chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Day after injection, redness and itch developed in skin near injection site. 10 days since injection, redness continues day 9 with decreased itch but more widespread redness. Redness somewhat improved with hydrocortisone cream twice a day which began on day 8.
Swollen lymph nodes in left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes in left arm) 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 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes in left arm). The patient was treated with Manual therapy (Cold compresses) for Vaccination site lymphadenopathy. At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Swollen lymph nodes in left arm) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
pt was vaxed 5 times w/MR vax & failed to seroconvert; No further details were provided;
Severe stomach pains and vomiting 11 hours after vaccination; treated with OTC Pepto Bismol Severe stomach pains and vomiting 19 hours after vaccination; no treatment Mild diarrhea 16 hours after vaccination; no treatment All symptoms/AEs resolved 32 hours after vaccination
Very severe headache, pain at injection site, chills, sweating, cough, malaise, R hip pain (osteopenia), fatigue
experiencing severe and sudden attack of bells palsy on right side of face; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (experiencing severe and sudden attack of bells palsy on right side of face) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN and FENOFIBRIC ACID for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (experiencing severe and sudden attack of bells palsy on right side of face) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (experiencing severe and sudden attack of bells palsy on right side of face) had not resolved.            Patient was treated with Antiviral and Steroid.  Historical condition was not reported.  The patient reports experiencing severe and sudden attack of bells palsy on right side of face which was now paralyzed. No other side effect was reported. The symptoms are ongoing.   This case was linked to MOD-2021-417783.; Sender's Comments: This case concerns a 64-year-old, male patient with no relevant medical history, who experienced the unexpected event of Bell's Palsy. The event occurred at unspecified interval after booster dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable as event occurred after booster dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.
headaches and stomach aches; headaches and stomach aches; This is a spontaneous report from a contactable consumer (patient) via Covid-19 self reporting system. A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 11Feb2021 08:30 (lot number and expiry date: unknown) at the age of 72-years-old, as dose 1, single, for Covid-19 immunisation. Medical history included high blood pressure and diabetes. The patient had no known allergies. Concomitant medications included telmisartan; glimepiride; carvedilol; and atorvastatin taken for unspecified indications, start and stop dates were not reported. The vaccine was administered in a hospital. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient has not been tested for COVID-19 since vaccination. The patient experienced headaches and stomach aches on 11Feb2021. The patient did not receive treatment for the events. Outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information is expected.
felt real weak in her legs; not feeling well; Stomach upset; felt weak; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number, NDC number and expiry date was not provided), dose 2 via an unspecified route of administration on 03Feb2021 (at the age of 76-years-old), as dose 2, single for covid-19 immunization. Medical history included ongoing asthma diagnosed when she was a child. There were no concomitant medications. Family medical history relevant to ae was not provided. The patient had previously taken the first dose of the bnt162b2 (batch number: EL9263) on 13Jan2021 (at 13:30-16:00, as reported) for covid-19 immunization (Unknown dose shot in right shoulder once, as reported). Patient age at first and subsequent immunizations if dates of birth or immunizations not available was not provided. No other medication were administered within four weeks prior to the first administration date of the suspect vaccine. Prior vaccinations patient had no adverse event. The patient stated that she felt real weak in her legs. Clarified that it is for the Pfizer Coronavirus shot. Wanted to know what to do about it. It was reported that the patient feeling weak started 3 days ago and feeling week in her legs which started 2 days ago. The patient stated she is still doing what she has been doing. Vaccination facility type was nursing home. On an unspecified date, the patient experienced "felt real weak in her legs", not feeling well, on 07Feb2021 felt weak and at 20:00, stomach upset. The adverse events did not cause emergency room or physician office visit. Treatment was for taken with Pepto Bismol as a result of stomach upset. Outcome of the events were not recovered.   Follow-up attempts completed. No further information expected.
This spontaneous report was received from a registered nurse and refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 19-JUL-2017, the patient was vaccinated with an improperly stored PROQUAD at a dose of 0.5 (units not specified), lot # N012491 with expiry date 17-OCT-2018 (dose number, route and anatomical location not reported) for prophylaxis. Concomitant therapies included a properly stored sterile diluent (manufacturer unknown). The administered dose of vaccine was stored in the temperature between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 20 hours and in the temperature between 15 degrees Fahrenheit and 46 degrees Fahrenheit for 6 hours. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No additional information was provided. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006208:
Syncope  Fatigue  Malaise  Chills  Weakness when walking  Dizziness  Lethargic
I have no idea which Tdap vaccine was used, ask hospital. Next day I had sharp stomach aches in the lever area all day. Also, I had pain in my arm at the shot area. Then, I had slight fever couple of times over the night and sharp stomach aches continued. During night severe diarrhea began.  All next day my stomach aches got heavier and longer, diarrhea continued until next morning. I had no appetite, felt very tired, had mild fever few times during the day. All problems began to subside in the morning on 09/08/2019, three days after shot was given. I did not seek any medical help, as it was during weekend.
