chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was nervous about injection but received it without compliant. Waited 15 minutes. Got up to go shopping and fainted at checkout about 25 minutes after injection.
None adverse reaction or side effects; pneumococcal 23v polysaccharide vaccine (PNEUMOVAX) (16-JAN-2013 and 13-JUL-2017); Information received from a case in litigation (# 1705USA006337) referring to a 69 year old male patient(pt). The pt's medical history, concurrent conditions and concomitant medications were not provided. On 16-JAN-2013 and 13-JUL-2017, the pt was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23)(reported as PNEUMOVAX; dose, route of administration, anatomical location, lot#, expiration date were unknown) for prophylaxis (inappropriate schedule of product administration). The pt did not experience any adverse event or side effects.; Sender's Comments:  US-009507513-1705USA006337: US-009507513-2002USA005475:
This is a spontaneous report from a contactable nurse who reported 10 cases for different patients. This is the 3rd of 10 cases. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at 0.5 ml single, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced the injection hurt a lot on an unspecified date with outcome of unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017083713 Same reporter/product, different patient.
Pt began with some itching and redness to neck, chest, torso and nose and flushed.  Upper extremities with some trembling noted with pt reports of feeling anxious due to itching.  Pt declined the 50mg po benadryl but did take the 25mg of po benadryl. VS. 141/88, HR 116  , 98% SaO2.   Pt with some improvement at left after approx 30 min to work without further issues.  VS upon dismissal 125/93, HR 106, 98% SaO2.
Soon after the vaccine, I had a blinding headache, painful arm at injection site, fatigue, muscle aches, and nausea.   Eight days after the vaccine, I?ve had unrelenting nausea, intermittent stomach pain, diarrhea, and pain in muscles/joints. I?m so weak that I can barely walk.
Periodic sense of dread/depression not ever experienced previously. All continuing symptoms are hormonal based; ongoing breast swelling; breast soreness (very painful); menstrual cycle is now every 20/21 days vs. 28-30 days and heavier than before vaccination.; menstrual cycle is now every 20/21 days vs. 28-30 days and heavier than before vaccination.; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non-pregnant female patient received BNT162B2 (COMIRNATY, Solution for injection) first dose via unspecified route in left arm on 09Apr2021 (Lot Number: EW0150) (at the age of 43-year-old) as DOSE 1, SINGLE, for covid-19 immunization and second dose via unspecified route in right arm on 30Apr2021 (Lot Number: EW0176) (at the age of 43-year-old) as DOSE 2, SINGLE for covid-19 immunization. Facility type vaccine reported as other. The patient medical history was none reported. The patient did not have any concomitant medications. The patient did not have any known allergies. No covid prior vaccination. No covid tested post vaccination. The patient did not receive any other vaccines within four weeks. No other medications in two weeks. On 16Apr2021, patient experienced ongoing breast swelling, breast soreness (very painful), menstrual cycle is now every 20/21 days vs. 28-30 days and heavier than before vaccination, Periodic sense of dread/depression not ever experienced previously. All continuing symptoms are hormonal based. No treatment received for the event. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Pain in my arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in my arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 VACCINATION SITE PAIN (Pain in my arm). At the time of the report, VACCINATION SITE PAIN (Pain in my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported.  The treatment information was not provided.   Reporter did not allow further contact
This is a spontaneous report received from a contactable pharmacist. A female patient received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the 1st and the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown) for immunization. The patient had pruritus (developed severe skin itchiness since taking the Pfizer booster August 2021), onset Aug 2021, with outcome of unknown. Additional information: Their HCP tried to prescribe medication that would help them with skin irritation. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Herpes zoster; Information has been received regarding a case in litigation from a lawyer, an elderly male patient of unknown age, and his spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 22-DEC-2011, at age 66, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from his zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. The outcome of the herpes zoster is unknown.  Additional information has been requested.
No additional AE; Expired PNEUMOVAX 23 was administered to a patient; This spontaneous report was received from a nurse via a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided.  On 09-AUG-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vial, lot # S036811, expiration date 02-AUG-2021 (exact dose, injection site and route of administration were not reported) for prophylaxis.  No prior temperature excursion was reported for the vaccine. No additional adverse events had occurred.
