chrisvoncsefalvay/vaers-outcomes huggingface dataset:
upper lip swelling; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FC3184), via an unspecified route of administration on 04Sep2021, as dose 1, single for COVID-19 immunization. The patient's medical history included upper lip swelling after taking a pill and eating Kiwi fruit. Concomitant medications were not reported. On 07Sep2021, 3 days after first dose of vaccine, the patient had reaction and her upper lip was swollen. The clinical outcome of the event was unknown.
felt a little woozy; severe fatigue; a little nausea; could not see straight; This spontaneous case was reported by a physician and describes the occurrence of VISUAL IMPAIRMENT (could not see straight), DIZZINESS (felt a little woozy), FATIGUE (severe fatigue) and NAUSEA (a little nausea) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced VISUAL IMPAIRMENT (could not see straight), FATIGUE (severe fatigue) and NAUSEA (a little nausea). On 24-Feb-2021, the patient experienced DIZZINESS (felt a little woozy). On 25-Feb-2021, VISUAL IMPAIRMENT (could not see straight), DIZZINESS (felt a little woozy), FATIGUE (severe fatigue) and NAUSEA (a little nausea) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.No treatment information was provided.Action taken with mRNA-1273 in response to the events was not applicable.
Began with pain and tenderness, progressed to excruciating pain, improved slightly but still has no strength in arm and cannot raise it.
FEVER, BODY ACHES, CHILLS, HEADACHE, NAUSEA
PT COULD NOT RESPOND, HAD SHORTNESS OF BREATH, BLOOD PRESSURE WAS HIGH 140/90, DIZZINESS, AND FAINTNESS FOR ALMOST 2 MINUTES AFTER THE INJECTION.  SHE WAS COHERENT AND WAS ABLE TO RESPOND.  AFTER 10 MINS SHE FELT FINE AGAIN BUT HAD A SLIGHT RED FLUSHING ON THE FACE.  PT WAS DIRECTED TO GO TO MDO TO ASSESS FURTHER ISSUES.  PATIENT LEFT OK AND FINE AFTER 30 MINS.
Patient wated at pharmacy for required 15 minutes. Went home and eyes started to swell.  Went to the urgent care in town and was administered a shot for allergic reaction and the swelling subsided.
This case was reported by a consumer and described the occurrence of injection site tenderness in a adult female patient who received SHINGRIX. Concomitant products included PNEUMOVAX. On 18th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 19th April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site tenderness, fever, general body pain and dizziness. On 20th April 2018, the patient experienced injected limb mobility decreased. The patient was treated with ibuprofen. In April 2018, the outcome of the fever, general body pain, injection limb mobility decreased and dizziness were recovered/resolved. On an unknown date, the outcome of the injection site tenderness was not recovered/not resolved. The reporter considered the injection site tenderness, fever, general body pain, injected limb mobility decreased and dizziness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller was placed on phone by retired GlaxoSmithKline employee. The patient received vaccine on Wednesday (on18th April 2018) and the next day experienced pain that got intense over the next few days. The patient stated that she could not roll on her arm to get out of bed and it got to where she could not lift her arm. The patient stated the issues had resolved except for tenderness still at the site at the time of reporting. This case has been linked with US2018071883 and US2018071884, reported by the same reporter.
Patient got 2 shots.   high dose flu shot and pneumovax (first in series only because we were out of prevnar 13 and pt insisted on getting a pneumonia).  Planned to give her the Prevnar in one year.  Both shots in the same are at least 1 inch apart.  Arm became red, swollen and hot to the touch.  Went to the emergency room.  Per patient, the nurse told her that it was probably an allergic reaction (when asked, she said she's had the flu shot every year with no problem).  They gave her a steroid shot and told her that the reaction was not severe enough to prevent her from getting the second pneumonia vaccine
The morning after the injection I woke up with nausea followed by an all-day migraine ending in the evening. Then on the 4th day after the injection, I began to hear electrical noises.  I was then diagnosed with Tinnitus and hearing loss by an Ear Nose & Throat Specialist in 3/2021.
