chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 28-Mar-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown demographic patient who was vaccinated with PENTACEL lot number not reported via intramuscular route in unknown administration site on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history and concomitant therapy were not provided. It is an actual medication error case due to Inappropriate reconstitution technique. It was reported that the patient received just the diluent of DTaP/IPV from the PENTACEL and not the HIB. It was not reported that the patient had adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
"Some soreness" after Vaccination; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (160354).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown  single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as ""Some soreness" after Vaccination".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021466770 same product/event, different patients
Blood clots have developed in both legs.  Started with swelling in feet and ankles and went to the doctor.  Ultrasound showed clot in artery behind left knee and second clot in right calf.
Pain in both arms, feverish, fatigue, nausea, headache, loss of appetite,
Fever 24 hours, chills 48 hours, body aches 60 hours, headache (ongoing), loss of appetite 48 hours, skin pain 24 hours, cough developing 24 hours after administering vaccine and is ongoing.
Patient presented on 3/29/21 with abdominal pain and was found to have acute pancreatitis not due to alcohol, gallstones, or hypertriglyceridemia. Patient was treated with supportive care and discharged from the hospital on 3/3/1/21.
Patient received booster during pregnancy; No adverse event; This spontaneous retrospective pregnancy case was reported by a patient and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Patient received booster during pregnancy) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient received booster during pregnancy) and NO ADVERSE EVENT (No adverse event). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Patient received booster during pregnancy) had resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown.    No concomitant and treatment medications were reported.  Patient received a booster while being pregnant. Patient received 4 doses of the Moderna COVID-19 vaccine.  Company comment: This spontaneous case concerns a pregnant patient of unknown age with no reported medical history who received the third dose of mRNA1273 at an unspecified stage of her pregnancy (maternal exposure during pregnancy). Latency of the event maternal exposure during pregnancy cannot be fully established since the exact onset date was not reported. The last menstrual period and gestational age of the patient was not provided in the case. Information regarding other COVID-19 vaccine were not mentioned. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-656363 (Patient Link).; Sender's Comments: This spontaneous case concerns a pregnant patient of unknown age with no reported medical history who received the third dose of mRNA1273 at an unspecified stage of her pregnancy (maternal exposure during pregnancy). Latency of the event maternal exposure during pregnancy cannot be fully established since the exact onset date was not reported. The last menstrual period and gestational age of the patient was not provided in the case. Information regarding other COVID-19 vaccine were not mentioned. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Allergy reaction, itching in my neck and my face. The doctor gave me too many cortisone ointments and 2 cortisone shots and cortisone tablets, sometimes I have some relief but at night is the worse, too much itching and I cannot sleep at all, somebody can help me.
Flu vaccine received 1145. Pre-screen negative; receives flu vaccine annually. Developed head ache a 1330; medicated with Tylenol 1400- experienced "chest tightness"; used inhaler; no results from inhaler. 1415 -administered albuterol 0. 083% updraft; symptoms continued; Assessed by Dr. epinephrine 1:000 and Benadryl IM ordered and  given. Respiratory symptoms gradually subsided. 1630- Patient experienced gradually increasing symptoms of upper airway "tightness"; upper body tremors; dizziness. VSS 1640- Assessed by Dr.; chest clear throughout. Dx allergic reaction to flu vaccine. 1645  Benadryl 25 mg IM given per order. 1700- Symptoms continued with no improvement; EMS activated. 1720- transported to ED via ambulance for treatment. Reported to have received IV solumedrol in ED with relief of symptoms. Discharged with oral prednisone and Epipen. 8/28/10- Seen in urgent care by NP for ongoing headache and "not feeling right". 8/30/10  Return to work; no symptoms. Fluzone 0.5mL; Lot UH181AC;  EXP 06/30/11
Itching and tenderness at injection site. About 1-2 hours after injection. Itching and skin irritation on chest. About 1-2 hours after. Headache. About 15 minutes after shot Arm tenderness a little while after shot and still sore.
Approximately 2-3 minutes after injections, patient's mouth started twitching causing it to be difficult for the patient to talk. Right side of mouth was droopy, and when asked to ambulate, wouldn't put much pressure on left foot.
Patient's daughter described patient to have bad shoulder pain, pain at injection site, dizziness, and patient fell. Told patient's daughter to contact physician.
she has a hearing problem; Constant chills; Cramps; Diarrhea; Nausea; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3248) via an unspecified route of administration on 25Jan2021 10:30 on the left arm at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. The patient stated that she did not experience any problems until 27Jan2021 around noon, in which she started experiencing chills, cramps, and diarrhea all afternoon. She would like to know if these reactions have been reported and if they continue to persist, can she take something like Imodium. She didn't have any effect at all from it on Monday or Tuesday, and at noon on 27Jan2021, she had nausea and constant chills and diarrhea, she doesn't think this was a side effect, but wanted to check and see. She was not terribly ill, just uncomfortable, is this something she should be reporting? Stated she has a hearing problem, wished for DSU agent to speak slower. Nausea: was off and on all the time since noon today, it is better, the main thing is diarrhea, and the nausea is connected Constant chills: improving, it came and went all afternoon, she doesn't know if it has gone away, she thinks it is still here, but she is not constantly bothered, it has been periodically since noon today. Diarrhea: better since she has nothing left; nothing was getting worse, she was reporting it because she thought it may be a side effect. Outcome of the events constant chills and nausea was recovering, diarrhea was recovered on an unspecified date while unknown for the other events.
