chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist referring to unspecified number of patients of unknown age and gender. On unspecified dates after 28-AUG-2014, the patients were vaccinated with improperly stored ZOSTAVAX (lot#, expiration date, dose and route were unknown). No adverse events were reported. Additional information has been requested.
Dizziness, hot flashes, and confusion about 15 minutes after vaccine and that lasted 24 hours. Fever and body chills - the next day - I also had hives and acne all over my face and neck. I had a tingling sensations on my forehead and on my head - I noticed those symptoms within 30 seconds after the vaccine. Three days that I couldn't go to work. I reported to my doctor - and she advised Benadryl. I took that and the rest of the symptoms went away after the third day. Dr advised that I didn't get the second a vaccine unless I was at the hospital - I did get the second vaccine and for the second vaccine it was the same symptoms for about the same length of time.
Second dose of vaccine administered after excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Second dose of vaccine administered after excursion) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Second dose of vaccine administered after excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Second dose of vaccine administered after excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-250488 (Patient Link).
Symptoms of covid/Unsure if he had covid or not/Was feeling the symptoms of covid; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (Symptoms of covid/Unsure if he had covid or not/Was feeling the symptoms of covid) in a male patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Nov-2021, the patient experienced SUSPECTED COVID-19 (Symptoms of covid/Unsure if he had covid or not/Was feeling the symptoms of covid). At the time of the report, SUSPECTED COVID-19 (Symptoms of covid/Unsure if he had covid or not/Was feeling the symptoms of covid) outcome was unknown.      Patient was not taking any concomitant medications.  No treatment was provided for the side effect.; Sender's Comments: This is a spontaneous case concerning a male patient of an unknown age with no relevant medical history reported, who experienced non serious, unexpected event of Suspected COVID 19. The event occurred on an unknown date after the second dose dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This is a spontaneous report from a contactable office manager reporting on behalf of a physician. A 17-year-old male patient received a dose of TRUMENBA, NDC 00050100-01, lot M74091, expiry date Jun2017) intramuscular in the right arm on 15Jul2016 between 11-11:30 am at 0.5 ml single. He did have a history of fainting once after a blood draw, he had ongoing allergy to latex and tomatoes, and he had ongoing pain on shoulder on both sides that was hurting his neck to turn side to side for years. The patient had received MENACTRA, lot U5180AH) administered intramuscular in the right arm on 06Jun2016 without any adverse event. The patient's concomitant medications were not reported. Immediately after having received the vaccine, the patient fainted, he was nauseous, dizzy, and was vomiting. It was reported that he began slipping off the table after it was administered, his dad assisted him back onto the table. They gave him some orange juice and they observed him for 1 hour before wheeling him out in a wheelchair to the vehicle to go home, when he was recovering. No emergency or doctor visit was required due to the events. No test was performed. They thought it was more of the trauma instead of the vaccine that caused the side effects.
SHORTNESS OF BREATH; BLURRED VISION; CHEST PAIN; LEG SWELLING; PERSISTENT ABDOMINAL PAIN; EASY BRUISING OR TINY BLOOD SPOTS UNDER THE SKIN BEYOND THE SITE OF THE INJECTION; SEVERE OR PERSISTENT HEADACHES; 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, and batch number were not reported) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 02-JUN-2021, the patient experienced shortness of breath, blurred vision, chest pain, leg swelling, persistent abdominal pain, easy bruising or tiny blood spots under the skin beyond the site of the injection, and severe or persistent headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, leg swelling, persistent abdominal pain, severe or persistent headaches, easy bruising or tiny blood spots under the skin beyond the site of the injection, shortness of breath, and blurred vision. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Two nodules appeared on my right arm below my elbow on 2/1.  They were firm, red and tender.  I showed them to the physicians I work with and they said it was erythematosis nodules.  They appear to be clearing without treatment.
