chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccine did hurt some; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain 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 stated the worst case of shingles in past. The patient stated that the vaccine did hurt some, but he/she would take the 2 shots any day over having shingles again. The follow-up would not be possible as no contact details were available. This case has been linked to US2021AMR259929, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR259929:Samepatient differentdose
1153AM pt became lightheaded & dizzy, nauseous p/vax;11:55 pt lying on exam table BP 110/78 given OJ & sucker
Swollen painful unilateral cervical (neck) lymph nodes (rock hard firm) on side of injection . Lasted for two weeks gradually dissipating in firmness and tenderness without any treatment
chills and lot's of cold; got an eye lip swollen like with an allergic reaction; started to get the upper lip, the lip and the cheek and part of the right nose swollen and on the; throat swollen; reaction to vaccine; feels on top of the head like pressure; Swollen lymph nodes on the right side; chills and lot's of cold; body aches really strong/body aches; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (chills and lot's of cold), EYE SWELLING (got an eye lip swollen like with an allergic reaction), SWELLING FACE (started to get the upper lip, the lip and the cheek and part of the right nose swollen and on the), PHARYNGEAL SWELLING (throat swollen) and ALLERGY TO VACCINE (reaction to vaccine) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMINS NOS and VITAMIN D3 for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (chills and lot's of cold), EYE SWELLING (got an eye lip swollen like with an allergic reaction), SWELLING FACE (started to get the upper lip, the lip and the cheek and part of the right nose swollen and on the), PHARYNGEAL SWELLING (throat swollen), ALLERGY TO VACCINE (reaction to vaccine), HEAD DISCOMFORT (feels on top of the head like pressure), LYMPHADENOPATHY (Swollen lymph nodes on the right side), CHILLS (chills and lot's of cold) and MYALGIA (body aches really strong/body aches). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (chills and lot's of cold), EYE SWELLING (got an eye lip swollen like with an allergic reaction), SWELLING FACE (started to get the upper lip, the lip and the cheek and part of the right nose swollen and on the), PHARYNGEAL SWELLING (throat swollen), ALLERGY TO VACCINE (reaction to vaccine), HEAD DISCOMFORT (feels on top of the head like pressure), LYMPHADENOPATHY (Swollen lymph nodes on the right side), CHILLS (chills and lot's of cold) and MYALGIA (body aches really strong/body aches) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-095205 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: No specific follow-up information recorded.
MODERNA 6-11 GIVEN AS A BOOSTER AFTER PATIENT RECEIVED PRIMARY SERIES WITH PFIZER 6-11.
Numbness of 4th & 5th (L) fingers - "a few days after receiving injections" (vaccinations) (3/1/11).
This spontaneous report as received from a nurse manager refers to unspecified number of patients of unknown age and gender. On an unknown dates, since October 2014, the patients were vaccinated with a doses of ROTATEQ (doses, routes, lot numbers and expiration date were not provided) which were exposed to multiple excursions. No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Hives and swelling all over body, face, armpits, vagina, and feet. Difficulty breathing.  Zyrtec, Benadryl, and Prednisone all given at different ER visits. 4 ER visits in 3 days due to new or worsening symptoms.