Pt presented to office 7/25/18, with raised rash on Right forearm and states the rash developed Monday night after getting SHINGRIX vaccine and TD vaccine on Monday 7/23/18. Pt states rash was itchy the first night but the itching has subsided. The rash is on the same arm that SHINGRIX was given so pt concerned it was a reaction. Denies pain, SOB, dizziness, drainage, fever or chills. Vitals taken in office were WNL BP- 118/70, HR- 74, 02 sat- 97% and Temp- 97.7 PO. He said he takes Benadryl at night regularly so he did take this but denies taking anything else. Spoke to PCP who advised pt continue with Benadryl and try otc hydrocortisone cream and if no improvement by the beginning of next week pt should be seen. Pt also aware that if his symptoms worsen he should call sooner to be seen.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. On or about 17-OCT-2012, a pharmacist administered ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries and conditions (dose, route, and lot number not provided). On or about 01-MAY-2014, the patient was treated by a healthcare professional for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Covid arm, minor. Directly around vaccination area for the past 9 days since getting the vaccine. Red, itchy, slightly raised
This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced diarrhea, severe vomiting, and severe exhaustion. The action taken with covid-19 vaccine was not applicable. The outcome of the severe vomiting, diarrhea and severe exhaustion was not reported. This report was non-serious.
Moderna COVID-19   Chills, whole body aches, headache, tired, dizziness
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 21-SEP-2015 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (0.5 ml; lot # K026247, expiration date: 29-JAN-2017; dose, frequency and route unspecified). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion 3 times. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius), Celsius conversion of the lowest recorded temperature (Fahrenheit degree/ Celsius) and the type of excursion (R/F) for each time were was 24, 33, 0.555555556 and R; 132, 34, 1.111111111 and R; 200, 32.0 and R. This is one of several reports received from the same source. Additional information has been requested.
broken ribs; broken pelvis; bike accident; fell off his bike; This is a spontaneous report from a contactable consumer (patient's wife). A 78-year-old male patient (reporter's husband) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 24Feb2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter was asking how to get her husband his second vaccine dose which was due on 17Mar2021 not that he is in the hospital. The reporter then explained that the patient received his first Pfizer Covid vaccine on 24Feb2021 but on the day of the report, 13Mar2021, the patient had a bike accident. The patient fell off his bike and is now admitted to the hospital with broken ribs and a broken pelvis. The outcome of the events was unknown. The case was reported as non-serious.  Information about lot/batch has been requested.
Information has been received from a healthcare worker concerning a female nurse who was vaccinated with two doses of VARIVAX (Merck) (Lot # not reported).  Subsequently the patient failed to seroconvert.  There was no adverse event reported.  The nurse sought unspecified medical attention.  A "titer" test was performed with no results provided.  At the time of the report, the outcome of the patient was unknown.  Additional information has been requested.
LEGS SWOLLEN FROM THE KNEE DOWN; ARMS FEEL KIND OF WEIRD; FEELING OF LEGS KIND OF DETACHING FROM THE BODY; FEELING LIKE WHEN YOU PRESS YOUR FEET AND IT'S DIFFERENT, NOT PUFFY; ARMS FEEL SWOLLEN; TINGLING IN RIGHT ARM; WHEN GOING TO SLEEP LEGS FEEL VERY HEAVY/LEGS FROM THIGHS TO FEET, ENTIRE LEG, FEELS HEAVY JUST BEFORE FALLING ASLEEP; VERY TIRED; A LITTLE BIT OF HEADACHE; FLAVOR IN HER MOUTH LIKE ORANGE OR CHERRY; This spontaneous report received from a patient concerned a 59 year old female. The patient's weight was not reported and height was 64 inches. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included patient had no known drug allergies and medical conditions. the patient did not take medication regularly.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A, and batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced flavor in her mouth like orange or cherry. On 08-APR-2021, the subject experienced very tired. On 08-APR-2021, the subject experienced a little bit of headache. On an unspecified date, the subject experienced legs swollen from the knee down, arms feel kind of weird, feeling of legs kind of detaching from the body, feeling like when you press your feet and it's different, not puffy, arms feel swollen, tingling in right arm, and when going to sleep legs feel very heavy/legs from thighs to feet, entire leg, feels heavy just before falling asleep. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flavor in her mouth like orange or cherry on 08-APR-2021, and very tired, and a little bit of headache on 09-APR-2021, and had not recovered from legs swollen from the knee down, arms feel kind of weird, when going to sleep legs feel very heavy/legs from thighs to feet, entire leg, feels heavy just before falling asleep, feeling of legs kind of detaching from the body, arms feel swollen, tingling in right arm, and feeling like when you press your feet and it's different, not puffy. This report was non-serious.
pt mom reports on Tuesday morning.  PT HAS FEVER, SWELLING OF LEGS, SHORTNESS OF BREATHE, NO BLOOD FLOW IN EXTREMETIES. PT REPORTS FEELING NUMBNESS IF EXTREMETIES. CANT SEE OUT OF HIS RIGHT EYE, REFERRED TO hospital.
