chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My mother came to the pharmacy on 11-09-16 and received a FLUZONE HD injection. At the time of injection, it was extremely painful unlike any vaccine she had ever received. When she got home, her upper arm began to swell 3x the usual size. She sent a picture to me and I was shocked at the bruising and swollen tissue. I instructed her to ice her bicep, elevate her limb and take a pain reliever. Upon inquiring about her condition the next morning, she sent another picture and conveyed the painful night that she had with her arm. It was hot to touch and the bruising had spread. She continued to ice her arm and take pain medication. After another night, she was urged to go to the ER to which she went to. This was on the 11th of November, two days' post injection. She was diagnosed with Traumatic ecchymosis of right shoulder pain at the initial site. I asked my mother how the injection was administered, and she described that the needle was introduced deeply and the injection given. The FLUZONE HD vaccine an intradermal injection. The instructions for an intradermal injection is to use your non-dominant hand to pull skin taut over the injection site. Remove needle can with non-dominant hand by pulling it straight off. Place the needle almost flat against the patient's skin, by pulling it straight off. Place the needle almost flat against the patient's skin, bevel side up. Insert the needle so that the point of the needle can be seen through the skin-only about 1/8 of an inch. This type of injection creates a wheal or blister on the skin. It is apparent that the administrator of the injections needs to be educated on the process of this type of vaccine and administration. My mother had been diagnosed with Thrombocythemia a few years ago, this condition requires multiple blood draws to calibrate the dosage of her medications. She has never had a complication such as this. This is not a reaction; it is a mechanical induced trauma to her tissues after having a vessel pierced by a needle. Not only has this event been painful, it has been extremely stressful to my mother and our family. Given her diagnoses, she is extremely careful and mindful of her safety. You will find images of her arm attached to this letter. I am hopeful that you will assess the level of education that your pharmacists receive when doing procedures. I will be waiting for your response to this matter and eager to hear your plan of action.
Called Dr 2/11/07 after onset of seizures, began at 1200, duration 72 hours and hospitalized for 36 hours. Has appt on 3/19/07. Temp was around 100 deg F.  04/02/2007 MR received for hospital admission for possible seizure.  Infant had had several episodes of diarrhea, one episode of vomiting, and a fever of 101 at home.  She had 5-6 episodes of fine shaking of her upper extremities, she would get stiff and the head turned to left. These lasted ~10 seconds each. PE: WNL. Impression:  Possible new onset seizures.  Probable viral gastroenteritis.
3/30/21 AM = (Patient's notes) "Chest/breast PAIN throughout night and (previous) day. Pain continuously in back last two (2) days. Nauseated, weak bladder every hour or so. No appetite. 1st Covid shot 3-27.
High fever, febrile seizure, lethargy, heart pounding hard with documented pulse rate over 120
Approximately  10 minutes after receiving the Pfizer BioNtech COVID-19 vaccine, pharmacist was alerted by the vaccine ambassador that a patient was sitting on the ground likely having a reaction to the vaccine. The pharmacist came to the patient to assess the situation. Patient described that she was experiencing "a warm sensation to going to her head" and was not feeling well. Patient was breathing, alert, and conscious. She did not state that she had any medical conditions that could be contributing to the reaction.  A nurse who was shopping at the store also stopped to assist. Out of precaution, 911 was called and paramedics arrived on site. Blood pressure and heart rate were normal.
Per Client, on 5/7/2021 at 1630, received first COVID 19 vaccine in left arm. Client C/O, that on next day left arm sore, tender, and left side of neck, mid way down, with a tender lump. Per Client, on 5/9/2021, the lump on left side of neck, increased tenderness, movable, no rash, no warmth, and no redness. Per Client, is not having any other symptoms, and has not followed up with PCP, or taken any medication. PHN suggested that Client follow up with her PCP, go into urgent care, ER, and to call 911 if having a medical emergency. Client verbalized understanding information provided.
Unknown precisely when fatigue and Epstein Barr began. Aug 19th on fatigue was a complaint followed by   sore throat (which was assumed a cold or hayfever). The event causing an ER visit and IV demerol for upper abdominal pain occurred at 8AM on 08/20/02 (See 12). Following this visit was overwhelming constant fatigue, sometime a headaches and an ongoing "off and on" upper abdominal mild pain. Fatigue required 1 day/week off school and no extra activity for a month and taper to allow 2 evening. 6 -10 weeks job after 2 months and now to do some exercise (?) following this exercise expended requires some "nays" Prior to  restarting exercise, brachial bicep/ triceps pain developed and lasted  a week. "Freezing fingers" and postural hypotension (?)began 1 month ago and continue as does intermittent fatigue.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 09-JUN-2009, the patient was inoculated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 17-JUL-2016, the patient was treated at a medical center for a vesicular outbreak, which was diagnosed as shingles. The patient had been prescribed VALTREX and NORCO for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient was seen at our health location where she was given her 12 month vaccines which included varicella. Patient had a slight bruise then 24 hours later the bruise turned into a large welt and patient anded up getting hives in the area where the welt was. welt was warm to the touch.
