chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Temperature excursion for opened IPOL with no adverse event; product administered to a patient with no adverse event; Initial information received on 27-Apr-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an unknown age and gender patient who was administered IPV (vero) [IPOL] that underwent temperature excursion with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect IPV (vero) (lot: Z1B901M, V1A121M; expiry date: 02-Jun-2024, 15-Feb-24) via unknown route in unknown administration site for immunization that underwent temperature excursion (product storage error) (poor quality product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event temperature excursion for opened ipol with no adverse event and was Unknown for the event product administered to a patient with no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
This spontaneous report as received from a friend of the patient via company representative refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX vial injections (Lot number, expiry date, route and dose were not reported). On an unknown date, approximately two weeks following administration of dose of ZOSTAVAX the patient developed non-painful rash on chest. The patient sought medical attention for the same (physician appointment). The rash cleared up within an unspecified period of time. On an unknown date, the event non-painful rash on chest was recovered/resolved. Additional information has been requested.
Information has been received from a physician concerning a 2 week old female infant who on 01-NOV-2007 was vaccinated with a 2 ml oral dose of Rotavirus (Lot# 657667/1392U). No product quality complaint was involved. No other information was provided. Additional information has been requested.
One week after first Moderna dose, I started to feel intense pressure in my head as well as dizziness. 3 days after that partially subsided, I began to experience severe tinnitus, which has been debilitating and has persisted for over 4 weeks.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 17-MAY-2016, the patient was vaccinated with improperly stored M-M-R II lot # reported as L027434, expiry date 22-JUL-2017, (dose, route and site of administration were not reported. No adverse effect were reported. Administered vaccine experienced the temperature excursion of 6 degrees Fahrenheit for 1.5 hours on 14-MAY-2016. Data logger was involved. This is one of several reports received from the same source. Additional information has been requested.
8 days following the first vaccine, extreme chills came on rapidly. Vomit. Unable to sit alone in bed. Paramedics called and to ER.  Treatment included EKG, CTscan, antibiotics, etc. Sent home at 1:00am.  Still too weak to stand and walk independently.  4:00am rolled off of bed onto floor; collapsed.  Unable to raise his body. Paramedics called again.  Hospital said being treated for vaccine reaction.  Sent home again at 4:00 by ambulance. Continues to feel extremely fatigued and upset stomach. He is ambulatory.  We are being told for him to get his next Covid Vac this Friday, the 2/19.  Worried
pt recvd 1st dose of Hep Bax 17JAN92 & the evening of 18JAN92 pt devel temp; following morning temp had inc to approx 104 degrees; treated w/APAP & fluids; 20JAN92 temp dec to 99; 28JAN92 pt recovered;
Sunday morning patient woke up with body aches and bone pain it lasted from about 6am-8pm
Missed miscarriage. Ovulation 5/5/21, resulting in a miscarriage between 5-6 weeks.
Sick; Cough; Chest pressure; A spontaneous report was received from a consumer concerning a 76- year old male patient, who received the first dose of the Moderna's COVID-19 vaccine (mRNA-1273) and experienced chest pressure/ chest discomfort, sick/ vaccination complication and cough.  The patient's medical history was not provided. Concomitant medications included acetylsalicylic acid, vitamin d nos, famotidine, isosorbide mononitrate, levothyroxine, metoprolol, ascorbic acid, calcium, minerals nos, retinol, tocopheryl acetate, vitamin b nos, vitamins nos, zinc, fish oil, pantoprazole and simvastatin for unknown indication.  On 13 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Batch Number: unknown) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 13 Feb 2021, same day of receiving vaccine, the patient fell sick, has chest pressure and was taken to emergency room by ambulance on 19 Feb 2021. He is coughing and took cough medications that will not relief his cough. He was discharged 2 days later, on 21 Feb 2021.   Treatment medication included Promethazine and Codeine 5mg: takes 5ml q6H, Benzonatate 100mg TID.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Hives like all over different parts of body; Type 4 hypersensitivity reaction; itchy; burning; This is a spontaneous report from a contactable physician. A 69-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9262), via an unspecified route of administration, administered in Deltoid Right on 27Jan2021 (the day of vaccination) (at the age of 69 years) at UNKNOWN, SINGLE for covid-19 immunization. Medical history included colitis ulcerative. Concomitant medication(s) included mesalamine (MESALAMINE) taken for colitis ulcerative and multivitamins for unspecified indication. On an unspecified date, the patient experienced hives like all over different parts of body, type 4 hypersensitivity reaction, itchy, burning. Physician stated that "patient received the first Pfizer vaccine, the Covid 19 vaccine on 27Jan2021 and two days ago came down with some kind of rash that was diagnosed as hives like all over different parts of body. Primary care, urgent care and patient received with triple medication you know Corticosteroids, Cetirizine you know like histamine type of medication and that's it H2 blockers to treat it for kind of interact with the reactions. So, patient was schedule for the second one today and was advised to delay and try contacting other Authorities like they advised to contact you and contact may be the VAERS you know the Vaccine Adverse Event Reporting System, patient don't, she wants to visit Immunology and it looks like Type 4 hypersensitivity reaction, it was very well documented and they took pictures it came all over body very itchy, burning and never had difficulty breathing that was the concern you know at the urgent care that was impressive enough to put full scope medication you know, patient have all the information, her husband also got at the same time, then patient and her husband was schedule this morning to get the second dose but her husband didn't had any reaction like that and she was not the allergic type, she don't had any allergy from any medication any ways whatever, she just want to report it she think she should get the second, patient going to get it but not going to get it today." Physician was informed about the role of Pfizer Drug safety department. Patient was due to second shot on 16Feb2021. Lab work: Physician stated that "No, patient was due for some test, but it's not done yet." Causality: Physician stated, "patient don't know in opinion, last night patient spoke to three of her colleagues one is infectious disease, one is pulmonary Immunology and her primary care three of them said kind of warn her on this is a typical allergic reaction and she don't get hives out of the blue sky, she had never 69 years, never she had something like that. Vaccination Facility Type: Physician stated that It was a park, drive through the park and they would give it there was nurses at the end. Time of vaccination: Physician stated, It was about we were scheduled for 8:30 am so it was 9:30 - 9:45 AM on 27Jan2021. The outcomes of events were unknown.