Severe chilling  on and off in the night. My mouth was so dry and never remember it being so dry. In the morning, I started feeling weak, nauseous and headache. I started asking for help. I passed out on the floor for 3-4 mins. My husband helped me out. I was all bruised. He called 911 and they took my blood pressure and it would drop. They took me to the Emergency room. IV fluid, I started feeling better. They did EKG and blood work and everything came out normal. The doctor at the ER said it was orthostasis vaccination reaction. I believe I was dehydrated and doctor also thought as well.
Case number PHEH2016US008638, is an initial spontaneous report received from a nurse on 05 Apr 2016. This report refers to a 3 years old female patient. Past medical history and concomitant medications were not reported. This patient under the age of 18 was vaccinated with FLUCELVAX (batch number: 174087A) intramuscularly on 04 Dec 2015, instead of FLUARIX (manufacturer: unknown, batch number: 9JX2N, expiry date: 16 Jun 2016) on an unknown date. No adverse event was reported following this maladministration (wrong vaccine administered). Follow up information received from nurse on 22 Jun 2016: Added new suspect drug FLUARIX and its details (lot number and expiry date), added new event (wrong vaccine administered), deleted the event inappropriate age at vaccine administration and updated narrative accordingly.
Patient received DTaP and Flu shot (1st 1/2 dose) to left thigh on 01/25/05. Both immunizations in same leg D/T rash on right thigh. Reaction site is 7.5cm x 6cm, red, raised and warm to touch. No other symptoms noted. Mom called today to schedule appointment for this afternoon.
I tested positive for COVID-19 on 12/1/22. I had a runny nose, and a sore throat. I had no other symptoms. Due to my chronic health conditions, they prescribed molnupiravir. She told me to take TYLENOL as needed. My symptoms lasted for about 8 days. I still have some fatigue and a little brain fog in the morning.
Redness, swelling, warm to the touch and very sore by injection site along with a "knot" if you ran you hand over the area. That lasted until 01/12/2021. As of today, 01/13/2021, the previous symptoms are almost gone. I still have a decently large pink in the side of the injection site but all other symptoms are gone.
Pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 34-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Live birth on 31-May-2015, Pregnancy induced hypertension and Hemorrhage postpartum. Concurrent medical conditions included Drug allergy (Morphine), Bee sting hypersensitivity and Drug allergy (toradol). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and DOXYLAMINE SUCCINATE (UNISOM [DOXYLAMINE SUCCINATE]) for an unknown indication.    On 20-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 27-Jul-2020 and the estimated date of delivery was 10-May-2021. On 20-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fifth week of the pregnancy.  On 20-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Aug-2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment drugs are not provided by reporter.
Pt reports her arm is sore and skin is red from above injection site down to the elbow.
Pt recvd Td vax & devel pain, itching, redness & swelling @ the site of inject, numbness in the fingers, tingling of lt arm from shoulder to fingertips, back pain, giant hive, 13JUN92 devel acute brachial plexus neuritis w/neck, shoulder;
The pt complained of soreness at the site of the injection. She called on 12/31/01 and said that she had difficulty in raising her arm. She was vaccinated on 11/7/01.
At 5:40 we discovered a welt (we thought it was a bruise at first) on my daughter's face.  At 7:20 she had flesh colored pimples around her eyes (like a mask).  We went to the ER at Children's Memorial.  Arrived around 7:40.  Her ears were red, she was covered in hives, cheeks looked chapped, she was cranky, lethargic.  Triage administered unknown dose of children's benedryl, and gave us a room.  She began experiencing vomiting, facial swelling, difficulty breathing.  Attending ordered epinephrine, xantac, albuterol nebulizer, and orapred.  Nurse administered meds.  Within 20 minutes symptoms reversed.  Chaviva was admitted for overnight observation.  The next day we left with instructions on how to use an epi-pen, benedryl, orapred and doses for the next two days.  Thursday afternoon around noon Chaviva began rubbing her eyes, pulling her ears and scratching her face.  Her cheeks were red so I gave her 3.6 benedryl and called pediatric allergist.  Saw pediatric allergist Thursday afternoon, he ordered continual doses of benedryl and orapred through Saturday.  Friday-Saturday Chaviva ran a low grade fever (100) and had runny stools.  By sunday she was better.