Little tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Little tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Little tired). At the time of the report, FATIGUE (Little tired) outcome was unknown.            No concomitant and treatment medications were provided.  Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD-2021-226455 (Patient Link).
Client came in to start Cholera #1 and complained of reaction to Typhoid #1 as follows: Large amount of edema from deltoid to elbow, red and hot and complaining of feeling achy all over and a headache.
5 days post dose 2 I began to suffer from fatigue combined with symptoms of sinus infection. The fatigue worsened while the other symptoms remained static (minor sore throat, dry cough, clear nose). Fatigue continued for weeks. Finally realized I needed to see a doctor -- that I was not actually sick with COVID-19 or sinus infection. First doctor appointment was on 5/18/2021. Fatigue appears to have been caused by liver issue. Results below.
Very achy all over to the point of causing nausea from booster though the first round did not result in hardly any reaction despite being coupled with tetanus booster.
Adverse reactions started approximately after 14h -- Headache for 12 hours,  pain to left arm/shoulder for 16 days; malaise and extreme fatigue for 5 days.
Tired for a few days after first shot; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired for a few days after first shot) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included Pulmonary embolism. Concurrent medical conditions included Arthritis.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced FATIGUE (Tired for a few days after first shot). In January 2021, FATIGUE (Tired for a few days after first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were reported.   This case was linked to MOD-2021-351022, MOD-2021-351023 (Patient Link).
Adverse Events: Lack of muscle strength, thought capacity, sore eyes, sore left elbow. less coherent thoughts, headache, woken up from sleep. starting at 0230 all lasting approx. 6 hours. Treatment: 3x ibuprofen tablets taken approx 4 hours in. all events completely faded by 1000.
No adverse event; Adult patient received a Bivalent dose as a first primary dose of the Moderna COVID19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Adult patient received a Bivalent dose as a first primary dose of the Moderna COVID19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 32-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049d22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Adult patient received a Bivalent dose as a first primary dose of the Moderna COVID19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Adult patient received a Bivalent dose as a first primary dose of the Moderna COVID19 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Adult patient received a Bivalent dose as a first primary dose of the Moderna COVID19 vaccine).    No concomitant medications were reported.  No treatment information was provided.
Itchy red, raised blotches spread from diaper area, to legs, to face, neck, trunk, arms - no respiratory symptoms. (24 hours later persistent hives).
Information has been received from a pharmacist referring to 2 patients of unknown age and gender. There was no medical history of drug reaction/allergies reported. On unknown dates the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # L003777 with expired date 04-FEB-2017, dose and route were unknown). No concomitant medication was reported. No adverse effect was reported. This is one of several reports from the same source. Additional information is not expected since the reporter refused further contact.
Chills, muscle aches, coughing headache which lasted for 3 days. Began about 3 hours after receiving vaccination.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 13-MAR-2014, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J011828 and expiry date: 26-DEC-2014, reported as 16-DEC-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 06-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route of administration were not specified; lot # L035686 and expiration date on 16-FEB-2017) that "might" have been improperly stored (it was unknown if the vaccines underwent a temperature excursion). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Began having chills and fever that night. Throughout the night, I could not sleep and was in an out of body experience. My skin was on fire all over my body and I couldn't even stand to have clothes on me. Had the worst headache for the day after.