My right arm developed a large hive, very hot, and red below the injection site; same location was painful to the touch and ached; My right arm developed a large hive, very hot, and red below the injection site; My right arm developed a large hive, very hot, and red below the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (My right arm developed a large hive, very hot, and red below the injection site), INJECTION SITE ERYTHEMA (My right arm developed a large hive, very hot, and red below the injection site), INJECTION SITE URTICARIA (My right arm developed a large hive, very hot, and red below the injection site) and INJECTION SITE PAIN (same location was painful to the touch and ached) in a 74-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7645A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Aug-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) 1 dosage form. On 16-Aug-2023, the patient experienced INJECTION SITE ERYTHEMA (My right arm developed a large hive, very hot, and red below the injection site) and INJECTION SITE URTICARIA (My right arm developed a large hive, very hot, and red below the injection site). On an unknown date, the patient experienced INJECTION SITE WARMTH (My right arm developed a large hive, very hot, and red below the injection site) and INJECTION SITE PAIN (same location was painful to the touch and ached). On 22-Aug-2023, INJECTION SITE WARMTH (My right arm developed a large hive, very hot, and red below the injection site), INJECTION SITE ERYTHEMA (My right arm developed a large hive, very hot, and red below the injection site) and INJECTION SITE URTICARIA (My right arm developed a large hive, very hot, and red below the injection site) had resolved. At the time of the report, INJECTION SITE PAIN (same location was painful to the touch and ached) outcome was unknown.            No concomitant or treatment medications were provided. It was reported that the reactions with previous Moderna Covid injections were similar in reaction but not as severe as this time. Reactions were lasted through 18-Aug-2023 and started to reduce slowly through 21-Aug-2023. On 22-Aug-2023 the hive was gone, skin temperature normal, no pain or achiness, and only a pink color instead of red.
Malaise, back pain, elevated heart rate, fatigue, pain at site,  inability to perform daily activities
Vomited 10 min after immunizations. Pt immediately developed head to toe hives, severe itching, treated with fexofenadine. Afterwards, sleepy but was his nap time. Observed in ER for 2 hrs. with no other symptoms.
Rash 7.5" x 6"-red, elevated, irregular circumference itching fever.
Pneumonia due to COVID-19-has been treated with IV steroids. Presented with SOB, cough. Id has been on board.  Has needed 2 L oxygen while here but walk study done did not qualify her for any home O2.  She has been cleared for discharge by ID on short course of steroids
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored VARIVAX, subcutaneously, lot # of M034583 and an expiration date of 27-JUL-2018, reported lot#: M035140 with expiration date: 08-AUG-2018 and reported lot # M037008 with expiration date: 25-AUG-2018 for; however, dosage number was not reported) for prevention of chickenpox at one and four year checks. Nevertheless, no adverse effects were reported.  The vaccines experienced the following temperature excursions during 19 hours of more than 8 degree Celsius but less than 25 degree Celsius. Reportedly, there had been previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint (PQC) was involved. It was reported that the patients did not receive treatment.  Additional information has been requested.
Swollen arm with a 5-6' increase in diameter, really hot almost like a cellulitis, occurred with 24 hrs after immunization.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 3:29 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 3:30 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 71.58 for dose administered on 28-Feb-2021 and 71.65 for dose administered on 28-Mar-2021. No concomitant medications were reported. Batch number  014M20A underwent temperature excursion on 28-Feb-2021 with temperature 26, 27 degrees Fahrenheit on 9am and 1 pm respectively. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 27-Feb-2021. Batch number 019B21A underwent temperature excursion on 28-Mar-2021 with temperature 35 degrees Fahrenheit at 10am. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.
