chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Aprx 3 hours after injection, I experienced extreme tiredness.  Later that evening  I felt like I had been hit by a truck - severe muscle aches and fever of 100.3 F.  The full following day the tiredness, muscle aches and fever continued.  I stayed in bed.  Around midnight of the 2nd day after vaccination I felt some relief.  48 hours later I am much better but not fully recovered.
Erythema and edema to injection site (mild). Pt prescribed BENADRYL 12.5/5 and hydrort cream.
got sicker than a dog both times for over a week; Initial information was received on 11-Nov-2020 regarding an unsolicited valid serious case received from a consumer or non-health care professional via social media.   This case involves a patient (unknown demographics) who got sicker than a dog both times for over a week (illness), after the patient received vaccine INFLUENZA VACCINE (flu shot).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  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 unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, (Unknown latency) the patient had the INFLUENZA VACCINE (flu shot) twice in adult life and got sicker than a dog both times for over a week (illness).  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There will be no information available on batch number for this case.
A physician reported that his 71 year old wife received an injection of flu shield on an unspecified date. On 11/24/2001, approx 2 weeks following vaccination, the pt experienced nausea, vomiting, and diarrhea. No further info was available at the date of this report.
On 1/13/22, pharmacy intern accidentally gave Pfizer vaccine as Covid vaccine booster instead of requested Moderna booster.  Patient did not experience any side effects.  Pt was notified and ok with the error.
Moderna COVID?19 Vaccine EUA. Fatigue, extreme body aches, nausea, vomiting, chills, fever, headache and sore throat.
11/15/21 presents to ED for "abdominal pain and fever". PMHx "HLD, Sjogren disease's and osteoporosis".
This spontaneous report as received from a pharmacist refers to a 60 year old male patient. The patient concurrent condition included diabetes mellitus. The patient's medical history was not reported. The patient had no drug reaction/allergy. The patient had concomitant medications (name unspecified). On 17-AUG-2017, the patient was vaccinated with ZOSTAVAX, (lot # N014942 with expiration date on 06-JUL-2018 (also reported as 02-FEB-2018) subcutaneous for prophylaxis and Sterile diluent (lot# L048686 with expiration date on 20-JUN-2018) was used to reconstitute the vaccine. On 23-AUG-2017, the patient "threw out his back" and was prescribed Prednisone (manufacturer unknown), 10mg (unknown lot and expiration date), 1 tablet by mouth once daily (QD) for 10 days, as well as NORCO, 7.5mg, (unknown manufacturer, lot and expiration date), 1 tablet by mouth, QD for 10 days to "help with the pain". The outcome of the event was reported as not recovered. The causality assessment was not provided by the reporter.
Pt recvd DTP on 4MAR88; @ approx 245M same date started screaming that lasted seven hrs x 2 mo; slept heavy only awakened for feeding, rt pupil dilated more than lt, constipated, wgt gain dec, cranial atrophy;
This spontaneous report was received from a physician via company representative, concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 03-DEC-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot number L024129; expiration date 21-JAN-2017) "10 PK 0.5 ml SD-PFS LLok w tip" (route of administration and anatomical location were not reported). On an unspecified dates, the PNEUMOVAX 23 had one temperature excursion of 24 hours. The lowest recorded temperature was 34 F (1.1111111111 Celsius). No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
One episode of moderate abdominal cramping, resolved with diarrhea x1. No prior history of abdominal pain/diarrhea, no known food pathogens.
