chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came by to show that she has a blister where she got a shot. The blister is now broken. She does not have any fever, chills, itchings, or anything.
See Description on next page (despite filling out all fields on this page, I was unable to enter info through the field in the PDF so I added a text box with the information)
J&J COVID-19 VACCINE ADMINISTERED 28 DAYS AFTER MODERNA COVID-19 VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned an 86 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included COPD. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: unknown) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. Concomitant medications included MRNA 1273 for prophylactic vaccination. On an unspecified date, the subject experienced J&J covid-19 vaccine administered 28 days after Moderna covid-19 vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of J&J covid-19 vaccine administered 28 days after Moderna covid-19 vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210428348.
flu like symptoms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was Not Applicable.       No information about concomitant medication was reported.  No information about treatment medication was reported.     Reporter did not allow further contact
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 42 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included: penicillin allergy, erythromycin allergy, drug allergy (Dilaudid (hydromorphone), Cardura (doxazosin)), MRI dyes allergy, dairy allergy, and gluten allergy, and other pre-existing medical conditions included: Patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-APR-2021 08:00 in right arm for prophylactic vaccination. Age at time of vaccination 41 years old. No concomitant medications were reported.   The patient additionally received non-company suspect vaccine: Pfizer biontech covid-19 vaccine (tozinameran) (dose number in series 2) (form of admin, route of admin were not reported, batch number: 3313OBA expiry: UNKNOWN) dose was not reported, administered on 08-JAN-2022 07:00 in left arm for prophylactic vaccination.  On 18-JUN-2022, the patient had COVID-19 virus test Positive (confirmed covid-19 infection (dose number in series 2) and confirmed clinical vaccination failure (dose number in series 1)). The patient received treatment drug for COVID as Paxlovid (nirmatrelvir and ritonavir) from 21-JUN-2022 till 25-JUN-2022. The patient was recovered form covid-19.  On 05-JUL-2022 at 06:00, the patient began getting COVID-19 symptoms again and tested positive 17 days after first positive test.  The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20220725227-COVID-19 VACCINE AD26.COV2.S-confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Patient received her 2nd dose of moderna. Within the next 2 mins pt started to have bilateral redness/warmth across both arms. pt was offered diphenhydramine injection and she declined. pt was monitored for a total of 30 mins. Over the 30 mins the pt's redness and warmth did dissipate back to normal. Pt also said she was experiencing some tingling/numbness in her right leg - but did explain she was in a car accident previously so it may have been a unrelated. After the 30 mins pt seemed ok and did leave. She did not experience any shortness of breath, swelling of the tongue/mouth, or chest pain. Pt blood pressure was 119/69
blood pressure also spike 24 hours after receiving a flu vaccine; Initial information received on 16-Dec-2022 regarding an unsolicited valid  non-serious case received via consumer/non-hcp.  This case involves an unknown age male patient whose blood pressure also spike 24 hours after receiving a flu vaccine while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer (dose, strength, frequency, formulation, route, batch number, expiry date: unknown) in unknown administration site for Immunization  On an unknown date the patient diagnosed with a non-serious blood pressure also spike 24 hours after receiving a flu vaccine (blood pressure increased) (unknown latency) following the administration of influenza vaccine.  It was reported "Caller stated her friend is a male and he was born in 1947. She states his blood pressure also spike 24 hours after receiving a flu vaccine".   Relevant laboratory test results included:  Blood pressure measurement - On an unknown date:  [also spike 24 hours]   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown
got covid and got visibly sick from it.; got covid and got visibly sick from it.; got covid and got visibly sick from it.; This is a spontaneous report received from a Pfizer employee reported for a female patient. A 26-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EW0173), via an unspecified route of administration on 08May2021 (at the age of 26-year-old), DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. It was unknown Prior to vaccination the patient diagnosed with COVID-19. It was unknown if the patient received list of any other medications within 2 weeks of vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. On 03Aug2021, the patient got covid and got visibly sick from it. Post vaccination, the patient underwent lab test which included sars-cov-2 test (nasal swab): positive on 03Aug2021. The event resulted into to doctor or other healthcare professional office/clinic visit. it was unknown if the patient received treatment for the event. The patient outcome of the events got covid and got visibly sick from it (covid-19 and sickness) was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
10/25/21 was 33.3 weeks pregnant on day of vaccine administration  Within 15-20 minutes of vaccine administration patient began experiencing slurred speech, vision changes, headache, and low blood pressure. Was evaluated in ER. Resolved in 3 hours.
