chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 5-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-009507513-2005USA004968: 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-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004990: US-009507513-2005USA004991: US-009507513-2005USA004992: US-009507513-2005USA004993:
This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender, who on 23-FEB-2015 received a dose of ZOSTAVAX, 0.65 ml, subcutaneous, but the patient was prescribed to receive VARIVAX (Merck). No adverse events were reported. Additional information has been requested.
patient had clear mucus production which caused heavy coughing. She also felt a bit nauseous. She didn't have any other symptoms.
ARM AND FEELING FEVERISH, BLURRED VISION, TIRED (OF COURSE) ARM IS STILL HURTING AND SCARED OF GETTING SECOND DOSE BUT WANT TO.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 29Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 57 years, in left arm for covid-19 immunization; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "dysthymia" (unspecified if ongoing). Concomitant medication(s) within 2 weeks of covid vaccine included: LEVOTHYROXINE oral; NP THYROID oral; BUPROPION oral. Past drug history included: Tetanus toxoid, reaction(s): "known allergies: Drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of covid-19 with Paxlovid via oral route from 11May2022 to 15May2022 and had Rebound symptoms with positive Abbott rapid antigen test requiring re-isolation on 20May2022.; Sender's Comments: Based on the information in the case report, a causal association between reported events and suspect BNT162B2 is possible.
body aches; fatigue; sore ''armpit''; This is spontaneous report from a contactable consumer (Patient) reported for himself. A male patient of unspecified age received second dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced body aches, fatigue, sore ''armpit'', all on an unspecified date with outcome of unknown. Event took place after use of product.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
EXPIRED VACCINE ADMINISTERED ON 26-AUG-2021 (VACCINE WAS EXPIRED ON 24-AUG-2021); This spontaneous report received from a health care professional concerned a 25 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 (suspension for injection, route of admin not reported, batch number: 1805031 expiry: 24-AUG-2021) dose was not reported, administered on 26-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-AUG-2021, the patient experienced expired vaccine administered on 26-AUG-2021 (vaccine was expired on 24-AUG-2021). The action taken with covid-19 vaccine was not applicable. The outcome of expired vaccine administered on 26-AUG-2021 (vaccine was expired on 24-AUG-2021) was not reported. This report was non-serious. This case, from the same reporter is linked to 20210931951, 20210931982, 20210932036, 20210931810, 20210932240, 20210932593, 20210932567, 20210932874, 20210933076 and 20210933129.
This spontaneous report as received from a nurse practitioner refers to a 4 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 08-JAN-2015, the patient was vaccinated with the dose of PEDVAXHIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
On April 8th at 4am, I woke up feeling a strong pain in my heart / esophagus region. I was alone and out of town and didn't know what to do, so I just sat in the hotel bed and waited for morning to come. I didn't know if i was having a heart attack or if it was gas from drinking soda the previous day. I went to work. At work, the left side of my tongue suddenly started swelling and a tingling and numbness set in my upper lip. I was very scared, rushed to the drugstore and bought GasX, Ricola drops (my throat was slightly sore, too) and Allegra 24 hours. I immediately took the Allegra pill but still went to the hospital. When getting to the parking of the hospital, though, the anti-allergic started kicking in and the tongue started getting back to normal, so I went back to work and didn't enter the hospital. I was ok for a while. Hours later, rashes started showing all over my body. Starting in my arms then under my breasts. On the night of the 8th, I even had fever and chills. Still, I had to go to work so it was a real nightmare. I also had diarreah. I then went to the drugstore again and also bought regular and night Advil, lots of water and electrolytes drink, Peptobismol and Benadryl (only Allegra was not enough). The following day, April 9th, the rashes started spreading all over my body, the fever was only being controlled by Advil. I flew back to Miami and was bedridden until the April the 11th. On the night of April the 11th I still woke up with very strong headache and on the 12th spent the day with a headache, but since have gotten better.
12/30/22 presents to ED for "breathing problem". PMHx of "Parkinson's disease"
Numbness on left side of face, chin, behind ear, around eye, and inside of mouth.
