chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient called 1/21/10 to tell us she had spoken to her MD who encouraged her to call. Approx 4:00 pm on 1/15/10 she said her breathing became more difficult and her lips started to tingle and swell. She used an ASTERLIN HFA and BENADRYL with no decrease in symptoms. She went to ER they told her they thought she had a Ran to vaccination. Previously received flu vaccine - 10/09 with no problems.
One of nine cases: An event of Expired Drug Administered occurred in a seven-year-old female. The report was received from a registered nurse . No medical or drug history was reported for this child. The child received a one-time dose of FluMist intranasally on 15-Jan-2008. On 15-Jan-2008, the child received FluMist which had an expiration date of 19-Dec-2007. The reporter stated this is one of nine children that was vaccinated on the same date. In discussing the error with two reporters from the site, they both indicated that the front of the FluMist box states "For the 2007/2008 Season", there is an expiration date on the side of the box. The reporter indicated they also administer a competitor's product, which is good for that entire season and does not expire until May/June timeframe. One reporter also stated many of the vaccines they give do not have an expiration date. She also indicated they do look for expiration dates but it was confusing to have the front of the box indicate the vaccine was "For the 2007/2008 Season". The vaccination nurse at the site stated they placed the order for FluMist on 26-Nov-2007 for pick up 1 week later, and she was unsure why the site would be supplied with product that was to expire in less than three weeks. Outcome: the child had no ill effects, the site has not had any contact from the child's family. Further dosing with FluMist is not indicated. Causality assessment is not applicable for this vaccination error. This reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
began experiencing itching on buttocks, upper thighs & waist Sunday Am (recvd inject Firday afternoon); had fine red rash on those areas; had to take DPH to relieve itching; rash inc some by Monday AM; had runny nose;
10/26/2005 11:00 shots administered (16:45) child seized in his sleep eyes rolled back in his head. Seizure lasted 5 minutes. Child was dazed 1 hour later presented to the ED at 18:50.
Right arm (+) swelling. Measurements: Right upper arm/deltoid 11", Left upper arm/deltoid 10 1/2". Right forearm 7 3/4" below elbow area, Left forearm 7 1/4". Advil 200mg PO, Naproxen.
Narrative:  COVID infection following COVID vaccine series 03/18, Pfizer, dose #1 04/08, Pfizer, dose #2 12/26 COVID swab, result: detected 12/23 pt cc: cough, rhinorrhea exposure: unknown 12/26 CXR impression: No acute cardiopulmonary abnormality. 12/26 SARS-COV-2 Variant Sequencing: pending 12/26 pt admit ED cc: Covid test dx: Covid-19 LOS: 1 day
Day after second injection I felt tightness in chest with related shortness of breath lasting over six hours. Consid ered going to Emergency facility but symptoms relieved by afternoon and was able to rest well that night.
chills; body aches; terrible headache; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (terrible headache), CHILLS (chills) and MYALGIA (body aches) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 030L20A) for COVID-19 vaccination.     The patient's past medical history included Hypertension since an unknown date. Concurrent medical conditions included Penicillin allergy.   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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 28-Jan-2021, the patient experienced HEADACHE (terrible headache). On an unknown date, the patient experienced CHILLS (chills) and MYALGIA (body aches). At the time of the report, HEADACHE (terrible headache), CHILLS (chills) and MYALGIA (body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant information provided. No treatment information provided.
brittle hair; hives; hair loss; This case was reported by a consumer via call center representative and described the occurrence of hives in a 76-year-old female patient who received HAV (Havrix 1440) for prophylaxis.   Previously administered products included Havrix 1440 (Received 1st dose on an unknown date). Concurrent medical conditions included mosquito bite.   On 1st December 2019, the patient received the 2nd dose of Havrix 1440 (intramuscular). In December 2019, less than 3 weeks after receiving Havrix 1440, the patient experienced hives, hair loss and brittle hair. On an unknown date, the outcome of the hives was unknown and the outcome of the hair loss and brittle hair were not recovered/not resolved.   It was unknown if the reporter considered the hives, hair loss and brittle hair to be related to Havrix 1440.  Additional details were provided as follows: The patient received 2nd dose of Havrix 1440 and noticed hair was very brittle and falling out more than usual. The patient could hear her hair breaking when she runs her hand gently through it, and was constantly sweeping hair off the floor, some with the root. The patient had a few hives and there which might be mosquito bites. The follow up consent was not granted.