Ears are messed up; her ears are swollen on the inside; Running a temperature/low-grade fever; Headache; Nervousness; like a chronic ear ache; infection somewhere/earaches which turned out to be infected; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284; expiry date: unknown) , via an unspecified route of administration in the left arm, on 18Jan2021, at a single dose for COVID-19 immunisation.  Medical history included ear problems in the past and sick. There were no concomitant medications. The patient had her first COVID shot on 18Jan2021. By Wednesday, two days later (20Jan2021), both ears were messed up, she was running a temperature (also reported as low-grade fever), had a headache, and was very nervous. She went to the doctor and her doctor gave her an antibiotic shot, two steroid shots, and some antibiotic ear drops, which did not work. She then did a home call with the doctor and she provided more steroids, an oral pack, and an oral antibiotic for 5 days. She was still having problems with her ears. Mainly her left ear. It goes from ear to ear. She went to the ENT about the earaches which turned out to be infected, and has subsequently been on two rounds of antibiotics, with persistent symptoms that have gotten better over time. Patient wanted to know if this could relate to the COVID Vaccine. She has never had this happen before, and she has been really sick but not this bad. She has had ear problems in the past, but normally the antibiotic liquid drops clear it up. It was like a chronic ear ache. Her earaches were hurting bad. What she is wondering is if it could be a side effect from the first COVID shot. She clarifies that her ears are swollen on the inside. It was an infection somewhere. The antibiotics and steroids have not healed it up. All of these events were still occurring but come and go. For instance, yesterday she had a low temperature but has not yet had one today. The antibiotic ear drops prescribed were Neopoly HC OTSC 1% OTIC SU. NDC: 24208-635-62. Expiry date: Jun2022. She was unsure what the lot was but also sees: 349111. The oral antibiotics she has is Amoxicillin 875mg/125mcg. These are in a pharmacy vial. Use before: 26Jan2022. She was given two steroid shots. One shorter acting and one longer acting. She was unsure of the names. Oral steroid pack: Manufactured by Pharmaceutical name. Prednisone USP 5mg. REV 1016. 314518. lot: 1150419. Expiry date: Feb2022. She also pre-treated with allergic reaction medications. She goes back to the ENT on Thursday. Patient wanted to know if these had happened to anyone before. Outcome of the event pyrexia was unknown, for events ear swelling, ear pain and ear infection was recovering, while for the other events was not recovered.
Is my arm supposed to be hurting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Is my arm supposed to be hurting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Is my arm supposed to be hurting). At the time of the report, VACCINATION SITE PAIN (Is my arm supposed to be hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medications were provided. No Concomitant medications were reported.   Reporter did not allow further contact
Manufacturer-Sanofi Pasteur Patient is a 70 year old female here today acutely because of having: Patient presents with:Adverse Reaction Patient was seen yesterday and received an influenza vaccine in her left deltoid. She states that last night she noticed her arm became very sore, red, warm to the touch and swollen. Patient states that she became short of breath last night and almost went to the ER. Patient had an influenza vaccine last year and had this same issue. Left deltoid 9 cm x 12 cm erythema, faint, with irregular borders. BP 116/74  | Pulse 60  | Temp (97 °F) (Temporal)  | Resp 18
started w/rash (hives) Saturday noc, day p/vax;no fever;DPH given;no further problems;
AA which is some sort of autoimmune response; Hair loss where approximately 50% of her hair has been removed; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose number: 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose number: 3, 1st booster, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "AA which is some sort of autoimmune response"; ALOPECIA (non-serious), outcome "unknown", described as "Hair loss where approximately 50% of her hair has been removed". The clinical course was reported as the patient had her 4th booster shot and experienced side effects including hair loss where approximately 50% of her hair has been removed; and she has something called AA which is some sort of autoimmune response.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mild pain at injection site for a few days, but late on day seven swelling and rash started, worse on day eight (today)
FLUZONE HD given 11/14/11. The next evening, she found a "sore, itchy lump in left arm pit. She saw the doctor on 11/16/11 and told us he said it was an "infected lymph gland due to bacteria that migrated from the site of the flu shot." Patient was given BACTRIM DS to take twice daily for 3 days.
This case was reported by a nurse and described the occurrence of extensive swelling of vaccinated limb in a female patient who received SHINGRIX. Concomitant products included SHINGRIX. On 14th May 2018, the patient received the 2nd dose of SHINGRIX. On 15th May 2018, 1 days after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site warmth, fever, general body pain, chills and nausea. In May 2018, the patient experienced neck pain and neck mass. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site warmth, fever, general body pain, chills, nausea and neck pain were. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site warmth, fever, general body pain, chills, nausea, neck pain and neck mass to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On or around 15th March 2018, the patient received 1st dose of SHINGRIX. After receiving 2nd dose of SHINGRIX, the patient developed symptoms upon awakening on 15th May 2018. The symptoms included fever, generalized body aches, chills, nausea and redness, swelling with increased temperature to the injection site which extended over an approximately 4 inch oval area. The patient also had soreness in the neck and felt a lump or ball (about the size of a dime). The symptoms were gradually resolved and today (on the day of reporting) only has the lump in her neck. The patient asked for to contact if need any further information and would be happy to speak to someone regarding her symptoms.
