chrisvoncsefalvay/vaers-outcomes huggingface dataset:
OFF LABEL USE; RECEIVED ONLY 2.5ML OF THE JANSSEN COVID-19 VACCINE; This spontaneous report received from a health care professional concerned a 47 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: 14-DEC-2021) 2.5 ml, administered on 14-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-NOV-2021, the patient experienced received only 2.5ml of the janssen covid-19 vaccine. On an unspecified date, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of received only 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211220916, 20211219681, 20211220301, 20211220527, 20211220697 and 20211220928.
Patient passed out after the vaccination while she was waiting 15 minutes post immunization. I was alerted and she was on the floor. She said she had dozed off from the chair and the next thing she knew she feel
did not receive second dose of Moderna Covid-19 vaccine within 35 days of first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not receive second dose of Moderna Covid-19 vaccine within 35 days of first dose) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular)  (lot no unknown) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not receive second dose of Moderna Covid-19 vaccine within 35 days of first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (did not receive second dose of Moderna Covid-19 vaccine within 35 days of first dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.; Sender's Comments: .
Patient had cardiac reaction; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), in Feb2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious) with onset Feb2023, outcome "unknown", described as "Patient had cardiac reaction".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
8/10/2021 tested positive for COVID; 8/10/2021 tested positive for COVID; swollen sinuses with very little clear mucus from my nose; insomnia; sinus pressure; This is a spontaneous report from a contactable consumer. This 55-year-old female consumer(patient) reported for herself that: A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EN6199; Expiration Date: on an unspecified date in Jun2021), dose 2 via an unspecified route of administration on 08Mar2021 (age at vaccination was 55-year-old) as DOSE 2, single dose and dose 1 via an unspecified route of administration on 15Feb2021 (Lot Number: EL9261 and Expiry date was not reported) as DOSE 1, single dose, both for covid-19 immunisation. She was a Pfizer representative vaccinated with first dose 15Feb2021 and the second dose 08Mar2021. Medical history included anxiety from an unknown date and unknown if ongoing. Concomitant medications included escitalopram oxalate (LEXAPRO) taken for anxiety, start and stop date were not reported. Although overweight she relatively healthy. she exercises 50 minutes daily. On 04Aug2021 she came home from work early because she was so tired, constantly sneezing, on 05Aug2021 patient experienced sore throat, but she frequently had a sore throat, headache, fatigue/ tired, lots of drainage, sinus pressure, no energy, on 07Aug2021, she was feeling better just lots of congestion, lost taste, lost smell, on 10Aug2021, tested positive for covid, currently her symptoms are swollen sinuses with very little clear mucus from her nose, insomnia. Still having quite, a bit of drainage down my throat, sore throat, insomnia the last 2 nights. On 05Aug2021 and 06Aug2021 stayed in bed most of the days with symptoms listed above. She was able to clean house and steam all her floors. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 02Aug2021, sars-cov-2 test: tested again for covid on 09Aug2021, sars-cov-2 test: positive on 10Aug2021. Treatment received for the event insomnia was Ambien PRN. Outcome of the event covid 19 was unknown, sore throat, lots of drainage, swollen sinuses with very little clear mucus from her nose and insomnia was not recovered, and rest of the events was recovered.
Patient stated she experienced arm numbness/tingling and feelings of throat tightness a few hours following vaccination.
This case was reported by a consumer and described the occurrence of allergic reaction in a 79-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included Zoster vaccine with an associated reaction of herpes zoster (had the original Zoster vaccine in 2010 and contracted Shingles in 2014). On 15th May 2018, the patient received the 2nd dose of SHINGRIX. In May 2018, 3 days after receiving SHINGRIX, the patient experienced allergic reaction, pruritus, itchy rash and varicella. On an unknown date, the outcome of the allergic reaction and varicella were unknown and the outcome of the pruritus was not recovered/not resolved and the outcome of the itchy rash was recovered/resolved. The reporter considered the allergic reaction, pruritus, itchy rash and varicella to be unrelated to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX shot from his health provider. About three days after receiving this last SHINGRIX shot the patient began suffering severe itching, starting on the palms of my hands and moving to my feet and other parts of my body. At one point for a week or so he had red itching bumps on his back resembling chicken pox, but the dermatologist did a biopsy and it concluded it was some allergy to a medication, but the patient was not taking any that could have caused that. The patient stated, that did clear up, but he was having frequent itching on his hands, feet, arms and so on other areas at the time of reporting. After several visits to the dermatologist, allergist and the patient's primary internist, he had not received any definite cause or effective relief from his itching. In the week before reporting the patient's internist did a very thorough blood test and abdominal sonogram and did not find anything abnormal in it. All the physicians did not believe that the patient's symptoms could have been caused by the SHINGRIX vaccine, but, since they were so close to the Shingles that he had in 2014 and started so soon after the SHINGRIX shots it seemed like more than a coincidence to him. The patient thought he would just contact the company to see if they could confirm if there could be any possibility of a reaction or not. The patient appreciated the representative's attention and did appreciate the development of the product SHINGRIX to greatly decrease the occurrence of the very painful Shingles disease for so many in the future.
