chrisvoncsefalvay/vaers-outcomes huggingface dataset:
redness; sore; swelling; Vaccine administered to pregnant patient; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient), ERYTHEMA (redness), PAIN (sore) and SWELLING (swelling) in a 36-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Hypothyroidism in August 2018, Ectopic pregnancy in January 2018, Pregnancy (Live, full-term birth) on 07-May-2019 and Alcohol use (1-2 drinks/week) from 2004 to May 2020. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and ACETYLSALICYLIC ACID (BABY ASPIRIN) for Pregnancy, LEVOTHYROXINE for Thyroid activity decreased.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 03-May-2020 and the estimated date of delivery was 15-Feb-2021. On 30-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient). On an unknown date, the patient experienced ERYTHEMA (redness), PAIN (sore) and SWELLING (swelling). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fourth week of the pregnancy.  On 30-Dec-2020, EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient) had resolved. At the time of the report, ERYTHEMA (redness), PAIN (sore) and SWELLING (swelling) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Dec-2020, Glucose tolerance test: negative. On an unknown date, Ultrasound scan: normal every Monday: normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this XX-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy (or "patient declined further contact). Based on the current available information and the temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.
This case was reported by a consumer via call center representative and described the occurrence of itchy skin in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 13th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 13th April 2018, 2 hrs after receiving SHINGRIX, the patient experienced headache and fever. In April 2018, the patient experienced itchy skin, hypersensation skin, tiredness and pain. The patient was treated with Cortisone Topical Cream and medication unknown (Over The Counter Medication (Unknown)). On an unknown date, the outcome of the itchy skin and hypersensation skin were not recovered/not resolved and the outcome of the headache, tiredness, fever and pain were recovered/resolved. It was unknown if the reporter considered the itchy skin, headache, hypersensation skin, tiredness, fever and pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient reported that she had the a of SHINGRIX at 1:00 pm. She had a fever and she stayed in bed the following day and she had a headache and a lot of pain. Started in April 2018, the patient experienced itchy skin. The itching was incessant and she had tried cortisone creams, and over the counter products (OTC) and the only relief she could get was with scalding hot water which provided temporary relief and had a fever and she stayed in bed the following day and she had a headache and a lot of pain. The patient was reporting a sensitivity to her skin after the vaccination. For example, she had a mosquito bite that was super itchy and the site is red, thick and nasty at the time of reporting. The patient also had an electrocardiogram monitor on her chest and within one week, they had to move the leads for the monitor to her back and her chest was itching from April where the monitor electrodes were placed, back of her shoulders were also itching as well. Headache, pain, and fever resolved within 24 hours as well as tiredness. By Saturday (15th April 2018) the patient spent the day in bed and she felt okay other than the itching which was worse at the time of reporting. The contact details of physician was provided. For tolerance see case US2018GSK173824.
5 minutes after I started seeing floating lights. Then at around 9:00PM I started shaking uncontrollably, and couldn't talk. My heart was racing.  So my wife took me to the ER. Now I've been having enlarged lymph nodes, my tounge was swollen, my ears hurt.
Patient reported feeling throat tight, tongue thick - lightheaded with fluctuating temperature :  bp 168-144/100-94 during episode with pulse ox 96%.  patient was rosy and flush.  Administered 1 epinephrine pen and 50 mg oral diphenhydramine .  patient monitored from 3 pm until 530 pm and advised to see primary care provider
Client came in on 10/19/2021 for her 2nd dose of Moderna. The client was asked by the vaccinator if she had received any other COVID vaccine previously. She reported "no". The client was with her daughter who also stated "no", and did not provide any other vaccine record, only the record showing a Moderna 1st dose on 09/24/2021. The client received her 2nd Moderna dose on 10/19/2021. After she left the facility, it was discovered that she had also received a 2 dose series of Pfizer vaccine. She received a 1st dose of Pfizer vaccine on 01/23/2021 and a 2nd dose Pfizer on 02/13/2021. She also received a 1st dose, 0.5ml, of Moderna on 09/21/2021. The client was supposed to be checked in the computer system for record of any previous doses. This was not done for the client as the staff were trying to accommodate her vaccine in a less populated area. Proper completion of this step would have helped identify the client was in fact receiving the wrong vaccine. Client was called after the information was discovered and the daughter did state that yes, her mother did in fact receive a 2nd dose of Moderna after already receiving 2 doses of Pfizer. She explained that the client has Multiple Myeloma and that at the time of her first Covid vaccines, when she received Pfizer, she was under heavy chemotherapy and when tested, her doctor stated she had not activated an immune response. The daughter reported that her doctor suggested she receive Moderna as an alternate dose. The daughter stated that the client had no side effects after any of the Covid vaccines this far. Per the client's daughter, the client will have her immunity levels checked again in a few weeks.
