chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vials that were more than 30 days in refrigerator administered to patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vials that were more than 30 days in refrigerator administered to patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vials that were more than 30 days in refrigerator administered to patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vials that were more than 30 days in refrigerator administered to patients) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
No adverse symptoms; Inadvertently administered an expired dose of Proquad; This spontaneous report was received from a nurse via company representative, referring to a 4-year-old male patient. Information regarding the patient's pertinent medical history, concurrent condition, drug allergies/reactions and concomitant medication were not provided.  On 25-FEB-2020, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) (strength, exact dose, schedule, route of administration were not reported; lot# R023500, expiry date: 13-FEB-2020) 1 dosage form; in the right arm for prophylaxis (expired product administered) along with a sterile diluent (strength, dose, frequency, route of administration, lot# and expiry date were not provided). No adverse symptoms reported. There was no associated product quality complaint.
2.27 at 1530 Pt complained of rash srated in the 26th.  Noted one red raised area on her left wrist 0.5mm in size.  Three same type on Left lower shin.  One on the left elbow.  Has been outside with her dogs so may be bug bites. 2.28.03 1030  right arm went away but has three more on Left shin.  To see Dr today. 1330 MD saw pt related non specific in nature no itching noted no treatment at this time.  Untetermined etiology
bruising of b/l forearms and finger joint pain of b/l hands since 12/23/2021 after the 3rd booster shot
Change in body odor ever since vaccine. It smells spicy? I don?t know how to describe it
Patient fainted; Migraine; Shortness of breath; Felt very tired; Fever; A spontaneous report was received from a consumer who was also a 34-year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced fainting (syncope), migraine, shortness of breath (dyspnoea), fever (pyrexia), and felt very tired (fatigue).  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included fexofenadine hydrochloride and birth control.  On 17 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 026L20A) intramuscularly in right arm for prophylaxis of COVID-19 infection.   On 18 Jan 2021, the patient fainted. She felt very tired, had migraine, fever, and shortness of breath. The symptoms continued on and off. Treatment for the event included paracetamol.  Action taken with mRNA-1273 in response to the events was not provided.  The outcomes of the events fainted, migraine, shortness of breath, fever, and felt very tired, was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset of the reported  events, a causal relationship cannot be excluded. Fever and fatigue are consistent with the known safety profile of the vaccine.
Fever over 100 degrees; swollen lymph nodes; unable to swallow; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date unknown), via an unspecified route of administration in the left arm, on 30Jan2021 07:30, at single dose, for COVID-19 immunization, at the hospital. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Concomitant medication included an unspecified birth control medication. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. The patient experienced "fever over 100 degrees and swollen lymph nodes causing me to be unable to swallow" on 30Jan2021 at 22:00. No treatment was received for the events. The outcome of the events was not resolved. The reporter assessed the events as non-serious.
Flu-like symptoms: muscle/body aches, headache, lethargy, and nausea. Lasted 3 full days, then just lethargy for about 2 weeks.
Coughing; This is a spontaneous report from a contactable other healthcare professional. A 28-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), via an unspecified route of administration on 02Jan2021 12:00 single dose (left arm, dose 1) for COVID-19 immunization. Medical history included bipolar disorder from an unknown date. No other vaccine in four weeks was given. Patient took other unspecified medications in two weeks. The patient has no COVID prior vaccination. The patient was not tested for COVID post vaccination. Patient has no known allergies. The patient experienced coughing on 02Jan2021 12:30 with outcome of not recovered. Treatment was not given. The reporter considered the event as non-serious.  Information about lot/batch number has been requested.
Patient received Pfizer vaccine on 6/29/21 and 7/21/21.  11 year old patient received both doses of Pfizer, which does not yet have an emergency use authorization for under 12 years old.
She got her vaccine at her doctors office, no problems.  Later that evening at 11:00 PM she had tenderness, couldn't sleep on that arm due to the pain, thought she had a heart attack.  She had headaches on the right temporal lobe, and then on the temporal lobe with warmth in that area and tenderness.  She also had fever up to 101.4.  She left messages with her doctor and they called her on Monday and told her that she had an allergic reaction and to go to the ER.  She went to the UC, and they reported that they went in for the allergic reaction.  Her hands started swelling up and with high blood pressure.  Then her eyes felt like the blood vessels were bad, had real bad redness in them.  She kept telling them that something was not right.   She wondered what vaccine she got and they did blood work on 12/3/21, and then had other FU's.   She went back to work and her boss told her that her eyes looked bad, and was going back and forth to the doctor every 2 weeks.  She is still having the same problems since then.    She spikes a fever periodically for no reason, and the temporal region has the pain as well, and also the red eyes.  She wants to know what happened and nobody has given her any information.    She talked to the manager in the office and feels that something was wrong with the dosage of what she received, and the lot# says one thing and feels there was an error.    When she went to the ER they were upset and asked why they sent her to the ER if they were the one who administered the vaccine.   She told the doctor what the ER told her and that she should go back to the doctor.    She went to the eye doctor and told them it was from a vaccine injury, who did not confirm that.  She has an APT with an Ophthalmologist in March.
