chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; the vaccine was administered undiluted to a 3 year old female patient; the vaccine was administered undiluted to a 3 year old female patient; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 3-year-old female patient received BNT162b2 (BNT162B2), on 14Oct2022 as dose 3 (maroon cap; booster), single (Lot number: FT9142) at the age of 3 years for covid-19 immunisation. The patient's relevant medical history included: "antibiotic" (unspecified if ongoing). Concomitant medication(s) included: BACTRIM PAEDIATRIC taken for antibiotic therapy, start date: 08Aug2022. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 29Jul2022, for Covid-19 immunization; BNT162b2 (DOSE 2, SINGLE), administration date: 19Aug2022, for Covid-19 immunization. The following information was reported: OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 14Oct2022, outcome "unknown" and all described as "the vaccine was administered undiluted to a 3 year old female patient"; PAIN IN EXTREMITY (non-serious) with onset 15Oct2022, outcome "recovered" (16Oct2022), described as "sore arm".  Additional information: A non-diluted covid vaccine was administered to a 3-year-old patient. Forgot to dilute in sodium chloride. The reporter was asking for advice on what to inform patient and what to do next. It was clarified that the type of medication error was overdose. The stage of medication error was preparation and administration. It was reported that pharmacy student comes once a week and was very busy and made the mistake. The overdose event was for the 3rd dose of the vaccine. The reporter called the patient 4-5 times since the overdose incident to check on them. Friday, 14Oct2022, the day of the overdose, the patient was fine and did not need any medical evaluation or treatment. Saturday (15Oct2022) she called the patient at 10:00 and the mom said the patient had a sore arm. Sunday (16Oct2022) she called the patient at 9:30 and the mom said the arm was arm still a little sore, but by 17:00 on Sunday no more sore arm. She called the patient on Monday (17Oct2022) and the patient was fine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (18Oct2022): This is a spontaneous follow-up report received from a contactable Pharmacist. This pharmacist reported in response to HCP telephonic follow-up activity. Updated information included: Historical vaccines (dose 1 and dose 2 added), medical history (antibiotic therapy added), Suspected vaccine (lot number FT9142, vaccination date, Dosage regimen, Vaccination facility details for dose 3), concomitant (Bactrim paediatric added), event data (Pain in arm added, onset date for vaccine overdose and product concentrate not diluted added) and additional information updated.
Symptoms started in evening of date received- fatigue, soreness injection site. During the night i woke with high severe shaking interfered with ability to walk without holding onto the wall. I was afraid to go downstairs to take my temp for fear of falling down the stairs. Went back to bed, awoke later  - still had a fever but was able to walk properly. After take my temp 101.6 and taking ibuprofen I went back to bed, awoke around 7 am had a temp of 99.6 throughout the day, had a slight headache which remained through the weekend. Monday I felt well enough to go to the gym for a Tai Chi class. Each shot has had a worse reaction. If there is a 4th booster, I will NOT be getting it if this is what I have to look forward to.
extreme irritability & inc temp;pt adm to hosp;pt is not gaining any weight;marked thrombocytosis;dx lymph node abscess w/staphylococcus & leukocytosis & thrombocytosis;bronchiolitis w/hypoxia resolved;pt anemic;
Started with sore arm, upset stomach.  Within two days, sore neck and echo ringing in both ears and ears felt full.  Nerve pain in neck, tingling through out her body, numbness in bilateral arms and legs; fingers turning purple, racing heart rate, burning at the base of her head and neck and her heart feels hot.   Shakiness, cold and struggling to eat.  Doesn't feel hungry.  Treatment: One visit to Urgent Med;  physical exam ruled out heart attack and stroke and was prescribed muscle relaxers for possible pinched nerve.  Four visits to naturopathic  provider and was given remedies to calm nervous system and detoxify.  Symptoms continue and are progressively getting worse.
