chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she took her 4th shot from Pfizer for Covid and she okay and it is working good/potential unexpected benefit ("feel good") recognized after the call; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID: The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3, Manufacturer Unknown), for Covid-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 13Apr2022, outcome "unknown", described as "she took her 4th shot from Pfizer for Covid and she okay and it is working good/potential unexpected benefit ("feel good") recognized after the call".  Additional Information: Question: Customer Verbatim: She want to know about the medicine Suntinibe 50 mg (name) a friend in (country) have cancer and they said that Pfizer give a dose free she wants to know about. Outbound Callback Attempt 14Apr2022 at 11:53 AM ET: Reached the customer and she clarified her question. She stated she has a friend in (country) that has cancer and Pfizer is giving one bottle of this medicine for free. The friend has not received any medication she just "knows" Pfizer will give one bottle of this medication for free and she wants to know if she can get it. She wanted information on how her friend can get this product. Her friend said another country does not have this medication or it is not in stock, she cannot get it. she wanted to know if she could get this product and bring it to (country) for a friend. she got her 4 shots of the COVID vacine and feel good Thank you." She also stated over the phone that she trusts Pfizer. Additional Details: Outbound Callback Attempt 14Apr2022 at 11:53 AM ET: Reached the customer and she added that yesterday she took her 4th shot from Pfizer for Covid and she okay and it is working good. E-transmitting as potential AE for potential unexpected benefit ("feel good") recognized after the call. she stated, thank you so much for you prompt answer [call back], I am so happy for that.she got her 4 shots of the COVID vaccine and feel good Thank you." She also stated over the phone that she trusts Pfizer. Additional Details: Outbound Callback Attempt 14Apr2022 at 11:53 AM ET: Reached the customer and she added that yesterday she took her 4th shot from Pfizer for Covid and she okay and it is working good. E-transmitting as potential AE for potential unexpected benefit ("feel good") recognized after the call. she stated, thank you so much for you prompt answer [call back], I am so happy for that.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
SMALL AMOUNT OF BLOOD IN NOSE; SMALL AMOUNT OF MUCUS IN NOSE; DRY NOSE; HARD TIME BEING HYDRATED; CRAMPING LEGS; This spontaneous report received from a consumer concerned a 50 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: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced small amount of blood in nose. On APR-2021, the subject experienced small amount of mucus in nose. On APR-2021, the subject experienced dry nose. On APR-2021, the subject experienced hard time being hydrated. On APR-2021, the subject experienced cramping legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the small amount of blood in nose, dry nose, hard time being hydrated, cramping legs and small amount of mucus in nose was not reported. This report was non-serious.
Doses of possibly frozen FLUZONE QUDRIVALENT HIGH-DOSE and FLUZONE QUADRIVALENT were administered on accident; Initial information received on 29-Sep-2021 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via Medical Information (MI) number: 00814993 '.  This case was linked to case 2021SA345065 (CLUSTER).  This case involves an 81-year-old female patient who was received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] were administered on accident from the frozen shipment (product storage error).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no other vaccines.   On 27-Sep-2021 01:59, the patient received a 0.7 mL total dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [Influenza Quadrival A-B High Dose Hv Vaccine, Strength : high-dose, frequency: once, Dose :0.70 mL , lot UJ716AA, expiry: 30-Jun-2022] via intramuscular route in the left deltoid for prophylactic vaccination.  On unknown date, dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number and expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to product storage error temperature too low (latency same day).  It was reported " The caller reported that the doses were accidently used before realizing the shipment was frozen due to the doses used were at the top and were not frozen; that the packages underneath were frozen; that the entire rest of the shipment was frozen and likely all the product was frozen at some time; that 2- FLUZONE QUADRIVALENT doses and 13- FLUZONE HIGH-DOSE doses were administered from the frozen shipment."  At the time of reporting, no adverse event was reported.   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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.  There will be no information available on the batch number for the FLUZONE QUADRIVALENT.
