chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itching underneath the area where received the shot; the area was red; fever of 100F; read area was broken out with a rash, rash on her arm; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PRURITUS (itching underneath the area where received the shot), VACCINATION SITE RASH (read area was broken out with a rash, rash on her arm), VACCINATION SITE ERYTHEMA (the area was red) and PYREXIA (fever of 100F) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 041L20A) for COVID-19 vaccination.     The patient's past medical history included Seizures in 1972. Concurrent medical conditions included Drug allergy (Avelox), Drug allergy (Codeine) and Acid reflux (esophageal). Concomitant products included OMEPRAZOLE for Acid reflux (oesophageal), EZETIMIBE and SIMVASTATIN for Cholesterol, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Rhinorrhea, TOPIRAMATE for Seizures.   On 22-Jan-2021 at 2:50 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021 at 1:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021 at 8:00 AM, the patient experienced VACCINATION SITE RASH (read area was broken out with a rash, rash on her arm). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itching underneath the area where received the shot), VACCINATION SITE ERYTHEMA (the area was red) and PYREXIA (fever of 100F). The patient was treated with HYDROCORTISONE for Rash, at a dose of 1 dosage form. On 30-Jan-2021, VACCINATION SITE RASH (read area was broken out with a rash, rash on her arm) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itching underneath the area where received the shot) and VACCINATION SITE ERYTHEMA (the area was red) had resolved and PYREXIA (fever of 100F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) fever of 100F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow-up received on 20-Apr-2021 included:  Age at Vaccination added. Relevant history added. All concomitant medication added, Action taken updated to not applicable. Laboratory test added. Treatment drug coded.Rash updated to vaccination site rash. Fever and vaccination site redness added as new event. On 26-Jun-2021: NNI FU - No new information provided
Pt had 2 episodes of right sided arm and leg jerky, rhythmic movement for 15-30 seconds and became sleepy afterwards. These occurred 12 hours after shots.
Breakthrough case: I tested positive for Covid-19 on August 11, 2021. My symptoms include: Headaches Sore throat Body aches Chills Fatigue Runny nose Coughing
She stated she began to have spams and tingling in her left shouler down to fingers. Then her fingers became swollen. The injection site has redness, swelling and tender to touch. Began to feel dizzy, lightheaded with mild wheezing.
Patient complaint of reverse redness at the site of injection and swelling. The redness was at the upper left arm.
10-15-14 6:30 am noticed red swollen raised area around injection site. Notice soreness when red swollen 50 x 55 mm and beside it (swollen not red 30 x 45 mm). Injection given too low and posterior. Begin ice, ibuprofen as needed.
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 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 19-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      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 medications were not reported.
On 7/5/21 I received vaccine and I began to feel a numbness in my entire left arm.  The next day, 7/6/21, I started feeling pain at the injection area, that lasted for three days.  The when the arm was feeling better (it improved with ice), I started to feel fatigue and very week on 7/7/21.  I was not able to complete my physical therapy  on my other shoulder.  I did not recover until after 7/11/21.  I started feeling much better, my energy started to come back.  On 7/14/21, I started feeling like I had needles on my head and pain in the muscle on my shoulder and neck of the left side of my body.  It was very tense and very sore.   On the dates of 7/15/21 thru 7/18/21  I started getting headaches that got worse and worse as time when on. I took Tylenol but it did nothing.  On the 19th I had a really bad migraine like nothing I have ever felt.  It was only on my left side nothing on the right.  On 7/27/21 I went to the ER and was there until the 7/28/21.  I was referred to a neurologist, I saw him on 8/3/21. and he prescribed medications, what have not taken yet.  I still have some pain and some dizziness and stomach has been bothering me as well.
