chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 21 year old female patient with no known drug allergies and a history of ovarian cyst during pregnancy in October 2008 who on 01-JUL-2009 was vaccinated with the first dose of GARDASIL. On 18-AUG-2009, the patient was vaccinated with the second dose of GARDASIL. There was no concomitant medication. On 18-AUG-2009, during night the patient experienced muscle aches, pain in her whole left arm where she received the 2nd dose, developed 102 F fever, nausea and her glands were swollen. The patient called the clinic and only spoke to her nurse but was schedule to see her midwife. The patient's muscle aches, pain in her whole left arm, 102 F fever, nausea and glands swollen persisted. Additional information has been requested.
This spontaneous report as received from a consumer refers to a 19 years old male patient with allergies an no drug reactions. The patient was vaccinated intramuscularly with 0.5 ml dose 1 and 2 of GARDASIL (lot # not reported) on 17-MAY-2012 and 15-JUN-2012 respectively. No other co-suspects were reported. There was no concomitant medication. On MAY-2012 the patient experienced chest pain. Within days of receiving the first dose of the vaccine, the patient experienced chest pain. He got his second dose of the vaccine and saw his doctor on 26-JUN-2012. The patient had tightness and pressure in his chest, anxiety, confusion, and tingling in his back, neck and left arm. He had all sorts of tests done: Chest x-ray, two electrocardiograms (EKG), blood work, abdominal cat scan and stress test (results not provided), and nothing had been found. All of the above symptoms had not yet gone away at the time of the report. No treatment was given for the events. The dose series of GARDASIL was discontinued. The relatedness for the reported events was not provided for GARDASIL. Additional information has been requested.
Fever, body aches and exacerbation of asthma that landed the patient in the hospital
Local reaction-Erythema 10cmX9cm pruritic. Mildly tender 48hr after injection reaction on right deltoid area.
It appears from my long term symptoms & diganosis of chronic Lymes that I had the disease at the time I was vacinated & this made my illness & pain very much worse.  My fatique & arthritic joints since Lymerix have made my life & livelihood unbearable.  I feel very old before my time. While being misdiagnosed over a period of approx. 5 yrs, I have had surgeries & proceedures to correct & eliminate my pain that didn't help & I didn't need.
Started with sore arm on Saturday 3/27, followed by continued soreness on Sunday 3/28 with a rash and itching. Symptoms have remained the same on Monday 3/28. Applied cortisone cream, cold compress and Ibupropen
Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Loss of mental focus and vision got blurry-Severe, Systemic: Headache-Severe, Systemic: Hypotension-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: Tongue was tingling all over, hands and feet were going numb
Lack of drug effect; Diarrhea; Nausea; Constipation; This is a solicited report from the USA marketing program facilitated collect received from a contactable physician.     A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration in May2021 (Batch/Lot number was not reported) as single dose for covid-19 vaccination; adalimumab (HUMIRA, Solution for injection in pre-filled pen), via subcutaneous from Aug2020 and from May2021 (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for moderate to severe adult crohn's disease. The patient's medical history and concomitant medications were not reported. On unknown dates, the patient experienced lack of effect, diarrhea and nausea. In 2021, the patient experienced constipation. Covid-19 Vaccine was also considered suspect. The action taken in response to the events for adalimumab was unknown. Outcome of all events was unknown.   Causality assessment of the reporter for constipation was possibly related with bnt162b2.   The reporter's assessment of the causal relationship of the events lack of effect, diarrhea and nausea with suspect products was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.; Sender's Comments: The events are all assessed as related to the suspect product,  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE).  This case will be updated when new information becomes available.
The first two days after my flu shot and pneumonia shot, I experienced the typical sore arm and thought nothing of it. I had some concern the next day when the pain became significantly greater, especially when lifting or moving my arm. I went to a local urgent care on day 4 when my arm and shoulder began to really bother me. I was told it was probably a muscle inflammation and given a sling and told to use warm compresses and take Tylenol #3 1 table up to 4 times a day. The pain has now settled in my inner shoulder especially. It is now very difficult for me to lift that arm without the help of my other arm, It is very painful to dress myself or do anything that I must raise my arm for or reach behind me like put my coat on. This is especially distressing to me because my husband had a stroke 3 years ago affecting his left arm and I am the person who helps him. This has become challenging.