Rheumatoid arthritis flare up; Burning leg; Cramps legs; Foot cramps; Swelling of legs; Lower extremities weakness; Generalized aching; CHILLS; Headache; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.  No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), BURNING SENSATION (Burning leg), MUSCLE SPASMS (Cramps legs), MUSCLE SPASMS (Foot cramps), PERIPHERAL SWELLING (Swelling of legs), MUSCULAR WEAKNESS (Lower extremities weakness), PAIN (Generalized aching), CHILLS (CHILLS) and HEADACHE (Headache). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), BURNING SENSATION (Burning leg), MUSCULAR WEAKNESS (Lower extremities weakness), PAIN (Generalized aching), CHILLS (CHILLS) and HEADACHE (Headache) outcome was unknown and MUSCLE SPASMS (Cramps legs), MUSCLE SPASMS (Foot cramps) and PERIPHERAL SWELLING (Swelling of legs) had not resolved.  No concomitant medications were reported.No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  Company Comment: Very limited information regarding the events and vaccination dates has been provided and is insufficient for causality assessment at this time. A causal relationship cannot be excluded. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up information received on 04 Jun 2021.Second dose events were added.; Sender's Comments: Very limited information regarding the events and vaccination dates has been provided and is insufficient for causality assessment at this time. A causal relationship cannot be excluded. Further information has been requested.
A lot more fatigued; Ringing in his right ear; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 22Feb2021 (at the age of 41 years old) (Lot Number: EN6201) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 27Jan2021 (at the age of 41 years old) for COVID-19 immunisation and experienced pain, redness, swelling, itching, and rash. On an unspecified date, the patient experienced a lot more fatigued and ringing in his right ear. The outcome of the events was unknown.   No follow up attempts are possible. No further information is expected.
04/09/09 vomit, diarrhea, stomach pain. 04/10/09 fever (104.7) rash. No GI symptoms except anorexia. 04/11/09 varicella - like rash.
Initial and follow up information has been received through the Merck Pregnancy Registry from a registered nurse concerning a 25 year old female with a history of a spontaneous abortion at five weeks from her last menstrual period and malignant melanoma at age 19, with a dysplastic nervous system, and an allergy to penicillin and an allergic reaction to CECLOR, who on 16-MAY-2007 was vaccinated IM in the left deltoid with a 0.5 ml first dose of Gardasil (lot # 657736/0389U).  On 16-JUL-2007 the patient was vaccinated IM in the right deltoid with a 0.5 ml second dose of Gardasil (lot # 658100/0525U).  There was no concomitant medication.  Subsequently the patient became pregnant.  Unspecified medical attention was sought.  On 03-AUG-2007 the patient had a positive beta-human chorionic gonadotropin test (unspecified).  Her last menstrual period was 27-JUN-2007.  The estimated date of delivery was 03-APR-2008.  It was reported that the patient had one previous pregnancy and one spontaneous abortion at 5 weeks.  At the time of the report, the outcome of the patient was unknown.  Follow-up information indicated that 39 weeks from her last menstrual period on 27-MAR-2008 the patient gave birth to a male infant.  The infant weighed 7 pounds 6 ounces, was 19.5 inches long, and had an Apgar score of 8/9.  It was reported that the infant was normal, with no complications or abnormalities.  The infant did develop a minimal cleft lip.  Other medications used during the pregnancy were ZITHROMAX for a urinary tract infection, prenatal vitamins, and GYNAZOLE for candida. The reporter considered the minimal cleft lip to be a congenital anomaly.  Additional information has been requested.
Dizzy  Felt like I was going to pass out  Severe upper and lower back pain Chest pains
Developed headache within 2-3 hours after Typhoid vaccine. Within 24-30 hr joint paint in hips,shoulders,elbows and knees. Elevated temp at 72 hours after injection lasting 4 days. Seen 3/2/09 1 wk after injection placed on Clindamycin for 10days. Continues on Naprosyn and Motrin for joint pain. Has had 4 outpatient visits related to symptoms.
This case was reported by a physician via a sales representative and described the occurrence of stinging at the injection site in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline).  On an unspecified date the subject received unspecified dose of TWINRIX.  At an unspecified time after vaccination with TWINRIX, the subject experienced stinging and burning at the injection site.  This was also reported to be a product complaint as the reporter felt the events were related to a quality issue with the TWINRIX injection.  The outcome of the events was unspecified.  It was reported that 10 subjects (including this one) experienced burning and stinging at the injection site following administration of TWINRIX from the same lot.  Linked cases include: A0752060A, A0752087A, A0752088A, A0752089A, A0752090A, A0752091A, A0752092A, A0750294A and A0752095A.