chrisvoncsefalvay/vaers-outcomes huggingface dataset:
runny nose; sneezing; Testing Positive for Covid.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Testing Positive for Covid.), RHINORRHOEA (runny nose) and SNEEZING (sneezing) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, CITALOPRAM and TRAZODONE for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced COVID-19 (Testing Positive for Covid.). On an unknown date, the patient experienced RHINORRHOEA (runny nose) and SNEEZING (sneezing). At the time of the report, COVID-19 (Testing Positive for Covid.), RHINORRHOEA (runny nose) and SNEEZING (sneezing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Upon internal review on 04-Aug-2021, age units was updated to years.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with ROTATEQ, lot # M041184, M043836, M040267, M041770, M046008, N000175 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ.; Sender's Comments: US-009507513-1708USA007446: US-009507513-1708USA007447:
The day after immunization, patients leg swelled up two times the size of the other leg.The area was very warm to the touch and very red. The area was also hard as a rock. As the day went on the swelling did continue to worsen moving from the thigh area down below the knee area. The patient could not walk on his leg. Treatment for this was Motrin and also Benadryl, along with warm compress. The reaction did last for 2 days after this and then finally went down to normal size.
Patient had a PREVENAR vaccine on 10/26/2017 and today she came into the pharmacy with a red, swollen arm that was hot to touch and it covered the majority of her arm. I had a NP in the clinic look at it and she was worried it may be cellulitis. Patient called her primary care doctor and went in to be seen. She was prescribed a steroid.
swollen lymph nodes in his armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered", described as "swollen lymph nodes in his armpit". Therapeutic measures were taken as a result of lymphadenopathy. Additional information: Clinical course: The patient got swollen lymph nodes in his armpit after the Covid 19 vaccine and the pharmacist told him to rub it. He kept rubbing and the swelling went away. It was reported that the patient received both of his Covid 19 vaccines.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021349262 Same reporter and drug; similar event; different patient.
mom was holding rt hand holding pt up eyes rolled & fell to the floor while mom was trying to hold pt up;
I had moderate to severe covid in August 2020.  I recovered.  I had antibodies test completed on 12/22/2020 at hospital, my results were positive for antibodies with score of 205.  Dec 31, 2020:  Severe Chilling and shaking, teeth rattling shaking, unable to get warm,  Extreme fatigue, unable to stay awake, watch registered 4k steps despite me being in recliner for the day due to the shaking of body.   Jan 1, 2021:  Intense head ache, muscle aches and red and swelling welt at immunization site.  Recurrent fever, excessive sweating, soaked through tshirt, polo shirt twice, extreme fatigue. Same symptoms continue until Jan 5, 2021.  Symptoms were definitely more intense than just a casual body ache or fever. It felt like my body had covid again even though i know it is not possible to catch covid again from vaccine.
Pain traveling from upper arm down the arm on same side as shot. Going down to hand. Pain continuing over days to other arm and hands. Pain stays for months. Hands coordination poor--dropping things. Gait somewhat unstable. Choking easily on food. Starting late spring, pain starts subsiding in arms. As of Sept. 2015, pain is only in both thumbs. Pain is not easily localized. It is not constant but occurs when doing some motion and is not localized in joints, more like in nerves or muscles/tendons and may be anywhere in thumb. Choking is now rarer and unstable gate is once in a while.
Information has been received from a medical assistant (MA) concerning a 6 month old female with no known allergies and acid reflux who on 19-DEC-2006 was vaccinated PO with the third dose 2.0 mL dose of Rotateq reassortant vaccine live (human-bovine) (lot # 655483/1116F) (1st dose administered on 29-AUG-2006, date of 2nd dose not reported). Concomitant therapy included Ranitidine HCl (ZANTAC). The MA reported that on 14-JAN-2007, the patient experienced abdominal pain. The patient was taken to the Emergency Room (ER), but not admitted. Abdominal x-rays were abnormal and the patient was sent to another ER. A barium enema was performed. The patient also noted to have had heme positive stool. The patient required no treatment and was not hospitalized. At the time of this report, the outcome was unknown. Upon internal review, heme positive stool was determined to be an other important medical event. Additional information has been requested.
