chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient has a 10"x 4" area of swelling, redness and warmth originating  at site of injection  and has progressed since getting injection. It is itchy and painful to touch.
Lower lip is swollen; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Lower lip is swollen) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (Lower lip is swollen). At the time of the report, LIP SWELLING (Lower lip is swollen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details were not reported by the reporter.
Patient received (FLUZONE) flu shot in right arm on 4 October 2012. She came to ER 6 October 2012 & Dx with cellulitis in right shoulder.
Patient was given the Monovalent PFIZER vaccine rather than the intended Bivalent PFIZER vaccine booster.
Case number PHEH2015US017656, is an initial spontaneous report from a nurse received on 09 Sep 2015. This report refers to a 30 years old male patient. Historical conditions were not reported. Vaccination history included administration of FLUVIRIN (batch number: not reported) once and the patient tolerated the vaccination well. Concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 157103) pre-filled syringe (PFS) intramuscularly at a dose of 0.5 ml on 08 Sep 2015. It was reported that the patient received vaccine which was out of temperature range at 33.2 degree Fahrenheit on 08 Sep 2015. The event was reported as non-serious. No adverse events were reported following the inadvertent administration. Follow up report received from the nurse on 27 Oct 2015: Updated patient demographics, vaccination history, vaccination time, vaccination site and other clinically relevant information in the narrative.
Woke up the morning of 12/5/2021 and had tingling and numbness all along the right side of my body.  Went to Emergency Room and was diagnosed with a small left-sided thalamic stroke.  Evaluated and started on medications to prevent further strokes.  Continue to have some tingling and increased sensation and sensitivity along right side of body, which neurologist said could continue for a year or two.  I had been doing the CDC V-safe check-ins and during my February 2022 check-in noted that I'd had a stroke since my previous check-in.  Someone called me to discuss and said I should fill out this report.
Got shot at 8:15am and got reaction at 9:45pm with violent chills-got into hot shower & got temp up to 95 degrees; went to bed with several blankets;  temp went up to 100 degrees about 11pm with stomach ache, horrible headache, & loose stool; lasted all night all next day; day 3 Saturday 4am got up to pee dizzy & faint & fell into glass closet doors then into wooden door then to floor & broke nose & bruised several other areas besides face.  Now 11am still dizzy & sick to stomach & loose stool so called CDC but no help so took meds on hand.  Zofran 4mg & Loperamide 2mg.
Pregnant patient received both doses of vaccine; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received both doses of vaccine) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013L21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. The patient's last menstrual period was on 13-Oct-2020 and the estimated date of delivery was 20-Jul-2021. On 01-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received both doses of vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifteenth week of the pregnancy.  On 01-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received both doses of vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
Two days following Covid vaccine2,I woke up with severly painful red left eye. I went to opthamologist on emergency. Treated for split/cornea above above the pupil, then covered with contact patch & given antibiotic & drops for redness; returned for several follow up visits w/associate, Dr. who continued treating me even with oral antibiotics to try to treat the severe redness now in both eyes. He also prescribed Rx for dry eyes. I was referred to eye specialist. Dr. diagnosed as immune reaction to Covid vaccine. I saw all Drs. still visual impairment persists!
lost his sense of taste, did not taste break fast; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (lost his sense of taste, did not taste break fast) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced AGEUSIA (lost his sense of taste, did not taste break fast). At the time of the report, AGEUSIA (lost his sense of taste, did not taste break fast) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported Treatment information was not provided
on the evening of vax & had flu like sx w/ h/a, fever/chills & body aches, pt has cont to have low grade body aches;
Hives; I got the itchiness; Headache; Soreness at the spot and achiness; Stomach cramping; Arm was swollen and sore and achy body thing; This is a spontaneous report received from a contactable consumer. A 66-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810), via an unspecified route of administration on 04Feb2021 at right arm as a single dose for COVID-19 immunization. Co-suspect medications included paracetamol (TYLENOL) and sulfamethoxazole, trimethoprim (MORTIN). The patient medical history included high blood pressure and allergic to sulfa drugs. Concomitant medications included amlodipine (5mg once daily) (MANUFACTURER UNKNOWN), clonidine (0.1 mg, 2x/day) (MANUFACTURER UNKNOWN) and acetylsalicylic acid (BABY ASPIRIN). The patient had the second Pfizer vaccine on 04Feb2021 and on fifth day 08Feb2021 or beginning of the fifth day experienced hives. The patient had some little headache, soreness, achiness at the spot and reported patient was fine but took some motrin and Tylenol for few days because somebody said after Pfizer vaccine, it works well but then patient got hives on all over my body, so she was suspecting that the allergic reaction was due to the motrin and I want to report it because I got this on fifth day after my second vaccine. The patient got hives on the fifth day after the second vaccine. The patient had itchy, hives all around my body and some stomach cramping. The patient reported arm was swollen and sore and had a headache and achy body thing. Outcome of reported events were unknown.  Follow-up information has been requested and pending to receive.
