chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen lymph nodes on left side of neck the size of marbles day 6 until now; Headache for 5 days; This is a spontaneous report from a contactable consumer (patient).   This 47-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown), via an unspecified route of administration administered in the left arm, on 29Aug2021 at 09:00 (at the age of 47-year-old) at single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have a relevant medical history. The patient did not have known allergies. The patient did not receive concomitant medications. On 29Aug2021 at 15:00, the patient had headache for 5 days. On 04Sep2021, the patient had swollen lymph nodes on left side of neck the size of marbles. On unknown date, a sonogram was done but results were not provided. No seriousness criterion was provided. The events required physician office visit. Therapeutic measures taken as result of the events included steroids and painkillers. Pre-vaccination and post-vaccination COVID tests were not performed. The patient had recovered from headache in Sep2021 while she had not recovered from the other event.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Myalgia, Arthralgia, left arm soreness, redness, and swelling Narrative:
This non-serious initial spontaneous case, was received on 30-Aug-2017 from a pharmacist, concernng a 32-year-old adult female pregnant patient. The patient's medical history, concomitant medications and the contraceptive use were not reported. On 11-Aug-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, batch number: 1785503 (as reported), expiry date: Apr-2018, route of administration: intramuscular, anatomical location: not reported), explicitly coded as Vaccine exposure during pregnancy. It was reported that the patient was 39 weeks pregnant at the time of this report. The reporter stated that, adverse event had been reported in pregnant woman and in foetus. The outcome of the event was not reported. The reporter assessed the event as non-serious.
Information has been received from a medical assistant concerning a male patient with no allergies and no medical history who on 11-JUN-2001 was vaccinated with a first subcutaneous dose of varicella virus vaccine live (Oka/Merck) (Lot # 636575/1467K). There was no concomitant medication. The patient developed breakthrough chickenpox rash all over the body and was seen at the office on 16-APR-2007 for the diagnosis. No further information was available. Unspecified medical attention was sought. There were no laboratory or diagnostic tests performed. No product quality complaint was involved. Additional information has been requested.
Pt mom miss represented child age at offsite school clinic.  No way of knowing that was not the correct age at the time of  the immunization.  Incorrect date of birth was given.
no further ae reported; product storage error temperature too high; This spontaneous report was received from a nurse referring to a 66 years old, female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  The vaccine was improperly stored on 22-NOV-2021 and on 24-NOV-2021, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously, in the left arm (lot U020244, expiration date 28-JUN-2023) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneously, in the right arm (lot number T027914, expiration date 18-AUG-2022) (strength and dose were not provided for any vaccine).  The temperature of storage and time frame of the excursion were 6° to 14° Fahrenheit (F) for 10 minutes and 14° to 46° F, for 3 hours respectively.  If a digital data logger was involved was not reported.  No adverse event.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2201USA003515:
2 hrs subsequent to vax, pt began persistent vomiting & became pale, limp & non-responsive; pt was taken to ER & admitted & dx w//hyporesponsive collapse, gastroenteritis & dehydration due to a react to immun, probably pertussis;
baseball sized localized swelling, redness, and pain at the injection site 48 hours post injection
This spontaneous report as received from a healthcare worker refers to a unspecified number of neonate patients of unknown gender. The patient's concurrent conditions and medical history were not reported. It was reported that on an unspecified dates, prior to child's birth, nurse's leave RECOMBIVAX HB at room temperature before the vaccine was administered (unknown strength, route and dose). No adverse effects were reported. Concomitant medications were not reported. The outcome of the event was unknown. Additional information is not expected as the reporter did not wish further contact.
After receiving Janssen covid vaccine at 10:45, patient reported feeling lightheaded and weak at 10:47am. Patient lowered to the ground safely, alert and oriented, state has Hx Vasovagal response s/p vaccine injections and blood draws. Patient alert throughout the episode, laying flat on the ground with leg elevated, initial B/P 88/60 HR 50, R 18, O2 sats 98-99% ra. Orange juice and cookies provided to patient, ate and drank and stated felt better. Repeat VS: B/P 92/64 HR 65 R 18 O2 98-99%.Dr at the patient site, patient observed for 30 minute- patient felt he's at his baseline and d/c home, no distress noted. Re-evaluated by Dr, BP on/dc 102/72.
the 54 years old patint received gardasil 9.; patient had a prescription from his doctor; Information has been received from a pharmacist via company representation referring to a 54 year old male patient. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. The patient had a prescription from the doctor(product administered to patient of inappropriate age and product prescribing error).
