chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Constipation; 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 CONSTIPATION (Constipation) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONSTIPATION (Constipation). At the time of the report, CONSTIPATION (Constipation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
she got tested positive on Covid virus; in between the 1st and 2nd dose she got tested positive on Covid virus; This is a spontaneous report from Pfizer-sponsored program. A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number: unknown), via an unspecified route of administration on 29Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 22Apr2021, the patient was scheduled for 2nd dose. On an unspecified date, the patient got tested positive on Covid virus in between the 1st and 2nd dose and she finished the quarantine last 19Apr2021.The lab test included Covid test, results: positive. Outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
gall bladder issues; This is a spontaneous report from a contactable consumer. An 85-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number not reported, via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. The patient experienced gall bladder issues on an unspecified date. Consumer is reporting about the Pfizer COVID-19 vaccine on behalf of her father in law, who got his first dose of the vaccine at the health department in (name), and was due to get his second dose on 08Feb2021, but he was in the hospital for like a week and a half. She says after he got out of the hospital they contacted the health department but they said they were only getting Moderna right now and he can't get Pfizer vaccine at that site. She says they have contacted different pharmacies and health care providers but they are not getting anywhere, and he needs to get back to get his second dose but they can't find Pfizer vaccine to get. Reporter clarified that her father in law got his first dose of the vaccine on 18Jan2021, and was due for his second on 08Feb2021, but he was hospitalized. Caller says that her father in law's hospitalization is not related to COVID-19, he had gall bladder issues and was recovering.  Information on the lot/batch number has been requested.
I started with severe chills all night to the point I could not quit shaking.  That next morning I couldn't walk without legs going numb and my vision blacking out, also nausea.   This happened 3-4 times before I got back in bed.  After getting up about 2 hours later I didn't have the "blacking out" anymore, just body aches and fever rest of day.
Stiff and sore neck; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 26Jan2021 11:00 as unknown, single for covid-19 immunization. The patient medical history was not reported. Concomitant medications included infliximab (REMICADE), omeprazole (OMEPRAZOLE), ascorbic acid, biotin, calcium pantothenate, cyanocobalamin, folic acid, nicotinic acid, pyridoxine hydrochloride, riboflavin, thiamine hydrochloride, tocopheryl acetate (MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE]) taken for an unspecified indication, start and stop date were not reported. On 27Jan2021, the patient experienced stiff and sore neck. The treatment was not received for the adverse event. The outcome of event was recovered.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
30 minutes after vaccine (After valid Quad. Inactive) vaccine got - itching (L) hand, the redness (L) arm, then Rx IM and Oral steroids. B/L Arm and B/L Leg itching and hives low back.
This case was reported by a consumer via call center representative and described the occurrence of eye red in a 61-year-old male patient who received SHINGRIX for prophylaxis. On 27th June 2018 13:00, the patient received the 2nd dose of SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced eye red. On an unknown date, the outcome of the eye red was unchanged. It was unknown if the reporter considered the eye red to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient reported that he noticed that white part on his left eye ball was red and it had gotten worse since. The patient had denied permission to contact their physician. No further details were provided. The patient would follow up with their health care provider.
severe allergic reaction; swelling; developed infection; had a flare up due to eating something that had egg in it a week ago; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  An elderly female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONDITION AGGRAVATED (medically significant) with onset Apr2022, outcome "unknown", described as "had a flare up due to eating something that had egg in it a week ago"; HYPERSENSITIVITY (medically significant), outcome "unknown", described as "severe allergic reaction"; SWELLING (medically significant), outcome "unknown"; INFECTION (medically significant), outcome "unknown", described as "developed infection". The events "severe allergic reaction", "swelling" and "developed infection" required emergency room visit. Clinical Information: Description of event: Patient had a severe allergic reaction with swelling and developed infection and had to go to the emergency room for treatment. This was the patient's first time getting a pneumonia vaccine. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Considering the nature of the reported events and product profile, a causal role of the suspect drug cannot be denied for the reported events.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.
patient stated that after about an hour after injection she became very sick feeling worse than when she had Covid. she had muscle tension and headache. The next morning she woke up with a swollen face and took Benadryl which reduced the swelling. as of 3/8 she is still experiencing a lot of pain over entire body as well as light shaking of limbs
VERTIGO; CONDITION AGGRAVATED; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient concerned an adult female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: ankylosing spondylitis, moderate to severe rheumatoid arthritis, moderate to severe chronic plaque psoriasis, and moderate to severe ulcerative colitis. The patient was previously received covid-19 vaccine ad26. cov2.s (dose 1) (dose number in series: 1) (suspension for injection, intramuscular, batch number and expiry was not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following covid-19 vaccine ad26. cov2.s (dose number in series: 1). The patient was previously received covid-19 vaccine ad26. cov2.s (dose 2) (dose number in series: 2) (suspension for injection, intramuscular, batch number and expiry was not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following covid-19 vaccine ad26. cov2.s (dose number in series: 2). The patient received booster covid-19 vaccine ad26.cov2.s (dose 3) (dose number in series 3) (suspension for injection, intramuscular, batch number and expiry was not reported) dose, start therapy date were not reported, 1 total administered for covid-19 vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. The drug was associated with Off label use (off label dosing frequency) (dose number in series: 3). No concomitant medications were reported. Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for ankylosing spondylitis, moderate to severe rheumatoid arthritis, moderate to severe chronic plaque psoriasis, and moderate to severe ulcerative colitis. On an unspecified date, the patient experienced vertigo, condition aggravated (flare up) (dose number in series: 3). The patient experienced vertigo when moving from the laying position with her head turned toward the right and moved into a sitting position. She had spoken to her health care provider. Covid vaccine caused a flare up. Vertigo was a side effect of her taking upadacitinib. It was unknown if patient was enrolled in a covid-19 Vaccine Trial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of upadacitinib was not changed. The patient recovered from condition aggravated, had not recovered from vertigo, and the outcome of off label dosing frequency was not reported. This report was non-serious.