pt recvd vax & 13MAY lab eval revealed elevated liver enzymes; alkaline phosphatase was 466, SGOT was 35, SGPT 83, GGT 737; diagnostic tests revealed nl CBC neg Eptstein-Barr antibody & neg CMV;
After receiving second dose patient had vomiting, loose bowel movements, chills Temp 101, weak, dyspnea, presented to hospital 4/16/21 with increased SOB.  COVID test on admission positive
neurological event, instant memory loss confusion , couldnt remember basic this like how to get home, use phone, passwords, missing time, couldnt do job any more, she was nurse responsible to distribute meds to 50 patients, angry, frustration , had to quit job, later heart issues started within 2 months of 2nd shot, had cardiac dr, ablation therapy ,shortness of breath, tachycardia, rapid heart beat, dizziness
high CRP; This spontaneous case was reported by a consumer and describes the occurrence of C-REACTIVE PROTEIN INCREASED (high CRP) 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 C-REACTIVE PROTEIN INCREASED (high CRP). At the time of the report, C-REACTIVE PROTEIN INCREASED (high CRP) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, C-reactive protein: high High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were reported. No Treatment Medications were reported.
Coatinous breakouts hives, rashes, red spots.  Small little bumps.  Arms, stomach, back, face, legs.  And where he got his shots.
Severe, sharp pain in right side of womb lasting 1.5 minute.  Went into full labor on Nov. 4 and delivered baby stillborn. Doctors believed he died a few days before, likely coinciding with pain I felt. I think pain might have been baby seizing. Doctors had not expected problems with birth due to Aperts.
22 days p/vax started vomiting-improved then 1wk later vomiting, chills, fever 104.2;9SEP went to ER tx w/ATV;
Hives on back of neck. Slightly itchy.  Noticed a couple hours after vaccine.  Noticed a bit more the next morning. Took Benadryl 3/7 night. No increase or decrease in hives noticed so far.
Dose 1:  aching that immediately moved from injection site down to wrist / top of hand and remained there - 4 days; soreness at injection site - 7 days; headache - 2 days;  tiredness - 5 days; diarrhea - 12 hours and again on day 7  Dose 2:  feinted on day 2; lightheadedness requiring prone position with legs elevated - 3 days; lightheadedness that randomly arrives - still occurring; severe headache - 4 days; migraine and nausea - 1 day; severe leg and foot muscle cramping - 2 days; burning / itching  feet and hands w/ under-skin welts - 4 days;  flu-like symptoms of high fever - chills - achiness for 3 days; soreness at injection site - 7 days; severe tiredness - 5 days  Used OTC:  Advil and Benadryl
Pt called and stated her arm felt "jittery" ever since recieving the flu shot. I asked her what jittery meant and she said it was like nerve issues and her arm seemed to go numb, it went away and then came back but it started after getting the flu shot. I told her to please follow up with her provider
PATIENT WAS GIVEN A PFIZER VACCINE AT AROUND 10:15AM AT A HEALTH CLINIC. SHE WAS ANXIOUS AND NERVOUS AT THE TIME. AFTER THE INJECTION SHE WAS SITTING IN THE WAITING AREA WITH HER FAMILY .  AFTER A FEW MINUTES WE WERE INFORMED SHE NEEDED SOME WATER . OUR VOLUNTEER MEDICAL DOCTOR WENT OVER WITH THE WATER AND OBSERVED HER WITH NO FURTHER ISSUES.  WE WERE INFORMED ON 12/21 BY DEPT OF PUBLIC HEALTH THAT SHE HAD GONE TO VISIT DOCTOR LATER THAT DAY AND WAS DIAGNOSED WITH SYNCOPE.
The spontaneous information was received from a physician regarding 22 patients of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. This report refers to a patient who on 23-APR-2014 was vaccinated with PROQUAD (Merck) lot # J015595, expiration date 05-JUN-2015, that were exposed to highest temperature of 5 Celsius degree for 5 months (also reported as exposed to refrigerator temperatures not greater than 46F), (strength, dose and dose schedule were not reported). No concomitant therapies were reported. No adverse effects reported. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves male patient of an unknown age who received vaccine FLUZONE HIGH DOSE lot UJ000AB via unknown route (expiry date, dose and site of administration were unknown). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to underdose. It was also the case of syringe issue. It was reported that when nurse attached the needle to the prefilled syringe there was no leaking but when she went to inject and started pressing, it squirted out from where the hub or leur lock attaches barrel portion of syringe and was leaking down his arm. It was unknown whether patient experienced any adverse reaction after vaccination. 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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. Documents held by sender: none.