Extremely sore and swollen armpit. It is affecting my ability to function as a mother and stay at home employee. I feel fine otherwise but the pain is unbearable. I can't lift anything, including my toddler.
injection site (immediate), headache, chills, nausea, slight fever (within 12 hours), vomiting (within 24 hours). All symptoms disappeared within 36 hours.
Headache - severe & low grade fever within 24 hrs had experienced same symptoms with anthrax #3, but was much worse with anthrax #4 vaccination. Resolved by day 2 post injection.
2 1/2 in area of induration/bruising and 4 in area of redness around where shot was given, no fever, sore to touch otherwise no complaint.
Lethargic; Tired all day; Tenderness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic), FATIGUE (Tired all day) and VACCINATION SITE PAIN (Tenderness at the injection site) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LETHARGY (Lethargic), FATIGUE (Tired all day) and VACCINATION SITE PAIN (Tenderness at the injection site). At the time of the report, LETHARGY (Lethargic), FATIGUE (Tired all day) and VACCINATION SITE PAIN (Tenderness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment details not provided.    This case was linked to MOD21-074744 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: Follow up was received on 13 Apr 2021 included no new information.
Information has been received from a nurse referring to a patient of unknown age and gender. On 12-SEP-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # M013636, expiration date 15-FEB-2018, dose and route were unknown). The vaccine was stored under 0.4 degree Centigrade for 18 hours. It was called because of a data logger. There was no previous temperature excursion. No adverse effect was reported. No PQC was involved. This is one of three reports received from the same reporter. Additional information has been requested.
- Stomache AE (diarrhea, nausea), - body aches, - drowsiness > x 2 days.
Pregnant; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 29-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT), METOCLOPRAMIDE (REGLAN [METOCLOPRAMIDE]), PROBIOTICS NOS, VITAMIN B6 and DOXYLAMINE SUCCINATE (UNISOM [DOXYLAMINE SUCCINATE]).   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 12-Dec-2020 and the estimated date of delivery was 18-Sep-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  tenth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Pregnancy test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. Action taken with mRNA-1273 in response to the event is not applicable.
No adverse event; patient received RECOMBIVAX and PEDIARIX at the same visit; did receive a hepatitis B vaccination on 17Feb2017. When the patient came in today 19Mar2019 they accidentaly received both Recombivax HB; This spontaneous report was received from a registered nurse and refers to a 2-years-old female patient. Patient's pertinent medical history included being very behind on immunizations. The patient received an unspecified hepatitis B vaccination on 17-FEB-2017. No information about patient's concomitant medications, concurrent diseases or allergies was provided.  On 19-MAR-2019, the patient was vaccinated with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot # R021370, expiration date: 07-NOV-2020, 0.5 milliliter (also reported as mgl)) (route of administration was not provided) to immunize her against hepatitis B. On the same day, the patient was vaccinated with diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (PEDIARIX) (dose, lot#, expiration date, route of administration were not provided). There was no adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1903USA010025: US-009507513-1903USA010026:
Documented in database that patient received Moderna booster, but patient did received Pfizer booster.
Employee states she woke 14 1/2 hrs later extremely dizzy, with double vision, difficulty to sit or walk. She had numbness (R) side of face and right arm. All symptoms subsided by that evening. Followed up with her PCP.
This spontaneous report as received from an unspecified reporter from an online article via company representative refers to an unspecified number of pediatric patients of unknown gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with zoster vaccine live (manufacturer unknown) (dose, route and site of administration were not reported) and varicella virus vaccine live (manufacturer unknown) (dose, route and site of administration were not reported), (also reported as varicella zoster virus vaccine or chickenpox and shingles vaccine). On unknown dates, patients experienced corneal inflammation. By studying case reports from national and international registries, unspecified number of pediatric patients (out of at least 20 cases which was found in both, children and adults) experienced keratitis within a month of administration of the chickenpox and shingles vaccine. Also, a review of a registry database and previously published reports found that for children symptoms of inflammation developed within 14 days of vaccination. The outcome of the adverse event was unknown. The article stated that a link was found between the zoster vaccine live (manufacturer unknown) and varicella virus vaccine live (manufacturer unknown) and corneal inflammation. Follow up information was received on 09-MAR-2016. A call was placed to physician in regards to article. Receptionist requested that all data requests should be submitting in writing. This is one of two reports received from the same reporter. Additional information has been requested.