Information has been received from a physician concerning a female who on an unspecified date was vaccinated with GARDASIL. Subsequently the patient experienced lupus like reactions. No other information reported. This is one of several reports from the same source. Additional information has been requested.
Leg became red, swollen, hot to touch and tender at injection site.  Pt very irritable through out the night with fever no more than 100 degrees.
Patient has both chicken pox and the shingles.  She acquired both post vaccination.  She stated that after initially believing she had the chicken pox as a child, her mother communicated to her post vaccination that now she wasn't sure if the patient had chicken pox as a child. She hasn't recovered yet.
welt appeared 1 1/2 - 2" below injection site within 1 minute of injection - MD notified. Benadryl 25 mg given po 5 minutes after event. Observed x 1 hour - no other problems noted, discharged to home - welt still present
Fever 101, muscle and joint pain beginning at 11pm and continuing overnight until morning.  Responding to Acetaminophen.
Swelling, warmth, redness of entire left upper arm, onset 24 hours after vaccination.
He missed 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (He missed 2nd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A,) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (He missed 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (He missed 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
TOOK TWO DOSES IN A ROW; This spontaneous case (PVX2019-1081) was received from a nurse on 02-May-2019. It describes a 32-year-old female consumer who "took two doses in a row". The consumer was receiving oral Vivotif for typhoid prophylaxis.  Case report: The consumer took first two doses in a row. The doses were taken on 30-Apr-2019 and 01-May-2019, respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took two doses in a row" was unknown.  Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two doses in a row" was considered as not applicable.
Vaccine administered beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient age was reported as 26 years and 3 months.  No concomitant medications were reported.  On 10-Jun-2022, the vaccine facility was notified of an audit that was done and it was informed that vaccines were administered beyond use date after the thaw process. There was no patient that had any adverse reactions and no reports of any reactions after the administration of these vaccines. The patient got Moderna with vaccine Ndc code 80777027399. Patient requested Pfizer-BioNTech COVID-19 Vaccine (12 plus).  It was unknown whether the patient was ever diagnosed/tested positive for COVID-19.   It was unknown whether the patient had any acute illness at the time of vaccination and up to one month before it. It was unknown whether the patient had any chronic or long-standing health conditions.  Prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at the time of vaccination and/or at the time of adverse event was unknown.  No treatment medications were reported.
Following 2nd dose, I experienced headache, body aches, and a mild fever along with injection site soreness
administration error. Patient was given 0.25 ml rather than 0.5 ml as a first dose.
Pt. received H1N1 shot on Thursday at work. Wife said when he got home he c/o feeling achy and bad and had temp. She said she gave him TYLENOL to help with the fever. She called MD on Friday AM and was told to alternate MOTRIN with TYLENOL. Wife said this worked and pt was better Sat.
Pericarditis; Covid-19; This spontaneous case was reported by a patient and describes the occurrence of PERICARDITIS (Pericarditis) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Covid-19). On an unknown date, the patient experienced PERICARDITIS (Pericarditis) (seriousness criterion medically significant). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral use) from 02-May-2023 to 07-May-2023 for COVID-19 treatment, at a dose of UNK, bid. On 19-May-2023, COVID-19 (Covid-19) had resolved. At the time of the report, PERICARDITIS (Pericarditis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-May-2023, SARS-CoV-2 test: Positive. On 19-May-2023, SARS-CoV-2 test: Negative.         Concomitant medication was not reported.  Patient started taking Paxlovid and felt better. Then on 11-May-2023 patient became very ill again for seven days and developed pink eye in right eye and stated covid-19 rebound. On 19-May-2023, patient felt better. It was reported patient had pericarditis symptoms after Moderna doses and thought it was a heart attack and went to ER. It was reported that patient didn't receive Pfizer vaccine.  Company comment:  This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who experienced the unexpected serious (medically significant) event of Pericarditis and non-serious event of Pericarditis and the non-serious event of COVID-19. The event pericarditis is reported in relationship with the administration of mRNA-1273 vaccine. The patient received three doses in a correct schedule. About 2 years later, the patient had COVID-19 and was treated with Paxlovid. No further information on clinical course, investigations and treatment received was available in the report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2023: Significant follow-up received: Suspect drug and events were updated.
1MAY96 mom noticed rash on arm where inj given;pt has been feel good & did not complain of any pain;MD wanted to observe arm;2MAY96 2x3" swelling w/some heat in area;
This spontaneous report as received from a nurse refers to a patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, multiple unspecified patients were inadvertently vaccinated with PROQUAD (dosing details, lot# and expiry date were not reported). It was reported that the vaccines were exposed (excursion 1) to the temperature of -4.3C during a time frame of 1 hour and 6 minutes. It was reported that the vaccines were exposed (excursion 2) to the temperature of -2C during a time frame of 2 hours and 20 minutes. No previous temperature excursion was reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. This is second of the two reports from the same reporter. Additional information has been requested.