I started with stomach cramping lasting a week then, I got a severe rash starting on my knee where I previously has meniscus surgery and prior to that had viscosupplementation, prior to that cortisone shots.  The rash moved out into my legs and upper thigh.  The rash is now in my groin feet and hands.   I contacted my Physician who has given me a prescription for prednisone and antibiotics.
rash that was itchy; large red ring about 2 inches in size at the area; delayed allergic reaction; covid arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (rash that was itchy), VACCINATION SITE ERYTHEMA (large red ring about 2 inches in size at the area), HYPERSENSITIVITY (delayed allergic reaction) and TYPE IV HYPERSENSITIVITY REACTION (covid arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced RASH PRURITIC (rash that was itchy), VACCINATION SITE ERYTHEMA (large red ring about 2 inches in size at the area), HYPERSENSITIVITY (delayed allergic reaction) and TYPE IV HYPERSENSITIVITY REACTION (covid arm). At the time of the report, RASH PRURITIC (rash that was itchy), VACCINATION SITE ERYTHEMA (large red ring about 2 inches in size at the area), HYPERSENSITIVITY (delayed allergic reaction) and TYPE IV HYPERSENSITIVITY REACTION (covid arm) outcome was unknown. Not Provided      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.
H1N1 vaccine given 0.5 cc IM dose needed 0.25 cc IM.
5 days after the second dose my period started, it was a week early. It lasted from 31Mar to 21Apr, it was extremely heavy. On 28Apr it started again and as of today 09May, it still has not stopped; 5 days after the second dose my period started, it was a week early. It lasted from 31Mar to 21Apr, it was extremely heavy. On 28Apr it started again and as of today 09May, it still has not stopped; developed the "Covid arm" rash around the injection site; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 37-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 26Mar2021 13:00 (at the age of 37 years), (Batch/Lot Number: ER8732) as DOSE 2, SINGLE for covid-19 immunisation at medical facility. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medications included venlafaxine; buspirone and phentermine taken for an unspecified indication, start and stop date were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 (Batch/Lot Number: EN6204) for covid-19 immunisation. The Patient stated, "5 days after the second dose my period started, it was a week early. It lasted from 31Mar to 21Apr, it was extremely heavy. On 28Apr it started again and as of today 09May, it still has not stopped. It had been extremely heavy the entire time. I also developed the "Covid arm" rash around the injection site". The events resulted in visit to Physician office. Treatment received for events was unknown. The clinical outcome of the events was not recovered at the time of vaccination.  No follow-up attempts are possible. No further information is expected.
Patient observed for 15 minutes post vaccine when she vernalized head pressure 3/10. Patient stated she did not have this reaction after the first dose. After an enhanced observation SE dissipated
heat and pain at the injection side; heat and pain at the injection side; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (heat and pain at the injection side) and VACCINATION SITE PAIN (heat and pain at the injection side) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE WARMTH (heat and pain at the injection side) and VACCINATION SITE PAIN (heat and pain at the injection side). The patient was treated with PHENIRAMINE MALEATE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (heat and pain at the injection side) and VACCINATION SITE PAIN (heat and pain at the injection side) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. treatment information  provided includes Pheniramine maleate(avil)   Reporter did not allow further contact
Pt received his routine 4 month immunizations. Parents took him home and he slept for a few hours. After patient awoke, he was screaming in what seemed to be pain and mom noted both legs to be bright red and hot from thighs to feet. Legs appeared more swollen. Mom gave a dose of Tylenol to help patient. The baby slept through the night and did okay. The following morning when the baby woke up he had what sounds like a petechial rash on both entire legs from thigh to ankle but was behaving normally. Did not appear to be in any pain. Did have a fever to 100.7F the morning after his shots but only that once.  Rash on the legs faded over the next week.
