chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Seizure (partial complex) occurred approximately 5 hours after immunization. Off and on seizure for 2 hours; active seizure witnessed by physician. Patient has known seizure disorder/developmental delay.
BI-lateral Pulmonary Emboli; This is a spontaneous reporter from a contactable physician via Pfizer Sales Representative. The physician reported same events for 4 patients (3 patients were male, 1 was female). This is for one of 3 male patients. An elderly male (age at 70 or older) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) at single dose for COVID-19 immunisation on unknown date. Relevant history and concomitant drug was unknown. The patient experienced BI-lateral Pulmonary Emboli (serious due to medically important) on unknown date. The outcome of event was unknown.     The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: The information provided is limited and does not allow a meaningful medical assessment of the case. However, based on the available information in the case, a possible contributory role of the suspect product BNT162B2 to the development of reported event of Pulmonary embolism cannot be completely excluded. The case will be reassessed further upon receipt of additional information. 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.,Linked Report(s) : US-PFIZER INC-202101406989 Same reporter, different patient/event.
TROUBLE TO MOVE HEAD AND ARM; JOINT PAIN; MUSCLE PAIN; TIREDNESS; HEADACHE; DRY MOUTH; BITTER TASTE; This spontaneous report received from a patient concerned a 53 year old female. 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 not reported, batch number: 207A21A, expiry: 23-JUN-2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 06-MAY-2021, the subject experienced dry mouth. On 06-MAY-2021, the subject experienced bitter taste. On 06-MAY-2021, the subject experienced headache. On 07-MAY-2021, the subject experienced trouble to move head and arm. On 07-MAY-2021, the subject experienced joint pain. On 07-MAY-2021, the subject experienced muscle pain. On 07-MAY-2021, the subject experienced tiredness. Treatment medications (dates unspecified) included: naproxen sodium, and cyclobenzaprine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle pain, headache, dry mouth, bitter taste, tiredness, and joint pain, and the outcome of trouble to move head and arm was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.
0.25 ml of Pediatric covid-19 vaccine was given to adult. After notifying supervisors and Dr. Patients were called back to receive 0.25 ml of adult Covid-19 vaccine. Patient did not have any adverse reactions.
Feels like I have the COVID Virus again. Fever, chills, shakes, sore throat, restless, weak, no appetite, 102 fever on first day 101 fever second day. Tylenol to relieve fever and sever body aches.
Client received a TDaP and MMR in her left arm, Hep A in her right arm.  Complained that her left upper arm has been very painful when she tries to move it.  No redness.  If continues advised to see MD.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication.  On or about 23-JUL-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy for routine health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX vaccine, the patient developed a painful rash under her left eye and nerve pain causing throughout the left side of her face, contributing to reduced vision in her left eye. Thereafter, in response to these complaints, the patient presented to her primary care physician/MD at a clinic, and was diagnosed as suffering from shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Upon internal review, the event of Herpes zoster ophthalmicus was determined to be medically significant. Additional information has been requested.
pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (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.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain). At the time of the report, VACCINATION SITE PAIN (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Disconfort; Egg sized inflammation of the lymph node under the armpit; This spontaneous case was reported by a nurse and describes the occurrence of DISCOMFORT (Disconfort) and LYMPHADENOPATHY (Egg sized inflammation of the lymph node under the armpit) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included INSULIN for Type 1 diabetes mellitus.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced DISCOMFORT (Disconfort) and LYMPHADENOPATHY (Egg sized inflammation of the lymph node under the armpit). The patient was treated with IBUPROFEN for Swelling, at a dose of 400mg during 4 days. At the time of the report, DISCOMFORT (Disconfort) and LYMPHADENOPATHY (Egg sized inflammation of the lymph node under the armpit) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) and CHILLS (Chills) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced MYALGIA (Body aches) and CHILLS (Chills). At the time of the report, MYALGIA (Body aches) and CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-090242 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090242:Crosslinked case
This spontaneous report as received from a physician refers to a fetus patient with approximately date of conception on 07-JUN-2012. The patient's mother was vaccinate with GARDASIL third dose on 01-JUN-2012. On 06-OCT-2012 a ultrasound was performed to the patients mother and revealed fetal Pelviectasis. On 09-JAN-2013 follow up growth of fetal pelviectasis was performed. It was reported the estimated delivery date on 28-FEB-2013. The outcome of fetal pelviectasis is unknown. Additional information has been requested.