Was due for dose number 3 of Pfizer series for 6mo-4yr. Dose should have been bivalent and was given a monovalent.
Patient called 4:30 pm 9-21-15 to ask about a facial numbness above lip and circling around cheek to chin which she said had started on Sunday afternoon around 5 pm.
Patient has sore arm. It has been 5 days since vaccination. Sore, redness, painful to touch.
Received 3 Shingrix doses; This non-serious case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) (batch number 429MK, expiry date 28-MAY-2024) for prophylaxis.   On 21-FEB-2023, the patient received the 3rd dose of Shingrix. On 21-FEB-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Received 3 Shingrix doses). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt date: 27-APR-2023 The reporter wanted to know that what should patient watch for if given three doses of Shigrix and not two.  The reporter did consent to follow up. The vaccine administration facility was same as primary reporter. The reporter also confirmed that the patient received 3rd dose of Shingrix. The reporter had only the gender information as the vaccine was administered at another facility. The reporter did consent to follow up via email. The patient received extra dose of Shigrix in error, which led to extra dose administered.
Site: Pain at Injection Site-Severe, Additional Details: Pt. contacted the pharmacy on 1/28/2023 to indicate that he and his wife have been experiencing pain the arm of their vaccine. He described his pain as paralyzing. He also said that it comes and goes but has been happening since vaccine administration. He has not seen a Dr as of this time.
Symptoms: shortness of breath, chest pain, peripheral cyanosis, lightheadedness, dizziness, increased heart rate with very minor activities (conversations, very light walking), mental confusion  Went to urgent care after my wife pointed out that I wasn't speaking coherently to her, which is when I noticed that I was short of breath and had chest pain. Urgent care believed I may have a cardiac issue from receiving the covid booster  Still having the same issues three weeks after the adverse event
TIRED; weak, no energy; very loose bowl movement with a lot of mucus; feels yucky; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (TIRED), ASTHENIA (weak, no energy), DIARRHOEA (very loose bowl movement with a lot of mucus) and MALAISE (feels yucky) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced FATIGUE (TIRED), ASTHENIA (weak, no energy), DIARRHOEA (very loose bowl movement with a lot of mucus) and MALAISE (feels yucky). At the time of the report, FATIGUE (TIRED), ASTHENIA (weak, no energy), DIARRHOEA (very loose bowl movement with a lot of mucus) and MALAISE (feels yucky) outcome was unknown.            no concomitant medication and treatment information provided
bell's palsy (paralyze of the left side of the face); This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (bell's palsy (paralyze of the left side of the face)) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced FACIAL PARALYSIS (bell's palsy (paralyze of the left side of the face)) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (bell's palsy (paralyze of the left side of the face)) had not resolved.      No relevant concomitant medications were reported.  The patient was treated with Valtrex (valaciclovir) and prednisone.  Action taken with mRNA-1273 in response to events was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event of facial paralysis, a causal relationship cannot be excluded.
Information has been received from a registered nurse concerning an 8-year-old male who on 29-SEP-2000 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot # 632616/1688J). On 14-NOV-2007, the patient developed breakthrough chickenpox. The patient had a rash on his legs, feet and trunk. No fever was noted. It was also reported the patient had 50 to 500 lesions and was diagnosed by his parents. The patient sought unspecified medical attention. On an unspecified date, the patient recovered. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Chills, fever , nauseous, sore arm, vomiting , nasal congestion, mild cough, headaches and body aches
Chills, convulsions, strong injection site pain, and strong body aches which were mild for about 1/2 day, then were very strong over the next day and 1/2.  By Day 3 the symptoms subsided, except the strong pain at injection site remained.
Extremely severe leg cramps.  Debilitating pain unable to walk. Two rounds first at 6 or 7 pm, second at 9 pm.  Both lasted for at least 45-minutes.  Now right calf is extremely tight and I?m unable to put weight on it.  I had metaxalone and took one 800 mg on Thursday night, Friday night; and tonight (Saturday).  Woke up this morning with severe pain in next muscle area and there?s a little swelling.  By the way, with the first and second injection no side effects.
