chrisvoncsefalvay/vaers-outcomes huggingface dataset:
elevated temperature; rash all over; This spontaneous case was reported by a consumer and describes the occurrence of BODY TEMPERATURE INCREASED (elevated temperature) and RASH (rash all over) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced BODY TEMPERATURE INCREASED (elevated temperature) and RASH (rash all over). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 12-Mar-2021, BODY TEMPERATURE INCREASED (elevated temperature) and RASH (rash all over) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  Concomitant product use was not provided.      Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Additional information received on 15-JUL-2021 and reporter information updated
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. Developed severe bone and joint pain following vaccination. His blood work showed positive evidence of auto-immunity. (OMIC)
Patient complains of stomach upset, diarrhea, and "bone pain" & chills.
We were against the MMR and tried to avoid giving it to him but our School forced us, no MMR shot no school! So Doctor gave him the first MMR shot AND the FLU Shot at the same time. I would NEVER would have let him give both shots, only MMR. Pretty stupid choice from Dr!!!Awoke with chills, super wet, super high fever 105.2. Red bumps, hives, sore throat. We soaked him in the bath with room temp water until the fever came down. It is now 11/24/2012 and we have been giving patient 2 tsp doses of Motrin since 11/17/2012, every 6 to 8 hours. If we stop his fever jumps back up to 103 to 104.8. Took him back to Doctor, asking for blood work to be done, and was told that we should wait until Sunday 11/25/2012. If his fever doesn't break by then to bring him in for blood work. This is why I refused as I knew that this would not turn out well!
Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from Non-health professional. This case involves female patient of an unknown age who experienced itchy, slightly raised red rash developed all over top half of arm and rash is warm to touch and the arm is still very red, swollen, itchy and painful, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported (expiry date, route and site of administration were unknown). On an unknown date, the patient developed a non-serious itchy, slightly raised red rash developed all over top half of arm and rash is warm to touch and the arm is still very red, swollen, itchy and painful of an unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Relevant tests were not reported. Final diagnosis was rash is warm to touch and the arm is still very red, swollen, itchy and painful, slightly raised red rash developed all over top half of arm and itchy. It was not reported if the patient received a corrective treatment. The outcome of the events were reported as unknown. List of documents held by sender- none.
Warmth of skin at injection site in the left upper arm; Itching at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warmth of skin at injection site in the left upper arm) and VACCINATION SITE PRURITUS (Itching at injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ATORVASTATIN and VITAMINS NOS for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warmth of skin at injection site in the left upper arm) and VACCINATION SITE PRURITUS (Itching at injection site). At the time of the report, VACCINATION SITE WARMTH (Warmth of skin at injection site in the left upper arm) and VACCINATION SITE PRURITUS (Itching at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication details was reported.
Started with nausea and aches, low fever on 25 Mar; persisted for only about 6 hours. Some digestive/diarrhea issues on 26 Mar. Did not check arm until 26 Mar; injection site is warm to touch and slightly itchy, redness area a little larger than a silver dollar.
Altered mental status, confusion, nausea vomiting, acute metabolic encephalopathy
Swollen lymph nodes under armpit and near collar bone. Have not had treatment for reaction to booster.  Will see PCP on 1/10/2022 for annual visit.  Will advise at visit of condition/reaction.
Body aches, fever 99.6, headache, very sore, red and warm at site of injection. Using ibuprofen every four hours.   No fever and body aches aren?t as bad as this mort.
diaphoretic passed out;lungs clear no wheezing;4:45 resp easy & regular;BP 90/60;
Allergic reaction to antibiotic Cipro (have never had any reaction to antibiotics previously)   Dehydration  Fatigue Brain fog  Elevated d dimer  Abdominal Gas pains  Concentrated Muscle pains in various parts of the body, arms, legs, chest, head neck  Ovarian cyst (have never had any previously)  Lymph nodes swollen and painful in neck, both underarms and collar bone  Had multiple tests and blood tests to see if other issues and all clear
During Colonoscopy prep after drinking first 8 ounce dose of Miralax / Gatorade solution began to get hot, couldn't breath, called the doctors office, while on hold passed out and cracked open my head.  Woke up on the floor called doctors office again, Son came home called 911.  By the time I was in the ambulance I had hives over 90% of my body and skin was bright red.  They used an EPI and benadryl before transport to the ER.  Ended with  Staple in skull, stopped taking all medications.
