chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; administered with 0.25ml of the bivalent booster dose instead of the 0.5ml dose; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (administered with 0.25ml of the bivalent booster dose instead of the 0.5ml dose) and NO ADVERSE EVENT (No adverse event) in a 68-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 04-Sep-2022, the patient experienced UNDERDOSE (administered with 0.25ml of the bivalent booster dose instead of the 0.5ml dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (administered with 0.25ml of the bivalent booster dose instead of the 0.5ml dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (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 UNDERDOSE (administered with 0.25ml of the bivalent booster dose instead of the 0.5ml dose).    Concomitant medication details were not reported by the reporter.  On 02-Mar-2021, patient received First dose of Moderna COVID-19 vaccine with batch number 002A21A.  On 30-Mar2021, patient received second dose  of Moderna COVID-19 vaccine with batch number 028A21A.  On 25-Oct-2021, patient received First booster  of Moderna COVID-19 vaccine dose with batch number 076C21A.  On 18-Apr-2022, patient received Second booster  of Moderna COVID-19 vaccine dose with batch number 001M21A.  A retired pediatric nurse practitioner reported that she got the bivalent booster dose of the Moderna Covid-19 vaccine last 04Sep2022. Patients were given 0.25ml instead of the 0.5ml dose. Vaccine provider called and informed patients that CDC recommended giving a full 0.5ml of the vaccine again instead of just 0.25.  Treatment details was not reported by the reporter.
11 x 12 cm size of redness, swelling to injection site, R deltoid.
Low Grade fever on Saturday 8/14/10. Rash all over upper torso Monday 8/16/2010
Donor states approximately 1/2 hour after receiving Tetanus Toxoid he became nauseous; no vomiting;  Donor states nauseous lasted approximately 2-3 hours. He did not seek any medical attention
5/13/2020 Patient called in (by phone) to report her upper right arm in the back is swollen, red, and warm to the touch.  Patient reported this started yesterday (5/12/2020).  Advised to apply cold compresses and keep monitoring.
Experience symptom similar to restless leg for about half to one hour in evening. Feeling I had to move lower extremities.  Didn't last long.
Immediate heart palpitations once received injection , about 1-2 minutes after injections.  Elevated heart rate continued for weeks, has now turned into POTS. Ringing in the ears Muscle pains Headaches
Patient has developed a bump under the skin along with itching at the site.  She did go to a doctor for follow up and received an antibiotic for treatment.
Patient waited the suggested 15 minute observation period with no history of vaccine issues.  After departing about 25-30 minutes after vaccination the patient noticed some moderate/severe throat closure, and went to an ER for treatment, and was given an EPI-pen, which seemed to aid the patient. They were discharged about 1-2 hours later   The pharmacy was contacted about an hour or so after vaccination.  The patient is well, with some minor swelling remaining.
This case was considered medically important. Information regarding Prevnar was received from a healthcare professional regarding a 2-year-old patient who experienced recurrent infections and incomplete antibody response. The patient received the fourth dose on an unspecified date. Relevant medical history was not provided. Concomitant medications were not reported. On unspecified dates, the patient experienced recurrent infections and had what appeared to be an incomplete antibody response. The patient reportedly received 4 doses of Prevnar. The outcome is unknown. No additional information was available at the time of this report.
Since my son accidentally received the Tdap shot, he has been very whiny and in pain. From the time that we left the doctor?s office I noticed the change in his behavior. Usually he does fine with other vaccinations, but I knew something was different as soon as we left. This is day 3 after receiving the shot and he is still acting the same (whiny and in pain).
After first dose I was hot with fever, muscle pain for 3 days, very tired.  The second dose I had body pain, mostly in my legs, and the muscles pain I have it for six months. I am going to therapy now.