Difficulty breathing, wheezing, tightness in throat. Treated with inhaler and Benadryl.
Pt received PNEUMOVAX shot 11/3/14. She called Monday night 11/3/14 and stated she was having a reaction. Arm was swollen. I told her to take NSAIDS, use ice and take BENADRYL which she said she would do. She came into store today. Arm swollen - inside arm and low breast clean area. I told her to see a doctor but she said she was getting better. ph told her to continue BENADRYL.
Immediate redness and swelling to site down to elbow x several days. Eventually treated with EES for Cellulitis.
Triggered a HSV outbreak. Husband had 2nd dose of vaccine 4 days later and he ALSO had an outbreak as a result.
Case number PHEH2015US002320, is an initial spontaneous report received from a physician on 30 Jan 2015. This report refers to a 14 year old male patient. Medical history and concomitant medication was not reported. He was vaccinated with expired MENVEO (batch number: M13014) intramuscular on 30 Jan 2015. No adverse event was reported. No further information was provided.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 72-year-old male patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. It was reported that the data logger that caller was unable to download were for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter also stated that no adverse reactions were reported by any patients. The reporter reiterated that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. Treatment information was not provided.
Patient stated to have fallen on 2/25/2022.  On 3/12/2022 brought to ED for intermittent SOB and weakness.  Dx:  LLL pneumonia.
This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a male patient who received SHINGRIX. On 2nd March 2018, the patient received SHINGRIX (intramuscular). In March 2018, less than a month after receiving SHINGRIX, the patient experienced injection site pain and tiredness. In March 2018, the outcome of the injection site pain and tiredness were recovered/resolved. The reporter considered the injection site pain and tiredness to be related to SHINGRIX. Additional details were reported as follows: The reporter himself was the patient. The age at vaccination was not reported. The patient experienced pain after starting upon SHINGRIX. No specific details were provided by the reporter about the site of injection or exact dose received. Within a couple of day's receiving after SHINGRIX, the patient had a feeling of tiredness. No further details were provided by the reporter. The reporter did not provide any contact information or demographics except a phone number. The reporter gave permission to be contacted by the phone. It was unknown if the phone number was a personal or pharmacy phone number.
Information has been received from a nurse concerning her child who on an unspecified date, was vaccinated with the second dose of VARIVAX (Merck). Subsequently the patient experienced injection site reactions of rash, redness and swelling. At the time of this report, the patient was recovering. It was unknown if the patient sought medical attention. Follow-up information has been received from the nurse in the physician's office who reported that they cannot give patient names due to The Health Insurance Portability and Accountability Act (HIPAA). This is the first of four reports received from the same source. No further information is available.
CHILLS, SORE THROAT, CONGESTED CHEST, COUGH, SORE EYES, DIZZY, RUNNY NOSE.
Vaccine was received and placed in the fridge on 11-Jan-2022 with expiration date of 05-May-2022 and administered on 11-May-2022; 82 patients administered expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (82 patients administered expired moderna vaccine) and PRODUCT STORAGE ERROR (Vaccine was received and placed in the fridge on 11-Jan-2022 with expiration date of 05-May-2022 and administered on 11-May-2022) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 031A21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (82 patients administered expired moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was received and placed in the fridge on 11-Jan-2022 with expiration date of 05-May-2022 and administered on 11-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (82 patients administered expired moderna vaccine) and PRODUCT STORAGE ERROR (Vaccine was received and placed in the fridge on 11-Jan-2022 with expiration date of 05-May-2022 and administered on 11-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that health care facility inadvertently administered expired dose of the Moderna Covid-19 vaccine. lot number 084J21A was received and placed in the fridge on 11-Jan-2022, which means that all doses administered more than 30 days of use by date were not in accordance with the EUA. The vial did not undergo any temperature excursions. They identified an additional issue that staff were not dating the boxes of vaccine when placing them in the fridge for storage. Patient not reported adverse reaction to the HCP's knowledge. No treatment medications were provided.