I felt crampy around lunch time. It lasted for about a week after the shot. I had headache, fatigue, nausea, no appetite. I called into the triage nurse, and they told me it was normal. They told me to keep track to make sure I didn't get a fever.
pt recv vax; 10x10cm area of erythema around inject site, cellulitis; tx w/ augmentin x 5 days;
Patient became faint and passed out in parking lot, patient was also dizzy, nauseous and had an elevated heart rate for the 72 hours after receiving the Gardasil vaccine. Patient was sent to the emergency room for observation.
She had Tdap (ADACEL) administered on 3/14/2018 had muscle aches and cramps from hip to lower legs the whole night with diarrhea. The next morning she feels less muscle aches.
Positive swelling of left parotid gland with erythema along left jaw line. Elevated fever (102-103), pain in left cheek 2 weeks after MMR immunization. Treatment with Tylenol #3, no citrus drinks, Ibuprofen every 6 hours, respiratory isolation for 3 days, meningitis, orchiitis precautions. Given follow up in office after 3 days.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 11 years old child patient and unknown gender. On 30-SEP-2014 the patient was vaccinated with a dose of an improperly stored GARDASIL (lot H020901, expiration date 05-JUL-2015) (dose, route, were not reported). No adverse effect was reported. The outcome of events reported was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Immediate onset of flushing sensation in face and upper extremities, along with slight swelling of the left upper extremity (especially in the hand).  Benadryl 37.5 mg oral was administered, and symptoms gradually improved and resolved over the next 10-15 minutes.  Patient did not meet the clinical diagnosis of anaphylaxis, and epinephrine was not administered while patient was in the office.  Patient never developed respiratory compromise, GI symptoms, or reduced BP/end-organ dysfunction.  Vital signs remained normal and stable following reaction and at the time of resolution of symptoms.  It was recommended that patient go to the ED (by EMS) for monitoring purposes/delayed reaction.  EMS transport was declined by patient.
Pfizer/BioNTech COVID-19 Vaccine administration error. Patient received vaccine at 6:10 pm; however, the labeled expiration time was 4:42 pm.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXEMIA 12/24/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
This spontaneous report as received from an immunization official, refers to an unspecified number of patient of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not mentioned. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # L047307, expiry date: 23-MAY-2017, (dose#, site of administration and route not provided). No adverse effects were reported. No additional information was provided. Product quality complaint was not filed. Additional information is not expected as the reporter did not wish further contact. This is one of the two reports from the same reporter.
SORE ARM; This spontaneous report received from a patient concerned a 78 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and other pre-existing medical conditions included the patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore arm. This report was non-serious.
1st morning-golf sized l;ump on lymphnodes, felt bad, itching everywhere on 7/7/2022..took claritin and benedryl, hand, back, breast itching, bumps under arm of injection-went away after an hour
This case was reported by a nurse and described a an adolescent female pt who experienced hair loss following immunization with hepatitis B vaccine (manufacturer unknown).  Family history was significant for hair loss in the pt's sister following receipt of hepatitis B vaccine.  On unspecified dates, the pt received an unspecified number of doses of hepatitis B vaccine (manufacturer unknown).  Subsequently, on an unspecified date, the pt experienced hair loss.  The hair loss resolved but the hair regrowth was different than prior to the hair loss.
4/7-4/8: 101.8 fever 4/9 through current day: Autoimmune reaction - fingers are sore, swollen, itchy,  white and red, cold and hot.  Treatment: Dr. visit on 4/13, prescribed prednisone and nifedipine to reduce/relieve inflammation and constricted blood vessels in fingers.  Time course: 4/9/21 through current day
PERSISTENT AND INCREASING LEFT UPPER EXTREMITY PAIN WITH REPORTED LEFT UPPER EXTREMITY WEAKNESS.
dizziness; fatigue; extreme nausea; This is a spontaneous report from a contactable Consumer or other non-HCP reported for a patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Lot number was not reported), as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced dizziness, fatigue and extreme nausea. The reported stated that keep hearing and various communication sites that the side effects of the booster shot in 5 percent of the people are sore arms and swollen gland. I personally was down and out for three days with dizziness, fatigue and extreme nausea. Three of my friends had the same thing. The patient outcome of the events was unknown at the time of this report.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
During monitoring period of patient's second dose, pt had intense muscle contractions of her upper extremity with minor tonic-clonic like movements.  Pt was conscious and AAO x 3 the entire duration of the ~2-3 minute episode.   The tonic-clonic episodes subsided as did the patient's sustained contractions.  Patient regained full ROM and was watched for a period of 1 hour.