From the 20th to the 27th of March I was extremely tired, and I did not feel well. The injection site was really red a swollen and it went all the way up to my clavicle. I tired warm compress and ice to relieve it. On that Saturday the 27th my arm went completely numb and I could not lift my arm. I could not move my fingers. I started to feel it go down into my leg. I consulted my doctor and she said if it happens again to go be seen. The 31st it happened again, and I went to the doctor and she said it happens again to go to the ER. On the 10th, I felt like the pain was going up into my head and my vision became impaired. I went to the ER and they did a CAT scan, and bloodwork.  They decided to keep me overnight to observe me to make sure I wasn't having a stroke. I still felt weird, and my vision was still impaired. I went back to the ER the following week because the symptoms were still happening.  My arm was still painful, had a rash but did not see the rash. I also developed a bruise on the inside of my arm. It was also tender to the touch and there was so much pressure in my neck and back. I went completely numb over my whole body. I had another visit with my doctor, and she advised that I should go to see a neurologist. My swelling never goes completely down. The neurologist had me do an EKG; it did not conclude anything. I also been doing physical therapy. They are doing an electric stimulus to try to make my muscle relax. It was got to the point where I have muscle spasms in my neck and my vision is still distorted. My arm also swells down to my wrist all the time. I feel like I have not found anything to get rid of it. I also feel like I am also tired all the time. I feel like I can not do my daily activities.
onset @ 430PM of shaking chills, nausea, no vomiting; no sore throat, runny nose or cough; sore rt arm; t103.3; P80, R20, BP 98/60;
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 10-JUN-2014, the patient was vaccinated with (Oka-Merck) PROQUAD (dose strength and route was not reported) (lot # J014235 and expiry date: 07-MAY-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting (Oka-Merck) PROQUAD, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for (Oka-Merck) PROQUAD. This is one of the several reports from the same source. Additional information has been requested.
Severe headache for a week after the vaccine; This is a spontaneous report from a contactable consumer. A 16-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on Apr2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient did not received any other vaccine prior to COVID vaccine. The patient experienced severe headache for a week after the vaccine on Apr2021 which resulted in doctor's clinic visit. Prescription migraine medication was received as treatment for the event. Patient was not diagnosed with COVID prior to vaccination and had not been tested post-vaccination. Outcome of the event was not recovered.
This spontaneous report as received from a pharmacist refers to a 68 year old female patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 25-JUL-2017 the patient received a dose of PNEUMOVAX 23 (unknown lot number & expiration date). On 30-JUL-2017, the patient inadvertently received another dose of PNEUMOVAX 23 (unknown lot number & expiration date) (extra dose administered). No adverse effects reported. No PQC involved. No further information provided.
Moderna COVID-19 Vaccine EUA flu like - achiness, chills, low fever, headache.  Started 16 hrs after injection. Started to subside after 45 hrs injection site - pain, swollen -diameter or a navel orange, hard, warm to touch and slight itchiness. Started few hrs after injection, got progressively larger, more uncomfortable.  Currently at 95 hrs after injection, size still same (navel size) or slightly larger, still hard, warm, slightly less sore but more itchy.
Under eye swelling; mild erythema remains this morning. Right eye worse than left. No new skin or hair products.
