chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had a terrible experience w/the pharmacist who didn't make vaccinating a teenager very comforting; This is a spontaneous report from a contactable consumer (patient's mother). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 2 via an unspecified route of administration on an unspecified date as dose2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine of BNT162B2 as first dose for Covid-19 immunization. The patient had a terrible experience w/the pharmacist who didn't make vaccinating a teenager very comforting on an unspecified date. So, I question the entire thing. The outcome of event was unknown.  Information about batch/ lot number has been requested.
I woke up about 12am and had chills, bodyaches, and headache for about an hour. The chills subsided, but I had a headache and I was very stiff and sore when I got up for the day at about 630am. I layed back down and rested, ate breakfast and took 1000mg of Tylenol at about 9am. Stiffness and soreness and a minor headache finally subsided at about 11am
Good morning, Thank you for making the kids check up fun and easy yesterday! Pt. received a few shots and is having a reaction to one of them. Last night before bed we noticed that the injection site was surrounded by big, raised, red blotches. It was sore to the touch and he said it felt like it was burning. I saw on the paperwork that a rash may occur with the MMR/Varicella vaccine, so we decided to see how it was this morning. Today it has turned into one large,  bigger red blotch, that is still painful to the touch. I do have pictures from last night and now today if that helps. I'm wondering if I need to take him in or if there is anything I can do at home? He's never had a reaction before so I'm curious what our next steps should be. Thank you!  Sincerely
Itching in right arm (Pneumovax 23 inj 25MCG/0.5ML PF SYR, quantity 0.5),  arm hurting from shoulder to wrist, swelling from shoulder to elbow by 6:00 am 09/18/20 (arm swelled 2" more than normal), very red, burning.  3:00 pm 09/18/20, swelling the entire arm, deep burning pain, headache, light headed.  4:00 pm 09/18/20 emergency clinic administered high dose steroids,  prescribed Prednisone 20mg 2xda for 5 days.  Watch for red streaks. Advised I go to ER
ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY HYPOTENSION 6/22/2022,  7/2/2022,  2/21/2023 -- RECURRENCE OF SAME SYMPTOMS
Abnormal reading / Neutrophils were slightly elevated; Neutrophils were slightly elevated; This case was reported by a consumer via call center representative and described the occurrence of complete blood count abnormal in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number BY2Y4, expiry date 13th November 2021) for prophylaxis.   On 2nd September 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 3rd September 2019, 1 days after receiving Shingrix, the patient experienced complete blood count abnormal and neutrophils increased. On an unknown date, the outcome of the complete blood count abnormal and neutrophils increased were unknown.   It was unknown if the reporter considered the complete blood count abnormal and neutrophils increased to be related to Shingrix.  Additional details were provided as follows: The patient stated that the following day after receiving vaccine had a complete blood count test and resulted an abnormal reading which is unusual because blood test normally is within normal limits. The patient stated that the neutrophils were slightly elevated. The patient stated that the expiry date was September 2020 from her paperwork because that was 1 year from administration date, but system show 13th November 2021. The patient consented to follow up.
Began itching - generalized 1 hr after receiving vaccine. Subsided on its own. Did not take anything for treatment.
Urinary Tract Infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary Tract Infection) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 13M20A) for COVID-19 vaccination.     Concurrent medical conditions included UTI.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (Urinary Tract Infection). At the time of the report, URINARY TRACT INFECTION (Urinary Tract Infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No relevant concomitant medications were reported.
This spontaneous report as received from a pharmacist refers to a 16 year old male patient. the patient's concurrent conditions, medical history and concomitant medications were none. The patient completed, the series with GARDASIL (date unspecified). On 19-MAR-2015, the patient was vaccinated with the first dose of GARDASIL 9 lot # L001312, expiration date: 24-FEB-2017, intramuscular (dose was not reported), while sitting in the pharmacy chair. Within a few minutes (about 1-2) after receiving the GARDASIL 9, the patient began walking and reported feeling dizzy. the patient passed out and fell from a standing position onto the floor, where he hit his head, bit his lip and had now marks on his nose. During this time, the patient's muscles were rigid. The patient woke up after about 2-3 minutes and stated that he felt like he had a dream. The patient was then escorted to a local hospital. The patient sought medical attention. The patient's present status was unspecified by the reporter. The outcome of the event was not reported, at the time of the report. The relatedness between the events and the vaccine was not provided. Additional information has been requested.