sore limbs; numbness in her fingers; brain fog; limbs falling asleep; hands were cold and numb, dropping items, clumsy with her hands; hands were cold and numb, dropping items, clumsy with her hands; sore arm; nerve pain going up and down her arms and hands; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date 24Mar2021 (Lot number: EN6205, Expiration Date: 28Apr2021) at the age of 56 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore limbs"; HYPOAESTHESIA (non-serious) with onset 05Apr2021, outcome "recovered" (16Apr2021), described as "limbs falling asleep"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbness in her fingers"; CONFUSIONAL STATE (non-serious) with onset 10Apr2021, outcome "recovered" (15Apr2021), described as "brain fog"; NEURALGIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "nerve pain going up and down her arms and hands"; PERIPHERAL COLDNESS (non-serious), HYPOAESTHESIA (non-serious) all with onset Apr2021, outcome "recovered" (Apr2021) and all described as "hands were cold and numb, dropping items, clumsy with her hands"; PAIN IN EXTREMITY (non-serious) with onset 24Mar2021, outcome "recovered" (26Mar2021), described as "sore arm".  Additional information: The patient had no prior vaccinations within 4 weeks and no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  No follow-up attempts are possible. No further information is expected.
Pt in clinic for 4 month old well care and immunizations given, #2 DTaP, IPV, Hib, Prevnar. Pt and parent returned approx 30 minutes after vaccine administration. Pt had edema around mouth and hives on face, chin, neck and chest. Epinephrine and Benadryl administered in clinic. EMS called and pt sent to local ER. Pt totally recovered with no further interventions required.
Swelling, redness, and warmth of the upper arm a week after injection. Cold compress and Tylenol administered with no relief redness and swelling spreading across arm. Shoulder, neck and arm pain. Also experiencing nausea.
Cough Nasal Congestion  Headache Fatigue Poor Appetite Chills Body Aches
About 30 min after vaccine administration, she felt generalized pruritis that resolved the next day.
The patient came in 7/1 to report reaction which included redness and inflammation at the injection site approximately the diameter of a half dollar. I recommended she take oral BENADRYL and if the reaction did not get better to seek medical care. She asked if she should use topical BENADRYL and I said I would take oral BENADRYL instead. She also asked about the use of a cold compress and I agreed she could do so. She came back 7/2 and the redness had spread along the upper portion of her left arm; additionally blisters were present. She had gone to urgent care and they prescribed VALTREX, a MEDROL DOSEPAK, and tramadol.
1st Shot(5/3/21): Soreness in arm, Fatique  2nd shot(5/31/21): Soreness in arm, Fatique, headaches, developed a cough a week later which lasted about a week. Adverse event (7/6/21): Started coughing and spitting blood around 5:00pm. Coughing persisted throughout the evening. At 6:00am I told my mom I was having a problem. around 6:30am my body went numb, loud ringing in my ears, and broke out into a cold sweat, so we called 911. The paramedics arrived and checked me out, and they believed I was okay. When they left we decided to go to the ER. Admitted on 7/7/21-7/12/21
Flu shot given approximately 11:00am. Client had indicated she had no allergies. 11:45 client returned complained of itching and red rash on neck. No wheezing or SOB. Denies dizziness, lightheadedness. Given Chlorpheniramine 90 mg tab PO. Observed x 30 min symptoms resolving by 12:20. After reaction client remembered previous allergic reaction to thimerosal in contact solution. Client counseled to only vaccine thimerosal free vaccine in future.
