chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received second dose outside doisng interval; Pain at injection site (right) arm; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose outside doisng interval) and VACCINATION SITE PAIN (Pain at injection site (right) arm) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose outside doisng interval). 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site (right) arm). On 24-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose outside doisng interval) had resolved. At the time of the report, VACCINATION SITE PAIN (Pain at injection site (right) arm) outcome was unknown.            No concomitant medication information was provided. No treatment medication were provided.    This case was linked to MOD-2021-021891, MOD-2021-021891 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: email added.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot # 012A21A) with AE reported of vaccination site pain.
chills; fever /Temperature 101.0 f; aches; lethargy; feel really awful; This case was reported by a consumer via call center representative and described the occurrence of chills in a 59-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th January 2020, the patient received the 2nd dose of Shingrix. On 15th January 2020, 1 days after receiving Shingrix, the patient experienced chills, fever, pain, lethargy and feeling abnormal. On an unknown date, the outcome of the chills, fever, pain, lethargy and feeling abnormal were unknown.   It was unknown if the reporter considered the chills, fever, pain, lethargy and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had fever, aches, chills, lethargy and feel really awake full. The patient understand that these are normal side effects. The reporter asked how long should expect this to last.
fully immunized (Pfizer, 4/10/21, 5/4/21).  developed symptoms on 7/19/21
NO adverse reactions or signs or symptoms until 24 hours later. Then patient present to ER with red, swollen bicep going towards elbow. Patient was treated in ER for cellulitis. left arm.  Nurse follow up on 07/07/04 states: "Per review of hospital records, please add fever (FEVER), increase in hypertension (REACT AGGRAV), and flu-like symptoms (FLU SYND). Additional diagnosis to cellulitis was allergic reaction. DOB was corrected to 03/01/1956 (from 05/01/1965)."
This spontaneous report as received from a 69 year old female patient with no pertinent medical history refers to herself with drug allergy to aspirin and iodine. On 13-MAR-2014 the patient was vaccinated with one single injection of ZOSTAVAX. The patient reported on 14-MAR-2014, she developed loss of voice, cough, low grade fever, injection site reaction and rash after receiving the ZOSTAVAX vaccine. She was now left with a swollen gland and it was sore. She went to Urgent Care (demographics unknown) and the doctors didn't know what's wrong with her. She also had a tube down her throat and nose and nothing was wrong. The ear-nose-throat (ENT) doctor did all the throat and nose testing. The ENT doctor put her on prednisone 10 MG/3 pills daily for three days and as the days went on the dose lowered and nothing worked and she really could no talk a lot now and this had been going on for almost 10 weeks now. She was also using many other unspecified medications (names/dosages/frequencies/manufacturers unknown) but she could even talk to be able to tell what they were. The outcome of the events was reported as not recovered. Upon internal review, loss of voice was determined to be medically significant. Additional information has been requested.
A report was received from a health care professional on 13Jan04 concerning a 2.5 year old female vaccinee who received Fluvirin on 12Jan04. On 12Jan04 the vaccinee received Fluvirin. The vaccinee did not have any complaint as a result. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
After I got the vaccine, the next day in the morning, while driving my kids to school, I felt my scalp was itchy. Initially I thought maybe it?s because I?m sweating so that?s why it felt itchy. But the itch persisted. I didn?t notice any rash then and my head is covered with hair. Around noon, I went to the gym to work out and while headed to the locker room I felt my scalp itching was getting worse. Once I started taking a shower though, my entire body broke out in hives with intense itching everywhere. I have never experienced anything like this before. I headed home and had a Benadryl. It helped somewhat but itching was still intense. I also had fexofenidine tablet . The next day I still had the hives and the itchiness so I had the fexofenqdine tablet again. This continued for a few days and then stopped
Initial unsolicited report received from a pharmacist on 26 October 2015. This case involves a patient (age and gender was not reported) who was vaccinated with a dose of FLUZONE (batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unknown date. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. Concomitant medications were not reported. On an unspecified date, three to four days after the vaccination, the patient experienced vestibular neuritis with symptom of vertigo. Patient required emergency room and doctor visit. Lab data and corrective treatments were not reported. The patient was recovering (reported as unknown) from the events as it was reported that symptom of vertigo that had lessened but was still constant now at 4 weeks past vaccination. List of documents held by sender: none.
The first shot made me feel really sick and dizzy for about 6 days. The second shot was even worse because I couldn't get out of bed for 3 days and was still sick and dizzy another 4 days after. Months after i'm still having issues. I'm still feeling sluggish and sometimes I wake up feeling dizzy and disoriented. I never got sick with covid.