headaches at the top of his head; his ears was bothering him specifically the back of the ear; some dizziness; He almost passed out when he stood up; his bones hurt a little bit; exacerbated his arthritis; his arm was a little touchy; turning his head was very difficult; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (his bones hurt a little bit), TENDERNESS (his arm was a little touchy), ARTHRITIS (exacerbated his arthritis), VERTIGO (turning his head was very difficult) and DIZZINESS (some dizziness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VERTIGO (turning his head was very difficult). On 24-Jan-2021, the patient experienced TENDERNESS (his arm was a little touchy). On 26-Jan-2021, the patient experienced BONE PAIN (his bones hurt a little bit), ARTHRITIS (exacerbated his arthritis), DIZZINESS (some dizziness) and PRESYNCOPE (He almost passed out when he stood up). On 09-Feb-2021, the patient experienced EAR PAIN (his ears was bothering him specifically the back of the ear). On 15-Feb-2021, the patient experienced CLUSTER HEADACHE (headaches at the top of his head). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, BONE PAIN (his bones hurt a little bit), TENDERNESS (his arm was a little touchy), ARTHRITIS (exacerbated his arthritis), VERTIGO (turning his head was very difficult), DIZZINESS (some dizziness), PRESYNCOPE (He almost passed out when he stood up), EAR PAIN (his ears was bothering him specifically the back of the ear) and CLUSTER HEADACHE (headaches at the top of his head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  When he drinks water or milkshake, it helps clear the headache or back of his neck for a while. He also took a towel and a belt around his neck to create a neck support collar.
vaccine was given incorrectly / gave the liquid part of SHINGRIX only; vaccine was given incorrectly / gave the liquid part of SHINGRIX only; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 29-MAR-2022 Reporter's Comments: Caller was a pharmacist calling to ask for more diluent for the shingrix vaccine that was given incorrectly.  The reporter was asking for another adjuvant of shingrix because the nurse who administered, only gave the adjuvant. She did not reconstitute the adjuvant with antigen. She gave the liquid part of shingrix only. The caller provided some of the information but did not have lot number or expiration. Call was disconnected and due to technical difficulty, reporter was not able to connect with this caller again. The reporter did not consent to follow up. No further information was provided. Additional Supportive Information: The nurse only gave liquid part of shingrix only which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
pt recv vax 14JUN95 & 15JUN95 pt exp blotches, vesicles, bumps & itching all over body; No further details were provided;
Chest pains, back pain, fatigue began 4 days post vaccine.  Proceeded to Urgent Care facility, EKG performed, referred to Emergency Room, proceeded to ER, EKG performed, blood work ran, chest XRay taken.   Instructed to take NSAID (Motrin) follow up with primary care dr with talk of possible pericarditis.
on morning following vax pt c/o not feeling well, h/a, & stomachache-did not have diarrhea, fever;
Presented with SOB, sore throat, dizziness;  onset 12/08/2021.  +Covid  12/11/2021 Dx: Covid PNA Labs: D-dimer: >20; Procal 0.2. CXR: clear TX: 1 Dose of Toci given 12/12; steroids, remdesivir, (12/11/2021 to 12/15/2021) lovenox, sigulair, zinc; Initially HFNC 60/84 O2; down to 3 LPM NC upon d/c
Pt. had already received an influenza vaccine at a different location in September.  Because the vaccinations were billed after a vaccine clinic at the facility, this error was not discovered until after administration.
shingles shot and he still got it/Suspected vaccination failure; shingles shot and he still got it; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 31-July-2022 Reporter's comment: The case was received from the patient's children via interactive digital media. The reporter's dad had a shingles shot a couple of years ago and still got them. The reporter was so not convinced about that shot. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Patient states he was in his normal state of health prior to the vaccine and then started to notice left foot numbness and tingling along with left hand weakness/tingling approximately 5 minutes after his vaccine administration in the left arm.  Patient denies any similar reaction with the first dose of the vaccine.  Pt denies any anxiety about the vaccine or previous reactions to other vaccines.  He states the left hand weakness seemed to have resolved over about 2 minutes but the strange feeling in his foot persisted.  The original numbness seems to be better, but he has a persistent icy-hot feeling confined to the left foot.  Pt denies any trauma to the limb.  He is able to ambulate normally.  No concerns for TIA/stroke, reassuring neurvascular exam.  Patient was evaluated for an additional 30 minutes in the medical department aboard the ship with no resolution of foot symptoms.  Pt given return precautions and advised to proceed to ER with any progressive symptoms.
I have developed dermatographia over my whole body that will not go away and is decreasing my quality of life.