t101; diaphoretic; eyes nystagmus generalized tremor; lt to rt movement of tongues, high pitched cry; sz;
Headache; Dizziness; Nausea; Fever 100.6; Fell in shower; Lethargic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 11 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 27Nov2021 17:00 (Batch/Lot number: unknown) at the age of 11 years as dose 2 (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 06Nov2021, when the patient was 11 years old, for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 28Nov2021 09:00, outcome "not recovered", described as "Headache"; DIZZINESS (non-serious) with onset 28Nov2021 09:00, outcome "not recovered", described as "Dizziness"; NAUSEA (non-serious) with onset 28Nov2021 09:00, outcome "not recovered", described as "Nausea"; PYREXIA (non-serious) with onset 28Nov2021 09:00, outcome "not recovered", described as "Fever 100.6"; FALL (non-serious) with onset 28Nov2021 09:00, outcome "not recovered", described as "Fell in shower"; LETHARGY (non-serious) with onset 28Nov2021 09:00, outcome "not recovered", described as "Lethargic". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, dizziness, nausea, pyrexia, fall, lethargy.  Additional Information: The treatment received for the adverse event was Tylenol. The patient was not diagnosed with Covid-19 prior to vaccination. The patient has not been tested for Covid-19 since the vaccination.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sick after receiving Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick after receiving Vaccine) 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 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced ILLNESS (Sick after receiving Vaccine). At the time of the report, ILLNESS (Sick after receiving Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter.  Treatment information was not provided.
Pt reportedly received FLUMIST at school 10/10/11 pt with hx RAD - occasional inhaler use - per mom --> form was completed for consent to get FLUMIST by her but she didn't indicate on the form that pt had hx wheezing/asthma - Pt had felt chest tightness, throat tightness for approximately 2 hr after - relieved inhaler use.
Pt. called to report that she has physician - diagnosed shingles in spite of having received ZOSTAVAX 5 1/2 yrs ago. On 1/20/13 had onset of severe (L) side back pain. On 1/24/13 noted 2 red spots on (L) breast which progressed to multiple spots on (L) chest, back & axilla - spots progressed to blisters - pain subsided somewhat - seen at urgent care with dx of shingles on 1/26/13. Rx - Prednisone, acyclovir, hydrocodone.
During his 30 minute waiting period after the injection, the patient began to experience itching; Systemic reaction (hypoglycemia, hypotension, generalized rash); Systemic reaction (hypoglycemia, hypotension, generalized rash); Systemic reaction (hypoglycemia, hypotension, generalized rash); This is a spontaneous report from a non-contactable Other Healthcare Professional reporting for a patient. A 78-years-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6206) via an unknown route of administration on an unknown date as first dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, during his 30 minute waiting period after the injection, the patient began to experience itching and the differential diagnosis was systemic reaction (hypoglycemia, hypotension, generalized rash). Patient complained of itching of skin (chronic vs new itching). It was reported that patient denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, lightheadedness, dizz. Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, dizziness and headache facial swelling, lip swelling and tongue swelling. Patient was discharge as stable to go home and follow up with PCP. Patient reported immediately upon getting back to the bay that he doesn't think it's anything but his chronic itching that he gets. Patient declines feeling like this is an allergic response like he had in the past. Benadryl given as requested. The outcome of the events was unknown.  No follow-up attempts were possible. No further information was expected.
Itching at injection site; Red rash at injection site 10 days after vaccination and increasing in size; Red rash at injection site 10 days after vaccination and increasing in size; pain at injection site; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Mar-2021. The most recent information was received on 07-May-2021 and was forwarded to Moderna on 07-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE PAIN (pain at injection site), VACCINATION SITE RASH (Red rash at injection site 10 days after vaccination and increasing in size) and VACCINATION SITE ERYTHEMA (Red rash at injection site 10 days after vaccination and increasing in size) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site). On 14-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE RASH (Red rash at injection site 10 days after vaccination and increasing in size) and VACCINATION SITE ERYTHEMA (Red rash at injection site 10 days after vaccination and increasing in size). At the time of the report, VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE PAIN (pain at injection site), VACCINATION SITE RASH (Red rash at injection site 10 days after vaccination and increasing in size) and VACCINATION SITE ERYTHEMA (Red rash at injection site 10 days after vaccination and increasing in size) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  Treatment medication included antihistamine for itching.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow-up information received on 07-May-2021 included second dose details, events outcome and action taken updated.
She reported dizziness and fatigue, described as severe.  She reports spending much of the time since her visit in bed.  She has not been seen since the date that the vaccine was administered.
Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 05-APR-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Had shot on 3/25/2021. Had arm soreness for a few days then gone. On 4/2/2021 around 10:00 pm, experienced itching at site. The morning of 4/3, felt lump on injection area and itching. Looked in mirror and noticed a red rash about 2-3 inches in diameter.  Showed husband who told me to report it.
Systemic: Fainting / Unresponsive-Severe, Systemic: Shakiness-Medium, Systemic: Tachycardia-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: Pt said he was feeling tingling in arms and legs
This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via an unspecified route of administration in the left arm on 04Oct2021 at 11:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis (MS), Grave's disease, high blood pressure and bee sting allergy. The patient took unspecified concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccines within four weeks prior to the vaccination which included first dose of influenza vaccine (MANUFACTURER UNKNOWN) (reported as flu) via an unspecified route of administration in the arm on 28Sep2021 for immunisation. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM6202) via an unspecified route of administration in the left arm on 02Mar2021 at 13:00 (at the age of 58-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Mar2021 at 10:15 (at the age of 58-years-old); both as single doses for COVID-19 immunisation. On 09Oct2021 at 06:00, five days after the COVID-19 booster, the patient woke up with extremely swollen lips. She never had that happen before. 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 event which included application of ice and paraffin soft (VASELINE) and the swelling subsided slowly over about 24 hours. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extremely swollen lips was resolved on an unknown date in 2021.
This case was reported by a consumer and described the occurrence of feeling of burning in brain in a 30-year-old female patient who received TREXIMET tablet over a period of 9 days for migraine. A physician or other health care professional has not verified this report. The patient's past medical history included tonsils removed. Concurrent medical conditions included Crohn's disease. Co-suspect medication included Flu vaccine. Concurrent medications included IMURAN and LIALDA. On 23 October 2008 the patient started Naproxen + sumatriptan succinate (oral). Same day later, on 23 October 2008, the patient experienced feeling of burning in brain and body pain. Treatment with Naproxen + sumatriptan succinate was discontinued. At the time of reporting, the event were resolved. Patient stated that she took TREXIMET on October 23, 2008 and felt like her brain was on fire (which resolved after 3 to 4 hours) and experienced body aches which resolved on October 24, 2008. Patient experienced that same symptoms after taking a TREXIMET on October 31, 2008.
..... that turned to a rash. Started at neck and went down to hand........... started right after shot was received (about 2 hours post injection). "Tightness in chest".
expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 17-Aug-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up information was received include no new information.
pt describes foot pain which started only after vaccination. It is unclear that this is related but patient felt strongly it was possible
930PM lethargy-could not arouse p/prolonged sleep white as death per mom, limp, would not feed; hypotonic; hyporesponsive collapse most likely
redness mild facial swelling, fussiness, low grade fever, congestion, runny nose, diarrhea, vomiting seen in ed on 01/20/2023 given zofran, benadryl. tolerating pedialyte no further vomiting, redness and swelling on face improved, patient was given tylenol shortly before discharged home from ed.
It started with pressure in my ear and my ears were popping, I had a bad headache that became a migraine. Later that night I had excessive coughing, congestion, sore throat, and I was sneezing my head off. That was all at once in one day. A couple of days later I started throwing up and had nonstop diaharea, throwing up and nausea. I was taking OTC medications because I didn't realize I had COVID-19 because I've been using precautions until 3 days later. I then tested and it was positive, by then it was too late to take the antiviral. I still have fluid in one of my ears, a sinus infection, and a cough and dealing with fatigue a lot.
Patient stated today that she  believes that her skin is breaking out after having received the above vaccine on 12/22/21.
Information has been received from a physician assistant concerning a 15 year old female with a history of ulcerative colitis who was vaccinated with a dose of varicella virus vaccine live. The reporter indicated that the patient was vaccinated and a year or so later, had a severe case of chicken pox. She had been on steroid treatment when exposed to wild type chicken pox. Subsequently, the patient was hospitalized for three days. A product quality complaint was not involved. Additional information has been requested.
Shoulder pain starting the day after patient received flu vaccine on 10/5. Pain spread into neck and worsened over several days. Patient saw chiropractor (no adjustments, but "worked" on his neck with "tools") and then went to ED on 10/11. Patient had CT scan which was normal. ED note states no evidence of infection, myositis, or vascular injury. Neuro exam was normal. ED physician advised patient to use NSAIDs regularly to help with pain and pt was discharged from ED with prescriptions for hydrocodone/APAP and cyclobenazprine. ED note does not mention flu vaccine as a possible cause of the patients symptoms and it was not added to his allergy list. Note from PCP on 10/20 states patient still complaining of shoulder and neck pain. Performed Xray which was normal. PCP note did not list flu vaccine as a possible cause for the pain and it was not added as an allergy.