chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vials that were put in the fridge and after that refrozen and thawed again 100 adults' male patients; No adverse event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults' male patients) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults' male patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults' male patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (vials that were put in the fridge and after that refrozen and thawed again 100 adults' male patients).    This case contains information for the 46 of 100 patients described by the reporter.  No concomitant medications were reported.  Nurse reported an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again 100 adults' male patients are involved, lot numbers unknown to the HCP.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
On Tuesday 3/23 I woke up with a stabbing pain in my left shoulder blade and pain going down my left arm.  This was especially painful in my wrist. Three fingers on my left hand are numb.  Today is 7 days later and I am not any better.  I am in pain 24/7 .  I have tired Aleve, Tylenol and Advil nothing works.  I can only sleep for a few hours and then I am awaken by the pain.
Customer reports that she has an interruption in schedule pertaining to GARDASIL 9. Customer reports that she is passed her 2 month mark for receiving her 2nd dose of GARDASIL 9.; No additional AEs reported.; This spontaneous report was received from a consumer and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, first dose, for prophylaxis (strength, lot #, expiry date, anatomical location, and route of administration were not provided). The patient reported that she had an interruption in schedule pertained to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). The patient reported that she was passed her two month mark for receiving her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration).  There were no adverse events reported (no adverse event).
induration, warmth, erythema, pruritis to right upper arm area, treated w topical hydrocortisone
Parent called Health Department re: daughter received shots previous week (7/12/17), parent stated that child's left thigh near injection sites was red, swollen, and had a hard lump the size of a quarter present. Stated child has not been fussing or had fever in days since injections. Parent stated she only noted lump today (7/21/17) when changing child. Recommended child be seen by primary care physician, parent stated she will call for an appointment.
2 Vaccines 1/29/2007 right arm Hep A hurt immediately hurt for several hours. Left arm - no problem. But kept feeling like it was hurting. Sore when raising arm - no better.  8/16/07 Received MD medical records which reveal patient seen on 12/21/06 after experienced left hand pain for approx 6 weeks after having direct trauma to that hand.  Exam at that time revealed swelling & tenderness w/full ROM & strength intact.  X-ray of left hand reveal diffuse arthritic changes.  Dx: left hand interosseous ligament sprain.  Referred to hand therapy.  Returned to MD on 6/28/07 for right shoulder pain exp w/overhead activities & lifting objects above her head.  Shoulder exam revealed tenderness bilaterally over greater tuberosity w/full ROM & strength.  Had positive Hawkins & Neer impingement tests.  X-rays of right shoulder showed type 2-type 3 acromion w/adequate subacromial space.  DX: right shoulder pain c/w subacromial impingement.  Given steroid injection & referred to PT.
feeling run down; experienced fatigue/tiredness for 48 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 73 year-old male patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Type 2 diabetes" (unspecified if ongoing), notes: He has Type 2 diabetes.; "blood pressure" (unspecified if ongoing), notes: Takes medication for diabetes, cholesterol and blood pressure.; "cholesterol" (unspecified if ongoing), notes: Takes medication for diabetes, cholesterol and blood pressure. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, MANUFACURER UNKNOWN), for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "experienced fatigue/tiredness for 48 hours"; FEELING ABNORMAL (non-serious), outcome "recovered", described as "feeling run down".  Additional information: Patient received his booster dose of Pfizer covid vaccine in Nov2021, He just told me about his experience this morning on 02Mar2022. He experienced fatigue/tiredness for 48 hours. He described it as just feeling run down. He said he felt good after that. No other adverse events. Event took place after use of product.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Gave HPV in left arm; within 10-15 (patient was sitting in an arm chair) seconds patient went blank, pale, starting shaking all over, head went back, I cradled back of head went to my knees to prevent him coming out of chair.
Unable to lift affected arm high enough to get a bowl out the cabinets, since this date my range of motion in that arm has decreased with daily activities..ie dressing, cleaning, etc...experience pain & discomfort. Hurts to sleep on this arm as well, currently prescribed muscle relaxers and pain meds.
Information has been received from a nurse concerning a patient who was vaccinated with a dose of Rotateq. The nurse reported that the patient subsequently regurgitated the Rotateq. It was unknown if medical attention was sought. At the time of this report, the outcome was unknown. Additional information has been requested.
The DTap-IPV diluent portion of Pentacel was administered in the left thigh of a patient without being used to reconstitute the HIB portion; Initial information received on 30-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old male patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.  On 29-Jul-2019, the patient received a fourth dose 0.5ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ122AAA, expiry date 29-Sep-2020 via intramuscular route in the left thigh.  It was an actual medication error due to inappropriate reconstitution technique.  It was reported that the DTap-IPV diluent portion of Pentacel was administered in the left thigh of a patient without being used to reconstitute the HIB portion.  It was unknown whether patient experienced any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of documents held by sender: none.
I had vaccination on 09/07/2022. In 12/2022 I had been having this headache on the right side of my head with repeated sinus infections. It seemed that I had a new infection in which I was coughing up phlegm. I had a culture done and was positive for Staph Infections. In 12/2022 it seemed to get worse. I have been on rounds of antibiotics but I have not received an answer from the medical staff on what they want to do next.
