chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the vial was initially stored in the refrigerator; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  On 22-Sep-2021, the vial was placed in the refrigerator. The vial did not undergo any temperature excursion and the patient had no adverse event.  The reporter also said that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  No treatment information was provided.   This case was linked to MOD-2022-491837 (Patient Link).
12 hours later, fever, headache, neck pain, chest pain, shortness of breathe, abdominal pain.
Patient reports development of the shingles virus in February 2018, approximately 10 months after receiving the vaccine. I explained that the vaccine does not fully prevent the virus, but that if the patient acquires the virus, the symptoms and length of the virus would be less severe. She was concerned that she had seen that the 'previous' shingles vaccine (ZOSTAVAX) had some 'problems' and didn't work.
This is what I sent to my doctor earlier today. I've added an update to the bottom. My doc recommended I report it here and to take an antihistamine like Claritin and use cold compresses to bring down the swelling.     I'm having a very minor issue that I believe is related to the Pfizer booster I got on Saturday. Wondering what I should do, if anything, and if I ought to report it somewhere.  -Got my booster this Saturday (12/11/21), late afternoon. Moderna for both initial vax doses, Pfizer booster. -By midday Sunday my face was weirdly achy along my cheekbones, the lower portions of my eye sockets, that whole area. I thought maybe it was a sinus thing. -Mirror check revealed my whole under-eye area was swollen (both eyes) and my tear troughs (both eyes) were darkened and reddened, and swollen, almost like bruising. Looks like I'm recovering from double black eyes. -Earlier this year, I had dermal fillers placed in the tear trough / under eye area and along my cheekbone. Pretty sure that's what's swollen. -Consulted the internet (I know, I know), found several papers documenting similar reactions. -As of midday Monday 12/13/21 the swelling has gone down a bit. -As of Monday evening the swelling remains about the same as it was earlier today.
Severe hives. On going everyday . On steroids and Benadryl nothing is working
Information has been received from a liscensed practical nurse concerning a patient who was vaccinated with a dose measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (WISTER RA 27/3). Subsequently the patient developed mumps. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Information has been received from a woman at a Pediatric office concerning a male patient with no allergies who in 1970 was vaccinated with a dose of mumps virus vaccine live (lot # not reported). It was reported that the patient had a seizure 2 days after receiving the vaccine and that the patient was allergic to the vaccine. It was reported that it was unknown if the seizure was a febrile seizure. It was unknown if medical attention was sought. Upon internal review, seizure was determined to be an other important medical event (OMIC). The reporter also reported that the patient's son experienced a fever, bilateral otitis media and bilateral bronchitis after being vaccinated with a dose of MMR (second generation) (lot # not reported0. Additional information has been requested.
Sleepiness but about 24 hrs later. Redness and induration right arm approx 12 hrs, small purple ecchymosis 24hr later.
MMR, Varicella, KINRIX vaccines given at time of health care maintenance given. Returned to office 20 minutes later. Complete body hive rash noted. No difficulty breathing noted no fever. Vital signs stable. 10cc BENADRYL Elixir given PO.
Felt tongue tingle; had a weird sensation on tongue. At first I thought I was tasting something but I wasn't; felt a bit of nausea which is a normal side effect; This is a spontaneous report from a contactable other hcp (patient). A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via an unspecified route of administration at left arm on 29Dec2020 09:30 at single dose for COVID-19 immunization. No medical history. No known allergies. The patient's concomitant medications were not reported. The patient felt tongue tingle and had a weird sensation on tongue. At first she thought she was tasting something but she wasn't. This lasted for about 30 mins. She also felt a bit of nausea which was a normal side effect. She was not sure what the tongue feeling was. Events onset date was 29Dec2020 10:00. No treatment received. This report is non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were not any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovered on an unspecified date.
