chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reaction/allergies were reported. On 12-MAY-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L035276 and expiration date 09-JUN-2017) (strength, dosing details and anatomical location were not reported). No adverse effects were reported. No product quality complaint was involved. This is one of the several reports reported by the same reporter. Additional information has been requested.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was called back to the clinic and vital signs were taken and were within normal limit. No signs and symptoms of any distress was present and when patient was asked if he had signs and symptoms he denied any at that time.  No concomitant medications was provided.  No treatment medications was provided.   This case was linked to MOD-2021-391981 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: IRD of the follow up version is 19-Nov-2021 but taken as 23-Nov-2021 due to Argus limitations owing to the IRD being 23-Nov-2021 of the initial version. patient detail and dose number was updated.
fever; chills; slight nausea; headache; loss of appetite; tiredness; This is a spontaneous report from a contactable consumer (patient) other non-healthcare professional. A 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 19Feb2021,01:45 PM (age at vaccination: 28), in left arm as dose 2, single for COVID-19 immunization. The patient's medical history included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 27Jan2021, 02:15 PM (age at vaccination: 28), in left arm as dose 1, single for COVID-19 immunization. No concomitant medication was reported. Known allergies reported as no and other medical history reported as none. The patient reported no other vaccines taken in four weeks and no other medication taken in two weeks. Patient reported no covid prior vaccination and not tested for covid post vaccination. On 19Feb2021, 05:00 PM Within 3 hours of vaccination, experienced tiredness and felt ok on next day, then the patient had fever, chills, slight nausea, headache, loss of appetite, and tiredness. No treatment was taken. The clinical outcome of all events were recovered on 21Feb2021.   No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
No additional adverse events; the patient was inadvertently administered a dose of MMR II , that was expired; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies were not reported.  On 04-DEC-2019 the patient was inadvertently administered a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot # N032757, expiration date 20-NOV-2019; dose was not reported) via subcutaneous for prophylaxis, which was expired (expired product administered). No additional adverse events.
Tested positive with a rapid test on 11/10/2021 during a community outbreak of COVID-19.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EN6205) at the age of 46 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing); "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: TIROSINT taken for thyroid disorder. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Information has been received from a registered nurse concerning an over 6 years old male who on approximately 21-JUL-2008 was vaccinated with a second dose of VARIVAX (Oka/Merck) (lot # 660219/0154X) (route and administration site not reported).  Concomitant therapy included other vaccines (unspecified) which were not administered at the same site.  Within hours of the shots the patient experienced a reaction of "unusually large swelling, redness and fever at the injection site".  The swelling worsened the day after the vaccination.  His sister received VARIVAX (Oka/Merck) from the same lot and had no adverse event.  The patient sought medical attention by calling the doctor.  Additional information has been requested.  This is one of several reports from the same source.
29AUG94 pt had Td shot lt delotid pt had sensation of zing; pt devel tightness & ache lt neck, lt shoulder & lt upper arm; soreness of lt upper arm has persisted;
Information has been received from a physician concerning a female patient who was vaccinated on an unspecified date with a dose of Gardasil.  One month after the dose, the patient developed a grand mal seizure.  The patient sought unspecified medical attention.  The reporter was unsure if this was the patient's first or second dose of the vaccine.  At the time of the report the patient's outcome was unknown.  No product quality complaint was involved.  Upon internal review, grand mal seizure was considered to be an other important medical event.  Additional information has been requested.
administered 1st dose 09/30/2022 and 2nd dose 10/04/2022; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a patient who received HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On 4th October 2022, the patient received the 2nd dose of Engerix B. On 4th October 2022, unknown after receiving Engerix B, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 05-OCT-2022 Reporter's comment: Medical assistant administered 1st dose of Engerix B on 30th September 2022.  HCP was unable to provide any additional detail. Adverse event contained all information provided. The reporter consented to follow up. Additional Supportive Information: The patient received 2nd dose of Engerix B earlier than the recommended interval, which led to shortening of the recommended interval between vaccine doses.
Experienced crying and anxiety all day since vaccination. Unable to focus on task, seems confused and broke out with red blotches the day vaccination was received and the blotches continue to appear everyday sine that time. Allergy medication is given to help with the itching and it resolves but reappears once medication wears off.
