chrisvoncsefalvay/vaers-outcomes huggingface dataset:
became almost immobile; chronic severe pain to the point of immobility; Abnormal breathing; joint pain; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMOBILE (became almost immobile), PAIN (chronic severe pain to the point of immobility), RESPIRATION ABNORMAL (Abnormal breathing) and ARTHRALGIA (joint pain) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Osteoarthritis (osteoarthritis in her spine and hip).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMOBILE (became almost immobile), PAIN (chronic severe pain to the point of immobility), RESPIRATION ABNORMAL (Abnormal breathing) and ARTHRALGIA (joint pain). At the time of the report, IMMOBILE (became almost immobile), PAIN (chronic severe pain to the point of immobility), RESPIRATION ABNORMAL (Abnormal breathing) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was reported.; Sender's Comments: This case concerns a 90 year-old female patient with medical history of osteoarthritis, who experienced the unexpected non-serious event of Became almost immobile. The event occurred an unknown number of days after an unspecified dose of mRNA-1273 vaccine. Seriousness criteria of Medically significant override completed based on medical judgement and review of source document that does not support seriousness criteria.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
PATIENT RECEIVED 2 VACCINES ON 06/04/2023 ( ADACEL ON THE RIGHT ARM) AND ( SHINGRIX ON THE LEFT ARM). SHE COMPLAINED FROM SWOLLEN ARM AND RASH IN HER ( RIGHT ARM ONLY) WHERE ADACEL WAS INJECTED , AND HER LEFT ARM WAS OKAY, SHE CONTACTED HER HEALTH CAREPROVIDER WHO ASKED HER TO CONTACT THE PHARMACY AND REPORT THIS REACTION
Patient felt immediate pain/tingling upon injection.  Has been sore the entire month and is difficult for her to use her arm.
Information has been received from a physician concerning a 20 year old female patient with no drug reaction/allergies history who on 16-JAN-2009 was vaccinated with her first dose of GARDASIL (lot # 661046/0546X) IM.  Concomitant medication included oral contraceptive.  The patient had an abnormal pap result from a specimen taken on 16-JAN-2009.  The PAP result was low Grade Squamous Intraepithelial Lesion with both high risk and low risk HPV.  The patient had visited office for medical attention.  The outcome of the patient's adverse effect was not reported.  Additional information has been requested.
Pain in the injection arm; Pain in the neck; Numbness of the Face; Pain in the Shoulder; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Pain in the neck), HYPOAESTHESIA (Numbness of the Face), ARTHRALGIA (Pain in the Shoulder) and VACCINATION SITE PAIN (Pain in the injection arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced NECK PAIN (Pain in the neck), HYPOAESTHESIA (Numbness of the Face) and ARTHRALGIA (Pain in the Shoulder). On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain in the injection arm). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) ongoing since an unknown date for Pain, at an unspecified dose and frequency. At the time of the report, NECK PAIN (Pain in the neck) and VACCINATION SITE PAIN (Pain in the injection arm) outcome was unknown and HYPOAESTHESIA (Numbness of the Face) and ARTHRALGIA (Pain in the Shoulder) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter.
Breakthrough exposure and positive test with the first vaccination; Breakthrough exposure and positive test with the first vaccination; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration in Feb2021 (lot number was not reported) as dose 1, single for COVID-19 immunization. Medical history included COVID-19 (mild exposure) from Mar2020. The patient's concomitant medications were not reported. The patient reported that he is an essential employee. His wife and daughter are nurses in (city name). All three of them had a mild exposure from COVID-19 in Mar2020. The patient had a breakthrough exposure and positive test in Feb2021 with the first Pfizer vaccination in Feb2021. The patient mentioned that he is exposed in his job to over 25 people a day, he would like to volunteer for the Pfizer 3rd booster study. The patient was vaccinated with the 2nd Pfizer vaccine in Mar2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
MA administered Hib vaccine instead of Flu vaccine which was ordered by doctor. Patient will have to received additional dose of Hib vaccine at 15 month physical. Parent contacted and no adverse reaction reported by parent at the time.
