chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse who is also the patient's mother refers to her son a 16 month old male patient. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On 29-MAR-2008, the patient was vaccinated with the first dose of inactivated VAQTA (strength, dose, route of administration, lot number and expiration date were not provided). Then on 06-AUG-2008, the patient was vaccinated with the second dose of VAQTA (dose, route and site of administration, lot # and expiry date were not reported), which was considered as a product use issue, because the doses were administered within a shorter interval than it was recommended in the prescribing information. Other suspect and concomitant therapies were not reported. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of PNEUMOVAX 23 which had Lot number M038359 with expiry date on 13-MAY-2018 and lot # M039060 with expiry date on 22-MAY-2018 (strength and route were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccines were exposed to temperature of > 8 but <25 Centigrade range for a time frame of 1 hour and 4 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA008046: US-009507513-1703USA008047: US-009507513-1703USA008049: US-009507513-1703USA008050: US-009507513-1703USA008051: US-009507513-1703USA008052: US-009507513-1703USA001827.
Per TC from pt: t100.4 started 13DEC91; chills, diarrhea & stomach cramps; pt thinks sxs due to hepatitis vax;
Extreme body achees; Severe headache; lymphadenopathy in the armpit.; This is a spontaneous report from a contactable nurse (patient). A 46-year-old female patient (no pregnancy) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly at site of left arm at 10:30 on 11Jan2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took first dose of BNT162B2 on an unspecified date. The patient experienced extreme body achees, severe headache, lymphadenopathy in the armpit, all at 21:30 on 11Jan2021. Adverse reactions did not result any serious consequences. Facility type vaccine was hospital. No need treatment for adverse event. No covid prior vaccination. No covid tested post vaccination. No known allergies. Other medical history was none. The outcome of events was recovering.   Information on the lot/batch number has been requested.
Headache; nauseous; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown", described as "nauseous".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Began having muscle aches about 4 hours after injection. By evening had fever, and whole body aches. Next day could not get out of bed. Fever, pain, headache, nausea, chills. Fever broke approximately 3 am on 4/7/2021. Now have fever blisters all over my lips. Will have to think long and hard before ever getting another one.
When I depressed the syringe, it did not expel the liquid into her arm, therefore another syringe was taken from the fridge and administered and no further problems.
pt recvd vax & devel urtucaria; pt exp also myalgias & devel fibromyalgia;
throat numb;  coughing, clearing throat;  HX seasonal allergies- take zyrtec and allegra;  no HX: anaphylaxis
Patent had a 7.1 cm x 6.5 cm left lateral deltoid redness
1 day after TD (tetanus Diph) inj pt complained of swollen, inflamed hard to the touch at injection site. Pt says it hurts.
Vomiting, body ache, dizziness, upper body itching, joint pain that started on the wrists and continued afterwards to every joint. Occasional headaches.
administered the first dose of Moderna to a 15-year-old patient; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered the first dose of Moderna to a 15-year-old patient) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered the first dose of Moderna to a 15-year-old patient). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered the first dose of Moderna to a 15-year-old patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported.  No treatment details were reported.
1st night couldn't sleep 2nd day headache that wouldn't go away along with dizzy/light headedness 3rd day about an hour after her evening peanut immunotherapy dose of 4 peanuts her skin got very itchy, burning hot, red with some hives. She said her throat felt swollen.  A couple hours after a double dose of benadryl and ice packs she began to improve.   4th day she was much better. We spoke with her allergist over the phone, and he said it was reasonable to chalk the reaction up to extra stress on her body due to the vaccine/her bodies response to the vaccine. We only did half her peanut dose. 5th day she was normal.
Sore Throat; All the typical symptoms of a sinus infection; Headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat), SINUSITIS (All the typical symptoms of a sinus infection) and HEADACHE (Headache) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat), SINUSITIS (All the typical symptoms of a sinus infection) and HEADACHE (Headache). At the time of the report, OROPHARYNGEAL PAIN (Sore Throat), SINUSITIS (All the typical symptoms of a sinus infection) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided. No treatment medication was provided.   This case was linked to MOD-2021-270540 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow-up received on 04-AUG-2021, contains no new information.
Right arm with localized redness (2 3/4" X 2 1/2") , mild swelling and tender to touch.
Mild headache; chills; some joint pains; This is a spontaneous report from a contactable consumer (patient). A 78-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL8982), via an unspecified route of administration in the left arm on 26Jan2021 11:15 at 0.3 mL, single for COVID-19 immunization. Medical history included hypertension and known allergies to penicillin. The patient is not pregnant at the time of vaccination. The patient has no COVID prior vaccination. The patient has not been tested for COVID post vaccination. Concomitant medications included atenolol, chlorthalidone, felodipine, losartan, and potassium acetate (POTASSIO ACETATO). On 26Jan2021 15:00, the patient experienced mild headache, chills, and some joint pains. The patient did not receive any treatment for the adverse events. The outcome of the events was not recovered.