Allergy; Cold; This is a spontaneous report from contactable consumer (patient) via Pfizer sponsored program. A patient of unknown age and gender received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/ Lot number not reported and expiry date was unknown), via an unspecified route of administration on as a single dose for covid-19 immunization on 24Mar2021. Patient medical history and concomitant medications were not reported. On an unknown date in 2021 patient had allergy and cold. Reporter seriousness for events was unspecified. Patient had received the first dose and scheduled for second dose tomorrow. Patient had COVID at the Christmas and it was the first year and he did not have really issue with the first one. However, what he thought it was allergies last two week and now believed it was a cold. Normally he did not have a fever. Patient questions that if have cold or flu or whatever should get or pick a vaccine or not.  The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt vaccinated with DTP/OPV mother noted to become limpness "like he was dead", period of pale, then became normal.
one dose of VARIVAX and one dose of PROQUAD were inadvertently administered to the patient; This spontaneous report as received from a registered nurse referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, drug reactions/allergies and concomitant therapies was not provided.       On 09-DEC-2019, the patient was inadvertently administered varicella virus vaccine live (oka/merck)(VARIVAX) (1 dose, lot# S011952, expiration date 16-APR-2021) subcutaneously  and measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) ) rHA (recombinant Human albumin)(1 dose, lot# S007074, expiration date 06-SEP-2020) for prophylaxis (inappropriate schedule of product administration). The outcome of inappropriate schedule of product administration was unknown.
Patient brought to ED shortly after testing positive for Covid-19 d/t increased confusion, vomiting, and decreasing oxygen saturation.  Patient was admitted to hospital services with acute hypoxemic respiratory failure secondary to covid-9.  Patient was unable to be on BiPap  with vomiting.  Patient started on Bronchodilator, dexamethasone and remdesivir and Baricitinib. Patient expired on 02/21/2022 with diagnosis of acute metabolic encephalopathy, Afib, AMS, aspiration PNA, CKD, Covid-19 virus infection, chronic combined systolic and diastolic CHF, Diabetes, Respiratory failure.
A non-serious, spontaneous report of swollen glands, fever, chills, runny nose and positive B flu has been received from a registered nurse concerning a 12-year-old female patient subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 27-Aug-2009. On 31-Aug-2009, the patient presented with fever of 102.5 degrees for two to three days, swollen glands, chills and runny nose. She tested positive for B flu. The outcome of the events was not reported.
fever at 99.8 degrees; Body was hot; Cold chills in lower back; This case was reported by a consumer via call center representative and described the occurrence of fever in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th April 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 1st May 2020, 1 days after receiving Shingrix, the patient experienced fever, feeling hot and chills. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the fever and feeling hot were recovered/resolved and the outcome of the chills was unknown.   It was unknown if the reporter considered the fever, feeling hot and chills to be related to Shingrix.  Additional details were reported as follows:  Caller was field sales representative reporting adverse event for herself.  She received the second dose of Shingrix vaccine the day before reporting.  On the day of reporting, in the morning the patient woke up with fever at 99.8 degrees and her body was hot.  She took an Advil after which she recovered from fever and hot body feeling.  Now she was experiencing cold chills in the lower back. No further details were provided.  The reporter consented to follow up.
No adverse event reported, however the (booster) dose was administered 2 weeks prior to the six month span.  Recommend per Pharmacy Operations Manager to report to VAERS.
Numbness of my tongue and lips; This is a spontaneous report from a contactable nurse (patient). A 38-year-old non-pregnant female patient started to receive bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL8982; expiration date: unknown), via an unspecified route of administration left arm on 21Jan2021 17:00 at a single dose for covid-19 immunization. Medical history included migraine. The patient was not diagnosed with COVID prior vaccination. The patient has no known allergies. Concomitant medication included allopurinol (ELAVIL), paracetamol (TYLENOL), vitamin c [ascorbic acid] (VITAMIN C) zinc and prenatal vitamins. The patient has not had other vaccine in four weeks. The patient received her vaccine in a hospital. On 22Jan2021 01:00 AM, the patient experienced numbness of her tongue and lips. No treatment was received for the adverse events. The patient has not been COVID tested post vaccination. The outcome of the event was not recovered.
