chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report received from a nurse practitioner referred to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The nurse practitioner reported that the patient who received a dose of M-M-R II (dose, route, lot number and expiry date not reported) on an unspecified date experienced muscle dystrophy after receiving the vaccination. Outcome of the event was unknown and causality assessment was not reported. Additional information is not possible as permission to contact the reporter was not available.
patient stated that his arm is numb and his arm movement became limited since he got the shot, did not report till 04/19/22 , however he received the shot 09/03/21
Red, itch rash on torso, arms, and legs. Treated with Benedryl and Hydrocortisone cream.  Improved overnight and continued improving.
Numbness and tingling from the waist down almost felt like I had an epidural. Has been going on for the whole week.
Patient received a vaccine on 15-Apr-2022, which had got expired on 04-Apr-2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine on 15-Apr-2022, which had got expired on 04-Apr-2022.) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine on 15-Apr-2022, which had got expired on 04-Apr-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine on 15-Apr-2022, which had got expired on 04-Apr-2022.) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The vial did not undergo any temperature excursions. Concomitant drugs were not reported.  Treatment details were not given.
Patient was vaccinated with Pfizer on 7/26/21. After giving the Pfizer vaccine patient stated they were vaccinated with Janssen in state, and his provider directed him to get revaccinated with Moderna or Pfizer due to his respiratory conditions and new variants. I explained the current guidelines do not recommend booster doses and vaccinating with multiple manufacturers. Currently the patient has been vaccinated with one dose of Janssen and one dose of Pfizer. No symptoms or adverse events occurred while patient was at the pharmacy.
Site reaction, immediate, tingle in arm. Numbness, no loss of breathing but subsequent nausea when she got home.
Hours 1-12 Post Admin- Mild Headache; 12-36 Moderate Headache, Chills, nausea, Light headed, 60 Hours out swollen lymph nodes under the arms (Friday 2:00 am) walnut size. Friday 11:45 am  nodes are still enlarged but not as much
On 10/13/21, he received an IM Fluzone HD vaccination in his left deltoid by pharmacy intern. The patient returned on 11/2/2021 to receive his first booster of Moderna. The same intern, gave the patient's Moderna booster in the opposite arm (right).  At some point after the Moderna booster on 11/2/21, the patient told pharmacist, who is an acquaintance, that he was having trouble with his arm/shoulder.   I became involved because pharmacist told the patient that he needed to talk to me. She did not feel comfortable since she is acquainted with him and his wife and was not directly involved. I reached out to the patient on 11/23/21 by phone. From my documentation at that time, he told me that the flu shot was "real high." He stated that after about 4 hours, his arm began throbbing. He also stated that he had not slept in about a week. He had initially been taking 1600 mg of Ibuprofen per day, but the pain had improved so at the time of the phone call, he was taking 800 mg/day of Ibuprofen. He said that he still had difficulty lifting his arm, twisting his arm while holding any weight, and he can't go play golf. He also stated that he had not been to see a doctor. Additionally, he stated that he wasn't complaining, but wanted us to know. I told the patient at the time that I wanted to contact his PCP. Dr. office said that if it keeps hurting to come in to be seen.
This spontaneous report as received from a nurse refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored (that were exposed to 9 degree celsius for 29 minutes) ROTATEQ suspension 2 (units unknown), 2 ml, orally (lot # K011948, expiry date: 07-JUN-2016) and (lot # K023534, expiry date: 22-MAY-2016). No concomitant medication were reported. No adverse effects were reported. The outcome of the event was unknown. There were not product quality complaints (PQC) involved. No further information was provided. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 64-year-old female patient who received SHINGRIX (batch number CX5BG, expiry date 18th May 2021) for prophylaxis. On 30th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 31st January 2019, 1 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site induration, injection site pain and injection site bruising. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site erythema, injection site induration and injection site pain were not recovered/not resolved and the outcome of the injection site bruising was unknown. It was unknown if the reporter considered the injection site erythema, injection site induration, injection site pain and injection site bruising to be related to SHINGRIX. Additional details were provided as follows: On 31st January 2019, the patient noticed a red area at the injection site. She took Benedryl same day.  On 1st February 2019, she noticed the red area was 4 times bigger than yesterday. It was red, hard and sore like a bruise, but not hot.
