chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Slight pain in the left arm where vaccine was given i; This is a spontaneous report from a contactable consumer (Patient) or other non-HCP.  A 61-years-old male received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, on 22Feb2021 at 11:30 (age at the time of vaccination was 61-years-old) as DOSE 1, SINGLE dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient had no other vaccines in 4 weeks and no other medications in 2 weeks. The patient did not have COVID-19 prior to vaccination and was not been tested for COVID-19 post the vaccination. On 22Feb2021 (at 20:00), the patient experienced Slight pain in the left arm where vaccine was given i. The clinical outcome of the event was not recovered.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Received pneumonia vaccine (poly 23) on 2-21-12 in (L) delt. States chest pain began 2 hrs later. Went to E.R. EKG - tachy. (L) arm redness also c/o headache, dizziness. Ice applied to arm TID x 3 days - labs OK - chest pain resolved 2-22-12 will defer anymore PNEUMOVAX.
flu like symptoms; extremely soreness at injection site; body aches; pain; 101 fever,; red area around breast bone; fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE PAIN (extremely soreness at injection site), PAIN (body aches), PAIN (pain) and PYREXIA (101 fever,) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE PAIN (extremely soreness at injection site), PAIN (body aches), PAIN (pain), PYREXIA (101 fever,), ERYTHEMA (red area around breast bone) and FATIGUE (fatigue). On 25-Mar-2021, INFLUENZA LIKE ILLNESS (flu like symptoms), VACCINATION SITE PAIN (extremely soreness at injection site), PAIN (body aches), PAIN (pain), PYREXIA (101 fever,), ERYTHEMA (red area around breast bone) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 101.     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.
This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 18-DEC-2012 was vaccinated with an improperly stored dose of (Merck) PROQUAD (dose and route unknown), Lot #: H015623, Exp date; 21-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Patient's outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
Resident complained of being dizzy and not feeling well, went unresponsive and passed away at 9:30 PM. Resident was a comfort care only resident no medical attention was necessary.  01/12/2010 Death Certificate received. DOD 12/27/09. Cause of Death: Congestive Heart Failure as a consequence of CAD. Additional information abstracted: Contributing factors - Diabetes mellitus.
On August 9th, I laid in bed with chest pain for maybe 30-45 minutes. On August 11 (today), I am at work. Around 5 AM, I started feeling pain in stomach. Possibly could be hunger pain. However, the pain migrated to my chest quickly. Chest pain has been consistent and is still occurring (6:33 am). My lower back is also hurting, and when I try to laugh it increases the pain in my chest. I have a history of heartburn, but my heartburn has not been an issue since last summer (after changing my diet).
fainted immediately following vaccination; Mom described movements as tonic clonic with stiffening of muscles and jerking movements during fainting episode; This is a spontaneous report from a contactable pharmacist (parent). A 12-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE DOSE for covid-19 immunisation. Medical history included fainting where the mother reports withheld has fainted in the past following administration of a vaccine. Unsure of the vaccine and exact date not known. The patient's concomitant medications were not reported. On an unspecified date, the patient fainted immediately following vaccination. The mother described movements as tonic clonic with stiffening of muscles and jerking movements during fainting episode. The outcome of the events was unknown.  Information about the lot/batch number has been requested.; Sender's Comments: Based on the close temporal relationship, the association between the events "fainted immediately" and "tonic clonic with stiffening muscles and jerking movements" with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
t102, shaking which stops when held; 1 day following vax not treatment necessary; sx resolved w/APAP;
I am diabetic, and at the time I didn't know I was anemic. I was vaccinating at the coliseum before receiving my shot. The site had 2500 people through it when I was there.  Symptoms were fever, malaise, aches, lethargy When I felt "better" we went to an ER where I tested negative for Covid 19 Lungs were clear. It was considered a reaction.
This spontaneous report was received from a certified medical assistant, referring to an unspecified number of patients of unknown age and gender.  Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored VARIVAX (lot # L048465, expiration date 02-DEC-2017; lot # M009765, expiration date 23-FEB-2018); which were exposed to temperature of 11F for 30 minutes. There was not previous temperature excursion and the call was because of a data logger. No adverse effects were reported. This is one of the several reports received from the same reporter. On 13-DEC-2016, all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.; Sender's Comments:  US-009507513-1610USA015290:US-009507513-1610USA015314: US-009507513-1610USA015315:US-009507513-1610USA015316: US-009507513-1610USA015317:,MERCK 1610USA015317:Mfr number.