I had a raspy sore throat and cough which were both moderate. I had 105 low grade fever, minimal muscle aching. Mild to moderate fatigue that lasted 2-3 days. I was pretty good 10 days after that. I wanted Paxlovid but Doctor recommended 2 medications Prednisone and Plaquenil for 5 days. For the onset of symptoms they lasted 3 days maybe. The moderate fatigue stabilized for the last 4 weeks. The majority symptom developed the end/middle of July a feeling of fullness in my head and some headache in the lateral skull. These symptoms are usually not present when i was up but become present later in the morning and get worse and I take 1-2 doses of Motrin in the afternoon and then evening. Those symptoms have bothered me to the point that last week I spoke to a neurologist and will have a mri.
Vomited approximately 10 hours after vaccine, but no memory of it Diarrhea approximately 10 hours after vaccine, but no memory of it Malaise for 3-4 days Fatigued for 3-4 days Headache for ~2 days Chills (extreme) Arm sore for ~3 days Loss of appetite for ~3 days Confused Dizzy/equilibrium issues for ~2 days
Heart palpitations. Went to ER, and found to be in atrial fibrillation with RVR. I had to get a calcium-channel blocker to break rhythm to sinus tachycardia. Beta-blocker to convert the sinus tachycardia to normal sinus rhythm.
Felt unwell; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunisation. The following information was reported: MALAISE (non-serious) with onset 12Mar2021, outcome "recovered" (Mar2021), described as "Felt unwell". Therapeutic measures were not taken as a result of malaise.  Additional information: It was unknown if patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient received any other medications within 2 weeks of vaccination was unknown. Prior to vaccination, it was unknown if patient diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient been tested for COVID-19. Known allergies was unknown and Other medical history was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer (patient's parent). A male patient of unspecified age and race/ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Relevant medical history and concomitant medications were not reported. The patient experienced Streptococcus pneumoniae serotype 35B. On an unspecified date the patient underwent lab tests and procedures which included serology test: serotype 35B. The patient died due to the event on 05May2017, he was almost 9 months old. It was unknown if an autopsy was performed. Reported Cause(s) of Death: Streptococcus pneumoniae serotype 35B.
administered with the vaccine which has been stored in the refrigerator for more than 30 days; administered with the vaccine which has been stored in the refrigerator for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information use was not reported.  Treatment information was not provided.   This case was linked to MOD-2021-265450 (Patient Link).
Patient had itching after vaccine no swelling of tongue no SOB, no throat closing. Administered benadryl 25mg po patient tolerated well. 20 minutes later patient stated she felt fine.
given only 1 vial of the 2 vial presentation; given only 1 vial of the 2 vial presentation; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Meningitis ACWY vaccine (potential Menveo)) for prophylaxis.   On an unknown date, the patient received Meningitis ACWY vaccine (potential Menveo). On an unknown date, an unknown time after receiving Meningitis ACWY vaccine (potential Menveo), the patient experienced inappropriate preparation of medication (Verbatim: given only 1 vial of the 2 vial presentation) and inappropriate dose of vaccine administered (Verbatim: given only 1 vial of the 2 vial presentation). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 08-MAR-2023 This case was submitted by public reporting reference via the online direct entry reporting system. The pharmacist reported that the patient in health system were given only 1 vial of the 2 vial of Menveo presentation of Meningitis ACWY vaccine (potential Menveo). Nursing thought they were giving the one vial presentation. The reporter did not consent to follow up. The patient in health system were given only 1 vial of the 2 vial of Menveo presentation of Meningitis ACWY vaccine (potential Menveo), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case was linked with US2023036692, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2023036692:same reporter
Systemic: Dizziness / Lightheadness-Medium, Systemic: Tachycardia-Medium