Tiredness'fatigue. Loss of appetite/weight loss. Chills. Nausea. Thigh/upper arm weakness. Cough. Sore muscles.
achy all over,back; achy all over,collar bone; achy all over,shoulders; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (achy all over,collar bone), BACK PAIN (achy all over,back) and ARTHRALGIA (achy all over,shoulders) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced MYALGIA (achy all over,collar bone), BACK PAIN (achy all over,back) and ARTHRALGIA (achy all over,shoulders). At the time of the report, MYALGIA (achy all over,collar bone), BACK PAIN (achy all over,back) and ARTHRALGIA (achy all over,shoulders) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported No treatment medication was reported
Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was admitted on 2/4/21 with rhabdomyolysis and a hematoma after a a fall. Details surrounding his death on 2/16/21 uncertain due to admission at non-facility. Comorbidities include CHF, anemia, history of stroke, traumatic brain injury, and aortic aneurysm.
Approximately 5 hours after vaccine began having symptoms; struggled to go upstairs for bed; very cold and trembling; was burning up - had fever.
Within 6 hours post vax, the pt developed left arm numbness/tingling. Dx as possible brachial plexus neuropathy. Pt started on NSAIDS, ulnar support/protection.
devel on 10MAY97 fatigue also x 2 days;2 large papules on back;over next 3 days, so far, has devel up to 12 large papules, pruritic and/or painful;mostly over trunk;no vesicular center some small hemorrhagic centers;
Onset of spontaneous urticaria within one week of Moderna COVID booster (dose 3).
Patient had an unwitnessed cardiac arrest while outside walking his dog.  AED in the field initially advised shock and was shocked 3 times without effect. At the time EMS ALS arrived, patient was in PEA arrest. He was transferred to Hospital with CPR in progress. Time of death called at 1857.
Site redness induration and pain 4x4 cm area with referred pain under arm, shoulder, neck lymph nodes sore as well started day after vaccination continuing 3 days later as well as subjective fever and chills.
Lost eight sight in right eye for 2 hrs. Large blind spot, related to clotting in the eye.  Went to over the course of two weeks urgent care, opthamoligist, ER, Retina specialist, hematologist. 2nd episode happened last friday april 23rd. Reported to Pfizer and FDA with no response.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L045953 exp date 17-NOV-2017 and lot # L045954 exp date 17-NOV-2017) (route not reported). The vaccines were stored at a temperature of 6.5F for a time frame of 28 minutes. The previous temperature excursion was 7F for 22 minutes and 7.5F for 23 minutes. No adverse effects were reported. Additional information is not expected as the reporter did not wish further contact.
Pt was seen 2 wks after injection-arm still slightly sore but still has a lump at injection site.
This spontaneous report was received from a physician regarding a 92-year-old male patient. His concurrent conditions included hypothyroidism, reflux, and arthritis. The patient's historical conditions included aortic aneurysm, anemia, gastrointestinal bleeding, drug allergy with atenolol and ULTRAM. His past drugs included atenolol and ULTRAM. The patient's concomitant therapies included omeprazole, melatonin and finasteride. On 12-MAR-2019, the patient was vaccinated with PNEUMOVAX 23 (lot # R027299, expiration date 09-APR-2020) (dose, strength, and location were not provided) via intramuscular route for vaccination. On the same day, 3 hours after the injection, the patient began to experience pain (injection site pain), swelling (injection site swelling) and redness (injection site erythema) at the injection site, she was also sweating (hyperhidrosis) and had an episode of syncope. On an unknown date, the patient had gone to an unspecified emergency room and was treated with pain medication. The patient was not admitted to the hospital. The patient was recovering from the events. Causality assessment was not provided by the reporter. There was no involvement of product quality complaint (PQC). Upon internal review, the event syncope was determined to be medically significant.
