chrisvoncsefalvay/vaers-outcomes huggingface dataset:
G3P1010, currently pregnant at 9 weeks. Vaccine was administered at 9 1/7 weeks. Due date is 8/9/2021. Had normal arm soreness starting about 4 hours after received the vaccine, limited to deltoid region of left arm, plus some mild fatigue. Soreness was significantly better by about 30 hours post-vaccine, and gone by 48 hours.  On 1/6/2021, one week after receiving the vaccine, I started to develop itching in my left arm around the vaccine site. By 1/7/2021, there was erythema, mild edema, ongoing pruritus and felt warm to the touch. Today, 1/8/2021, all symptoms are gone.
Itchy; Red; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), ERYTHEMA (Red) and RASH (Rash) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concomitant products included HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PRURITUS (Itchy), ERYTHEMA (Red) and RASH (Rash). At the time of the report, PRURITUS (Itchy), ERYTHEMA (Red) and RASH (Rash) 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.   Concomitant product include methotrexate No treatment was reported.
cold like symptoms starting on 11/4/21. Two other members in household tested positive for COVID. All vaccinated
arm swelling; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swelling) in a 65-year-old male 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 first 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 2 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (arm swelling). At the time of the report, PERIPHERAL SWELLING (arm swelling) outcome was unknown.            Concomitant medications were not provided. Per report, the patient received 2 doses of Moderna COVID-19 vaccine and experienced arm swelling after received doses. Treatment information was not reported.   This case was linked to MOD-2021-091367 (Patient Link).
Severe chills-1 night; aching muscles-1day; weakness, 1.5 days; fatigue-1.5 days  No temperature
arm got a little bit red; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (arm got a little bit red) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3), ATORVASTATIN (AVISTATIN), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) and LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for an unknown indication.  On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm got a little bit red). On 17-Jan-2021, VACCINATION SITE ERYTHEMA (arm got a little bit red) 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.   Treatment details included Claritin.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Nov2021 as dose 1, single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  Additional information: Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment?: No. Did you/the patient previously receive a COVID-19 Vaccine?: Yes. Reported Event: Stuffy nose, Sneezing, Headache, Fatigue, Fever.adverse event start date: 28Jun2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Breakthrough case admission after 3 vaccines Moderna 1/26/21 lot# 027L20A;  Moderna 2/23/21 lot# 029L20A;  Moderna 12/16/21 lot# 067H21A
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 10-DEC-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L012482, expiration date: 10-APR-2014 (incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
1 week, post vax, she has pain in her left arm. Pain if felt during any movement of her arm. Pain is present even when arm is still, it is exacerbated with movement. Not tender to touch.
Patient reports raised bumps on thighs and abdomen on Friday (day after vaccine), both hands swollen on Saturday. She took Benadryl to help. She reports rash persisted and she had a new rash on leg a few days later. Her primary care doctor attributed it to anxiety.
Information has been received from a woman in a physician's office concerning a retired 83 year old white female with an allergy to codeine and tape who on 10/23/03 was vaccinated IM in the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine (Lot # 647636/0944N). There was no illness at the time of vaccination. On 10/24/03 the pt developed right arm pain, swelling and tenderness and was unable to raise her arm. Unspecified medical attention was sought. The pt was treated with anti-inflammatories. No product quality complaint was involved. Subsequently the pt recovered. The reported expressed a concern with the lot.  It was also reported that 3 other pt's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 647636/0944N) and developed adverse reactions (WAES # 0311USA00842, 0312USA00976, 0312USA00977). The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. No further information is expected.
was laid up in bunk with a 102.2 fever; had a touch of the flu; couldnt hold food down; Initial information received on 08-Dec-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (consumer).   This case involved a patient of unknown demographics who was laid up in bunk with a 102.2 fever (pyrexia), couldn't hold food down (Dyspepsia) and had a touch of the flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications 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 were not reported) via unknown route in unknown administration site.   On an unknown date, 2 days latency, after initiating the suspect drug, the patient was laid up in bunk with a 102.2 fever (pyrexia), could not hold food down (Dyspepsia)  and was told by a base doc that had a touch of the flu (influenza).   Other laboratory details were provided.  It was not reported if the patient received a corrective treatment.  The outcome of the events was unknown.  There will be no information available on the batch number for this case.
patient only received the liquid CYW-135 component; patient only received the liquid CYW-135 component; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 20-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 06-JUL-2023, the patient received Menveo. On 06-JUL-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: patient only received the liquid CYW-135 component) and inappropriate dose of vaccine administered (Verbatim: patient only received the liquid CYW-135 component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 7-JUL-2023 Pharmacist reported she administered a dose of Menveo to a patient, without realizing there were 2 vial components. The patient only received the liquid CYW-135 component. At the time of reporting, the pharmacist did not have the lot number/expiration date available, and did not have the patient initials.  A report dose had not yet been administered.  The Vaccine Administration Facility was the same as Primary Reporter. Reporter gave permission for follow-up. Consented to follow up.