This case was reported by a physician via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 11-year-old male patient who received MENVEO (batch number M17095, expiry date 31st August 2019) for prophylaxis. On 27th August 2018, the patient received the 1st dose of MENVEO (intramuscular). On 27th August 2018, less than a day after receiving MENVEO, the patient experienced extensive swelling of vaccinated limb. On an unknown date, the outcome of the extensive swelling of vaccinated limb was recovering/resolving. It was unknown if the reporter considered the extensive swelling of vaccinated limb to be related to MENVEO. Additional details were reported as follows: The patient received SHINGRIX in right arm and experienced swelling in the same arm. The swelling started the evening of the injection and by the next day almost his entire arm was swollen. The physician stated that the swelling was 4 by 7 inches.
On the 16th of July 2021 around 6:28pm patient  was given the 1st dose of Moderna Vaccine. Patient stated that he started to have a massive ache on his nape on the 20th around 10am. July 23rd-25 he started to have chest pains also he noticed that his right foot started to swell and  continuously did so. On the 26th of July his left foot started to swell. He went to Urgent Care on the 9th of August since he cannot function normally anymore at that time. He was seen but was not given any medication to help with his complaints instead he had been referred to nurse practitioner of the same company  to do some laboratory tests.   He had been seen on the 13th labs were ordered and no medication was given until she had the laboratory results on the 19th of August where he was given a Ciprofloxacin and a Lasix. He is now getting second opinion starting today August 24th.
Deep vein thrombosis,  extensive, left leg.  Pain started within  a week? of  2nd Moderna shot. Was at first misdiagnosed as muscle injury, but then with acute worsening, was seen at ER, 7/2/21, where US was done.
Person  received Jynneos vaccine at the Health department due to work exposure to MPV.  On the day of the vaccine, the person reports (no medical attention sought) arm at the injection site became warm/hot with a 4 inch red welt and gulf ball sized lump. Patient also reports headache, dizziness, moderate pain in neck, arm and shoulder as well as weakness and fatigue. It took 4 days to begin resolving.
soreness at injection site; nausea; achiness; Drug dose administration interval too long; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose receivied on 29th May 2019, refer case US2020AMR006246). Concurrent medical conditions included genital herpes.   On 9th January 2020, the patient received the 2nd dose of Shingrix. On 9th January 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 10th January 2020, the patient experienced injection site pain, nausea and pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, nausea and pain were recovering/resolving and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the injection site pain, nausea and pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced soreness at the injection site, nausea and achiness the next day after receiving 2nd dose of Shingrix. The patient planned to follow up with her physician on an unknown date. After receiving 1st dose the patient received 2nd dose later than the recommended interval of vaccination schedule, which led to drug dose administration interval too long. Consent to follow up was provided.