fever; Chills; Headache; Muscle pain; This is a spontaneous report from a non-contactable consumer, the patient. A 59-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration on an unknown date (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 21:30, the patient experienced fever, chills, headache, muscle pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 24Mar2021, the patient underwent COVID test and the result was negative. The clinical outcome of the events fever, chills, headache, muscle pain was recovering.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Relevant medical history and concomitant medication were not provided. On 26-FEB-2014 the patient was vaccinated with M-M-R II. Lot number, dose, route and frequency were not provided. The vaccine was exposed to 56F for 10 days, an excursion that was found to be unsupported by in-house stability data. No adverse event was reported. Additional information has been requested.
Received Hep B vaccine on 8/16/07 and next AM noted itchy and rash on left deltoid, site of injection. Deltoid induration.
Information has been received from a company representative concerning his 15 month old male son with eczema and food allergy, who on approximately 16-JUN-2009, was vaccinated with a dose of RECOMBIVAX HB (Lot# not reported). Concomitant therapy included vitamins (unspecified). In approximately June 2009, after received an unnamed Hep B injection experienced a worsening of eczema behind his knees. He had a prior history of eczema since age 6 months from food allergies. At the time of the report the patient had recovered. The patient sought unspecified medical attention. The patient also experienced "screamed for 7 hours" after vaccination of Hib (unspecified carrier) (manufacturer unknown) (WAES #1101USA00414). Additional information has been requested.
J18.9 - Pneumonia D69.6 - Thrombocytopenia
Fever elevated 104 degrees. Per MDS, took pt to ER was given appropriate dosage of MOTRIN and TYLENOL fever resolved pt sent home.
Nausea, vomiting, headache, severe dizziness, mild swelling everywhere, moderate swelling at vaccination site, back pain, aches, chills, pain at vaccination site.  Time: 5 days.
Case number PHEH2013US013241 is an initial spontaneous report received from a nurse on 14 Jun 2013 with a follow up information received from a nurse on 09 Jul 2013. This case refers to an 11-year-old male patient. His medical history and concomitant medication were not provided. It was reported that previous vaccinations were tolerated in the past. he was vaccinated with MENVEO (batch number: M12025 and expiry date: 31 Dec 2014) at a dose of 0.5 ml intramuscularly in the left deltoid on 11 Jun 2013. Reporter stated that un-reconstituted MENVEO reached minus 1 degree Celsius for at least 30-minutes before going back up to 6 degree Celsius on 07 Jun 2013 (vaccine did not freeze). No adverse event was reported following this administration error. Follow up information received from a nurse on 09 Jul 2013: Patient demographics (gender, height and weight), site and date of vaccination updated.
4:28pm vaccinated 4:47pm c/o lightheadedness, weakness; patient placed in semi-reclining chair; brief medical h/o revealed the following: Stated that she has severe allergies to shellfish, nuts, carries epipen; takes Benadryl every night, 50mg for excema; BP 145/88, HRT 87, states breathing fine; denies tightness in chest or difficulty breathing; states she believes it may be due to anxiety, had anxiety prior to being vaccinated. Sips of water tolerated well; patient appears pale, hands shaking. As requested by patient, fiance came up to comfort her 4:56pm patient states she feels lightheaded; given cool cloth for forehead; BP 132/88, HRT 94. States that she ate full lunch, felt nauseous at 2:30pm, believes it was due to anxiety about getting the vaccine 5:01pm BP 142/73; states her mouth feels like it is tingling; given 25mg benadryl liquid by mouth, tolerated well. 5:10pm BP 136/79, HRT 87 Patient requested to use rest room; was wheeled to bathroom with assist to toilet, tolerated well; 5:24pm BP 132/85, HRT 73 5:47pm feels better, BP 131/83, 72 HRT Discharged ambulating, with fiance accompanying and parents outside waiting to drive her home; patient will stay at parents' house tonight.
This spontaneous report was received from the patient's mother concerning her infant daughter, a female patient of unknown age. No concurrent conditions or medical history were reported. On an unknown date, the patient was accidentally vaccinated with a dose of PNEUMOVAX 23 instead of PVC13. No adverse reaction reported. No Product Quality Complaint (PQC) was involved. Additional information is not expected as no contact details were provided.
