chrisvoncsefalvay/vaers-outcomes huggingface dataset:
LOW PLATELET COUNT; INFLAMED LIVER; BLOOD CLOTS; HEADACHES; This spontaneous report received from a patient, via social media, via a company representative concerned a 33 year old male. The patient's weight, height, and medical history were not reported.  The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, two weeks after vaccination, the patient experienced headaches, low platelet count, inflamed liver, and blood clots. It was stated the patient had an inflamed liver because of all the blood clots found; the patient is now on blood thinners for a minimum of 6 months. Laboratory data (dates unspecified) included: Low platelets (NR: not provided) 26K. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The outcome of the headaches, inflamed liver, blood clots and low platelet count was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report received from a patient, via social media, via a company representative concerned a 33-year-old man who experienced blood clots and low platelet (26,000) count two weeks after vaccine. Medical history, concomitant medications, and other details were not reported. It was stated the patient had an "inflamed liver because of all the blood clots found"; the patient is now on blood thinners for a minimum of 6 months. Information is limited in this case, and the occurrence of blood clots and low platelet count could represent background incidence of such events in the general population. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate (Brighton Collaboration Criteria level 5).
This spontaneous report as received from a licensed practical nurse refers to a 3 months old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-SEP-2015, the patient was vaccinated with the first dose of ROTATEQ (orally, lot # K002991; dose and expiration date were not reported) that had experienced a temperature excursion. On 14-DEC-2015, the patient was vaccinated with the second dose of ROTATEQ (orally, lot # L013202; dose and expiration date were not reported) that had experienced a temperature excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Diffused red rash (similar to rash experienced with sulfa drug) from top of chest to neck. No itching at first sign of rash, but itching developed later that day and has persisted for a few days.
16 year old patient made an appointment and came in with her father. The consent form form was completed and signed by patients' father. Patient received the vaccine before we caught the fact that the patient was 16 years old. Patient was observed for approx. 20 minutes with no ill effects.
I still got infected after being vaccinated/Got COVID after receiving vaccine; I still got infected after being vaccinated/Got COVID after receiving vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I still got infected after being vaccinated/Got COVID after receiving vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
received a vaccine which was more than 30 days in the refrigerator; received a vaccine which was more than 30 days in the refrigerator; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (received a vaccine which was more than 30 days in the refrigerator) in an 85-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history and laboratory data was provided by the reporter.     On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (received a vaccine which was more than 30 days in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (received a vaccine which was more than 30 days in the refrigerator) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Information has been received from an NP concerning a 26 year old female pt with no known allergies who on 7/9/01 was vaccinated with MMRII, SC (lot 637433/0149L). Concomitant therapy included Hep-B, IM (lot 637981/0283L). On 7/12/01, the pt developed a low-grade temperature (99.5F) and swelling and heat at the site of injection. On approx. 7/14/01, 2-3 days, the low-grade temperature, swelling and heat at the injection site resolved. No additional information is expected.
SLIGHTLY ENLARGED AXILLARY LYMPH NODES AND LEFT CERVICAL LYMPH NODES
08:32 -> Face neck feel like they are "on fire" - cold rag placed. 09:11 -> Itching in BUE - MD paged twice [shortness of breath, wheeze, swelling, etc]. 09:40-> MD at clinic ordered CLARITIN hydroxyzine. Pt has less redness/itching. 10:00 -> CLARITIN given - hydroxyzine given. Pt has no itching or redness anymore.
Patient experienced redness and swelling at site of injection. In addition, patient had body aches and her bones/joints were hurting all over.
NA 9/11/07 Received Autopsy Report which states COD as probable suffocation secondary to being placed face down on top a large pillow in the bassinet & having significant livor & blanching of the head & face.
LOWER PART OF LEFT LEG FROM ANKLE UP TO KNEE PERIODICALLY PAINFUL- NOT SHARP PAIN JUST AN ACHE; HEADACHE; FEVER 106 DEGREES; MUSCLE ACHE; STOMACH CRAMPS; SEVERE RINGING IN EARS; RUNNY NOSE; STUFFY NOSE; TROUBLE BREATHING IN MORNING; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included asymptomatic covid, and concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 at  right arm for prophylactic vaccination. No concomitant medications were reported. On 27-MAR-2021, the subject experienced stomach cramps. On 27-MAR-2021, the subject experienced severe ringing in ears. On 27-MAR-2021, the subject experienced runny nose. On 27-MAR-2021, the subject experienced stuffy nose. On 27-MAR-2021, the subject experienced trouble breathing in morning. On 27-MAR-2021, the subject experienced headache. On 27-MAR-2021, the subject experienced fever 106 degrees. On 27-MAR-2021, the subject experienced muscle ache. Laboratory data included: Body temperature (NR: not provided) 106 F. On 28-MAR-2021, the subject experienced lower part of left leg from ankle up to knee periodically painful- not sharp pain just an ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach cramps, severe ringing in ears, trouble breathing in morning, headache, and fever 106 degrees on 27-MAR-2021, had not recovered from runny nose, stuffy nose, and lower part of left leg from ankle up to knee periodically painful- not sharp pain just an ache, and the outcome of muscle ache was not reported. This report was non-serious.