Breakthrough case admission after 3 vaccines Moderna 2/17/21 Lot# 031M20A;  Moderna 3/17/21 Lot# 045A21A;  Moderna 12/1/21 Lot# 045J21A
rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-OCT-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingrix vaccine and experienced rash. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Brain fog, dizziness, headaches, pain and numbness to left side of head, chills, body aches, trouble breathing, heart arrhythmia, anxiety, left breast pain, upper left arm pain, confusion, trouble concentrating and focusing eyes.  All these symptoms began 5-10min after shot was administered and have continued for 2 weeks off and on.
a week or so p/vax a vesicle appeared @ the inj site & also one vesicle appeared about one inch next to it on the lt thigh;
Patient was given vaccine and felt fine right after. After awhile a customer came back and alerted the pharmacy that she had fainted and was in one of the aisles with her mom. she did not injure herself in the fall. We had her lay on the floor and took her blood pressure which was slightly low. We had her stay laying down until she felt better and her blood pressure increased. After about 25 more minutes she felt well enough to leave the store with her mom.
Itching swelling of face, including lip, eyelids, swelling of hands and feet, hives at body.
she even had the same reaction when she received the first two doses of the Moderna/It clears up her lungs/her asthma was good/helps with her asthma/had a positive reaction/clears up all her respiratory system; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (she even had the same reaction when she received the first two doses of the Moderna/It clears up her lungs/her asthma was good/helps with her asthma/had a positive reaction/clears up all her respiratory system) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Protein deficiency (Patient had a blood clotting disorder called Protein D deficiency and protein C.) and Asthma. Concomitant products included ZAFIRLUKAST (ACCOLATE) for Asthma, RIVAROXABAN (XARELTO) and HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE HCTZ) for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (she even had the same reaction when she received the first two doses of the Moderna/It clears up her lungs/her asthma was good/helps with her asthma/had a positive reaction/clears up all her respiratory system). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (she even had the same reaction when she received the first two doses of the Moderna/It clears up her lungs/her asthma was good/helps with her asthma/had a positive reaction/clears up all her respiratory system) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-306161, MOD-2021-306179 (Patient Link).
bronchospasms; This is a spontaneous report from a non-contactable pharmacist. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248, expiry date: unknown), intramuscular on 21Jan2021 at a single dose for covid-19 immunization. The patient's medical history included chest pain in the past (has experienced this on and off unrelated to medication administration). Concomitant medications were not reported. The patient previously took first dose of bnt162b2 on unspecified date for covid-19 immunization. The patient is not pregnant. The patient was not diagnosed with covid-19 prior to vaccination and was not tested for covid-19 post vaccination. On 21Jan2021, the patient complained shortly after second dose of covid vaccine, having what she felt were bronchospasms. Medical Emergency Rapid Response call was made. RRT personnel arrived and administered 2 puffs of albuterol inhaler with subsequent improvement of status. No other complaints of chest pain, etc. It was reported that the event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken as a result of the event. Outcome of the event was recovered on unspecified date in Jan2021.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
pt recv vax 1130AM 4NOV98 & 3PM same day red watery, irritated eyes, persistent cough, tightness in throat, wheezing, diff breathing, red/flushed skin appearance, severe h/a;
patient was suppose to receive Prevnar 13 but instead was given Gardasil 9 - spoke with Merck & was told there have been other cases with no safety issues or abnormal sequela
Limited range of motion due to pain. Pain in arm, shoulder, neck. Popping sound. Pain in showering, shampooing, doing laundry, household chores, cooking (any pressure applied to arm), lifting, dressing. Had steroid shot in shoulder for pain, 01/15/18. Will begin physical therapy 01/26/18.
