chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness from the deltoid injection site that extended to the elbow; This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number 275KY, expiry date unknown) or (batch number P7HK7, expiry date unknown) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the injection site erythema to be related to FluLaval Quadrivalent.   Additional details were as follows: The age at vaccination was not reported. Patient received FluLaval Quadrivalent with batch number either P7HK7 or 275KY. It was reported that the Immunization Consultant from the Immunization Program provided a high-level overview. It was reported that one clinic site got call and patient reported that after he vaccination with FluLaval experienced redness that extended from the leg injection site to the knee. It was stated It is possible that these were administration technique errors and not related to vaccine product quality. They are currently evaluating the administration technique and retraining. This case is one of the 4 cases reported by same reporter. The reporter did not consent to follow up. It was unknown, which batch number reported for which case, hence both batch number added in subtab.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR189451:Same Reporter US-GLAXOSMITHKLINE-US2020AMR189448:Same Reporter US-GLAXOSMITHKLINE-US2020AMR189418:Same Reporter US-GLAXOSMITHKLINE-US2020AMR189450:same reporter
This case was reported by a pharmacist and described the occurrence of fever of 103 in an adult subject of unspecified gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date in 2012 the subject received dose of FLULAVAL (.5 ml, details unknown). On an unspecified date in 2012, less than one year after vaccination with FLULAVAL, the subject experienced fever of 103, gastroenteritis and dehydration. The pharmacist considered the events were clinically significant (or requiring intervention). The subject required medical attention at the emergency room. The subject was treated with intravenous fluid(s) at the emergency room and was discharged home. At the time of reporting the outcome of the events was unspecified. The pharmacist also reported two other subjects experienced events after receiving FLULAVAL (see case ids A0996177A and A0996178A for more details).
Left Axcillary pain and swelling with, moderate lymph node tenderness. Pain Grade 7/10. Discomfort developed during the late night following injection.
Breakthrough case admission after 2 vaccines Pfizer 4/2/21 lot# EN6207  Pfizer 4/22/21 lot# Ew0150
Resident passed on  3/23/2021. Resident continues to decline medically. 2/22  He was admitted to nursing home with worsening pressure injury.
The pt developed chicken pox on hands and legs (over 50), vesicular and fever by touch.
This spontaneous report was received from a health care worker referring to multiple unspecified patients. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with an improperly stored doses PROQUAD which had lot # L050910, expiry date: 14-JUN-2017 and lot # M004894, expiry date: 26-JULY-2017 (strength, dose and route not reported). No adverse effects reported. No product quality complaint (PQC) involved. No further information reported. This is one of several reports received from the same reporter. Additional information has been requested.
High fever; High headache; Feeling like coming down with the flu; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age (age 68 unit unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 24Feb2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, as single dose for COVID-19 immunization and did not have any kind of reaction or anything. The patient reported that after receiving the second dose of vaccine on an unknown date in Feb2021 she experienced high fever, headache and feeling like coming down with the flu. The reporter wanted to ask if it was normal. The patient did not have lot number at the time of report in hand since she has her granddaughter, so she said she will have to call back. The outcome of the events was unknown.   Information about lot/batch no. has been requested.   Follow-up attempts completed. No further information expected.
Patient received vaccines on 08/07/07; on 08/09/07 patient woke up with rash spreading from trunk toinner thighs and face.  Swelling to face noted. Primary notified and Benadryl ordered and given by parent.
Patient returned to the pharmacy on 2/1/20 in the afternoon to report that he was unable to lift his arm due to it being so sore from his Shingrix shot on 1/26/20. He reports that it felt like the shot was given pretty high up on his arm - and from my perspective it appears it was injected too high, which is causing the symptoms he is experiencing. I encouraged him to go get checked out by a doctor either at urgent care or his primary care doctor.