developed s/s of COVID, tested positive 12/9.  S/S worsened and pt was admitted to the hospital 12/18/2021
contacted COVID/Nasal Swab Positive; contacted COVID/Nasal Swab Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 04Mar2021 at 13:00 as dose 1, single (Lot number: EN6205), in left arm and on 26Mar2021 at 14:00 as dose 2, single (Lot number: ER8733) at the age of 55 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No covid prior vaccination. No known allergy.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2021, outcome "unknown" and all described as "contacted COVID/Nasal Swab Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2021) Positive.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300300687 same patient/vaccine, different events;
24hr p/vax onset of fever, malaise, anorexia, rhinorrhea, cough, sore throat;sx for 2 days, gradual resolution over 1wk;final resolution of cough & weakness 2wk p/onset;mild flu immed p/vax;
On 10/13/21 I was made aware of a vaccination error by pharmacist for patient. The patient had come into the pharmacy with her mother to receive the Johnson & Johnson (J&J) COVID vaccination.  The patient completed the J&J Patient Consent & Release Form and screening questionnaire for COVID19 immunization from the CDC.  The form was given to pharmacist to administer the vaccination.  Upon completion of the vaccination, pharmacist had noticed we did not have the insurance information for the patient to process the claim.  The patient?s mother called the pharmacy and provided the insurance information.  After attempting to process the vaccination through the insurance, the patient?s insurance rejected the claim due to the patient?s age.  Pharmacist then brought this to my attention. My course of action is to fill out a VAERS report.  Additionally, I have contacted the manufacturer of J&J (Janssen) and have contacted the patient?s mother to make her aware.  I explained to her that a miscalculation was made with patient's age and she received the J&J vaccine, but it is not currently approved through EUA for her age?therefore, there is no concrete safety & efficacy data.  The patient?s mother kept repeating ?we are good here? and reported no current adverse effects.  I recommended for the patient to contact her primary care doctor to make them aware and to seek recommendation for further course of action as far as being evaluated for any potential adverse effects.  I have attempted to contact the physician?s office personally to make them aware of the vaccination error and am currently waiting on a return phone call after having to leave a voicemail.  I am following up on Friday with the patient?s mother & will also next week.  We are amending our vaccination forms to include in bold print EUA ages for each respective vaccination, as well as emphasizing the importance of workflow with our staff and the necessity of a pharmacist looking at the consent/release forms & screening questionnaires prior to vaccine administration.
bad headache; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th October 2022, the patient received the 2nd dose of Shingrix. In October 2022, less than a week after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-Oct-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received the second dose of Shingrix shot before the day of reporting. The patient experienced a bad headache after second dose. The patient was asking for any medication for headache could take.  Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Chills; Fever of 100.4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 78 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Jul2021 10:30 (Lot number: FAC780) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "removed a lymph node" (unspecified if ongoing), notes: removed a lymph node.; "Breast cancer" (unspecified if ongoing), notes: Taking Ibrance for his breast cancer. He got much better. Concomitant medication(s) included: IBRANCE taken for breast cancer (ongoing). The following information was reported: CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Chills"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fever of 100.4". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient was on the line reporting for her and her husband. She called about booster dose questions. Her husband was 78-year-old. She also shared with her that he was taking Ibrance and that his cancer markers went from 368 to 178 from Feb2020 to Jun2021. They dropped 190 points. He got the vaccine in Withheld. She knows it was Withheld, but does not know the address. He had no prescribing doctor. This was his second dose. Second dose: Pfizer FD8448, received on 19Aug2021, right arm. They got both doses at 10:30 am. He did not have to go the doctor or ER. With his first dose, he had chills and a fever of 100.4 the day after. It broke, and he got better. He was also taking Ibrance for his breast cancer. He got much better. History of all previous immunization with the Pfizer vaccine considered as suspect was not provided. Additional Vaccines Administered on Same Date of the Pfizer Suspect was not provided. Prior Vaccinations (within 4 weeks) was not provided. Patient history was reported as no. Patient's Medical History (including any illness at time of vaccination): Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity was not provided. Relevant Tests: List other relevant diagnostic and confirmatory test results for event(s), for example, from blood tests, cerebrospinal fluid culture, bacterial sero-type, diagnostic imaging, (e.g., chest X-ray, MRI) was not provided. He had to get both vaccines in his right arm because when he was diagnosed with breast cancer, they removed a lymph node, and he cannot have a blood test or shots done in the arm. She does not have the NDC/lot/expiration for his Ibrance 75mg. He just threw it out because he was done with that cycle. No follow-up attempts are possible. No further information is expected.
This is a spontaneous report from a non-contactable consumer via a Pfizer sales representative. A patient of unspecified age and race received TRUMENBA, via an unspecified route of administration on an unspecified date at 0.5ml single for immunisation. The patient medical history and the patient's concomitant medications were not reported.  The patient experienced rash, peeling of the skin on hand and 2 bumps on the arms on an unspecified date with outcome of unknown.
"On 10-11-10 I received vaccine at 4PM. At 8:30PM I had a severe headache unrelieved with TYLENOL. Hot/cold, diarrhea, nausea & vomiting, ill enough to go to ER but did not. Very ill for 8 hours."
pt recv vax 19AUG97 & 5NOV97 pt devel chickenpox that consisted of 40 lesions;
Swelling of upper arm larger than a dollar bill, shivering, bone aches over whole body lasted three day, swelling lasted a week.
Narrative: 46yo pt died on 09/26/2021. Pt had received covid vaccines on 5/5/21 & 6/4/21. No information in agency records regarding pt's death. Not able to assess if death is related to vaccines.