No adverse event; inadvertently administered an expired (30 day use by date - 13-Oct-2022); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administered an expired (30 day use by date - 13-Oct-2022)) and NO ADVERSE EVENT (No adverse event) in a 45-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administered an expired (30 day use by date - 13-Oct-2022)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administered an expired (30 day use by date - 13-Oct-2022)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (inadvertently administered an expired (30 day use by date - 13-Oct-2022)).    No concomitant medications was reported. It was reported that the vaccine was administered on 18-oct-2022 around noon time. No treatment drug details was reported.
fever; arm got itchy and sore; arm got itchy and sore; felt dizzy and woozy; tasted a metal-ish taste; This is a spontaneous report from a contactable consumer (patient herself). A 66-years-old female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0172, Expiry date: Unknown) via an unspecified route of administration on 07Apr2021 on left arm as 1st dose, single dose for COVID-19 immunization. The patient's medical history included systemic lupus erythematosus, diagnosed in 2010 and is under control and COVID-19 as caller did not want to get COVID again bad. There were no concomitant medications. On 07Apr2021, the same day of vaccination, the patient experienced felt dizzy and woozy, tasted a metalish taste, on 08Apr2021, experienced fever, arm got itchy and sore. After the caller left the vaccination site, she drove about a block and then she tasted a metalish taste and felt dizzy but it went away. A couple of days after receiving the first dose, the caller's arm got itchy and sore. The caller got a fever of 99.2 which lasted about 2 days. After about 2 weeks, the fever and arm soreness flared back up, right before it was time for her second shot. The caller's arm was sore in that area and around the shoulder a little bit. Then the caller was feeling okay. The patient underwent lab tests and procedures include fever of 99.2 and shoulder x-ray which was negative on 27May2021. The outcome of the events felt dizzy and woozy and tasted a metalish taste recovered on 07Apr2021, fever recovered on 10Apr2021 and arm got itchy and sore was recovered on an unspecified date in 2021.
Patient reports feeling very fatigued for 2-4 days after receiving the vaccines. She felt "out of sorts", no energy and exhausted. reported/completed this report done by providers office staff as an FYI No need to contact us. Thank you.
A report has been received from a literature source via regulatory authority, vaccine adverse event reporting system (VAERS) concerning an adult, female subject who had been receiving FLUSMIT. FLUMIST started on an unknown date. The patient received FLUMIST while she was pregnant . The patient experienced respiratory condition . The outcome of the event of pregnant patient received FLUMIST and respiratory condition  is unknown. The outcome of the pregnancy was unknown. The reporter's description of the event(s) was as follows: There were four reports of non-serious respiratory conditions after receiving FLUMIST during pregnancy. Based on the information in this report, and awaiting the reporter's assessment, the company physician considered the event of respiratory condition to be not related to the suspect drug FLUMIST. The company causality was implied to be no for the event of pregnant patient received FLUMIST.
Fever, body aches, chills, involuntary violent full body convulsions  that comes in waves, leg nerve pain, nausea, headache, muscle weakness: all symptoms began at 5 am waking me up from my sleep, currently still feeling symptoms 12 hours since symptoms began. Time of onset of symptoms was exactly 12 hours from vaccination injection. Important to note I have previously tested positive for covid in July of 2020.
STARTING SEVERAL MINUTES AFTER VACCINE-FEELING HOT, HEADACHE, DIZZINESS, NAUSEA
pt called to report that she suffer from asthma attack-like symptoms such wheezing, coughing up phlegm about 30 minutes after receiving prizer vaccine on 08/24/21, per pt her symptoms resolved after using a rescue inhaler. Per pt she has a history asthma but had not had an attack in over 10 years and had not had one since. she thinks it is related to the vaccine and is concern about getting the second dose.
Child had five chickenpox or started getting them on 12/15/2001. Mom stated that he was scratching all over. Some of them seemed infected so I recommended what to do and advised her to call her physician.
Patient came in 8/20/17 for a Pnemococcal 23 shot at 11 AM. On Monday she went to ER and was complaining about Swelling, vomiting, redness, pain, nausea and Joint pain. ER MD stated that this was possibly an allergic reaction gave her BENADRYL. No other issues reported