Vaginal Bleeding; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Vaginal Bleeding) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-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 04-Mar-2021, the patient experienced VAGINAL HAEMORRHAGE (Vaginal Bleeding). At the time of the report, VAGINAL HAEMORRHAGE (Vaginal Bleeding) outcome was unknown.            Patient received treatment for cancer. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. No relevant concomitant medications reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: NNI
PATIENT CAME IN FOR CHECK UP APPOINTMENT AND MENTIONED BUMP BY LEFT SHOULDER. HE RECIEVED HIS DOSE A A LOCAL STORE.  SINCE WE ARE THE PCP AND PATIENT DID NOT CALL WE DECIEDE TO REPORT REACTION. DOCTOR CALLED ID AT LOCATION. ID DOCTOR ON CALL CONFIRMED  REACTION WAS FROM THE VACCINE AND IF PATIENT SEEMED OK , JUST NEED A FOLLOW UP IN 6-8 WEEEKS.
Acute kidney injury superimposed on CKD. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Pain in arm; This is a spontaneous report from a contactable consumer (patient). A 53-year-old male patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 26Jan2021 08:00 AM at a single dose on the left arm for COVID-19 immunization. The most recent COVID-19 vaccine was administered at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history was none. The patient had no known allergies to medications, food, or other products. The patient had no concomitant medications. On 26Jan2021 02:00 PM, the patient experienced pain in arm. No treatment was received for the event. Outcome of the event was recovering. Since the vaccination, the patient has not been tested for COVID-19. The reporter assessed the event as non-serious.   Information on the lot/batch number has been requested.
I have developed a loud tinnitus in both ears that is constant and very upsetting.  I can hardly concentrate it's so loud and persistent.  I have not sought treatment yet.
It was reported that a female pt received a Fluzone SV '99-'00 and a Pnu-Imune 23 vaccination mixed in one syringe, on 11/4/99. Reportedly, on 11/6/99, the pt developed urticaria, erythema and an induration. Benadryl 25mg per oral every 4 hours was prescribed. Reportedly, the pt recovered from this experience. No additional information was provided from correspondence returned on 12/15/99.
Evening after the vaccination patient was sore and red. Next morning she had larger rash, itching , redness and swelling at the injection site.  Next day today, she is itching a lot, swollen and rash has expanded to 5 x 7 inches.
Pt called  and Complaint  on 08/26/2023 and told me that SHE THNIKS THAT SHE MIGHT HAVE SOME  reaction ; she told me that she had noticed  redness on the arm  below the injection area.   i had asked the pt she feels any  other side effects  as per  pt she doent have  any SOB  only  side effects she had is fever and  tendeness on the injection site . i had told the pt thoses are common side effects  of the vaccination and recommended  her  to take   some Benadryl since she might  be minor allergic  reaction one of the adjuvants   of the vaccine .  pt had called me back 08/29/2023 and had told me that she feels  lot better and redness and gone   and feels  lot better
Vaccine administered after temperature excursion; Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Vaccine administered after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Vaccine administered after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion). On 02-Apr-2021, PRODUCT ADMINISTRATION ERROR (Vaccine administered after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) had resolved.        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.   It was reported that there was a power outage on 02-Apr-2021 and vials were in freezer and refrigerator where Temperature dropped to -13.79 C for 47 minutes and 12 C for 59 minutes respectively.  No concomitant products were reported.  No treatment information was provided.
About a week after the vaccine my arm began itching then swollen and red. Used Benadryl cream for 3 days before the swelling and itching started to subside.
About 18 hours after getting the vaccine (Thursday morning) I was extremely fatigued and got a massive headache. The headache felt like a cross between a migraine and a concussion. I got chills and an elevated temp around noon that lasted for about 8 hours, and I felt nauseous. The massive headache lasted about a day and a half. By Saturday I started to feel better, but still today I have a slight headache and occasional nauseous feeling.
Fever 103.6 highest it?s gotten so far. Arm pain, shoulder pain, legs both hurt, headache.
pt recv vax 27SEP97 & 24OCT pt began therapy w/sulindac (mylan);27OCT exp heartburn, gastric reflux, SOB, dry cough & hoarseness;discontinued sulindac therapy & sx began to resolve;
This spontaneous report was received from a nurse and refers to 2 patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions and allergies were not reported. on 30-JUN-2015 the patients were vaccinated with improperly stored GARDASIL (dose, route of administration, anatomical location, lot# and expiration date were not reported). No adverse events were reported. This is one of the two reports received from the same source. Additional information has been requested.
