chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The mother informed me her daughter threw-up in the bathroom and felt dizzy. The patient almost fainted. We sat her down. I administered epinephrine jr (1 dose) and called 911. In the meantime, we gave her some water and Gatorade, which she was able to take some sips but looked "sleepy." She felt cold so we gave her a blanket. I called mother later that afternoon to check in on her daughter. The mother said her daughter got released from hospital and her vital signs were normal. The physician recommended they inform pediatrician about the incident and that it should be ok for her to get her second dose of vaccine.
No adverse reaction.  Aunt here requesting patient 12 month Immunization and daycare certificate. Checked Immunization in GRITS. GRITS show patient needs 12 month and 15 month Immunization to obtain certificate. Aunt signed consent and Immunization given. Mom returned approx. 330pm and states patient received Immunization last week. Phoned Dr office and was informed patient received Hib, MMR, VZV and PCV on 7-24-08 therefore. Patient received 2nd MMR, 2nd VZV and PCV. Notified CDC. (See attached GRITS)
Pt developed seizures x 3; the third seizure was stopped by rectal valium after approximately 5 minutes. Pt admitted to ICU. Started on phenobarbital.
PATIENT DESCRIBES BRUISING IN THE ARM.PATIENT DESCRIBES BRUISING AS NEVER SEEN BEFORE
I got little 'disturbed', soreness where the injection spot was; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 29Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "I got little 'disturbed', soreness where the injection spot was".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
February 8- 10:00 pm nauseous  February 9- sore arm, nausea, headache, 1:00 low grade fever, 4:00 fever of 102.9, stomach pains February 10- sore arm, nauseous, headache, onset of  diarrhea, 100-101 fever. Stomach pains February 11- sore arm, nausea, headache, diarrhea, stomach pain, low grade fever February 12- February 19- nausea, headache, diarrhea, low grade fever February 20-21 nausea, diarrhea, shortness of breath  February 22- fever of 100.8, nausea, diarrhea, chills, headache
hearing loss; Ears popping; tinnitus/wavy sounds; headache; joint pain; This spontaneous case was reported by a pharmacist and describes the occurrence of DEAFNESS (hearing loss) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced HEADACHE (headache) and ARTHRALGIA (joint pain). On 18-Apr-2021, the patient experienced DEAFNESS (hearing loss) (seriousness criterion medically significant), EAR DISCOMFORT (Ears popping) and TINNITUS (tinnitus/wavy sounds). At the time of the report, DEAFNESS (hearing loss), EAR DISCOMFORT (Ears popping), TINNITUS (tinnitus/wavy sounds), HEADACHE (headache) and ARTHRALGIA (joint pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.  No treatment information provided.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Further  information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Further  information has been requested.
I thought I had allergy symptoms at first.  My husband and I had a little sneezing, runny nose, never stuffy.  I don't think I ever ran a temperature.  That evening I finally got a hold of my doctor.  They did a Telehealth with my doctor office.  I couldn't say two or three words without coughing. I was able to start Paxlovid medicine immediately.  The next day I was feeling much better.  The day after that I didn't know I was sick.  By the fourth day I was fine.
delayed my second vaccine; did fine with the second shot (just a bit of a sore arm).; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, (Batch/Lot number was not reported)), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 on an unspecified date for COVID-19 immunisation and experienced headache and sore arm. Due to the symptoms of dose 1 the patient delayed his/her second dose vaccine which was an off label scenario and post vaccination the patient experienced just a bit of a sore arm on an unspecified date. The outcome of all the events was unknown.  This lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.  No follow-up attempts are possible. No further information is expected.
Expired dose of pentacel was administered with no adverse event; Initial information was received on 19-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old and unknown gender patient to whom expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] was administered with no adverse event  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Oct-2022, the patient received expired dose (expiry date-11-Oct-22) of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (expired product administered, latency same day) (dose, formulation, strength, and lot: unknown) via unknown route in unknown administration site for prophylaxis vaccination.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) was not applicable.  At time of reporting, the outcome was Unknown for the event  expired dose of pentacel was administered with no 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 the Directive 2001/83/EC 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.
Double vision using both eyes noticed morning of Wednesday November 3, 2021. Seen that day at Emergency Department of Community Hospital and diagnosed with 6th nerve palsy on left. Seen November 4th by Dr (PCP) & Dr (Opthomology)  Told it would improve.  Symptoms resolved on Monday November 8th.