Info has been received from a nurse practitioner concerning a 72 year old female with gastroesophageal reflux, fibromyalgia, lumbar stenosis and allergies to penicillin, sulfa, diazepam (VALIUM), cephalexin (KEFLEX), iodine, azithromycin (ZITHROMAX), levofloxacin (LEVAQUIN), rofecoxib (MSD) (see WAES #0303USA02245), and an unspecified therapy, and no illness at the time of vaccination who at 10:00 on 10/24/2002 was vaccinated with a 2nd dose of pneumococcal vaccine 23 polyvalent (lot 641116/1160L). Concomitant therapy included omeprazole (PRILOSEC). On 10/24/2002, the pt developed a red, swollen, painful arm and went to the ER. She was treated with warm compress to arm and elevation, acetaminophen (TYLENOL), and diphenhydramine (BENADRYL). The pt was given a prescription for unspecified steroids which she did not fill. The pt was seen by the nurse on day 2. On 10/28/2002, the pt recovered. The nurse indicted that she would like a lot check performed on lot 641116/1160L. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. No additional info is expected.
Headache & Palpitations Narrative:  EMPLOYEE HAD SECOND DOSE OF COVID VACCINE. AT 0945 PT COMPLAINED OF PALPATIONS AND HEADACHE. PT'S VITAL SIGNS WERE STABLE. PT STILL WAS COMPLAINING OF THE PALPATIONS, VITAL SIGNS TAKEN AGAIN AND STABLE. PT TAKEN TO ER VIA WHEELCHAIR BY RN. 0947 BP 133/82, 92HR, 100%, 0955 BP 131/78 HR 88, 100%
Patient presented to emergency department on 10/12/2021 with shortness of breath and lightheadedness.  He was found to be COVID-19 positive. He was previously admitted to observation unit from 10/2/21 to 10/5/21 following a fall and was given a loop recorder. He was treated with dexamethasone, baricitinib, remdesivir, and supplemental oxygen. His condition did improved during stay, but eventually decompensated.  He was placed on comfort care measures only on 10/20/21. Patient expired on 10/23/2021.
This spontaneous case, initially received from a pharmacist 29-Oct-2018 concerns a 54-year-old, adult, female patient. The patient had no relevant medical history. The patient's concomitant medications were unknown. On 24-Oct-2018, the patient (under age of 65 years) was administered FLUAD (TIV) [dose: 0.5 ml, anatomical location: deltoid, route of administration: intramuscular, batch number: 250798, expiry date: 31-May-2019] (explicitly coded as inappropriate age at vaccine administration). No adverse event was reported. The reporter assessed the event as non-serious. This case (201805056) was cross-linked to the source case number: 201805049 due to the same reporter.
Presented to Emergency Department with swelling and mild redness at site of vaccine administration. Swelling began within 24 hours of vaccine administration; redness developed 2 days after vaccine administration.  Also c/o back pain similar to shingles pain in the past (1.5 years ago).
3 hours post vax, the infant developed an "uncharacteristic" high - pitched crying episode for 30 minutes. The symptoms abated and has not reoccurred. No other symptoms such as fever. The child slept well after the episode and was her "usual self" upon awakening.
SPIKEVAX (COVID-19 Vaccine, mRNA) Moderna COVID?19 Vaccine EUA- Developed a skin rash all over body.  Severe rash, hives. Red blotchy spots, large welts, itchy tingly skin, fire burning sensation, constant irritation. Urgent care prescribed prednisone- after completion it did nothing. It did not lessen the rash, slow down, or stop it. Zyrtec and Benadryl taken daily- is not helping or slowing/stopping rash. Rash is continuing to worsen. Unbearable red welts and itching.
As I was admin the immunization in the Left arm the vaccine came out of the syringe and ran down the patient's arm. I retrieved a new vaccine and admin in the patient's right arm. Pt did not complain of any ill effect - but I had to give a second injection. I don't know if there was a defect in the pre-filled syringe or the needle.