Pass out; Feel disoriented; Severe body pain; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Pass out) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Pass out) (seriousness criterion medically significant), DISORIENTATION (Feel disoriented) and MYALGIA (Severe body pain). At the time of the report, LOSS OF CONSCIOUSNESS (Pass out), DISORIENTATION (Feel disoriented) and MYALGIA (Severe body pain) outcome was unknown.            The action taken with mRNA-1273 in response to the event was not applicable.  The patient had side effects after the second dose, severe body pain. The patient passed out and felt disoriented. Concomitant medications were not provided. Treatment information was not provided.  Company comment: Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Pt received flu vaccine on 12/02/2005. Pt called MD on 12/09/2005 and stated he broke out in welts on arm and chest on 12/07/2005 then more appeared on legs 12/08/2005. No itchiness. Referred to PMD pt agreeable to f/u with PMD.
Some acidic foods like tomatoes had a metallic taste for about a week.  Nothing serious just strange taste.    I still feel like I should report.
fatigue - muscle pain - chills - diarrhea Felling better the second day after the second injection. No problems existed after the first injection.
On approximately 10/31/2022, I started coughing with a lot of mucus. The cough would go on all day long and into the evening. It is an irritating cough that sounds bad but I feel fine, just a chronic cough. I went to my allergist and nothing has been decided. I continue to have the cough today.
This spontaneous case reported by a consumer, describes the occurrence of lymphadenopathy (swollen lymph nodes) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced lymphadenopathy (swollen lymph nodes). At the time of the report, lymphadenopathy (swollen lymph nodes) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided. Patient reported at follow-up, the EKG value: sinus brady not so great. Most recent follow-up information incorporated: On Aug 11, 2021: Follow-up received. In follow-up EKG, chest X-ray and mammogram done.
I am experiencing tightness and pain in my shoulder - I think it is called myalgia.  It happened about 3 days after my first dose (Feb.14). It has not subsided.  Just got my second dose on March 14.
Client received her Pfizer COVID Bivalent booster lot # GJ3277 exp. 12.05.22 IM on her right arm at 1112 by RN on 10.02.22 at Testing Vaccine Site. At 1126, client reported to RN that she was having ?anxiety,? and feeling like she ?couldn?t breathe and having a dry throat,? with feeling of dizziness and ?shaking internally.? RN assisted client to antigravity chair and placed client in a high fowler position. RN notified lead PHN. Lead PHN assessed client. Client is alert and oriented x 4. Client reported she has a history of anxiety and took one pill by mouth anti-anxiety medication (Atarax) when she sat at the observation area at 1113. Client denied any shortness of breath (SOB) or any chest pain. At 1129, RN took client's vitals: BP 127/74, HR 92, R 20, O2 Sat. 100%, and client stated, she ate breakfast at 0900 today. Client denied any history of allergies or any chronic health conditions. Client reported that she ?feel the same? when she experienced anxiety with the symptoms of feeling unable to breathe well, dry throat, dizziness, and ?shaking internally.? At 1137, RN took client's vitals: BP 113/78, HR 94, R 20, O2 Sat. 99%, and client denied any previous symptoms above and stated, ?I feel a little better.? At 1144, RN took client's vitals: BP 112/74, HR 86, R 18, O2 Sat. 99%, and denied any previous symptoms. At 1150, lead PHN educated client on adverse reactions and when to seek EMS. At 1150, client?s mother came to see client at the observation area and client requested to leave because she stated, ?I feel better now.? At 1151, client left the vaccination site with a steady gait with her mother.
Achy, stuff/runny nose, fever/chills, tiredness, slight sore throat. Stuff/runny nose lasted for a few weeks, not a couple of days like the doctor said.
pt recv vax 11MAY95 & 30APR97 pt devel a fever of 101 & 6 spots on body;
I believe the shot was given too high and I felt the needle enter by shoulder bone area. It was above the muscle and not overly painful at the time but I did feel it much more than my first shot. It became sore within and hour or so - not as much muscle pain but more joint pain. I believe the worker was an amazing nurse but the staff was not being overseen and all probably needs to be reminding not to give shots too high. I have an appointment with a doctor Monday, I do not know if there will be last effects. Now I have lots of pain when lifting my arm or putting weight on it.
Mother states baby had difficulty breathing, eyes rolled back, skin color turned bluish. Mother called 911. States temperature at the hospital 105F rectal. Mother also states baby's color was yellow.
Information has been received from a veterinarian concerning a "couple of older" female pts who were vaccinated with MMR and 2 months, post vax, the pts' lab results revealed a lack of seroconversion. Follow-up information from a veterinarian reported that the first antibody titer was done 52 days, post vax, and the EIA <15. Only the rubella titer was done and the IgG checked. Additional information has been requested.