Information has been received from a healthcare professional concerning a 7 year old female who on 5/9/00 was vaccinated with a 2nd dose of Hep-B. On 5/10/00, the pt developed hives, mild redness at the injection site and a cellulitis-type reaction. The pt remained afebrile. The pt sought unspecified medical treatment. Additional information has been requested.
diarrhea recurrent; erythema of extremities; swelling arm; This spontaneous case was reported by a physician and describes the occurrence of DIARRHOEA (diarrhea recurrent), ERYTHEMA (erythema of extremities) and PERIPHERAL SWELLING (swelling arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for an unknown indication.    No Medical History information was reported.   On 20-Oct-2020, the patient started IBRUTINIB (IMBRUVICA) (Oral) at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea recurrent), ERYTHEMA (erythema of extremities) and PERIPHERAL SWELLING (swelling arm). At the time of the report, DIARRHOEA (diarrhea recurrent), ERYTHEMA (erythema of extremities) and PERIPHERAL SWELLING (swelling arm) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
After the second vaccination, it continued and has changed to a more metallic, sour taste; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 53-year-old male patient received BNT162B2 (BNT162B2), administered in arm left, administration date 18Apr2021 11:15 (Lot number: ER8736) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "overweight" (unspecified if ongoing); "hypertension" (unspecified if ongoing). Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE]. Vaccination history included: BNT162B2 (Dose 1, Single, Lot number: ER8732.), for Covid-19 immunisation, reaction(s): "Salty taste in my mouth". The following information was reported: DYSGEUSIA (non-serious), outcome "not recovered", described as "After the second vaccination, it continued and has changed to a more metallic, sour taste". Therapeutic measures were not taken as a result of dysgeusia. Additional Information: About a week or two after the first vaccination, the patient started having a salty taste in my mouth. After the second vaccination, it continued and has changed to a more metallic, sour taste. He had his 6-month dental checkup a few days ago, and my gums were in excellent condition, with no infections or gingivitis. The sour taste continued at the time of report.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021465515 same patient and reporter, different dose and event
a red itchy area for about 3-4 days; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (a red itchy area for about 3-4 days) in a 63-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) 1 dosage form. On 02-Apr-2021, the patient experienced ERYTHEMA (a red itchy area for about 3-4 days). On 06-Apr-2021, ERYTHEMA (a red itchy area for about 3-4 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: unknown (Inconclusive) Unknown.         No relevant concomitant medications were reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not applicable.   This case was linked to MOD-2021-059919 (Patient Link).
This is a spontaneous report from a contactable physician. This report was received via a Pfizer sales representative. A 16-year-old patient of an unspecified gender received TRUMENBA, via an unspecified route of administration on an unspecified date as the first single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced general malaise on an unspecified date. The events lasted for several weeks. The outcome of general malaise was unknown. The lot number for the vaccine, meningococcal group b rlp2086, was not provided and will be requested during follow up.
Local reaction within 24hrs.  But lasted for nearly a full week.  Red, firm, about 6-7cm in diameter, with some surface vesiculation. Initially given Keflex with no change, then given orapred.
It began with an extremely sore arm in the evening, which I expected. The following day, I experienced what felt like the worst arthritic, fibromyalgia, flare/pain I had ever had. Then add on to it what felt like an intense flu. REAL discomfort. Exhaustion- the first two days were the worst. I was literally unable to do my farm chores or anything else. Headache, extreme pain in neck, spine, lower back, hips, knees. A bad headache by afternoon of the first day. No appetite. I ate only Chex cereal w/ milk and tea for the following five days. This wiped me out more than anything I have experienced. I had no fever that I recall, no chills. My arm was very painful, (with limited mobility the first 3 days), extreme tenderness in bicep and around shot site through to February 21st, 2019. It was an extreme enough reaction that I looked up SHINGRIX online and read about this VEARS site; meanwhile my husband had the exact same shot six days later and had the exact same adverse response, which made me see that we both had a "beyond usual" reaction to this shingles booster. Until I saw his reaction that was just like mine, I hadn't been completely sure it was the vaccine and thought perhaps I had simply gotten a horrible flu and it was a coincidence that I had the shot then.
so sick, ended up in bed for almost 2 weeks; Initial information was received on 06-Oct-2021 regarding an unsolicited valid non-serious case received from social media from consumer/non-health care professional via Medical information (under reference number - US-SA-SAC20211011000847).  This case involves a patient of (unknown demographics) who experienced so sick, ended up in bed for almost 2 weeks (illness), after receiving vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  Concomitant medications included ACETYLSALICYLIC ACID (ASPIRIN [ACETYLSALICYLIC ACID]) for Cold; and GUAIFENESIN (GUAIFENESINE) for Cold.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious so sick, ended up in bed for almost 2 weeks (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "it made me so sick I ended up in bed for almost 2 weeks. Damn near died from it.NEVER AGAIN! I deal with colds and flu with guiafenesin, aspirin, and chicken soup.and am doing fine with that."  No additional laboratory data was reported.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  There will be no information available on batch number for this case.