Patient - Moderna Covid Vaccine - February 15, 2021, Ft Tuthill, 10:00 AM Post-vaccine events: Feb 16, 2021  Mild pain in left arm Feb 17, 2021 - Moderate pain in left arm, mild fatigue Feb 18, 2021  Less pain in arm; Fatigue, back muscles seize, hip muscles seize, thigh muscles seize while on short walk (1/4 mile). Retire to couch for entire day Feb 19, 2021  Retire to couch for entire day Feb 20,2021 - Retire to ouch for entire day Feb 21, 2021  Recovery to 70% energy Mar 1, 2021  Discussed reaction form vaccine with family physician who suggested I postpone  my second shot until more is known. I concur. March 5, 2021  Recovery to 100% energy  Pre-vaccine relevant events: Dec. 9-13, 2019  Attend meeting of an agency with  ~30,000 people from around the world.  Dec 15, 2019  Feeling sick, return from travels Dec 16-17, 2019 Illness worsens  Dec 18-22, 2019 Extreme fatigue, exhausted by climbing only 1 flight of stairs, lay on couch.  Persistent cough. Felt the unusual sensation at this illness was not something I had  experienced during prior 70 years. Too weak for a trip to doctor.  Dec 23, 2019 - resumed mild activity.  March, 2021  Recovery to 100% energy.  May 5, 2020. Coronavirus COVID-19 SARS-CoV-2 Antibody lgG test: Negative.   June, 2021  Cough becomes less frequent.   Guidance for second shot for people who likely had Covid is non existent.
Headache, joints achy, tired, arm very sore, flu like symptoms. Took an anti histamine and an aspirin and went to bed. Very tired. Arm swollen and red, still is very sore 6" below injection site.
patient came in for second dose of vaccine today and stated he had previous received Moderna vaccine and it was discovered that he had previously received the pfizer vaccine.   patient was given the Moderna vaccine instead..
Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BIOTIN;MINERALS NOS;NICOTINIC ACID;RETINOL;TOCOPHEROL;VITAMIN B NOS;VITAMIN D NOS] for an unknown indication.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 29-Sep-2020 and the estimated date of delivery was 06-Jul-2021. On 30-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirtieth week of the pregnancy.  On 30-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment to the events not provided.
This spontaneous report as received from a physician refers to a patient of unknown age. On 06-JUN-2014 the patient was vaccinated with expired dose of M-M-R II, Lot # H01013G 0.5 ml, subcutaneous. No adverse effect reported. No further information was provided. Additional information has been requested.
Pt came in on 10/28/2021 to get a flu vaccine. When asked if she had already received her flu shot, pt said no. After the vaccine was given and we went to put it into IRIS to document it, we noticed a flu vaccine for her was already in there from 10/05/2021.
just some arm pain/ arm hurt some the first shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Family history included shingles (husband and younger sister had them).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: just some arm pain/ arm hurt some the first shot). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR084836   Additional Information: GSK receipt date: 14-jun-2023 This case was reported by a patient via interactive digital media. The patient reporter that she had her first shot and was good just some arm pain and no others affect.  The follow-up could not be possible as no contact details were available. For tolerance of 2nd dose, refer case US2023AMR084836, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR084836:Same patient/second shingles shot
2-4 wk after vax pt exp myalgia, arthralgia, fatigue, night sweats
Very loud Tinnitis developed soon after shot.  Debilitating decrease in his quality of life has ensued.
This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA, HEADACHE and FATIGUE in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 17-Apr-2021, the patient experienced ASTHENIA, HEADACHE and FATIGUE. The patient was treated with IBUPROFEN for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, ASTHENIA, HEADACHE and FATIGUE outcome was unknown. Patient declares that she is not taking medication. Concomitant product use was not provided by the reporter.
About 5-10 minutes after receiving injections, patient complained of diaphoresis, difficulty breathing, ears ringing, and chest tightening. Provider came to bedside and a stat page was called. Patient was placed in a Trendelenburg and feet were raised. Patient started to come to and stated that he was ok. He was able to give his name, date of birth, and identify where he was. He said he breathing and chest were better. Patient was able to stand up with no difficulties and was coherent. Patient was discharged.
This spontaneous report as received from a nurse refers to an 11 years old patient (unknown gender). No concurrent condition, medical history or allergy/drug reactions were reported. On 09-JUN-2015, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, dose number 1, lot # K006960, exp. date: 19-FEB-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Pt recv vax on 2/2/98; on the same day pt exp pain & stiffness of LA x 2-3 day
Felt unusually tired, then in the bath I noticed my muscles on my arm were getting more defined.  But when I got out of the bath I saw that my arm was swollen and hot in a large red whelp a few inches under the vaccine bruise. My mother had similar reaction to first Moderna vaccine.