Covid Arm and three days later a hives/welt rash that I have had for 4 weeks.  Getting better, but still flare ups.
PATIENT PRESENTED TOOBSERVATION NURSE WITH INCREASED DIFFICULTY SWALLOWING AND SENSATION OF SWOLLEN THROAT.  VITAL SIGNS WERE OBTAINED OF BP 142/96, P - 101, R - 14, SPO2 - 99%.  DIPHENHYDRAMINE 25 mg ADMINISTERED ORALLY PER ON SITE MEDICAL PROVIDER.  MONITORING OF PATIENT CONTINUED FOR 15 MINUTES WHEN PATIENT NOTED INCREASED DIFICULTY SWALLOWING.  VITAL SIGNS OBTAINED BP 132/ 94, P - 98, R- 14, SPO2 - 97%.  PROVIDER ORDER AND PATIENT WAS GIVEN 10 mg DEXAMETHASONE PO.  MONITORING OF PATIENT CONTINUED PATIENT REPORTS DECREASE IN SYMPTOMS.   PATIENTED RELEASED TO HOME
15YO received Adult doses; 15YO received Adult doses; This case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 15-year-old female patient who received HAV (Havrix adult) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   Co-suspect products included HBV (Engerix B adult) (batch number 337TC, expiry date 29th March 2024) for prophylaxis.   On 24th January 2023, the patient received Havrix adult and Engerix B adult. On 24th January 2023, unknown after receiving Havrix adult and Engerix B adult, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 25-JAN-2023 Reporter's Comments: A Health Care professional called to report that a 15-year-old patient received adult doses of Havrix and Engerix-B.  The reporter asked how to proceed with this patient. The reporter consented to follow up. Additional Supportive Information: The child patient received adult formulation of Havrix and Engerix B, which led to accidental overdose and Adult product administered to child.
Day two after injection my arm began to itch around the injection site, had rash that lasted 3 days above and below injection site. Used hydrocortisone to help with itching. Had a few hives also. Injection site very sore for 3 days also.
Date and time the vial was initially stored in the refrigerator on 25-Feb-2022 and date administered on 20-Apr-2022; Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25-Feb-2022 and date administered on 20-Apr-2022) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included ATENOLOL and HCTZ for an unknown indication.    On 20-Apr-2022 at 11:27 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022 at 11:27 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25-Feb-2022 and date administered on 20-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Date and time the vial was initially stored in the refrigerator on 25-Feb-2022 and date administered on 20-Apr-2022) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vaccine expiration date was 25-Mar-2022. The date and time the vial was initially stored in the refrigerator was on 25-Feb-2022. The vial did not undergo any temperature excursions. The patient had not experienced any side effects yet. Treatment medications were not reported.
Warm to the touch at injection site, red, swollen (local symptoms) night of receiving vaccination.
Red, itching, sore and swollen injection site which started on day 8 after vaccine was given.  Approximately the size of a half dollar.
The morning after the Zoster vaccine she had redness and induration, subsequently she developed flu like symptoms and then developed an annular, vesicular rash at the injection site with associated regional pain.
Pt vaccinated with MMR developed a fine rash & low grade fever. Seen by MD dx vaccine reaction.
needle was not attached tightly enough and patient received about half the dose and the other half went down her arm with no reported adverse event; needle was not attached tightly enough and patient received about half the dose and the other half went down her arm with no reported adverse event; Initial information received on 03-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient and reporter stated that needle was not attached tightly enough and patient received about half the dose and the other half went down her arm with no reported adverse event after receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.    On an unknown date, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B VACCINE Suspension for injection (strength, lot number and expiry date was unknown) via unknown route in unknown administration site for Prophylactic vaccination.  On an unknown date the patient developed a non-serious event of needle was not attached tightly enough and patient received about half the dose and the other half went down her arm with no reported adverse event (accidental exposure to product, incorrect dose administered) (latency: same day) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.. It was unknown if suspect product inappropriately used as per local Marketing authorization.  Action taken : not applicable.  Outcome: Unknown  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.
