chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme pain at injection site for the first week making it extremely difficult to sleep.  On 10/11, left eye started twitching uncontrollably.  This twitching was found on search to be a know side effect. Second dose on 11/1 resulted in extreme dizziness and a migraine headache that lasted over 2 days even with prescription migraine medication.  Left eye twitch has gotten much worse and  twitching has moved down into my mouth also.  I have had extreme exhaustion and confusion, along with inability to follow conversations and coherently reply when asked questions.  There is a constant fluttering feeling in the left side of my head and it never stops.  Due to these symptoms increasing and being  similar to the signs of a stroke, i was taken to the Emergency Room of a local hospital on 12/2 to be examined.  I had a CT scan, an EKG and various blood tests.  The ER staff have diagnosed me with a post vaccine reaction.  The second dose of the Moderna vaccine was on 11/1 at the same store and was Lot # 033F21A, if the vaccine card is to be believed.  The online records for store show different lot numbers for both injections.
Approx 10 min after injection pt told mother "I'm going blind" and he passed out in seat of car and fell over. Went to ER and approx 1 hours later increased B/P and  is jerking  arms, legs and stomach ache. Stayed till 11:15 pm. doctor told me didn't know what cause  episode.
instead of Moderna 2nd dose patient received Pfizer vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTRATION ERROR (instead of Moderna 2nd dose patient received Pfizer vaccine) 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 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (instead of Moderna 2nd dose patient received Pfizer vaccine). At the time of the report, PRODUCT ADMINISTRATION ERROR (instead of Moderna 2nd dose patient received Pfizer vaccine) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Fast Heart beat-   Light Headed,Fatique and weakness, extreme Blood pressure  Spikes     Unable to work   1 year now    Still in treatment-   over 20 ER Visits  3 Hospital Admissions   Cardiologist test and exams  Neurologist- Test and exams  Endocrinologist Test and Exams  Waiting for referral approval for high level of care Hospital-    End Results-  ( POTS)
pts received j&j sunday  24th at pharmacy slight loss of control lips ,slight control in legs,felt wobbily, heavey prespiration ,blurry vision  traveling pain in the back of his legs , pain lower back
sore arm; temperature was near 100 degrees F; chills at night, was very cold, woke up freezing; chills at night, was very cold, woke up freezing; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Feb-2021 and was forwarded to Moderna on 27-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), FEELING COLD (chills at night, was very cold, woke up freezing), PYREXIA (temperature was near 100 degrees F) and CHILLS (chills at night, was very cold, woke up freezing) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 041L20A) for COVID-19 vaccination.     Concomitant products included TICAGRELOR (BRILINTA), MULTIVITAMIN [VITAMINS NOS], ACETYLSALICYLIC ACID (ASPIRIN 81), LISINOPRIL and ROSUVASTATIN (STATINOR [ROSUVASTATIN]) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced FEELING COLD (chills at night, was very cold, woke up freezing) and CHILLS (chills at night, was very cold, woke up freezing). On 26-Feb-2021, the patient experienced PYREXIA (temperature was near 100 degrees F). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (sore arm), FEELING COLD (chills at night, was very cold, woke up freezing), PYREXIA (temperature was near 100 degrees F) and CHILLS (chills at night, was very cold, woke up freezing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable   This case was linked to MOD-2021-028418, MOD-2021-028418 (Patient Link).
Enteritis and gallstones. Had severe abdominal pain under ribs and right upper stomach area. Nauseous too
Patient reported pain in left arm with injection and facial redness. Had similar response to the first injection- advised to wait an additional 15 minutes for observation and patient accepted. Offered benadryl and patient declined. at 1830 patient stated she felt warm but no respiratory distress or hives noted on observation. This was 2nd Pfizer vaccine lot ER8732.
pt exp onset of lower extremity weakness;pt could hardly walk around;very weak;balance is not good;BP 172/80;wide base gait that is unsteady;edema in ankles;possible GBS;Annual follow-up dated 10/4/00 provided no additional data.