Localized redness (7 cm diameter) and mild swelling over deltoid area beginning few hours after administration of MENACTRA and HPV #2 immunizations IM.
Allergic reactions; Have more muscular pain and main in my knee; Have more muscular pain and main in my knee/joint pain; Itching; Rash; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration Date not reported) via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced allergic reactions, have more muscular pain and main in my knee/ joint pain, itching and rash. The report was received as, the patient states was calling from her daughters phone number. The patient had some allergic reactions after the first dose of the Pfizer COVID 19 vaccine. The reactions were not that bad, I didn't have to go to the hospital or anything like that. The patient called doctor, which was a new doctor that hasn't known me long, because I haven't had a primary care doctor in while, and they said that they thought it would be fine for me to receive the second dose based on my side effects. They couldn't give a definite answer and the patient don't know if she should get the second dose or not. The patient stated as, have more muscular pain and main in my knee since the patient had the vaccine that patient didn't have before. Every time patient move her knee a certain way it hurts, patient also experienced as joint pain. Do you recommend getting the second dose after I had side effects from the first dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Pain, red swollen arm about five inches wide at injection site, fussiness for four days, vomiting four days after vaccine.
Patient got hot, nauseous and dizzy 30 minutes after vaccine administration and told her Mom she was very hungry. Patient was also very pale.
Right leg around injection site displayed redness, swelling, warm to the touch, tender.  By the next morning, the red area had spread considerably, covering about 1/4 of the thigh.  By the evening of 10/25/15, it stopped spreading, and by 10/26/15, it wasn't any worse and started to resolve.
swelling on both sides of neck  and soreness of right breast  Had sonogram on neck negative results swelling is still there almost 10 months after 2nd dose soreness of breast went away after about 5 months than come back right away after booster shot on January 3rd 2022
After receiving my vaccine I started having pain in my hands, feet, and joints, including my knees. subside somewhat continued for several continued for up to 6 weeks. did not correlate it to vaccine the shot until sometime later. I called my doctor because I thought I might have rheumatoid arthritis because f so much joint pain. My doctor order blood test for RA which came back neg. There was no treatment given since test came back negative. My symptoms have mostly resolved.
Information has been received from a pharmacist concerning his 70 year old wife who on 21-JAN-2008 was vaccinated with a dose of Zostavax (Oka/Merck).  On approximately 23-JAN-2008 the patient developed a red area at injection site that was itchy.  At the time of report the patient had not recovered.  Unspecified medical attention was sought.  A product quality complaint was not involved.  No further information is available.
Rash started on face spread to torso, legs, palms and soles. No fever, sore throat - mild, mild headache. Rash mildly itchy, no pain or discharge from rash.
2 cm x 2 cm area of redness & elevated temp (local). RUA (ADACEL site IM).
Symptoms within a few hours to 1 day of receiving vaccine: Hives, chills, muscle pain, cough, shortness of breath, headache, sleeplessness/trouble sleeping, chronic fatigue, brain fog. Benadryl for the hives; rash went away after 2 days. Chills, muscle pain and cough went away after 3 days. I took ibuprofen for the muscle pain and headache.The shortness of breath persisted for 7 days and is still noticeable occasionally, even when just sitting. The headache, sleeplessness, chronic fatigue and brain fog have persisted from onset and I've had no relief. I continue to take ibuprofen or acetaminophen and started an OTC sleep aid the second week of symptoms. Nothing is helping. These symptoms are causing issues with job performance and in daily life.
Pt called health dept and c/o wasting away of upper arm from Td received last year.  Instructed pt to see her own MD for evaluation and call back with MD's report. Per HCP follow up report- Patient called health dept and complained of "wasting away of upper arm from Td received last year." Received flu vaccine same day but patient states the arm into which Td was administered in the arm bothering her. Instructed patient to see her own doctor for evaluation and call back with doctor's report.
fever (low grade) 100; severe joint/muscle pain w/swelling @ site; swelling in shoulder chest pain, headache, lethargy;
This spontaneous report as received from a health professional refers to an unspecified number of patients of unknown age. On 20-SEP-2013 the unspecified number of patients might be vaccinated with RECOMBIVAX HB (Lot#, dose and route not reported). The health care worker reported the RECOMBIVAX HB were out of temperature range and were not supported by their in house stability data and an unspecified number of patients (no patient information known at that time) might have been administered the vaccines. No adverse effects were reported. No PQC (Product Quality Complaints) was involved. It was unspecified if the patients had sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Approximately 7 days after the injection - a rash developed at the injections sight.  Small area at first but second day a patch upto 6+inches - patchy, red, and itchy
A physician reported the occurrence of vomiting in a 7 month old male who was vaccinated with Infanrix for prophylaxis. This report was received from other manufacturer (HQ48182250OCT2002). The subject's medical history, concurrent conditions, and concurrent medications were not reported. ON 8/12/02, the subject received an injection of Infanrix. One day later, on 10/13/02, the subject developed vomiting and retching. The outcomes of these events were unknown.
