chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PSYCHOSIS, PARANOID OR DELUSIONAL; FEVER STATE; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced psychosis, paranoid or delusional, and fever state. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from psychosis, paranoid or delusional, and the outcome of fever state was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Begining December 17, 2021:  Shooting pain throughout body, felt like electricity coursing through the subcutaneous tissues; clawing of hand, rapid and painful involuntary contractions of hands; severe chest pains under clavicles and breasts; lateral shooting pains in femoral area; lumbar pain, jolts of electricity; tingling, numbness; fatigue, temporal headache; inability to sleep and concentrate; loss of appetite; dizzy; inbalaance at times;  tightening of tibialis, gastrocnemius, and foot muscles; nausea; no energy
Soreness at first.  Then turned into sharp and stinging pain, full arm ache, tingling and numbness throughout arm and into fingers.
Tingling, burning sensation, numbness in half of face. Same side as injection, left. Same sensation in left forearm and hand.
pt recv vax & 2 wk later devel rash mainly in the diaper area which appeared as a reddened area w/white centers;rash lasted for several months & the pt was seen by a dermatologist who dx the rash a dog scabies; treated for fungal infect
Information has been received from a Certified Medical Assistant (C.M.A.) concerning multiple unspecified patients of unknown age and gender. On unknown dates, the patients were inadvertently vaccinated with improperly stored PEDVAXHIB, lot # J010385 with expiration date 28-MAY-2016, lot# L030871 with expiration date 10-JUN-2018 (dose and route unspecified), which was exposed to temperature excursion 47.78 Fahrenheit degree (F) for 22 hours 44 minutes or 15 hours. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
pretty deep pain in my neck, shoulder and arm opposite of the side I got the injection; pretty deep pain in my neck, shoulder and arm opposite of the side I got the injection; pretty deep pain in my neck, shoulder and arm opposite of the side I got the injection; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient received the first dose of the Pfizer BioNTech covid vaccine a week ago.  She was due back in 2 more weeks.  Just today she woke up with some of the side effects.  In particular, she had a pretty deep pain in my neck, shoulder and arm opposite of the side she got the injection.  Outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
First loss of appetite, Sore achy muscles and joints.  5 days later fever at 101-102.  With Tylenol lowered to 99. Still today (day 6) back at 100.2.   Note. Same day as vax, started  Rx of Spiriva R for COPD.
Rash itches very much; Small rash size of a quarter, gotten much bigger,oval size about 6 inches; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash itches very much) and RASH (Small rash size of a quarter, gotten much bigger,oval size about 6 inches) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced RASH (Small rash size of a quarter, gotten much bigger,oval size about 6 inches). On 10-Mar-2021, the patient experienced RASH PRURITIC (Rash itches very much). At the time of the report, RASH PRURITIC (Rash itches very much) and RASH (Small rash size of a quarter, gotten much bigger,oval size about 6 inches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment information included itch cream on the rash.
05/15/22022 I developed congestion and seem to a be a postnasal drip. The next morning, I had a mild cough and creepy skin. I took a home COVID test which was negative. Several days later I took a second test, and it was positive. My doctor prescribed Paxlovid. I am on the third day of the Paxlovid, and I still feel a lot better. I only have a little bit of congestion still.
Severe itching on left shoulder. Patient did not go to doctor. The patient took BENDADRYL, CORDIZONE spray and 30 min later patient applied BENADRYL gel over the next 3 to 4 hrs.
Patient initially had right arm pain and headache, which resolved after 24 hours, then experienced left arm pain and chest pain  (radiating pain spreading up to the neck and downward) which necessitated a hospital visit, where the cardiologist determined this was a possible side effect from the vaccine. The cardiologist referred the patient to receive an EKG and monitored their blood pressure and heart rate, where the patient had 178/99 with 155 BPM, and 149/98 with 153 BPM
Pt came in Sports PE, was missing, 2nd varicella, per doctor 2nd varicella given, within 2 minutes of injection pt fell back on bed;  became unresponsive, became having tonic-clonic body movements, it lasts 10 seconds. Pt's grandmother awaken him, vitals within normal limits, pt nauseated, cold to touch. Sat pt up, Cheerios & water given. Pt observed for an hour, all vital signs stable. Pt up walking around. Pt. left with informed to go to ER if another seizure or activity happened again.
