Reporter details were updated. The nurse reported that the VARIVAX (Merck) was administered by the pediatric department of her facility. She did not know who the provider was at the pediatric department. Follow up information as received from a Certified Nurse-Midwife refers to the 18 year old female patient with no previous pregnancy. The patient became pregnant with LMP of 23-SEP-2012 (previous reported 17-SEP-2012) and EDD of 30-JUN-2013. On 15-JAN-2013 the patient was tested for varicella antibodies and the results showed negative. On 22-JAN-2013 the patient was vaccinated with VARIVAX (Merck) (lot number H017133). It was unknown if there were any local reaction at vaccination site, and if there were any varicella symptoms/Herpes zosters symptoms post vaccination. The patient did ultrasound test on 25-MAR-2013, 29-APR-2013 and 31-MAY-2013 due to varicella exposure and the result revealed choroid plexus cyst. Patient did not performed amniocentesis and Maternal Serum Alpha-Fetoprotein (MSAFP). Additional information has been requested.
pt was here for his third dose of the vaccination and was given the pfizer instead of the mondera shot
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 7-month-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004950: US-009507513-2005USA004951: US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004972: US-009507513-2005USA004973: US-009507513-2005USA004974: US-009507513-2005USA004975: US-009507513-2005USA004976: US-009507513-2005USA004977: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004982: US-009507513-2005USA004983: US-009507513-2005USA004984: US-009507513-2005USA004985: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004990: US-009507513-2005USA004991: US-009507513-2005USA004992: US-009507513-2005USA004993:
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received SHINGRIX (batch number B9739, expiry date 22nd November 2020) for prophylaxis. On 18th June 2018, the patient received the 1st dose of SHINGRIX. On 19th June 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, pain in arm, chills, fever and swelling arm. On an unknown date, the outcome of the injection site pain, pain in arm, chills, fever and swelling arm were not recovered/not resolved. The reporter considered the injection site pain, pain in arm, chills, fever and swelling arm to be almost certainly related to SHINGRIX. Additional details were provided as follows: The health care professional reported that a patient received the 1st dose of SHINGRIX on 18th June 2018 and experienced pain at the injection site and upper arm, swelling of the arm, fever and chills. The reactions started on 19th June 2018, the patient called the pharmacy and reported the symptoms on 23rd June 2018. The patient had seen the physician on 24th June 2018. The symptoms had not resolved till the date of reporting. No additional information was provided.
Headache; Low temperature (100); Myalgia; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 06Apr2021 at 11:30 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included prostate cancer and COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other medication within two weeks prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 09:00, the patient experienced headache, myalgia and had low temperature (100). On that day, the patient underwent body temperature test and the result was 100 (units unspecified). The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. 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 headache, myalgia and low temperature (100) was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a 58 year-old male physician referring to himself. The patient did not have concurrent conditions, medical history, drug reactions or allergies or concomitant medications. On an unspecified dates in 1986 and 1987, the patient was vaccinated with 3 doses of Hepatitis B Vaccine (Recombinant) (manufacturer unknown) injection (dose, frequency, route, lot # and expiration date were not reported), for prevention of hepatitis B. On an unspecified date in March 2015 (reported as "2 years ago"), the patient had a hepatitis B titer test with "positive titers" as result. The outcome of the adverse event was unknown. No product quality complaint was involved (PQC). The causality between the adverse event and Hepatitis B Vaccine (Recombinant) (manufacturer unknown) was unknown. Additional information has been requested.
Dose 2: Moderna/Dose 3: Pfizer; headache; sore throat and lymph nodes along jaw line swell and hurt; sore throat and lymph nodes along jaw line swell and hurt; sore throat and lymph nodes along jaw line swell and hurt; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Nov2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic Fatigue Syndrome" (unspecified if ongoing); "chronic myofascial pain" (unspecified if ongoing); "POTS" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: moderna (Dose Number: 1, is bivalent: False, Batch/Lot No: 002B21A, Location of injection: Arm Left), administration date: 10Mar2021, when the patient was 50-year-old, for COVID-19 immunization; moderna (Dose Number: 2, is bivalent: False, Batch/Lot No: OUDB21A, Location of injection: Arm Left), administration date: 10Apr2021, when the patient was 50-year-old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 29Nov2021, outcome "unknown", described as "Dose 2: Moderna/Dose 3: Pfizer"; HEADACHE (non-serious) with onset 29Nov2021, outcome "unknown"; OROPHARYNGEAL PAIN (non-serious), LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 29Nov2021, outcome "unknown" and all described as "sore throat and lymph nodes along jaw line swell and hurt". Additional information: headache 9 minutes after shot (has happened with every mRNA vaccine), 25 minutes after shot - sore throat and lymph nodes along jaw line swell and hurt has happened 30 min after 3rd. The patient did not receive any other vaccines in four weeks. covid prior vaccination and covid tested post vaccination was reported as no.  Follow-up attempts are completed. No further information is expected.
moment shot recv site started to swell like a large boil-given 2 claritene; next day green & multi-colored bruise;
Fever of 102 for 3 or more days, wheezing, Low O2 sat, cough
Pt had onset of sxs to include dizzy/tremors/"jerkiness"/"yellow vision" x 30 minutes. All started within 2-12 hours after vaccine.