The patient suffered a stroke and was admitted to the Hospital for 3 days after receiving his second dose.
Patient presented to the pharmacy 3 days after receiving the injection and reported swelling and redness at the injection site along with aches on her left side and diarrhea. She said it was worse the day after and has been improving since then.
Hypotomic/hyporesponsive episode, pallor/floopy. Paramedics to ER. Recovered completely.
vaccine expiration date 4/02/2022 & Dilutant 4MT3A/Exp 5/20/2022. Next morning felt achy and tired.  By 3pm, had 102 fever, disseminated rash on forehead and down arms, discreet bumps on thorax, inner left thigh, dry cough and nausea.   Patient contacted pharmacist via phone and was encouraged to call doctor and was told that they were not sure whether could receive the 2nd shot.   Rash lasted through Sunday.  Fever would spike around 100-101 at 3pm every afternoon for 12 days.   Patient took Ibuprofen but only when pain was high--took only 1 time every 3rd day.  Even now patient gets temperature spikes on afternoon periodically. It is hay fever season so it could be related to that as well. Patient has not spoken to doctor
This spontaneous report has been received from a registered nurse and referred to a patient of an unknown age and gender. The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of PROQUAD (strength, dose, frequency, and route of administration were not reported; Lot number M041508 with an expiration date 09-APR-2018) for prophylaxis and despite this, the patient was also vaccinated with a dose of VARIVAX (strength, dose, frequency, and route of administration were not reported; Lot number M044349 with an expiration date 04-NOV-2018) for prophylaxis. Both vaccines reconstituted with a sterile diluent (manufacturer unknown) (lot number and expiration date were not reported). It was reported that there was no product confusion involved and there was no adverse reaction reported. Additional information has been requested.
Patient called pharmacy 6 weeks after receiving Flu and Prevnar13 shot stating that she has been having constant pain and not able move her left arm where she received the Prevnar13 vaccine. Patient states that she had tried several self treatment to help with the pain such Opiods, NSAIDs as well as applying Ice pack at the site of injection without relieve of the pain.
Diffuse swelling of entire upper left leg from hip to knee. Swelling began 48 hours after vaccine, Any resolved 24 hours later. Severe pain day of vaccine, Resolved 40 hour.
Large golf ball size lump to injection site with the whole area of my bicep hot and swollen. Pain rsdiating down to elbow.
I received a vaccination as it was the soonest available. 12-13 hours after the booster, I awoke to fever, sweats and chills. It was more mild than my second dose of Pfizer but persisted longer. I awoke to a fever of 101.5 at 4 am, which is when I took Tylenol. For most of the day, I had a low-grade fever, sweating and general fatigue. I took the day off. I felt generally weak/tired. I slept most of the morning and afternoon. Around 6 pm, I felt back to normal but still a bit weak.
This is a spontaneous report from a contactable other HCP, a contactable medical assistant, calling from Doctor's office and from a contactable Physician. A 26-year old female patient received TRUMENBA (lot # J29203, Exp. Date: JUN2016 via intramuscular route of administration 0.5 ml single dose in MAR2015 at 9:30 AM in left deltoid. The patient did not have any other medical condition. Concomitant medication included TOPIRAMATE 100 mg, VITAMIN B, VITAMIN D, PROBIOTICS. On an unspecified date the patient experienced rash at the injection site over the half of the upper arm: there was kind of an imprint of the rash but could feel redness of the rash but had recovered. The outcome of the events was recovered. The event did not require an emergency room or physician visit. The physician assessed there a reasonable possibility that the event is related to suspect product. Follow up (16JUL2015): New information from a contactable Physician included: vaccine details, reporter's assessment. Follow up attempts completed. No further information expected.