At about 10:00pm the same day, all of my joints began hurting and it escalated to brain fog, memory loss. I suffered from severe stomach cramps. About 3 weeks ago I experienced a hypertensive crisis with blood pressure of 260/140 I believe.  I felt pressure on my chest and was really weak. I was admitted to the hospital for 2 days. Hypertension medications. I have renal stints and they did check to see if that was ok. Currently I am being monitored. I am still having symptoms like severe memory loss, brain fog and joint and muscle pain. I had to quit my job because I do not have the energy to work. I have seen my family physician regarding this also.
erythema, edema, warmth 5cm x 7cm around inj site @ 18 hr p/vax of rt upper extremity;increasing erythema, edema, warmth 42 hr to 16cm x 13cm;devel fever to 102 @ 18hr p/vax;dec use of arm on 1st day p/vax
No additional AE; The nurse reported the patient received improperly stored vaccines; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 15-MAR-2022, the patient was vaccinated with an improperly stored of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) for prophylaxis (lot # U026217 has been verified to be a valid lot number haemophilus b conjugate vaccine (meningococcal protein conjugate), expiration date reported and establish as 02-NOV-2023) (strength, dose, route of administration and anatomical location were not provided).   The temperature of storage and time frame of the excursion were 34.3° Fahrenheit (C) for 55 minutes respectively.  If a digital data logger was involved was not reported.  The vaccine did not experience a previous temperature excursion.  No adverse event reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA001821: US-009507513-2204USA001816: US-009507513-2204USA001791:
This spontaneous report was received from a nurse, refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-JUN-2016, the patient was vaccinated with expired M-M-R II lot # K012472, expiry date 11-JUN-2016, .5 ml, subcutaneous. No adverse effects were reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further information provided. Additional information has been requested.
3:31 PM.  Client complained of increased hear rate within one minute after receiving Covid 19 vaccine.  Client reports "felt his heart was racing".  Client alert and talking without difficulty.  Denies difficulty breathing and denies tightness in throat.  BP 183/105 and Pulse 100.  Client complained of heart racing.  Approximately 3:50 PM BP 147/101 and Pulse 92.  Discussed calling 911 with client and he stated was not sure he wanted us to call.  Client reports "I just feel weird". RN consulted with Nursing Supervisor and Dr. with decision to call 911.  RN called 911. Informed client he can decline transport to emergency room if needed.  Client reports he does not have insurance.  EMT arrived.  BP by EMT at 4:10 pm 162/92 Pulse 95.  Client declined transport to emergency room for evaluation.  Client referred to local Health Department and insurance application started. At 4:36 pm client reports he's feeling better and requests to return home.  BP 170/85 Pulse 85.  client reports he feel he can drive home without problems.  Application for insurance pending  at health department.  Client released. Addendum: Initially client denied feeling anxious after vaccination but later admitted he was nervous about getting a shot.
Her arm was a little sore; The soreness at the injection site lasted 2 days; This is a spontaneous report from a contactable consumer reporting for herself. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration (arm left) on 08Dec2020 (lot unknown) at SINGLE DOSE; and second dose via an unspecified route of administration on 06Jan2021 at SINGLE DOSE (lot number EJ1685) for COVID-19 immunization. The patient medical history was not reported. The patient was taking unspecified concomitant medications (same medications that she usually takes and has not started anything new). Patient reported that she was fine after the first shot. Her arm was a little sore on Dec2020 and that was it. The soreness at the injection site lasted 2 days and then recovered completely. She has no breathing difficulties or anything similar. Outcome of the event "Her arm was a little sore" was unknown while recovered for " The soreness at the injection site lasted 2 days" on Dec2020.
Diarrhea beginning later in the day after receiving the shot.  Reports about 5 episodes a day, one sibling with similar symptoms 3 days after.  Neither ate anything unusual  I tried to reassure mom but she is convineed that the sx are due to the vaccine.
