chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CONFIRMED COVID-19 INFECTION; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously received 2 doses of covid-19 vaccine (Sanofi) (dose number in series 1) (form of admin, route of admin were not reported, batch number: VAT00002 and expiry: unknown) dose was not reported, administered on 26-FEB-2021 and 19-MAR-2021 for prophylactic vaccination. It was unknown if the patient had any adverse events with covid-19 vaccine (Sanofi) (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 043A21A and expiry: 19-SEP-2021) dose was not reported, 1 total administered on 10-SEP-2021 on left arm for prophylactic vaccination which was off label use (dose number in series 2) and inappropriate schedule of vaccine administered (dose number in series 2). No concomitant medications were reported. On 02-FEB-2022, the patient experienced confirmed covid-19 infection. On 03-FEB-2022, the patient tested positive using a Abbott home kit. On 07-FEB-2022, the patient went to clinic and got a PCR (Polymerase Chain Reaction) test done and it came back positive (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection, off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
only 'fluey' symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), 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: INFLUENZA (non-serious), outcome "unknown", described as "only 'fluey' symptoms". Additional information: Patient reported that she had 3 shots all together - all Pfizer COVID 19 vaccines with her last shot on Aug2021 (primary series and a booster). Reported that she 'had a very strong reaction to last 2 COVID shots'. Stated that the 1st shot (Pfizer COVID vaccine) 'didn't do anything that bad'- reported only 'fluey' symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201346626 Same patient and drug; different dose and events.;US-PFIZER INC-202201346627 Same patient and drug; different dose and events.;
chills; fatigue; has an increase in blood pressure; has difficulty with physically strenuous activities; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): EC-2021-097823 (Eisai).  A female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 25Oct2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; lenvatinib mesilate (LENVIMA), oral since 08Nov2021 (ongoing) (Batch/Lot number: unknown) at 14 mg for endometrial cancer. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "recovering", described as "chills"; FATIGUE (non-serious), outcome "not recovered", described as "fatigue"; BLOOD PRESSURE INCREASED (non-serious), outcome "not recovered", described as "has an increase in blood pressure"; DECREASED ACTIVITY (non-serious), outcome "not recovered", described as "has difficulty with physically strenuous activities". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for lenvatinib mesilate was unknown.  Additional information: Patient reports ongoing fatigue after start of therapy has difficulty with physically strenuous activities but can do light house work. Unknown if MD is aware. Patient states she had second covid vaccine on 10/25/2021 and has chills but states it is improving. unknown if MD aware. Patient reports after start of therapy she has an increase in blood pressure. Patient will notify MD.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My arm is still sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 28Jun2022 as dose 4 (booster), single (Lot number: FM0173) at the age of 58 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (First Dose, Lot Number: EN6201), administration date: 11Feb2021, when the patient was 56-year-old, for COVID-19 immunization; BNT162b2 (Second Dose, Lot Number: EN6025), administration date: 06Mar2021, when the patient was 56-year-old, for COVID-19 immunization; BNT162b2 (Third Dose/Booster Dose, he can barely read it on his card, reports Lot Number as FF8841), administration date: 11Oct2021, when the patient was 57-year-old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "not recovered", described as "My arm is still sore".  Additional information: Caller mentioned that he got the Pfizer Booster Vaccine on 28Jun2022 and his arm is still sore from that booster. The caller stated that it has been three months and he has questions regarding this side effect. Caller stated that right after the vaccine it was the usual soreness like the other vaccines. It was really sore for a day or two. Since then, especially when he goes to the gym or golfs, he notices that it is more prevalent. Caller stated that he can also feel it if he sleeps the wrong way on his left arm. Stated that he feels it and its not like a bruise, it feels like it is inside of his arm. Caller stated that it has been ongoing and persistent. States that lately in his workouts he has been trying not to use his left arm as much. Then today he did use it, and now he was really feeling it. Patient did not receive any vaccinations within four weeks prior to the first administration date of the suspect vaccine. Caller denies any other medication.
