chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Leg red, temp 100F, would not move leg; Cried when sheets applied; 2nd inject, no problem with 1st;
Information has been received from a consumer concerning her 18 month old nephew with no medical history who in January 2008, was vaccinated with a dose of MMR II 0.5 mL, subcutaneously. It was reported that the patient could have been on other medications. The reporter stated that at 18 months old, the patient was diagnosed with autism after getting vaccinated with MMR II. At the time of this report, the patient was recovering. The patient sought unspecified medical attention. Upon internal review, autism was considered an other important medical event. This is one of several reports from the same source. No further information is available.
multi-dose vials of Fluzone and has been giving more than the 10 doses of either .25 or .5 mL doses of flu to their patients.; Initial information received on 18-Dec-2019 regarding an unsolicited non-valid non-serious case received from a nurse.  This was a Non-valid case as number of patients are not identified.  This case involves patients with unknown demographics who were vaccinated with INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] which was given more than 10 doses of either 0.25 or 0.5 ml doses of flu (wrong technique in product usage process).  Medical history, medical treatments, vaccinations and family history were not provided.     On an unknown date, the patients received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [lot number and other dosing details were not reported] via unknown route in unknown administration site.  It was reported that provider was not aware of the rule with multi-dose vials of Fluzone and has been has given more than 10 doses to unknown number of patients.  It was a case of actual medication error due to wrong technique in product usage process.  At the time of report no adverse event was reported.  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 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.  Information on the batch number was requested.
Vomiting, fainting, vaso vagal reaction, later numbness and tingling in fingers, after 3rd shot, numbness and tingling in fingers, diplopia and loss of vision, diagnosed with multiple sclerosis.
Pt recv vax on 11/6/98; 2 hr later pt exp soreness, fever, myalgia in arms & legs, renal failure, rhabdomyolysis
This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age and gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 05-DEC-2017, the patient was vaccinated with expired dose of VARIVAX, subcutaneously for prophylaxis (lot number: L037559, expiration date 29-SEP-2017). The vaccine was reconstituted with sterile diluent (lot number: N022038, expiration date 27-NOV-2019). No adverse effects were reported.
Patient completed first dose of Pfizer Vaccine and sat in observation for 20 minutes and then started to complain about difficulty breathing and fast heart rate. Three sets of vital signs initiated with abnormal results showing tachycardic. EMS activated at 0415 pm and arrived at 04:26 pm. patient was transferred to hospital at 04:46pm. hotline called, DOH notified.
C/O severe itching, increase anxiety. C/O tongue itching, remained a & o x 3 no SOB lungs clear. Given Benadryl 50mg po x 1 with resolution of symptoms. 10:10 given vaccine. 10:20 c/o severe itching, anxious, no hives, lungs clear bilaterally BP 158/100 P 80 R 18 unlabored. Approx 10:22 contacted PCP. 10:28 50mg Benadryl po x 1. 10:35 itching severe, c/o tongue itching. No c/o SOB, midly anxious. No c/o tongue thickness a & o x 3. BP 140/86 P 76 RR 22. 10:50 c/o generalized itching tongue itching resolved. 10:55 lung sounds clear bilaterally no stridor noted 140/85 P 76 R 20 anxiety minimal, itching sensation partially relieved. 11:05 BP 140/90 R 20 P 72 lungs clear. Skin not as pink/ flushed, itching much less. 11:40 BP 132/78 P 78 R 16 breath sounds clear bilaterally calm no anxiety, states itching almost resolved. 12:15 allowed to leave clinic site.
Flu-like symptoms, violent shaking, extreme nausea, dizziness, fever. All only lasting a couple hours 3-5:00am.
Myalgia, Fever, c/o chills,injection site pain. Told to follow up with primary care if no improvement Narrative:
Developed a lymph node size of 2 cue ball's in armpit of injected arm; fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Developed a lymph node size of 2 cue ball's in armpit of injected arm), FATIGUE (fatigue) and HEADACHE (Headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     Concomitant products included METFORMIN and ATORVASTATIN for an unknown indication.    On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced LYMPHADENOPATHY (Developed a lymph node size of 2 cue ball's in armpit of injected arm), FATIGUE (fatigue) and HEADACHE (Headache). At the time of the report, LYMPHADENOPATHY (Developed a lymph node size of 2 cue ball's in armpit of injected arm), FATIGUE (fatigue) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication were not provided.
