chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feels like when she had Covid 19; Feeling tired; Feels like sleeping or resting all the time; Dry cough; Arm is sore; Headache; Sick to stomach; Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Feels like when she had Covid 19), the first episode of FATIGUE (Feeling tired), SOMNOLENCE (Feels like sleeping or resting all the time), COUGH (Dry cough) and PAIN IN EXTREMITY (Arm is sore) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01ZLZA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Recovery date not provided) from March 2020 to 2020. Concomitant products included SIMVASTATIN, PANTOPRAZOLE and TRIAMTERENE for an unknown indication.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Feels like when she had Covid 19), the first episode of FATIGUE (Feeling tired), SOMNOLENCE (Feels like sleeping or resting all the time), COUGH (Dry cough), PAIN IN EXTREMITY (Arm is sore), HEADACHE (Headache), NAUSEA (Sick to stomach) and the second episode of FATIGUE (Feeling tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (Feels like when she had Covid 19), SOMNOLENCE (Feels like sleeping or resting all the time), COUGH (Dry cough), PAIN IN EXTREMITY (Arm is sore), HEADACHE (Headache), NAUSEA (Sick to stomach) and the last episode of FATIGUE (Feeling tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Tylenol was used as treatment medication.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Non-Significant Follow-Up; Sender's Comments: This case concerns a 68-year-old female with a nonserious unexpected event of influenza like illness, somnolence, illness, cough, pain in extremity, and expected headache, nausea, fatigue. Event onset the same day as first dose mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sore Rt arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 26Jan2021 (Lot number: EN5318) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Brain Bleed", start date: 20Jan2021 (unspecified if ongoing); "cerebral shunt installed", start date: 1999 (unspecified if ongoing), notes: Admitted to the hospital after C.T. Scan confirmed Brain Bleed , previously installed Cerebral Shunt failed and was replaced. Concomitant medication(s) included: CRESTOR, start date: Dec2020, stop date: Feb2021; PLAVIX, start date: Dec2020, stop date: Feb2021; ASPIRINE, start date: Dec2020, stop date: Feb2021; SPIRONOLACTONE, start date: Dec2020 (ongoing); D3, start date: Oct2020 (ongoing); TURMERIC +, start date: Oct2020 (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore Rt arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient's concomitant medications included CoQ10 (ongoing), start date Dec2021.  No follow-up attempts are possible. No further information is expected.
A non-serious spontaneous report of "a patient received a dose of expired FLUMIST" was received from a health care professional concerning an adult of unknown age and sex. The patient's medical history and concomitant medications were not reported. On 21-Dec-2009, the patient was administered FLUMIST with expiration date of 08-Dec-2009. The lot number was unavailable. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Severe cough, chest pain, brain fog, fatigue, headache, loss of taste and smell, poor appetite
Around 4-5 hours after receiving injection, I noticed two large lumps at the base of my buttocks that were never there before, just inside the crack below my spine.  These lumps are about the size of a small lemon and hard, not soft like a cyst would be.  I Googled it and saw that we have lumph nodes all throughout our bodies, even in that area, and when I called my doctor, he told me to take Benedryl and to come in and see him the following week.  I have read of many side effects of these vaccinations, but nothing like this!
Fever for 2 days, decreased appetite, arm swollen, red & tender from upper arm site of shot down past elbow.
Injection site reaction. Patient had confusion day after injection. Arm hurting. Redness and bruising on upper arm around injection site. On Saturday patient developed cellulitis, according to daughter and physician phoned in Z-PAK. Patient seems Ok now.
Febrile seizure 24 hours after immunization Information from medical records states fever, vomiting, diarrhea. msv
1 day aching & tiredness 3 days red eye (bloodshot eye) 1 week blood in stool 1 week (and ongoing) rash (itchiness)
Pt developed burning pain in (R) hip 12/24, which persisted & radiated to (R) groin. She saw me 12/30/10 with rash c/w zoster. T. 99.4.
Felt ill 2 days post administration - site extremely swollen & hot took BENADRYL 12/17/11 & felt better 12/19/11. Also alternated using hot & cold packs.
Constant headache, malaise, nausea, unable to keep food down, extreme fatigue, intermittent low-grade fevers.
Patient has a history of DVT's and PE's and was hospitalized 26JUN21 for DVT.
lower extremity weakness, lower extremity pain beginning the day after vaccine administration, lasting for several days.