After receiving this vaccination on a Monday that same week on Friday, he had two seizures and then the following month he had two seizures because all of the heavy metals were still in his system. His provider never never warned me about the side effects that this vaccine could have, and she never reported it to the CDC. Instead, they intentionally wrongfully diagnosed him with epilepsy instead of a vaccine injury like it was. He was wrongfully, diagnosed and placed on medication. I?ve been fighting with them for years about this. With them, knowing that a seizure to be the outcome to this particular vaccine
pt recvd vax;pain in feet,knees,back to elbows;extreme fatigue,lost of strength;dx w/ rheumatoid arthritis;tx w/ anti-inflam meds for a mo; now pt had regained strength, endurance & mobility thru daily exercise routine;
throat tightness; This is a spontaneous report from a non-contactable other healthcare professional (HCP). An 18-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231) via an unspecified route of administration on Jan2021 at a single dose in the left deltoid muscle for COVID 19 vaccination. Medical history and concomitant medications were not reported. The patient denied any history of previous adverse reactions to vaccines and denied reaction to her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID 19 vaccination on an unspecified date. The patient was seen at a COVID vaccine clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15-minute waiting period after the injection, the patient began to experience throat tightness on Jan2021. Treatment included: Benadryl 25mg po (orally) and Solumedrol 125mg IM. The event did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The outcome of the event was unknown.     No follow-up attempts are possible. Information about lot/batch has been obtained. No further information is expected.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of throat tightness cannot be excluded, considering the plausible temporal relationship. Sever allergic reaction is the known risk for the product.  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.
fever at 101 more 5 days cough and running nose one week heartbeat fast, more than 100/min
Severe bruising all around injection site, and diarrhea with blood in the discharge both starting on 01/29/2021
Received a dose of BioThrax vaccine beyond 28 days from the first puncture of the vial; Spontaneous report received on 18APR2021.  Based on the information obtained from the nurse, two individual case safety reports 21000046SP and 21000047SP were created and cross-linked in the database.  The nurse reported that the patient "received a dose of BioThrax vaccine beyond 28 days from the first puncture of the vial" (PT: Vaccination error). The patient received BioThrax (anthrax vaccine adsorbed) (dose: 9, lot number: 300070, and expiry date: 26MAY2021) for immunisation. It was reported that a BioThrax vial was opened (first puncture) on 20FEB2021, and the 28-day expiry from the first puncture was on 20MAR2021. On 09APR2021, this patient received a dose of BioThrax vaccine from the same vial. This was series 9 of BioThrax for the patient.   Additionally, it was reported that as per the Centers for Disease Control and Prevention (CDC), multi-dose vials are to be discarded 28 days after ?rst puncture. Moreover, the nurse stated that "our specific training and guidance states BioThrax is to be discarded 28 days from ?rst puncture" but there was no information about recommendation to be discarded after 28 days from the first puncture with the product.  Action taken with BioThrax with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A patient received a dose of BioThrax vaccine beyond 28 days from the first puncture of the vial (vaccination error), and further details of the event are limited. BioThrax Vials are multi-dose vials and should not be used beyond 28 days of fist puncture. The causality of vaccination error is assessed as not applicable to BioThrax due to the nature of the event.; Sender's Comments: A patient received a dose of BioThrax vaccine beyond 28 days from the first puncture of the vial (vaccination error), and further details of the event are limited. BioThrax Vials are multi-dose vials and should not be used beyond 28 days of fist puncture. The causality of vaccination error is assessed as not applicable to BioThrax due to the nature of the event.
A spontaneous report has been received from a Health Professional concerning a patient born on 09-MAR-2002, male subject, who had been receiving FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. The reporter stated that patient was accidentally given expired FLUMIST Quadrivalent to two patients on 31-DEC-2014. The outcome of the event of accidentally gave expired FLUMIST Quadrivalent to two patients is  unknown. The report was considered to be non-serious.
