chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Reaction to Moderna and Humira did not wotk; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Reaction to Moderna and Humira did not wotk) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced IMMUNISATION REACTION (Reaction to Moderna and Humira did not wotk). At the time of the report, IMMUNISATION REACTION (Reaction to Moderna and Humira did not wotk) outcome was unknown.            No concomitant medications were reported No treatment drugs were reported It was unknown if patient was enrolled in a COVID-19 vaccine trial.   Reporter did not allow further contact
This spontaneous report was received from a pharmacist and refers to a 26 year old male patient with asthma who was an illegal drug user. The patient had no drug reactions or allergies. On 28-SEP-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, route of administration, lot# and expiration date were not reported). Concomitant therapies were not reported. Since the date of vaccination (reported as "since then"), the patient experienced an injection site reaction with a swollen and red unspecified upper arm. On an unknown date, in 2015, the patient experienced an unspecified dog bite and was subsequently admitted to the hospital due to this event (date of the hospitalization was not provided). The patient sought medical attention and he was given a warm compress as a treatment for the events. No lab diagnostic studies were carried out. The outcomes of the events were not reported. Relatedness between the events and PNEUMOVAX 23 was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a physician via sales rep and described the occurrence of injection site pain in a female patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain and influenza-like symptoms. On an unknown date, the outcome of the injection site pain and influenza-like symptoms were unknown. It was unknown if the reporter considered the injection site pain and influenza-like symptoms to be related to Shingrix. Additional information was received as follows: The age at vaccination was not reported. The patient experienced pain at injection site and flu like symptoms. The reporter agreed to provide follow up information.
Left arm was red and swollen; Left arm was red and swollen; This is a spontaneous report from a contactable consumer (patient's mother).  A 26-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number: ER8731 and expiry date was not reported), via an unspecified route of administration into left arm on 20Apr2021 at 15: 00 (at the age of 26-year-old) as Dose 2, single for COVID-19 immunization. Medical history and family history was not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EP6955) via an unspecified route of administration on 28Mar2021 at 14: 00 for Covid-19 immunization after being exposed to hundreds of kids at skatepark. The patient's concomitant medications were not reported. Patient did not receive prior vaccinations within 4 weeks and did not receive any additional vaccines while taking BNT162B2. On 22Apr2021, the patient's Left arm was red and swollen after getting second shot of the Pfizer Covid vaccine. Treatment information and laboratory data was not reported. The outcome of adverse events was not recovered at the time of reporting.  No follow-up attempts are needed. No further information is expected.
9FEB93 9PM father reported pt was limp & not breathing; no fever; no prolonged crying; no local reactions @ inject site;
Abdominal pain (chronic gastritis), Anxiety, trouble remembering recent information, short term memory loss, depression, Insomnia, anxious, runny nose, nervousness, weight loss,  2/8/07 Received medical records from VAMC which reveal that from 8/2004 to present patient experienced: Major depression, mod to severe; neck & back pain; smoker; Hep C +; BPH. He has been under ongoing psych care for depression w/suicidal ideation.  Has been evaluated & treated by PMR & PT/OT for neck/back/shoulder pain & found to have muscle spasm, DJD & rotator cuff tendinitis.  Began to have neck & shoulder pain s/p trauma while on active duty.  Has been evaluated & treated by GI service for abdominal pain w/nausea & found to gastritis & was H.pylori +.
Subcutaneous injection; A spontaneous report was received on 23 Feb 2021 from a healthcare professional for a male patient of an unspecified age, who received Moderna's COVID-19 vaccine (mRNA-1273) and it was given incorrect via subcutaneous as oppose to intramuscular  The patient's medical history was not provided. No concomitant product use was reported.  On 22 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) subcutaneously for prophylaxis of COVID-19 infection. The patient's skin was pinched, and vaccine was injected subcutaneously as oppose to intramuscularly.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event, incorrect subcutaneous vaccine shot as oppose to intramuscular, was considered resolved on 22 Feb 2021.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # unknown) with no associated AEs reported.
Possible reaction to medication ongoing since January, peeling, swelling of lips and itching, stopped fenofibrate about 2 nights ago, symptoms seem to get worse when taking. Allergic urticaria. Inject/Meds/Vaccines: DEPO-MEDROL 40mg, Prednisone 10 MG (21) pack, Once a day as directed by Taper Pack, 6 days, 0 refills, VISTARIL 25 MG capsule, as needed 1 BID for itching, 30 days, 0 refills. Personal history of anaphylaxis. Epinephrine 0.3 MG/0.3ML kit, as needed IM injection x1 for anaphylaxis may repeat in 5-10 min if needed, 30 days, 0 refills.
