chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HEART ATTACK; MASSIVE BLOCKAGES IN HEART; This spontaneous report received from a consumer concerned an 84 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had perfect health. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, frequency 1 total administered for prophylactic vaccination (Dose number in series 1). 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, the patient experienced heart attack 2 weeks later after the vaccination and had massive blockages in heart and doctors did not do anything. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart attack and massive blockages in heart was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20211213021-COVID-19 VACCINE AD26.COV2.S- heart attack, massive blockages in heart. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
swollen arm; redness; injection site that is hard,itchy and hot/Reaction site; Injection site that is hard, itchy and hot; Injection site that is hard, itchy and hot; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), ERYTHEMA (redness), VACCINATION SITE INDURATION (injection site that is hard,itchy and hot/Reaction site), VACCINATION SITE PRURITUS (Injection site that is hard, itchy and hot) and VACCINATION SITE WARMTH (Injection site that is hard, itchy and hot) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included Glaucoma (takes an unspecified eye drop as treatment medication for glaucoma) since an unknown date.    On 02-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 PERIPHERAL SWELLING (swollen arm), ERYTHEMA (redness), VACCINATION SITE INDURATION (injection site that is hard,itchy and hot/Reaction site), VACCINATION SITE PRURITUS (Injection site that is hard, itchy and hot) and VACCINATION SITE WARMTH (Injection site that is hard, itchy and hot). At the time of the report, PERIPHERAL SWELLING (swollen arm), ERYTHEMA (redness), VACCINATION SITE INDURATION (injection site that is hard,itchy and hot/Reaction site), VACCINATION SITE PRURITUS (Injection site that is hard, itchy and hot) and VACCINATION SITE WARMTH (Injection site that is hard, itchy and hot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that she applied a cold pack as treatment for the events.
States had generalized itching and ask for benedryl.  50mg Benedryl Tablet given PO after 10 minutes ask for Pepcid. After 15 minutes states he feels better and issues resolved
August 3rd back pain left shoulder blade, 1am August 4th shoulder pain and left chest pain. Difficult taking deep breaths as it became painful chest. Sudden movements caused pain to chest. Pain persisted until visit to ER at 8am and diagnosis for pericarditis.
Starting on 8/11 child developed rash and pain on right thigh/hip. Patient presented 8/14/19 with classic Shingles rash in RIGHT L1, L2 dermatomes.
Pt received vaccine on 12/18 and developed erythematous, pruritic hives on 12/21. Was rx'd hydroxyzine without significant benefit (has brief relief is sx but recur before next hydroxyzine dos is due). Pt was seen twice in the ED for these sx. Pt was told sx were related to muscle strain. Pleuritic chest pain and cough. Ongoing cutaneous and respiratory adverse reaction.
This is a spontaneous report from a non-contactable consumer, the patient. A 56-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the right arm on 06May2021 at 15:00 (at the age of 56-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the right arm on an unknown date in Apr2021 at 15:00 (at the age of 56-year-old), as a single dose for COVID-19 immunisation. On 07May2021 at 01:00, the patient experienced low grade fever, chills, body aches and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the reported events and included treatment with paracetamol (TYLENOL) from an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event low-grade fever, chills, body aches and fatigue was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
About 20 minutes after administration child began throwing up, stating blurry vision, looked to be going in and out of consciousness.  Sometimes was alert, other times did not respond.  Called 911. Paramedics came. By this time, patient was up and alert and followed directions.  Father did not feel necessary for patient to go to hospital.  Patient and family left around 30 minutes after ordeal and patient was smiling and waving  bye to everyone in the pharmacy.
This case was reported by a other health professional via call center representative and described the occurrence of local reaction in a patient who received BEXSERO (batch number 1645401A, expiry date April 2018) and (batch number 165401A, expiry date April 2018). This case was associated with a product complaint. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced local reaction and product complaint. On an unknown date, the outcome of the local reaction and product complaint were unknown. It was unknown if the reporter considered the local reaction to be related to BEXSERO. Additional details were reported as follows: The patient developed a local reaction after receiving a dose of BEXSERO. One of the reactions was severe enough, it required the patient to follow up with an orthopaedic doctor. The healthcare provider was on a tight schedule and didn't have time to go through the adverse event details with the reporter. The physician said she would try and call back on Tuesday, 6th June 2017 with more details. This case is one of the 3 cases which were reported by the same reporter for the patients who received the same lot of BEXSERO. The batch number reported for BEXSERO could 165401A or 1645401A, clarification has been requested for the same. No further details were given.