Pfizer / BioNTech: Dose Number: 3; Treatment of COVID-19; Pfizer / BioNTech: Dose Number: 3; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Nov2021 at 17:00 as dose 3 (booster), single (Lot number: FO3527) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing). Concomitant medication(s) included: CETIRIZINE, start date: 31Dec2019; AREDS (Brand name: Bausch lomb), start date: 31Dec2019.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Pfizer / BioNTech: Dose Number: 3; Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received COVID-19 treatment with anti-viral (start date: 21Jun2022).
No adverse event; We gave 1 booster dose of Moderna that was expired.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 1 booster dose of Moderna that was expired.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 1 booster dose of Moderna that was expired.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 1 booster dose of Moderna that was expired.) 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 EXPIRED PRODUCT ADMINISTERED (We gave 1 booster dose of Moderna that was expired.).    No concomitant medications was provided. The Vial size was 2.5 ml the vial did not undergo any temperature excursions. Reporter was unsure that the patient has taken Moderna Covid-19 Vaccine, Bivalent or Monovalent. No treatment medications was provided.
Friday (9-17-09 evening facial area above upper lip extending to above eyes and from left of eyes to right side of face redness with some itching. Redness in bend of left arm. No redness or itching at injection site. Started BENADRYL 50mg q 4 hrs. Sat. am Sun had BENADRYL injection symptoms improving.
6cm x 3cm red raised area around injection site.  Area itchy, indurated and started several hours after receiving MENACTRA vaccine (local reaction).
EXPIRED VACCINE WAS ADMINISTERED  TO PATIENT - EXPIRED ON 5/2/22
Moderna 2/5/21, 3/8/21, 10/22/21. Positive on 7/3/22
Pt recv vax on 2/17/99; 5 min post vax pt exp red face w/ hive-like rash, also on inner thigh; tx=Benadryl
Frozen shoulder, unable to use arm and hand to full, decreased range of motion, intense pain. Intense for 10 days, then slowly decreased for two weeks. Some weakness for three months.
Pt devel fever 103 night of immun, emesis x 1, fever continued for 5 days;
A 37-year old male consumer reported experiencing a fever, a sore throat and tiredness coincident with RabAvert post-exposure vaccination therapy.    The consumer's medical history included occasional pollen allergy for which he takes Proventil via an inhaler and no known drug allergies. He received day 0 and day3 of post-exposure therapy for RabAvert 1 ml IM (exact date unk. He developed a fever of 100-degrees F. As of 06/21/2001, the subject was scheduled to receive day vaccination and it is unknown whether the events had resolved.
Information has been received from a registered nurse, for the GARDASIL, concerning a 17 year old female patient with a history of pelvic inflammatory disease who on 19-Mar-2009 was vaccinated with a dose of GARDASIL (lot# not specified). It was reported that 2 weeks ago the patient was being treated for pelvic inflammatory disease, and that time was given an urine hCG test which was negative. On 19-Mar-2009 the patient was given vaccines (not specified) and afterward was also given another urine hCG pregnancy test which was positive. LMP was not provided. The nurse indicated that the patient has an office visit on 23-Mar-2009 for counseling. The patient will not receive prenatal care there since this is a pediatric office. The nurse will provide whatever health care professional contact information for the patient's prenatal care that she obtains. Follow up information has been received from a health professional and a registered nurse concerning a 17 year old female with oligomenorrhoea and a history of pelvic inflammatory disease who on 19-Mar-2009 was vaccinated with third dose of GARDASIL (dose and route not reported, lot number 661531 / 1311X). The registered nurse reported that the patient's mother had called the clinic on 26-Mar-2009 to report that her daughter had an appointment on 30-Mar-2009. In a subsequent phone call to the clinic on 22-Apr-2009, the mother reported that the pregnancy had been electively terminated. Upon internal review, pregnancy had been electively terminated was determined to be an other important medical event. Additional information has been requested.
Within 10 minutes of receiving vaccine, patient became dizzy/woozy feeling.  Patient complained of feeling "drunk", with muscle weakness and cotton/dry mouth.  Patient was taken back into a private room, BP was taken and patient was monitored.  Around 30-45 minutes later, patient started feeling better.
Right sided Lymph Node swelling and Tenderness at neck, under arm, and groin.
Pt was hospitalized 9/12/2023 for COPD/CHF exacerbation
It began with severe muscle and joint pain in early August. I am unable to raise my hands over my head. The pain is in my hips, shoulders, arms and legs. It is extremely painful in on both sides. It is worse in my shoulders and thighs. On the pain scale it is a 10 in the night and when I wake up. I take TYLENOL during the daytime for the pain and it helps but as soon as sit the pain returns and then again at night.