A mass was found on the right kidney. Currently thought to be RCC; Lower ventricular tachycardia; Heart palpations; Sweats; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 25Apr2022 at 14:00 as dose 4 (booster), single (Lot number: FM9992) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Tylox, reaction(s): "Drug allergy". Vaccination history included: BNT162b2 (AT 09:00 AM, DOSE 1, SINGLE, Batch/lot no: EN6202, Anatomical location: Right arm), administration date: 09Mar2021, for COVID-19 immunization; BNT162b2 (AT 11:00 AM, DOSE 2, SINGLE, Batch/lot no: ER8733, Anatomical location: Right arm), administration date: 30Mar2021, for COVID-19 immunization; BNT162b2 (AT 10:00 AM, DOSE 3 (BOOSTER), SINGLE, Batch/lot no: FE3592, Anatomical location: Left arm), administration date: 06Oct2021, for COVID-19 immunization. The following information was reported: RENAL CELL CARCINOMA (medically significant) with onset May2022, outcome "recovering", described as "A mass was found on the right kidney. Currently thought to be RCC"; FATIGUE (non-serious) with onset May2022, outcome "recovering"; PALPITATIONS (medically significant) with onset May2022, outcome "recovering", described as "Heart palpations"; VENTRICULAR TACHYCARDIA (medically significant) with onset May2022, outcome "recovering", described as "Lower ventricular tachycardia"; HYPERHIDROSIS (non-serious) with onset May2022, outcome "recovering", described as "Sweats". The events "a mass was found on the right kidney. currently thought to be rcc", "lower ventricular tachycardia", "heart palpations", "sweats" and "fatigue" required physician office visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: mass was found on the right kidney. Therapeutic measures were taken as a result of ventricular tachycardia, palpitations. Clinical Course: Patient also received BNT162b2, BNT162b2 omi ba.4-5 on 09Nov2022 at 10:00 as dose 5 (booster), single (Lot number: CH6738), in right arm for covid-19 immunisation. Began in May2022, sweats, heart palpations, fatigue. It continued to worsen finally went to see a cardiologist to find lower ventricular tachycardia. No previous heart problem up to that time and no heart familiar heart problems. Heart ablation was done but on the CT scan before the procedure a mass was found on the right kidney. Currently thought to be RCC (Renal Cell Carcinoma). No previous prior kidney problems. Patient had no other vaccine in four weeks nor had any Other medications in two weeks.
could not move neck, arms; covid vaccine had left arm sore; rheumatoid arthritis flare; MARKETING PROGRAM NAME NOT AVAILIBLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4296985-00.  A 52 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), intramuscular (Batch/Lot number: unknown) till Oct2021 at citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 2021, outcome "not recovered", described as "rheumatoid arthritis flare"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "could not move neck, arms"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "covid vaccine had left arm sore". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive; (Feb2022) positive. The action taken for adalimumab was unknown. Clinical course: it was unknown if patient was enrolled in a covid-19 vaccine trial.  Causality for Humira (adalimumab): The reporter's causality for the event(s) of covid vaccine had left arm sore with Humira (adalimumab) was no reasonable possibility. the reporter's causality for the event(s) of rheumatoid arthritis flare with Humira (adalimumab) was a reasonable possibility. the reporter's causality for the event(s) of could not move neck, arms was not provided.   Causality for Pfizer BioNTech Covid-19 Vaccine: The reporter's causality for the event of covid vaccine had left arm sore was possible, the reporter's causality for the event Rheumatoid arthritis flare up and Joint range of motion decreased was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported event Rheumatoid arthritis which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
she was positive; a little chill; pretty bad cough; little muscle aches; fever of about 100; ulcers in her mouth; This is a spontaneous report from a contactable consumer. This female consumer reported that:   The 73-years-old female patient received first dose of bnt162b2 (COMIRNATY, solution for injection) (Batch/Lot Number: EL9264A) via an unspecified route of administration on 29-JAN-2021 as 1St DOSE, as single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported. It was reported that patient (age 73) and her husband (age 72) both got their first dose of the Pfizer vaccine on 29Jan2021. Two days later, she developed a chill, a fever of about 100, a bad cough for 48 hours, and ulcers in her mouth, little muscle aches. Patient was supposed to get her second vaccine on 19Feb but on 07Feb, they she was tested for covid and came back positive. Patient had since had follow up tests and on 22Feb, her husband tested negative but she was still positive but on 14Mar , she finally tested negative. They are hearing a lot of different information on how long to wait before getting the second one and if they need to repeat the doses since the first and second will be so far apart. Some told them to wait 3 months before getting the second dose and they are trying to get more info. The outcome of the event covid 19 positive was not recovered and chills, cough, myalgia, pyrexia, mouth ulceration was unknown.  Follow-up (02Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported that: New information regarding adverse events has been received.  Follow-up (19Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported that: New information regarding adverse events has been received (chill, a fever of about 100, a bad cough for 48 hours, and ulcers in her mouth).  Follow-up (25Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported that: no new information has been received.  No follow-up attempts are possible. No further information is expected.
SEVERE PAIN AND RESTRICTED RANGE OF MOTION RIGHT SHOULDER DIAGNOSED SUBACROMIAL BURSITIS.  SUSPECT INADVERTENT INJECTION INTO SUBACROMIAL SPACE.