Information has been received from a nurse concerning a 5 year old female who received her first dose of VARIVAX (Oka/Merck) (lot# 647719/1248N) on 19-MAR-2004 and her second dose of VARIVAX (Oka/Merck) on 13-JUN-2007 (0.5 ml, subcutaneously). Two days ago (approximately 20-OCT-2008) the patient developed chicken pox. The patient was seen in the office today (22-OCT-2008) and she has less than 50 lesions in her back. The patient is recovering. Follow up information has been received from a registered nurse concerning a 5-year-old female student with no pre-existing allergies, birth defects or medical conditions. She was vaccinated in the left lateral thigh on 19-MAR-2007 and 13-JUN-2007 with a first and second dose of VARIVAX (Oka/Merck) (lot# 658435/1248N and 657185/0301U, respectively). Subsequently, on 22-OCT-2008, the patient developed <50 lesions on her back. It was reported that they were itching and that she did not have a fever. No diagnostic or laboratory tests were performed. The patient recovered as of 27-OCT-2008. Additional information has been requested.
pt recv vax OCT97 & devel mild nausea;pt recovered from exp p/several weeks;
patient received the product FLUZONE QUADRIVALENT HIGH DOSE, but the patient is less than 65 years old, with no reported adverse event; Initial information received on 30-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 58 years old male patient who received the product fluzone quadrivalent high dose(INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE), but the patient is less than 65 years old, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Sep-2022, the patient received a  dose of 0.7 ml of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength: unknown) lot UJ895AC, expiration date:30-Jun-2023 via intramuscular route in the left deltoid as Immunization  On 30-SEP-2022 the patient received the product fluzone quadrivalent high dose, but the patient is less than 65 years old, with no reported adverse event (product administered to patient of inappropriate age) same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (patient received the product FLUZONE QUADRIVALENT HIGH DOSE, but the patient is less than 65 years old, with no reported adverse event).  At time of reporting, the outcome was Unknown for the event   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 guidelines. 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.
Pt developed fussiness on 8/3 She then developed a rash shortly after to her trunk and extremities
Large lump at top of arm very red down to elbow lasted about 3 weeks before going away but in mean time very sore in arm muscle, xrays  MRIs numerous Drs physical therapy. Surgery on frozen shoulder I got  because I wasn't using the arm hurt too much, Dr said cause and effect, still ongoing.
pt was put to bed (crib) to sleep 9:45AM & was found unresponsive 1045AM;
1 week after vaccine; redness, swelling, hard to touch, itching all around injection site with associated pain with movement and pressure on arm
w/in 4 hrs of vax pt devel t103; pink flat rash devel in 2-3 days; seen by pt who stated pt had rubella;
I experienced  24 hours after my vaccine, right thigh and leg swelling. On 04-27-2021, I was hospitalized due to varicose veins. My right thigh was red with some tenderness. I also had premature ruptured placenta at 28 weeks pregnant. To this day I still have the varicose veins.
This report was received from the investigator in the above mentioned trial on 12 April 2010. A 25 year-old male subject received the following vaccines on 06 March 2009: ACAM2000 (lot number not reported); and anthrax vaccine (other manufacturer and lot number not reported). Twelve days after vaccination, the subject was diagnosed with unspecified disease of the pericardium. The subject had a history of headaches. No other information was provided. The outcome was not reported. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
1/30/15 he received 4 mo vaccines including ROTATEQ. That evening he a had a temp. 1/31/15-afebrile but loose stool. 2/3 frothy liquid stools with temp to 103.2 to 104 rectal. Sepsis workup done due to high white blood count. All cultures, urine and blood negative.
SHRILL CRYING X 1 DAY, FEVER 100, 2CM X 2CM INDURATED AREA AT SITE OF INJECTION (COMVAX)
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 11-MAY-2017, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB injection, lot # M046373 with expiration date: 04-NOV-2018 (dose, route and site of administration were not reported). The vaccine was stored in a nurse's unmonitored refrigerator and was exposed to temperature excursions of 47 to 77 degrees Fahrenheit for 46 hours and 32 to 35 degrees Fahrenheit for 46 hours. There were no previous temperature excursions and digital data logger was not involved. No adverse effects were reported. There was no product quality complaint involved in this case. This is one of five reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1705USA011219: US-009507513-1705USA011218: US-009507513-1705USA007715: US-009507513-1705USA011217:
Felt feverish ~4-5 hours after injection, but had walked over 3 miles at 3.4 mph in sun,  wind and 75 degree day and did not contribute it to Shingrix.  Started shivering around 6:00 p.m. but also commonly occurs after a good walk as my body continues to kick off heat.   Took temp around 8:00 p.m. and was 100.1, then took 400mg ibuprofen. At 11:00 p.m. temp was 99.7.   On 11/10/202, temp remained from 100.1 to 99.7  throughout the day with continual doses of ibuprofen.   Arm was sore, slightly swollen and warm. Had headache, tiredness and felt lousy.  Temp at 11:00 p.m. was down to 97.7 about 7 hours after the last ibuprofen.  11/11/20220 no fever. Arm red at injection site, swollen, and warm
temp of 104.4 w/in 1hr p/vax;circumoral cyanosis;seen in ER: exam negative, blood work (CBC) negative;
No energy, fatigue, hoarse voice, tightness of the throat, temperature, and dizziness.
Bilateral upper extremity numbness/tingling.  Unusual fatigue and malaise.  Axillary swelling bilaterally with pain to left axillae.