This spontaneous report was received from a physician via company representatives and from a support services director concerning to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications was not reported. On 11-NOV-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5ml SD-PFS LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016 (dosage number and route of administration were not reported). On an unspecified date, the vaccine had a temperature excursion for 40 hours in which the highest recorded temperature was 47 degrees Fahrenheit (8.333333333 degrees Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported and no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient is 15years, 11 months old and this vaccine is not yet approved for under 16.
No adverse event; Patient was administered with an expired dose of the Moderna COVID-19 bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with an expired dose of the Moderna COVID-19 bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-May-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with an expired dose of the Moderna COVID-19 bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with an expired dose of the Moderna COVID-19 bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered with an expired dose of the Moderna COVID-19 bivalent vaccine).    No concomitant medications were provided. It was reported that patient did not reported any adverse reactions at this time.  No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-727939 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727939:Same reporter
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 30-APR-2018, the patient was vaccinated with an improperly stored dose of PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029:US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513-1806USA009054: US-009507513-1806USA009055: US-009507513-1806USA009056.
Large hives started about 24 hours after vaccine given. BENADRYL given as needed and hives continued to appear and disappear. On day 4 after vaccine hives so large and thick all over body especially on abdomen went to emergency room. Received 125 mg methylprednisolone IV, PEPCID 20 mg IV, and BENADRYL 25 mg IV. Hives did improve and relief noted. Prescribed Prednisone 40 mg daily for 5 days and BENADRYL 25 mg orally every 4 hours as needed. Large itchy hives still appearing at this time despite prednisone and BENADRYL.
hives; wheezing; palpitations; rapid heart rate; This is a spontaneous report from a contactable consumer (patient, self-reporting).   A 52-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection Batch/Lot number: EN6206 and Expiration date was not reported), via an unspecified route of administration on 05Mar2021 at 12: 00 pm, on the left arm as second dose, single for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. The patient had no known allergy. Patient's medical history included high cholesterol. The patient was receiving Other medications in two weeks. On 08Mar2021 at 10:00 pm (3 days after vaccination), the patient experienced broke out into large and hot hives all over the body, wheezing with palpitations and rapid heart rate. The patient did not receive any treatment for the events. The outcome of the events was resolved.  No follow-up attempts are possible. No further information is expected.
Work as RN at UCSF, required shot for us,at time of injection burned and pain sensation shot down entire arm, told normal. within 5 minutes got dizzy, heart raced, "felt very strange" shakey.
1 dose Moderna / second dose Johnson and Johnson; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (1 dose Moderna / second dose Johnson and Johnson) 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 INTERCHANGE OF VACCINE PRODUCTS (1 dose Moderna / second dose Johnson and Johnson). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (1 dose Moderna / second dose Johnson and Johnson) 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 medications were provided.  No specific patient information was provided.
01/06/2021 r eyelid swollen, face and upper lip; provider gave epi -- reduced some swelling.  L wrist swelling today 1/07/2020  sinus tachycardia 140-150.
I started getting symptoms of sore throat, chest congestion, runny nose, and muscle aches. This lasted about 5 days. I did an at home COVID-19 test which was positive. I contacted my doctor and was told no use to get the antiviral drug.
10/28 arm very painful to move; 10/29 swollen; 10/30 less swollen but sore to touch; 10/31-11/1 pink but only slight soreness; 11/2 worse.
Shot administered on 10/22/05. Redness at injection site on posterior upper L arm began next day. Diagnosed with cellulitis on 10/27/05. Started on oral cef..  Recheck on 10/31/05 showed vast improvement. Will complete 7-day course
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 13-NOV-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September of 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
patients arm was swelling the day after. it was on the inner part of the bicep and was very hot and swollen. It looks as if the doctor thought it might have been cellulitis as well as they prescribed diphenhydramine, prednisone, and cleocin. Patient stated that it hurt and was very hot but the pain was local and no systemic effects.
The patient's INR was decreased out of range a month and a half after first dose of vaccination after being within range for months and was low for many consecutive readings despite adjustments. Patient's family was concerned that the decreased INR was due to the vaccine and requested it be reported to the CDC. No clotting events occurred due to out of range INR. Warfarin dose has been adjusted and INR is now back in range.
