chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown genders and ages. Patient's medical history and concurrent conditions were not provided. On an unknown date in November 2015, the patients were vaccinated with an improperly stored doses of ROTATEQ, lot # L008054, expiration date 30-NOV-2016, oral, (route, anatomical place and dose number were not provided). Concomitant therapies were not provided. At the time of the report, no adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a 21 year old female patient. The patient's medical history was not provided. None concomitant medications and drug reactions/allergies were reported. On an unknown date, the patient was vaccinated with dose of MMR II (dose, route of administration, lot # and expiration date were not reported). In 1999, the patient received the second dose of MMR II (dose, route of administration, lot # and expiration date were not reported). It was reported that on 18-JUN-2015, the patient had titers drawn and the titers for measles were low. The outcome of the adverse event was reported as not recovered. The relatedness between the adverse event and the vaccination with MMR II. Additional information has been requested.
poor quality vaccine administered with no reported adverse event; cold chain break is reported and excursion vaccine was administered with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves Infant and unknown gender patient and reporter reported cold chain break of haemophilus type B (HIB) (PRP/T) vaccine [ACT-HIB] is reported and excursion vaccine was administered with no reported 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 a dose of suspect haemophilus type B (HIB) (PRP/T) vaccine Powder and solvent for solution for injection (lot number, strength, dosage, expiry date- not reported) via unknown route in unknown administration site for prophylactic vaccination. Information on the batch number was requested  On an unknown date the caller reported cold chain break of haemophilus type B (HIB) (PRP/T) vaccine [ACT-HIB] (product storage error) and excursion vaccine was administered to patient with no reported adverse event (poor quality product administered) (latency- same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.   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.
Information has been received from a physician concerning an adolescent female (NOS0 who on an unspecified date was vaccinated intramuscularly with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not provided). Subsequently, shortly after receiving the vaccination the patient fainted. Subsequently, the patient recovered from the syncope. Unspecified medical attention was sought. Additional information has been requested.
Received injection 9/11 - woke up next morning in distress, muscle aches/pains - resolved as of 9/13 w/o medical attention.
Right upper arm swollen reddened warm to touch (large area of redness) fever 102 headache
Information has been received from an office manager concerning a 43 year old female who on 02-JUN-2010 was vaccinated with a dose of MMR II. On 21-JUN-2010 the patient "did not show immunity against measles". Titers were drawn, result not reported. The reporter was unknown if it is safe to revaccinate after 30-JUN-2010. The patient received unspecified medical attention. At the time of the reporting, the patient's status was unknown. Additional information has been requested.
Woke up Saturday morning with swollen, red, hard lump at injection site. As the day went on, I started to feel more tired and run down. Got a headache at the base of my of my neck. Felt so tired, went to bed at 9:30 pm and woke up at 10:20 and got up for about 20 minutes and went back to bed until 2 pm. - very unusual for me. Still achy and tired for the rest of the day. When I checked the injection site on Sunday night, it was bigger around, warm and still red. That's when we looked up more about the side effects and found this form. Hopefully will be better tomorrow!
Developed hypotension, complete loss of bladder control (which I did not know until felt wet), nausea, and dim vision.
Was so achy; headaches; threw up; Allergies; Sick to stomach; Gas; indigestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): EC-2023-149448 (RA).  An elderly female patient received bnt162b2 (BNT162B2 NOS), on 16Oct2023 as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation; lenvatinib mesilate (LENVIMA), since 21Sep2023 (Batch/Lot number: unknown) at 20 mg daily; amlodipine (AMLODIPINE), first regimen since 12Oct2023 (Batch/Lot number: unknown) at 2.5 mg daily and second regimen since 25Oct2023 (Batch/Lot number: unknown) at 5 mg daily, all unknown for blood pressure increased. The patient's relevant medical history included: "Blood pressure increased" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Keytruda for C54.1: Malignant neoplasm of endometrium. The following information was reported: DRUG HYPERSENSITIVITY (non-serious) with onset Oct2023, outcome "unknown", described as "Allergies"; FLATULENCE (non-serious) with onset Oct2023, outcome "unknown", described as "Gas"; NAUSEA (non-serious) with onset Oct2023, outcome "unknown", described as "Sick to stomach"; DYSPEPSIA (non-serious) with onset Oct2023, outcome "unknown", described as "indigestion"; PAIN (non-serious) with onset 16Oct2023, outcome "recovered" (17Oct2023), described as "Was so achy"; HEADACHE (non-serious) with onset 16Oct2023, outcome "recovered" (17Oct2023), described as "headaches"; VOMITING (non-serious) with onset 16Oct2023, outcome "recovered" (17Oct2023), described as "threw up". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for lenvatinib mesilate and amlodipine was unknown. Additional information: The patient reported being sick to stomach, gas, indigestion, and was not sure if it's related to her amlodipine, or Lenvima, or both. The cause was unknown but occurred while on Lenvima. Event started sometime in Oct2023. The patient also reported she received a COVID shot on 16Oct2023 and said she was so achy, with headaches, and thew up for about 24 hours after getting the COVID shot. The patient said this was resolved and thinks this event was related to the COVID shot but it also occurred while she was on Lenvima. The event started on 16Oct2023 and ended 17Oct2023. The patient also reported that she still has headaches. She also has allergies, so she not sure if the headaches are from Lenvima or her seasonal allergies. The cause was unknown but occurred while on Lenvima. The event started in Oct2023. The patient reported she was also put on Amlodipine 2.5 milligrams daily, which started around 12Oct2023, but she is now on Amlodipine 5 milligrams daily since 25Oct2023.Her blood pressure is now "down to 157" after a couple days of having her Amlodipine dose doubled. The cause was thought to be related to Lenvima and occurred while on Lenvima. The event started in Oct2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Systemic: Chills-Severe, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Medium, Systemic: Visual Changes/Disturbances-Severe, Additional Details: Patient felt weak, fainted once, slumped over in his chair forward, woke back up, was complaining of not being able to see, could only see maybe 2% of visual field, per patient. Paramedics showed up, he fainted again.  Pulse of 47, and O2 sats of 95.   Paramedics were leaning towards panic attack, but recommended patient go to ER just to be sure.