Fever (101.4 F), chills, body aches, fatigue lasting 20 hours
Significant discomfort at injection site for approximately 4 days. During the evening after the injection, experienced significant chills necessitating wearing a coat. The next day, continued experiencing chills. Experienced significant lethargy. I normally drink a considerable amount of water every day, but didn't have the energy to get up to get some, possibly leading to dehydration. Ate very little (1/2 orange for lunch, 1 pc pizza for dinner). At around 6pm, went to bathroom. Experienced stomach cramps; attempted to get up to get PEPTO-BISMOL. Didn't make it to closet before collapsing. My wife called 911 because I had momentarily blacked out and couldn't get up. After EMTs arrived, threw up. They carried me out to ambulance. Blood pressure was 60-something over 30-something. I spent 4 nights in the hospital (January 17-20).
Pt called physician on 6/24/05 and stated that she had completed the last dose of the typhoid vaccine (oral)tablets and she c/o of "little red rash @face. Denies sob,increased heartrate.  No pain noted.  Only sx/sx is a rash @ face/red patch.  Instructed pt to take benadryl po prn. Continue to moniter.  Report any changes to our office. Pt agreed
Mild muscle soreness reported by mother, resolved within 2 days. No other adverse events.  Vaccine given in error at our office and Health Department recommended reporting event to VARES during process of ongoing follow up.
Client and parents both reported client was 16 years old when they were really 15. Client received Pfizer dose, and age was discovered afterward.
Rt arm-area red-warm-swollen-tender to touch. (varicella like) raised area about size of silver dollar-red area about 3" wide and 4 1/2-5" long- Recommended ice 20 min on-20 min off and Ibuprofen if no relief or s/s increase to see phy. for eval.
On April 4, two weeks after receiving my first dose of Moderna Covid vaccinge, I began feeling strong muscle aches.  Within a couple hours I had a fever of 102. In the next few hours I began having abdominal pain.  The pain grew worse over the next day.  On Tuesday April 6 I had a telehealth appointment with my primary care physician.  He advised me to go the the ER.  I went to my local ER where they found via ct scan, that my appendix was inflamed and they told me it needed to come out.  I had an appendectomy on April 7.  I am feeling much better now that my appendix has been removed.
Severe dizziness, vertigo, nausea, vomiting,headache, fast heartbeat, over period of two days.  Occurred on the 11th and 12th days after my second Moderna vaccination shot. Ressol,ved after two days
Shortly after midnight, I awoke with general body aches and severe discomfort in the arm where I got the shot- my arm, my shoulder, axilla, breast, and back of my shoulder ached, and my temperature was 100.9. I had started taking naprosyn the day before the vaccination, and continued taking every 12 hours. In the morning of 9/28, i still had a temperature of 100.5 and also developed joint aches in addition to the body aches. I was too sick to work that day (wednesday). Thursday my temperature was 99.5 and I continued naprosyn.  Later that day the fever broke and the overall pain was better but the arm /shoulder pain continued. Friday, my left arm was swollen from the injection site down to about an inch above my elbow. The skin continued to be hot and red,  and later in the day became shiny and taut. My left arm at the deltoid was 2 inches larger than my right arm. I continued naprosyn and began applying ice packs to my arm in 20-minute intervals. Saturday and today, the arm swelling is better, but I am still fatigued. I have had reactions to my previous covid vaccinations but not this bad, and my arm never swelled up before.
Swelling of upper arm; redness: pain: extreme limitation of mobility of arm - diagnosed as cellulitis.