Pt got a whelp associated with the DTaP.  Lt was more indurated on 6-26-08 better today 6-27-08 had some fever.  Eating & drinking well.
shingles; This spontaneous report has been received from a lawyer regarding a case in litigation and refers to a 61-year-old female patient. The patent's concurrent conditions, medical history and concomitant medications were not reported. On 04-MAR-2013, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for prophylaxis. As a result of her receipt or zoster vaccine live (ZOSTAVAX), on 04-SEP-2013, the patient was caused to suffer shingles, including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), she had been caused to suffer severe personal injuries, pain, suffering and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions she requires and/or will require more health care and services and did incur medical, health, incidental and related expenses. The patient is informed and believes and further alleges that she will in the future be required to obtain further medical and/or hospital care, attention, and services. As a foreseeable, direct, and proximate consequence of zoster vaccine live (ZOSTAVAX), the patient suffered shingles and other related health complications. In addition, she requires and will continue to require healthcare and services. The patient has incurred and will continue to incur medical and related expenses. She also has suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The patient's direct medical losses and costs include physician care, monitoring, and treatment. She has incurred and will continue to incur mental and physical pain and suffering. The outcome of shingles was considered to be not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was determined to be disabling by the reporter.
Left arm, purplish, lump, complain of itching, redness and warmth. Painful to touch. No fever, no difficulty breathing, states started itching day after shot. 1/12/07 arm is completely better.
Information has been received from a 57 year old female pt with no allergies and no history, who on 1/8/02 was vaccinated SC with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included "AVIPRO" Avapro, Topril, Toprol XL and Orthopresfest. The pt reported that she did not know the dosage of the vaccine or the lot number. She reported that on the same day as the vaccine (1/8/02), she experienced a temp of 103 deg. Over the next three days the pt's temp got as high as 106 deg and she went to see her physician. There was no treatment required for the adverse event and there were no lab or diagnostic tests performed. The pt reported that she "felt terrible" during the time her temp was so high. The pt reported that her temp was back to normal a few days later and she completely recovered. There was no product quality complaint reported. The pt felt that her temp of 103 deg and "felt terrible" were life-threatening and disabling. Additional info has been requested.
Side effect NOS; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Side effect NOS) 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 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 08-Feb-2021, the patient experienced ADVERSE EVENT (Side effect NOS).   At the time of the report, ADVERSE EVENT (Side effect NOS) outcome was unknown. Not Provided    Concomitant product use was not provided by the reporter. No treatment information was provided.
Mother of PT states this survey report is for her her son. Mother of PT states her son received  the Pfizer vaccine NOT the Moderna as stated on this survey. Mother of PT states her son received the second dose Pfizer vaccine on 06-10-2021and her son experienced fever, chills, fatigue and more soreness to his left arm with also lump under his left armpit. Mother of PT states she gave her son on the night of the second vaccine, Tylenol for relief of pain. Mother of PT states her son states that as of this morning her son does not have the lump under his left armpit nor any pain.  Also Mother of PT states that for her son's first dose, was on 05-20-2021 and that he  experienced soreness to his left arm, tiredness, pain and a lump under his left arm pit.   Mother of PT states she did not take his son to see a doctor.
Chest discomfort, mild. Hurts with getting up and moving a lot. Not sore to touch. No shortness of breath, palpitations, fatigue.
Patient reported waking up the morning after her second dose of the Moderna COVID-19 shot fine, but within 5 minutes of waking she began sweating profusely, vomited, and passed out.  She reported that the sweating and nausea persisted for about a day and a half and that she is feeling mostly better today (2 days later)
27JUL94 approx 2PM awoke from afternoon nap w/t102 a was jerking, unable to form words & talking crazy; also was c/o pain/stiffness in lt leg
Patient passed out twice after administration of vaccine.  She came back to within a few seconds of each episode.  Called EMS to come check her out.  She left afterwards on her own and did not go to the hospital with EMS.
Left arm pain and peripheral neuropathy on day #8.  Initially wit pain at injection site, resolved, and then day #8 with severe sharp pains down left arm.  intermittent.  Responded favorably to Gabapentin.  Still with SX today.  No rash.  No evidence of Zoster to explain this.
This spontaneous report was received from a nurse and refers to a 13-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-FEB-2023, the patient was vaccinated with PROQUAD subcutaneous injection, 0.5 milliliter, lot #W028564, expiration date: 06-MAR-2024, administered for prophylaxis (strength and route of administration were not provided) (product administered to patient of inappropriate age). No additional adverse event was reported (no adverse event).
