chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received 1st Pfizer dose on 4/2/21. On (or about) April 15th (13 days later) I  had a sudden sensation and felt the back of my knees and the bottoms of my feet overcome by a strong numbing sensation as if they had fallen asleep. This persisted for a half a day before suddenly going away. This is not a sensation I've ever experienced prior. I drank a lot of water and took magnesium for fear I was dehydrated. The sensation subsided later that day.   Received 2nd dose of Pfizer on 4/21/21. On (or about)  May 14th (21 days later) and another episode has started, however this has lasted for several days now persistently. This time a numbing sensation only resides on my left side starting from just above the back of my knee down  the back of my calf and into the bottom of my foot. The sensation sometimes feels like a vibrating buzzing sensation, to a tingling/numbness. I also feel a numbness sensation on the bottom of my foot with each step taken. In addition, I have a slight numbness in my left arm that radiates from the shoulder, into the armpit, along the inner elbow, and into the palm of my hand and down to my fingers. My right side is not affected. The arm sensation comes and goes.
The temperature excursion involved a low temperature of 29.0F and the total excursion time was for 45 minutes with no reported adverse event; vaccines being administered post-excursion with no reported adverse event; Initial information received on 26-Sep-2022 regarding an unsolicited valid non-serious case via health professional.   This case involves pediatric patient (Patient-09) being administered Influenza Quadrival A-B Vaccine [Fluzone QIV] post-excursion with no reported adverse event and reported temperature excursion involved a low temperature of 29.0f and the total excursion time was for 45 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   This case is linked to cases 2022SA409526, 2022SA409520, 2022SA409707 and 2022SA408679.   On 23-SEP-2022, the health care professional reported temperature excursion involved a low temperature of 29.0f and the total excursion time was for 45 minutes with no reported adverse event (product storage error).  On 23-SEP-2022, the adult patient being administered post-excursion suspect Fluzone QIV NP vaccine at dose 0.5 ml (lot:  UT7689LA, expiration date: 30-Jun-2023) via unknown route in unknown administration site for prophylactic vaccination with no reported adverse event (poor quality product administered) (latency same day).  Action taken: Not applicable.   At time of reporting, the outcome was Unknown for both events.  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.; Sender's Comments:  SAD20220927002156:
really bad headache; Nausea; She threw up up once today. It was watery; Low grade fever; Chills; This is a spontaneous report from a contactable consumer (patient). A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 28Mar2021 14:00 (Lot Number: ER8727) (at the age of 44-years-old) as dose 2, single for covid-19 immunisation. Medical history included diverticulitis, prolactin high, diabetes. Patient had no family medical history relevant to adverse event. Concomitant medications included vitamin c taken for an unspecified indication from Feb2021 and ongoing; probiotic taken for diverticulitis from 2014 and ongoing; metformin taken for diabetes from Jan2021 and ongoing; spironolactone taken for prolactin high from Jan2021 and ongoing. The patient previously took vitamin D prior to taking vitamin C because she was unable to find vitamin C. Historical vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 07Mar2021 (Lot Number: EN6199) (at the age of 44-years-old) as dose 1, single for covid-19 immunisation. The patient stated that she received the second dose of Covid-19 vaccine a day before reporting and she has been having a really bad headache on 29Mar2021. She received the vaccine at 2:00pm and she was ok at first. During the night, she had a headache. She also had a low-grade fever on 28Mar2021 and nausea on 29Mar2021. She took Tylenol 325mg and aspirin 325mg as treatment for headache and cannot get rid of the headache. She woke during the night with a light headache, and it was getting worse. She didn't check her temperature, but she was sure she had a fever because she had chills on 28Mar2021. On 29Mar2021, her temperature had been 99.5-100.5 degrees. She threw up once on 29Mar2021, it was watery. Nausea was reported as worsened. The events did not result in emergency room and physician office visit. No relevant tests were done. The outcome of the event vomiting was recovered on 29Mar2021 and outcome of all other events was not recovered.  No follow-up attempts are possible. No further information is expected.
I received a shot around 9:20. About 9:25 I fainted while in the 15 minute waiting period. I was "out" long enough for 911 to be called. I "woke" up a little later, in enough time to cancel the 911 call, and regained my composer. I waited another 10 minutes and felt much better. I have had no other side effects since.   I want to add that I was not nervous about the vaccination. I did not have any fear or anxiety about the shot.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On unspecified dates, the unspecified number of patients received improperly stored doses of PNEUMOVAX 23 (dose, lot#, expiration date, route of administration and indication were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
p/vax pt arm rt arm swelled up, ached really bad, then 1 1/2 days later broke out w/severe rash;took DPH;arm sore;
Mom says pt cried for 3 days, episodes lasting 3 hrs sometimes was able to calm down, but would continue to cry, cry would be not as loud; temp <100; Did not see MD;
Jerking both arms and legs and gasping for air for 6-7 minutes.  09/05/2008 MR received for DOS 8/08-11/2008 with D/C DX:  Possible post-vaccine reaction. Pt presented to ERafter an episode of jerking of arms and legs and gasping for air which occured shortly after arriving home from receiving vax. Episode lasted 6-7 minutes.  Admitted with dx: Seizure activity, meningitis. Full sepsis w/u and started on abx. No further events.
