chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 days after receiving second shot i developed a rash on my elbows, face, knees and buttocks. after it didn't go away i email pictures to my dr who assigned me to see a dermatologist.  during the appointment she took a biopsy and had blood drawn. it came back that i now have celiac disease. she prescribed me Dapsone for the rash and said i need to follow a gluten free diet from now on.
This spontaneous report as received from a medical assistant, refers to a currently 6 months old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patient was vaccinated with an improperly stored ROTATEQ per oral, (which had a lot # of N030366 and an expiration date of 13-MAR-2019; however, dosage number was not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccine experienced the following temperature excursion since an unknown date: 49 F for 9 days. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1808USA006354.
Highest temp measured 105, local rxn @ inject site, rash other than @ inject site; MD dx rash as roseola unrelated to immun;
Cannot sleep (20 hours); Joint pain; Fever; Dose 1: 21May2021 05:00; Dose 2: 21May2021 17:00; BNT162b2 received in the right leg; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the right leg on 21May2021 at 05:00 (at the age of 47-year-old) as a single dose and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the right arm on 21May2021 at 17:00 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took penicillin and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22May2021 at 01:00, the patient could not sleep (20 hours) until she received the 2 doses and had fever and joint pain. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the events cannot sleep (20 hours), Joint pain and fever were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Experienced severe pain in the right shoulder/bicep area, the opposite arm from the injection (injection was given in the left arm). Pain became worse and worse as days went on, and eventually limited what I can use the arm for. I can not raise it up past my rib cage with severe pain. After speaking with a friend who is a doctor, they mentioned Parsonage Turner Syndrome and Brachial neuritis, all the symptoms match the discriptions of those. I immediately started using a Tens unit to help stimulate the shoulder and arm area, began ice treatment and taking tylenol for the pain. The doctor in the office I work at after listening to the issue and symptoms said the same thing and started me on Gabapentin to help with the nerve pain and is going to continue to monitor the symptoms. It has been 46 days since getting the 2nd shot, and I have been at a 8 to a 9 out of 10 pain-wise almost 24/7, it has affected my ability to work and i have had to call in a few days because of the pain and being unable to use my right arm proficiently (I am right handed), it has affected my family and my ability to get things done around the house and engage my children and it has affected my ability to get a good sleep.
On onset was a really bad headache which has been ongoing since then arm pain too and also some numbness in hands and fingers on 06/10/2015.
Altered mental status. Unresponsiveness. Moans to any stimulus. Symptoms started upon awakening on 9/23/19. Labs including CBC, CMP, lumbar puncture, PCR for viral meningitis, CSF culture all normal. No evidence for infectious etiology. Venous blood gas normal. Provided supportive care and he improved over a period of 24-36 hours. Has no recollection of the event or day following.
tired; nauseous; bad headache; A spontaneous report was received from a consumer concerning a 79-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tired, nauseous, bad headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 18 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 046A21A) via unknown route for prophylaxis of COVID-19 infection.  On 18 Mar 2021, the patient experienced the event(s) tired, nauseous, bad headache.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.  On 20 Mar 2021 the outcome of event(s), tired, nauseous, bad headache was resolved.
Swelling, red, burning, itch, sensitivity around injection site - per patient. Vaccine was not given by us.
Patient received vaccine and a couple hours later her arm site became really red and itchy and tender to touch and it is about 2 inches below injection site.
Gave a Moderna Covid vaccine shot that was 1 day beyond it's "use by date";, 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 (Gave a Moderna Covid vaccine shot that was 1 day beyond it's "use by date") 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 EXPIRED PRODUCT ADMINISTERED (Gave a Moderna Covid vaccine shot that was 1 day beyond it's "use by date"). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Gave a Moderna Covid vaccine shot that was 1 day beyond it's "use by date") had resolved. Not Provided  No concomitant medication information available. No treatment medication information available.
This spontaneous report was received from a physician and from a nurse practitioner via a company representative and refers to a 2 patients of unknown age and gender. No information about the patients' medical history, concurrent conditions and drug reactions or allergies was provided. On unknown dates (reported as "over 2 years ago"), the patients were vaccinated with single dose of ZOSTAVAX injection, dose reported as ".065", subcutaneously (lot# and expiration date were not reported) for prevention of shingles. No information about the concomitant therapies was provided. On unknown dates, the patients experienced a mild case of shingles. The outcome of the event and the causality between the event and ZOSTAVAX were not reported. Product quality complaint was not involved. Additional information has been requested.
temperature of 102/still has a fever of 101; This is a spontaneous report from a contactable female consumer (Patient) via Pfizer Sponsored Program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included breast cancer (breast cancer survivor) and concomitant medications were not reported. On an unspecified date, the patient had temperature of 102. She took Advil and still has a fever of 101 and wants to know since she isn't allowed to have Advil how does she bring down her temperature. The patient underwent lab tests and procedures which included Body temperature: 102 and 101. The outcome of the events was not recovered.