Swollen/sore left armpit. Lasted for the next 3 days. Wasn?t extreme, could still use arms but was uncomfortable and slightly painful.
Received varicella vaccine (dose #2)  2 days ago and developed itching/swelling of R upper arm at injection site the following day. C/o mild pain. Denies fever, fatigue, malaise, SOB, or rash anywhere else.  R posterior upper arm with 13 by 9 cm area of redness, warmth, and induration. R radial pulse normal. No axillary lymphadenopathy or tenderness. Appeared well, non-toxic. Patient was walked over to urgent care for evaluation.
COVID 19 Treatment; Rebound of covid virus because of Paxlovid.; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EL9264), in right arm and on 22Feb2021 as dose 2, single (Lot number: EN6203) at the age of 45 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Nov2021 as dose 3 (booster), single (Lot number: 017F21A), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset Aug2022, outcome "recovered" (Aug2022), VACCINATION FAILURE (medically significant) with onset 26Aug2022, outcome "not recovered" and all described as "COVID 19 Treatment"; DISEASE RECURRENCE (medically significant) with onset 26Aug2022, outcome "recovering", described as "Rebound of covid virus because of Paxlovid.". The patient underwent the following laboratory tests and procedures: SARS-CoV-1 test: (24Aug2022) Negative, notes: Tested negative by day 8 and again on day 10; (26Aug2022) Negative, notes: Tested negative by day 8 and again on day 10; (26Aug2022) Positive, notes:Left isolation, my negative test had turned positive when I saw it that night; (27Aug2022) Positive, notes: so retested and was positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of disease recurrence. Clinical course:Symptoms of virus returned morning of day 11 with sore throat. No other medication in 2weeks was reported.
Expired dose of Havrix administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 25-year-old male patient who received HAV (Havrix) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 17-MAR-2023, the patient received Havrix. On 17-MAR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired dose of Havrix administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date:20-MAR-2023 The nurse reported that a patient administered a expired dose of Havrix.  The reporter consented to follow up. The patient was administered with expired vaccine of Havrix which led to Expired vaccine used.
They feel like their face is on fire; had like a sunburn mostly their face; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (They feel like their face is on fire) and SUNBURN (had like a sunburn mostly their face) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concomitant products included DOXYCYCLINE for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced FEELING HOT (They feel like their face is on fire) and SUNBURN (had like a sunburn mostly their face). At the time of the report, FEELING HOT (They feel like their face is on fire) and SUNBURN (had like a sunburn mostly their face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that after experiencing the events the patient applied 30 sunblock.
Pt recv vax on 11/23/98; 3 min post vax pt exp red, warm, swollen vax site; hives on chest, neck; chest tight; tx=Benadryl, Epi kit
2 day post vac 3x6 cm rash warm rasied hwere Rx L arm.
I got an extremely painful stiff neck on same day as Moderna Shot 2, and was unable to sleep for 3 full days from the intense pain in my neck. I am still having a horrible neck ache over 2 weeks later. Also had bad chills, fever, headache, vomiting, severe muscle aches & pains, severe joint pain. Was ill for 5 days with all symptoms, am still dealing with the intense stiff neck, & severe neck pain.
Patient was fully vaccinated for COVID 19 with Pfizer (3/18/21 and 4/8/21). She presented to the ER for symptoms of abdominal pain. She also reported low back pain that radiated down her legs and up her back. She also had a cough, but no SOB. She was fully vaccinated, but noted to have COVID-19 positive individuals in her home. Her COVID PUI LIAT test was found to be positive in the ED. She had reassuring CT scan and was discharged home with close follow-up.
urticaria @ site of 1 of 3 vax & on trunk;rx DPH;
Red rash on arm. Started at injection site and moved out to about the size of a lemon. Some itching. Using ice and an antihistamine.
Sore at the injection site, fever, chills, body aches, sore muscles, head ache, fatigue
Skin rash and urticaria pruritus. Diphenhydramine 25 mg PRN.
This spontaneous report was received a female patient of unknown age, who was reporting on herself. On an unknown date, the patient had been vaccinated with an unspecified shingles vaccine. No other information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a booster dose (also reported as "doses") of shingles vaccine ZOSTAVAX could not be ruled out) (manufacturer, route of administration, lot number and expiration date were not reported). On an unknown date the patient experienced asthma. It could not be determined if the patient had asthma prior to receiving shingles vaccine (manufacturer unknown). As treatment for asthma, the patient was taking mometasone furoate (+) formoterol fumarate (DULERA) inhalation. The outcome of asthma was not reported. The relatedness between asthma and shingles vaccine (manufacturer unknown) was not provided. Additional information is not expected as no contact details were provided.