swollen left eye, temperature of 101.7 followed by cough and nasal congestion
She was miserable; Could barely move; Aches and pains; chills; Tired/Fatigued; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (She was miserable), HYPOKINESIA (Could barely move), MYALGIA (Aches and pains), CHILLS (chills) and FATIGUE (Tired/Fatigued) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 immunisation.     The patient's past medical history included COVID-19 (tested positive on 27 Dec 2020) from 25-Dec-2020 to 06-Jan-2021. Concomitant products included MULTIVITAMIN FOR WOMEN, CHONDROITIN SULFATE SODIUM, GLUCOSAMINE SULFATE POTASSIUM CHLORIDE, METHYLSULFONYLMETHANE (GLUCOSAMINE & CHONDROITIN & MSM) and EMERGEN C for an unknown indication.   On 28-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced FEELING ABNORMAL (She was miserable), HYPOKINESIA (Could barely move), MYALGIA (Aches and pains), CHILLS (chills) and FATIGUE (Tired/Fatigued). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 30-Jan-2021, FEELING ABNORMAL (She was miserable), HYPOKINESIA (Could barely move), MYALGIA (Aches and pains), CHILLS (chills) and FATIGUE (Tired/Fatigued) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2020, SARS-CoV-2 test: positive (Positive) positive.         Treatment medication included Ibuprofen. Patient also states she drank lots of water and slept almost round the clock.  Action taken with mRNA-123 is not applicable.   This case was linked to MOD-2021-080655 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Patient information updated. Concomitant medications updated. Event treatment information updated.; Sender's Comments: based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
high fever - over 104 strong headache pain on my legs  pain on back  low energy  blurry vision  not able to walk the first day
About 16 hours later I had exhaustion, temp of 101, myalgias, headache and right arm pain. Lasted about 24 hours and now is back to normal
When injection was finished, patient passed out. Slumped back in his chair and the retuned to upright. Had patient put head between legs, after a while he sat upright, drank some coke and ate crackers. After about 30 minutes he was able to leave store saying he felt fine. At 7:00 PM his mother caled to say he was fine, no problems.
Heart palpitations at night. Dr diagnosed as tachycardia. Treated with atenolol 25mg
3:00PM Observer was alerted by patient. Patient stated she had a sudden headache, and felt like she had heart burn. Patient also informed staff that she has been diagnosed with ulcerative colitis. Patient states she ate a ham and cheese sandwich prior to coming in for vaccination. Observer gave water to patient, and patient is being closely monitored for an additional 15 minutes. Patient has already been in observation sine 2:45PM. Will monitor and follow up.  3:15PM Patient states; "I feel much better after drinking water," Patient denies having a headache or heartburn. Patient states she feels safe to drive home. No other concerns, patient walked out of observation area with no complication.
A nurse reported that a 9 year old female developed an injection site reaction following vaccination with Prevnar (date unspecified). The child has a history of cerebral palsy and takes "many" unspecified medications. The child received other unspecified vaccinations on the day of vaccination with Prevnar. The child developed erythema (4" X 3") and swelling on the thigh at the Prevnar injection site. Benadryl (diphenhydramine hydrochloride was given and ice was placed on the injection site.
Patient came in for 6 months shots. 5 min after injection this nurse notice patients legs turn red from injection site down to toes and circling entire left and right leg. Patients father was holding at the time so I asked him to lay her on the table. This nurse touched infants legs both right and left leg felt warm to touch, tight, and were visible red, purplish with white blanching. This nurse went and found a provider in the facility who came and observed infant. Infant appeared in no distress, was cooing and active. Physician recommend family take infant to ER to be on the safe side for reaction.
Persistent migraine for 6 days, on-going visible change of appearance (color) and texture of skin around injection site that continues to persist even after 6 months
Slight fever; Cough from sinus drainage; Nasal sinus discharge; Allergies/ Allergy season was really bad; Lethargic; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), COUGH (Cough from sinus drainage), PARANASAL SINUS HYPERSECRETION (Nasal sinus discharge), SEASONAL ALLERGY (Allergies/ Allergy season was really bad) and PYREXIA (Slight fever) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    The patient's past medical history included Root canal procedure (Recovering/Resolving). Concurrent medical conditions included Hidradenitis suppurativa (Moderate to severe hidradenitis suppurativa).   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form once a day. In 2021, the patient experienced LETHARGY (Lethargic). In May 2022, the patient experienced COUGH (Cough from sinus drainage), PARANASAL SINUS HYPERSECRETION (Nasal sinus discharge) and SEASONAL ALLERGY (Allergies/ Allergy season was really bad). On 01-Jun-2022, the patient experienced PYREXIA (Slight fever). On 02-Jun-2022, PYREXIA (Slight fever) had resolved. At the time of the report, LETHARGY (Lethargic), COUGH (Cough from sinus drainage) and PARANASAL SINUS HYPERSECRETION (Nasal sinus discharge) outcome was unknown and SEASONAL ALLERGY (Allergies/ Allergy season was really bad) was resolving.     No concomitant medications were reported. No treatment medications were reported.