Fever; body aches; few rigors; few rigors and severe left pelvic and hip bone pains and aches 3 days; few rigors and severe left pelvic and hip bone pains and aches 3 days; Now my Ig G is 400; This is a spontaneous report from a contactable physician (patient). A male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 04Mar2021 as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced fever, body aches, few rigors and severe left pelvic and hip bone pains and aches 3 days. Now his Ig G was 400. The patient scheduled to receive the second dose of the vaccine tomorrow could he take it and was it dangerous for him to take the second dose with these high IG G levels or can he postpone the second dose. Adverse event was for 3 days. The patient underwent lab tests and procedures which included blood immunoglobulin g: 400 on an unspecified date in Mar2021. Booster date was unknown. Health authority notified: Unknown. Enquiry did not involve a report of exposure during pregnancy. The outcome of the events was resolved on an unspecified date in 2021.  Information on lot/ batch number has been requested.
Migraine D1, Migraine D2, D3 chills, shortness of breath, heart palpitations, tinnitus; called MD at  Clinic, RN  spoke to told me to go to the ER since I had to keep pausing conversation to breathe. SOB lasted 3-4hrs and was gradually improving as I drove to  ER.  Tinnitus not improved, Chills improved, SOB severe improved but still occasional mild SOB, Palpitations improved, Migraines improved
sore in the arm; a lot of fatigue; felt sleepy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 27Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "High risk heart condition" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore in the arm"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "a lot of fatigue"; SOMNOLENCE (non-serious) with onset 2021, outcome "unknown", described as "felt sleepy".  Additional information: Patient was waiting a long time to speak with Medical Information and was supposed to have 2nd dose of the Pfizer vaccine unfortunately, vaccination center closed. The Pfizer vaccine was through a federal program. Monday they are doing the state program which was Monderna. Patient got the normal side effects after the first dose of the Pfizer vaccine; it was nothing. it was good. Patient's parents got it in another country the Pfizer one and had the same side effects (not very big sore arm, light sore arm).  No follow-up attempts are possible. Information about lot/batch number cannot be requested.
Headache developed before 7pm. Chills soon after for the remainder of the night. Woke up the next morning feeling like hit by a bus with so many muscle aches. Also was warm/hot most of the day. Didn't feel good in general. Headache came and went most of the day. The next morning still felt 'off', but not horrible like the previous day.
Left Deltoid swollen, red, hot extending down the arm toward his elbow.  He had fever 101, 2 days.  Seen by Pediatrician.  Tylenol for signs/symptoms.
Flu and H1N1 nasal given 10/12/09 and later that day few (hours later) got rash, itchy on legs only. Using BENADRYL helps but rash recurs. No other symptoms.
NUMBNESS TINGLING FEELING FROM LEFT ARM TO CHEEK, AND JAN 24, STAYING ON BABY ASPIRIN.
- Severe pain at injection site; inability to move arm; pain lasted 48 hours with site still red, swollen, and hot (over 53 hours post shot). - Severe flu symptoms: body aches, headache, fever, nausea: lasted 52 hours with the exception of fever which lasted 24 hours.
have had ringing in my ears constantly since receiving the second dose of the pfizer vaccine in april, this has been constantly for over 4 months now
pt reported feeling lightheadedness and nausea, vs completed, bp 145/79 @11:25a.  rest of vitals wnl.  pt was released by physician and drove home at 11:55a
completed the primary series and tested positive for COVID19; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Jan-2022 and was forwarded to Moderna on 26-Jan-2022.    This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (completed the primary series and tested positive for COVID19) in a 47-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced SARS-COV-2 TEST POSITIVE (completed the primary series and tested positive for COVID19). At the time of the report, SARS-COV-2 TEST POSITIVE (completed the primary series and tested positive for COVID19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 antibody test: positive (Positive) Positive.         No concomitant medications reported by reporter No treatment medications provided by the reporter.  Company comment: This is a spontaneous case concerning a 47-year-old patient of unknown gender with no reported medical history, who experienced the unexpected, non-serious, AESI event of Covid-19 virus test positive. The patient received 2 doses of mRNA-1273 vaccine with unknown dosage interval. The event Covid-19 virus test positive occurred approximately 9 months after the second dose of mRNA-1273 vaccine administration. No reported treatment information. The outcome of the event Covid-19 virus test positive was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a 47-year-old patient of unknown gender with no reported medical history, who experienced the unexpected, non-serious, AESI event of Covid-19 virus test positive. The patient received 2 doses of mRNA-1273 vaccine with unknown dosage interval. The event Covid-19 virus test positive occurred approximately 9 months after the second dose of mRNA-1273 vaccine administration. No reported treatment information. The outcome of the event Covid-19 virus test positive was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Fever, chills, shortness of breath, cough, nasal congestion, body aches and chills, fatigue.