Pt reports IBS flare starting approximately 7 hours after injection, developing into severe diarrhea.  After approximately 1 wk, pt presented to ER for severe dehydration and AKI.  Pt was hospitalized for 3 days.  She is home but being followed closely by her primary care
No adverse event; Patient that received the Moderna Covid-19 vaccine Monovalent, instead of the Moderna Covid-19 Vaccine, Bivalent booster dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient that received the Moderna Covid-19 vaccine Monovalent, instead of the Moderna Covid-19 Vaccine, Bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an 86-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient that received the Moderna Covid-19 vaccine Monovalent, instead of the Moderna Covid-19 Vaccine, Bivalent booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient that received the Moderna Covid-19 vaccine Monovalent, instead of the Moderna Covid-19 Vaccine, Bivalent booster dose) 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 that received the Moderna Covid-19 vaccine Monovalent, instead of the Moderna Covid-19 Vaccine, Bivalent booster dose).    No concomitant medications were provided.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-654131, US-MODERNATX, INC.-MOD-2022-654129, US-MODERNATX, INC.-MOD-2022-654135 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654131:same reporter US-MODERNATX, INC.-MOD-2022-654129:same reporter US-MODERNATX, INC.-MOD-2022-654135:same reporter
This patient presented to the pharmacy for vaccination and informed the pharmacy staff that this was his first dose. The patient deliberately misled the pharmacy to obtain a third" booster shot".
This case was considered medically important (OMIC). Follow up information pertaining to patient identification, adverse events, lab data and patient outcome was received. Information regarding Flumist nasal solution was received from a health care professional regarding a 5 year old male patient who experienced fever, headache, body ache and jerky movements of his extremities. At 5 years of age, the patient received the first dose on 1/7/04. Patient had not relevant medical history. Indication for Flumist was immunization. Product was administered on 1/7/04. Dose regimen was 1 dose (IN). Patient was not taking concomitant therapy. On 2/16/04, the patient experienced fever, headache, body ache and jerky movements of his extremities. On 2/17/04 he was taken to the ER where lab tests were performed. The patient's white blood cell count was 37.1 x10^3/mm^3. While awaiting blood culture results, the patient began treatment with Rocephin. A nasal swab performed at this time returned positive for influenza A&B. The patient was discharged on the same day. Repeat lab tests done on 2/25/04 showed a white cell count of 13.5 x10^3/mm^3 and neutrophil and lymphocyte percentage of 37.5% and 54.4% respectively. It was noted that the patient recovered.
High fever (103 rectal) at midnight. Gave TYLENOL, took to ER @0600 on 11/4/09. Dx with viral infection, sent home.
Complained of head hurting, had to close her eyes on the trip home. Said she felt very nauseated. When we got home, she threw up several times (~8:00 pm). Threw up several times on 9/19, went to the urgent care that evening. Was tested for strep, also had blood and urine tests. Was given an antibiotic shot and anti-nausea medicine. Her head continued to hurt on Wednesday, Thursday and Friday. She vomited and had a sever headache for a total of 4 days in a row. Was dehydrated.
Pt would be engaged in play or conversation and would spontaneously "phase out" with a vacant, still stare off into space. He was unresponsive to his name for first 2-3 call outs lasting - 1/2-3/4-1 min in duration. He had never had this behavior before and continued for about 2 mos. When he would "come back" he had no awareness of "phasing out". Seemed like a seizure. Sevl practitioners have indic that it seems like Jacksonian seizures.
Flu shot administered 10/29/07 at 10 a.m. by 4 p.m., site of injection (left deltoid) became painful. Pain progressively worsened limiting R.O.M. and radiating to front and back of shoulder. Pain persists 7 days after injection.
This spontaneous report as received from a pharmacist refers to a patient of unknown demographics. On 16-NOV-2013, the patient was vaccinated with an expired dose of ZOSTAVAX (dose 0.65 ml, subcutaneous) (lot number H012575 and expiry date 28-DEP-2013). No concomitant therapy was administered. No adverse effects were reported. Additional information has been requested.