PATIENT HAD A SORE ARM AND WAS RED AND SWOLLEN, DECIDED TO GO TO THE EMERGENCY ROOM ON SATURDAY. 2 DAYS AFTER THE INJECTION.
Rash developed 1/2 hr - 1 1/2 hrs after administration.
Feeling sore; Dizzy; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Feeling sore) and DIZZINESS (Dizzy) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Feeling sore) and DIZZINESS (Dizzy). At the time of the report, PAIN (Feeling sore) and DIZZINESS (Dizzy) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Mild chest pain; Body ache; Low grade fever (101°F); Head ache; Welt on the arm at the injection site about a week after being vaccinated; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Mild chest pain), MYALGIA (Body ache), PYREXIA (Low grade fever (101°F)) and HEADACHE (Head ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No relevant medical history provided).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHEST PAIN (Mild chest pain) (seriousness criterion hospitalization), MYALGIA (Body ache) (seriousness criterion hospitalization), PYREXIA (Low grade fever (101°F)) (seriousness criterion hospitalization), HEADACHE (Head ache) (seriousness criterion hospitalization) and VACCINATION SITE SWELLING (Welt on the arm at the injection site about a week after being vaccinated). At the time of the report, CHEST PAIN (Mild chest pain), MYALGIA (Body ache), PYREXIA (Low grade fever (101°F)), HEADACHE (Head ache) and VACCINATION SITE SWELLING (Welt on the arm at the injection site about a week after being vaccinated) outcome was unknown.        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.   The patient has no know history of COVID (had 2 negative tests; no antibody test was completed).   Concomitant product use was not reported. Treatment medication included dexamethasone which relieved the symptoms for a while. However, at the time of this report on 07-Apr-2021, the caller was on the way home from taking the patient back to the ER (emergency room) for the symptoms.  This case concerns a female of unknown age hospitalized with serious unexpected events of chest pain, pyrexia, myalgia, headache, and expected vaccination site swelling. Event onset with unknown latency after first dose mRNA-1273. Treated with dexamethasone. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a female of unknown age hospitalized with serious unexpected events of chest pain, pyrexia, myalgia, headache, and expected vaccination site swelling. Event onset with unknown latency after first dose mRNA-1273. Treated with dexamethasone. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 12-NOV-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.9 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L028666, exp. date: 04-NOV-2016) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
slight rash that became red and itchy; slight rash that became red and itchy; some soreness and pain in the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (some soreness and pain in the injection arm), RASH ERYTHEMATOUS (slight rash that became red and itchy) and RASH PRURITIC (slight rash that became red and itchy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (some soreness and pain in the injection arm). On 27-Jan-2021, the patient experienced RASH ERYTHEMATOUS (slight rash that became red and itchy) and RASH PRURITIC (slight rash that became red and itchy). At the time of the report, PAIN IN EXTREMITY (some soreness and pain in the injection arm) and RASH PRURITIC (slight rash that became red and itchy) outcome was unknown and RASH ERYTHEMATOUS (slight rash that became red and itchy) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included lotion.
Child vomited and then late developed red blotches all over body. The next morning the red blotches are still present and a little more along with swollen face and eye. Child was given Benadryl.
This spontaneous report was received from a pharmacist referring to a 78-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were unknown by the reporter. On 19-SEP-2018, the patient was vaccinated with PNEUMOVAX23 (the dosage regimen information was not reported) lot # N025384 (expiration date: 19-APR-2019) for prophylaxis. On that same date, a few hours after vaccination, her arm was red, swollen, warm to touch extending down to her elbow. No treatment was provided to the patient. On 21-SEP-2018, the patient went to the pharmacist and it was found that the patient's arm was still swollen but it was getting better. No causality assessment was provided.