Within 2 hours of shot: pain at the injection site, mild in intensity but onset sooner than after shot 1.  Within 12 hours: Woke up in the night with body aches, joint (knee) aches. Left arm pain progressed to moderate in intensity. No fever
INJECTION SITE REACTION- REDNESS, SWELLING, WARM TO TOUCH IN AREA LARGER THAT 2 INCH CIRCUMFERENCE. REPORTED 03/17. PATIENT STATED IT HADN'T IMPROVED SINCE VACCINATION. RECOMMENDED APPLICATION OF BENADRYL CREAM.
Moderna COVID-19 Vaccine EUA  About 10 hours after I received the second dose of the Moderna vaccine I began to experience severe chills and body aches. These persisted throughout the following day. I was also extremely fatigued the following day. I managed the symptoms with Tylenol which helped tremendously.
A nurse reported that a 26 year old pt received an injection, the pt developed an injection site reaction characterized by a fluid-filled blister and redness that extended down the pt's arm. As of 10/25/99, the blister had gone down and the redness was "better".
I started having a sore throat and nasal congestion on the 24th in the evening. I woke up the next morning with a horrible cough and had a fever. I was very tired and aching all over- I took a home test on the 25th which was negative but I knew I must have CoVID so I called for an appointment and then I tested positive. **My first shot was the J&J vaccine and that was in March 2021 so while this was my second shot I did not have any other shots with in the month before my Moderna dose* *
I ha d what felt like a sinus infection. My head was foggy and my ears for clogged. I heard a ringing in my ears. I ended up with a diagnosis of hearing. I have hyper accuses. I started to have issues with my blood pressure from being so high. I experienced dizziness. Extreme fatigue. MY thyroid and I had hyper thyroid for quite some time.
This spontaneous report as received from clinical medical assistant refers to a patient of unknown age and gender. On 04-APR-2014 the patient was vaccinated with one dose of PNEUMOVAX 23, (lot number and expiration date unknown), 0.5 ml, intramuscularly and on 29-APR-2014 a second dose of PNEUMOVAX 23 was accidentally administered instead of ZOSTAVAX. No adverse effects were reported. It was also reported that ZOSTAVAX has not been administered to the patient yet. Additional information has been requested.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 07-JAN-2015 the patient was vaccinated with a dose of GARDASIL (lot# was unspecified, 0.5 ml, intramuscular) which both underwent a temperature excursion. No adverse effect was reported. This is one of several reports received from same reporter. Additional information has been requested.
Ear Infection before second dose; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (Patient) reported that, an unspecified age of female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection) via an unspecified route of administration, on 02Feb2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date patient experienced an ear infection before her second dose. The outcome of event is unknown. Information about lot/Batch number has been requested.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient has been administrated suspect product  after six day of the first puncture the vial.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up received contains NNI
p/vax pt became irritable & devel a fever up to 101;pt was treated w/APAP;5/27/99 pt temp was 100.2;
Information has been received on 15-FEB-2019 regarding a case in litigation concerning a 71 year old female patient. The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 01-AUG-2013, a pharmacist administered the ZOSTAVAX vaccine by a pharmacist. In 2014, the patient was treated by a healthcare provider for shingles as a result of her vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.
Pt. reported skin reaction pt. presented with red raised rash on anterior portion of upper (R) arm c/o pain and tenderness.
Red raised itchy rash that started around the neck and ears.  By next morning rash was over chest, abdomen, back and some on extremities 3/14/2012 - given Pediapred 15/5 one-half tsp/day.  Also using Benedryl otc. Throat was red and mild Right OM - given Zithromax 200/5 at usual dose.
Around mid-March began having issues with pain in lower left buttock, saw primary physician and sent to orthopedic doctor. By then pain was spreading to upper part of buttock. Did a CATSCAN and found an abcess on the colon, did PT for 2 months, seeing GI doctor and a spine doctor. Have repeat CATSCAN, repeat ultrasound on the 29th of October. Given ciprofloxifin and flagil for 10 days and just finished taking that. The symptoms have slightly diminished, hoping abcess resolves on itself. Also found fluid buildup at L4 and l5 vertebrae, scheduled to have a steroid injection once other health issues resolved.
received the shot and in less than a week came down with it; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but selected as adult as per the vaccine indication. The patient received the shot and in less than a week came down with shingles. The patient returned to the place where he or she had received the vaccine and the doctor stated that, this vaccine wasn't even 50 percent able to keep from getting the disease. The patient was given medicines to counter act and was over it quite rapidly.
Three months after the second dose my left shoulder started to hurst and progressed to a point where the pain is severe and then the pain spread though the back of my neck and now I have the same severe pain in my right shoulder and have limited movement. I can not fully extend either arm straight up! This has changed my life and my ability to work and my normal exercise routine.