chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to "about 15" unspecified patients of unknown age and gender. Patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Concentration, dose and route of administration were not reported), lot # L005299, expiration date 17-FEB-2017. Patient's concomitant medication was no reported. No adverse effects were reported. A product complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested.
warm to touch; Hard; Received second dose, has a large amount of swelling at the site; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Some of the swelling is expanding), VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE INDURATION (Hard) and VACCINATION SITE SWELLING (Received second dose, has a large amount of swelling at the site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (Some of the swelling is expanding), VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE INDURATION (Hard) and VACCINATION SITE SWELLING (Received second dose, has a large amount of swelling at the site). At the time of the report, SWELLING (Some of the swelling is expanding), VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE INDURATION (Hard) and VACCINATION SITE SWELLING (Received second dose, has a large amount of swelling at the site) outcome was unknown.            Concomitant product use and treatment information was not provided.
Patient was given Pfizer-BioNTech Covid-19, Bivalent Original and Omicron BA.4/BA.5 for 6 months to <5yrs, LOT #GK1667 on 7/10/2023 as the second dose in series. The vaccine's beyond use date was 07/03/2023.
ACUTE PANCREATITIS; CHILLS; FATIGUE; FEVER; This spontaneous report received from a patient concerned a 54 year old male.  The patient's weight was 240 pounds and height was 69 inches. The patient's concurrent conditions included: abstains from alcohol and non-smoker. The patient had no known allergies. The patient did not have any drug abuse or illicit drug use. Patient never had pancreatitis previously.  On unspecified dates in APR-2021, the patient previously received the series bnt 162 (dose number in series 1, manufacturer: Pfizer) (form of admin, route of admin and batch number: unknown expiry: unknown) dose was not reported, for prophylactic vaccination.   On 18-NOV-2021, the patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose was not reported, 1 total, administered for prophylactic vaccination on left arm. The batch number was not reported and has been requested. No concomitant medications were reported. 12 to 24 hours after vaccination, the patient experienced fever, chills and fatigue (dose number in series 2).   On 28-NOV-2021, the patient began experiencing severe epigastric pain around 12pm. That same evening at 7pm, patient went to local hospital emergency room (ER) since the pain was not resolving. The patient was seen and treated for acute pancreatitis (dose number in series 2) with treatment medications which included: pain medications (unable to capture) and an antiemetic (unable to capture). Laboratory data included: CAT (computed tomography) scan abdominal which confirmed acute pancreatitis diagnosis.  On 29-NOV-2021 (Monday), the patient was discharged from the ER.   On 30-NOV-2021 (Tuesday), the patient followed-up with gastroenterologist who confirmed the diagnosis of acute pancreatitis but unsure of the cause. It was reported, by the patient that he recovered and was on a low fat diet. The patient has a scheduled for an abdominal MRI (Magnetic resonance imaging) for 20-DEC-2021 for further evaluation of the cause.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from acute pancreatitis and the outcome of fever, chills, and fatigue was not reported.  This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211201960-covid-19 vaccine ad26.cov2.s-Acute pancreatitis . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
2 weeks after the 1st vaccination, 01/18/2021, on February 1st, 2021, I went to my PCP to get a routine diabetic check up and the doctor notice my Blood Pressure level was elevated. I have never had high blood pressure before.
Itchy, swollen reddened arm at sit of injection, starting on 6th day after injection.  Left armpit axillary swollen lymph node
Febrile reaction; This case was reported by a physician via call center representative and described the occurrence of febrile reaction in a 60-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2018-2019 season) for prophylaxis.   On an unknown date, the patient received FluLaval Tetra 2018-2019 season at an unknown dose. On an unknown date, less than 2 years after receiving FluLaval Tetra 2018-2019 season, the patient experienced febrile reaction. On an unknown date, the outcome of the febrile reaction was unknown.   It was unknown if the reporter considered the febrile reaction to be related to FluLaval Tetra 2018-2019 season.  Additional details were provided as follows: The age at vaccination was not provided. The patient experienced 103 degree F after receiving what he believed to be a GlaxoSmithKline Trivalent Flu vaccine. The patients febrile reaction resolved within 12 hours. The patient had received the vaccine at work and the event was reported by his consulting PCP. No additional details were provided at the time of report. The Vaers details were provided. The reporter Consented to follow up.      Lab Comments: On an unspecified date, Lab test performed.
Received vx reconstituted with other diluent; Received vx reconstituted with other diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA585A, expiry date August 2022) for prophylaxis.   On 9th December 2021, the patient received Menveo. On 9th December 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient received Menveo vaccination that was reconstituted with other diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No data available when asked) received Menveo vaccination that was reconstituted with other diluent. The vaccine administration facility was the same as primary reporter. No further information reported. The reporter consented to follow-up.
after receiving her first dose of the Moderna vaccine she experienced very noticeable increase in pain for the shoulder where she received the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE JOINT PAIN (after receiving her first dose of the Moderna vaccine she experienced very noticeable increase in pain for the shoulder where she received the vaccine) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Shoulder discomfort.    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 VACCINATION SITE JOINT PAIN (after receiving her first dose of the Moderna vaccine she experienced very noticeable increase in pain for the shoulder where she received the vaccine). At the time of the report, VACCINATION SITE JOINT PAIN (after receiving her first dose of the Moderna vaccine she experienced very noticeable increase in pain for the shoulder where she received the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2021-354449 (Patient Link).
