chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administering Menquadfi to a patient and that the patient pulled back resulting in getting a partial dose, full dose was not able to be administered with no reported adverse event; Initial information received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves administering Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] to a 11 years old female patient and that the patient pulled back resulting in getting a partial dose, full dose was not able to be administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (TDAP) for Prophylactic vaccination.  On 27-Jul-2023, the patient while receiving a dose (1x) of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine solution for injection (lot: U7616AB) with unknown strength & expiry date via unknown route in unknown administration site for Immunization and that the patient pulled back resulting in getting a partial dose, full dose was not able to be administered with no reported adverse event (incorrect dose administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Ache/Pain; Fatigue; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ache/Pain), FATIGUE (Fatigue) and PYREXIA (Fever) 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 02-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 an unknown date, the patient experienced PAIN (Ache/Pain), FATIGUE (Fatigue) and PYREXIA (Fever). At the time of the report, PAIN (Ache/Pain), FATIGUE (Fatigue) and PYREXIA (Fever) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter. Treatment information was not provided.
PATIENT RECEIVED VACCINE THAT EXPERIENCED A TEMPERATURE EXCURSION, VACCINE WAS KEPT IN THE REFRIGERATOR FOR MORE THAN 30 DAYS. NO ADVERSE REACTIONS
Patient developed hives from left shoulder all the way down her left arm about 5 to  7 minuets after receiving her booster . PT was stable with no Dyspnea, lung sounds clear equal bilaterally.  Patient given 25mg of diphenhydramine IM to RT deltoid.  Patient was observed for 30 minuets in exam room. Patient condition improved and the hives went away. Patient was release with her mother and advised to seek further medical attention if needed.
mild prickly sensations on the back of my hands; soon after the vaccine, the sensations are more intense; It burns to wash my hands; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 31Mar2021 13:30 (Lot number: EP7533) at the age of 52 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Lot number=EN6206 , Administration time=10:30 AM , vaccine location=Right arm, dose number=1), administration date: 11Mar2021, when the patient was 52 years old, for Covid-19 immunization, reaction(s): "mild prickly sensations on the back of my hands". The following information was reported: PARAESTHESIA (non-serious), outcome "not recovered", described as "mild prickly sensations on the back of my hands; soon after the vaccine, the sensations are more intense"; BURNING SENSATION (non-serious), outcome "not recovered", described as "It burns to wash my hands". Therapeutic measures were not taken as a result of paraesthesia, burning sensation.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021355060 same patient/vaccine, different dose /event
Severe nausea and vomiting that presented gradually (about 24 hours after receiving the Covid booster), then quickly became so severe that I could not even tolerate fluids or sips of water. I eventually had to go to emergency room on January 9, 2022, after 4 days of vomiting and inability to tolerate fluids, where I was given the anti-nausea medicine ondansetron via an I.V., and a prescription for more to stop the vomiting.
From initial information received on 07/15/04 from a nurse regarding an adverse event occurring in the USA, it was reported that an 18 year old female patient received her first dose of Menomune A/C/Y/W-135 lot number Ue111AA, subcutaneously in the right arm on 07/12/04. Three days later, the patient developed generalized hives and wheezing. Reportedly, the patient used a steroid inhaler. Her parent called the doctor's office and set up an appointment that same day. The patient has a pre-existing history of cystic fibrosis and multiple medication allergies. Recovery status was not reported. From additional information received on 07/19/04 through a telephone call to the reporter, it was verified that the patient does have a history of cystic fibrosis. It was reported that on 07/12/04, the patient also received a dose of Tubersol 5 TU, lot number C1954AA, which was read as negative. Route and sit of administration were not reported. The reporter stated that on follow up visit on 07/15/04, hives were almost gone and the patient had improved. It was also reported that the patient was prescribed an EPI pen. From additional information received on 09/09/04 from a health care professional, it was reported that the patient recovered from these events. The following patient medical history was reported. "Diagnosed at birth with cystic fibrosis with perforated meconium ileus. The cystic fibrosis complaints she has experienced have been largely related to her sinuses. She also has a history of hematuria secondary to hypercalciuria and hyperoxaluria and a history of chronic constipation." Reportedly at the time of vaccination the patient was also taking the following medications: Albuterol, Flovent, Flonase, Zadex, Miralax, Piperacillin, Cephalosporins and Tobramycin. No further information is anticipated, this case is considered closed.