Information has been received from a medical assistant concerning a 32 year old female patient with no pertinent medical history, who on 20-JAN-2009 was vaccinated with the first 0.5 ml dose of PNEUMOVAX (Lot # 663012/1163X) intramuscularly in her right arm.  Concomitant therapy included ALBUTEROL, ZOLOFT, PULMICORT and hormonal contraceptives (unspecified).  It was reported that the patient experienced pain, tenderness, and swelling in her right arm after administration of her first dose of PNEUMOVAX.  It was reported that she was not able to sleep or pick up her kids because of pain.  The patient sought medical attention with an office visit.  At the time of the report, the patient had not recovered.  Follow-up information has been received from the physician's office (reporter source not identified) that at 2:30 PM on 20-JAN-2009 the patient with no known drug allergies and no illness at the time of vaccination was vaccinated with the first 0.5 ml dose of PNEUMOVAX (Lot # 663012/1163X) intramuscularly in her right arm.  At 9:00 AM on 21-JAN-2009 the patient experienced skin irritation, fatigue, swelling, redness and hard at the injection site.  The patient also experienced pain and the patient could lift arm to carry child.  The patient could not sleep.  The patient recovered from the adverse events on 24-JAN-2009.  The reporter assessed the events as non serious.  This is one of several cases from the same source.  No further information is available.
This pt experienced burning at the injection site during administration. Within 30 minutes, she experienced itching at the injection site, and then developed redness, swelling also but which comes and goes. She was prescribed Augmentin. Achiness at injection site ensued and radiated down her arm and up into her shoulders and neck. On 10/20, she developed "flu-like" symptoms of sore throat and achiness. She recovered.
We gave a Moderna shot to a 12 years old who is not eligible for the shot.
Information has been received from a pharmacist referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 06-DEC-2016, the patient was vaccinated with ZOSTAVAX (strength, dose, route, lot number and expiration date were unknown) for prophylaxis and later recalled that she had previously received a dose of ZOSTAVAX (dose, route, lot number and expiration date were unknown) in the "previous year" (on unknown date of 2015), also reported as "the previous year". No adverse effects were reported. Additional information has been requested.
pt recv vax & devel redness, warmth, itching & swelling the size of a hamburger @ the site of vax;this is 1 of 4 pt from this site to have an inj site rxn p/vax;
Information has been received from a registered nurse, concerning a 12 year old female patient who on 16-JUL-2008 was vaccinated with the first dose of GARDASIL in her right arm. The patient subsequently, had "complications involving her left arm". The patient had to be hospitalized and was diagnosed with osteomyelitis. The patient was still in the hospital at the time of this report. No other details were provided. The patient's osteomyelitis persisted. The patient did seek medical attention. There was no product quality complaint. The patient's experience was considered an other important medical event by the reporter. Additional information is expected.
HEART BURN; CHEST PAIN; DIZZINESS; FOGGINESS; CONCENTRATION ISSUES; FATIGUE/ TIRED; HEADACHES; This spontaneous report received from a patient concerned a 24 year old female. The patient's height, and weight were not reported. The patient's past medical history included rash, itchy, and gastrointestinal issues, and concurrent conditions included depression, egg allergy, chicken allergy, non alcoholic, non smoker, stress, and family problems, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 16-APR-2021, the subject experienced heart burn. On 16-APR-2021, the subject experienced chest pain. On 16-APR-2021, the subject experienced dizziness. On 16-APR-2021, the subject experienced fogginess. On 16-APR-2021, the subject experienced concentration issues. On 16-APR-2021, the subject experienced fatigue/ tired. On 16-APR-2021, the subject experienced headaches. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Negative, Chest X-ray (NR: not provided) Negative, and Electrocardiogram (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, heart burn, dizziness, headaches, fogginess, concentration issues, and fatigue/ tired. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard operating procedure as the case was assessed as non-serious.
Patient  came into the pharmacy on 7/9/19 for her 2nd dose of the Shingrix vaccine.  She reported she bled and experienced pain right away after the injection. She used an ice pack to help alleviate the pain the first day.   She said her injection site is  painful, itchy, burning, and numb,  and the experience is very different from her 1st dose (pain was minimal).   She said she experienced a lot of discomfort on 7/10/19. Upon observing the injection site on 7/11/19, it was red and swollen around the site.   Patient said she will take ibuprofen for the pain.
Injection site right upper arm. Patient reported swelling from elbow to lower arm next day. Area from elbow down was red, warm to touch, swollen, discoloration noted on elbow. State slight soreness at injection site. Questionnable cellulitis.
1)constant runny nose 2)post nasal drip, pressure in sinuses 3)headache, itchy eyes, ears and throat 4)coughing 5)mild wheezing  Doctor said this was dust allergy. Symptoms still continuing as of 1/13/2009. Why would allergies suddenly become exponentially worse? I've never had this type of reaction before.
Patient with seizure disorder had seizure 3 1/2 hours after receiving seasonal and H1N1 vaccine.