Patient was given 3 Monovalent Pfizer vaccine and should have been given Bivalent Pfizer Vaccine.
Uncontrollable shaking and convulsions occurred in the middle of the night. Experienced bad fever and chills.
A three year old boy was vaccinated with Rabipur (rabies vaccine) after a cat bite per post exposure. The first vax was carried out after the cat bite in the middle of June (possible June 12, 2000). Further vax on June 15, June 19, June 26. The boy suffered from focal convulsions on July 2 and 3.  No rabies specific immunoglobulin had been given. The child has not had any convulsions before.   This is considered Medically significant. Causality is pending.
Lightheadedness/nausea, fever, chills, fatigue, body aches
Crisis Hypertension, Thrombocytopenia with internal bleeding from stomach and intestines  (replaced 4 pints of blood), shortness of breath.
Widespread muscle and tendon pain as well as stiffness in neck, shoulders, groin, low back. Extreme fatigue. Swelling of hands, fingers and knees. Low iron. Diagnosed with Inflammatory Arthritis. Treated with Gastroenteritis and abdominal bloating eventually treated by Gastroenterologist due to small intestine bacterial overgrowth with constipation. Worsening symptoms through rejection of two initial antiinflammatory medications prescirbed by another rheumatologist elsewhere used to treat Inflammatory Arthritis. Somewhat improving with Plaquenil started 11/26/2022 together with oral prednisonel. Continuing gastroenteritis after treatment with Xifaxin for SIBO. Low iron treated with one dose of ferheme iron infusion.
5NOV93 devel sore throat & h/a through 15NOV93 had flu like sx including malaise, sore throat & upper resp sx; sx cont for approx 4 wks;
Breakthrough case admission after 5 vaccines Moderna 2/20/21 lot# 023M20A;  Moderna 3/6/21 lot# 002B21a;  Moderna 3/16/21 Lot# 002B21A;  Moderna 11/12/21 lot# 034F21A;  Moderna 6/16/22 lot# 037A22B
Extreme severe pain on the guts; Stomach extremely sore/very sharp stomach pain; Crying and screaming; Too sick and couldn't retain anything even water; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL PAIN (Extreme severe pain on the guts), ABDOMINAL PAIN UPPER (Stomach extremely sore/very sharp stomach pain), CRYING (Crying and screaming), ILLNESS (Too sick and couldn't retain anything even water) and VOMITING (Vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GASTROINTESTINAL PAIN (Extreme severe pain on the guts), ABDOMINAL PAIN UPPER (Stomach extremely sore/very sharp stomach pain), CRYING (Crying and screaming), ILLNESS (Too sick and couldn't retain anything even water) and VOMITING (Vomiting). At the time of the report, GASTROINTESTINAL PAIN (Extreme severe pain on the guts), ABDOMINAL PAIN UPPER (Stomach extremely sore/very sharp stomach pain), CRYING (Crying and screaming), ILLNESS (Too sick and couldn't retain anything even water) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug information was not provided.  Treatment information  was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Information has been received from the author of a literature article titled as stated concerning a 69 year old male with a history of mild cirrhosis presumed to be from non-alcoholic steatohepatitis. He had a history of chronic thrombocytopenia presumed to be secondary to his cirrhosis and mild splenomegaly. On an unspecified date the patient was vaccinated with a dose of RECOMBIVAX HB (manufacture unknown) (lot number not reported). Two weeks prior to admission, the patient's platelet count was 92000 and his lowest previous platelet count recorded was 53000. The patient was admitted after routine blood work revealed a platelet count of 13000. After admission, the patient's platelets continued to drop despite platelet transfusions reaching a nadir of 7000. Initial hematologic consultation suggested his thrombocytopenia was still due to his cirrhosis and splenic sequestration. Gastroenterology was asked to see him to for further recommendations. On careful review, it was noted that the patient had received the RECOMBIVAX HB (manufacturer unknown) 2 weeks prior to admission as routine care for his chronic liver disease. Immune thrombocytopenia purpura (ITP) secondary to the RECOMBIVAX HB (manufacturer unknown) was suspected. The patient was started on prednisone and intravenous immunoglobulin (IVIG) therapy. Confirming the diagnosis of immune thrombocytopenic purpura, his platelets improved to 59000 within 12 days. His platelet count has remained stable since, off of any therapy. The author of the article reported that ITP secondary to the hepatitis B vaccine occurred infrequently. In this case, severe thrombocytopenia could ensure requiring hospitalization and prompt treatment. The author of the article reported that recognizing and reporting this rare life threatening complication was imperative. Immune thrombocytopenia purpura (ITP) was considered to be life threatening by the physician. Additional information has been requested.
