chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Prescription for PREVNAR-13 was sent from Dr. to our pharmacy on 10/10/17. Patient came to pharmacy on 10/16/17 to receive vaccine. Patient reports that she had pain at the injection site beginning at 8pm on the evening of the vaccine 10/12/17. She states she then had a lot of pain through the weekend, Friday, Saturday and Sunday. On Sunday she reports that she had a welt and the site of the injection was hot. At 8pm on Sunday 10/15/17 patient states "her chest started hurting and she had a hard time breathing". She describes the pain as "being a sharp pain on the back of her shoulder blade, circling internally". She states that it reminded her of the pain of when she had fluid in her lung. She took her temperature Sunday 10/15/17 and it was 99.9 degrees F. She went to the emergency room at 11:30am on 10/16/17 and called our pharmacy. She had a complete cardiac workup and was discharged. I received a copy of the discharge summary stating "shoulder pain and chest pain of uncertain etiology".
Received 2nd dose 2 weeks after the first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 2 weeks after the first dose) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059H21A and 007J212A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 2 weeks after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 2 weeks after the first dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.
Initial and follow-up information has been received from a nurse and a physician concerning a 23-year-old female patient.  According to the physician, on 23-OCT-2008 the patient was vaccinated IM with a first dose of 0.5 ml GARDASIL (lot # 660618/0572X) in the left deltoid.  Concomitant medication included YASMIN.  About three days post vaccination, the patient experienced "swelling in the neck-top of the shoulder area".  The nurse reported that the patient received a dose of GARDASIL on 15-AUG-2008;  also reported that she developed hardening of lymph nodes in her arm 3 days after receiving her second dose of GARDASIL.  The patient sought unspecified medical attention and recovered on an unspecified date.  Additional information has been requested.
This spontaneous report as received from a physician refers to a 15 month old male patient without pertinent medical history or drug reactions/allergies. On 13-MAR-2013 the patient was vaccinated with M-M-R II (dose and lot# not reported) (dose and lot# not reported) and (Merck) VARIVAX (dose and lot# not reported) concomitantly on the same day. On 22-MAR-2013, the patient was diagnosed with otitis media and was prescribed amoxicillin. The patient later developed a fever and a body rash that was diagnosed as a "vaccine induced measles rash". "Blood work-CBC. BMP" was performed without result At the time of reporting, the patient was recovering from the events. The patient sought medical attention by office visit. Additional information has been requested.
SHINGLES BLISTERS; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-smoker, penicillin allergy, and shellfish allergy. The patient was previously treated with gabapentin, vitamin b12 nos, salbutamol, fluticasone propionate, meloxicam, omeprazole, rosuvastatin calcium, levothyroxine, tizanidine hydrochloride, valaciclovir hydrochloride, estradiol, nystatin, amlodipine, hyoscyamine sulfate, ketorolac tromethamine, ondansetron, loratadine, and biotin; and experienced drug allergy when treated with ciprofloxacin, and trimethoprim. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: 09-JUN-2021) dose was not reported, administered on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-MAR-2021, the subject experienced shingles blisters. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from shingles blisters on 30-MAR-2021. This report was non-serious.
No other AE; Caller was reporting a temperature excursion for GARDASIL 9; This spontaneous report was received from a clinical coordinator referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 22-FEB-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, route, dose, frequency, and anatomical location date were unknown) with lot # 1687291 and expiration date 11-SEP-2022.   The information regarding the temperature excursion and if it a data logger was involved was not reported. No other adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: 1687291; expirationdate: 11-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sweating, dizziness, vomiting and diarrhea a week later after getting the vaccine
Really achy; her armpit in the same armpit is super swollen; nauseous; Armpit sore; Her arm where she had the shot is really sore; This is a spontaneous report from a contactable consumer (Patient herself). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number:EN5318, Batch number: Unknown. Expiration date:31May2021) via unspecified route of administration on an right arm on 21Apr2021 at SINGLE DOSE for COVID-19 Immunization. The patients medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN5318 Batch number: Unknown. Expiration date:31May2021) via unspecified route of administration on an right arm on 01Apr2021 at SINGLE DOSE for COVID-19 Immunization. Patient had her second dose of the Covid vaccine yesterday at 10:00. This morning, she woke up and she was really achy. Her arm where she had the shot is really sore, as well as her armpit in the same arm is super swollen. She is really nauseous today. She is mostly concerned about how swollen her armpit Treatment: She took Tylenol. The outcome of the event Arm where she had the shot is really sore was not recovered and outcome of all other events was recovering.  No follow-up attempts are possible. No further information is expected.