Patient reported feeling their throat swelling shut and difficulty breathing during 15 minute wait post vaccination. I observed and interviewed the patient, whose breathing was labored. They reported the feeling of throat swelling and difficulty breathing was worsening; 911 was called and administered a 0.3mg epipen. After 7 minutes, the swelling and difficulty breathing were continuing to worsen, so a second epipen was administered. EMTs arrived shortly after the second dose and transported patient to hospital.
WOKE UP GROGGY; SORE ARM; UNCONTROLLABLE SHIVERS; MUSCLE ACHINESS; UNCONTROLLABLE SHAKING; FEELING VERY HOT; FEELING VERY COLD; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 06-APR-2021 13:00 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 06-APR-2021 22:00, the subject experienced uncontrollable shaking. On 06-APR-2021 22:00, the subject experienced feeling very hot. On 06-APR-2021 22:00, the subject experienced feeling very cold. On 06-APR-2021 22:00, the subject experienced uncontrollable shivers. On 06-APR-2021 22:00, the subject experienced muscle achiness. Treatment medications included: paracetamol. On 07-APR-2021 04:00, treatment medications included: paracetamol. On 07-APR-2021 10:00, the subject experienced woke up groggy. On 07-APR-2021 10:00, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle achiness, and the outcome of uncontrollable shaking, uncontrollable shivers, feeling very hot, feeling very cold, woke up groggy and sore arm was not reported. This report was non-serious.
"Covid arm"; pains like shingles; itches; rash; swelling of the arm; really bad chills; dizziness; very light headed; very tired; I didnt feel like myself; she was not feeling good; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH ("Covid arm"), HERPES ZOSTER (pains like shingles), PRURITUS (itches), RASH (rash) and PERIPHERAL SWELLING (swelling of the arm) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE RASH ("Covid arm"), HERPES ZOSTER (pains like shingles), PRURITUS (itches), RASH (rash), PERIPHERAL SWELLING (swelling of the arm), CHILLS (really bad chills), DIZZINESS (dizziness), DIZZINESS (very light headed), FATIGUE (very tired), FEELING ABNORMAL (I didnt feel like myself) and FEELING ABNORMAL (she was not feeling good). The patient was treated with HALOBETASOL at an unspecified dose and frequency; LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH ("Covid arm"), HERPES ZOSTER (pains like shingles), PRURITUS (itches), RASH (rash), PERIPHERAL SWELLING (swelling of the arm), CHILLS (really bad chills), DIZZINESS (dizziness), DIZZINESS (very light headed), FATIGUE (very tired), FEELING ABNORMAL (I didnt feel like myself) and FEELING ABNORMAL (she was not feeling good) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: No specific follow-up information recorded.
Felt weird 5 minutes after shot.  10 minutes after shot I called over a tech and said I didn't feel right.  The took my vitals and found the my blood pressure had dropped to 85/45.  They called 911 and hit me with an EpiPen.  I never blacked out.  After another 10 minutes the fire department arrived and they took vital signs; all normal.  Another 10 minutes and ambulance arrived.  Vitals in the back of the ambulance were fine.  Got to the emergency room and vitals were fine including ekg.  Was released from the hospital about 4.5 hours after the initial shot.  I feel a little sluggish today but otherwise fine.
No additional ae reported; PROQUAD was administered to a patient post-expiry; This spontaneous report was received from a nurse referring to a patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      The nurse reported that one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rha) (PROQUAD) lot # S021326 was administered to a patient post-expiry (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). The administration was performed by a medical assistant with the practice, not the reporting nurse. She was calling to determine the "integrity" of the vaccine and if the dose needed to be repeated. The involved measles, mumps, rubella and varicella (oka-merck) virus vaccine live, (rha) (PROQUAD) expired on 05-JAN-2021 and was administered on 06-JAN-2021. No additional adverse event reported, and no further information provided.
