chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccinee rec'd a 3 dose series of Engerix-B (deltoid) according to 0, 1, 2 mo schedule; Found to be a non-responder. "Wants to re-vaccinate."
Patient came in on 11/28/18 around 3:35pm just to inform the RPH about reaction to vaccine: (Redness around injection site about 2 to 3 inch in circumference. Slight swelling. No pain and no burning sensation) No other symptoms. Patient saw the primary care to and primary care informed patient of minor reaction to vaccine. Patient was suggested to use ice pack and TYLENOL if required, but patient claims of no pain at all.
Started with head ache moved to stomach ache and pains. Next moved to uncontrollable shakes about 11:30 PM got a 99.5 fever at 1:00AM stuffy noise and allover body ache. No treatment.
PATIENT LEFT A MESSAGE REPORTING RASH BEGAN DAY AFTER VACCINE; RASH WAS NOTED ON BOTH ARMS AND BOTH KNEES; CLIENT USED BENADRYL TOPICAL CREAM WHICH RELIEVED THE ITCHING
Chills, headache, bodyaches, nausea, and tiredness started overnight on 3/19 and lasted throughout Saturday. Woke up fine on Sunday, March 20th. The injection site was also sore for 2 days after vaccination, but is better now too. I did have Covid-19 in August of 2020.
Systemic: Abdominal Pain-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild
After my flu shot I began getting hives on my left arm. Throughout the weeks, the hives got worse and appeared all over my body. I had to go to the ER on 10-18-14 b/c the hives were so bad and I was having breathing issues. Given steroids.
About 14 hours after my injection, I had severe nausea and vomited. I also had chills and body aches.
Patient received 3 separate injections on 8/17/12 and on Saturday 8/18/12 mom was driving with patient when patient had a seizure and was brought to emergency room for evaluation.
Severe chest pains about 3 or 4 hrs of receiving shot of Zostavax. Diag as Gall Bladder problem. Required emerg. room treatment on 4/2/07 onset of pain after shot-2-4 hours.
RASH TO ABDOMEN NOTED BY MOM 2/22/13. LINEAR CONFLUENT MACULES AND PAPULES IN VARYING STAGES WITH SOME SCABBING/CRUSTING OF LESIONS. LESIONS APPEAR ONLY ON LEFT SIDE OF BODY ON BUTTOCKS, ABDOMEN AND LEG. QUESTIONABLE FEW VESICULAR LESIONS. SUPPORTIVE CARE ONLY AT THIS TIME. MAY USE CALAMINE LOTION, OATMEAL BATH, OR OTC BENADRYL. NO NEED FOR ACYCLOVIR. CONTINUE TO MONITOR. POSSIBLE DX INCLUDES: SCABIES, ECZEMA HERPETICUM, RHUS DERMATITIS, OR MEASLES (DOUBT).
My mother didn't feel well after the 2nd shot. She died in her bathtub overnight 3/12 into 3/13
Severe Chills and High Fever for two days. Dizziness & Nausea and lack of appetite for 4 days. Headaches for 3 days. Pain at injection site for 3 days. Hoarseness & Cough & Severe Sore thraoat (On Fire Feelings) for 3 days. Muscle Aches & weakness, paleness for 3 days. Currently Hoarse, coughing, stuffy nose and tired by mid day, but on the mend with lots of rest and fluids.
Thurs. Nov 6, 2003 Received Influenza vaccine for the first time.  Monday, Nov. 10, 2003 client started noticing Headache, stuffiness in nasal passage, then runny nose, cough at first was a dry cough, progressed to slightly productive. That same evening she began itching.  First her face and scalp, then her left thigh.  She described bumps on her forehead and chin that look similar to bug bites - white in the center and red surrounding.  These bumps come and go as does the itchiness at various sites.
This case was reported by a healthcare professional and described the occurrence of overdose in a 2-month-old subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included poliomyelitis vaccine, (unspecified manufacturer, unknown route, injection site and batch number) given on an unspecified date. On an unspecified date, the subject received unspecified dose of KINRIX (unknown route and injection site) at the same time with a monovalent polio vaccine that led to overdose. Additional information received on 29 September 2014: A nurse called back and followed up with patient which is fine. There are no adverse event.