Patient continue to have pain at site of injection.  Treated with ibuprofen, Lortab without relief, no infection noted.
Her left arm was red and swollen, started with 24 hr of vaccine. It lasted for couple of days. Some redness was still there today.
Pt experienced chicken pox from head to toe subsequent to receiving one dose of varicella virus vaccine live.
Hot sweats followed by light headed and faint like spells. Episodes of feeling off for the past 5 days now
Received on 8/10/10; 8/11/10 began as dime size redness not raised but red from elbow to shoulder, no rash or hives, temp 99.9; on 8/12/10 now around arm, swelling down a little no worse 8/13/10 resolving.
Mother called office the day after immunizations were given to report that several hours after the immunizations were given on 1/27/2021, she noticed what she thought were "mosquito bites" on patient after a walk. On 1/28/2021, at the time of the phone call to pediatrician office, she was beginning to notice more "mosquito bites" and some "splotches" and "swelling" of one eye. This nurse discussed it with a pediatrician in the office who advised giving Benadryl, topical HC cream to non-facial areas, stay in air conditioning and give Motrin for any fever. Mom had reported a low-grade fever of 100.8 and said patient was "fussy". Spoke with Mom several times on the phone between the initial phone call and closing hours, and advised Mom to call and speak with physician-on-call after 5:00 pm if any other symptoms were noted. During the initial phone conversation, and phone calls after, Mom denied any respiratory symptoms. Later that evening, Mom called pediatrician-on-call, who advised ER visit due to what Mom thought was perhaps some wheezing, and increased facial swelling and coughing. Patient was admitted to Hospital for what was later diagnosed as a "vaccine reaction".
Approx 18 hours after recieving vaccine, parents noted a red swollen area at the injection site. Patient complained of itching at area.He also complained of sore throat. Temperature was 100.4 (oral) when examined in the office.He was given oral diphenhydramine and a topical steroid to apply to the area, instructed to apply cool compresses and return within 24 hours for follow-up.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION (FAR THE MOST AFFECTED); This spontaneous report received from a consumer via social media through company representative concerned a male of unspecified age, race and ethnicity. 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: Unknown and expiry: UNKNOWN) 1 total, 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, the patient experienced suspected clinical vaccination failure and suspected covid-19 infection (far the most affected). As per the reporter, "My vaccinated uncle was with my family when we all got covid. He was by far the most affected. Poison dealers." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection (far the most affected) and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with Product Quality Complaint. This case, from the same reporter is linked to 20211140382.; Sender's Comments: V0: 20211139879-Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS
This spontaneous report as received from a pharmacist refers to a 70 years old female patient with nickel allergic and chrome allergic and medical history nickel chrome dermatitis. The patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (Lot# 0366AE, Exp date: 23-MAR-2013) on 24-JUL-2012. On 25-JUL-2012 the patient experienced itchy, rash about 2 1/2 inches long and 1 inch wide at the injection site of left arm. No treatment information was given. The patient sought medical attention by calling to the pharmacy. At the time of reporting, the outcome was unknown. Additional information has been requested.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 18-JUN-2013, the patient was administered with a dose of VARIVAX (merck) (Lot # H012351, expiry date 21-JUN-2014) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
I had trouble moving arm, could not  lift things. I went to doctor and he did cat scan and did not find any damage and they referred to a physical therapist.