PATIENT STATES HAVING ALL SIDE EFFECTS LISTED WITH BOTH VACCINES.  SHE STATES SPECIFICALLY MUSCLE ACHES, JOINT ACHES, FEVERISH,  FATIGUE, AND GI UPSET.  SHE MAINLY WAS CONCERNED ABOUT THE NAUSEA AND DIARRHEA THAT SHE STATES LASTED OVER 3 WEEKS AND WAS CONCERNED IF THIS WAS VACCINE RELATED. SHE STATED THAT SHE FELT LIKE SHE LOST SOME WEIGHT.  PATIENT STATES FEELING FINE AND BACK TO NORMAL NOW WITH NO ISSUES TO RESOLVE. PATIENT WAS UNAVAILABLE FOR FOLLOW UP CALL LATER DURING THE DAY
Sore arm, couldn't lift arm this morning. Inj site is painful. The whole muscle is sore. When she got up she need to eat immediately because she felt like she would pass out. Had to go back and lay down. The head temples hurt.  Cheeks feel very hot, flu like symptoms. No fever.
T012 on 4MAR98 evening; 7PM on 5MAR98 was T104.6 to MD on 5MAR98 evening;APAP & motrin;this AM 6MAR98 temp was 101;cont w/meds;URI in family;
Pain in arm where flu vaccine given - pain started just after shot given and has not subsided.  Vaccine give 10/31/2004.  No redness, no edema at site, x-ray and follow up per orthopaedic.  X-ray taken of arm 02/08/2005, x-ray verified no needle object broken off in left deltoid.
This is a spontaneous report from a contactable pharmacist who reported similar events for two patients. This is the second of two reports. A female patient of an unspecified age and race/ethnicity received PREVNAR 13 (Lot number S51635, Expiry date Oct 2018, NDC number 00005197101), via an unspecified route of administration at single dose in the right arm on 13Oct2017 for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced redness and swelling of the right arm on 15Oct2017 with outcome of unknown.
expired vaccine used / 233 Patients given expired doses; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine used / 233 Patients given expired doses) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021 at 1:18 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine used / 233 Patients given expired doses). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used / 233 Patients given expired doses) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  14 vials were utilized. All vials were stored in a vaccine freezer set to -20C. At the date and times of our vaccine clinic, depending on how many signed up for that day, either 1 or 2 vials were removed from the freezer and placed on counter at room temperature for 30 minutes. The vaccine was drawn up and then placed in vaccine fridge for the duration of the clinic, taken out when patient was ready to receive. Temperature readings of fridge were at either 3.8C or 5.6C depending on the date (we had received and set up a new vaccine fridge between 23-Dec-2021 and 07-Jan-2022). No temperature excursions were noted at any time during the administration of the vaccine.  No treatment medications were reported.
Patient presented with fever and cough and wheezing. Patient received 6 mg dexamethasone PO for 3 doses January 15-January 17. Patient received Heparin 5000 units q8h subcutaneous for 6 doses.
Local urticaria around (R) thigh vaccine site = MMR and on (L) lower vaccine site = varicella. No swelling or erythema around upper (L) thigh site = Hep A. No other symptoms.
Systemic: Headache-Mild, Systemic: Other- Increased blood pressure, lightheadedness
This is a prospective pregnancy case. This female subject was enrolled in an open label study titled Boostrix Pregnancy Registry: a prospective exploratory, cohort study to detect and describe any abnormal pregnancy outcome sin women intentionally or unintentionally vaccinated with Boostrix during pregnancy or with 26 days preceding conception. The subject received BOOSTRIX Intramuscular) .5 on 5th AUGUST 2014. Co-suspect products included FLUARIX. This subject received BOOSTRIX during the third trimester of pregnancy. On an unknown date, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Other possible cause(s) of the vaccine exposure during pregnancy included Influenza Virus Vaccine Polyvalent.   Additional information: The last menstrual period, the due date and the number of gestational weeks were not reported.   This is one of the 17 cases reported by the same reporter for the same vaccine.
Patient was administered vaccine. Patient then began to have a vasovagal syncope reaction. Patient was immediately given oxygen. Patient was layed in the prone position with feet elevated and a cold compress a applied to the forehead. Vitals were constatntly monitored. Patient was stable and recovered quickly.
received her COVID 19 Booster vaccination and displayed no signs or symptoms of adverse reaction during her monitoring time. She stated feeling well with no allergic reactions to any component of the vaccine after receiving her first 2 vaccinations. She was vaccinated with Moderna each time. She denies any health conditions,  denies undergoing treatment that would make her immunocompromised.   states that approximately 5 hours after receiving her Booster vaccination on 12/1/2021 she began to experience tacycardia and heart palpitations. She went to Emergency Department where they did an EKG. states the EKG was normal. On Monday, 12/6/2021 she went to her doctor as she had worked
Axillary lymphadenopathy of the injection arm that developed about 48 hours after the 2nd injection and resolved about 7 days after the 2nd injection.