nausea, vomiting, and legs and arm ache; nausea, vomiting, and legs and arm ache; cold from the feet up; chest and back hurt, she is experiencing weakness, and shortness of breathe.; chest and back hurt, she is experiencing weakness, and shortness of breathe.; only able to eat one meal per day.; chest and back hurt, she is experiencing weakness, and shortness of breathe.; tired and fatigue; chills to the bone; unable to eat or drink all day.; nausea, vomiting, and legs and arm ache; headache; "every symptom that was described on that sheet of paper."; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills to the bone), FEELING COLD (cold from the feet up), FEEDING DISORDER (unable to eat or drink all day.), NAUSEA (nausea, vomiting, and legs and arm ache) and the first episode of PAIN IN EXTREMITY (nausea, vomiting, and legs and arm ache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A211A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced CHILLS (chills to the bone), FEEDING DISORDER (unable to eat or drink all day.), NAUSEA (nausea, vomiting, and legs and arm ache), HEADACHE (headache) and ADVERSE REACTION ("every symptom that was described on that sheet of paper."). On 28-Feb-2021, the patient experienced FATIGUE (tired and fatigue). On 02-Mar-2021, the patient experienced BACK PAIN (chest and back hurt, she is experiencing weakness, and shortness of breathe.), DYSPNOEA (chest and back hurt, she is experiencing weakness, and shortness of breathe.) and DECREASED APPETITE (only able to eat one meal per day.). On an unknown date, the patient experienced FEELING COLD (cold from the feet up), the first episode of PAIN IN EXTREMITY (nausea, vomiting, and legs and arm ache), the second episode of PAIN IN EXTREMITY (nausea, vomiting, and legs and arm ache) and ASTHENIA (chest and back hurt, she is experiencing weakness, and shortness of breathe.). At the time of the report, CHILLS (chills to the bone), FEEDING DISORDER (unable to eat or drink all day.), HEADACHE (headache), ADVERSE REACTION ("every symptom that was described on that sheet of paper."), FATIGUE (tired and fatigue), BACK PAIN (chest and back hurt, she is experiencing weakness, and shortness of breathe.) and DECREASED APPETITE (only able to eat one meal per day.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Pt was okay immediately following the shots.  She became hot, lightheaded and weak about 15 minutes later.  BP and HR were very slightly elevated, but not of a concerning value.  She lied down and rested.  Family member  came to pick her up to go home.
Significant loss of vision R eye-awoke on Feb 6 and noted splotches in vision of R eye. Workup suggests compromised blood flow to that eye
vaccine doses were administered 13 days apart; diarrhea was still continuing, 18 days after the second dose; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 02Feb2021 13:15 (Lot number: EM9809) at the age of 65 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "osteoporosis" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "known allergies: crabmeat" (unspecified if ongoing); "known allergies: wool" (unspecified if ongoing). Concomitant medication included: MELOXICAM. Vaccination history included: BNT162B2 (dose 1, administered in the left arm, Lot number: EL9261), administration date: 21Jan2021 13:00, when the patient was 65 years old, for COVID-19 immunisation, reactions: "stomach cramps", "ongoing daily bouts of diarrhea". The following information was reported: DIARRHOEA (non-serious) with onset 2021, outcome "not recovered", described as "diarrhea was still continuing, 18 days after the second dose"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 02Feb2021, outcome "unknown", described as "vaccine doses were administered 13 days apart". Therapeutic measures were not taken as a result of diarrhoea.  Additional information: The patient's diarrhea started on 25Jan2021 (after the first dose) and was still continuing, 18 days after the second dose. Changes in diet did not seem to help. She planned to call her doctor. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination, and she has not been tested for COVID-19 since the vaccination.   No follow up attempts are possible. No further information is expected.
pt recvd vax 30NOV94 & 2DEC pt seen by MD exp swelling @ inj site, area red, hive-like (erythematous) & painful;no fever;no treatment prescribed;pt recovered;
devel vomiting & watery stool 3 day 20JUN p/vax; seen by MD was hydrated; next AM pt found unresponsive in bed; taken to ER but did not respond;
Nose bleed never ever do i get nose bleeds 19 hours after vaccine very odd This was my second vaccine nothing happened with the first one