6PM while in high chair for supper pt had tremors of entire body for 10sec;appeared to mom to be holding breath during this time;3min later had 2nd episode same as first;called ER told to come out if pt had another episode;
I got a headache and chills around 5 hours after I got the shot and I took a nap. I woke up with a fever, nausea, and dizziness, headache, and on and off chills. I took acetaminophen to help. Everything stopped around a day and a half later.
Loss of consciousness with hospitalization for six days; This is a spontaneous report from a contactable Other HCP (Nurse) and a contactable consumer (patient).  An 85-year-old patient received second dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Not reported), via an unspecified route of administration on 09Apr2021 as dose 2, single for COVID-19 immunisation. The patient medical history included high blood pressure, for which she takes "critical blood pressure medications- that are compounded by a special pharmacy", lot of allergies including cannot tolerate artificial sugars as they cause headaches, sensitive to many things for which she responds with flu and can only tolerate brand medications as generic" have too many fillers" for which she also developed a headache and "feels awful". She had been independent and living alone (her husband has dementia and lives in a care centre), She was able to drive and able to walk independent of assistive deceives. A history of a loss of consciousness in the past was denied. Concomitant medications included Doxazosin Mesilate (CARDURA) for high blood pressure, Vitamin D3 as dietary supplement, Alprazolam (XANAX), Metoprolol tartrate (LOPRESSOR), Cipcal Vitamin D3 Gummies and Nature's Bounty D3 Gummies, Strawberry, Orange & Lemon Flavored Gummies (Lot number:5164590, Expiry Date: 31Jan2022). The patient previously received first dose of BNT162B2 (Lot number and Expiry date: Not reported), via an unspecified route of administration, administered on 19Mar2021 as dose 1, single for COVID-19 immunisation. On 13Apr2021 the patient experienced loss of consciousness with hospitalization for six days and inpatient rehabilitation for ten days. In Apr2021, the patient had a head scan, urinalysis, throat test, unspecified blood tests and heart tests (all heart tests they could do). Outcome of the event was unknown.   No Follow-up attempts are needed, information about lot/batch number can not be obtained.; Sender's Comments: Considering a plausible temporal relationship, a causal association between the reported event of loss of consciousness and suspect drug bnt162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Rheumatoid Arthritis; Right hand was extremely swollen almost twice the size/Right foot was extremely swollen, not able to wear shoe; Wrist was extremely swollen almost twice the size; Right foot was red; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid Arthritis), PERIPHERAL SWELLING (Right hand was extremely swollen almost twice the size/Right foot was extremely swollen, not able to wear shoe), JOINT SWELLING (Wrist was extremely swollen almost twice the size) and ERYTHEMA (Right foot was red) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Rheumatoid arthritis. Concomitant products included TRAMADOL for Pain, METHOTREXATE for an unknown indication.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PERIPHERAL SWELLING (Right hand was extremely swollen almost twice the size/Right foot was extremely swollen, not able to wear shoe), JOINT SWELLING (Wrist was extremely swollen almost twice the size) and ERYTHEMA (Right foot was red). On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid Arthritis). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid Arthritis), PERIPHERAL SWELLING (Right hand was extremely swollen almost twice the size/Right foot was extremely swollen, not able to wear shoe), JOINT SWELLING (Wrist was extremely swollen almost twice the size) and ERYTHEMA (Right foot was red) outcome was unknown.            Concomitant drug includes Blood pressure medications  Treatment Received 2 Prednisone shot at the inflammatory joint and also taking Prednisone pill and Toradol pill daily.  Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.  Action taken with mRNA-1273 in response to the events was not Applicable.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
adult patient received pediatric dose; adult patient received pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 51-year-old male patient who received HAV (Havrix) (batch number Y4SL4, expiry date 28th January 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th November 2021, the patient received the 2nd dose of Havrix .5 ml and Havrix Pre-Filled Syringe Device. On 4th November 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The adult male patient received a pediatric 0.5ml dose of Havrix, which led to underdose and adult use of a child product. No symptoms reported. The reporter consented to follow up.