The patient had their 1st dose one year ago; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (The patient had their 1st dose one year ago) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (The patient had their 1st dose one year ago) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (The patient had their 1st dose one year ago) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (The patient had their 1st dose one year ago).    No concomitant medication were reported. No treatment information was provided by the reporter.   Reporter did not allow further contact
Itchy; Headache; Body aches; She had no energy; A low grade fever; Diarrhea; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis without rheumatoid factor, multiple sites" (unspecified if ongoing), notes: Rheumatoid arthritis without rheumatoid factor, multiple sites; "Pain" (unspecified if ongoing). Concomitant medication(s) included: MODERNA COVID-19 VACCINE taken for covid-19 immunisation; OXYCODONE. Past drug history included: Percocet, reaction(s): "Hurt her stomach". The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "Itchy"; HEADACHE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "Body aches"; ASTHENIA (non-serious), outcome "unknown", described as "She had no energy"; PYREXIA (non-serious), outcome "unknown", described as "A low grade fever"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dizziness after receiving the vaccine and continuing afterward. I felt lightheaded dizzy (not dizzy like vertigo). The dizziness started right after receiving the vaccine and got better after sitting for 30 minutes, but still feel a little dizzy 2.5 hours later.
got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient self reported the case. The patient got shingles. For tolerance of 2nd dose refer case US2021AMR041514.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR041514:1-shingles case
Knees and legs had pain and swelling; Knees and legs had pain and swelling; Knees and legs had pain and swelling; Knees and legs had pain and swelling; unable to work; This is a spontaneous report received from a contactable consumer (patient himself). A male patient of unspecified age received both the doses of BNT162B2 (PFIZER BIONTECH COVID 19 VACCINE, formulation: Unknown, Batch/Lot Number: Unknown) via unspecified route of administration first dose on 20Feb2021 and second dose on 13Mar2021 as a SINGLE DOSE for COVID-19 immunization. Medical history of the patient included high blood pressure and Diabetes from an unknown date and unknown if ongoing. A few weeks prior to receiving her first vaccine dose she had a pretty bad fall at work and hurt both knees. She reports that, she had the next day or two off to recover. The patient's concomitant medications were not reported. Few hours after patient received her first vaccine dose it made everything worse, all over again. Patient reported that her knees and legs had pain and swelling. After the second dose she continued to see no improvement in her symptoms. Patient also reported that, she had been unable to work. She reports having seen her doctor a few days after getting the second vaccine dose where she was started on Diabetic and high blood pressure medicine. Patient is planning other doctors visit for follow up and will potentially have an MRI to both knees. Outcome of all the events were recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Fatigue / her legs feel tired; Myalgia; pain; her legs feel tired and sore/Injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th September 2020, the patient received the 1st dose of Shingrix (intramuscular). In September 2020, less than a week after receiving Shingrix, the patient experienced injection site pain, fatigue, myalgia, pain, injection site warmth and leg pain. On an unknown date, the outcome of the injection site pain, fatigue and myalgia were not recovered/not resolved and the outcome of the pain, injection site warmth and leg pain were unknown.   It was unknown if the reporter considered the injection site pain, fatigue, myalgia, pain, injection site warmth and leg pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that her left arm, where she received the injection, was hurting, pain, and she had been icing the area. She also stated that she felt tired, fatigue and her legs feel tired and sore, myalgia.  The reporter consent to follow up.
FLUZONE QUAD was given in the tricep area instead of deltoid area and wants to know if the vaccine will still be effective or if they need to readminister; Initial information received on 02-Nov-2020 regarding an unsolicited valid non-serious case received from a healthcare professional via call center.  This case involves a patient of an unknown age who received quadrivalent influenza vaccine (Fluzone Quadrivalent), 450 - FLZ QIV NP in the tricep area instead of deltoid area (incorrect route of product administration) (batch number: unknown and expiration date: unknown) at an unknown dose and frequency via unknown route and site for prophylactic vaccination. Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  This was an actual medication error case due to the event incorrect route of product administration (latency: unknown).  Disclaimer: 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 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. There will be no information available regarding batch number in this case.
This patient's left arm became sore and very swollen, her fingers were very numb and painful, and she had a headache. She was seen by ER physician on 02/05/01. At that time she reported her last TD was 4 years ago. Prescribed Motrin for the pain, and ice to the affected arm.
COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4157318.  A female patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 01Apr2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), from 2016 (Batch/Lot number: unknown) to 2021, subcutaneous for juvenile idiopathic arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 23Dec2021, outcome "recovered" and all described as "COVID-19". The action taken for adalimumab was dosage permanently withdrawn in 2021. Additional information: Company's opinion was that the causality for the event(s) of COVID-19 with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. The reporter's causality for the event(s) of COVID-19, with Adalimumab Solution for Injection was Not Provided  The reporter's assessment of the causal relationship of "covid-19" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information, close temporal association and known product profile, a possible causal relationship cannot be excluded between the suspect vaccine bnt162b2 and the reported events DRUG INEFFECTIVE and SUSPECTED COVID-19.
