chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; lot that had been expired was administered to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (lot that had been expired was administered to patient) and NO ADVERSE EVENT (No adverse event) in a 58-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (lot that had been expired was administered to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (lot that had been expired was administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (lot that had been expired was administered to patient).    Patient age was reported as 58 Year 10 Month. No concomitant medication was provided. ID number was reported as 80777027399. Treatment medication was not provided by the reporter.
Swelling, erythema, warmth of deltoid muscle. Bruising at site.
Sick; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Sick) in a 70-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included Flu (had flu may be once or twice in 70 yrs.).    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick). At the time of the report, ILLNESS (Sick) had resolved. Not Provided          No relevant concomitant medications were reported. It was reported the patient got Moderna covid shot and booster.   No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-690385, US-MODERNATX, INC.-MOD-2022-690377 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-690377:Reporter's Case US-MODERNATX, INC.-MOD-2022-690385:MOD-2022-690376 - Reporter's Case
Seizure like activity within minutes after vaccine; pt does have history of seizure disorder as well as some non-epileptic spells
The child returned one week after vax with a 25 cent piece sized hardened area and with slight bruising evident.
Patient had lightheadedness and lost consciousness for 3-5 seconds before regaining consciousness, she then proceeded to use the bathroom to vomit, before returning to the waiting area and drinking some water.  After a few minutes, she was feeling much better.
Site: Pain at Injection Site-Medium, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Headache-Severe, Systemic: Nausea-Severe
This spontaneous report was received from a pharmacist and refers to a female patient of an unknown age. The patient had no pertinent medical history and no concomitant medications. She was allergic to penicillin and cephalosporins. On 10-AUG-2018, the patient was inadvertently vaccinated with an expired dose of VARIVAX lot# M030138, expiration date: 15-JUN-2018 (exact dose and route of administration were not reported) for prophylaxis, reconstituted with sterile diluent (MRK INJ) lot# N034444, expiration date: 27-MAR-2019. On an unknown date in August 2018 (reported as after the vaccination), the patient experienced raised, red, warm welt-like area at injection site. The patient did not seek medical attention, no treatment was given for the events. No lab diagnostic tests were performed. The outcome of the events was reported as recovered on an unknown date. The relatedness between the events and suspect therapies was not reported.
pt has systemic itching without airway concern , no chest pain/pressure, shortness of breath
Tender, itchy, red, swollen, warm by injection site 9 days after first dose.
Information has been received from a registered nurse concerning a 20 year old female with no relevant medical history and no known drug allergies who was vaccinated with a first and second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) on 09/23/1983 and on 08/20/1993, respectively (Lot # not provided).  There was no concomitant medication.  On 07/30/2002, a rubella titer was done and it was negative.  Unspecified medical attention was sought.  Additional information has been requested.
had my booster on 12/06/21 and suffered a stroke; This spontaneous case was reported by an other health care professional and describes the occurrence of CEREBROVASCULAR ACCIDENT (had my booster on 12/06/21 and suffered a stroke) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Dec-2021, the patient experienced CEREBROVASCULAR ACCIDENT (had my booster on 12/06/21 and suffered a stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (had my booster on 12/06/21 and suffered a stroke) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Company Comment This case concerns a patient of unknown age and gender, with no relevant medical history reported, who experienced the unexpected event of cerebrovascular accident. The event occurred 13 days after the third dose of mRNA-1273. The rechallenge was not applicable since the events happened after the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender, with no relevant medical history reported, who experienced the unexpected event of cerebrovascular accident. The event occurred 13 days after the third dose of mRNA-1273. The rechallenge was not applicable since the events happened after the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
I developed pain in right first MTP joint at about 8 hour.  No prior h/o gout or other arthritis in that joint in past.  Over the next 30 hours pain intensified and was associated with swelling, warmth, but no redness.  Limited range of motion d/t pain and restricted activity as a result.  No other joint issues or arthralgias, myalgias, fever, chills arm pain at injection site or any other significant symptoms.  I took 3 doses of naproxen 440 mg 12 hours apart and the swelling and pain are significant ly improved at about 50-60 hours after vaccination.  I researched gout as this seemed suspicious and it is reported in the literature that vaccination is a risk factor for precipitating gout attacks which I have never experienced.  It never reached the point of severity that I wanted to get arthrocentesis done to prove it was gout, but since this vaccine is new I felt it was important to report my experience.