bad irritation all day long; her arm was very, very itchy / very itchy all night long; red bandage mark / arm was all red; arm with a rash; hurting under her armpit / feels uncomfortable under the armpit / it bothers her under the armpit / armpit hurts when it´s touched; can feel something in the lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of SKIN IRRITATION (bad irritation all day long), PRURITUS (her arm was very, very itchy / very itchy all night long), ERYTHEMA (red bandage mark / arm was all red), RASH (arm with a rash) and AXILLARY PAIN (hurting under her armpit / feels uncomfortable under the armpit / it bothers her under the armpit / armpit hurts when it´s touched) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 047B21A and 016E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced SKIN IRRITATION (bad irritation all day long), PRURITUS (her arm was very, very itchy / very itchy all night long), ERYTHEMA (red bandage mark / arm was all red), RASH (arm with a rash), AXILLARY PAIN (hurting under her armpit / feels uncomfortable under the armpit / it bothers her under the armpit / armpit hurts when it´s touched) and LYMPH NODE PAIN (can feel something in the lymph nodes). At the time of the report, SKIN IRRITATION (bad irritation all day long), PRURITUS (her arm was very, very itchy / very itchy all night long), ERYTHEMA (red bandage mark / arm was all red), RASH (arm with a rash) and LYMPH NODE PAIN (can feel something in the lymph nodes) outcome was unknown and AXILLARY PAIN (hurting under her armpit / feels uncomfortable under the armpit / it bothers her under the armpit / armpit hurts when it´s touched) was resolving.            It was reported patient date of birth.   The patient is not on any concomitant medication. No treatment was given.  On 29Jan2022, patient stated that arm pain was not too bad, but while touching her armpit it hurts, and when she was moving the arm she could feel something in the lymph nodes.   This case was linked to MOD-2022-465645 (Patient Link).
Information has been received from a physician concerning a patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient experienced an allergic reaction (rash) at injection site. It was unknown whether medical attention was sought. The patient's outcome was not reported. No product quality complaint was involved. Additional information has been requested.
SOME TERRIBLE J AND J SHOT; This spontaneous report received from a consumer via a company representative concerned multiple patients. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. 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 some terrible j and j shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of some terrible j and j shot was not reported. This report was non-serious. This case, from the same reporter is linked to 20220802964.
Patient reported by phone message that he had "severe arm pain and headache". That arm was immobile for 36 hours.
5 minutes, post vax 1st Anthrax, left upper extremity was "numb". Then developed pain in mid-arm with spreading to left shoulder and left elbow with minimal swelling at site. Hand swollen but held down. Left upper extremity not used due to pain (no weakness noted). 48 hours, later, hand is normal.
Vaccine was administered to the patient after 13+ hours when the recommendation is to administer in a 12 hour period after vial puncture.  No adverse events reported at the time.
Hours after flu vaccine administered, developed diffuse eczematous rash that persisted months after vaccine given. Rash comes and goes.
Information has been received from a licensed practical nurse concerning a 20 year old female patient who in June 2008, was vaccinated with the first dose of GARDASI, lot # was not reported. It was reported that the patient became pregnant with twins and had a miscarriage about one week ago. Patient was hospitalized. LMP was 25-JUL-2008. Additional information has been requested.
About 3 minutes after vaccination while seating patient said that he fills that he is going to faint.  911 was called by the stuff. Second later  his eyes rolled his and started shaking.  In a few minutes he came back and said he fills better. EMS arrived checked his vitals. Hi seemed fine, refused to go to the hospital. Eventually he left after sitting for 30 more min saying he is fine.
Chills, significant body aches, tired. This started about 12 hours after the shot and continued for approximately 24 hours. I had the same reaction the first time I got the shot but since I was prepared for it and quickly took Ibuprofen, it was not as bad. However, I had to take Ibuprofen regularly during the period to feel even halfway decent.
pt recv vax 3NOV97 & 12DEC97 pt devel a rash;
This spontaneous report as received from a physician refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route, lot# and expiry date were not reported) for prevention of shingles. After the patient was injected she had a large local reaction approximately 15-20cm in diameter. It was reported that the patient has recovered (unknown date). The physician believed that the local reaction was nothing to much to be concerned with. The physician felt that was a normal event sometimes associated with the ZOSTAVAX. Additional information is not expected because there is no permission to contact a physician.
7 - 14 days, post vax, the pt developed skin lesions at spots other than the injection site. Unspecified medical attention was sought. Additional information has been requested.
Possible TIA.  Two minutes of combination of not being able to get words out along with speech not making sense.
This spontaneous report as receievd from a pharmacist refers to a newborn male patient of unknown age. On 30-OCT-2012 13:53, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a pharmacist and refers to a 45-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reaction or allergies were not reported. On 17-FEB-2017, the patient received a dose of GARDASIL 9 injected intramuscularly (dose, anatomical location, lot # and expiration date were not reported) for prophylaxis. There were not known any adverse effects. No product quality complaint (PQC) was involved. Additional information has been requested.
Chills Fever 101.8  was the highest averaged 100.8 from 8:30 AM Thurs-3 AM Fri Headache Muscles Aches I have experienced Chills a fever with vaccines before but NEVER have my hands and feet been so cold. Took Aleve prior to receiving vaccine Wed Afternoon. Took 2nd Aleve at bedtime.  Walked like normal at 6:15 AM Thursday. I went down hill from there.  By 8:30 the chills and fever set in. Took Aleve and Benadryl . Went to bed with heated rice packs for the 1st time in my life. I could not get my hands and feet warm .  Switched to Ibuprofen Thurs  night and took a 2nd Benadryl at bedtime. Very tired.
Sudden onset of shortness of breath early morning 3/15/2021. EMS called, transported patient to Adventist to ER code blue in asystole. Asystole on arrival, no response to resuscitative efforts, pronounced dead in ER.