Patient indicated that she had swelling in the armpit following the injection and sit was still present today 5/14.
Information has been received regarding a case in litigation for PROFECIA (MARRS # 1404USA007875) form a physician via medical records concerning a male patient (age not reported), non-smoker, who had reported at an office visit on 10-NOVEMBER-2011 that he received additional "Hep B vaccine" (Hepatitis B Vaccine (Recomninant)) (manufacturer not specified) (No date(s) of vacciantion(s) were reported) after he came up with "negative surface antibody" and now wishes to be retested to see whether that has converted, for example (i.e) to verify immunity status. No further information is available. All available medical records will be provided upon request.
Redness; Swelling; This case was reported by a nurse via sales rep and described the occurrence of erythema in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced erythema and swelling. On an unknown date, the outcome of the erythema and swelling were unknown.   The reporter considered the erythema and swelling to be related to Bexsero.  Additional details were provided as follows: The patient experienced redness and swelling. The reporter agreed to follow up from GlaxoSmithKline (GSK).
A report had been received from a literature source via regulatory authority, vaccine adverse event reporting system (VAERS) concerning an adult, female subject, who had been receiving FLUMIST (intranasal). FLUMIST (intranasal) started on an unknown date. There was one report of vaginal discharge with cramps after receiving QLAIV3 during pregnancy. The outcome of the event of pregnant patient received LAIV3, vaginal discharge and cramps is unknown. The reporter's description of the event(s) was as follows: There was one report of vaginal discharge with cramps after receiving QLAIV3 during pregnancy. The report was considered to be non-serious. Based on the information in this report, and awaiting the reporter's assessment, the company physician considered the causality between the events pregnant patient received LAIV3, vaginal discharge and cramps with the suspect drug of FLUMIST to be unrelated.
Within minutes of getting the injection, became faint with a severe drop in blood pressure.  Under observation at the site by Health professionals for 50 minutes.  On leaving the facility, on the 15 minute drive home, had some tongue swelling and other indications of anaphlyaxsis, so drove directly Hospital ER.  They suggested fluids and prescribed Benedryl and waiting nearby.  When symptoms did not worsen, left and arrived at home around 2 p.m.  Now 24 hours later, still some swelling of tongue and tinnitus, along with site soreness and dizziness.
Information has  been received from a physician referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 26-OCT-2015 the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # L008031 with expiration date of 03-AUG-2016; strength, dosage and frequency) orally. No adverse symptoms were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Rt. shoulder with redness and swelling a day after inj. lasted approx 2-3 days.
No adverse effect reported; improperly stored vaccines were administered into an unknown number of patients; This spontaneous report as received from a medical assistant referring to a female patients of unknown age. Information about pertinent medical history, concurrent condition, drug reaction/allergy and concomitant medication was not provided.  On 20-JUN-2019, the patient was vaccinated with improperly stored doses varicella virus vaccine live (oka/merck) (VARIVAX) (lot # N023960, expiration date 01-SEP-2019; vaccine dosage detail and route of administration were not reported) for prophylaxis. The storage temperature of varicella virus vaccine live (oka/merck) (VARIVAX) was 9 Celsius degrees to 25 Celsius degrees for 15 minutes. There was no previous temperature excursion reported. No adverse effects was reported. No product quality complaint (PQC) was involved in this case. Digital data logger was involved.; Sender's Comments:  US-009507513-2005USA003625: US-009507513-1911USA003982: US-009507513-2005USA003619:
Initial report received from a health care professional on 06 Oct 2010: This patient was received only a intramuscular dose of MenA liquid conjugate component of MENVEO (batch number 024011) powder and diluent on 30 Sep 2010. He had not received the MenCYW-135 liquid conjugate component of MENVEO. The outcome of the event was not reported.
A few days after my vaccine I had a slight fever and started to feel weak and out of my body, I started to feel fatigue, off  balance and dizzy for about two weeks. Then that I saw the doctor and he sent me for a CT Scan and it came back clear with no strokes. I still feel fatigue and off balance at time. I then noticed a weird change in my menstrual cycle it is now ten days early or twice a month now. They did some blood work and see high platelets in my count.