PT comes into clinic to receive second dose of moderna. PT previously received first dose of moderna on 1/5/22 at the age of 17. PT did not have any visual signs of being symptomatic before or after the vaccine administration. PT and family were notified of medical error. PT was advised that only pfizer should have been given as she is a minor. PT was advised that if she had any reaction or concerns about the vaccine, she can contact her PCP or ED dept., if necessary. PT said she was feeling okay upon exiting the clinic and did not have any further questions or concerns.
Pericarditis- presented to my office 5 days after receiving the vaccine and his chest pain had already resolved and ECG had normalized. Normal echocardiogram. Therefore, no treatment started. Labs ordered are pending.
FluBlok given to 16 yo patient.  This vaccination intended for 18  and up.
Localized reaction - LUA. Injection site was red, swollen & warm to the touch that was painful & itchy, lasting 4-5 days. Pt applied 'Anti-itch' medication until resolution.
Vaccine expired on 26-Feb-2023, vial was initially stored in the refrigerator on 14-Mar-2023 and administered on 15-Mar-2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, vial was initially stored in the refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 36-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, vial was initially stored in the refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, vial was initially stored in the refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, vial was initially stored in the refrigerator on 14-Mar-2023 and administered on 15-Mar-2023).    No concomitant medications were reported.  This lot number 060B22A of vaccine was administered to patients with a count of in between 75 and 125. There were a total of 82 patients involved. The healthcare provider wanted to know if the vaccine administered on 15-MAR-2023 would be considered as valid for the patients.  It was also reported that there was potentially a second lot number of vials that had expired on 28-Feb-2023 and was administered to patients on 03-Mar-2023, but the healthcare provider did not have any details of that event at that time. The second potential lot was confirmed to not be used.  The vial size was reported as 10 dose vial.  The vial had not undergone any temperature excursions.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
anaphylaxis/stroke; anaphylaxis/stroke; This spontaneous report was received from a physician (discrepant information, also reported as a consumer) via Pfizer and refers to a male patient, who was 24 years old at the time of the report. There was no information regarding his medical history, concurrent condition nor concomitant therapies provided.  On an unspecified date (reported as previously), the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (manufacturer unknown) (reported as chickenpox/varicella vaccine) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. On an unknown date, after the vaccine administration, he experienced anaphylaxis or stroke. The outcome of the event was unknown.  The causal relationship between the event and the suspect vaccine was not reported.  Upon internal review, the events of anaphylactic reaction and cerebrovascular accident were considered to be medically significant.
This spontaneous report as received from a 81 years old female consumer who was referring to herself. The patient's current conditions included high blood pressure osteoporosis, Sjogren's syndrome and allergy to CIPRO. In August 2007 the patient was vaccinated with ZOSTAVAX (lot number, expiration, dose, route were not reported). No concomitant medications were reported. In March 2014 (reported as last month) the patient experienced a mild case of Shingles. The patient had little nerve pain and was prescribed an unspecified medication for the nerve pain. No lab diagnostics studies were performed. The patient sought medical attention - saw the physician. The outcome of a mild case of Shingles was reported as not recovered/not resolved. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 030M20A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), PROBIOTICS NOS and IRON for Pregnancy.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 20-May-2020 and the estimated date of delivery was 02-Mar-2021. On 21-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fifth week of the pregnancy.  On 21-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jun-2020, Pregnancy test: positive (Positive) Positive. In 2021, Ultrasound scan: normal (normal) Normal. In November 2021, Blood glucose: normal (normal) Normal.         Treatment history was not reported .
Covid positive 11Apr; Covid positive 11Apr; Cold like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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: NASOPHARYNGITIS (non-serious) with onset 11Apr2022, outcome "unknown", described as "Cold like symptoms"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11Apr2022, outcome "unknown" and all described as "Covid positive 11Apr". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Apr2022) Positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a registered nurse refers to an unknown age and gender patient. Pertinent medical history, drug reactions or allergies were not reported. On 21-JUN-2013, the patient was vaccinated with an improperly stored dose of VARIVAX, (dose was not reported), lot # H009635, expiration date: 09-MAY-2014. Concomitant medication was not reported. The reporter stated that VARIVAX was improperly stored from 03-JUN-2013 to 21-JUN-2013, and the total amount of time that the doses were above the recommended storage range of -15 Celsius (C) was 187.5 hours. Though most of the temperatures recorded in that time period were below -10C, there were three occasions where a highest temperature of 0C was recorded. The three temperature excursions were: 1). 88.5 hours to as warm as 0C, 2). 7.5 hours to as warm as -6C, and 3). 88.5 hours to as warm as -8C. No adverse effect had been observed or reported. This is one of four cases linked to the same reporter (MARR# 1310USA008540, 1310USA010120 and 1310USA010121). Additional information has been requested.