The morning after administration I had extreme hives all over my body, chills, headache and fever.
Rash on back and neck, fever 101, limp, behavior changed, constantly crying, poor balance, couldn't walk or stand. This occurred for 2 days. Afterward got sick with cough, ear infections, diarrhea and as of 11/7/02, still sick. Tylenol and Amoxillin for ear infection.
4/10 - sore arm, no other symptoms 4/11 - headache 8/10, brain fog, nausea, dizziness, 7/10 neck and back pain, 8/10 exhaustion 4/12-4/17 - low grade headache 3-4/10 4/19 - 8/10 headache, 8/10 exhaustion, extreme weakness on right-side, rapid onset of stroke-like symptoms (Est 815am) to right side (face droop with impaired slurred slow speech, right arm, right leg immobility) facial symptoms resolved quickly (less than 1 minute), complete speech impairment lasting 2-3 minutes, partial speech impairment sustaining through to mid-day, complete right side weakness lasting 3-5 minutes before total resolve and intermittent R-side weakness after transport to hospital. Arrived at Emergency department about 930/10am, most symptoms subsided by time of admission - slowed speech persisted to mid-day. Discharged at 4pm to home.  4/19 - 6/10 exhaustion through most of the day 4/20-4-21 unusually high level of energy 4/21 - back pain and low grade headache return 3/10 4/22 - back pain more intense 4/10, intermittent headache 3/10 - report to CDC 4/26 - scheduled follow up appointment with Neurology
My left arm was extremely weak. It was difficult to use that arm for anything besides the lightest of work. It hurt to even open my bedroom door which is light and hollow.  Lifting my arm above my shoulder hurt as well.  I felt lots of fatigue all over my body.  I was so exhausted after a hike that I fell asleep in the afternoon for a couple hours. I hike every other day and haven't experienced this before. This hike was also way shorter than usual. I hiked maybe a mile. Usual hikes are 2-15 miles. When I returned from the hike I took some excedrin for a headache that started during the hike. I went to bed early. When I woke up today I only have slight fatigue and my arm is starting to feel better, although it is still sore at the injection site.
chills; No Appetite (haven't been able to eat very much); headache; terrible diarrhea; pain in the arm; nauseous; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of   in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No treatment medications provided by the reporter.   This case was linked to MOD21-030914 (E2B Linked Report).; Sender's Comments:  MOD21-030914:
10 month old patient that did not received the second dose of fluzone quadrivalent in 28 days / no AE; Initial information received on 02-Dec-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 10 months old patient who received first 0.25 mL dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number and Expiry date unknown) via unknown route in unknown administration site on an unknown date.  The patients past medical history, medical treatments, vaccinations and family history were not provided.   It was an actual medication error case due to Incomplete course of vaccination as 10 months old patient that did not received the second dose of fluzone quadrivalent in 28 days.   At the time of reporting no adverse reaction 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.
The patient came today to receive his 2nd dose of Pfizer.  But The pharmacist on duty administered Moderna as second dose instead.  The pharmacist did call the patient to make sure he's ok a few hours later after realizing the wrong vaccine was given.  So far the patient stated that he is fine and have not experienced any side effects.
no adverse event; pediatric monovalent dose (6 months-5years) which expired on 13-Feb-2023 was inadvertently administered on 14-Feb-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pediatric monovalent dose (6 months-5years) which expired on 13-Feb-2023 was inadvertently administered on 14-Feb-2023) and NO ADVERSE EVENT (no adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Feb-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (pediatric monovalent dose (6 months-5years) which expired on 13-Feb-2023 was inadvertently administered on 14-Feb-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pediatric monovalent dose (6 months-5years) which expired on 13-Feb-2023 was inadvertently administered on 14-Feb-2023) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (pediatric monovalent dose (6 months-5years) which expired on 13-Feb-2023 was inadvertently administered on 14-Feb-2023).    No concomitant product was reported. No treatment information was reported.