Pt came in Lt arm after (lt) arm with localize swelling min. redness, no c/o pain states itchy-Advise to start TYLENOL/BENADRYL.
My 16 year old daughter reported "breathing feeling off" and "odd chest pain" within a few days of vaccination.  She thought her heart was racing.  She is usually of extremely robust health.  She was able to attend school and complete work.  At the time, we did not make the connection to the vaccination timing - all news stations reported no adverse effects from vaccine.  so we did not report.  In hindsight, it was a clear onset after vaccination.  I have mentioned this to her primary care physician; however, while they are willing to consider testing for myocarditis if she has additional issues, they are dismissive of connection and minimize potential link.
About an hour after receiving the vaccine, I experienced numbness in my left hand.  Later in the day the numbness wore off and I've experienced periods of a weakness in my left hand.
I was vaccinated at 12:45 pm on July 9th, 2022.  At approximately 12:48 AM, I awoke from a sleep and I had a strong urge to move my body.  I was continuously feeling I needed to move my arms, legs, and stretch my back.  I could not stop it.  I had to get up from my bed several times to walk around my house to ease my distress.  This lasted until 5 AM.    Due to the constant movement of my body for that time, I was extremely sore and could not move around well for 24 hours after that.
dizziness and vertigo for 3 days along with  intermittent nausea (no vomiting) following vaccine administration
She was taking to Er from Assisted Living. She was having complications. She was extremely weak all over her body. She could hardly talk, and she was babbling like a baby. She was admitted on 11/24/2022. She was tested several days later 11/26/2022 and was positive. She tested positive for the next thirty days. She was sent to a rehab and was there for about 10 days and then back to the Assistant living facility. She just had a lot of weakness. No breathing problems or anything. She came home the end of February and has been doing much better since being home. She is walking and doing more and more on her own.
Hives breakout on arms and legs (both sides); Itchiness; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives breakout on arms and legs (both sides)) and PRURITUS (Itchiness) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     Concurrent medical conditions included Fruit allergy (Allergies to Grapes), Drug allergy (Propofol caused tremors) and Seasonal allergy (Season allergies).    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2021, the patient experienced URTICARIA (Hives breakout on arms and legs (both sides)) and PRURITUS (Itchiness). At the time of the report, URTICARIA (Hives breakout on arms and legs (both sides)) and PRURITUS (Itchiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment information was provided.
At apx. 1355 this nurse was called to come assess a patient in the monitoring area of the vaccine clinic. Patient was AAOx3 sitting upright in a chair. She complained of feeling itchy on her arms. Patient stated she had a similar reaction after receiving her first covid vaccine when she got to her car to go home. Patient had bilateral erythema noted on antecubital areas of arms. Erythema also noted on her chest. Patient denied any shortness of breath or chest tightness. I advised patient I was going to administer Benadryl IM for the itching. Patient verbalized understanding. EMS was called. At 1359, 50mg Benadryl was administered IM into left deltoid. Patient had received her second Covid vaccine today (Pfizer 30mcg/0.3mL, Lot # EN6200, exp. 6/30/2021). VS assessed: BP 140/80, HR 79, pulse ox 98% room air. Patient stated she had an allergy to topical lidocaine. At 1405, patient verbalized relief from itching. Erythema decreased. Nurse went to reassess vital signs, pulse ox was 98% room air, HR 79. EMS arrived before BP was taken. Patient refused to go to ED for further evaluation. Refusal form was signed with EMS. Patient called a neighbor who came to take her home via private vehicle. Patient stated she has an Epi-pen at home and would use it if needed. Patient was held in monitoring area without further incident until her ride arrived
left side of face numb, and left eye; left side of face numb, and left eye; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (left side of face numb, and left eye) and HYPOAESTHESIA EYE (left side of face numb, and left eye) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced HYPOAESTHESIA (left side of face numb, and left eye) and HYPOAESTHESIA EYE (left side of face numb, and left eye). The patient was treated with PREDNISONE for Adverse event, at a dose of 1 dosage form. At the time of the report, HYPOAESTHESIA (left side of face numb, and left eye) and HYPOAESTHESIA EYE (left side of face numb, and left eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported.