fever of 100.9 F; Chill; pain in left hand; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in left hand), PYREXIA (fever of 100.9 F) and CHILLS (Chill) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 009C21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (pain in left hand). On 28-Apr-2021, the patient experienced PYREXIA (fever of 100.9 F) and CHILLS (Chill). On 31-Mar-2021, PAIN IN EXTREMITY (pain in left hand) had resolved. At the time of the report, PYREXIA (fever of 100.9 F) and CHILLS (Chill) outcome was unknown. Not Provided         This case was linked to US-MODERNATX, INC.-MOD-2021-095068 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-095068:Case for dose 2
pt had fever 101.7 & bulging fontanelle w/in 24hr of vax;
Large red, warm, firm swelling on right arm at site of vaccine. Lesion 60 cm x 55 cm.
vaccination site swelling; Vaccination site erythema; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (vaccination site swelling) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced VACCINATION SITE SWELLING (vaccination site swelling) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). At the time of the report, VACCINATION SITE SWELLING (vaccination site swelling) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drugs not provided. Treatment information not reported.
This spontaneous report was received from nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about patient's pertinent medical history reported and concurrent conditions. The patient's concomitant therapies included sterile diluent. On an unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot number M038228 with expiration date 06-MAR-2018; lot number M049123 with expiration date 13-JUN-2018; lot number reported as M048201 with expiration date 05-JUN-2020 and lot number reported as M044719 with expiration date 07-MAY-2018 (dose, route and anatomical location were not reported) for prophylaxis. The vaccines were exposed to temperature of -14 Celsius (C) during 9 days, there was no previous temperature excursion and digital data logger was filed. This is one of two reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1706USA003470.
3 members of the family who had Heart problems after taking the vaccines; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:  An elderly male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "3 members of the family who had Heart problems after taking the vaccines".  Additional information: The reporter mentioned that these vaccines are dangerous according to the news and it can be seen that all the healthy people are dying from heart failure. The reporter had 3 members of the family who had heart problems after taking the vaccines.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s) : PFIZER INC-202300034770 same reporter/vaccine/event, different patient; PFIZER INC-202300034771 same reporter/vaccine/event, different patient;
Malaise, weakness, chills, productive cough, itching aching throat. Stomach ache 2x loose BM, during the week following.
Presented to ED w/syncope; tested COVID+ & admitted for COVID-19 & severe sepsis; tx w/abx, steroids, Singulair, zinc; pt did not require O2 therapy; dc'd home stable condition
3 months old was given Kinrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 12-APR-2023, the patient received Kinrix (left thigh). On 12-APR-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 3 months old was given Kinrix). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date:13-APR-2023 The reporter was the patient's mother. She stated that his 2 months old baby was administered Kinrix a day before yesterday. The reporter consented to follow up. The patient administered the Kinrix vaccine at wrong age which led to Inappropriate age at vaccine administration.
Breakthrough case admission after 4 vaccines Moderna 2/20/21 Lot# 031L20A;  Moderna 3/20/21 Lot# 030A21A;  Moderna 12/1/21 Lot# 013F21A;  Moderna 6/24/22 Lot# 059A22A
In February coughs after the vaccination and chest congestions took some antibiotics. The first week of march diagnosed for palmonogist called ammonia.  For 20 days I had antibiotics and after that i had blood test and physical on 15 march with the primary doctor. Protein test and allergies test. The test indicated the blood levels for were high. Regpa treatment, shrug/Strauss syndrome and was admitted in the hospital in April because of the syndrome had fatigue. Heart rates test and kidneys test and kind of vascular disease and they had me on steroids. EGPI diagnosed since then.
I experience back pain and light bleeding period. The symptom has been presented from 01/13/11 until today 01/30/11. Which I think, it should not be my period schedule. My period is pretty normal and never last long.
pt cried & held breath & became sleepy;mom attempted to comfort child;pt fell asleep on way from exam room to exit;mom stated that this was nl behavior-to fall asleep p/crying hard;on exam T36.9, HR 131, BP 119/77, good color;02 sat 87-97%
Hi temp (>101 degrees) for approx 12 hours after injection, malaise, lethargy. Pt reports feels well after 6 am the next morning.
The pt experienced hives which were present on upper thighs, abdomen, arms and face. Accompanied by a fever of 102 rectally. Brought in on 5/1/01 to health department.  Vaccines given on 4/30. Referred to PMD.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: Numbness, tingling in hands/ mouth/ tongue. History of similar reactions with other vaccinations per patient. Patient has a phobia with needles.