Pt came to ER the following day with c/o redness and pain after receiving immunization. Pt was diagnosed with localized cellulitis. Symptoms: 1. Rash and pain. Treatment Drugs Used: 1-CEPHALEXIN Dose: 500 Units: MG Freq: QID Route: PO 2-Acetaminophen Dose: Units: Freq: Route:
Pentacel vaccine was given without the Acthib portion/ NO AE; Based on information received on 06-Aug-2020, the report previously considered as non-valid became valid: [no patient identifier updated to identifiable patient].  Initial information was received on 06-Aug-2020 regarding an unsolicited non-valid non-serious case from a Other health care professional.   This case involves six months old female patient who received third dose of 0.5 mL once  DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot U622AA expiry date 16-Feb-2021) via an intramuscular route in the right vastus lateralis on 04-Aug-2020 (HIB lot UJ179AA) for prophylactic vaccination, which was administered without the ACT-HIB portion (Product preparation issue) (vial).  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), HEPATITIS B VACCINE (HEPATITIS B VACCINE) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of an actual medication error due to Inappropriate reconstitution technique.  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.  Follow up information was received on 06-Aug-2020 regarding an unsolicited valid non-serious case from a nurse.   Validity of the case, patients details, dosage regimen updated, reporter updated (other healthcare professional to nurse) and concomitant medication added.
Wrong vaccine type was given.  Patient was given Adacel (Tdap) and should have been given DTaP (Infanrix).   No additional treatment was needed for the patient.
Site where shot was given is red and warm to touch and slightly itchy. Symptoms began on day 8 following first dose of Moderna vaccine.
pain in arm/pain in left arm; I can hardly lift; left shoulder and under arm and shoulder blade have been in pain/ left shoulder the wing where arm goes up and down in back; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm/pain in left arm), MYALGIA (I can hardly lift) and ARTHRALGIA (left shoulder and under arm and shoulder blade have been in pain/ left shoulder the wing where arm goes up and down in back) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, 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 IN EXTREMITY (pain in arm/pain in left arm), MYALGIA (I can hardly lift) and ARTHRALGIA (left shoulder and under arm and shoulder blade have been in pain/ left shoulder the wing where arm goes up and down in back). At the time of the report, PAIN IN EXTREMITY (pain in arm/pain in left arm) and MYALGIA (I can hardly lift) had not resolved and ARTHRALGIA (left shoulder and under arm and shoulder blade have been in pain/ left shoulder the wing where arm goes up and down in back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment information was provided. The patient gone to urgent care, still had not got the events resolved.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: New event Muscular weakness added, outcome of an event pain in arm and narrative updated. On 28-Jul-2021: Follow up was received does not contains any new information
Information has been received from a consumer concerning a potential varicella outbreak in a female who was vaccinated with varicella virus vaccine live (Oka/Merck). A woman in her sister's neighborhood had a bad case of shingles and did not restrict her contact with others. The woman's daughter, who was vaccinated with varicella virus vaccine live, then came down with a case of varicella (150 blisters). The pediatrician of the child asked that the child not be brought into the office, since they felt that she was contagious. At the time of the report, the outcome of the patient's varicella (150 blisters) was unknown. The product quality complaint was not involved. Additional information has been requested. The consumer also provided information regarding other patients' experience while on treatment with varicella virus vaccine live (WAES #'s 0706USA04140 and 0706USA04141).
This is a non-serious spontaneous case, initially received from other non-health professional on 29-Nov-2017, concerning a patient of an unspecified age and gender. On an unspecified date, the patient was administered with FLUVIRIN (dose, route of administration, anatomical location, batch number and expiry date: not reported). It was reported that, the patient received the vaccine, which underwent temperature excursion (explicitly coded as incorrect product storage and drug administration error). Follow-up received on 08-Feb-2018: This case was considered as lost to follow-up since the reporter could not be contacted for further information after 2 attempts in 30 days.
Information has been received from a pharmacy technician and a licensed practical nurse concerning a patient (age and gender not reported) who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. It was reported that the the patient experienced a "similar reaction" such as warmth and redness at the injection site. However, the licensed practical nurse stated that she could not supply further patient details, lot number, severity and exact symptoms. The pharmacy technician noted that "it seemed like more patients had this experience this year than patients who received the vaccine last year." Additional information is not expected.