headache, fever, listless, aches in back, arms, legs, upset stomache, burning eyes occured soon after still continuing after 24 hrs
injection site swelling; injection site knot; skin tightening; extreme soreness; fever; headaches; fatigue; blotchy redness; injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (injection site swelling), INJECTION SITE ABSCESS (injection site knot), SUBCUTANEOUS ABSCESS (skin tightening), PAIN (extreme soreness) and PYREXIA (fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE SWELLING (injection site swelling), INJECTION SITE ABSCESS (injection site knot), SUBCUTANEOUS ABSCESS (skin tightening), PAIN (extreme soreness), PYREXIA (fever), HEADACHE (headaches), FATIGUE (fatigue), RASH MACULAR (blotchy redness) and INJECTION SITE ERYTHEMA (injection site redness). At the time of the report, INJECTION SITE SWELLING (injection site swelling), INJECTION SITE ABSCESS (injection site knot), SUBCUTANEOUS ABSCESS (skin tightening), PAIN (extreme soreness), PYREXIA (fever), HEADACHE (headaches), FATIGUE (fatigue), RASH MACULAR (blotchy redness) and INJECTION SITE ERYTHEMA (injection site redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment details included Took ibuprofen for symptoms the first day, then switched to Tylenol 500mg x 2 B.I.D.   Reporter did not allow further contact
Tired, chills, headache , sore throat, horrible runny nose, sneezing, coughing, horrible body aches.
Bed ridden in pain for 40 hours. Was then sick for 14 days with fatigue/lethargy  Secondarily - extreme menstrual cycle each month for the last two cycles - extreme bleeding, and extreme duration.
sore arm, fatigue, mild headache, some slight chills, malaise.  Sore arm immediately afterwards and other symptoms in the later evening, thru the night and in the morning on 4/1/2022
Hit me in the sinuses and my eyes were hurting, It felt like a head cold a real bad head cold. I went to get checked they offered antibodies and I did not want to go to the hospital, a few days later it hit me hard I got really fatigued and broke out into sweats.
Patient denied any allergies or reactions to medication prior to vaccination. Patient received COVID-19 Moderna vaccination. 5 minutes after receiving vaccination patient c/o swelling tongue, tingling in mouth, shortness of breath, and dizziness. After assessing patients tongue, noted swelling and administered 0.3mg auto-injector epinephrine. 911 was called and ambulance was dispatched.  After about a minute or two after epi patient's tongue was not as swollen and it was easier for patient to breath. Patient still had burning and tingling of the mouth and throat. Patient then made us aware that has had to have epi after an influenza vaccine and was also hospitalized a couple weeks ago for a medication reaction.  Patient was taken by ambulance to local ER. Full outcome unaware at this time.
NO POWER TO GET OUT OF BED; FEELING TERRIBLY BAD; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 12-APR-2021, the subject experienced feeling terribly bad. On 13-APR-2021, the subject experienced no power to get out of bed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling terribly bad, and no power to get out of bed. This report was non-serious.
pt recvd vax & devel redness, inc warmth, tenderness at inject site;
nausea and vomitting, refusing food and drink (clear liquid diet initiated as well as zofran), covid test - negative, IV fluids initiated, 1 gram Rocephin given to right deltoid Vitals 11/13/2021 BP- 94/64, PULSE-79, RESPIRATIONS-18, TEMP-99F, O2 92%
Swollen lymph nodes, under arm, neck, pelvic area.; Left arm pain is so bad "I" am unable to sleep; Left arm pain is so bad "I" am unable to sleep.; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 07Mar2021 at 13:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medications included zolpidem tartrate (AMBIEN), buspirone (MANUFACTURER UNKNOWN), sertraline hydrochloride (ZOLOFT) and pantoprazole sodium sesquihydrate (PROTONIX); all for unknown indications from unknown dates and unknown if ongoing. On 08Mar2021 at 00:00, the patient experienced swollen lymph nodes, under arm, neck, pelvic area and left arm pain was so bad that the patient was unable to sleep. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not 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 swollen lymph nodes, under arm, neck, pelvic area and left arm pain was so bad that the patient was unable to sleep was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient presented to the ED on 2/18/2021 with nausea and vomiting and was subsequently admitted for gastroenteritis. Patient presented to the ED on 3/5/2021 and was diagnosed with a lung infection, was subsequently admitted. These visits are within 6 weeks of receiving COVID vaccination.
already nine months from my first shot; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose nine months ago in 2020.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follow: The patient was the reporter. The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.