Hard to touch; Soreness is getting worse/redness was getting darker and darker; She started with sore left arm that evening; Heavy left arm that evening; She has a really big dark red spot on left arm that started at same night; Warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (She started with sore left arm that evening), LIMB DISCOMFORT (Heavy left arm that evening), ERYTHEMA (She has a really big dark red spot on left arm that started at same night), FEELING HOT (Warm to touch) and INDURATION (Hard to touch) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included GABAPENTIN for an unknown indication.   On 06-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced PAIN IN EXTREMITY (She started with sore left arm that evening), LIMB DISCOMFORT (Heavy left arm that evening), ERYTHEMA (She has a really big dark red spot on left arm that started at same night) and FEELING HOT (Warm to touch). On 13-May-2021, the patient experienced INDURATION (Hard to touch) and CONDITION AGGRAVATED (Soreness is getting worse/redness was getting darker and darker). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (She started with sore left arm that evening), ERYTHEMA (She has a really big dark red spot on left arm that started at same night), INDURATION (Hard to touch) and CONDITION AGGRAVATED (Soreness is getting worse/redness was getting darker and darker) had not resolved and LIMB DISCOMFORT (Heavy left arm that evening) and FEELING HOT (Warm to touch) outcome was unknown.            Concomitant medication also included blood pressure medication.  Action taken with mRNA-1273 in response to the events was not applicable.
Muscle ache; Fatigue; The vaccine was taken from the freezer on 06Apr2022 at 12:00 pm. Vaccine that was administered to 5 patients while the vaccine was expired.; The vaccine was taken from the freezer on 06Apr2022 at 12:00 pm. Vaccine that was administered to 5 patients while the vaccine was expired.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team, Program ID:   A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 11Aug2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 11Aug2022, outcome "unknown" and all described as "The vaccine was taken from the freezer on 06Apr2022 at 12:00 pm. Vaccine that was administered to 5 patients while the vaccine was expired."; MYALGIA (non-serious), outcome "unknown", described as "Muscle ache"; FATIGUE (non-serious), outcome "unknown".  Additional information: Caller was asking about the gray cap vaccine. The vaccine was expired and was administered to 5 patients. Caller mentioned that she was going to report this to VAERS and wants to check on what to do next. She said that this vaccine has an expiration date of 15Jun2022. Caller said at least that helps with one patient and all the patients were similar. No one of the 5 really had adverse reaction to the expired doses though 3 did report they had several days of side effects - so they thought event though expired that the vaccine had some effect on their sometimes muscle aches, fatigue.  Follow-up attempts are completed. No further information is expected.  Follow-up (26Sep2022): This is a spontaneous follow-up report received from the same contactable other HCP. This other HCP reported for the patient in response to HCP letter sent in cross reference case. Updated information included: Reporter middle name and suffix was updated and new events muscle aches and fatigue was added.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202201070713 Same reporter/drug/event, different patient; PFIZER INC-202201070271 Same reporter/drug/event, different patient;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 70 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 11-SEP-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose, dose#, administration route and anatomical location were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster and an infection in eye due to herpes zoster. On an unknown date, the patient was treated by a physician and an ophthalmologist for the herpes zoster and the infection in eye due to herpes zoster resulting from the ZOSTAVAX use. The outcome of the herpes zoster and an infection in eye due to herpes zoster was not reported. The reporter considered the events to be related to ZOSTAVAX. Upon internal review, the event infection in eye due to herpes zoster was determined to be medically significant. Additional information has been requested.
Patient reported to pharmacy 2 days after IMZ. Right arm was swollen down to elbow, very red, hot, and hard to the touch. Symptoms started about 24 hours after receiving the vaccine. Patient has been taking acetaminophen and applying cold compress. Advised patient to keep us informed of the progression and gets worse, patient will see her physician.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 69-year-old male patient received BNT162b2 (BNT162B2), on 19Apr2022 as dose 4, (booster) single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3, (booster) single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. No known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: negative 7 days after beginning Paxlovid treatment; Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This dose intensified my vertigo symptoms. I have been dealing with it for about a month now and it was mostly resolved. The night I got my 2nd dose my symptoms came back full force. They are getting better again but the dizziness was intense for about 6 days.
The pt received typhoid IM #1 11/5/10 without adverse event. The pt reports that she received her second Typhoid vaccination (IM) on 12/13/11 at 1000. Around noon the pt noted that her eyes were swelling and soon after she felt that she was having difficulty breathing. While on route to the nearest ER the pt noted that her hands were swelling which was soon followed by generalized hives and itching. In the ER she was treated with albuterol, BENADRYL and PEPCID. She was seen by medical on the next am. It was noted that all of her symptoms were resolved. The pt required a typhoid vaccination for work.