Loss of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Loss of taste) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced AGEUSIA (Loss of taste). At the time of the report, AGEUSIA (Loss of taste) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported Treatment medications was not provided
Vaccine given (L) upper arm subcutaneous due to being on heparin drip. 1 day post administration site is tender, red, swollen, warm.
Lymphadenopathy on ipsilateral size in a axillary and infraclavicle site. Size 2-3 inches. No tender at first them tenderness from compression on other tissues. None
H/A, T 102.8 po, bilat. scleral redness. Referred to PCP.
This spontaneous report as received from a physician via company representative, refers to a 16 year old female patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not provided. On an unknown date in 2018, the patient was vaccinated with GARDASIL 9 for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not reported). On an unknown date in 2018 (reported as "subsequently"), the patient developed Sjogren's syndrome. The patient sought medical attention, however, she did not receive any treatment. It was unknown if diagnostic laboratories were performed. At the time of reporting, the outcome of Sjogren's syndrome was unknown. Additionally, the causality assessment between Sjogren's syndrome and GARDASIL 9 was not provided. Upon internal review, Sjogren's syndrome was determined to be a medically significant event.
Severe pox like rash all over body, swelling in extremities, pain in joints, numbness in fingers
My arm starting going numb, and extreme amount of pain, could not lift my arm as the day went on, very weak. The pain got worse as the day progressed, spreading up my neck and down my back.
This spontaneous report as received from a health professional refers to a 4 year old patient. On 24-JUN-2014 the patient was vaccinated with a dose of MMR II (lot # J011332, EXP date: 13-SEP-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
headache, sweating, tiredness,low back pain,fever, nadseau, diarrhea, coughing, taste off
Father of pt called office 6/25/09 sts. small red area to vaccine site. Adv. Dad to watch area and if area spread and/or become redder, hot or hard to touch to seek treatment. Pt went to ER later that night.
Case number PHEH2013US022985 is an initial spontaneous report from consumer (patient) received on 31 Oct 2013. This case refers to 59-year-old male patient. His vaccination history included vaccination with FLUVIRIN after which he developed rheumatoid arthritis (see case: PHEH2013US022979). He was vaccinated with FLUVIRIN (batch number: not reported) intramuscularly, around 01 Oct 2013. On an unknown date after vaccination, he developed rheumatoid arthritis. The patient was on methylprednisone and methotrexate to keep the inflammation down. The reporter stated that his symptoms were related FLUVIRIN vaccination. The seriousness and outcome of event was not reported.
PFIZER BIVALENT LOT #GL0087 EXPIRES 5/11/23 WAS GIVEN ON 05/16/23.
Covid vaccine date was 4/1/21.  Site was my right arm.  Regularly scheduled annual mammogram was 6/14/21.  Mammo showed enlarged lymph nodes in the right breast.  Dr office received the results the SAME DAY.   Her office called me for a phone consult. During phone appointment they were seeing more enlarged lymph nodes in women on the same side as their last Covid vaccine. Dr insisted on a ultrasound of right breast in July to ensure that the nodes return to normal.  That will take place on 7/23/21
About 5 minutes after receiving her vaccine, patient described feeling light headed, had hearing and visual disturbances, felt like she might pass out. after several minutes of sitting with head between her leg, those symptoms went away but she said she had developed a headache.  At time she left pharmacy she said she felt ok other than her headache.
2 mo after receiving TDAP reported to employee health with a sore left deltoid at site of injection. Had pain and feeling of a mass at site of IM injection on exam has an area of density - sent for US of area. Placed on MOTRIN - no help.
Anaphylactic Shock  - Dizziness at about 18 minutes after shot. Tongue swelled / Throat swelled  Two Epi Pens given by pharmacist  Taken by ambulance Given IV steroids (not sure if other meds) in ambulance.  Stayed in Emergency Room for several hours.  Discharged w/ Epi Pen and steroid pills.
nausea, headaches, muscle aches, chills, fever, throbbing down arm where vaccinated.  Exhausted.
Starting about 4-5 hours after vaccination and lasting for about 48 hours, patient experienced a variety of symptoms including chills, weakness, lightheadedness, and inability to eat.  They experienced similar symptoms after having a Pfizer vaccination in the past, so this was the second time this has occurred.
This case was reported by a health professional on 15 August 2007.  An adult patient was inadvertently administered Tripedia (lot number not reported) instead of Tdap on 14 August 2007.  The patient subsequently complained of fever, achiness, and fatigue.  The events remained ongoing.