Lightheaded, dizzy, low blood pressure. Approx 10 min in length, no treatment.
Extreme fatigue, migraine headaches, neuropathy, electrocuting shocks, "pins and needles" in my extremities, muscle weakness, inflamed blood vessels, brain fog, muscle spasms, muscle cramps and pain in my left arm shooting down the left-side of my body.
Per patient approximately 3 hours after receiving flu vaccine, patient experienced uncontrollable shaking, fever 101 degrees lasting 1-1 1/2 hours.  Also nauseated, dizziness, severe aches in joints, felt like coming down with the flu.
Head tic. Child would jerk head quickly in an upward motion, repeatedly. Worsened with increased activity. Was unaware of it. Sought medical advice, but was dismissed.
pt recvd vax & became inc fussy, irritable crying a deep guteral scream as not before; no temp;
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 21-Feb-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 21-Feb-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 21-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 21-Feb-2022) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     Chronic or long-standing health conditions were unknown. Acute illness at the time of vaccination and upto1 month before were unknown.     On 21-Feb-2022 at 5:07 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 21-Feb-2022 at 5:07 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 21-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 21-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 21-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 21-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter.  The patient received Moderna vaccine past its 30 day of expiry date. Vaccine went into 2-to-8-degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. No treatment information was provided.
Phone call from mother stated she took child to hospital while being out of town due to fever, chills, and redness on both arms, diarrhea.
Constant raised hives itching under my arms, breaststroke, trunk, thighs they come and go and move to different locations.   They are very large patchy areas and I have not had one good day since taking the 2nd dose of the covid vaccine.   Regardless of what is done there is no relief.
Date the vial was initially stored in the refrigerator was 03-Jan-2023; No adverse event; 2 patients of 6 years old received doses after its BUD of the Monovalent Moderna COVID19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 patients of 6 years old received doses after its BUD of the Monovalent Moderna COVID19 vaccine), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 03-Jan-2023) and NO ADVERSE EVENT (No adverse event) in a 6-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 018c22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (2 patients of 6 years old received doses after its BUD of the Monovalent Moderna COVID19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 03-Jan-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 patients of 6 years old received doses after its BUD of the Monovalent Moderna COVID19 vaccine), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 03-Jan-2023) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (2 patients of 6 years old received doses after its BUD of the Monovalent Moderna COVID19 vaccine) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 03-Jan-2023).    No concomitant product reported by the reporter. It was reported that the vials were in the carton. Vial size was reported as 2.5ml. It was reported that the vial did not undergo any temperature excursions. No treatment medication reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-709519 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-709519:2nd patient
Nause and headaches started 05 JAN 1021 around 5:00 pm. On 06 JAN 2021 I start experience dizziness and vomit.
Information has been received from a physician concerning a 5 year old male who was vaccinated on an undisclosed date with 0.5mL of varicella virus vaccine live (Oka/Merck) and subsequently "had a break through" and developed varicella after receiving varicella virus vaccine live (Oka/Merck). At the time of reporting the patient's status was unknown. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
pt recvd vax & was core antibody pos; RN felt pt had subclinical hepatitis b;
Dizziness; Fever; Vomiting; Headache; Chills; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 21Apr2021 at 12:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any vaccination within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via unspecified route of administration in the left arm on 31Mar2021 (at the age of 23-year-old) at 12:00 as a single dose for COVID-19 immunisation. On 21Apr2021 at 20:00 the patient experienced dizziness, fever, vomiting, headache, chills and fatigue. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of these events. The clinical outcome of the events dizziness, fever, vomiting, headache, chills and fatigue were not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Severe leg/thigh pain,12 hrs after administration abdominal pain - day#2, with nausea, diarrhea (5/20/); Temp 100.4 day #3, sternal chest discomfort - responded to Albuterol (history of asthma) (5/21)
pt recv vax & had a violent rxn of n/v/d, etc that lasted approx 1wk