chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a medical assistant referring to multiple patients of unknown ages and genders. There was no pertinent medical history or drug allergies/drug reactions described. The reporter stated that from 29-SEP-2015 through 30-SEP-2015, the patients received improperly stored doses of GARDASIL 9 injection (lot # L011846 with expiration date 16-JUN-2017 and lot # L014415 with expiration date 25-JUL-2017; dose and route were not provided). There was no concomitant medication. Product quality complaint was not involved. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Typical symptoms first few days i.e. headache, nausea, vomiting, dizziness, fever. By third day facial numbness and swelling, and chronic nosebleeds which lasted 5 days. Fatigue, dizziness, and weakness lasting for 2 weeks. Attempted to return to work 11/17 and had dizziness, nausea, and vomiting after 4 hours of work and needed to go home. Evaluated at urgent treatment clinic and prescribed Zofran
PT ADMINISTERED TETANUS TOXOID ADSORBED IN LEFT BRACHIUM FOR TREAT OF LACERATED FINGER.AREA BECAME RED, PAINFUL. PAIN HAS PERSISTED ON MOVEMENT OF ARM.TREATED 9-29-89 WITH XYLOCAINE 2%PLUS DECADRON INTO TRIGGER POINT
Fast breathing/lack of air within 1 hr; total body itching after 3 hours; hives/rash on face snd head (used pseudoephedrine and albuterol inhaler - asthma lessened but chest still tight - day 2 still itching all over and tight bronchus but not asthma attack.
Localized Pain and Swelling at injection site. Patient states reaction began within minutes of receiving vaccine.  Patient reported  incident 4 days later . Recommended patient take Benadryl orally every night for 3 nights - if no  change - patient will report to her Doctor for follow up.
Pt rec'd 3 Engerix-B vax. Jul90 hosp for chest pain. Since then running low grade fever;9NOV90 needle stick  & found to be non-immune.  Booster vax 15NOV90, still non-immune as of 02JAN91.  Chest pain & fever "simply concurrent events".
A report has been received from a Health Professional concerning a 7 month old, female subject, who had been receiving FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) stared on 09-Dec-2013. It ws reported that the patient had ADMINISTRATION OF EXPIRED FLUMIST which started o 09-Dec-2013. The outcome of the event of ADMINISTRATION OF EXPIRED FLUMIST is unknown. The report was considered to be non-serious.
Pregnant; Sore arm; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and PAIN IN EXTREMITY (Sore arm) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 11-Jun-2020 and the estimated date of delivery was 22-Mar-2021. On 29-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and PAIN IN EXTREMITY (Sore arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-eighth week of the pregnancy.  On 29-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) 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; Reporter's Comments: This is a case of product exposure during pregnancy with associated sore arm for this 29-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy
Patient was seen 1/23/04 with approximately 50 varicella lesions diffusely spread over face, torso, and scalp.   Sib of patient(3yo with history of AML S/P Bone Marrow Transplant) received VZIG at hospital.  He also acquired a similar case of varicella, and he was placed on acyclovir.  Patient's cousin (also vaccinated) had only a few lesions.
pt recv vax & devel tenderness & swelling in the rt shoulder & ax which was treated w/Pred & DPH;
tingling around the mouth area and lips; her mouth or lips were moving in a way that she had no control over/It was just a feeling she was having; This is a spontaneous report from a contactable consumer (patient).  A 91-year-old female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE)Lot # EL3247, via an unspecified route of administration on 19Jan2021 18:00 at single dose at left shoulder for covid-19 immunisation.  Medical history included osteoporosis from Aug2020, rash on her legs from Aug2020, (lower leg below the knee, she was using a steroid but she had stopped as she was told not to use it too often by her doctor and just use Vaseline to keep the skin moist. She was asked if she had used any steroids but she hadn't used it in the past week and maybe only once in the previous week but couldn't be certain it wasn't in the last 10 days. She resisted the urge to use Mometasone 0.01 as it damaged the skin.); allergies to Sulfa a few years before. The patient reported her daughter who died at 41 years old of breast cancer. There were no concomitant medications. There was no additional vaccines administered on same date of BNT162B2 and no prior vaccinations within 4 weeks.The patient previously took brimonidine tartrate/timolol maleate (COMBIGAN) a few years before and experienced allergies, the eye drops didn't her any good at all and was told not to use it anymore. She previously received flu shot most every year and never had a problem. She stated that evening on 19Jan2021 she felt fine and then the next morning on 20Jan2021 she experienced tingling around the mouth area and lips. Almost as though her mouth or lips were moving in a way that she had no control over. She looked in the mirror and saw no evidence of it moving but could feel it moving. It was just a feeling she was having. The feeling was about the same. The first 2 days was on just the right side but she has had now had 2 occasions where it was on the left side. This was not constant, just occasionally during the day. She wanted to know if this was a known side effect and will it go away. She wanted to know if she should receive the second dose of the vaccine considering these side effects.The outcome of the events was not resolved.
