chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm at the injection site after first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm at the injection site after first dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm at the injection site after first dose). At the time of the report, VACCINATION SITE PAIN (sore arm at the injection site after first dose) outcome was unknown.            Concomitant product use was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-048203 (Patient Link).
Fever, body aches, joint pain, sore throat, migraine and fatigue more than 3 days
Patient was given the entire vial of the undiluted Pfizer Covid vaccine.  I spoke with the patient and he stated that he only had a sore arm on 9/11/21.  He has no other adverse effects.
R upper arm - erythematous, tender, swollen around injection site, 2" x 1 1/2" area.
Each of dose days, became "loopy".  Having a hard time concentrating. Example- turned off lights, shut door and was getting ready to go home from work in the middle of the day until coworker stopped her.  Also had fever- exact degrees unknown.  Stayed home last two dose days.
Pharmacist doesn't know how much patient received; needle and syringe was leaking; A spontaneous report was received from a health care professional concerning a non-identifiable patient , who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced "needle leaking and syringe leaking" and "pharmacist doesn't know how much patient received".  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received his/her 2nd dose of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  It was reported that the pharmacist gave second dose of Moderna Covid-19 vaccine to the patient and needle and syringe was leaking. Pharmacist doesn't know how much dose was given to the patient.  Action taken with mRNA-1273 in response to the events was not reported.  Out come of the events "needle leaking and syringe leaking" and "pharmacist doesn't know how much patient received" was considered as resolved on 02 Feb 2021.; Reporter's Comments: This report refers to a case of Incorrect dose administered and device connection issue for mRNA-1273, lot # 013l20a.  There were no reported AEs associated with this case of Incorrect dose administered and device connection issue.
I noticed a rash of red dots on my left hand and wrist 3 days after getting the vaccination. The dots were small and not raised.  They went from the knuckles on my hand to about 4 inches past my wrist up my arm. It faded and was completely gone in about 5 days.   This rash looked the same as the beginning of the rash I get when taking penicillin or sulfa drugs. I will usually get bad hives everywhere with penicillin and sulfa after the red dots. I did not get hives with the Covid vaccine.
soreness of the arm injected arm; her blood pressure was 174/114/high blood pressure; Tachycardia  with heart rate at 140,163,110 beats per minute; This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On 23rd October 2020, unknown after receiving Shingrix, the patient experienced pain in arm, blood pressure high and tachycardia. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the blood pressure high and tachycardia were recovered/resolved.   It was unknown if the reporter considered the pain in arm, blood pressure high and tachycardia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Physician stated a customer received the 1st dose of the Shingrix vaccine in an unknown date, and in unknown arm and was seen by the physician on 23th October 2020, and the patient reported that she got the Shingrix vaccine and experienced tachycardia with heart rate at 140 beats per minute which sustained for 5 minutes and then the heart rate went upto 163 beats per minute which sustained for 20 minutes and then the heart rate went to 110 beats per minute. During this time, her blood pressure was 174/114 and then she laid down to rest and then her vital signs returned to normal.  The patient also reported soreness of the arm injected arm. The reporter consented to follow-up.
Acute pericarditis with pericardial effusion,  index AF Myocarditis, with new cardiomyopathy
Severe swelling throughout entire arm, difficulty lifting arm. Arm was red, hot and swollen from shoulder to wrist. Swelling did not reduce for a week.
pt recvd vax 1030AM; 1PM pt started screaming mom unable to comfort pt screaming lasted approxx 2 hrs; went to MD no ear infect; MD rx'ed liquid Motrin which helped; aobut 7PM another episode of screaming lasting 45 mins;
Developed body aches and fatigue within 24 hours after receiving vaccine. Symptomatic treatment only.
-Approximately one week after my second Moderna vaccine, I experienced Conjunctivitis (which I have never had before). Prescription eye drops were prescribed by a physician -Approximately 18 days after my second Moderna vaccine, I developed Shingles. The rash appeared on April 30 and I was not diagnosed until May 7. I was prescribed topical ointment for the rash, as well as an oral prescription (Valacyclovir)
T101, muscles pain, occurred approx 24hr p/vax sx relieved by APAP q 3-4hr;pt feeling better eating more;
Hives - bilateral lower legs 10 minutes after vaccines. Administered Q-DRYL per dr. hives resolved. Diffuse redness with hives only in lower extremity.
A 14 year old patient was given a Shingrix / errors in administration for the pediatric population; This case was reported by a other health professional via media and described the occurrence of inappropriate age at vaccine administration in a 14-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: Age at vaccination was reported. The reporter reported that a 14 year old patient was given a Shingrix shot, which led to inappropriate age at vaccine administration. The reporter was hoping to see if they have any information about errors in administration for the pediatric population.