Not achieving immunity most likely secondary to Ocrevus immunosuppression.  I was a participant and testing covid antibodies with an at home antibody test, which never indicated a positive response to either IgG or IgM after vaccination.  On 5/21/2021 I had a SARC Covid quantitative antibody test performed which indicated no antibodies present. I am reporting ineffectiveness of vaccine possibly due to a medication interaction (Ocrevus) and hope that be reporting this there can be recommendations on boosters and infusion timing with vaccinations.  Nearly 1 million people have MS in the US and there are 17 different disease-modifying drugs.
Patient complaints the area on her left arm red, warm to touch and itchy. This redness was 1" X 1", this is in a lighter red area that is 2" X 4". The Lighter red area appeared on Sunday. The redness is at the site of the injection. Patient used a Calming cream on the reaction which has helped the itching. We discussed the use of Claritin and or Zyrtec to help with the itchiness as patient is taking blood pressure medication.
15 hours after KINRIX vax was injected into (R) arm, pt. demonstrated 3 inch redness, swelling, and hardness. No rash or fever. Pt. is able to move arm but painful to touch/movement. No treatment needed but icing and pain medication.
Swollen, redness if you do a C with your hand it's about that size, that's what the parent stated.
1)  6 weeks after taking the 2nd Pfizer vaccine, I developed shingles in my lower right leg and foot.  I was on gabapentin for 8 months.  I'm still having periodic pain in my right foot but don't take anything for it. 2)  In the last 4 months, my hair is thinning out on the top of my head. 3)  On Saturday, January 8, 2022, I developed a deep bronchial cough.  My doctor would not see me until after I had tested negative for Covid.  When I received the negative results a week later after being tested at Hospital, in a virtual visit with my dr. he prescribed a z-pack and a chest xray, which came out that my lungs were clear.  Though I am better, I am still having bronchial coughing.
Information has been received from a RN concerning a 36 yr old white female with hypersensitivity to meperidine hydrochloride (Demerol), asthma and Addison's disease who on 26Apr04 was vaccinated IM in the left deltoid with pneumococcal 23v polysaccharide vaccine (lot646494/1201N). Illnesses at the time of vaccination included sinusitis. On 27Apr04, in the PM, the pt developed redness and swelling at the injection site and a temp of 103 degrees. The swelling was the size of a half dollar. The pt was advised to take acetaminophen (Tylenol) or ibuprofen (Advil) every 4 to 6 hours and apply ice to the injection site. Subsequently, the pt recovered from the redness and swelling at the injection site and fever of 103 degrees two days later. Additional information is not expected.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant medications were reported.   This case was linked to MOD-2021-395985 (Patient Link).
This spontaneous report was received from a registered nurse concerning an unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unspecified date in early July 2017, the patients were vaccinated an improperly stored doses of with GARDASIL 9 0.5 ml, injection, lot number N013276, expiration date 21-JAN-2020 (route of administration was not reported) for prophylaxis. The temperature of excursion with GARDASIL 9 was 47 to 77 Fahrenheit degrees during 5 minutes. No previous temperature of excursion was performed. The temperature of excursion was detected by a data logger. No adverse effects were reported. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1709USA011511: US-009507513-1709USA011512.
FEELING VERY TIRED/ FATIGUE; DIDN'T SLEEP THROUGH THE NIGHT; BODY ACHES; CHILLS; HEADACHE; FEVER; This spontaneous report received from a consumer concerned a 50 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced didn't sleep through the night. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced chills. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced feeling very tired/ fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 10-APR-2021, had not recovered from headache, fever, body aches, and feeling very tired/ fatigue, and the outcome of didn't sleep through the night was not reported. This report was non-serious.
Initial unsolicited report received from a non-health care professional via other company (Pfizer) (Manufacturer report number: 2016219273) on 21 April 2016. This case involves a male (age was not reported) patient who was vaccinated with a dose of DPT (batch number, expiration date, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had a reaction. Lab data and corrective treatment was not reported. Outcome of event was not reported. List of documents held by sender: none.
Patient was seen in our office on 12/30/21 and given her flu vaccine and HPV vaccine. After leaving our office she went to Pharmacy and received her covid vaccine in the RA.  After receiving that vaccine she developed a golfball size lymph node in her right underarm. Size of lymph node stayed the same but the location changed. The lymph node was very tender to the touch.
Patient had his Covid vaccine 5/10/21 upper left arm, then a  week  later he presented with puffy left arm.  Staff attempted x 2 to assess his left arm. Patient refused both times. Staff observed that patient did have full range of motion with no complaints of pain or discomfort.  Appt  was  set up to assess his left arm edema. Both times patient refused.  Dr was made aware  that patient still has some edema and that staff was unable to measure related to uncooperative nature of  patient.  Dr. feels it is an adverse reaction to his Covid-19 (Adenovirus) Vaccine. This is now listed on his Allergy list.  Dr feels this edema will resolve itself.
Large urticarial rash on left bicep where I had received the injection 8 days previously.  Itching resolved within an hour, rash resolved over next 48-72 hours