This case was reported by a physician via regulatory authority and described the occurrence of vestibular neuronitis in a 55-year-old female patient who received FLUARIX TETRA (batch number AFLBA090AB, expiry date 30th June 2016). Concurrent medical conditions included menopause. Concomitant products included melatonina. On 23rd October 2015, the patient received FLUARIX TETRA (intramuscular). On 25th October 2015, 2 days after receiving FLUARIX, the patient experienced vestibular neuronitis (serious criteria hospitalization), vertigo, nausea and vomiting. On an unknown date, the outcome of the vestibular neuronitis, vertigo, nausea and vomiting were recovering/resolving. The reporter considered the vestibular neuronitis, vertigo, nausea and vomiting to be possibly related to FLUARIX TETRA. Additional details were provided as follows: On 28th October 2015, the patient was hospitalized for worsening of vertigo, nausea and vomiting symptoms. On 30th October 2015, the patient was discharged with marked improvement in clinical condition. Follow up was received on 6th November 2015 from a physician via regulatory authority: The patient's date of birth was changed. The patient's medical history included bilateral breast fibroadenoma which was removed surgically, appendicectomy, bilateral saphenectomy and right knee ligament reconstruction. The patient's neurological assessment revealed severe vertiginous symptoms during head movements with nausea and left sided nystagmus. Ear assessment revealed Romberg test with right lateropulsion. Stepping test was done with right deviation, spontaneous horizontal nystagmus to the left inhibited by visual fixation, position nystagmus to the left-in lateral decubitus. Audiometry showed mild bilateral neurosensorial hypoacusia (mainly right side). The patient showed marked improvement after magnesium sulphate administration, steroid and symptomatic therapy. The patient was advised ENT assessment. Home therapy was suggested as Deltacortene 25 mg 1 tablet for 10 days and then 0.5 tablet for 10 days, Lansoprazole 30 mg 1 tablet, Microser 8 mg 3 tablets for 20 days. Arlevertan 20 mg 2 tablets for 10 days and then 1 tablet for 10 days and TORVAST 20 mg 1 tablet. The physician considered a clear causality relationship between events and FLUARIX TETRA administration.
I notice red itchy bumps on my neck, chest, stomach, back and legs; I notice red itchy bumps on my neck, chest, stomach, back and legs; Hives and dry patches of skin; Hives and dry patches of skin; This is a spontaneous report from a contactable other healthcare professional. A 61-years-old female patient (non-pregnant) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date in May2021 (Batch/Lot number and Expiry date was not reported) (at the age of 61-years-old) as DOSE 1, SINGLE for covid-19 immunization. Medical history included covid-19 (Prior to vaccination, the patient was diagnosed with COVID-19). Concomitant medications included vitamins nos (DAILY VITAMINS), ascorbic acid (VIT C), Coq 10 and cholecalciferol (COLECALCIFEROL) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19. On 04May2021 11:00, the patient experienced i notice red itchy bumps on my neck, chest, stomach, back and legs, hives and dry patches of skin. It was reported as Three days after the patient received the vaccine, she noticed red itchy bumps on her neck, chest, stomach, back and legs and they began to increase in number in the days following. She went to the clinic at the withheld Pharmacy where she got the vaccine and was prescribed a prednisone pack to take over 6 days. When she has completed the pack, the red bumps returned along with hives and dry patches of skin. She further stated that she was trying to decide whether to get the 2nd dose. Laboratory tests on an unspecified date included sars-cov-2 test: positive. The patient received treatment with prednisone. The clinical outcome of the events was not recovered.   Follow-up attempts completed. No further information is expected.
On Apr. 2, 2021 I awoke about 10:00 with blurred vision and feeling dizzy but since my husband and I had medication pick up, we left home. I made the pick up from pharmacy but, when I arrived back at the car I informed my husband that I felt dizzy that morning. We immediately drove to ER.  After reporting symptoms, I was admitted. Receiving physician interviewed me and decided on essential tests (Blood Test, CAT SCAN, MRI, etc.) to be conducted. After each test, indications did not prove a definitive prognosis. After six hours we were finally discharged from ER and were instructed to contact PCP. We emailed PCP, and on Apr. 3, 2021 she called and did an on-phone interview. From tests PCP was privy to she decided to first prescribed another blood test followed by  an Apr. 7 visit with ophthamalogist at 1:00 PM. The following day PCP informed us that eye exam showed signs of eye nerve/muscle damage, so, an Esophagogastroduodenoscopy (EGD) and colonoscopy procedure/s will be performed for Apr. 20, 2021, pre-ops to be accomplished before that date.
received a vaccine which was more than 30 days in the refrigerator/the number of days that have passed were 11; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator/the number of days that have passed were 11) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator/the number of days that have passed were 11). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator/the number of days that have passed were 11) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was provided by the reporter.  No treatment information was provided.