He has been sick ever since getting the flu shot. Stomach bug immediately followed by respiratory infection immediately followed by what appears to be the flu or possibly just a nasty viral infection. Waiting to be seen by PCP.
PE 3/16/11; received immunizations. On 3/17/11, began vomiting (non-bloody, non-bilious)-daily episodes but continued to breast/bottle feed. Wet diapers; no diarrhea. Wt loss.
Right after vaccine I waited in the waiting room for a while because they were having problems with their system, and because I had known allergies. I was in there for about 45 minutes. I was told I could leave, and about 5 minutes later I was driving and felt funny. 3 minutes later I called the pharmacy, and they were closed and referred me to a doctor on call, and I told her I was having a reaction, but my throat wasn't swelling, and it only felt a little tight and my face was swelling but it didn't affect my throat. She said to take Benadryl, and I contacted the doctor again, and I remained swollen I would say for about a week and a half. Then about a week after that, I started breaking out on both arms with what looked like goosebumps, and they are still on me and itchy. I've tried everything even oatmeal treatment and it's still here. I then developed a pain in my neck, in the upper part of my neck, my shoulder, and arm, and that pain in perpetual and consistent. The pain is a 9 out of 10 on pain scale. It has stayed like that up until about a week ago. I was able to go to physical therapy and now the pain is sporadic, a 5 out of 10 pain level. Recently, about a week ago I noticed my skin was changing and looked like Eczema and I still have those bumps on my arm, legs, back, stomach, and patches in different places. I have to reach out to my Doctor to see what to do about this, but I'm still using oatmeal treatment at this point.
This spontaneous prospective pregnancy report as received from a nurse refers to a female patient of an unknown age. The patient's pertinent medical history and concurrent conditions were none. There was no history of allergies or reactions. Prior to administering the vaccine, the patient had two negative urine pregnancy tests done in the office on 24-AUG-2015. Then, on the same day, on 24-AUG-2015, the patient was vaccinated with first dose of GARDASIL lot # K010215 with expiry date of 05-MAY-2017, intramuscular. Concomitant medications were none. And for some unknown reason, a third pregnancy test was conducted in the office on 24-AUG-2015, which showed a positive result. The nurse noted that this patient may be pregnant and was administered the GARDASIL. Last month period (LMP) and Expected date of delivery (EDD) was not known. The pregnancy outcome was outcome pending. Additional information has been requested.
Large red welt adjacent to the injection site that is 4? long x 3? wide and is sore and hard and itches.
6.5x4 cm eruption (erythema, slight induration, vesicles/papules) at site.
A report was received from a health professional on 10/16/02, concerning about 20 vaccinees between the age of 6-35 months who were inadvertently administered Fluvirin in the vastus lateralis between 14-16 October 2002. None of the vaccinees have exhibited any signs or symptoms of an adverse event. The vaccinees will be closely monitored. Update (1) 12/27/02: A report received from a health care professional indicated that a 14 month old female vaccinee inadvertently received Fluvirin vaccination on 10/14/02. There were no adverse effects noted at the time of the report. See ref: PJP200200575, PJP200300020, PJP200300022, PJP200300023, PJP200300024, PJP200300025, PJP200300026, PJP200300027, PJP200300028, PJP200300029.
54-year-old female presents the emergency room for evaluation of hypoxia.  She has a known positive COVID test.  Patient reports  08/11/2021 in which she developed sinus congestion sore throat and cough.  She was seen by her primary care physician on 08/12/2021 and had a positive COVID test.  She reports that she ran fever to 102 for 4 days.  She has not had any fever for the past 3 days.  She has not had any nausea vomiting or diarrhea.  Patient reports having the Johnson & Johnson immunization in April.  She states that she had a video conference with her primary care physician earlier today who advised her to get a home pulse ox which she did.  She then sent him a picture of the reading which she states was 89%.  This was on room air.  He has advised her to come to the emergency room.  According to the emergency room physician Dr. the patient did have pulse ox readings of 90% on room air on presentation.  She has been placed on 2 liters/minute oxygen.  I have been asked to admit the patient due to her hypoxia.  Patient has a history of asthma and is on albuterol as needed. Pt was discharged on 08/21/2021 -  Admitted with COVID-19 viral pneumonia Vaccinated with J and J in April The patient has been having 7-8 days of symptoms at admission, she was hypoxic per home pulse ox reading and by verbal report her initial pulse ox reading on room air at our facility was 90%,  started dexamethasone 6 mg IV daily. Patient has mild elevation of liver function test but they are within the parameters of starting remdesivir Inflammatory marker labs per COVID order set On 3 L, repeat CXR in am stable and same O2 requirements  Has stabilized here and unlikely to worsen, will dc home on oxygen and oral steroid course
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 15:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 31Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 03Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 13Apr2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
improperly stored vaccine administration in reference to temperature excursion; This spontaneous report was received from an unspecified reporter referring to a currently 1 year old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.       On an unknown date, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (0.5 milliliter (mL), lot # S038702, expiration date 01-DEC-2021; strength,  frequency and route of administration were not reported) for prophylaxis (product storage error). Current temperature excursion was -9.5 Celsius degrees for 8 hours and 53 minutes and -10.1 Celsius degrees for 6 hours and 40 minutes. There was no previous temperature excursion. Data logger was involved.