SEVERE SWELLING, WARMTH, AND PAIN IN LEFT ARM. WENT TO EMERGENCY ROOM TWICE AND THEN WAS ADMITTED FOR TREATMENT.
exposure made it first two weeks; Sinus; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age reported that she received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced exposure made it first two weeks (exposure to sars-cov-2) and sinus. First dose 05Mar2021. Miscalculated quarantine period exposure made it first two weeks. Second weeks no symptoms, testing negative. Sinus. I am wondering. Two times I was exposed. They had a mask on. Where would that leave me? Miscalculated. If I am fighting it, and I am adding? Potential AE. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Right back of arm 2 in x 1 in red area, non-raised, no complaints of itching, afebrile, no numbness or tingling of extremity. Full ROM present.
At almost exactly 12 hours past 2nd vaccination it started instantly with severe chills, vomiting then fever ranging 101.2-101.7. Fever continued for about 24 hours along with chills, headache, arm pain and body aches. 24-48 hours still suffering severe headache and arm pain which includes it be swollen, warm to touch and a red circle (rash like) the size of a baseball.
This spontaneous report as received from a nurse and a nurse manager refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On the following dates: 29-OCT-2015, 03-DEC-2015, 11-DEC-2015 and 22-DEC-2015, the unspecified patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection (lot# L004754, expiry date 10-NOV-2016; dose and route of administration were not reported). There were no concomitant therapies reported. The nurse manager stated that the doses of RECOMBIVAX HB were exposed to the temperature of 34.7 degrees Fahrenheit for a total cumulative time of 31 minutes. No adverse effects were reported. There was no product quality complaint involved. This is one of two reports received from the same reporter. Additional information is not expected as the reporters declined any further contact.
This spontaneous report as received from a consumer via Clinic refers to a currently 90 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-OCT-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX 23 1 dose unit (lot # M036728, Expiry date was not reported) for prophylaxis (product storage error). There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1801USA000166:
L arm - distal from vaccine site, developed 5x4 cm red, raised & firm spot. Took ibuprofen 400mg. Emp. also started experiencing sore throat & nasal congestion over the weekend after she started having the above symptoms.
CHILLS; HEADACHE; This spontaneous report received from a patient concerned a 57 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN: expiry date: UNKNOWN) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, the subject experienced chills. On 2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and headache on 2021. This report was non-serious.
After 2nd shot, I got headaches and had super low energy, fatigue the day after the shot.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 59year old female. 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: 1805031, and expiry: 10-JUL-2021) dose was not reported, 1 total administered on 12-MAR-2021 for prophylactic vaccination to the left arm. No concomitant medications were reported. On 19-JUL-2021, the patient consulted with Primary care physician (PCP), and ordered antibody tests (immunoglobulin IG test and spike test) against COVID-19. On 26-JUL-2021, the test result came as negative with zero antibody. The incubation period of 28 days has been completed (confirmed immunological vaccine failure). The patient's PCP recommended her to get a shot of the Pfizer vaccine but her local pharmacist said it was against the Centers for Disease Control (CDC) protocol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210757801:Covid-19 Vaccine Ad26.Cov2.S : Confirmed immunological vaccine failure. This event(s) is considered not related. 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
This initial spontaneous report was received from a nurse referring to an unspecified number of patients of unknown ages and genders. Concurrent conditions and medical history were not provided. The nurse stated that on an unspecified dates, "about 250" patients received doses of improperly stored vaccines, within them GARDASIL injection (dose, route, lot number and expiration date not provided). There was no concomitant medication described. No adverse effect reported. This is one of several reports received from the same reporter. Additional information ha been requested,
sporadic hives and I have never had them. I am taking Benadryl twice a day. Hydrocortisone on spots. Still having reactions.
A report was received from a health care professional on 11/11/03 concerning an unspecified number of vaccinees who inadvertently received 1ml of Fluvirin on an unspecified date. On an unspecified date an unspecified number of vaccinees received 1ml of Fluvirin. No adverse symptoms were exhibited at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 12/4/03: An update report was received from a health care professional concerning a 96 year old female vaccinee who inadvertently received 1ml Fluvirin SC on 10/31/03. On 10/31/03 the vaccine inadvertently received Fluvirin SC. No adverse symptoms were exhibited at the time of reporting. No follow up pending.
Sick; 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 ILLNESS (Sick) 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 ILLNESS (Sick). At the time of the report, ILLNESS (Sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No patient details provided  No treatment and concomitant medications were reported.
Patient had received Janssen vaccine on 7/15/21, but was admitted for COVID infection issues.