Information was received from a consumer on 30-OCT-2015 via Sanofi Pasteur (MSD) and refers to an unspecified number of children patients of unknown ages and genders. This report was found in the comments part of a petition about HPV vaccine. On an unspecified date, the patients were vaccinated with a dose of GARDASIL (lot number, expiration date, dose and route of administration were not reported). There was no concomitant medication reported. The reporter stated that "it's hard to imagine that GARDASIL and other vaccines for the HPV virus were still on the market knowing the hundreds of our children that had died (dates were not specified) and those that had harmful adverse reactions and were living with new medical conditions after receiving the vaccine". The cause of death was not reported and it was unknown if autopsy was performed. This is one of several reports from the same reporter. Additional information is not expected as no reporter details were provided.
Injection site became swollen, painful, and itched. Sought treatment in ER - received IM: BENADRYL, SOLUMEDROL, and PEPCID. Rx given for: ALLEGRA and Medrol dose pak.
-Mild tingling along left trigeminal nerve and left arm within 30 minutes. Still ongoing after 45 hours, but almost gone.  -Mild headache starting within 3 hours and lasted less than 24 hours. -Trouble taking deep breaths starting around 10-15 minutes. O2 was 100 (even with asthma/pneumonia, my O2 is always above 92). I was otherwise breathing normally so I stayed calm and didn't need a rescue inhaler. The issue continued for about 30 hours.  -Blood pressure spike. Although I was calm, I had a "weird" feeling starting within 5-10 minutes and my heart was speeding up. BP was checked around 20 minutes after injection. It was 168/106 with heart rate of 90.  My usual BP is 120/68 with 62 heartrate. My BP has never been that high before as far as I know. Within another 30 minutes it was down to 145/94 and heart rate of 82,  and I  was released from observation to go home. I was seated and calm throughout episode. I felt "off" for several hours afterward, but had no way to check my BP.  My heartrate averaged around 75-85 during that time.  -Fatigue followed feeling "off" for another 30 hours.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; ATORVASTATIN; METFORMIN; FAXIGEN XL. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Report about Covid treatment was Yes. If vaccine received reported as Yes. Other medications in 2 weeks reported as Yes. Anti viral details: product: COVID 19 Treatment, brand: Paxlovid, Treatment start date: 16Sep2022, Lot number: GE4518, Indication: Treatment of COVID-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the events Drug ineffective, COVID-19, interchange of vaccine products and the suspect drug BNT162B2 cannot be excluded.
Itchy throat, hard to swallow. Resolved with 25mg. benadryl in about 30 min.
that night I woke up at 4 am and started throwing up violently; This is a spontaneous report from a non-contactable consumer, the patient. A 21-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 21-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included lamotrigine (LAMICTAL), quetiapine fumarate (SEROQUEL), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), bupropion hydrochloride (WELLBUTRIN) and duloxetine hydrochloride (CYMBALTA); all from unknown date for unspecified indication. The patient had no known allergies to medications, food or other products. Prior to 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 an unknown date, after receiving the first dose in the morning and that night the patient woke up at 04:00 and started throwing up violently. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event throwing up violently was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
shingles; This initial spontaneous report was received from a lawyer and the patient regarding a case in litigation involving a female patient (pt) of unknown age. There was no information about the pt's concurrent conditions, concomitant therapies or medical history provided. In or around 15-OCT-2015, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (Herpes Zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a bad case of the shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of Zostavax, the pt sustained severe and permanent personal injuries. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event of shingles was considered as not recovered.  The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).   The event of shingles was considered to be disabling.
Client was 12 years old and received a pediatric 0.2 ML dose of Pfizer vaccine. Client then received an appropriate  12+ 0.3 mL dose of the Pfizer vaccine.  Client had a sore arm which has since resolved.
Patient went to pharmacy and got PREVNAR 13 then came to another pharmacy to get flu shot high dose. Patient got both shots in same arm, 1" apart. The following day, patient's arm was swollen and very painful. She went to ER.
Local pain at injection site followed by red rash limited to upper arm surrounding injection site and skin hot to touch that resolved completely in 24 hours.
About 30 minutes after receiving the J & J vaccine, my left arm, and then left leg began to feel heavy and intermittently tingly (that was not what I consider the adverse event, but I want to give you the full context). Then approximately 40-45 minutes after the vaccine was administered, I was sitting and typing on my computer when out of the blue I felt considerable  tightness in neck. The sensation began at the base of my neck and moved upwards across my neck and rose into my head. At that point, it felt like my neck and head were in a vise. That continued while at the same time it felt like there was a great deal of pressure directly on my sinuses.  This all continued for 1-2  minutes, at which point the tightness in the necks  diminishing until I  did not feel it any long. The tightness and pressure in my head lasted another 10 minutes or so. It gradually diminished, before fully dissipating after. The entire event lasted about 12-15 minutes and was very scary, as nothing like that has ever happened to me. Once it was over, I continued to feel heaviness and intermittent tingling in my left arm and left leg for another couple of hours. By the next day the heaviness was gone, but I was a bit congested and had a headache.  I didn't know who to report this to until the J & J vaccine administration was halted and it occurred to me that maybe my experience  should be documented and reported. A friend found this website for me.