problem sleeping because of arm; can't put arm behind her back; a little bit swollen; arm has been hurting, it really hurts, it still hurts; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (problem sleeping because of arm), VACCINATION SITE MOVEMENT IMPAIRMENT (can't put arm behind her back), VACCINATION SITE SWELLING (a little bit swollen) and VACCINATION SITE PAIN (arm has been hurting, it really hurts, it still hurts) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007A21A and 031M20A) for COVID-19 vaccination.     No medical history was reported by the reporter. .  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), AMLODIPINE, METOPROLOL, ISOSORBIDE, ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN 81) and VITAMINS NOS for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced INSOMNIA (problem sleeping because of arm), VACCINATION SITE MOVEMENT IMPAIRMENT (can't put arm behind her back), VACCINATION SITE SWELLING (a little bit swollen) and VACCINATION SITE PAIN (arm has been hurting, it really hurts, it still hurts). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and LIDOCAINE at an unspecified dose and frequency. At the time of the report, INSOMNIA (problem sleeping because of arm), VACCINATION SITE MOVEMENT IMPAIRMENT (can't put arm behind her back), VACCINATION SITE SWELLING (a little bit swollen) and VACCINATION SITE PAIN (arm has been hurting, it really hurts, it still hurts) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Trouble walking; Trouble moving arm; Muscle soreness; This is a spontaneous report from a contactable other health care professional (hcp). This other hcp reported similar events for 3 patients. This is the second of 3 reports. A 16-year-old male patient received meningococcal group b rlp2086 (TRUMENBA, lot CN1583, expiry date Aug2022, NDC number: 0005010005), via an unspecified route of administration on 24Aug2020 (reported as yesterday) at 0.5 mL, single (1 injection, dose given twice 6 months apart) for vaccination. There were no medical history and concomitant medications. Reporter stated that they give the vaccine either in the arm or in the thigh if a patient has small arms. On Aug2020, the patient had muscle soreness and had trouble moving arm or trouble walking if given in the thigh (pending clarification). The outcome of events muscle soreness, had trouble moving arm and trouble walking was unknown.   No follow up attempts are needed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020330359 Same reporter/drug/event for different patients;US-PFIZER INC-2020330595 Same reporter/drug/event for different patients
Redness & swelling day p/vax (TD) given; On 6th day diffuse splotchiness below site (LUA) about size of grapefruit;
One day after immuniz pt. had severely sore arm, swelling and erythema in entire deltoid area.  LImited ROM of arm, fever
March 14, 2022, my left shoulder felt sore (like muscle soreness) and throughout the week my left arm felt tight and sore.  By Friday evening my arm was swollen, red and the veins were protruding.  Saturday morning (March 19, 2022) I went to Urgent Care, and Urgent Care immediately sent me to the ER.  In the ER a sonogram was performed and the sonogram detected a blood clot running from my left clavicle area through my shoulder and under my arm.  A CT scan was performed and a small blood clot was detected in the lower part of my left lung.  My lungs were described as "inflamed".  I was asked if I ever had COVID-19 and I have not, only the COVID-19 vaccinations.  I was admitted to the hospital and given a shot of Lovenox (50 mg) to try to resolve the blood clot.  The next morning I was given Eliquis (blood thinner) and sent home in the afternoon with a prescription for Eliquis and follow up referrals to a Hematologist and Radiologist.  When I met with the Hematologist, he was concerned about how my lungs looked on the CT scan and referred me to a Pulmonologist for further evaluation.  My appointment with the Pulmonologist is scheduled for April 8, 2022.  The Hematologist will see me every two months and review bloodwork and anticipates I will continue to take Eliquis for a minimum of 6 months.  Because the swelling in my arm is much improved, I did not follow up with a Radiologist.
redness, swelling, measuring 9"x7", warm to touch, non-tender.
arm weakness; This case was reported by a pharmacist via call center representative and described the occurrence of weakness of arms in a 87-year-old female patient who received Herpes zoster (Shingrix) (batch number 99D9F, expiry date 14th April 2020) for prophylaxis.   On 26th April 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 26th April 2019, unknown after receiving Shingrix, the patient experienced weakness of arms. The patient was treated with steroids nos (Steroid Injection). On an unknown date, the outcome of the weakness of arms was not recovered/not resolved.   It was unknown if the reporter considered the weakness of arms to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix in the right arm. The pharmacist reported that the patient was seen by her physician and was given a Steroid injection in her right arm. The reporter consented to follow up.
This case was reported by a nurse and described the occurrence of a needle stick injury in a 77 year old female subject who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. Follow-up was received by an office manager. There were no concurrent medications. On 03 October 2005 the subject received 1st dose of Fluarix in an unspecified arm. The nurse reported that she, "attached a 25 gauge, 5/8 inch needle to the prefilled syringe of Fluarix. Upon pulling back on the dose, the needle released form the hub of the syringe and stayed in the patient's arm. The needle did not break." The subject was "taken to the emergency room." At the emergency room, "a specialist was called in and had to make a cut" to remove the needle from the subject's arm. The procedure was completed in the emergency room and the subject was discharged from the emergency room on the same day. It was not reported if the subject received any of the Fluarix. The event was ongoing at the time of follow-up reporting, 25 October 2005. The office manager reported that it was determined that the incident was caused by a fault with the needle, not any problem with the Fluarix syringe.
Patient woke up around 2 am the night after receiving Shingrix with chills and shivering for about an hour.  He went back to sleep and woke up in the morning feeling tired and his arm is sore where he had the injection.