Child got dizzy, lightheaded.  She told mom she felt like she couldn't hear, then fainted.  Woke up immediately, RPh checked for claminess (none), no sweating, no injury to head as mom was able to keep her from falling. Felt better after sitting for few minutes with mom and drinking some juice.  Parent declined ambulance and was instructed to monitor child for next several hours, follow up with pediatrician
Parent c/o child having rash on day 9 following shots. Red raised circles nickel sized in a band around bilateral thighs where injection shots. C/O itching, lasted few days and disappeared with no left over signs.
pt recvd vax & condition of tinnitus & rhinitis got worse & exp h/a;
little bit of shortness of breath, she was out of breath; got tired very easily; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (little bit of shortness of breath, she was out of breath) and FATIGUE (got tired very easily) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 023M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Scoliosis and Sciatica. Concomitant products included HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced DYSPNOEA (little bit of shortness of breath, she was out of breath) and FATIGUE (got tired very easily). At the time of the report, DYSPNOEA (little bit of shortness of breath, she was out of breath) and FATIGUE (got tired very easily) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient had low hemoglobin since it resolved on its own after a transfusion after the second dose of the vaccine.   This case was linked to MOD-2021-071259 (Patient Link).
Anaphylactic shock, unspecified, subsequent encounter on 2023-08-15.
Tetanus/Diptheria administered 07/01/02 739 pm. Since than c/o pain in upper left arm. Had arm checked 7/8 and 7/9 for same. No redness- minimal swelling, general deep muscle area in left upper arm left upper arm. No other s/s.
Sever headache, chills, fever, muscle pain, joint pain, nausea, swollen glands in the throat. 36 hours  Self medicated with Acetaminophen 2 x 500 mg every 4-6 hours. Symptoms started to subside 48 hours later.
not received third dose; Recombivax on 19Oct2017, Engerix-B on 28Nov2017; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 65-year-old female patient who received HBV (Engerix B) (batch number 4795H, expiry date 14th July 2020) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (RECOMBIVAX).   On 28th November 2017, the patient received the 2nd dose of Engerix B. On an unknown date, the patient received the 3rd dose of Engerix B. On 28th November 2017, unknown after receiving Engerix B and not applicable after receiving Engerix B, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination were unknown.   Additional details were reported as follows: This case was reported by the pharmacist. The pharmacist reported that patient received Recombivax vaccine on and then received Engerix-B , which led to drug dose administration interval too long. The pharmacist also reported that the patient had not yet received a third dose of Hepatitis B vaccine till the time of reporting, which led to incomplete course of vaccination. The pharmacist consented to follow-up.
COVID19 MODERNA EUA- MODERNA USED PAST THE 12 HOUR WINDOW OF USE ONCE VIAL PUNCTURED. STORED IN FRIDGE ENTIRE TIME AND CLEANED BETWEEN EACH USE WITH ALCOHOL. DOSE ONE ON 6/25/21 AND DOSE 2 7/23/21 ALSO USED PAST THE 12 HOUR WINDOW. DIFFERENT VIALS SAME LOT  NUMBER. CONTACTED PT. AND NO ADVERSE REACTION, STATES SHE DID WELL WITH INJECTION.
Persistent atrial flutter that required electric cardioversion.  Labs show early stage kidney failure. 10 months prior showed upper dude of normal. eGFR was 58. All previous labs were 78-81. Ache in joints.
This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information about the patient pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 02-JUL-2018, the patient was vaccinated with a improperly stored dose of ROTATEQ orally, lot # N030175, expiration date 16-JUN-2019 (strength and vaccination site were not provided) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion at of above 32 degrees Fahrenheit up to 35 degrees Fahrenheit for 84 hours. There was no previous temperature excursion. Information was received from a data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1807USA010993: US-009507513-1807USA010304: US-009507513-1807USA010994.
Pt recvd Hep B vax & w/in 24 hrs of vax pt exp fever, nausea, vomiting, h/a, lethargy; @ the time of the report pt recovered;
Erythema and swelling at site of injection 2 x 1 1/2 inches Lt upper arm. PO Benadryl helping. Local reaction to chicken pox vaccine.
26MAR97 pt feeling cranky & cried all day;28MAR97 rashes started appearing;1APR97 back to clinic DPH was prescribed & steroid;
pt recvd vax & jerking movement of head to rt side; seen by MD; pt taken to MD whole body w/jerking movements-arching back; seen in ER 27JAN94; gagging, rt eye twitching;
Anaphylaxis, post vax, with difficulty breathing, wheezing, swollen lips, eyes and tongue. Treated with epinephrine, Benadryl and albuterol nebulizer. The follow up received on 1/5/01 states, "Dr. reporter, states that child's SOB resolved within 15 minutes of the time treated with Benadryl, Epinephrine, and Albuterol inhaler. Child was observed in Dr's office for an additional 30 minutes before being released to home with parent. Father had marked on questionnaire that child had a problem after first hep B vaccine but attendant at immunization dept gave hep B #2 anyway. Dr. was called in to assist when problem started. Child had to go to ER first hep B vaccine for treatment with Epinephrine.