Causing psoriasis to flare; Initial information was received on 13-Oct-2020 regarding an unsolicited valid non-serious social media case from the patient.  This case was linked to case 2020SA290167 (same reporter).  This case involved an unknown demographic patient who experienced psoriasis flare (psoriasis), after receiving INFLUENZA VACCINE.  The patient had received flu vaccine since last three years which caused his/her psoriasis to flare.  The patient's past medical treatment(s), family history and concomitant medication were not reported.  At the time of the event, the patient had ongoing Psoriasis.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient developed non-serious psoriasis flare (psoriasis), (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that, the patient had broken out 2 weeks after taking these shots.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was not reported.  There would be no information available on the batch number for this case.
Pt develop papular rash in bilat armpits and inguinal crease 15 days post smallpox vaccination.  Good take.
Irregular period. Spotting and then full blown cycle. This is irregular due to before receiving the vaccine I did not have a menstrual cycle.
Extremely high fever 103. Body shakes so bad I couldn?t stand up. Accelerated heart rate on and off. Contemplated going to ER. Was worse than my Covid symptoms when I had it. Was like this for three days.
fever of 103 ax x 4 days-irritable; started about 3 hrs p/vax; APAP given q 4 hrs around the clock; phone call to MD-did not see pt, but ordered next ped DT instead of DTP;
patient has been experiencing a redness at the injection site, swelling, and hot to the touch sensation. she has used ibuprofen and ice but it has lasted about 2 days so far
Pain at injection site; high persistent fever; Chills; Nausea; Severe headache; Diffuse aches; This is a spontaneous report from a contactable physician (patient). A 28-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL1284), intramuscularly in the left arm, on 08Jan2021 at 16:45 (at the age of 28-years-old) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 22Dec2020 for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced pain at injection site, high persistent fever, chills, nausea, severe headache, and diffuse aches on 09Jan2021 at 06:00. The events were reported as non-serious. The events were reported to have started 12 hours after vaccination. The patient did not receive any treatment for the events. The clinical outcome of pain at injection site, high persistent fever, chills, nausea, severe headache, and diffuse aches was recovered in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
12/2/22 severe blurred vision /  could  not read or drive . But could see well enough to walk around house   12/3/22-12/4/22 blurred vision disappeared / had severe sore throat, runny nose, migraine  ,
headaches since vaccine; 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 HEADACHE (headaches since vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 HEADACHE (headaches since vaccine). At the time of the report, HEADACHE (headaches since vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided  No Treatment medications were provided
swollen lymph nodes, axillary, above left and right breasts. sore, and tender to touch. consistent pain.
Patient had a skin reaction to vaccine approximately 10 days after injection. The reaction was approximately 3 inches in diameter, was itchy, red, had a knot under the skin and was warm to the touch.
This spontaneous report as received from a registered nurse refers to a 56 years old female patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated IM with the first 3 doses series of RECOMBIVAX HB on 09-APR-2011, 21-MAY-2011 and 22-SEP-2011 and the second 3 doses series of RECOMBIVAX HB on 24-OCT-2011, 22-MAR-2012 and 14-MAY-2012. The dosage information was 10 microgram each dose. No other co-suspects were reported. There was no concomitant therapy. The nurse reported that the patient did not respond to the first series of RECOMBIVAX HB, and anti-HBs titers levels were less than 0.1 on 22-OCT-2011. The second series of the vaccine was given, but anti-HIBs titers levels were still low at less than 0.26 on 11-JUL-2012. The patient contacted the nurse for medical attention. At the time of the report, the outcome was unknown. Additional information is not expected.
immobile/being immobile during the night; pain on the interior of his left arm  / sore, stiff and painful; sore, stiff and painful; pain in the arm pit; sore/painful; This case was reported by a pharmacist via call center representative and described the occurrence of injected limb mobility decreased in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th May 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, 1 week after receiving Shingrix, the patient experienced injected limb mobility decreased, pain in arm, stiffness, axillary pain and pain. On an unknown date, the outcome of the injected limb mobility decreased, pain in arm, stiffness, axillary pain and pain were not recovered/not resolved.   It was unknown if the reporter considered the injected limb mobility decreased, pain in arm, stiffness, axillary pain and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported pain on the interior of his left arm toward the arm pit but not all the way up to the armpit.  It was not near the injection site and was not a burning pain.   It was sore, stiff and painful. The symptoms presented a week after receiving the vaccine.   It presents in the morning after being immobile during the night and said he sometimes forgets about it during the day. The reporter consented to follow up.