After two hours arm started to hurt as with first injection. About 6-8 hours after shot, pain continued up into my neck and head, then proceeded to go down my left side and sciatic nerve. Then I started to feel really bad all over. Ears plugged, equilibrium off. Every joint and muscle in my body ached. Could not get out of bed for about 24 hours, drinking only water and no food. Second day started to feel better and ate a small meal of eggs for dinner. Continued to feel better but still very tired and worn out from the ordeal. Felt like the worst flu I've ever had but my husband had the same shot with the same results.
no adverse event; dose of MMRII intramuscularly rather than subcutaneous; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concomitant medications and concurrent conditions were not reported. On an unknown date in December 2019, the pharmacist inadvertently administered a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) one dosage form, lot number S015284, expiry date19-MAY-2021(strength was not reported) for prophylaxis intramuscularly rather than subcutaneously (incorrect route of product administration). No additional adverse effects were reported. There was no product quality complaint (PQC) present.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 39-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  No treatment information was provided.
Couple of bumps on neck the same day as vaccine was given 2/9/11 - Following day temp 99.4 - red bumps with itching noted in day care given BENADRYL - worsened and seen in office - treated with PRELONE & BENADRYL 2/11/11 - urticaria - face trunk & extremities.
I got Covid on 12/16/2022. I suffered 18 days of Covid symptoms were: chills, fever, body aches and cough (coughing up phelgm). I took Paxvolid, the first 5 days of  the onset of the symptoms. Feeling better.  Tested Covid Negative on Day 9.  On Day 11, feeling nasal congestion. On Day 13, tested positive again for Covid. Symptoms included: nasal congestion, fatigue and pink eye (conjunctivitis) in left eye. On Day 17, eye cleared up and feeling better. I tested negative for Covid on Day 17 and Day 18.
Several weeks after the second injection I was diagnosed with Tinnitis.  I have had it ever since with no breaks in this maddening tone in my head.
Middle of that night felt pain in that arm with some redness.  Next day, pt felt some sob and had swollen right arm down to fingers.  Following day felt aches, pains, HA in back and arm pain was getting worse.  Redness progressing every day.  Pt also felt her face "blew up".
Numbness in arm from shoulder to elbow on injection arm Severe headache Body ache Shoulder pain on non-injection arm
pt states they are fully vaccinated against COVID with Pfizer. Unable to obtain dates of vaccination. Pt admitted to hospital and tested positive for COVID-19
8Feb2021, I felt bad, fever 102, headache, night sweats and next week severe chest pains and headache. Went to urgent care 18Feb2021 with chest pain. The next week my left arm turned blue, and tingling and other hand and feet started tingling too. Continued the pain in left arm was numb. Went for vein treatment and went to see cardiologist and had Holter. Got a bad reaction to Cymbalta. Went to hospital in June 2021. Having treatment with neurologist.
"Moderna COVID-19 Vaccine EUA"  On 2/11/2021 adverse events were chills and severe dizziness, weakness, nausea, rash all over my back including a smaller rash on stomach. These side effects are still present as of 2/21/2021. I have taken Dramamine for the dizziness in order to function. I have applied Cortisone to the rash for relief in itching. I have not been seen by a physician as I would expect these side effects to subside in 14 days.