Tested positive for COVID-19; Lack of drug effect; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038c21a and 03Bc21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-May-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 25-Jun-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 13-Jan-2022, the patient experienced COVID-19 (Tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not have allergies to medications, food and other products. Patient did not have chronic or long standing health conditions. No concomitant medications were reported. No treatment information was reported.  Company Comment: This spontaneous case concerns a 21-year-old, female patient with no medical history reported, who experienced the unexpected, non-serious, AESI of COVID-19. Additional non-serious event of Drug ineffective was also reported. The events occurred approximately 6 and a half months after the second dose of mRNA-1273 vaccine. SARS-CoV-2 test done on 13-Jan-22 was positive. Current COVID-19 pandemic is a confounder. Outcome of the events was Unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-504787 (Patient Link).; Sender's Comments: This spontaneous case concerns a 21-year-old, female patient with no medical history reported, who experienced the unexpected, non-serious, AESI of COVID-19. Additional non-serious event of Drug ineffective was also reported. The events occurred approximately 6 and a half months after the second dose of mRNA-1273 vaccine. SARS-CoV-2 test done on 13-Jan-22 was positive. Current COVID-19 pandemic is a confounder. Outcome of the events was Unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Fatigue; Headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-023809 (Moderna).  A 35-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Trimethoprim for Drug allergy. The following information was reported: FATIGUE (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown".  Additional information: She had very mild side effects with Pfizer doses. She might have had fatigue and headache, but no side effects from the booster dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
He threw up his dinner; Running a low grade fever of 103°F; Body aches; Has not been feeling well; It felt like he had the flu; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache), VOMITING (He threw up his dinner), PYREXIA (Running a low grade fever of 103°F) and PAIN (Body aches) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031421A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Dec-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache), PYREXIA (Running a low grade fever of 103°F), PAIN (Body aches), MALAISE (Has not been feeling well) and INFLUENZA (It felt like he had the flu). On 16-Dec-2021, the patient experienced VOMITING (He threw up his dinner). At the time of the report, CHILLS (Chills), HEADACHE (Headache), VOMITING (He threw up his dinner), PYREXIA (Running a low grade fever of 103°F), PAIN (Body aches), MALAISE (Has not been feeling well) and INFLUENZA (It felt like he had the flu) had not resolved.            No concomitant medications provided. No treatment medications provided.
I received a Moderna Covid-19 immunization on 2/1/2021. Here are the after effects I am experiencing:   (1) mild sore throat and mild flu-like symptoms (slight headache, malaise, & fatigue) beginning 3 days after my shot continuing to this day, 13 days after shot (2/14/2021).            (2) A lump, between the inside of my mouth & the outside of my cheek, which began on 2/6/21, 5 days after Covid-19 Moderna vaccination. On 2/6/21, I discovered a raison-size lump in my cheek. I could feel it with my tongue. By midnight, swelling visible from outside, in the mirror, was .5 inch from top to bottom & 1.5 inches from side to side, from below the left edge of my mouth toward the middle of my mouth. On 2/7/21, at 1:30 p.m., I could see the lump in the mirror, inside of my mouth, about .75" wide; I could see it from the outside of my cheek in the mirror, a swollen area about .75" from top to bottom & 1.5 inches wide. I felt puffiness, which I couldn't see, which extended 4" up my cheek & down across the visibly puffy area. Slightly after midnight on the morning of 2/11/21, what I felt with my tongue was between the size of a raison & an almond; from the outside, the swelling was about .75" from top to bottom & 1.75" across. Now, 13 days after my vaccine shot, the lump has receded to be about the size of a BB and the swelling outside of my mouth is going down. Is this a Covid-19 vaccination reaction? Is it serious?  I read in the Washington Post that folks who have a reaction to shot #1 tend to have more of a reaction to shot #2, so that makes me anxious.  Should I even take shot #2?
It started early morning with loud screaming and moving around. Very sleepy, didn't want to open eyes, slept for an unusual amount of time. He was very pale and lethargic. He vomited and was very limp and unresponsive. He also has bloody stool. We went to one emergency room and they turned us away saying it was too serious for their office and sent us to another ER. There we were told he was very dehydrated and so they started him on an IV. They took X-Rays sent us to a third hospital and took more xrays of his intestine came out to be Intussusception.
MMR II was shipped without the DILUENT MRK; This spontaneous report was received from a pharmacist referring to a 48 year old female patient. The patient's medical history included unspecified immunisation. Information about patient's concurrent condition, concomitant medication was not reported.  On 07-FEB-2020, the patient was unable to get the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) albumin status: rHA (recombinant Human albumin) (lot #R036582, expiry date:17-DEC-2020) because it was shipped without sterile diluent (product dispensing error). It was reported that the patient was scheduled for the vaccine because she had negative titers and needed to receive the vaccine as she was a medical device salesperson and needed it for her job.
fever 102 , chills , myalgias on day after vaccine symptoms persisted for 12 days CBC done on 3/3/21 shows PANCYTOPENIA  referred to hematology and plan is for monitoring of CBC  for now fever has improved
Mom reported post baby received Prevnar a persistent blanched area approx. 2cm circ. from inj. site with increase superficial blood vessels beyond the area of blanching.