Patient reported a rash at the injection site, with itching and skin peeling off. No treatment, the rash was healing.
patient received FLUZONE QUADRIVALENT by subcutaneously or intradermally/ NO AE; Initial information regarding an unsolicited valid non-serious case received from a other healthcare professional via call-center (Reference number- 00363166) and transmitted to Sanofi on 18-Nov-2020.  This case involves patient (unknown demographics) who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number or expiry date not reported) via subcutaneously or intradermally (incorrect route of product administration) on an unknown date for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to inappropriate route of vaccination (latency: same day).  At the time of reporting, no adverse event was reported.  Reporter want to know what are the complications or adverse effect if FLUZONE QUADRIVALENT given subcutaneously or intradermally .  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 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.  There will be no information available on the batch number for this case.
Approximately 4 in dia redness. Warm to touch. Painful, swollen upper arm.
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. No treatment medication were reported.   This case was linked to (Patient Link).
Patient had prior arm swelling after first Moderna vaccine.  She had immediate arm swelling post second Moderna vaccine.  Ice was applied to her arm.  She was given 25 mg of Benadryl and her vital signs were monitored every 3-5 minutes.  She had a slight headache, felt light headed and her hands were cold.  Her headache and dizziness improved after 5 minutes.  Vital signs monitored for 30 minutes before the patient went to work.
SOB, Fever, Tachycardia in 180s-presented to ER for symptoms
This spontaneous report as received from a vaccine coordinator refers to a 15-year-old female patient. The patient's medical history was not reported. On 17-JAN-2018, the patient was vaccinated with improperly stored VARIVAX lot # N021315, expiration date 07-AUG-2019 for prophylaxis (dose, route and site of administration were not reported). The vaccine underwent a temperature excursion of 20 degrees Fahrenheit for 1 hour and 42 minutes. Other temperature excursions were: 6 degrees Fahrenheit for 48 minutes, 18 degrees Fahrenheit for 1 hour and 5 minutes and 8 degrees Fahrenheit for 1 minute. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1801USA013248: US-009507513-1802USA005174: US-009507513-1802USA005175: US-009507513-1802USA005176: US-009507513-1802USA005177: US-009507513-1802USA005179.
9/2/09 Pt woke next day after FLUZONE administered with nausea, dizziness, generalized body/joint aches. Spent next 2 days in bed.
Patient was given TRUMENBA vaccine (#2 of series) on 10/10/16. Mom reports within an hour he developed a severe headache and nausea, dizziness. Was transported via ambulance from home to hospital. Lab, CT scan, and vitals were normal. Injection site was red, swollen and tender. Was discharged and has been fine since per mom.
That Monday 09/26/2022 I tested positive. The first day I slept all day. I had a bad cough, body aches, headache, and weakness. I called my doctor and he suggested I take PAXLOVID and I took that the same day. Tuesday, I was a little better. The cough subsided quickly. The headache, body aches, and weaknesses lasted Tuesday. Wednesday, Thursday, and Friday I felt about 50%, and I was able to work from home. Wednesday and Thursday were tougher days. Friday, I felt a little better. The symptoms overall lasted about 7 days, a week. By the next Monday, I was testing negative. I also recently had another infection of COVID-19. 02/08/2023 is when I first felt symptoms. 02/09/2023 was when I tested positive. It was very similar. The day before, I had a really bad cough. I tested 02/08 and I was negative. I tested again 02/09 and I was positive. That Thursday, the cough subsided and I thought I was fine. The next day, I had a really bad headache, body aches, and weakness. It was the weekend, so I had a televisit and was prescribed PAXLOVID again. I started that the same day.
Information has been received from a pharmacist who reported on 06-OCT-2012 one unspecified patient received expired (Merck) ZOSTAVAX (lot #0618AA exp date 26-JUL-2012). The patient was not experiencing any known symptoms. The outcome was unknown at the time of report. This is one of several reports received from the same source. Additional information has been requested.
Advrs effect of pertuss vaccine, inc combin w pertuss, init on 2016-03-03.