Hot flashes, nausea, vomiting, fever, severe headache, joint pain particularly in hands and feet, dizziness, fatigue, injection site hot, warm and raised w/ itchiness, developed rash on trunk and lower extremities and back of head and neck after 24 hours -fever resolved after 60 hrs.   -vomiting onset after 48 hrs -joint pain resolved after 72 hrs still having headaches, fatigue and nausea with vomiting after 5 days
All 11 of the 12 listed.  Also shot is still swollen and itching; All 11 of the 12 listed.  Also shot is still swollen and itching; This is a spontaneous report from a contactable Other HCP(Patient). A 72-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number: unknown), via an unspecified route of administration on 05Mar2021 at 10:00 administered in Arm Left as a single dose for COVID-19 immunisation at Hospital. Medical history included Lung cancer, COVID-19 (all from an unknown date and unknown if ongoing). Concomitant medication(s) included levothyroxine sodium (THYROXINE) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Post vaccination, the patient has not been tested for COVID-19. The patient had no allergies. On 05Mar2021 at 19:00 PM, the patient experienced all 11 of the 12 listed. Also shot is still swollen and itching. No treatment was given for the events. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information received from a health care professional concerning a female who was exposed to her daughter who was vax with one dose of varicella virus live. Subsequently the pt developed greater than 25 lesions but less than 50 approximately 22 days after her daughter was vaccinated with varicella. The mother had no known exposure to wild type chickenpox. The child did not have a post vax rash. Twenty one days after the child's vax, the mother developed a fever of 102 nausea, vomiting, and pruritus all of which lasted approximately 5 days.
four patients who present with symptoms of hyperthyroidism after receiving SARS-CoV-2 mRNA vaccine; This is a literature report for the following literature source(s):  An adult female patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Graves disease" (unspecified if ongoing), notes: in remission remission for longer than 3 years, and presented. The patient's concomitant medications were not reported. The following information was reported: HYPERTHYROIDISM (medically significant), outcome "unknown", described as "four patients who present with symptoms of hyperthyroidism after receiving SARS-CoV-2 mRNA vaccine". The patient underwent the following laboratory tests and procedures: Blood thyroid stimulating hormone: positive, notes: range 6.21-11.87 IU/L.  Clinical Information: Four patients who present with symptoms of hyperthyroidism after receiving SARS-CoV-2 mRNA vaccine. All were females, median age 49 (range 44-59). Two patients have previously had diagnosed Graves disease in remission for longer than 3 years and presented after 40-60 days after receiving SARS-CoV-2 mRNA vaccine. All four patients had TSH receptor antibodies positive.; Sender's Comments: Based on the information provided, and a temporal association, a causal association between reported events hyperthyroidism and suspect BNT162B2 cannot be excluded.This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300081270 Same article/drug/event and different patient;
Swelling in both eyelids and mouth, started at about 8:00, intensified until 4:00am. Treated with prednisone for the next two days.
The patient did not wake up on 31-Oct-2019; Initial information received on 07-Nov-2019 regarding an unsolicited valid non-serious case received from a physician..  This case involves a 19 month old male patient who did not wake up on 31-Oct-2019 (Hypersomnia), while he received vaccine influenza quadrival A-B vaccine [Fluzone Quadrivalent].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza quadrival A-B vaccine (lot UT6647JA, pre-filled syringe) via unknown route in unknown administration site.  On 31-Oct-2019, the patient did not wake up (hypersomnia), unknown latency following the administration of influenza quadrival A-B vaccine.  Other lab tests were not reported.  Final diagnosis was hypersomnia.   It was not reported if the patient received a corrective treatment.  The outcome of the event was not reported.
Severe itchiness, started the day of and has continued a week later I am still itchy everywhere
Shortness of breath started around 12 hours after vaccination. Took aspirin.  Stayed awake in sitting up position until about 5 am. Fell asleep sitting up. Woke at 7:30 am shortness of breath was gone. Will not receive 2nd dose! Other symptoms that where expected, headache, fatigue, flu like feeling, painful injection site. All symptoms gone in 48 hours
There is no adverse event reported by the patient. The only complaint of the patient was that the injection site of  the vaccine in his left arm was sore and painful.
Angioedema  Narrative: Patient claims that his throat is closing up after the vaccine, but is able to speak normally and POX is 99 at this time visit.
body aches; chills; headaches; cold feet and hands; injection site was sore; fatigue; This case was reported by a other health professional and described the occurrence of general body pain in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number PR5B2, expiry date 8th November 2021) for prophylaxis.   On 1st August 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 1st August 2020, less than a day after receiving Shingrix, the patient experienced general body pain, chills, headache, cold feet, injection site pain and fatigue. On an unknown date, the outcome of the general body pain, chills, headache, cold feet, injection site pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the general body pain, chills, headache, cold feet, injection site pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received the dose of Shingrix and experienced severe body aches, chills, headaches, cold feet and hands at night, her injection site was sore and she had fatigue.  These side effects started the same day that she received the vaccination. The patient spoke with the physician on 26th August 2020, and she explained that her side effects had improved. The reporter consent to follow up.