Severe chills, could not get warm at all. Headache, existing tinnitus got significantly more intense at painfully high pitches. Entire body ached and was extremely fatigued
Received vaccine at noon on 4/27/2021, no symptoms until upon awakening on 4/28/2021 at 0800.  Pt stated she felt dizzy and her "mind went blank and I fainted".  Her mother drove her to Hospital ED upon arousal (patient was able to walk to the car and into hospital, presented at Triage area). Pt was mildly febrile on arrival, given PO Tylenol.  C/o mild nausea on arrival, given Zofran 4mg PO.  Orthostatic hypotension noted and given 2.5 liters of 0.9% Normal Saline IV.  Magnesium level 1.7, given 2gms Magnesium Sulfate IVPB. Urine Hcg Negative. Pt stated all symptoms improved, Vital Signs stable, patient discharged accompanied by mother at 3:15pm.
pt recvd flu vax 30SEP94 & the next day exp hearing loss in the rt ear; the pt's daughter notes that an ENT specialist was consulted; The ENT specialist did not feel the hearing loss was related to flu vax;
Patient was brought in by father requesting first dose of Covid vaccine; dose was administered. After dose, sibling reported that patient had received a dose the previous day. After dose was administered and medication was reconciled, it was noted that patient had in fact received 2 previous doses, with the most recent dose on 4/29/22.
Extreme fatigue.  Slept most of the time for two days.   Got shot at 10:40 AM.  Left Arm immediately felt odd---sore, heavy, tingly all the way down to my wrist.  By noon, I was asleep.  Slept for about 3 hours.  Up for 3 hours.  Slept for 3.  Up for 3.  Then slept all night.   I had a headache and slept most of the next day.  Definitely felt like my body was fighting something.     I have an approximately 3 inch diameter circle around injection site that is a red, swollen, hard, lump,  It is hot to the touch and extremely sore---at times it itches.  I am shocked how big and hard the knot is.  Its crazy!  I cannot put weight on that arm.  Extremely sore.  It is now 4 days after the vaccine and the knot does not seem to be getting smaller.  In fact, it may be bigger.
Tired. Then aching all over body. Fever. Chills/shaking. Headache, lasting two days.
Chills then sweats followed by dizziness then syncope.   After recovery from syncope had nausea, fatigue, general body aches and headache for about 8 hours.
The patient complains of finger tips and feet numb and has also felt "off balance."  The patient stated her symptoms have been ongoing for about 3 months
FEVER; MUSCLE ACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced fever, and muscle ache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and muscle ache was not reported. This report was non-serious.
Dizzy every now and then; Hard to walk; back pain; arm and leg pain; arm and leg pain; Fever between 99.1-100 F; Vomiting; Not been to work; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (Dizzy every now and then), GAIT DISTURBANCE (Hard to walk), BACK PAIN (back pain), the first episode of PAIN IN EXTREMITY (arm and leg pain) and the second episode of PAIN IN EXTREMITY (arm and leg pain) in a 57-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.     The patient's past medical history included No adverse event.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced DIZZINESS (Dizzy every now and then), GAIT DISTURBANCE (Hard to walk), BACK PAIN (back pain), the first episode of PAIN IN EXTREMITY (arm and leg pain), the second episode of PAIN IN EXTREMITY (arm and leg pain), PYREXIA (Fever between 99.1-100 F), VOMITING (Vomiting) and FATIGUE (Not been to work). On 07-Feb-2021, PYREXIA (Fever between 99.1-100 F) outcome was unknown. On 08-Feb-2021, VOMITING (Vomiting) had resolved. At the time of the report, DIZZINESS (Dizzy every now and then), GAIT DISTURBANCE (Hard to walk), BACK PAIN (back pain), the last episode of PAIN IN EXTREMITY (arm and leg pain) and FATIGUE (Not been to work) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information not provided. Treatment information not provided
got the shot but did get shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles shot but did get shingles, but not bad. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown at the time of reporting.
Due date is July 28  Severe swelling and redness at site injection - lasted about 4 days Excess vomiting  Nosebleeds Chills Headache Fatigue Body aches Dizziness Nausea Stomach ache Bedridden for one full day
Localized allergic rxn left deltoid approx 15cm diameter with an approx 3cm raised area at injection site. Rubor, erythema and itching that lasted 3 days and was the worst on the last day
Pt's mother reports that pt broke out in Hives morning after receiving flu vaccine. Pt was seen in Urgent care, given benadryl for hives.
Fever, chills, ache, loss of taste for 24 hours. Then a large swollen red rash appeared on 4/27 and has continued to spread from injection site down to elbow. The area is tender to touch and itches, feels like fiberglass is stabbing the affected area.