Right side directly to the side of breast hurt within 3 hours.   I could not take deep breath without feeling that pain.  It is still that way today on the 24th. Cramps . Very strong Very painful stomach cramps.
Fever 102.2, body aches, fatigue, pain and redness at injection site
Hives all over body and legs sudden and lasting 48 hours. BENADRYL did not have an effect. Hives moved all over body and would come and go in the same location. Pt was prescribed oral steroids and  BENADRYL 0n 8/29/18. Neither had an effect. After 48 hours, the hives subsided on its own. No new occurrences or products were used at home when she broke out in sudden hives. Pt saw the nurse practitioner at the office. Dr is the pt's regular doctor and was updated on her hives by pt's mother during the office visit. Pt's hive were extreme and prolonged all over her body, legs, and face. They would reoccur in the same spots.
14 dead relatives and friends that took that; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 7-Jul-2022 Reporter's Comments: This case was reported by a patient's relative or friend via interactive digital media. The reporter reported that she/he had 14 dead relatives and friends that took that crap poison (Shingles vaccine). Additional Supportive Information:  The follow-up would not possible as no contact details were available. This case is 1 of 16 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR104773:Same reporter US-GLAXOSMITHKLINE-US2022AMR104782:Same reporter US-GLAXOSMITHKLINE-US2022AMR104785:Same reporter US-GLAXOSMITHKLINE-US2022AMR104786:Same reporter US-GLAXOSMITHKLINE-US2022AMR104787:Same reporter US-GLAXOSMITHKLINE-US2022AMR104789:Same reporter US-GLAXOSMITHKLINE-US2022AMR104793:Same reporter US-GLAXOSMITHKLINE-US2022AMR104794:Same reporter US-GLAXOSMITHKLINE-US2022AMR104795:Same reporter US-GLAXOSMITHKLINE-US2022AMR104796:Same reporter US-GLAXOSMITHKLINE-US2022AMR104797:Same reporter US-GLAXOSMITHKLINE-US2022AMR104799:Same reporter US-GLAXOSMITHKLINE-US2022AMR104801:Same reporter US-GLAXOSMITHKLINE-US2022AMR104876:Same reporter US-GLAXOSMITHKLINE-US2022AMR104854:Same reporter; Reported Cause(s) of Death: Unknown cause of death
tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer (patient). The consumer reported for self and husband. This is the first of two reports, and concerns the reporter (patient). A patient of an unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EJ1685/expiration date: 31Mar2021), via an unspecified route of administration, on 19Dec2020, as a single dose for COVID-19 immunization. Relevant medical history and concomitant medication were not provided. On an unspecified date in Dec2020, the patient tested positive for COVID. The outcome of the event tested positive for COVID was unknown.
right deltoid swelling, erythema, superficial exconations, min tenderness to palpition
Case previously recorded as MA2009-6109. Case received on 25 NOV 2009 via agency from a healthcare professional the following information: A 62-year-old male patient was vaccinated i.m. with a partial dose FLUVIRIN, batch no. unknown on an unknown date. No adverse events were reported. MedCom no:NA09-008801.
no adverse event; patient received expired vaccine dose; This spontaneous case was reported by an other health professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired vaccine dose) and NO ADVERSE EVENT (no adverse event) in a 24-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 074B22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 14-Mar-2023, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 14-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired vaccine dose). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). On 14-Mar-2023, EXPIRED PRODUCT ADMINISTERED (patient received expired vaccine dose) and NO ADVERSE EVENT (no adverse event) had resolved.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient received expired vaccine dose).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.
sore arm; why i was part of the may be 1% whose appendix hot infected; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and APPENDIX DISORDER (why i was part of the may be 1% whose appendix hot infected) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and APPENDIX DISORDER (why i was part of the may be 1% whose appendix hot infected). At the time of the report, PAIN IN EXTREMITY (sore arm) and APPENDIX DISORDER (why i was part of the may be 1% whose appendix hot infected) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Dec-2021: Follow up received include new event information.