Patient presented with syncope immediately following that administration of Janssen vaccine. Vaccination nurses helped patient to the floor where consciousness was restored without aid. Patient appeared pale and diaphoretic. BP 95/60 HR 56. EMS was called at 18:03 when symptoms did not resolve. Patient was helped back into chair.  EMS arrive at 18:10 - BP 100/60, HR 66, SpO2 98%, blood glucose 107, 12 lead EKG SR 66 18:16 BP 110/86 HR 67 Patient reported last food/drink was 6 hours prior to vaccine Patient reported history of anxiety and syncope with vaccinations Patient refused transport to hospital
Arms are slightly sore; Nauseated; I am not able to be lie down; I am totally prone but if I stand up it hurts again; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 11Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 11Mar2021, outcome "unknown", described as "Arms are slightly sore"; NAUSEA (non-serious) with onset 11Mar2021, outcome "unknown", described as "Nauseated"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 11Mar2021, outcome "unknown", described as "I am not able to be lie down; I am totally prone but if I stand up it hurts again".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
/Vaccination administered on 12/30/2020 Experienced soreness for about 24 hours post vaccination which cleared.  01/07/2021 itching, redness and site was  warm to touch. 01/ 09/2021 contacted my MD.  Recommended Zyrtec and hydrocortisone (working diagnosis: delayed allergic reaction-asked to contact her if not better, may be developing a cellulitis) 01/09/2021 took Zyrtec 01/10/2021 took Zyrtec and applied hydrocortisone 01/11/2021 work up with tingling in the arm . Contacted MD. waiting on response. Took 1  zyrtec.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: about 5 min after vaccine pt stated feeling nauseous, vision loss, felt cold, body went limp, eyes rolled back and pt was found collapsed on the ground. She did no hit her head. 1st BP 83/66 HR 83, 10 min later 2nd BP 97/79 HR 80. After 30 min of monitoring pt stated feeling better and was able to leave with no side effects
Pt was given MMR, VARIVAX, Hep A 11/14/14. Pt was inadvertently given MMR, VARIVAX, Hep A 12/19/14.
This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Patients are not immunocompromised, receiving a 0.5ml booster dose instead of a 0.25ml booster dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: J&J Vaccine (one dose). Past adverse reactions to the above products included No adverse event with J&J Vaccine. In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In December 2021, the patient experienced ACCIDENTAL OVERDOSE (Patients are not immunocompromised, receiving a 0.5ml booster dose instead of a 0.25ml booster dose). At the time of the report, ACCIDENTAL OVERDOSE (Patients are not immunocompromised, receiving a 0.5ml booster dose instead of a 0.25ml booster dose) outcome was unknown. Concomitant medications were not reported. Patient was not immunocompromised. Treatment information was not reported. This case was linked to MOD-2022-511255 (Patient Link).
PT HAD WANTED SHINGRIX NOT THE MODERNA VACCINE- NO EVENTS AT ADMINISTRATION EXCEPT PATIENT BEING UPSET THAT RECEIVED MODERNA INSTEAD OF SHINGRIX
This spontaneous report as received from a pharmacist referring to a patient of unknown age who was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported) on 13-MAR-2012 and following the vaccination (when the needle was removed from patient's arm) part of a dose leaked out and ran down the patient's arm. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Additional information is not expected.
THROAT SWOLLEN; This spontaneous report received from a patient concerned a male 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 and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced throat swollen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of throat swollen was not reported. This report was non-serious.
100 DEGREE FEVER, NAUSEA, SWOLLEN PAINFUL ARM, HOT TO TOUCH.
The patient had completed a Covid Johnson and Johnson immunization on 3/5/21. They presented to  to request Covid Pfizer vaccine. The patient did not disclose that they had received the J&J vaccine and it was not caught by checking the   immunization registry. They were given a duplicate vaccination series.
Chills, sweats, severe body aches, headache, fevers, diarrhea,  severe pain and swelling under left arm, fatigue, nausea
Worse headache; Chills; Fever; Body ache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Worse headache), CHILLS (Chills), PYREXIA (Fever), MYALGIA (Body ache) and FATIGUE (Fatigue) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Cholesterol. Concomitant products included PRAVASTATIN for an unknown indication.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever), MYALGIA (Body ache) and FATIGUE (Fatigue). On 15-Mar-2021 at 4:00 AM, the patient experienced HEADACHE (Worse headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at a dose of 2 Advil. On 14-Mar-2021, CHILLS (Chills), PYREXIA (Fever), MYALGIA (Body ache) and FATIGUE (Fatigue) had resolved. At the time of the report, HEADACHE (Worse headache) outcome was unknown.