No adverse effects were reported; Patients were administered improperly stored vaccines doses; This spontaneous report was received from a registered nurse, concerning a patient of unspecified age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported.   On 14-APR-2019, the patient was vaccinated with improperly storage doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis, lot #R034700 and expiration date 16-JUN-2020 (strength, dose, frequency and route of administration were not reported); with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, lot #R033080 and expiration date 06-JUN-2020 (strength, dose, frequency and route of administration were not reported); and with hepatitis a vaccine, inactivated (VAQTA) for prophylaxis lot #S001485, expiration date 12-MAY-2020 and lot #R012988 and expiration date 30-MAY-2019. No adverse effects were reported.   The temperature excursion was reported as below 36°F (35.4°F) during a time frame of 27 minutes. Previous temperature excursion was reported as below 36°F (35.4°F) during a time frame of 15 minutes.   A digital data logger was involved.   This is one of several reports received from the same  reporter.; Sender's Comments:  US-009507513-1904USA012221: US-009507513-1905USA002744: US-009507513-1905USA002745: US-009507513-1905USA002746: US-009507513-1905USA002747: US-009507513-1905USA002748: US-009507513-1905USA002749: US-009507513-1905USA002750: US-009507513-1905USA002751: US-009507513-1905USA002752: US-009507513-1905USA002753: US-009507513-1905USA002754: US-009507513-1905USA002755: US-009507513-1905USA002756: US-009507513-1905USA002757: US-009507513-1905USA002758: US-009507513-1905USA002759: US-009507513-1905USA002761: US-009507513-1905USA002762: US-009507513-1905USA002763: US-009507513-1905USA002764: US-009507513-1905USA002765: US-009507513-1905USA002766: US-009507513-1905USA002767: US-009507513-1905USA002768: US-009507513-1905USA002769: US-009507513-1905USA002770:
C/O tingling in lips and pain in arm.  per patient report - Went to urgent care did have fever at urgent care.  received Benedryl and Tylenol at urgent care per patient report.  3 days later patient states does not feel energetic.
Nausea/vomiting, fatigue, mild hypoxia  around 1/14, tested as an outpatient. presented on 1/21 to hospital w worsening symptoms
01/18/22 presents to ED for "Generalized malaise, fever". PMHx of "congenital posterior urethral valves, CKD IV s/p renal transplant (10/21/2021; follows), HTN, HLD, sleep apnea, anemia, GERD, depression, obesity, recent COVID-19 infection (12/2021)".
twitching in the legs; flutters in the legs; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (twitching in the legs) and LIMB DISCOMFORT (flutters in the legs) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 04-Feb-2021, the patient experienced MUSCLE TWITCHING (twitching in the legs) and LIMB DISCOMFORT (flutters in the legs).   At the time of the report, MUSCLE TWITCHING (twitching in the legs) and LIMB DISCOMFORT (flutters in the legs) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Developed hives and fever following Hepatitis A and Varicella vaccine at the local health department
Initial unsolicited report received from a nurse on 8 June 2015. This case is linked to 2015SA081386 and 2015SA081396. (Same vaccine, same lot number). A 51-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of ADACEL (batch number- C4712AA, route of administration, site of administration were not reported) on 3 June 2015. On 5 June 2015; 2 days after vaccination, the patient experienced red hot injection site reaction and which was diagnosed with cellulitis. The patient required emergency room/doctor visit. Laboratory investigations were not reported. The patient was treated with KEFLEX and MOTRIN. At the time of this report the patient was recovered from the events. Upon medical review, the case was considered as serious due to important medical event: vaccination site cellulitis. Documents held by sender: none.
heart problems; Congestive heart failure; afib was out of whack; Her new 2nd dose schedule is due tomorrow 30Apr2021 and the interval is so long; Her new 2nd dose schedule is due tomorrow 30Apr2021 and the interval is so long; This is a follow-up spontaneous report from a contactable consumer via the Pfizer-sponsored program. A 77-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that she missed her 2nd dose schedule which is on 25MAR2021 because the day before her 2nd dose appointment she was hospitalized due to heart problems (Congestive heart failure and afib was out of whack, they wanted to change my meds and monitor me; unrelated to the vaccine) and she needs rehab. Her new 2nd dose schedule is due tomorrow 30Apr2021 and the interval is so long, She wanted to know if it's safe to receive her 2nd dose of the vaccine. Events occurred on an unspecified date. The patient was hospitalized for heart problems from 24Mar2021 to an unknown date. Therapeutic measures were taken as a result of heart problems. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available the reported events are considered not related to suspect drug.