day 3 - swollen tingly lips, allergy symptoms of running nose, dry cough, itchy eyes - worsening over days 4-5 day 6 - same as above plus red, puffy eyes/hives going down cheeks - at doctors direction began benedryl day 7-10 - same as above and worsening with swelling/hives coming down sides of face into neck - still taking benedryl day 11 - same as above but worsening - started 6 day course of steroids - stopped benedryl day 12-17 - same as above but not worsening - stopped steriod after day 17 day 18-22 -  same as above, minor reduction in facial swelling- began taking zyrtec per doctor day 25-31 same as above, more reduction in facial swelling, rashes start on arms and back day 25- stop taking zyrtec day 25
Pt received dose 10/02/22, lot expired 09/30/2022 then changed to 10/19/2022
Flu like feeling very bad for 2-3 days - fever over 100.  muscle aches and pains- still occurring now.
The patient developed vomiting and diarrhea 48 hours after receiving 2 month vaccines. The  vomiting continued for 7 days and then subsided and returned about 2 weeks later. The diarrhea has continued to present and is mucusy looking. Pateint was seen in our office 11/6/07 and sent to the ER do to possible dehydration. The patient was PO challenged and discarged home. The patient followed up in our office 11/7/07 .
extreme pain in right arm down to fingertips, could not get out of bed Friday am so I slid to the floor and could not get up,  had to call my apt facility to get help, Friday afternoon fell asleep on couch and slid to floor while sleeping and had to get hep again to get me up, could not stay awake all day or night for about 48 hours, my daughter had to help dressing me, could not walk without a walker, loss of appetite, pain subsided in arm but still severe pain in shoulder
redness and itchy at injection site arm; redness and itchy at injection site arm/it itches; This is a spontaneous report from a contactable consumer (mother-in law of patient) or other non-health care professional.  A 94-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. The patient medical history, concomitant medications were not reported. On an unspecified date patient experienced redness and itchy at injection site arm (vaccination site erythema), redness and itchy at injection site arm/it itches (vaccination site pruritus). The outcome of events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I ran a 101 degree fever from about 4:00 a.m. into the next day. I was so light-headed and weak that I could barely make it out of bee. The tips of my fingers went numb along with part of my bottom lip. I had an upset GI for several hours and had an accompanied migraine. The next day a gland was so swollen in my armpit that I could barely raise my arm. It was on the same side as the injection.
Localized redness, hot to touch on L arm 2-3 days after shot.
Allergy; Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection) and HYPERSENSITIVITY (Allergy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose once a day. In July 2022, the patient experienced SINUSITIS (Sinus infection). On an unknown date, the patient experienced HYPERSENSITIVITY (Allergy). At the time of the report, SINUSITIS (Sinus infection) was resolving and HYPERSENSITIVITY (Allergy) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication was reported.  No treatment medication was reported.  The reporter's causality for the events of sinus infection with humira (adalimumab) was no reasonable possibility. The reporter's causality for the events of allergies was not provided.
8 days after measles and mumps vaccines were given, he developed a fever of 106.2 for 2 days. No other symptoms noted.
Painful rash & fatigue developed 3 weeks after 1st dose on the upper arm/injection site.
Pain at site of injection with pain & swelling up into the shoulder, (L) arm, no redness or heat. Limitation of range of motion of (L) arm. Ice applied. TYLENOL taken by patient.
Patient has been diagnosed with polymyalgia rheumatica. States symptoms began after vaccination. Patient also reports a flare of his dermatitis immediately post vaccination
2 days after flu vaccine, patient developed a "golf ball sized redness at the area of the injection. Area was warm and hard to the touch. By the next day, the redness extended to covering most of the lateral upper arm. Patient was treated with BENADRYL and cool compresses. She did not require antibiotics. The area of redness resolved.
Sjogren's; MOUTH SORE THAT JUST CAME UP SOME HOW/THERE WAS ABOUT FIVE THAT CAME UP AT ONCE; HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of SJOGREN'S SYNDROME (Sjogren's) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In 2021, the patient experienced HEADACHE (HEADACHE). In July 2021, the patient experienced ORAL PAIN (MOUTH SORE THAT JUST CAME UP SOME HOW/THERE WAS ABOUT FIVE THAT CAME UP AT ONCE). On an unknown date, the patient experienced SJOGREN'S SYNDROME (Sjogren's) (seriousness criterion medically significant). At the time of the report, SJOGREN'S SYNDROME (Sjogren's), ORAL PAIN (MOUTH SORE THAT JUST CAME UP SOME HOW/THERE WAS ABOUT FIVE THAT CAME UP AT ONCE) and HEADACHE (HEADACHE) outcome was unknown.            No concomitant medication information was reported. No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a spontaneous case concerning a 67-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of Sjogren's syndrome, after receiving the third dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Medical history of rheumatoid arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 67-year-old female patient with medical history of rheumatoid arthritis, who experienced the unexpected, serious (medically significant) event of Sjogren's syndrome, after receiving the third dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. Medical history of rheumatoid arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient reported palpitations shortly after vaccination. On exam in post-vaccine waiting area blood pressure found to be 161/101 and patient advised to go to emergency room. Patient declined.