I had been with my granddaughter, she woke up with a fever, sneezing, excess mucus. The next day she tested positive for COVID-19, I tested with home COVID-19 test the next day and it was positive. I called my doctor to get the PAXLOVID that I started on June 18, 2022. Although the only symptoms I really had was body aches the nest day I felt better. On June 28, 2022 I started feeling like I had a summer cold, runny nose, fever. I finally tested negative on July 4, 5, and 6, 2022. I was not desperately sick just miserable.
No adverse event; Received 0.25 ml instead of 0.5 ml of the Bivalent Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 11-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25 ml instead of 0.5 ml of the Bivalent Booster).    Concomitant product use was not provided by the reporter.  27 adult patients received pediatric dose of Bivalent COVID-19 vaccine 0.25 ml instead of 0.5 ml.  Treatment information was not provided.  This case contains information for the 6th of 27 adult patients described by the reporter.
I was up the next morning and I though my head was going to exploded off. I literally had to lay on the couch and not move. Due to the head ache i was very sick to my stomach. It lasted for 2 days I could not eat or so any thing but lay on the couch. My BP was high normally run 120 but was 148.
Information has been received from a registered nurse concerning a 19 year old female with a drug hypersensitivity to amoxicillin who on 21-MAY-2007 was vaccinated IM, into the left arm, with a second dose of Gardasil (Lot # 658094/0524U).  There was no concomitant medication.  While the patient was driving home she developed an itchy rash on her right warm which has since spread to her torso and right knee.  The patient was to be seen by the physician on 22-AUG-2007.  At the time of the report the patient had not recovered.  Additional information has been requested.
patient received 4 vaccines listed above in the same sitting, "passed out" as per colleague report upon returning to work later that day, was then hospitalized; patient currently in hospital
No adverse event; Patient was administered underage Moderna 6 months to 5 years vaccine instead of the bivalent Booster; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient was administered underage Moderna 6 months to 5 years vaccine instead of the bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient was administered underage Moderna 6 months to 5 years vaccine instead of the bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient was administered underage Moderna 6 months to 5 years vaccine instead of the bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient was administered underage Moderna 6 months to 5 years vaccine instead of the bivalent Booster).    No concomitant medications were reported. No treatment information was provided. They had 5 patients scheduled and gave all 5 patients a 0.5 ml dose of the pediatric vaccine when they meant to give them all bivalent boost doses.   This case was linked to US-MODERNATX, INC.-MOD-2022-650478, US-MODERNATX, INC.-MOD-2022-650483, US-MODERNATX, INC.-MOD-2022-650485 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-650478: US-MODERNATX, INC.-MOD-2022-650483: US-MODERNATX, INC.-MOD-2022-650485:patient 2
Seizure lasted 15 seconds after shot, started seizure started right after shot, resolved without meds.
Patient had lump on lower arm, swelling, and red spots starting 12/15/21. Called 12/16/21. Had been taking benadryl. Ended up going to ER to get it check out. They ran labs:no infections. Patient given toradol and tylenol and arm was wrapped
Left upper arm with erythematic, edematous, warm area approx 10cm x 10cm in size. Mom noticed 2 days following vaccine administration. No sign of illness, child demonstrated full ROM and only mild discomfort with movement or touch.
Headache started the next day, persisted for about 3 days. Have also noticed increased incidence of headaches over past 3 weeks. Tension and migraine. Last migraine yesterday. (Now 3 weeks out from vaccine) I do not have any significant headache history. Only usually have headaches from caffeine withdrawal, which has not been an issue these weeks.