Information has been received from a physician concerning a 2 month old male who "about a month ago", on approximately 10-Dec-2006, was vaccinated with an oral first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). "The day after starting", on approximately 11-Dec-2006, the patient developed bloody diarrhea. Unspecified medical attention was sought. The patient was recovering. There was so product quality complaint involved. Upon internal review, the patient's bloody diarrhea was considered to be an other important medical event (OMIC). Additional information has been requested.
Nausea; Decreased appetite; Fatigue; Severe chills 8 days post 2nd does.; This is a spontaneous report from a contactable consumer. This 60-years-old (at the time of vaccination) female consumer reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL9264) via an unspecified route of administration from 06Feb2021 to 06Feb2021 at single dose (dose number; 2) on left arm for covid-19 immunisation. Patient's medical history and concomitant medications (if other vaccine in four weeks; no) were not reported. Patient experienced severe chills 8 days post 2nd dose, could not get warm on 15Feb2021, nausea and loss of appetite and severe fatigue for 24 hrs on an unknown date. Treatment for adverse event was reported as no. If covid prior vaccination; no, if covid tested post vaccination; yes, covid test type post vaccination; nasal swab, covid test name; PNR, covid test date; 16Feb2021, covid test result; pending. The outcome of events was recovered for chills while for other events was unknown.  Information about batch number has been requested.
facial numbness to the left side with neck and shoulder pain. symptoms only started after 24 hrs
She got her vaccine, didn't have a reaction at that time.  On 4/27/21 she had a sudden onset of severe dizziness accompanied by headache and nausea, and eventually quit a few palpitations.  She went to her doctor for this and was hospitalized in May for 4 days.  They couldn't come up with an answer, and still has all of the symptoms and no answers and no resolutions of her problems.  She cannot leave her home to go to a store, cannot walk around for any length of time because the dizziness and headaches become increasingly bad.  The doctors are trying to figure out what are going on with her.  They said that they could possibly be related to the vaccine and to report it to VAERS.    She has not taken any of the COVID vaccines as they do not know if it's related to the vaccine or not and not wanting to complicate what she has going on.
24hr p/vax pt exp fever of 104, tinnitus, sore joints, diff swallowing;
58 y/o W female with onset of LOC with involuntary UE/LE movements approximately 3-5 minutes after receiving vaccination. Member was transferred to wheelchair and after brief period of time regained responsiveness. Member reported nausea, unable to recall recent events and denied any medical hx to include current medication. Member with multiple episodes of vomiting. Member's care was transferred to EMS and transferred to University of Hospital for elevation of care.
Pt received Tdap and PNEUMOVAX on 4-7-2015 at 3:20 PM. Pt returned to clinic on 4-8-15 (-) 10:00 AM with left arm swelling and pain. Pt sent to ER for evaluation and treatment.
Developed hives on scalp, progressed to face around mouth and lips, mild  rash on abdomen, extreme itching.  Was treated in ER with IV Benadryl, IV Prednisone, and IV Pepcid. Sent home with RX?s for Prednisone and instructed to continue Benadryl and Pepcid Symptoms resolving following day slowly 11/13
whiteness on their tongue; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISCOLOURATION (whiteness on their tongue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse effect.   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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TONGUE DISCOLOURATION (whiteness on their tongue). At the time of the report, TONGUE DISCOLOURATION (whiteness on their tongue) outcome was unknown.            Concomitant drugs were not reported. Treatment information was not provided.   This case was linked to MOD-2021-075749 (Patient Link).
PATIENT RECEIVED FIRST PFIZER COVID VACCINE. IMMEDIATELY FELT DIZZY AND NAUSEOUS AND HER HEAD WAS HEAVY. PT STATED SHE HASN'T EATEN ALL DAY. SO WE GAVE HER WATER AND SOME CRACKERS. IT'S BEEN 30 MINUTES AND SHE STILL FEELS DIZZY AND HEAVY HEADED. PATIENT DENIES WANTING AN AMBULANCE. PATIENT ADVISED NOT TO DRIVE. SHE IS LOOKING FOR SOMEONE TO PICK HER UP. SHE STATED SHE DRANK WATER AND TOOK TYLENOL BEFORE COMING TO GET VACCINE.
Extreme skin hypersensitivity. Became overwhelming for any sort of tactile stimulation on skin, such as showering, toweling off, and wearing a shirt. It lasted roughly 6 hours and then subsided.   I also felt extreme fatigue.