I received my Moderna vaccine 12/28/2020. First symptom began that day with pain, soreness of injection site. Later throughout the day I began to have chills, and body aches. I had a sleepless night. The following morning 12/29/2020, I still felt chills, body. Then, I felt nausea, and headache. I slept most of the day today since I felt fatigue too, but it's better than going through Covid .
Red, Hot, Swelling, hard around injection site. Received Flu vaccination on 9/7/2011.
She got her second COVID vaccine on 8/19. On 8/21 she developed nausea and dizziness that has persisted through today 8/30/21. She will see Cardiology and have labwork done.
pt recv vax 1230PM 14OCT98 & pt reported itching & redness in a hive formation below site;reported feeling light headed & nervous w/a very sl feeling of SOB;given epi;vs BP 146/86, R22, P88;pt reported sx improved but still c/o lightheaded
RED BUMP ABOUT THE SIZE OF A QUARTER THAT GREW TO 4CM IN DIAMETER BY THE NEXT DAY (9/19/15).
Frontal Headache and Throat Tightness for 20 minutes.  Symptoms resolved after mom gave Benadryl 37.5mg orally.
No additional AE; VARIVAX was administered to patient with temperature excursion; This spontaneous report has been received from a nurse, regarding to a patient of unknown gender and age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 29-MAR-2023, the patient was vaccinated with an improperly stored dose of with improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) Subcutaneous Injection, at a dose of 0.5 millilites (ml), for prophylaxis (lot number: W008712, which was determined to be valid, with an expiration date on 14-MAR-2024) (strength, vaccination scheme, route of administration, and anatomical site of injection were not reported).   Administered doses were stored at a temperature of 15.7 degrees Fahrenheit (F), during a time frame of 20 minutes (product storage error). There was no previous temperature excursion.  No additional adverse events were reported in the patient.
Noticed whelps on right wrist.  When patient woke up on 10/29/09 she had a bright red, raised rash on both hands, both arms and all over her trunk with intense itching.
Red, blotchy rash on R arm, swollen, painful, fever to 102.4F, wheezing.
Bladder spasms; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old patient of unknown gender 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 27Mar2021 at 10:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included birth control and allergy to possible others (unspecified). 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 vaccination. Concomitant medications included medroxyprogesterone acetate (DEPO PROVERA) for birth control from an unknown date and unknown if ongoing. The patient previously received sulfamethoxazole; trimethoprim (BACTRIM) and acetylsalicylic acid (ASPIRIN) for unknown indication on an unknown date and experienced drug allergy. On 27Mar2021 at 16:00, the night after receiving the shot the patient began to feel symptoms similar to a UTI (urinary tract infection). The patient went to urgent care but there was no infection, but had bladder spasms ever since and it had not gone away. It was stated that, the patient would see the doctor this week. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event (also reported as yes and yes but hope to). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event bladder spasms was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Ache in injection site, muscle aches in joints throughout body, fever of 102 throughout night, loss of sense of taste, headache, chills
Patient was administered an expired booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered an expired booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-369020 (Patient Link).
This case was reported by a nurse via call center representative and described the occurrence of injection site induration in a adult female patient who received FLUARIX QUADRIVALENT (batch number LM55C, expiry date 23rd June 2015). In October 2014, the patient received FLUARIX QUADRIVALENT (intramuscular) .5 ml. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced injection site induration and injection site warmth. On an unknown date, the outcome of the injection site induration and injection site warmth were recovered/resolved. It was unknown if the reporter considered the injection site induration to be related to FLUARIX QUADRIVALENT. The reporter considered the injection site warmth to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient was in her 40s, at the time of reporting. The patient experienced an induration at the injection site (deltoid) after receiving last year's FLUARIX vaccine. The injection site induration was about 14 cm which was warm to touch. The reaction resolved after 4 days from the onset. The patient would be receiving her FLUARIX vaccine this year. The reported lot number (4M7GD) corresponds to FLUARIX QIV and not to FLUARIX TIV as per the sales data sheet. Therefore, the suspect vaccine was updated to FLUARIX QIV. This case was one of the five cases, reported by the same reporter (see cases US2015GSK133984, US2015GSK133985, US2015GSK133988 and US2015GSK134910).