Bad nausea; Abdominal upset; Lightheaded; Tired; Joint hurt; Strong metallic taste; Arm hurt; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Mar2021 (at the age of 52-years-old) at 10:30, as a single dose for COVID-19 immunisation. Medical history included RA (rheumatoid arthritis), Reynauds and bone cancer. The patient has known allergies to inapsine and guaifenesin. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not diagnosed with COVID-19, prior to vaccination. The patient had not been tested for COVID-19, since the vaccination. Started with in minutes on 23Mar2021, patient experienced strong metallic taste in mouth. It got worse as the day went on and was still current. Her arm hurt during the night and current.  On 24Mar2021 at 10:30 (It was 24 hours in and she had bad nausea and abdominal upset, was somewhat lightheaded, tired and had joint hurt). she experienced bad nausea, abdominal upset, lightheaded, tired and joint hurt. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient received treatment for nausea. The clinical outcome of metallic taste in mouth, arm hurt was not recovered and outcome of the events bad nausea, abdominal upset, lightheaded, tired, joint hurt was resolving.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 13-JAN-2016, the patient was vaccinated with an expired dose of PROQUAD (Merck) (lot # K009891, expiry date 11-JAN-2016; dose and route were not reported). The nurse reported that PROQUAD did not have any previous temperature excursions. No adverse symptoms were reported. Additional information has been requested.
Patient got the second dose of series even though he completed the whole series in 2019.    Patient was informed  on 8/16/2023 that he completed the series in 2019 but still came in on 8/17/2023 to get the second dose.  Database and other profile were not available for the pharmacist to check at the time of administering the second dose on 8/17/2023.
Sl fever, chills, stomach cramps started Thurs AM 7NOV91; still cramping not feeling well; Has not contacted MD; 13NOV feeling better cramping remained thru 10NOV91; weak but ok now;
Patient is fully vaccinated and boosted on 12/7/2021. chief complaint, corona virus concern.  Patient is positive for cough, chest pain and dizziness.  BP 130/74  | Pulse 89  | Resp 24  | SpO2 95%   CT chest is negative for PE, infiltrated present consistent with COVID. Referred for mAB therapy.  Discharged home. EKG IBM NSR 92, no acute ischemic changes
Patient reports getting flu-like symptoms the day after getting the 2nd Shingrix dose which lasted for a few days. But the pain and soreness in his arm is still present 2 months after getting the vaccine.
Pt received a flu vaccine (R) arm on 10/28/2014 - I received a phone call from pt on 10/29/14 - she states she began to have pain/numbness and achy feeling in (R) arm about 12 hours after receiving vaccine. Pain has increased - I instructed her to call her PCP for evaluation.
Patient was administered Moderna COVID-19 vaccine as a booster; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was administered Moderna COVID-19 vaccine as a booster) in a 6-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFizer (Pfizer-BNT 10mcg) on 10-Nov-2021 and PFIZER BIONTECH COVID-19 VACCINE (Pfizer-BNT 10mcg) on 01-Dec-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFizer.    On 13-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was administered Moderna COVID-19 vaccine as a booster). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was administered Moderna COVID-19 vaccine as a booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. Patient received booster vaccine 50 mcg on 13-Jul-2022. No treatment medication information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-612998 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-612998:AA Female, 6 years old (Same reporter)
It was reported that a female pt received a TriHibit (combination of Tripedia and Act-Hib), Prevnar and IPOL vaccinations on 1/24/01. Reportedly, that same day, the pt developed a local reaction of redness and swelling. Further information is requested. Insufficient reporter information was provided, several attempts have been made to contact the reporter. As of 3/7/01, no further information has been received for this case. This case is closed.
Constant sinus pain in both cheek bone areas and sinus headache ongoing non-stop above the eyes and on the forehead. The other issues that is the worst is the constant Tinnitus that did not exist prior to the shot. A course of anti-biotics was attempted in case it was a sinus infection with no success.
felt terrible / still feel bad; has a red area around his shot; This case was reported by a consumer via interactive digital media and described the occurrence of feels awful in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2020, the patient received Shingrix. In July 2020, 1 days after receiving Shingrix, the patient experienced feels awful and injection site erythema. On an unknown date, the outcome of the feels awful was not recovered/not resolved and the outcome of the injection site erythema was recovering/resolving.   It was unknown if the reporter considered the feels awful and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient received Shingrix vaccine 2 days ago and felt terrible. The patient experienced redness around shot size of a man's hand. The patient was feeling better. The case has been linked with case US2020AMR143186 reported as same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR143186:same reporter
Pt felt /win 7 min of vax weakness, lightheaded, dizzy also had swelling, redness & itchiness lt hand
Swelling, redness with streaking down left arm. Patient had a positive D-Dimer was referred to Emergency Department from Urgent Care but US was negative at ER.
Vasovagal response after receiving first dose of Pfizer COVID-19 vaccine. Emesis x3. Per patient, possibly blood glucose related, orange juice was given and symptoms resolved.    Able to receive second vaccine with no difficulty.