Chronic, constant, non-relenting left chest pain. Chest tightness, constriction, and heaviness. Tachycardia. Extreme shortness of breath, where I can't function. Lightheadedness and Fatigue that make it difficult to work. I feel faint when I stand. Wheezing, chronic sputum following covid infection March 2020 has gotten worse. In the past 3 months, my oxygen has been dropping to as low as 88. I was a steady 99 before this booster, now I'm lucky if I get it up to 96.   I can hardly carry a grocery bag without cutting off circulation in my fingers.  I am not the same person I was before I took this vaccine. Covid damaged me, but I recovered. I have not recovered from this second booster, and the symtoms that emerged following vaccination.   The reported date of adverse events is approximate. I was bedridden for the first 2 weeks following the booster, symptoms emerged during those first 2 weeks and never went away.  Additionally, I seem to have developed Ehler's Danlos like-symptoms.2 instances of whiplash, confirmed by an ER visit from injuries obtained during looking in the mirror, and reinjuring when eating. Additionally, a hyperextended knee and dislocated rib. All within the last 6 months.
Really bad upper abdominal pain; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the arm left on 08Apr2021 at 12:00(at the age of 19-year-old) as a single dose for COVID-19 immunisation. Medical history included arthritis rheumatoid and penicillin allergy. The patient received medication(unspecified) within two weeks of 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 00:00, the patient experienced really bad upper abdominal pain .The patient did not receive any treatment for the reported event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event really bad upper abdominal pain was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
I began to have body aches at 11 am the next day. Throughout the day I was achy and nauseous. By 7 pm I had chills and a fever of 102.4. I was also short of breath and felt like I had to cough every time I talked. I also have mitral valve and left bundle branch block, and I've experienced this feeling before. So I took 2 baby aspirin and drank a Gatorade and the shortness of breath/cough sensation improved within 30 minutes. Felt better the next day. Then, had insomnia and bought of energy 3 days after the shot (Sunday, 4/11/21). All worth it to avoid COVID, but reporting it in case the information is useful to you. THANK YOU!!!!
Pt experienced redness, swelling, and itching the day after receiving the yellow fever vaccine. The following day the redness started moving down to her elbow. On the third day she was seen at clinic and was diagnosed with cellulitis and was treated with KEFLEX 500mg.
fluttering in her heart; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (fluttering in her heart) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced CARDIAC FLUTTER (fluttering in her heart) (seriousness criterion medically significant). At the time of the report, CARDIAC FLUTTER (fluttering in her heart) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment drug information provided.  Patient stated that fluttering in her heart was ongoing, at the time of this report.  Patient did not take any concomitant medications. She had no history of myocarditis/COVID-19.  Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Throat tightening. Rapid heart rate of 120 bpm while resting. Tingling/numb mouth.
Seizure; Cardiac ischemia; This spontaneous case was received on 18-Nov-2022 from other non-healthcare professional (consumer's daughter) via Agency (reference number: SEQW22-05924), and concerned a 74-year-old, male patient.  The patient's concurrent condition included communication problems as result of the stroke. The patient's past procedures included transcatheter aortic valve replacement (TAVR) in May-2022 (reported as 'six months ago') and pacemaker. The patient's historical condition included stroke in 2020 (reported as 'two years ago'). The patient's concomitant medications included unspecified medications used as blood thinner. The patient did not have hypercholesterolemia nor diabetes.   On 17-Nov-2022, at 9:30 a.m., the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration, anatomical location: not reported) for active immunization of persons 65 years of age and older against influenza caused by influenza virus subtypes A and B contained in the vaccine. The batch number reported was 346378 and expiration date was 14-Jun-2023.  On the same day, a few hours later, at 04:00 p.m., after receiving Fluad Quadrivalent, the patient had severe seizure and cardiac ischemia, and was hospitalized as a consequence.   At the time of initial reporting, the patient had not recovered from the events and was still hospitalized.  The reporter did not provide a causality assessment.  Both events were assessed as serious due to seriousness criterion of hospitalisation. Additionally, both events were considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment: A 74-year-old, male patient was vaccinated with the suspect product Fluad Quadrivalent. On the same day after vaccination the patient had severe seizure and cardiac ischemia and was hospitalized consequently. As reported patient's concurrent condition included communication problems as result of the stroke. Information regarding the related diagnostic findings was not provided. Based on plausible temporal relationship, causality for the event seizure could not be ruled out and is assessed as possibly related. Causality for cardiac ischemia could not be assessed due to limited information provided. Limited information precludes assessment of agency criteria for seizure.; Sender's Comments: A 74-year-old, male patient was vaccinated with the suspect product Fluad Quadrivalent. On the same day after vaccination the patient had severe seizure and cardiac ischemia and was hospitalized consequently. As reported patient's concurrent condition included communication problems as result of the stroke. Information regarding the related diagnostic findings was not provided. Based on plausible temporal relationship, causality for the event seizure could not be ruled out and is assessed as possibly related. Causality for cardiac ischemia could not be assessed due to limited information provided. Limited information precludes assessment of agency criteria for seizure.
Immediately after and again 5 days after "my" left hand is tingling a lot; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE ;Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included depression and gold allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included citalopram hydrobromide (CELEXA) for unknown indication from an unknown date and unknown if ongoing. The patient previously received acetylsalicylic acid (ASPIRIN) and paracetamol (ACETAMINOPHEN), for unknown indication on an unknown date and experienced drug allergy. On an unknown date, the patient experienced immediately after and again 5 days after, the patient's left hand was tingling a lot. The patient had not heard that effect reported so she wanted to report it. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event immediately after and again 5 days after left hand is tingling a lot was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I believe the symptoms started after the second dose. Patient has been having fainting spells where she gets dizzy and sees black with white spots and she loses her balance. It only lasts a few seconds. It has happened at least 25 times or more.  2/23/09 PCP rec received for OV 12/15/08 with c/o black-out episodes  x several months. Sees "spots" then blacks out. Reported loses vision x 4-5 seconds with slow return. PE WNL. Sent for labs and testing.
