chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease. There was no reported medical history.  On 23-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In September 2021, the patient experienced VOMITING (Vomiting). In September 2021, VOMITING (Vomiting) had resolved.  No concomitant medication details were provided. No treatment medication details were provided., The reporter's causality for the event of vomiting was not provided with HUMIRA(ADALIMUMAB). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 19-OCT-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L004754, expiry date- 10-NOV-2016) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
It started that same evening after getting vaccinated. I was dizzy, extreme fatigue, couldn't go down the stairs by myself. I got up in the middle of the night, I was real dizzy and lost my balance and fell down, I had a low grade fever for 24 hour. I was sick for 2 days and the 3rd day I started getting my strength back. My arm was so sore for 5 days. My booster shot was worse and I was throwing up and had fever as well.
Information has been received from a nurse practitioner concerning a pt (age and gender not reported) with unk medical history and unk allergies who on an unspecified date was vaccinated with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot unk). Subsequently, the pt developed cellulitis as a result of the vaccination. It was also reported that the pt was treated with antibiotics (unspecified) and recovered from cellulitis on an unspecified date. The reporter felt that the pt's cellulitis was related to therapy with pneumococcal 23v polysaccharide vaccine. There was no product quality complaint involved. No additional information is expected.
I don't feel comfortable; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 61 year-old patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: Mar2021, for COVID-19 Immunization. The following information was reported: DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "I don't feel comfortable". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient asked the rheumatologist should the patient get the booster and he checked the antibodies, and he does the blood work, the patient don't know it was a PCR test (consumer was unsure) It was not sure what the physician did but when it came the range was 1 (Clarification unknown) The patient's dates for the blood work came out, when it came the range was 1 and the patient came out at 250 and the physician said that the patient is perfectly protected, cancel the booster vaccine. The patient was not comfortable with that. Then the patient went online and did another research as the patient was Registered nurse. The physician was telling the patient two hundred and fifty times (250 times) the antibodies that's very-very good let's wait and see but then the patient read online that you can have up to thousands so 250 is not that great. Limited information was available over the call.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Injection given on 10-16-06 in Left deltoid - red, bruised, warm to touch reaction approx. six inches in length and mildly itchy.  Treatment at home with warm packs to area, over the counter anti-itch cream.
indication=Treatment of COVID-19; indication=Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Dec2020 as dose 1, single (Batch/Lot number: unknown), on 18Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 05Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history included: "splenectomy" (unspecified if ongoing); "Adult onset Bethlem myopathy" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE oral, start date: 16Jul2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "indication=Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 and treatment with paxlovid . The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Vaccine administered from vial which has been punctured for more than 6 hours; A spontaneous report was received from a nurse concerning a 44-years old, female patient who received Moderna's Covid-10 vaccine (mRNA-1273) and experienced vaccine administered from vial which has been punctured for more than 6 hours.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number 026L20A) in the right deltoid intramuscularly for prophylaxis of COVID-19 infection.   On 30 Dec 2020, between 8:00-11:00 am, the patient was administered a vaccine dose from a vial that had been punctured on 29 Dec 2020 at 6:00 pm. No adverse events were reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The event, vaccine administered from vial which has been punctured for more than 6 hours, was resolved on 30 Dec 2020.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273, lot # 026L20A. There were no reported AEs associated with this case of expired product administered.
Fever chills X1 day, swollen red area around inj site for 5 days. Narrative:  Other Relevant History:
FLU; A spontaneous report has been received from a consumer. The report concerns a female patient (age not provided) of Unknown ethnic origin.    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient received Flumist (influenza virus vaccine live, intranasal) once/single administration, via nasal route, on an unknown date.     On an unknown date, the patient experienced flu (preferred term: Influenza).     The outcome of the event was unknown.    The event was considered non-serious.
Myalgias, Fever, headache, nausea, hives, urticaria.
could not move in bed for a whole day; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (could not move in bed for a whole day) in a female 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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (could not move in bed for a whole day). At the time of the report, MOBILITY DECREASED (could not move in bed for a whole day) had resolved.            No relevant concomitant medication was reported. Treatment information was not provided.