Nausea,  Heart  Beat changes , high heart beats  tiredness, anxiety, depression and fear.
This spontaneous report was received from a Medical Assistant referring to 2 patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX lot # M045204, expiration date 11-NOV-2018, for prophylaxis (dose and route of administration were not reported). It was stated that the VARIVAX underwent a temperature excursion between 15 to 46 Fahrenheit degrees for 24 hours. The temperature excursion was captured using a digital data logger. No previous temperature excursion was reported. No adverse symptoms were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
inc temp 102 x 3 days, rash on body & neck, myalgia, & sore throat;
This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 65-year-old female patient who received SHINGRIX (batch number YE9YL, expiry date 6th February 2021) for prophylaxis. On 20th August 2018 17:00, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In August 2018, less than a month after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, general body pain and fever. On an unknown date, the outcome of the extensive swelling of vaccinated limb, general body pain and fever were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, general body pain and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine in the left deltoid. The patient had experienced a swollen left arm approximately double the normal size of her arm, fever, and body aches. The reporter was unable to provide additional information other than the patient stated that they would not receive the second dose of the SHINGRIX vaccine.
I started feeling bad about 6 hours after the vaccine. I had a fever of  102 on 01/1/2021,  headache, muscle aches and joint pain.  I consulted a doctor at UC where I work on 01/05/2021.
I was exposed to COVID-19 and had an excess amount of nasal drainage. I took a home COVID-19 test but it came up negative. Called my physician and he suggested I come in to the drive through testing site for the PCR COVID-19 test. My test came back positive so my doctor called in the antiviral that I started as soon as I went to the pharmacy and picked it up.
Severe fatigue lasting 10 days. Swollen axillary glands both arms continues, left side is worse. Vaginitis flare but unsure if it was due to vaccine.
On 01/28, this patient had progressive weakness of the lower extremities, aching and pain of lower extremities, numbness, and difficulty walking. The symptoms have been ongoing for 3 months.
Developed a rash red with red pustules ( No drainage) on my fingers approx 3 days after injection. I have since developed these all over both hands palms and top as well as my arms, feet and legs its itchy and painful. . Saw Dr today and he is unsure what the rash is. but says it could be related to shot. Gave me a Medrol Dose pack.
right side,,,,,  nerve tingling and numbness   blurry eyes    fatigue   unbalanced  slurred speech
nausea 4-5 hours post vaccine; arm pain next day; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 03Mar2021 at 02:00 (at the age of 72 years old) (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation in the pharmacy. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of the event and at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID-19 prior to vaccination. On 03Mar2021, the patient experienced nausea 4-5 hours post vaccine and arm pain next day (04Mar2021). No treatment was received for the events. The patient had not been tested for COVID-19 post-vaccination. The patient recovered from the events on an unspecified date in Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PT FELT DIZZY AND LIGHTHEADED KEPT PT IN OBSERVATION FOR ADDITIONAL 30 MINS / UNTIL PT FELT  NO ADVERSE
I was having so much shortness of breath and they thought I was having an asthma attack. My doctor told me to go to urgent care. They put on Prednisone. My symptoms increased as far as weakness in legs and arms and dizziness. That became worse. My breathing became worse. Everything increased. I had a doctors appointment and she thought I needed to be admitted to the ER because I was not doing well. They took me by ambulance. I was there for a few hours and then I was sent home. They checked for clots anywhere, they checked my heart. They referred me to a lung and heart doctor. I went through a series of tests with both of them. They concluded I had a big event and apparently, the vaccine complicated the things I already had with MS and fibromyalgia. Now I have symptoms I was left with, which seem to increase whenever I get a shot. They did not find anything besides I have a fast heartbeat. I have had 3 other vaccines after this one, the flu shot in August, 2 shingles shots, and I experienced the same reaction.