In pain a lot. Sometimes on steroids. After the shots pain goes away for sometime; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "have very bad joint pain" (unspecified if ongoing); "In pain a lot" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "In pain a lot. Sometimes on steroids. After the shots pain goes away for sometime".  Additional Information: The patient noted a good side effect to the covid vaccine. The patient had very bad joint pain. Lower leg circulation problem. In pain a lot. Sometimes on steroids. After the shots pain went away for sometime.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
got COVID; got COVID; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The reporter stated that: her sister in law got COVID and then passed it to her and their kids, it was clarified that her sister-in-law had Pfizer COVID-19 vaccine. The patient outcome of the event was unknown.  The information on the lot/batch number has been requested.
Vasovagal syncope; stated that she was having difficulty breathing. She was taken to the ED, where she was observed and deemed to NOT be in anaphylaxis.
I was very sick; so cold, couldn't get my body warm; My arm was very sore both days; fatigue like I never had before, tired; Terrible terrible headaches; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I was very sick), PERIPHERAL COLDNESS (so cold, couldn't get my body warm), PAIN IN EXTREMITY (My arm was very sore both days), FATIGUE (fatigue like I never had before, tired) and HEADACHE (Terrible terrible headaches) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced ILLNESS (I was very sick), PERIPHERAL COLDNESS (so cold, couldn't get my body warm), PAIN IN EXTREMITY (My arm was very sore both days), FATIGUE (fatigue like I never had before, tired) and HEADACHE (Terrible terrible headaches). At the time of the report, ILLNESS (I was very sick), PERIPHERAL COLDNESS (so cold, couldn't get my body warm), PAIN IN EXTREMITY (My arm was very sore both days), FATIGUE (fatigue like I never had before, tired) and HEADACHE (Terrible terrible headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Patient reported she did not take any medications for treatment, just moved her arms around.
Vaccine was administered to patient with punctured vial that had been punctured for 5 days; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient with punctured vial that had been punctured for 5 days) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     NO Medical History Information was reported.     On 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient with punctured vial that had been punctured for 5 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient with punctured vial that had been punctured for 5 days) 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 information was provided.  No Treatment medication information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Jan-2021 and was forwarded to Moderna on 16-Jun-2021.    This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient with punctured vial that had been punctured for 5 days) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     NO Medical History Information was reported.     On 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient with punctured vial that had been punctured for 5 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient with punctured vial that had been punctured for 5 days) 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 information was provided.  No Treatment medication information was provided.
By early the next morning, my mouth started developing sores & my tongue became increasingly swollen.  I had a sore throat for about 15 days; at about one week past this dose, my right shoulder froze & the rotator joint was swollen & incredibly painful to the touch.  I lost the use of my right arm entirely for about five days, then the swelling & pain slowly subsided.  My eyes were burning & my arm was weak but I made a full recovery about 18 days after this dose.  The last symptoms were severe headaches, accompanied by an inability to remain asleep.  I took Tylenol & Tylenol PM to alleviate pain & regain some sleep & did report these symptoms to my doctor.
Day after receiving vaccine, lip was swollen- 2 days later had hives on legs, 4 days later hives on arm, upper back with itching.
migraine; This is a spontaneous report from a contactable consumer.  An adult female patient (middle-aged) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in Dec2020, at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced migraine in Dec2020.  The patient was not responding to their usual migraine medicines.  The clinical outcome of migraine was unknown.    No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Pt presented to hospital with positive COVID status s/p full vaccine completed in June. pt is symptomatic, with  apparent GGO on CXR
I had a fever of 101 F. I had a migraine that I felt like I was going to die. I have chills, body pain, and I could not eat anything. These symptoms only lasted for about 24 to 48 hours and then they were gone. About a 5 weeks, I had blood work done, I test positive ANA.
arm pain, mild nausea mild nausea, injection site pain, and body aches days 1-3 after vaccine
Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: pt. father (sherif) came to the pharmacy on 11/19/21 at 3PM letting us know that patient developed rash 24 hours after she received pfizer covid-19 vaccination. the rash was all over the body red and inflammed on the back, stomach, arm, leg, and back of ears. Father stated that she has no allergy to anything and has not taken any allergy medication since the rash happened. I adviced patient to take benadryl and if symptoms doesn't go away after 24 hours, to go to the urgent care/dr office.
11 days after the vaccine I came down with a bad case shingles,  It has been 8 weeks and I still haven't recovered, I couldn't eat for three days because I kept vomiting from the pain.