No additional AE; VARIVAX that had undergone temperature excursion; This spontaneous report has been received from a registered nurse concerning a 11-month-old patient of unknown gender. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On an unknown date, a temperature excursion occurred for varicella virus vaccine live (oka/merck) (VARIVAX), in a timeframe of 1 hour and 45 minutes. A previous temperature excursion was also reported.  On 15-SEP-2022, the patient received a vaccine dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U039726, expiration date: 15-DEC-2023) (dose, route of administration and anatomical location were not provided) as prophylaxis (product storage error). No additional events were reported (no adverse event).
This case was reported by a healthcare professional and described a 35 year old male subject who tested positive for hepatitis B surface antigen following vaccination with hepatitis B vaccine for prophylaxis. The subject's medical history included positive hepatitis C. On 31 October 2006 the subject received unspecified dose of hepatitis B vaccine. On 01 November 2006, 1 day after vaccination with hepatitis B vaccine, the subject tested positive for hepatitis B surface antigen. On 31 October 2006, the subject also received an unspecified dose of hepatitis a vaccine. The outcome of the event was not reported. Follow-up was received from the healthcare professional on 19 December 2006. The subject received Twinrix rather than separate injections of hepatitis B vaccine and hepatitis A vaccine as initially reported. The subject received the 1st dose of Twinrix on 31 October 2006 and tested positive for hepatitis B surface antigen on 01 November 2006. The immunization series with Twinrix was delayed "until the follow-up blood work results were available." On 08 December 2006, a repeat test for hepatitis B surface antigen was negative and serology results for hepatitis B core IgM were negative.
NON-LETHAL HEART ATTACK - REDUCED LUNG CAPACITY BY 25-30%
mom states took pt to ER 25JAN96;pt passed out, went limp & turned blue;stayed in hosp x 4 days;pt fine now
Approximately 1 week after my 2nd booster shot (Dose 4) I tested positive for COVID-19 and have the following symptoms: Just a little bit of sneezing (Asymptomatic). I took a home test to check if I have COVID-19 and I did. As of now I am isolating for 10 days.
Vaccine approved for persons 18 and up. Patient was 17 at time of administration.
Hearing loss; Inner ear issues / Damage to the inner ear; Breathing issues; Issues with eyes; Breast soreness on the right sore.; Sore lymph nodes; Diarrhea; Nausea; This is a spontaneous report from a contactable consumer (patient). This consumer reported events for two separate vaccine doses. This is the second of two reports. This report is for the events related to the second vaccine dose. This report is serious. The additional report is non-serious.   A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via an unspecified route of administration in the right arm on 06Apr2021 (Batch/Lot Number: EP6955) as a single dose for COVID-19 immunization at a church. Medical history included MGUS (Monoclonal gammopathy of unknown significance / hypergammaglobulinaemia benign monoclonal) and drug hypersensitivity (the patient has known allergies to Penicillin and Macrobid). Historical vaccine included the patient previously received the first dose of BNT162B2 vaccine (Batch/Lot Number: unknown, at the age of 50 years) in the right arm on 16Mar2021 at 11:30 AM for COVID-19 immunisation and experienced soreness and arm pain at injection site along with minor breathing difficulties on 16Mar2021. The patient did not received any other vaccine within four weeks prior to receiving the BNT162B2 vaccine. The patient did not have COVID-19 infection prior to receiving the BNT162B2 vaccine. Concomitant medication included levothyroxine, liothyronine (NP THYROID), epinephrine (ADRENAL), estradiol and famotidine. Past drug history included the patient previously took clarithromycin (MACROBID) and Penicillin and experienced drug hypersensitivity. On 06Apr2021, the patient received the second dose of the BNT162B2  vaccine. In Apr2021, the patient still has breathing issues after two weeks. In Apr2021, a few days after the second dose of the vaccine, the patient started having inner ear issues, nausea when breathing gets more labored, diarrhea and issues with her eyes. The patient reported that the main issues are the breathing and the damage to the inner ear causing temporary hearing loss. This was the right ear. Also, she had really sore lymph nodes and breast soreness on the right side. Her ear was getting worse after two weeks. The events resulted in a doctor or other healthcare professional office/clinic visit. No treatment was received. The patient did not get tested for COVID-19 post vaccination. The outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021440332 same patient, different events that occurred after each dose
Extreme fatigue Severe aches at base of skull, lower back, right hip Alleviated by resting and taking ibprophen. Symptoms lasted approximately 24 hours.