Patient came in to office on 9/2/09. Patient received DTaP and Varicella in right thigh and MMR and Polio in left thigh. On 9/3/09 patient returned to office. Right thigh red and swollen and tender to touch around injection site. 2" size.
Beginning at stated time began to have body aches, headache, chills, and uncontrollable shaking and tremors.
Fluzone administered on 10/20/2006 - L deltoid.  Developed L arm pain.  In the evening had muscle aches in cheat and arms. 10/21/2006 had R sided upper lip swelling, aches and chills, the L sided upper lip swelling in pm. Severe difficulty moving L arm and generalized weakness. 10/22/06 Decreased lip swelling, R eye swollen, Decrease in body aches. 10/23/06 lower lip swollen, but is feeling better.
Starting 7pm night of vaccine, extreme fatigue, shakes, chills and rigors. Developed temperature to 102 with aches throughout. Then developed diffuse rash over entire trunk, front and back, blochy, not hive like. Rash changed colors and lasted until 12/25. Also had dry cough, sounded like whooping cough. By 7am on 12/25, felt completely better, no fever or other symptoms.
Patient received Moderna COVID 19 vaccine for first dose on 2/3/2021 by drive through vaccine clinic at fire department. She had burning at injection site for 15 minutes, followed by sore feeling. Within 2 hours, she developed severe arm pain from shoulder to hand, and could not move her arm. On that night, she had severe left shoulder pain, and tingling and lumbness of left arm and hand along the radial distribution. Her left hand felt ice cole but actually warm to touch. The next day, she could not lift her left arm due to the pain. She was seen by PCP and was told it could be SIRVA. Since 2/5, she had severe nausea, dizziness, headache, fatigue, verrtigo when turning her head. Symptoms last
Exactly one week after first dose, right arm became  very tender again, as it was immediately following vaccine.  Also very itchy. Developed a red rash with a white center. This continued for approximately 60 hours and then symptoms began to lesson. (Covid Arm)  19 hours after 2nd dose, began to get chills, extreme fatigue set in, developed severe headache, achy jaw, pain in teeth, temple, sinus - all on left side. Managed it with Motrin. Severe symptoms lasted about 24 hours. Headache and fatigue lasted about 5 days.
child started having siezures 12 hours after taking DTAP VACCINE AND CHICKENPOX VACCINE SHE HAD 15 SIEZURES FROM AUG 13 2008 UNTIL AUG 29 2008SHE SPENT 10 DAYS IN THE HOSPITAL SHE NOW HAS BEEN PUT ON MEDICATION FOR SIEZURES AN EEG CONFIRMED THE SIEZURES 9/3/08-records received for DOS 8/19-8/21/08-DC DX: Seizure disorder. Presented to ED after 3 episodes of falls to floor and mouth started to twitch. In hospital one episode witnessed. Transferred to another facility. 10/24/08-records received for DOS 8/21-823/08-DC DX: New onset seizures. 1/26/2010 Patient has seizures that started approximately 12 hours after vaccines, she is under dr. care and has to take seizure medication. She has been diabled and has bee concerned by this.
Today is 5/25/2021 and I have had diarrhea daily since 4/16/2021 after my first dose on 4/15/2021
Patient complained of nausea, dizziness and being lightheaded. Escorted patient via wheelchair to triage area at 1144.   Initial vitals BP 147/102, temp 98.2, heart rate 89, o2 99%.   1147 BP 137/98, heart rate 85, o2 100%  1150 BP 125/92, Heart rate 86, o2 100%  1155 BP 116/90, Heart rate 83, o2 99%  1200 BP 126/89, heart rate 83, o2 99%  1205 BP 120/93, heart rate 81, o2 99%  Symptoms resolved and the patient stated she was no longer dizzy. She was able to leave at 1207.
DIZZINESS; This report received from a business partner via clinical trial 21-0012: A Phase 1 2 Study of Delayed Heterologous SARS CoV 2 Vaccine Dosing Boost After Receipt of EUA Vaccines, (subject number and site number were not reported). The subject's weight, height, and medical history were not reported. The subject initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On 22-JUL-2021, the subject experienced dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The subject recovered from dizziness on 23-JUL-2021. The investigator assessed the severity of dizziness as grade 2 moderate adverse event. The investigator considered the causality between covid-19 vaccine ad26.cov2.s and dizziness as possible.  This report was non-serious.