Patient came in for her second Moderna vaccine after 28 days and was accidentally given Pfizer vaccine instead . patient is in good spirits and feels ok. No reaction to getting mixed vaccine . doctor assured her safety of situation
Information has been received from a consumer concerning a 1 year old female who on 10-OCT-2008 was vaccinated via injection with MMR II. Secondary suspect therapy included VARIVAX (MSD), PNEUMOVAX 23 (mfr unknown) and VAQTA (mfr unknown). The caller stated that her baby received her MMR II vaccine and (8-10 days later) is now covered in what looks like a measles type rash. The caller did consult the physician who stated that it could be a reaction to MMR II, however did not specify whether it was measles. The patient was considered to be not recovered. The patient sought medical attention and consulted a physician. There was no product quality complaint. No further information is expected.
Hospitalization: 3/28/2023 - 3/30/2023 (2 days) Presentation to the ED: palpitations COVID + date: 3/29/2023 Treatment: asymptomatic - no treatment.  Discharge to: home.  011L20A 1/5/2021 012M20A  2/2/2021 048F21A 9/9/2021
24 hrs after vaccination patient developed nausea, vomiting and fatigue.  After 1 week went to ER dx with Aki, Since in followup after ER. Diclofenac stopped d/t aki.  Had significant weight gain and was admitted over the weekend.  Further testing at the hospital with biopsy of kidney revealed minimal change nephropathy
This spontaneous report was received from a registered nurse (also reported as a licensed practical nurse) and refers to a 60 year old female patient with allergy to SULFA. There was no patient's pertinent medical history reported. On 21-SEP-2015, the patient was vaccinated with ZOSTAVAX (lot# L024999, expiration date 06-OCT-2016) 0.65 ml, frequency reported as once, subcutaneously in the left arm. Concomitant therapies included CITRACAL. On 22-SEP-2015, reported as on the "next morning", the patient experienced mild burning and redness at the injection site, which developed into a rash that had traveled down her left arm and was 6 inches by 2 inches. On 25-SEP-2015, the patient sought medical attention and was diagnosed to have a local reaction to the vaccine by unspecified physician. No treatment was given and no lab diagnostic studies were performed. The patient not recovered from the events. The relatedness between the events and ZOSTAVAX was not reported. Lot number L024999 had been verified to be a valid number for ZOSTAVAX. Additional information has been requested.
I have numbness and tingling in my entire left thumb.  It is constant numbness that has not gone away.   I feel tingling in my wrist all the way up my arm to my elbow.
+ hives and joint swelling after FLUMIST spray was given. Symptoms developed after 10 hours from the dose.
COVID-19; COVID-19; Felt pain of aching; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1155991), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "recovered" and all described as "COVID-19"; PAIN (non-serious), outcome "not recovered", described as "Felt pain of aching". The action taken for adalimumab was unknown.  Clinical Course: The reporter's causality for the event (s) of Felt pain of aching with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event (s) of Covid-19 with Humira (Adalimumab) was not provided.The reporter's causality for the event (s) of Felt pain of aching and Covid-19 with Moderna covid-19 vaccine was possible. The reporter's causality for the event (s) of Felt pain of aching and Covid-19 with Pfizer-BioNTech Covid-19 Vaccine was possible.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
The day following my second vaccination I had body aches, headache and chills that lasted for approximately 3 hours. In addition, on this same day I experienced mild tiredness for most of the day.
Patient called the pharmacy to report side effects. She stated she got really hot and looked pale, then she got really dizzy. Pharmacist asked if she had ever had hot flashes before. Patient said yes, but this felt different. She doesn't get dizzy with hot flashes. She had one episode this morning. No treatment was advised.