My daughter, although has cognitive issues, has not ever displayed any adverse behavior.  We first noticed some unusual behavior on March 31st 2021.  Three days later, on April 3rd, her behavior became more noticeable and unusual for her.  She was saying things that didn't make any sense and wasn't sleeping well or not at all.  On Sunday April 4th, her behavior intensified into delusions and hallucinations.  She was talking to people not there and making bizarre statements.  She was taken to emergency hospital late Sunday night and given a blood and urine test and sent home.  By Monday morning, she had not slept the entire night and was shouting out, trying to leave the house and her hallucinations and delusions had intensified.  We took her to Emergency room, where she was diagnosed with psychotic behavior and was admitted to the psychiatric ward.  She is expected to be released today, April 11th, 2021.
This is a spontaneous report from a non-contactable consumer received via a Pfizer sales representative. This female patient in her 30s received a single dose of PREVNAR 13, via an unspecified route of administration in arm on 10Dec2015 and prednisone (manufacturer unknown), via an unspecified route of administration from 10Dec2015 to 11Dec2015 at 1x/day for back disorder. Medical history included ongoing asthma. The patient took an unspecified asthma medication. Concomitant medications were not reported. The patient experienced abscess thyroid, she was having trouble swallowing, she had swelling at injection site, soreness and redness at injection site, lump the size of a walnut on her thyroid; thyroid function came back not normal, she woke up and felt awful, all on 11Dec2015 with outcome of unknown. Clinical course was reported as follows: The patient received PREVNAR 13 on 10Dec2015. She woke up and had a lump the size of a walnut on her thyroid on 11Dec2015. She went back to her primary care doctor and felt awful on 11Dec2015. She woke up on 11Dec2015 and was having trouble swallowing. She contacted her PCP who sent her for the CT and then went to the surgeon who started her on antibiotics (SEPTRA) and she went back to the surgeon on 14Dec2015. Blood work on 11Dec2015 was done by the surgeon and some of her thyroid labs came back not normal. A bunch of different panels were run with unknown results. White blood cell count was normal. The patient had also swelling at injection site, it was also sore and red. The patient stopped taking the steroids on 11Dec2015 because she was afraid to take it with an infection.
high fever; Chills; severe body aches; This is a spontaneous report from a contactable consumer (patient husband). A female patient of an unspecified age received bnt162b2 (PFIZER BIONTECH VACCINE FOR COVID-19, solution for injection, lot number was not reported), dose 2 via an unspecified route of administration on may2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unknown date, the patient received the second shot and after 24 hours she experienced a high fever, her fever was 101.7. Patient also had chills and severe body aches. The outcome of the event was unknown.   No follow-up attempts were completed; information about lot/batch number could not be obtained.
Pruritis and erythema without pain on the right thigh (9/17/03). Cephaloxin and benadryl started. Follow up 9/19/03 increased area of tenderness and arid margin of erythema with fever 102.8 and pain of the right knee. Pt sent to medical center ER.
lack of appetite (eating way less than usual); sleeps more than usual; fatigue; muscle pain; chills; headache; arm swollen; pain and tenderness on arm; nausea when trying to eat; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swollen), DECREASED APPETITE (lack of appetite (eating way less than usual)), HYPERSOMNIA (sleeps more than usual), PAIN IN EXTREMITY (pain and tenderness on arm) and NAUSEA (nausea when trying to eat) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) 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 medical history reported).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced PERIPHERAL SWELLING (arm swollen), PAIN IN EXTREMITY (pain and tenderness on arm) and NAUSEA (nausea when trying to eat). On 30-Dec-2020, the patient experienced HEADACHE (headache). On an unknown date, the patient experienced DECREASED APPETITE (lack of appetite (eating way less than usual)), HYPERSOMNIA (sleeps more than usual), FATIGUE (fatigue), MYALGIA (muscle pain) and CHILLS (chills). On 30-Dec-2020, NAUSEA (nausea when trying to eat) had resolved. At the time of the report, PERIPHERAL SWELLING (arm swollen) and PAIN IN EXTREMITY (pain and tenderness on arm) outcome was unknown, DECREASED APPETITE (lack of appetite (eating way less than usual)), HYPERSOMNIA (sleeps more than usual), FATIGUE (fatigue), MYALGIA (muscle pain) and CHILLS (chills) had not resolved and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 24-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX vial (dose, route, lot # and expired date were not reported) that was improperly stored at 77F for a presently unknown time frame. Concomitant therapy was not reported. No adverse effects reported. Additional information has been requested.
Pt. received vaccine. Approx. 20 minutes after injection child presented with rash on shoulders, R arm. BENADRYL 25mg po given. Rash improved, left school with parent.
Pt given a pedi/adolescent dose of Hepatitis A. Pt was out of the age range of the vaccine and will need to be revaccinated.
Muscle weakness/pain. Muscle weakness has been present for 3 weeks & got progressively worse. 1 month post injection pain is resolving slowly, but still having some pain with lifting.