24 hours after injection - fatigue, generalized achiness, arm was red, swollen & painful. Fever, headache, chills, redness size of grapefruit, loss of appetite.
pt recvd Typhoid vax & devel redness & swelling @ inject site; 2 days following inject devel nausea which lasted for 2 to 3 days;
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: numbness in extremeties
several individuals failed to produce pos titers following vax w/3 doses of Engerix-B;
Patient reported tightness in throat, numbness in face,  headache and had dry heaves shortly after receiving the second dose of Pfizer COVID vaccine.
tested positive for Covid after vaccination; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid after vaccination) and DRUG INEFFECTIVE (Lack of drug effect) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder. Concomitant products included IMMUNOGLOBULIN HUMAN NORMAL (HIZENTRA) for Autoimmune disorder.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced COVID-19 (tested positive for Covid after vaccination). 04-May-2021, the patient experienced DRUG INEFFECTIVE (Lack of drug effect). On 04-May-2021, DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. At the time of the report, COVID-19 (tested positive for Covid after vaccination) outcome was unknown. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, SARS-CoV-2 test: positive (Positive) SARS-CoV-2 test Positive.         Treatment information was not provided.  This is a case of lack of efficacy of the vaccine. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as not applicable.   This case was linked to MOD-2021-016951 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Upon internal review on 11-AUG-2021, an event lack of effect was added to the case.; Sender's Comments: This is a case of lack of efficacy of the vaccine. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as not applicable.
This spontaneous report was received from a nurse practitioner referring to unspecified patients of unknown age and gender. The concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ, Oral, route defaulted to oral, lot #: K016261, expiration date on 23-JUL-2016 and lot #: L008578, expiration date on 14-DEC-2016 (dose and anatomical location were not reported). Concomitant therapies were not provided. No adverse events were reported. No product quality issue was involved. This is one of several reports coming from the same source. Additional information has been requested.
This case was reported by a nurse and described the occurrence of nonspecific reaction in a child patient who received KINRIX (batch number KB75Z, expiry date 20th March 2017). On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced nonspecific reaction. On an unknown date, the outcome of the nonspecific reaction was unknown. It was unknown if the reporter considered the nonspecific reaction to be related to KINRIX. Additional information received: No further information was reported regarding the event. 3 pediatric patients returned with moderate reactions to KINRIX. Nurse was not sure if it is coincidence or a bad batch.
Tramadol arthritis and taking blood thinner and steroid on 3rd June2021. Migraine 22 times threw up. The 2nd day, that evening I felt like I had the flu and I ached all over. Nausea and didn't puke, slight headache and tired. Both arms were sore and couldn't raise up. I took Tylenol. 13th June2021, my head hurt very badly, I puked 22 times, I couldn't stand light, I was out of it. I almost don't have any memory. I looked like death. I was dehydrated. I couldn't eat anything for 4 days, I lost 10 pounds. 17th Jun2021 went to Urgent Care. On 13th, I went to ER.
This is a spontaneous report received from contactable consumer or other non-HCP (patient). A 38-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FD0809), at the age of 38, in left arm, Oct 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient had  lymphadenopathy (lymph node near left collarbone swelled-up a week after the COVID-19 vaccine), onset Nov 2, 2021, at 14:00, with outcome of not recovered. The event evaluated at a physician office visit. No therapeutic measures taken as a result of lymphadenopathy. Additional information: Prior to vaccination, patient not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, patient has not tested positive for COVID-19. The patient did not receive any treatment for the adverse events. No follow-up attempts possible. No further information expected.
After receiving vaccination, that night the patient felt "warm all night."  The next day he noticed his entire body was red, and subsequently developed red bumps all over his body.  The rah was itchy, skin felt warm, and it was scaling.  His leg had some weeping.  He felt more tired than usual and thirsty.  Drinking a lot of water.  He felt anxious during this time.  He denies nausea, vomiting, diarrhea, fever, chills, difficulty breathing, cough, or abnormal bleeding.  On 1/25/21 he was treated with 125 mg methylprednisolone sod succinate injection X 1 doe, 50 mg diphenhydramine injection, and prednisone tablet 10 mg daily for 30 days.  On 03/01/2021, the patient did not improve after receiving treatment.
1/5/21 VACCINE 1/14/21 - FINGER TIPS AND FEET ESPECIALLY COLD NEEDING EXTRA SOX AND GLOVES 1/15/21 INTERMITTENT BOUTS OVER 3-4 EPISODES OF SEVERE CHILLS LASTING 30 MIN - USED HEAT MAD, BLANKETS, SOCKS  1/15/21- 1/16/21 INCONTINENT OF URINE, DRY MOUTH, LOSS OF APPETITE, WEAKNESS, BALANCE, VISION DISTORTIONS. 1/16/- PRESENT- HYPPERSENSITIVITY TO SALT AND SUGAR, WEAK, COGNITIVE AND WORD RECALL, LEFT EYE VISION DISTOTIONS, BRAIN FOG.
Severe erythema at site of injection (right upper arm) with edema and tenderness.  Applied cold pack and took 2 Tylenol ; next am redness lessened but extended over larger area with tenderness into inner aspect of upper arm.  Advised to continue cold occasionally and OTC anti-inflammatory as directed on package and if signs and symptoms were not relieved, to see PMD or ER.
pts left arm became very sore and she has a red hard painful knot.  The arm is in alot of pain at times and does not seem to be getting any better at this time and it has been more than two weeks.  Pt will contact PCP.