Intense pain in injection site at the time of the injection and continuing until the present time, pain in left hand and temple at the time of the injection and continuing until the present time, intense headache beginning around 4:00 pm on the day of the injection and showing no sign of improvement at this time. intense muscle pain and muscle spasms in back and calf muscles. high fever and chills all night until around 6:00am today (04/08/2021)
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Sometime in July 2015 and August 2015 (specific dates unavailable) these patients received doses of improperly stored GARDASIL (dose was not reported, lot # K008931, expiration date 04-MAR-2017) (incorrect product storage). No symptoms were reported. This is one of several cases received from the same source. Additional information has been requested.
This spontaneous report was received from a pharmacist regarding a 64 year patient of unknown age. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 21-JUL-2017, the patient received VARIVAX reconstituted with sterile diluent for prophylaxis (dosing details not reported). The pharmacist reported that the patient received VARIVAX in error rather than ZOSTAVAX (Wrong drug administered). No side effects were reported.
Moderna COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 2/25/2021 and 3/25/2021. Presented to ED on 1/1/2022 with cough and hemoptysis. Per EMS was hypoxic at 77% on 3L O2 which he is on chronically. Admitted for respiratory failure related to COVID-19 pneumonia. Treated w/remdesivir, antibiotics and steroids. Chest tube place for pneumothorax. H/O COPD w/fibrosis not a candidate for intubation. He required tube feed for nutrition and after evaluation from speech, was not safe for an oral diet. His prognosis was poor so palliative care was consulted. Patient expired on 1/26/2022
Received booster at 3:30pm. At 5:30am next morning, woke up to use the bathroom. After coming up the stairs while returning to bedroom, felt light headed and nauseous. Sat in chair and fainted, losing consciousness for a few seconds. After about 15 minutes was feeling better, checked blood pressure and it was slightly low but within normal range. Afterwards had expected vaccine side effects of arm pain, mild fever, and achiness, but with added vertigo-like dizziness. The fever and achiness and arm pain faded after about a day, but dizziness remained. Approximately one week after vaccination, began feeling pressure in the upper chest. It would come and go about every other hour. It seems to worsen in the coming days, occasionally causing pain behind the shoulder blades or in the armpits. Began to limit exercise and take Ibuprofen to  manage pain. Occasional instances of sharper chest pain accompanied by shortness of breath and nausea that would last about half an hour before fading. Admitted myself into ER at Medical Center at 6:00 PM on 12/21. Was released, symptoms continuing as before.
Multiple blood clots in my leg; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 (Lot number: ER8734) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "PCN allergy" (unspecified if ongoing). No covid prior vaccination. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, dose brand: Pfizer, Batch/Lot No: EP7534, Location of injection: Arm Left), administration date: 19Mar2021, when the patient was 48 years old, for covid 19 immunization. No other vaccine received in four weeks. The following information was reported: THROMBOSIS (life threatening), outcome "not recovered", described as "Multiple blood clots in my leg". The event "multiple blood clots in my leg" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: post vaccination. Therapeutic measures were taken as a result of thrombosis: Blood thinners administered.  No follow-up attempts are possible. No further information is expected.
Pt had acupuncture after immunization. Patient developed dizziness, nausea, fatigue, weakness that was prolonged over 4 hrs - enough for patient to go to ER. At ER blood drawn patient fainted. Got IV fluids and ZOFRAN. Dxed by ER at "vaccine reaction".
BODY ACHES, MUCUS COUGH, NO FEVER, MUSCLE SPASMS, RESTLESS SLEEP, PROGRESS TO DEEP UNPRODUCTIVE HACKING/HONKING SPASMING COUGH, NO SLEEP BECAUSE WHEN I LAY DOWN START WHEEZING BADLY, BETTER UPON SITTING UPRIGHT. SO TIRED NEED COUGH MEDICINE WITH CODEINE.
Information has been received from a consumer concerning her daughter a female who was vaccinated with a dose of VARIVAX (Merck) (date, route, lot number and dose not reported). Suspect vaccine included MMR II (date, route, lot number and dose not reported). The consumer reported that the patient received the two vaccines on the same day. It was reported that the following day the patient experienced hives (date unspecified). At the time of the report the outcome of the patient was unknown. It was unspecified if the patient sought medical attention. No further information is available.
20mm mass that needs to be removed; pituitary tumors; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: INTRACRANIAL MASS (medically significant), outcome "unknown", described as "20mm mass that needs to be removed"; PITUITARY TUMOUR BENIGN (medically significant), outcome "unknown", described as "pituitary tumors". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: (01Jul2020) 20mm mass, notes: had a 15 mm according to the report but according to my neurosurgeon it is a 20mm mass that needs to be removed; (06Mar2020) clear of my brain. Clinical course:The growth rate of that mass is really high were trying to figure out if it might be linked to the COVID-19 vaccine. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This non-serious spontaneous case, initially received from other non-health professional via Merck on 23-Oct-2018, concerns an elderly female patient of an unspecified age. On an unspecified date, the patient was administered Influenza vaccine (dose, route of administration, anatomical location, batch number, trade name, manufacturer and expiry date: not reported). On an unspecified date, after vaccination, the patient complained of sore arm. At the time of this report, the patient had not recovered from the event (reported as still sore). This case: 201804840 was cross-linked to the case: 201804841 (same reporter).
Child received TDAP, VZV. Walked out of clinic in good spirits, alert, coherent, color good. Ten minutes later mom came back to clinic to report client had passed out for few seconds in car. Child alert when nurse arrived. Still dizzy, pale. BP 90/60, P 60, cold comp applied. Juice and H2O given. After few minutes child alert. BP 100/60, P 60.
Within 5 minutes - my lips and face felt somewhat numb - that passed.  Within 4 hours my arm began to hurt - and that has continued to the next day (pain is a 6 on a scale of 1-10).  Felt tired and generally unwell starting about 7 hours after the vaccine.   24 hours after the vaccine the pain in my arm is still about a 4 on a (1-10 scale) but feel better today
Febrile (101) 24 hours after immunizations - red rash on trunk 10 days after immunization
About 5 hrs after vaccine, coughing started and progressively got worse. Could not breathe. Progressively got worse. Gasping for air. Both symptoms gone after 8 hrs. Almost called ambulance.
pt devel signs of optic neuritis;the sx resolved however over the course of time, new & additional neuro conditions devel;4MAY96 pt recv MRI which was dx of multiple sclerosis;pt had relapsing remitting MS d/t flu vax;also encephalomyelitis
achy; tired; feeling draggy; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain, tiredness and sluggishness. On an unknown date, the outcome of the pain, tiredness and sluggishness were unknown.   It was unknown if the reporter considered the pain, tiredness and sluggishness to be related to Shingrix.  Additional details were provided as follows: The reporting pharmacist was the patient. The age at vaccination was not reported but the patient could be 65 or 66 years old. The reporter reported that, he was achy, tired, and draggy after receiving a dose of Shingrix. The reporter reported his experience in passing after reporting his wife's experience. The reporter did not consent to follow up. This case was 1 of 3 cases, reported by same reporter.
Hospitalization for COVID-19 Reported per Janssen COVID-19 Vaccine EUA
bee stings on bottom of feet and back of his skull, cold and hot flashes, was in a semi coma for 5 hours
This spontaneous report as received from a pharmacist refers to a 76 year old female patient with no drug reactions or allergies who on 10-JAN-2013, was vaccinated with a dose of ZOSTAVAX (lot # H019035, expiration date 17-JAN-2014) subcutaneously. The pharmacist reported that one month ago in approximately January 2013 after receiving the dose of ZOSTAVAX, the patient developed pain at the injection site. It was reported the patient sought medical attention (the patient saw the pharmacist). No lab diagnostic test was performed. No treatment was given for the adverse event. The outcome of pain at the injection site was reported as not recovered/not resolved. Additional information is not expected.
Client had a vasovagal episode which occurred immediately after receiving Janssen COVID-19 vaccine. (1 minute). Client was out of it for about 5-10 seconds. Client assessed. Vital signs checked and within normal limits and normal to client range. After episode client alert and oriented x 3. Denied pain, dizziness, headache, lightheadedness, or  nausea after event. EMS called and responded. Client assessed by EMS and refused transfer to the ER stating "I feel fine".
My 3 year old received the flu shot and 3 hours later he started having fevers which lasted 7 days straight. He had to stay at hospital for 4 days straight and now is developing very bad coughs.
approx 4-6hr p/vax pt refused to stand or put weight on the affected leg;pt later became very stiff (upper & lower body) & was unable to sit & seemed very uncomfortable when put in the sitting position;on 2 occasions pt appeared to go limp;
A report was received from a consumer on 30Jan03 concerning a 3 year old male vaccinee who experienced a sinus infection 21 days and respiratory infection 2 months after inadvertently received Fluvirin on 04Nov02. The vaccinee also experienced a rash after receiving amoxicillin on 17Dec02. On 25Nov02 the vaccinee experienced a sinus infection presenting as fever, rhinitis and cough which resolved after treatment with amoxicillin on 23Dec02. The vaccinee developed a rash which was attributed to amoxicillin. On 04Jan03 the vaccinee developed a respiratory infection which presented as rhinitis, cough and a short episode of eye infection which subsequently resolved. The rhinitis and cough have not resolved.
Patient is a 40 y.o. female who received the Pfizer lot # EW0158 on 4/15/2021. The patient experienced the following reaction(s) during the immediate of observation: 2:25pm Patient vaccinated. 2:46pm Patient c/o left sided "throat tightness and heaviness." Patient was treated/managed as follows:   Patient alert and verbal. Denies shortness of breath or difficulty breathing. VS BP 100/60, HR 70, RR 18, O2 sat 99% on room air. Patient reports arthritis to area and receiving PT two days ago. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. 2:59pm O2 sat 99% on room air. Patient reports feeling better. Escorted to car by son and  RN.
her arm remain sore still after the 2nd injection of Shingrix; her shoulder remain sore still after the 2nd injection of Shingrix; sleep disturbance; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th January 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm, shoulder pain and sleep disturbance. On an unknown date, the outcome of the pain in arm, shoulder pain and sleep disturbance were recovering/resolving.   It was unknown if the reporter considered the pain in arm, shoulder pain and sleep disturbance to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient experienced arm and shoulder pain after 2nd injection of Shingrix. The patient stated that the pain in her shoulder wakes her up at night. The patient did not consent to follow up.
?43hrs after first dose, SOB, dizziness, weakness, extreme heart palpitations and feeling of fainting.  ?always dehydrated even if hydrating and feeling weak for about 10 days post (1st) vaccination. ?about 3 weeks after second dose (administered on May 21, 2021) started feeling easily fatigued, dyspnea, shortness of breath(like breathing through a straw feeling) heart palpitations. (Went to ER 2x since then due to this symptoms)  ?Now (present time Nov 2021) still having those symptoms and on top of that, feels "woozy" and off-balance, lightheaded from time to time (the feeling that someone gets when drinking alcoholic beverages) forgetful,  hard to concentrate, easily gets confused and longer to process thoughts when problem solving (which I wasn't all like this prior to being vaccinated, I was always able to multi task) also noticed more ringing in ears and eyes noticed more sensitive to light. Sometimes also have hard time pronouncing certain words which I haven't have problems before.
pt stated that she started getting a cough and scratchy throat soon after taking the covid vax.  She also had a sore arm and her heart was beating harder that usual.  Pt went to bed and woke up hot and feverish, she got up to use the bathroom and was unsteady on her feet and very disoriented.   She had severe head fog and pain in her head, neck, shoulders and abdomen like her body was extremely inflamed. She would experience this every time she got up about which was about every 2 hours.  She slept most of the day the next day and had swollen lymph nodes in her neck.  She had fatigue and head fog for over a week. Pt had headache and dizziness yesterday 3/1/2021 on still has some fatigue today on 3/2/2021.  Pt has not contacted her PCP at this time.  Pt states she will not get another vaccine.
Tested positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive) 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 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  The patient reported tested positive, after patient's husband was admitted to the hospital with COVID-19 symptoms and never got sick. No concomitant medications were reported.  No treatment information for the event was reported.