Watery Eye on Sunday, then noticed when I spit it was coming out only from one side. Slight tingle/spasm on left side of face. Noticed left side of face wasn't as mobile as right side when smiling, frowning and opening mouth wide.
Case received from a healthcare professional on 30 April 2010 under the local reference number BR2010-103. A 29-year-old female patient, with an unknown personal and family medical history, had received her dose of Influenza A/H1N1 vaccine (manufacturer not reported, batch number, route and anatomical site of administration unknown on 10 April 2010. The patient had no reported concomitant therapy. On 10 April 2010, post-vaccination, the patient experienced sore throat and fever. She was seen in the hospital and received LORATADINE and DECADRON on 10 April 2010. It was not known whether she was hospitalized or not. On 22 April 2010, she developed hypertension, body ache, headache, breathing difficulty and asthmatic crisis sensation. There was no local reaction. The patient started on CEPHALEXIN from 25 April 2010 to 02 May 2010. The outcome was "ongoing" at the time of the report. List of documents held by sender: none.
Skin was exceptionally sensitive; Skin itchy; This spontaneous case was reported by a patient and describes the occurrence of SENSITIVE SKIN (Skin was exceptionally sensitive) and PRURITUS (Skin itchy) in a  patient of an unknown age and 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 Sickness (Sick with 104.2 temperature.), Fever (104.2 temperature.) and Flu. Previously administered products included for Flu prophylaxis: Flu vaccine. Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Diabetes.    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 SENSITIVE SKIN (Skin was exceptionally sensitive) and PRURITUS (Skin itchy). At the time of the report, SENSITIVE SKIN (Skin was exceptionally sensitive) and PRURITUS (Skin itchy) outcome was unknown.            No concomitant medications were reported. It was reported that patient got the Moderna for first immunization, that was two shots. No treatment medications were reported.
Fingers tingling, throat felt scratchy; BP 150/114  HR 101 sat 99%   Placed supine and observed.  Symptoms resolved. Repeat BP 136/98  HR 94  Sat 97%
Day after, felt typical reactions. After 4-5 hours felt fine. Had a red bump the day after. Became a patch extended up to shoulder to forearm. Took Benadryl but made it worse. Went to urgent care the day after. Said it was just a new allergy. Took a shower and had full body hives. The day after, it was gone. Have not had hives since then.
Severe swelling in the arm & extreme difficulty breathing, asthma allergies to pets ect p/the inject, nearly fatal;
The Moderna vaccine was administered past it's expiration date. We contacted Moderna, the mfg who performed an analysis of lot #043H22A. They determined "the vaccine administered from June 9, 2023 to July 5, 2023 maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at the time of administration."
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 25-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) lot # J003528, expiry date: 25-MAR-2015 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Saturday, March 6  felt fine all day with normal activity. Woke up at 7:05 am Sunday, March 7 with dizziness, nausea and sweats that would last about a minute.  Remained  sitting still with my eyes closed about 3 hours and then eyes could be open but could not move without the dizziness and subsequent nausea. I did not vomit. My temperature was-low in the morning but climbed just to 99.3 Sunday. By Sunday afternoon, I no longer had the short sweats but remained dizzy and nauseous mostly upon any movement. I went to sleep at 11:00 pm Sunday night with the slight 99 fever. Woke Monday , March 8 much improved  from the dizziness and temperature 98.6., but felt extreme tiredness. I did not go tot work Tuesday and rested on the couch most of the day-temperature 98.6.
Information was received from a nurse referring to a 2 month old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies were not reported. On an unknown date, the patient was inadvertently vaccinated with M-M-R II, subcutaneously (lot number N027780 and expiration date 08-AUG-2019), VAQTA, intramuscularly (lot number R006209 and expiration date 14-MAR-2019) and VARIVAX, subcutaneously (lot number N034555 and expiration date 05-DEC-2019) for prophylaxis (dose, frequency and anatomical location for all vaccines were not reported). The reporter stated that the patient was vaccinated due to medication error and not due to product confusion (drug administered to patient of inappropriate age); however, no adverse effects were reported.