Hemodialysis; dizziness and seizure secondary to uremia 1 week after vaccination
pt vaxed w/no problems; was walking around office & collapsed; did not lose consciousness; pt was pale, listless & cyanotic around the mouth; episode lasted 5 to 10 minutes; recovered w/no residual sequelae; dx as hypotonic-hyporesponsive ;
Tested positive for COVID on12Sep2021; Tested positive for COVID on 12Sep2021; Tested positive for COVID on12Sep2021; This is a spontaneous report from a contactable other health care professional (patient). A 60-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number: EL3247, Expiration Date: not reported) via intramuscular route of administration, administered in right arm on 21Jan2021 at 14:30 as dose 1, single (at the age of 59 years) and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number:EL3247, Expiration Date: not reported) via intramuscular route of administration on 21Jan2021 as dose 2, single (at the age of 59 years) at Workplace clinic for covid-19 immunisation. The patient medical history included hypertension. The patient concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient received other medication in two weeks. The patient was not diagnosed with COVID-19 prior vaccination. The patient was not tested for COVID-19 since the vaccination. The patient had no known allergies. On 21Jan2021, the patient was administered two doses of bnt162b2 (Inappropriate schedule of vaccine administered). On 12Sep2021, the patient was tested positive for covid. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 12Sep2021. The patient did not receive any treatment for the reported adverse event. Outcome of the event covid-19 was recovering.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be completely excluded.
pt recv vax NOV76 & has had & cont to have various medical conditions & illness;
Pt recieved a booster dose of COVID -19 and dad had indicated after vaccine was given that pt may have rceived elsewhere.
My symptoms began with sneezing, congestion, coughing and fever of 101.5.  I was vomiting and had aches, pains and a headache.  I tested positive for COVID-19 on March 1, 2023.  I began taking Paxlovid.  I recovered pretty quickly.  The only symptom I have had is diarrhea and a bit of a cough regularly.
Aches, chills, fever, sore throat, running nose, short of breath, almost fainted, fatigue, & nausea
Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: ONSET OF ADVERSE REACTION REPORTEDLY WAS WITHIN ABOUT AN HOUR AFTER RECEIVING THE VACCINE. PATIENT REPORTED ITCHY RASH NOT RESOLVING TO PHARMACY; PLANS TO TAKE 50MG OF BENADRYL AND TRACK RESPONSE AFTER SHE ARRIVES HOME TODAY.
itch on face and arm; sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itch on face and arm) and INJECTION SITE PAIN (sore at the injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included METHOTREXATE and OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced PRURITUS (itch on face and arm) and INJECTION SITE PAIN (sore at the injection site). At the time of the report, PRURITUS (itch on face and arm) and INJECTION SITE PAIN (sore at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
sleeping a lot; sore arm; Nauseas; headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Dec-2021 and was forwarded to Moderna on 04-Dec-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (sleeping a lot), PAIN IN EXTREMITY (sore arm), NAUSEA (Nauseas) and HEADACHE (headache) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Blood pressure high.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced HYPERSOMNIA (sleeping a lot), PAIN IN EXTREMITY (sore arm), NAUSEA (Nauseas) and HEADACHE (headache). At the time of the report, HYPERSOMNIA (sleeping a lot), PAIN IN EXTREMITY (sore arm), NAUSEA (Nauseas) and HEADACHE (headache) outcome was unknown.            Concomitant medications included for Diabetes and High blood pressure medications.  Company Comment: This case concerns a 55 year-old male patient with a history of diabetes mellitus and high blood pressure who experienced the unexpected adverse event of special interest of hypersomnia which occurred at an unspecified date relative to vaccination with mRNA-1273 vaccine. The medical history of diabetes mellitus remains a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed as per Regulatory Authority reporting.   This case was linked to MOD-2021-404776, MOD-2021-404788 (Patient Link).; Sender's Comments: This case concerns a 55 year-old male patient with a history of diabetes mellitus and high blood pressure who experienced the unexpected adverse event of special interest of hypersomnia which occurred at an unspecified date relative to vaccination with mRNA-1273 vaccine. The medical history of diabetes mellitus remains a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events' seriousness assessed as per Regulatory Authority reporting.
After reconciling the clinic's inventory and lot number, it was noted patient received a diluted dose (diluted with 1.3mL of normal saline) of the adult vial (0.2mL injected, 10-20mcg of diluted adult vaccine likely administered). She did not suffer from any adverse reactions nor an increased immune response, therefore no treatment needed.
I had an outbreak of hives, no treatment was given. I now have a reaction to the sun, once I am exposed to the sun for longer than 15-20 minutes I have a reaction to the sun. I break out wherever I have been exposed by the sun in small, itchy, red patches. I was prescribed a steroid cream to help with the irritation.