VOMITING; DIARRHEA; HEADACHE; NAUSEA; This spontaneous report received from a consumer concerned a 7 decade old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included parkinsons disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced vomiting. On 26-MAR-2021, the subject experienced diarrhea. On 26-MAR-2021, the subject experienced headache. On 26-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, diarrhea, headache, and nausea on 27-MAR-2021. This report was non-serious.
Vaccine was stored for freezer temperature too long. We have recommended to the patient to get revaccinated.
We were on a cruise and I had taken some test kits on the cruise. I tested myself since my husband had already tested positive. I developed chills, fever and nasal congestion. I also had a sore throat along with fatigue. I contacted the medical unit on the cruise ship who did another test on us. We had 2 days remaining on the cruise so we had to wait until the cruise was over and immediately went to the urgent care. We started the treatment. I started to anti viral at that time. My fever and chills had subsided by then. I am still testing positive and still have a cough and a runny nose.
Covid arm:  bright red circular welt at injection site, lots of itching.  Had pain in arm day after injection.
Pneumovax given in left arm, 09/02/2005.  The patient had a 3 inch long, red, swollen area around injection site, was painful.  Symptoms cleared up 09/07/2005.  The patient called with this information 09/08/2005.
Hepatitis B titer was negative despite reports of vaccination; she got the first dose at birth, and then 2 month, 6 month; This spontaneous report was received from a physician and refers to a female patient currently 18 years old. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On an unknown date in 2005 (at birth), the patient  was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, administered for prophylaxis (strength, dose, lot #, expiry date, anatomical site of administration and route of administration were not provided). Then she got 2 shots at 2 months and 6 months (Inappropriate schedule of product administration).  On an unknown date, the patient experienced hepatitis B titer was negative despite reports of vaccination. At the time of reporting, the outcome of the event hepatitis B titer was negative was not known. Physician was asking if she need to re-vaccinate patient with hepatitis b vaccine (recombinant) (RECOMBIVAX HB). The causal relationship between hepatitis B titer was negative and hepatitis b vaccine (recombinant) (RECOMBIVAX HB) was unknown.
No additional AE's/PQC's; Caller reporting a temperature excursion for frozen products/ Caller notes PROQUAD lots: U006313, T030760, and U002539 have been administered to patients, as well as V ARlV AX lot: U010401.; This spontaneous report was received from an unspecified reporter (also reported on physician's field) (conflicting information) referring to a patient with unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 11-AUG-2021, the frozen product varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number U010401, was verified to be a valid lot number with an expiration date reported and established as 01-APR-2023) experienced a temperature excursion of 7.2 degrees Fahrenheit (F) during a time frame of 56 minutes.  On 17-AUG-2021, the patient was vaccinated with this improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) at a dose/frequency reported as one (1) (units not provided) (concentration, exact dose, exact vaccination scheme frequency, route and anatomical site of administration were not reported) for prophylaxis (product storage error).  It was stated that no previous temperature excursion was reported. The reporter was unaware if the patient had experienced any symptoms after administration. No additional adverse events (AEs) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA000273:
39 y/o reports painful/burning rash after vaccine. States he received his second dose of the Moderna vaccine on Friday 16 April. Friday he developed chills, arm pain/redness at injection site, headache and felt feverish but didn't check his temperature. He also developed a painful rash on his left mid-upper back that has now spread to under his arm along his side and to his chest, consistent with Shingles. States he is also experiencing like he inhaled smoke, like a burning sensation when he inhales. Denies any SOB, chest pain, wheezing, coughing.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 25-FEB-2015 the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml (lot#J010613, expiration date 11-JUN-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion four times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius and the type of excursion (R/F) for each time were 48, 1 and R; 0 and R; 24, -1 and R; 72, unknown and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.