Received Pneumococcal at 10:00AM 10/1/10. Approximately 3 hours later noticed tender to touch, deep red and warm to touch. That evening arm swollen and bruised. Applied ice after called health dept in afternoon. Denies other adverse rxn. (R) arm noted on 10/4/10 to have resolving bruising upper arm decreased to slightly below elbow. No warmth, redness and no tender to touch.
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to 2018SA284709, 2018SA284710, 2018SA284711, 2018SA284707, 2018SA284722, 2018SA284723, 2018SA284724, 2018SA284725, 2018SA284726, 2018SA284727, 2018SA284728, 2018SA284729, 2018SA284730,  2018SA284731 , 2018SA284732, 2018SA284734, 2018SA284735, 2018SA284736 and 2018SA277767 (same reporter). This case involves a six-years old patient (gender not reported) who was vaccinated with FLUZONE QUADRIVALENT (Batch number: UI997AA, expiration date: 30-JUN-2019) via intramuscular in the left deltoid on 02-OCT-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to incorrect product storage. It was reported that vaccines that were outside of the recommended temp range (below 32 F). It was not reported that the patient had any adverse event. 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 Directive 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. List of documents held by sender: none.
Dermatographism diagnosed on 12/31/21 - treatment course Fexofenadine 180mg 4 x daily for 2 weeks, reduce dosage by 180mg each day until symptoms reappear and continue on that dosage for 2 weeks.
Itching "from the inside out", hands and palms very itchy, swelling in hands.
I BECAME VERY SICK AND WAS UNABLE TO GET OUT OF BED WITH A FEVER.  MY CHILD WAS LATER BORN ON 09/07/2012 WITH A HEART CONDITION AND MANY BIRTH DEFECTS INCLUDING CLEFT LIP, MISSING EAR AND EAR DRUM, SCOLIOSIS, MUSCLE THAT DO NOT WORK ON THE LEFT SIDE OF HIS FACE, MISSING BONE IN NECK AND MANY MORE BIRTH DEFECTS.  HE HAS HAD TWO HEART SURGERIES, IS DUE FOR A THIRD.  HE HAS A FEEDING TUBE, TAKES MEDICINE TWICE A DAY FOR HIS HEART, AND ALMOST DIED WHEN HE WAS BORN DUE TO HIS HEART.  HE WAS ON A BREATHING TUBE FOR THE FIRST MONTH OF HIS LIFE BEFORE HIS HEART SURGERY.
Pt recvd MMR on 29MAY90 & the same day pt devel half-dollar size redness & swelling @ inject site; w/in 15min the redness was gone; There were no other sx;
I received the Pfizer booster on 11/5/2021. On 11/17/2021, I noticed my foot dragging. I have no mobility in my right foot, and no ROM. Therefore, I made an appointment with my primary doctor. She sent me to the emergency room immediately.
pt recvd pneumococcal vax 5AUG94 & devel GBS around 20SEP94;
lightheadedness/presyncope, palpitations, racing heart, premature ventricular contractions with bigeminy,  atrial tachycardia, fever  101, chills, myalgias, arthralgias, headache, right arm pain
CHILLS; MYALGIA; LOW GRADE FEVER; HEADACHE; This spontaneous report received from a patient concerned a 58 year old female. 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: Unk) dose was not reported, administered on 11-MAR-2021 14:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced myalgia. On 11-MAR-2021, the subject experienced low grade fever. On 11-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from myalgia, low grade fever, chills, and headache. This report was non-serious.
Patien's son called pharmacy saying his mom had stroke on 9/26/2021, 9 days after she received her 2nd Pfizer dose on 9/17/2021