Low platelet level, heavy menstrual cycle, fatigue, prescribed steroids by healthcare professional.
three friends die; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 39-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, 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: DEATH (death, medically significant), outcome "fatal", described as "three friends die". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. It was reported that after assisting caller with her questions, prior to disconnection, the caller states we had "three friends die, 39-year-old, die. Yea."  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-202200835907 same reporter/drug/event for different patients.;US-PFIZER INC-202200835754 same reporter/drug/event for different patients.;; Reported Cause(s) of Death: three friends die
Pain at the injection site that continues 29 hours later; some fatigue day of and day after injection
Swelling and pain at injection site started on day of injection, on post-injection day 1, erythema developed at the injection site, about 3 cm diameter. The erythema and tenderness persisted for over 7 days. COMIRNATY 12+(COVID) 23-24 PFS
I went home and did my normal routine. I was tired, but no soreness. Felt swelling in my armpit the next morning. By that afternoon, it had swollen to the point where it looked like another boob. I was told to go to the urgent care and they told me they hadn't seen this, but were aware that the vaccine could result in swollen lymph nodes, so that's probably what it was. They told me to take Tylenol for pain and told me to stay home from work for 2 days. I haven't had any issues since then.
Vaccine was given at Health in my state.       24 hours later I had other unrelated pain in my let that may have contributed to me not feeling so hot. Had some inflammation and I was making coffee and I started feeing woozy and I out my arms and head on the counter and I start to stand up to walk I was upright and standing in the kitchen. I remember trying to walk and I guess I passed out and found myself flat on the kitchen floor. I remember the cool floor felt good. and seeing my husbands. I had some sweaty hands. No pain at that time. I did not have a head injury from the fall. Other then my knee & leg felt it had got twisted with crapping and pain in the leg. I took  1 some Advil. I may take 1 or 2 more. For the leg. I am having some sweating and fever from the flu shot.
Initial report received on 15 August 2012 from the Investigator participating in a post-marketing study under the reference number of M5A16. A case of pertussis disease in an 11-month-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3801AA received on 13 June 2011, lot number C3930AA received on 15 August 2011 and lot number C4001AB received on 17 October 2011 (routes and sites of administration not reported). The subject developed a cough on 28 March 2012, approximately five months after the last dose. On 01 April 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced apnea and sleep disturbance. Laboratory testing included positive PCR on 09 April 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 09 April 2012 for five days. The subject was not hospitalized. At the time of final contact on 17 April 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 20 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
No adverse patient reaction noted  Vaccine was administered 12 hrs after vial was punctured.
Itchiness in arms and shins, 50mg of Benadryl given orally. Symptoms improved, no new symptoms developed.
Swelling of arm from shoulder to elbow, very warm area around muscle. Itching. Skin is rough to touch/no treatment.
10/22/09 1200 Tiredness, joint pain. 10/23/09 0230 Urtcaria to hips and legs-took OTC BENADRYL 25mg x 2. 10/24/09 0900 Awoke. Felt Pruritus. No Urtcaria.                 1900 Scattered Urticaria-took OTC BENADRYL 25mg x 2.                 2300 Urticaria to trunk legs, neckm face. Denies breathing difficutlies/Rx PREDNISONE                 2315 Seen in emergency dept. Dy Allergic reaction BENADRYL, ZANTAC, Continuing on XYZEL, PREDNISONE and HYDROXYZINE
cold feeling; shortness of breath; dizziness; This case was reported by a consumer via call center representative and described the occurrence of feeling cold in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th March 2021, the patient received the 1st dose of Shingrix. On 31st March 2021, 1 days after receiving Shingrix, the patient experienced feeling cold, shortness of breath and dizziness. On an unknown date, the outcome of the feeling cold, shortness of breath and dizziness were unknown.   It was unknown if the reporter considered the feeling cold, shortness of breath and dizziness to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The reporter reported that she received Shingrix on Tuesday and she was feeling fine until 5 pm of Wednesday then after that she experienced cold feeling, dizziness and shortness of breath. The patient also reported that she did not have a fast heartbeat and that her blood pressure was fine at 127. The reporter did not consented to follow up.