Hives. Itchy, raised red bumps on arms, neck, face, and thighs.  First appeared several days ago and has been getting progressively worse. The first welts appeared on my face. The arm where I received the vaccine is more affected than the other arm. Because onset was so long after the jab, I'm not sure the vaccine is the cause. But I have barely left the house, not eaten anything new, not changed any soap or perfume or anything and have no history of hives. Prednisone prescribed.
Both flu and pneumonia shots given on 10/4/02 in different arms. One day later arm became very swollen and sore R arm where pneumonia shot given. She became very weak and fell x 2. Went to MD and he placed in hospital x 2 days with IV antibiotics. Vomiting, diarrhea, and dehydration.
Seizures, pain in joints mostly neck, left shoulder, middle back, lower back, left hip, left wrist, arms feel numb/tingly like. I have real bad headaches now where I used to have real mild ones. I feel tired all the time, muscles wear out to fast, light sensitivity, memory problems, loss of time, confusion.
All 0.5ml of the vaccine was not administered into the deltoid; Tensed up; This spontaneous case was reported by a health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (All 0.5ml of the vaccine was not administered into the deltoid) and TENSION (Tensed up) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (All 0.5ml of the vaccine was not administered into the deltoid) and TENSION (Tensed up). At the time of the report, ACCIDENTAL UNDERDOSE (All 0.5ml of the vaccine was not administered into the deltoid) and TENSION (Tensed up) outcome was unknown.        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.   No relevant concomitant medications were provided. No treatment information was provided.
Urinary Tract Infection; Extreme fatigue; Fever; Nausea; Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 33-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 right arm on 27Aug2021 at 18:00 (at the age of 33-years old) as a single dose for COVID-19 immunisation. Medical history included factor V Leiden, asthma, chronic bronchitis and psoriasis. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received measles vaccine/ mumps vaccine/ rubella vaccine (MMR) and experienced reaction to MMR vaccine. On 27Aug2021 at 23:00, the patient experienced urinary tract infection, extreme fatigue, fever, nausea and diarrhea. The events resulted in emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measure was taken as a result of the events which included treatment with sulfamethoxazole/ trimethoprim (BACTRIM). The clinical outcome of the events urinary tract infection, extreme fatigue, fever, nausea and diarrhea were resolving 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.
This spontaneous report was received from a nurse, referring to multiple unspecified patients of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On an unknown date in 2015, an unspecified number of patients were vaccinated with PROQUAD (Merck), lot # L007228 and expiration date 03-SEP-2016 (dose number, strength, and route of administration were not reported), that were improperly stored and exposed to temperatures of 1.6 C. At the time of this report, it was not reported any adverse event. This is one of two cases received from the same source. Additional information has been requested.
provided 6 patients with Moderna vaccines from a vial that expired two days prior; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (provided 6 patients with Moderna vaccines from a vial that expired two days prior) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (provided 6 patients with Moderna vaccines from a vial that expired two days prior). On 05-Jan-2022, EXPIRED PRODUCT ADMINISTERED (provided 6 patients with Moderna vaccines from a vial that expired two days prior) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported. No adverse event was reported.
Our pharmacy accidently ordered the pediatric dose and used it for several adults. Age of patient at time of event: 40 years.
20 hours after injection patient reported myalgia and fever to 100.5 with dizziness and fatigue lasting until started to clear by 2000 that evening and totally resolved by next morning. Symptoms did not recure and he is "normal" feeling now (1/14/21). Complete ROS is negative including gi, respiratory, derm,
My husband, had a heart attack just one month after receiving the second dose of the vaccine. On May 21, 2021, his breathing didn't sound quite right. It was making a crackling sound. Shortly thereafter, he collapsed due to a heart attack. He had no history of heart problems himself. There is no history of heart problems in his family. Both doses of the vaccine were injected into his arm, but I don't remember which arm. He was admitted to hospital after he had a heart attack at home. They ran a multitude of tests, but I don't remember much. It was very traumatic. He was in the ICU for four days before he passed away on May 24, 2021.