So Cold; Hazy,not clear; Feels like going to fall; Can't really concentrate; Chills; Felt like worst; Couldn't even get out of bed; Headache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Felt like worst), BEDRIDDEN (Couldn't even get out of bed), NASOPHARYNGITIS (So Cold) and FEELING ABNORMAL (Hazy,not clear) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 12-Mar-2021, the patient experienced HEADACHE (Headache). On 13-Mar-2021, the patient experienced FEELING ABNORMAL (Felt like worst), BEDRIDDEN (Couldn't even get out of bed) and CHILLS (Chills). On 18-Mar-2021, the patient experienced NASOPHARYNGITIS (So Cold), FEELING ABNORMAL (Hazy,not clear), BALANCE DISORDER (Feels like going to fall) and DISTURBANCE IN ATTENTION (Can't really concentrate). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Headache, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at a dose of Extra Strength. On 12-Mar-2021, HEADACHE (Headache) had resolved. On 13-Mar-2021, FEELING ABNORMAL (Felt like worst) and BEDRIDDEN (Couldn't even get out of bed) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), NASOPHARYNGITIS (So Cold), FEELING ABNORMAL (Hazy,not clear), BALANCE DISORDER (Feels like going to fall), DISTURBANCE IN ATTENTION (Can't really concentrate) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient describes pain as 8-10 normally. When he taken Acetaminophen it was decreased to 3-4 Concomitant product information includes High Blood Pressure Medication
A little bit of a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A little bit of a sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Patient receives an allergy shot as a maintenance for environmental allergies.).    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced PAIN IN EXTREMITY (A little bit of a sore arm). At the time of the report, PAIN IN EXTREMITY (A little bit of a sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: NNI
No adverse event; given a half dose of the bivalent Moderna booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (given a half dose of the bivalent Moderna booster) and NO ADVERSE EVENT (No adverse event) in a 36-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Sep-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-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (given a half dose of the bivalent Moderna booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (given a half dose of the bivalent Moderna 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 (given a half dose of the bivalent Moderna booster).    No concomitant medication were reported.             No treatment information was provided by the reporter.
Pt recvd vax on 8FEB93 & 24FEB93 pt exp joint pain & numbness; No further details were provided;
Pt. states 24 hours after receiving flu vaccine she got nasal congestion, muscle aches, hoarse voice & fatigue. No fever. No nausea, vomiting or diarrhea. No cough. She stayed in bed, increased fluid intake. Is starting to feel better.
felt sharp pain behind right ear which lasted 2 hours; headache; This is a spontaneous report received from a contactable other healthcare professional (who is also the patient). An 18-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318, expiry date: unknown), via an unspecified route of administration in the left arm, on 24Jan2021 13:00, at single dose, for COVID-19 immunization, at the workplace clinic. Medical history included depression. The patient was not pregnant at the time of vaccination. The patient has no known allergies. Concomitant medication included an unspecified birth control pill, melatonin and multivitamins. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry date: unknown), via an unspecified route of administration in the left arm, on 03Jan2021 12:00, for COVID-19 immunization. The patient did not receive any other vaccine in four weeks. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. On 24Jan2021 17:00, 4 hours after vaccination, the patient felt sharp pain behind right ear which lasted 2 hours. On 24Jan2021 15:00, a few hours after vaccination, the patient started having a headache which, as the patient reported, "hasn't gone away, even with a Tylenol, actually feels worse than when it started on Sunday". Treatment for the events included Tylenol, heat, and quiet and dark room. The outcome of the event "felt sharp pain behind right ear which lasted 2 hours" was recovered on 24Jan2021 at 19:00; and headache was not recovered.
Uncontrollable shaking shivering lasting an hour; icy cold; body aches; headache.  Took generic ibuprofen to help relieve headache and body aches. As of 11/13 still experiencing body aches and general malaise.
Fever, chills, muscle aches, pain at injection site, swelling at injection site, axillary swelling
2-3 days following second vaccination I woke in night with hands swollen and painful trying to use them even to pull up sheets in bed. Pain not changed by Tylenol.  Ordered Paraffin and used  baths on hands with only temporary relief. Symptoms seemed to constantly change over following days and weeks. Individual joints in hands would be inflamed and tender to touch. This varied from day to day as to which joint was inflamed. Shooting pains in lower arms and hands in April and May,. Sometimes extended to all joints. Pain when interlacing fingers. Pains shooting through fingers when just sitting.  Sensations of pin pricks  or bugs crawling on my skin when nothing touching me.
Swelling, redness, itchiness, hardness, and increased temp of 1/2 dollar size region around injection site.
Patient is a 71-year-old male with a history of advanced COPD who continues to smoke a pack of cigarettes a day.  Patient was also diagnosed with multiple bilateral pulmonary embolisms in December 2021 which required thrombectomy.  He is currently on warfarin.  Patient also has a history of abdominal aortic aneurysm that he is scheduled for surgery in 2 months.  He presents to the emergency room ambulatory by private auto in the company of his wife complaining of increasing shortness of breath and a dry nonproductive cough over the last 3 to 4 days.  Patient states tonight he was coughing so hard that he had a syncopal episode and vomited.  He denies fever or chills.  Denies any associated chest pain.  Patient does admit to being short of breath at rest but it is significantly worse when he is coughing or attempts to ambulate.
MUSCLE SORENESS FOR 6 HOURS FOLLOWING THE INJECTION; This spontaneous report received from a consumer concerned a 60 year old male. The patient's weight was not reported and height was 182.88 centimeters. The patient's concurrent conditions included alcohol user, and smoker, and other pre-existing medical conditions included the patient did not have any history of allergies to vaccine, drug or food nor any drug abuse.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the subject experienced muscle soreness for 6 hours following the injection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle soreness for 6 hours following the injection on 06-MAR-2021. This report was non-serious.  Additional information was received from patient on 30-Mar-2021. The following information was updated and incorporated into the case narrative: Reporter details (patient), patient demographics (patient initials), height, patient history including pre-existing medical conditions, medical history, event and event details (outcome, onset and cessation date), product and product details (route of administration, therapy start and end date, batch number) and case level outcome.