I felt dizzy for a few hours after the vaccine and felt like I might pass out. Shaking for about an hour. Anxiety for a few days.  Nausea off and on for two days. Trouble sleeping the night of vaccine. Sore throat for two days. Sore arm for 3 days.
Erythema of injection site with warmth and tenderness. Area of erythema approximately 10 cm in circumference. Enlarged, tender lymph node on axilla of the same side. Breast tenderness on same side of vaccination.
She had every adverse reaction; Slept for 15hs; Fever; Chills; Body aches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (She had every adverse reaction), HYPERSOMNIA (Slept for 15hs), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 91875) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 VACCINATION COMPLICATION (She had every adverse reaction), HYPERSOMNIA (Slept for 15hs), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches). At the time of the report, VACCINATION COMPLICATION (She had every adverse reaction), HYPERSOMNIA (Slept for 15hs), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) outcome was unknown.            No concomitant medication was reported.  No treatment medication was reported. Company comment: This is a regulatory case concerning unknown age, female patient with no medical history reported, who experienced the non-serious unexpected, according Regulatory Authority of Hypersomnia. The event occurred after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as non-serious as per Regulatory Authority´s report.   This case was linked to MOD-2022-437646 (Patient Link).; Sender's Comments: This is a regulatory case concerning unknown age, female patient with no medical history reported, who experienced the non-serious unexpected, according Regulatory Authority Hypersomnia. The event occurred after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as non-serious as per Regulatory Authority´s report.
Sore arm since time of vaccination till next day; Chills developed at 10pm same day; Headache next day not alleviated with Excedrin
HCP stated that she gave an dose with a temperature excursion to almost 4 patients (she is no sure); This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated that she gave an dose with a temperature excursion to almost 4 patients (she is no sure)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated that she gave an dose with a temperature excursion to almost 4 patients (she is no sure)). On 10-Dec-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated that she gave an dose with a temperature excursion to almost 4 patients (she is no sure)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.  Excursion information, Storage condition at the time of the excursion- Room temperature. Maximum or minimum temperatures reached, as applicable- 64 degree F. Excursion duration- 32 hours. Date vial(s) moved from freezer to refrigerator- 9 DEC 2021. Where are they stored now? Were thrown into the corresponding trash. Visual inspection- Nothing . Proposed desired Use by Date- 9 JAN 2022. Number of vials impacted- 1 vial Pertinent details- The vials were punctured, no previous excursions.
Mild persistent lightheadedness, frequent feeling of nausea and occasional vertigo. Started 06/03/21, still persists.
p/vax pt devel severe pain & induration @ the site of pnu-imune 23;the next morning pain radiated throughout entire rt arm;pt recovered;
Tired (slept all day the day after the shot), fever, swelling and redness at injection site, nausea.   All symptoms except for redness and swelling in arm lasted two days.  The arm is ongoing.
17OCT97 pt became faint p/vax;inj was painful & exp spasms sensation lt arm/hand;BP 102/62, 108/64;pt drank juice & left feeling fine;18OCT97 pt was vacuuming for 1/2hr heart started pounding, rapid heart rate, tightness in throat;lt arm  h
5 PTS EXPERIENCED FEVER,CHILLS,NAUSEA,AND VOMITING WITHIN 48 HRS AFTER IMMUNIZATION.ALL PTS RECEIVED IMMUN FROM SAME VIAL BETWEEN 6-1-89 AND 6-15-89. ONE PT TREATED WITH TYLENOL AND COMPAZINE
LOSS OF APPETITE; NAUSEA; MYAGLIA; DIZZINESS; LETHARGIC; DISORIENTATION; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included pelvic pain from a previous surgery. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced disorientation. On 10-MAR-2021, the subject experienced dizziness. On 10-MAR-2021, the subject experienced lethargic. On 10-MAR-2021, the subject experienced myaglia. On 12-MAR-2021, the subject experienced loss of appetite. On 12-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from disorientation, and dizziness on 11-MAR-2021, and loss of appetite, and nausea on 18-MAR-2021, and was recovering from lethargic, and myaglia. This report was non-serious.
Pt recv vax on 3/5/99; on 3/14/99 pt exp fever (103), lesions (pox) on back/ shoulders