Post vax, the pt experienced tiredness, malaise, intermittent nausea, body puffiness, skin tightness throughout the body, headache (
Wed night hives on back on Thrus all over torso, and Friday it all over body, feet, face and threw up , and had diarrhea  and went to urgent care on Saturday night.
she took the 3rd dose; felt so hot; fever; hair got curly and frizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Jul2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, UNKNOWN MANUFACTURER), for COVID-19 Immunization, reaction(s): "felt tired", "sleepy", "in pain on the injection site"; Covid-19 vaccine (DOSE 2, UNKNOWN MANUFACTURER), for COVID-19 Immunization, reaction(s): "felt tired", "sleepy", "in pain on the injection site". The following information was reported: IMMUNISATION (non-serious) with onset Jul2021, outcome "unknown", described as "she took the 3rd dose"; FEELING HOT (non-serious) with onset 2021, outcome "unknown", described as "felt so hot"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; HAIR TEXTURE ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "hair got curly and frizzy".  Additional information: The medical questions addressed by this program forwarded/referred to Medical Information. Customer and/or medical inquiry forwarded or referred to MI.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient said shot hurt badly, arm was sore but felt better after 15 minute observation time. Patient was able to grocery shop after and felt fine. She started to feel bad later in the day and went to bed around 8PM. Patient says she could not sleep, dozed on and off and had chills and sweats. When she woke up at 5:30AM, she said her legs felt like they had been crushed, she was in extreme pain and her legs felt paralyzed and she could not move them an inch. She had to use her arms to move her legs. She states it took her an hour to get to a chair. She sat in the chair for 45 minutes and was then able to gradually prop herself up to a dresser and eventually made it to her bathroom.  Her condition gradually improved over time and she was able to walk much better on 5/29, Today she reports no leg pain, but reduced energy levels.
Covid arm. Swelling, redness, pain, irritation. Beginning 9 days after initial dose.
no adverse event; Incorrect product storage; This spontaneous report was received from a office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported.  On 03-MAR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) dose/ frequency: 1,  lot # T015598, expiration date 02-NOV-2021, for prophylaxis (route were not reported).  The temperature involved was 16.5 degrees F for 4 hours. The previous temperature excursion was 14.5 degrees F for 2 hours and 45 minutes, 15.6 degrees F for 3 hours and 21 degrees F for 5 hours and 30 minutes. A data logger was involved. No adverse events.  This is one of multiples cases received from the same reporter.; Sender's Comments:  US-009507513-2104USA003878:Original Case : 2104USA003483 US-009507513-2104USA003885:Original Case : 2104USA003483 US-009507513-2104USA003880:Original Case : 2104USA003483 US-009507513-2104USA003483:Original Case : 2104USA003483 US-009507513-2104USA003882:Original Case : 2104USA003483 US-009507513-2104USA003883:Original Case : 2104USA003483 US-009507513-2104USA003884:Original Case : 2104USA003483 US-009507513-2104USA003877:Original Case : 2104USA003483 US-009507513-2104USA003876:Original Case : 2104USA003483 US-009507513-2104USA003879:Original Case : 2104USA003483
No reported adverse events.  Patient had already received a bivalent COVID19 booster on 9/16/2022 and had no indication to receive another one.  The pharmacy notified patient's primary care physician.
Narrative: Patient received the COVID 19 Vaccine Pfizer Vaccine and experienced nausea, blurred vision, and nightmares. This is reported per EUA
Woke up with a very, very very sore arm that I can barely move and creepy crawly skin like when you run a fever with chills chills low-grade fever. Stomachache
The participant woke up with a severe migraine headache. He couldn't focus on anything everything looked blurry, He went to work and couldn't focus on numbers, every time he tried to read everything was blurred, He had a constant headache for 2weeks and his eyes are still experiencing blurred vision. He heard that several others also experienced reactions who were vaccinated at his job. He missed 2 days of work  and went to urgent care, where he was advised to go to the ER immediately. He had someone take him to ER because he was advised not to drive. To this day he still has a hard time focusing on numbers, When reading the shelf tags at his job everything needs a lot more focus to help with blurriness.
My arm swelled up and red and hot to the touch.  I went to the doctor and they prescribed antibiotics.  I am unsure if my arm was infected.  The antibiotics worked.
Hot sensation; Soreness; Itchiness; Redness; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot sensation), VACCINATION SITE PAIN (Soreness), VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot sensation), VACCINATION SITE PAIN (Soreness), VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling). At the time of the report, VACCINATION SITE WARMTH (Hot sensation), VACCINATION SITE PAIN (Soreness), VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was mentioned. No treatment medication was mentioned.