Patient describes sore tendons/joints and says whole arm hurts to move for 8 days now. Explained to patient to try NSAIDS and cold ice packs on arm.
I have slight swelling and pain in the armpit of my left arm started the next day of Pfizer booster dose and continuing on the Day 2 as well. I took  2 capsules of Tylenol on 14Dec as well as 15Dec but not much effect. I am also feeling a bit hot but no fever.
Sleeplessness; This is a spontaneous report from a contactable Other-HCP (patient). A 65-years-non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6201) via an unspecified route of administration in Arm Left on 22Feb2021 as single dose for covid-19 immunization. Facility type vaccine was School or Student Health Clinic. Patient medical history was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid-19 prior to vaccination. The patient was tested for COVID-19 since the vaccination. Historical vaccination included first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Not reported) via an unspecified route of administration in arm right on 01Feb2021 at 10:00 as single dose for covid-19 immunization. Concomitant medication included vitamin D nos (VITAMIN D NOS) and vitamin B nos (VITAMIN B NOS) within 2 weeks of vaccination. The patient has allergies to sodium lauryl sulfate. It was reported that Sleeplessness starting about 8 days after shot two. Not consuming any caffeine or alcohol. Adverse event date was reported as 27Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 test (Pcr test): negative on 24Feb2021. Patient didn't receive any treatment for event. Outcome of the event were not recovered.  No follow-up attempts are possible. No further information is expected.
chest pain; Chest tenderness; feeling of fluttering In Chest; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), MUSCULOSKELETAL CHEST PAIN (Chest tenderness) and CHEST DISCOMFORT (feeling of fluttering In Chest) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pain), MUSCULOSKELETAL CHEST PAIN (Chest tenderness) and CHEST DISCOMFORT (feeling of fluttering In Chest). At the time of the report, CHEST PAIN (chest pain), MUSCULOSKELETAL CHEST PAIN (Chest tenderness) and CHEST DISCOMFORT (feeling of fluttering In Chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications or treatment details were reported.
it was rpt pt recv 1dose varivax & subsequently exp ``possible breakthrough''  in add pt exp ``another virus (had foot mouth virus), not breakthrough w/varivax''
Chest pain (left side) when breathing, flushing, dizziness, and difficulty breathing. BP within normal limits. Patient stabilized and left for home.
Patient contacted this pharmacy that she had the immunization at earlier today. Patient called and stated that she was sweating and felt agitated. I went through the "what if there is a serious reaction" section of the Vaccine information sheet that she had a copy of.  I recommended starting 25 mg of BENADRYL and taking TYLENOL (suggested dose on box) every 4 hours. I let her know if the reaction got worse that she could contact her Doctor, Urgent care or Emergency room. I let her know about the Vaccine Adverse event reporting system and told her she could contact it and we would try to as well from our end.
Problems with menstrual cycle, scanty menses, late menses, skin conditions, acne outbreak on shoulders, chest, face, and other random areas. Skin rashes, shingles hive, and discoloration.
I'm breastfeeding my 14 month old son. A couple of days after I received my first dose of the moderna vaccine, he broke out in red spots all over his body. A few days later, he developed a low grade fever. It's been one week since I was vaccinated. He does not have a fever anymore and the red spots are almost all gone. I will pump and dump after the next dose for the days and see if he has any reactions when I resume breastfeeding.
0.25 inch blister formed with fluid at the injection site. No fever, no itching, no redness at injection site.
Patient received DTaP vaccine as 11 year old who had received 5 previous DTaP vaccines. Should have received Tdap vaccine.
Patient feels weak; Mouth ulcers (it's hard to eat, drink and talk according to her); Body aches; Nausea; A spontaneous report was received from a consumer concerning a 30-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events patient felt weak, body aches, mouth ulcers and nausea.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 2 Feb 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 2 Feb 2021, the patient felt weak, had body aches, mouth ulcers, nausea. It was hard to eat, drink and talk due to mouth ulcer.  Treatment details included lidocaine gel.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of events patient felt weak, body aches, mouth ulcers and nausea were unknown.