Two weeks after my first dose of the GARDASIL, I started not feeling good. I became extremely irritable and exhausted. This continued and intensified after my second dose. By the time I received the third dose of GARDASIL, my hair was starting to fall out of my head, I was getting joint pain and muscle aches, moods were worsening, and my periods were getting worse. A year after my initial dose of GARDASIL I went back to the doctor and she ran tests for thyroid disease, anemia, etc. to attempt to pinpoint where this was coming from. All the results came back as normal. Five months later symptoms were still heightened. I was sent to an OBGYN where I was then diagnosed with Pre-Menstrual Dysphoric Disorder, put on birth control pills, sertraline and sent to cognitive behavioral therapy. Two years later I am back at the doctors since symptoms still haven't gone away. We did more testing and received normal results. I was the diagnosed with Chronic Fatigue Syndrome since there was no explanation for my muscle aches/joint pain, moods, and hair falling out of my head at only 14 years old. Still to this day, since the first dose of GARDASIL six years ago, I still feel horrible and my symptoms have started affecting my ability to carry out daily activities in my life, with no explanation as to why.
patient received the vaccines then sat down for the 15 minutes.   pt stated that his stomach was really hurting and that he was having ulcer problems the past few weeks and that it was acting up in the am.  He said it was not the vaccines but requested and ambulance about 5-10 minutes after receiving the vaccines.
The pt developed redness and swelling on left thigh (14cm x 14cm) for twodays after DTaP administration.
She was vaccinated on 3-15-06 between 4-6:00 pm.  Mom reported that within 1 hr patient began screaming non-stop for 4 1/2 hr.  Also patient developed a rash from her neck to her ankles - the description of this varies.  Three and a half hours after start of symptoms patient was taken to medical center.  They gave her one dose of Benadryl and Tylenol and sent her home in 4-5 hrs.  Mom continued Tylenol for 24 hrs.  Mom gave us the history.  Story is very scattered and changeable.  When I called mom for info for the VAER's report she also reported patient's half sister had a reaction to MMR.  This story goes that sister was given an MMR.  Within 20 min she had a temperature of 103-104.  Also in 10 min she developed a rash.  She was taken to medical center and admitted for 1-2 days.  Now she can't have chickenpox vaccine because of egg allergy - "But" - she may have recently had the chickenpox vaccine.  All her immunizations were administered at health department and mom says no report was filed.  I did call health department and they reviewed record and found she did have both the MMR and Chickenpox vaccines previously.
No adverse effects reported; The patient received VAQTA on 07-DEC-2010/the patient received a booster dose of VAQTA on 23-MAY-2011; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 12-JUL-2010, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (lot #, expiration date, route, dose and frequency were not reported) for prophylaxis.   It was also reported that, on 23-MAY-2011 (reported as "14 days early"), the patient received a booster dose of hepatitis a vaccine, inactivated (VAQTA) (lot # 0124AA has been verified to be a valid lot number, reported expiration date was 12-DEC-2013, but upon internal validation established as 12-FEB-2013; route, dose and frequency were not reported) for prophylaxis.   No adverse effects were reported. No product quality complaint (PQC) was involved.
My arm was sore at the injection site; My arm was red at the injection site; My arm was swollen at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (My arm was sore at the injection site), VACCINATION SITE ERYTHEMA (My arm was red at the injection site) and VACCINATION SITE SWELLING (My arm was swollen at the injection site) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21B and 043L20RT) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (My arm was sore at the injection site), VACCINATION SITE ERYTHEMA (My arm was red at the injection site) and VACCINATION SITE SWELLING (My arm was swollen at the injection site). At the time of the report, VACCINATION SITE PAIN (My arm was sore at the injection site), VACCINATION SITE ERYTHEMA (My arm was red at the injection site) and VACCINATION SITE SWELLING (My arm was swollen at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment medications was reported.   This case was linked to MOD-2021-422585 (Patient Link).   Reporter did not allow further contact
Shingles on R forehead, w painful tingling, erythematous patch w papular lesions.  Seen in Urgent Care 28 Sep, ER 10/4/21.