Liver Transplant; This spontaneous case was reported by a consumer and describes the occurrence of LIVER TRANSPLANT (Liver Transplant) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetic (I'm diabetic).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIVER TRANSPLANT (Liver Transplant) (seriousness criterion medically significant). At the time of the report, LIVER TRANSPLANT (Liver Transplant) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: had a low response.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient want to get a booster shot for the Covid vaccine.  Concomitant medications were not reported.  No treatment information was provided by the reporter.   This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in. Company comment-This spontaneous case concerns a patient of unspecified age and gender with no relevant medical history reported, who experienced the unexpected serious (medically significant) of Liver transplant that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date nor event onset date were provided. Patient had a quantitative antibody test which showed a low response on an unknown date.  No further information on detailed clinical course, investigations, procedure details was available in the report. Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement; Sender's Comments: This spontaneous case concerns a patient of unspecified age and gender with no relevant medical history reported, who experienced the unexpected serious (medically significant) of Liver transplant that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date nor event onset date were provided. Patient had a quantitative antibody test which showed a low response on an unknown date.  No further information on detailed clinical course, investigations, procedure details was available in the report. Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical
Fevers to 103 degrees, lethargy, weakness, myalgia in neck and shoulders severe.  Poor exercise tolerance.  Oxygen desaturation with walking.  Symptoms of severe neck and shoulder pain persisted greater than 3 weeks.  PT required. Still ongoing.  Then 2nd vaccine on March 12th. Symptoms of high fevers, weakness, myalgia this time in low back and hips.
Rash all over body; cold hands and feet; numb toes for 8 hours; violent shivering; headache; all body heat went to head and chest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Oct2021 16:45 (Batch/Lot number: unknown) at the age of 22 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "bee stings" (unspecified if ongoing), notes: bee sting; "pineapple" (unspecified if ongoing), notes: pineapple. There were no concomitant medications. Past drug history included: Tramadol, reaction(s): "known allergies: tramadol"; Sassafras, reaction(s): "known allergies: sassafras", notes: sassafras. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 28Sep2021, when the patient was 22 years old, for COVID-19 Immunization. The following information was reported: RASH (non-serious) with onset 19Oct2021 20:45, outcome "not recovered", described as "Rash all over body"; PERIPHERAL COLDNESS (non-serious) with onset 19Oct2021 20:45, outcome "not recovered", described as "cold hands and feet"; HYPOAESTHESIA (non-serious) with onset 19Oct2021 20:45, outcome "recovered" (20Oct2021), described as "numb toes for 8 hours"; CHILLS (non-serious) with onset 19Oct2021 20:45, outcome "not recovered", described as "violent shivering"; HEADACHE (non-serious) with onset 19Oct2021 20:45, outcome "not recovered", described as "headache"; FEELING HOT (non-serious) with onset 19Oct2021 20:45, outcome "not recovered", described as "all body heat went to head and chest". Therapeutic measures were not taken as a result of rash, peripheral coldness, hypoaesthesia, chills, headache, feeling hot.  Reported Event: Rash all over body (had it since 4 hours after vaccination), cold hands and feet, numb toes for 8 hours, violent shivering, headache, all body heat went to head and chest. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No 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. Device Date: 24Oct2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-MAY-2016, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 09-NOV-2016, the patient was treated by a physician for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, 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.
The patient had a near syncopal episode after receiving the HPV vaccine where he slumped in the chair.  It was the third injection out of three vaccines he received. the other two were HAVRIX and VARIVAX. His mother and I were able to catch him and hold him upright in the chair. He came around after jerking himself back to consciousness. I gave him a sucker and water and place a wrapped iced pack at the nape of his neck. His skin was sweaty and warm during the episode. I called someone to the room to translate to the mother and the patient the pathophysiology behind the reaction and that it is common with this vaccine. The mother was given the brochure to report the episode. She was told that I would be reporting the episode, however. The patient became nauseated and vomited x 2 during the explanation of the event to the Mom. After sitting and drinking water he recovered after approximately 10 minutes. He refused crackers after sitting for 5 more minutes and the nausea passed. He was fully alert and oriented upon recovery. He was able to ambulate to the waiting area without assistance where he waited an additional 10 minutes. The patient left without further incident or complaint. He had a steady gait upon discharge.
Headache, muscle aches, ear ache, 102.1 temp, muscle spasms and tired
2:30pm - Client administered hepatitis A (LA), IPV and MMR (RA). One minute after injection, site of MMR began to swell and redness spread over upper and lower arm. Patient complained of itching and burning. Face flushed. Cold compress administered to site. 50mg of Benadryl administered (LA) IM per standing order. Vital signs taken every 15 minutes 5 times. Within 15 to 30 minutes, all redness and swelling subsided.
Waves of extreme fatigue, headaches and body aches. Some brain fog. Difficult completing simple activities due to exhaustion.
Left arm has a pink area approximately 3"x5", warm to touch, mild swelling, tender with palpation.