uncontrollable nausea & diarrhea that started 24hr p/vax & cont for 4 days;
This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Pain), VACCINATION SITE PAIN (his left arm was painful), ARTHRALGIA (wrist was so painful) and HEADACHE (headache that felt like he was hit on the head) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 039K20A and 026L20A) for COVID-19 vaccination. No Medical History information was reported. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, the patient experienced PAIN (Pain), VACCINATION SITE PAIN (his left arm was painful), ARTHRALGIA (wrist was so painful) and HEADACHE (headache that felt like he was hit on the head). At the time of the report, PAIN (Pain), VACCINATION SITE PAIN (his left arm was painful), ARTHRALGIA (wrist was so painful) and HEADACHE (headache that felt like he was hit on the head) outcome was unknown.For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medication was reported.No treatment medication was reported.This case was linked to MOD-2021-388396, MOD-2021-388352 (Patient Link).
No additional adverse effect reported; The medical assistant administered properly stored GARDASIL 9 to a female patient. Which expired 10/29/2019; This spontaneous report was received from a medical assistant regarding a 24-year old female patient. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were no reported.   On 03-DEC-2019, the patient was vaccinated with properly stored vaccine HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) which was expired: lot number R024264, expiration date 29-OCT-2019, for prophylaxis (dose, and route of administration was not provided) (expired product administered). No additional adverse effect reported.
This is my fourth pregnancy never had any kind of preclampsia and protein n in my urine till I took this shot. My baby due date was March the 6 of 2022 but he was born early. I had to report to the labor and delivery several times during my doctor appointment due to my high blood pressure. The baby weighed 5 pounds and 7 ounces.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMOVAX23 (lot # and expiration date unspecified) (dose, route and anatomical location unspecified). The pharmacist reported that on an unknown date, after received PNEUMOVAX23, the patient's whole arm swelled. The outcome of the patient's whole arm swelled was unknown. Additional information is not expected.
This spontaneous report as received from a physician and from a support services director refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 22-JUL-2016, the patient was vaccinated with an improperly stored ROTATEQ 2 ml oral injection (lot# L008997, expiry date 04-DEC-2020; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to two separate temperature excursion (dates unspecified): one lasting for 712 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.11 degrees Celsius) and the second one lasting for 168 hours, with the lowest recorded temperature of 32 degrees Fahrenheit (0 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Not witnessed by medical staff - Father reports 30 minute period of unresponsiveness about 15 minutes after administration. baby had no seizure activity or cyanosis. Seemed to be in coma like state with non-responsive pupils. When Dad got to ED, she woke up and appeared fine. No fever or site reaction - no subsequent problems 18 hrs later.
This spontaneous report was received from a 77 year old female consumer referring to herself. The patient's medical history included breast cancer. The patient had no drug reactions/allergies. Information about concurrent conditions was not reported. On 02-MOV-2015, the patient was vaccinated with PNEUMOVAX23, intramuscularly, 1 dose, once, lot # K021030, expiration date JUNE 2022. Concomitant therapies included anastrozole (manufacturer unknown) and hydrochlorothiazide (manufacturer unknown). On 02-NOV-2015, within the hour of administration of PNEUMOVAX23 the patient experienced injection site swelling, redness and pain. The patient did not seek medical attention. The treatment reported, was that the patient put ice on it. Laboratory diagnostics were not performed. The outcome of the events was reported as recovered, also reported as: the symptoms were absorbed and decreased within 3-4 days, approximately on 06-NOV-2015. The reporter did not assess the relatedness from injection site swelling, redness and pain to PNEUMOVAX23. Additional information is not expected as reporter details were not provided.
Pt had a rash in the interior crook of her left elbow appx 15-20 minutes after vaccination.  The rash was in the form of uniform redness spreading outward from the crook of her elbow.  The vaccine had been delivered in her upper left deltoid muscle.  There was no sign of redness whatsoever at the injection site.  I cannot confirm that the redness was not present prior to the infection as I did not examine that area.  The patient believes that the redness came on suddenly after the vaccine.  I marked the edges of the rash with a marker and asked her to wait for another 30 minutes.  In that time there was no change and no spread of the redness.  The patient went home with instructions to seek immediate treatment if the rash grew.  It faded over time and had no negative effect on pt's health.