1st injection: Sore arm at injection site that lasted for 2 days 2nd injection: Sore arm, cold sweats, fever, body aches, nausea, runny nose, sore kidney pain and joint pain Runny nose happened within 1 hour of injection.  Could not eat because of nausea for 48 hours. Body aches, joint pain, sore arm, fever and cold sweats lasted for 2.5 days.  Kidney pain started around 10pm on day 2 and lasted for 24 hours. For treatment I have taken 3 doses of Tylenol for pain and fever.  Plus several hours in a warm to hot shower.
Vaccine drawn up by Covid vaccine clinic nurse for Pediatric patient coming in for monthly injection at request of parent. Patient is 7 years old and Covid 19 mRNA bivalent 12 year-adult booster administered in error.
Myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 006C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown.            Relevant concomitant medications were not reported.  The treatment information was  not provided.  The action taken with mRNA-1273 in response to event was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,   a causal relationship cannot be excluded.
Narrative:  An 88yo male with PMH of Lumbar stenosis, Neuropathy, HTN, A-fib, Achalasia of Esophagus, Wound, CHF, DM and under care of multiple providers Per nurse's documentation; He received Pfizer Covid -19 vaccine per policy and protocol without complication First dose on January 15, 2021 and the second dose on February 5, 2021 No ADE was reported Per March 11, 2021 telephone documentation , the patient's daughter confirmed he died on March 6, 2021 due to CHF and after being accepted at Hospice about a week and a half prior to his death
sz 2 days p/shots w/fever & hypoglycemia required ICu admit sepsis ruled out;
left arm swellimg at injection site, with rash.  pain down left arm and on left shoulder blade.  onset immediately after immunization was administered to present.  pateint took motrin.
This spontaneous report has been received from a Medical Assistant referring to a 5 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 05-OCT-2017, the patient was vaccinated with an improperly stored dose of PROQUAD first dose, lot # N014950, intramuscularly in the left deltoid (strength, and expiration date were not provided) for prophylaxis. Concomitant therapies included sterile diluent (STERILE MRK). The doses of PROQUAD were exposed to a temperature excursion of 6°Fahrenheit (°F) to 14°F (6.62°F) during a time frame of 4 hours, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported
No additional AE; improperly stored vaccine administered to patient; This spontaneous report as received from a licensed practical nurse refers to a 42-year-old patient. The patient's medical history and concurrent condition were not reported.   On 20-AUG-2020,  the patient was vaccinated with incorrectly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (product formulation pre-filed syringe, lot # T009744, expiry date: 28-JAN-2022, dose: 0.5 milliliter, route of administration not reported). The vaccine was stored under the temperature excursion of 48.39 degrees of Fahrenheit through 1 hour and 45 minutes. Temperature excursion was detected by Data Logger. There was no previous temperature excursion. No adverse event was reported.
Pt.'s wife states that after receiving the 1st dose of Moderna 09/23/2021, started experiencing symptoms 09/24/2021 of fatigue, dizziness, flu-like symptoms, fever, and vomiting (Lasting 5 days). Primary visit 10/27/2021 Covid-19=Negative, Emergency Room visit 12/28-29/2021 Blood Panel, Ultrasound, Urine Test, and Cat Scan. Liver Enzymes results were High. Gastrologist visit confirmed Liver Enzymes tested High, 10/05/2021 MICT preformed = Normal resulted in Stint used temporarily then removed after five days. 10/11/2021 Admitted to hospital = Discharged 10/13/2021.
Extreme swelling at injection site. Collapsed on floor, severe vomiting, controlled urinating and defacating on self. Unable to stand or walk without help.
localized redness & edema to lt deltoid area w/assoc tenderness, pain & itching beginning w/in 12 hrs post vax w/Engerix-B; treated on 18AUG94 afternon w/cool compresses, Advil, Hydrocortisone cream 1%, DPH;
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 14-AUG-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # L013068 with exp. 14-APR-2017, (dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Developed mild persistent numbness into left lower leg overnight 1 day after receiving J&J vaccine. Worse along front of lower leg, but appears to also be noticeable in  back of left upper leg.
Days 8 and 9 after injection, very sore right arm at injection site.  Day 10 sore arm, redness and swelling at injection site.