Vvery bad bone pain for 48 hours; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Vvery bad bone pain for 48 hours) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included to treat diabetes, to treat high blood pressure, to treat asthma and to treat high cholesterol for an unknown indication.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced BONE PAIN (Vvery bad bone pain for 48 hours). Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
received her first dose of the Covid vaccine and then twelve days later was diagnosed with Covid; This is a spontaneous report from a non-contactable consumer or other non hcp.    A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant was not reported. The patient experienced received her first dose of the covid vaccine and then twelve days later was diagnosed with covid on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: covid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine (ZOSTAVAX) administered on 4/28/12 in left arm subcut. 05/6/12 - patient notices pain in left shoulder, neck, & arm. She has tremors in both hands & generally feels weak. 5/10/12 - patient notices rash from shoulder to wrist on left arm.
Erythema, numbness, pruritis at injection site (Right arm). Tenderness of right axilla. Intermittent shooting pain in right arm.
I am feeling nausea, fatigue, having headaches, muscle pain and where I got a shot is really hurting
1st Dose Reactions-Fatigue/Tiredness: occurred two days after injection for four consecutive days & Injection Site Pain: occurred for 48hrs after injection  2nd Dose Reaction-Appendicitis: occurred four days after injection
She reports that the following morning she woke up with fever and chills That night, she had trouble breathing so tried albuterol nebulizer without relief.  She administered her epipen with improvement.  She continued albuterol and prednisone. For the following week, she has had persistent migraine and vomiting which she has been taking NSAIDs and anti-emetics.
The evening of the injection and the next day, hot, swollen upper arm. Two days after also lower arm swollen but not hot. Still ongoing.
4-5 inch red area around injection site with warmth and  hardness in center.. This lasted 8-10 days before completely fading.
30 minutes after receiving the vaccine, client reported feeling dizzy and itchy on his left leg.  One  subtle slightly red smooth circle was seen on his right upper back and then it quickly disappeared.  Five minutes later after reporting the symptoms, the client reported that the  symptoms subsided and client denied any symptoms at all.  Mother of client declined offer of Benadryl and stated that she would give it at home.  After observing client another 30 minutes, he went home.  Vital signs stable with slightly elevated blood pressure.
This spontaneous report as received from a physician via a company representative refers to an adult female patient who was currently in her 20's. The concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, route, lot number and expiration date were not reported) for prophylaxis. On an unknown date ("within 24 hours of receiving GARDASIL 9, the patient "went into a coma" for an unknown reason and for unknown length, and on an unknown date, she was admitted to a hospital for the coma; additionally, it was reported, that at the time of reporting the patient "was dying". The outcome of coma was unknown, and the outcome of terminal state was not recovered/not resolved. The causal relationship between the events and GARDASIL 9 was not reported. The reporter considered the events of coma and terminal state as life threatening, and the event of coma as a disabling event, and upon internal review, the event of terminal state was considered to be as medically significant.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose number, dose, frequency, route of administration, anatomical location, lot number was not reported). Concomitant medications were not reported. The reporter stated that possibly one dose of PNEUMOVAX 23 that was store at temperatures below the storage temperature range recommended in the prescribing information, may have been administered to an unspecified patient. No adverse effect reported. Additional information has been requested.
Arm which vaccine given became very painful - joints became painful & stiff - mobility/movement became difficult d/t pain.
Little sores in her mouth including her palate; Mouth is "burning"; Throat "was not feeling right"; Felt that her face was sunburnt; Dry lips; This spontaneous case was reported by a consumer and describes the occurrence of SUNBURN (Felt that her face was sunburnt), LIP DRY (Dry lips), OROPHARYNGEAL DISCOMFORT (Throat "was not feeling right"), ORAL PAIN (Little sores in her mouth including her palate) and ORAL DISCOMFORT (Mouth is "burning") in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included Oral disorder (For which the patient was prescribed with a low dose antibiotic.) from October 2020 to January 2021.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced SUNBURN (Felt that her face was sunburnt) and LIP DRY (Dry lips). On 13-Mar-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (Throat "was not feeling right"). On 17-Mar-2021, the patient experienced ORAL PAIN (Little sores in her mouth including her palate) and ORAL DISCOMFORT (Mouth is "burning"). The patient was treated with AMOXICILLIN at a dose of 1 dosage form. On 12-Mar-2021, SUNBURN (Felt that her face was sunburnt) had resolved. At the time of the report, LIP DRY (Dry lips), OROPHARYNGEAL DISCOMFORT (Throat "was not feeling right"), ORAL PAIN (Little sores in her mouth including her palate) and ORAL DISCOMFORT (Mouth is "burning") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
upset stomach; feeling crappy; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach) and FEELING ABNORMAL (feeling crappy) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Mar-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 ABDOMINAL DISCOMFORT (upset stomach) and FEELING ABNORMAL (feeling crappy). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach) and FEELING ABNORMAL (feeling crappy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
On 2/2 developed a R sided migraine that was worse in severity than her typical migraines with paresthesias in left arm and leg.