Information has been received from a mother concerning her daughter who on unspecified dates was vaccinated with 3 doses of GARDASIL.  Subsequently the patient "has been having seizures since she received the three doses of GARDASIL".  The outcome of the seizures was not reported.  It was unspecified if the patient sought medical attention.  No further information is available.
This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 28Mar2021 at 12:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medication. On 11Apr2021, the patient experienced blockage in the eustatian tube (ear). The patient had no allergies or recent cold which could have caused this and diagnosis was completed by an ENT doctor. The event resulted in doctor or other healthcare professional office or clinic visit. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of event blockage in the eustatian tube (ear) which included treatment with flonase (MANUFACTURER UNKNOWN) nasal spray to clear the blockage. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event blockage in the eustatian tube (ear) was not resolved at the time of this report. The patient had received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in 2021 as a single dose for COVID-19 immunisation.  No follow-up attempts are possible. No further information is expected.
Hypotensive, unresponsive for NSR.  Took 1 hr before could vagal episode - No LOC.
Case number PHEH2015US003113, is an initial spontaneous report received from a nurse on 10 Feb 2015. This report refers to a 15 year old female patient. Historical condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with MENVEO for the first time when her age was 11 years. She was again vaccinated with another dose of MENVEO (batch number: X14071) intramuscularly on 04 Feb 2015 when she was 15 year old. No adverse event was reported following this administration error (inappropriate schedule of vaccine administered).
to ED c/o AMS, TX: Regerneron, zinc, vit C, dexamethasone, maxipime, no O2 requirements; d/c'd home
Pain under the left arm in armpit - suspected swollen lymph node. Tender to the touch, but does not limit daily activity. Noticed around 10:00pm on February 21, EST. Symptoms still occurring 24 hours later.
MMR II given by nurse into patients thigh caused fat necrosis and thinning of skin, large patch approx 5cm in diameter.
Body Aches, Fever, Fatigued, Headaches lasting 24 hours
during the week of 24JUN97 hands became worse than usual in terms of achiness & cramping;had gen achy bones, esp in hips, feet p/sitting for long periods;has not been seen by MD yet says will see MD if sx persists;
Patient passed out and hit his head on the floor cause a laceration above left eyebrow which needed medical attention at local hospital. Also may have needed a concussion test done.
On 4/3/23 an internal vaccine audit identified this patient as being vaccinated on 12/8/22 with a Jynneos vaccine that was potentially exposed to room temperatures for greater than the allowable time. Patient is being contacted for revaccination.
LOCAL REACTION ON LEFT ARM.  ERYTHEMA, WARMTH, AND 2"X2" AREA OF SWELLING.  TREATED WITH MOTRIN AND ICE.
TEMPERATURE EXCURSION. vaccine (covid) was stored in the freezer longer than manufacture recommendations. Patient did not have any adverse reactions.
Pt received a pediatric dose of moderna booster #2 rather than adult dose. No adverse symptoms reported. Pt received a lower dose than recommended. Error identified when provider performing vaccine reconciliation in states vaccine system. CDC notified and received recommendation.
This spontaneous report as received from a physician refers to a 17 years old male patient. The patient was vaccinated intramuscularly with GARDASIL (lot number not reported) on 09-OCT-2012. Concomitant medications included: MENACTRA. On 09-OCT-2012 the patient was administered GARDASIL later, experienced a seizure and fainted on the floor cutting his chin after his first administration. The patient also bit his tongue from the impact when hitting the floor. The patient was taken to the Hospital where he was placed under further medical care. No treatment information was reported. The outcome of the events was unknown. Additional information has been requested.
Local swelling on the right, low grade fever, intense chills, shaking, jaw and head pain.
Pfizer Covid-19 monovalent was used for the patient as a booster instead of the bivalent.  Patient made aware, can schedule the bivalent in 2 months if she choses.