After receiving the shot at approximately 1600 (and waiting the 15 minutes at the clinic site), I returned to my desk for work.  Around 1740, I noticed a slight headache, which are abnormal for me, so I thought I might have been slightly dehydrated and increased my water intake, as well as ingested 8 ounces of gatorade.  The headache gradually got worse and by the time I left work at 2000 (8PM), it was so bad on the (primarily) right front part of my head (around my temple and behind my right eye), noise, light, and even my own walking hurt terribly.  I have never had a migraine in my life and rarely even get headaches, but the pain of this headache far surpassed any I have experienced before and based on what others tell me, might have been a migraine.  By the time I got home around 2100 (9PM), I took two extra strength Tylenol tablets and went to bed.  When I awoke in the morning around 0900 (9AM), I had a slight headache that dissipated after I took two more Tylenol tablets and did not return.
This is a spontaneous report from a contactable other healthcare professional (patient). A 64-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# 1045), at the age of 64, via an unspecified route of administration, in the left arm, on May 4, 2021, single dose, for COVID-19 immunisation. Medical history included COVID-19 (prior to the vaccination, patient diagnosed with COVID-19). The patient has no known allergies. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), via an unspecified route of administration, on an unknown date, single dose, for COVID-19 immunisation. On May 5, 2021, at 03:00, patient experienced left arm swelling/itch (dark red, almost black). The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Since the vaccination, patient has not tested for COVID-19. No therapeutic measures taken as a result of reported events. The outcome of left arm swelling/itch (dark red, almost black): not recovered (at the time of this report). No follow-up attempts needed. No further information expected.
Patient stated that she has a big rash in her arm and had to go to Urgent Care. The doctor stated that it was allergic reaction.
This is a spontaneous report from a contactable other HCP. A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Aug2021 13:30 (Lot number: EW0180) at the age of 57 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: if Covid prior vaccination Yes. Concomitant medication(s) included: VITAMIN B-12; VITAMIN C [ASCORBIC ACID]; CETIRIZINE. Past drug history included: Augmentin, reaction(s): "allergy". The following information was reported: HEADACHE (non-serious) with onset 09Aug2021 13:00, outcome "recovered" (2021), described as "1st day mild headache"; NAUSEA (non-serious) with onset 09Aug2021 13:00, outcome "recovered" (2021), described as "nausea"; VACCINATION SITE PAIN (non-serious) with onset 09Aug2021 13:00, outcome "recovered" (2021), described as "soreness at injection sight"; CHILLS (non-serious) with onset 10Aug2021 13:00, outcome "recovered" (10Aug2021 14:00), described as "an hour of cold chills"; CHILLS (non-serious) with onset 10Aug2021 13:00, outcome "recovered" (10Aug2021 14:00), described as "onset of uncontrollable shivering and teeth chattering"; CHILLS (non-serious) with onset 10Aug2021 13:00, outcome "recovered" (10Aug2021 14:00), described as "teeth chattering"; FEELING COLD (non-serious) with onset 10Aug2021 13:00, outcome "recovered" (2021), described as "felt like I was freezing to death"; GAIT DISTURBANCE (non-serious) with onset 10Aug2021 13:00, outcome "recovered" (2021), described as "felt unsteady walking". Therapeutic measures were not taken as a result of headache, nausea, vaccination site pain, chills, chills, chills, feeling cold, gait disturbance. Additional information: Patient reported for herself, patient took Multivitamin as concomitant drug. No vaccine in 4 weeks. Adverse event: 1st day mild headache & nausea, soreness at injection sight, 2nd day same with about an hour of cold chills, 3rd day same but, with onset of uncontrollable shivering & teeth chattering to the point of having to leave work- this lasted about an hour, felt like she was freezing to death, shivering to the point she could hardly use her hands and felt unsteady walking. Patient was infected with Covid prior vaccination and did not get Covid  tested post vaccination. No follow-up attempts are possible. No further information is expected.
Patient reported nausea, fever, chills and developed a red rash from shoulder to the elbow 3 days after administration (right arm).
tested positive for COVID; cough; A spontaneous report was received from a consumer, concerning a 66 years old male patient, who received Moderna's COVID-19 vaccine and was hospitalized due to COVID-19 and Cough.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.                                                                                                                                              On 11 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 12 Mar 2021, the patient tested positive for COVID -19 and was administered Monoclonal antibody infusion at hospital on 15 Mar 2021. The patient was scheduled to get second dose of Moderna COVID-19 vaccine on 13 Mar 2021 but it was rescheduled for 29 Mar 2021.  The patient was prescribed benzonatate for cough.  Treatment details included monoclonal antibodies and benzonante.  The second dose of mRNA-1273 was delayed in response to the events.  The outcome of the events, COVID-19 and cough was considered to be not resolved at the time of this report.; Reporter's Comments: This case concerns a 66 Y/O M hospitalized with serious unexpected events of COVID-19 and cough.  Event onset 30 days after first dose mRNA-1273. Treated with monoclonal antibodies and benzonante. Events ongoing. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.