was administered an underdose (<0.5mL); This case was reported by a pharmacist via call center representative and described the occurrence of incorrect dose administered in a male patient who received Herpes zoster (Shingrix) (batch number HM24H, expiry date 25th March 2023) for prophylaxis.   On 4th December 2021, the patient received the 1st dose of Shingrix. On 4th December 2021, unknown after receiving Shingrix, the patient experienced incorrect dose administered. On an unknown date, the outcome of the incorrect dose administered was unknown.  Additional details were reported as follows: Age at vaccination was not reported. The reporter reported that the patient received Shingrix dose less than 0.5mL, which led to incorrect dose administration. The reporter consented to follow up.
After the Bivalent booster she started feeling bad; bumps; Dizzy; Injection site hurting; Fever/ Hot; Tired; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (After the Bivalent booster she started feeling bad), SWELLING (bumps), DIZZINESS (Dizzy), INJECTION SITE PAIN (Injection site hurting) and PYREXIA (Fever/ Hot) in a 39-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Feb-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (After the Bivalent booster she started feeling bad), SWELLING (bumps), DIZZINESS (Dizzy), INJECTION SITE PAIN (Injection site hurting), PYREXIA (Fever/ Hot) and FATIGUE (Tired). At the time of the report, FEELING ABNORMAL (After the Bivalent booster she started feeling bad), SWELLING (bumps), DIZZINESS (Dizzy), INJECTION SITE PAIN (Injection site hurting), PYREXIA (Fever/ Hot) and FATIGUE (Tired) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not reported.  It was reported that patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient received first and second primary monovalent dose from Pfizer Lot and expiry date unknown. Third shot from J and J on 12-Jan-2022. Fourth monovalent booster shot from moderna on 31-Aug-2022.   Treatment medications were not reported.
I had covid and got the vaccine; I had covid and got the vaccine; This is a spontaneous report from a contactable other hcp. A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as unknown, dose for covid-19 immunisation; tofacitinib citrate (XELJANZ XR), oral from Jan2019 (expiration date: 30Jan2021) at 11 mg, daily for rheumatoid arthritis. Medical history included ongoing rheumatoid arthritis. Concomitant medications included denosumab (PROLIA); methotrexate sodium; estradiol (VIVELLE-DOT); pilocarpine hydrochloride; paracetamol, tramadol hydrochloride (ULTRAM); hydroxychloroquine phosphate (PLAQUENIL); ciclosporin (RESTASIS); pantoprazole; alendronate sodium (FOSAMAX); calcium carbonate, colecalciferol (CALTRATE 600 + D); chondroitin sulfate; meloxicam (MOBIC); glucosamine sulfate; acyclovir [aciclovir]; tizanidine hcl. The patient previously took Betadine swabstick, codeine phosphate 30 mg tab, sulfa drugs CEP ID 54550 and acetaminophen, experienced allergies. The patient stated she had covid and got the vaccine. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. The events are unlikely related to the suspected drug of  Xeljanz XR.   The case will be reassessed if additional information becomes available.  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-2021487323
Redness, swelling right quadramuscle with warmth, Motrin and Ice to area.
This spontaneous report was received from a lawyer and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies were provided. On an unknown date (reported also as "in 2017"), the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose and anatomical location were not provided) for permanent prevention and protection against shingles and zoster- related injuries at the pharmacy. On an unknown day in December in 2016 (reported also as "on or about December 16, 2016"), the vaccine did not prevent shingles as intended, and the patient subsequently was treated for shingles in medical center. The patient was diagnosed with shingles and/ or zoster-related injuries and suffered serious physical, emotional and economic damages as a result of this injury. The patient has continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering, extensive medical care and treatment for these injuries, significant medical and related expenses as a result of these injuries, including but not limited to medical losses costs include care for hospitalization, physical care, monitoring, treatment, medications and supplies, diminished capacity for enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions, lost wages, loss of earnings capacity and other losses and damages. The outcome of herpes zoster was reported as not recovered. The outcome of vaccination failure is unknown. The reporter considered herpes zoster and vaccination failure to be related to the suspected therapy.