Information has been received from a nurse practitioner concerning a 24 year old female, with no pertinent medical history, who on 26-FEB-2007 was vaccinated with Gardasil (LOT# 654702/0011U). There was no concomitant therapy. On 26-FEB-2007, within 24 hours of Gardasil administration, the patient experienced a rash on her abdomen. The patient had phoned the office to report the rash. The rash was not seen by the nurse practitioner or physician. No prescription medication therapy was provided to the patient. Subsequently, the patient recovered in 1 day. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/6/2007.  Initial and follow-up information has been received from a nurse practitioner (N.P.) concerning a 24 year old female, with no pertinent medical history, who on 26-FEB-2007 was vaccinated IM with a dose of GARDASIL (LOT# 654702/0011U).  There was no concomitant therapy.  On 26-FEB-2007, within 24 hours of GARDASIL administration, the patient experienced a rash on her abdomen.  The patient had phoned the office to report the rash.  The rash was not viewed by the nurse practitioner or physician.  No prescription medication therapy was provided to the patient.  Subsequently, the patient recovered in 1 day.  Additional information is not expected.
vomiting, nausea, diarehha, chills, body aches, headaches within four hours of receiving vaccine
Patient recieved vaccine at 1:35 pm and by 2 pm was complaining of pleuritic chest pain. Patient was sent out for further evaluation.
Within a few minutes of injection in left arm, arm went numb all the way to fingertips. Then I had a tingling sensation and dizziness then breathing difficulty.  Could not catch my breath, very heavy feeling in chest and chest tightness and wheezing.  I work in an intensive care and was observed closely. I took Benadryl within 20 min. of event and continued to take Benadryl Q 4-6 hours x next 3 days.  Chest tightness, intermittent dizziness, and overall weak feeling lasted 3-4 days.
muscle aching soreness, redness and swelling of upper arm and shoulder.  Subjective fever without measurable temperature elevation, dizziness, fatigue, headache.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender.  No information regarding the patient's medical history or concurrent conditions was provided. On 08-AUG-2014, the patient was vaccinated with dose of M-M-R II, injection (dose, route of administration, lot # and expiry date were not reported). On 25-AUG-2014, also reported as 17 days later, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX injection (dose, route of administration, lot # and expiry date were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. Additional information is not expected as the reporter declined any further contact.
This spontaneous report was received from a Medical Assistant referring to multiple unspecified patients of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # M045206 and expiration date on 27-JUN-2019 and lot # N003698 with expiration date on 31-OCT-2019 reconstituted with a properly stored sterile diluent (reported lot # K012930, expiration date 26-JUN-2017) for prophylaxis. PEDVAXHIB was involved on a temperature excursion if 9 °C to 25°C for 1 hour 11 minutes. Information was provided due to a data logger. No adverse effects were reported and no product quality issue was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA010361.
presents with worsening dyspnea and hypoxia.  He has been triple vaccinated for COVID-19, and was at a family vacation in another state. On 09/05/2021 he started developing symptoms of rhinorrhea and he and his wife both tested positive for COVID-19, same-day.  He has had overall increasing dyspnea over the past 9 days and was able to measure his oxygen saturation which had been fluctuating between 88 and 93%
VACCINE WAS MIXED USING DILUENT THAT WAS IN A 10ML VIAL THAT HAD BEEN PUNCTURED AND USED ON  A PREVIOUS DAY.
2nd dose of Rotarix vaccine at 9 month age; 1st dose of Rotarix vaccine at 5 month age; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 7L2D7, expiry date 24th February 2024) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis, Rota (Rotarix lyophilized formulation) for prophylaxis and rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 11th January 2023, the patient received the 2nd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 21st September 2022, the patient received the 1st dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 21st September 2022, not applicable after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device and unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate age at vaccine administration. On 11th January 2023, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate age at vaccine administration 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 Information: GSK Receipt Date: 11-JAN-2023 Reporter's Comment: The reporter was a nurse. The reporter reported that on 21st September 2022 the patient received first dose of Rotarix vaccine at a age of 5 months. The patient received second dose of Rotarix vaccine on 11th January 2023 at the age of 9 months who was behind on immunization. The reporter was not sure what to do. The reporter did not consent to follow up. Additional supportive information: According to disease control the 1st dose of Rotarix vaccine should be received before a child is 15 weeks of age but the patient received 1st dose of Rotarix vaccine at the age of 5 month which, led to inappropriate age at vaccine administration According to disease control the patient should receive all doses of rotavirus vaccine before they turn 8 months old but the patient received 2nd dose of Rotarix vaccine at the age of 9 months, which led to inappropriate age at vaccine administration.
A non-serious spontaneous report of fever has been received from a consumer/patient's parent concerning a seven-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported from this patient. The patient received FLUMIST on 21-Oct-2009 at about 3:30pm. On 22-Oct-2009, the patient woke up with a fever. Treatment was not provided.  The outcome of the event was not reported.