Pt admitted for advanced osteoarthritis of the right knee and was incidentally found to be COVID positive.
Blood in diaper; Dizziness; Bleeding in her left ear; Severe bruising on left side; Red dots all over her skin; Nausea; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Blood in diaper) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Heart disease, unspecified (Under hospice care for heart condition). Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for Heart disease, unspecified.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HAEMATOCHEZIA (Blood in diaper) (seriousness criterion medically significant), DIZZINESS (Dizziness), EAR HAEMORRHAGE (Bleeding in her left ear), CONTUSION (Severe bruising on left side), PETECHIAE (Red dots all over her skin), NAUSEA (Nausea) and HEADACHE (Headaches). At the time of the report, HAEMATOCHEZIA (Blood in diaper), DIZZINESS (Dizziness), EAR HAEMORRHAGE (Bleeding in her left ear), CONTUSION (Severe bruising on left side), PETECHIAE (Red dots all over her skin), NAUSEA (Nausea) and HEADACHE (Headaches) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medications were reported. It was reported that the patient hasn't seen the doctor about her side effects yet.  Company comment:Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Pt felt dizzy, hot and sweaty for about 5-10 minutes after the shot. Then the pt felt better after 10 minutes.
Patient walked to waiting room after vaccine + a few minutes later fainted. He immediatly wake up + said felt fine. We called EMS.  I placed his legs on a chair to increase blood flow to his head + told him to keep lying down till EMS came.
headache on the left side; Nausea; she didn't feel good; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Feb-2021 and was forwarded to Moderna on 10-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (she didn't feel good), HEADACHE (headache on the left side) and NAUSEA (Nausea) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included Adverse reaction. Concomitant products included FAMOTIDINE for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced FEELING ABNORMAL (she didn't feel good). On 10-Feb-2021, the patient experienced HEADACHE (headache on the left side) and NAUSEA (Nausea). The patient was treated with IBUPROFEN (ADVEL) ongoing since an unknown date at an unspecified dose and frequency; PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (she didn't feel good), HEADACHE (headache on the left side) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-164014:second dose
felt a pain in her heart and all the way throughout the back that was like she was stabbed; This is a spontaneous report from a Pfizer-sponsored program, from a contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 15Apr2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. After the 2nd dose (on an unspecified date in Apr2021), the patient felt a pain in her heart and all the way throughout the back that was like she was stabbed. The outcome of the event was unknown.    Information about batch/lot number has been requested.
RASH OVER THE CHEST CHEST PAIN LYMPHADENOPATHY LEFT SIDE OF BODY RIGORS FEVER 102 NECK SPASMS GASTRITIS FACIAL RASH WEAKNESS HEADACHE
This spontaneous report as received from a medical assistant refers to 5 patients of unknown age. From 05-JUN-2017 to 11-JUL-2017, the patients were vaccinated with improperly stored doses of ROTATEQ for prophylaxis, as follow: lot M040270, expiration date on 29-APR-2018: 1 dose on 05-JUN-2017, 1 dose on 07-JUL-2017, and 1 dose on 11-JUL-2017; lot M002254, expiration date on 15-NOV-2017: 1 dose on 05-JUL-2017, and 1 dose on 07-JUL-2017. No adverse effect reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1707USA010591:
Patient was given expired MMR. Vaccine expired on 03/09/2023. Patient did not have any adverse events.
26 hours following vaccination I developed a severe UTI. I have never had a UTI before, and not sure this is connected to the vaccine, but thought I would go ahead and report.
This spontaneous report was received from a consumer reporting on her 14 year old son via company field employee. The patient's pertinent medical history, concomitant medication and drug reactions/allergies were unknown by the reporter. On 23-SEP-2016, the patient was vaccinated with unidentified Merck HPV vaccine. On the same day, 2 minutes after vaccination the patient "passed out" (syncope). The reporter did not know if it was GARDASIL or GARDASIL 9. Lab diagnostics studies performed was unknown by the reporter. The patient did not seek medical attention. On an unknown date in September 2016, he recovered from the event. No product quality complaint (PQC) involved. The reporter did not provide relatedness between the events to the suspect therapy. Upon internal review "loss of consciousness" was considered to be serious due to medically significant. Follow up information has been received from the consumer on 08-NOV-2016. The consumer provided the physician's contact details. Upon internal review, the event coding of passed out has been corrected to syncope (previously coded to loss of consciousness). This case has been downgraded, since the event of syncope was not considered to be medically significant event. Additional information has been requested. Reporter details, event coding and narrative has been updated.
Headache, Arthralgia, Fatigue, Injection site pain and swelling Narrative: