chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Day 1 sore arm shoulder to fingers also teeth, arm warm to touch. Day 2 red blotchy spots like hives on arm also on chest and stomach area just below breast and under breast. Day 3 red blotchy spots turned into red like pimple looking that itched, day 4 upset stomach with diarrhea all day, day 5 red blotchy spots on chest area have now turned into red spots like a pimple looking rash that itch. Day 6 red spots that itch on my legs behind my knees. Day 7 most all of the above is gone but still have the red pimple looking rash on my chest area and behind the knee area they have now developed scabs and do not itch as bad. My doctor recommended I report these affects with you.
30 minutes after 1st dose I began to feel like my scalp was itchy. It became so severe that it felt like bee stings on my scalp. By the next day I felt weak and unwell.  After the 2cnd dose I had neck pain and swelling under my armpits and groin area. Which was my lymph nodes swollen. My body ached and my injection arm was very painful and swollen and feverish for a long time. My arm still hurts until today. My body continues to have body aches, inflammation that has me taking medication for my arthritis which I didn't need for the last 12-15 years.
(R) deltoid: skin erythematous, edematous, firm, warm to touch. Treated with ice, steroid cream, oral antibiotic.
A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353398USA. The Adenovirus vaccine was given 14-Sep-2012. A male between the ages of 19-24 years old who experienced Other Anaphylactic Shock, NEC (Serious, since 17-Mar-2012, until 17-Mar-2012) while enrolled in a Teva study. The event on 17-Mar-2012- treatment outpatient visit, medication and non drug treatment- outcome resolved- seriousness disability/incapacity- severity not assessed. Treatment provided: EPIPEN 0.3 mg injection started 22-Sep-2012 and last dose 09-Nov-2012; and Prednisone 5 mg oral started 22-Sep-2012 and last dose 04-Oct-2012. "Hospital Rx'd patient for anaphylaxis 8 days after vaccine- only information." At the time of the report the outcome of the AEs were: Other Anaphylactic Shock, NEC : Unknown. The medical history of the patient was not specified. The patient's concomitant medication included Influenza Vaccine (Nasal, since 14-Sep-2012, until 14-Sep-2012); IPV (since 14-Sep-2012, until 14-Sep-2012); MMR (since 14-Sep-2012, until 14-Sep-2012); Hepatitis A Vaccine w/Hepatitis B Vaccine (unknown; since 14-Sep-2012, until 14-Sep-2012; since 22-Oct-2012, until 22-Oct-2012); Diphtheria-Tetanus-Pertussis Vaccine (unknown; since 14-Sep-2012, until 14-Sep-2012); Meningococcal Vaccine (unknown; since 14-Sep-2012, until 14-Sep-2012). The patient's past medication were unspecified. Action taken with suspect drugs: Adenovirus Vaccine - Not applicable. Lab tests were not reported. This case was considered serious based on the following criteria: (Other Serious (Important Medical Events)). The medical monitor states this case is not related to Adenovirus vaccine.
He received his vaccine, had arm pain the first day and felt fine.  He was in the produce department and his hand started getting cold and white.  He does have Raynaud's disease and has a heart condition and was worried that it may be affecting that.  It has occurred a few times but has not happened that  often, and this was about 1 1/2 hours after the vaccine.  With the heart related conditions about noon on Saturday he had taken a few quick steps and his vision started going dark on both eyes, had labored breathing.  He checked his temp and everything was fine, 97.4.  He rested for a while and felt better, but he was sluggish all day, had fatigue.  He went to the CDC website and had a lot of the symptoms listed.  He had headache, some fatigue, malaise and arthralgia.  He did not feel well, he has low energy but as the day went on he ate something and felt better, but the headache stayed with him, pressure type in nature/numbness.  The more activity he did the worse it got.  After Tuesday the headache started coming and going.  Yesterday he started developing a rash on his back and on the left side of his chest/side and looks similar to shingles, but has no open sore or discharge.  He does not have real pain but does have discomfort.  He was feeling that the myocarditis was affecting his heart.  He saw pictures on the website and the pictures are similar to what he has and also has muscle fatigue/stiffness and soreness.   He has discomfort due to the symptoms.    He has not called his doctor regarding these symptoms.  He had his wellness check but was not able to address his issues he's have due to time restraints.    He did have aortic stenosis and surgery for that in the past, 7/23/2019 and now has a pacemaker.  He does have a history of toxoplasmosis and it looks like shingles.    He has had a Reclast infusion, but has had reactions to that of uncomfortable.  He had the 2nd a year later and then a 3rd dose a year after that, felt like he had been hit by a truck, multiple symptoms, but he tuft it out.  His Rheumatologist told him that he gets a fracture that he would be on medicine for the rest of his year.    His mother was in the hospital for a while after giving birth to him, and he was in the hospital as well after birth and had rheumatic fever as a child.
MMR and varicella given in same arm, (L), and approximately 1/2" apart, and given in deltoid muscle. Client states she had ot go to ER for local reaction. (+) Cellulitis.
no adverse effects reported; improperly stored dose of vaccine was administered to the patient; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 26-APR-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA, lot # R026720, expiration date: 17-MAY-2020 for prophylaxis (dose and route of administration were not reported) reconstituted in sterile diluent (STERILE DILUENT) (lot # and expiration date were not reported). It was unspecified of sterile diluent underwent any temperature excursions. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 16.6 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.  Lot No. R026720 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), expiration date reported as 17-MAY-2020, but upon internal validation established as 17-MAR-2020.; Sender's Comments:  US-009507513-1905USA011854: US-009507513-1905USA011855: US-009507513-1905USA011856: US-009507513-1905USA011857: US-009507513-1905USA011858: US-009507513-1905USA011859: US-009507513-1905USA011860: US-009507513-1905USA011861:
Patient began to have elevated heart rate and tingling in the left arm, lips and throat.  Patient had left the pharamcy and made it to her car after the recommended waiting period and decided to return to the pharmacy when her throat started to tingle.  Patient was given 25mg of benadryl solution (10 ml of the  12.5mg/5ml solution.) Symptoms began to improve, but EMTs were dispatched to check patient's blood pressure.  They verified the patient's blood pressure was elevated.  Patient and EMTs decided patient could leave and go home since her symptoms improved almost totally after administering benadryl.
Looks like arthritis in my thumb finger; Joint pain/Extreme knee pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Looks like arthritis in my thumb finger) and ARTHRALGIA (Joint pain/Extreme knee pain) 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.    In February 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRITIS (Looks like arthritis in my thumb finger) and ARTHRALGIA (Joint pain/Extreme knee pain). At the time of the report, ARTHRITIS (Looks like arthritis in my thumb finger) and ARTHRALGIA (Joint pain/Extreme knee pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
low grade fever; some headache/Some headaches; Extreme fatigue/ exhausted and tired; Very weak; This is a spontaneous report from a contactable consumer(patient herself) reported that a 88 years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EN6198 and expiration date: unknown), via an unspecified route of administration in left arm on 01Mar2021 at 10:45 AM as a single dose for COVID-19 immunisation. The patients medical history included asthma, sleep apnea, hypertension, bilateral hearing loss and exudative AMD, hashimotos, anaemia, aortic atherosclerosis, colonic diverticulosis, amplatzer atrial septal closure device and has got Covid-19 prior vaccination. The patient had a history of known allergies which includes severe reaction to penicillin. Concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EN6201 and expiration date: unknown), via an unspecified route of administration in right arm on 09Feb2021 at 10:45 AM as single dose for COVID-19 immunisation. The patient received no other vaccines in four weeks and has not been tested for Covid-19 post vaccination. The patient reported that there was no problem at all after am injection for next 13 hours. Then low-grade fever, some headache and EXTREME fatigue. Fell asleep about midnight and woke up 2pm next day (3rd). Very weak and exhausted and tired until about Friday the 5th. Some headaches and low-grade fever. Had no rest most days. No household chores possible. No treatment was received for adverse events. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
lt deltoid red & swollen from few hr of vax broke out in hives few days later, recommend DPH;
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 25-NOV-2013 the patient was vaccinated with the first dose of LIQUID PEDVAXHIB (dose and lot# were not provided). On 27-JAN-2014 the patient received the second dose of LIQUID PEDVAXHIB (dose and lot# were not provided). A third (dose and lot# were not provided) was received on 27-MAR-2014. The patient received LIQUID OEDVAXHIB outside of the recommended dosing schedule. No adverse effects reported. Additional information has been requested.
clogged ears; injcetion site rash; She almost fainted; She was nauseated and wanted to vomit; Sweating; blood pressure went low/down; pale; Fever; Headache; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (She almost fainted) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PAIN (Body ache), PYREXIA (Fever) and HEADACHE (Headache). On 04-Apr-2021, the patient experienced SYNCOPE (She almost fainted) (seriousness criterion medically significant), HYPERHIDROSIS (Sweating), HYPOTENSION (blood pressure went low/down), PALLOR (pale) and NAUSEA (She was nauseated and wanted to vomit). On an unknown date, the patient experienced EAR DISCOMFORT (clogged ears) and VACCINATION SITE RASH (injcetion site rash). At the time of the report, SYNCOPE (She almost fainted), PAIN (Body ache), HYPERHIDROSIS (Sweating), HYPOTENSION (blood pressure went low/down), PALLOR (pale), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (She was nauseated and wanted to vomit) outcome was unknown and EAR DISCOMFORT (clogged ears) and VACCINATION SITE RASH (injcetion site rash) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Apr-2021, Blood pressure measurement: Low.         Tylenol was used as treatment medication. Concomitant medications was not reported.   This case was linked to MOD-2021-067463, US-MODERNATX, INC.-MOD-2021-067463 (E2B Linked Report).; Sender's Comments:  MOD-2021-067463:First Dose Case US-MODERNATX, INC.-MOD-2021-067463:Second dose case
This is a spontaneous report from a contactable physician. This physician reported similar events for two brothers. This is the second of two reports. A 17 year-old male patient of an unspecified ethnicity received a dose of TRUMENBA (lot R4510, expiry date 01Jul2018) on 17Jul2017 at 0.5 ml single intramuscular in the left deltoid for routine vaccination. The patient medical history was none, concomitant medications were not reported. The patient experienced severe redness, swelling, and tenderness at the site of injection on 18Jul2017. Therapeutic measures were taken in response to the events and included the administration of BENADRYL and ibuprofen. The patient recovered after several days on an unspecified date in Jul2017. The events were considered non serious by the reporter. Sender's Comments: Linked Report(s): US-PFIZER INC-2017378481 same reporter/product/events, different patient.
positive test for Covid, not experiencing any symptoms; This spontaneous case was reported by a consumer and describes the occurrence of ASYMPTOMATIC COVID-19 (positive test for Covid, not experiencing any symptoms) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced ASYMPTOMATIC COVID-19 (positive test for Covid, not experiencing any symptoms). At the time of the report, ASYMPTOMATIC COVID-19 (positive test for Covid, not experiencing any symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, SARS-CoV-2 test: positive (Positive) Tested positive for Covid-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported  No treatment medication reported
small ischemic stroke; elevated white blood count; fever; body aches; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9269, expiration date May2021), via an unknown route of administration on 15Feb2021 (at the age of 68-years-old) as a single dose in the left arm for COVID-19 Prevention/ immunization. The patient's medical history included a dental procedure on 18Feb2021 for a cracked tooth from an unknown date. The patient received procaine hydrochloride (NOVOCAIN) on 18Feb2021 for the dental procedure. On 18Feb2021 the patient experienced fever, body aches, chills, and a headache; and on an unknown date in Feb2021 the patient experienced a small ischemic stroke. The patient was hospitalized for the ischemic stroke on 19Feb2021. The patient underwent lab tests and procedures which included a Magnetic resonance imaging (MRI) of the brain on 20Feb2021 which showed a small ischemic stroke and white blood cell count which was elevated (in the low 20s) on 19Feb2021 and on 20Feb2021, white blood cell count was normal. Therapeutic measures were taken as a result of the ischemic stroke which included Plavix. The clinical outcome of the ischemic stroke was unknown; fever, body aches and chills were recovered on 19Feb2021; white blood cell count increased recovered on 20Feb2021; headache was not recovered. The patient was hospitalized for three days. The patient mentioned that he was not associating the stroke with the vaccine but rather associates it with the added stress on his body.
Narrative: 70 year old male with uncontrolled hypertension presented to primary care clinic to re-establish care. BP was elevated upon check in (166/112) - was offered TDaP vaccine. A few minutes after vaccine administration, patient became unresponsive and a code was called. Patient was transferred to ED where he was diagnosed with right cerebellar hemorrhage. Patient transferred to another hospital for higher level of care and neurosurgical services for likely surgery.
Patient had a stroke on March 15, 2021 as described as a blood clot in her brain. Medical personnel were unable to correct it surgically and she passed away that evening in the hospital. Death was the final result.
Several hours after patient was administered flu shot, she complained of sore arm, bruising, and a knot at the site of the injection
Suspected light headedness from H1N1 flu shot. He sat & put head between his knees in waiting area. He said he was afraid of shots but his aunt & uncle talked him into getting the shot after they got theirs. His uncle bought him candy & Gatorade. Broke ammonia inhalant at patient request & he said it really helped x 3 whiffs. He walked out with his uncle - did not want me to call 911 - time about 15 minutes.
4 patients were administered expired doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 patients were administered expired doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients were administered expired doses). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (4 patients were administered expired doses) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vials were initially stored in refrigerator on 12-Oct-2021. Expiry date of vaccine is 09-Oct-2021.   No treatment medications were reported.
they know people that got sick (with COVID) after being vaccinated; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (they know people that got sick (with COVID) after being vaccinated) 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 COVID-19 (they know people that got sick (with COVID) after being vaccinated). At the time of the report, COVID-19 (they know people that got sick (with COVID) after being vaccinated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Company Comment : This case concerns a patient of unknown age nor gender with no relevant medical history, who experienced the non serious unexpected AESI of COVID-19. The event occurred at an unknown date after the mRNA-1273 vaccine, dose number not provided. The rechallenge was not applicable. This is an invalid case since the reporter states that an unknown number of people got sick (with COVID) after being vaccinated. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Caller stated that he does not know that Moderna vaccine or not. Unknown manufacturer.  No treatment details provided. No concomitant medications were reported.; Sender's Comments: This case concerns a patient of unknown age nor gender with no relevant medical history, who experienced the non serious unexpected AESI of COVID-19. The event occurred at an unknown date after the mRNA-1273 vaccine, dose number not provided. The rechallenge was not applicable. This is an invalid case since the reporter states that an unknown number of people got sick (with COVID) after being vaccinated. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
No additional adverse event; Received first dose in 2013 and the second dose on 3/20/2020; This spontaneous report as received from a physician refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  In 2013, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 20-MAR-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. There was no adverse event reported.
Moderna Booster shot Symptoms: Injection site - left arm.  1. Acute left underarm pain 2. Acute shoulder blade pain (mostly in left side),  3. Left chest area pain,  4. Some random shooting, throbbing, stabbing pain in the neck area, shoulder, throat area. 5. Very  red, swollen, painful, hard and itchy bump on the injection site 6. Fever, fatigue, chills 7. Triggered my migraine 6. On  day 3 - burning back pain and stiff neck Some symptoms such as underarm pain, swollen bump at injection site (Moderna arm) and occasional burning sensation in left chest area are still present today, at day 5.
Started several hours after injection with severe pain in entire (L) arm. Had chills. Unsure if any fever. Next day reports was "out of it". Still with severe pain. No with swelling of (L) upper arm. 2 days after injection has pain, redness, swelling down his back of (L) upper arm. Feels warm to touch. Reports is not red or swollen at injection site itself. Is out of town so will go to an urgent care for eval of symptoms.
Patient developed area of erythema and tenderness below where shot given - treated for presumed cellulitis on 8/25/08 follow up arranged for 8/26