my right eye started twitching; agitated; nauseated; accidental spraying of the Pfizer Covid vaccine into her right eye; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team. The reporter is the patient.  A 48 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OCCUPATIONAL EXPOSURE TO PRODUCT (non-serious) with onset 24Sep2021, outcome "unknown", described as "accidental spraying of the Pfizer Covid vaccine into her right eye"; BLEPHAROSPASM (non-serious) with onset 03Oct2021, outcome "unknown", described as "my right eye started twitching"; AGITATION (non-serious) with onset 03Oct2021, outcome "unknown", described as "agitated"; NAUSEA (non-serious) with onset 03Oct2021, outcome "unknown", described as "nauseated". The events "accidental spraying of the pfizer covid vaccine into her right eye", "my right eye started twitching", "agitated" and "nauseated" were evaluated at the physician office visit. Therapeutic measures were taken as a result of occupational exposure to product, blepharospasm, agitation, nausea.  Additional information: It was reported that, on 24Sep2021, she had just finished vaccinating a patient, she pulled out the needle and as she was priming it, she felt a spray in her right eye, but continued doing her work. 2 hours later when she got home she thought about it, and felt maybe she should have said something. 8 days after this happened her right eye started twitching, and agitated, and sometimes she feel nauseated. Her doctors said it may be just stress from work. Rinsed thoroughly with plenty of water for at least 15 minutes, lifting lower and upper eyelids. Consult a physician.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
having muscle spasms in the leg and left arm about 1.5 hours after the second dose; weakness; muscle pain; This is a spontaneous report from a contactable consumer (herself). A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6198; Expiration Date: 30Jun2021), dose 2 via an unspecified route of administration, administered in Arm Right on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN9581; Expiration Date: 31May2021), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced having muscle spasms in the leg and left arm about 1.5 hours after the second dose, weakness and muscle pain on an unspecified date. Caller stated that she received both doses of the Pfizer covid 19 vaccine. Caller stated she did fine after the first dose but started having muscle spasms in the leg and left arm about 1.5 hours after the second dose. Caller stated she got the vaccine in the right arm. Caller stated she continued to have muscle pain, weakness and spasms. Caller wanted to know if these were normal side effects. Caller stated she reported AE to safety already. Possible duplicate AE. Consumer also stated, she had been having some muscle pain and weakness and stuff like muscle spasms ever since she took her last vaccine. And she just wanted to find out was that some of the side effects. No therapeutic measures taken as a of result events. The clinical outcome of all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Really tired; really sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Really tired"; ILLNESS (non-serious), outcome "unknown", described as "really sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Reporter and her husband were coming off a trip. They both were really sick coming home and really tired. They tested in blue box, orange box and white box after returning home. Her husband took test and had COVID. Reporter tested in orange and white box and saw C. She thought she was positive for COVID and needed Paxlovid and her doctor prescribed Paxlovid. The patient was not positive as she read the test completely wrong. She asked if Paxlovid do any damage if someone took it with COVID negative.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300059314 same reporter, different patient, same drug, different event;US-PFIZER INC-202300137868 same reporter, same patient, different product, different event;
approx 24 hrs p/vax a red ring of hives appeared around vax site w/a few hives on legs & arms; w/in next 24 hrs hives became severe below the waist; very concentrated on buttocks, legs & feet; tx DPH;
Mother reported child woke at 5:15am with uncontrollable shaking, denies hives or rashes, denies trouble breathing, denies fevers and pain. Attempted to soothe and calm her, then 20 minutes after was going to go to ER for evaluation, and child with vomiting x1. Then 10 minutes after shaking subsided and she was able to drink water, TYLENOL was given to patient by mother and child returned to rest. Mother was advised to take patient to ER for evaluation for continued symptoms, or any new symptoms. Advised follow up with PCP, call today for appointment.