On Saturday morning at 9:15am, while having several bowel movements w cramping, I felt extremely weak. I was pale, in a cold sweat. Needed to lie down on floor. Spouse called 911. Paramedics established that my BP had fallen to 68/40. Transported to Hospital ER. Traponen checked but was not elevated and BP had returned to normal, so I was released at about 3:30 pm and returned home. No further adverse effects.
49M with PMH significant for anxiety and depression; unmedicated due to lack of health insurance presenting with vasovagal syncope 15 minutes after Janssen vaccine administration in left arm. Pt reported feeling nervous prior to vaccine administration with remote history of fainting one time due to needle phobia, pt was offered to prophylactically lie down in a cot to receive the vaccine, he refused. Pt stated that he began feeling flushed and sweaty when he lost consciousness falling from a seated position, hitting his face and head. Pt was lying in prone position unconscious for 10-15 seconds, EMS was notified and pt was turned using C-spine precautions and transferred to stretcher. Pt was placed in trendelenberg,
Administration error/deviation: unauthorized age group (Patient 16 years old at time of vaccination). Per CDC recommendations, second dose of Moderna vaccine may be administered as off-label use. Patient's second dose of Moderna COVID vaccine is scheduled for 4/23/2021.
Received vaccine on 6/9/2021,  the next day she started feeling cramp in left leg and swelling.  Went to see her physician.  Diagnosed with blood clots to left leg.  Given 1 lovenox shot at time of visit  and put on 81 mg ASA twice a day for 2 days.
Small red spot on leg, and very large knot in muscle under the red spot. Patient was only given the Hib vaccine on this date. Knot is still in her leg 5 days later.
Wasn't able to go to work; Body is tired/Felt fatigue for three days; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Wasn't able to go to work) and FATIGUE (Body is tired/Felt fatigue for three days) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Wasn't able to go to work) and FATIGUE (Body is tired/Felt fatigue for three days). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Wasn't able to go to work) and FATIGUE (Body is tired/Felt fatigue for three days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: The email address was deleted as it was wrong. No other significant information reported.
Had a fall the evening of 10/26/2021 after getting the vaccine.  And then continued to show signs of progressing weakness, unsteadiness, impaired cognition for the next 7-10 days.  Had several falls between 11/7 and 11/8/2021.  Admitted to hospital on 11/8/2021.  Unable to return to her prior living at our Assisted Living facility due to impaired cognition and mobility.  Reported to have ongoing hallucinations and falls.
Right after my fourth vaccine I had fatigue, a fever of about 101, and felt sluggish for about a day. Towards the end of February I noticed increase fatigue and it was very unusual for me. I could not get through my normal exercise routine, and I found that I was falling asleep easily and it was very abnormal. I am not sure if it is associated with the vaccine however, I believe that this is very out of the norm for me. I did reach out to my doctor for an in office visit. We did do some lab work and recommended a sleep study as well and now I am just waiting for the results.
Developed rash on the injection site with swelling and pain 4-6 hours after procedure. Self med with BENADRYL  and TYLENOL.
Swollen rash on vaccine arm, with itching. 9 days post onset. Extreme fatigue on day 8.
Had fever of 102.6 for 3 days and then the fever drop down to 100; He'd work a little bit and then had to lay down and take a nap; This is a spontaneous report from a contactable consumer, the patient. This consumer reported for a male patient (husband). A 78-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: Unknown), via an unspecified route of administration in right arm on an unknown date in Mar2021 as DOSE 2, SINGLE for COVID-19 immunization. Medical history was not reported. The patient's concomitant medications included aspirin and Tamasol which was a blood thinner. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Feb2021 for COVID-19 immunization. The second shot was 2 weeks later, now she could not remember the date on that. It was the beginning of Mar (about 3 weeks ago) and he had no reaction to the injection or the injection site. Patient had fever of 102.6 for 3 days and then the fever dropped down to 100 and then slowly after the second for two weeks, patient had fever and fatigue. Patient would work a little bit and then had to lay down and took a nap, he had been to the doctor 4 different times and they ran all kinds of test and they never came up with anything. Chest X-rays were done to make sure there was nothing going on with his chest. They checked him mosquito bites and all kinds of different diseases and stuff and nothing, absolutely nothing showed up. The patient did not receive any treatment. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Spotted, measles like rash developed on upper arms between arm pit and elbow on 4.20.2021. On 4.21.2021 the rash appeared on the lower legs, between ankles and knees. Rash is red, itchy at times. The rash is not oozing, bleeding or anything of the like. The rash is not raised however patient does take daily allergy medication.