Initial unsolicited report received from a pharmacist on 11 October 2016. This case involves a 85-year-old female patient who was vaccinated with a dose FLUZONE HD via intramuscular route (batch number- UI689AA, expiry date -26 April 2017, dose in series and dose was not reported) in left arm; with a dose of PREVENAR 13 via intramuscular route in right arm (Manufacturer: Pfizer, batch number, expiry date, dose in series and dose were not reported) on 04 October 2016. The patient's medical history, ongoing illness at the time of vaccination was denied and pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as none. Concomitant medications were not reported. On 11 October 2016, 7 day following the vaccination, the patient had experienced large area of redness and soreness at injection site. The previously the patient was vaccinated with FLUZONE HD on 2015 (on an unknown date). Relevant laboratory data and corrective treatment were not reported. The outcome of event was unknown. List of documents held by sender: none.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14May2021 as dose 1, single (Lot number: EW4109), in left arm, on 23Jun2021 as dose 2, single (Lot number: FC9001), in left arm and on 17Dec2021 as dose 3 (booster), single (Lot number: FK9708) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Contracted Covid in March 2020", start date: Mar2020 (unspecified if ongoing), notes: Contracted Covid in Mar2020. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: COVID-19: (unspecified date) Positive, notes: product=COVID 19 Treatment; (18Aug2022) Positive, notes: positive test result after taking Paxlovid for five days. Therapeutic measures were taken as a result of vaccination failure, covid-19 with paxlovid from 09Aug2022 to 14Aug2022. Clinical course: Rebound symptoms, such as a runny nose, congestion and upper back pain, and a positive test result after taking Paxlovid for five days. No follow-up attempts are possible. No further information is expected.
causing her to be unable to sleep at night; body aches that rotate location; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (causing her to be unable to sleep at night) and MYALGIA (body aches that rotate location) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced INSOMNIA (causing her to be unable to sleep at night) and MYALGIA (body aches that rotate location). At the time of the report, INSOMNIA (causing her to be unable to sleep at night) and MYALGIA (body aches that rotate location) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included steroid pack
was mistakenly given another dose of Menactra with no reported adverse event; Initial information received on 27-Jul-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 12 year old female patient who was mistakenly given another dose of meningococcal A-C-Y-W135 (D CONJ) vaccine (Menactra) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date in 2021(last year), the patient received Menactra at an unknown dose (lot number and expiry date, form, strength: not reported) via unknown route in unknown administration site for immunization. On 14-Jul-2022, the patient was mistakenly given another dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE at a dose of 0.5 ml total (lot U7492AA, expiry date: 26-Oct-2023) via intramuscular route in the left deltoid for immunization with no adverse event(latency: same day). Caller stated that the patient had provided a vaccine record from out of state and a note from the school stating that she needed Tdap and Menactra. Employee gave the vaccines to the patient and then realized that the patient had received those vaccines last year.  Action taken: Not applicable.  Outcome: Unknown for the event menactra last year and was mistakenly given another dose of vaccines with no reported adverse event.   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 the guidelines. 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.
her husband tested negative for covid twice and then tested positive but has no symptoms; her husband tested negative for covid twice and then tested positive but has no symptoms; This is a spontaneous report received from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 19Mar2021 (Batch/Lot Number: EN6207) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer stated she was calling and could not find another number to call but her husband and she had their 1st doses of the Pfizer Vaccine; states her husband had his 1st dose on 19Mar2021 and she had her 1st dose on 25Mar2021. The consumer stated her husband tested negative for covid twice and then tested positive but has no symptoms in 2021. The consumer stated her husband has his appointment for the 2nd dose of the Pfizer Vaccine scheduled for Friday 09Apr2021 and he wants to change that. The patient underwent lab tests and procedures which included Covid which showed negative for twice and positive but has no symptoms on an unknown date in 2021. The outcome of the events was unknown.
08/09/2021  51-year-old male medical history significant for obesity hypertension non-insulin-dependent diabetes mellitus presenting with respiratory failure on 08/09.  Patient failed high-flow cannula in the ED initially requiring intubation.  Per records patient was a difficult airway. Approximately 5 minutes after being being received, patient  suffered brief cardiopulmonary arrest secondary to mucus plug which was eventually dislodged.  Patient is now on 100% FiO2 saturations of 95%. TRANSFER: Patient transferred to another facility secondary to bed availability issues. 51-year-old male medical history significant for obesity hypertension non-insulin-dependent diabetes mellitus presenting with respiratory failure on 08/09.  Patient failed high-flow cannula in the ED initially requiring intubation.  Per records patient was a  difficult airway
swollen lymph nodes above and blow my left collar bone, and some in my left armpit area. Pain along my collar bone (lymph nodes), which increased with touch and pressure. It was hard to wear a seatbelt or have bra strap because of the pain. it felt a lot like nerve pain.   the pain is much less, but the swollen lymph nodes are still there.
Altered mental status Intracranial hemorrhage (CMS/HCC) Hypertension Cerebral brain hemorrhage (CMS/HCC