A report was received from a healthcare professional on 12Nov02 concerning a 64 year old male vaccinee who experienced chills immediately after receiving Fluvirin and developed Balls Palsy 3 days after vaccination on 02Nov02. Immediately after receiving 0.5ml Fluvirin IM the vaccinee experienced chills which resolved on an unreported date. 3 days after receiving Fluvirin the vaccinee developed Bells Palsy with drooping of the left eye and the left side of the face and lips. Symptoms had not resolved at the time of the report. There was insufficient information to determine the reporter's causality assessment.
Patient was seen and given a physical prior to the HIB vaccine on Friday August 11,2017 and was in perfect Health. He got a high fever 103.6 on Saturday evening. He was given MOTRIN, fever came down. His fever came back again 103.8. Kept treating with MOTRIN. Called pediatrician's office Sunday morning was told to keep giving either TYLENOL or MOTRIN. On Monday took him to pediatric quick care. He still was having high fevers. Quick care said his ears were clear, throat was fine. He didn't think it was from the vaccine. Patient is NOT in daycare, has not been around anyone with a cold or illness. No runny or stuffy nose, no vomiting or diarrhea. Everything ruled out BUT the vaccine. No other explanation as to why he was having high fevers. Again was told to treat with TYLENOL or MOTRIN, and if still having fevers in 2 days to return.
ANAYPHYLAXIS REACTION; Shortness of breath; Chest hurt; Hypertension/blood pressure was has been on 151/91; Headache; Difficulty speaking; Foggy brain; Left hand numbness; Face numbness; Injection site lump; Injection site swollen, sore; Injection site swollen, sore; injection site red; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (ANAYPHYLAXIS REACTION) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylactic reaction to food. Previously administered products included for an unreported indication: FLU VACCINE VII. Concurrent medical conditions included Food allergy (Food allergy to dairy, beef and cantaloupes).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC REACTION (ANAYPHYLAXIS REACTION) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest hurt), HYPERTENSION (Hypertension/blood pressure was has been on 151/91), HEADACHE (Headache), DYSARTHRIA (Difficulty speaking), FEELING ABNORMAL (Foggy brain), HYPOAESTHESIA (Left hand numbness), HYPOAESTHESIA (Face numbness), VACCINATION SITE MASS (Injection site lump), VACCINATION SITE SWELLING (Injection site swollen, sore), VACCINATION SITE PAIN (Injection site swollen, sore) and VACCINATION SITE ERYTHEMA (injection site red). At the time of the report, ANAPHYLACTIC REACTION (ANAYPHYLAXIS REACTION), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest hurt), HYPERTENSION (Hypertension/blood pressure was has been on 151/91), HEADACHE (Headache), DYSARTHRIA (Difficulty speaking), FEELING ABNORMAL (Foggy brain), HYPOAESTHESIA (Left hand numbness), HYPOAESTHESIA (Face numbness), VACCINATION SITE MASS (Injection site lump), VACCINATION SITE SWELLING (Injection site swollen, sore), VACCINATION SITE PAIN (Injection site swollen, sore) and VACCINATION SITE ERYTHEMA (injection site red) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 151/91 mmHg (abnormal) 151/91 mmHg.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medicines were reported. Treatment medicines includes epinephrine pen, and benadryl; Sender's Comments: This case concerns a 46-year-old female with serious expected event of anaphylactic reaction, along with nonserious unexpected dyspnea, chest pain, hypertension, dysarthria, hypoesthesia, vaccination site mass, and expected headache, vaccination site pain, vaccination site swelling, vaccination site erythema. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
SLEEPING ALL DAY; DIDN'T SLEEP; SINUSITIS STARTED IN THE NIGHT AND IN MORNING, HE WOKE UP WITH MILD TO MODERATE HEADACHE FROM SINUS PRESSURE; FELT TIRED ON THE DAY OF VACCINATION, STARTED TO FEEL FLU-LIKE SYMPTOMS SUCH AS FEVERISH (DID NOT MEASURE TEMPERATURE), CHILLS, BODY ACHES AND DIFFICULTY BREATHING THROUGH NOSE; This spontaneous report received from a consumer concerned a 39 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-AUG-2021, the patient experienced felt tired, started to feel flu-like symptoms such as feverish (did not measure temperature), chills, body aches and difficulty breathing through nose. On 06-AUG-2021, the patient experienced sinusitis started in the night and in morning, he woke up with mild to moderate headache from sinus pressure. On 06-AUG-2021, the patient experienced didn't sleep. On 07-AUG-2021, the patient experienced sleeping all day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from felt tired on the day of vaccination, started to feel flu-like symptoms such as feverish (did not measure temperature), chills, body aches and difficulty breathing through nose, and had not recovered from sinusitis started in the night and in morning, he woke up with mild to moderate headache from sinus pressure, sleeping all day, and didn't sleep. This report was non-serious.