Injection was given into the bursa of my left shoulder. The injection was given too high and was very painful, causing burning in my shoulder and all the way down my arm and into my hand.  The following days since, I have constant pain that wakes me up at night and the pain is severe with certain movements, restricting my range of motion.  I saw dr. and he diagnosed me with bursitis.  I have been told to take anti inflammatories as needed and that if things don't improve, I can get a steroid injection.  This has really affected my work and home life, seeing that I am a bedside nurse and a mother of two young and active children.
Patient developed itching and a rash over the majority of her body including scalp within 5-10 minutes of administration of the vaccine.  We administered 25 mg. diphenhydramine liquid by oral route and continued to monitor the patient for 30 minutes.  We contacted the patient's primary provider who stated they would see the patient.  The patient chose to be seen at a walk-in clinic.
On 10/22/2022, I had head and face congestion and my lungs felt tight. Similar to asthma symptoms that I had my whole life. I attempted to use my inhaler, but my inhaler was not helping, I decided that it probably wasn't just my asthma, so I decided to take a COVID-19 home test pm 10/23/2022. The result was immediately positive. I called my doctor the next morning, 10/24/2022.  The doctor thought I should take Paxlovid. And called in the prescription. I felt almost 100 percent back to normal after 3 doses.
did not have second dose; contracted shingles; pain is minimal; itching cab be very distracting; the problem is in the nerves; numbness; can be too itchy to sleep through; This case was reported by a consumer via other manufacturer and described the occurrence of shingles in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In January 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In March 2020, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles, pain, pruritus, nervous system disorder, numbness and sleep disturbance. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the shingles, pain, pruritus, nervous system disorder, numbness, sleep disturbance and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles, pain, pruritus, nervous system disorder, numbness and sleep disturbance to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Contracted shingles March 2020. These six weeks of shingles had taught me at least one thing.  You could wear a pair of pants amazingly low, even with the top button undone, without them falling down.  The shingles extended down patients left hip, so this was a very practical effect.  The patient still had the shingles, but the pain was minimal at this point.  It was clearly going away, but slowly. My shingles seem to have stalled at almost healed.  The pain was negligible, but the itchiness could be very distracting.  At this point, itching was not painful, either, but itching did not work because the problem was in the nerves.  According to patient's physician the virus had been gone for at least a month.  Tomorrow was 8 weeks.  The last two weeks had been easily bearable.  Very little pain two weeks ago and pretty much none now.  The patient had a little numbness and my side could be too itchy to sleep through.  Showers help, so might be Ipatient need to take two a day, one in the morning for the day, and one in the evening for the night. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Patient received less than intended amount of 0.3 mL.  The vaccinator did not draw up the vaccine correctly, creating a large bubble in the barrel, leading to an underdosage of vaccine.  No symptoms.  Patient is being notified today by our physician to come and receive another dose per recommendations.
Incorrect needle length was used to administer IM vaccine. (5/8 inch was used instead of 1 inch). Patient has no adverse effects
Pt recvd Engerix-B w/in a few hrs p/the vax pt exp chest tightness, numbness, tingling in hands, & a poss allergic rxn; pt went to ER where events were tx w/DPH; pt discharged from ER & is improving;
spent 3 days, being comatose; having suicidal thoughts; confused; sad, depressed; weak; tired, fatigued; dizzy; Initial information received on 01-Oct-2023 regarding an unsolicited valid serious case received from a consumer/non-hcp (non-healthcare professional).  This case involves an unknown age and unknown gender patient who had spent 3 days, being comatose, having suicidal thoughts, confused, sad, depressed, weak, tired, fatigued and dizzy after receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 27-Sep-2023, the patient received a dose of suspect influenza quadrival A-B high dose HV vaccine (lot number, strength, expiry date, formulation, dosage - not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation). Information on the batch number was requested.  In 2023, (latency- few days approximately), the patient spent 3 days, being comatose (coma), having suicidal thoughts (suicidal ideation), confused (confusional state), sad, depressed (depressed mood), weak (asthenia) , tired, fatigued (fatigue) and dizzy (dizziness) following the administration of influenza quadrival A-B high dose HV vaccine.  Reportedly, I got this flu shot 4 days ago. sanofi advertisers on TV how wonderful it is to get a flu shot and that everyone should get one and you might just have a little bit of a sore arm after the injection. What you don't advertise is that people such as myself, after getting the injection, spent 3 days, being comatose, confused, tired, sad, depressed, having suicidal thoughts, weak, fatigued and dizzy.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for all the events.  Seriousness criteria: medically significant for the events coma and suicidal ideation.; Sender's Comments: Sanofi company comment dated 07-OCT-2023: This case involves an unknown age and unknown gender patient who had spent 3 days, being comatose, having suicidal thoughts, confused, sad, depressed, weak, tired, fatigued and dizzy after receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent]. Based upon the reported information, the role of a vaccine cannot be assessed. Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses and concomitant medications.
Since I received the Moderna vaccine first dose I have felt physically exhausted. It?s been 8 days and I do not feel well yet.
insidious onset, rash, called on 27SEP; rash on trunk & neck fussy, no fever, MMR rash, sxs MMR rash; seen 28SEP rash on extremities, welts in places like hives, NAD, multi-form, erithematous, no vesicles, mouth clear, afeb