Patient had her first Pfizer shot on 11/16/21. She had her second shot of Pfizer as recommended on 12/7/21. In early 2022, she began to lose weight, was thirsty, and seemed weak and irritable. Finally, over the two-day period of 4/16/21-4/17/21, her parents noticed unbelievable thirst and inability to control urination at night. Took her to her pediatrician at local Health Associates the morning of 4/18/21, where her blood sugar was checked and she was sent to hospital with suspected Type 1 diabetes. The diagnosis was confirmed that day. She stayed in the hospital for 2 days. She now needs daily insulin therapy to control her type 1 diabetes. We believe the two-part COVID-19 vaccination led to her Type 1 diabetes. She was otherwise healthy.
2/16/2008:Call from family to Hospital Pediatric Nurse line to report a reaction to shots given on 2/15/2008.  One injection site is hot to the touch, increased from penny size to 3 inches across. Onset was "yesterday evening".  Temp 100.8; did not specify which extremity was affected.
Information has been received from a Registered Nurse concerning an 18 month old male patient with multiple food allergies including egg, wheat, corn and peanuts. On 08DEC2014 the patient was vaccinated with M-M-R II, .5 ml, subcutaneous. On 08DEC2014, the patient experienced redness of his facial cheeks after administration of M-M-R II. The outcome of redness of his facial cheeks was reported as not recovered/not resolved. Additional information is expected.
OUT OF WORK FROM THE REACTION TO THE SHOT; This spontaneous report received from a consumer via social media via a company representative concerned a female (nurse) of unspecified age. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received two shots of covid-19 vaccine (Dose number in series 1, Unspecified manufacturer) (form of admin, route of admin and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination and she got sick with both the shots of covid-19 vaccine (Dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient was out of work from the reaction to the shot (Dose number in series was 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of out of work from the reaction to the shot was not reported. This report was non-serious.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On 01-May-2013, the patient was inoculated with ZOSTAVAX by a healthcare professional as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 30-Nov-2015, the patient was treated at the same medical office for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
PUI is a symptomatic resident of  a LTCF currently in outbreak. PUI tested positive on 8/30/2021 by PCR. Symptoms as indicated above. PUI was admitted to hospital on 8/30/2021-9/7/2021. PUI was not admitted to ICU. PUI is a breakthrough case. Received Pfizer dose @1-1/5/2021 and dose #2 1/28/2021.
This spontaneous report as received from a healthcare worker (certified medical assistant) refers to a patient of unknown age. On 27-MAY-2014 the patient received expired M-M-R II (lot number H009781; expired date 15-MAY-2014) (dose, route and indication were not reported). The healthcare worker did not specify which dose number this was in the M-M-R II series. No adverse symptoms reported. The healthcare worker stated that M-M-R II in question has not had any previous temperature excursions. The outcome and action taken were not provided. It was not specified if the patient sought any medical attention. Additional information has been requested.
I have the shingles now and I got the shot years l ago; I didn't know there was a 2 shot; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) (batch number UNK, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported for 1st dose. The age at vaccination was not applicable for 2nd dose. The age group was not reported, however captured as adult as per vaccine indication. The patient received 1 dose of shingle vaccine years ago and experienced shingle. The patient did not know about two shot of shingle and received only one shot. Till the time of reporting patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Individual developed palpitations and then high blood pressure on the day she received the COVID-19 vaccine (1/4/21). She started having joint pain on the fourth day (1/7/21) and it lasted until 1/11/21. On 1/10/21, she couldn't stand to do dishes. She went to Urgent Care on 1/12/21.
Patient was not eligible for booster yet but I did not realize that and administered a second dose of Janssen. Patient said his heart doctor told him to get a booster shot and he wanted to stick with Janssen. Patient received his first dose of Jannsen on 1/23/22 and would be eligible two months after that. I called patient after I realized he was not yet eligible and left a message for him to call back.