Patient felt dizzy/lightheaded after vaccination. This resolved in about 15 minutes. Pt takes no antihypertensives or glucose-lowering medications.
This case was reported by a physician via sales rep and described the occurrence of swelling arm in a 16-year-old male patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, less than a week after receiving BEXSERO, the patient experienced swelling arm and erythema of extremities. On an unknown date, the outcome of the swelling arm and erythema of extremities were recovered/resolved. It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. After receiving BEXSERO, the patient experienced swollen and red arm, returned to doctor after one day with arm. Then returned 3 days later and it was fine. This was reported many weeks later and reporter did not have any further information. The patient initials were not known. The reporter did not agree to receive follow up from GSK.
pt recv vax 25FEB98 & 13MAR98 pt devel a varicella-like rash comprised of approx twenty skin lesions w/one described as vesicular-like;
75 year old female c/o shortness of breath post Moderna Covid19 vaccination. at 1325 PM a  heartrate of 50 and O2 sat of 99% on RA  1338 pm ambulance called  VS 207/94 60  28 respirations. Patient requested an ambulance.  She was then placed on 10 lpm non-re breather mask.   Reported that she was recently place on lopressor, Chart stated amlodipine stopped and started on lopressor and benicar for her blood pressure.  Hx of anxiety GERD, uncontrolled hypertension, bursitis of both hips  and a-fib     Note:  Patient is a poor historian    Medications prilosec, hctz, lipitor, lopressor, and benicar.  Allergies  Pt denied    Fire department arrived followed by ambulance.  Patient placed on gurney and taken to the hospital.  Oxygen removed by paramedic.  Pt speaking in short sentences and very anxious.  Husband followed the patient.    (site supervisor) aware of situation
Pfizer Booster Vaccine given.   At 9:13am the pt reported dry mouth.  Pt encouraged to drink water.  Pt then reported tingling lips and feeling anxious.  Pt escorted to nursing station.  VS - BP - 134/75, HR 87, 02 98%.   Pt encouraged to continue to drink and deep breath.  Continued to monitor.  Pt reported symptoms resolved and requested to return to her vehicle.  Pt escorted to vehicle.  Continued to monitor.  Pt reported feeling good to go after 30 mins of observation.  Pt was reassessed and cleared to leave clinic.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 9:01 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 9:01 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  The age of patient was provided as 68.71.  On 31-Mar-2021, Excursion time was 08 AM and 9 AM, temperature was 32 and 32 respectively, total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Apr-2021, vial was moved to clinic on 31-Mar-2021. 4 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Welt at the site; Tenderness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Welt at the site) and INJECTION SITE PAIN (Tenderness at the injection site) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE URTICARIA (Welt at the site) and INJECTION SITE PAIN (Tenderness at the injection site). At the time of the report, VACCINATION SITE URTICARIA (Welt at the site) and INJECTION SITE PAIN (Tenderness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Lymph node in right side of neck swelled up and didn?t go away after 3 months.
No adverse event noted.  Vaccine accidently given at 22 days instead of 28 day interval.
CONSTANT PAIN IN LEFT ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the patient experienced constant pain in left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from constant pain in left arm. This report was non-serious.
itchy; blisters on skin; terrible rash in his shoulder; shoulder was hurting; injection site swelling; injection site redness; discharge; arm became bright pink; arm was getting warm; swelling arm; puffy arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling arm), SKIN SWELLING (puffy arm), PRURITUS (itchy), BLISTER (blisters on skin) and VACCINATION SITE WARMTH (arm was getting warm) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PERIPHERAL SWELLING (swelling arm), SKIN SWELLING (puffy arm) and VACCINATION SITE WARMTH (arm was getting warm). On 17-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm became bright pink). On 24-Feb-2021, the patient experienced VACCINATION SITE DISCHARGE (discharge). On an unknown date, the patient experienced PRURITUS (itchy), BLISTER (blisters on skin), RASH (terrible rash in his shoulder), ARTHRALGIA (shoulder was hurting), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE ERYTHEMA (injection site redness). On 16-Feb-2021, PERIPHERAL SWELLING (swelling arm) and SKIN SWELLING (puffy arm) had resolved, VACCINATION SITE WARMTH (arm was getting warm) outcome was unknown. On 24-Feb-2021, VACCINATION SITE ERYTHEMA (arm became bright pink) had resolved. At the time of the report, PRURITUS (itchy), BLISTER (blisters on skin), VACCINATION SITE DISCHARGE (discharge), RASH (terrible rash in his shoulder), ARTHRALGIA (shoulder was hurting), VACCINATION SITE SWELLING (injection site swelling) and VACCINATION SITE ERYTHEMA (injection site redness) 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.   Concomitant medication not reported.  Treatment medication not reported.