Initial information was received on 03 February 2010 from a health care professional concerning a case of misuse. A 5 month old female patient developed a fever and a virus after she received H1N1 (lot number was unknown). The date of vaccination and event onset were unknown. Recovery status was unknown at the time of the report. List of Documents held by Sender: none.
Client informed vaccinator of receiving 2 doses of Sinopharm in Argentina shortly after being vaccinated with Pfizer.
4 yo boy who was given KINRIX on (R) thigh 5/21/10 developed swelling/redness/pain down to his knee. No fever.
This spontaneous report as received from a physician refers to a patient of unknown age. Physician was informed by an unspecified physician that a patient received two doses of with VARIVAX (merck) (dose, frequency, rout, lot# unknown) in 2009 separated by four weeks. On an unspecified date, titers were drawn which showed "antibody response below 0.9." Physician did not have any further information in regards to this case because she reports that it was not her patient and it was just a question asked to her by another unspecified physician. Additional information has been requested.
Patient was asked if this was her second Pfizer dose, she answered yes and received her second dose, after confirming her vaccination it was clear that patient's first dose was Moderna, when she was told about the incident patient said "sorry, I was confused".
she threw up; diarrhea; body pain; She had chills; Slight headache; Feeling hot; feverish; This is a spontaneous report from a contactable consumer (patient's father) and a non-contactable consumer (patient). A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1283), via an unspecified route of administration on 26Jan2021 as a single dose for COVID-19 immunisation. Medical history included fibromyalgia and dizziness from an unknown date and unknown if ongoing, Concomitant medications included amitriptyline (MANUFACTURER UNKNOWN), diazepam (MANUFACTURER UNKNOWN) for dizziness, ethinylestradiol, norethisterone (DASETTA 1/35) for birth control and multivitamins, all from an unknown date. The patient previously received first dose BNT162B2 (lot number EH9899) on 05Jan2021. On 26Jan2021 (about 10 in night) the patient experienced she threw up, diarrhea, body pain, and chills, she experienced slight headache, feeling hot and feverish on 26Jan2021. The patient did not receive any treatment for the events. The clinical outcome of the events vomiting, diarrhea, body pain, chills, headache, feeling hot and fever was recovering (reported as getting a little better now).
RD injection site 3 hrs after swelling & redness x 2 days. Day 3 also warm to touch. Initially Tx ice & BENADRYL. 11-18-11 seen in office - rec elevate, ice if not improved will take KEFLEX.
I had no adverse reaction to the vaccine. In late December 2022, I developed a rash in my right shoulder and on the right side of my neck. The rash is little bumps, tender to the touch and itchy. I'm not taking anything for the symptoms. Recently I had lower back pain and a high temperature, and I went to the emergency room. I was observed and discharged. The symptoms resolved within 24 hours.
Severe itching on skin all over body.  Too pain full to even touch any part of skin.  ENTIRE BODY.  Been lasting now for over eight hours.  Patient has no known allergies or reactions to any medications.  Did not have any of these effects after the 1st shot. This only occurred after second shot yesterday and pain continues.
Injection site warm to the touch; Injection site red; Injection site achy; Joint pain; Fatigue; Myalgia; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE WARMTH (Injection site warm to the touch), FATIGUE (Fatigue), MYALGIA (Myalgia), VACCINATION SITE ERYTHEMA (Injection site red) and VACCINATION SITE PAIN (Injection site achy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, the patient experienced FATIGUE (Fatigue) and MYALGIA (Myalgia). On 28-Jun-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warm to the touch), VACCINATION SITE ERYTHEMA (Injection site red), VACCINATION SITE PAIN (Injection site achy) and ARTHRALGIA (Joint pain). On 19-Jun-2021, FATIGUE (Fatigue) and MYALGIA (Myalgia) had resolved. On 05-Jul-2021, VACCINATION SITE WARMTH (Injection site warm to the touch), VACCINATION SITE ERYTHEMA (Injection site red), VACCINATION SITE PAIN (Injection site achy) and ARTHRALGIA (Joint pain) had resolved.        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 concomitant  medication were reported. No treatment information were provided.
Child started crying around 5:30 PM. Checked for fever. Fever was 101.5. Tylenol was administered. Child continued to scream/cry for the next four hours. Tylenol was repeated administered every four hours, but child was still crying and was inconsolable. A warm bath was given to try to help calm child, but was unsuccessful. Child stopped crying after 4-5 hours, but remained upset until the following morning.
Patient started with headache immediately after vaccine administered. Headache lasted 1 month & resolved on own. No improvement with Amoxicillin 600 mg BID x 10 D. and Flonase nasal spray
A 13 year old was administered a 3rd dose of Pfizer Covid 19 vaccine, before committee and state recommendation, but after agency approval.