This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-JUN-2018, the patient received an improperly stored dose of ROTATEQ taken orally (lot # N011651 and expiration date 02-DEC-2018)(dose, strength and frequency were not provided) for prophylaxis. The vaccines experienced a temperature excursion of 47 degrees Fahrenheit (F) to 77 degrees Fahrenheit (F) (60.33 degrees F) for a time frame of 42 hours. It was reported that there was no previous temperature excursion and no adverse effect was reported. It was reported that this call was due to a digital data logger. Furthermore, no product quality complaint (PQC) was reported. This is one of several reports from same source. Sender's Comments: US-009507513-1806USA012857: US-009507513-1807USA003053: US-009507513-1807USA003054: US-009507513-1807USA003055: US-009507513-1807USA003056: US-009507513-1807USA003057: US-009507513-1807USA003058: US-009507513-1807USA003059: US-009507513-1807USA003060: US-009507513-1807USA003061: US-009507513-1807USA003062: US-009507513-1807USA003063: US-009507513-1807USA003064: US-009507513-1807USA003065: US-009507513-1807USA003066: US-009507513-1807USA003068: US-009507513-1807USA003069: US-009507513-1807USA003177.
Approximately 5 days after receiving this booster dose of the COVID-19 vaccine, I began experiencing extremely heavy menstrual bleeding and clotting.  The bleeding and clotting began on November 3, 2021.  It is currently December 6, 2021 and I am still experiencing heavy bleeding with clotting, and now some cramping as well.   A few days after receiving my first dose of the Moderna vaccine on January 7, 2021, I experienced the same heavy bleeding and clotting. I made an urgent appointment with my OB/GYN on January 14, 2021 and was started on hormone therapy (Megace) to control the bleeding. At the time, I did not connect the bleeding with the vaccine. Following my second dose of the Moderna vaccine on February 4, 2021, the bleeding and clotting began again.  After multiple attempts, I was unable to wean from the Megace without experiencing heavy bleeding.  I underwent an endometrial ablation on August 12, 2021.  Samples of uterine tissue were sent to pathology at that time, and cancer was not detected and was ruled out as a reason for the bleeding. Following the ablation, I had minimal bleeding during menstruation.  On October 29, 2021, I received the booster dose of the Moderna vaccine, and by November 3, 2021 I was again experiencing severe bleeding and clotting, with some days being worse than others.  I was supposed to have an appointment on February 11, 2022, as a follow-up for my endometrial ablation.  I have had to move that appointment up to December 10, 2021, as my provider and I will have to discuss what to do now.  Hormone therapy is not a long-term solution, so it's possible that I will have to undergo a hysterectomy. I will know more after my appointment on December 10, 2021.
Patient presented to the ED and was subsequently hospitalized for severe anemia, hypoxia within 6 weeks of receiving covid booster vaccination.
Discharge diagnosis: Acute hypoxic respiratory failure secondary to viral pneumonia in the setting of COVID-19 Acute kidney injury Septic shock Right popliteal DVT Hyponatremia
About 36 hours after injection my face started itching and tingling and during the course of the day it swelled up.  I called my doctor to see if I could take Benadryl and he approved that.  Benadryl did not take effect and I went to the ER at Hospital on Thursday evening after my eyes became slits.  ER doc prescribed steroid (Prednisone 50 mg) for 5 days and continue Benadryl.  After a week everything is back to normal.  I am just curious if I should have the second Shingles shot in a few months time.
large lump in right axilla >7cm round soft mildly tender lump, no warmth, redness noted.
Starting the day after the shot, the arthritis in my hip flared up severely. I had a lot of trouble walking. With each dose it has progressively worsened and I have not had any resolution as of yet. I am doing physical therapy and taking diclofenac to help  improve mobility.
Worked nocs so came home and slept when awoke congested, achy, dizzy and weak. Awake Sat evening small red itchy rash on R arm. Throughout the night shift rash spread all the way down the R arm onto head. Left arm and both legs. No improvement on Sunday. Went to urgent care on Monday.
terrible symptoms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (terrible symptoms) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (terrible symptoms). At the time of the report, VACCINATION COMPLICATION (terrible symptoms) outcome was unknown. Not Provided          Med Info Agent: Adverse Event reported through Chatbot.   Patient reports that after the second Moderna vaccine side effects started one hour after dose and continued until now 25May21 which is 24 days later.  There is no information on dose received or patient information.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant follow up appended to MOD-2021-169806
This case was reported by a consumer interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 weeks after receiving Shingles vaccine, the patient experienced shingles and pins and needles. On an unknown date, the outcome of the shingles and pins and needles were unknown.   It was unknown if the reporter considered the shingles and pins and needles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got shingles about 3 weeks after booster and felt like pins poking to him/her.