Site: Pain at Injection Site-Medium, Additional Details: Patient still has pain as described by patient in the muscle where injection was given, unsure if related to condition which patient has- will be seeing dr.
Fever, fatigue, upset stomach, headache, sore arm .  The side effects lasted for approximately 48 hours.
Pain/soreness/stiffness to L deltoid upon waking the morning following injection. Pain/soreness/stiffness continues to this day with no improvement. Had a similar event to flu vaccine approximately 7 years ago to R deltoid, and continue to have a "lactic acid burn" in that arm to this day.
Patient hospitalized for 1 day due to COVID-19. He is fully vaccinated. Patient had fever, chills, cough, SOB, fatigue, headache
Patient received  1st dose Moderna  12/23/2020  Patient received 2nd dose Moderna 01/08/2021  Patient received 3rd dose Moderna 12/19/2021
Within a few minutes of receiving Pfizer booster and Fluzone quad vaccines, patient lost balance and fell to ground. Patient regained consciousness and was able to speak within about minute. After sitting up, patient's nose began to bleed but stopped within a couple of minutes.
Started as a small rash on thigh around injection site. Then spread to other thigh and then developed hives on back, neck, chest and abdomen. Called doctors office and the nurse I talked to said this was normal reaction for 7 day out from vaccinations.
This is a spontaneous report from a contactable consumer or other non-HCP (patient's wife), for a male patient (reporter's husband). A male patient, of an unspecified age, received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. Medical history included neuropathy from diabetes. Concomitant medications not reported. Additional Context: The report is cross referenced to report ID: 2T5JQW1M. Caller also called to report adverse reaction for herself with COVID-19 vaccine. Reporter consented to do a report for her husband. This report is for her husband. Reporter's husband was just tired after it. He also got Pfizer COVID-19 vaccine. He is always tired. He is in a walker because he fell when he was in a hurry to get to the bathroom (not related to the vaccine). He has neuropathy from diabetes. His feet are messed up. He cannot walk without the walker. Reporter stated he was sleeping, and he sleeps a lot. The outcome of the events: unknown. The lot number for the vaccine, (BNT162B2), not provided and will be requested during follow-up. Follow-up attempts completed. No further information expected.
feels over whelmed; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 01Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PSYCHIATRIC SYMPTOM (non-serious) with onset 05Mar2021, outcome "unknown", described as "feels over whelmed"; FATIGUE (non-serious) with onset Mar2021, outcome "not recovered", described as "fatigue".  Additional information: This spontaneous report is from a Pfizer sponsored program Support. It was reported that the patient received 1st shot on Monday 01Mar2021. "Today feels over whelmed, does not know how long the fatigue will last as it comes and goes."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
sick beyond belief; Initial information was received on 02-Dec-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional1  This case involves a female patient (age unspecified) who was sick beyond belief (illness) after receiving INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor  The patient's medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 30-Nov-2021, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient was sick beyond belief (illness) (unknown latency) following the administration of INFLUENZA VACCINE. The event was non-serious.  It was reported "I haven't had a flu shot since 1983 and I never got the flu ever again! My daughter got hers 2 days ago and is sick beyond belief! I'll never take another one but, I realize that's not for everyone"  It was unknown if the patient experienced any additional symptoms/events  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
no adverse event; Patient administered pediatric monovalent vaccine instead of bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient administered pediatric monovalent vaccine instead of 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) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient administered pediatric monovalent vaccine instead of 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 administered pediatric monovalent vaccine instead of bivalent booster) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient administered pediatric monovalent vaccine instead of bivalent booster).    This case contains information for the 4th of 16 adult patients described by the reporter. No concomitant product reported by reporter. No treatment medication reported by reporter.   This case was linked to MODERNATX, INC.-MOD-2022-692175 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-692175:Master
Exaggerated Vasovagal response, brady cardia dizziness clammy and shaking lasted about 45 min.  Brief syncope.  HR  down to low 60's
Received vaccine past its 30-days Exp date, Vaccines went into 2-8°C  thaw state on or about 24-Dec-2021.; Patient received vaccine past its 30 days expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date, Vaccines went into 2-8°C  thaw state on or about 24-Dec-2021.) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2022 at 4:50 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Feb-2022 at 4:50 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date, Vaccines went into 2-8°C  thaw state on or about 24-Dec-2021.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date, Vaccines went into 2-8°C  thaw state on or about 24-Dec-2021.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  patient's ethnicity was reported.  It was reported that this vaccine was administered up until its Mfg Exp date of 04-Apr-2022.  No treatment medication were reported.