pain and burning in injection site immediately that worsened. arm and hand swelling the point that her rings had to be cut off. difficulty moving arm due to swelling
I NEED HELP!!!!!!! For over a year (April 2021), I have had CONSTANT phlegm/mucus that causes me to hack and spit every day, all day, worse at night, chases my husband out of our bedroom and basically makes my life HELL!!!! Every doctor I've seen at facility has NO CLUE why all the tests/therapies/medications haven't even touched it. I am at my wit's end - suicidal at times. SOMEBODY PLEASE HEAR ME!!!!! I have reason to believe my issue may be COVID related. The last time I gave blood, (who always checks your blood for antibodies) showed I was highly reactive, meaning I either had it and had no 'normal' symptoms or was exposed and never knew it. I've written to the NIH with my story because I read this article that sounds like what's going on with me. Here's a link:  HELP!
Intermittent pain center of chest lasting ~5 min since given injection 24 hours prior.
Started to lose hair after getting first dose of the vaccine.; Runny nose after getting the first dose of vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Started to lose hair after getting first dose of the vaccine.) and RHINORRHOEA (Runny nose after getting the first dose of vaccine.) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H271A) for COVID-19 vaccination.     The patient's past medical history included Carpal tunnel syndrome in January 2022 and Surgery in January 2022. Concurrent medical conditions included Penicillin allergy (Patient is allergic since she was a kid.), Allergy to NSAIDs (Patient is allergic since she was a kid.) and Heartbeats irregular (Since patient was a kid.). Concomitant products included VITAMIN D NOS for Carpal tunnel syndrome, METOPROLOL for Heartbeats irregular.    On 23-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Dec-2021, the patient experienced ALOPECIA (Started to lose hair after getting first dose of the vaccine.) and RHINORRHOEA (Runny nose after getting the first dose of vaccine.). On 23-Dec-2021, RHINORRHOEA (Runny nose after getting the first dose of vaccine.) had resolved. At the time of the report, ALOPECIA (Started to lose hair after getting first dose of the vaccine.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Blood test: normal (normal) Normal. In January 2022, SARS-CoV-2 test negative: negative (Negative) Negative. In January 2022, Urine analysis normal: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. No vaccine received 1 month prior to Moderna Covid-19 Vaccine. Patient did not experienced similar events in the past. Patient mentioned that they do not have any family history of hair loss.   This case was linked to MOD-2022-553114 (Patient Link).
Site: Bruising at Injection Site-Mild, Additional Details: Patient noticed light green bruising on forearm of injection arm (no bruising, redness, swelling, etc at actual injection site on deltoid) while waiting in observation area. He is unsure if it was there prior to getting vaccination. Denies any systemic symptoms. Not warm to touch. RPh monitored patient for additional 15 minutes. No changes/further symptoms developed. RPh advised that patient continue to monitor and to seek medical treatment if any changes/systemic symptoms develop.
The pt developed a 2" area of tenderness that was red and swollen around the site of the vaccinia vaccination; treated with Cipro 500mg BID X 5 days.
She received anthrax #1, hepatitis A/B #1, meningococcal, smallpox and typhoid vaccines concurrently on 3 Mar 03.  On 18 Mar 03, she received her second anthrax vaccine.   Patient is unsure of exact time frame, but is sure that her symptoms began after the second anthrax vaccine.  The first thing she noticed was numbness along the side of her left leg.  During the summer of 2003 she developed a foot drop on the same side.  In January of 2004, she started "falling a lot", developed dysphagia, urinary incontinence, and started "tripping a lot".  Since that time she has developed paresthesias in her left hand.  A Neurology appointment was scheduled, but all of her symptoms except the leg numbness had resolved.  In early March 2004 a MRI of the brain was normal.  In July 2004, an EMG revealed mild carpal tunnel.  At the same time, she developed fatigue and her left arm became "limp" and did not swing when she walked.  In May or June 2004, she had an asthma attack.  She was coughing uncontrollably and went to the emergency room.  Resulting PFTs were abnormal and she was diagnosed with moderate, intermittent asthma.  Per the physician, she does not have asthma.  She admits having difficulty breathing when exposed to cigarette smoke.  This difficulty is relieved with an inhaler.  She does not experience any exercise-induced asthma symptoms. In the last few weeks she has felt better, but still has difficulty with fine motor skills.  She continues to have numbness on the lateral aspect of her left leg.  This numbness sometimes radiates to the calf when she stands for an extended period of time.  She also has pain in her lower back, left buttock and left leg that is constant and rates it as "3" on 0-10 pain scale.  This pain worsens with activity.