skin was inflamed; facial swelling; kind of rashy area; face got red and swelled; a bit more blotchy than the other side; face felt funny, felt super tight; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6203), dose 1 via an unspecified route of administration, administered in Arm Left on 02Mar2021 13:00 at the age of 43-year-old as dose 1, single for covid-19 immunisation from defense medical center. Medical history included ongoing asthma on inhaler , hypothyroidism (taken synthroid for many years) and seasonal allergy, Strange reactions to foods that does not follow a pattern; she is known to have the odd hive outbreak occasionally over the years. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and not administered additional vaccines on same date of the bnt162b2. Concomitant medication included levothyroxine sodium (SYNTHROID) taken 50mg taken once daily for hypothyroidism, start and stop date were not reported. Patient family Medical History include autoimmune diseases, psoriatic arthritis and crohn's disease. On 02Mar2021 13:20. (about 20 minutes after she got the vaccine) Patient face got red and swelled, skin was inflamed. It was reported as facial swelling and like a raised up red, kind of rashy area. She had just left the vaccine site and was driving when adverse reaction started. Her face felt funny, felt super tight. She looked in the mirror and her face was all raised up and had bright red skin raised up a bit on one side, that side was a bit more blotchy than the other side. The adverse reaction lasted several hours with bright redness that gradually started to fade but the swelling overall stayed until 03Mar2021 morning when she woke up it was gone. In morning patient noticed her face was till blotchy on one side but is getting better on its own. Patient has not seen the doctor or visit emergency room about this events an. Patients second dose is scheduled for 23Mar2021 and she wanted to know if she could still get the second dose of the vaccine. The outcome of event was recovering.  No follow-up attempts are possible. No further information is expected.
Chest pain for 2 weeks. Evaluated by cardiologist. Pericarditis confirmed by Echocardiogram.
Generalized non-pruritic skin eruption. 7/25/12 - > pt reports rash has resolved.
The patient presents with URI symptoms for Yesterday after getting his booster shot.        Symptoms include headache, cough, runny nose, chills, shoulder. neck and back pain. starting on 11/2/21. Received Moderna booster on 11/2/21. Wife recently tested positive for COVID (last week)
Chills, myalgias, jittery feeling, vomiting, local swelling.  Symptoms lasted for 12 hours.
muscle and joint very sore; muscle and joint very sore; arm shoulder swollen (still on swollen after 3rd day); Fever; This is a spontaneous report from a contactable consumer.  A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number EL8982 via an unspecified route of administration on 15Jan2021 10:00 at SINGLE DOSE for covid-19 immunisation. Vaccine location= Left arm, dose number= 1 Medical history included hypertension, blood cholesterol increased, overweight, back pain, hip arthroplasty, spinal operation. Concomitant medication included estradiol (ESTRACE), triamterene (TRIAMTERENE), vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]), melatonin (MELATONIN). The patient previously took dilaudid and experienced drug hypersensitivity. On 16Jan2021 01:00 patient experienced muscle and joint very sore, arm shoulder swollen (still on swollen after 3rd day), fever, all with outcome of recovering. The action taken was not applicable.
Narrative:  COVID infections following completion of COVID vaccine series 02/09/21 COVID vaccine dose #1 03/02/21 COVID vaccine dose #2 03/26/21 Pt presents to PCP and reports coughing up brown mucus with streaks of blood; given rx for azithromycin; CXR wnl 07/14/21 Pt reports presenting to ED on 07/10 for bronchitis 07/26/21 Pt reports he was admitted to hospital 07/20 for acute bronchitis and was diagnosed with COVID; states he is feeling better and declines COVID calls 07/29/21 Pt reports slowly getting slowly better; weak, tired, diarrhea 3-5 times a day, decreased appetite, no fever, and using inhalers for breathing 07/30/21 Pt reports diarrhea slowing down, fatigue improving, loss of taste/smell returning, and shortness of breath upon exertion 08/02/21 Pt reports improving shortness of breath 08/03/21 Pt is clinically resolved