This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 65-year-old male patient who received SHINGRIX for prophylaxis. On 21st February 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 21st February 2018, less than a day after receiving SHINGRIX, the patient experienced chills and fever. On 22nd February 2018, the patient experienced lethargy. On 22nd February 2018, the outcome of the chills, lethargy and fever were recovered/resolved. The reporter considered the chills, lethargy and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX after lunch in the right arm. On the same day, at the night the patient experienced low fever and chills. The patient experienced lethargy the day after receiving the SHINGRIX and it resolved by end of that day. The suspect vaccine lot number and expiry date was not available. For tolerance after the 2nd dose of SHINGRIX, refer case US2018GSK111503. This case is one of the 5 cases, reported by the same reporter.
LEFT DELTOID 6 X 8 CM OF ERYTHEMA, WARMTH, IRRITATION (PRURITIC), AND INDURATION SURROUNDING TDAP INJECTION SITE. PT EXAMINED BY FNP.
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium, Additional Details: Within 5 minutes of receiving vaccine, patient alerted store personnel that he was "seeing stars" and have impaired hearing (sounds like underwater). Within 10 minutes, he started feeling chills and sweating; he reported feeling weak, unable to walk or drive and had tingling on his forearms. He was offered acetaminophen and Benadryl. He refused Benadryl but took on tablet of acetaminophen 500mg. At about 25 minutes post-injection, he reported feeling better and refused paramedics.
And I just witnessed our arm got sore.; I got scars; This is a spontaneous report from a contactable other hcp (Patient). A female patient of an unspecified age received second dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 21Feb2021 as dose 2, single for COVID-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 13Jan2021 as dose 1, single for COVID-19 immunisation. It was reported that on 21Feb2021, the patient reported that we just kind of made it. The patient reported that they gave us the shot now and she did not get any reaction yet, usually about now she gets tingling. She did not get anything so far he was doing all right. She just witnessed our arm got sore. They need to look up and mine was all dried up. She was worried that if she took it too soon the immune system will flare it up again and she did not want any more scars all over my leg. She got scars. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
12/7/22 1330 Employee c/o soreness/pain in Lt arm 2 days after Tdap & Flu vaccine given. States difficult to lift her arm. Able to lift Left arm up at elbow. No visible redness or swelling noted. Able to move fingers, no numbness or tingling. States pain is in her lt shoulder blade, left elbows. Ice & ibuprofen by request. Management notified. States she is still working. Contract employee. Informed manager she can see a provider if needed.
FEVER OF 101.8, ACHY ALL OVER WITH SHOOTING PAINS DOWN ARMS AND LEGS OCCASIONALLY.  PATIENT ALSO FELT PAIN IN MIDDLE OF BACK AND NECK WHEN LOOKING DOWN. CHILLS AND SLIGHT NAUSEA.  C/O OF FEET HOT AND BRIGHT RED.
Herpes zoster keratitis; This spontaneous report has been received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patent's concurrent conditions, medical history and concomitant medications were not reported. On or about 11-NOV-2013, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) in the pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequent to the patient's inoculation, the patient was treated by a healthcare provider for zoster keratitis. As a direct and proximate result of patient's use of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of zoster keratitis was considered to be not recovered. The reporter consider the event to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of zoster keratitis was considered to be medically significant.
ACUTE COR PULMONALE 1/13/2022 UNSPECIFIED ANXIETY  ACUTE RESPIRATORY FAILURE 1/13/2022 UNSPECIFIED ANXIETY  ACUTE ON CHRONIC RESPIRATORY FAILURE 1/31/2022 UNSPECIFIED ANXIETY
She experienced sensitivity around injection site; She experienced warmness to touch around injection site; Itchy around injection site; She experienced swelling around injection site; She experienced redness around injection site; Fatigue; Body aches; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (She experienced sensitivity around injection site), VACCINATION SITE WARMTH (She experienced warmness to touch around injection site), VACCINATION SITE PRURITUS (Itchy around injection site), VACCINATION SITE SWELLING (She experienced swelling around injection site) and VACCINATION SITE ERYTHEMA (She experienced redness around injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included HYDROCHLOROTHIAZIDE, ENALAPRIL, LEVOTHYROXINE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), METFORMIN, VITAMIN C [ASCORBIC ACID], ELDERBERRY [SAMBUCUS NIGRA], VITAMIN D3 and ZINC for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced VACCINATION SITE REACTION (She experienced sensitivity around injection site), VACCINATION SITE WARMTH (She experienced warmness to touch around injection site), VACCINATION SITE PRURITUS (Itchy around injection site), VACCINATION SITE SWELLING (She experienced swelling around injection site), VACCINATION SITE ERYTHEMA (She experienced redness around injection site), FATIGUE (Fatigue), MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Fever and Chills, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (She experienced sensitivity around injection site), VACCINATION SITE WARMTH (She experienced warmness to touch around injection site), FATIGUE (Fatigue), MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown and VACCINATION SITE PRURITUS (Itchy around injection site), VACCINATION SITE SWELLING (She experienced swelling around injection site) and VACCINATION SITE ERYTHEMA (She experienced redness around injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list also included Black Seed oil tablet.