This case was reported by a consumer via call center representative and described the occurrence of nausea in a 55-year-old female patient who received SHINGRIX for prophylaxis. In October 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced nausea, fever, tiredness, headache, muscle pain, general body pain and lightheaded feeling. On an unknown date, the outcome of the nausea, fever, tiredness, headache, muscle pain, general body pain and lightheaded feeling were recovered/resolved. It was unknown if the reporter considered the nausea, fever, tiredness, headache, muscle pain, general body pain and lightheaded feeling to be related to SHINGRIX. Additional case details were provided as follows: The next day after vaccination, the patient experienced nausea, fever, tiredness, headache, muscle aches, body aches and felt lightheaded. These symptoms were lasted one day before resolving. The reporter did not consent to follow up.
hot flashes; trouble in breathing; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flashes) and DYSPNOEA (trouble in breathing) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HOT FLUSH (hot flashes) and DYSPNOEA (trouble in breathing). At the time of the report, HOT FLUSH (hot flashes) and DYSPNOEA (trouble in breathing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided Treatment for the events, were not provided   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Patients initials and contact information updated.
Mother states she noticed a rash on his arms on 10/10/00. She saw the doctor that afternoon and was dx'd with Idiopathic Thrombocytopenia. States child received immunogloblin at her doctor's office and again when in the hospital. Stated that in the hospital until 10/12/00. She is following-up with hematologist on 10/17/00.  Follow up on 12/02/2003: "Complete recovery sine initial hospitalization on 10/10/2000 to 10/12/2000.  Continue to have platelet levels drown on a regular basis.  Results are consistently within normal limits.  Whenever child is bruised, petechiae surrounds the bruise.  Child continues to bruise easily."
Itchy rash with hives started approximately 8 hours after flu vaccination. Off/on over next 48-72 hours.
Vaccine administered past the expiration date. The vaccine was labeled with a beyond use date when removed the from the freezer. The beyond use date used was past the manufacture expiration date. The vaccine was administered after the manufacture expiration date.
Booster; she has a few (hives) on her lower back; hives from elbow to inside of forearm to the top of her wrist of right arm; she has a few (hives) on the other hand (left); This is a spontaneous report from a contactable consumer (patient) reported for herself. A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 3 via an unspecified route of administration, administered in arm right on 22Oct2021 (Batch/Lot number was not reported) (age at vaccination 57-year-old) as dose 3 (booster), single for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient received historical vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered on 11Mar2021 (Lot number: EN6208) (age at vaccination 56-year-old) as dose 1, single, dose 2 via an unspecified route of administration, administered on 01Apr2021 (Batch/Lot number: ER8737) (age at vaccination 56-year-old) as dose 2, single for covid-19 immunization. The patient experienced hives from elbow to inside of forearm to the top of her wrist of right arm on 24Oct2021, she has a few (hives) on the other hand (left) on an unspecified date of 2021 and she has a few (hives) on her lower back on 27Oct2021. Seriousness criteria of the events was not reported. The adverse events resulted to visit physician office. Therapeutic measures included she was given a prescription for Benadryl at night and Cetirizine HCL 10mg as needed during the day were taken for all the events. The outcome of the event hives from elbow to inside of forearm to the top of her wrist of right arm and she has a few (hives) on her lower back were not recovered, she has a few (hives) on the other hand (left) was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Fatigue, hunger, nausea for 1 day. Got rest and ate to help alleviate symptoms.
After the 15 minute wait following the shot I was allowed to leave, but on my way home while driving I began to experience throat tightening and difficulty breathing that became increasingly worse until I could not continue to drive safely. I pulled over and dialled 911 for help.
Symptoms experienced from the vaccine cannot be transmitted; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (Symptoms experienced from the vaccine cannot be transmitted) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Symptoms experienced from the vaccine cannot be transmitted). At the time of the report, VACCINATION COMPLICATION (Symptoms experienced from the vaccine cannot be transmitted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was reported.  No treatment medication was reported.
I am pregnant, due 10/26/21. Adverse reactions included nausea, vomiting, low grade fever, severe body aches, chills, headache and restlessness
This is a spontaneous report received from a contactable consumer (patient's husband). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The Patient received the covid vaccine and the Patient did not have any complications, other than some joint pain on an unspecified date. Outcome of the event was unknown.  Follow-up attempts are needed. Information on the lot/batch number has been requested.