Auto Immune Hepatitis  I suspect Covid vaccine to be the cause. Not all care providers are in agreement and none are on the record.  My biopsy references the condition as chronic but blood work pre Vaccine was normal.    Any suspected cases are reported.   My diagnosis did not come until April  of 2022 but I ignored minor symptoms for about a year.
Pt states she felt "10 times worse" than her "worse day of COVID". C/O "horrible headache", "way worse than a migraine", as well as shortness of breath and body aches. Went to the ED at approximately 4:30 a.m. on 12/31/2020 due to the inability to relieve her headache with two separate doses (several hours apart) of 600mg then 800mg of OTC Motrin.
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Systemic: Fever-Mild
Not enough sterile diluent was added to the Pfizer vial prior to administration of the vaccine to the patient. It is likely that the patient did not receive enough MRNA to qualify as a booster dose.
blood clots; life threatening blood clots/ had blood clots that were 60% blockage from the brain/ The clot is in her neck was reported as worsened.; minor strokes; This is a spontaneous report from a contactable consumer or other non hcp. An 8 decade elderly (late 70's; unit: not provided) old female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: was not reported) via an unspecified route of administration on Feb2021 as dose number unknown, single for covid-19 immunisation. Unable to provide patient's date of birth or current weight. Patient took vaccine as she was elderly, wanted to protect herself from COVID virus, first was avail, and want to be first protected. Reporter unsure if patient had both shots. Medical history included high cholesterol and heart murmur from an unknown date and unknown if ongoing in the past, but caller does not know if it corrected itself in the past. Family Medical History Relevant to AE was none. Prior Vaccinations within 4 weeks was unknown. AE following prior vaccinations was None. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as none. Additional Vaccines Administered on Same Date of the Pfizer Suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect was reported as none. The patient's concomitant medications were not reported. On unspecified date in Feb2021 the patient experienced blood clots, life threatening blood clots/ had blood clots that were 60% blockage from the brain/ the clot is in her neck was reported as worsened and minor strokes. On unspecified date in Feb2021 the patient underwent lab tests and procedures which included x-ray result with blood clots (60%-80%). The doctor wanted to schedule her for immediate surgery, but they were trying to get her booked and they were all booked up. They said they can put her on a blood thinner medication, but she was already on a blood thinner. They had wanted to switch her from the current blood thinner she was on for another illness (not sure if it's for her age or cholesterol), to another one. Patient was on a blood thinner prior to getting the COVID shot, and she didn't want to switch up the blood thinners. Therapeutic measures were taken. The outcome of the event was not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Vaccination given at 1420. That evening she developed increased temp, nausea, and hives. Swollen eyes and general malaise. She took Tylenol. At 0900 the next day she still had allergy symptoms. 25mg of Benadryl given. Symptoms decreased.
This spontaneous report as received from a pharmacist refers to a 72 year old female patient. No known drug allergies were reported. The patient had never had chicken pox. On 27-JUN-2013 at 10:00 am, the patient was vaccinated with ZOSTAVAX (lot # H020683, exp. date 15-FEB-2013), 0.65 ml, subcutaneous. Concomitant medications included unspecified antihypertensive medication. On 27-JUN-2013, "around 08:00 pm" the patient began vomiting and "vomited all night until the morning". The pharmacist reported that the patient was "very weak". The pharmacist advised the patient to drink GATORADE and replenish her fluids and electrolytes so that patient did not get dehydrated. The outcome of events was reported as recovering/resolving. The relationship between ZOSTAVAX and the events was not reported. Additional information has been requested.