Case number PHEH2012US020627, is an initial spontaneous report received from a nurse on 11 Oct 2012 and a follow up received on 11 Oct 2012. This report refers to 10 month old male patient. He was vaccinated with MENVEO (batch number: M11051, expiration date: 30 Mar 2014), intramuscularly on 11 Oct 2012. No adverse event was reported. Follow up received from the nurse on 11 Oct 2012: updated expiration date of MENVEO vaccine.
Pt. has a history of dizziness/nausea after vaccination. 15 minutes after this vaccination, she had a short 'seizure-like' episode accompanied with slight shortness of breath. Pt. was also very dizzy and nauseous. Sweating came shortly after. EMS was called immediately when first symptoms began. She was responsive the entire time and reported gradually feeling better after about 5-10 minutes. EMS did a prompt check-up and revealed no unusual findings.
she was transferred to the hospital with tachycardia, congestion, shortness of breath, and is now unresponsive; she was transferred to the hospital with tachycardia, congestion, shortness of breath, and is now unresponsive; she was transferred to the hospital with tachycardia, congestion, shortness of breath, and is now unresponsive; she was transferred to the hospital with tachycardia, congestion, shortness of breath, and is now unresponsive; This is a spontaneous report from a contactable nurse.   A 95-year-old female patient received the second  dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), Lot# EH9899 Exipration on 06Jan2021 at 15:00 at SINGLE DOSE at deltoid  for COVID-19 immunization. The patient received first dose of the same vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), Lot# EH9899 Exipration date : 31Mar20221, on 16Dec2020. Medical history included : cardiac failure congestive, hypertension, cardiac murmur .There were no concomitant medications.  The patient previously took cymbalta , vasotec  and zocor and experienced drug hypersensitivity. The patient didn't  receive any other vaccines within 4 weeks prior to the COVID vaccine.This nurse,worker at a skilled nursing facility, reported that  this patient with a history of heart failure,  received her second dose of the Pfizer-BioNTech Covid-19 vaccine yesterday, 06Jan2021, at 3pm.  At 7am on 07Jan2021 she was transferred to the hospital with tachycardia, congestion, shortness of breath, and is now unresponsive.  Patient was stable prior to vaccination, but will now be transferred to hospice care. The nurse  added the patient  had the second COVID vaccine on 06Jan2021 yesterday and has now been transport to hospital due to a drastic decline after the shot. It was explained that this morning around 7 am she was transferred to the hospital. She was experiencing tachycardia, shortness of breath, and congestion. The events started this morning around 6-6:30am. The patient was admitted to the hospital. The shot was given at the facility. She received it at 3pm on 06Jan2021, First dose was on 16Dec2020.The caller relays she didn't know how aggressive the hospital will be for the patient. She was a full code when left and now a DNR and is unresponsive. The patient will be going on hospice care. The causality was reported as related. The outcome of the events was not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported tachycardia, shortness of breath, congestion, unresponsive, and the administration of the COVID 19 vaccine, BNT162B2, based on the reasonable temporal association. The patient's pre-existing medical condition of cardiac failure congestive, hypertension, cardiac murmur are confounding factors.   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 RA, IEC, as appropriate.
Pain at injection site; Tiredness; Headache; Fever; Feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL 3247), via an unspecified route of administration in the left arm on 02Mar2021 at 12:00 (at the age of 56-year-old), dose 1, single for COVID-19 immunisation. Medical history included COVID prior vaccination, anxiety disorder, thyroid nodules, essential hypertension, lumbar radiculopathy, cervical dystonia, allergy to casein in cow's milk, wheat intolerance, coffee and latex adhesive sensitivity. Concomitant medications included sertraline hydrochloride (ZOLOFT); losartan; lorazepam; diclofenac; thioctic acid (ALPHA-LIPON). Prior to vaccination, the patient was diagnosed with COVID-19 but did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. On 03Mar2021 at 09:45, the patient experienced pain at injection site, tiredness, headache, fever, and was feeling unwell. No treatment was received for the events. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was recovering.  No follow-up attempts are possible; No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021346169 same reporter/patient/product, different dose/similar event