angioimmunoblastic T-cell lymphoma; night sweats; swollen lymph nodes in his neck; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown), in arm and in 2021 as dose 2, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANGIOIMMUNOBLASTIC T-CELL LYMPHOMA (medically significant, life threatening), outcome "unknown"; NIGHT SWEATS (non-serious), outcome "unknown"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph nodes in his neck". The patient underwent the following laboratory tests and procedures: Computerised tomogram: It was cancer of the immune system-lymphoma., notes: revealed a smattering of inky spots, bunched near left armpit and running up along his neck. It was cancer of the immune system-lymphoma; The scans were clear, notes: yet another set of full-body CT images; The pictures showed a brand-new barrage of cancer, notes: -so many spots that it looked like someone had set off fireworks inside [name withheld] body. More than that, the lesions were now prominent on both sides of the body, with new clusters blooming in [name withheld] right armpit in particular, and along the right side of his neck; SARS-CoV-2 test: Just a few days before (name witheld) got COVID, notes: COVID had finally caught up with him. Therapeutic measures were taken as a result of angioimmunoblastic t-cell lymphoma including brentuximab vedotin. It was also reported that patient age was 67.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s) : BE-PFIZER INC-202101810811 Same patient, same vaccine in different dose, with same event;
Confirmed Breakthrough  1st Dose 1/15/2021 - Pfizer - EL3248 2nd Dose 2/8/2021 -Pfizer -  EM9810 3rd Dose 10/21/2021 - Pfizer - FF2590
1/20/21 HA, fever, chills, fatigue, pain and swelling at site, nausea and diarrhea
pt recv vax & had a cold but was afeb @ time of vax;w/in 3hr pt devel a fever of 102 & a sz lasting 2min;pt taken to ER;
MMR instant after injection- blister 3in x 2 in, welt, and later on in day felt dizzy, lethargic, and headache. No fever.
Left antecubital rash and pruritic lasting last 5 days, self treated with hydrocortisone 2.5% cream two times partially relieving the pruritic and redness, but still present at time of report.
she got COVID-19; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and COVID-19 (she got COVID-19) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Oct-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced COVID-19 (she got COVID-19). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 06-Oct-2021, PAIN IN EXTREMITY (Sore arm) outcome was unknown. At the time of the report, COVID-19 (she got COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.   This case was linked to MOD-2021-377596.; Sender's Comments: This case concerns a 31 year-old, female patient with no relevant medical history, who experienced the non serious unexpected AESI of COVID-19. The event occurred at an unknown date after the first dose of Moderna COVID-19 vaccine. The rechallenge was not applicable. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Father reports they were awakened in the middle of the night with patient screaming.  When they went to him, he was very hot, then he immediately started vomiting repeatedly.  After they were able to calm him, they checked his temp and found it was 105 degrees.  The vomiting continued and they could not get any fluids or medication into him.  His mother and a friend took him to the ER while dad stayed with the other children.  Patient also had a heart rate over 200.  He was rehydrated in the ER and tested for flu, pneumonia, and strep  all tests were negative.  The mother was told that by eliminating everything else, the ER staff felt this was likely a reaction to the Typhim vaccine received on 5-19-09 in the afternoon around 2 pm.  His fever is resolved now and he is tolerating fluids.  They have not yet tried solid food, so have coached dad on options which he will try soon.  Child had no localized reaction as of 5/20/09 at 10 am.  Dad was very calm and positive.  Child is up and about without limitations.