Tdap, HPV and polio given in left arm when patient became pale and began to slouch over. This was approximately 0945. He was lowered to a laying position on the exam table. He was tense and warm and not initially responding to his name. Assistance called for another nurse. No difficulty breathing noted. Within 30 seconds, patient was alert and responding. Cool towel applied to forehead, ice pack to neck. Blood pressure checked and found to be 108/70. Patient reports feeling better and denies any difficulty breathing. Patient reports he has not had any food or drink yet today so he is given water and a snack. Mother wishes to proceed with the immunizations that are left. At 1015, when patient reported he was feeling well, 2 nurses finished giving vaccinations. No further loss of consciousness and patient reports feeling well. Patient remained in office for approximately 30 more minutes after final vaccination. Prior to going home, BP 118/78. He is in good spirits and laughing. 3 day follow up call, Mom notes day after vaccination patient had vomiting/diarrhea/fever. States he felt better by day 2 and now on day 3 is well and back to school and eating.
Headache, Myalgia, chills, fatigue Narrative: Received 1st covid vaccine on 3/22/21 at 3 pm around 4 hours later started experieicning headache, muscle aches, chills, and fatigued. She went to bed and took ibuprofen. Still reports muscle aches and fatigue. Advised normal side effects of vaccine and should subside in the next day or two.
Took flu shot Tuesday 12/05/06 around 8:15am; 12/06/06 at (pt says "2:36AM") felt funny 12/06/06 AM. Developed Right side of tongue felt asleep. Right arm and hand weak and Right leg weak and reports slow in walking and joint tingles. (Friend with patient said patient thought she would get better and waited. 12/7/06 called Dr and went to see him around 9:30 12/07/06. Was "crying and depressed" (per patient) and Dr. told her no heart problem, no stroke and put her on Celexa. Today 12/11/06 (around 10:15am) patient here to report question about reaction to flu shot. Smile is normal, seems to have equal strength hands and legs. States her _____ is much better but she still feels funny, doesn't feel stable when walking. Doesn't write like normal and doesn't do things as fast as usual. She requested blood pressure taken. B/P 258/90. Sent immediately to Dr. if can't be seen to go to ER. Dr.'s office called and reported she is on her way.
Vaccine was administered in the morning and by afternoon patient had developed a red pruritic non-scaly, warm flat plaque in area of vaccination. The following morning the site doubled in size to approx. 5cmx5cm and became pruritic/slightly painful. No other symptoms or concerns. This is not her first flu vaccine, has never had a reaction before. Plan to treat with Zyrtec and ibuprofen for symptoms with return precautions.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of Drug ineffective, Covid-19. Paxlovid was taken as therapeutic measures as a result of drug ineffective, Covid-19 from 16Aug2023 to 20Aug2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300283780 Same patient/different product, different dose/event;
This case was reported by a physician via a sales representative and described the occurrence of Flu like symptoms in an adult patient who received hepatitis B vaccine recombinant (Engerix B). On an unspecified date, the patient received a dose of Engerix B (lot and dose number not specified). At an unspecified time later, the patient experienced flu like symptoms. The outcome of the event is unknown.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 29Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 16Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "breast cancer" (unspecified if ongoing). Concomitant medication(s) included: TAMOXIFEN; PROZAC; CHLORTHALIDONE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results, notes: Indication: Treatment of COVID-19; (17Jul2022) Negative; (21Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient started the treatment with Paxlovid for Covid-19 from 11Jul2022 to 16Jul2022 (Saturday). Tested negative on rapid antigen Sunday and Monday. The patient had congestion and mild cough on Wednesday, 20Jul. Tested positive on 21Jul.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient presents with a chief complaint of constant (but worse at times) skin sores of the mid-back since approximately 7 days ago. It has the following qualities: erythematous and pruritic. The patient describes the severity as mild. The problem is made worse by clothing and application of heat. Context: The patient reports that it had a gradual onset. The patient had no similar problems in the past. The patient reports no contact with a person with similar symptoms. Recent varicella vaccination.
Patient states she started running  a fever of 101-102  starting 4/21/21 with feelings of being achy and difficulty  sleeping. She can't cross her legs, her ears hurt, her knees hurt, side of body gets sharp pain and started coughing.  Her arm is so tender she cannot lay on the side the injection was given.   Patient declined treatment b/c she started feeling better on 4/22/2021.
Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to cases 2018SA274340 and 2018SA274341 (Same reporter). This case involves a 8 years old patient who was vaccinated with a dose of DAPTACEL (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration because children's of greater than 6 years old are vaccinated. It was unknown if any adverse event was occurred or not following the vaccination. 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. Documents held by sender: none.
Post vax, pt said she felt nauseous and immediately, her eyes rolled upward, she stiffened, went backward into my arms. I turned her head to the side, she was pale, cool and clammy and sweating. In 15 seconds, she came out of her state of faint and her BP was 120/86; pulse was 84 and respirations were 32. At 12:30, her BP was 110/86; pulse was 76 and respirations were 20. Her color was pink and she was alert. Mom is present.