Rash, dyspnea. Given steroids 10/14/14 at U.C. Returned to urgent care 10/15/14 after waking up with face burning, red from eyes to shoulders, stabbing headache on top of head, ringing in ears (still present 10/28/14).
Went to see a neurology on 11/21/17, 84 yr old female w/subacute onset of weakness in lower extremities, sensory loss, and absent reflexes. This is c/w GBS. Her NCS/EMG LE today confirmed this. Patient will be a direct admit to Hosp. If Cr is ok, start IVIG 4 gm/kg IV qd x 5 days. After vaccine given on 9/29/17, I left the hospital unable to walk. After going straight to rehab for 2 1/2 wks. still no better went to see a neurologist, where I was given a nerve test and from her office sent to hospital. She states this c/w GBS.
High blood pressure , it went up to 153/96 last night. Before the shot it was 124/84
PATIENT DEVELOPED HIVES AT INJECTION SITE, THEN ON BOTH ARMS AND TRUNK. TREATED WITH BENADRYL 50 MG.
Large blood blister in soft palate after eating hot foods. This happed again several days later at a different location in the soft palate.
Sore throat; This is a spontaneous report from a Pfizer sponsored program . A non-contactable consumer reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 29Apr2021 (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was stated that caller mother got a pcr test because she had a sore throat, but tested negative on an unspecified date in 2021. She got her first dose 29Apr2021. She wants to know when her mom can get second dose now. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Right arm red and sore. Redness down to elbow. Pt felt feverish and chilled. Reported to office on 05/09/05. Pt states symptoms cleared by 05/11/05. No TX given.
Patient received the COVID vaccine (Pfizer dose 1, Lot# ER8732, exp 7/31/2021) at 1316. Client reported ?my temperature is going up? at 1327. EMT and RN  responded. Client ambulated to the chair next to the EMT station with a steady gait. Client appeared flushed and diaphoretic. No complaints of shortness of breath, dizziness, numbness, or tingling. No appearance of hives or swelling. No loss of consciousness. Client has a history of multiple sclerosis and hypertention. Client was unaware of his baseline blood pressure ranges. Client takes no regular medications. The client has allergies to sulfa and seafood. At 1327, the client?s blood pressure was 140/110, with a pulse of 81, respiration rate of 18, and pulse oximeter reading of 98%. Eyes PERRLA, client was alert and oriented x4. Client was given orange juice and a bottle of water. The client reported not eating any food yet and only drinking some coffee and water before. Vital signs taken again at 1336, with a blood pressure of 150/110, 20 breaths per minute, heart rate 83, pulse oximeter reading 98%. At that time, the client?s color returned to normal and he was no longer diaphoretic. The client stated he felt ?much better.? Repeat blood pressure reading for the client at 1347 was 145/95. Final blood pressure reading for the client was 140/82 at 1352. The client stated he felt ?back to normal.? Education provided regarding emergency management and when to call 911. Client encouraged to follow up with his primary care provider within 24 hours. Client denied any further questions, was escorted to his car by EMT at 1357. The client left the facility with a steady gait and proceeded to drive himself home.
nervous cold chills, swelling of the arm, pain in all muscles, joints and bones, headache, sudden change of mood/depression, buzzing in ears, weakness,
arm soreness after first injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (arm soreness after first injection) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concomitant products included PROPRANOLOL and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm soreness after first injection). On 12-Feb-2021, VACCINATION SITE PAIN (arm soreness after first injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: The Non significant follow up received on 24-MAY-2021. The patient states that she already reported the adverse events.
Information has been received from a physician concerning a 19 year old female with unknown medical history, who on 04-APR-2008 was vaccinated (route unknown) with a second dose of GARDASIL (Lot # 655604/0052X).  The date and the lot number of the first vaccination were not reported.  The physician reported that the patient was "stuck" twice with two different prefilled syringes, because the first syringe did not function properly and did not release the vaccine.  The patient reported arm pain to the physician.  No laboratory diagnostic studies were performed.  The patient sought unspecified medical attention at the physician's office.  Subsequently, on an unspecified date the patient recovered.  This is one of several reports from the same source.  Additional information has been requested.
Morning after shot, shot injection site is red, painful to touch (even slight pressure), and firm.   Soreness in arm when raising arm.  Still there with no change 24 hours after initial onset.
I had a sore throat and felt kind of yucky on Friday night 07/08/2022. On Saturday, I felt fine when waking up, but about an hour later I felt terrible, so I went back to bed. I tested positive for COVID-19 that day. I had a fever of about 101. My temperature was elevated for 24-36 hours. I also experienced body aches and just felt lousy. I went to a walk-in clinic where they gave me an antiviral medication. Overall, I felt badly for about 3-4 days, but it took around 2 weeks for me to actually test negative for COVID-19.
Patient was administered vaccine beyond the published expiration date. Per Janssen Manufacturer, re-vaccination is not required, the vaccine was determined to still maintain the activity necessary to protect against Covid-19.