Got flu shot and setting with the flu, messed up family get togather; Initial information received on 26-Dec-2022 regarding an unsolicited valid social media (received via public post) non-serious case received from a consumer.  This case involves an unknown age and unknown gender patient who experienced got flu shot and setting with the flu, messed up family get together, after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer [formulation, lot number and expiry date was not provided] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious got flu shot and setting with the flu, messed up family get togather (influenza) (unknown latency) following the administration of influenza vaccine.  It was reported that, "Got flu shot and I'm setting with the flu, messed up our family get togather. Every in the dr office had their shot and they had the flu".  No relevant lab data reported.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown.; Sender's Comments:  SanofiPVPortal20221227000272:
chills for 2 days; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Apr-2021 and was forwarded to Moderna on 27-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills for 2 days) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced CHILLS (chills for 2 days). On 28-Mar-2021, CHILLS (chills for 2 days) had resolved. Not Provided          Action taken with mRNA-1273 in response to the events was not Applicable.  No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-091749 (Patient Link).   Reporter did not allow further contact
Started with odd pain in back shoulder bladearea on March 19, 2021,Got diarrhea with bloating 03/20/21 with I thiught was cause of shortness of breath. Shortness of breath got worse till I took some prednosone I had, on April 4, 2021 thinking I was having an asthma attack. Helped a few days. Shortness of breath returned on April 9, 2021. On April 10 we went to critical care thinking I was having asthma attack as extremely short of breath! They said it wasnt asthma but sent me to ER as my oxygen levels were low. In ER they took many tests including CAT scan and ultrasound, which resulted in diagnosis of several large bloodclots in both lungs
Patient experienced an uncontrollable crying event for over three hours.   Also mental and emotional issues over the following several days.  Elevated body temperature for 12 hours.  Fatigue and malaise observed as well.
5 inch by 3 3/4 red raised area at site of injection with small blisters through out area - No itching - burning etc - Temp 97.8.
This spontaneous report was received from a nurse and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions, drug reactions and allergies were reported. On 21-APR-2015, the patients were vaccinated with doses of VAQTA (dose, route of administration, anatomical location, lot# and expiration date were not reported), which were exposed to temperatures outside of the recommended range. No adverse events were reported. This is one of the several reports received from the same source. Additional information has been requested.
Rash on bilateral deltoid area 5 days after receiving DTP, IPV, MMR. Rest ok ROS Neg
I notices my arms were feeling tired 11/1/2021, by Wednesday my body was really hurting and feeling similar to how it felt when I had polymyositis in 2016. By the 11/7/2021 I was in bad shape and contacted my Rheumatology who had me come in for labs 11/8 and an office visit 11/11. My CPK 11/8 was >3400 (high normal was 143). I was started on prednisone 40mg and methyltrexate 2.5mg X 6 for 1 weeks then 2.5mg X8 going forward. My condition kept deteriorating.  My prednisone does was increase to 60mg and still I kept deteriorating. I was admitted to the hospital 11/29/2021 to obtain 2 IV IG treatments. Upon admission my CPK was 7100. By that time the muscle destruction that had taken place was severe. I was released from the hospital 12/3/2021 to an acute rehabilitation hospital to help me regain some of my mobility. At baseline my PT assessments showed lots of need for improvement in my static and dynamic balance and my OT assessments showed loss of 75-100% of my upper body capabilities. I was in the acute rehab hospital until 12/17/2021. I could not come home to my house with out 24/7 care as I was unable to do so many daily living activities - my sister had to fly in to care for me for 2 weeks. I then had a friend come for ~ 1 week. In addition to the hospitalizations I had to take leave and short term disability leave from work from 22Nov - 02Feb2022. I will be recovering from this situation through end of 2022 as I need to stay on methyltrexate until then. As soon as I am able (immunocompromised now) - I will resume my yoga practice to rebuild my muscle strength, stamina, etc.
Dizziness, Headache, Fever, NauseaVomiting, arm pain, fingers tingling, chills, injection site swelling/redness/pain Narrative:
Malaise; headache; flu-like; nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like), MALAISE (Malaise), HEADACHE (headache), FATIGUE (fatigue) and NAUSEA (nausea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder NOS since 1974, Rheumatoid arthritis since 1974, Allergy to antibiotic (Ampecelin), Allergy to antibiotic (Bactrim), Allergy to antibiotic (clendomycin), Drug allergy (Isoniazid) and Drug allergy (indocin). Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN), SIMVASTATIN and AMLODIPINE for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced FATIGUE (fatigue). On 01-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like). 01-Mar-2021, the patient experienced HEADACHE (headache) and NAUSEA (nausea). On an unknown date, the patient experienced MALAISE (Malaise). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like), HEADACHE (headache), FATIGUE (fatigue) and NAUSEA (nausea) had resolved and MALAISE (Malaise) outcome was unknown.            No treatment information was provided.   This case was linked to MOD-2021-027301 (Patient Link).   Reporter did not allow further contact