Fever of 100.8 severe headache very tired and weak severe body aches muscle aches sick to stomach severe chills slightly dizzy
Facial numbness, traveling down to neck, throat, and Shoulder. Muscle twitching, mainly at night.
One inch long raised red spot a few inches below left collarbone (roughly 3 inches in from armpit).; This is a spontaneous report from a contactable consumer (Patient). A 36-year-non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6198) via an unspecified route of administration, administered in left arm on 03Mar2021 at 17:00 (at the age of 36-years-old) as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications in 2 weeks of vaccination. Patient do not have allergies. The patient was not diagnosed with COVID-19 prior to vaccination. Medical history was none. Concomitant medications were not reported. On 04Mar2021 (next day of vaccination), patient experienced one inch long raised red spot a few inches below left collarbone (roughly 3 inches in from armpit). Patient had not received any treatment for the events. The patient was not tested for COVID-19 since the vaccination. The outcome of the event was not recovered.   No follow-up attempts are possible. No further information is expected
2 weeks after administration presented with intermittent abdominal pain - noted to be pulling legs up and crying f/b infant lying still and not moving.  After 24h of this pain brought in due to bloody stools and diagnosed with ileocecal intussusception.  Had bowel necrotic bowel resected in OR immediately and is currently recovering in the PICU. Discharge summary states lethergy. Medical record states irritable.
Myalgia, Arthralgia, Fever,  Injection site pain Narrative:  Received 1st dose 12/31/20 - noted injection site pain, myalgias/fatigue x 4 days, and reported symptoms of depression x 3 days. On 1/4/21 noted onset of sore throat, swollen tonsils and fever (100.6). Sought medical attention and diagnosed with viral pharyngitis. Symptoms resolved by 1/7/21. Received 2nd dose 1/26/21. On 1/27/21 noted myalgias, arthralgias, chills and slightly elevated temp (99.5). Symptoms resolved 1/28/21. No known prior COVID infection.
Flushing of face, chest, feeling of warmth internally  Vital Signs: BP 152/92 HR 85 Resp 16 O2Sat 98%  Skin Signs: Warm and dry, Other - Flush feeling in chest and face  Circulation: Cap Refill <2sec  Respiratory: Breath sound clear bilaterally  Initial Treatment: Vitals taken at 1:29 PM. No sign of anaphylaxis noted.   1:49 PM Vital Signs: BP 142/90 HR 78 Resp 16 O2Sat 98%  Skin Signs: Warm and dry, Other - Flush  Circulation: Cap Refill <1sec  Respiratory: Breath sound clear bilaterally  Follow up Treatment: 'Warm feeling internal chest'. Warm feeling in throat upon exhale.  2:08 PM  VItal Signs: BP 144/90 HR 85 Resp 12 O2Sat 97%  Respiratory: Breath sound clear bilaterally  Disposition: Home by self. Advised to drive into town with wife to see primary care doctor.
Broke out with rash after vaccination. Diagnosed with shingles on 08/28.
This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain), LYMPHADENOPATHY (swollen lymph nodes in left armpit which kept her up all night), FATIGUE (Fatigue), PYREXIA (low grade fever for 3 days) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 04-Mar-2021 and 2nd dose on 13-Apr-2021) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 04-Mar-2021 and 2nd dose on 13-Apr-2021). On an unknown date, the patient experienced BACK PAIN (lower back pain), LYMPHADENOPATHY (swollen lymph nodes in left armpit which kept her up all night), FATIGUE (Fatigue) and PYREXIA (low grade fever for 3 days). At the time of the report, BACK PAIN (lower back pain), LYMPHADENOPATHY (swollen lymph nodes in left armpit which kept her up all night), FATIGUE (Fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 04-Mar-2021 and 2nd dose on 13-Apr-2021) outcome was unknown and PYREXIA (low grade fever for 3 days) had resolved. No Concomitant product use was reported. The patient reported that after receiving the second dose, the patient experienced low grade fever for 3 days, swollen lymph nodes in their left armpit which kept them up all night, fatigue, and lower back pain. No treatment information was provided. This case was linked to MOD-2022-562865, MOD-2022-563382 (Patient Link).