his hands were screwed up. He could not make a fist.; trigger finger; He states that his feet hurt a little bit, but not a lot; fever; This spontaneous case was reported by a patient and describes the occurrence of ARTHROPATHY (his hands were screwed up. He could not make a fist.), TRIGGER FINGER (trigger finger), PAIN IN EXTREMITY (He states that his feet hurt a little bit, but not a lot) and PYREXIA (fever) in a 53-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (He stated that all the previous vaccines he received were Pfizer. His last shot was in 2022.) in 2022. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.   On 13-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 14-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced ARTHROPATHY (his hands were screwed up. He could not make a fist.). In November 2023, the patient experienced TRIGGER FINGER (trigger finger), PAIN IN EXTREMITY (He states that his feet hurt a little bit, but not a lot) and PYREXIA (fever). At the time of the report, ARTHROPATHY (his hands were screwed up. He could not make a fist.), TRIGGER FINGER (trigger finger), PAIN IN EXTREMITY (He states that his feet hurt a little bit, but not a lot) and PYREXIA (fever) had not resolved.            No concomitant medications were reported.  The patient received Spikevax vaccine on 13-Nov-2023 around 6 PM in the left arm. He had received a Flu shot in the right arm at the same time. He stated that all the previous vaccines he received were of Pfizer. His last shot was in 2022. On 14-Nov-2023, in the morning, his hands were screwed up. He could not make a fist. He now had trigger fingers. He stated that he never had trigger fingers prior to vaccination. He refused to share the physician's name who diagnosed him with trigger fingers. The physician told him that he had trigger finger in 8 fingers. He had a little fever. He stated that his left hand was much worst than the right hand. He still could not use the left hand to hold anything. The right hand was a little better. He stated that his feet hurt a little bit, but not a lot.  No treatment medications were reported.
Caregiver attended COVID vaccine clinic. Post vaccination, caregiver went to wait the 15 minutes when she became unresponsive, slumped over onto friend and clinical staff report they were unable to find a pulse. Caregiver transferred to floor so that CPR could begin when caregiver suddenly arose. Code team quickly at caregiver side to evaluated and stabilize. Caregiver taken to ER. Patient information not included in the ADR, but our institution has been using Pfizer COVID vaccine.
He has had a lot of symptoms since second COVID-19 vaccine 5 weeks ago-Pfizer vaccine. Notes tingling and numbness in his left arm, dizzy, nausea, "brain fog" and "loosing motor skills". Headaches are tapering off. He is on Amantadine from Neurology. His symptoms came on immediately after the 2nd shot. Severe symptoms- headache , brain fog. Had been in ED- had CT head. Saw neurology and then sent to Headache clinic. He has several people he knows with similar symptoms and had gone thru long term
CHEST PAIN (LEFT SIDE), SHORTNESS OF BREATH, LOW GRADE FEVER AND HEADACHE
Erythema, raise, pruritic, rash on upper thigh, and arms.  Presented to urgent care for steroid administration.
THE DAY AFTER THE PATIENT RECEIVED THE VACCINATION HE SPIT SOME BLOOD. HE DOES NOT KNOW IF IT RELATED TO THE VACCINE OR NOT. 2-3 MORE DAYS LATER THE PATIENT SPIT AGAIN AND THERE WAS MORE BLOOD. THE PHARMACIST AT PHARMACY (WHERE VACCINE WAS GIVEN) ADVISED THE PATIENT TO CALL HIS DR TO SCHEDULE AN APPT TO SEE IF THERE IS ANOTHER MEDICAL PROBLEM GOING ON.
Information has been received from a physician and a healthcare worker referring to unspecified number of patients of unknown ages and gender. On unspecified dates since 05-FEB-2015 the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (lot #, strength, dosage and route unspecified), which were exposed to temperatures outside of the recommended range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
hyporesponsive, hypotonic, pallid episodes x 2 lasting approx 5min each w/in 2hr of inj;1hr screaming spell next AM fine-fine since;
Temperature 102.7 at 10pm on 10-27-16 ran fever thru 9am on 10-28-16. No fever after 9AM 10-28-16. No other symptoms. Called mother 10-31-16 child doing well.
Within 24 hours, child became extremely congested in nose. Difficulty breathing while laying down and sometimes when upright. Engaged in new sensory seeking behaviors like biting, head banging. Irritable and almost manic. Has continued since then.
Within an hour, I had a severe attack of tachycardia, lasting approx 5 hrs,, incapacitating me to the extent I was too weak to move and when I did, would all but black out. I have had previous mild attacks but never with such severity and length. I have had the flu year annually for years. Consulted doctor following day and was advised to never had flu shot again.
Mother of the patient called our advise nurse at 10:37 PM on 12/23/2013 reporting the child had a fever and that she thought patient had a seizure. The child had a fever of 100.3 underarm. The advise nurse advised mother to take child to the ER. The ER determined the child had a febrile seizure. The patient was discharged and advised by ER to take tylenol and ibuprofen PRN for the fever.
31MAR, 02MAY, 03OCT90 pt vax;  did not seroconvert after 3rd dose.
Subsequent to receiving first and second dose of varicella virus vaccine live, on 7/23/99 and 8/23/99, the pts lab work on 11/12/99, revealed a titer of 0.52. Additional information has been requested.