This is a spontaneous report from a contactable physician via Sales representative. A 18-year old female patient of unspecified ethnicity received a first single dose of TRUMENBA (lot number L13515, expiry date 28JUL2016) via an unspecified route of administration, on unknown date, for immunization. Relevant medical history and concomitant medications were not reported. The patient experienced severe flu like symptoms, chills, stiff neck and fever on an unknown date after receiving the vaccine. The patient did not want second dose. The outcome of the events was unknown. Follow-up (15Aug2016): This is a follow-up spontaneous report from a contactable nurse. This nurse reported in response to HCP letter sent to physician which included that: Did the patient provide information to you regarding the reported adverse event (s) with the use of the product: Yes. If yes, above, do you consider the product had a causal effect to the adverse event?: No. Are you willing to be contacted again by Pfizer on the reported adverse event (s) ?: Yes. Suspect Vaccine: Please provide below information (if more than one suspect vaccine or other product is involved please add all available information. If more space is needed please use the Additional Comments section at the end of this form). Suspect vaccine name and/or generic name: TRUMENBA. Route of administration: IM. Start date (note dates for any subsequent dosing): 2016 Mar2016 due May. Anatomical location of the administration of the vaccine: Deltoid. Did any of the AEs require an emergency room or physician visit?: No. What was the final action taken with the product (s)? Pleas circle below: Permanently withdrawn. Adverse event: Please provide description of the course of events including body site and severity/seriousness criteria: Was the patient admitted to hospital Y/N: N. Causal relationship: Is there a reasonable possibility that the event is related to suspect product/s: Batch and/or Lot number and expiration date: L13515. Please circle the Outcome of each event: Recovered. As applicable, list all vaccines given on same date along with suspect vaccine: Vaccine Name: None. As applicable, list any other vaccinations within four weeks prior to date of vaccination: Vaccine Name: None. Were specific tests and/or treatment required?: No. Is patient deceased: No. Relationship to patient. Vaccine provider. Vaccinated at: Private physician's office/hospital. Vaccine purchased with: Private Funds. Illness at time of vaccination (Specify): None. Have you reported this adverse event previously?:No. concomitant Medications: Concomitant drug: None. Patient medical history: Provide other relevant medical history including but not limited to these conditions. Diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: Illness: None. May we contact you to request additional information if needed. Yes.
Patient husband said that he found her convulsing on the kitchen floor about 4 hours after her 2nd Moderna Covid Shot.  Patient has or suspected of a hereditary collagen disease  that runs in her first line relatives and it's prone to seizure but she had never suffered of a seizure episode of before.  Paramedics were called to scene but per husband she refused to go to hospital. Paramedics instructed her to follow-up with PCP if she continues with episodes.
Left eyelid is a little swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING OF EYELID (Left eyelid is a little swollen) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING OF EYELID (Left eyelid is a little swollen). At the time of the report, SWELLING OF EYELID (Left eyelid is a little swollen) 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.
Patient woke up the following morning with diminished hearing in bilateral ears. Tried claritin without improvement. Plan to send to audiology for additional evaluation.
3 DAYS AFTER RECEIVING THE IPV ONLY DEVELOPED A RED MACULAR PAPULAR RASH ON THE ANTECUBES,TRUNK AND EXTREMETIES
Fever, to T max 101.5 lasting approximately 24 hours, antipyretics used, malaise, mild tender lymphadenopathy
Severe cough Lethargy Nasal congestion  Chest congestion  Digestive issues  Gassy  Headaches  Achy neck  Shaking  Slight fever
Systemic: Other- Eye quivering, heart raced, quickly returned to normal-Mild
Patient presented with a chief complaint of an upper sore arm.  She also complained of insomnia due to the pain on the injection site.
Patient complained right away of being nauseated, light headed, and chest pains. She kept trying to throw up. When asked if she was having trouble breathing she nodded her head. Dose of epinephrine 0.3mg was administered to left thigh. Patient sat with water. Complained of same symptoms and dosed a second dose of epinephrine 0.3mg exactly 15 minutes later. Patient was taken to ER by ambulance shortly after.
Tingling around the mouth, tightness in the throat, and redness on the upper chest. Benadryl 25 mg po once and observed for more than 1 hr and improved